SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED OCTOBER 1, 2011 OR |
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o | 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: 1-12441
ST. JUDE MEDICAL, INC.
(Exact name of registrant as specified in its charter)
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Minnesota |
| 41-1276891 |
(State or other jurisdiction |
| (I.R.S. Employer |
of incorporation or organization) |
| Identification No.) |
One St. Jude Medical Drive, St. Paul, Minnesota 55117
(Address of principal executive offices, including zip code)
(651) 756-2000
(Registrant’s telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
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, and (2) has been subject to such filing requirements for the past 90 days.x Yeso No
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
x Yeso No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filerx | Accelerated filero |
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Non-accelerated filero (Do not check if a smaller reporting company) | Smaller reporting companyo |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
o Yesx No
The number of shares of common stock, par value $.10 per share, outstanding on October 31, 2011 was 318,989,032.
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ITEM |
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| DESCRIPTION |
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| Note 7 – Purchased In-Process Research and Development (IPR&D)and Special Charges |
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| Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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PART I - FINANCIAL INFORMATION
Item 1. FINANCIAL STATEMENTS
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ST. JUDE MEDICAL, INC. |
(In thousands, except per share amounts) |
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| Three Months Ended |
| Nine Months Ended |
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| October 1, 2011 |
| October 2, 2010 |
| October 1, 2011 |
| October 2, 2010 |
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Net sales |
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| $ | 1,382,558 |
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| $ | 1,239,905 |
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| $ | 4,204,822 |
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| $ | 3,814,370 |
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Cost of sales: |
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Cost of sales before special charges |
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| 362,942 |
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| 339,819 |
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| 1,111,261 |
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| 1,006,290 |
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Special charges |
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| 7,173 |
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| — |
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| 18,219 |
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| — |
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Total cost of sales |
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| 370,115 |
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| 339,819 |
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| 1,129,480 |
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| 1,006,290 |
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Gross profit |
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| 1,012,443 |
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| 900,086 |
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| 3,075,342 |
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| 2,808,080 |
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Selling, general and administrative expense |
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| 505,080 |
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| 438,723 |
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| 1,532,241 |
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| 1,329,623 |
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Research and development expense |
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| 176,320 |
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| 150,135 |
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| 528,387 |
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| 456,469 |
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Purchased in-process research and development charges |
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| — |
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| 12,244 |
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| 4,400 |
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| 12,244 |
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Special charges |
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| 21,376 |
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| — |
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| 53,545 |
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| — |
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Operating profit |
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| 309,667 |
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| 298,984 |
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| 956,769 |
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| 1,009,744 |
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Other income (expense), net |
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| (19,513 | ) |
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| (11,111 | ) |
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| (70,978 | ) |
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| (51,657 | ) |
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Earnings before income taxes |
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| 290,154 |
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| 287,873 |
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| 885,791 |
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| 958,087 |
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Income tax expense |
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| 63,682 |
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| 79,488 |
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| 184,997 |
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| 257,095 |
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Net earnings |
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| $ | 226,472 |
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| $ | 208,385 |
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| $ | 700,794 |
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| $ | 700,992 |
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Net earnings per share: |
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Basic |
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| $ | 0.70 |
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| $ | 0.63 |
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| $ | 2.15 |
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| $ | 2.14 |
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Diluted |
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| $ | 0.69 |
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| $ | 0.63 |
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| $ | 2.13 |
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| $ | 2.13 |
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Cash dividends declared per share: |
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| $ | 0.21 |
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| $ | — |
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| $ | 0.63 |
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| $ | — |
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Weighted average shares outstanding: |
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Basic |
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| 324,197 |
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| 328,231 |
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| 326,029 |
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| 326,822 |
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Diluted |
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| 326,819 |
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| 329,927 |
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| 329,446 |
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| 329,101 |
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See notes to the condensed consolidated financial statements.
1
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(In thousands, except par value and share amounts) |
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| October 1, 2011 |
| January 1, 2011 |
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ASSETS |
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Current Assets |
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Cash and cash equivalents |
| $ | 959,526 |
| $ | 500,336 |
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Accounts receivable, less allowance for doubtful accounts of |
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| 1,396,572 |
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| 1,331,210 |
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Inventories |
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| 658,756 |
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| 667,545 |
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Deferred income taxes, net |
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| 214,736 |
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| 196,599 |
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Other current assets |
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| 165,536 |
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| 216,458 |
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Total current assets |
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| 3,395,126 |
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| 2,912,148 |
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Property, plant and equipment, at cost |
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| 2,426,224 |
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| 2,224,349 |
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Less accumulated depreciation |
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| (1,034,979 | ) |
| (900,418 | ) |
Net property, plant and equipment |
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| 1,391,245 |
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| 1,323,931 |
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Goodwill |
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| 2,962,169 |
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| 2,955,602 |
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Other intangible assets, net |
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| 922,122 |
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| 987,060 |
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Other assets |
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| 431,449 |
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| 387,707 |
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TOTAL ASSETS |
| $ | 9,102,111 |
| $ | 8,566,448 |
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LIABILITIES AND SHAREHOLDERS’ EQUITY |
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Current Liabilities |
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Current debt obligations |
| $ | 84,845 |
| $ | 79,637 |
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Accounts payable |
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| 177,571 |
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| 297,551 |
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Dividends payable |
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| 66,964 |
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| — |
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Income taxes payable |
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| 8,211 |
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| — |
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Accrued expenses |
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Employee compensation and related benefits |
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| 301,354 |
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| 320,323 |
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Other |
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| 348,929 |
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| 319,739 |
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Total current liabilities |
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| 987,874 |
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| 1,017,250 |
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Long-term debt |
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| 2,917,207 |
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| 2,431,966 |
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Deferred income taxes, net |
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| 305,084 |
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| 310,503 |
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Other liabilities |
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| 456,528 |
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| 435,058 |
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Total liabilities |
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| 4,666,693 |
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| 4,194,777 |
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Commitments and Contingencies (Note 6) |
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Shareholders’ Equity |
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Preferred stock ($1.00 par value; 25,000,000 shares authorized; none outstanding) |
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Common stock ($0.10 par value; 500,000,000 shares authorized; 318,874,306 and 329,018,166 shares issued and outstanding at October 1, 2011 and January 1, 2011, respectively) |
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| 31,887 |
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| 32,902 |
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Additional paid-in capital |
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| 9,076 |
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| 156,126 |
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Retained earnings |
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| 4,326,043 |
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| 4,098,639 |
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Accumulated other comprehensive income (loss): |
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Cumulative translation adjustment |
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| 50,477 |
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| 68,897 |
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Unrealized gain on available-for-sale securities |
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| 17,935 |
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| 15,107 |
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Total shareholders’ equity |
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| 4,435,418 |
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| 4,371,671 |
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TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
| $ | 9,102,111 |
| $ | 8,566,448 |
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See notes to the condensed consolidated financial statements.
2
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ST. JUDE MEDICAL, INC. |
(In thousands) |
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Nine Months Ended |
| October 1, 2011 |
| October 2, 2010 |
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OPERATING ACTIVITIES |
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Net earnings |
| $ | 700,794 |
| $ | 700,992 |
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Adjustments to reconcile net earnings to net cash from operating activities: |
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Depreciation and amortization |
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| 224,633 |
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| 175,813 |
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Amortization of debt (premium)/discount |
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| (4,051 | ) |
| 692 |
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Inventory step-up amortization |
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| 29,442 |
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Stock-based compensation |
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| 58,682 |
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| 53,142 |
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Excess tax benefits from stock-based compensation |
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| (8,686 | ) |
| (10,963 | ) |
Gain on sale of investment |
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| — |
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| (4,929 | ) |
Purchased in-process research and development charges |
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| 4,400 |
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| 12,244 |
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Deferred income taxes |
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| (24,180 | ) |
| (7,442 | ) |
Changes in operating assets and liabilities, net of business acquisitions: |
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Accounts receivable |
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| (52,827 | ) |
| (89,313 | ) |
Inventories |
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| (18,642 | ) |
| (10,652 | ) |
Other current assets |
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| 57,953 |
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| (51,678 | ) |
Accounts payable and accrued expenses |
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| (68,046 | ) |
| 22,678 |
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Income taxes payable |
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| 22,143 |
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| 977 |
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Other, net |
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| 19,538 |
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| — |
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Net cash provided by operating activities |
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| 941,153 |
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| 791,561 |
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INVESTING ACTIVITIES |
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Purchases of property, plant and equipment |
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| (236,005 | ) |
| (226,299 | ) |
Business acquisition payments, net of cash acquired |
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| — |
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| (128,903 | ) |
Other, net |
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| (32,364 | ) |
| (113,573 | ) |
Net cash used in investing activities |
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| (268,369 | ) |
| (468,775 | ) |
FINANCING ACTIVITIES |
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Proceeds from exercise of stock options and stock issued |
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| 285,807 |
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| 107,343 |
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Excess tax benefits from stock-based compensation |
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| 8,686 |
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| 10,963 |
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Common stock repurchased, including related costs |
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| (809,204 | ) |
| — |
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Dividends paid |
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| (137,783 | ) |
| — |
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Issuances/(payments) of commercial paper borrowings, net |
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| 444,600 |
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| — |
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Borrowings under debt facilities |
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| 78,417 |
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| 671,094 |
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Payments under debt facilities |
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| (78,417 | ) |
| (655,723 | ) |
Net cash provided by (used in) financing activities |
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| (207,894 | ) |
| 133,677 |
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Effect of currency exchange rate changes on cash and cash equivalents |
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| (5,700 | ) |
| 2,224 |
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Net increase in cash and cash equivalents |
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| 459,190 |
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| 458,687 |
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Cash and cash equivalents at beginning of period |
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| 500,336 |
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| 392,927 |
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Cash and cash equivalents at end of period |
| $ | 959,526 |
| $ | 851,614 |
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See notes to the condensed consolidated financial statements.
3
ST. JUDE MEDICAL, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 – BASIS OF PRESENTATION
The accompanying unaudited condensed consolidated financial statements of St. Jude Medical, Inc. (St. Jude Medical or the Company) have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States (U.S. generally accepted accounting principles) for complete financial statements. In the opinion of management, these statements include all adjustments (consisting of normal recurring adjustments) considered necessary to present a fair statement of the Company’s consolidated results of operations, financial position and cash flows. Operating results for any interim period are not necessarily indicative of the results that may be expected for the full year. Preparation of the Company’s financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts in the financial statements and footnotes. Actual results could differ from those estimates. This Quarterly Report on Form 10-Q should be read in conjunction with the Company’s consolidated financial statements and footnotes included in its Annual Report on Form 10-K for the fiscal year ended January 1, 2011 (2010 Annual Report on Form 10-K).
NOTE 2 – NEW ACCOUNTING PRONOUNCEMENTS
In January 2010, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2010-6,Fair Value Measurements and Disclosures (ASC Topic 820): Improving Disclosures about Fair Value Measurements, which requires reporting entities to make new disclosures about recurring or nonrecurring fair value measurements including (i) significant transfers into and out of Level 1 and Level 2 fair value measurements and (ii) information on purchases, sales, issuances and settlements on a gross basis in the reconciliation of Level 3 fair value measurements. ASC Topic 820 was effective for interim and annual reporting periods beginning after December 15, 2009, except for Level 3 reconciliation disclosures which were effective for interim and annual periods beginning after December 15, 2010. The Company adopted the additional disclosures required for Level 1 and Level 2 fair value measurements beginning in fiscal year 2010 and adopted Level 3 disclosures beginning in fiscal year 2011.
NOTE 3 – GOODWILL AND OTHER INTANGIBLE ASSETS
The changes in the carrying amount of goodwill for each of the Company’s reportable segments (see Note 14) for the nine months ended October 1, 2011 were as follows (in thousands):
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| CRM/NMD |
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Balance at January 1, 2011 |
| $ | 1,231,120 |
| $ | 1,724,482 |
| $ | 2,955,602 |
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Foreign currency translation and other |
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| 6,538 |
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| 29 |
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| 6,567 |
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Balance at October 1, 2011 |
| $ | 1,237,658 |
| $ | 1,724,511 |
| $ | 2,962,169 |
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4
The following table provides the gross carrying amount of other intangible assets and related accumulated amortization (in thousands):
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| October 1, 2011 |
| January 1, 2011 |
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| Gross |
| Accumulated |
| Gross |
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Definite-lived intangible assets: |
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Purchased technology and patents |
| $ | 923,168 |
| $ | 258,058 |
| $ | 910,035 |
| $ | 208,362 |
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Customer lists and relationships |
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| 184,554 |
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| 114,803 |
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| 184,327 |
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| 100,608 |
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Trademarks and tradenames |
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| 24,219 |
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| 7,528 |
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| 24,370 |
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| 7,431 |
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Licenses, distribution agreements and other |
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| 6,346 |
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| 4,576 |
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| 6,170 |
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| 4,511 |
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| $ | 1,138,287 |
| $ | 384,965 |
| $ | 1,124,902 |
| $ | 320,912 |
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Indefinite-lived intangible assets: |
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Acquired IPR&D |
| $ | 120,000 |
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| $ | 134,270 |
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Trademarks and tradenames |
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| 48,800 |
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| 48,800 |
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| $ | 168,800 |
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| $ | 183,070 |
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During the third quarter of 2011, the Company received approval in Japan for its optical coherence tomography (OCT) technology acquired in conjunction with its LightLab Imaging, Inc. acquisition in 2010. As a result of the approval, the Company reclassified $14.3 million of acquired IPR&D from an indefinite-lived intangible asset to a purchased technology definite-lived intangible asset.
The Company’s inventories consisted of the following (in thousands):
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| October 1, 2011 |
| January 1, 2011 |
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Finished goods |
| $ | 458,402 |
| $ | 466,191 |
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Work in process |
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| 66,546 |
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| 62,607 |
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Raw materials |
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| 133,808 |
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| 138,747 |
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| $ | 658,756 |
| $ | 667,545 |
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The Company’s debt consisted of the following (in thousands):
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| October 1, 2011 |
| January 1, 2011 |
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2.20% senior notes due 2013 |
| $ | 462,415 |
| $ | 467,168 |
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3.75% senior notes due 2014 |
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| 699,407 |
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| 699,248 |
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2.50% senior notes due 2016 |
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| 517,515 |
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| 489,496 |
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4.875% senior notes due 2019 |
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| 495,039 |
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| 494,563 |
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1.58% Yen-denominated senior notes due 2017 |
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| 106,259 |
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| 99,737 |
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2.04% Yen-denominated senior notes due 2020 |
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| 166,472 |
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| 156,254 |
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Yen-denominated term loan due 2011 |
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| — |
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| 79,637 |
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Yen-denominated credit facilities due 2012 |
|
| 84,845 |
|
| — |
|
Commercial paper borrowings |
|
| 470,100 |
|
| 25,500 |
|
Total debt |
|
| 3,002,052 |
|
| 2,511,603 |
|
Less: current debt obligations |
|
| 84,845 |
|
| 79,637 |
|
Long-term debt |
| $ | 2,917,207 |
| $ | 2,431,966 |
|
Expected future minimum principal payments under the Company’s debt obligations are as follows: $84.8 million in 2012; $450.0 million in 2013; $700.0 million in 2014; $500.0 million in 2016; and $1,242.8 million in years thereafter.
5
Senior notes due 2013: On March 10, 2010, the Company issued $450.0 million principal amount of 3-year, 2.20% unsecured senior notes (2013 Senior Notes) that mature in September 2013. The majority of the net proceeds from the issuance of the 2013 Senior Notes was used to retire outstanding debt obligations. Interest payments are required on a semi-annual basis. The 2013 Senior Notes were issued at a discount, yielding an effective interest rate of 2.23% at issuance. The Company may redeem the 2013 Senior Notes at any time at the applicable redemption price. The debt discount is being amortized as interest expense through maturity.
Concurrent with the issuance of the 2013 Senior Notes, the Company entered into a 3-year, $450.0 million notional amount interest rate swap designated as a fair value hedge of the changes in fair value of the Company’s fixed-rate 2013 Senior Notes. On November 8, 2010, the Company terminated the interest rate swap and received a cash payment of $19.3 million. The gain from terminating the interest rate swap agreement is being amortized as a reduction of interest expense resulting in a net average interest rate of 0.8% that will be recognized over the remaining term of the 2013 Senior Notes.
Senior notes due 2014: On July 28, 2009, the Company issued $700.0 million principal amount, 5-year, 3.75% unsecured senior notes (2014 Senior Notes) that mature in July 2014. Interest payments are required on a semi-annual basis. The 2014 Senior Notes were issued at a discount, yielding an effective interest rate of 3.78% at issuance. The debt discount is being amortized as interest expense through maturity. The Company may redeem the 2014 Senior Notes at any time at the applicable redemption price.
Senior notes due 2016: On December 1, 2010, the Company issued $500.0 million principal amount of 5-year, 2.50% unsecured senior notes (2016 Senior Notes) that mature in January 2016. The majority of the net proceeds from the issuance of the 2016 Senior Notes was used for general corporate purposes including the repurchase of the Company’s common stock. Interest payments are required on a semi-annual basis. The 2016 Senior Notes were issued at a discount, yielding an effective interest rate of 2.54% at issuance. The debt discount is being amortized as interest expense through maturity. The Company may redeem the 2016 Senior Notes at any time at the applicable redemption price.
Concurrent with the issuance of the 2016 Senior Notes, the Company entered into a 5-year, $500.0 million notional amount interest rate swap designated as a fair value hedge of the changes in fair value of the Company’s fixed-rate 2016 Senior Notes. As of October 1, 2011, the fair value of the swap was a $17.9 million asset which was classified as other assets on the consolidated balance sheet, with a corresponding adjustment increasing the carrying value of the 2016 Senior Notes. Refer to Note 13 for additional information regarding the interest rate swap.
Senior notes due 2019: On July 28, 2009, the Company issued $500.0 million principal amount, 10-year, 4.875% unsecured senior notes (2019 Senior Notes) that mature in July 2019. Interest payments are required on a semi-annual basis. The 2019 Senior Notes were issued at a discount, yielding an effective interest rate of 5.04% at issuance. The debt discount is being amortized as interest expense through maturity. The Company may redeem the 2019 Senior Notes at any time at the applicable redemption price.
1.58% Yen-denominated senior notes due 2017: On April 28, 2010, the Company issued 7-year, 1.58% unsecured senior notes in Japan (1.58% Yen Notes) totaling 8.1 billion Yen (the equivalent of $106.3 million at October 1, 2011 and $99.7 million at January 1, 2011). The net proceeds from the issuance of the 1.58% Yen Notes were used to repay the 1.02% Yen-denominated Notes due May 2010 (1.02% Yen Notes). The principal amount of the 1.58% Yen Notes recorded on the balance sheet fluctuates based on the effects of foreign currency translation. Interest payments are required on a semi-annual basis and the entire principal balance is due on April 28, 2017.
2.04% Yen-denominated senior notes due 2020: On April 28, 2010, the Company issued 10-year, 2.04% unsecured senior notes in Japan (2.04% Yen Notes) totaling 12.8 billion Yen (the equivalent of $166.5 million at October 1, 2011 and $156.3 million at January 1, 2011). The net proceeds from the issuance of the 2.04% Yen Notes were used to repay the 1.02% Yen Notes. The principal amount of the 2.04% Yen Notes recorded on the balance sheet fluctuates based on the effects of foreign currency translation. Interest payments are required on a semi-annual basis and the entire principal balance is due on April 28, 2020.
Yen–denominated credit facilities: In March 2011, the Company borrowed 6.5 billion Japanese Yen under uncommitted credit facilities with two commercial Japanese banks that provide for borrowings up to a maximum of 11.25 billion Japanese Yen. The proceeds from the borrowings were used to repay the outstanding balance on the Yen-denominated term loan due December 2011. The outstanding 6.5 billion Japanese Yen balance was the equivalent of $84.8 million at October 1, 2011. The principal amount reflected on the balance sheet fluctuates based on the effects of foreign currency translation. Half of the borrowings bear interest at Yen LIBOR plus 0.25% and the other half of the borrowings bear interest at Yen LIBOR plus 0.275%. The entire principal balance is due in March 2012.
6
Other available borrowings: In December 2010, the Company entered into a $1.5 billion unsecured committed credit facility (Credit Facility) that it may draw on for general corporate purposes and to support its commercial paper program. The Credit Facility expires in February 2015. Borrowings under the Credit Facility bear interest initially at LIBOR plus 0.875%, subject to adjustment in the event of a change in the Company’s credit ratings. As of October 1, 2011 and January 1, 2011, the Company had no outstanding borrowings under the Credit Facility.
The Company’s commercial paper program provides for the issuance of short-term, unsecured commercial paper with maturities up to 270 days. The Company began issuing commercial paper during November 2010 and had an outstanding commercial paper balance of $470.1 million as of October 1, 2011 and $25.5 million as of January 1, 2011. During the first nine months of 2011, the Company’s weighted average effective interest rate on its commercial paper borrowings was approximately 0.28%. Any future commercial paper borrowings would bear interest at the applicable then-current market rates. The Company classifies all of its commercial paper borrowings as long-term debt, as the Company has the ability to repay any short-term maturity with available cash from its existing long-term, committed Credit Facility.
NOTE 6 – COMMITMENTS AND CONTINGENCIES
Litigation
Silzone® Litigation and Insurance Receivables: The Company has been sued in various jurisdictions beginning in March 2000 by some patients who received a heart valve product with Silzone® coating, which the Company stopped selling in January 2000. The Company has vigorously defended against the claims that have been asserted and will continue to do so with respect to any remaining claims.
The Company has two outstanding class action cases in Ontario, one individual case in British Columbia by the Provincial health insurer, one individual lawsuit in state court in Minnesota, and one individual lawsuit in federal court in Nevada. In Ontario, a class action case involving Silzone patients has been certified, and the trial on common class issues began in February 2010. The testimony and evidence submissions for this trial were completed in March 2011, and closing briefing and argument were completed in September 2011. Depending on the Court’s ruling in this common issues trial, there may be further proceedings, including appeal, in the future. A second case seeking class action status in Ontario has been stayed pending resolution of the ongoing Ontario class action. The complaints in the Ontario cases request damages up to 2.0 billion Canadian Dollars (the equivalent of $1.9 billion at October 1, 2011). The Minnesota state court complaint requests damages in excess of $50 thousand and the complaint in the recently filed in lawsuit in Nevada requests damages in excess of $75 thousand. Based on the Company’s historical experience, the amount ultimately paid, if any, often does not bear any relationship to the amount claimed. The British Columbia Provincial health insurer has a lawsuit seeking to recover the cost of insured services furnished or to be furnished to class members in the British Columbia class action resolved in 2010, and that lawsuit remains pending in the British Columbia court.
The Company has recorded an accrual for probable legal costs, settlements and judgments for Silzone related litigation. The Company is not aware of any unasserted claims related to Silzone-coated products. For all Silzone legal costs incurred, the Company records insurance receivables for the amounts that it expects to recover based on its assessment of the specific insurance policies, the nature of the claim and the Company’s experience with similar claims. Any costs (the material components of which are settlements, judgments, legal fees and other related defense costs) not covered by the Company’s product liability insurance policies or existing reserves could be material to the Company’s consolidated earnings, financial position and cash flows. The following table summarizes the Company’s Silzone legal accrual and related insurance receivable at October 1, 2011 and January 1, 2011 (in thousands):
|
|
|
|
|
|
|
|
|
| October 1, 2011 |
| January 1, 2011 |
| ||
Silzone legal accrual |
| $ | 23,714 |
| $ | 24,032 |
|
Silzone insurance receivable |
| $ | 15,808 |
| $ | 12,799 |
|
The Company’s current and final insurance layer for Silzone claims consists of $30 million of coverage with two insurance carriers. To the extent that the Company’s future Silzone costs and expenses exceed its remaining insurance coverage, the Company would be responsible for such costs. The Company has not recorded an expense related to any potential future damages as they are not probable or reasonably estimable at this time.
7
Volcano Corporation & LightLab Imaging Inc. (LightLab Imaging) Litigation:The Company’s subsidiary, LightLab Imaging, has pending litigation with Volcano Corporation (Volcano) and Axsun Technologies, Inc. (Axsun), a subsidiary of Volcano, in the Superior Court of Massachusetts and in state court in Delaware. LightLab Imaging makes and sells optical coherence tomography (OCT) imaging systems. Volcano is a LightLab Imaging competitor in medical imaging. Axsun makes and sells lasers and is a supplier of lasers to LightLab Imaging for use in OCT imaging systems. The lawsuits arise out of Volcano’s acquisition of Axsun in December 2008. Before Volcano acquired Axsun, LightLab Imaging and Axsun had worked together to develop a tunable laser for use in OCT imaging systems. While the laser was in development, LightLab Imaging and Axsun entered into an agreement pursuant to which Axsun agreed to sell its tunable lasers exclusively to LightLab in the field of human coronary artery imaging for a certain period of time.
After Volcano acquired Axsun in December 2008, LightLab Imaging sued Axsun and Volcano in Massachusetts, asserting a number of claims arising out of Volcano’s acquisition of Axsun. In January 2011, the court ruled that Axsun’s and Volcano’s conduct constituted knowing and willful violations of a statute that prohibits unfair or deceptive acts or practices or acts of unfair competition, entitling LightLab Imaging to double damages, and furthermore, that LightLab Imaging was entitled to recover attorneys’ fees. In February 2011, Volcano and Axsun were ordered to pay the Company for reimbursement of attorneys’ fees and double damages, which Volcano paid to the Company in July. The Court also issued certain injunctions against Volcano and Axsun when it entered its final judgment.
In Delaware, Axsun and Volcano commenced an action in February 2010 against LightLab Imaging, seeking a declaration as to whether Axsun may supply a certain light source for use in OCT imaging systems to Volcano. Axsun’s and Volcano’s position is that this light source is not a tunable laser and hence falls outside Axsun’s exclusivity obligations to Volcano. LightLab Imaging’s position, among other things, is that this light source is a tunable laser. The parties have conducted expedited discovery. Though the trial of this matter was expected to occur in early 2011, in a March 2011 ruling, the Delaware Court postponed the trial of this case because Axsun and Volcano did not yet have a finalized light source product to present to the Court.
In May 2011, LightLab Imaging initiated a lawsuit against Volcano and Axsun in the Delaware state court. The suit seeks to enforce LightLab Imaging’s exclusive contract with Axsun, to prevent Volcano from interfering with that contract, to bar Axsun and Volcano from using LightLab Imaging confidential information and trade secrets, and to prevent Volcano and Axsun from violating a Massachusetts statute prohibiting unfair methods of competition and unfair or deceptive acts or practices relating to LightLab Imaging’s tunable laser technology. In October 2011, LightLab Imaging filed an amended and supplemental complaint in this action, and in early November 2011, the Company received Volcano and Axsun’s response.
Volcano Corporation & St. Jude Medical Patent Litigation:In July 2010, the Company filed a lawsuit in federal district court in Delaware against Volcano for patent infringement. In the suit, the Company asserted five patents against Volcano and seeks injunctive relief and monetary damages. The infringed patents are part of the St. Jude Medical PressureWire® technology platform, which was acquired as part of St. Jude Medical’s purchase of Radi Medical Systems in December 2008.Volcano has filed counterclaims against the Company in this case, alleging certain St. Jude Medical patent claims are unenforceable and that certain St. Jude Medical products infringe four Volcano patents. The Company believes the assertions and claims made by Volcano are without merit. Trial on liability issues in this case is scheduled for October 2012.
Securities Class Action Litigation: In March 2010, a securities class action lawsuit was filed in federal district court in Minnesota against the Company and certain officers on behalf of purchasers of St. Jude Medical common stock between April 22, 2009 and October 6, 2009. The lawsuit relates to the Company’s earnings announcements for the first, second and third quarters of 2009, as well as a preliminary earnings release dated October 6, 2009. The complaint, which seeks unspecified damages and other relief as well as attorneys’ fees, alleges that the Company failed to disclose that it was experiencing a slowdown in demand for its products and was not receiving anticipated orders for Cardiac Rhythm Management (CRM) devices. Class members allege that the Company’s failure to disclose the above information resulted in the class purchasing St. Jude Medical stock at an artificially inflated price. The Company intends to vigorously defend against the claims asserted in this lawsuit. In October 2010, the Company filed a motion to dismiss the lawsuit, which was heard by the district court in April 2011.
AGA Securities Class Action: In connection with the acquisition of AGA Medical Inc. (AGA Medical), the Company, in addition to AGA Medical and other defendants, was named as a defendant in two putative stockholder class action complaints, one filed in the Fourth Judicial District Court of Minnesota and the other filed in the Delaware Court of Chancery, both in October 2010. The plaintiffs in the complaints alleged, among other claims, that AGA Medical’s directors breached their fiduciary duties to AGA Medical’s stockholders by accepting an inadequate price, failing to make full disclosure and utilizing unreasonable deal protection devices and further alleged that AGA Medical and the Company aided and abetted the purported breaches of fiduciary duty. The parties to this action entered into a memorandum of understanding in November 2010 to settle the litigation, the amount of which was not material. The parties have since executed a stipulation of settlement, pursuant to which the action was dismissed with prejudice by the Delaware Court of Chancery on September 27, 2011.
8
Other than disclosed above, the Company has not recorded an expense related to any potential damages in connection with these litigation matters because any potential loss is not probable or reasonably estimable.
Regulatory Matters
The FDA inspected the Company’s manufacturing facility in Minnetonka, Minnesota at various times between December 8 and December 19, 2008. On December 19, 2008, the FDA issued a Form 483 identifying certain observed non-conformity with current Good Manufacturing Practice (cGMP) primarily related to the manufacture and assembly of the SafireTM ablation catheter with a 4 mm or 5 mm non-irrigated tip. Following the receipt of the Form 483, the Company’s AF division provided written responses to the FDA detailing proposed corrective actions and immediately initiated efforts to address the FDA’s observations of non-conformity. The Company subsequently received a warning letter dated April 17, 2009 from the FDA relating to these non-conformities with respect to this facility.
The FDA inspected the Company’s Plano, Texas manufacturing facility at various times between March 5 and April 6, 2009. On April 6, 2009, the FDA issued a Form 483 identifying certain observed nonconformities with cGMP. Following the receipt of the Form 483, the Company’s Neuromodulation division provided written responses to the FDA detailing proposed corrective actions and immediately initiated efforts to address FDA’s observations of nonconformity. The Company subsequently received a warning letter dated June 26, 2009 from the FDA relating to these non-conformities with respect to its Neuromodulation division’s Plano, Texas and Hackettstown, New Jersey facilities.
With respect to each of these warning letters, the FDA notes that it will not grant requests for exportation certificates to foreign governments or approve pre-market approval applications for Class III devices to which the quality system regulation deviations are reasonably related until the violations have been corrected. The Company is working cooperatively with the FDA to resolve all of its concerns.
On April 23, 2010, the FDA issued a warning letter based upon a July 29, 2009 inspection of the Company’s Sunnyvale, California facility and a review of its website. The warning letter cited the Company for its promotion and marketing of the Epicor™ LP Cardiac Ablation System and the Epicor UltraCinch LP Ablation Device based on certain statements made in the Company’s marketing materials. The Company worked cooperatively with the FDA to resolve the issues noted, and the Company’s corrective actions were verified during a follow-up FDA audit of the facility with no observations noted.
Customer orders have not been and are not expected to be impacted while the Company works to resolve the FDA’s concerns. The Company is working diligently to respond timely and fully to the FDA’s requests. While the Company believes the issues raised by the FDA can be resolved without a material impact on the Company’s financial results, the FDA has recently been increasing its scrutiny of the medical device industry and raising the threshold for compliance. The government is expected to continue to scrutinize the industry closely with inspections, and possibly enforcement actions, by the FDA or other agencies. The Company is regularly monitoring, assessing and improving its internal compliance systems and procedures to ensure that its activities are consistent with applicable laws, regulations and requirements, including those of the FDA.
Other Matters
Boston U.S. Attorney Investigation: In December 2008, the U.S. Attorney’s Office in Boston delivered a subpoena issued by the U.S. Department of Health and Human Services, Office of the Inspector General (OIG) requesting the production of documents relating to implantable cardiac rhythm device and pacemaker warranty claims. The Company has been cooperating with the investigation.
U.S. Department of Justice - Civil Investigative Demand: In March 2010, the Company received a Civil Investigative Demand (CID) from the Civil Division of the U.S. Department of Justice. The CID requests documents and sets forth interrogatories related to communications by and within the Company on various indications for tachycardia implantable cardioverter defibrillator systems (ICDs) and a National Coverage Decision issued by Centers for Medicare and Medicaid Services. Similar requests were made of the Company’s major competitors. The Company has produced all documents and information requested in the CID.
The Company has not recorded an expense related to any potential damages in connection with these matters because any potential loss is not probable or reasonably estimable. The Company is also involved in various other lawsuits, claims and proceedings that arise in the ordinary course of business.
9
Product Warranties
The Company offers a warranty on various products, the most significant of which relates to its ICDs and pacemakers systems. The Company estimates the costs that may be incurred under its warranties and records a liability in the amount of such costs at the time the product is sold. Factors that affect the Company’s warranty liability include the number of units sold, historical and anticipated rates of warranty claims and cost per claim. The Company periodically assesses the adequacy of its recorded warranty liabilities and adjusts the amounts as necessary.
Changes in the Company’s product warranty liability during the three months and nine months ended October 1, 2011 and October 2, 2010 were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Nine Months Ended |
| ||||||||
|
| October 1, |
| October 2, |
| October 1, |
| October 2, |
| ||||
Balance at beginning of period |
| $ | 28,968 |
| $ | 22,213 |
| $ | 25,127 |
| $ | 19,911 |
|
Warranty expense recognized |
|
| 2,191 |
|
| 2,154 |
|
| 7,859 |
|
| 5,536 |
|
Warranty credits issued |
|
| (1,462 | ) |
| (575 | ) |
| (3,289 | ) |
| (1,655 | ) |
Balance at end of period |
| $ | 29,697 |
| $ | 23,792 |
| $ | 29,697 |
| $ | 23,792 |
|
Other Commitments
The Company has certain contingent commitments to acquire various businesses involved in the distribution of the Company’s products and to pay other contingent acquisition consideration payments. While it is not certain if and/or when these payments will be made, as of October 1, 2011, the Company estimates it could be required to pay approximately $25.7 million in future periods to satisfy such commitments. Refer to Part II, Item 7,Management’s Discussion and Analysis of Financial Condition and Results of Operations – Off-Balance Sheet Arrangements and Contractual Obligationsof the Company’s 2010 Annual Report on Form 10-K for additional information.
NOTE 7 – PURCHASED IN-PROCESS RESEARCH AND DEVELOPMENT (IPR&D) AND SPECIAL CHARGES
IPR&D Charges
During the second quarter of 2011, the Company recorded IPR&D charges of $4.4 million in conjunction with the purchase of intellectual property in its CRM segment since the related technological feasibility had not yet been reached and such technology had no future alternative use.
Special Charges
During the first nine months of 2011, the Company incurred charges totaling $71.8 million primarily related to ongoing restructuring actions that began in the second quarter of 2011 to realign certain activities in its CRM business as well as costs primarily associated with continuing efforts to improve the Company’s international sales and sales support organization.
Employee Termination Costs: A key component of these restructuring activities related to the Company’s decision to transition CRM manufacturing out of Sweden to more cost-advantaged locations. As part of these actions as well as the efforts to enhance the efficiency and effectiveness of the Company’s international sales and sales support organization, the Company recorded $33.9 million related to severance and benefit costs for approximately 380 employees. These costs were recognized after management determined that such severance and benefits were probable and estimable, in accordance with Accounting Standards Codification (ASC) Topic 712,Nonretirement Postemployment Benefits. Of the total $33.9 million charge, $2.8 million was recorded in cost of sales.
Inventory Charges: The Company recorded a $6.5 million charge in cost of sales relating to inventory obsolescence charges.
Long-Lived Asset Charges: The Company recorded $19.4 million of impairment and accelerated depreciation charges, of which $12.0 million related to an impairment charge to write-down the Company’s CRM manufacturing facility in Sweden to its fair value. The impairment charge was recognized in accordance with ASC Topic 360,Property, Plant and Equipment after it was determined that its remaining undiscounted future cash flows did not exceed its carrying value. Of the $19.4 million charge, $7.9 million was recorded in cost of sales.
10
Other Charges: The Company recorded charges of $11.9 million associated with contract terminations and other costs. Of the $11.9 million charge, $1.5 million was recorded in cost of sales.
A summary of the activity related to the 2011 special charge restructuring accrual is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Employee |
| Inventory |
| Long-lived |
| Other |
| Total |
| |||||
Balance at January 1, 2011 |
| $ | — |
| $ | — |
| $ | — |
| $ | — |
| $ | — |
|
Special charges |
|
| 33,921 |
|
| 6,484 |
|
| 19,425 |
|
| 11,934 |
|
| 71,764 |
|
Non-cash charges used |
|
| — |
|
| (6,484 | ) |
| (19,425 | ) |
| (574 | ) |
| (26,483 | ) |
Cash payments |
|
| (20,429 | ) |
| — |
|
| — |
|
| (3,517 | ) |
| (23,946 | ) |
Foreign exchange rate impact |
|
| (2 | ) |
| — |
|
| — |
|
| (348 | ) |
| (350 | ) |
Balance at October 1, 2011 |
| $ | 13,490 |
| $ | — |
| $ | — |
| $ | 7,495 |
| $ | 20,985 |
|
As part of the Company’s decision to transition CRM manufacturing out of Sweden, the Company expects to incur additional costs of approximately $50 - $70 million over the next several quarters related to additional employee termination costs, accelerated depreciation and other restructuring related costs. The Company expects to fully transition its manufacturing operations out of Sweden by the end of fiscal year 2012.
NOTE 8 – NET EARNINGS PER SHARE
The table below sets forth the computation of basic and diluted net earnings per share (in thousands, except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Nine Months Ended |
| ||||||||
|
| October 1, |
| October 2, |
| October 1, |
| October 2, |
| ||||
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings |
| $ | 226,472 |
| $ | 208,385 |
| $ | 700,794 |
| $ | 700,992 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted average shares outstanding |
|
| 324,197 |
|
| 328,231 |
|
| 326,029 |
|
| 326,822 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee stock options |
|
| 2,461 |
|
| 1,696 |
|
| 3,276 |
|
| 2,279 |
|
Restricted stock units |
|
| 156 |
|
| — |
|
| 137 |
|
| — |
|
Restricted stock awards |
|
| 5 |
|
| — |
|
| 4 |
|
| — |
|
Diluted weighted average shares outstanding |
|
| 326,819 |
|
| 329,927 |
|
| 329,446 |
|
| 329,101 |
|
Basic net earnings per share |
| $ | 0.70 |
| $ | 0.63 |
| $ | 2.15 |
| $ | 2.14 |
|
Diluted net earnings per share |
| $ | 0.69 |
| $ | 0.63 |
| $ | 2.13 |
| $ | 2.13 |
|
Approximately 7.8 million and 21.1 million shares of common stock subject to stock options, restricted stock awards and restricted stock units were excluded from the diluted net earnings per share computation for the three months ended October 1, 2011 and October 2, 2010, respectively, because they were not dilutive. Additionally, approximately 7.3 million and 19.1 million shares of common stock subject to stock options, restricted stock awards and restricted stock units were excluded from the diluted net earnings per share computation for the nine months ended October 1, 2011 and October 2, 2010, respectively, because they were not dilutive.
11
The table below sets forth the principal components in other comprehensive income (loss), net of the related income tax impact (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Nine Months Ended |
| ||||||||
|
|
| October 1, |
|
| October 2, |
|
| October 1, |
|
| October 2, |
|
Net earnings |
| $ | 226,472 |
| $ | 208,385 |
| $ | 700,794 |
| $ | 700,992 |
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative translation adjustment |
|
| (127,098 | ) |
| 108,001 |
|
| (18,420 | ) |
| (9,757 | ) |
Unrealized gain on available-for-sale securities |
|
| 2,111 |
|
| 1,659 |
|
| 2,828 |
|
| 4,243 |
|
Reclassification of realized gain to net earnings |
|
| — |
|
| (3,081 | ) |
| — |
|
| (3,081 | ) |
Total comprehensive income |
| $ | 101,485 |
| $ | 314,964 |
| $ | 685,202 |
| $ | 692,397 |
|
NOTE 10 – OTHER INCOME (EXPENSE), NET
The Company’s other income (expense) consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Nine Months Ended |
| ||||||||
|
| October 1, |
| October 2, |
| October 1, |
| October 2, |
| ||||
Interest income |
| $ | 1,256 |
| $ | 785 |
| $ | 3,201 |
| $ | 1,507 |
|
Interest expense |
|
| (16,986 | ) |
| (14,714 | ) |
| (51,747 | ) |
| (50,299 | ) |
Other |
|
| (3,783 | ) |
| 2,818 |
|
| (22,432 | ) |
| (2,865 | ) |
Total other income (expense), net |
| $ | (19,513 | ) | $ | (11,111 | ) | $ | (70,978 | ) | $ | (51,657 | ) |
During 2011, legislation became effective in Puerto Rico that levied a 4% excise tax for most purchases from Puerto Rico. As the excise tax is not levied on income, the Company has classified the tax as other expense. The Company recognized $6.6 million and $21.8 million of excise tax expense in the third quarter and first nine months of 2011, respectively, for purchases made from its Puerto Rico subsidiary. This tax is almost entirely offset by the foreign tax credits which are recognized as a benefit to income tax expense.
As of October 1, 2011, the Company had $181.0 million accrued for unrecognized tax benefits, all of which would affect the Company’s effective tax rate if recognized. Additionally, the Company had $35.5 million accrued for interest and penalties as of October 1, 2011. At January 1, 2011, the liability for unrecognized tax benefits was $162.9 million and the accrual for interest and penalties was $33.8 million. The Company recognizes interest and penalties related to income tax matters in income tax expense. The Company does not expect its unrecognized tax benefits to change significantly over the next 12 months.
The Company is subject to U.S. federal income tax as well as income tax of multiple state and foreign jurisdictions. The Company has substantially concluded all U.S. federal income tax matters for all tax years through 2001. Additionally, substantially all material foreign, state, and local income tax matters have been concluded for all tax years through 1999. The U.S. Internal Revenue Service (IRS) completed an audit of the Company’s 2002 through 2005 tax returns and proposed adjustments in its audit report issued in November 2008. The IRS completed an audit of the Company’s 2006 and 2007 tax returns and proposed adjustments in its audit report issued in March 2011. The Company is vigorously defending its positions and initiated defense at the IRS appellate level in January 2009 for the 2002 through 2005 adjustments and in May 2011 for the 2006 through 2007 adjustments. An unfavorable outcome could have a material negative impact on the Company’s effective income tax rate in future periods.
12
NOTE 12 – FAIR VALUE MEASUREMENTS AND FINANCIAL INSTRUMENTS
The fair value measurement accounting standard, codified in ASC Topic 820,Fair Value Measurement(ASC Topic 820), provides a framework for measuring fair value and defines fair value as the price that would be received to sell an asset or paid to transfer a liability. Fair value is a market-based measurement that should be determined using assumptions that market participants would use in pricing an asset or liability. The standard establishes a valuation hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs market participants would use in valuing the asset or liability developed based on independent market data sources. Unobservable inputs are inputs that reflect the Company’s assumptions about the factors market participants would use in valuing the asset or liability developed based upon the best information available. The valuation hierarchy is composed of three categories. The categorization within the valuation hierarchy is based on the lowest level of input that is significant to the fair value measurement.
The categories within the valuation hierarchy are described as follows:
|
|
|
| • | Level 1 – Inputs to the fair value measurement are quoted prices in active markets for identical assets or liabilities. |
| • | Level 2 – Inputs to the fair value measurement include quoted prices in active markets for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, and inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. |
| • | Level 3 – Inputs to the fair value measurement are unobservable inputs or valuation techniques. |
Assets and Liabilities that are Measured at Fair Value on a Recurring Basis
The fair value measurement standard applies to certain financial assets and liabilities that are measured at fair value on a recurring basis (each reporting period). These financial assets and liabilities include money-market securities, trading marketable securities, available-for-sale marketable securities and derivative instruments. The Company continues to record these items at fair value on a recurring basis and the fair value measurements are applied using ASC Topic 820. The Company does not have any material nonfinancial assets or liabilities that are measured at fair value on a recurring basis. A summary of the valuation methodologies used for the respective financial assets and liabilities measured at fair value on a recurring basis is as follows:
Money-market securities: The Company’s money-market securities include funds that are traded in active markets and are recorded at fair value based upon the quoted market prices. The Company classifies these securities as level 1.
Trading securities: The Company’s trading securities include publicly-traded mutual funds that are traded in active markets and are recorded at fair value based upon quoted market prices of the net asset values of the funds. The Company classifies these securities as level 1.
Available-for-sale securities: The Company’s available-for-sale securities include publicly-traded equity securities that are traded in active markets and are recorded at fair value based upon the closing stock prices. The Company classifies these securities as level 1. The following table summarizes the components of the balance of the Company’s available-for-sale securities at October 1, 2011 and January 1, 2011 (in thousands):
|
|
|
|
|
|
|
|
|
| October 1, 2011 |
| January 1, 2011 |
| ||
Adjusted cost |
| $ | 9,327 |
| $ | 9,116 |
|
Gross unrealized gains |
|
| 29,342 |
|
| 24,988 |
|
Gross unrealized losses |
|
| (196 | ) |
| (359 | ) |
Fair value |
| $ | 38,473 |
| $ | 33,745 |
|
Derivative instruments: The Company’s derivative instruments consist of foreign currency exchange contracts and interest rate swap contracts. The Company classifies these instruments as level 2 as the fair value is determined using inputs other than observable quoted market prices. These inputs include spot and forward foreign currency exchange rates and interest rates that the Company obtains from standard market data providers. The fair value of the Company’s outstanding foreign currency exchange contracts was not material at October 1, 2011 or January 1, 2011.
13
A summary of financial assets measured at fair value on a recurring basis at October 1, 2011 and January 1, 2011 is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Balance Sheet |
| October 1, 2011 |
| Quoted Prices |
| Significant |
| Significant |
| |||||
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money-market securities |
| Cash and cash equivalents |
| $ | 727,331 |
| $ | 727,331 |
| $ | — |
| $ | — |
| |
Available-for-sale marketable securities |
| Other current assets |
|
| 38,473 |
|
| 38,473 |
|
| — |
|
| — |
| |
Trading marketable securities |
| Other assets |
|
| 207,864 |
|
| 207,864 |
|
| — |
|
| — |
| |
Interest rate swap |
| Other assets |
|
| 17,906 |
|
| — |
|
| 17,906 |
|
| — |
| |
Total assets |
|
|
|
| $ | 991,574 |
| $ | 973,668 |
| $ | 17,906 |
| $ | — |
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
|
| Balance Sheet |
| January 1, 2011 |
| Quoted Prices |
| Significant |
| Significant |
| |||||
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money-market securities |
| Cash and cash equivalents |
| $ | 364,418 |
| $ | 364,418 |
| $ | — |
| $ | — |
| |
Trading marketable securities |
| Other assets |
|
| 190,438 |
|
| 190,438 |
|
| — |
|
| — |
| |
Available-for-sale marketable securities |
| Other current assets |
|
| 33,745 |
|
| 33,745 |
|
| — |
|
| — |
| |
Total assets |
|
|
|
| $ | 588,601 |
| $ | 588,601 |
| $ | — |
| $ | — |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate swap |
| Other liabilities |
| $ | 10,046 |
| $ | — |
| $ | 10,046 |
| $ | — |
| |
Total liabilities |
|
|
|
| $ | 10,046 |
| $ | — |
| $ | 10,046 |
| $ | — |
|
Assets and Liabilities that are Measured at Fair Value on a Nonrecurring Basis
The fair value measurement standard also applies to certain nonfinancial assets and liabilities that are measured at fair value on a nonrecurring basis. For example, certain long-lived assets such as goodwill, intangible assets and property, plant and equipment are measured at fair value in connection with business combinations or when an impairment is recognized and the related assets are written down to fair value. The Company did not make any material business combinations during the first nine months of 2011.
The following table provides information by level for assets and liabilities that were measured at fair value on a nonrecurring basis during 2010 for business combinations closed during the first nine months of 2010. The table provides the fair value of net identifiable tangible and intangible assets and liabilities (excluding goodwill). The Company used inputs other than quoted prices that are observable, such as interest rates, cost of capital and market comparable royalty rates, which are applied to income and market valuation approaches. A summary of the nonfinancial assets and liabilities measured at fair value in conjunction with our business combinations during the first nine months of 2010 is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Fair Value |
| Quoted Prices |
| Significant |
| Significant |
| ||||||||
Description |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Business Combination |
| $ | 52,238 |
|
| $ | — |
|
| $ | 52,238 |
|
| $ | — |
|
|
During the first nine months of 2011, the Company initiated restructuring actions resulting in the planned future closure of its CRM manufacturing facility in Sweden, resulting in the recognition of a $12.0 million impairment charge to write-down the facility to its estimated fair value. Additionally, $7.4 million of other asset write-downs and/or impairments were recorded during the first nine months of 2011. Refer to Note 7 for further detail. No material impairments of the Company’s long-lived assets were recognized during the first nine months of 2010.
14
The Company also holds investments in equity securities that are accounted for as cost method investments, which are classified as other assets and measured at fair value on a nonrecurring basis. The carrying value of these investments approximated $128 million at October 1, 2011 and $124 million at January 1, 2011. The fair value of the Company’s cost method investments is not estimated if there are no identified events or changes in circumstances that may have a significant adverse effect on the fair value of these investments. When measured on a nonrecurring basis, the Company’s cost method investments are generally considered Level 3 in the fair value hierarchy, due to the use of unobservable inputs to measure fair value.
Fair Value Measurements of Other Financial Instruments
The aggregate fair value of the Company’s fixed-rate debt obligations at October 1, 2011 (measured using quoted prices in active markets) was $2,534.9 million compared to the aggregate carrying value of $2,447.1 million (inclusive of unamortized debt discounts and interest rate swap fair value adjustments). The fair value of the Company’s variable-rate debt obligations at October 1, 2011 approximated the aggregate $554.9 million carrying value due to the short-term, variable rate interest rate structure of these instruments.
NOTE 13 – DERIVATIVE FINANCIAL INSTRUMENTS
The Company follows the provisions of ASC Topic 815,Derivatives and Hedging(ASC Topic 815), in accounting for and disclosing derivative instruments and hedging activities. All derivative financial instruments are recognized on the balance sheet at fair value. Changes in the fair value of derivatives are recognized in net earnings or other comprehensive income depending on whether the derivative is designated as part of a qualifying hedging relationship under ASC Topic 815. Derivative assets and derivative liabilities are classified as other current assets, other assets, other current liabilities or other liabilities, as appropriate.
Foreign Currency Forward Contracts
The Company hedges a portion of its foreign currency exchange rate risk through the use of forward exchange contracts. The Company uses forward exchange contracts to manage foreign currency exposures related to intercompany receivables and payables arising from intercompany purchases of manufactured products. These forward contracts are not designated as qualifying hedging relationships under ASC Topic 815. The Company measures its foreign currency exchange contracts at fair value on a recurring basis. The fair value of outstanding contracts was immaterial as of October 1, 2011 and January 1, 2011. During the third quarter of 2011 and 2010, the net amount of gains (losses) the Company recorded to other income (expense) for its forward currency exchange contracts not designated as hedging instruments under ASC Topic 815 was a net gain of $2.1 million and a net loss of $8.4 million, respectively. During the first nine months of 2011 and 2010, the net amount of gains (losses) recorded to other income (expense) for its forward currency exchange contracts not designated as hedging instruments was a net loss of $6.2 million and a net loss of $1.7 million, respectively. These net gains (losses) were almost entirely offset by corresponding net (losses) gains on the foreign currency exposures being managed. The Company does not enter into contracts for trading or speculative purposes. The Company’s policy is to enter into hedging contracts with major financial institutions that have at least an “A” (or equivalent) credit rating.
Interest Rate Swap
The Company hedges the fair value of certain debt obligations through the use of interest rate swap contracts. For interest rate swap contracts that are designated and qualify as fair value hedges, the gain or loss on the swap and the offsetting gain or loss on the hedged debt instrument attributable to the hedged risk are recognized in net earnings. Changes in the value of the fair value hedge are recognized in interest expense, offsetting the changes in the fair value of the hedged debt instrument. Additionally, any payments made or received under the swap contracts are accrued and recognized as interest expense. The Company’s current interest rate swap is designed to manage the exposure to changes in the fair value of its 2016 Senior Notes. The swap is designated as a fair value hedge of the variability of the fair value of the fixed-rate 2016 Senior Notes due to changes in the long-term benchmark interest rates. Under the swap agreement, the Company agrees to exchange, at specified intervals, fixed and floating interest amounts calculated by reference to an agreed-upon notional principal amount. As of October 1, 2011, the fair value of the interest rate swap was a $17.9 million asset which was classified as other assets on the condensed consolidated balance sheet.
15
NOTE 14 – SEGMENT AND GEOGRAPHIC INFORMATION
Segment Information
The Company’s four operating segments are Cardiac Rhythm Management (CRM), Cardiovascular (CV), Atrial Fibrillation (AF), and Neuromodulation (NMD). The primary products produced by each operating segment are: CRM – ICDs and pacemakers; CV – vascular products, which include vascular closure products, pressure measurement guidewires, optical coherence tomography (OCT) imaging products, vascular plugs and other vascular accessories, and structural heart products, which include heart valve replacement and repair products and structural heart defect devices; AF – EP introducers and catheters, advanced cardiac mapping, navigation and recording systems and ablation systems; and NMD – neurostimulation products, which include spinal cord and deep brain stimulation devices.
The Company has aggregated the four operating segments into two reportable segments based upon their similar operational and economic characteristics: CRM/NMD and CV/AF. Net sales of the Company’s reportable segments include end-customer revenues from the sale of products they each develop and manufacture or distribute. The costs included in each of the reportable segments’ operating results include the direct costs of the products sold to customers and operating expenses managed by each of the reportable segments. Certain operating expenses managed by the Company’s selling and corporate functions, including all stock-based compensation expense, impairment charges, certain acquisition-related charges, IPR&D charges, excise tax expense and special charges have not been recorded in the individual reportable segments. As a result, reportable segment operating profit is not representative of the operating profit of the products in these reportable segments. Additionally, certain assets are managed by the Company’s selling and corporate functions, principally including trade receivables, inventory, corporate cash and cash equivalents, certain marketable securities and deferred income taxes. For management reporting purposes, the Company does not compile capital expenditures by reportable segment; therefore, this information has not been presented, as it is impracticable to do so.
The following table presents net sales and operating profit by reportable segment (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| CRM/NMD |
| CV/AF |
| Other |
| Total |
| ||||
Three Months ended October 1, 2011: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
| $ | 852,774 |
| $ | 529,784 |
| $ | — |
| $ | 1,382,558 |
|
Operating profit |
|
| 522,465 |
|
| 281,041 |
|
| (493,839 | ) |
| 309,667 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months ended October 2, 2010: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
| $ | 830,902 |
| $ | 409,003 |
| $ | — |
| $ | 1,239,905 |
|
Operating profit |
|
| 514,788 |
|
| 225,637 |
|
| (441,441 | ) |
| 298,984 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months ended October 1, 2011: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
| $ | 2,602,835 |
| $ | 1,601,987 |
| $ | — |
| $ | 4,204,822 |
|
Operating profit |
|
| 1,623,378 |
|
| 834,341 |
|
| (1,500,950 | ) |
| 956,769 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months ended October 2, 2010: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
| $ | 2,549,768 |
| $ | 1,264,602 |
| $ | — |
| $ | 3,814,370 |
|
Operating profit |
|
| 1,595,378 |
|
| 713,748 |
|
| (1,299,382 | ) |
| 1,009,744 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table presents the Company’s total assets by reportable segment (in thousands):
|
|
|
|
|
|
|
|
Total Assets |
| October 1, 2011 |
| January 1, 2011 |
| ||
CRM/NMD |
| $ | 2,407,250 |
| $ | 2,150,359 |
|
CV/AF |
|
| 3,108,236 |
|
| 3,097,190 |
|
Other |
|
| 3,586,625 |
|
| 3,318,899 |
|
|
| $ | 9,102,111 |
| $ | 8,566,448 |
|
16
Geographic Information
The following table presents net sales by geographic location of the customer (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Nine Months Ended |
| ||||||||
Net Sales |
| October 1, |
| October 2, |
| October 1, |
| October 2, |
| ||||
United States |
| $ | 657,227 |
| $ | 657,627 |
| $ | 2,011,629 |
| $ | 1,996,655 |
|
International |
|
|
|
|
|
|
|
|
|
|
|
|
|
Europe |
|
| 359,132 |
|
| 281,017 |
|
| 1,139,202 |
|
| 949,540 |
|
Japan |
|
| 162,049 |
|
| 141,089 |
|
| 466,256 |
|
| 399,344 |
|
Asia Pacific |
|
| 111,406 |
|
| 83,773 |
|
| 310,061 |
|
| 233,080 |
|
Other (a) |
|
| 92,744 |
|
| 76,399 |
|
| 277,674 |
|
| 235,751 |
|
|
|
| 725,331 |
|
| 582,278 |
|
| 2,193,193 |
|
| 1,817,715 |
|
|
| $ | 1,382,558 |
| $ | 1,239,905 |
| $ | 4,204,822 |
| $ | 3,814,370 |
|
(a) No one geographic market is greater than 5% of consolidated net sales.
The amounts for long-lived assets by significant geographic market include net property, plant and equipment by physical location of the asset as follows (in thousands):
|
|
|
|
|
|
|
|
Long-Lived Assets |
| October 1, 2011 |
| January 1, 2011 |
| ||
United States |
| $ | 1,014,381 |
| $ | 965,936 |
|
International |
|
|
|
|
|
|
|
Europe |
|
| 82,177 |
|
| 85,961 |
|
Japan |
|
| 30,204 |
|
| 25,583 |
|
Asia Pacific |
|
| 79,550 |
|
| 74,537 |
|
Other |
|
| 184,933 |
|
| 171,914 |
|
|
|
| 376,864 |
|
| 357,995 |
|
|
| $ | 1,391,245 |
| $ | 1,323,931 |
|
17
Item 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
Our business is focused on the development, manufacture and distribution of cardiovascular medical devices for the global cardiac rhythm management, cardiology, cardiac surgery and atrial fibrillation therapy areas and implantable neurostimulation medical devices for the management of chronic pain. We sell our products in more than 100 countries around the world. Our largest geographic markets are the United States, Europe, Japan and Asia Pacific. Our four operating segments are Cardiac Rhythm Management (CRM), Cardiovascular (CV), Atrial Fibrillation (AF), and Neuromodulation (NMD). Our principal products in each operating segment are as follows: CRM – tachycardia implantable cardioverter defibrillator systems (ICDs) and bradycardia pacemaker systems (pacemakers); CV – vascular products, which include vascular closure products, pressure measurement guidewires, optical coherence tomography (OCT) imaging products, vascular plugs and other vascular accessories, and structural heart products, which include heart valve replacement and repair products and structural heart defect devices; AF – atrial fibrillation products which include electrophysiology (EP) introducers and catheters, advanced cardiac mapping, navigation and recording systems and ablation systems; and NMD – neurostimulation products, which include spinal cord stimulation and deep brain stimulation devices. References to “St. Jude Medical,” “St. Jude,” “the Company,” “we,” “us” and “our” are to St. Jude Medical, Inc. and its subsidiaries.
Our industry has undergone significant consolidation in the last decade and is highly competitive. Our strategy requires significant investment in research and development in order to introduce new products. We are focused on improving our operating margins through a variety of techniques, including the production of high quality products, the development of leading edge technology, the enhancement of our existing products and continuous improvement of our manufacturing processes. We expect competitive pressures in the industry, cost containment pressure on healthcare systems and the implementation of U.S. healthcare reform legislation to continue to place downward pressure on prices for our products, impact reimbursement for our products and potentially reduce medical procedure volumes.
In March 2010, significant U.S. healthcare reform legislation was enacted into law. As a U.S. headquartered company with significant sales in the United States, this health care reform legislation will materially impact us. Certain provisions of the legislation are not effective for a number of years and there are many programs and requirements for which the details have not yet been fully established or consequences not fully understood, and it is unclear what the full impacts will be from the legislation. The legislation does levy a 2.3% excise tax on all U.S. medical device sales beginning in 2013. This is a significant new tax that will materially and adversely affect our business and results of operations. The legislation also focuses on a number of Medicare provisions aimed at improving quality and decreasing costs. It is uncertain at this point what impacts these provisions will have on patient access to new technologies. The Medicare provisions also include value-based payment programs, increased funding of comparative effectiveness research, reduced hospital payments for avoidable readmissions and hospital acquired conditions, and pilot programs to evaluate alternative payment methodologies that promote care coordination (such as bundled physician and hospital payments). Additionally, the provisions include a reduction in the annual rate of inflation for hospitals starting in 2011 and the establishment of an independent payment advisory board to recommend ways of reducing the rate of growth in Medicare spending. We cannot predict what healthcare programs and regulations will be ultimately implemented at the federal or state level, or the effect of any future legislation or regulation. However, any changes that lower reimbursements for our products or reduce medical procedure volumes could adversely affect our business and results of operations.
We participate in several different medical device markets, each of which has its own expected growth rate. A significant portion of our net sales relate to CRM devices – ICDs and pacemakers. During the last three weeks in March 2010, a competitor in the CRM market, Boston Scientific Inc. (Boston Scientific), suspended sales of its ICD products in the United States. Although Boston Scientific resumed sales on April 16, 2010, we experienced an incremental ICD net sales benefit of approximately $40 million the first nine months of 2010 ICD net sales. Management remains focused on increasing our worldwide CRM market share, as we are one of three principal manufacturers and suppliers in the global CRM market. We are also investing in our other three major growth platforms – cardiovascular, atrial fibrillation and neuromodulation – to increase our market share in these markets.
Net sales in the third quarter and first nine months of 2011 were $1,382.6 million and $4,204.8 million, respectively, increases of 12% and 10%, respectively, over the same prior year periods. During the third quarter and first nine months of 2011, our net sales increases were led by incremental net sales from our 2010 acquisitions of AGA Medical Inc. (AGA Medical) and LightLab Imaging, Inc. (LightLab Imaging). Our products to treat atrial fibrillation also contributed to the increase. Our AF net sales increased 20% and 17% during the third quarter and first nine months of 2011, respectively, over the same periods in 2010. Compared to the same prior year period, our foreign currency translation comparisons increased our third quarter and first nine month net sales during 2011 by $73.2 million and $164.9 million, respectively. Refer to theSegment Performance section for a more detailed discussion of the results for the respective segments.
18 |
Our third quarter 2011 net earnings of $226.5 million and diluted net earnings per share of $0.69 increased 12% and 10%, respectively, compared to our third quarter 2010 net earnings of $208.4 million and diluted net earnings per share of $0.63. Third quarter 2011 net earnings were negatively impacted by $20.9 million of after-tax charges related to realigning certain activities in our CRM operating segment and costs associated with improving our international sales and sales support organization, and $8.5 million related to an account receivable write-down associated with one customer in Europe. Net earnings and diluted net earnings per share for the first nine months of 2011 were $700.8 million, an increase of 10% in net earnings over the first nine months of 2010. Diluted net earnings per share for the first nine months of 2011 of $2.13 per diluted share remained flat compared to the same prior year period. During the first nine months of 2011, net earnings were negatively impacted by $49.8 million of restructuring charges discussed previously, $19.3 million of AGA Medical inventory step up costs of sale expenses, $18.8 million of AGA Medical-related post-acquisition expenses, $8.5 million of accounts receivable allowance charges discussed previously and $2.8 million of in-process research and development (IPR&D) charges.
We generated $941.2 million of operating cash flows during the first nine months of 2011, compared to $791.6 million of operating cash flows during the first nine months of 2010, an 18.9% increase. We ended the third quarter with $959.5 million of cash and cash equivalents and $3,002.1 million of total debt. We also repurchased 11.7 million shares of our common stock for $500.0 million at an average repurchase price of $42.79 per share. Additionally, our Board of Directors authorized three quarterly cash dividends of $0.21 per share paid on April 29, 2011, July 29, 2011 and October 31, 2011.
Certain new accounting standards became effective for us in the first quarter of fiscal year 2011. Information regarding the new accounting pronouncement that impacted our 2011 disclosures is included in Note 2 to the Condensed Consolidated Financial Statements. Information regarding new accounting pronouncements that will impact future periods are included below.
In September 2011, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2011-08,Intangibles – Goodwill and Other (ASC Topic 350): Testing Goodwill for Impairment, which allows an entity to first assess qualitative factors to determine whether the existence of events or circumstances lead to a determination that it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If after the assessment the entity determines it is unlikely that the fair value of a reporting unit is less than its carrying amount, then the two-step impairment test is unnecessary. If however, an entity concludes otherwise, then the first step of the two-step impairment test is required. ASU 2011-08 is effective for interim and annual reporting periods beginning after December 15, 2011, with early adoption permitted. We expect to adopt this new accounting pronouncement during our fourth quarter 2011 annual goodwill impairment assessment and do not expect a material impact.
In June 2011, the FASB issued ASU 2011-05,Comprehensive Income (ASC Topic 220): Presentation of Comprehensive Income, which eliminates the current option to report other comprehensive income and its components in the consolidated statements of shareholders’ equity. The update to ASU 2011-05 requires an entity to present items of net income and other comprehensive income in one continuous statement – referred to as the statement of comprehensive income – or in two separate, but consecutive, statements. Each component of net income and each component of other comprehensive income is required to be presented with subtotals for each and a grand total for total comprehensive income. The updated guidance does not change the calculation of earnings per share. ASU 2011-05 is effective for interim and annual reporting periods beginning after December 15, 2011. We expect to adopt this new account pronouncement beginning in fiscal year 2012.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
We have adopted various accounting policies in preparing the consolidated financial statements in accordance with U.S. generally accepted accounting principles. Our significant accounting policies are disclosed in Note 1 to the Consolidated Financial Statements included in our Annual Report on Form 10-K for the fiscal year ended January 1, 2011 (2010 Annual Report on Form 10-K).
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Preparation of our consolidated financial statements in conformity with U.S. generally accepted accounting principles requires us to adopt various accounting policies and to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. On an ongoing basis, we evaluate our estimates and assumptions, including those related to accounts receivable allowance for doubtful accounts; inventory reserves; valuation of IPR&D, other intangible assets and goodwill; income taxes; litigation reserves and insurance receivables; and stock-based compensation. We base our estimates on historical experience and various other assumptions that are believed to be reasonable under the circumstances, and the results form the basis for making judgments about the reported values of assets, liabilities, revenues and expenses. Actual results may differ from these estimates. There have been no material changes to our critical accounting policies and estimates from the information provided in Part II, Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our 2010 Annual Report on Form 10-K.
Our four operating segments are Cardiac Rhythm Management (CRM), Cardiovascular (CV), Atrial Fibrillation (AF), and Neuromodulation (NMD). The primary products produced by each operating segment are: CRM – ICDs and pacemakers; CV – vascular products, which include vascular closure products, pressure measurement guidewires, optical coherence tomography (OCT) imaging products, vascular plugs and other vascular accessories, and structural heart products, which include heart valve replacement and repair products and structural heart defect devices; AF – atrial fibrillation products which include EP introducers and catheters, advanced cardiac mapping, navigation and recording systems and ablation systems; and NMD – neurostimulation products, which include spinal cord stimulation and deep brain stimulation devices.
The Company has aggregated the four operating segments into two reportable segments based upon their similar operational and economic characteristics: CRM/NMD and CV/AF. Net sales of the Company’s reportable segments include end-customer revenues from the sale of products they each develop and manufacture or distribute. The costs included in each of the reportable segments’ operating results include the direct costs of the products sold to customers and operating expenses managed by each of the reportable segments. Certain operating expenses managed by our selling and corporate functions, including all stock-based compensation expense, impairment charges, IPR&D charges and special charges have not been recorded in the individual reportable segments. As a result, reportable segment operating profit is not representative of the operating profit of the products in these reportable segments.
The following table presents net sales and operating profit by reportable segment (in thousands):
CRM/NMD | CV/AF | Other | Total | ||||||||||
Three Months ended October 1, 2011: | |||||||||||||
Net sales | $ | 852,774 | $ | 529,784 | $ | — | $ | 1,382,558 | |||||
Operating profit | 522,465 | 281,041 | (493,839 | ) | 309,667 | ||||||||
Three Months ended October 2, 2010: | |||||||||||||
Net sales | $ | 830,902 | $ | 409,003 | $ | — | $ | 1,239,905 | |||||
Operating profit | 514,788 | 225,637 | (441,441 | ) | 298,984 | ||||||||
Nine Months ended October 1, 2011: | |||||||||||||
Net sales | $ | 2,602,835 | $ | 1,601,987 | $ | — | $ | 4,204,822 | |||||
Operating profit | 1,623,378 | 834,341 | (1,500,950 | ) | 956,769 | ||||||||
Nine Months ended October 2, 2010: | |||||||||||||
Net sales | $ | 2,549,768 | $ | 1,264,602 | $ | — | $ | 3,814,370 | |||||
Operating profit | 1,595,378 | 713,748 | (1,299,382 | ) | 1,009,744 | ||||||||
The following discussion of the changes in our net sales is provided by class of similar products within our four operating segments, which is the primary focus of our sales activities. Effective January 2, 2011, we realigned our significant cardiovascular product categories and reclassified prior period amounts to conform to the current period presentation.
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Cardiac Rhythm Management
Three Months Ended | Nine Months Ended | ||||||||||||||||||
(in thousands) | October 1, 2011 | October 2, 2010 | % Change | October 1, 2011 | October 2, 2010 | % Change | |||||||||||||
ICD systems | $ | 444,889 | $ | 439,333 | 1.3 | % | $ | 1,387,479 | $ | 1,362,042 | 1.9 | % | |||||||
Pacemaker systems | 305,700 | 298,669 | 2.4 | % | 917,845 | 915,574 | 0.2 | % | |||||||||||
$ | 750,589 | $ | 738,002 | 1.7 | % | $ | 2,305,324 | $ | 2,277,616 | 1.2 | % |
Cardiac Rhythm Management’s net sales increased 2% and 1% during the third quarter and first nine months of 2011, respectively, compared to the same periods in 2010. During the third quarter and first nine months of 2011, foreign currency translation had a $38.5 million and $84.4 million favorable impact on net sales, respectively, compared to the same prior year periods. ICD net sales increased 1% and 2% in the third quarter and first nine months of 2011, respectively, compared to the same prior year periods, as a result of favorable foreign currency translation and sales of recently launched products, partially offset by the incremental benefit on 2010 U.S. ICD net sales resulting from a suspension of a competitor’s product sales. In the United States, third quarter 2011 ICD net sales of $257.2 million decreased 9% over the prior year’s third quarter and ICD net sales in the first nine months of 2011 of $809.9 million decreased 6% over the same period last year. The nine month decrease included the incremental benefit of approximately $40 million during the first nine months of 2010, resulting from the suspension of U.S. ICD sales by one of our competitors in the CRM market. Internationally, third quarter 2011 ICD net sales of $187.7 million increased 21% compared to the third quarter of 2010. During the first nine months of 2011 ICD net sales of $577.6 million increased 16% compared to the first nine months of 2010. These increases are primarily a result of favorable foreign currency translation and the second quarter 2011 launch of our UnifyTM cardiac resynchronization therapy defibrillator (CRT-D) and FortifyTM ICD in Japan. The UnifyTM CRT-D and FortifyTM ICD are smaller, deliver more energy and have a longer battery life than comparable conventional devices. Foreign currency translation had a $19.9 million and $43.3 million favorable impact on international ICD net sales in the third quarter and first nine months of 2011, respectively, compared to the same periods in 2010.
Pacemaker net sales were flat in both the third quarter and first nine months of 2011 compared to the same prior year periods. In the United States, our third quarter 2011 pacemaker net sales of $126.2 million decreased 6% compared to the third quarter of 2010. Additionally, during the first nine months of 2011, U.S. pacemaker net sales of $385.6 million decreased 4% over the same period last year. Internationally, our 2011 net sales during the third quarter of $179.5 million and first nine months of $532.2 million increased 9% and 4%, respectively, compared to the same prior year periods. Foreign currency translation had an $18.5 million and $41.1 million favorable impact during the third quarter and first nine months of 2011, respectively, compared to the same prior year periods.
Cardiovascular
Three Months Ended | Nine Months Ended | ||||||||||||||||||
(in thousands) | October 1, 2011 | October 2, 2010 | % Change | October 1, 2011 | October 2, 2010 | % Change | |||||||||||||
Vascular products | $ | 177,156 | $ | 161,063 | 10.0 | % | $ | 549,941 | $ | 496,128 | 10.8 | % | |||||||
Structural heart products | 150,828 | 79,122 | 90.6 | % | 447,640 | 253,791 | 76.4 | % | |||||||||||
$ | 327,984 | $ | 240,185 | 36.6 | % | $ | 997,581 | $ | 749,919 | 33.0 | % |
Cardiovascular net sales increased 37% and 33% during the third quarter and first nine months of 2011, respectively, compared to the same periods one year ago driven by incremental net sales from our 2010 acquisitions of AGA Medical and LightLab Imaging. CV net sales were also favorably impacted by foreign currency translation of $20.7 million and $47.7 million during the third quarter and first nine months of 2011, respectively, compared to the same prior year periods. Vascular products’ net sales increased 10% and 11% during the third quarter and first nine months of 2011, respectively, compared to the same periods in 2010 primarily due to incremental AGA Medical net sales of vascular plugs, and LightLab Imaging net sales of Optical Coherence Tomography (OCT) products and favorable foreign currency translation, partially offset by decreased sales volumes associated with our Angio-Seal™ active closure devices. Vascular products include vascular closure products, fractional flow reserve (FFR) Pressure Wire™, OCT products, vascular plugs and other vascular accessories. Foreign currency translation favorably impacted the third quarter and first nine months of 2011 by $12.0 million and $29.5 million, respectively. Structural heart products’ net sales increased 91% and 76% during the third quarter and first nine months of 2011, respectively, due to the incremental AGA Medical net sales of Amplatzer® occluder products and international net sales growth associated with our Trifecta™ tissue valve, which was recently launched in the United States after receiving U.S. FDA approval in April 2011. Structural heart products include heart valve replacement and repair products and Amplatzer® occluder products. Foreign currency translation favorably impacted structural heart products’ net sales by $8.6 million and $18.2 million during the third quarter and first nine months of 2011, respectively, compared to the same prior year period.
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Atrial Fibrillation
Three Months Ended | Nine Months Ended | ||||||||||||||||||
(in thousands) | October 1, 2011 | October 2, 2010 | % Change | October 1, 2011 | October 2, 2010 | % Change | |||||||||||||
Atrial fibrillation products | $ | 201,800 | $ | 168,818 | 19.5 | % | $ | 604,406 | $ | 514,683 | 17.4 | % |
In our Atrial Fibrillation division, our access, diagnosis, visualization, recording and ablation products assist physicians in diagnosing and treating atrial fibrillation and other irregular heart rhythms. AF net sales increased 20% and 17% during the third quarter and first nine months of 2011, respectively, compared to the same prior year periods due to the continued increase in EP catheter ablation procedures, the continued market penetration of our EnSite® Velocity System and related connectivity tools (EnSite Connect™, EnSite Courier™ and EnSite Derexi™ modules) and the on-going rollout of recently approved EP irrigated ablation catheters in the U.S. (Safire BLU™) and internationally (Therapy™ Cool Flex™, Safire Blu™ Duo and Therapy™ Cool Path™ Duo bi-directional). Foreign currency translation had a favorable impact on AF net sales of $11.5 million and $26.4 million in the third quarter and first nine months of 2011, respectively, compared to the same periods in 2010.
Neuromodulation
Three Months Ended | Nine Months Ended | ||||||||||||||||||
(in thousands) | October 1, 2011 | October 2, 2010 | % Change | October 1, 2011 | October 2, 2010 | % Change | |||||||||||||
Neurostimulation devices | $ | 102,185 | $ | 92,900 | 10.0 | % | $ | 297,511 | $ | 272,152 | 9.3 | % |
Neuromodulation net sales increased 10% and 9% during the third quarter and first nine months of 2011, respectively, compared to the same periods in 2010. The increase in NMD net sales was driven by continued market acceptance of our products and sales growth in our neurostimulation devices that help manage chronic pain. Specifically, international net sales in the third quarter and first nine months of 2011 increased 41% and 42%, respectively, driven by sales growth in the Eon Mini platform and growing market acceptance of the Epiducer Lead Delivery system which gives physicians the ability to place multiple neurostimulation leads through a single entry point. Foreign currency translation had a $2.6 million and $6.4 million favorable impact on NMD net sales during the third quarter and first nine months of 2011, respectively, compared to the same prior year periods.
Net sales
Three Months Ended | Nine Months Ended | ||||||||||||||||||
(in thousands) | October 1, 2011 | October 2, 2010 | % Change | October 1, 2011 | October 2, 2010 | % Change | |||||||||||||
Net sales | $ | 1,382,558 | $ | 1,239,905 | 11.5 | % | $ | 4,204,822 | $ | 3,814,370 | 10.2 | % |
Overall, net sales increased 12% and 10% during the third quarter and first nine months of 2011 compared to the same prior year periods led by incremental net sales from our 2010 acquisitions of AGA Medical and LightLab Imaging and sales growth from our products to treat atrial fibrillation. Our first nine months of 2010 net sales also benefited by approximately $40 million from suspended Boston Scientific U.S. ICD sales. Foreign currency translation had a favorable impact on the third quarter and first nine months of 2011 net sales of $73.2 million and $164.9 million, respectively, due primarily to the weakening of the U.S. Dollar against the Euro and Japanese Yen. This amount is not indicative of the net earnings impact of foreign currency translation for the third quarter and first nine months of 2011 due to partially offsetting foreign currency translation impacts on cost of sales and operating expenses.
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Net sales by geographic location of the customer were as follows (in thousands):
Three Months Ended | Nine Months Ended | ||||||||||||
Net Sales | October 1, 2011 | October 2, 2010 | October 1, 2011 | October 2, 2010 | |||||||||
United States | $ | 657,227 | $ | 657,627 | $ | 2,011,629 | $ | 1,996,655 | |||||
International | |||||||||||||
Europe | 359,132 | 281,017 | 1,139,202 | 949,540 | |||||||||
Japan | 162,049 | 141,089 | 466,256 | 399,344 | |||||||||
Asia Pacific | 111,406 | 83,773 | 310,061 | 233,080 | |||||||||
Other (a) | 92,744 | 76,399 | 277,674 | 235,751 | |||||||||
725,331 | 582,278 | 2,193,193 | 1,817,715 | ||||||||||
$ | 1,382,558 | $ | 1,239,905 | $ | 4,204,822 | $ | 3,814,370 |
(a) No one geographic market is greater than 5% of consolidated net sales.
Gross profit
Three Months Ended | Nine Months Ended | ||||||||||||
(in thousands) | October 1, 2011 | October 2, 2010 | October 1, 2011 | October 2, 2010 | |||||||||
Gross profit | $ | 1,012,443 | $ | 900,086 | $ | 3,075,342 | $ | 2,808,080 | |||||
Percentage of net sales | 73.2 | % | 72.6 | % | 73.1 | % | 73.6 | % |
Gross profit for the third quarter of 2011 totaled $1,012.4 million, or 73.2% of net sales, compared to $900.1 million, or 72.6% of net sales for the third quarter of 2010. Gross profit for the first nine months of 2011 totaled $3,075.3 million, or 73.1% of net sales, compared to $2,808.1 million, or 73.6% of net sales for the first nine months of 2010. The positive impact from our gross profit percentage during the third quarter of 2011 compared to the same period in 2010 was primarily a result of favorable foreign currency translation impacts as well as favorable product mix from our AGA Medical sales. Our gross profit percentage for the first nine months of 2011 was negatively impacted by $29.4 million (or 0.7 percentage points) due to inventory step-up amortization costs associated with our AGA Medical acquisition.
Selling, general and administrative (SG&A) expense
Three Months Ended | Nine Months Ended | ||||||||||||
(in thousands) | October 1, 2011 | October 2, 2010 | October 1, 2011 | October 2, 2010 | |||||||||
Selling, general and administrative | $ | 505,080 | $ | 438,723 | $ | 1,532,241 | $ | 1,329,623 | |||||
Percentage of net sales | 36.5 | % | 35.4 | % | 36.4 | % | 34.9 | % |
SG&A expense for the third quarter of 2011 totaled $505.1 million, or 36.5% of net sales, compared to $438.7 million, or 35.4% of net sales, for the third quarter of 2010. SG&A expense for the first nine months of 2011 totaled $1,532.2 million, or 36.4% of net sales, compared to $1,329.6 million, or 34.9% of net sales, for the first nine months of 2010. The increase in SG&A expense as a percent of net sales is primarily the result of $24.9 million of contract termination and international integration charges related to our AGA Medical acquisition, which negatively impacted our first nine months SG&A expense as a percent of net sales by 0.6 percentage points. Incremental intangible asset amortization expense from the AGA Medical acquisition also negatively impacted both our 2011 third quarter and first nine months of SG&A expense as a percent of net sales by 0.5 percentage points. The remaining increase in SG&A expense as a percent of net sales is primarily associated with our increased investment in sales and marketing activities to support the growth and launch of our new technologies, particularly outside of the United States.
Research and development (R&D) expense
Three Months Ended | Nine Months Ended | ||||||||||||
(in thousands) | October 1, 2011 | October 2, 2010 | October 1, 2011 | October 2, 2010 | |||||||||
Research and development expense | $ | 176,320 | $ | 150,135 | $ | 528,387 | $ | 456,469 | |||||
Percentage of net sales | 12.8 | % | 12.1 | % | 12.7 | % | 12.0 | % |
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R&D expense in the third quarter of 2011 totaled $176.3 million, or 12.8% of net sales, compared to $150.1 million, or 12.1% of net sales, for the third quarter of 2010. R&D expense in the first nine months of 2011 totaled $528.4 million, or 12.7% of net sales, compared to $456.5 million, or 12.0% of net sales, for the first nine months of 2010. R&D expense as a percent of net sales increased during the third quarter and first nine months of 2011 compared to the same prior year periods, reflecting our continuing commitment to fund future long-term growth opportunities. We will continue to balance delivering short-term results with our investments in long-term growth drivers.
Purchased in-process research and development charges
Three Months Ended | Nine Months Ended | ||||||||||||
(in thousands) | October 1, 2011 | October 2, 2010 | October 1, 2011 | October 2, 2010 | |||||||||
Purchased in-process research and development charges | $ | — | $ | 12,244 | $ | 4,400 | $ | 12,244 |
During the second quarter of 2011, we recorded IPR&D charges of $4.4 million in conjunction with the purchase of intellectual property in our CRM segment since the related technological feasibility had not yet been reached and such technology had no future alternative use. During the third quarter of 2010, we recorded IPR&D charges of $12.2 million in conjunction with the purchase of cardiovascular-related intellectual property since the related technological feasibility had not yet been reached and such technology had no future alternative use.
Special charges
Three Months Ended | Nine Months Ended | ||||||||||||
October 1, 2011 | October 2, 2010 | October 1, 2011 | October 2, 2010 | ||||||||||
Cost of sales special charges | $ | 7,173 | $ | — | $ | 18,219 | $ | — | |||||
Special charges | 21,376 | — | 53,545 | — | |||||||||
$ | 28,549 | $ | — | $ | 71,764 | $ | — |
During the first nine months of 2011, we incurred charges totaling $71.8 million primarily related to ongoing restructuring actions that began in the second quarter of 2011 to realign certain activities in our CRM business as well as costs primarily associated with our continuing efforts to improve the our international sales and sales support organization. A key component of these restructuring activities related to our decision to transition CRM manufacturing out of Sweden to more cost-advantaged locations. As part of these actions as well as the efforts to enhance the efficiency and effectiveness of our international sales and sales support organization, we recorded $33.9 million related to severance and benefit costs for approximately 380 employees.
We also recorded a $6.5 million charge in cost of sales related to inventory obsolescence charges and $19.4 million of other long-lived asset charges, of which $12.0 million was recorded as an impairment charge to write-down our CRM manufacturing facility in Sweden to its fair value. We also recorded charges of $11.9 million related to contract terminations and other costs.
As part of our decision to transition CRM manufacturing out of Sweden, we expect to incur additional pre-tax costs of approximately $50 - $70 million ($35 - $50 million after-tax costs) over the next several quarters related to additional employee termination costs, accelerated depreciation and other restructuring related costs. We expect to fully transition our manufacturing operations out of Sweden by the end of fiscal year 2012.
Other income (expense), net
Three Months Ended | Nine Months Ended | ||||||||||||||||||||
October 1, 2011 | October 2, 2010 | October 1, 2011 | October 2, 2010 | ||||||||||||||||||
Interest income | $ | 1,256 | $ | 785 | $ | 3,201 | $ | 1,507 | |||||||||||||
Interest expense | (16,986 | ) | (14,714 | ) | (51,747 | ) | (50,299 | ) | |||||||||||||
Other | (3,783 | ) | 2,818 | (22,432 | ) | (2,865 | ) | ||||||||||||||
Total other income (expense), net | $ | (19,513 | ) | $ | (11,111 | ) | $ | (70,978 | ) | $ | (51,657 | ) | |||||||||
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The unfavorable change in other income (expense) during the third quarter and first nine months of 2011 compared to the same periods in 2010 was due to $6.6 million and $21.8 million, respectively, of Puerto Rico excise tax expense recognized in other expense. The 4% Puerto Rico excise tax became effective in 2011, and we incur this tax on most purchases made from our Puerto Rico subsidiary. This excise tax is almost entirely offset by the resulting foreign tax credits or income tax deductions which are recognized as a benefit to income tax expense.
Income taxes
Three Months Ended | Nine Months Ended | ||||||||||||||||||||
(as a percent of pre-tax income) | October 1, 2011 | October 2, 2010 | October 1, 2011 | October 2, 2010 | |||||||||||||||||
Effective tax rate | 21.9% | 27.6% | 20.9% | 26.8% | |||||||||||||||||
Our effective income tax rate was 21.9% and 27.6% for the third quarter of 2011 and 2010, respectively, and 20.9% and 26.8% for the first nine months of 2011 and 2010, respectively. As discussed previously, the 4% Puerto Rico excise tax, which is levied on most purchases from Puerto Rico, became effective beginning in 2011. Because the excise tax is not levied on income, U.S. generally accepted accounting principles do not allow for the excise tax to be recognized as part of income tax expense. However, the resulting foreign tax credit or income tax deduction is recognized as a benefit to income tax expense, thus favorably impacting our effective income tax rate. As a result, our effective tax rate was favorably impacted by 1.3 percentage points and 1.4 percentage points in the third quarter and first nine months of 2011, respectively, compared to the same periods in 2010. As discussed previously, this favorable impact on our effective tax rate is more than offset by the excise tax expense recognized in other expense.
Our effective tax rate for the first nine months of 2010 does not include the impact of the federal research and development tax credit (R&D tax credit), as the R&D tax credit was not enacted into law until the fourth quarter of 2010. As a result, our effective tax rates for both the third quarter and first nine months of 2010 were negatively impacted by 2.0 percentage points.
We believe that our existing cash balances, future cash generated from operations and available borrowing capacity under our $1.5 billion long-term committed credit facility (Credit Facility) and related commercial paper program will be sufficient to fund our operating needs, working capital requirements, R&D opportunities, capital expenditures, debt service requirements and shareholder dividends over the next 12 months and in the foreseeable future thereafter. We do not have any significant debt maturities until 2013. The majority of our outstanding October 1, 2011 debt portfolio matures after December 2015.
We believe that our earnings, cash flows and balance sheet position will permit us to obtain additional debt financing or equity capital should suitable investment and growth opportunities arise. Our credit ratings are investment grade. We monitor capital markets regularly and may raise additional capital when market conditions or interest rate environments are favorable.
At October 1, 2011, substantially all of our cash and cash equivalents was held by our non-U.S. subsidiaries. A portion of these foreign cash balances are associated with earnings that we have asserted are permanently reinvested and which we plan to use to support our continued growth plans outside the U.S. through funding of operating expenses, capital expenditures and other investment and growth opportunities. The majority of these funds are only available for use by our U.S. operations if they are repatriated into the United States. The funds repatriated would be subject to additional U.S. taxes upon repatriation; however, it is not practical to estimate the amount of additional U.S. tax liabilities we would incur. We currently have no plans to repatriate funds held by our non-U.S. subsidiaries.
We use two primary measures that focus on accounts receivable and inventory – days sales outstanding (DSO) and days inventory on hand (DIOH). We use DSO as a measure that places emphasis on how quickly we collect our accounts receivable balances from customers. We use DIOH, which can also be expressed as a measure of the estimated number of days of cost of sales on hand, as a measure that places emphasis on how efficiently we are managing our inventory levels. These measures may not be computed the same as similarly titled measures used by other companies. Our DSO (ending net accounts receivable divided by average daily sales for the most recently completed quarter) increased from 90 days at January 1, 2011 to 92 days at October 1, 2011. Our DIOH (ending net inventory divided by average daily cost of sales for the most recently completed six months) decreased from 163 days at January 1, 2011 to 157 days at October 1, 2011. Special charges recognized in cost of sales as well as acquisition impacts to cost of sales and inventory during the last six months reduced our October 1, 2011 DIOH by 7 days. Special charges recognized in cost of sales in the second half of 2010 reduced our January 1, 2011 DIOH by 7 days; however, the impact of our acquisitions in the second half of 2010 offset the special charge impact, increasing our DIOH by 7 days.
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A summary of our cash flows from operating, investing and financing activities is provided in the following table (in thousands):
Nine Months Ended | |||||||
October 1, 2011 | October 2, 2010 | ||||||
Net cash provided by (used in): | |||||||
Operating activities | $ | 941,153 | $ | 791,561 | |||
Investing activities | (268,369 | ) | (468,775 | ) | |||
Financing activities | (207,894 | ) | 133,677 | ||||
Effect of currency exchange rate changes on cash and cash equivalents | (5,700 | ) | 2,224 | ||||
Net increase in cash and cash equivalents | $ | 459,190 | $ | 458,687 |
Operating Cash Flows
Cash provided by operating activities was $941.2 million during the first nine months of 2011, an 18.9% increase compared to $791.6 million during the first nine months of 2010. Operating cash flows can fluctuate significantly from period to period due to payment timing differences of working capital accounts such as accounts receivable, accounts payable, accrued liabilities and income taxes payable.
Investing Cash Flows
Cash used in investing activities was $268.4 million during the first nine months of 2011 compared to $468.8 million during the same period last year. Our purchases of property, plant and equipment, which totaled $236.0 million and $226.3 million in the first nine months of 2011 and 2010, respectively, primarily reflect our continued investment in our product growth platforms currently in place. During the first nine months of 2010, we made certain acquisitions and strategic investments by acquiring LightLab Imaging for $92.2 million in net cash consideration, investing $60 million in CardioMEMS, Inc. (CardioMEMS) and making our final scheduled acquisition payment of $31.3 million for MediGuide, Inc. CardioMEMS is a privately-held company focused on the development of a wireless monitoring technology that can be placed directly into the pulmonary artery to assess cardiac performance via measurement of pulmonary artery pressure.
Financing Cash Flows
Cash used in financing activities was $207.9 million during the first nine months of 2011 compared to $133.7 million of cash provided by financing activities in the first nine months of 2010. Our financing cash flows can fluctuate significantly depending upon our liquidity needs, stock repurchase plans and the amount of stock option exercises. During the first nine months of 2011, we repurchased $809.2 million of our common stock, which was financed primarily with cash generated from operations and net commercial paper issuances of $444.6 million. During the first nine months of 2010, we received net proceeds of $671.1 million from debt borrowings consisting of $450.0 million principal amount of 2013 Senior Notes, 2.04% Yen Notes (12.8 billion Yen) and 1.58% Yen Notes (8.1 billion Yen). The proceeds from these debt issuances were used to repay $655.7 million of outstanding debt borrowings consisting of a 3-year unsecured 2011 Term Loan ($432.0 million) and 1.02% Yen Notes (20.9 billion Yen). Proceeds from the exercise of stock options and stock issued provided cash inflows of $285.8 million and $107.3 million during the first nine months of 2011 and 2010, respectively. We also paid $137.8 million of cash dividends to shareholders in the first nine months of 2011.
We have a long-term $1.5 billion committed Credit Facility used to support our commercial paper program and for general corporate purposes. The Credit Facility expires in February 2015. Borrowings under this facility bear interest initially at LIBOR plus 0.875%, subject to adjustment in the event of a change in our credit ratings. Commitment fees under this Credit Facility are not material. There were no outstanding borrowings under the Credit Facility as of October 1, 2011 or January 1, 2011.
Our commercial paper program provides for the issuance of short-term, unsecured commercial paper with maturities up to 270 days. We began issuing commercial paper during November 2010 and had an outstanding commercial paper balance of $470.1 million and $25.5 million at October 1, 2011 and January 1, 2011, respectively. Any future commercial paper borrowings would bear interest at the applicable then-current market rates. Our commercial paper has historically been issued at lower interest rates than borrowings available under the Credit Facility.
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In March 2010, we issued $450.0 million principal amount of 2013 Senior Notes and used the proceeds to retire outstanding debt obligations. Interest payments on the 2013 Senior Notes are required on a semi-annual basis. We may redeem the 2013 Senior Notes at any time at the applicable redemption price. The 2013 Senior Notes are senior unsecured obligations and rank equally with all of our existing and future senior unsecured indebtedness.
Concurrent with the issuance of the 2013 Senior Notes, we entered into a 3-year, $450.0 million notional amount interest rate swap designated as a fair value hedge of the changes in fair value of our fixed-rate 2013 Senior Notes. On November 8, 2010, we terminated the interest rate swap and received a cash payment of $19.3 million. The gain from terminating the interest rate swap agreement is being amortized as a reduction of interest expense over the remaining life of the 2013 Senior Notes.
In July 2009, we issued $700.0 million aggregate principal amount of 5-year, 3.75% Senior Notes (2014 Senior Notes) and $500.0 million aggregate principal amount of 10-year, 4.875% Senior Notes (2019 Senior Notes). In August 2009, we used $500.0 million of the net proceeds from the 2014 Senior Notes and 2019 Senior Notes to repay all amounts outstanding under our credit facility. We may redeem the 2014 Senior Notes or 2019 Senior Notes at any time at the applicable redemption prices. Both the 2014 Senior Notes and 2019 Senior Notes are senior unsecured obligations and rank equally with all of our existing and future senior unsecured indebtedness.
In December 2010, we issued our $500.0 million principal amount 5-year, 2.50% unsecured senior notes (2016 Senior Notes). The majority of the net proceeds from the issuance of the 2016 Senior Notes were used for general corporate purposes including the repurchase of our common stock. Interest payments are required on a semi-annual basis. We may redeem the 2016 Senior Notes at any time at the applicable redemption price. The 2016 Senior Notes are senior unsecured obligations and rank equally with all of our existing and future senior unsecured indebtedness.
Concurrent with the issuance of the 2016 Senior Notes, we entered into a 5-year, $500.0 million notional amount interest rate swap designated as a fair value hedge of the changes in fair value of our fixed-rate 2016 Senior Notes. As of October 1, 2011, the fair value of the swap was a $17.9 million asset which was classified as other assets on the consolidated balance sheet, with a corresponding adjustment increasing the carrying value of the 2016 Senior Notes. Refer to Note 13 of the Consolidated Financial Statements for additional information regarding the interest rate swap.
In April 2010, we issued 10-year, 2.04% unsecured senior notes in Japan (2.04% Yen Notes) totaling 12.8 billion Yen (the equivalent of $166.5 million at October 1, 2011 and $156.3 million at January 1, 2011) and 7-year, 1.58% unsecured senior notes in Japan (1.58% Yen Notes) totaling 8.1 billion Yen (the equivalent of $106.3 million at October 1, 2011 and $99.7 million at January 1, 2011). We used the net proceeds from these issuances to repay our 1.02% Yen-denominated notes that matured on May 7, 2010 totaling 20.9 billion Yen. Interest payments on the 2.04% Yen Notes and 1.58% Yen Notes are required on a semi-annual basis and the principal amounts recorded on the balance sheet fluctuate based on the effects of foreign currency translation.
In March 2011, we borrowed 6.5 billion Japanese Yen under uncommitted credit facilities with two commercial Japanese banks that provide for borrowings up to a maximum of 11.25 billion Japanese Yen. The proceeds from the borrowings were used to repay the outstanding balance on the Yen-denominated term loan due December 2011. The outstanding 6.5 billion Japanese Yen balance was the equivalent of $84.8 million at October 1, 2011. The principal amount reflected on the balance sheet fluctuates based on the effects of foreign currency translation. Half of the borrowings bear interest at the Yen LIBOR plus 0.25% and the other half of the borrowings bear interest at the Yen LIBOR plus 0.275%. The entire principal balance is due in March 2012 with an option to renew with the lenders’ consent.
Our Credit Facility and Yen Notes contain certain operating and financial covenants. Specifically, the Credit Facility requires that we have a leverage ratio (defined as the ratio of total debt to EBITDA (net earnings before interest, income taxes, depreciation and amortization)) not exceeding 3.0 to 1.0. The Yen Notes require that we have a ratio of total debt to total capitalization not exceeding 60% and a ratio of consolidated EBIT (net earnings before interest and income taxes) to consolidated interest expense of at least 3.0 to 1.0. Under the Credit Facility, our senior notes and Yen Notes we also have certain limitations on how we conduct our business, including limitations on additional liens or indebtedness and limitations on certain acquisitions, mergers, investments and dispositions of assets. We were in compliance with all of our debt covenants as of October 1, 2011.
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On August 2, 2011, our Board of Directors authorized a share repurchase program of up to $500.0 million of our outstanding common stock. We completed the repurchases under the program on August 29, 2011, repurchasing 11.7 million shares for $500.0 million at an average repurchase price of $42.79 per share.
On October 15, 2010, our Board of Directors authorized a share repurchase program of up to $600.0 million of our outstanding common stock. On October 21, 2010, our Board of Directors authorized an additional $300.0 million of share repurchases as part of this share repurchase program. We continued repurchasing shares in 2011 and completed the repurchases under the program on January 20, 2011, repurchasing a total of 22.0 million shares for $900.0 million at an average repurchase price of $40.87 per share. From January 1 through January 20, 2011, we repurchased 6.6 million shares for $274.7 million at an average repurchase price of $41.44 per share.
The following table provides dividend authorization, shareholder record and dividend payable dates as well as the cash dividends declared per share. We expect to continue to pay quarterly cash dividends in the foreseeable future, subject to Board approval.
Board of Directors’ Dividend Authorization Date | Shareholders’ Record Date | Dividend Payable Date | Cash Dividends Declared Per Share | ||||
February 26, 2011 | March 31, 2011 | April 29, 2011 | $ | 0.21 | |||
May 11, 2011 | June 30, 2011 | July 29, 2011 | $ | 0.21 | |||
August 2, 2011 | Septemeber 30, 2011 | October 31, 2011 | $ | 0.21 | |||
Total dividends declared per share for the nine months ended October 1, 2011 | $ | 0.63 |
We have certain contingent commitments to acquire various businesses involved in the distribution of our products and to pay other contingent acquisition consideration payments. While it is not certain if and/or when these payments will be made, as of October 1, 2011, we could be required to pay approximately $25.7 million in future periods to satisfy such commitments. A description of our contractual obligations and other commitments is contained in Part II, Item 7,Management’s Discussion and Analysis of Financial Condition and Results of Operations– Off-Balance Sheet Arrangements and Contractual Obligations, included in our 2010 Annual Report on Form 10-K. We have no off-balance sheet financing arrangements other than that previously disclosed in our 2010 Annual Report on Form 10-K. Our significant legal proceedings are discussed in Note 6 to the Condensed Consolidated Financial Statements in this Quarterly Report on Form 10-Q.
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In this Quarterly Report on Form 10-Q and in other written or oral statements made from time to time, we have included and may include statements that constitute “forward-looking statements” with respect to the financial condition, results of operations, plans, objectives, new products, future performance and business of St. Jude Medical, Inc. and its subsidiaries. Statements preceded by, followed by or that include words such as “may,” “will,” “expect,” “anticipate,” “continue,” “estimate,” “forecast”, “project,” “believe” or similar expressions are intended to identify some of the forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are included, along with this statement, for purposes of complying with the safe harbor provisions of that Act. These forward-looking statements involve risks and uncertainties. By identifying these statements for you in this manner, we are alerting you to the possibility that actual results may differ, possibly materially, from the results indicated by these forward-looking statements. We undertake no obligation to update any forward-looking statements. Actual results may differ materially from those contemplated by the forward-looking statements due to, among others, the risks and uncertainties discussed in the sections entitledOff-Balance Sheet Arrangements and Contractual ObligationsandMarket Riskin Part II, Item 7,Management’s Discussion and Analysis of Financial Condition and Results of Operations of our 2010 Annual Report on Form 10-K and in Part II, Item 1A,Risk Factors of this Quarterly Reports on Form 10-Q for the periods ended April 2, 2011 and July 2, 2011 and in Part I, Item 1A,Risk Factors of our 2010 Annual Report on Form 10-K, as well as the various factors described below. Since it is not possible to foresee all such factors, you should not consider these factors to be a complete list of all risks or uncertainties. We believe the most significant factors that could affect our future operations and results are set forth in the list below.
1. | Any legislative or administrative reform to the U.S. Medicare or Medicaid systems or international reimbursement systems that significantly reduces reimbursement for procedures using our medical devices or denies coverage for such procedures, as well as adverse decisions relating to our products by administrators of such systems on coverage or reimbursement issues. | ||
2. | Assertion, acquisition or grant of key patents by or to others that have the effect of excluding us from market segments or requiring us to pay royalties. | ||
3. | Economic factors, including inflation, contraction in capital markets, changes in interest rates, changes in tax laws and changes in foreign currency exchange rates. | ||
4. | Product introductions by competitors that have advanced technology, better features or lower pricing. | ||
5. | Price increases by suppliers of key components, some of which are sole-sourced. | ||
6. | A reduction in the number of procedures using our devices caused by cost-containment pressures, publication of adverse study results, initiation of investigations of our customers related to our devices or the development of or preferences for alternative therapies. | ||
7. | Safety, performance or efficacy concerns about our products, many of which are expected to be implanted for many years, some of which may lead to recalls and/or advisories with the attendant expenses and declining sales. | ||
8. | Declining industry-wide sales caused by product quality issues or recalls or advisories by our competitors that result in loss of physician and/or patient confidence in the safety, performance or efficacy of sophisticated medical devices in general and/or the types of medical devices recalled in particular. | ||
9. | Changes in laws, regulations or administrative practices affecting government regulation of our products, such as FDA regulations, including those that decrease the probability or increase the time and/or expense of obtaining approval for products or impose additional burdens on the manufacture and sale of medical devices. | ||
10. | Regulatory actions arising from concern over Bovine Spongiform Encephalopathy, sometimes referred to as “mad cow disease,” that have the effect of limiting our ability to market products using bovine collagen, such as Angio-Seal™, or products using bovine pericardial material, such as our Biocor®, Epic™ and Trifecta™ tissue heart valves, or that impose added costs on the procurement of bovine collagen or bovine pericardial material. | ||
11. | The intent and ability of our product liability insurers to meet their obligations to us, including losses related to our Silzone® litigation, and our ability to fund future product liability losses related to claims made subsequent to becoming self-insured. | ||
12. | Severe weather or other natural disasters that can adversely impact customers purchasing patterns and/or patient implant procedures or cause damage to the facilities of our critical suppliers or one or more of our facilities, such as an earthquake affecting our facilities in California or a hurricane affecting our facilities in Puerto Rico. | ||
13. | Healthcare industry changes leading to demands for price concessions and/or limitations on, or the elimination of, our ability to sell in significant market segments. | ||
14. | Adverse developments in investigations and governmental proceedings. | ||
15. | Adverse developments in litigation, including product liability litigation, patent or other intellectual property litigation, qui tam litigation or shareholder litigation. | ||
16. | Inability to successfully integrate the businesses that we have acquired in recent years and that we plan to acquire. | ||
17. | Failure to successfully complete or unfavorable data from clinical trials for our products or new indications for our products and/or failure to successfully develop markets for such new indications. | ||
18. | Changes in accounting rules that adversely affect the characterization of our results of operations, financial position or cash flows. | ||
19. | The disruptions in the financial markets and the economic downturn that adversely impact the availability and cost of credit and customer purchasing and payment patterns. | ||
20. | Conditions imposed in resolving, or any inability to timely resolve, any regulatory issues raised by the FDA, including Form 483 observations or warning letters, as well as risks generally associated with our regulatory compliance and quality systems. | ||
21. | Governmental legislation, including the recently enacted Patient Protection and Affordable Care Act and the Health Care and Educational Reconciliation Act, and/or regulation that significantly impacts the healthcare system in the United States and that results in lower reimbursement for procedures using our products, reduces medical procedure volumes or otherwise adversely affects our business and results of operations, including the recently enacted medical device excise tax. |
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Item 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
There have been no material changes since January 1, 2011 in our market risk. For further information on market risk, refer to Part II, Item 7A,Quantitative and Qualitative Disclosures About Market Risk in our 2010 Annual Report on Form 10-K.
Item 4. | CONTROLS AND PROCEDURES |
As of October 1, 2011, the Company carried out an evaluation, under the supervision and with the participation of the Company’s management, including the Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of its disclosure controls and procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934 (the Exchange Act)). Based on that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the Company’s disclosure controls and procedures were effective as of October 1, 2011.
There were no changes in the Company’s internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) during the third quarter of 2011 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
PART II | OTHER INFORMATION |
Item 1. | LEGAL PROCEEDINGS |
We are the subject of various pending or threatened legal actions and proceedings, including those that arise in the ordinary course of our business. Such matters are subject to many uncertainties and to outcomes that are not predictable with assurance and that may not be known for extended periods of time. We record a liability in our consolidated financial statements for costs related to claims, including future legal costs, settlements and judgments, where we have assessed that a loss is probable and an amount can be reasonably estimated. Our significant legal proceedings are discussed in Note 6 to the Condensed Consolidated Financial Statements in this Quarterly Report on Form 10-Q and are incorporated herein by reference. While it is not possible to predict the outcome for most of the legal proceedings discussed in Note 6, the costs associated with such proceedings could have a material adverse effect on our consolidated earnings, financial position or cash flows of a future period.
Item 1A. | RISK FACTORS |
The risks factors identified in Part I, Item 1A of our Annual Report on Form 10-K for the year ended January 1, 2011, Part II, Item 1A of our Quarterly Report on Form 10-Q for the period ended April 2, 2011 and in Part II, Item 1A of our Quarterly Report on Form 10-Q for the period ended July 2, 2011 have not changed in any material respect.
Item 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
Issuer Purchases of Equity Securities
On August 3, 2011, our Board of Directors announced a share repurchase program of up to $500.0 million of our outstanding common stock with no expiration date. We completed the repurchases under the program on August 29, 2011, repurchasing 11.7 million shares for $500.0 million at an average repurchase price of $42.79 per share.
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The following table provides information about the shares we repurchased during the third quarter of2011:
Period | Total Number of Shares Purchased | Average Price Paid per Share | Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs | Approximate Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs | |||||||||
7/3/2011 - 7/30/2011 | — | $ | — | — | $ | — | |||||||
7/31/2011 - 9/3/2011 | 11,684,681 | 42.79 | 11,684,681 | — | |||||||||
9/4/2011 - 10/1/2011 | — | — | — | — | |||||||||
Total | 11,684,681 | 42.79 | 11,684,681 | $ | — |
Item 6. | EXHIBITS |
12 | Computation of Ratio of Earnings to Fixed Charges. | |
31.1 | Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
31.2 | Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
32.1 | Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
32.2 | Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
101 | Financial statements from the quarterly report on Form 10-Q of St. Jude Medical, Inc. for the quarter ended October 1, 2011, formatted in XBRL: (i) the Condensed Consolidated Statements of Earnings, (ii) the Condensed Consolidated Balance Sheets, (iii) the Condensed Consolidated Statements of Cash Flows and (iv) the Notes to the Condensed Consolidated Financial Statements. |
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
ST. JUDE MEDICAL, INC. | |||
November 9, 2011 | /s/ JOHN C. HEINMILLER | ||
DATE | JOHN C. HEINMILLER Executive Vice President and Chief Financial Officer (Duly Authorized Officer and Principal Financial and Accounting Officer) |
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Exhibit No. | Description | |
12 | Computation of Ratio of Earnings to Fixed Charges. | |
31.1 | Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
31.2 | Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
32.1 | Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
32.2 | Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
101 | Financial statements from the quarterly report on Form 10-Q of St. Jude Medical, Inc. for the quarter ended October 1, 2011, formatted in XBRL: (i) the Condensed Consolidated Statements of Earnings, (ii) the Condensed Consolidated Balance Sheets, (iii) the Condensed Consolidated Statements of Cash Flows and (iv) the Notes to the Condensed Consolidated Financial Statements. |
_________________
# Filed as an exhibit to this Quarterly Report on Form 10-Q.
* Furnished herewith.
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