e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2007
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 1-4448
BAXTER INTERNATIONAL INC.
(Exact name of registrant as specified in its charter)
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Delaware
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36-0781620 |
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(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
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One Baxter Parkway, Deerfield, Illinois
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60015-4633 |
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(Address of principal executive offices)
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(Zip Code) |
847-948-2000
(Registrants telephone number,
including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act.
Large accelerated filer þ Accelerated filer o Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
The number of shares of the registrants Common Stock, par value $1.00 per share, outstanding as of
October 30, 2007 was 634,072,529 shares.
BAXTER INTERNATIONAL INC.
FORM 10-Q
For the quarterly period ended September 30, 2007
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Baxter International Inc.
Condensed Consolidated Statements of Income (unaudited)
(in millions, except per share data)
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Three months ended |
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Nine months ended |
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September 30, |
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September 30, |
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2007 |
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2006 |
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2007 |
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2006 |
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Net sales |
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$ |
2,750 |
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$ |
2,557 |
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$ |
8,254 |
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$ |
7,615 |
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Costs and expenses |
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Cost of goods sold |
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1,374 |
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1,342 |
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4,220 |
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4,193 |
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Marketing and administrative expenses |
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663 |
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562 |
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1,867 |
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1,670 |
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Research and development expenses |
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203 |
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149 |
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539 |
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433 |
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Restructuring charges |
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70 |
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Net interest expense |
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6 |
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5 |
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10 |
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33 |
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Other expense, net |
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21 |
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20 |
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28 |
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55 |
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Total costs and expenses |
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2,267 |
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2,078 |
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6,734 |
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6,384 |
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Income before income taxes |
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483 |
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479 |
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1,520 |
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1,231 |
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Income tax expense |
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88 |
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105 |
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291 |
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266 |
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Net income |
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$ |
395 |
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$ |
374 |
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$ |
1,229 |
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$ |
965 |
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Earnings per common share |
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Basic |
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$ |
0.62 |
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$ |
0.58 |
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$ |
1.90 |
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$ |
1.49 |
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Diluted |
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$ |
0.61 |
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$ |
0.57 |
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$ |
1.87 |
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$ |
1.47 |
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Weighted average number of common
shares outstanding |
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Basic |
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641 |
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653 |
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647 |
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650 |
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Diluted |
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651 |
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661 |
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657 |
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656 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
2
Baxter International Inc.
Condensed Consolidated Balance Sheets (unaudited)
(in millions, except shares)
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September 30, |
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December 31, |
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2007 |
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2006 |
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Current assets |
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Cash and equivalents |
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$ |
1,818 |
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$ |
2,485 |
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Accounts and other current receivables |
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1,976 |
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1,838 |
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Inventories |
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2,320 |
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2,066 |
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Other current assets |
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526 |
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581 |
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Total current assets |
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6,640 |
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6,970 |
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Property, plant and equipment, net |
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4,216 |
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4,229 |
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Other assets |
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Goodwill |
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1,649 |
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1,618 |
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Other intangible assets, net |
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457 |
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480 |
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Other |
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1,185 |
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1,389 |
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Total other assets |
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3,291 |
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3,487 |
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Total assets |
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$ |
14,147 |
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$ |
14,686 |
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Current liabilities |
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Short-term debt |
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$ |
46 |
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$ |
57 |
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Current maturities of long-term debt and lease
obligations |
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500 |
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177 |
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Accounts payable and accrued liabilities |
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3,143 |
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3,376 |
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Total current liabilities |
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3,689 |
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3,610 |
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Long-term debt and lease obligations |
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2,024 |
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2,567 |
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Other long-term liabilities |
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2,142 |
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2,237 |
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Commitments and contingencies |
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Shareholders equity |
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Common stock, $1 par value, authorized
2,000,000,000 shares, issued 683,494,944 shares
in 2007 and 2006 |
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683 |
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683 |
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Common stock in treasury, at cost, 49,669,849
shares in 2007 and 33,016,340 shares in 2006 |
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(2,420 |
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(1,433 |
) |
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Additional contributed capital |
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5,251 |
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5,177 |
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Retained earnings |
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4,039 |
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3,271 |
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Accumulated other comprehensive loss |
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(1,261 |
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(1,426 |
) |
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Total shareholders equity |
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6,292 |
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6,272 |
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Total liabilities and shareholders equity |
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$ |
14,147 |
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$ |
14,686 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
Baxter International Inc.
Condensed Consolidated Statements of Cash Flows (unaudited)
(in millions)
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Nine months ended |
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September 30, |
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2007 |
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2006 |
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Cash flows from operating activities |
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Net income |
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$ |
1,229 |
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$ |
965 |
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Adjustments |
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Depreciation and amortization |
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428 |
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431 |
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Deferred income taxes |
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32 |
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76 |
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Stock compensation |
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99 |
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68 |
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Restructuring and infusion pump charges |
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70 |
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76 |
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Average wholesale pricing litigation charge |
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56 |
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In-process research and development charges |
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46 |
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Other |
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53 |
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29 |
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Changes in balance sheet items
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Accounts and other current receivables |
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(114 |
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33 |
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Inventories |
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(261 |
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(108 |
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Accounts payable and accrued liabilities |
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(85 |
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(159 |
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Restructuring payments |
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(20 |
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(34 |
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Other |
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21 |
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44 |
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Cash flows from operating activities |
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1,554 |
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1,421 |
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Cash flows from investing activities |
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Capital expenditures |
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(424 |
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(336 |
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Acquisitions of, and investments in, businesses
and technologies |
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(83 |
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(3 |
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Divestitures and other |
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490 |
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140 |
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Cash flows from investing activities |
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(17 |
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(199 |
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Cash flows from financing activities |
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Issuances of debt |
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73 |
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707 |
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Payments of obligations |
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(501 |
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(1,235 |
) |
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Cash dividends on common stock |
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(598 |
) |
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(363 |
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Proceeds from stock issued under employee
benefit plans |
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500 |
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195 |
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Other issuances of stock |
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1,249 |
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Purchases of treasury stock |
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(1,641 |
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(479 |
) |
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Cash flows from financing activities |
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(2,167 |
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74 |
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Effect of currency exchange rate changes on cash and equivalents |
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(37 |
) |
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(70 |
) |
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(Decrease) increase in cash and equivalents |
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(667 |
) |
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1,226 |
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Cash and equivalents at beginning of period |
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2,485 |
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|
841 |
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Cash and equivalents at end of period |
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$ |
1,818 |
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$ |
2,067 |
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The accompanying notes are an integral part of these condensed consolidated financial
statements.
4
Baxter International Inc.
Notes to Condensed Consolidated Financial Statements (unaudited)
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The unaudited interim condensed consolidated financial statements of Baxter International Inc. and
its subsidiaries (the company or Baxter) have been prepared pursuant to the rules and regulations
of the Securities and Exchange Commission. Accordingly, certain information and footnote
disclosures normally included in financial statements prepared in accordance with generally
accepted accounting principles have been condensed or omitted. These interim condensed
consolidated financial statements should be read in conjunction with the consolidated financial
statements and notes included in the companys 2006 Annual Report to Shareholders (2006 Annual
Report).
In the opinion of management, the interim condensed consolidated financial statements reflect all
adjustments necessary for a fair presentation of the interim periods. All such adjustments,
unless otherwise noted herein, are of a normal, recurring nature. The results of operations for
the interim period are not necessarily indicative of the results of operations to be expected for
the full year.
Adoption of FIN No. 48
On January 1, 2007, the company adopted Financial Accounting Standards Board (FASB) Interpretation
(FIN) No. 48, Accounting for Uncertainty in Income
Taxes - an Interpretation of FASB Statement
109 (FIN No. 48). FIN No. 48 prescribes a two-step process for the financial statement
measurement and recognition of a tax position taken or expected to be taken in a tax return. The
first step involves the determination of whether it is more likely than not (greater than 50
percent likelihood) that a tax position will be sustained upon examination, based on the technical
merits of the position. The second step requires that any tax position that meets the
more-likely-than-not recognition threshold be measured and recognized in the financial statements
at the largest amount of benefit that is greater than 50 percent likely of being realized upon
ultimate settlement. FIN No. 48 also provides guidance on the accounting for related interest and
penalties, financial statement classification and disclosure. The cumulative effect of applying
FIN No. 48 is to be reported as an adjustment to the opening balance of retained earnings in the
period of adoption.
The adoption of FIN No. 48 by the company on January 1, 2007 had no impact on the opening balance
of retained earnings.
At January 1, 2007, the companys liability for uncertain tax positions totaled $405 million,
including liabilities related to interest and penalties. The liabilities related to interest and
penalties at January 1, 2007 were not material. At December 31, 2006, the entire balance was
classified as a current liability. In applying FIN No. 48s liability classification provisions,
the company reclassified $200 million of the total liability to noncurrent liabilities on January
1, 2007. There was no material change in the liability for uncertain tax positions during the
third quarter or first nine months of 2007.
None of the positions included in the liability for uncertain tax positions related to tax
positions for which the ultimate deductibility is highly certain but for which there is
uncertainty about the timing of such deductibility.
The company has historically classified interest and penalties associated with income taxes in the
income tax expense line in the consolidated statement of income, and this treatment is unchanged
under FIN No. 48. Interest and penalties recorded during the third quarter or first nine months
of 2007 were not material.
Refer to the Annual Report included in the companys Form 10-K for the year ended December 31,
2006 for a description, by major tax jurisdiction, of tax years that remain subject to
examination. Other than the settlement of a tax audit outside the United States during the second
quarter, there were no material changes during the first nine months of 2007.
As of January 1, 2007, Baxter had ongoing audits in several jurisdictions, as well as bilateral
Advance Pricing Agreement proceedings that the company voluntarily initiated between the U.S.
government and the governments of Switzerland and Japan with respect to intellectual property,
product, and service transfer pricing arrangements.
Baxter expects to settle these proceedings within the next 12 months. In the opinion of
management, the company has made adequate tax provisions for all years subject to examination.
There is a reasonable possibility that the ultimate settlements will be more or less than the
amounts reserved for these unrecognized tax benefits.
5
Issued but not yet effective accounting standards
SFAS No. 157
In September 2006, the FASB issued Statement of Financial Accounting Standards (SFAS) No. 157,
Fair Value Measurements (SFAS No. 157), which clarifies the definition of fair value whenever
another standard requires or permits assets or liabilities to be measured at fair value.
Specifically, the standard clarifies that fair value should be based on the assumptions market
participants would use when pricing the asset or liability, and establishes a fair value hierarchy
that prioritizes the information used to develop those assumptions. SFAS No. 157 does not expand
the use of fair value to any new circumstances, and must be applied on a prospective basis except
in certain cases. The standard also requires expanded financial statement disclosures about fair
value measurements, including disclosure of the methods used and the effect on earnings. The
company is in the process of analyzing this new standard, which will be effective for the company
on January 1, 2008.
SFAS No. 159
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities, Including an Amendment of FASB Statement No. 115 (SFAS No. 159). SFAS No.
159 permits entities to choose to measure many financial instruments and certain other items at
fair value, which are not otherwise currently required to be measured at fair value. Under SFAS
No. 159, the decision to measure items at fair value is made at specified election dates on an
instrument-by-instrument basis and is irrevocable. Entities electing the fair value option would
be required to recognize changes in fair value in earnings and to expense upfront costs and fees
associated with the item for which the fair value option is elected. At the adoption date,
unrealized gains and losses on existing items for which the fair value option has been elected are
reported as a cumulative adjustment to beginning retained earnings. The company is in the process
of analyzing this new standard, which will be effective for the company on January 1, 2008.
2. SUPPLEMENTAL FINANCIAL INFORMATION
Net pension and other postemployment benefits expense
The following is a summary of net expense relating to the companys pension and other
postemployment benefit (OPEB) plans.
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Three months ended |
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Nine months ended |
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September 30, |
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September 30, |
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(in millions) |
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2007 |
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2006 |
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2007 |
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2006 |
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Pension benefits |
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Service cost |
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$ |
22 |
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|
$ |
23 |
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|
$ |
65 |
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$ |
68 |
|
Interest cost |
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|
47 |
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|
44 |
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|
139 |
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|
131 |
|
Expected return on plan assets |
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(54 |
) |
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(50 |
) |
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(161 |
) |
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(149 |
) |
Amortization of net loss, prior service cost
and transition obligation |
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24 |
|
|
|
29 |
|
|
|
73 |
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|
|
87 |
|
|
Net pension plan expense |
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$ |
39 |
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|
$ |
46 |
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|
$ |
116 |
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$ |
137 |
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OPEB |
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Service cost |
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$ |
1 |
|
|
$ |
2 |
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|
$ |
4 |
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|
$ |
5 |
|
Interest cost |
|
|
8 |
|
|
|
7 |
|
|
|
23 |
|
|
|
22 |
|
Amortization of net loss and prior service cost |
|
|
1 |
|
|
|
1 |
|
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|
3 |
|
|
|
4 |
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|
Net OPEB plan expense |
|
$ |
10 |
|
|
$ |
10 |
|
|
$ |
30 |
|
|
$ |
31 |
|
|
Net interest expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Three months ended |
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Nine months ended |
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|
September 30, |
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September 30, |
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(in millions) |
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
Interest expense, net of capitalized interest |
|
$ |
30 |
|
|
$ |
25 |
|
|
$ |
90 |
|
|
$ |
70 |
|
Interest income |
|
|
(24 |
) |
|
|
(20 |
) |
|
|
(80 |
) |
|
|
(37 |
) |
|
Net interest expense |
|
$ |
6 |
|
|
$ |
5 |
|
|
$ |
10 |
|
|
$ |
33 |
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|
6
Comprehensive income
Total comprehensive income was $429 million and $410 million for the three months ended September
30, 2007 and 2006, respectively, and $1,394 million and $1,003 million for the nine months ended
September 30, 2007 and 2006, respectively. The increase in comprehensive income in both periods
was principally due to higher net income and favorable movements in currency translation
adjustments, partially offset, particularly in the third quarter, by unfavorable movements in the
fair value of the companys net investment hedges.
Effective tax rate
The companys effective income tax rate was 18.2% and 21.9% in the third quarters of 2007 and 2006,
respectively, and 19.1% and 21.6% in the nine-month periods ended September 30, 2007 and 2006,
respectively. For a discussion of the effective tax rate anticipated for the full-year 2007, see
the Income Taxes section of Managements Discussion and Analysis below.
The decrease in the third quarter was principally due to a $57 million reduction of the valuation
allowance on net operating loss carryforwards in a foreign jurisdiction due to recent profitability
improvements, a $12 million reduction in tax expense due to recently enacted legislation reducing
corporate income tax rates in Germany, as well as an approximately $8 million net favorable tax
impact of a charge related to the companys average wholesale pricing litigation (see Note 6 for
further information regarding this charge) and in-process research and development (IPR&D) charges
recorded in the quarter (see Acquisitions of, and investments in, businesses and technologies
section below for further information regarding these charges). In addition, as a result of
profitability in lower tax rate jurisdictions around the world that was higher than previous
estimates, the company lowered its expected full-year tax rate on earnings excluding special items,
which reduced income tax expense in the quarter by approximately $14 million related to earnings
through the first half of 2007. Partially offsetting these items in the quarter was $84 million of
U.S. income tax expense related to foreign earnings, which are no longer considered permanently reinvested
outside of the United States because management now believes these
earnings will be remitted to the United States in the foreseeable future.
In addition to the items noted above, the decrease in the year-to-date period was due to the
extension of tax incentives and the favorable settlement of a tax audit in jurisdictions outside of
the United States, as well as the impact of the second quarter 2007 restructuring charges. These
benefits were partially offset by the tax impact of the gain on the divestiture of the Transfusion
Therapies (TT) business and related charges. The effective tax rate for the nine months ended
September 30, 2006 was impacted by costs associated with the COLLEAGUE and SYNDEO infusion pumps
that have lower tax benefits. Refer to Note 3 for further information on the divestiture and Note
4 for further information on the restructuring charges recorded in 2007 and the infusion pump
charges recorded in 2006.
Earnings per share
The numerator for both basic and diluted earnings per share (EPS) is net income. The denominator
for basic EPS is the weighted-average number of common shares outstanding during the period. The
dilutive effect of outstanding employee stock options, employee stock purchase subscriptions, the
purchase contracts in the companys equity units (which were settled in February 2006), restricted
stock units, performance share units and restricted stock is reflected in the denominator for
diluted EPS principally using the treasury stock method.
Employee stock options to purchase 11 million and 28 million shares for the third quarters of 2007
and 2006, respectively, and 11 million and 42 million for the nine-month periods ended September
30, 2007 and 2006, respectively, were not included in the computation of diluted EPS because the
assumed proceeds were greater than the average market price of the companys common stock,
resulting in an anti-dilutive effect on diluted EPS.
Refer to the 2006 Annual Report regarding the purchase contracts included in the companys equity
units. The purchase contracts were settled in February 2006, and the company issued approximately
35 million shares of common stock in exchange for $1.25 billion. Using the treasury stock method,
prior to the February 2006 settlement date, the purchase contracts had a dilutive effect when the
average market price of Baxter stock exceeded $35.69.
The following is a reconciliation of basic shares to diluted shares.
7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
(in millions) |
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
Basic shares |
|
|
641 |
|
|
|
653 |
|
|
|
647 |
|
|
|
650 |
|
Effect of dilutive securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee stock options |
|
|
9 |
|
|
|
7 |
|
|
|
9 |
|
|
|
6 |
|
Performance share units,
restricted stock
units and other |
|
|
1 |
|
|
|
1 |
|
|
|
1 |
|
|
|
|
|
|
Diluted shares |
|
|
651 |
|
|
|
661 |
|
|
|
657 |
|
|
|
656 |
|
|
Inventories
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
(in millions) |
|
2007 |
|
|
2006 |
|
|
Raw materials |
|
$ |
650 |
|
|
$ |
526 |
|
Work in process |
|
|
667 |
|
|
|
676 |
|
Finished products |
|
|
1,003 |
|
|
|
864 |
|
|
Total inventories |
|
$ |
2,320 |
|
|
$ |
2,066 |
|
|
Property, plant and equipment, net
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
(in millions) |
|
2007 |
|
|
2006 |
|
|
Property, plant and equipment, at cost |
|
$ |
8,430 |
|
|
$ |
8,311 |
|
Accumulated depreciation and amortization |
|
|
(4,214 |
) |
|
|
(4,082 |
) |
|
Property, plant and equipment, net (PP&E) |
|
$ |
4,216 |
|
|
$ |
4,229 |
|
|
Goodwill
Goodwill at September 30, 2007 totaled $579 million for the BioScience segment, $921 million for
the Medication Delivery segment and $149 million for the Renal segment. Goodwill at December 31,
2006 totaled $579 million for the BioScience segment, $898 million for the Medication Delivery
segment and $141 million for the Renal segment. Approximately $12 million of goodwill in the
BioScience segment was included in the book value of the TT business in determining the divestiture
gain. Refer to Note 3 for further information. The remaining change in the goodwill balance from
December 31, 2006 to September 30, 2007 for each segment principally related to foreign currency
fluctuations.
Other intangible assets, net
The following is a summary of the companys intangible assets subject to amortization at September
30, 2007 and December 31, 2006.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Developed |
|
|
|
|
|
|
|
|
technology, |
|
|
|
|
|
|
|
(in millions, except amortization period data) |
including patents |
|
|
Other |
|
|
Total |
|
|
September 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
Gross intangible assets |
|
$ |
834 |
|
|
$ |
126 |
|
|
$ |
960 |
|
Accumulated amortization |
|
|
442 |
|
|
|
68 |
|
|
|
510 |
|
|
Net intangible assets |
|
$ |
392 |
|
|
$ |
58 |
|
|
$ |
450 |
|
|
Weighted-average amortization
period (in years) |
|
|
14 |
|
|
|
14 |
|
|
|
14 |
|
|
|
December 31, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
Gross intangible assets |
|
$ |
827 |
|
|
$ |
122 |
|
|
$ |
949 |
|
Accumulated amortization |
|
|
418 |
|
|
|
58 |
|
|
|
476 |
|
|
Net intangible assets |
|
$ |
409 |
|
|
$ |
64 |
|
|
$ |
473 |
|
|
Weighted-average amortization
period (in years) |
|
|
15 |
|
|
|
15 |
|
|
|
15 |
|
|
The amortization expense for these intangible assets was $14 million and $15 million for the three
months ended September 30, 2007 and 2006, respectively, and $43 million and $42 million for the
nine months ended September 30, 2007 and 2006, respectively.
8
The anticipated annual amortization expense for intangible assets
recorded as of September 30, 2007 is $57 million in 2007, $51 million in 2008, $50 million in 2009,
$48 million in 2010, $43 million in 2011 and $39 million in 2012.
Acquisitions of, and investments in, businesses and technologies
MAAS Medical, LLC
In June 2007, the company acquired certain assets of MAAS Medical, LLC, a company that specializes
in infusion systems technology. This acquisition expands Baxters R&D capabilities, as the talent
and technology acquired will be incorporated into Baxters R&D pipeline and applied in the
development of infusion systems and related technologies within the Medication Delivery segment.
The purchase price of $11 million was principally allocated to IPR&D, and expensed at the
acquisition date. The IPR&D relates to products under development which had not achieved
regulatory approval and had no alternative future use. Baxter may be required to make additional
payments of up to $14 million based on the achievement of specified regulatory approvals of
products as well as the retention of certain key employees. These contingent payments will be
recorded if and when the contingencies are resolved, as the outcomes of the contingencies are not
determinable beyond a reasonable doubt on the acquisition date.
HHD
In August 2007, the company entered into a collaboration with HHD, LLC (HHD) and DEKA Products
Limited Partnership and DEKA Research and Development Corp. (collectively, DEKA) for the
development of a next-generation home hemodialysis (HD) machine. This Renal business collaboration
highlights Baxters ongoing commitment to innovation in end-stage renal disease treatment, and
reflects the companys strategic approach to expediting and enhancing product development through
targeted partnerships. The arrangement will provide Baxter with the opportunity to offer two forms
of at-home dialysis, peritoneal dialysis (PD) and home HD, with the goal of continuing to offer
patients an improved quality of life, and greater flexibility and control as to when and where they
receive treatment.
HHD owns certain intellectual property and licensing rights that will be used in developing the
next-generation home HD machine. In addition, pursuant to an R&D and license agreement between HHD
and DEKA, DEKA will perform R&D activities for HHD in exchange for compensation for the R&D
services and licensing rights, plus royalties on any commercial sales of the developed product.
In connection with this collaboration, the company purchased an option for $25 million to acquire
the assets of HHD, and will reimburse HHD for the R&D services performed by DEKA, as well as other
of HHDs costs associated with developing the home HD machine. Pursuant to the option agreement
with HHD, the company can exercise the option at any time between the effective date of the
agreement and the earlier of U.S. Food and Drug Administration approval of the product or January
31, 2011. The exercise price is fixed, varying only based on the timing of exercise, with the
exercise price decreasing over the exercise period, from $45 million to $19 million. Upon
exercise, the company would make an additional payment of up to $4 million based on a contractual
relationship between HHD and a third party. Because the company is the primary beneficiary of the
risks and rewards of HHDs activities, the company is consolidating the financial results of HHD
from the date of the option purchase.
HHDs assets and technology have not yet received regulatory approval and no alternative future use
has been identified. In conjunction with the execution of the option agreement with HHD and the
related payment of $25 million, the company recognized a net IPR&D charge of $25 million during the
third quarter of 2007.
Halozyme Therapeutics, Inc.
In February 2007, the company entered into an arrangement to expand the companys existing
arrangements with Halozyme Therapeutics, Inc. (Halozyme) to include the use of HYLENEX recombinant
(hyaluronidase human injection) with the companys proprietary and non-proprietary small molecule
drugs. Under the terms of the arrangement, the company made an initial payment of $10 million for
license and other rights, which was capitalized as an intangible asset, and made a $20 million
investment in the common stock of Halozyme. The company assumes the development, manufacturing,
clinical, regulatory, and sales and marketing costs associated with the products included in the
arrangement. This arrangement will provide the Medication Delivery segment with a new route of
administration for injected drugs and fluids, and a potential pipeline of proprietary drug
applications through the kitting and co-formulating of HYLENEX with generic molecules.
9
In September 2007, the company entered into an arrangement with Halozyme to apply Halozymes
Enhanze technology to the development of a subcutaneous route of administration for Baxters
liquid formulation of IVIG (intravenous immunoglobulin). Under this arrangement, the company made
an initial payment of $10 million, which was expensed as IPR&D as the licensed technology had not
received regulatory approval and had no alternative future use. The goal of this BioScience
segment collaboration is to enable the company to provide patients with immunodeficiency disorders
access to enhanced administration of IVIG therapy.
With respect to both of these arrangements, the company may be required to make additional
payments of up to $62 million based on the successful completion of specified regulatory and sales
milestones, as well as royalty payments on future sales of the related products. Based on the
companys projections, any contingent payments made in the future will be more than offset over
time by the estimated net future cash flows related to the rights acquired for those payments.
Securitization arrangements
The companys securitization arrangements resulted in net cash outflows of $23 million and $71
million for the three months ended September 30, 2007 and 2006, respectively, and $31 million and
$105 million for the nine months ended September 30, 2007 and 2006, respectively. A summary of
the activity is as follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
(in millions) |
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
Sold receivables at beginning of period |
|
|
$337 |
|
|
|
$429 |
|
|
|
$348 |
|
|
|
$451 |
|
Proceeds from sales of receivables |
|
|
402 |
|
|
|
358 |
|
|
|
1,172 |
|
|
|
1,039 |
|
Cash collections (remitted to the
owners of the receivables) |
|
|
(425 |
) |
|
|
(429 |
) |
|
|
(1,203 |
) |
|
|
(1,144 |
) |
Effect of currency exchange rate changes |
|
|
13 |
|
|
|
(1 |
) |
|
|
10 |
|
|
|
11 |
|
|
Sold receivables at end of period |
|
|
$327 |
|
|
|
$357 |
|
|
|
$327 |
|
|
|
$357 |
|
|
3. SALE OF TRANSFUSION THERAPIES BUSINESS
On February 28, 2007, the company completed the disposition of substantially all of the assets and
liabilities of its TT business to an affiliate of TPG Capital, L.P. (TPG), which has established
the new company as Fenwal Inc. (Fenwal), for $540 million. This purchase price is subject to
customary adjustments based upon the finalization of the net assets transferred. Under the terms
of the sale agreement, TPG acquired the net assets of the TT business, including its product
portfolio of manual and automated blood-collection products and storage equipment, as well as five
manufacturing facilities located in Haina, Dominican Republic; La Chatre, France; Maricao and San
German, Puerto Rico; and Nabeul, Tunisia. The decision to sell the TT net assets was based on the
results of strategic and financial reviews of the companys business portfolio, and will allow the
company to increase its focus and investment on businesses with more long-term strategic value to
the company.
Under transition agreements, the company is providing manufacturing and a variety of support
services to Fenwal for a period of time after divestiture, which vary based on the products or
services provided and other factors, but generally approximate two years. Due to the companys
expected significant continuing cash flows associated with this business, the company continued to
include the results of operations of TT in the companys results of continuing operations through
the February 28, 2007 sale date. No facts or circumstances have arisen in the second or third
quarter of 2007 that change the expectation of significant continuing cash flows. TTs sales,
which were reported in the BioScience segment, were $79 million in 2007 through the February 28
sale date and $121 million and $371 million in the third quarter and first nine months of 2006,
respectively. Revenues associated with the manufacturing, distribution and other transition
services provided by the company to Fenwal post-divestiture, which were $44 million in the third
quarter of 2007 and $100 million in the year-to-date period, are reported at the corporate
headquarters level and not allocated to a segment.
The major classes of the assets and liabilities classified as held for sale as of the February 28,
2007 sale date and that were included in the companys consolidated financial statements as of
December 31, 2006 were as follows.
10
|
|
|
|
|
|
|
|
|
|
|
February 28, |
|
December 31, |
|
(in millions) |
|
2007 |
|
|
2006 |
|
|
Current assets |
|
$ |
149 |
|
|
$ |
208 |
|
Noncurrent assets |
|
$ |
224 |
|
|
$ |
206 |
|
|
Total assets |
|
$ |
373 |
|
|
$ |
414 |
|
Total liabilities |
|
$ |
58 |
|
|
$ |
64 |
|
|
The company recorded a pre-tax gain on the sale of the TT business of $58 million ($30 million, or
$0.05 per diluted share, on an after-tax basis) during the first quarter of 2007. Cash proceeds
were $473 million, representing the purchase price of $540 million net of certain items,
principally international receivables that have been retained by the company post-divestiture. The
gain on the sale was recorded net of transaction-related expenses and other costs of $36 million,
and a $12 million allocation of a portion of BioScience segment goodwill. In addition, $52 million
of the cash proceeds were allocated to the manufacturing, distribution and other transition
agreements because these arrangements provide for below-market consideration for those services.
Approximately $7 million and $17 million of deferred revenue related to these arrangements was
recognized during the third quarter of 2007 and in the year-to-date period, respectively, as the
services were performed.
In connection with the TT divestiture, the company recorded a $35 million pre-tax charge ($24
million, or $0.04 per diluted share, on an after-tax basis) principally associated with severance
and other employee-related costs. Reserve utilization in the third quarter of 2007 was $5 million.
The reserve is expected to be utilized by the end of 2008, and the company believes that the
reserves are adequate. However, adjustments may be recorded in the future as the program is
completed.
The gain on the sale of the TT business and the related charges were recorded in other income and
expense, net on the consolidated statement of income. These amounts were reported at the
corporate headquarters level and were not allocated to a segment.
4. RESTRUCTURING AND OTHER SPECIAL CHARGES
2007 restructuring charges
During the second quarter of 2007, the company recorded pre-tax restructuring charges of $70
million principally associated with the consolidation of certain commercial and manufacturing
operations outside of the United States. Based upon a review of current and future capacity
needs, the company decided to integrate several facilities in order to reduce the companys cost
structure and optimize the companys operations, principally within the Medication Delivery
segment.
Included in the charge was $17 million related to asset impairments, principally to write down PP&E
based on market data for the assets. Also included in the charge was $53 million for cash costs,
principally pertaining to severance and other employee-related costs associated with the
elimination of approximately 550 positions, or approximately 1% of the companys total workforce.
Reserve utilization through September 30, 2007 was not significant. The reserve for severance and
other costs is expected to be utilized by the end of 2009, with the majority of the payments to be
made in 2007 and 2008. The company believes that the reserves are adequate. However, adjustments
may be recorded in the future as the programs are completed.
2004 restructuring charge
During 2004, the company recorded a $543 million pre-tax restructuring charge principally
associated with managements decision to implement actions to reduce the companys overall cost
structure and to drive sustainable improvements in financial performance. Included in the 2004
charge was $196 million relating to asset impairments, almost all of which was to write down PP&E.
Also included in the 2004 charge was $347 million for cash costs, principally pertaining to
severance and other employee-related costs. Refer to the 2006 Annual Report for additional
information.
The following table summarizes cash activity in the companys 2004 restructuring reserve.
11
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee- |
|
Contractual |
|
|
|
|
|
|
related |
|
and other |
|
|
|
|
(in millions) |
|
costs |
|
|
costs |
|
|
Total |
|
|
Charge |
|
|
$212 |
|
|
|
$135 |
|
|
|
$347 |
|
Utilization and adjustments in 2004, 2005 and 2006 |
|
|
(198 |
) |
|
|
(94 |
) |
|
|
(292 |
) |
|
Reserve at December 31, 2006 |
|
|
$ 14 |
|
|
|
$ 41 |
|
|
|
$ 55 |
|
Utilization |
|
|
(2 |
) |
|
|
(1 |
) |
|
|
(3 |
) |
|
Reserve at March 31, 2007 |
|
|
$ 12 |
|
|
|
$ 40 |
|
|
|
$ 52 |
|
Utilization |
|
|
(2 |
) |
|
|
(1 |
) |
|
|
(3 |
) |
|
Reserve at June 30, 2007 |
|
|
$ 10 |
|
|
|
$ 39 |
|
|
|
$ 49 |
|
Utilization |
|
|
(4 |
) |
|
|
(2 |
) |
|
|
(6 |
) |
|
Reserve at September 30, 2007 |
|
|
$ 6 |
|
|
|
$ 37 |
|
|
|
$ 43 |
|
|
Substantially all of the reserve is expected to be utilized by the end of 2007, with the rest
of the cash outflows principally relating to certain long-term leases and remaining employee
severance payments. The company believes that the restructuring program is substantially
complete and that the remaining reserves are adequate. However, remaining cash payments are
subject to change.
Other charges
The 2005 and 2006 charges discussed below were classified in cost of goods sold in the companys
consolidated income statements. The actual costs relating to certain of these matters may differ
from the companys estimates. It is possible that additional charges may be required in future
periods, based on new information or changes in estimates. For additional information on these
other charges, please refer to the 2006 Annual Report.
Infusion Pumps
The company began to hold shipments of COLLEAGUE infusion pumps in July 2005, and continues to hold
shipments in the United States. Please refer to the companys 2006 Annual Report for further
information on the charges related to the COLLEAGUE and SYNDEO pumps, and the Certain Regulatory
Matters section in Managements Discussion and Analysis below regarding recent developments
related to this matter.
The company recorded pre-tax charges of $77 million in the second quarter of 2005 and $76 million
in the second quarter of 2006 related to issues associated with its COLLEAGUE and SYNDEO infusion
pumps. Included in the 2005 charge was $4 million relating to asset impairments and $73 million
for cash costs, representing an estimate of the cash expenditures for the materials, labor and
freight costs expected to be incurred to remediate the design issues. Included in the 2006 charge
was $3 million relating to asset impairments and $73 million for cash costs, which related to
additional customer accommodations and adjustments to the previously established reserves for
remediation costs based on further definition of the potential remediation requirements and the
companys experience remediating pumps outside of the United States. Also, in the first quarter of
2006, the company recorded an additional $18 million pre-tax expense, of which $7 million related
to asset impairments and $11 million related to additional warranty and other commitments made to
customers.
In the fourth quarter of 2005, the company recorded a charge associated with the withdrawal of its
6060 multi-therapy infusion pump from the market. Included in the $49 million pre-tax charge was
$41 million for cash costs. The charge principally consisted of the estimated costs to provide
customers with replacement pumps, with the remainder of the charge related to asset impairments,
principally to write off customer lease receivables. During 2006, the company recorded a $16
million adjustment to reduce the amount of the reserve, as the estimated costs associated with
providing customers with replacement pumps were refined.
The following table summarizes cash activity in the companys infusion pump reserves, including
the COLLEAGUE, SYNDEO and 6060 infusion pumps, through September 30, 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COLLEAGUE |
|
|
|
|
|
|
|
(in millions) |
and SYNDEO |
|
|
6060 |
|
|
Total |
|
|
Charge |
|
$ |
157 |
|
|
|
$41 |
|
|
$ |
198 |
|
Utilization and adjustments |
|
|
(46 |
) |
|
|
(33 |
) |
|
|
(79 |
) |
|
Reserve at December 31, 2006 |
|
$ |
111 |
|
|
|
$ 8 |
|
|
$ |
119 |
|
Utilization |
|
|
(9 |
) |
|
|
(2 |
) |
|
|
(11 |
) |
|
Reserve at March 31, 2007 |
|
$ |
102 |
|
|
|
$ 6 |
|
|
$ |
108 |
|
Utilization |
|
|
(9 |
) |
|
|
(2 |
) |
|
|
(11 |
) |
|
Reserve at June 30, 2007 |
|
$ |
93 |
|
|
|
$ 4 |
|
|
$ |
97 |
|
Utilization |
|
|
(18 |
) |
|
|
(1 |
) |
|
|
(19 |
) |
|
Reserve at September 30, 2007 |
|
$ |
75 |
|
|
|
$ 3 |
|
|
$ |
78 |
|
|
12
Substantially all of the remaining
infusion pump reserves are expected to be utilized during 2007 and 2008.
Hemodialysis Instruments
During 2005, the company recorded
a $50 million pre-tax charge associated with managements
decision to discontinue the manufacture of HD instruments, including the companys Meridian
instrument. Included in the $50 million charge was $23 million relating to asset impairments,
principally to write down inventory, equipment and other assets used to manufacture HD
machines. The remaining $27 million of the charge related to the estimated cash payments
associated with providing customers with replacement instruments. The company has utilized
$18 million of the reserve for cash costs through the third quarter of 2007. Substantially
all of the remaining reserve is expected to be utilized in 2007 and 2008.
5. COMMON STOCK
Stock-based compensation plans
On January 1, 2006, the company adopted SFAS No. 123 (revised 2004), Share-Based Payment (SFAS
No. 123-R) using the modified prospective transition method. Stock compensation expense measured
in accordance with SFAS No. 123-R totaled $36 million ($24 million on a net-of-tax basis, or $0.04
per diluted share) and $30 million ($19 million on a net-of-tax basis, or $0.03 per diluted share)
for the three months ended September 30, 2007 and 2006, respectively, and $99 million ($66 million
on a net-of-tax basis, or $0.10 per diluted share) and $68 million ($45 million on a net-of-tax
basis, or $0.07 per diluted share) for the nine months ended September 30, 2007 and 2006,
respectively. Approximately three-quarters of stock compensation expense is classified in
marketing and administrative expenses, with the remainder classified in cost of goods sold and
research and development expenses.
In March 2007, the company made its annual stock compensation grants, which consisted of
approximately 7.2 million stock options and 1.1 million performance share units (PSUs) and
restricted stock units (RSUs). Stock compensation grants made in the second and third quarters of
2007 were not material.
Stock options
The weighted-average assumptions used in estimating the fair value of stock options granted during
the period, along with the weighted-average fair values, were as follows.
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
Expected volatility |
|
|
23.4% |
|
|
|
27.5% |
|
Expected life (in years) |
|
|
4.5 |
|
|
|
5.5 |
|
Risk-free interest rate |
|
|
4.5% |
|
|
|
4.7% |
|
Dividend yield |
|
|
1.2% |
|
|
|
1.5% |
|
Fair value per stock option |
|
|
$13 |
|
|
|
$11 |
|
|
Employee stock options granted prior to 2007 generally vest 100% on the third anniversary of the
grant date and have a contractual term of 10 years. Beginning in the first quarter of 2007, stock
options granted generally vest in one-third increments over a three-year period, and have a
contractual term of 10 years.
The total intrinsic value of stock options exercised was $37 million and $52 million during the
three months ended September 30, 2007 and 2006, respectively, and $225 million and $78 million
during the nine months ended September 30, 2007 and 2006, respectively.
As of September 30, 2007, $120 million of pre-tax unrecognized compensation cost related to all
unvested stock options is expected to be recognized as expense over a weighted-average period of
1.9 years.
Performance share and restricted stock units
As part of an overall periodic reevaluation of the companys stock compensation programs, the
company made changes to its long-term incentive plan for senior management effective in the first
quarter of 2007. The RSU component of the plan has been replaced by PSUs
13
with market-based conditions. In addition, the
overall mix of stock compensation awarded under the plan has changed, from a weighting of 70% stock
options and 30% RSUs to 50% stock options and 50% PSUs.
Awards of PSUs will be earned by comparing the companys growth in shareholder value relative to a
performance peer group over a three-year period. Based upon the companys performance, the
recipient of a PSU may earn a total award ranging from 0% to 200% of the initial grant. As part of
the transition to the new program, the March 2007 annual grant also included RSUs.
The fair value of PSUs is estimated at the grant date using a Monte Carlo simulation. Expense is
recognized on a straight-line basis over the service period. As of September 30, 2007, pre-tax
unrecognized compensation cost related to all unvested RSUs and PSUs of $57 million is expected to
be recognized as expense over a weighted-average period of 2.0 years.
Realized excess income tax benefits
Realized excess tax benefits associated with stock-based compensation are required to be presented
on the statement of cash flows as an outflow within the operating section and an inflow within the
financing section. No income tax benefits were realized from stock-based compensation during the
first nine months of 2007 or 2006, due primarily to the companys U.S. net operating loss position.
Stock issuances
Refer to the 2006 Annual Report regarding the purchase contracts included in the companys equity
units. The purchase contracts were settled in February 2006, and the company issued 35 million
shares of common stock in exchange for $1.25 billion.
Stock repurchases
As authorized by the board of directors, from time to time the company repurchases its stock
depending upon the companys cash flows, net debt level and current market conditions. During the
three- and nine-month periods ended September 30, 2007, the company repurchased 15.3 million
shares and 30.4 million shares for $827 million and $1.64 billion, respectively, under stock
repurchase programs authorized by the board of directors. In March 2007, the board of directors
authorized the repurchase of up to an additional $2.0 billion of the companys common stock. At
September 30, 2007, $1.37 billion remained available under this authorization.
6. LEGAL PROCEEDINGS
Baxter is involved in product liability, patent, shareholder, commercial, and other legal
proceedings that arise in the normal course of the companys business. The company records a
liability when a loss is considered probable and the amount can be reasonably estimated. If the
reasonable estimate of a probable loss is a range, and no amount within the range is a better
estimate, the minimum amount in the range is accrued. If a loss is not probable or a probable loss
cannot be reasonably estimated, no liability is recorded.
Baxter has established reserves for certain of the matters discussed below. The company is not
able to estimate the amount or range of any loss for certain of the companys legal contingencies
for which there is no reserve or additional loss for matters already reserved. While the liability
of the company in connection with the claims cannot be estimated with any certainty and although
the resolution in any reporting period of one or more of these matters could have a significant
impact on the companys results of operations for that period, the outcome of these legal
proceedings is not expected to have a material adverse effect on the companys consolidated
financial position. While the company believes that it has valid defenses in these matters,
litigation is inherently uncertain, excessive verdicts do occur, and the company may in the future
incur material judgments or enter into material settlements of claims.
In addition to the matters described below, the company remains subject to other additional
potential administrative and legal actions. With respect to regulatory matters in particular,
these actions include product recalls, injunctions to halt manufacture and distribution, other
restrictions on the companys operations, civil sanctions, including monetary sanctions, and
criminal sanctions. Any of these actions could have an adverse effect on the companys business
and subject the company to additional regulatory actions and costly litigation. With respect to
patents, the company may be exposed to significant litigation concerning patents and products,
challenges to the coverage and
14
validity of the companys patents on products or processes, and allegations that the companys
products infringe patents held by competitors or other third parties. A loss in any of these types
of cases could result in a loss of patent protection or the ability to market products, which could
lead to a significant loss of sales, or otherwise materially affect future results of operations or
cash flows.
Patent Litigation
ADVATE Litigation
In April 2003, A. Nattermann & Cie GmbH and Aventis Behring L.L.C. filed a patent infringement
lawsuit in the U.S.D.C. for the District of Delaware naming Baxter Healthcare Corporation as the
defendant. The complaint, which sought injunctive relief, alleged that Baxters planned
manufacture and sale of ADVATE would infringe U.S. Patent No. 5,565,427. In November 2003, the
lawsuit was dismissed without prejudice. In October 2003, re-examination proceedings were
initiated in the U.S. Patent and Trademark Office. During these proceedings certain of the
original claims were amended or rejected, and new claims were added. On October 10, 2006, the
Patent Office issued a reexamination certificate and subsequently on October 16, 2006, Aventis
Pharma S.A. filed a patent infringement lawsuit naming Baxter Healthcare Corporation as the
defendant in the U.S.D.C. for the District of Delaware. A trial date of December 8, 2008 has been
set and discovery has begun.
Sevoflurane Litigation
In September 2005, the U.S.D.C. for the Northern District of Illinois ruled that a patent owned by
Abbott Laboratories and the Central Glass Company, U.S. Patent No. 5,990,176, was not infringed by
Baxters generic version of sevoflurane. Abbott and Central Glass appealed and Baxter filed a
cross-appeal as to the validity of the patent. In November 2006, the Court of Appeals for the
Federal Circuit granted Baxters cross-appeal and held Abbotts patent invalid. Abbotts motions
to have that appeal re-heard were denied in January 2007.
Related actions are pending in various jurisdictions in the United States and abroad. Another
patent infringement action against Baxter remains pending in the U.S.D.C. for the Northern District
of Illinois on a related patent owned by Abbott and Central Glass. Baxter has filed a motion
asserting that judgment of non-infringement and invalidity should be entered based in part on
findings made in the earlier case. In May 2005, Abbott and Central Glass filed suit in the Tokyo
District Court on a counterpart Japanese patent and in September 2006, the Tokyo District Court
ruled in favor of Abbott and Central Glass on this matter. Baxter has appealed this decision. In
June 2005, Baxter filed suit in the High Court of Justice in London, England seeking revocation of
the U.K. part of the related European patent and a declaration of non-infringement. In March 2007,
the High Court ruled in Baxters favor, concluding that the U.K. patent was invalid. Parallel
opposition proceedings in the European and Japanese Patent Offices seeking to revoke certain
versions of the patent are also pending.
GAMMAGARD Liquid Litigation
In June 2005, Talecris Biotherapeutics, Inc. filed a patent infringement lawsuit in the U.S.D.C.
for the District of Delaware naming Baxter Healthcare Corporation and Baxter International Inc. as
defendants. The complaint, which sought injunctive relief, alleged that Baxters manufacture and
sale of GAMMAGARD liquid infringes U.S. Patent No. 6,686,191. In July 2007, the parties settled
this litigation on terms which did not require a material payment by Baxter.
Peritoneal Dialysis Litigation
On October 16, 2006, Baxter Healthcare Corporation and DEKA Products Limited Partnership filed a
patent infringement lawsuit in the U.S.D.C. for the Eastern District of Texas against Fresenius
Medical Care Holdings, Inc. and Fresenius USA, Inc. The complaint alleges that Fresenius sale of
the Liberty Cycler peritoneal dialysis systems and related disposable items and equipment infringes
U.S. Patent No. 5,421,823, as to which DEKA has granted Baxter an exclusive license in the
peritoneal dialysis field. The case has been transferred to the U.S.D.C. for the Northern District
of California. The trial is expected to commence in January 2009.
Product Liability
Mammary Implant Litigation
The company is currently a defendant in various courts in a number of lawsuits seeking damages for
injuries of various types allegedly caused by silicone mammary implants previously manufactured by
the Heyer-Schulte division of American Hospital Supply Corporation (AHSC). AHSC, which was
acquired by Baxter in 1985, divested its Heyer-Schulte division in 1984. The majority of the
claims and lawsuits against the company have been resolved. After concluding a class action
settlement with a large group of U.S. claimants, the company will continue
15
to participate in the resolution of class member claims, for which reserves have been established,
until 2010. In addition, as of September 30, 2007, Baxter remains a defendant or co-defendant in
approximately 20 lawsuits relating to mammary implants brought by claimants who have opted out of,
or are not bound by, the class settlement. The company has also established reserves for these
lawsuits. Baxter believes that a substantial portion of its liability and defense costs for
mammary implant litigation may be covered by insurance, subject to self-insurance retentions,
exclusions, conditions, coverage gaps, policy limits and insurer insolvency.
Plasma-Based Therapies Litigation
Baxter currently is a defendant in a number of lawsuits and subject to additional claims brought by
individuals who have hemophilia and their families, all seeking damages for injuries allegedly
caused by anti-hemophilic factor concentrates VIII or IX derived from human blood plasma (factor
concentrates) processed by the company from the late 1970s to the mid-1980s. The typical case or
claim alleges that the individual was infected with the HIV virus by factor concentrates that
contained the HIV virus. None of these cases involves factor concentrates currently processed by
the company.
After concluding a class action settlement with a group of U.S. claimants for whom all eligible
claims have been paid, Baxter remained as a defendant in approximately 95 lawsuits and subject to
approximately 145 additional claims. Among the lawsuits, the company and other manufacturers have
been named as defendants in approximately 70 lawsuits pending or expected to be transferred to the
U.S.D.C. for the Northern District of Illinois on behalf of claimants, who are primarily non-U.S.
residents, seeking unspecified damages for HIV or Hepatitis C infections from their use of
plasma-based factor concentrates. In March 2005, the District Court denied plaintiffs motion to
certify purported classes. Thereafter, plaintiffs have filed additional lawsuits on behalf of
individual claimants outside of the U.S. In December 2005, the District Court granted defendants
motion to return U.K. claimants to their home jurisdiction. The appellate court has affirmed that
decision.
In addition, through its 1996 acquisition of Immuno International AG (Immuno), the company has
unsettled claims and lawsuits for damages for injuries allegedly caused by Immunos plasma-based
therapies. The typical claim alleges that the individual with hemophilia was infected with HIV or
Hepatitis C by factor concentrates. Additionally, the company has received notice of a number of
claims arising from Immunos vaccines and other biologically derived therapies.
The company believes that a substantial portion of the liability and defense costs related to its
plasma-based therapies litigation may be covered by insurance, subject to self-insurance
retentions, exclusions, conditions, coverage gaps, policy limits and insurer insolvency.
Althane Dialyzers Litigation
Baxter was named as a defendant in a number of civil cases seeking unspecified damages for alleged
injury or death from exposure to Baxters Althane series of dialyzers, which were withdrawn from
the market in 2001. All of these suits have been resolved. The Spanish Ministry of Health has
previously raised a claim, but a suit has not been filed. Currently, the U.S. government is
investigating Baxters withdrawal of the dialyzers from the market. In December 2002, Baxter
received a subpoena to provide documents to the U.S. Department of Justice and has cooperated fully
with the investigation.
Vaccines Litigation
As of September 30, 2007 the company has been named as a defendant, along with others, in
approximately 120 lawsuits filed in various state and U.S. federal courts, seeking damages,
injunctive relief and medical monitoring for claimants alleged to have contracted autism or
attention deficit disorders as a result of exposure to vaccines for childhood diseases containing
the preservative thimerosal. These vaccines were formerly manufactured and sold by North American
Vaccine, Inc., which was acquired by Baxter in June 2000, as well as by other companies.
Securities Laws
In August 2002, six purported class action lawsuits were filed in the U.S.D.C. for the Northern
District of Illinois naming Baxter and its then Chief Executive Officer and then Chief Financial
Officer as defendants. These lawsuits, which were consolidated, alleged that the defendants
violated the federal securities laws by making misleading statements regarding the companys
financial guidance that allegedly caused Baxter common stock to trade at inflated levels. The Court
of Appeals for the Seventh Circuit reversed a trial court order granting Baxters motion to dismiss
the complaint and the U.S. Supreme Court declined to grant certiorari in March 2005. In February
2006, the trial court denied Baxters motion for judgment on the pleadings. The court has twice
denied Plaintiffs request for certification of a class action based on the inadequacy of their
class representatives but allowed Plaintiffs a final chance to find new ones. In October 2006, separate plaintiffs law firms identified
16
new, different proposed class representatives, but in January 2007, the trial court found both new proposed class
representatives to be inadequate. In October 2007, the Court of Appeals for the Seventh Circuit
dismissed plaintiffs appeal of this decision, effectively ending the suit as a class action.
In October 2004, a purported class action was filed in the U.S.D.C. for the Northern District of
Illinois against Baxter and its current Chief Executive Officer and then current Chief Financial
Officer and their predecessors for alleged violations of the Employee Retirement Income Security
Act of 1974, as amended. Plaintiff alleges that these defendants, along with the Administrative and
Investment Committees of the companys 401(k) plans, breached their fiduciary duties to the plan
participants by offering Baxter common stock as an investment option in each of the plans during
the period of January 2001 to October 2004. Plaintiff alleges that Baxter common stock traded at
artificially inflated prices during this period and seeks unspecified damages and declaratory and
equitable relief. In March 2006, the trial court certified a class of plan participants who
elected to acquire Baxter common stock through the plans between January 2001 and the present. The
court denied defendants motion to dismiss but has allowed Baxter to seek an interlocutory appeal
of the decision, which Baxter has done. Discovery is underway in this matter.
In July 2004, a series of four purported class action lawsuits, now consolidated, were filed in the
U.S.D.C. for the Northern District of Illinois, in connection with the companys restatement of its
consolidated financial statements, previously announced in July 2004, naming Baxter and its current
Chief Executive Officer and then current Chief Financial Officer and their predecessors as
defendants. The lawsuits allege that the defendants violated the federal securities laws by making
false and misleading statements regarding the companys financial results, which allegedly caused
Baxter common stock to trade at inflated levels during the period between April 2001 and July 2004.
As of December 2005, the District Court had dismissed the last of the remaining actions. The
Court of Appeals for the Seventh Circuit affirmed the lower courts decision on July 27, 2007.
Other
On October 12, 2005 the United States filed a complaint in the U.S.D.C. for the Northern District
of Illinois to effect the seizure of COLLEAGUE and SYNDEO pumps that were on hold in Northern
Illinois. Customer-owned pumps were not affected. On June 29, 2006, Baxter Healthcare
Corporation, a direct wholly-owned subsidiary of Baxter, entered into a Consent Decree for
Condemnation and Permanent Injunction with the United States to resolve this seizure litigation.
The Consent Decree also outlines the steps the company must take to resume sales of new pumps in
the United States. Additional third party claims may be filed in connection with the COLLEAGUE
matter.
The company is a defendant, along with others, in over 50 lawsuits brought in various state and
U.S. federal courts, which allege that Baxter and other defendants reported artificially inflated
average wholesale prices for Medicare and Medicaid eligible drugs. These cases have been brought
by private parties on behalf of various purported classes of purchasers of Medicare and Medicaid
eligible drugs, as well as by state attorneys general. A number of these cases were consolidated
in the U.S.D.C. for the District of Massachusetts for pretrial case management under Multi
District Litigation rules. The lawsuits against Baxter include a number of cases brought by state
attorneys general and New York entities, which seek unspecified damages, injunctive relief, civil
penalties, disgorgement, forfeiture and restitution. In June 2006, Baxter settled the claims
brought by the Texas Attorney General related to the unique requirements of the Texas
reimbursement system. Various state and federal agencies are conducting civil investigations into
the marketing and pricing practices of Baxter and others with respect to Medicare and Medicaid
reimbursement. These investigations may result in additional cases being filed by various state
attorneys general. Due to anticipated progress with respect to resolution of portions of the
matter, during the third quarter of 2007, the company established a $56 million reserve for this
matter.
7. SEGMENT INFORMATION
Baxter operates in three segments, each of which is a strategic business that is managed separately
because each business develops, manufactures and sells distinct products and services. The
segments and a description of their products and services are as follows:
The BioScience business is a manufacturer of plasma-based and recombinant proteins used to treat
hemophilia. Other products include plasma-based therapies to treat immune disorders, alpha
1-antitrypsin deficiency and other chronic blood-related conditions; albumin, used to treat burns
and shock; products for regenerative medicine, such as proteins used in hemostasis, and
wound-sealing and tissue regeneration; and vaccines. In addition, the business manufactured manual
and automated blood and blood-component separation and collection systems (the TT
17
business). Refer to Note 3 regarding the companys February 28, 2007 sale of substantially all of
the assets and liabilities of the TT business.
The Medication Delivery business is a manufacturer of products used to deliver fluids and drugs to
patients. These include intravenous (IV) solutions and administration sets, pre-mixed drugs and
drug-reconstitution systems, pre-filled vials and syringes for injectable drugs, and electronic
infusion devices. The business also provides IV nutrition products, inhalation anesthetics for
general anesthesia, pharmaceutical company partnering services, and drug formulation and packaging
technologies.
The Renal business is a manufacturer of products for PD, a home therapy for people with
irreversible kidney failure who require renal replacement therapy. These products include PD
solutions and related supplies to help patients manually perform solution exchanges, as well as
automated PD cyclers that provide therapy to patients overnight. The business also distributes
products for HD, which is generally conducted in a hospital or clinic.
Management uses more than one measurement and multiple views of data to measure segment performance
and to allocate resources to the segments. However, the dominant measurements are consistent with
the companys consolidated financial statements and, accordingly, are reported on the same basis
herein. Management evaluates the performance of its segments and allocates resources to them
primarily based on pre-tax income along with cash flows and overall economic returns. Intersegment
sales are generally accounted for at amounts comparable to sales to unaffiliated customers, and are
eliminated in consolidation.
Certain items are maintained at the corporate level and are not allocated to the segments. They
primarily include most of the companys debt and cash and equivalents and related net interest
expense, corporate headquarters costs, certain non-strategic investments and related income and
expense, certain nonrecurring gains and losses, certain special charges (such as certain
restructuring, IPR&D and litigation-related charges), deferred income taxes, certain foreign
currency fluctuations, certain employee benefit costs, stock compensation expense, the majority of
the foreign currency and interest rate hedging activities, certain litigation liabilities and
related insurance receivables, and the revenues, income and expenses related to the manufacturing,
distribution and other transition agreements with Fenwal.
Special charges that were not allocated to a segment in the third quarter and year-to-date period
were a third quarter 2007 charge of $56 million related to the average wholesale pricing litigation
and IPR&D charges totaling $46 million, with $25 million related to the companys third quarter
2007 collaboration with HHD and DEKA, $10 million related to the companys third quarter 2007
in-licensing arrangement with Halozyme, and $11 million related to the second quarter 2007
acquisition of certain assets of MAAS Medical, LLC. See Note 6 for further information regarding
the litigation charge and Note 2 for further information regarding the IPR&D charges. Costs of $94
million recorded in the first nine months of 2006 relating to COLLEAGUE infusion pumps are
reflected in the Medication Delivery segments pre-tax income in the table below. See Note 4 for
further information regarding the COLLEAGUE infusion pumps.
Financial information for the companys segments for the three and nine months ended September 30
is as follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
(in millions) |
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
Net sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BioScience |
|
$ |
1,099 |
|
|
$ |
1,088 |
|
|
$ |
3,440 |
|
|
$ |
3,209 |
|
Medication Delivery |
|
|
1,047 |
|
|
|
950 |
|
|
|
3,076 |
|
|
|
2,878 |
|
Renal |
|
|
560 |
|
|
|
519 |
|
|
|
1,638 |
|
|
|
1,528 |
|
Transition services to Fenwal |
|
|
44 |
|
|
|
|
|
|
|
100 |
|
|
|
|
|
|
Total |
|
$ |
2,750 |
|
|
$ |
2,557 |
|
|
$ |
8,254 |
|
|
$ |
7,615 |
|
|
Pre-tax income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BioScience |
|
$ |
464 |
|
|
$ |
414 |
|
|
$ |
1,338 |
|
|
$ |
1,083 |
|
Medication Delivery |
|
|
183 |
|
|
|
157 |
|
|
|
508 |
|
|
|
385 |
|
Renal |
|
|
91 |
|
|
|
75 |
|
|
|
280 |
|
|
|
273 |
|
|
Total pre-tax income from segments |
|
$ |
738 |
|
|
$ |
646 |
|
|
$ |
2,126 |
|
|
$ |
1,741 |
|
|
18
Net sales and pre-tax income for the BioScience segment include the results of the TT business
until the completion of the sale of the TT business on February 28, 2007. Net sales related to
transition services to Fenwal represent revenues associated with manufacturing, distribution and
other services provided by the company to Fenwal subsequent to the divestiture. Refer to Note 3
for further information.
The following is a reconciliation of segment pre-tax income to income before income taxes per the
consolidated income statements.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
(in millions) |
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
Total pre-tax income from segments |
|
$ |
738 |
|
|
$ |
646 |
|
|
$ |
2,126 |
|
|
$ |
1,741 |
|
Unallocated amounts |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest expense |
|
|
(6 |
) |
|
|
(5 |
) |
|
|
(10 |
) |
|
|
(33 |
) |
Certain foreign currency fluctuations
and hedging activities |
|
|
(2 |
) |
|
|
(10 |
) |
|
|
(11 |
) |
|
|
(31 |
) |
Stock compensation |
|
|
(36 |
) |
|
|
(30 |
) |
|
|
(99 |
) |
|
|
(68 |
) |
Restructuring charges |
|
|
|
|
|
|
|
|
|
|
(70 |
) |
|
|
|
|
Average wholesale pricing litigation charge |
|
|
(56 |
) |
|
|
|
|
|
|
(56 |
) |
|
|
|
|
IPR&D charges |
|
|
(35 |
) |
|
|
|
|
|
|
(46 |
) |
|
|
|
|
Other corporate items |
|
|
(120 |
) |
|
|
(122 |
) |
|
|
(314 |
) |
|
|
(378 |
) |
|
Income before income taxes |
|
$ |
483 |
|
|
$ |
479 |
|
|
$ |
1,520 |
|
|
$ |
1,231 |
|
|
19
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Refer to the companys 2006 Annual Report to Shareholders (2006 Annual Report) for managements
discussion and analysis of the financial condition and results of operations of the company for the
year ended December 31, 2006. The following is managements discussion and analysis of the
financial condition and results of operations of the company for the three and nine months ended
September 30, 2007.
RESULTS OF OPERATIONS
NET SALES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
Percent |
|
|
September 30, |
|
|
Percent |
|
(in millions) |
|
2007 |
|
|
2006 |
|
|
change |
|
|
2007 |
|
|
2006 |
|
|
change |
|
|
BioScience |
|
$ |
1,099 |
|
|
$ |
1,088 |
|
|
|
1% |
|
|
$ |
3,440 |
|
|
$ |
3,209 |
|
|
|
7% |
|
Medication Delivery |
|
|
1,047 |
|
|
|
950 |
|
|
|
10% |
|
|
|
3,076 |
|
|
|
2,878 |
|
|
|
7% |
|
Renal |
|
|
560 |
|
|
|
519 |
|
|
|
8% |
|
|
|
1,638 |
|
|
|
1,528 |
|
|
|
7% |
|
Transition services to
Fenwal Inc. |
|
|
44 |
|
|
|
|
|
|
|
N/A |
|
|
|
100 |
|
|
|
|
|
|
|
N/A |
|
|
Total net sales |
|
$ |
2,750 |
|
|
$ |
2,557 |
|
|
|
8% |
|
|
$ |
8,254 |
|
|
$ |
7,615 |
|
|
|
8% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
Percent |
|
|
September 30, |
|
|
Percent |
|
(in millions) |
|
2007 |
|
|
2006 |
|
|
change |
|
|
2007 |
|
|
2006 |
|
|
change |
|
|
International |
|
$ |
1,539 |
|
|
$ |
1,445 |
|
|
|
7% |
|
|
$ |
4,708 |
|
|
$ |
4,257 |
|
|
|
11% |
|
United States |
|
|
1,211 |
|
|
|
1,112 |
|
|
|
9% |
|
|
|
3,546 |
|
|
|
3,358 |
|
|
|
6% |
|
|
Total net sales |
|
$ |
2,750 |
|
|
$ |
2,557 |
|
|
|
8% |
|
|
$ |
8,254 |
|
|
$ |
7,615 |
|
|
|
8% |
|
|
Foreign currency fluctuations benefited sales growth by 4 and 3 percentage points in the three- and
nine-month periods ending September 30, 2007, respectively, principally due to the weakening of the
U.S. Dollar relative to the Euro in both periods.
Certain reclassifications have been made to the prior year sales by product line data within the
BioScience and Medication Delivery segments to conform to the current year presentation.
Specifically, for BioScience, sales of recombinant FIX (BeneFIX), which were previously reported in
Recombinants, are now reported in Other. Sales of BeneFIX, which the company marketed for Wyeth
outside of the United States, ceased when the company transferred marketing and distribution rights
back to Wyeth as of June 30, 2007. The BioSurgery product line is now referred to as Regenerative
Medicine. For Medication Delivery, sales of generic injectables, previously included in
Anesthesia, are now included in Global Injectables, which was previously referred to as Drug
Delivery. There were no sales reclassifications between business segments.
BioScience
Net sales in the BioScience segment increased 1% during the third quarter and 7% for the nine
months ended September 30, 2007 (including a 3 and 4 percentage point favorable impact from foreign
currency fluctuations in the three and nine months ended September 30, 2007, respectively).
The following is a summary of sales by significant product line.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
Percent |
|
|
September 30, |
|
|
Percent |
|
(in millions) |
|
2007 |
|
|
2006 |
|
|
change |
|
|
2007 |
|
|
2006 |
|
|
change |
|
|
Recombinants |
|
$ |
432 |
|
|
$ |
389 |
|
|
|
11% |
|
|
$ |
1,251 |
|
|
$ |
1,118 |
|
|
|
12% |
|
Plasma Proteins |
|
|
246 |
|
|
|
214 |
|
|
|
15% |
|
|
|
714 |
|
|
|
619 |
|
|
|
15% |
|
Antibody Therapy |
|
|
245 |
|
|
|
196 |
|
|
|
25% |
|
|
|
705 |
|
|
|
578 |
|
|
|
22% |
|
Regenerative Medicine |
|
|
82 |
|
|
|
72 |
|
|
|
14% |
|
|
|
251 |
|
|
|
220 |
|
|
|
14% |
|
Transfusion Therapies |
|
|
|
|
|
|
121 |
|
|
|
N/A |
|
|
|
79 |
|
|
|
371 |
|
|
|
(79% |
) |
Other |
|
|
94 |
|
|
|
96 |
|
|
|
(2% |
) |
|
|
440 |
|
|
|
303 |
|
|
|
45% |
|
|
Total net sales |
|
$ |
1,099 |
|
|
$ |
1,088 |
|
|
|
1% |
|
|
$ |
3,440 |
|
|
$ |
3,209 |
|
|
|
7% |
|
|
20
Recombinants
The primary driver of sales growth in the Recombinants product line during the third quarter and
first nine months of 2007 was increased sales volume of the companys advanced recombinant therapy,
ADVATE (Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method) rAHF-PFM, which is used in
the treatment of hemophilia A, a bleeding disorder caused by a deficiency in blood clotting factor
VIII. Sales growth of ADVATE was fueled by the continuing adoption of this therapy by customers,
with strong patient conversion in both the United States and international markets, and increased
demand for new dosage forms that reduce both the volume of drug and infusion time required for
hemophilia patients needing high doses of factor VIII.
Plasma Proteins
Plasma Proteins include specialty therapeutics, such as FEIBA, an anti-inhibitor coagulant complex,
and ARALAST (alpha 1-proteinase inhibitor (human)) for the treatment of hereditary emphysema,
plasma-derived hemophilia treatments and albumin. Sales growth in the third quarter and first nine
months of 2007 was driven by strong volume growth of FEIBA, particularly in Europe, improved
pricing of albumin in the United States, and the continuing launch of FLEXBUMIN [Albumin (Human)],
an albumin therapy packaged in flexible containers, in the United States. Also impacting sales
growth, particularly in the third quarter, were strong sales of plasma-derived factor VIII due to
increased volume and improved pricing. Sales growth in both periods was also favorably impacted by
foreign currency fluctuations.
Antibody Therapy
Higher sales of the liquid formulation of IVIG (intravenous immunoglobulin), which is used in the
treatment of immune deficiencies, spurred sales growth during the third quarter and first nine
months of 2007, with increased volume, driven by strong patient conversion from lyophilized IVIG to
the liquid formulation, and continuing improvements in pricing in the United States and Europe.
Regenerative Medicine
This product line principally includes plasma-based and non-plasma-based biosurgery products for
hemostasis, wound-sealing and tissue regeneration. Growth in both the third quarter and first nine
months of 2007 was principally driven by increased sales volume of the companys sealants, FloSeal
and CoSeal.
Transfusion Therapies
The transfusion therapies product line included products and systems for use in the collection and
preparation of blood and blood components. See Note 3 for information regarding the companys
February 28, 2007 sale of substantially all of the assets and liabilities of this business.
Other
Other BioScience products primarily consist of vaccines and sales of plasma to third parties. The
decrease in sales in this product line in the third quarter was due to the transfer of marketing
and distribution rights for recombinant FIX (BeneFIX) back to Wyeth effective June 30, 2007. Sales
of BeneFIX were approximately $110 million in 2007 through the June 30, 2007 transition date, and
approximately $45 million and $130 million in the third quarter and first nine months of 2006,
respectively. Partially offsetting this impact in the quarter was approximately $15 million of
milestone revenue associated with the development of a candidate pandemic vaccine and a seasonal
influenza vaccine for the U.S. government, and strong international sales of FSME Immun (for the
prevention of tick-borne encephalitis) and NeisVac-C (for the prevention of meningitis C). Sales
growth in the first nine months of 2007 was driven by increased sales of FSME Immun and NeisVac-C,
sales related to shipments of influenza vaccines for government stockpiles around the world, and
the favorable impact of foreign currency fluctuations. Sales of vaccines may fluctuate from period
to period based on the timing of government tenders and new supply agreements, and are generally
higher in the first half of the year as a result of increased seasonal usage of certain vaccines,
such as FSME Immun.
Medication Delivery
Net sales for the Medication Delivery segment increased 10% during the third quarter and 7% for the
nine months ended September 30, 2007 (including a 4 and 3 percentage point favorable impact from
foreign currency fluctuations in the three and nine months ended September 30, 2007, respectively).
21
The following is a summary of sales by significant product line.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
Percent |
|
|
September 30, |
|
|
Percent |
|
(in millions) |
|
2007 |
|
|
2006 |
|
|
change |
|
|
2007 |
|
|
2006 |
|
|
change |
|
|
IV Therapies |
|
$ |
346 |
|
|
$ |
317 |
|
|
|
9% |
|
|
$ |
1,012 |
|
|
$ |
944 |
|
|
|
7% |
|
Global Injectables |
|
|
372 |
|
|
|
350 |
|
|
|
6% |
|
|
|
1,114 |
|
|
|
1,079 |
|
|
|
3% |
|
Infusion Systems |
|
|
207 |
|
|
|
197 |
|
|
|
5% |
|
|
|
624 |
|
|
|
596 |
|
|
|
5% |
|
Anesthesia |
|
|
111 |
|
|
|
76 |
|
|
|
46% |
|
|
|
296 |
|
|
|
225 |
|
|
|
32% |
|
Other |
|
|
11 |
|
|
|
10 |
|
|
|
10% |
|
|
|
30 |
|
|
|
34 |
|
|
|
(12% |
) |
|
Total net sales |
|
$ |
1,047 |
|
|
$ |
950 |
|
|
|
10% |
|
|
$ |
3,076 |
|
|
$ |
2,878 |
|
|
|
7% |
|
|
IV Therapies
This product line principally consists of intravenous (IV) solutions and nutritional products.
Growth for the third quarter and first nine months of 2007 was principally driven by the favorable
impact of foreign currency fluctuations, strong international sales of nutritional products, and
increased sales volume of IV therapy products in Asia, particularly in China, and Europe. Also
impacting sales growth in the third quarter were modest pricing improvements for IV therapy
products in the United States.
Global Injectables
This product line primarily consists of the companys pharmaceutical company partnering business,
enhanced packaging, pre-mixed drugs and generic injectables. Sales levels in the third quarter and
first nine months of 2007 benefited from accelerated growth associated with the pharmaceutical
company partnering business, but were unfavorably impacted by a decrease in sales of generic
injectables, primarily driven by the continued decline in sales of generic propofol due to the
transfer of marketing and distribution rights for propofol back to Teva Pharmaceutical Industries
Ltd. effective July 1, 2007. Sales of propofol were insignificant in the third quarter of 2007,
and were approximately $20 million in the third quarter of 2006. Sales of propofol totaled
approximately $35 million and $85 million in the first nine months of 2007 and 2006, respectively.
Infusion Systems
Sales growth in this product line was consistent with market growth. Increased international sales
of disposable tubing sets used in the administration of IV solutions and the favorable impact of
foreign currency fluctuations contributed to the sales growth in both the third quarter and first
nine months of 2007. Also impacting sales growth in the first nine months of 2007 were increased
international sales of COLLEAGUE infusion pumps. Refer to the 2006 Annual Report and Note 4 in
this report and the Certain Regulatory Matters section below for additional information.
Anesthesia
Sales growth in the third quarter and first nine months of 2007 was due to strong sales of SUPRANE
(desflurane, USP) and sevoflurane, as well as the impact of favorable foreign currency
fluctuations. Sales growth of SUPRANE for the third quarter was
positively impacted by wholesaler purchasing patterns in the United
States in the prior year. The company continues to benefit from its position as the only global supplier of
all three modern inhaled anesthetics (SUPRANE, sevoflurane and isoflurane).
Other
This category primarily includes other hospital-distributed products in international markets.
Renal
Net sales in the Renal segment increased 8% during the third quarter and 7% for the nine months
ended September 30, 2007 (including a 5 and 4 percentage point favorable impact from foreign
currency fluctuations in the three and nine months ended September 30, 2007, respectively).
The following is a summary of sales by significant product line.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
Percent |
|
|
September 30, |
|
|
Percent |
|
(in millions) |
|
2007 |
|
|
2006 |
|
|
change |
|
|
2007 |
|
|
2006 |
|
|
change |
|
|
PD Therapy |
|
$ |
448 |
|
|
$ |
409 |
|
|
|
10% |
|
|
$ |
1,310 |
|
|
$ |
1,205 |
|
|
|
9% |
|
HD Therapy |
|
|
112 |
|
|
|
110 |
|
|
|
2% |
|
|
|
328 |
|
|
|
323 |
|
|
|
2% |
|
|
Total net sales |
|
$ |
560 |
|
|
$ |
519 |
|
|
|
8% |
|
|
$ |
1,638 |
|
|
$ |
1,528 |
|
|
|
7% |
|
|
PD Therapy
Peritoneal dialysis, or PD Therapy, is a dialysis treatment method for end-stage renal disease. PD
Therapy, which is used primarily at home, uses the peritoneal membrane, or abdominal lining, as a
natural filter to remove waste from the bloodstream. The sales growth in the third quarter and
first nine months of 2007 was primarily driven by an increased number of patients in Latin America,
Asia, particularly in China, and the United States, as well as the favorable impact of foreign
currency fluctuations. Increased penetration of PD Therapy products continues to be strong in
emerging markets, where many people with end-stage renal disease are currently under-treated.
22
HD Therapy
Hemodialysis, or HD Therapy, is another form of end-stage renal disease dialysis therapy, which is
generally performed in a hospital or outpatient center. HD Therapy works by removing wastes and
fluid from the blood by using a machine and a filter, also known as a dialyzer. Sales levels in
the third quarter and first nine months of 2007 benefited from the favorable impact of foreign
exchange, partially offset by a decline in sales of dialyzers in both periods.
Transition services to Fenwal Inc.
Net sales in this category represent revenues associated with manufacturing, distribution and other
services provided by the company to Fenwal Inc. (Fenwal) subsequent to the divestiture of the
Transfusion Therapies (TT) business on February 28, 2007. See Note 3 for further information.
GROSS MARGIN AND EXPENSE RATIOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
2007 |
|
|
2006 |
|
|
Change |
|
2007 |
|
|
2006 |
|
|
Change |
|
Gross margin |
|
|
50.0% |
|
|
|
47.5% |
|
|
2.5 pts |
|
|
48.9% |
|
|
|
44.9% |
|
|
4.0 pts |
Marketing and
administrative expenses |
|
|
24.1% |
|
|
|
22.0% |
|
|
2.1 pts |
|
|
22.6% |
|
|
|
21.9% |
|
|
0.7 pts |
|
Gross Margin
The improvement in gross margin in the third quarter and first nine months of 2007 was principally
driven by the continued adoption by customers of ADVATE, customer conversion to the liquid
formulation of IVIG, manufacturing efficiencies and yield improvements, improved pricing for
certain plasma protein products, and strong sales of vaccines. Also contributing to the
improvement in 2007 were costs of $94 million in the first nine months of 2006 relating to the
Medication Delivery segments COLLEAGUE infusion pumps. Refer to Note 4 for further information.
Marketing and Administrative Expenses
The increase in the marketing and administrative expenses ratio in the third quarter and first nine
months of 2007 was principally due to fluctuations in foreign currency, an increase in compensation
costs, including both cash and stock-based compensation, and a pre-tax charge of $56 million to
establish reserves related to the average wholesale pricing litigation, partially offset by a
reduction in expenses due to the February 28, 2007 divestiture of the TT business. See Note 3
regarding the divestiture of the TT business and Note 6 regarding the average wholesale pricing
litigation.
RESEARCH AND DEVELOPMENT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
Percent |
|
|
September 30, |
|
|
Percent |
|
(in millions) |
|
2007 |
|
|
2006 |
|
|
change |
|
|
2007 |
|
|
2006 |
|
|
change |
|
|
Research and development (R&D) expenses |
|
|
$203 |
|
|
|
$149 |
|
|
|
36% |
|
|
|
$539 |
|
|
|
$433 |
|
|
|
24% |
|
As a percent of sales |
|
|
7.4% |
|
|
|
5.8% |
|
|
|
|
|
|
|
6.5% |
|
|
|
5.7% |
|
|
|
|
|
|
R&D expenses increased during the third quarter and first nine months of 2007, reflecting the
companys commitment to accelerate R&D investments. Refer to the 2006 Annual Report for a
discussion of the companys R&D pipeline. The increase in the third quarter and first nine months
of 2007 was driven by a significant increase in R&D spending in the BioScience segment related to
the adult stem-cell therapy program and certain clinical trials. In addition, the increase in R&D
expenses in both periods was due to a $25 million in-process R&D (IPR&D)
23
charge related to a collaboration for the development of a next-generation home HD machine and a
$10 million IPR&D charge related to an in-licensing arrangement with Halozyme Therapeutics, Inc.
(Halozyme). The increase in the year-to-date period was also due to an $11 million IPR&D charge
relating to the acquisition of certain assets of MAAS Medical, LLC, a company that specializes in
infusion systems technology. See Note 2 for further information regarding these IPR&D charges.
RESTRUCTURING PROGRAMS
2007 Restructuring Charges
During the second quarter of 2007, the company recorded pre-tax restructuring charges of $70
million principally associated with the consolidation of certain commercial and manufacturing
operations outside of the United States. Based upon a review of current and future capacity
needs, the company decided to integrate several facilities in order to reduce the companys cost
structure and optimize the companys operations.
Included in the charge was $17 million related to asset impairments, principally to write down
property, plant and equipment based on market data for the assets. Also included in the charge
was $53 million for cash costs, principally pertaining to severance and other employee-related
costs associated with the elimination of approximately 550 positions, or approximately 1% of the
companys total workforce. Reserve utilization through the third quarter of 2007 was not
significant. The reserve for severance and other costs is expected to be utilized by the end of
2009, with the majority of the payments to be made in 2007 and 2008. The company believes that
the reserves are adequate. However, adjustments may be recorded in the future as the programs are
completed. Cash expenditures are being funded with cash generated from operations.
Management estimates that these initiatives will yield savings of approximately $0.02 per diluted
share when the programs are fully implemented in 2009. The savings from these actions will impact
cost of sales, general and administrative expenses and R&D, principally within the companys
Medication Delivery segment.
2004 Restructuring Charge
During 2004, the company recorded a $543 million pre-tax restructuring charge principally
associated with managements decision to implement actions to reduce the companys overall cost
structure and to drive sustainable improvements in financial performance. The charge was primarily
for severance and costs associated with the closing of facilities and the exiting of contracts.
Refer to Note 4 for further information, including reserve utilization through September 30, 2007.
The company believes that the restructuring program is substantially complete and that the
remaining reserves are adequate. However, remaining cash payments are subject to change. The cash
expenditures are being funded with cash generated from operations. Original estimates of the
benefits of the program are substantially unchanged.
NET INTEREST EXPENSE
Net interest expense was $6 million and $5 million during the third quarters of 2007 and 2006,
respectively, and $10 million and $33 million for the nine months ended September 30, 2007 and
2006, respectively. The decrease in the first nine months of 2007 was principally due to a higher
average cash balance and higher interest rates. As discussed below, during the first quarter of
2006, certain maturing debt was paid down using a portion of the $1.25 billion cash proceeds
received upon settlement of the equity units purchase contracts in February 2006.
OTHER EXPENSE, NET
Other expense, net was $21 million and $20 million during the third quarters of 2007 and 2006,
respectively, and $28 million and $55 million during the nine-month periods ended September 30,
2007 and 2006, respectively. Other expense, net in both periods principally included amounts
relating to foreign exchange, minority interests and equity method investments. In the first nine
months of 2007, other expense, net included a gain on the sale of the TT business of $58 million
less related charges of $35 million, for a net impact of $0.01 per diluted share on an after-tax
basis. See Note 3 for further information.
PRE-TAX INCOME
Refer to Note 7 for a summary of financial results by segment. Certain items are maintained at the
companys corporate level and are not allocated to the segments. The following is a summary of
significant factors impacting the segments financial results.
24
BioScience
Pre-tax income increased 12% and 24% for the three- and nine-month periods ending September 30,
2007, respectively. The primary drivers of the increase in both periods were strong sales of
higher-margin products, which were fueled by the continued adoption of ADVATE, the conversion to
the liquid formulation of IVIG, volume growth and improved pricing of certain plasma protein
products, strong sales of vaccines, as well as continued cost and yield improvements. Partially
offsetting this growth was increased spending related to the adult stem-cell therapy program and
certain clinical trials. Also contributing to the growth in pre-tax income in both periods was the
favorable impact of foreign currency fluctuations.
Medication Delivery
Pre-tax income increased 17% and 32% for the three- and nine-month periods ending September 30,
2007, respectively. The primary driver in the third quarter was an improved product mix, with
sales of higher-margin SUPRANE and disposable access sets offsetting the continued decline in sales
of generic propofol. Also contributing to the increase in pre-tax income in the nine months ended
September 30, 2007 were costs of $94 million related to COLLEAGUE infusion pumps recorded in the
nine months ended September 30, 2006. See Note 4 for further information. Pre-tax income in both
periods also benefited from the favorable impact of foreign currency fluctuations, partially offset
by increased spending on R&D and marketing programs.
Renal
Pre-tax income increased 21% and 3% for the three- and nine-month periods ending September 30,
2007, respectively. The segments sales growth, which was driven by continued PD patient growth in
developing countries and the favorable impact of foreign currency fluctuations, was partially
offset by increased spending on marketing programs and new product development.
Other
Certain income and expense amounts are not allocated to the segments. These amounts are detailed
in a table in Note 7 and include net interest expense, certain foreign currency fluctuations and
the majority of the foreign currency and interest rate hedging activities, stock compensation
expense, income and expense related to certain non-strategic investments, corporate headquarters
costs, certain employee benefit plan costs, certain nonrecurring gains and losses and certain
special charges (such as certain restructuring, litigation-related and IPR&D charges), and income
related to the manufacturing, distribution and other transition agreements with Fenwal. Refer to
the discussion above regarding restructuring charges and net interest expense, and Note 5 regarding
stock compensation expense.
Net costs not allocated to the segments increased in the third quarter due to a pre-tax charge of
$56 million to establish reserves related to the average wholesale pricing litigation and IPR&D
charges of $25 million associated with the companys collaboration for the development of a
next-generation home HD machine and $10 million related to the in-licensing arrangement with
Halozyme. In the year-to-date period, net costs not allocated to the segments increased due to the
items noted above as well as an $11 million IPR&D charge associated with the second quarter
acquisition of certain assets of MAAS Medical, LLC. The increase in the year-to-date period was
partially offset by other income of $23 million, which reflects a $58 million gain on the first
quarter sale of the TT business less related charges of $35 million, and reduced spending on
corporate staffing costs. Refer to Note 2 regarding the acquisitions of, and investments in,
businesses and technologies, Note 3 regarding the divestiture of the TT business and Note 6
regarding the average wholesale pricing litigation.
INCOME TAXES
The companys effective income tax rate was 18.2% and 21.9% in the third quarters of 2007 and 2006,
respectively, and 19.1% and 21.6% in the nine-month periods ended September 30, 2007 and 2006,
respectively. The company anticipates that the effective tax rate, calculated in accordance with
generally accepted accounting principles, will be approximately 19% for full-year 2007, excluding
any impact from additional audit developments or other special items.
The decrease in the third quarter was principally due to a $57 million reduction of the valuation
allowance on net operating loss carryforwards in a foreign jurisdiction due to recent profitability
improvements, a $12 million reduction in tax expense due to recently enacted legislation reducing
corporate income tax rates in Germany, as well as an approximately $8 million net favorable tax impact of a charge related to the
25
companys average wholesale pricing litigation (see Note 6 for further information regarding this charge) and
IPR&D charges recorded in the quarter (see Note 2 for further information regarding these charges).
In addition, as a result of profitability in lower tax rate jurisdictions around the world that
was higher than previous estimates, the company lowered its expected full-year tax rate on earnings
excluding special items, which reduced income tax expense in the quarter by approximately $14
million related to earnings through the first half of 2007. Partially offsetting these items in
the quarter was $84 million of U.S. income tax expense related
to foreign earnings, which are no longer considered permanently
reinvested outside of the United States because management now
believes these earnings will be remitted to the United States in the
forseeable future.
In addition to the items noted above, the decrease in the year-to-date period was due to the
extension of tax incentives and the favorable settlement of a tax audit in jurisdictions outside of
the United States, as well as the impact of the second quarter 2007 restructuring charges. These
benefits were partially offset by the tax impact of the gain on the divestiture of the TT business
and related charges. The effective tax rate for the nine months ended September 30, 2006 was
impacted by costs associated with the COLLEAGUE and SYNDEO infusion pumps that have lower tax
benefits. Refer to Note 3 for further information on the divestiture and Note 4 for further
information on the restructuring charges recorded in 2007 and the infusion pump charges recorded in
2006.
INCOME AND EARNINGS PER DILUTED SHARE
Net income was $395 million and $374 million for the three months ended September 30, 2007 and
2006, respectively, and $1,229 million and $965 million for the nine months ended September 30,
2007 and 2006, respectively. Net income per diluted share was $0.61 and $0.57 for the three months
ended September 30, 2007 and 2006, respectively, and $1.87 and $1.47 for the nine months ended
September 30, 2007 and 2006, respectively. The significant factors and events contributing to
these changes are discussed above.
CRITICAL ACCOUNTING POLICIES
The preparation of financial statements in accordance with generally accepted accounting principles
requires management to make estimates and judgments that affect the reported amounts of assets,
liabilities, revenues and expenses. A summary of the companys significant accounting policies as
of December 31, 2006 is included in Note 1 to the companys consolidated financial statements in
the 2006 Annual Report. Certain of the companys accounting policies are considered critical, as
these policies are the most important to the depiction of the companys financial statements and
require significant, difficult or complex judgments, often employing the use of estimates about the
effects of matters that are inherently uncertain. Such policies are summarized in the Managements
Discussion and Analysis of Financial Condition and Results of Operations section in the 2006 Annual
Report.
LIQUIDITY AND CAPITAL RESOURCES
CASH FLOWS
Cash flows from operating activities
Cash flows from operating activities increased by $133 million during the first nine months of 2007
as compared to the prior year due to the impact of higher earnings (before non-cash items) and the
other factors discussed below.
Accounts Receivable
Cash flows relating to accounts receivable decreased during the first nine months of 2007 as
compared to the prior year. Days sales outstanding increased from 55.9 days at September 30, 2006
to 58.7 days at September 30, 2007, primarily due to a shift in the geographic mix of sales to
certain international locations with longer collection periods, partially offset by an improvement
in the collection of receivables in the United States and an increase in the cash proceeds from the
securitization and factoring of receivables.
Inventories
The companys investment in inventories increased in 2007, resulting in cash outflows of $261
million in the first nine months of 2007, compared to cash outflows of $108 million in the first
nine months of 2006. The following is a summary of inventories at September 30, 2007 and December
31, 2006, as well as inventory turns for the nine months ended September 30, 2007 and 2006, by
segment.
26
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventories |
|
|
Annualized inventory turns |
|
|
|
September 30, |
|
|
December 31, |
|
|
for the nine months ended September 30, |
|
(in millions, except inventory turn data) |
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
BioScience |
|
|
$1,232 |
|
|
|
$1,138 |
|
|
|
1.43 |
|
|
|
1.72 |
|
Medication Delivery |
|
|
850 |
|
|
|
719 |
|
|
|
2.85 |
|
|
|
3.01 |
|
Renal |
|
|
238 |
|
|
|
209 |
|
|
|
4.55 |
|
|
|
4.24 |
|
|
Total |
|
|
$2,320 |
|
|
|
$2,066 |
|
|
|
2.28 |
|
|
|
2.44 |
|
|
The lower inventory turns in the BioScience segment were due to a planned increase in plasma
inventories and increased inventory as a result of a settlement with a supplier during the first
quarter of 2007, partially offset by a decline in inventory related to the divestiture of the TT
business. The lower inventory turns in the Medication Delivery segment were primarily due to an
increase in infusion pump inventory related to the above-mentioned sales hold on COLLEAGUE pumps in
the United States.
Liabilities, Restructuring Payments and Other
Cash outflows related to liabilities, restructuring payments and other decreased in the first nine
months of 2007 as compared to the prior year period, principally due to $52 million of cash inflows
resulting from a prepayment relating to the Fenwal manufacturing, distribution and other transition
agreements. Refer to Note 3 for further information. Also contributing to the decrease in cash
outflows were reduced payments related to the companys restructuring programs, which declined by
$14 million, and decreased contributions to the companys pension plans. The first nine months of
2006 included a contribution to a non-U.S. plan of $31 million. There were no significant pension
plan contributions in the first nine months of 2007.
Partially offsetting the decrease in cash outflows in the first nine months of 2007 were operating
cash outflows of $31 million related to the settlement of certain mirror cross-currency swaps.
There were no settlements of cross-currency swaps during the first nine months of 2006. Refer to
the 2006 Annual Report for further information regarding these swaps.
Cash flows from investing activities
Capital Expenditures
Capital expenditures increased $88 million for the nine months ended September 30, 2007, from $336
million in 2006 to $424 million in 2007. The company is investing in various multi-year capital
projects across its three segments, including ongoing projects to upgrade facilities or increase
manufacturing capacity for global injectables, plasma-based (including antibody therapy) and other
products.
Acquisitions of, and Investments in, Businesses and Technologies
Cash outflows relating to the acquisitions of, and investments in, businesses and technologies of
$83 million in the first nine months of 2007 included $30 million related to the expansion of the
companys existing agreements with Halozyme to include the use of HYLENEX recombinant
(hyaluronidase human injection) with the companys proprietary and non-proprietary small molecule
drugs, $25 million related to the companys collaboration with HHD, LLC, DEKA Products Limited
Partnership and DEKA Research and Development Corp. for the development of a next-generation home
HD machine, $11 million for the acquisition of certain assets of MAAS Medical, LLC, a company that
specializes in infusion systems technology, and $10 million related to an in-licensing arrangement
to apply Halozymes Enhanze technology to the development of a subcutaneous route of administration
for Baxters liquid formulation of IVIG. See Note 2 for further information.
Divestitures and Other
Cash inflows relating to divestitures and other in the first nine months of 2007 principally
related to $421 million of cash proceeds from the divestiture of the TT business. Refer to Note 3
for further information about the TT divestiture. The $421 million represented the $473 million
cash received upon divestiture less the $52 million prepayment related to the manufacturing,
distribution and other transition agreements, which was classified in the operating section of the
statement of cash flows. The cash inflows in both 2007 and 2006 also included collections on
retained interests associated with securitization arrangements.
Cash flows from financing activities
Debt Issuances, Net of Payments of Obligations
Net cash outflows relating to debt and other financing obligations totaled $428 million during the
first nine months of 2007 as compared to $528 million during the prior year period. The first nine
months of 2007 included financing cash outflows of $196 million related to the
27
settlement of certain cross-currency swaps. Refer to
the 2006 Annual Report for further information regarding these swaps. Using the cash proceeds from
the settlement of the equity units purchase contracts in February 2006 (further discussed below),
the company paid down maturing debt during the first quarter of 2006.
Other Financing Activities
Cash dividend payments, which totaled $598 million in the first nine months of 2007, increased from
the prior year due to a change in the companys dividend payment schedule. Beginning in 2007, the
company converted from an annual to a quarterly dividend and increased its dividend by 15% on an
annual basis. The second quarterly dividend of $0.1675 per share was paid on July 2, 2007 to
shareholders of record as of June 10, 2007.
Cash received for stock issued under employee stock plans increased by $305 million, from $195
million in the first nine months of 2006 to $500 million in the first nine months of 2007,
primarily due to an increase in stock option exercises, as well as a higher average exercise price.
In February 2006, the company issued 35 million shares of common stock for $1.25 billion in
conjunction with the settlement of the purchase contracts included in the companys equity units.
In August 2006, the company issued $600 million of term debt, maturing in September 2016 and
bearing a 5.9% coupon rate. Refer to the 2006 Annual Report for further information regarding the
equity units and the August 2006 debt issuance.
Stock repurchases totaled $1.64 billion in the first nine months of 2007 as compared to $479
million in the prior year period. As authorized by the board of directors, from time to time the
company repurchases its stock depending upon the companys cash flows, net debt level and current
market conditions. In March 2007, the board of directors authorized the repurchase of up to an
additional $2.0 billion of the companys common stock. At September 30, 2007, $1.37 billion
remained available under the February 2007 authorization.
CREDIT FACILITIES AND ACCESS TO CAPITAL
Refer to the 2006 Annual Report for further discussion of the companys credit facilities and
access to capital.
Credit facilities
The company had $1.8 billion of cash and equivalents at September 30, 2007. The company has two
primary revolving credit facilities, which totaled approximately $2.2 billion at September 30,
2007. One of the facilities totals $1.5 billion and matures in December 2011 and the second
facility, which is denominated in Euros, totals approximately $698 million and matures in January
2008. These facilities enable the company to borrow funds in U.S. Dollars, Euros, Japanese Yen or
Swiss Francs on an unsecured basis at variable interest rates and contain various covenants,
including a maximum net-debt-to-capital ratio and, solely with respect to the Euro-denominated
facility, a minimum interest coverage ratio. At September 30, 2007, the company was in compliance
with the financial covenants in these agreements. There were no borrowings outstanding under these
facilities at September 30, 2007.
Access to capital
The company intends to fund short-term and long-term obligations as they mature through cash on
hand, future cash flows from operations, or by issuing additional debt or common stock. During the
first nine months of 2007, Fitch upgraded the companys debt ratings on senior debt from A- to A
and short-term debt from F2 to F1, with a Stable outlook, and Moodys favorably changed its outlook
on Baxter from Stable to Positive.
The companys ability to generate cash flows from operations, issue debt, enter into other
financing arrangements and attract long-term capital on acceptable terms could be adversely
affected if there is a material decline in the demand for the companys products, deterioration in
the companys key financial ratios or credit ratings, or other significantly unfavorable changes in
conditions. The company believes it has sufficient financial flexibility in the future to issue
debt, enter into other financing arrangements, and attract long-term capital on acceptable terms to
support the companys growth objectives.
LEGAL CONTINGENCIES
Refer to Note 6 for a discussion of the companys legal contingencies. Upon resolution of any of
these uncertainties, the company may incur charges in excess of presently established liabilities.
While the liability of the company in connection with the claims cannot be estimated
28
with any certainty, and although the
resolution in any reporting period of one or more of these matters could have a significant impact
on the companys results of operations for that period, the outcome of these legal proceedings is
not expected to have a material adverse effect on the companys consolidated financial position.
While the company believes that it has valid defenses in these matters, litigation is inherently
uncertain, excessive verdicts do occur, and the company may in the future incur material judgments
or enter into material settlements of claims.
CERTAIN REGULATORY MATTERS
The company began to hold shipments of COLLEAGUE infusion pumps in July 2005, and continues to hold
shipments of new pumps in the United States. In October 2005, the United States filed a complaint
in the U.S.D.C. for the Northern District of Illinois to effect the seizure of approximately 5,400
Baxter-owned COLLEAGUE pumps, as well as 830 SYNDEO PCA syringe pumps that were on hold in Northern
Illinois. Customer-owned pumps were not affected. In June 2006, Baxter Healthcare Corporation
(BHC), a direct wholly-owned subsidiary of the company, entered into a Consent Decree for
Condemnation and Permanent Injunction with the United States to resolve this seizure litigation.
The Consent Decree outlines the steps BHC must take to resume sales of new pumps in the United
States. The steps include obtaining U.S. Food and Drug Administration (FDA) approval of BHCs plan
to resolve issues with the pumps currently in use in the United States, third-party expert reviews
of COLLEAGUE and SYNDEO operations, and other measures to ensure compliance with FDAs Quality
System Regulations. In December 2006, BHC received conditional approval from FDA for its plan to
resolve issues with the COLLEAGUE pumps currently in use in the United States. In February 2007,
BHC received clearance from FDA on its COLLEAGUE infusion pump 510(k) pre-market notification,
which included modifications to the current COLLEAGUE device to resolve the issues with the pumps.
BHC began deployment of the modifications in the second quarter.
In June 2007, BHC halted modifications to triple channel COLLEAGUE pumps as a result of a field
corrective action related to the modifications made to the pumps, which FDA subsequently classified
as a Class I recall. BHC removed approximately 4,500 affected modified triple channel COLLEAGUE
pumps from use. The 75,000 non-modified triple channel COLLEAGUE
pumps remain in use pending future modifications to be made subject
to FDA approval. Modifications continue on the
200,000 single channel COLLEAGUE pumps not affected by the recall.
In July 2007, FDA classified BHCs field corrective action regarding service and repair data for
the COLLEAGUE and FLO-GARD infusion pumps as a Class I recall. The recall pertained to infusion
pumps in the United States brought in for routine maintenance or corrections and is not directly
associated with the COLLEAGUE remediation efforts discussed above.
In August 2007, FDA classified BHCs field corrective action regarding certain remediated COLLEAGUE
infusion pumps as a Class I recall. The recall pertained to certain infusion pumps in remediation
where all elements required under the companys remediation plan failed to be completed. All
infusion pumps subject to this Class I recall have been removed from use.
As required under the Consent Decree, the companys outside expert (Paraxel) has reviewed and
certified the companys facilities, processes and controls. The certification was delivered to FDA
in October 2007. As provided for in the Consent Decree, FDA may now inspect the companys
facilities, processes and controls to determine that the requirements of the Consent Decree have
been met.
As previously disclosed, BHC received a Warning Letter from FDA in March 2005 regarding
observations, primarily related to dialysis equipment, that arose from FDAs inspection of the
companys manufacturing facility located in Largo, Florida. During 2007, the FDA re-inspected the
Largo manufacturing facility and, in a follow-up regulatory meeting, indicated that a number of
observations remain open.
While the company continues to work to resolve the issues described above, there can be no
assurance that additional costs or penalties will not be incurred or that additional regulatory
actions will not occur or that sales of any other product may not be adversely affected. Please
see Item 1A. Risk Factors in the companys Form 10-K for the year ended December 31, 2006 for
additional discussion of regulatory matters.
29
ISSUED BUT NOT YET EFFECTIVE ACCOUNTING STANDARDS
SFAS No. 157
In September 2006, the Financial Accounting Standards Board (FASB) issued Statement of Financial
Accounting Standards (SFAS) No. 157, Fair Value Measurements (SFAS No. 157), which clarifies the
definition of fair value whenever another standard requires or permits assets or liabilities to be
measured at fair value. Specifically, the standard clarifies that fair value should be based on
the assumptions market participants would use when pricing the asset or liability, and establishes
a fair value hierarchy that prioritizes the information used to develop those assumptions. SFAS
No. 157 does not expand the use of fair value to any new circumstances, and must be applied on a
prospective basis except in certain cases. The standard also requires expanded financial statement
disclosures about fair value measurements, including disclosure of the methods used and the effect
on earnings. The company is in the process of analyzing this new standard, which will be effective
for the company on January 1, 2008.
SFAS No. 159
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities, Including an Amendment of FASB Statement No. 115 (SFAS No. 159). SFAS No.
159 permits entities to choose to measure many financial instruments and certain other items at
fair value, which are not otherwise currently required to be measured at fair value. Under SFAS
No. 159, the decision to measure items at fair value is made at specified election dates on an
instrument-by-instrument basis and is irrevocable. Entities electing the fair value option would
be required to recognize changes in fair value in earnings and to expense upfront costs and fees
associated with the item for which the fair value option is elected. At the adoption date,
unrealized gains and losses on existing items for which the fair value option has been elected are
reported as a cumulative adjustment to beginning retained earnings. The company is in the process
of analyzing this new standard, which will be effective for the company on January 1, 2008.
FORWARD-LOOKING INFORMATION
This quarterly report includes forward-looking statements, including accounting estimates and
assumptions, litigation outcomes, statements with respect to infusion pumps and other regulatory
matters, expectations with respect to restructuring and acquisition activities, strategic plans,
sales and pricing forecasts, developments with respect to credit and credit ratings, including the
adequacy of credit facilities, estimates of liabilities, statements regarding ongoing tax audits,
management of currency risk, future capital and R&D expenditures, the sufficiency of the companys
financial flexibility and the adequacy of reserves, the effective income tax rate in 2007,
statements with respect to ongoing cash flows from the TT business, and all other statements that
do not relate to historical facts. The statements are based on assumptions about many important
factors, including assumptions concerning:
|
|
|
demand for and market acceptance risks for new and existing products, such as ADVATE and
IVIG, and other therapies; |
|
|
|
|
the companys ability to identify business development initiatives and growth
opportunities for existing products and to exit low margin businesses or products; |
|
|
|
|
the balance between supply and demand with respect to the market for plasma protein
products; |
|
|
|
|
reimbursement policies of government agencies and private payers; |
|
|
|
|
product quality or patient safety issues, leading to product recalls, withdrawals,
launch delays, sanctions, seizures, litigation, or declining sales; |
|
|
|
|
future actions of regulatory bodies and other government authorities, that could delay,
limit or suspend product development, manufacturing or sale or result in seizures,
injunctions, monetary sanctions or criminal or civil liabilities, including any sanctions
available under the Consent Decree entered with the FDA concerning the COLLEAGUE and SYNDEO
pumps; |
|
|
|
|
product development risks, including satisfactory clinical performance, the ability to
manufacture at appropriate scale, and the general unpredictability associated with the
product development cycle; |
|
|
|
|
the ability to enforce the companys patent rights or patents of third parties
preventing or restricting the companys manufacture, sale or use of affected products or
technology; |
|
|
|
|
the impact of geographic and product mix on the companys sales; |
|
|
|
|
the impact of competitive products and pricing, including generic competition, drug
reimportation and disruptive technologies; |
|
|
|
|
inventory reductions or fluctuations in buying patterns by wholesalers or distributors; |
|
|
|
|
foreign currency fluctuations; |
|
|
|
|
the availability of acceptable raw materials and component supply; |
|
|
|
|
global regulatory, trade and tax policies; |
|
|
|
|
future actions by tax authorities in connection with ongoing tax audits; |
|
|
|
|
the companys ability to realize in a timely manner the anticipated benefits of
restructuring initiatives; |
30
|
|
|
continued developments in the market for transfusion therapies products and Fenwals
ability to execute with respect to the acquired business; |
|
|
|
|
change in credit agency ratings; and |
|
|
|
|
other factors identified elsewhere in this report and other filings with the Securities
and Exchange Commission, including those factors described under the caption Item 1A. Risk
Factors in the companys Form 10-K for the year ended December 31, 2006, all of which are
available are on the companys website. |
Actual results may differ materially from those projected in the forward-looking statements. The
company does not undertake to update its forward-looking statements.
31
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Currency Risk
Refer to the caption Financial Instrument Market Risk in the companys 2006 Annual Report. As
part of its risk-management program, the company performs sensitivity analyses to assess potential
changes in the fair value of its foreign exchange instruments relating to hypothetical and
reasonably possible near-term movements in foreign exchange rates.
A sensitivity analysis of changes in the fair value of foreign exchange option and forward
contracts outstanding at September 30, 2007, while not predictive in nature, indicated that if the
U.S. Dollar uniformly fluctuated unfavorably by 10% against all currencies, on a net-of-tax basis,
the net liability balance of $39 million with respect to those contracts would increase by $47
million.
With respect to the companys cross-currency swap agreements (including the outstanding mirror
swaps), if the U.S. Dollar uniformly weakened by 10%, on a net-of-tax basis, the net liability
balance of $338 million with respect to those contracts outstanding at September 30, 2007 would
increase by $83 million. Any increase or decrease in the fair value of cross-currency swap
agreements designated as hedges of the net assets of foreign operations relating to changes in spot
currency exchange rates is offset by the change in the value of the hedged net assets relating to
changes in spot currency exchange rates. With respect to the portion of the cross-currency swap
portfolio that is no longer designated as a net investment hedge, but is fixed via the mirror
swaps, as the fair value of this fixed portion of the portfolio decreases, the fair value of the
mirror swaps increases by an approximately offsetting amount, and vice versa.
The sensitivity analysis model recalculates the fair value of the foreign currency forward, option
and cross-currency swap contracts outstanding at September 30, 2007 by replacing the actual
exchange rates at September 30, 2007 with exchange rates that are 10% unfavorable to the actual
exchange rates for each applicable currency. All other factors are held constant. These
sensitivity analyses disregard the possibility that currency exchange rates can move in opposite
directions and that gains from one currency may or may not be offset by losses from another
currency. The analyses also disregard the offsetting change in value of the underlying hedged
transactions and balances.
Interest Rate and Other Risks
Refer to the caption Financial Instrument Market Risk in the companys 2006 Annual Report. There
were no significant changes during the third quarter and nine months ended September 30, 2007.
32
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Baxter carried out an evaluation, under the supervision and with the participation of its
Disclosure Committee and management, including the Chief Executive Officer and Chief Financial
Officer, of the effectiveness of Baxters disclosure controls and procedures (as defined in Rules
13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the Exchange Act))
as of September 30, 2007. Baxters disclosure controls and procedures are designed to ensure that
information required to be disclosed by Baxter in the reports it files or submits under the
Exchange Act is recorded, processed, summarized and reported on a timely basis and that such
information is communicated to management, including the Chief Executive Officer, Chief Financial
Officer and its Board of Directors to allow timely decisions regarding required disclosure.
Based on that evaluation the Chief Executive Officer and Chief Financial Officer concluded that the
Companys disclosure controls and procedures were effective as of September 30, 2007.
Changes in Internal Control over Financial Reporting
There has been no change in Baxters internal control over financial reporting (as such term is
defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended September
30, 2007 that has materially affected, or is reasonably likely to materially affect, Baxters
internal control over financial reporting.
33
Review by Independent Registered Public Accounting Firm
Reviews of the interim condensed consolidated financial information included in this Quarterly
Report on Form 10-Q for the three and nine months ended September 30, 2007 and 2006, respectively,
have been performed by PricewaterhouseCoopers LLP, the companys independent registered public
accounting firm. Its report on the interim condensed consolidated financial information follows.
This report is not considered a report within the meaning of Sections 7 and 11 of the Securities
Act of 1933 and therefore, the independent accountants liability under Section 11 does not extend
to it.
34
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders of Baxter International Inc.:
We have reviewed the accompanying condensed consolidated balance sheet of Baxter International Inc.
and its subsidiaries as of September 30, 2007, and the related condensed consolidated statements of
income for each of the three-month and nine-month periods ended September 30, 2007 and 2006 and the
condensed consolidated statements of cash flows for the nine-month periods ended September 30, 2007
and 2006. These interim financial statements are the responsibility of the Companys management.
We conducted our review in accordance with the standards of the Public Company Accounting Oversight
Board (United States). A review of interim financial information consists principally of applying
analytical procedures and making inquiries of persons responsible for financial and accounting
matters. It is substantially less in scope than an audit conducted in accordance with the
standards of the Public Company Accounting Oversight Board (United States), the objective of which
is the expression of an opinion regarding the financial statements taken as a whole. Accordingly,
we do not express such an opinion.
Based on our review, we are not aware of any material modifications that should be made to the
accompanying condensed consolidated interim financial statements for them to be in conformity with
accounting principles generally accepted in the United States of America.
We previously audited, in accordance with the standards of the Public Company Accounting Oversight
Board (United States), the consolidated balance sheet as of December 31, 2006, and the related
consolidated statements of income, cash flows and shareholders equity and comprehensive income for
the year then ended, and in our report dated February 27, 2007, we expressed an unqualified opinion
on those consolidated financial statements. The consolidated financial statements referred to
above are not presented herein. In our opinion, the information set forth in the accompanying
condensed consolidated balance sheet as of December 31, 2006, is fairly stated in all material
respects in relation to the consolidated balance sheet from which it has been derived.
|
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|
|
/s/ PricewaterhouseCoopers LLP
|
|
|
|
|
|
PricewaterhouseCoopers LLP |
|
|
Chicago, Illinois November 5, 2007 |
|
|
35
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
The information in Part I, Item 1, Note 6 is incorporated herein by reference.
36
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
The following table includes information about the companys common stock repurchases during the
three-month period ended September 30, 2007.
Issuer Purchases of Equity Securities
|
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|
Approximate Dollar Value of |
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Total Number |
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Total Number of Shares |
|
|
Shares that May Yet Be |
|
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|
of Shares |
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Average Price |
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Purchased as Part of Publicly |
|
|
Purchased Under the |
|
Period |
|
Purchased (1)(2) |
|
|
Paid per Share |
|
|
Announced Programs (1)(2) |
|
|
Program (2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
July 1, 2007
through July 31, 2007 |
|
|
3,685,259 |
|
|
|
$56.88 |
|
|
|
3,685,259 |
|
|
|
|
|
August 1, 2007
through August 31, 2007 |
|
|
7,732,984 |
|
|
|
52.31 |
|
|
|
7,732,984 |
|
|
|
|
|
September 1, 2007
through September 30, 2007 |
|
|
3,902,108 |
|
|
|
54.43 |
|
|
|
3,902,108 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
15,320,351 |
|
|
|
$53.97 |
|
|
|
15,320,351 |
|
|
|
$1,365,415,552 |
|
|
|
|
|
(1) |
|
In February 2006, the company announced that its board of directors authorized the
company to repurchase up to $1.5 billion of its common stock on the open market. During
the third quarter of 2007, the company repurchased 3.4 million shares for $192 million
under this program. No amount remains under this authorization at September 30, 2007. |
|
(2) |
|
In March 2007, the company announced that its board of directors authorized the
repurchase of up to an additional $2.0 billion of the companys common stock on the open
market. During the third quarter of 2007, the company repurchased 11.9 million shares for
$635 million under this program, and the remaining authorization totaled $1.37 billion at
September 30, 2007. This program does not have an expiration date. |
37
Item 6. Exhibits
Exhibit Index:
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
15
|
|
Letter Re Unaudited Interim Financial Information |
|
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a) of the
Securities Exchange Act of 1934 |
|
|
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a) of the
Securities Exchange Act of 1934 |
|
|
|
32.1
|
|
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350 |
|
|
|
32.2
|
|
Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350 |
38
Signature
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.
|
|
|
|
|
|
|
|
|
|
|
BAXTER INTERNATIONAL INC.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Registrant) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Date:
November 5, 2007
|
|
By:
|
|
/s/ Robert M. Davis |
|
|
|
|
|
|
|
|
|
|
|
|
|
Robert M. Davis |
|
|
|
|
|
|
Corporate Vice President and Chief Financial Officer |
|
|
|
|
|
|
(duly authorized officer and principal financial officer) |
|
|
39