e10vq
U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark one)
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Quarterly report pursuant to Section 13 or 15 (d) of the Securities Exchange Act of 1934 |
For the quarterly period ended June 28, 2008
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
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(I.R.S. Employer Identification No.) |
or organization) |
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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, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one):
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Large accelerated filer þ
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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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 July 26, 2008, the registrant had 54,648,929 shares of common stock outstanding.
THORATEC CORPORATION
TABLE OF CONTENTS
Thoratec, the Thoratec logo, Thoralon, TLC-II, HeartMate, and HeartMate II are registered
trademarks of Thoratec Corporation, and IVAD is a trademark of Thoratec Corporation.
CentriMag is a registered trademark of Levitronix LLC.
ITC, A-VOX Systems, AVOXimeter, HEMOCHRON, ProTime, Surgicutt, Tenderlett, Tenderfoot, and IRMA are
registered trademarks of International Technidyne Corporation, Thoratec Corporations wholly-owned
subsidiary.
2
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
THORATEC CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
(in thousands)
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June 28, |
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December 29, |
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2008 |
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2007 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
61,106 |
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$ |
20,689 |
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Short-term available-for-sale investments |
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135,018 |
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197,661 |
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Receivables, net of allowances of $647 and $861, respectively |
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55,710 |
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45,368 |
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Inventories |
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56,000 |
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54,935 |
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Short-term deferred tax assets |
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6,077 |
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6,077 |
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Prepaid expenses and other assets |
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7,613 |
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6,379 |
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Total current assets |
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321,524 |
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331,109 |
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Property, plant and equipment, net |
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46,035 |
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46,477 |
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Goodwill |
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98,368 |
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98,368 |
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Purchased intangible assets, net |
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115,175 |
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121,767 |
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Long-term deferred tax assets |
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2,112 |
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62 |
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Income tax receivable |
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2,800 |
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2,755 |
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Long-term available-for-sale investments |
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31,863 |
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Other assets |
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12,793 |
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13,181 |
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Total Assets |
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$ |
630,670 |
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$ |
613,719 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
9,536 |
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$ |
9,770 |
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Accrued compensation |
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15,666 |
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14,314 |
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Accrued income taxes |
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2,566 |
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Other accrued liabilities |
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9,125 |
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5,289 |
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Total current liabilities |
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36,893 |
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29,373 |
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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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33,485 |
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35,953 |
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Other |
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6,673 |
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6,614 |
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Total Liabilities |
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220,801 |
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215,690 |
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Shareholders equity: |
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Common shares: no par, authorized 100,000; issued and
outstanding 54,633 and 54,108 as of June 28, 2008 and
December 29, 2007, respectively |
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Additional paid-in capital |
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464,900 |
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458,383 |
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Accumulated deficit |
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(53,073 |
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(61,577 |
) |
Accumulated other comprehensive (loss) income: |
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Unrealized (loss) gain on investments |
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(2,838 |
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317 |
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Cumulative translation adjustments |
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880 |
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906 |
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Total accumulated other comprehensive (loss) income |
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(1,958 |
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1,223 |
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Total Shareholders Equity |
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409,869 |
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398,029 |
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Total Liabilities and Shareholders Equity |
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$ |
630,670 |
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$ |
613,719 |
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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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Six Months Ended |
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June 28, |
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June 30, |
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June 28, |
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June 30, |
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2008 |
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2007 |
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2008 |
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2007 |
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Product sales |
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$ |
82,648 |
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$ |
57,333 |
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$ |
147,075 |
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$ |
114,643 |
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Cost of product sales |
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31,825 |
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23,648 |
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60,415 |
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46,445 |
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Gross profit |
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50,823 |
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33,685 |
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86,660 |
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68,198 |
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Operating expenses: |
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Selling, general and administrative |
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23,857 |
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19,134 |
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44,493 |
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41,079 |
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Research and development |
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12,839 |
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10,767 |
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25,358 |
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21,660 |
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Amortization of purchased intangible assets |
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3,296 |
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3,143 |
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6,592 |
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6,296 |
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Total operating expenses |
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39,992 |
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33,044 |
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76,443 |
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69,035 |
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Income (loss) from operations |
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10,831 |
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641 |
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10,217 |
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(837 |
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Other income and (expense): |
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Interest expense |
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(1,131 |
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(1,074 |
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(2,021 |
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(2,142 |
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Interest income and other |
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2,281 |
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1,766 |
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4,459 |
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3,953 |
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Income before income taxes |
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11,981 |
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1,333 |
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12,655 |
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974 |
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Income tax (expense) benefit |
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(3,330 |
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(80 |
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(3,655 |
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4 |
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Net income |
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$ |
8,651 |
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$ |
1,253 |
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$ |
9,000 |
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$ |
978 |
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Net income per share: |
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Basic |
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$ |
0.16 |
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$ |
0.02 |
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$ |
0.17 |
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$ |
0.02 |
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Diluted |
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$ |
0.15 |
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$ |
0.02 |
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$ |
0.16 |
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$ |
0.02 |
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Shares used to compute net income per share: |
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Basic |
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54,556 |
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53,370 |
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54,389 |
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53,055 |
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Diluted |
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62,624 |
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54,728 |
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62,396 |
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54,421 |
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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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Six Months Ended |
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June 28, |
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June 30, |
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2008 |
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2007 |
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Cash flows from operating activities: |
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Net income |
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$ |
9,000 |
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$ |
978 |
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Adjustments to reconcile net income to net cash provided by (used in) operating activities: |
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Depreciation and amortization |
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11,565 |
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10,755 |
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Investment premium amortization (net) |
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634 |
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369 |
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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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165 |
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542 |
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Tax benefit related to stock options |
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1,961 |
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Share-based compensation expense |
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5,493 |
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6,231 |
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Excess tax benefits from share-based compensation |
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(68 |
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(1,147 |
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Loss on disposal of assets |
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384 |
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50 |
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Change in net deferred tax liability |
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(2,412 |
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(925 |
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Changes in assets and liabilities: |
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Receivables |
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(11,028 |
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538 |
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Inventories |
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(2,950 |
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(10,094 |
) |
Prepaid expenses and other assets |
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(793 |
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(1,240 |
) |
Accounts payable and other liabilities |
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4,933 |
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(5,172 |
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Accrued income taxes, net |
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3,045 |
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(4,137 |
) |
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Net cash provided by (used in) operating activities |
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17,968 |
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(1,076 |
) |
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Cash flows from investing activities: |
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Purchases of available-for-sale investments |
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(98,548 |
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(202,283 |
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Sales of available-for-sale investments |
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78,670 |
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144,375 |
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Maturities of available-for-sale investments and restricted investments |
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44,765 |
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1,712 |
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Purchases of property, plant and equipment |
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(3,251 |
) |
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(3,408 |
) |
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Net cash provided by (used in) investing activities |
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21,636 |
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(59,604 |
) |
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Cash flows from financing activities: |
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Excess income tax deficit on stock options exercises |
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(111 |
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Proceeds from stock option exercises |
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871 |
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8,612 |
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Proceeds from stock issued under employee stock purchase plan |
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1,050 |
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1,084 |
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Excess tax benefits from share-based compensation |
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68 |
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1,147 |
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Repurchase and retirement of common shares |
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(1,092 |
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(775 |
) |
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Net cash provided by financing activities |
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786 |
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10,068 |
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Effect of exchange rate changes on cash and cash equivalents |
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27 |
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48 |
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Net increase (decrease) in cash and cash equivalents |
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40,417 |
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(50,564 |
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Cash and cash equivalents at beginning of period |
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20,689 |
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67,453 |
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Cash and cash equivalents at end of period |
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$ |
61,106 |
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$ |
16,889 |
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Supplemental disclosure of cash flow information: |
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Cash paid for taxes |
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$ |
3,507 |
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$ |
3,600 |
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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 to property, plant and equipment |
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$ |
1,685 |
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$ |
1,977 |
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See notes to condensed consolidated financial statements.
5
THORATEC CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(unaudited)
(in thousands)
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Three Months Ended |
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Six Months Ended |
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June 28, |
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June 30, |
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June 28, |
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June 30, |
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2008 |
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2007 |
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2008 |
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2007 |
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Net income |
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$ |
8,651 |
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$ |
1,253 |
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$ |
9,000 |
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$ |
978 |
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Other net comprehensive income (loss): |
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Unrealized loss on investments (net of
taxes of $269 and $55 for the three
months ended and $2,103 and $55 for the
six months ended June 28, 2008 and June
30, 2007, respectively) |
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(403 |
) |
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(83 |
) |
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(3,155 |
) |
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(82 |
) |
Foreign currency translation adjustments |
|
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(194 |
) |
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|
225 |
|
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|
(26 |
) |
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|
240 |
|
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Comprehensive income |
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$ |
8,054 |
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$ |
1,395 |
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$ |
5,819 |
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$ |
1,136 |
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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 2007 consolidated financial statements,
and the accompanying notes thereto, filed with the SEC in our Annual Report on Form 10-K (the 2007
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. Fair Value Measurement
We adopted Statement of Financial Accounting Standards (SFAS) No. 157, Fair Value
Measurements, as of December 30, 2007 to measure the fair value of certain of our financial assets
and financial liabilities required to be measured on a recurring basis. Under SFAS No. 157, based
on the observability of the inputs used in the valuation of such assets and liabilities, we are
required to provide the fair value according to the fair value hierarchy. The fair value hierarchy
ranks the quality and reliability of the information used to determine fair values. Financial
assets and liabilities carried at fair value will be classified and disclosed in one of the
following three categories:
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Level 1: |
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Quoted prices (unadjusted) in active markets for identical assets or liabilities. |
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Level 2: |
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Directly or indirectly observable market based inputs used in models or other
valuation methodologies. |
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Level 3: |
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Unobservable inputs that are not corroborated by market data which require
significant management judgment or estimation. |
7
The following table represents the fair value hierarchy for our financial assets and financial
liabilities measured at fair value on a recurring basis:
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As of June 28, 2008 |
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Significant |
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Quoted prices in |
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other |
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Significant |
|
|
|
|
|
|
|
active markets for |
|
|
observable |
|
|
unobservable |
|
|
|
|
|
|
|
identical assets |
|
|
inputs |
|
|
inputs |
|
|
|
Total |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
|
(in thousands) |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
61,106 |
|
|
$ |
61,106 |
|
|
$ |
|
|
|
$ |
|
|
Short term investments municipal bonds |
|
|
135,018 |
|
|
|
|
|
|
|
135,018 |
|
|
|
|
|
Long term investments auction rate securities |
|
|
31,863 |
|
|
|
|
|
|
|
|
|
|
|
31,863 |
|
Convertible debenture (fair value for purposes of disclosure in Note 9) |
|
|
5,000 |
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
232,987 |
|
|
$ |
61,106 |
|
|
$ |
135,018 |
|
|
$ |
36,863 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mark to market on financial instruments (fair value for purposes of
disclosure in Note 6) |
|
$ |
58 |
|
|
$ |
|
|
|
$ |
58 |
|
|
$ |
|
|
Make-whole provision (fair value for purposes of disclosure in Note 11) |
|
|
153 |
|
|
|
|
|
|
|
|
|
|
|
153 |
|
Senior subordinated convertible notes (fair value for purposes of
disclosure in note 11) |
|
|
156,201 |
|
|
|
156,201 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
156,412 |
|
|
$ |
156,201 |
|
|
$ |
58 |
|
|
$ |
153 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets measured at fair value, on a recurring basis using significant unobservable Level 3
inputs consist of securities with an auction reset feature (auction rate securities) whose
underlying assets are student loans issued by various tax-exempt state agencies, most of which are
supported by federal government guarantees. In addition, we are using significant unobservable
Level 3 inputs for our disclosure of the fair value of our convertible debenture.
The following table provides a reconciliation of the beginning and ending balances for the
assets and liabilities measured at fair value using significant unobservable inputs (level 3):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurement Using Significant |
|
|
|
Unobservable Inputs (Level 3) |
|
|
|
Auction Rate |
|
|
Other Long |
|
|
Other Long |
|
|
|
Securities |
|
|
Term Assets |
|
|
Term Liabilities |
|
|
|
(in thousands) |
|
Balance at December 29, 2007 |
|
$ |
|
|
|
$ |
5,000 |
|
|
$ |
96 |
|
Transfer to Level 3 |
|
|
46,050 |
|
|
|
|
|
|
|
|
|
Settlements at par |
|
|
(8,850 |
) |
|
|
|
|
|
|
|
|
Realized
holding loss, included in interest income and other |
|
|
|
|
|
|
|
|
|
|
116 |
|
Unrealized holding loss, included in other comprehensive loss |
|
|
(5,049 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 29, 2008 |
|
$ |
32,151 |
|
|
$ |
5,000 |
|
|
$ |
212 |
|
|
|
|
|
|
|
|
|
|
|
Realized
holding gain, included in interest income and other |
|
|
|
|
|
|
|
|
|
|
(59 |
) |
Unrealized holding loss, included in other comprehensive loss |
|
|
(288 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 29, 2008 |
|
$ |
31,863 |
|
|
$ |
5,000 |
|
|
$ |
153 |
|
|
|
|
|
|
|
|
|
|
|
Given the complexity of our investments in auction rate securities, we estimated the fair
value of these auction rate securities based on the following: (i) the underlying structure of each
security; (ii) the present value of future principal and interest payments discounted at rates
considered to reflect current market conditions; (iii) consideration of the probabilities of
default, auction failure, or repurchase at par for each period; and (iv) estimates of the recovery
rates in the event of default for each security. These estimated fair values could change
significantly based on future market conditions.
8
3. Investments in Available-for-Sale Securities
Our investment portfolio is comprised of short-term and long-term investments. Investments
classified as short-term available-for-sale consist primarily of corporate and municipal bonds, and
United States government obligations with callable bond features. Investments classified as
long-term available-for-sale consist primarily of auction rate securities, whose underlying assets
are student loans.
Our investments in available-for-sale securities are recorded at estimated fair value on our
financial statements, and the temporary differences between cost and estimated fair value are
presented as a separate component of accumulated other comprehensive income.
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
June 28, |
|
|
December 29, |
|
|
|
2008 |
|
|
2007 |
|
|
|
(in thousands) |
|
Short-term investments |
|
|
|
|
|
|
|
|
Unrealized gains on corporate and
municipal bonds (before taxes) |
|
$ |
782 |
|
|
$ |
517 |
|
Unrealized loss on corporate and municipal
bonds (before taxes) |
|
|
(189 |
) |
|
|
|
|
Long-term investments |
|
|
|
|
|
|
|
|
Unrealized loss on auction rate securities
(before taxes) |
|
|
(5,337 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gain (loss) (before taxes) |
|
$ |
(4,744 |
) |
|
$ |
517 |
|
|
|
|
|
|
|
|
The specific identification method is used to determine realized gains and losses on
investments.
As of June 28, 2008, we owned approximately $37.2 million of auction rate securities that are
marketed by financial institutions and structured to periodically reset through auctions ranging
from 7 to 35 days. The underlying collateral of the auction rate securities consists of student
loans. Beginning in February of 2008, these auctions began to fail. As a result, we will not be
able to access these funds until future auctions for these securities are successful, until a
secondary market is established, or until these securities are called for redemption. As such, our
auction rate securities are classified as long-term and are valued at $31.9 million.
We intend and have the ability to hold these auction rate securities until the market recovers
or until maturity. We do not anticipate having to sell these securities in order to operate our
business. We believe that, based on our current unrestricted cash, cash equivalents and short- term
available for-sale securities with an aggregate value of $196.1 million at June 28, 2008, the
current lack of liquidity in the credit and capital markets will not have an impact on our
liquidity, our cash flow or our ability to fund our operations. If the issuers of the auction rate
securities are unable to successfully complete future auctions and their credit ratings
deteriorate, we may in the future be required to record an impairment charge on these investments.
It could conceivably take until the final maturity of the underlying notes (up to 30 years) to
realize our investments recorded value.
4. Recently Issued Accounting Pronouncements
In
June 2008, the Financial Accounting Standards Board
(FASB) Issued Financial Statement Position (FSP) Emerging Issues
Task Force (EITF) 03-6-1, Determining Whether Instruments Granted in Share-Based Payment
Transactions Are Participating Securities. FSP EITF 03-6-1 clarified that all outstanding unvested
share-based payment awards that contain rights to non-forfeitable dividends participate in
undistributed earnings with common shareholders. Awards of this nature are considered
participating securities and the two-class method of computing basic and diluted earnings per share
must be applied. FSP EITF 03-6-1 is effective for financial statements issued for fiscal years and
interim periods beginning after December 15, 2008. We are currently evaluating the accounting
impact and disclosure requirements that this guidance will have on our consolidated results of
operations or financial condition when we adopt FSP EITF 03-6-1 at the beginning of our fiscal year
2009.
9
In
May 2008, the FASB issued FSP Accounting Principles Board (APB) 14-1, Accounting For
Convertible Debt Instruments That May Be Settled in Cash Upon Conversion (Including Partial Cash
Settlement) that alters the accounting treatment for convertible debt instruments that allow for either mandatory or optional cash settlements. FSP APB 14-1,
will impact the accounting associated with our senior subordinated convertible notes recorded at a
book value of $143.5 million. FSP APB 14-1 will require us to recognize additional (non-cash)
interest expense based on the market rate for similar debt instruments without the conversion
feature. Furthermore, it will require recognizing interest expense in prior periods pursuant to the
required retrospective accounting treatment upon adoption. The FSP will be effective for fiscal
years beginning after December 15, 2008. We are currently evaluating the accounting impact and
disclosure requirements that this guidance will have on our consolidated results of operations or
financial conditions when we adopt FSP APB 14-1 at the beginning of our fiscal year 2009.
In May 2008, the FASB issued SFAS No. 162, Hierarchy of Generally Accepted Accounting
Principles. SFAS No. 162 identifies the source of accounting principles and the framework for
selecting the principles used in the preparation of financial statements. SFAS No. 162 is effective
60 days following the SECs approval of the Public Company Accounting Oversight Board amendments to
AU Section 411, The Meaning of Present Fairly in Conformity with Generally Accepted Accounting
Principles. The implementation of this standard will not have a material impact to our
consolidated financial position and results of operations.
In
April 2008, the FASB issued FSP No. 142-3, Determination
of the Useful Life of Intangible Assets. FSP No. 142-3
amends the factors that should be considered in developing renewal or extension assumptions used to
determine the useful life of a recognized intangible asset under SFAS No. 142,
Goodwill and Other Intangible Assets. FSP No. 142-3 is effective for financial statements issued for fiscal years and
interim periods beginning after December 15, 2008. We are currently evaluating the accounting
impact and disclosure requirements that this guidance will have on our consolidated results of
operations or financial conditions when we adopt FSP No. 142-3 at the beginning of our fiscal year
2009.
In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and
Hedging Activities, which is intended to help investors better understand how derivative
instruments and hedging activities affect an entitys financial position, financial performance and
cash flows through enhanced disclosure requirements. The main requirement is to disclose the
objectives and strategies for using derivative instruments by their underlying risk as well as a
tabular format of the fair values of the derivative instruments and their gains and losses. SFAS
No. 161 is effective for financial statements issued for fiscal years and interim periods beginning
after November 15, 2008. We are currently evaluating the impact this pronouncement will have on our
disclosure requirement for our derivatives at the beginning of our fiscal year 2009.
In February 2008, the FASB issued SFAS No. 157-2,
Effective Date of FASB Statement No. 157.
With the issuance of SFAS No. 157-2, the FASB agreed to: (a) defer the effective date of SFAS No.
157 for one year for certain nonfinancial assets and nonfinancial liabilities, except those that
are recognized or disclosed at fair value in the financial statements on a recurring basis (at
least annually), and (b) remove certain leasing transactions from the scope of SFAS No. 157. The
deferral is intended to provide the FASB time to consider the effect of certain implementation
issues that have arisen from the application of SFAS No. 157 for nonfinancial assets and nonfinancial liabilities. We are
currently evaluating the additional accounting and disclosure requirements that we will be required
to provide following the expiration of the deferral period.
In December 2007, the FASB issued SFAS No. 141R, Business Combinations, which requires the
acquiring entity in a business combination to record all assets acquired and liabilities assumed at
their respective acquisition-date fair values, changes the recognition of assets acquired and
liabilities assumed arising from contingencies, changes the recognition and measurement of
contingent consideration, and requires the expensing of acquisition-related costs as incurred. SFAS
No. 141R also requires additional disclosure of information surrounding a business combination,
such that users of the entitys financial statements can fully understand the nature and financial
impact of the business combination. The provisions of SFAS No. 141R will only impact us if we are a
party to a business combination after our fiscal year 2008.
5. Cash and cash equivalents
Cash and cash equivalents are defined as short-term, highly liquid investments with original
maturities of 90 days or less at the purchase date.
10
6. Financial Instruments
We
conduct business in foreign countries. Our international operations consist primarily of
sales and service personnel for our ventricular assist products who report to our U.S.
sales and marketing group and are internally reported as part of that group. All assets and
liabilities of our non-U.S. operations are translated into U.S. dollars at the period-end exchange
rates and the resulting translation adjustments are included in other comprehensive income. The
period-end translation of the non-functional currency assets and liabilities (primarily assets and
liabilities on our UK subsidiarys condensed consolidated balance sheet that are not denominated in
UK pounds) 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 condensed consolidated balance sheet that are not denominated in UK pounds).
Our contracts typically have maturities of three months or less.
Our financial instrument contracts qualify as derivatives under SFAS No. 133,
Accounting for Derivative Instruments and Hedging Activities, and we valued
these contracts at the estimated fair value at June 28, 2008. 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 |
|
|
Six Months Ended |
|
|
|
June 28, 2008 |
|
|
June 30, 2007 |
|
|
June 28, 2008 |
|
|
June 30, 2007 |
|
|
|
|
|
|
|
( in thousands) |
|
|
|
|
|
Foreign currency
exchange gain
(loss) on foreign
currency contracts |
|
$ |
(107 |
) |
|
$ |
41 |
|
|
$ |
(1,147 |
) |
|
$ |
(42 |
) |
Foreign currency
exchange gain
(loss) on foreign
translation
adjustments |
|
|
122 |
|
|
|
(54 |
) |
|
|
1,230 |
|
|
|
2 |
|
As of June 28, 2008, we had forward contracts to sell euros with a notional value of 7.1
million and to purchase UK pounds with a notional value of £5.0 million, and as of June 30, 2007 we
had forward contracts to sell euros with a notional value of 5.4 million and to purchase UK
pounds with a notional value of £3.0 million. As of June 28, 2008, our forward contracts had an
average exchange rate of one U.S. dollar to 0.6455 euros and one U.S. dollar to 0.5036 UK pounds.
The forward contracts are valued based on exchange rates derived from an independent source of
market participant assumptions and compiled from the best information available. As of June 28,
2008, the estimated fair of value of these foreign currency contracts were $0.1 million.
7. Inventories
Inventories consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
June 28, |
|
|
December 29, |
|
|
|
2008 |
|
|
2007 |
|
|
|
(in thousands) |
|
Finished goods |
|
$ |
21,198 |
|
|
$ |
20,732 |
|
Work in process |
|
|
13,613 |
|
|
|
10,053 |
|
Raw materials |
|
|
21,189 |
|
|
|
24,150 |
|
|
|
|
|
|
|
|
Total |
|
$ |
56,000 |
|
|
$ |
54,935 |
|
|
|
|
|
|
|
|
11
8. Property, Plant and Equipment, net
Property, plant and equipment, net, consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
June 28, |
|
|
December 29, |
|
|
|
2008 |
|
|
2007 |
|
|
|
(in thousands) |
|
Land, building and improvements |
|
$ |
16,135 |
|
|
$ |
16,135 |
|
Equipment and capitalized software |
|
|
66,014 |
|
|
|
61,886 |
|
Furniture and leasehold improvements |
|
|
22,764 |
|
|
|
22,804 |
|
|
|
|
|
|
|
|
Total |
|
|
104,913 |
|
|
|
100,825 |
|
Less accumulated depreciation |
|
|
(58,878 |
) |
|
|
(54,348 |
) |
|
|
|
|
|
|
|
|
|
$ |
46,035 |
|
|
$ |
46,477 |
|
|
|
|
|
|
|
|
Depreciation expense for the three months ended June 28, 2008 and June 30, 2007 was $2.6
million and $2.4 million, respectively and for the six months ended June 28, 2008 and June 30, 2007
was $5.0 million and $4.5 million, respectively.
9. Other Assets
On August 23, 2006, we purchased a $5.0 million convertible debenture from Levitronix LLC
(Levitronix), a company with which we have a distribution arrangement to sell Levitronix
products. The convertible debenture is a long-term note receivable with an annual interest rate of
5.7%, to be accrued monthly and at the option of Levitronix, paid in cash or in-kind semi-annually
on February 23rd and August 23rd until its maturity on August 23, 2013. We may convert the
debenture at any time at our option into membership interests of Levitronix at a conversion price
of $4.2857, which may be adjusted as a result of certain corporate events. This conversion feature
is not an embedded derivative under SFAS No. 133 because the membership interests of the issuer are
not readily convertible to cash. If we had converted the debenture as of June 28, 2008, our
ownership in Levitronix would have been less than 5%.
The $5.0 million outstanding principal amount of the Levitronix convertible debenture plus
accrued but unpaid interest of $0.5 million thereon, is included in Other assets on our condensed
consolidated balance sheet. As of June 28, 2008, the fair value of the convertible debenture, based
on a discounted cash flows valuation approach using significant unobservable inputs, was
approximately $5.0 million.
12
10. Goodwill and Purchased Intangible Assets
The carrying amount of goodwill was $98.4 million as of June 28, 2008 and December 30, 2007,
$94.1 million of which is attributable to our Cardiovascular division and $4.3 million of which is
attributable to International Technidyne Corporations (ITC) acquisition of the outstanding
common shares of privately held A-VOX Systems, Inc. (Avox).
In February 2001, we merged with Thermo Cardiosystems, Inc. (TCA). Prior to the merger with
TCA (the Merger), TCA was a subsidiary of Thermo Electron Corporation (TCI). The components of
identifiable intangible assets related to the Merger include: patents and trademarks, core
technology (Thoralon, our proprietary bio-material), and developed technology (patent technology,
other than core technology, acquired in the Merger). The components of intangible assets related to
the October 2006 Avox acquisition include: patents and trademarks, developed technology and
customer and distributor relationships and other. The combined components are included in purchased
intangibles on the condensed consolidated balance sheets as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 28, 2008 |
|
|
|
Gross |
|
|
|
|
|
|
Net |
|
|
|
Carrying |
|
|
Accumulated |
|
|
Carrying |
|
|
|
Amount |
|
|
Amortization |
|
|
Amount |
|
|
|
(in thousands) |
|
Patents and trademarks |
|
$ |
38,515 |
|
|
$ |
(26,945 |
) |
|
$ |
11,570 |
|
Core technology |
|
|
37,485 |
|
|
|
(12,779 |
) |
|
|
24,706 |
|
Developed technology |
|
|
125,742 |
|
|
|
(47,422 |
) |
|
|
78,320 |
|
Customer and distributor relationships and other |
|
|
897 |
|
|
|
(318 |
) |
|
|
579 |
|
|
|
|
|
|
|
|
|
|
|
Total purchased intangible assets |
|
$ |
202,639 |
|
|
$ |
(87,464 |
) |
|
$ |
115,175 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 29, 2007 |
|
|
|
Gross |
|
|
|
|
|
|
Net |
|
|
|
Carrying |
|
|
Accumulated |
|
|
Carrying |
|
|
|
Amount |
|
|
Amortization |
|
|
Amount |
|
|
|
(in thousands) |
|
Patents and trademarks |
|
$ |
38,515 |
|
|
$ |
(25,086 |
) |
|
$ |
13,429 |
|
Core technology |
|
|
37,485 |
|
|
|
(11,793 |
) |
|
|
25,692 |
|
Developed technology |
|
|
125,742 |
|
|
|
(43,748 |
) |
|
|
81,994 |
|
Customer and distributor relationships and other |
|
|
897 |
|
|
|
(245 |
) |
|
|
652 |
|
|
|
|
|
|
|
|
|
|
|
Total purchased intangible assets |
|
$ |
202,639 |
|
|
$ |
(80,872 |
) |
|
$ |
121,767 |
|
|
|
|
|
|
|
|
|
|
|
Amortization expense related to purchased intangible assets was $3.3 million and $3.1 million
for the three months ended June 28, 2008 and June 30, 2007, respectively, and $6.6 million and $6.3
million for the six months ended June 28, 2008 and June 30, 2007, respectively. Our amortization
expense is expected to be approximately $13.2 million in 2008, declining to $9.1 million by 2012.
This decline in amortization expense is because of certain intangibles which will be fully
amortized in 2009 and 2010. Patents and trademarks have useful lives ranging from one to thirteen
years, core and developed technology assets have useful lives ranging from three to sixteen years
and customer and distributor relationships and other have useful lives ranging five to ten years.
Further, the adoption of FSP No. 142-3 may impact the useful life of our purchased intangible
assets and the related amortization expense from our fiscal year beginning in 2009.
13
11. Long-Term Debt
In 2004, we completed the sale of $143.8 million initial principal amount of senior
subordinated convertible notes due in 2034. The convertible notes were sold to Qualified
Institutional Buyers pursuant to the exemption from the registration requirements of the Securities
Act of 1933, as amended, provided by Rule 144A thereunder. A portion of the proceeds were used to
repurchase 4.2 million shares of our outstanding common stock for $60 million. The balance of the
proceeds has been and will be used for general corporate purposes, which may include additional
stock repurchases, strategic investments or acquisitions. Principal amount of the convertible notes
at maturity is $247.4 million offset by the original issue discount of $103.7 million and net debt
issuance costs of $4.3 million equaling net proceeds of $139.4 million.
The senior subordinated convertible notes were issued at an issue price of $580.98 per note,
which is 58.098% of the principal amount at maturity of the notes. The 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 16 and November 16 of each year, from November 16,
2004 until May 16, 2011. Beginning on May 16, 2011, the original issue discount will accrue daily
at a rate of 2.375% per year on a semi-annual bond equivalent basis and, on the maturity date, a
holder will receive $1,000 per note. As a result, the aggregate principal amount of the notes at
maturity will be $247.4 million.
The deferred debt issuance costs of $1.8 million, $4.3 million net of $2.5 million in
amortization, are included in Other assets on the condensed consolidated balance sheet as of June
28, 2008. The deferred debt issuance costs are amortized on a straight line basis until May 2011 at
which point the Company can redeem the debt. These charges are included in Interest expense on
our condensed consolidated statements of operations.
Holders of the senior subordinated convertible notes may convert their convertible notes into
shares of our common stock at a conversion rate of 29.4652 shares per $1,000 principal amount of
senior subordinated convertible notes, which represents a conversion price of $19.72 per share,
subject to adjustments upon the occurrence of certain events. Holders have been and are able to
convert their convertible notes at any point after the close of business on September 30, 2004 if,
as of the last day of the preceding 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 June 28, 2008, 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, $0.2 million at June 28, 2008. There are significant variables and assumptions used in
valuing the make-whole provision including, but not limited to, the Companys stock price,
volatility of the Companys stock, the probability of our being acquired and the probability of the
type of consideration used by a potential acquirer.
We may redeem either 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, either in whole or
in part at a redemption price equal to the sum of the issue price and the accrued original issue
discount.
14
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 June 28, 2008, based
on quoted market prices in active markets, was $156.2 million.
12. Share-Based Compensation
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. SFAS No. 123(R), Share-Based
Payments, requires forfeitures to be estimated at the time of grant and revised, if necessary, in
subsequent periods if actual forfeitures differ from those estimates.
Share-based compensation included in the condensed consolidated statement of operations
consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 28, |
|
|
June 30, |
|
|
June 28, |
|
|
June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
|
(in thousands) |
|
Cost of product sales |
|
$ |
574 |
|
|
$ |
381 |
|
|
$ |
913 |
|
|
$ |
738 |
|
Selling, general and administrative |
|
|
1,562 |
|
|
|
1,757 |
|
|
|
3,236 |
|
|
|
4,105 |
|
Research and development |
|
|
596 |
|
|
|
591 |
|
|
|
1,343 |
|
|
|
1,389 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
2,732 |
|
|
$ |
2,729 |
|
|
$ |
5,492 |
|
|
$ |
6,232 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense of $0.5 million and $0.7 million, respectively, was
capitalized to inventory as of June 28, 2008 and June 30, 2007, respectively.
We
receive a tax deduction for certain stock option exercises during the period the options
are exercised, generally for the excess of the fair market value of the options at the date of
exercise over the exercise prices of the options. Prior to the adoption of SFAS No. 123(R), we reported all tax benefits resulting from the exercise of stock options as
operating cash flows in our condensed consolidated statements of cash flows. In accordance with
SFAS No. 123(R), our condensed consolidated statements of cash flows presentation reports the
excess tax benefits from the exercise of stock options as financing cash flows of approximately
$68,000 and $1.1 million for the six months ended June 28, 2008 and June 30, 2007, respectively,
rather than operating cash flows.
Cash proceeds from the exercise of stock options were $0.9 million and cash proceeds from our
employee stock purchase plan were $1.1 million for the six months ended June 28, 2008. Cash
proceeds from the exercise of stock options were $8.6 million and cash proceeds from our employee
stock purchase plan were $1.1 million for the six months ended June 30, 2007.
Equity Plan
In April 2006, the Board of Directors approved the 2006 Incentive Stock Plan (2006 Plan), in
May 2006 the 2006 Plan was amended by the Board of Directors and approved by our shareholders and
in May 2008 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 5.4 million shares of stock. Each share issued from and after May 20, 2008 as
restricted stock bonuses, restricted stock units, phantom stock units, performance share bonuses,
or performance share units reduces the number of shares available for issuance under the 2006 Plan
by one and seventy-four hundredths (1.74) shares, and each share issued as stock options,
restricted stock purchases or stock appreciation rights reduces the shares available for issuance
under the 2006 Plan on a share-for-share basis. During the six months ended June 28, 2008, 379,880
options were granted under the 2006 Plan at an exercise price equal to the fair market value on the
date of grant, and 481,460 shares of restricted stock and restricted stock units were granted under
the 2006 Plan. At June 28, 2008, 3.2 million shares remained available for grant under the 2006
Plan.
15
Stock Options
Upon approval in May 2006, the 2006 Plan replaced our previous common stock option plans and
equity incentive plans. At June 28, 2008 we had options outstanding under the 2006 Plan and the
replaced plans. Options under the 2006 Plan may be granted by the Board of Directors at the fair
market value on the date of grant and generally become fully exercisable within four years after
the grant date and expire between five and ten years from the date of grant. Vesting on options
granted to officers will be accelerated in certain circumstances following a change in control of
the Company.
The fair value of each option is estimated at the date of grant using the Black-Scholes option
pricing model with the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 28, 2008 |
|
June 30, 2007 |
|
June 28, 2008 |
|
June 30, 2007 |
Risk-free interest rate (weighted average) |
|
|
3.10 |
% |
|
|
4.73 |
% |
|
|
3.25 |
% |
|
|
4.81 |
% |
Expected volatility |
|
|
40 |
% |
|
|
40 |
% |
|
|
40 |
% |
|
|
40 |
% |
Expected option term (years) |
|
|
5.09 to 6.07 |
|
|
|
5.02 to 6.06 |
|
|
|
5.09 to 6.07 |
|
|
|
5.08 to 6.06 |
|
Dividends |
|
None |
|
|
None |
|
|
None |
|
|
None |
The risk-free interest rate is based on the United States Treasury yield curve in effect at
the time of grant. The expected term of options represents the period of time that options are
expected to be outstanding. We use separate assumptions for groups of employees (for example,
officers) that have similar historical exercise behavior. The range above reflects the expected
option impact of these separate groups.
At June 28, 2008, there was $5.2 million of unrecognized compensation expense related to stock
options. The aggregate intrinsic value of in-the-money options outstanding was $18.8 million, based
on the closing price of the Companys common stock on June 27, 2008, the last trading day in the
six months ended June 28, 2008, of $17.62, and the aggregate intrinsic value of options exercisable
was $17.1 million. The intrinsic value of options exercised was $0.4 million for the six months
ended June 28, 2008. The fair value of the options granted during the six months ended June 28,
2008 was $2.4 million.
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 29, 2007 |
|
|
5,748 |
|
|
$ |
15.46 |
|
|
|
6.19 |
|
Granted |
|
|
380 |
|
|
|
14.97 |
|
|
|
|
|
Exercised |
|
|
(78 |
) |
|
|
11.58 |
|
|
|
|
|
Forfeited or expired |
|
|
(79 |
) |
|
|
18.81 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding options at June 28, 2008 |
|
|
5,971 |
|
|
$ |
15.43 |
|
|
|
5.97 |
|
|
|
|
|
|
|
|
|
|
|
Outstanding options exercisable at June 28, 2008 |
|
|
4,353 |
|
|
$ |
14.40 |
|
|
|
5.08 |
|
|
|
|
|
|
|
|
|
|
|
Outstanding
options vested at June 28, 2008 and expected to vest |
|
|
5,766 |
|
|
$ |
15.35 |
|
|
|
5.87 |
|
|
|
|
|
|
|
|
|
|
|
16
Restricted Stock
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.
Share-based compensation expense related to these restricted stock grants was $2.5 million for
the six months ended June 28, 2008. As of June 28, 2008, we had $12.4 million of unrecognized
compensation expense related to these restricted stock awards, which amount we expect to recognize
over 2.99 years. The total fair value of the shares granted during the six months ended June 28,
2008 was $7.0 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 29, 2007 |
|
|
768 |
|
|
$ |
18.29 |
|
Granted |
|
|
467 |
|
|
|
15.02 |
|
Vested |
|
|
(196 |
) |
|
|
18.20 |
|
Forfeited or expired |
|
|
(33 |
) |
|
|
18.38 |
|
|
|
|
|
|
|
|
Outstanding unvested restricted stock at June 28, 2008 |
|
|
1,006 |
|
|
$ |
16.79 |
|
|
|
|
|
|
|
|
Restricted Stock Units
In the first six months of 2008, we granted restricted stock units to certain of our non-U.S.
employees under the 2006 Plan. As of June 28, 2008, we had $0.3 million of unrecognized
compensation expense related to these restricted stock units. The aggregate intrinsic value of the
units outstanding, based on the Companys stock price on June 28, 2008, was $0.5 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 29, 2007 |
|
|
21 |
|
|
$ |
18.58 |
|
|
|
2.82 |
|
Granted |
|
|
14 |
|
|
|
14.84 |
|
|
|
|
|
Released |
|
|
(6 |
) |
|
|
18.61 |
|
|
|
|
|
Forfeited or expired |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding units at June 28, 2008 |
|
|
29 |
|
|
$ |
16.74 |
|
|
|
2.97 |
|
|
|
|
|
|
|
|
|
|
|
17
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 was 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 each of March 1, 2006 and March 1, 2008; our Board of
Directors specified no increase as of March 1, 2007. Eligible employees may purchase over six month
periods, a limited number of shares of the Companys common stock at 85% of the lower of the market
value on the offering date (the first day of the six month period) or the market value on the
purchase date (the last date of the six month period). During the six months ended June 28, 2008,
approximately 64,900 shares of common stock were issued under the ESPP. As of June 28, 2008,
approximately 169,400 shares remained available for issuance under this plan.
The estimated subscription date fair value of the current offering under the ESPP is
approximately $0.3 million using the Black-Scholes option pricing model and the following
assumptions:
|
|
|
|
|
Risk-free interest rate |
|
|
1.73 |
% |
Expected volatility |
|
|
40 |
% |
Expected option life |
|
0.50 years |
|
Dividends |
|
None |
|
As of June 28, 2008, there was approximately $0.2 million of unrecognized compensation expense
related to ESPP subscriptions that began on May 1, 2008, which amount we expect to recognize during
the fourth quarter of 2008.
13. Income Taxes
Our effective income tax rates were 28% and 6%, for the three months ended June 28, 2008 and
June 30, 2007, respectively. Our effective income tax rates were an expense of 29% and a benefit
of 0.4%, for the six months ended June 28, 2008 and June 30, 2007, respectively.
The tax years 2004 through 2007 remain subject to audit by certain jurisdictions in which we
are subject to taxation, with the exception of California and New Jersey, which remain subject to
audit from 2003 to 2007, and the UK, which remains subject to audit from 2005 through 2007.
However, as we had net operating losses and credits carried forward in several jurisdictions,
including U.S. federal and California, certain items attributed to closed years remain subject to
adjustment by the relevant tax authority through an adjustment to tax attributes carried forward to
open years.
At June 28, 2008 and December 29, 2007, we reported a net deferred tax liability of
approximately $25.3 million and $29.8 million, respectively, comprised principally of temporary
differences between the financial statement and income tax bases of intangible assets.
We
adopted 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. During the six months ended June 28, 2008, we released
certain foreign indirect items valued at approximately $0.4 million which had previously offset
income tax exposures as a result of the filing of a foreign return. This release was partially
offset by certain return-to-provision true-ups resulting in net tax expense of approximately $0.2
million. Our unrecognized tax benefits were not adjusted for this item since it related to an
indirect benefit. However, we did reduce unrecognized tax benefits by approximately $50,000 as a
result of audit settlements and the passage of time on which certain exposures may be assessed. We
believe it is reasonably possible that unrecognized tax benefits approximating $0.1 million will be
reduced as a result of the filing of income tax returns in a foreign jurisdiction within the next
twelve months.
18
14. Net Income Per Share
Basic and diluted net income per share was calculated as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 28, |
|
|
June 30, |
|
|
June 28, |
|
|
June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
|
(in thousands, except per share data) |
|
Net income for basic share calculation |
|
$ |
8,651 |
|
|
$ |
1,253 |
|
|
$ |
9,000 |
|
|
$ |
978 |
|
Interest expense on senior subordinated convertible notes (after tax) |
|
|
512 |
|
|
|
|
|
|
|
1,024 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income for diluted share calculation |
|
$ |
9,163 |
|
|
$ |
1,253 |
|
|
$ |
10,024 |
|
|
$ |
978 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares-basic |
|
|
54,556 |
|
|
|
53,370 |
|
|
|
54,389 |
|
|
|
53,055 |
|
Dilutive effect of stock-based compensation plans |
|
|
778 |
|
|
|
1,358 |
|
|
|
717 |
|
|
|
1,366 |
|
Dilutive effect on conversion of senior subordinated convertible notes |
|
|
7,290 |
|
|
|
|
|
|
|
7,290 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares-diluted |
|
|
62,624 |
|
|
|
54,728 |
|
|
|
62,396 |
|
|
|
54,421 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per common share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.16 |
|
|
$ |
0.02 |
|
|
$ |
0.17 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
$ |
0.15 |
|
|
$ |
0.02 |
|
|
$ |
0.16 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share is computed by dividing net income by the weighted-average number
of common shares outstanding during the period. Diluted net income 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 |
|
Six Months Ended |
|
|
June 28, |
|
June 30, |
|
June 28, |
|
June 30, |
|
|
2008 |
|
2007 |
|
2008 |
|
2007 |
|
|
(in thousands) |
Options to
purchase shares
not included in
the computation of
diluted income per
share because
their inclusion
would be
antidilutive |
|
|
2,411 |
|
|
|
1,992 |
|
|
|
2,486 |
|
|
|
1,977 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The computation of diluted net income per share for the three and six months ended June 30,
2007, 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 the three and six month periods in 2007.
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,
2007 as a $20 million program. No shares of our common stock were repurchased under our publicly
announced repurchase programs during the three months ended June 28, 2008 and June 30, 2007. All
repurchased shares have been retired and are not included in net income per common share.
19
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 |
|
|
Six Months Ended |
|
|
|
June 28, |
|
|
June 30, |
|
|
June 28, |
|
|
June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
|
(in thousands) |
|
Product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular |
|
$ |
57,506 |
|
|
$ |
34,153 |
|
|
$ |
97,727 |
|
|
$ |
69,691 |
|
ITC |
|
|
25,142 |
|
|
|
23,180 |
|
|
|
49,348 |
|
|
|
44,952 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
82,648 |
|
|
$ |
57,333 |
|
|
$ |
147,075 |
|
|
$ |
114,643 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes and other: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular (a)(c) |
|
$ |
13,399 |
|
|
$ |
1,268 |
|
|
$ |
15,225 |
|
|
$ |
2,395 |
|
ITC(a)(c) |
|
|
1,272 |
|
|
|
1,861 |
|
|
|
2,077 |
|
|
|
3,259 |
|
Corporate (b)(c) |
|
|
(3,840 |
) |
|
|
(2,488 |
) |
|
|
(7,085 |
) |
|
|
(6,491 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
10,831 |
|
|
|
641 |
|
|
|
10,217 |
|
|
|
(837 |
) |
Other income and (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense (b) |
|
|
(1,131 |
) |
|
|
(1,074 |
) |
|
|
(2,021 |
) |
|
|
(2,142 |
) |
Interest income and other (b) |
|
|
2,281 |
|
|
|
1,766 |
|
|
|
4,459 |
|
|
|
3,953 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
$ |
11,981 |
|
|
$ |
1,333 |
|
|
$ |
12,655 |
|
|
$ |
974 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
June 28, |
|
|
December 29, |
|
|
|
2008 |
|
|
2007 |
|
|
|
(in thousands) |
|
Total assets: |
|
|
|
|
|
|
|
|
Cardiovascular |
|
$ |
320,288 |
|
|
$ |
312,691 |
|
ITC |
|
|
62,468 |
|
|
|
62,642 |
|
Corporate (b) |
|
|
247,914 |
|
|
|
238,386 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
630,670 |
|
|
$ |
613,719 |
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
The Cardiovascular segment includes amortization expense on purchased intangible assets of
$3.1 million and $6.2 million for the three and six months ended June 28, 2008, respectively,
and $2.9 million and $5.9 million for the three and six months ended June 30, 2007,
respectively. The ITC segment includes amortization expense on purchased intangible assets of
$0.2 million and $0.4 million for both of the three and six months ended June 28, 2008 and
June 30, 2007, respectively. |
|
(b) |
|
Represents unallocated costs, income and assets, not specifically identified to any
particular business segment. |
|
(c) |
|
Includes SFAS No. 123(R) expense of $1.6 million, $0.7 million and $0.4 million for
Cardiovascular, ITC and Corporate, respectively, for the three months ended June 28, 2008 and
$1.5 million, $0.8 million and $0.6 million for Cardiovascular, ITC and Corporate,
respectively, for the three months ended June 30, 2007 and SFAS No. 123(R) expense of $3.2
million, $1.4 million and $0.8 million for Cardiovascular, ITC and Corporate, respectively,
for the six months ended June 28, 2008 and $3.4 million, $1.6 million and $1.2 million for
Cardiovascular, ITC and Corporate, respectively, for the six months ended June 30, 2007. |
20
Geographic Areas:
The geographic composition of our product sales was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 28, 2008 |
|
|
June 30, 2007 |
|
|
June 28, 2008 |
|
|
June 30, 2007 |
|
|
|
(in thousands) |
|
Domestic |
|
$ |
60,684 |
|
|
$ |
41,222 |
|
|
$ |
106,057 |
|
|
$ |
84,900 |
|
International |
|
|
21,964 |
|
|
|
16,111 |
|
|
|
41,018 |
|
|
|
29,743 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
82,648 |
|
|
$ |
57,333 |
|
|
$ |
147,075 |
|
|
$ |
114,643 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21
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 2007 Annual Report on Form 10-K (the 2007 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 any revisions or updates 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 unaudited 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. Our business is comprised of
two operating divisions: Cardiovascular and International Technidyne Corporation (ITC), a wholly
owned subsidiary.
For advanced HF, our Cardiovascular division develops, manufactures and markets proprietary
medical devices used for mechanical circulatory support (MCS). 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 and we refer to the
HeartMate XVE and the HeartMate II collectively as the HeartMate product line. The PVAD, IVAD,
HeartMate XVE and HeartMate II are approved by the U.S. Food and Drug Administration (FDA) and CE
Mark approved in Europe. In addition, for acute HF we market the CentriMag Blood Pumping System
(CentriMag), which is manufactured by Levitronix LLC (Levitronix) and distributed by us in the
U.S. under a distribution agreement with Levitronix. We also manufacture a vascular access graft
for renal dialysis.
Our VADs have been clinically proven to improve patient survival and quality of life. We
currently offer the widest range of products to serve this market, including VADs for acute,
intermediate and chronic support. Collectively, our MCS devices are FDA-approved for the following
indications: bridge-to-transplantation (BTT), long-term support for patients suffering from
advanced stage HF who are not eligible for heart transplantation (Destination Therapy or DT),
post-cardiotomy myocardial recovery, and support during cardiac surgery. We believe that our
long-standing reputation for quality and innovation and our excellent relationships with leading
cardiovascular surgeons worldwide position us to capture growth opportunities in the expanding HF
market.
Our ITC division develops, manufactures and markets two product lines: point-of-care
diagnostic test systems for hospital point-of-care and alternate site point-of-care markets,
including diagnostic test systems that monitor blood coagulation while a patient is being
administered certain anticoagulants, and that monitor blood gas/electrolytes, oxygenation and
chemistry status; and incision products including devices used to obtain a patients blood sample
for diagnostic testing and screening for platelet function.
22
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. |
|
|
|
|
Incision. Our incision products include devices used to obtain a patients blood sample
for diagnostic testing and screening for platelet function. |
Cardiovascular Division
VADs supplement the pumping function of the heart in patients with advanced HF. In most cases,
a cannula connects the left ventricle of the heart to a blood pump. Blood flows from the left
ventricle to the pump chamber via the cannula, powered by an electric or air driven mechanism that
drives the blood through another cannula into the aorta. From the aorta, the blood then circulates
throughout the body. Mechanical or tissue valves enable unidirectional flow in some devices.
Currently, the power source remains outside the body for all FDA-approved VADs.
Certain VADs are implanted internally, while others are placed outside the body. Some external
devices are placed immediately adjacent to the body (paracorporeal), while other external VADs are
positioned at a distance from the body (extracorporeal).
In addition to our MCS devices, we sell vascular access graft products used in hemodialysis
for patients with late-stage renal disease.
Our product portfolio of implantable and external MCS devices and graft products is described
below.
The Paracorporeal Ventricular Assist Device
The PVAD is an external, pulsatile, ventricular assist device, FDA approved for BTT, including
home discharge, and post-cardiotomy myocardial recovery and provides left, right and biventricular
MCS. The PVAD is a paracorporeal device that is less invasive than implantable VADs since only the
cannula is implanted. The paracorporeal nature of the PVAD has several benefits including shorter
implantation times (approximately two hours) and the ability to use the device in smaller patients.
A pneumatic power source drives the PVAD. It is designed for short-to-intermediate duration
use of a few weeks to several months, although this device has supported numerous patients for six
to eighteen months. Offering left, right or biventricular support, the PVAD and the IVAD, described
below, are the only biventricular support systems approved for use as BTT. This characteristic is
significant since approximately 50% of bridge-to-transplant patients treated with the PVAD require
right as well as left-sided ventricular assistance. The PVAD is also the only device approved for
both bridge-to-transplantation and recovery following cardiac surgery. The PVAD incorporates our
proprietary biomaterial, Thoralon, which has excellent tissue and blood compatibility and is
resistant to blood clots.
23
The Implantable Ventricular Assist Device
The IVAD is an implantable, pulsatile, ventricular assist device FDA approved for BTT,
including home discharge, and post-cardiotomy myocardial recovery and provides left, right, or
biventricular MCS. The IVAD maintains the same blood flow path, valves and blood pumping mechanism
as the PVAD, but has an outer housing made of a titanium alloy that makes it suitable for
implantation.
We received CE Mark approval to market the IVAD in Europe in July 2003 and FDA approval for
the U.S. market in August 2004. The IVAD was approved in Canada in November 2004. The IVAD is
currently the only approved implantable VAD that can provide left, right or biventricular support.
The HeartMate XVE
The HeartMate XVE is an implantable, pulsatile, left ventricular assist device for
intermediate and longer-term MCS and is the only device approved in the U.S., Europe and Canada for
long term support of patients ineligible for heart transplantation. Patients with a HeartMate XVE
do not require anticoagulation drugs, other then aspirin, because of the products incorporation of
proprietary textured surfaces and tissue valves. 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 VE initially received FDA approval in September 1998 for BTT and in November
2002 for DT. The enhanced version of the product, called the HeartMate XVE, received FDA approval
in December 2001 for BTT. In April 2003, the HeartMate XVE received FDA approval for DT.
The HeartMate II
The HeartMate II is an implantable, electrically powered, continuous flow, left ventricular
assist device consisting of a miniature rotary blood pump designed to provide intermediate and
long-term MCS. The HeartMate II is designed to improve survival and quality of life and to provide
five to ten years of circulatory support for a broad range of advanced HF patients. Significantly
smaller than the HeartMate XVE and with only one moving part, the HeartMate II is simpler and
designed to operate more quietly than pulsatile devices. As of June 30, 2008, more than 1,600
patients worldwide have been implanted with the HeartMate II. In April 2008, we received FDA
approval for the HeartMate II for BTT. In addition, the HeartMate II is in a Phase II pivotal trial
in the U.S. for Destination Therapy. The device received CE Mark approval in November 2005,
allowing for its commercial sale in Europe.
The CentriMag
The CentriMag, manufactured by Levitronix, is approved to provide MCS for up to six hours for
patients suffering from severe, but potentially reversible, cardiac failure and is based on
Levitronixs magnetically levitated bearingless motor technology. We entered into a distribution
agreement with Levitronix in August 2007, with an initial term effective through December 2011, to
distribute the CentriMag in the U.S. The CentriMag is 510(k) cleared by the FDA for use in patients
requiring short-term extracorporeal circulatory support during cardiac surgery and Levitronix has
CE Mark approval in Europe to market the product to provide support for up to thirty days.
Levitronix is currently in discussion with the FDA regarding an Investigational Device Exemption
(IDE) to begin a pivotal trial to demonstrate safety and effectiveness of the CentriMag for
longer periods of support.
Vascular Graft Products
The Vectra Vascular Access Graft was approved for sale in the U.S. in December 2000 and in
Europe in January 1998. It is designed for use as a shunt between an artery and a vein, primarily
to provide access to the bloodstream for renal hemodialysis patients requiring frequent needle
punctures during treatment.
24
ITC Division
Our product portfolio of point-of-care diagnostic test systems and incision products includes
the following:
Hospital point-of-care
The HEMOCHRON Whole Blood Coagulation System
The HEMOCHRON Whole Blood Coagulation System (HEMOCHRON) is used to quantitatively monitor a
patients coagulation status while the patient is being administered anticoagulants. It may be used
in various hospital 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. The system consists of a small portable instrument and disposable test
cuvettes or tubes and delivers results in minutes.
The IRMA TRUpoint Blood Analysis System
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
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.
Our integrated data management system connects the HEMOCHRON, IRMA and AVOXimeter products.
Alternate site point-of-care
The ProTime Microcoagulation System
The ProTime Microcoagulation System (ProTime) is designed to safely monitor blood clotting
activity in patients on anticoagulation therapy, specifically warfarin. The system can be
prescribed for patient use 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
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 ProTime and Hgb Pro products are sold into 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.
25
Incision Products
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.
These products are sold to both the hospital point-of-care and alternate site point-of-care
segments of the market. These products offer certain advantages, command a premium over the
competition and are sold in the higher end of the market. Our growth in this segment is limited due
to lower priced products competing for the same customers.
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 condensed consolidated financial statements included in this Quarterly Report on Form 10-Q
and our 2007 Annual Report filed with the SEC. Preparation of financial statements in accordance
with generally accepted accounting principles requires management to make estimates and assumptions
that affect the reported amount of assets, liabilities, revenue and expenses and the disclosure of
contingent assets and liabilities. There can be no assurance that actual results will not differ
from those estimates and assumptions.
Revenue Recognition
We recognize revenue from product sales for our Cardiovascular and ITC business divisions when
evidence of an arrangement exists, title has passed (generally upon shipment) or services have been
rendered, the selling price is fixed or determinable and collectibility is reasonably assured.
Sales to distributors are recorded when title transfers upon shipment. A reserve for sales returns
is recorded for sales through the distributor applying reasonable estimates of product returns
based upon historical experience.
We recognize sales of certain Cardiovascular division products to first-time customers when we
have determined that the customer has the ability to use the products. These sales frequently
include the sale of products and training services under multiple element arrangements. Training is
not considered essential to the functionality of the products. The amount of revenue under these
arrangements allocated to training is based upon fair market value of the training, which is
typically performed on our behalf by third party providers. The amount of product sales allocated
to the Cardiovascular division products is made using the fair value method. Under this method, the
total value of the arrangement is allocated to the training and the Cardiovascular division
products based on the relative fair market value of the training and products.
In determining when to recognize revenue, management makes decisions on such matters as the
fair values of the product and training elements when sold together, customer credit worthiness and
warranty reserves. If any of these decisions proves incorrect, the carrying value of these assets
and liabilities on our condensed consolidated balance sheets or the recorded product sales 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 the 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. In determining the warranty reserve
estimate, management makes judgments and estimates on such matters as repair costs and probability
of warranty obligations.
26
Estimated excess and obsolete inventory reserves are recorded when inventory levels exceed
projected sales volume for a projected period of time. In determining the excess obsolete reserve,
management makes judgments and estimates on such matters as forecasted sales volume. If sales
volume differs from projection, adjustments to these reserves may be required.
Management must make judgments to determine the amount of reserves to accrue. If any of these
decisions proves incorrect, our condensed consolidated financial statement 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 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.
We believe we have provided adequate reserves for anticipated tax audit adjustments by United
States federal, state and local, as well as foreign, tax authorities based on our estimate of
whether, and the extent to which, additional taxes, interest and penalties may be due. If events
occur which indicate payment of these amounts is unnecessary, the reversal of the liabilities would
result in tax benefits being recognized in the period when we determine the accrued liabilities are
no longer warranted. If our estimate of tax liabilities proves to be less than the ultimate
assessment, a further charge to expense would result.
Evaluation of Purchased Intangibles and Goodwill for Impairment
In accordance with Statement of Financial Accounting Standards (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, if
necessary, 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, such assets with
indefinite lives are not amortized but are subject to annual impairment tests. If there is an
apparent impairment, a new fair value would be determined. If the new fair value is less than the
carrying amount, an impairment loss would be recognized.
27
Valuation of Share-Based Awards
We account for share-based compensation in accordance with the fair value recognition
provisions of SFAS No. 123(R) Share-Based Payment. Under SFAS No. 123(R), share-based compensation
cost is measured at the grant date based on the value of the award and is recognized as expense
over the vesting period. Determining the fair value of option awards at the grant date requires
judgment, including estimating the expected term of stock options, the expected volatility of our
stock, expected forfeitures and expected dividends. The computation of the expected volatility
assumption used in the Black-Scholes option pricing model for option grants is based on historical
volatility. When establishing the expected life assumption, we review annual historical employee
exercise behavior of option grants with similar vesting periods. In addition, judgment is also
required in estimating the amount of share-based awards that are expected to be forfeited. If
actual results differ significantly from these estimates, share-based compensation expense and our
results of operations could be materially affected.
Fair Value Measurements
We adopted the provisions of SFAS No. 157, Fair Value Measurements, on December 30, 2007. SFAS
No. 157 defines fair value as the price that would be received to sell an asset or paid to transfer
a liability (exit price) in an orderly transaction between market participants at the measurement
date.
In determining fair value, we use various approaches, including market, income and/or cost
approaches, and each of these approaches requires certain inputs. SFAS No. 157 establishes a
hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and
minimizes the use of unobservable inputs by requiring that observable inputs be used when
available. Observable inputs are inputs that market participants would use in pricing the asset or
liability developed based on market data obtained from sources independent of us. Unobservable
inputs are inputs that reflect our assumptions as compared to the assumptions market participants
would use in pricing the asset or liability developed based on the best information available in
the circumstances. The hierarchy is broken down into three levels based on the reliability of
inputs as follows:
|
|
|
Level 1-Valuations based on quoted prices in active markets for identical assets or
liabilities that we have the ability to access. Assets and liabilities utilizing Level 1
inputs include broker-dealer quote securities that can be traded in an active market. We
used Level I assumptions for our cash and cash equivalents, for auction rate securities
called at par in April 2008 and for the straight convertible debt feature of our senior
subordinated convertible debt notes, except for the make-whole provision using a Level 3
input, described below. Since valuations are based on quoted prices that are readily and
regularly available in an active market, a significant degree of judgment is not required. |
|
|
|
|
Level 2-Valuations based on quoted prices of similar investments in active markets, of
similar or identical investments in markets that are not active or model based valuations
for which all significant inputs and value drivers are observable, directly or indirectly.
Assets and liabilities utilizing Level 2 inputs include primarily municipal bonds. |
|
|
|
|
Level 3-Valuations based on inputs that are unobservable and significant to the overall
fair value measurement. Assets and liabilities utilizing Level 3 inputs include certain
auction rate securities, our Levitronix convertible debenture and the make-whole feature of
our senior subordinated convertible notes. Our estimates are subject to significant judgment
by management. |
Fair value is a market-based measure considered from the perspective of a market participant
who holds the asset or owes the liability rather than an entity-specific measure. Therefore, even
when market assumptions are not readily available, our own assumptions are set to reflect those
that market participants would use in pricing the asset or liability at the measurement date. See
Note 2 to the condensed consolidated financial statements for further information about our
financial assets that are accounted for at fair value.
Due to the uncertainty inherent in the valuation process, estimates of fair value may differ
significantly from the values that would have been obtained had an active market for the securities
existed, and the differences could be material. Additionally, changes in the market environment and
other events that may occur over the life of the investments may cause the gains or losses
ultimately realized on these investments to be different than the valuations currently assigned.
There is no single standard for determining fair value in good faith, as fair value depends upon
circumstances of each individual case. In general, fair value is the amount that we might
reasonably expect to receive upon the current sale of the security in an arms-length transaction in
the securitys principal market.
28
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 |
|
Six Months Ended |
|
|
June 28, |
|
June 30, |
|
June 28, |
|
June 30, |
|
|
2008 |
|
2007 |
|
2008 |
|
2007 |
Product sales |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
Cost of product sales |
|
|
38 |
|
|
|
41 |
|
|
|
41 |
|
|
|
40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
62 |
|
|
|
59 |
|
|
|
59 |
|
|
|
60 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
29 |
|
|
|
33 |
|
|
|
30 |
|
|
|
36 |
|
Research and development |
|
|
16 |
|
|
|
19 |
|
|
|
17 |
|
|
|
19 |
|
Amortization of purchased intangible assets |
|
|
4 |
|
|
|
6 |
|
|
|
5 |
|
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
49 |
|
|
|
58 |
|
|
|
52 |
|
|
|
61 |
|
Income (loss) from operations |
|
|
13 |
|
|
|
1 |
|
|
|
7 |
|
|
|
(1 |
) |
Interest expense |
|
|
(1 |
) |
|
|
(2 |
) |
|
|
(1 |
) |
|
|
(2 |
) |
Interest income and other |
|
|
3 |
|
|
|
3 |
|
|
|
3 |
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
15 |
|
|
|
2 |
|
|
|
9 |
|
|
|
1 |
|
Income tax expense |
|
|
(4 |
) |
|
|
|
|
|
|
(3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
11 |
% |
|
|
2 |
% |
|
|
6 |
% |
|
|
1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See Note 15 to our unaudited condensed consolidated financial statements in this Quarterly Report
for data presented by business segment.
Three months ended June 28, 2008 and June 30, 2007
Product Sales
Product sales in the second quarter of 2008 were $82.6 million compared to $57.3 million in
the second quarter of 2007. The primary components of the total $25.3 million increase in product
sales were the following:
|
|
|
Cardiovascular product sales increased by
$23.3 million primarily due to higher sales
from our HeartMate product line. These higher sales resulted from increased HeartMate II
volume, partly attributable to FDA BTT commercial approval in April 2008,
including the
addition of twenty-six U.S. centers, and commercial price increase on our HeartMate II
pumps. In addition, favorable foreign currency translation contributed to our increased
product sales. |
|
|
|
|
ITC product sales increased by $2.0 million primarily due to higher international sales
of our Alternate Site products, AVOXimeter and HEMOCHRON product lines. |
Sales originating outside of the U.S. and U.S. export sales accounted for approximately 27%
and 28% of our total product sales in the second quarter of 2008 and 2007, respectively.
29
Gross Profit
Gross profit in the second quarter of 2008 was $50.8 million compared to $33.7 million in the
second quarter of 2007. As a percentage of product sales, gross margin in the second quarter of
2008 and 2007 was 62% and 59%, respectively. The increase in gross margin percentage was primarily
due to the following:
|
|
|
Cardiovascular gross margin percentage increased by 4% primarily due to HeartMate II pump
price increases, improved manufacturing variances, favorable pump product mix, and favorable
foreign currency translations. |
|
|
|
|
ITC division gross margin percentage decreased by 5% due to unfavorable geographic mix,
product mix and competitive pricing pressure on our skin incision business during the second
quarter of 2008 as compared to the second quarter of 2007, in addition to a favorable
variance from returned units in 2007. |
Selling, General and Administrative
Selling, general and administrative expenses in the second quarter of 2008 were $23.9 million,
or 29% of product sales, compared to $19.1 million, or 33% of product sales, in the second quarter
of 2007. The $4.8 million increase in expenses was primarily attributable to the following:
|
|
|
Cardiovascular costs increased by $3.0 million in the second quarter of 2008 as compared
to the second quarter of 2007 primarily due to market development initiatives,
commercialization efforts around the HeartMate II and higher compensation expense. |
|
|
|
|
ITC costs increased by $0.4 million in the second quarter of 2008 as compared to the
second quarter of 2007 primarily due to higher compensation and consulting expenses. |
|
|
|
|
Corporate costs increased by $1.4 million in the second quarter of 2008 as compared to
the second quarter of 2007 primarily due to higher compensation and various other corporate
expenses. |
Research and Development
Research and development expenses in the second quarter of 2008 were $12.8 million, or 16% of
product sales, compared to $10.8 million, or 19% of product sales, in the second quarter of 2007.
Of the $2.0 million increase, our Cardiovascular and ITC divisions incurred $1.6 million and $0.4
million, respectively, in additional expenses, quarter over quarter. Research and development costs
are largely project driven, and depend 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 the HeartMate product line peripheral enhancements.
The increase in costs at our ITC division was primarily due to new product development.
Amortization of Purchased Intangible Assets
Amortization of purchased intangible assets in the second quarter of 2008 was $3.3 million as
compared to $3.1 million in the second quarter of 2007. The $0.2 million increase in amortization
expense resulted from decreasing the useful estimated lives of certain of our intangible assets at
our Cardiovascular division at the beginning of fiscal year 2008.
Interest Expense
Interest expense was $1.1 million in the second quarter of each of 2008 and 2007. Interest
expense includes amortization of debt issuance costs related to our senior subordinated convertible
notes of $0.2 million for each of the second quarters of 2008 and 2007.
30
Interest Income and Other
Interest income and other for the second quarter of 2008 was $2.3 million as compared to $1.8
million for the second quarter of 2007. Interest income was $2.1 million and $1.9 million in the
second quarters of 2008 and 2007, respectively. This increase in interest income of $0.2 million
was due to higher investment balances in our portfolio and higher short-term interest rates as a
result of the auction failures, with higher than market interest rates on our auction rate
securities. The remaining $0.3 million increase related to
increase of $0.1 million in the value of the make-whole
provision on our senior subordinated convertible notes during the second quarter of 2008 and an
impairment loss from an investment of $0.2 million during the second quarter of 2007.
Income Taxes
Our effective income tax rates were 28% and 6%, for the second quarter of 2008 and 2007,
respectively. The 22% increase in our effective tax rate for the three month period in 2008 as
compared to the same period in 2007 was primarily related to an increase in projected pre-tax
earnings and the absence of research and development tax credits in 2008, which will be recognized
in a future period upon Congressional approval.
Our effective tax rate is calculated based on the statutory tax rates imposed on projected
annual pre-tax income or loss in various jurisdictions. Since relatively small changes in our
forecasted profitability for 2008 can significantly affect our projected annual effective tax rate,
we believe our tax rate will be dependent on our profitability and could fluctuate significantly.
Six months ended June 28, 2008 and June 30, 2007
Product Sales
Product sales in the first half of 2008 were $147.1 million compared to $114.6 million in the
first half of 2007. The primary components of the total $32.5 million increase in product sales
were the following:
|
|
|
Cardiovascular product sales increased by
$28.0 million primarily due to higher sales
from our HeartMate product line These higher sales resulted from increased HeartMate II
volume partly attributable to FDA BTT approval, including the addition of twenty-six
U.S. centers, and commercial price increase on our HeartMate II pumps. In addition,
favorable foreign currency translation contributed to our increased product sales. |
|
|
|
|
ITC product sales increased by $4.5 million due primarily to higher international and
domestic sales of our Alternate Site products and HEMOCHRON product lines. |
Sales originating outside of the U.S. and U.S. export sales accounted for approximately 28%
and 26% of our total product sales in the first half of 2008 and 2007, respectively.
Gross Profit
Gross profit in the first half of 2008 was $86.7 million compared to $68.2 million in the
first half of 2007. As a percentage of product sales, gross margin in the first half of 2008 and
2007 was 59% and 60%, respectively. The decrease in gross margin percentage was primarily due to
the following:
|
|
|
Cardiovascular gross margin percentage was the same for the first half of 2008 and 2007. The
major fluctuations in 2008 were the HeartMate II pump price increased and favorable foreign
currency translations, offset by less favorable manufacturing variances. |
|
|
|
|
ITC division gross margin percentage decreased by 4% due to unfavorable geographic and
product mix during the first half of 2008 in comparison to the first half of 2007, in
addition to favorable manufacturing variances. |
31
Selling, General and Administrative
Selling, general and administrative expenses in the first half of 2008 were $44.5 million, or
30% of product sales, compared to $41.1 million, or 36% of product sales, in the first half of
2007. The $3.4 million increase in expenses was primarily attributable to the following:
|
|
|
Cardiovascular costs increased by $3.0 million in the first half of 2008 as compared to
the first half of 2007 primarily due to market development initiatives, commercialization efforts around the
HeartMate II and higher compensation expense. |
|
|
|
|
ITC costs increased by $0.6 million in the first half
of 2008 as compared to the first
half of 2007 primarily due to higher sales and marketing personnel and travel cost |
|
|
|
|
Corporate costs decreased by $0.2 million during the first half of 2008 as
compared to the first half of 2007 primarily due to consulting fees during the first half of
2007 related to a stock option review that did not recur in the first half of 2008, offset
by higher compensation expense during the first half of 2008. |
Research and Development
Research and development expenses in the first half of 2008 were $25.4 million, or 17% of
product sales, compared to $21.7 million, or 19% of product sales, in the first half of 2007. Of
the $3.7 million increase, our Cardiovascular and ITC divisions accounted for $2.8 million and $0.9
million, respectively. Research and development costs are largely project driven, and depend 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 Phase II
of the HeartMate II pivotal trial and HeartMate product line peripheral enhancements. The increase
in costs at our ITC division was primarily due to new product development.
Amortization of Purchased Intangible Assets
Amortization of purchased intangible assets in the first half of 2008 was $6.6 million as
compared to $6.3 million in the first half of 2007. The $0.3 million increase in amortization
expense resulted from decreasing the useful estimated lives of certain of our intangible assets at
our Cardiovascular division at the beginning of fiscal year 2008.
Interest Expense
Interest expense was $2.0 million in the first half of 2008 as compared to $2.1 million in the
first half of 2007. Interest expense includes amortization of debt issuance costs related to our
senior subordinated convertible notes of $0.3 million for the first half of each of 2008 and 2007.
Interest Income and Other
Interest income and other for the first half of 2008 was $4.5 million as compared to $4.0
million for the first half of 2007. Interest income was $4.3 million and $3.9 million in the first
half of 2008 and 2007, respectively. This increase in interest income of $0.4 million was due to
higher investment balances in our portfolio and higher short-term interest rates as a result of the
auction failures with higher than market interest rates on our auction rate securities. The
remaining $0.1 million increase related to gains from foreign currency translation.
Income Taxes
Our effective income tax rates were 29% for the six months ended June 28, 2008 and a benefit
of 0.4% for the six months ended June 30, 2007, respectively. The 29% increase in our effective tax
rate for the six month period in 2008 as compared to the same period in 2007 was primarily due to a
significant increase in projected profit taxed at the statutory tax rates, a release of reserves
recorded under FIN 48, Accounting for Uncertainty in Income Taxes, an interpretation of SFAS No.
109, related to certain foreign exposures, and the absence of research and development tax credits
in 2008, which will be recognized in a future period upon Congressional approval.
32
Our effective tax rate is calculated based on the statutory tax rates imposed on projected
annual pre-tax income or loss in various jurisdictions. Since relatively small changes in our
forecasted profitability for 2008 can significantly affect our projected annual effective tax rate,
we believe our tax rate will be dependent on our profitability and could fluctuate significantly.
Liquidity and Capital Resources
At June 28, 2008, we had net working capital of $284.6 million compared with $301.7 million at
December 29, 2007. Cash and cash equivalents on June 28, 2008 were $61.1 million compared to $20.7
million on December 29, 2007. The increase in cash and cash equivalents was mainly due to an
increase in net sales of available-for-sale investments, cash provided by operations, proceeds from
the exercise of stock options and employee stock purchase plan, partially offset by purchases of
property, plant and equipment and repurchases of restricted stock for payment of income withholding
taxes due upon vesting.
Cash provided by operating activities for the six months ended June 28, 2008 was $18.0
million. This amount includes net income for the period of $9.0 million increased by positive
non-cash adjustments to net income of approximately $15.8 million, and a net decrease of
approximately $6.8 million from changes in assets and liabilities. The positive non-cash
adjustments to net income were primarily due to $11.6 million for depreciation and amortization,
$5.5 million related to share-based compensation expense, partially offset by $2.4 million in
changes to net deferred tax liabilities. The change in assets and liabilities were primarily due
to an $11.0 million increase in receivables, a $3.0 million increase in inventory and a $0.8
million increase in prepaid expenses and other assets, partially offset by a $5.0 million increase
in accounts payable and a $3.0 million increase in income taxes payable.
Investing activities for the six months ended June 28, 2008 provided cash of $21.6 million,
primarily due to net sales and maturities of $24.9 million from available-for-sale investments,
partially offset by $3.3 million for purchases of property, plant and equipment, net of $1.7
million in transfers of drivers and demonstration equipment from inventory into fixed assets. The
purchased property, plant and equipment included $1.6 million for leasehold improvements and
purchases of management information systems equipment at our Cardiovascular division and $1.7
million for facility expansion costs at our ITC division.
Financing activities for the six months ended June 28, 2008 provided cash of $0.8 million,
from net proceeds of stock option and employee stock purchase plan purchases partially offset by
repurchases of restricted stock for payment of income withholding taxes due upon vesting.
As of June 28, 2008, we owned approximately $37.2 million of auction rate securities that are
marketed by financial institutions and are periodically reset through auctions ranging from 7 to 35
days. The underlying collateral of the auction rate securities consists of student loans. Beginning
in February of 2008, these auctions began to fail. As a result, we will not be able to access these
funds until future auctions for these securities are successful, until a secondary market is
established, or until these securities are called for redemption. As such, our auction rate
securities are classified as long-term and are valued at $31.9 million using significant
unobservable inputs. Based on our expected operating cash flows, and our other sources of cash, we
do not anticipate the potential lack of liquidity of these investments will affect our ability to
execute our current business plan.
We estimated, with the fair value of these auction rate securities based on the following: (i)
the underlying structure of each security; (ii) the present value of future principal and interest
payments discounted at rates considered to reflect current market conditions; (iii) consideration
of the probabilities of default, auction failure, or repurchase at par for each period; and (iv)
estimates of the recovery rates in the event of default for each security. These estimated fair
values could change significantly based on future market conditions.
33
The following table provides a reconciliation of the beginning and ending balances for the
assets and liabilities measured at fair value using significant unobservable inputs (level 3):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurement Using Significant |
|
|
|
Unobservable Inputs (Level 3) |
|
|
|
Auction Rate |
|
|
Other Long |
|
|
Other Long |
|
|
|
Securities |
|
|
Term Assets |
|
|
Term Liabilities |
|
|
|
(in thousands) |
|
Balance at December 29, 2007 |
|
$ |
|
|
|
$ |
5,000 |
|
|
$ |
96 |
|
Transfer to Level 3 |
|
|
46,050 |
|
|
|
|
|
|
|
|
|
Settlements at par |
|
|
(8,850 |
) |
|
|
|
|
|
|
|
|
Realized
holding loss, included in interest income and other |
|
|
|
|
|
|
|
|
|
|
116 |
|
Unrealized holding loss, included in other comprehensive loss |
|
|
(5,049 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 29, 2008 |
|
$ |
32,151 |
|
|
$ |
5,000 |
|
|
$ |
212 |
|
|
|
|
|
|
|
|
|
|
|
Realized
holding gain, included in interest income and other |
|
|
|
|
|
|
|
|
|
|
(59 |
) |
Unrealized holding loss, included in other comprehensive loss |
|
|
(288 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 29, 2008 |
|
$ |
31,863 |
|
|
$ |
5,000 |
|
|
$ |
153 |
|
|
|
|
|
|
|
|
|
|
|
We continue to monitor the market for auction rate securities and consider its impact (if any)
on the fair value of our investments. If the current market conditions deteriorate further, or the
anticipated recovery in fair values does not occur, we may be required to record additional
unrealized losses in other comprehensive income or other-than-temporary impairment charges to the
condensed consolidated statement of operation in future periods.
We intend and have the ability to hold these auction rate securities until the market recovers
or until maturity. We do not anticipate having to sell these securities in order to operate our
business. We believe that, based on our current unrestricted cash, cash equivalents and short- term
marketable security balances of $196.1 million at June 28, 2008, the current lack of liquidity in
the credit and capital markets will not have an impact on our liquidity, our cash flow or our
ability to fund our operations. If the issuers of the auction rate securities are unable to
successfully complete future auctions and their credit ratings deteriorate, we may in the future be
required to record an impairment charge on these investments. It could conceivably take until the
final maturity of the underlying notes (up to 30 years) to realize our investments recorded value.
Off Balance Sheet Arrangements
We maintain an Irrevocable Standby Letter of Credit as part of our workers compensation
insurance program. The Letter of Credit is not collateralized. The Letter of Credit automatically
renews on June 30th of each year, unless terminated by one of the parties. At June 28, 2008, our
Letter of Credit balance was approximately $660,000.
Contractual Obligations
As of June 28, 2008, the liability for uncertain tax positions was $7.5 million including
interest and penalties. Due to the high degree of uncertainty regarding the timing of potential
future cash flows associated with these liabilities, we are unable to make a reasonably reliable
estimate of the amount and period in which these liabilities might be paid.
During the six months ended June 28, 2008 there were no other material changes outside our normal
course of business to our contractual obligations reported in our 2007 Annual Report.
34
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE OF MARKET RISK
Interest Rate Risk
Our investment portfolio is made up 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 fair market
value and are treated as available-for-sale. Investments with maturities beyond one year may be
classified as short-term based on their highly liquid nature due to the frequency with which the
interest rate is reset and because such marketable securities represent the investment of cash that
is available for current operations. Our auction rate securities that are not liquid are treated as
long term. 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 and by 50
basis points, the change in our net unrealized gain or loss on investments would be $0.4 million
and $0.7 million, respectively. We do not utilize derivative financial instruments to manage
interest rate risks.
Our senior subordinated convertible notes and the Levitronix convertible debenture do not bear
interest rate risk as the notes were issued at a fixed rate of interest.
Foreign Currency Rate Fluctuations
We conduct
business in foreign countries. Our international operations consist primarily of
sales and service personnel for our ventricular assist products who report to our U.S.
sales and marketing group and are internally reported as part of that group. All assets and
liabilities of our non-U.S. operations are translated into U.S. dollars at the period-end exchange
rates and the resulting translation adjustments are included in comprehensive income. The
period-end translation of the non-functional currency assets and liabilities (primarily assets and
liabilities on our UK subsidiarys condensed 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 condensed consolidated balance sheet that are not denominated in UK pounds).
Our contracts typically have maturities of three months or less.
Our financial instrument contracts qualify as derivatives under SFAS No. 133, and we valued
these contracts at the estimated fair value at June 28, 2008. 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 |
|
Six Months Ended |
|
|
June 28, 2008 |
|
June 30, 2007 |
|
June 28, 2008 |
|
June 30, 2007 |
|
|
|
|
|
|
( in thousands) |
|
|
|
|
Foreign currency
exchange gain
(loss) on foreign
currency contracts |
|
$ |
(107 |
) |
|
$ |
41 |
|
|
$ |
(1,147 |
) |
|
$ |
(42 |
) |
Foreign currency
exchange gain
(loss) on foreign
translation
adjustments |
|
|
122 |
|
|
|
(54 |
) |
|
|
1,230 |
|
|
|
2 |
|
As of June 28, 2008, we had forward contracts to sell euros with a notional value of 7.1
million and to purchase UK pounds with a notional value of £5.0 million, and as of June 30, 2007 we
had forward contracts to sell euros with a notional value of 5.4 million and to purchase UK
pounds with a notional value of £3.0 million. As of June 28, 2008, our forward contracts had an
average exchange rate of one U.S. dollar to 0.6455 euros and one U.S. dollar to 0.5036 UK pounds.
The forward contracts are valued based on exchange rates derived from an independent source of
market participant assumptions and compiled from the best information available. As of June 28,
2008, the estimated fair of value of these foreign currency contracts were $0.1 million, recorded
in Other assets. The potential fair value gain or loss for a
hypothetical 10% change in foreign currency
exchange rates at June 28, 2008 would be approximately $2.1 million.
35
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.
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 June 28, 2008. The evaluation of our disclosure controls and
procedures included a review of our processes and implementation and the effect on the information
generated for use in this Quarterly Report on Form 10-Q. In the course of this evaluation, we
sought to identify any significant deficiencies or material weaknesses in our disclosure controls
and procedures, to determine whether we had identified any acts of fraud involving personnel who
have a significant role in our disclosure controls and procedures, and to confirm that any
necessary corrective action, including process improvements, was taken. This type of evaluation is
done quarterly so that our conclusions concerning the effectiveness of these controls can be
reported in our periodic reports filed with the SEC. The overall goals of these evaluation
activities are to monitor our disclosure controls and procedures and to make modifications as
necessary. We intend to maintain these disclosure controls and procedures, modifying them as
circumstances warrant.
Based on that evaluation, our management, including the Chief Executive Officer and Chief
Financial Officer, concluded that as of June 28, 2008 the Companys disclosure controls and
procedures, as defined in Rule 13a-15(e) under the Exchange Act, were effective to provide
reasonable assurance that information required to be disclosed by us in the reports that we file or
submit under the Exchange Act is recorded, processed, summarized, and reported within the time
periods specified in the SECs rules and forms, and to provide reasonable assurance that such
information is accumulated and communicated to our management, including our principal executive
officer, as appropriate to allow timely decisions regarding required disclosures.
Changes to Internal Controls
There have been no changes in our internal controls over financial reporting during the
quarter ended June 28, 2008 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 our disclosure controls and procedures and our 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.
36
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 June 28, 2008, 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 2007 Annual Report, which
could materially affect our business, financial condition or future results. The risks described in
our 2007 Annual Report are not the only risks facing us. Additional risks and uncertainties not
currently known to us or that we currently deem to be immaterial also may materially adversely
affect our business, financial condition and/or operating results.
ITEM 2: UNREGISTERED SALE OF EQUITY SECURITIES AND USE OF PROCEEDS
There were no unregistered sales of our equity securities during the three months ended June
28, 2008.
The following table sets forth certain information about our common stock repurchased during
the three months ended June 28, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total number |
|
|
Approximate |
|
|
|
|
|
|
|
|
|
|
|
of shares |
|
|
value of shares |
|
|
|
Total |
|
|
|
|
|
|
purchased |
|
|
authorized to be |
|
|
|
number |
|
|
|
|
|
|
under |
|
|
purchased under |
|
|
|
of shares |
|
|
Average |
|
|
publicly |
|
|
publicly |
|
|
|
purchased |
|
|
price paid |
|
|
announced |
|
|
announced |
|
|
|
(2) |
|
|
per share |
|
|
programs (1) |
|
|
programs |
|
|
|
(in thousands, except per share data) |
|
March 30, 2008 through April 26, 2008 |
|
|
3.5 |
|
|
$ |
15.36 |
|
|
|
|
|
|
$ |
|
|
April 27, 2008 through May 24, 2008 |
|
|
1.7 |
|
|
|
16.11 |
|
|
|
|
|
|
|
|
|
May 25, 2008 through June 28, 2008 |
|
|
2.6 |
|
|
|
17.66 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
7.8 |
|
|
$ |
16.27 |
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Our share repurchase programs, which authorized us to repurchase up to a total of $130
million of the Companys common shares, were announced on February 11, 2004 as a $25 million
program, on May 12, 2004 as a $60 million program, on July 29, 2004 as a $25 million program
and on February 2, 2006 as a $20 million program. These programs authorize us to acquire
shares in the open market or in privately negotiated transactions and do not have an
expiration date. No shares were repurchased under these programs during the three and six
months ended June 28, 2008. |
|
(2) |
|
Shares purchased that were not part of our publicly announced repurchase programs represent
the surrender value of shares of restricted stock used to pay income taxes due upon vesting,
and do not reduce the dollar value that may yet be purchased under our publicly announced
repurchase programs. |
37
ITEM 4: SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
The annual meeting of shareholders was held on May 20, 2008. The following items were voted
upon and approved at the meeting:
1. |
|
To elect the following directors to serve for the ensuing year until their successors are
elected: |
|
|
|
|
|
|
|
|
|
|
|
Number of Votes |
|
|
For |
|
Withheld |
Gerhard F. Burbach |
|
|
42,626,960 |
|
|
|
5,541,657 |
|
Howard E. Chase |
|
|
42,607,967 |
|
|
|
5,560,650 |
|
J. Daniel Cole |
|
|
42,631,209 |
|
|
|
5,537,408 |
|
Steven H. Collis |
|
|
42,132,624 |
|
|
|
6,035,993 |
|
Neil F. Dimick |
|
|
42,183,779 |
|
|
|
5,984,838 |
|
Elisha W. Finney |
|
|
42,905,274 |
|
|
|
5,263,343 |
|
D. Keith Grossman |
|
|
42,591,048 |
|
|
|
5,577,569 |
|
J. Donald Hill |
|
|
41,707,848 |
|
|
|
6,460,769 |
|
Daniel M. Mulvena |
|
|
41,758,549 |
|
|
|
6,410,068 |
|
2. |
|
To approve the amendment of the Thoratec Corporation 2006 Incentive Stock Plan: |
|
|
|
|
|
|
|
Number of |
|
|
Votes |
For |
|
|
38,299,562 |
|
Against |
|
|
4,118,019 |
|
Abstain |
|
|
831,562 |
|
Broker Non-Votes |
|
|
4,919,384 |
|
3. |
|
To ratify of the appointment of Deloitte & Touche LLP as the Companys independent auditors
for its fiscal year ending January 3, 2009: |
|
|
|
|
|
|
|
Number of |
|
|
Votes |
For |
|
|
47,794,327 |
|
Against |
|
|
347,707 |
|
Abstain |
|
|
26,583 |
|
38
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. |
39
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: August 6, 2008 |
/s/ Gerhard F. Burbach
|
|
|
Gerhard F. Burbach |
|
|
Chief Executive Officer |
|
|
|
|
|
Date: August 6, 2008 |
/s/ David V. Smith
|
|
|
David V. Smith |
|
|
Chief Financial Officer |
|
|
40
EXHIBIT INDEX
|
|
|
Number |
|
Description |
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. |