e10vq
U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark one)
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þ |
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Quarterly report pursuant to Section 13 or 15 (d) of the Securities Exchange Act of 1934 |
For the quarterly period ended July 2, 2005
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: 1-8145
THORATEC CORPORATION
(Exact name of registrant as specified in its charter)
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California |
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(State or other jurisdiction of
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94-2340464 |
incorporation or organization)
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(I.R.S. Employer Identification No.) |
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6035 Stoneridge Drive, Pleasanton, California
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94588 |
(Address of principal executive offices)
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(Zip Code) |
Registrants telephone number, including area code: (925) 847-8600
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed
by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule
12b-2 of the Exchange Act): Yes þ No o
As
of August 5, 2005 registrant had 49,388,722 shares of common stock outstanding.
THORATEC
CORPORATION AND SUBSIDIARIES
TABLE OF CONTENTS
2
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
THORATEC CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
(in thousands)
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July 2, |
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January 1, |
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2005 |
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2005 |
Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
20,396 |
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$ |
16,017 |
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Short-term available-for-sale investments |
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150,104 |
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129,842 |
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Restricted short-term investments |
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3,347 |
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3,362 |
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Receivables, net of allowances of $856 and $708 respectively |
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29,625 |
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33,051 |
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Inventories |
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39,953 |
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39,141 |
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Deferred tax asset |
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6,470 |
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6,470 |
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Prepaid expenses and other assets |
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3,722 |
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3,873 |
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Total current assets |
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253,617 |
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231,756 |
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Property, plant and equipment, net |
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27,104 |
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27,584 |
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Goodwill |
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94,097 |
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94,097 |
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Purchased intangible assets, net |
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147,537 |
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153,141 |
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Restricted long-term investments |
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3,221 |
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4,845 |
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Long-term deferred tax asset |
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6,430 |
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6,381 |
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Other assets |
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6,364 |
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6,611 |
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Total Assets |
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$ |
538,370 |
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$ |
524,415 |
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Liabilities and Shareholders Equity |
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Current liabilities: |
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Accounts payable |
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7,528 |
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7,699 |
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Accrued compensation |
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9,814 |
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9,507 |
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Accrued income tax |
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4,272 |
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2,299 |
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Other accrued expenses |
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6,022 |
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6,001 |
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Total current liabilities |
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27,636 |
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25,506 |
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Senior subordinated convertible notes |
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143,750 |
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143,750 |
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Long-term deferred tax liability and other liabilities |
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61,219 |
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63,051 |
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Total liabilities |
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232,605 |
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232,307 |
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Shareholders Equity: |
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Common shares; 100,000 authorized; issued and
outstanding 49,185 and 48,735, respectively |
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373,519 |
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364,775 |
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Deferred compensation |
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(1,173 |
) |
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(1,586 |
) |
Accumulated deficit |
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(66,442 |
) |
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(71,514 |
) |
Accumulated other comprehensive income (loss): |
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Unrealized loss on investments |
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(285 |
) |
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(325 |
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Cumulative translation adjustments |
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146 |
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758 |
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Total accumulated other comprehensive income (loss) |
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(139 |
) |
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433 |
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Total shareholders equity |
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305,765 |
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292,108 |
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Total Liabilities and Shareholders Equity |
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$ |
538,370 |
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$ |
524,415 |
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See notes to condensed consolidated financial statements.
3
THORATEC CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share data)
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Three Months Ended |
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Six Months Ended |
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July 2, |
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July 3, |
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July 2, |
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July 3, |
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2005 |
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2004 |
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2005 |
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2004 |
Product sales |
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$ |
47,588 |
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$ |
40,603 |
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$ |
98,076 |
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$ |
83,395 |
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Cost of product sales |
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18,387 |
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16,314 |
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38,435 |
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34,035 |
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Gross profit |
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29,201 |
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24,289 |
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59,641 |
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49,360 |
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Operating expenses: |
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Selling, general and administrative |
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14,806 |
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13,774 |
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29,623 |
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26,787 |
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Research and development |
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7,925 |
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7,380 |
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15,644 |
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14,718 |
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Amortization of purchased intangible assets |
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2,800 |
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2,931 |
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5,604 |
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5,862 |
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Litigation and other costs |
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(1 |
) |
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177 |
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133 |
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Total operating expenses |
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25,530 |
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24,085 |
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51,048 |
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47,500 |
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Income from operations |
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3,671 |
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|
204 |
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8,593 |
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1,860 |
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Other income and (expense): |
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Interest expense |
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(1,037 |
) |
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(418 |
) |
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(2,045 |
) |
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(418 |
) |
Interest income and other |
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1,034 |
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|
475 |
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1,870 |
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939 |
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Income before income tax expense |
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3,668 |
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|
261 |
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8,418 |
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2,381 |
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Income tax expense |
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(1,247 |
) |
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(54 |
) |
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(2,862 |
) |
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(881 |
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Net income |
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$ |
2,421 |
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$ |
207 |
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$ |
5,556 |
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$ |
1,500 |
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Net income per share, basic and diluted |
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$ |
0.05 |
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$ |
0.00 |
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$ |
0.11 |
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$ |
0.03 |
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Shares used to compute net income per share: |
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Basic |
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48,735 |
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53,722 |
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48,470 |
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54,907 |
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Diluted |
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50,146 |
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55,175 |
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49,530 |
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|
56,315 |
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See notes to condensed consolidated financial statements.
4
THORATEC CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
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Six Months Ended |
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July 2, |
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July 3, |
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2005 |
|
2004 |
Cash flows from operating activities: |
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Net income |
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$ |
5,556 |
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$ |
1,500 |
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Adjustments to reconcile net income to net cash provided by operating activities: |
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Depreciation and amortization |
|
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9,445 |
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|
9,327 |
|
Investment premium amortization |
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|
288 |
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|
270 |
|
Non-cash interest and other expenses |
|
|
313 |
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|
418 |
|
Tax benefit related to stock options |
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2,062 |
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|
388 |
|
Amortization of deferred compensation |
|
|
481 |
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|
455 |
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Loss on disposal of assets |
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|
158 |
|
|
|
1 |
|
Change in net deferred tax liability |
|
|
(2,111 |
) |
|
|
(1,698 |
) |
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
Receivables |
|
|
3,426 |
|
|
|
275 |
|
Inventories |
|
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(1,564 |
) |
|
|
(3,257 |
) |
Prepaid expenses and other assets |
|
|
151 |
|
|
|
(696 |
) |
Accounts payable and other liabilities |
|
|
2,305 |
|
|
|
2,443 |
|
Other |
|
|
139 |
|
|
|
(7 |
) |
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|
|
|
|
|
|
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|
Net cash provided by operating activities |
|
|
20,649 |
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|
9,419 |
|
Cash flows from investing activities: |
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|
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|
|
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|
Purchases of available-for-sale investments |
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(53,265 |
) |
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|
(52,310 |
) |
Sales of available-for-sale investments |
|
|
20,808 |
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|
31,050 |
|
Maturities of available-for-sale investments |
|
|
13,535 |
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|
16,620 |
|
Purchases of property, plant and equipment, net |
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(2,866 |
) |
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|
(3,628 |
) |
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|
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Net cash used in investing activities |
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|
(21,788 |
) |
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|
(8,268 |
) |
Cash flows from financing activities: |
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Net proceeds from issuance of convertible notes |
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|
139,181 |
|
Proceeds from stock option exercises, net |
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|
7,684 |
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|
|
2,070 |
|
Proceeds from stock issued under employee stock purchase plan |
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|
684 |
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|
|
788 |
|
Repurchase of common stock |
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(2,238 |
) |
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|
(71,759 |
) |
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Net cash provided by financing activities |
|
|
6,130 |
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|
70,280 |
|
Effect of exchange rate changes on cash and cash equivalents |
|
|
(612 |
) |
|
|
60 |
|
|
|
|
|
|
|
|
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|
Net increase in cash and cash equivalents |
|
|
4,379 |
|
|
|
71,491 |
|
Cash and cash equivalents at beginning of period |
|
|
16,017 |
|
|
|
18,270 |
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|
|
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Cash and cash equivalents at end of period |
|
$ |
20,396 |
|
|
$ |
89,761 |
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|
|
|
|
|
|
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|
Supplemental disclosure of cash flow information: |
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Cash paid for taxes |
|
$ |
1,044 |
|
|
$ |
465 |
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|
|
|
|
|
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Cash paid for interest |
|
$ |
1,707 |
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|
$ |
|
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Supplemental disclosure of non-cash investing and financing activities: |
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Transfers of equipment from inventory |
|
$ |
752 |
|
|
$ |
208 |
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|
|
|
|
|
|
|
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|
See notes to condensed consolidated financial statements.
5
THORATEC CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(unaudited)
(in thousands)
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|
|
|
|
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Three Months Ended |
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Six Months Ended |
|
|
July 2, |
|
July 3, |
|
July 2, |
|
July 3, |
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
Net income |
|
$ |
2,421 |
|
|
$ |
207 |
|
|
$ |
5,556 |
|
|
$ |
1,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Other net comprehensive income : |
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|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on
investments (net of taxes of
$(58) and $102 for the three
months ended and $50 and
$122 for the six months
ended July 2, 2005 and July
3, 2004, respectively) |
|
|
97 |
|
|
|
(160 |
) |
|
|
40 |
|
|
|
(191 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation
adjustments (net of taxes of
$122 and $0 for the three
months ended and $155 and $0
for the six months ended
July 2, 2005 and July 3,
2004, respectively) |
|
|
(479 |
) |
|
|
(11 |
) |
|
|
(612 |
) |
|
|
60 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
$ |
2,039 |
|
|
$ |
36 |
|
|
$ |
4,984 |
|
|
$ |
1,369 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See notes to condensed consolidated financial statements.
6
THORATEC CORPORATION AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
(in thousands, unless otherwise stated)
1. Basis of Presentation
The interim condensed consolidated financial statements of Thoratec Corporation, referred to
herein as we, our, Thoratec, or the Company, have been prepared and presented in accordance
with accounting principles generally accepted in the United States of America and the rules and
regulations of the Securities and Exchange Commission, referred to as the SEC, without audit, and
reflect all adjustments necessary (consisting only of normal recurring adjustments) to present
fairly our financial position, results of operations and cash flows. Certain information and
footnote disclosures normally included in our annual financial statements, prepared in accordance
with accounting principles generally accepted in the United States of America, have been condensed
or omitted. The accompanying financial statements should be read in conjunction with our fiscal
2004 consolidated financial statements filed with the SEC in our Annual Report on Form 10-K. The
operating results for any interim period are not necessarily indicative of the results that may be
expected for any future period.
The preparation of our condensed consolidated financial statements necessarily requires us to
make estimates and assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the consolidated balance sheet dates and the
reported amounts of revenues and expenses for the periods presented.
We have made certain reclassifications of 2004 amounts to conform to the current presentation.
In balance sheets prior to January 1, 2005, auction rate securities were classified as cash
and cash equivalents. These securities have been reclassified for all periods presented from cash
and cash equivalents to short term available-for-sale investments. These auction rate securities
have an underlying component of a long-term debt or equity instrument; however, they are traded or
mature on a shorter term based on an auction bid that resets the interest rate over time intervals
of 28 to 49 days. These resets allow for a much higher level of liquidity than typical long term
investments. As of January 3, 2004, we reclassified $43.8 million of these securities to
short-term available-for-sale investments from cash and cash equivalents based on the period
from purchase date to the reset date and as they are not intended to be held to the maturity date.
2. Stock Based Compensation
We account for stock-based compensation to employees using the intrinsic value method in
accordance with Accounting Principals Board Opinion (APB) No. 25, Accounting for Stock Issued to
Employees. Accordingly, no accounting recognition is given to stock options granted at fair market
value until they are exercised. Upon exercise, net proceeds, including tax benefits realized, are
recorded in shareholders equity. Similarly, no accounting recognition is given to our employee
stock purchase plan until a purchase occurs. Upon purchase, net proceeds are recorded in common
stock. Under the fair value recognition provisions of Statement of Financial Accounting Standard
(SFAS) No. 123, the fair value of each option granted as a stock option or as an option to
purchase shares under the employee stock purchase plan is estimated using the Black-Scholes
option-pricing model. If compensation cost for our stock-based plans had been determined based on
the fair value at the grant dates for awards under those plans, consistent with the method of SFAS
No. 123, our reported net income would have been adversely affected, as shown in the following
table:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
July 2, |
|
July 3, |
|
July 2, |
|
July 3, |
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
|
|
(in thousands, except per share data) |
|
|
|
|
|
|
(Restated) |
|
|
|
|
|
(Restated) |
Net income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As reported |
|
$ |
2,421 |
|
|
$ |
207 |
|
|
$ |
5,556 |
|
|
$ |
1,500 |
|
Add: Stock-based compensation expense
included in reported net income, net of
related tax effects |
|
|
164 |
|
|
|
148 |
|
|
|
318 |
|
|
|
287 |
|
Deduct: Total stock-based compensation
expense determined under fair value
based method for all awards, net of
related tax effects |
|
|
(1,475 |
) |
|
|
(3,981 |
) |
|
|
(3,499 |
) |
|
|
(5,877 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net income (loss) |
|
$ |
1,110 |
|
|
$ |
(3,626 |
) |
|
$ |
2,375 |
|
|
$ |
(4,090 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted earnings (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As reported |
|
$ |
0.05 |
|
|
$ |
0.00 |
|
|
$ |
0.11 |
|
|
$ |
0.03 |
|
Pro forma income (loss) |
|
$ |
0.02 |
|
|
$ |
(0.07 |
) |
|
$ |
0.05 |
|
|
$ |
(0.07 |
) |
7
Subsequent to the issuance of our condensed consolidated financial statements for the quarter
ended October 2, 2004, management determined that total stock based employee compensation expense
determined under the fair value based method, net of related tax effects, for the first three
quarters of 2004 had been calculated incorrectly. Accordingly, such pro forma amounts presented
above have been restated. The effect was to increase pro forma stock-based compensation expense,
net of tax and pro forma net loss by $0.6 million for the three months ended and $0.5 million for
the six months ended July 3, 2004. Pro forma earnings per share were also decreased by $0.02 per
share for basic and diluted earnings per share for the three months ended July 3, 2004 and $0.01
for basic and diluted earnings per share for the six months ended July 3, 2004. This correction did
not impact the Companys consolidated financial position, results of operations, or cash flows for
any of the periods presented.
3. New Accounting Pronouncements
In December 2004, the Financial Accounting Standards Board (FASB) issued statement 123R
Share-Based Payment. This statement requires that stock-based compensation be recognized as a
cost in the financial statements and that such cost be measured based on the fair value of the
stock-based compensation. Our adoption of this statement, which we expect to occur in the first
quarter of 2006, will have a material, although non-cash, impact on our consolidated statements of
operations.
4. Cash and cash equivalents
We consider highly liquid investments with original maturities of three months or less to be
cash and cash equivalents.
5. Investments
Our investments are primarily held in auction rate securities, corporate and municipal bonds
and U.S. government obligations and are classified as available-for-sale and are reported at fair
value based upon quoted market price. All investments mature within two years or less from the date
of purchase, except for some investments in U.S. Treasuries held as restricted investments as
collateral for future interest payments related to our convertible debt, which mature within three
years from the date of purchase. Investments with maturities beyond one year may be classified as
short-term, if they are intended for use in operations, based on their highly liquid nature or due
to the frequency in which the interest rate is reset such as with auction rate securities. In
addition, these securities represent the investment of cash that is available and intended for
current operations. Investments that are not intended for use in current operations are classified
as long-term investments.
Securities classified as restricted are investments held in U.S. Treasuries as collateral for
future interest payments related to our convertible debt and are reported at fair value based upon
quoted market price. The investments that relate to interest payments due within one year have been
classified as restricted short-term investments and the investments that relate to interest
payments due after one year have been classified as restricted long-term investments. We determined
that these investments had no impairments that were other-than temporary.
For all investments, temporary differences between cost and fair value are presented as a
separate component of accumulated other comprehensive income. The specific identification method is
used to determine realized gains and losses on investments.
6. Financial Instruments
We have a foreign currency exchange risk management program principally designed to mitigate
the change in value of assets and liabilities (primarily assets and liabilities on our UK
subsidiarys consolidated balance sheet that are denominated in UK pounds). Forward exchange
contracts that generally have terms of three months or less are used to hedge these currency
exposures on our books. The derivatives used in the foreign currency exchange risk management
program are not designated as cash flow or fair value hedges under SFAS 133. These contracts are
recorded on the condensed consolidated balance sheets at fair value in Deferred Tax Asset and
Other Prepaid Assets current assets. Changes in the fair value of the contracts and the underlying
exposures being hedged are included concurrently in Interest income and other. At July 2, 2005
the Company had forward foreign currency contracts to exchange Pounds Sterling for Euros with a
notional value of $2.9 million. At January 1, 2005, the Company had forward foreign currency
contracts to exchange Pounds Sterling and Euros for U.S. Dollars with a notional value of $6.9
million. For both periods the fair values of these contracts were negligible. Net foreign currency
exchange loss was $0.1 million for both three months ended and $0.3 million and $0.2 million for
the six months ended July 2, 2005 and July 3, 2004, respectively.
8
7. Inventories
Inventories consist of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
July 2, |
|
January 1, |
|
|
2005 |
|
2005 |
|
|
(in thousands) |
Finished goods |
|
$ |
17,785 |
|
|
$ |
18,562 |
|
Work in process |
|
|
8,286 |
|
|
|
4,582 |
|
Raw materials |
|
|
13,882 |
|
|
|
15,997 |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
39,953 |
|
|
$ |
39,141 |
|
|
|
|
|
|
|
|
|
|
8. Property, Plant and Equipment
Property, plant and equipment consist of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
July 2, |
|
January 1, |
|
|
2005 |
|
2005 |
|
|
(in thousands) |
Property, plant and equipment, at cost |
|
$ |
64,241 |
|
|
$ |
61,670 |
|
Less accumulated depreciation |
|
|
(37,137 |
) |
|
|
(34,086 |
) |
|
|
|
|
|
|
|
|
|
Total |
|
$ |
27,104 |
|
|
$ |
27,584 |
|
|
|
|
|
|
|
|
|
|
In the second quarter of 2005 we adjusted the estimated lives of some computer equipment from five
years to three years.
9. Goodwill and Purchased Intangible Assets
The change in the carrying amount of goodwill, which is attributable to our Cardiovascular
business segment, for the six and twelve month periods ended July 2, 2005 and January 1, 2005 was
as follows:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
July 2, |
|
January 1, |
|
|
2005 |
|
2005 |
|
|
(in thousands) |
Beginning balance |
|
$ |
94,097 |
|
|
$ |
96,065 |
|
Realization of acquired deferred tax asset |
|
|
|
|
|
|
(1,153 |
) |
Reversal of accrual for securities registration costs |
|
|
|
|
|
|
(815 |
) |
|
|
|
|
|
|
|
|
|
Ending balance |
|
$ |
94,097 |
|
|
$ |
94,097 |
|
|
|
|
|
|
|
|
|
|
There were no adjustments to Goodwill in the first six months of 2005. In 2004, goodwill
related to the merger of Thoratec with Thermo Cardiosystems, Inc. (TCA) was adjusted by $1.2
million to reflect the utilization of tax net operating loss (NOL) benefits related to our
subsidiary in the United Kingdom (UK). At the time of the merger, a deferred tax asset related to
these NOL tax benefits was established with a corresponding valuation allowance for the full
amount. As our UK subsidiary more likely than not will begin utilizing a portion of this NOL
benefit, a portion of the original valuation allowance has been reversed against goodwill.
In addition, goodwill was also adjusted by $0.8 million in the first quarter of 2004 to
reflect the reversal of an accrual established at the time of the merger with TCA for securities
registration costs. Under the terms of the agreement, we agreed to pay these costs should Thermo
Electron Corporation (TCI) (the majority shareholder of TCA prior to the merger) decide to sell
its shares of the Companys common stock in a public offering. This commitment was enforceable
until TCIs holdings in Thoratec fell below 10%, which occurred in the first quarter of 2004.
9
The components of purchased intangible assets, net are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of July 2, 2005 |
|
|
Gross Carrying |
|
Accumulated |
|
|
|
|
Amount |
|
Amortization |
|
Net Carrying Amount |
|
|
(in thousands) |
Patents and Trademarks |
|
$ |
37,815 |
|
|
$ |
(15,873 |
) |
|
$ |
21,942 |
|
Core Technology |
|
|
37,485 |
|
|
|
(8,002 |
) |
|
|
29,483 |
|
Developed Technology |
|
|
122,782 |
|
|
|
(26,736 |
) |
|
|
96,046 |
|
Non-compete Agreement |
|
|
90 |
|
|
|
(24 |
) |
|
|
66 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Purchased Intangible Assets, net |
|
$ |
198,172 |
|
|
$ |
(50,635 |
) |
|
$ |
147,537 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of January 1, 2005 |
|
|
Gross Carrying |
|
Accumulated |
|
|
|
|
Amount |
|
Amortization |
|
Net Carrying Amount |
|
|
(in thousands) |
Patents and Trademarks |
|
$ |
37,815 |
|
|
$ |
(14,051 |
) |
|
$ |
23,764 |
|
Core Technology |
|
|
37,485 |
|
|
|
(7,242 |
) |
|
|
30,243 |
|
Developed Technology |
|
|
122,782 |
|
|
|
(23,721 |
) |
|
|
99,061 |
|
Non-compete Agreement |
|
|
90 |
|
|
|
(17 |
) |
|
|
73 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Purchased Intangible Assets, net |
|
$ |
198,172 |
|
|
$ |
(45,031 |
) |
|
$ |
153,141 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effective January 1, 2005, the Company revised its estimate for the remaining useful lives for
certain of its core and developed technology intangible assets. The effect of the change was to
decrease amortization expense by $0.3 million during the six months ended July 2, 2005 and is
expected to decrease amortization by $0.5 million during each of the next five years. Amortization
expense related to purchased intangible assets, net was $2.8 million and $5.6 million for the three
and six months ended July 3, 2005, respectively. Amortization expenses were $2.9 million and $5.9
million for the three and six months ended July 3, 2004, respectively. Amortization expense on our
existing purchased intangible assets is expected to be approximately $11.2 million for each of the
next five years. Patents and trademarks have useful lives of eight to twenty years, core and
developed technology assets have useful lives ranging from nine to twenty four years and the useful
life of the non-compete agreement is approximately six years.
10. Long-Term Debt
In the second quarter of 2004, we completed the sale of $143.8 million initial principal
amount of senior subordinated convertible notes due 2034. The convertible notes were sold to
Qualified Institutional Buyers pursuant to the exemption from the registration requirements of the
Securities Act of 1933, as amended, provided by Rule 144A thereunder. We used $9.8 million of the
net proceeds to purchase and pledge to the trustee under the indenture for the exclusive benefit of
the holders of the convertible notes, U.S. Treasury securities to provide for the payment, in full,
of the first six scheduled interest payments. These securities are reflected on our condensed
consolidated balance sheets as restricted short-term and long-term investments. Additional net
proceeds were used to repurchase 4.2 million shares of our outstanding common stock for $60
million. The remaining net proceeds will be used for general corporate purposes, which may include
additional stock repurchases, strategic investments or acquisitions. Total net proceeds to the
Company from the sale of these convertible notes were $139.4 million, after debt issuance costs of
$4.3 million.
The convertible notes were issued at an issue price of $580.98 per note, which is 58.098% of
the principal amount at maturity of the notes. The convertible notes bear interest at a rate of
1.3798% per year on the principal amount at maturity, payable semi-annually in arrears in cash on
May 16 and November 16 of each year, from November 16, 2004 until May 16, 2011. Beginning on May
16, 2011, the original issue discount will accrue daily at a rate of 2.375% per year on a
semi-annual bond equivalent basis and, on the maturity date, a holder will receive $1,000 per note.
As a result, the aggregate principal amount of the notes at maturity will be $247.4 million.
The deferred debt issuance costs of $3.6 million, net of $0.7 million in amortization, are
included in other assets on the condensed consolidated balance sheet. 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 the condensed consolidated statement
of operations.
10
|
|
|
|
|
Long Term Debt Offering Proceeds (in millions): |
|
|
|
|
Principal amount of convertible notes at maturity |
|
$ |
247.4 |
|
Original issue discount |
|
|
(103.7 |
) |
Debt issuance costs |
|
|
(4.3 |
) |
|
|
|
|
|
Net proceeds |
|
$ |
139.4 |
|
|
|
|
|
|
Holders of the convertible notes may convert their convertible notes into shares of our common
stock at a conversion rate of 29.4652 shares per $1,000 principal amount of convertible notes,
which represents a conversion price of $19.72 per share, subject to adjustments upon the occurrence
of certain events. Holders were able to convert their convertible notes at any point after the
close of business on September 30, 2004 if, as of the last day preceding the calendar quarter, the
closing price of our common stock for at least 20 trading days in a period of 30 consecutive
trading days ending on the last trading day of such preceding calendar quarter is more than 120% of
the accreted conversion price per share of our common stock. Holders may surrender their
convertible notes for conversion on or prior to 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; provided that if on the day prior to any conversion the closing
sale price of our common stock is greater than the accreted conversion price but less than or equal
to 120% of the accreted conversion price, then holders will receive upon conversion, in lieu of
shares of common stock based on the conversion rate, cash or common stock, or a combination of cash
and common stock, at our option, with a value equal to the accreted principal amount of the notes
plus accrued but unpaid interest as of the conversion date. Additionally, holders may convert their
convertible notes if we call them for redemption or if specified corporate transactions or
significant distributions to holders of our stock have occurred. As of July 2, 2005, no notes have
been converted or called.
Holders may require us to repurchase all or a portion of their convertible notes on each of
May 16, 2011, 2014, 2019, 2024 and 2029 at a repurchase price equal to 100% of the issue price,
plus accrued original issue discount, if any. In addition, if we experience a change in control or
a termination of trading 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. The fair value of
the make whole premium at April 2, 2005 was zero. We may redeem any of the convertible notes at any
time beginning May 16, 2011, by giving the holders at least 30 days notice, either in whole or in
part at a redemption price equal to the sum of the issue price and the accrued original issue
discount, plus accrued and unpaid interest and liquidated damages, if any for our failure to comply
with our registration obligations regarding the convertible notes.
The convertible notes are subordinated to all of our senior indebtedness and structurally
subordinated to all indebtedness of our subsidiaries. Therefore, in the event of a bankruptcy,
liquidation or dissolution of us or one or more of our subsidiaries and acceleration of or payment
default on our senior indebtedness, holders of the convertible notes will not receive any payment
until holders of any senior indebtedness we may have outstanding have been paid in full.
The aggregate fair value of the convertible notes at July 2, 2005, based on market quotes, was
$143.2 million.
11. Common Stock
In February 2004 and again in July 2004, the Board of Directors authorized stock repurchase
programs under which up to $50 million in the aggregate of our common stock could be acquired in
the open market or in privately negotiated transactions. The number of shares to be purchased and
the timing of purchases are based on several conditions, including the price of our stock, general
market conditions and other factors. In May 2004, in conjunction with our convertible notes
offering, the Board of Directors authorized the repurchase of an additional $60 million of our
common stock. As of July 2, 2005, we had repurchased and retired 8.5 million shares with an
aggregate purchase price of $104.9 million under these combined programs.
12. Litigation and Other Costs
Litigation and other costs are comprised of:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
July 2, |
|
July 3, |
|
July 2, |
|
July 3, |
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
|
|
(in thousands) |
Litigation |
|
$ |
(1 |
) |
|
$ |
|
|
|
$ |
177 |
|
|
$ |
133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11
Litigation
In April 2003, a patent infringement claim was filed against the Company by Bodycote Materials
Testing Canada, Inc. and David C. MacGregor, M.D. This claim related to materials used in our
HeartMate LVAS. On February 3, 2004, the Company settled the claim and recorded a charge of $2.3
million in the fourth quarter of 2003 for the settlement and related legal costs. The expense
recorded in the first quarter of 2004 is primarily comprised of additional legal expenses related
to the settlement.
In June of 2004, MicroMed Technology, Inc. (MicroMed), a potential competitor of the
Company, sued the Company in Texas. MicroMed sought injunctive relief and unspecified damages and
fees against the Company in connection with the Companys HeartMate II phase I clinical trial on
the grounds that the Company had provided the HeartMate II VAD to clinical sites without charge and
that doing so was a violation of Texas anti-trust law. Based on discussions with MicroMeds counsel
and from documents filed with the SEC, we believe that MicroMed intends to abandon this law suit.
On August 3, 2004, a putative Federal securities law class action entitled Johnson v. Thoratec
Corporation, et al. was filed in the United States District Court for the Northern District of
California on behalf of purchasers of the publicly traded securities of the Company between April
28, 2004 and June 29, 2004. Subsequent to the filing of the Johnson complaint, additional
complaints were filed in the same court alleging substantially similar claims. On November 24,
2004, the Court entered an order consolidating the various putative class action complaints into a
single action entitled In re Thoratec Corp. Securities Litigation and thereafter entered an order
appointing Craig Toby as Lead Plaintiff pursuant to the Private Securities Litigation Reform Act
of 1995. On or about January 18, 2005, Lead Plaintiff filed a Consolidated Complaint. The
Consolidated Complaint generally alleges violations of the Securities Exchange Act of 1934 by the
Company, its chief executive officer, cardiovascular division president and former chief financial
officer based upon, among other things, alleged false statements about the Companys expected sales
and the market for HeartMate as a Destination Therapy treatment. The Consolidated Complaint seeks
to recover unspecified damages on behalf of all purchasers of the Companys publicly traded
securities during the putative class period. On March 4, 2005, defendants moved to dismiss the
Consolidated Complaint and that motion currently is pending.
On or about September 1, 2004, a shareholder derivative action entitled Wong v. Grossman was
filed in the California Superior Court for Alameda County based upon essentially the same facts as
the Federal securities class action suits referred to above. This action names the individual
members of the Companys Board of Directors, including the Chief Executive Officer and certain
other Executive Officers of the Company as defendants and alleges that the defendants breached
their fiduciary duties and wasted corporate assets, and that certain of the defendants traded in
the Companys securities while in possession of material nonpublic information. Proceedings in
Wong vs. Grossman are currently stayed until at least October 2005.
We believe that the claims asserted in both the Federal securities law putative class action
and the state shareholder derivative actions are without merit. We have moved to dismiss the
Federal action and will file a similar motion in the Wong action if necessary. We are unable to
predict at this time the final outcome of these actions.
We carry sufficient insurance to cover what management believes to be any reasonable exposure
on these actions; however, we cannot give assurance that our insurance will cover all costs or
other exposures we may incur with respect to these actions.
13. Income Taxes
Our effective income tax expense rates were 34% and 21%, respectively, for the first three
months ended July 2, 2005 and July 3, 2004. The effective income tax expense rates were 34% and
37%, respectively, for the six months ended July 2, 2005 and July 3, 2004. The change in our
quarterly effective tax rate is due primarily to our projected annual profitability on a
comparative basis.
The change in our six month effective tax expense rate is due primarily to additional interest
income from tax favorable investments and increased research tax credits. In addition, we have
reserved amounts for anticipated tax audit adjustments in the U.S., state and other foreign tax
jurisdictions based on our estimate of whether, and the extent to which, additional taxes and
interest may be due.
At July 2, 2005 and January 1, 2005, we reported a net deferred tax liability of approximately
$47.1 million and $49.2 million, respectively, comprised principally of temporary differences
between the financial statement and income tax bases of intangible assets.
12
14. Net Income Per Share
Basic and diluted net income per share were calculated as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
July 2, |
|
July 3, |
|
July 2, |
|
July 3, |
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
|
|
(in thousands, except per share data) |
Net income |
|
$ |
2,421 |
|
|
$ |
207 |
|
|
$ |
5,556 |
|
|
$ |
1,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares-basic |
|
|
48,735 |
|
|
|
53,722 |
|
|
|
48,470 |
|
|
|
54,907 |
|
Dilutive effect of stock options & ESPP shares |
|
|
1,411 |
|
|
|
1,453 |
|
|
|
1,060 |
|
|
|
1,408 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares-diluted |
|
|
50,146 |
|
|
|
55,175 |
|
|
|
49,530 |
|
|
|
56,315 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per common share-basic and diluted |
|
$ |
0.05 |
|
|
$ |
0.00 |
|
|
$ |
0.11 |
|
|
$ |
0.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share are computed by dividing net income by the weighted average number of
common shares outstanding during the period. Diluted earnings per share reflect the potential
dilution that could occur if securities or other contracts to issue common stock were exercised or
converted into common stock. Options to purchase 2.7 million and 3.8 million shares of common stock
were not included in the computation of diluted earnings and losses per share for the three months
ended July 2, 2005 and July 3, 2004, respectively, as their inclusion would be antidilutive.
Options to purchase 2.6 million and 4.9 million shares of common stock were not included in the
computation of diluted earnings and losses per share for the six months ended July 2, 2005 and July
3, 2004, respectively, as their inclusion would be antidilutive. In addition, the computation of
diluted earnings per share excludes the effect of assuming the conversion of our convertible notes,
which are convertible at $19.72 per share into 7.3 million shares of common stock, because their
effect would have been antidilutive for the three and six months ended July 2, 2005 and July 3,
2004, respectively.
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 develops, manufactures
and markets proprietary medical devices used for circulatory support and vascular graft
applications. The ITC segment designs, develops, manufactures and markets point-of-care diagnostic
test systems and incision devices.
Business Segments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
July 2, |
|
July 3 |
|
July 2, |
|
July 3, |
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
|
|
|
|
|
|
(in thousands) |
|
|
|
|
Product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular |
|
$ |
28,776 |
|
|
$ |
23,072 |
|
|
$ |
60,842 |
|
|
$ |
49,625 |
|
ITC |
|
|
18,812 |
|
|
|
17,531 |
|
|
|
37,234 |
|
|
|
33,770 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
47,588 |
|
|
$ |
40,603 |
|
|
$ |
98,076 |
|
|
$ |
83,395 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular(a) |
|
$ |
4,262 |
|
|
$ |
1,420 |
|
|
$ |
10,391 |
|
|
$ |
4,314 |
|
ITC(a) |
|
|
3,467 |
|
|
|
2,348 |
|
|
|
6,618 |
|
|
|
4,641 |
|
Corporate (b) |
|
|
(4,059 |
) |
|
|
(3,564 |
) |
|
|
(8,239 |
) |
|
|
(6,961 |
) |
Litigation and other costs (c) |
|
|
1 |
|
|
|
|
|
|
|
(177 |
) |
|
|
(133 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations |
|
|
3,671 |
|
|
|
204 |
|
|
|
8,593 |
|
|
|
1,860 |
|
Other income and (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(1,037 |
) |
|
|
(418 |
) |
|
|
(2,045 |
) |
|
|
(418 |
) |
Interest income and other |
|
|
1,034 |
|
|
|
475 |
|
|
|
1,870 |
|
|
|
939 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income tax expense |
|
$ |
3,668 |
|
|
$ |
261 |
|
|
$ |
8,418 |
|
|
$ |
2,381 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Amortization expense of $2.8 million and $5.6 million for the three and six months ended July
2, 2005 and $2.9 million and $5.9 million for the three and six months ended July 3, 2004,
respectively, related to the Cardiovascular segment. The ITC segment had amortization expense
of $40,000 for the three months ended and $79,000 for each of the six months ended July 2,
2005 and July 3, 2004, respectively. |
|
(b) |
|
Represents primarily general and administrative items not specifically identified to a
particular business segment. |
13
|
|
|
(c) |
|
Relates to expenses not specifically identified to a particular business segment. |
Geographic Areas:
The geographic composition of our product sales were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
July 2, |
|
July 3, |
|
July 2, |
|
July 3, |
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
|
|
(in thousands) |
Domestic |
|
$ |
35,948 |
|
|
$ |
31,392 |
|
|
$ |
75,151 |
|
|
$ |
65,173 |
|
International |
|
|
11,640 |
|
|
|
9,211 |
|
|
|
22,925 |
|
|
|
18,222 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
47,588 |
|
|
$ |
40,603 |
|
|
$ |
98,076 |
|
|
$ |
83,395 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Forward-Looking Statements
This Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.
These statements can be identified by the words expects, projects, hopes, believes,
intends, should, estimate, will, would, may, anticipates, plans, could, and words
of similar import and the negatives thereof. Actual results 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. Investors are
cautioned that all such statements involve risks and uncertainties, including risks related to the
development of new markets such as Destination Therapy, the growth of existing markets for our
products, customer and physician acceptance of our products, changes in the mix of our product
sales and the related gross margin for such product sales, the results of clinical trials including
the HeartMate II, the ability to improve financial performance, regulatory approval processes, the
effect of healthcare reimbursement and coverage policies, the effects of seasonality in our product
sales, the effects of price competition from any of our competitors and the effects of any merger
and acquisition related activities. 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 Factors That May Affect Future Results section below and in other documents we
file with the Securities and Exchange Commission, or SEC. Actual results, events or performance may
differ materially. These forward-looking statements speak only as of the date hereof. We undertake
no obligation to publicly release the results of any revisions to these forward-looking statements
that may be made to reflect events or circumstances after the date hereof, or to reflect the
occurrence of unanticipated events.
The following presentation of managements discussion and analysis of our financial condition
and results of operations should be read together with our consolidated financial statements
included in this Form 10-Q, and our Annual Report on Form 10-K for 2004 filed with the SEC.
Overview
We are a leading manufacturer of circulatory support products for use by patients with
congestive heart failure, or CHF. Our Ventricular Assist Devices, or VADs, are used primarily by
CHF patients to perform some or all of the pumping function of the heart. We currently offer the
widest range of products to serve this market. We believe that our long-standing reputation for
quality and innovation and our excellent relationships with leading cardiovascular surgeons
worldwide position us to capture growth opportunities in the expanding congestive heart failure
market. Through our wholly-owned subsidiary, ITC, we design, develop, manufacture and market
point-of-care diagnostic test systems and incision products that provide for fast, accurate blood
test results to improve patient management, reduce healthcare costs and improve patient outcomes.
Our Business Model
Our business is comprised of two segments; Cardiovascular and ITC.
The major product lines within our Cardiovascular segment are:
|
|
|
Circulatory Support Products. Our circulatory support products include VADs for the
short-term and long-term treatment of congestive heart failure. |
|
|
|
|
Vascular Graft Products. We have developed small diameter grafts using our proprietary
materials to address the vascular access market. Our grafts are sold in the United States
and internationally for use in hemodialysis. |
The major product lines of our ITC segment are:
|
|
|
Point-of-Care Diagnostics. Our point-of-care products include coagulation diagnostic test
systems that monitor a patient while being administered certain anticoagulants, blood
gas/electrolyte and chemistry status, or anemia. |
|
|
|
|
Incision. Our incision products include devices used to obtain a patients blood sample
for diagnostic testing and screening for platelet function. |
15
Cardiovascular segment
We offer the following broad product portfolio of implantable and external circulatory support
product devices:
|
|
|
The Thoratec Ventricular Assist Device System is an external device for short to mid-term
cardiac support, which is sold worldwide. The device is approved to assist the left and the
right ventricle and is worn outside of the body. The Thoratec VAD is approved for use in
bridge-to-transplant, or BTT. |
|
|
|
|
The Thoratec Implantable Ventricular Assist Device, or IVAD, is the only bi-ventricular
implantable blood pump approved for BTT and post-cardiotomy recovery. It can be used for
left, right, or biventricular support. The IVAD utilizes the same internal working
components as the Thoratec VAD System blood pump, but has an outer housing made of a
titanium alloy that makes it more suitable for implantation. |
|
|
|
|
The HeartMate Left Ventricular Assist System, also called the HeartMate XVE, is an
implantable device for mid to long-term cardiac support and the only device approved in the
United States, Europe and Canada for permanent support of those patients ineligible for
heart transplantation. The HeartMate XVE is approved for use in both BTT and Destination
Therapy, which is for permanent support for patients suffering from end-stage heart failure
who are not eligible for heart transplantation. |
|
|
|
|
The HeartMate II, which is currently in clinical trials for BTT and Destination Therapy,
is an implantable LVAS consisting of a miniature rotary blood pump that is designed to
provide long-term support. Its design is intended to be not only smaller, but also simpler,
quieter, and longer lasting than current generation assist devices. |
|
|
|
|
The Vectra vascular access graft 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. |
The primary markets for our VAD products are those patients suffering from heart failure and,
in particular, from CHF. CHF is a chronic disease that occurs when degeneration of the heart muscle
reduces the pumping power of the heart, causing the heart to become too weak to pump blood at a
level sufficient to meet the bodys demands. CHF can be caused by artery or valve diseases or a
general weakening of the heart muscle itself. Other conditions, such as high blood pressure or
diabetes, can also lead to CHF.
In the United States, there are currently two FDA-approved indications for the use of VADs in
patients with CHF as a bridge to heart transplant and as Destination Therapy. We are currently
pursuing one additional indication for our Thoratec VAD products for therapeutic recovery of the
heart. Beyond the CHF markets, VADs are also approved for use during recovery following cardiac
surgery.
We currently market VADs that may be implanted or worn outside the body and that are suitable
for treatments for different durations for patients of varying sizes and ages. We estimate that
doctors have implanted over 9,500 of our devices in patients suffering from heart failure. Our
devices are currently used primarily for patients awaiting a heart transplant or Destination
Therapy implants. On November 6, 2002, the United States Food and Drug Administration, or FDA,
approved the HeartMate VAD as the first heart assist device for Destination Therapy. On April 7,
2003, the FDA approved the HeartMate XVE, an enhanced version of the HeartMate VAD, for Destination
Therapy. Thoratec is the only company to have a ventricular assist device approved for Destination
Therapy in the United States. In August 2004, we received FDA approval in the U.S. to market the
IVAD for use in bridge-to-transplantation and post-cardiotomy recovery patients who are unable to
be weaned from cardiopulmonary bypass. This makes the IVAD the only currently approved implantable
cardiac assist device that can provide left, right or biventricular support.
ITC Segment
The major product lines of diagnostic test systems and incision device products are:
|
|
|
The Hemochron Point of Care, or POC, coagulation system is used to monitor a patients
coagulation while being administered anticoagulants in various settings, including in the
cardiovascular operating room to monitor the drug Heparin and in an anticoagulation clinic
to monitor the drug Coumadin. Hemochron is considered a moderately complex device and must
be used by professionally trained personnel. The system consists of a small, portable
analytical instrument and disposable test cuvettes. |
|
|
|
|
The Immediate Response Mobile Analysis, or IRMA, POC blood gas/electrolyte and chemistry
system is used to monitor a patients blood gas/electrolyte and chemistry status. It is
considered moderately complex and its use requires supervision by professionally trained
personnel. The system consists of a small, portable analytical instrument and disposable
test cartridges. |
16
|
|
|
The ProTime coagulation monitoring system is used to monitor a patients coagulation
while they are taking oral anticoagulants such as Coumadin, and can be prescribed for use by
patients at home or can be used in the physicians office or clinic. The system consists of
a small, portable analytical instrument and disposable test cuvettes. |
|
|
|
|
The Hemoglobin Pro System, or Hgb Pro is used by professionals, mainly in the doctors
office to test for anemia; it provides quick results from a very small blood sample. The
system consists of a small, hand held test meter and disposable test strips. |
|
|
|
|
Tenderfoot, Tenderlett and Surgicutt incision products are used by professionals to
obtain a patients blood sample for diagnostic testing. The tenderfoot is a heel stick
used for infant testing, Tenderlett is used for finger incisions and the Surgicutt is used
to perform screening tests to determine platelet function. All products feature permanently
retracting blades for safe, virtually pain-free incision. |
The Hemochron and IRMA products are primarily sold into the hospital POC segment of the
market. The ProTime and Hemoglobin Pro products are sold into the alternate site (non-hospital) POC
market comprising physicians offices, long-term care facilities, clinics, visiting nurse
associations, and home healthcare companies.
Our incision products are sold to both the hospital POC market and the alternate site POC. Our
most successful incision product is the Tenderfoot. Although we market this product based on its
high-end features, we believe that, in the long-term, customers will increasingly make purchasing
decisions on these types of products based on price. Therefore, we expect a gradual erosion of
market share over time.
Critical Accounting Policies and Estimates
We have identified the policies below as critical to our business operations and the
understanding of our results of operations. The impact and any associated risks related to these
policies on our business operations are discussed below. For a more detailed discussion on the
application of these and other accounting policies, see the notes to the condensed consolidated
financial statements included in this Quarterly Report on Form 10-Q and our Annual Report on Form
10-K for fiscal 2004 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.
Evaluation of Purchased Intangibles and Goodwill for Impairment
In accordance with SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived
Assets, we periodically evaluate the carrying value of long-lived assets to be held and used,
including intangible assets subject to amortization, when events or circumstances warrant such a
review. The carrying value of a long-lived asset to be held and used is considered impaired when
the anticipated separately identifiable total undiscounted cash flows from such an asset are less
than the carrying value of the asset. In that event, a loss is recognized based on the amount by
which the carrying value exceeds the fair value of the long-lived asset. Fair value is determined
primarily using the anticipated cash flows discounted at a rate commensurate with the risk
involved. Management must make estimates of these future cash flows and the approximate discount
rate, and if any of these estimates proves incorrect, the carrying value of these assets on our
consolidated balance sheet could become significantly impaired.
As of the beginning of fiscal year 2002, we adopted SFAS No. 142, Goodwill and Other
Intangible Assets, and ceased amortizing purchased goodwill. Since then, we complete an annual
impairment test of goodwill and other intangible assets subject to amortization as required by SFAS
No. 142 and SFAS No. 144. Upon completion of our impairment tests as of the end of fiscal year
2004, we determined that neither goodwill nor intangible assets were impaired. Based on changes in
business conditions, we did modify the economic useful lives of certain components of our core and
developed technology assets as disclosed in footnote 9 to the condensed consolidated financial
statements.
17
Revenue Recognition
We recognize revenue from product sales for our Cardiovascular and ITC business segments when
evidence of an arrangement exists, title has passed (generally upon shipment) or services have been
rendered, the selling price is fixed or determinable and collectibility is reasonably assured.
Sales to distributors are recorded when title transfers upon shipment. One of our distributors has
certain limited product return rights. Other distributors have certain rights of return upon
termination of their distribution agreements. A reserve for sales returns is recorded for these
customers applying reasonable estimates of product returns based upon historical experience. No
other direct sales customers or distributors have return rights or price protection.
Sales of certain Cardiovascular segment products to first-time customers are recognized when
it has been determined that the customer has the ability to use such 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 our products. The amount of revenue
under these arrangements allocated to training is based upon the fair market value of the training,
which is typically performed on behalf of the Company by third party providers. The amount of
product sales allocated to Cardiovascular segment products is done on a fair value basis. Under
this approach, the total value of the arrangement is allocated to the training and the
Cardiovascular segment products based on the relative fair market value of the training and the
products. The amount of product sales allocated to training is recorded as deferred revenue and is
recognized when the training is completed. As of the fiscal quarter ended July 2, 2005, all
products that had been delivered and recorded as product sales were delivered to customers for
which training had been completed. There was no amount of product sales deferred related to
training not yet completed at the end of the six months ended July 2, 2005 and none at 2004 fiscal
year end.
The majority of our products are covered by up to a two-year limited manufacturers warranty
from the date of installation. Estimated contractual warranty obligations are recorded when related
sales are recognized and any additional amounts are recorded when such costs are probable and can
be reasonably estimated.
In determining when to recognize revenue, management makes decisions on such matters as the
relative fair values of the product and training elements when sold together, customer credit
worthiness and warranty reserves. If these decisions prove incorrect, the carrying value of these
assets and liabilities on our condensed consolidated balance sheets could be significantly
different.
Reserves
We maintain allowances for doubtful accounts for estimated losses resulting from the inability
of our customers to make payments owed to us for product sales. If the financial condition of our
customers were to deteriorate, resulting in an impairment of their ability to make payments,
additional allowances may be required.
Management must make judgments to determine the amount of reserves to accrue. If management
estimates prove incorrect, our financial statements could be adversely affected.
Accounting Pronouncements
In December 2004, the FASB issued statement 123R Share-Based Payment. This statement
requires that stock-based compensation be recognized as a cost in the financial statements and that
such cost be measured based on the fair value of the stock-based compensation. Our adoption of this
statement, which we expect to occur in the first quarter of 2006, will have a material, although
non-cash, impact on our condensed consolidated statements of operations.
18
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 |
|
|
July 2, |
|
July 3, |
|
July 2, |
|
July 3, |
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
Product sales |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
Cost of product sales |
|
|
39 |
|
|
|
40 |
|
|
|
39 |
|
|
|
41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
61 |
|
|
|
60 |
|
|
|
61 |
|
|
|
59 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
31 |
|
|
|
34 |
|
|
|
30 |
|
|
|
32 |
|
Research and development |
|
|
16 |
|
|
|
18 |
|
|
|
16 |
|
|
|
18 |
|
Amortization of purchased intangible assets |
|
|
6 |
|
|
|
7 |
|
|
|
6 |
|
|
|
7 |
|
Litigation and other costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
53 |
|
|
|
59 |
|
|
|
52 |
|
|
|
57 |
|
Income from operations |
|
|
8 |
|
|
|
1 |
|
|
|
9 |
|
|
|
2 |
|
Other income and (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(2 |
) |
|
|
(1 |
) |
|
|
(2 |
) |
|
|
|
|
Interest income and other |
|
|
2 |
|
|
|
1 |
|
|
|
2 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income tax expense |
|
|
8 |
|
|
|
1 |
|
|
|
9 |
|
|
|
3 |
|
Income tax expense |
|
|
3 |
|
|
|
0 |
|
|
|
3 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
5 |
% |
|
|
1 |
% |
|
|
6 |
% |
|
|
2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See Note 15 to our unaudited condensed consolidated financial statements in this report for data
presented by business segment.
Three months ended July 2, 2005 and July 3, 2004
Product Sales
Product sales in the second quarter of 2005 were $47.6 million compared to $40.6 million in
the second quarter of 2004. The Cardiovascular segment increased sales by $5.7 million and the ITC
segment increased sales by $1.3 million. Product sales increases are due to an increase in volume
unless otherwise noted. The primary components of the total $7.0 million increase in product sales
were the following:
|
|
|
VAD product sales increased $4.1 million. The majority of this increase came from higher
sales of our HeartMate II and IVAD products of $3.0 million and $2.8 million, respectively.
This was partially offset by a reduction in sales of our PVAD product line of $2.3 million. |
|
|
|
|
Other ancillary product sales (drivers, cannulae, service, rentals and spares) increased
$1.0 million, including an increase in Destination Therapy ancillary products as well as
modest increases in TLC II driver revenue principally from Home Discharge. |
|
|
|
|
Graft product sales increased by $0.6 million due to a higher average selling price
combined with increased volume. |
|
|
|
|
Point-of-care diagnostic product sales increased $1.3 million, due primarily to a $0.8
million increase in sales of our Hemochron and $0.6 million increase in sales of our Protime
products coupled with modest decreases in sales of our Hgb Pro products quarter over
quarter. |
|
|
|
|
Incision product sales were flat because of what we believe to be lower volume offset by
higher average selling prices. |
For the three months ended July 2, 2005 and July 3, 2004, sales originating outside of the United
States and U.S. export sales accounted for approximately 25% and 23%, respectively, of our total
product sales.
19
Gross Profit
Gross profit in the second quarter of 2005 was 61% compared to 60% in the second quarter of
2004. The modest change in gross profit was due to the following fluctuations:
|
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The Cardiovascular segment increased gross profit by 1% due to higher incremental revenue
in conjunction with higher margin VAD product sales offset in part by an increase in
manufacturing costs; and |
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The ITC segment increased gross profit by 2%, due to higher incremental revenue in higher
margin products and increased margins in the point-of-care market related to the shift in
mix from distributor to direct channels sales. |
Selling, General and Administrative
Selling, general and administrative expenses in the second quarter of 2005 were $14.8 million,
or 31% of product sales, compared to $13.8 million, or 34% of product sales, in the second quarter
of 2004. The $1.0 million increase in spending resulted from:
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Increased personnel costs associated with higher product sales and overall headcount
increases in the Cardiovascular segment of $0.9 million offset in part by reduced personnel
costs related to alternate site sales for the ITC segment of $0.3 million. |
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Higher spending on marketing and related activities, primarily associated with our
HeartHope Center Program, Destination Therapy, and costs associated with training efforts in
the Cardiovascular segment totaling $0.3 million. |
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Higher professional fees, including legal, audit and financial consulting services
relating to our compliance with the Sarbanes-Oxley Act of 2002 and enterprise resource
planning software system (ERP system) implementation expenses of an additional $0.1
million. |
Research and Development
Research and development expenses in the second quarter of 2005 were $7.9 million compared to
$7.4 million in the second quarter of 2004, representing 16% and 18% of product sales for the
respective periods. Our Cardiovascular segment incurred $0.5 million of the increase while the ITC
segment recorded no increase in these expenses quarter over quarter. Research and development costs
are largely project driven, and the level of spending depends on the level of project activity
planned and subsequently approved and conducted. The primary component of our research and
development costs is employee salaries and benefits. Research and development costs also include
regulatory and clinical costs associated with our compliance with FDA regulations.
Amortization of Purchased Intangible Assets
Amortization of purchased intangible assets in the second quarter of 2005 was $2.8 million
compared to $2.9 million in the second quarter of 2004. The decrease of $0.1 million is the result
of changes in business conditions which caused us to modify the remaining economic useful lives of
certain of our core and developed technology assets. These changes were made in accordance with our
periodic valuation of the useful lives of our identifiable intangible assets under FAS 144 as of
January 1, 2005.
Interest Expense
Interest expense for the second quarter 2005 was $1.0 million compared to $0.4 million in the
second quarter of 2004. The expense for the three months ended July 2, 2005 and July 3, 2004,
respectively, includes $0.8 million and $0.3 million in interest payments and $0.2 million and $0.1
million in amortization of the debt issuance costs related to our convertible notes issued in May
2004.
Interest Income and Other
Interest income and other for the three months ended July 2, 2005 was $1.0 million compared to
$0.5 million in the three months ended July 3, 2004. This increase was primarily due to higher
interest income earned on increased cash and investment balances as a result of the proceeds
received from the May 2004 issuance of our convertible notes and positive cash generated by
operations between 2004 and 2005.
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Income Taxes
Our effective income tax expense rates were 34% and 21%, respectively, for the second quarters
of 2005 and 2004. The change in our quarterly tax rate is due primarily to our profitability on a
comparative basis. The reduction in our effective tax expense rate is due primarily to additional
interest income from tax favorable investments and increased research tax credits. In addition, we
have provided adequate amounts for anticipated tax audit adjustments in the U.S., state and other
foreign tax jurisdictions based on our estimate of whether, and the extent to which, additional
taxes and interest may be due. If events occur which indicate payment of these amounts are
unnecessary or the liability proves to be more than anticipated, the reversal of the liabilities
would result in tax benefits being recognized or a further charge to expense would result in the
period in which the event occurs.
Our effective tax rate is calculated based on the statutory tax rate imposed on projected
annual pre-tax income or loss in various jurisdictions. Since relatively small changes in our
forecasted profitability for 2005 can significantly affect our projected annual effective tax rate,
we believe our quarterly tax expense rate of 34% is the most reliable estimate of our effective tax
expense rate. Accordingly, our quarterly tax rate for the remainder of 2005 will be largely
dependent on our profitability and could fluctuate significantly.
Six months ended July 2, 2005 and July 3, 2004
Product Sales
Product sales for the first six months of 2005 were $98.1 million compared to $83.4 million
for the same six month period in 2004. Cardiovascular segment sales increased by $11.2 million and
the ITC segment sales increased by $3.5 million. Product sales increases are due to an increase in
volume unless otherwise noted. The primary components of the total $14.7 million increase in
product sales were the following:
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VAD product sales increased $8.5 million. The majority of this increase came from higher
sales of our HeartMate II and IVAD products of $4.0 million and $6.9 million, respectively.
This was partially offset by a reduction in sales of our PVAD products of $3.3 million. |
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Other ancillary product sales (drivers, cannulae, service, rentals and spares) increased
$1.9 million, including an increase in Destination Therapy ancillary products and TLC II
driver revenue principally from Home Discharge. |
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Graft product sales increased by $0.8 million due to a higher average selling price. |
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Point-of-care diagnostic product sales increased $3.8 million, due primarily to a $3.4
million increase in sales of our Hemochron and $0.7 million increase in our ProTime
products. This was partially offset by decreased sales of our Hgb Pro products year over
year. |
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Incision product sales decreased by $0.5 million due in part to lower volume partially
offset by higher average selling prices. |
For the six months ended July 2, 2005 and July 3, 2004, sales originating outside of the United
States and U.S. export sales accounted for approximately 23% and 22%, respectively, of our total
product sales.
Gross Profit
Gross profit for the six months ended July 2, 2005 was 61% compared to 59% for the six months
ended July 3, 2004. The change in gross profit was due to the following fluctuations:
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The Cardiovascular segment increased gross profit by 1% due to higher incremental revenue
in conjunction with higher margin VAD product sales offset in part by an increase in
manufacturing costs; and |
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The ITC segment increased gross profit by 2%, due to higher incremental revenue in higher
margin products and increased margins in the point-of-care market related to the shift in
mix from distributor to direct channels sales. |
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Selling, General and Administrative
Selling, general and administrative expenses for the six months ended July 2, 2005 were $29.6
million, or 30% of product sales, compared to $26.8 million, or 32% of product sales, for the six
months ended July 3, 2004. The $2.8 million increase in spending resulted from:
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Increased personnel costs associated with higher product sales and overall headcount
increases in both the Cardiovascular and ITC segments of $1.6 million, partially offset by
reduced recruiting and consulting fees for the ITC segment of $0.3 million. |
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Higher spending on marketing and related activities, primarily associated with our
HeartHope Center Program and Destination Therapy in the Cardiovascular segment and costs
associated with IRMA and international marketing efforts in the ITC segment totaling $0.6
million. |
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Higher professional fees, including legal, audit and financial consulting services
relating to our compliance with the Sarbanes-Oxley Act of 2002, project related business
development activities and ERP system implementation expenses, of an additional $0.9
million. |
Research and Development
Research and development expenses for the six months ended July 2, 2005 were $15.6 million
compared to $14.7 million for the six months ended July 3, 2004, representing 16% and 18% of
product sales for the respective periods. Our Cardiovascular and ITC segments incurred $0.7 million
and $0.2 million in additional expenses, respectively, year over year. Research and development
costs are largely project driven, and the level of spending depends on the level of project
activity planned and subsequently approved and conducted. The primary component of our research and
development costs is employee salaries and benefits. Research and development costs also include
regulatory and clinical costs associated with our compliance with FDA regulations.
Amortization of Purchased Intangible Assets
Amortization of purchased intangible assets for the first six months of 2005 was $5.6 million
compared to $5.9 million in the same six months of 2004. The decrease of $0.3 million is the result
of changes in business conditions which caused us to modify the remaining economic useful lives of
certain of our core and developed technology assets. These changes were made in accordance with our
periodic valuation of the useful lives of our identifiable intangible assets under FAS 144 as of
January 1, 2005.
Interest Expense
Interest expense for the six months ended July 2, 2005 was $2.0 million compared to $0.4
million for the six months ended July 3, 2004. The expense for the six months ended July 2, 2005
and July 3, 2004, respectively, includes $1.7 million and $0.3 million in interest payments and
$0.3 million and $0.1 million in amortization of the debt issuance costs related to our convertible
notes issued in May 2004.
Interest Income and Other
Interest income and other for the six months ended July 2, 2005 was $1.9 million compared to
$0.9 million for the six months ended July 3, 2004. This increase was primarily due to higher
interest income earned on increased cash and investment balances as a result of the proceeds
received from our May 2004 convertible notes issuance, for the full six months in 2005 compared to
one month out of the first six months of 2004.
Income Taxes
Our effective income tax expense rates were 34% and 37% for the first six months of 2005 and
2004, respectively. The change in our projected annual tax rate is due primarily to our
profitability on a comparative basis. The reduction in our effective tax expense rate is due
primarily to additional interest income from tax favorable investments and increased research tax
credits. In addition, we have provided adequate amounts for anticipated tax audit adjustments in
the U.S., state and other foreign tax jurisdictions based on our estimate of whether, and the
extent to which, additional taxes and interest may be due. If events occur which indicate payment
of these amounts are unnecessary or the liability proves to be more than anticipated, the reversal
of the liabilities would result in tax benefits being recognized or a further charge to expense
would result in the period the event occurs.
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Our effective tax rate is calculated based on the statutory tax rate imposed on projected
annual pre-tax income or loss in various jurisdictions. Since relatively small changes in our
forecasted profitability for 2005 can significantly affect our projected annual effective tax rate,
we believe our quarterly tax expense rate of 34% is the most reliable estimate of our effective tax
expense rate. Accordingly, our tax rate for the remainder of 2005 will be largely dependent on our
profitability and could fluctuate significantly.
Liquidity and Capital Resources
At July 2, 2005, we had working capital of $226.0 million compared with $206.3 million at
January 1, 2005. Cash and cash equivalents at July 2, 2005 were $20.4 million compared to $16.0
million at January 1, 2005. The increase is due primarily to cash generated from operations and
proceeds from stock option exercises, offset in part by net purchases of property, plant and
equipment and purchases of investment securities.
Cash provided by operating activities for the six months ended July 2, 2005 was $20.6 million.
This included net income of $5.6 million and non-cash adjustments to net income of $10.6 million
primarily made up of $9.4 million for depreciation and amortization and $2.1 million related to tax
benefits on stock options, partially offset by a $2.1 million change in the deferred tax liability.
Additionally, $3.4 million was provided by a decrease in accounts receivable, primarily due to an
overall decrease of 4 days in our consolidated DSOs due to timing of sales, and $2.3 million
provided by an increase in accounts payable and other liabilities, driven by increased accruals for
income taxes and personnel related costs. These increases were partially offset by an increase in
cash used for inventory of $1.6 million. Investing activities used $21.8 million, with $19.0
million net purchases of investment securities and $2.9 million to acquire property, plant and
equipment, net of $0.7 million in product inventory transfers for demonstration purposes. The
purchases of property, plant and equipment consisted of equipment purchases of $3.6 million, of
which $1.9 million of the purchases relates to the Cardiovascular segment and $1.7 million relates
to the ITC segment. Cash provided by financing activities for the six months ended July 2, 2005 was
$6.1 million, including $8.3 million from proceeds related to stock option exercises and purchases
under our Employee Stock Purchase Plan partially offset by, $2.2 million paid to repurchase 0.2
million shares of stock under our stock repurchase programs.
In March 2005, we agreed to purchase a new ERP system for our ITC segment. The estimated cost
of the purchased software licenses, hardware, implementation costs and consulting for the ERP
system is approximately $0.8 million over the 2005 fiscal year, of which $0.6 million was paid in
the first six months of 2005.
We believe that cash and cash equivalents, short-term available-for-sale investments on hand
and expected cash flows from operations, will be sufficient to fund our operations, capital
requirements and stock repurchase programs for at least the next twelve months.
FACTORS THAT MAY AFFECT FUTURE RESULTS
Our business faces many risks. These risks include those related to the development of new
products and markets including Destination Therapy, the growth of existing markets for our
products, customer and physician acceptance of our products, changes in the mix of our product
sales, and the related gross margins for such product sales, the results of clinical trials,
including those for the HeartMate II, the ability to improve financial performance, regulatory
approval processes, the effect of healthcare reimbursement and coverage policies, our product
sales, the effects of price competition from any of our competitors and the effects of any merger
and acquisition related activities. The risks described below are what we believe to be the
material risks facing our company. However, the risks described below may not be the only risks we
face. Additional risks that we do not yet know of or that we currently believe are immaterial may
also impair our business operations. If any of the events or circumstances described in the
following risk factors actually occurs, our business, financial condition or results of operations
could suffer, and the trading price of our common stock could decline significantly. Investors
should consider the following risks, as well as the other information included in this Quarterly
Report and our Annual Report on Form 10-K, and other documents we file from time to time with the
SEC, such as our current reports on Form 8-K and any public announcements we make from time to
time.
We have a history of net losses.
We were founded in 1976 and we have a history of incurring losses from operations. We
anticipate that our expenses will increase as a result of increased pre-clinical and clinical
testing, research and development and selling, general and administrative expenses. We could also
incur significant additional costs in connection with our business development activities and the
development and marketing of new products and indicated uses for our existing products as well as
litigation and equity based compensation costs. Such costs could prevent us from achieving or
maintaining profitability in future periods.
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Since our physician and hospital customers depend on third party reimbursement, if third party
payors fail to provide appropriate levels of reimbursement for our products, our results of
operations will be harmed.
Significant uncertainty exists as to the reimbursement status of newly approved health care
products such as VADs and vascular grafts, which uncertainty can delay or prevent adoption in
volume by hospitals. Government and other third party payors are increasingly attempting to contain
health care costs. Payors are attempting to contain costs by, for example, limiting coverage and
the level of reimbursement of new therapeutic products. Payors are also attempting to contain costs
by refusing, in some cases, to provide any coverage for uses of approved products for disease
indications other than those for which the FDA has granted marketing approval.
To date, a majority of private insurers with whom we have been involved and the Centers for
Medicine & Medicaid Services, or the CMS, have determined to reimburse some portion of the cost of
our VADs and our diagnostic and vascular graft products, but we cannot estimate what portion of
such costs will be reimbursed and our products may not continue to be approved for reimbursement.
In addition, changes in the health care system may affect the reimbursability of future products.
If coverage is not expanded or if the reimbursement levels are not increased or are partially or
completely reduced, our revenues would be reduced.
If we fail to obtain approval from the FDA and from foreign regulatory authorities, we cannot
market and sell our products under development in the United States and in other countries, and if
we fail to adhere to ongoing FDA Quality System Regulations, the FDA may withdraw our market
clearance or take other action.
Before we can market new products in the United States, we must obtain clearance from the FDA.
This process is lengthy and uncertain. In the United States, one must obtain clearance from the FDA
of a 510(k) pre-market notification or approval of a more extensive submission known as a PMA
application. If the FDA concludes that any of our products does not meet the requirements to obtain
clearance under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, then we would be
required to file a PMA application. The process for a PMA application is lengthy, expensive and
typically requires extensive pre-clinical and clinical trial data.
We may not obtain clearance of a 510(k) notification or approval of a PMA application with
respect to any of our products on a timely basis, if at all. If we fail to obtain timely clearance
or approval for our products, we will not be able to market and sell them, thereby harming our
ability to generate sales. The FDA may also limit the claims that we can make about our products.
We may also be required to obtain clearance of a 510(k) notification or PMA Supplement from the FDA
before we can market products that have been cleared, but we have since modified or that we
subsequently wish to market for new disease indications.
The FDA also requires us to adhere to Quality System Regulations, which include production
design controls, testing, quality control, storage and documentation procedures. The FDA may at any
time inspect our facilities to determine whether we have adequate compliance. Compliance with
Quality System Regulations for medical devices is difficult and costly. In addition, we may not be
found to be compliant as a result of future changes in, or interpretations of, regulations by the
FDA or other regulatory agencies. If we do not achieve compliance, the FDA may withdraw marketing
clearance, require product recall or take other enforcement action, which in each case would harm
our business. Any change or modification to a device is required to be made in compliance with
Quality System Regulations, which compliance may cause interruptions or delays in the marketing and
sale of our products. The FDA also requires device manufacturers to submit reports regarding
deaths, serious injuries and certain malfunctions relating to use of their products.
Sales of our products outside the United States are subject to foreign regulatory requirements
that vary from country to country. The time required to obtain approvals from foreign countries may
be longer or shorter than that required for FDA approval, and requirements for foreign licensing
may differ from FDA requirements. In any event, if we fail to obtain the necessary approvals to
sell any of our products in a foreign country, we will not be able to sell those products there.
The federal, state and foreign laws and regulations regarding the manufacture and sale of our
products are subject to future changes, as are administrative interpretations and policies of
regulatory agencies. If we fail to comply with applicable federal, state or foreign laws or
regulations, we could be subject to enforcement actions. Enforcement actions could include product
seizures, recalls, withdrawal of clearances or approvals, and civil and criminal penalties, which
in each case would harm our business.
Certain lawsuits have been filed against us.
Commencing on or about August 3, 2004, several Federal securities law putative class action
suits were filed in the United States District Court for the Northern District of California on
behalf of purchasers of the publicly traded securities of the Company between
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April 28, 2004 and June 29, 2004. These suits were consolidated in a consolidated complaint
filed on or about January 18, 2005. The complaint seeks to recover unspecified damages on behalf of
all purchasers of our publicly traded securities during the class period.
On or about September 1, 2004, a shareholder derivative action entitled Wong v. Grossman was
filed in the California Superior Court for Alameda County based upon essentially the same facts as
the Federal securities suit. This action names the individual members of our Board of Directors,
our Chief Executive Officer and our former Chief Financial Officer as defendants.
In June of 2004, MicroMed Technology, Inc. (MicroMed), a potential competitor of the
Company, sued the Company in Texas. MicroMed sought injunctive relief and unspecified damages and
fees against the Company in connection with the Companys HeartMate II phase I clinical trial on
the grounds that the Company had provided the HeartMate II VAD to clinical sites without charge and
that doing so was a violation of Texas anti-trust law. Based on our discussions with MicroMed
Technology Inc.s counsel and from documents filed with the SEC, we believe that MicroMed intends
to abandon this law suit.
We believe that the claims asserted in the MicroMed action, and both the Federal securities
law putative class action and the state shareholder derivative action are without merit. We have
filed a motion to dismiss in the Federal securities law putative class action and the shareholder
suit currently is stayed until at least October 2005.
We are unable to predict at this time the final outcome of these actions.
We carry sufficient insurance to cover what management believes to be any reasonable exposure
on these actions; however, we cannot give assurance that our insurance will cover all costs or
other exposures we may incur with respect to these actions.
Our debt obligations expose us to risks that could adversely affect our business, operating results
and financial condition.
We have a substantial level of debt. The terms of our convertible notes do not restrict our
ability to incur additional indebtedness, including indebtedness senior to the convertible notes.
The level of our indebtedness, among other things, could:
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make it difficult for us to make payments on our debt; |
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make it difficult for us to obtain any necessary financing in the future for working
capital, capital expenditures, debt service, acquisitions or general corporate purposes; |
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limit our flexibility in planning for or reacting to changes in our business; |
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reduce funds available for use in our operations; |
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impair our ability to incur additional debt because of financial and other restrictive
covenants proposed for any such additional debt; |
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make us more vulnerable in the event of a downturn in our business or an increase in
interest rates; or |
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place us at a possible competitive disadvantage relative to less leveraged competitors
and competitors that have better access to capital resources. |
If we experience a decline in product sales due to any of the factors described in this
section or otherwise, we could have difficulty paying interest or principal amounts due on our
indebtedness. If we are unable to generate sufficient cash flow or otherwise obtain funds necessary
to make required payments, or if we fail to comply with the various requirements of our
indebtedness, including the convertible notes, we would be in default, which would permit the
holders of our indebtedness to accelerate the maturity of the indebtedness and could cause defaults
under our other indebtedness. Any default under our indebtedness could have a material adverse
effect on our business, operating results and financial condition.
If hospitals do not conduct Destination Therapy procedures using our VADs, our product sales will
be diminished.
The use of our VADs as long-term therapy in patients who are not candidates for heart
transplantation (i.e., they are Destination Therapy patients) was approved by the FDA in 2002, and
was approved for reimbursement by the CMS in late 2003.
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The number of Destination Therapy procedures actually performed depends on many factors, most
of which are out of our direct control, including:
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the number of CMS sites approved for Destination Therapy; |
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the clinical outcomes of Destination Therapy procedures; |
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cardiologists and referring physicians education, and their commitment to Destination Therapy; |
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the economics of the Destination Therapy procedure for individual hospitals, which
include the costs of the VAD and related pre- and post-operative procedures and their
reimbursement; |
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the impact of changes in reimbursement rates on the timing of purchases of VADs for
Destination Therapy; and |
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the economics for individual hospitals of not conducting a Destination Therapy procedure,
including the costs and related reimbursements of long-term hospitalization. |
The different outcomes of these and other factors, and their timing, will have a significant
impact on our future operating results. Sales of our VADs for Destination Therapy have proved
slower than we had originally anticipated, and we are unable to predict when, if ever, these sales
will generate significant revenue for us.
The long and variable sales and deployment cycles for our VAD systems may cause our product sales
and operating results to vary significantly, which increases the risk of an operating loss for any
given fiscal period.
Our VAD systems have lengthy sales cycles and we may incur substantial sales and marketing
expenses and expend significant effort without making a sale. Even after making the decision to
purchase our VAD systems, our customers often deploy our products slowly. For example, the length
of time between initial contact with cardiac surgeons and the purchase of our VAD systems is
generally between nine and eighteen months. In addition, the cardiac centers that buy the majority
of our products are usually led by cardiac surgeons who are heavily recruited by competing centers
or by centers looking to increase their profiles. When one of these surgeons moves to a new center
we sometimes experience a temporary but significant reduction in purchases by the departed center
while it replaces its lead surgeon. As a result, it is difficult for us to predict the quarter in
which customers may purchase our VAD systems and our product sales and operating results may vary
significantly from quarter to quarter, which increases the risk of an operating loss for us for any
given quarter. In particular, sales of our VADs for Destination Therapy have been lower than we had
originally anticipated, and we cannot predict when, if ever, sales of our VADs for this indication
will generate the level of revenues we expect.
Physicians may not accept or continue to accept our current products and products under
development.
The success of our current and future products will require acceptance or continued acceptance
by cardiovascular and vascular surgeons, and other medical professionals. Such acceptance will
depend on clinical results and the conclusion by these professionals that our products are safe,
cost-effective and acceptable methods of treatment. Even if the safety and efficacy of our future
products are established, physicians may elect not to use them for a number of reasons. These
reasons could include the high cost of our VAD systems, restrictions on insurance coverage,
unfavorable reimbursement from health care payors, or use of alternative therapies. Also, economic,
psychological, ethical and other concerns may limit general acceptance of our ventricular assist,
graft and other products.
Our future product sales will be affected by the number of heart transplants conducted.
A significant amount of our current product sales is generated by our VADs implanted
temporarily in patients awaiting heart transplants. The number of heart transplants conducted
worldwide depends on the number of hearts available to transplant, which number in turn depends on
the death rate of otherwise healthy people from events such as automobile accidents.
We have experienced rapid growth and changes in our business, and our failure to manage this and
any future growth could harm our business.
The number of our employees has substantially increased during the past several years. We
expect to continue increasing the number of our employees, and our business may suffer if we do not
manage and train our new employees effectively. Our product sales may not continue to grow at a
rate sufficient to support the costs associated with an increasing number of employees. Any future
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periods of rapid growth may place significant strains on our managerial, financial and other
resources. The rate of any future expansion, in combination with our complex technologies and
products, may demand an unusually high level of managerial effectiveness in anticipating, planning,
coordinating and meeting our operational needs as well as the needs of our customers.
If we fail to successfully introduce new products, our future growth may suffer.
As part of our growth strategy, we intend to develop and introduce a number of new products
and product improvements. We also intend to develop new indications for our existing products. For
example, we are currently developing updated versions of our HeartMate products. If we fail to
commercialize these new products, product improvements and new indications on a timely basis, or if
they are not well accepted by the market, our future growth may suffer.
Amortization of our intangible assets, which represent a significant portion of our total assets,
will adversely affect our net income and we may never realize the full value of our intangible
assets.
A substantial portion of our assets are comprised of goodwill and purchased intangible assets.
We may not receive the recorded value for our intangible assets if we sell or liquidate our
business or assets. The material concentration of intangible assets increases the risk of a large
charge to earnings if the revenue from, and recoverability of, these intangible assets is impaired.
We completed an assessment of the current values of our intangible assets at the end of fiscal 2004
and determined that no impairment exists; however, the lives have been modified on several
components of these identified assets. In the event however, of such a charge to net income, the
market price of our common stock could be adversely affected. For example, in the first quarter of
2004, we completed an assessment of the final results from the feasibility clinical trial for the
Aria CABG graft, which was ongoing through fiscal 2003. Based on the clinical trial results, we
determined not to devote additional resources to development of the Aria graft. Upon the decision
to discontinue product development, we recorded an impairment charge of approximately $9 million as
of January 3, 2004 to write off purchased intangible assets related to the Aria graft, recorded as
a result of our merger with TCA.
We may encounter problems manufacturing our products.
We may encounter difficulties manufacturing our products. We do not have experience in
manufacturing some of our products in the commercial quantities that might be required if we
receive FDA approval of several or all of the products and indications currently under development,
including the HeartMate II VAD. If we have difficulty manufacturing any of our products, our
business will be harmed.
We rely on specialized suppliers for certain components and materials in our products and
alternative suppliers may not be available.
We depend on a number of custom-designed components and materials supplied by other companies
including, in some cases, single source suppliers for components, instruments and materials used in
our VAD products and blood testing products. For example, single sources currently manufacture and
supply our ProTime and Hemoglobin instruments and the heart valves used in our HeartMate products.
The suppliers of our ProTime and Hemoglobin products are located in China and Germany,
respectively. We do not have long-term written agreements with most of our vendors and from these
vendors receive components on a purchase order basis only. If we need alternative sources for key
raw materials or component parts for any reason, such alternative sources may not be available and
our inventory may not be sufficient to fill orders before we find alternative suppliers or begin
manufacturing these components or materials ourselves. Cessation or interruption of sales of
circulatory support products or our point-of-care products would seriously harm our business,
financial condition and results of operations.
Alternative suppliers, if available, may not agree to supply us. In addition, we may require
FDA approval before using new suppliers or manufacturing our own components or materials. Existing
suppliers could also become subject to an FDA enforcement action, which could also disrupt our
supplies. If alternative suppliers are not available, we may not have the expertise or resources
necessary to produce these materials or component parts internally.
Because of the long product development cycle in our business, suppliers may discontinue
components upon which we rely before the end of life of our products. In addition, the timing of
the discontinuation may not allow us time to develop and obtain FDA approval for a replacement
component before we exhaust our inventory of the legacy component.
If suppliers discontinue components on which we rely, we may have to:
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pay premium prices to our suppliers to keep their production lines open or to obtain
alternative suppliers; |
27
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buy substantial inventory to last through the scheduled end of life of our product, or
through such time that we will have a replacement product developed and approved by the FDA;
or |
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stop shipping the product in which the legacy component is used once our inventory of the
discontinued component is exhausted. |
Any of these interruptions in the supply of our materials could result in substantial
reductions in product sales and increases in our production costs.
If we fail to compete successfully against our existing or potential competitors, our product sales
or operating results may be harmed.
Competition from medical device companies and medical device subsidiaries of health care and
pharmaceutical companies is intense and is expected to increase. Principal competitors for the VAD
system include WorldHeart Corporation, MicroMed Technology, Inc., Abiomed, Inc., and Berlin Heart
in Europe. Principal competitors in the vascular graft market include W.L. Gore, Inc., C.R. Bard
Corporation, which is also a distributor of our Vectra product line, and Boston Scientific
Corporation. Principal competitors in the hospital coagulation and blood gas monitoring equipment
market include the Cardiac Surgery Division of Medtronic, Inc., iSTAT, Radiometer, Abbott
Diagnostics, and Instrument Laboratories. Our primary competitor in the skin incision device market
is Becton, Dickson and Company. Competitors in the alternate site point-of-care diagnostics market
include Roche Diagnostics and HemoSense.
Many of our competitors have substantially greater financial, technical, distribution,
marketing and manufacturing resources than we have. Accordingly, our competitors may be able to
develop, manufacture and market products more efficiently and at a lower cost than we can. We
expect that the key competitive factors will include the relative speed with which we can:
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develop products; |
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complete clinical testing; |
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receive regulatory approvals; and |
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manufacture and sell commercial quantities of products. |
Large medical device companies dominate the markets in which ITC competes. We expect that any
growth in this market will come from expanding our market share at the expense of other companies,
and from testing being shifted away from central laboratories to the point-of-care. However, this
market segment is very competitive, and includes the following potential drivers:
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New drug therapies under development may not require the intense monitoring of a
patients coagulation that the current anti-coagulation drug of choice (Heparin) requires. |
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New competitors might enter the market with broader test menus. |
Any of the devices of our competitors in clinical trials and in development could prove to be
clinically superior, easier to implant, and/or less expensive than current commercialized devices,
thereby impacting Thoratecs marketshare.
The price of our common stock may fluctuate significantly.
The price of our common stock has been, and is likely to continue to be, highly volatile,
which means that it could decline substantially within a short period of time. For example our
stock price has ranged from $8.46 to $15.60 in the 12 months ended July 2, 2005. The price of our
common stock could fluctuate significantly for many reasons, including the following:
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future announcements concerning us or our competitors; |
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timing and reaction to the publication of clinical trial results; |
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quarterly variations in operating results, which we have experienced in the past
and expect to experience in the future; |
28
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charges, amortization and other financial effects relating to our merger with TCA; |
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introduction of new products or changes in product pricing policies by us or our competitors; |
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acquisition or loss of significant customers, distributors or suppliers; |
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business acquisitions or divestitures; |
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changes in earnings estimates by analysts; |
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changes in third party reimbursement practices; |
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regulatory developments, enforcement actions bearing on advertising, marketing or sales,
and disclosure regarding completed ongoing or future clinical trials; and |
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fluctuations in the economy, world political events or general market conditions. |
In addition, stock markets in general, and the market for shares of health care stocks in
particular, have experienced extreme price and volume fluctuations in recent years, which
fluctuations have frequently been unrelated to the operating performance of the affected companies.
These broad market fluctuations may adversely affect the market price of our common stock. The
market price of our common stock could decline below its current price and the market price of our
stock may fluctuate significantly in the future. These fluctuations may be unrelated to our
performance.
Shareholders have often instituted securities class action litigation after periods of
volatility in the market price of a companys securities. Several securities class action suits
have been filed against us, and if other such suits are filed against us in the future, we may
incur substantial legal fees and our managements attention and resources would be diverted from
operating our business in order to respond to the litigation. See Certain lawsuits have been filed
against us above.
Since we depend upon distributors, if we lose a distributor or a distributor fails to perform, our
operations may be harmed.
With the exception of Canada and the larger countries in Europe, we sell our Thoratec VAD and
HeartMate systems in foreign markets through distributors. In addition, we sell our vascular access
graft products through the Bard Peripheral Vascular division of C.R. Bard Corporation (which is
also a competitor of ours) in the United States, and selected countries in Europe, the Middle East
and Africa, and through Goodman Co. Ltd. in Japan. Substantially all of the international
operations and a large portion of the alternate site domestic operations of ITC are conducted
through distributors. For the three and six months ended July 2, 2005, 10% and 17% respectively, of
ITCs total product sales were through Cardinal Healthcare, a distributor of our blood coagulation
testing equipment and skin incision devices.
To the extent we rely on distributors, our success will depend upon the efforts of others,
over which we may have little or no control. If we lose a distributor or a distributor fails to
perform to our expectations, our product sales may be harmed.
Changes we make to our method of distributing and selling our products could hurt our relationship
with distributors and their customers.
In March 2004, we began changing our manner of distributing our Hemochron product line to our
hospital point-of-care customers in the United States from a distributor model to a direct sales
model.
This transition to a direct sales model necessitated expanding the sales, technical service,
customer service and shipping headcount at ITC in order to provide our customers with the support
and service that they historically obtained from our distributors, resulting in an increase in our
sales and general and administrative costs. This transition process concluded in the first quarter
of 2005, which resulted in the United States hospital point-of-care market now being served
directly and exclusively by ITC. This transition and its execution involve significant risks,
including:
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the promotion by our former distributors of products from competitors rather than our products; |
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the potential loss of customers who prefer to deal with a particular distributor; and |
29
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the challenges and costs associated with building an effective direct sales force. |
If we fail to build an effective direct sales force for our hospital point-of-care product
lines, our revenues may fail to increase as expected or could decrease, which could adversely
affect our results of operations and financial condition.
Our inability to protect our proprietary technologies or an infringement of others patents could
harm our competitive position.
We rely on patents, trade secrets, copyrights, know-how, trademarks, license agreements and
contractual provisions to establish our intellectual property rights and protect our products.
These legal means, however, afford only limited protection and may not adequately protect our
rights. In addition, we cannot assure you that any of our pending patent applications will issue.
The Patent and Trademark Office, or PTO, may deny or significantly narrow claims made under patent
applications and the issued patents, if any, may not provide us with commercial protection. We
could incur substantial costs in proceedings before the PTO or in any future litigation to enforce
our patents in court. These proceedings could result in adverse decisions as to the validity and/or
enforceability of our patents. In addition, the laws of some of the countries in which our products
are or may be sold may not protect our products and intellectual property to the same extent as
U.S. laws, if at all. We may be unable to protect our rights in trade secrets and unpatented
proprietary technology in these countries.
Our commercially available VAD products, which account for a majority of our sales, generally
are not protected by any patents. We rely principally on trade secret protection and, to a lesser
extent, patents to protect our rights to our HeartMate product line. We rely principally on patents
to protect our coagulation testing equipment, skin incision devices, Hemochron disposable cuvettes,
IRMA analyzer, IRMA disposable cartridges, and Hgb Pro disposable test strips.
We seek to protect our trade secrets and unpatented proprietary technology, in part, with
confidentiality agreements with our employees and consultants. Although it is our policy to require
that all employees and consultants sign such agreements, we cannot assure you that every person who
gains or has gained access to such information has done so. Moreover, these agreements may be
breached and we may not have an adequate remedy.
Our products may be found to infringe prior or future patents owned by others. We may need to
acquire licenses under patents belonging to others for technology potentially useful or necessary,
and such licenses may not be available to us. We could incur substantial costs in defending suits
brought against us on such patents or in bringing suits to protect our patents or patents licensed
by us against infringement.
For example, in 2003, a patent infringement claim was filed against us by Bodycote Materials
Testing Canada, Inc. and David C. MacGregor, M.D. related to materials used in the HeartMate LVAS.
On February 3, 2004, we settled the claim and recorded a charge of $2.3 million in the fourth
quarter of 2003 for the settlement and related legal costs.
Product liability claims could damage our reputation and hurt our financial results.
Our business exposes us to an inherent risk of potential product liability claims related to
the manufacturing, marketing and sale of human medical devices. We maintain a limited amount of
product liability insurance. Our insurance policies generally must be renewed on an annual basis.
We may not be able to maintain or increase such insurance on acceptable terms or at reasonable
costs, and such insurance may not provide us with adequate coverage against potential liabilities.
A successful claim brought against us in excess, or outside, of our insurance coverage could
seriously harm our financial condition and results of operations. Claims against us, regardless of
their merit or potential outcome, may also reduce our ability to obtain physician acceptance of our
products or expand our business.
Identified quality problems can result in substantial costs and write-downs.
FDA regulations require us to track materials used in the manufacture of our products, so that
any problems identified in a finished product can easily be traced back to other finished products
containing the defective materials. In some instances, identified quality issues require scrapping
or expensive rework of the affected lot(s), not just the tested defective product, and could also
require us to stop shipments.
In addition, since some of our products are used in situations where a malfunction can be life
threatening, identified quality issues can result in the recall and replacement, generally free of
charge, of substantial amounts of product already implanted or otherwise in the marketplace.
30
Any quality issue identified can therefore both harm our business reputation and result in
substantial costs and write-offs, which could materially harm our financial results.
If we make acquisitions or divestitures, we could encounter difficulties that harm our business.
We may acquire companies, products or technologies that we believe to be complementary to our
business. If we do so, we may have difficulty integrating the acquired personnel, operations,
products or technologies and we may not realize the expected benefits of any such acquisition. In
addition, acquisitions may dilute our earnings per share, disrupt our ongoing business, distract
our management and employees and increase our expenses, which could harm our business. We may also
sell businesses or assets as part of our strategy or if we receive offers from third parties. If we
do so, we may sell an asset or business for less than its full value.
Our non-U.S. sales present special risks.
A substantial portion of our total sales occurs outside the United States. We anticipate that
sales outside the United States and U.S. export sales will continue to account for a significant
percentage of our product sales and we intend to continue to expand our presence in international
markets. Non-U.S. sales are subject to a number of special risks. For example:
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we generally sell many of our products at a lower price outside the United States; |
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sales agreements may be difficult to enforce; |
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receivables may be difficult to collect through a foreign countrys legal system; |
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foreign customers may have longer payment cycles; |
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foreign countries may impose additional withholding taxes or otherwise tax our foreign
income, impose tariffs or adopt other restrictions on foreign trade; |
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U.S. export licenses may be difficult to obtain; |
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intellectual property rights may be (and often are) more difficult to enforce in foreign countries; |
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terrorist activity or war may interrupt distribution channels or adversely impact our
customers or employees; and |
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fluctuations in exchange rates may affect product demand and adversely affect the
profitability, in U.S. dollars, of products sold in foreign markets where payments are made
in local currencies. |
Any of these events could harm our operations or operating results.
Any claims relating to improper handling, storage or disposal of hazardous chemicals and
biomaterials could be time consuming and costly.
Producing our products requires the use of hazardous materials, including chemicals and
biomaterials. We cannot eliminate the risk of accidental contamination or discharge and any
resultant injury from these materials.
We could be subject to both criminal liability and civil damages in the event of an improper
or unauthorized release of, or exposure of individuals to, hazardous materials. In addition,
claimants may sue us for injury or contamination that results from our use or the use by third
parties of these materials, and our liability may exceed our total assets. Compliance with
environmental laws and regulations is expensive, and current or future environmental regulations
may impair our research, development or production efforts or harm our operating results.
The occurrence of a catastrophic disaster or other similar events could cause damage to our
facilities and equipment, which would require us to cease or curtail operations.
We are vulnerable to damage from various types of disasters, including earthquake, fire,
terrorist acts, flood, power loss, communications failures and similar events. For example, in
October 1989, a major earthquake that caused significant property
31
damage and a number of fatalities struck near the area in which our Pleasanton, California
facility is located. If any such disaster were to occur, we may not be able to operate our business
at our facilities, in particular because our premises require FDA approval, which could result in
significant delays before we can manufacture products from a replacement facility. The insurance we
maintain may not be adequate to cover our losses resulting from disasters or other business
interruptions. Therefore, any such catastrophe could seriously harm our business and results of
operations.
If we are unable to favorably assess the effectiveness of our internal control over financial
reporting, or if our independent auditors are unable to provide an unqualified attestation report
on our assessment, our stock price could be adversely affected.
Under the Sarbanes-Oxley Act of 2002, or the Act, beginning in 2004 we are required to assess
the effectiveness of our internal controls for financial reporting annually and assert that such
internal controls are effective. Our independent auditors must evaluate managements assessment of
the effectiveness of our internal controls over financial reporting and render an opinion on
managements assessment and the effectiveness of our internal controls over financial reporting.
The Act has resulted in and is likely to continue to result in increased expenses, and has required
and is likely to continue to require significant efforts by management and other employees.
Although we believe that our efforts will enable us to remain compliant under the Act, we can give
no assurance that in the future such efforts will be successful. Our business is complex and
involves significant judgments and estimates as described in our Critical Accounting Estimates
above. If we have material weaknesses in internal controls, we will not be able to assert that our
internal controls over financial reporting are effective, which could adversely affect investor
confidence in us and the market price of our common stock.
Fluctuations in foreign currency exchange rates could result in declines in our reported sales and
earnings.
Because some of our international sales are denominated in local currencies and not in U.S.
dollars, our reported sales and earnings are subject to fluctuations in foreign exchange rates. At
present, we use forward foreign currency contracts to hedge the gains and losses created by the
remeasurement of non-functional currency denominated assets and liabilities. However, we do not
engage in hedge exposures that will arise from future sales. As a result, sales occurring in the
future that are denominated in foreign currencies may be translated into U.S. dollars at a less
favorable rate than our current exchange rate environment resulting in reduced revenues and
earnings.
The competition for qualified personnel is particularly intense in our industry. If we are unable
to retain or hire key personnel, we may not be able to sustain or grow our business.
Our ability to operate successfully and manage our potential future growth depends
significantly upon retaining key research, technical, sales, marketing, managerial and financial
personnel, and attracting and retaining additional highly qualified personnel in these areas. We
face intense competition for such personnel, and we may not be able to attract and retain these
individuals. We compete for talent with numerous companies, as well as universities and nonprofit
research organizations, throughout all our locations. The loss of key personnel for any reason or
our inability to hire and retain additional qualified personnel in the future could prevent us from
sustaining or growing our business. Our success will depend in large part on the continued services
of our research, managerial and manufacturing personnel. We cannot assure you that we will continue
to be able to attract and retain sufficient qualified personnel.
We may be unable to repay or repurchase our convertible notes or our other indebtedness.
At maturity, the entire outstanding principal amount of our convertible notes will become due
and payable. Holders of the convertible notes may also require us to repurchase the convertible
notes on May 16 in each of 2011, 2014, 2019, 2024 and 2029. In addition, if certain fundamental
changes to our company occur, the holders of the convertible notes may require us to repurchase all
or any portion of their convertible notes. We may not have sufficient funds or may be unable to
arrange for additional financing to pay the principal amount due at maturity or the repurchase
price of the convertible notes. Any such failure would constitute an event of default under the
indenture, which could, in turn, constitute a default under the terms of any other indebtedness we
may have incurred. Any default under our indebtedness could have a material adverse effect on our
business, operating results and financial condition.
Conversion of the convertible notes or other future issuances of our stock will dilute the
ownership interests of existing shareholders.
The conversion of some or all of the convertible notes will dilute the ownership interest of
our existing shareholders. Any sales in the public market of the common stock issuable upon such
conversion could adversely affect prevailing market prices of our common stock. Further, the
existence of the convertible notes may encourage short selling by market participants because the
conversion of the convertible notes could depress the price of our common stock. In addition,
future sales of substantial amounts of our stock in the
32
public market, or the perception that such sales could occur, could adversely affect the
market price of our stock. Sales of our shares and the potential for such sales could cause our
stock price to decline.
Our adoption of Emerging Issues Task Force (EITF) Issue No. 04-8 in the fourth quarter of
2004, which requires the inclusion of all shares available upon conversion of our convertible notes
in our diluted earnings per share, or EPS, regardless of whether the notes are then convertible,
did not have a material impact on our consolidated results for the periods in which the notes were
outstanding as the effect of the 7.3 million shares was anti-dilutive. However, if in future
periods the shares are dilutive, then 7.3 million shares will be added to our share count used to
calculate diluted earnings per share, and this inclusion could result in significantly lower
diluted EPS than if we had not adopted EITF 04-8.
Anti-takeover defenses in our governing documents could prevent an acquisition of our company or
limit the price that investors might be willing to pay for our common stock.
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Our governing documents could make it difficult for another company to acquire control of our
company. For example: |
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Our Articles of Incorporation allow our Board of Directors to issue, at any time and
without shareholder approval, preferred stock with such terms as it may determine. No shares
of preferred stock are currently outstanding. However, the rights of holders of any of our
preferred stock that may be issued in the future may be superior to the rights of holders of
our common stock. |
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We have a rights plan, commonly known as a poison pill, which would make it difficult
for someone to acquire our company without the approval of our Board of Directors. |
All or any one of these factors could limit the price that certain investors would be willing
to pay for shares of our common stock and could delay, prevent or allow our Board of Directors to
resist an acquisition of our company, even if the proposed transaction was favored by a majority of
our independent shareholders.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE OF MARKET RISK
Interest Rate Risk
Our investment portfolio is made up of cash equivalent and marketable investments in auction
rate securities, money market funds, debt instruments of government agencies, U.S. Treasuries,
local municipalities, and high quality corporate issuers. All investments are carried at market
value and are treated as available-for-sale. All investments mature within two years or less from
the date of purchase, except for some investments in U.S. Treasuries held as restricted investments
as collateral for future interest payments related to our convertible notes, which mature within
three years from the date of purchase. Our holdings of the securities of any one issuer, except
government agencies, do not exceed 10% of the portfolio. If interest rates rise, the market value
of our investments may decline which could result in a loss if we are forced to sell an investment
before the scheduled maturity. If interest rates were to rise or fall from current levels by 25
basis points or less the change in our net unrealized loss on investments would be nominal. We do
not utilize derivative financial instruments to manage interest rate risk.
Our convertible notes do not bear interest rate risk as the notes were issued at a fixed rate
of interest. The aggregate fair value of the convertible notes at July 2, 2005, based on market
quotes, was $143.2 million.
Foreign Currency Rate Fluctuations
We conduct business in foreign countries. Our international operations consist primarily of
sales and service personnel for our ventricular assist products who report to our U.S. sales and
marketing group and are internally reported as part of that group. All assets and liabilities of
our non-U.S. operations are translated into U.S. dollars at the period-end exchange rates and the
resulting translation adjustments are included in comprehensive income. The period-end translation
of the non-functional currency assets and liabilities (primarily assets and liabilities on our UK
subsidiarys consolidated balance sheet that are not denominated in UK Pounds Sterling) at the
period-end exchange rates result in foreign currency gains and losses, which are included in
Interest Income and Other.
We use forward foreign currency contracts to hedge the gains and losses generated by the
revaluation of these non-functional currency assets and liabilities. These derivatives are not
designated as cash flow or fair value hedges under SFAS No. 133. As a result, changes in the fair
value of the forward foreign currency contracts are included in Interest Income and Other. The
change in the fair value of the forward foreign currency contracts typically offsets the change in
value from revaluation of the non-functional currency
33
assets and liabilities. These contracts typically have maturities of three months or less. At
July 2, 2005, we had forward foreign currency contracts to exchange Pounds Sterling into Euros with
a notional value of $2.9 million and at July 3, 2004 we had a notional value of $9.6 million in
Pounds Sterling and Euros contracts. These contracts had an average exchange rate of Euros to
Pounds Sterling of .6872 and Pounds Sterling to the U.S. Dollar of .5495 as of July 2, 2005. The
impact of fluctuations in foreign currency exchange rates, net of forward foreign currency
contracts, was $0.3 million and $0.1 million for the six month periods ended July 2, 2005 and July
3, 2004, respectively.
ITEM 4. CONTROLS AND PROCEDURES
Attached as exhibits to this Form 10-Q are certifications of our Chief Executive Officer and
principal financial officer, which are required in accordance with Rule 13a-14 of the Securities
Exchange Act of 1934, as amended (the Exchange Act). This Controls and Procedures section
includes information concerning the controls and controls evaluation referred to in the
certifications. Item 8 of our 2004 Annual Report on Form 10-K sets forth the report of Management
and of Deloitte & Touche LLP, our independent registered public accounting firm, regarding its
audit of our internal control over financial reporting and of managements assessment of internal
control over financial reporting.
Disclosure Controls and Procedures
An evaluation was performed under the supervision and with the participation of our
management, including our Chief Executive Officer and principal 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 July 2, 2005. 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 principal
financial officer, concluded that as of July 2, 2005 the Companys disclosure controls and
procedures, as defined in Rule 13a-15(e) under the Exchange Act, were effective.
Changes to Internal Controls
As part of the implementation of section 404 of the Sarbanes Oxley Act, the Company instituted
internal controls that were designed to and did detect the situation which resulted in the
restatement of the pro forma stock compensation fair value disclosures for the years ended January
3, 2004 and December 28, 2002. Management concluded that the control deficiency which resulted in
the restatement was not indicative of a material weakness in internal controls as of January 1,
2005. There have been no changes in our internal controls over financial reporting during the six
months ended July 2, 2005 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 principal financial officer,
does not expect that internal controls will prevent all error and all fraud. A control system, no
matter how well designed and operated, can only provide reasonable assurances that the objectives
of the control system are met. The design of a control system reflects resource constraints; the
benefits of controls must be considered relative to their costs. Because there are inherent
limitations in all control systems, no evaluation of controls can provide absolute assurance that
all control issues and instances of fraud, if any, within the Company have been or will be
detected. As these inherent limitations are known features of the financial reporting process, it
is possible to design into the process safeguards to reduce, though not eliminate, these risks.
These inherent limitations include the realities that judgments in decision-making can be faulty
and that breakdowns occur because of simple error or mistake. Controls can be circumvented by the
individual acts of some persons, by collusion of two or more people, or by management override of
the control. The design of any system of controls is based in part upon certain assumptions about
the likelihood of future events. While our disclosure controls and procedures are designed to
provide reasonable assurance of achieving their objectives, there can be no assurance that any
design will succeed in achieving its stated goals under all future conditions; over time, controls
may become inadequate because of changes in conditions or
34
deterioration in the degree of compliance with the policies or procedures. Because of the
inherent limitations in a cost-effective control system, misstatements due to error or fraud may
occur and not be detected.
We intend to review and evaluate the design and effectiveness of our disclosure controls and
procedures on an ongoing basis and to improve our controls and procedures over time and to correct
any deficiencies that we may discover in the future. While our Chief Executive Officer and
principal financial officer have concluded that, as of July 2, 2005, the design of our disclosure
controls and procedures, as defined in Rule 13a-15(e) under the Exchange Act, was effective, future
events affecting our business may cause us to significantly modify our disclosure controls and
procedures.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
See Note 12 to our unaudited condensed consolidated interim financial statements in this Quarterly
Report on Form 10Q.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
The annual meeting of shareholders was held on May 25, 2005. 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:
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Number of Votes |
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For |
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Withheld |
Howard E. Chase |
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45,003,630 |
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223,114 |
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J. Daniel Cole |
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45,091,586 |
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135,158 |
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Neil F. Dimick |
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45,089,202 |
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137,542 |
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D. Keith Grossman |
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44,972,510 |
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254,234 |
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J. Donald Hill |
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40,623,188 |
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4,603,556 |
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William M. Hitchcock |
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45,092,500 |
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|
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134,244 |
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George W. Holbrook, Jr. |
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40,658,199 |
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4,568,545 |
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Daniel M. Mulvena |
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40,665,990 |
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4,560,754 |
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2. To ratify Deloitte & Touche LLP as companys independent auditors
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Number of Votes |
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For |
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Against |
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Abstain |
Beneficial Common |
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39,128,146 |
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131,223 |
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|
|
10,172 |
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Registered Common |
|
|
5,9525,588 |
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|
|
3,315 |
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1,300 |
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ITEM 6. EXHIBITS
(a) Exhibits:
31.1 |
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Section 302 Certification of Chief Executive Officer |
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31.2 |
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Section 302 Certification of principal financial officer. |
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32.1 |
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Section 906 Certification of Chief Executive Officer |
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32.2 |
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Section 906 of principal financial officer. |
35
SIGNATURES
In accordance with the requirements of the Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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THORATEC CORPORATION
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Date: August 9, 2005 |
/s/ D. Keith Grossman
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D. Keith Grossman, |
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Chief Executive Officer |
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Date: August 9, 2005 |
/s/ Jeffrey M. McCormick
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Jeffrey M. McCormick, |
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Corporate Controller,
(principal financial and accounting officer) |
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36