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 March 31, 2008
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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
incorporation or organization)
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(I.R.S. Employer
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, a
non-accelerated filer or a smaller reporting company. See definition of large accelerated filer,
accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
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Large accelerated filer
þ |
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Accelerated filer
o |
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Non-accelerated filer
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(Do not check if a smaller reporting company)
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Smaller reporting company
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
The number of shares of the registrants Common Stock, par value $1.00 per share, outstanding as of
April 30, 2008 was 627,379,237 shares.
BAXTER INTERNATIONAL INC.
FORM 10-Q
For the quarterly period ended March 31, 2008
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Baxter International Inc.
Condensed Consolidated Statements of Income (unaudited)
(in millions, except per share data)
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Three months ended |
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March 31, |
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2008 |
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2007 |
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Net sales |
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$ |
2,877 |
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$ |
2,675 |
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Costs and expenses |
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Cost of goods sold |
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1,497 |
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1,409 |
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Marketing and administrative expenses |
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640 |
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583 |
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Research and development expenses |
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190 |
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159 |
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Net interest expense |
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17 |
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5 |
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Other income, net |
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(1 |
) |
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(10 |
) |
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Total costs and expenses |
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2,343 |
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2,146 |
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Income before income taxes |
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534 |
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529 |
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Income tax expense |
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105 |
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126 |
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Net income |
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$ |
429 |
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$ |
403 |
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Earnings per common share |
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Basic |
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$ |
0.68 |
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$ |
0.62 |
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Diluted |
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$ |
0.67 |
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$ |
0.61 |
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Weighted average number of common shares outstanding |
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Basic |
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632 |
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650 |
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Diluted |
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644 |
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659 |
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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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March 31, |
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December 31, |
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2008 |
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2007 |
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Current assets |
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Cash and equivalents |
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$ |
1,736 |
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$ |
2,539 |
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Accounts and other current receivables |
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2,096 |
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2,026 |
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Inventories |
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2,536 |
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2,334 |
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Other current assets |
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645 |
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656 |
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Total current assets |
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7,013 |
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7,555 |
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Property, plant and equipment, net |
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4,633 |
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4,487 |
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Other assets |
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Goodwill |
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1,768 |
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1,690 |
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Other intangible assets, net |
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461 |
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455 |
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Other |
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1,097 |
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1,107 |
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Total other assets |
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3,326 |
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3,252 |
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Total assets |
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$ |
14,972 |
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$ |
15,294 |
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Current liabilities |
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Short-term debt |
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$ |
44 |
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$ |
45 |
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Current maturities of long-term debt and
lease obligations |
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97 |
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380 |
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Accounts payable and accrued liabilities |
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3,095 |
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3,387 |
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Total current liabilities |
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3,236 |
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3,812 |
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Long-term debt and lease obligations |
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2,731 |
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2,664 |
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Other long-term liabilities |
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2,008 |
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1,902 |
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Commitments and contingencies |
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Shareholders equity |
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Common stock, $1 par value, authorized
2,000,000,000 shares, issued 683,494,944 shares
in 2008 and 2007 |
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683 |
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683 |
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Common stock in treasury, at cost,
55,832,435 shares in 2008 and 49,857,061
shares in 2007 |
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(2,930 |
) |
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(2,503 |
) |
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Additional contributed capital |
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5,322 |
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5,297 |
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Retained earnings |
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4,671 |
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4,379 |
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Accumulated other comprehensive loss |
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(749 |
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(940 |
) |
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Total shareholders equity |
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6,997 |
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6,916 |
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Total liabilities and shareholders equity |
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$ |
14,972 |
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$ |
15,294 |
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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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Three months ended |
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March 31, |
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2008 |
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2007 |
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Cash flows from operating activities |
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Net income |
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$ |
429 |
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$ |
403 |
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Adjustments |
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Depreciation and amortization |
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156 |
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140 |
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Deferred income taxes |
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61 |
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(13 |
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Stock compensation |
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38 |
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27 |
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Infusion pump charge |
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53 |
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Other |
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9 |
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4 |
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Changes in balance sheet items |
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Accounts and other current receivables |
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18 |
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(98 |
) |
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Inventories |
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(105 |
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(128 |
) |
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Accounts payable and accrued liabilities |
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(341 |
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(158 |
) |
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Restructuring payments |
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(12 |
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(3 |
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Other |
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56 |
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41 |
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Cash flows from operating activities |
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362 |
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215 |
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Cash flows from investing activities |
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Capital expenditures |
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(157 |
) |
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(93 |
) |
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Acquisitions of and investments in businesses
and technologies |
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(61 |
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(31 |
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Divestitures and other |
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29 |
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447 |
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Cash flows from investing activities |
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(189 |
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323 |
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Cash flows from financing activities |
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Issuances of debt |
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4 |
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15 |
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Payments of obligations |
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(459 |
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(221 |
) |
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Cash dividends on common stock |
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(138 |
) |
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(380 |
) |
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Proceeds and realized excess tax benefits from
stock issued under employee
benefit plans |
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112 |
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226 |
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Purchases of treasury stock |
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(545 |
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(270 |
) |
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Cash flows from financing activities |
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(1,026 |
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(630 |
) |
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Effect of currency exchange rate changes on cash and equivalents |
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50 |
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(9 |
) |
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Decrease in cash and equivalents |
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(803 |
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(101 |
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Cash and equivalents at beginning of period |
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2,539 |
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2,485 |
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Cash and equivalents at end of period |
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$ |
1,736 |
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$ |
2,384 |
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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 (SEC). Accordingly, certain information and footnote
disclosures normally included in financial statements prepared in accordance with generally
accepted accounting principles (GAAP) 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 2007 Annual Report to Shareholders (2007 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 new accounting standards
SFAS No. 159
On January 1, 2008, the company adopted Statement of Financial Accounting Standards (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 are 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. The new standard did not impact the companys consolidated
financial statements as the company did not elect the fair value option for any instruments
existing as of the adoption date. However, the company will evaluate the fair value measurement
election with respect to financial instruments the company enters into in the future.
Issued but not yet effective accounting standards
SFAS No. 161
In March 2008, the Financial Accounting Standards Board (FASB) issued SFAS No. 161, Disclosures
about Derivative Instruments and Hedging Activities, an amendment of FASB Statement No. 133 (SFAS
No. 161). The standard expands the disclosure requirements of SFAS No. 133, Accounting for
Derivative Instruments and Hedging Activities, and requires qualitative disclosures about the
objectives and strategies for using derivatives, quantitative disclosures about the fair value
amounts of and gains and losses on derivative instruments, and disclosures about
credit-risk-related contingent features in derivative agreements. The company is in the process of
analyzing this new standard, which will be effective for the company in the first quarter of 2009.
SFAS No. 160
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated Financial
Statements, an amendment of ARB No. 51 (SFAS No. 160). The new standard changes the accounting
and reporting of noncontrolling interests, which have historically been referred to as minority
interests. SFAS No. 160 requires that noncontrolling interests be presented in the consolidated
balance sheets within shareholders equity, but separate from the parents equity, and that the
amount of consolidated net income attributable to the parent and to the noncontrolling interest be
clearly identified and presented in the consolidated statements of income. Any losses in excess of
the noncontrolling interests equity interest will continue to be allocated to the noncontrolling
interest. Purchases or sales of equity interests that do not result in a change of control will be
accounted for as equity transactions. Upon a loss of control, the interest sold, as well as any
interest retained, will be measured at fair value, with any gain or loss recognized in earnings.
In partial acquisitions, when control is obtained, the acquiring company will recognize at fair
value, 100% of the assets and liabilities, including goodwill, as if the entire target company had
been acquired. SFAS No. 160 is effective for fiscal years, and interim periods within those fiscal
years, beginning on or after December 15, 2008, with early adoption prohibited. The new standard
will be applied prospectively, except for the presentation and disclosure requirements, which will
be applied retrospectively for all periods presented. The company is in the process of analyzing
the standard, which will be adopted by the company at the beginning of 2009.
5
SFAS No. 141-R
In December 2007, the FASB issued SFAS No. 141 (revised 2007), Business Combinations (SFAS No.
141-R). The new standard changes the accounting for business combinations in a number of
significant respects. The key changes include the expansion of transactions that will qualify as
business combinations, the capitalization of in-process research and development as an
indefinite-lived asset, the recognition of certain acquired contingent assets and liabilities at
fair value, the expensing of acquisition costs, the expensing of costs associated with
restructuring the acquired company, the recognition of contingent consideration at fair value on
the acquisition date, and the recognition of post-acquisition date changes in deferred tax asset
valuation allowances and acquired income tax uncertainties as income tax expense or benefit. SFAS
No. 141-R is effective for business combinations that close in years beginning on or after December
15, 2008, with early adoption prohibited. The company is in the process of analyzing this new
standard, which will be adopted by the company at the beginning of 2009.
Partial adoption of SFAS No. 157
In September 2006, the FASB issued 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.
In February 2008, FASB Staff Position (FSP) FAS No. 157-2, Effective Date of FASB Statement No.
157 (FSP No. 157-2) was issued. FSP No. 157-2 defers the effective date of SFAS No. 157 to
fiscal years beginning after December 15, 2008, and interim periods within those fiscal years, for
all nonfinancial assets and liabilities, except those that are recognized or disclosed at fair
value in the financial statements on a recurring basis (at least annually). Examples of items
within the scope of FSP No. 157-2 are nonfinancial assets and nonfinancial liabilities initially
measured at fair value in a business combination (but not measured at fair value in subsequent
periods), and long-lived assets, such as property, plant and equipment and intangible assets
measured at fair value for an impairment assessment under SFAS No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets.
The partial adoption of SFAS No. 157 on January 1, 2008 with respect to financial assets and
financial liabilities recognized or disclosed at fair value in the financial statements on a
recurring basis did not have a material impact on the companys consolidated financial statements.
See Note 5 for the fair value measurement disclosures for these assets and liabilities. The
company is in the process of analyzing the potential impact of SFAS No. 157 relating to its planned
January 1, 2009 adoption of the remainder of the standard.
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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March 31, |
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(in millions) |
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2008 |
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2007 |
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Pension benefits |
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Service cost |
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$ |
21 |
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$ |
21 |
|
Interest cost |
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|
51 |
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|
46 |
|
Expected return on plan assets |
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(58 |
) |
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|
(53 |
) |
Amortization of net loss, prior service cost and
transition obligation |
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|
20 |
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24 |
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|
Net pension plan expense |
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$ |
34 |
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$ |
38 |
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OPEB |
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Service cost |
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$ |
1 |
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$ |
1 |
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Interest cost |
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8 |
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8 |
|
Amortization of net loss and prior service cost |
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|
1 |
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|
Net OPEB plan expense |
|
$ |
9 |
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$ |
10 |
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6
Net interest expense
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|
|
|
|
|
|
|
|
|
Three months ended |
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|
March 31, |
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(in millions) |
|
2008 |
|
|
2007 |
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|
Interest expense, net of capitalized interest |
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$ |
37 |
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|
$ |
29 |
|
Interest income |
|
|
(20 |
) |
|
|
(24 |
) |
|
Net interest expense |
|
$ |
17 |
|
|
$ |
5 |
|
|
Comprehensive income
Total comprehensive income was $620 million and $464 million for the three months ended March 31,
2008 and 2007, respectively. The increase in comprehensive income in 2008 was principally due to
higher net income and favorable movements in currency translation adjustments, partially offset by
unfavorable movements in the fair value of the companys net investment hedges.
Effective tax rate
The companys effective income tax rate was 19.7% and 23.8% in the first quarters of 2008 and 2007,
respectively. The effective tax rate in the first quarter of 2007 was unusually high due to the
tax impact of the gain on the divestiture of the Transfusion Therapies (TT) business and related
charges recorded in that period. Refer to Note 3 for further information about the divestiture of
the TT business.
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, performance share units, restricted stock
units and restricted stock is reflected in the denominator for diluted EPS principally using the
treasury stock method.
In the first quarters of 2008 and 2007, 8 million and 12 million employee stock options,
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.
The following is a reconciliation of basic shares to diluted shares.
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|
Three months ended |
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|
|
March 31, |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
Basic shares |
|
|
632 |
|
|
|
650 |
|
Effect of employee stock options and other dilutive securities |
|
|
12 |
|
|
|
9 |
|
|
Diluted shares |
|
|
644 |
|
|
|
659 |
|
|
Inventories
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
Raw materials |
|
$ |
672 |
|
|
$ |
624 |
|
Work in process |
|
|
779 |
|
|
|
695 |
|
Finished products |
|
|
1,085 |
|
|
|
1,015 |
|
|
Total inventories |
|
$ |
2,536 |
|
|
$ |
2,334 |
|
|
7
Property, plant and equipment, net
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|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
Property, plant and equipment, at cost
|
|
$ |
9,182 |
|
|
$ |
8,824 |
|
Accumulated depreciation and amortization |
|
|
(4,549 |
) |
|
|
(4,337 |
) |
|
Property, plant and equipment, net |
|
$ |
4,633 |
|
|
$ |
4,487 |
|
|
Goodwill
Goodwill at March 31, 2008 totaled $609 million for the BioScience segment, $993 million for the
Medication Delivery segment and $166 million for the Renal segment. Goodwill at December 31, 2007
totaled $587 million for the BioScience segment, $948 million for the Medication Delivery segment
and $155 million for the Renal segment. The increase in the goodwill balance is principally due
to several small acquisitions in the Medication Delivery and BioScience segments, as well as
foreign currency fluctuations.
Other intangible assets
The following is a summary of the companys intangible assets subject to amortization at March 31,
2008 and December 31, 2007.
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Developed |
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|
technology, |
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(in millions) |
|
including patents |
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|
Other |
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|
Total |
|
|
March 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
Gross other intangible assets |
|
$ |
874 |
|
|
$ |
138 |
|
|
$ |
1,012 |
|
Accumulated amortization |
|
|
(481 |
) |
|
|
(77 |
) |
|
|
(558 |
) |
|
Other
intangible assets, net |
|
$ |
393 |
|
|
$ |
61 |
|
|
$ |
454 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
Gross other intangible assets |
|
$ |
848 |
|
|
$ |
130 |
|
|
$ |
978 |
|
Accumulated amortization |
|
|
(458 |
) |
|
|
(72 |
) |
|
|
(530 |
) |
|
Other
intangible assets, net |
|
$ |
390 |
|
|
$ |
58 |
|
|
$ |
448 |
|
|
The amortization expense for these intangible assets was $13 million and $15 million for the three
months ended March 31, 2008 and 2007, respectively. The anticipated annual amortization expense
for intangible assets recorded as of March 31, 2008 is $54 million in 2008, $52 million in 2009,
$51 million in 2010, $44 million in 2011, $41 million in 2012 and $37 million in 2013.
Securitization arrangements
The companys securitization arrangements resulted in net cash outflows of $16 million and $27
million for the three months ended March 31, 2008 and 2007, respectively. A summary of the
activity is as follows.
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
Sold receivables at beginning of period |
|
$ |
129 |
|
|
$ |
348 |
|
Proceeds from sales of receivables |
|
|
104 |
|
|
|
356 |
|
Cash collections (remitted to the owners of the receivables) |
|
|
(120 |
) |
|
|
(383 |
) |
Effect of currency exchange rate changes |
|
|
16 |
|
|
|
(1 |
) |
|
Sold receivables at end of period |
|
$ |
129 |
|
|
$ |
320 |
|
|
3. SALE OF TRANSFUSION THERAPIES BUSINESS
On February 28, 2007, the company divested substantially all of the assets and liabilities of its
TT business to an affiliate of TPG Capital, L.P., which established the new company as Fenwal Inc.
(Fenwal), for $540 million. Prior to the divestiture, the TT business was part of the BioScience
business. Refer to the 2007 Annual Report for further information.
8
Under transition agreements, the company is providing manufacturing and support services to Fenwal
for a period of time after divestiture, which varies based on the product or service provided and
other factors, but generally
approximates two years. Due to the companys actual and 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 arose subsequent to the divestiture date that changed the initial expectation of
significant continuing cash flows. Revenues associated with the manufacturing, distribution and
other transition services provided by the company, which were $44 million and $9 million in the
first quarters of 2008 and 2007, respectively, are reported at the corporate headquarters level and
not allocated to a segment. Included in these revenues in the first quarter of 2008 was $8 million
of deferred revenue related to the manufacturing, distribution and other transition agreements. As
of March 31, 2008, deferred revenue that will be recognized in the future as the services under
these arrangements are performed totaled $21 million.
In the first quarter of 2007, the company recorded a pre-tax gain on the sale of the TT business of
$58 million. In the first quarter of 2008, the company recorded an income adjustment to the gain
of $16 million as a result of the finalization of the net assets transferred in the divestiture.
In connection with the TT divestiture, in the first quarter of 2007, the company recorded a $35
million pre-tax charge principally associated with severance and other employee-related costs.
Reserve utilization through the end of the first quarter of 2008 was $6 million. The reserve is
expected to be substantially utilized by the end of 2009, and the company believes that the
reserves are adequate. However, adjustments may be recorded in the future as the transition is
completed.
The gain on the sale of the TT business and the related charges and adjustments in 2008 and 2007
were recorded in other income, net on the consolidated statements of income.
4. RESTRUCTURING AND OTHER SPECIAL CHARGES
Restructuring charges
The following is a summary of restructuring charges recorded in 2007 and 2004. Refer to the 2007
Annual Report for additional information about these charges.
2007
In 2007, the company recorded a restructuring charge of $70 million principally associated with the
consolidation of certain commercial and manufacturing operations outside of the United States.
Based on a review of current and future capacity needs, the company decided to integrate several
facilities to reduce the companys cost structure and optimize operations, principally in the
Medication Delivery segment.
Included in the charge was $17 million related to asset impairments, principally to write down
property, plant and equipment (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.
2004
In 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.
9
Restructuring reserves
The following table summarizes cash activity in the companys 2007 and 2004 restructuring charges.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee- |
|
|
Contractual |
|
|
|
|
|
|
related |
|
|
and other |
|
|
|
|
(in millions) |
|
costs |
|
|
costs |
|
|
Total |
|
|
2004 Charge |
|
$ |
212 |
|
|
$ |
135 |
|
|
$ |
347 |
|
Utilization and adjustments in 2004, 2005 and 2006 |
|
|
(198 |
) |
|
|
(94 |
) |
|
|
(292 |
) |
|
Reserve at December 31, 2006 |
|
|
14 |
|
|
|
41 |
|
|
|
55 |
|
2007 Charge |
|
|
46 |
|
|
|
7 |
|
|
|
53 |
|
Utilization |
|
|
(15 |
) |
|
|
(12 |
) |
|
|
(27 |
) |
|
Reserve at December 31, 2007 |
|
|
45 |
|
|
|
36 |
|
|
|
81 |
|
Utilization |
|
|
(6 |
) |
|
|
(6 |
) |
|
|
(12 |
) |
|
Reserve at March 31, 2008 |
|
$ |
39 |
|
|
$ |
30 |
|
|
$ |
69 |
|
|
Restructuring reserve utilization in the first quarter of 2008 totaled $12 million, with $3 million
relating to the 2007 program and $9 million relating to the 2004 program. The 2007 and 2004
reserves are expected to be utilized by the end of 2009, with the majority of the payments to be
made in 2008. The company believes that the reserves are adequate. However, adjustments may be
recorded in the future as the programs are completed.
Other charges
The charges discussed below were classified in cost of goods sold in the companys consolidated
income statements, and were reflected in the Medication Delivery segment. 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.
While the company continues to work to resolve the issues associated with COLLEAGUE infusion pumps
and its heparin products described below, there can be no assurance that additional costs or civil
and criminal penalties will not be incurred, that additional regulatory actions with respect to
the company will not occur, that the company will not face civil claims for damages from
purchasers or users, that substantial additional charges or significant asset impairments may not
be required, or that sales of any other product may not be adversely affected.
COLLEAGUE Infusion Pumps
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. Please refer to the companys 2007 Annual Report for
further information.
The company recorded charges of $171 million ($157 million for cash costs and $14 million for asset
impairments) in 2006 and 2005 related to issues associated with its COLLEAGUE infusion pumps. The
reserve for cash costs represented an estimate of the cash expenditures for the materials, labor
and freight costs expected to be incurred to remediate the design issues, customer accommodations,
and warranty and other commitments made to customers. In 2007, the company increased its reserve
for cash costs by $14 million as estimates were refined based on the companys experience executing
the remediation plan.
As a result of delays in the remediation plan, principally due to additional software modifications
and validation and testing required to remediate the pumps, and other changes in the estimated
costs to execute the remediation plan, the company recorded an additional $53 million charge
associated with the COLLEAGUE pumps during the first quarter of 2008. The charge consisted of
$39 million for cash costs and $14 million principally relating
to asset impairments. The reserve for cash costs
principally relates to customer accommodations, including extended warranties, and other costs
associated with the delay in the recommercialization timeline.
The following table summarizes cash activity in the companys COLLEAGUE infusion pump reserves
through March 31, 2008.
|
|
|
|
|
|
(in millions) |
|
|
|
|
|
Charges in 2005 and 2006 |
|
$ |
157 |
|
Utilization and adjustments in 2005 through 2007 |
|
|
(87 |
) |
|
Reserve at December 31, 2007 |
|
|
70 |
|
Charge |
|
|
39 |
|
Utilization |
|
|
(12 |
) |
|
Reserve at March 31, 2008 |
|
$ |
97 |
|
|
The majority of the remaining infusion pump reserves are expected to be utilized in 2008 and 2009.
10
Heparin
During the first quarter of 2008, the company recorded a charge of $19 million related to the
companys recall of its heparin sodium injection products in the United States. During the first
quarter of 2008, the company identified an increasing level of severe allergic-type and hypotensive
adverse reactions occurring in patients using its heparin sodium injection products in the United
States, and initiated a field corrective action with respect to these products.
Included in the charge were $14 million of asset impairments, primarily heparin inventory that will
not be sold, and $5 million of cash costs related to the recall. The reserve for cash costs is
expected to be utilized by the end of 2008.
The companys sales of these heparin products totaled approximately $30 million in 2007.
5. FAIR VALUE MEASUREMENTS
The
following table summarizes the bases used to measure financial assets
and liabilities that are carried at fair
value on a recurring basis in the balance sheet.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basis of Fair Value Measurement |
|
|
|
|
|
|
|
Quoted Prices in |
|
|
|
|
|
|
Significant |
|
|
|
|
|
|
|
Active Markets for |
|
|
Significant Other |
|
|
Unobservable |
|
|
|
Balance at |
|
|
Identical Assets |
|
|
Observable Inputs |
|
|
Inputs |
|
(in millions) |
|
March 31, 2008 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency hedges |
|
$ |
22 |
|
|
$ |
|
|
|
$ |
22 |
|
|
$ |
|
|
Interest rate hedges |
|
|
32 |
|
|
|
|
|
|
|
32 |
|
|
|
|
|
Equity securities |
|
|
14 |
|
|
|
14 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
68 |
|
|
$ |
14 |
|
|
$ |
54 |
|
|
$ |
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency hedges |
|
$ |
127 |
|
|
$ |
|
|
|
$ |
127 |
|
|
$ |
|
|
Net investment hedges |
|
|
455 |
|
|
|
|
|
|
|
455 |
|
|
|
|
|
|
Total liabilities |
|
$ |
582 |
|
|
$ |
|
|
|
$ |
582 |
|
|
$ |
|
|
|
For assets that are measured using quoted prices in active markets, the fair value is the published
market price per unit multiplied by the number of units held, without consideration of transaction
costs. The majority of the derivatives entered into by the company are valued using internal
valuation techniques as no quoted market prices exist for such instruments. The principal
techniques used to value these instruments are discounted cash flow and Black-Scholes models. The
key inputs, which are observable, depend on the type of derivative, and include contractual terms,
interest rate yield curves, foreign exchange rates and volatility.
6. COMMON STOCK
Stock-based compensation plans
Stock compensation expense totaled $38 million ($26 million on a net-of-tax basis, or $0.04 per
diluted share) and $27 million ($18 million on a net-of-tax basis, or $0.03 per diluted share) for
the three months ended March 31, 2008 and 2007, 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 2008, the company made its annual stock compensation grants, which consisted of
approximately 7 million stock options and 0.7 million performance share units (PSUs).
11
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.
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
|
|
|
|
2008 |
|
|
2007 |
|
|
Expected volatility |
|
|
23.8% |
|
|
|
23.5% |
|
Expected life (in years) |
|
|
4.5 |
|
|
|
4.5 |
|
Risk-free interest rate |
|
|
2.4% |
|
|
|
4.5% |
|
Dividend yield |
|
|
1.5% |
|
|
|
1.2% |
|
Fair value per stock option |
|
|
$12 |
|
|
|
$13 |
|
|
The total intrinsic value of stock options exercised during the three months ended March 31, 2008
and 2007 was $61 million and $85 million, respectively.
As of March 31, 2008, $145 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
2.3 years.
Performance share and restricted stock units
The assumptions used in estimating the fair value of PSUs granted during the period, along with the
fair values, were as follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
|
|
2008 |
|
|
2007 |
|
|
Baxter volatility |
|
|
19.7% |
|
|
|
17.8% |
|
Peer group volatility |
|
|
12.4% - 37.1% |
|
|
|
13.0% - 38.6% |
|
Correlation of returns |
|
|
0.12 - 0.40 |
|
|
|
0.09 - 0.34 |
|
Risk-free interest rate |
|
|
1.9% |
|
|
|
4.5% |
|
Dividend yield |
|
|
1.5% |
|
|
|
1.2% |
|
Fair value per PSU |
|
|
$64 |
|
|
|
$64 |
|
|
As of March 31, 2008, pre-tax unrecognized compensation cost related to all unvested PSUs of $51
million is expected to be recognized as expense over a weighted-average period of 2.4 years, and
pre-tax unrecognized compensation cost related to all unvested restricted stock units of $19
million is expected to be recognized as expense over a weighted-average period of 1.7 years.
Realized excess income tax benefits
In
accordance with SFAS No. 123 (revised 2004), Share-Based
Payment, in the first quarter of 2007, realized excess tax benefits of
$25 million, principally associated with stock option exercises, were presented as an outflow
within the operating section and an inflow within the financing section of the statement of cash
flows. No income tax benefits were realized from stock-based compensation during the first quarter
of 2008, due to the companys U.S. net operating loss position.
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-month period ended March 31, 2008, the company repurchased 9.1 million shares for $545
million under the board of directors March 2007 $2.0 billion share repurchase authorization. In
March 2008, the board of directors authorized the repurchase of up to an additional $2.0 billion of
the companys common stock. At March 31, 2008, $2.6 billion remained available under the March
2007 and March 2008 authorizations.
7. LEGAL PROCEEDINGS
Baxter is involved in product liability, patent, 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 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
12
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 potential
administrative and legal actions. With respect to regulatory matters, these actions may lead to
product recalls, injunctions to halt manufacture and distribution, other restrictions on the
companys operations and monetary sanctions. With respect to intellectual property, the company
may be exposed to significant litigation concerning the scope of the companys and others rights.
Such litigation 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.
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. In November 2003, the lawsuit was dismissed without prejudice. 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 October 2003, reexamination 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. again filed a
patent infringement lawsuit naming Baxter Healthcare Corporation as the defendant in the U.S.D.C.
for the District of Delaware. The parties have agreed to resolve this matter through binding
arbitration and without injunctive relief.
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. In 2007,
Abbott brought a patent infringement action against Baxter in the Cali Circuit Court of Colombia
based on a Colombian counterpart patent, and obtained an injunction preliminarily prohibiting the
approval of Baxters generic sevoflurane in Colombia during the pendency of the infringement suit.
Baxter has moved to overturn the injunction and has answered the lawsuit. Parallel opposition
proceedings in the European and Japanese Patent Offices seeking to revoke certain versions of the
patent are also pending.
Peritoneal Dialysis Litigation
On October 16, 2006, Baxter Healthcare Corporation and DEKA Products Limited Partnership filed a
patent infringement lawsuit against Fresenius Medical Care Holdings, Inc. and Fresenius USA, Inc.
The complaint alleges that Freseniuss sale of the Liberty Cycler peritoneal dialysis systems and
related disposable items and equipment infringes nine U.S. patents owned by Baxter, as to which
DEKA has granted Baxter an exclusive license in the peritoneal dialysis field. The case is pending
in the U.S.D.C. for the Northern District of California with a trial date scheduled for April 2009.
Hemodialysis Litigation
Since April 2003, Baxter has been pursuing a patent infringement action against Fresenius Medical
Care Holdings, Inc. for infringement of certain Baxter patents. The
patents cover Freseniuss 2008K
hemodialysis instrument.
13
In 2007, the court entered judgment in Baxters favor holding the patents valid and infringed, and a
jury assessed damages at $14 million for past sales only. On April 4, 2008, the U.S.D.C. for the
Northern District of California granted Baxters motion for permanent injunction, and granted
Baxters request for royalties on Freseniuss sales of the 2008K hemodialysis machines during a
nine-month transition period before the permanent injunction takes effect. The order also granted
a royalty on disposables. Fresenius has filed a notice of appeal.
Securities Laws
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. 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. In April 2008, the Court of Appeals for the Seventh Circuit denied Baxters
interlocutory appeal and upheld the trial courts denial of Baxters motion to dismiss. Baxter has
filed a motion for judgment on the pleadings. Discovery is underway in this matter.
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.
In connection with the recall of heparin products in the United States described in Note 4,
approximately 20 lawsuits, some purported class actions, have been filed alleging that plaintiffs
suffered allergic or hypotensive symptoms following the administration of heparin, in some cases
resulting in fatalities. These cases are each in their earliest stages, and no discovery has
commenced.
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. In April 2008,
the court preliminarily approved a class settlement resolving Medicare Part B claims and
independent health plan claims against Baxter and others, which had
previously been reserved for by the company. Final approval of this settlement is expected later this year.
Remaining 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. 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.
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 and other acquired entities from the late 1970s to the
mid-1980s. The typical case or claim alleges that the individual was infected with the HIV or HCV
virus by factor concentrates that contained one or the other or both viruses. None of these cases
involves factor concentrates currently processed by the company.
As of March 31, 2008, the company has been named as a defendant, along with others, in
approximately 125 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.
14
8. 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 manufactures recombinant and plasma-based proteins to treat hemophilia and
other bleeding disorders, plasma-based therapies to treat immune deficiencies, biosurgery and other
products for regenerative medicine, and vaccines. Prior to the divestiture of the TT business on
February 28, 2007, the business also manufactured manual and automated blood and blood-component
separation and collection systems.
The Medication Delivery business manufactures intravenous (IV) solutions and administration sets,
premixed drugs and drug-reconstitution systems, pre-filled vials and syringes for injectable drugs,
IV nutrition products, infusion pumps, and inhalation anesthetics, as well as products and services
related to drug formulation and enhanced packaging technologies.
The Renal business provides products to treat end-stage renal disease, or irreversible kidney
failure. The business manufactures solutions and other products for peritoneal dialysis, a
home-based therapy, and also distributes products for hemodialysis, which is generally conducted in
a hospital or clinic.
The company 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. The company 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, certain foreign exchange fluctuations and the majority of the foreign currency and
interest rate hedging activities, corporate headquarters costs, stock compensation expense, certain
non-strategic investments and related income and expense, certain employee benefit plan costs,
certain nonrecurring gains and losses, deferred income taxes, certain litigation liabilities and
related insurance receivables, and the revenues and costs related to the manufacturing,
distribution and other transition agreements with Fenwal.
Financial information for the companys segments for the three months ended March 31 is as follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
Net sales |
|
|
|
|
|
|
|
|
BioScience |
|
$ |
1,210 |
|
|
$ |
1,151 |
|
Medication Delivery |
|
|
1,065 |
|
|
|
990 |
|
Renal |
|
|
558 |
|
|
|
525 |
|
Transition services to Fenwal Inc. |
|
|
44 |
|
|
|
9 |
|
|
Total |
|
$ |
2,877 |
|
|
$ |
2,675 |
|
|
Pre-tax income |
|
|
|
|
|
|
|
|
BioScience |
|
$ |
500 |
|
|
$ |
412 |
|
Medication Delivery |
|
|
92 |
|
|
|
153 |
|
Renal |
|
|
77 |
|
|
|
93 |
|
|
Total pre-tax income from segments |
|
$ |
669 |
|
|
$ |
658 |
|
|
Net sales and pre-tax income for the BioScience segment include sales of TT products until the
completion of the sale of the TT business on February 28, 2007. Transition services to Fenwal
represents 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.
15
The following is a reconciliation of segment pre-tax income to income before income taxes per the
consolidated income statements.
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
Total pre-tax income from segments |
|
$ |
669 |
|
|
$ |
658 |
|
Unallocated amounts |
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
(17 |
) |
|
|
(5 |
) |
Certain foreign currency fluctuations and hedging activities |
|
|
1 |
|
|
|
(8 |
) |
Stock compensation |
|
|
(38 |
) |
|
|
(27 |
) |
Other corporate items |
|
|
(81 |
) |
|
|
(89 |
) |
|
Income before income taxes |
|
$ |
534 |
|
|
$ |
529 |
|
|
16
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Refer to the 2007 Annual Report for managements discussion and analysis of the financial condition
and results of operations of the company for the year ended December 31, 2007. The following is
managements discussion and analysis of the financial condition and results of operations of the
company for the three months ended March 31, 2008.
RESULTS OF OPERATIONS
NET SALES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
Percent |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
change |
|
|
BioScience |
|
$ |
1,210 |
|
|
$ |
1,151 |
|
|
|
5% |
|
Medication Delivery |
|
|
1,065 |
|
|
|
990 |
|
|
|
8% |
|
Renal |
|
|
558 |
|
|
|
525 |
|
|
|
6% |
|
Transition services to Fenwal Inc. |
|
|
44 |
|
|
|
9 |
|
|
|
389% |
|
|
Total net sales |
|
$ |
2,877 |
|
|
$ |
2,675 |
|
|
|
8% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
Percent |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
change |
|
|
International |
|
$ |
1,698 |
|
|
$ |
1,536 |
|
|
|
11% |
|
United States |
|
|
1,179 |
|
|
|
1,139 |
|
|
|
4% |
|
|
Total net sales |
|
$ |
2,877 |
|
|
$ |
2,675 |
|
|
|
8% |
|
|
During the first quarter of 2008, foreign currency fluctuations benefited sales growth by 6
percentage points, principally due to the weakening of the U.S. Dollar relative to the Euro.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
Percent |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
change |
|
|
Total net sales |
|
$ |
2,877 |
|
|
$ |
2,675 |
|
|
|
8% |
|
Pre-divestiture sales of Transfusion Therapies products (included in
BioScience segment through the February 28, 2007 divestiture date) |
|
|
|
|
|
|
79 |
|
|
|
(100% |
) |
Transition services to Fenwal Inc. (subsequent to the February 28, 2007
divestiture date) |
|
|
44 |
|
|
|
9 |
|
|
|
389% |
|
|
Total net sales excluding Transfusion Therapies |
|
$ |
2,833 |
|
|
$ |
2,587 |
|
|
|
10% |
|
|
Net sales excluding Transfusion Therapies (TT) increased 10% during the first quarter of 2008
(including a 6 percentage point favorable impact from foreign currency fluctuations). Management
believes that net sales and sales growth excluding TT facilitates a more meaningful analysis of the
companys net sales growth due to the divestiture of this business in 2007. See Note 3 for further
information regarding the divestiture of the TT business.
BioScience
Sales in the BioScience segment increased 5% during the first quarter of 2008 (including a 5
percentage point favorable impact from foreign currency fluctuations).
The following is a summary of sales by significant product line.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
Percent |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
change |
|
|
Recombinants |
|
$ |
436 |
|
|
$ |
388 |
|
|
|
12% |
|
Plasma Proteins |
|
|
260 |
|
|
|
225 |
|
|
|
16% |
|
Antibody Therapy |
|
|
286 |
|
|
|
222 |
|
|
|
29% |
|
Regenerative Medicine |
|
|
94 |
|
|
|
82 |
|
|
|
15% |
|
Transfusion Therapies |
|
|
|
|
|
|
79 |
|
|
|
(100% |
) |
Other |
|
|
134 |
|
|
|
155 |
|
|
|
(14% |
) |
|
Total net sales |
|
$ |
1,210 |
|
|
$ |
1,151 |
|
|
|
5% |
|
|
17
Recombinants
The primary driver of sales growth in the Recombinants product line during the first quarter of
2008 was increased sales volume of recombinant factor VIII therapies. Factor VIII products are
used in the treatment of hemophilia A, which is a bleeding disorder caused by a deficiency in blood
clotting factor VIII. Sales growth was fueled by the continuing adoption by customers of the
advanced recombinant therapy, ADVATE (Antihemophilic Factor (Recombinant), Plasma/Albumin-Free
Method) rAHF-PFM, 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. Sales of ADVATE totaled
approximately $325 million in the first quarter of 2008, compared to $260 million in the first
quarter of 2007.
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 first quarter of 2008 was
driven by strong sales of albumin, FLEXBUMIN [Albumin (Human)] (an albumin therapy packaged in
flexible containers), FEIBA and ARALAST, with both volume and pricing improvements contributing to
the sales growth of these products.
Antibody Therapy
Higher sales of IGIV (immune globulin intravenous), which is used in the treatment of immune
deficiencies, fueled sales growth during the first quarter of 2008, with increased volume,
continuing improvements in pricing in the United States and Europe, and continuing customer
conversions to the liquid formulation for the product. Because it does not need to be
reconstituted prior to infusion, the higher-yielding liquid formulation offers added convenience
for clinicians and patients.
Regenerative Medicine
This product line principally includes plasma-based and non-plasma-based biosurgery products for
hemostasis (the stoppage of bleeding), wound-sealing and tissue regeneration. Growth in the first
quarter of 2008 was driven by increased sales of the companys FLOSEAL and COSEAL sealants.
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 first quarter of 2008 was primarily 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 $50 million in the first quarter of 2007. Also
contributing to the decrease in sales were large shipments of candidate H5N1 influenza vaccine to
various governments worldwide in the first quarter of 2007. Partially offsetting these declines in
the quarter were strong international sales of FSME Immun (for the prevention of tick-borne
encephalitis), principally due to pricing improvements. Sales of vaccines may fluctuate from
period to period based on the timing of government tenders and new supply agreements.
Medication Delivery
Net sales for the Medication Delivery segment increased 8% during the first quarter of 2008
(including a 6 percentage point favorable impact from foreign currency fluctuations).
18
The following is a summary of sales by significant product line.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
Percent |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
change |
|
|
IV Therapies |
|
$ |
371 |
|
|
$ |
320 |
|
|
|
16% |
|
Global Injectables |
|
|
368 |
|
|
|
361 |
|
|
|
2% |
|
Infusion Systems |
|
|
220 |
|
|
|
209 |
|
|
|
5% |
|
Anesthesia |
|
|
99 |
|
|
|
89 |
|
|
|
11% |
|
Other |
|
|
7 |
|
|
|
11 |
|
|
|
(36% |
) |
|
Total net sales |
|
$ |
1,065 |
|
|
$ |
990 |
|
|
|
8% |
|
|
IV Therapies
This product line principally consists of intravenous (IV) solutions and nutritional products.
Growth for the quarter was principally driven by increased demand for IV therapy products in
Europe, Latin America, and Asia, particularly in China, and strong international sales of
nutritional products. Also impacting sales growth in the quarter were pricing improvements for IV
therapy products in the United States and the favorable impact of foreign currency fluctuations.
Global Injectables
This product line primarily consists of the companys pharmaceutical company partnering business,
enhanced packaging, premixed drugs and generic injectables. Contributing to sales growth in the
first quarter of 2008 were strong international sales in the pharmacy-compounding business. Sales
levels in the quarter were unfavorably impacted by a decline in revenues in the pharmaceutical
company partnering business in the United States and lower sales of generic injectables,
principally due to the transfer of marketing and distribution rights for generic propofol back to
Teva Pharmaceutical Industries Ltd. effective July 1, 2007. Sales of propofol totaled
approximately $20 million in the first quarter of 2007.
Infusion Systems
Sales growth in the first quarter of 2008 was driven by the favorable impact of foreign currency
fluctuations and increased sales of disposable tubing sets used in the administration of IV
solutions. Sales of COLLEAGUE infusion pumps were flat in the first quarter of 2008 as compared to
the prior year period. Refer to Note 4 and the Certain Regulatory Matters section below for
additional information, including charges recorded in the first quarter of 2008, related to the
COLLEAGUE infusion pump.
Anesthesia
Sales growth in the first quarter of 2008 was driven by strong international sales, principally as
a result of increased penetration of SUPRANE (desflurane, USP) and the impact of the launch of
sevoflurane in additional geographic markets. Partially offsetting this growth were decreased
sales in the United States, which were unfavorably impacted by wholesaler purchasing patterns in
the first quarter of 2008.
Renal
Sales in the Renal segment increased 6% during the first quarter of 2008 (including an 8 percentage
point favorable impact from foreign currency fluctuations).
The following is a summary of sales by significant product line.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
Percent |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
change |
|
|
PD Therapy |
|
$ |
445 |
|
|
$ |
419 |
|
|
|
6% |
|
HD Therapy |
|
|
113 |
|
|
|
106 |
|
|
|
7% |
|
|
Total net sales |
|
$ |
558 |
|
|
$ |
525 |
|
|
|
6% |
|
|
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. Excluding the impact of foreign currency,
sales declined slightly in the quarter, as increased numbers of patients in Asia, particularly in
China, the United States, and Central and Eastern Europe were more than offset by the loss of a
government tender in Mexico. 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.
19
HD Therapy
Hemodialysis, or HD Therapy, is another form of end-stage renal disease dialysis therapy that is
generally performed in a hospital or outpatient center. In HD Therapy, the patients blood is
pumped outside the body to be cleansed of wastes and fluid using a machine and an external filter,
also known as a dialyzer. The sales growth during the first quarter of 2008 was principally driven
by the favorable impact of foreign exchange, which was partially offset by a decline in sales of
dialyzers.
Transition Services to Fenwal Inc.
Net sales in this category represents revenues associated with manufacturing, distribution and
other services provided by the company to Fenwal Inc. (Fenwal) subsequent to the divestiture of the
TT business on February 28, 2007. See Note 3 for further information.
GROSS MARGIN AND EXPENSE RATIOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
March 31, |
|
|
|
|
2008 |
|
|
2007 |
|
|
Change |
|
Gross margin |
|
|
48.0% |
|
|
|
47.3% |
|
|
0.7 pts |
Marketing and administrative expenses |
|
|
22.2% |
|
|
|
21.8% |
|
|
0.4 pts |
|
Gross Margin
The improvement in gross margin in the first quarter of 2008 was principally driven by continued
customer conversion to ADVATE and the liquid formulation of IGIV, manufacturing efficiencies and
yield improvements, improved pricing for certain plasma protein products, and strong sales of
certain vaccines.
Included in the companys gross margin in the first quarter of 2008 were charges of $53 million
related to COLLEAGUE infusion pumps and $19 million related to the companys recall of its heparin
products in the United States. These charges decreased the gross margin by approximately 2.5
percentage points in the quarter. Refer to Note 4 for further information on these charges.
Marketing and Administrative Expenses
The increase in the marketing and administrative expense ratio in the first quarter of 2008 was
principally due to an increase in stock compensation costs and
spending related to certain marketing programs, particularly in the BioScience segment, partially
offset by a reduction in expenses due to the February 28, 2007 divestiture of the TT business. See
Note 3 for further information about the TT divestiture.
RESEARCH AND DEVELOPMENT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
March 31, |
|
Percent |
(in millions) |
|
2008 |
|
2007 |
|
change |
|
Research and development (R&D) expenses |
|
|
$190 |
|
|
|
$159 |
|
|
|
19% |
|
As a percent of sales |
|
|
6.6% |
|
|
|
5.9% |
|
|
|
|
|
|
R&D expenses increased during the first quarter of 2008, with strong growth in spending on R&D
projects across all three of the companys businesses reflecting the companys commitment to
accelerate R&D investments. Refer to the 2007 Annual Report for a discussion of the companys R&D
pipeline.
2007 RESTRUCTURING CHARGE
During 2007, the company recorded a restructuring charge 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 and $53 million for cash
costs, principally pertaining to severance and other employee-related costs. The reserve for cash
costs is expected to be utilized by the end of 2009. Refer to Note 4 for further information,
including reserve utilization through March 31, 2008.
20
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.
NET INTEREST EXPENSE
Net interest expense was $17 million in the first quarter of 2008, compared to $5 million in the
first quarter of 2007. The increase was driven by a higher average debt level, principally due to
the December 2007 issuance of $500 million of senior unsecured notes, and a lower average cash
balance, partially due to share repurchases in the quarter. Also contributing to the increase in
net interest expense was the impact of the terminations of certain cross-currency swap agreements.
OTHER INCOME, NET
Other income, net was $1 million and $10 million during the first quarters of 2008 and 2007,
respectively. Other income, net in both periods principally included amounts relating to foreign
exchange, minority interests and equity method investments. Other income, net in the first quarter
of 2008 included $16 million of income related to the finalization of the net assets transferred in
the divestiture of the TT business. Other income, net in the first quarter of 2007 included a gain
on the sale of the TT business of $58 million less related charges of $35 million. See Note 3 for
further information.
PRE-TAX INCOME
Refer to Note 8 for a summary of financial results by segment. The following is a summary of
significant factors impacting the segments financial results.
BioScience
Pre-tax income increased 21% in the first quarter of 2008. The primary drivers of the increase
were strong sales of higher-margin products, which were fueled by the continued adoption of ADVATE,
the conversion to the liquid formulation of IGIV, improved pricing of certain plasma protein
products, strong sales of certain vaccines, continued cost and yield improvements and the favorable
impact of foreign currency fluctuations. Partially offsetting this growth was the impact of higher
spending on new marketing programs and increased R&D spending related to the adult stem-cell
therapy program and certain clinical trials.
Medication Delivery
Pre-tax income decreased 40% in the first quarter of 2008. The primary drivers of the decline were
charges in the first quarter of 2008 of $53 million related to COLLEAGUE infusion pumps and $19
million related to the companys recall of its heparin products in the United States, as well as
increased spending on marketing programs and R&D. See Note 4 for further information about the
COLLEAGUE and heparin charges. Partially offsetting the impact of these items was an improved
product mix, particularly outside of the United States, and the favorable impact of foreign
currency fluctuations.
Renal
Pre-tax income decreased 17% in the first quarter of 2008. The decrease was principally due to the
loss of a PD tender in Mexico and increased spending on marketing programs and new product
development, including the next-generation home HD machine, partially offset by the favorable
impact of foreign currency fluctuations.
Other
Certain items are maintained at the companys corporate level and are not allocated to the
segments. These items primarily 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
income related to the manufacturing, distribution and other transition agreements with Fenwal.
Refer to Note 8 for a reconciliation of segment pre-tax income to income before income taxes per
the consolidated income statements. The significant factors impacting these other items are
described below.
21
Refer to the discussion above regarding net interest expense. The $9 million change related to
foreign exchange fluctuations and hedging activities was due to the favorable impact of the
companys cash flow hedges. The increase in stock compensation expense was principally due to
recent changes in the companys stock compensation programs, including the granting of performance
share units beginning in 2007 and an amendment to the companys employee stock purchase plan
effective January 1, 2008. Refer to the 2007 Annual Report for further information regarding these
changes.
The decrease in other corporate items in the first quarter of 2008 was primarily due to income of
$16 million related to the finalization of the net assets transferred in the divestiture of the TT
business, revenue recognized as services were performed under the manufacturing, distribution and
other transition agreements with the buyer of the TT business, and the impact of a $10 million
voluntary contribution to the Baxter International Foundation in the first quarter of 2007. These
items were partially offset by income of $23 million in the first quarter of 2007, reflecting the
$58 million gain on the sale of the TT business less related charges of $35 million. Refer to Note
3 for further information regarding the divestiture of the TT business.
INCOME TAXES
The companys effective income tax rate was 19.7% and 23.8% in the first quarters of 2008 and 2007,
respectively. The effective tax rate in the first quarter of 2007 was unusually high due to the
tax impact of the gain on the divestiture of the TT business and related charges recorded in that
period. Refer to Note 3 for further information about the divestiture of the TT business. The
company anticipates that the effective tax rate, calculated in accordance with generally accepted
accounting principles (GAAP), will be approximately 19% to 19.5% in 2008, excluding any impact from
additional audit developments or other special items.
INCOME AND EARNINGS PER DILUTED SHARE
Net income was $429 million, or $0.67 per diluted share, for the first quarter of 2008 and $403
million, or $0.61 per diluted share, in the prior year quarter. The significant factors and events
contributing to the changes are discussed above.
CRITICAL ACCOUNTING POLICIES
The preparation of financial statements in accordance with GAAP 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, 2007 is
included in Note 1 to the companys consolidated financial statements in the 2007 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 2007 Annual Report.
LIQUIDITY AND CAPITAL RESOURCES
CASH FLOWS
Cash flows from operating activities
Cash flows from operating activities increased during the first quarter of 2008 as compared to the
prior year, totaling $362 million in the first quarter of 2008 and $215 million in 2007. The
increase in cash flows was primarily due to higher earnings (before non-cash items) and the other
factors discussed below.
Accounts Receivable
Cash flows relating to accounts receivable increased during the first quarter of 2008 as compared
to the prior year. Days sales outstanding increased from 55.3 days at March 31, 2007 to 56.3 days
at March 31, 2008, primarily due to a shift in the geographic mix of sales to certain international
locations with longer collection periods and a decrease in cash proceeds from the securitization
and factoring of receivables, principally due to the termination of the European securitization
arrangement in the fourth quarter of 2007. See the 2007 Annual Report for further information.
The impact of these factors was partially offset by an improvement in the collection of receivables
in the United States.
22
Inventories
Cash outflows relating to inventories decreased in 2008. The following is a summary of inventories
at March 31, 2008 and December 31, 2007, as well as inventory turns for the three months ended
March 31, 2008 and 2007, by segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventories |
|
Annualized inventory turns |
|
|
March 31, |
|
|
December 31, |
|
|
for the three months ended March 31, |
(in millions, except inventory turn data) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
BioScience |
|
$ |
1,355 |
|
|
$ |
1,234 |
|
|
|
1.44 |
|
|
|
1.87 |
|
Medication Delivery |
|
|
880 |
|
|
|
826 |
|
|
|
2.98 |
|
|
|
3.08 |
|
Renal |
|
|
263 |
|
|
|
236 |
|
|
|
4.18 |
|
|
|
4.48 |
|
Other |
|
|
38 |
|
|
|
38 |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
2,536 |
|
|
$ |
2,334 |
|
|
|
2.27 |
|
|
|
2.59 |
|
|
Inventories increased $202 million in the first quarter of 2008, with approximately half of the
increase related to foreign currency fluctuations. The lower inventory turns in the BioScience
segment were primarily due to an increase in plasma inventories as a result of the transition to
the companys new plasma fractionation facility in Los Angeles, California, as well as planned
increases in stock levels of certain plasma protein products to ensure continuity of care. 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 increased in the first three
months of 2008 as compared to the prior year period, principally driven by the timing of accounts
payable and the payment of income taxes. Also contributing to the increase in cash outflows were
the impact of cash inflows in the first quarter of 2007 of $52 million resulting from a prepayment
relating to the Fenwal manufacturing, distribution and other transition agreements and $25 million
of excess tax benefits from stock option exercises. Refer to Note 3 for further information
regarding the agreements with Fenwal and Note 6 regarding the excess tax benefits from stock option
exercises. Also contributing to the increase in cash outflows were payments related to the
companys restructuring programs, which increased by $9 million.
Partially offsetting these increases in cash outflows were the settlements of certain mirror
cross-currency swaps, which resulted in operating cash inflows of $12 million in the first quarter
of 2008 as compared to cash outflows of $31 million in the first quarter of 2007. Refer to the
2007 Annual Report for further information regarding these swaps.
Cash flows from investing activities
Capital Expenditures
Capital expenditures increased $64 million for the three months ended March 31, 2008, from $93
million in 2007 to $157 million in 2008. 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 acquisitions of and investments in businesses and technologies of $61
million in the first quarter of 2008 principally related to an IV solutions business in China and
certain smaller acquisitions and investments. Included in the cash outflows in the first quarter
of 2008 were payments of $10 million related to the companys fourth quarter 2007 agreement with
Nycomed Pharma AS (Nycomed) to market and distribute Nycomeds TachoSil surgical patch in the
United States, and $5 million related to the fourth quarter 2007
amendment of the companys exclusive
R&D, license and manufacturing agreement with Nektar Therapeutics (Nektar) to include the use of
Nektars proprietary PEGylation technology in the development of longer-acting forms of blood
clotting proteins.
Cash outflows relating to the acquisitions of and investments in businesses and technologies of $31
million in the first quarter of 2007 principally related to the expansion of the companys existing
agreements 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.
23
Refer to the 2007 Annual Report for further information about the arrangements with Nycomed, Nektar
and Halozyme.
Divestitures and Other
Cash inflows relating to divestitures and other in the first quarter of 2008 principally consisted
of cash collections from customers relating to previously securitized receivables. In the fourth
quarter of 2007, the company repurchased the third party interest in receivables previously sold
under the European securitization arrangement, and the European facility was not renewed. Refer to
the 2007 Annual Report for further information.
Cash inflows in the first quarter of 2007 principally related to cash proceeds from the divestiture
of the TT business. Refer to Note 3 for further information. Cash inflows in both 2008 and 2007
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 in the first quarter of 2008
totaled $455 million, as compared to $206 million in the prior year period. Financing cash
outflows related to the settlement of certain cross-currency swaps were $169 million and $147
million during the first quarters of 2008 and 2007, respectively. Refer to the 2007 Annual Report
for further information regarding these swaps. Cash outflows in the first quarter of 2008 also
included the repayment of the companys 5.196% notes, which approximated $250 million, upon their
maturity in February 2008.
Other Financing Activities
Cash dividend payments totaled $138 million in the first quarter of 2008 and $380 million in the
first quarter of 2007. Beginning in 2007, the company converted from an annual to a quarterly
dividend payment and increased the dividend by 15% on an annualized basis, to $0.1675 per share per
quarter. The final annual dividend of $380 million was paid in January 2007, and the first
quarterly dividend was paid in the second quarter of 2007. In November 2007, the board of
directors declared a quarterly dividend of $0.2175 per share ($0.87 per share on an annualized
basis), which was paid on January 3, 2008 to shareholders of record as of December 10, 2007. This
dividend represented an increase of 30% over the previous quarterly rate of $0.1675 per share.
Cash received for stock issued under employee stock plans decreased by $89 million, from $201
million in the first quarter of 2007 to $112 million in the first quarter of 2008, primarily due to
a decrease in stock option exercises. Also, realized excess tax benefits of $25 million,
principally associated with stock option exercises, were presented as an inflow within the
financing section of the statement of cash flows in the first quarter of 2007. No income tax
benefits were realized from stock-based compensation during the first quarter of 2008 due to the
companys U.S. net operating loss position. Refer to Note 6 for further information.
Stock repurchases totaled $545 million in the first quarter of 2008 as compared to $270 million in
the prior year quarter. 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 $2.0 billion
of the companys common stock. In March 2008, the board of directors authorized the repurchase of
up to an additional $2.0 billion of the companys common stock. At March 31, 2008, $2.6 billion
remained available under the March 2007 and March 2008 authorizations.
CREDIT FACILITIES AND ACCESS TO CAPITAL
Refer to the 2007 Annual Report for further discussion of the companys credit facilities and
access to capital.
Credit facilities
The company had $1.7 billion of cash and equivalents at March 31, 2008. The companys primary
revolving credit facility has a maximum capacity of $1.5 billion and matures in December 2011. The
company also maintains a credit facility denominated in Euros with a maximum capacity of
approximately $475 million at March 31, 2008. This facility, which matures in January 2013,
replaced the previous Euro-denominated facility, which matured in January 2008. The companys
facilities enable the company to borrow funds on an unsecured basis at variable interest rates, and
contain various covenants, including a maximum net-debt-to-capital ratio. At March 31, 2008, the
company was in compliance with the financial covenants in these agreements. There were no
borrowings outstanding under either of the two outstanding facilities at March 31, 2008.
24
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. There were
no changes in the companys debt ratings in the first quarter of 2008.
The companys ability to generate cash flows from operations, issue debt or enter into other
financing arrangements 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 7 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 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. Following a number of Class I recalls (recalls at the
highest priority level for the U.S. Food and Drug Administration (FDA)) relating to the performance of the pumps, as well as the seizure
litigation described in Note 7, the company entered into a Consent Decree in June 2006 outlining
the steps the company must take to resume sales of new pumps in the United States. Additional
Class I recalls related to remediation and repair and maintenance activities were addressed by the
company in 2007. The Consent Decree provides for reviews of the companys facilities, processes
and controls by the companys outside expert, followed by the FDA. In December 2007, following the
outside experts review the FDA inspected and remains in a dialogue with the company with respect
to observations from its inspection as well as the validation of modifications to the pump required
to be completed in order to secure approval for recommercialization.
As previously disclosed, the company received a Warning Letter from the FDA in March 2005 regarding
observations, primarily related to dialysis equipment, that arose from the 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.
In the first quarter of 2008, the company identified an increasing level of severe allergic-type
and hypotensive adverse reactions occurring in patients using its heparin sodium injection products
in the United States. The company initiated a field corrective action with respect to the
products; however, due to users needs for the products, the company and the FDA concluded that
public health considerations warranted permitting selected dosages of the products to remain in
distribution for use where medically necessary until alternate sources became available in the
quarter, at which time the companys products were removed from distribution.
While the company continues to work to resolve the issues described above, there can be no
assurance that additional costs or civil and criminal penalties will not be incurred, that
additional regulatory actions with respect to the company will not occur, that the company will not
face civil claims for damages from purchasers or users, that substantial additional charges or
significant asset impairments may not be required, that sales of any other product may not be
adversely affected, or that additional legislation or regulation will not be introduced that may
adversely affect the companys operations. Please see Item 1A. Risk Factors in the companys
Form 10-K for the year ended December 31, 2007 for additional discussion of regulatory matters.
25
NEW ACCOUNTING STANDARDS
SFAS No. 161
In March 2008, the Financial Accounting Standards Board (FASB) issued Statement of Financial
Accounting Standards (SFAS) No. 161, Disclosures about Derivative Instruments and Hedging
Activities, an amendment of FASB Statement No. 133 (SFAS No. 161). The standard expands the
disclosure requirements of SFAS No. 133, Accounting for Derivative Instruments and Hedging
Activities, and requires qualitative disclosures about the objectives and strategies for using
derivatives, quantitative disclosures about the fair value amounts of and gains and losses on
derivative instruments, and disclosures about credit-risk-related contingent features in
derivative agreements. The company is in the process of analyzing this new standard, which will be
effective for the company in the first quarter of 2009.
SFAS No. 160
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated Financial
Statements, an amendment of ARB No. 51 (SFAS No. 160). The new standard changes the accounting
and reporting of noncontrolling interests, which have historically been referred to as minority
interests. SFAS No. 160 requires that noncontrolling interests be presented in the consolidated
balance sheets within shareholders equity, but separate from the parents equity, and that the
amount of consolidated net income attributable to the parent and to the noncontrolling interest be
clearly identified and presented in the consolidated statements of income. Any losses in excess of
the noncontrolling interests equity interest will continue to be allocated to the noncontrolling
interest. Purchases or sales of equity interests that do not result in a change of control will be
accounted for as equity transactions. Upon a loss of control, the interest sold, as well as any
interest retained, will be measured at fair value, with any gain or loss recognized in earnings.
In partial acquisitions, when control is obtained, the acquiring company will recognize at fair
value, 100% of the assets and liabilities, including goodwill, as if the entire target company had
been acquired. SFAS No. 160 is effective for fiscal years, and interim periods within those fiscal
years, beginning on or after December 15, 2008, with early adoption prohibited. The new standard
will be applied prospectively, except for the presentation and disclosure requirements, which will
be applied retrospectively for all periods presented. The company is in the process of analyzing
the standard, which will be adopted by the company at the beginning of 2009.
SFAS No. 141-R
In December 2007, the FASB issued SFAS No. 141 (revised 2007), Business Combinations (SFAS No.
141-R). The new standard changes the accounting for business combinations in a number of
significant respects. The key changes include the expansion of transactions that will qualify as
business combinations, the capitalization of in-process research and development as an
indefinite-lived asset, the recognition of certain acquired contingent assets and liabilities at
fair value, the expensing of acquisition costs, the expensing of costs associated with
restructuring the acquired company, the recognition of contingent consideration at fair value on
the acquisition date, and the recognition of post-acquisition date changes in deferred tax asset
valuation allowances and acquired income tax uncertainties as income tax expense or benefit. SFAS
No. 141-R is effective for business combinations that close in years beginning on or after
December 15, 2008, with early adoption prohibited. The company is in the process of analyzing
this new standard, which will be adopted by the company at the beginning of 2009.
SFAS No. 157
In September 2006, the FASB issued 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.
In February 2008, FASB Staff Position (FSP) FAS No. 157-2, Effective Date of FASB Statement No.
157 (FSP No. 157-2) was issued. FSP No. 157-2 defers the effective date of SFAS No. 157 to
fiscal years beginning after December 15, 2008, and interim periods within those fiscal years, for
all nonfinancial assets and liabilities, except those that are recognized or disclosed at fair
value in the financial statements on a recurring basis (at least annually). Examples of items
within the scope of FSP No. 157-2 are nonfinancial assets and nonfinancial liabilities initially
measured at fair value in a business combination (but not measured at fair value in subsequent
periods), and long-lived assets, such as property, plant and equipment and intangible assets
measured at fair value for an impairment assessment under SFAS No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets.
The partial adoption of SFAS No. 157 on January 1, 2008 with respect to financial assets and
financial liabilities recognized or disclosed at fair value in the financial statements on a
recurring basis did not have a material impact
26
on the companys consolidated financial statements. See Note 5 for the fair value measurement
disclosures for these assets and liabilities. The company is in the process of analyzing the
potential impact of SFAS No. 157 relating to its planned January 1, 2009 adoption of the remainder
of the standard.
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, the adequacy of credit facilities, estimates of liabilities,
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 2008,
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
IGIV, and other therapies; |
|
|
|
|
the companys ability to identify business development and growth opportunities for
existing products and to exit low-margin businesses or products; |
|
|
|
|
product quality or patient safety issues, leading to product recalls, withdrawals,
launch delays, sanctions, seizures, litigation, or declining sales, including with respect
to the companys heparin products; |
|
|
|
|
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 into with the FDA concerning the COLLEAGUE and
SYNDEO pumps; |
|
|
|
|
fluctuations in the balance between supply and demand with respect to the market for
plasma protein products; |
|
|
|
|
reimbursement policies of government agencies and private payers; |
|
|
|
|
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; |
|
|
|
|
the availability of acceptable raw materials and component supply; |
|
|
|
|
global regulatory, trade and tax policies; |
|
|
|
|
actions by tax authorities in connection with ongoing tax audits; |
|
|
|
|
the companys ability to realize the anticipated benefits of restructuring initiatives; |
|
|
|
|
continued developments in the market for transfusion therapies products and Fenwals
ability to execute with respect to the acquired business; |
|
|
|
|
foreign currency fluctuations; |
|
|
|
|
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, 2007, all of which are
available 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.
27
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Currency Risk
The company uses derivative instruments to hedge the foreign currency risk to earnings relating to
certain firm commitments, forecasted transactions, intercompany and third-party receivables,
payables and debt denominated in foreign currencies. The company has also historically hedged
certain of its net investments in international affiliates, using a combination of debt denominated
in foreign currencies and cross-currency swap agreements. Gains and losses on the hedging
instruments offset losses and gains on the hedged transactions and reduce earnings and
shareholders equity volatility relating to foreign currency fluctuations. Refer to the caption
Financial Instrument Market Risk in the companys 2007 Annual Report for further information.
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 hedge contracts outstanding
at March 31, 2008, 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 $79 million, which principally related to a hedge of U.S. Dollar-denominated debt issued
by a foreign subsidiary, would increase by $67 million.
With respect to the companys net investment hedges, if the U.S. Dollar uniformly weakened by 10%,
on a net-of-tax basis, the liability balance of $288 million with respect to those contracts
outstanding at March 31, 2008 would increase by $74 million. Any increase or decrease in the fair
value of the net investment hedge contracts is almost entirely offset by the change in the value of
the hedged net assets.
The sensitivity analysis model recalculates the fair value of the foreign currency option, forward
and cross-currency swap contracts outstanding at March 31, 2008 by replacing the actual exchange
rates at March 31, 2008 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 2007 Annual Report. There
were no significant changes during the quarter ended March 31, 2008.
28
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 March 31, 2008. 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 March 31, 2008.
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 March 31,
2008 that has materially affected, or is reasonably likely to materially affect, Baxters internal
control over financial reporting.
29
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 months ended March 31, 2008 and 2007 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.
30
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 March 31, 2008, and the related condensed consolidated statements of
income and cash flows for each of the three-month periods ended March 31, 2008 and 2007. 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, 2007, 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 26, 2008, 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, 2007, is fairly stated in all material
respects in relation to the consolidated balance sheet from which it has been derived.
/s/ PricewaterhouseCoopers LLP
PricewaterhouseCoopers LLP
Chicago, Illinois
May 2, 2008
31
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
The information in Part I, Item 1, Note 7 is incorporated herein by reference.
32
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 March 31, 2008.
Issuer Purchases of Equity Securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Approximate Dollar Value of |
|
|
|
Total Number |
|
|
|
|
|
|
Total Number of Shares |
|
|
Shares that May Yet Be |
|
|
|
of Shares |
|
|
Average Price |
|
|
Purchased as Part of Publicly |
|
|
Purchased Under the |
|
Period |
|
Purchased (1) |
|
|
Paid per Share |
|
|
Announced Program (1) |
|
|
Programs (1)(2) |
|
|
|
January 1, 2008
through January 31, 2008 |
|
|
1,197,391 |
|
|
|
$62.64 |
|
|
|
1,197,391 |
|
|
|
|
|
February 1, 2008
through February 29, 2008 |
|
|
3,857,304 |
|
|
|
$60.48 |
|
|
|
3,857,304 |
|
|
|
|
|
March 1, 2008
through March 31, 2008 |
|
|
4,091,258 |
|
|
|
$57.69 |
|
|
|
4,091,258 |
|
|
|
|
|
|
|
|
|
|
9,145,953 |
|
|
|
$59.51 |
|
|
|
9,145,953 |
|
|
|
$2,606,963,542 |
|
|
|
|
|
(1) |
|
In March 2007, the company announced that its board of directors authorized the company to
repurchase up to $2.0 billion of its common stock on the open market. During the first
quarter of 2008, the company repurchased 9.1 million shares for $545 million under this
program, and the remaining authorization totaled $607 million at March 31, 2008. This program
does not have an expiration date. |
|
(2) |
|
In March 2008, the company announced that its board of directors authorized the company to
repurchase up to an additional $2.0 billion of its common stock on the open market. No
repurchases have been made under this authorization. This program does not have an expiration
date. |
33
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 |
34
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: May 2, 2008
|
|
By:
|
|
/s/ Robert M. Davis |
|
|
|
|
|
|
|
|
|
|
|
|
|
Robert M. Davis |
|
|
|
|
|
|
Corporate Vice President and Chief Financial Officer |
|
|
|
|
|
|
(duly authorized officer and principal financial officer) |
|
|
35