10-Q
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2009
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 1-4448
BAXTER INTERNATIONAL INC.
(Exact name of registrant as specified in its charter)
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Delaware
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36-0781620 |
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(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
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One Baxter Parkway, Deerfield, Illinois
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60015-4633 |
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(Address of principal executive offices)
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(Zip Code) |
847-948-2000
(Registrants telephone number,
including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files).
Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
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Large accelerated filer þ |
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Accelerated filer o |
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Non-accelerated filer o (Do not check if a smaller reporting company) |
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Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
The number of shares of the registrants Common Stock, par value $1.00 per share, outstanding as of
April 30, 2009 was 605,024,157 shares.
BAXTER INTERNATIONAL INC.
FORM 10-Q
For the quarterly period ended March 31, 2009
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Baxter International Inc.
Condensed Consolidated Statements of Income (unaudited)
(in millions, except per share data)
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Three months ended |
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March 31, |
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2009 |
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2008 |
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Net sales |
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$ |
2,824 |
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$ |
2,877 |
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Cost of sales |
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1,336 |
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1,497 |
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Gross margin |
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1,488 |
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1,380 |
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Marketing and administrative expenses |
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611 |
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640 |
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Research and development expenses |
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212 |
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190 |
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Net interest expense |
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26 |
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17 |
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Other expense (income), net |
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2 |
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(4 |
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Income before income taxes |
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637 |
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537 |
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Income tax expense |
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119 |
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105 |
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Net income |
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518 |
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432 |
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Less: Noncontrolling interests |
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2 |
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3 |
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Net income attributable to Baxter International Inc. (Baxter) |
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$ | 516 |
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$ | 429 |
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Net income attributable to Baxter per common share |
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Basic |
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$ | 0.84 |
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$ | 0.68 |
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Diluted |
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$ | 0.83 |
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$ | 0.67 |
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Weighted-average number of common shares outstanding |
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Basic |
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613 |
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632 |
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Diluted |
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621 |
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644 |
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Cash dividends declared per common share |
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$ | 0.260 |
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$ | 0.218 |
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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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2009 |
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2008 |
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Current assets |
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Cash and equivalents |
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$ | 1,703 |
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$ | 2,131 |
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Accounts and other current receivables |
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1,940 |
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1,980 |
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Inventories |
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2,421 |
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2,361 |
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Prepaid expenses and other |
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626 |
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676 |
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Total current assets |
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6,690 |
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7,148 |
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Property, plant and equipment, net |
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4,598 |
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4,609 |
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Other assets |
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Goodwill |
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1,642 |
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1,654 |
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Other intangible assets, net |
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401 |
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390 |
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Other |
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1,622 |
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1,604 |
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Total other assets |
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3,665 |
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3,648 |
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Total assets |
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$ | 14,953 |
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$ | 15,405 |
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Current liabilities |
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Short-term debt |
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$ | 230 |
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$ | 388 |
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Current maturities of long-term debt and
lease obligations |
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5 |
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6 |
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Accounts payable and accrued liabilities |
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2,887 |
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3,241 |
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Total current liabilities |
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3,122 |
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3,635 |
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Long-term debt and lease obligations |
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3,675 |
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3,362 |
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Other long-term liabilities |
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1,998 |
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2,117 |
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Commitments and contingencies |
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Equity |
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Common stock, $1 par value, authorized
2,000,000,000 shares, issued 683,494,944 shares
in 2009 and 2008 |
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683 |
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683 |
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Common stock in treasury, at cost,
75,799,962 shares in 2009 and 67,501,988 shares in 2008 |
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(4,379 |
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(3,897 |
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Additional contributed capital |
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5,620 |
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5,533 |
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Retained earnings |
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6,152 |
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5,795 |
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Accumulated other comprehensive loss |
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(1,977 |
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(1,885 |
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Total Baxter shareholders equity |
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6,099 |
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6,229 |
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Noncontrolling interests |
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59 |
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62 |
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Total equity |
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6,158 |
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6,291 |
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Total liabilities and equity |
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$ | 14,953 |
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$ | 15,405 |
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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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2009 |
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2008 |
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Cash flows from operations |
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Net income |
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$ | 518 |
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$ | 432 |
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Adjustments |
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Depreciation and amortization |
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148 |
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156 |
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Deferred income taxes |
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59 |
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61 |
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Stock compensation |
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38 |
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38 |
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Realized excess tax benefits from
stock issued under employee benefit plans |
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(78 |
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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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6 |
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Changes in balance sheet items |
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Accounts and other current receivables |
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45 |
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18 |
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Inventories |
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(86 |
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(105 |
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Accounts payable and accrued liabilities |
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(304 |
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(341 |
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Restructuring payments |
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(21 |
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(12 |
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Other |
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(91 |
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56 |
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Cash flows from operations |
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237 |
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362 |
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Cash flows from investing activities |
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Capital expenditures |
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(171 |
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(157 |
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Acquisitions of and investments in businesses
and technologies |
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(61 |
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Other |
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(25 |
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29 |
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Cash flows from investing activities |
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(196 |
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(189 |
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Cash flows from financing activities |
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Issuances of debt |
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358 |
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4 |
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Payments of obligations |
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(164 |
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(459 |
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Cash dividends on common stock |
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(160 |
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(138 |
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Proceeds and realized excess tax benefits from
stock issued under employee benefit plans |
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139 |
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112 |
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Purchases of treasury stock |
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(566 |
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(545 |
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Cash flows from financing activities |
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(393 |
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(1,026 |
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Effect of currency exchange rate changes on cash and equivalents |
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(76 |
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50 |
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Decrease in cash and equivalents |
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(428 |
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(803 |
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Cash and equivalents at beginning of period |
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2,131 |
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2,539 |
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Cash and equivalents at end of period |
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$ | 1,703 |
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$ | 1,736 |
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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) in the United States 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 2008 Annual Report to
Shareholders (2008 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 standard
SFAS No. 160
On January 1, 2009, the company adopted Statement of Financial Accounting Standards (SFAS) No. 160,
Noncontrolling Interests in Consolidated Financial Statements, an amendment of ARB No. 51 (SFAS
No. 160). The new standard changed 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 equity, but
separate from Baxter shareholders equity, and that the amount of consolidated net income
attributable to Baxter and to the noncontrolling interests 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, Baxter recognizes, at fair value, 100% of the assets and
liabilities, including goodwill, as if the entire target company had been acquired. The new
standard has been applied prospectively as of January 1, 2009, except for the presentation and
disclosure requirements, which have been applied retrospectively for prior periods presented.
Prior to the adoption of SFAS No. 160, the noncontrolling interests share of net income was
included in other expense (income), net in the consolidated statement of income and the
noncontrolling interests equity was included in other long-term liabilities in the consolidated
balance sheet.
Issued but not yet effective accounting standard
FSP FAS No. 132(R)-1
In December 2008, the Financial Accounting Standards Board (FASB) issued FASB Staff Position (FSP)
FAS No. 132(R)-1, Employers Disclosures about Postretirement Benefit Plan Assets (FSP FAS No.
132(R)-1). This FSP expands the disclosure requirements relating to pension and other
postretirement benefits to require enhanced disclosures about how investment allocation decisions
are made and the investment policies and strategies that support those decisions, major categories
of plan assets, the input and valuation techniques used in measuring plan assets at fair value, and
significant concentrations of credit risk within plan assets. The company will include the
disclosures required by this standard beginning with its 2009 year-end consolidated financial
statements.
Reclassifications
Certain reclassifications have been made to conform prior period consolidated financial statements
and notes to the current period presentation, including reclassifications related to the companys
adoption of SFAS No. 160.
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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2009 |
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2008 |
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Pension benefits |
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Service cost |
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$ | 21 |
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$ | 21 |
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Interest cost |
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54 |
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51 |
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Expected return on plan assets |
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(62 |
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(58 |
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Amortization of net losses and other deferred amounts |
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25 |
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20 |
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Net pension plan expense |
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$ | 38 |
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$ | 34 |
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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 |
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Amortization of net losses and other deferred amounts |
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(1 |
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Net OPEB plan expense |
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$ | 8 |
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$ | 9 |
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Net interest expense
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Three months ended |
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March 31, |
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(in millions) |
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2009 |
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2008 |
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Interest expense, net of capitalized interest |
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$ | 31 |
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$ | 37 |
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Interest income |
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(5 |
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(20 |
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Net interest expense |
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$ | 26 |
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$ | 17 |
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Comprehensive income
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Three months ended |
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March 31, |
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(in millions) |
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2009 |
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2008 |
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Comprehensive income |
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$ | 422 |
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$ | 616 |
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Less: Comprehensive loss attributable to noncontrolling interests |
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(2 |
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(4 |
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Comprehensive income attributable to Baxter |
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$ | 424 |
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$ | 620 |
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The decrease in comprehensive income attributable to Baxter was principally due to unfavorable
movements in currency translation adjustments.
Effective tax rate
The companys effective income tax rate was 18.7% and 19.6% in the first quarters of 2009
and 2008, respectively. The effective tax rate in the first quarter of 2008 was higher due to a
lower tax rate associated with the COLLEAGUE infusion pump charge recorded in that period. Refer
to Note 3 for further information on the COLLEAGUE charge.
Earnings per share
The numerator for both basic and diluted earnings per share (EPS) is net income attributable to
Baxter. 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 and restricted stock units is reflected in the denominator for diluted EPS using the treasury
stock method.
The computation of diluted EPS excludes employee stock options to purchase 17 million and 8 million
shares for the first quarters of 2009 and 2008, respectively, 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.
6
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Three months ended |
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March 31, |
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(in millions) |
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2009 |
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2008 |
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Basic shares |
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613 |
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632 |
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Effect of employee stock options and other dilutive securities |
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8 |
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12 |
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Diluted shares |
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621 |
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644 |
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Inventories
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March 31, |
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December 31, |
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(in millions) |
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2009 |
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2008 |
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Raw materials |
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$ | 647 |
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$ | 600 |
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Work in process |
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722 |
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737 |
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Finished goods |
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1,052 |
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|
1,024 |
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Inventories |
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$ | 2,421 |
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$ | 2,361 |
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Property, plant and equipment, net
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March 31, |
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December 31, |
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(in millions) |
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2009 |
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2008 |
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Property, plant and equipment, at cost |
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$ | 9,068 |
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$ | 9,021 |
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Accumulated depreciation and amortization |
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(4,470 |
) |
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(4,412 |
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Property, plant and equipment, net |
|
$ |
4,598 |
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$ |
4,609 |
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Goodwill
The following is a summary of the activity in goodwill by business segment.
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Medication |
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(in millions) |
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BioScience |
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Delivery |
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Renal |
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Total |
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Balance as of December 31, 2008 |
|
$ | 585 |
|
|
$ | 917 |
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|
$ | 152 |
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$ | 1,654 |
|
Cumulative translation adjustment |
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(3 |
) |
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(6 |
) |
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(3 |
) |
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(12 |
) |
|
Balance as of March 31, 2009 |
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$ | 582 |
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|
$ | 911 |
|
|
$ | 149 |
|
|
$ | 1,642 |
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As of March 31, 2009, the company has recorded no goodwill impairment losses since its adoption of
SFAS No. 142, Goodwill and Other Intangible Assets.
Other intangible assets, net
The following is a summary of the companys intangible assets subject to amortization at March 31,
2009 and December 31, 2008.
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Developed |
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technology, |
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(in millions) |
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including patents |
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Other |
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Total |
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March 31, 2009 |
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Gross other intangible assets |
|
$ | 806 |
|
|
$ | 108 |
|
|
$ | 914 |
|
Accumulated amortization |
|
|
(457 |
) |
|
|
(63 |
) |
|
|
(520 |
) |
|
Other intangible assets, net |
|
$ | 349 |
|
|
$ | 45 |
|
|
$ | 394 |
|
|
December 31, 2008 |
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|
|
|
|
|
Gross other intangible assets |
|
$ | 777 |
|
|
$ | 117 |
|
|
$ | 894 |
|
Accumulated amortization |
|
|
(444 |
) |
|
|
(67 |
) |
|
|
(511 |
) |
|
Other intangible assets, net |
|
$ | 333 |
|
|
$ | 50 |
|
|
$ | 383 |
|
|
The amortization expense for these intangible assets was $12 million and $13 million for the three
months ended March 31, 2009 and 2008, respectively. The anticipated annual amortization expense
for intangible assets recorded
7
as of March 31, 2009 is $50 million in 2009, $49 million in 2010, $44 million in 2011, $41 million
in 2012, $38 million in 2013 and $34 million in 2014.
Collaborative arrangements
On January 1, 2009, the company adopted Emerging Issues Task Force Issue No. 07-1, Accounting for
Collaborative Arrangements (EITF No. 07-1). EITF No. 07-1 was required to be applied
retrospectively to all periods presented for all collaborative arrangements existing as of the
effective date. The adoption of EITF No. 07-1 did not result in a change to the companys
historical consolidated financial statements.
In the normal course of business, and as part of the execution of the companys strategy to achieve
sustainable growth and deliver shareholder value, Baxter enters into collaborative arrangements
with third parties. Certain of these collaborative arrangements include joint operating activities
involving active participation by both partners, where both Baxter and the other entity are exposed
to risks and rewards dependent on the commercial success of the activity. These collaborative
arrangements exist in all three of the companys segments, take a number of forms and structures,
principally pertain to the joint development and commercialization of new products, and are
designed to enhance and expedite long-term sales and profitability growth.
The collaborative arrangements can broadly be grouped into two categories, those relating to new
product development, and those relating to existing commercial products.
New Product Development Arrangements
The companys joint new product development and commercialization arrangements generally provide
that Baxter license certain rights to manufacture, market or distribute a specified technology or
product under development. Baxters consideration for the rights generally consists of some
combination of up-front payments, ongoing research and development (R&D) cost reimbursements,
royalties, and contingent payments relating to the achievement of specified pre-clinical, clinical,
regulatory approval or sales milestones. Joint steering committees often exist to manage the
various stages and activities of the arrangement. Control over the R&D activities may be shared or
may be performed by Baxter. Baxter generally controls the commercialization phase, sometimes
purchasing raw materials from the collaboration partner.
During the development phase, Baxters R&D costs are expensed as incurred. These costs may include
R&D cost reimbursements to the partner, as well as up-front and milestone payments to the partner
prior to the date the product receives regulatory approval. Milestone payments made to the partner
subsequent to regulatory approval are capitalized as intangible assets and amortized to cost of
sales over the useful life of the related asset. Royalty payments are expensed as cost of sales
when they become due and payable. Any purchases of raw materials from the partner during the
development stage are expensed as R&D, while such purchases during the commercialization phase are
capitalized as inventory and recognized as cost of sales when the related finished products are
sold. Baxter generally records the amount invoiced to the third-party customer for the finished
product as sales, as Baxter is the principal and primary obligor in the arrangement.
Payments to collaborative partners classified in cost of sales were not significant in the quarters
ended March 31, 2009 and March 31, 2008. Payments to collaborative partners classified in R&D
expense principally related to the BioScience segment and totaled
approximately 7% and 8%
of total R&D expense in the first quarters of 2009 and 2008, respectively. The payments
principally related to the development of tissue repair products, longer-acting forms of blood
clotting proteins to treat hemophilia and a next-generation home hemodialysis device.
Commercial Product Arrangements
The companys commercial product collaborative arrangements generally provide for a sharing of
manufacturing, marketing or distribution activities between Baxter and the partner, along with a
sharing of the related profits. The nature and split of the shared activities varies, sometimes
split by type of activity and sometimes split by geographic area.
The entity that invoices the third-party customer is generally the principal and primary obligor in
the arrangement and therefore records the invoiced amount as a sale. Cost-sharing payments are
generally recorded in cost of sales. Baxters payments to partners under these types of
arrangements totaled less than 1% of total cost of sales in both the first quarter of 2009 and
the first quarter of 2008.
8
3. RESTRUCTURING AND OTHER CHARGES
Restructuring charges
The company recorded restructuring charges of $70 million and $543 million in 2007 and 2004,
respectively. The 2007 charge was principally associated with the consolidation of certain
commercial and manufacturing operations outside of the United States. The 2004 charge was
principally associated with managements decision to implement actions to reduce the companys
overall cost structure and to drive sustainable improvements in financial performance. Refer to
Note 5 to the companys consolidated financial statements in the 2008 Annual Report for additional
information about these charges.
Included in the 2007 and 2004 restructuring charges were $53 million and $347 million of cash
costs, respectively. The following table summarizes the current year cash activity and outstanding
reserves related to the companys 2007 and 2004 restructuring charges.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee- |
|
|
Contractual |
|
|
|
|
|
|
|
related |
|
|
and other |
|
|
|
|
|
(in millions) |
|
costs |
|
|
costs |
|
|
Total |
|
|
Reserves at December 31, 2008 |
|
$ | 25 |
|
|
$ | 14 |
|
|
$ | 39 |
|
Utilization |
|
|
(15 |
) |
|
|
(3 |
) |
|
|
(18 |
) |
|
Reserves at March 31, 2009 |
|
$ | 10 |
|
|
$ | 11 |
|
|
$ | 21 |
|
|
The 2007 and 2004 reserves are expected to be substantially utilized by the end of 2009. The
company believes that the reserves are adequate. However, adjustments may be recorded in the
future as the programs are completed.
Transfusion Therapies
During 2007, the company divested substantially all of the assets and liabilities of its
Transfusion Therapies (TT) business. In connection with the TT divestiture, the company recorded a
$35 million charge principally associated with severance and other employee-related costs. Reserve
utilization through March 31, 2009 was $15 million. The reserve is expected to be substantially
utilized by the end of 2009. The company believes that the reserve is adequate, however,
adjustments may be recorded in the future as the transition is completed. Refer to Note 3 to the
companys consolidated financial statements in the 2008 Annual Report for further information
regarding the TT divestiture.
Other charges
The COLLEAGUE and SYNDEO infusion pump and heparin charges discussed below were classified in cost
of sales in the companys consolidated statements of income, and were included in the Medication
Delivery segments pre-tax income.
With respect to COLLEAGUE, the company remains in active dialogue with the U.S. Food and Drug
Administration (FDA) about various matters, including the companys remediation plan and reviews of
the companys facilities, processes and quality controls by the companys outside expert pursuant
to the requirements of the companys Consent Decree. The outcome of these discussions with the FDA
is uncertain and may impact the nature and timing of the companys actions and decisions with
respect to the COLLEAGUE pump. The companys estimates of the costs related to these matters are
based on the current remediation plan and information currently available. It is possible that
additional charges related to COLLEAGUE may be required in future periods, based on new
information, changes in estimates, and modifications to the current remediation plan as a result of
ongoing dialogue with the FDA.
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,
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.
9
COLLEAGUE and SYNDEO 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. Refer to the Certain Regulatory Matters section below
and Note 5 to the companys consolidated financial statements in the 2008 Annual Report for further
information on COLLEAGUE and SYNDEO infusion pumps.
In 2008, the company recorded charges totaling $125 million ($53 million in the first quarter and
$72 million in the third quarter) related to issues associated with its COLLEAGUE infusion pumps.
From 2005 through 2007, the company recorded charges and other costs totaling $185 million related
to its COLLEAGUE and SYNDEO infusion pumps. In aggregate, these charges included $256 million of
cash costs and $54 million principally related to asset impairments. The reserves for cash costs
related to customer accommodations, estimated expenditures for the materials, labor and freight
costs expected to be incurred to remediate the design issues, additional warranty and other
commitments made to customers.
The following table summarizes cash activity in the companys COLLEAGUE and SYNDEO infusion pump
reserves through March 31, 2009.
|
|
|
|
|
(in millions) |
|
|
|
|
|
Charges in 2005 through 2008 |
|
$ | 256 |
|
Utilization in 2005 through 2008 |
|
|
(141 |
) |
|
Reserves at December 31, 2008 |
|
|
115 |
|
Utilization |
|
|
(8 |
) |
|
Reserves at March 31, 2009 |
|
$ | 107 |
|
|
The remaining infusion pump reserves are expected to be substantially utilized by 2010.
Heparin
In 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 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. The charge principally related to asset
impairments. The reserve established for cash costs has been substantially utilized.
4. DEBT, FINANCIAL INSTRUMENTS AND RELATED FAIR VALUE MEASUREMENTS
Significant debt issuances and redemptions
In February 2009, the company issued $350 million of senior unsecured notes, maturing in March 2014
and bearing a 4.0% coupon rate. The net proceeds were used for general corporate purposes,
including the repayment of approximately $160 million of outstanding borrowings related to the
companys Euro-denominated credit facility. There were no borrowings outstanding under the
companys primary revolving or Euro-denominated credit facilities as of March 31, 2009. In
addition, during the first quarter of 2009, the company issued and redeemed commercial paper, of
which $200 million was outstanding as of March 31, 2009, with a weighted-average interest rate of
0.38%.
Securitization arrangements
The companys securitization arrangements resulted in net cash outflows of $19 million and $16
million for the three months ended March 31, 2009 and 2008, respectively. A summary of the
activity is as follows.
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
(in millions) |
|
2009 |
|
|
2008 |
|
|
Sold receivables at beginning of period |
|
$ | 154 |
|
|
$ | 129 |
|
Proceeds from sales of receivables |
|
|
124 |
|
|
|
104 |
|
Cash collections (remitted to the owners of the receivables) |
|
|
(143 |
) |
|
|
(120 |
) |
Effect of currency exchange rate changes |
|
|
(8 |
) |
|
|
16 |
|
|
Sold receivables at end of period |
|
$ | 127 |
|
|
$ | 129 |
|
|
10
Derivatives and hedging activities
The company operates on a global basis and is exposed to the risk that its earnings, cash flows and
equity could be adversely impacted by fluctuations in foreign exchange and interest rates. The
companys hedging policy attempts to manage these risks to an acceptable level based on the
companys judgment of the appropriate trade-off between risk, opportunity and costs.
The company is primarily exposed to foreign exchange risk with respect to recognized assets and
liabilities, forecasted transactions and net assets denominated in the Euro, Japanese Yen, British
Pound, Australian Dollar, Canadian Dollar and certain Latin American currencies. The company
manages its foreign currency exposures on a consolidated basis, which allows the company to net
exposures and take advantage of any natural offsets. In addition, the company uses derivative and
nonderivative instruments to further reduce the net exposure to foreign exchange. Gains and losses
on the hedging instruments offset losses and gains on the hedged transactions and reduce the
earnings and equity volatility resulting from foreign exchange. The recent financial market and
currency volatility may reduce the benefits of the companys natural hedges and limit the companys
ability to cost-effectively hedge these exposures.
The company is also exposed to the risk that its earnings and cash flows could be adversely
impacted by fluctuations in interest rates. The companys policy is to manage interest costs using
a mix of fixed- and floating-rate debt that the company believes is appropriate. To manage this
mix in a cost-efficient manner, the company periodically enters into interest rate swaps in which
the company agrees to exchange, at specified intervals, the difference between fixed and floating
interest amounts calculated by reference to an agreed-upon notional amount.
The company does not hold any instruments for trading purposes and none of the companys
outstanding derivative instruments contain credit-risk-related contingent features.
All derivative instruments subject to SFAS No. 133, Accounting for Derivative Instruments and
Hedging Activities (SFAS No. 133) and its amendments are recognized as either assets or
liabilities at fair value in the consolidated balance sheets and are classified as short-term or
long-term based on the scheduled maturity of the instrument. Based upon the exposure being hedged,
the company designates its hedging instruments as cash flow or fair value hedges.
Cash Flow Hedges
The company uses options, including collars and purchased options, forwards and cross-currency
swaps to hedge the foreign exchange risk to earnings relating to forecasted transactions
denominated in foreign currencies and recognized assets and liabilities. The company periodically
uses forward-starting interest rate swaps and treasury rate locks to hedge the risk to earnings
associated with movements in interest rates relating to anticipated issuances of debt. Certain
other firm commitments and forecasted transactions are also periodically hedged. Cash flow hedges
primarily relate to forecasted intercompany sales denominated in foreign currencies, a hedge of
U.S. Dollar-denominated debt issued by a foreign subsidiary and anticipated issuances of debt.
For each derivative instrument that is designated and effective as a cash flow hedge, the gain or
loss on the derivative is accumulated in accumulated other comprehensive income (AOCI), a component
of equity, and then recognized in earnings consistent with the underlying hedged item. Option
premiums or net premiums paid are initially recorded as assets and reclassified to other
comprehensive income (OCI) over the life of the option, and then recognized in earnings consistent
with the underlying hedged item.
The notional amounts of foreign exchange contracts, interest rate contracts and cross-currency
swaps (used to hedge U.S. Dollar-denominated debt issued by a foreign subsidiary) were $1.9
billion, $700 million and $500 million, respectively, as of March 31, 2009.
As of March 31, 2009, $43 million of deferred, net after-tax gains on derivative instruments
included in AOCI are expected to be recognized in earnings during the next 12 months, coinciding
with when the hedged items are expected to impact earnings.
The maximum term over which the company has cash flow hedge contracts in place related to
forecasted transactions at March 31, 2009 is 15 months.
Fair Value Hedges
The company uses interest rate swaps to convert a portion of its fixed-rate debt into variable-rate
debt. These instruments hedge the companys earnings from changes in the fair value of debt due to
fluctuations in the
11
designated benchmark interest rate. For each derivative instrument that is
designated and effective as a fair value hedge, the gain or loss on the derivative is recognized
immediately to earnings, and offsets the gain or loss on the underlying hedged item.
The total notional amount of interest rate contracts designated as fair value hedges was $1.2
billion as of March 31, 2009.
Dedesignations
If it is determined that a derivative or nonderivative hedging instrument is no longer highly
effective as a hedge, the company discontinues hedge accounting prospectively. If the company
removes the cash flow hedge designation because the hedged forecasted transactions are no longer
probable of occurring, any gains or losses are immediately reclassified from AOCI to earnings.
Gains or losses relating to terminations of effective cash flow hedges in which the forecasted
transactions are still probable of occurring are deferred and recognized consistent with the income
or loss recognition of the underlying hedged items. If the company terminates a fair value hedge,
an amount equal to the cumulative fair value adjustment to the hedged items at the date of
termination is amortized to earnings over the remaining term of the hedged item.
Undesignated Derivative Instruments
The company uses forward contracts to hedge earnings from the effects of foreign exchange relating
to certain of the companys intercompany and third-party receivables and payables denominated in a
foreign currency. These derivative instruments are generally not formally designated as hedges,
and the change in fair value of the instruments, which substantially offsets the change in book
value of the hedged items, is recorded directly to other expense (income), net. Generally, the
terms of these instruments do not exceed one month.
The total notional amount of undesignated derivative instruments was $329 million as of March 31,
2009.
Gains and Losses on Derivative Instruments
The following table summarizes the locations and gains and losses on the companys derivative
instruments for the three months ended March 31, 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Gain) loss |
|
|
Location of (gain) loss in |
|
(Gain) loss reclassified |
|
|
Loss recognized |
|
(in millions) |
|
recognized in OCI |
|
|
income statement |
|
from AOCI into income |
|
|
in income |
|
|
Cash flow hedges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts |
|
$ |
(20 |
) |
|
Net interest expense |
|
$ | 1 |
|
|
|
n/a |
|
Foreign exchange contracts |
|
|
1 |
|
|
Net sales |
|
|
(2 |
) |
|
|
n/a |
|
Foreign exchange contracts |
|
|
(12 |
) |
|
Cost of sales |
|
|
(24 |
) |
|
|
n/a |
|
Foreign exchange contracts |
|
|
2 |
|
|
Other expense (income), net |
|
|
(9 |
) |
|
|
n/a |
|
|
Total |
|
$ |
(29 |
) |
|
|
|
|
|
$ |
(34 |
) |
|
|
n/a |
|
|
Fair value hedges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts |
|
|
n/a |
|
|
Net interest expense |
|
|
n/a |
|
|
$ | 17 |
|
|
Undesignated derivative instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
n/a |
|
|
Other expense (income), net |
|
|
n/a |
|
|
$ | 27 |
|
|
For the companys fair value hedges, an equal and offsetting gain of $17 million was recognized in
net interest expense as an adjustment to the underlying hedged item, fixed-rate debt.
Ineffectiveness related to the companys cash flow and fair value hedges in the three months ended
March 31, 2009 was not material.
12
Fair Values of Derivative Instruments
The following table summarizes the location and fair value amounts of derivative instruments
reported in the consolidated balance sheet as of March 31, 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives in asset positions |
|
|
Derivatives in liability positions |
(in millions) |
|
Balance sheet location |
|
Fair value |
|
|
Balance sheet location |
|
Fair value |
|
|
Derivative instruments
designated as hedges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts |
|
Other long-term assets |
|
$ | 130 |
|
|
Accounts payable and accrued liabilities |
|
$ | 30 |
|
Foreign exchange contracts |
|
Prepaid expenses and other |
|
|
102 |
|
|
Accounts payable and accrued liabilities |
|
|
12 |
|
Foreign exchange contracts |
|
Other long-term assets |
|
|
10 |
|
|
Other long-term liabilities |
|
|
55 |
|
|
Total derivative
instruments designated as
hedges |
|
|
|
|
|
$ | 242 |
|
|
|
|
|
|
$ | 97 |
|
|
Undesignated derivative
instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
Prepaid expenses and other |
|
$ | |
|
|
Accounts payable and accrued liabilities |
|
$ | |
|
|
Total derivative instruments |
|
|
|
|
|
$ | 242 |
|
|
|
|
|
|
$ | 97 |
|
|
Presentation in the Statement of Cash Flows
Derivatives, including those that are not designated as hedges under SFAS No. 133, are principally
classified in the operating section of the consolidated statements of cash flows, in the same
category as the related consolidated balance sheet account. Derivatives that include an
other-than-insignificant financing element at inception are classified in the financing section of
the consolidated statements of cash flows.
Fair value measurements
On January 1, 2009, the company completed the adoption of SFAS No. 157, Fair Value Measurements,
as it relates to nonfinancial assets and liabilities that are measured at fair value on a
nonrecurring basis. There were no fair value adjustments in the first quarter of 2009 for
nonfinancial assets or liabilities required to be measured at fair value on a nonrecurring basis.
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 consolidated 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, 2009 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
$ |
112 |
|
|
$ |
|
|
|
$ |
112 |
|
|
$ |
|
|
Interest rate contracts |
|
|
130 |
|
|
|
|
|
|
|
130 |
|
|
|
|
|
Equity securities |
|
|
12 |
|
|
|
12 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
254 |
|
|
$ |
12 |
|
|
$ |
242 |
|
|
$ |
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
$ |
67 |
|
|
$ |
|
|
|
$ |
67 |
|
|
$ |
|
|
Interest rate contracts |
|
|
30 |
|
|
|
|
|
|
|
30 |
|
|
|
|
|
|
Total liabilities |
|
$ |
97 |
|
|
$ |
|
|
|
$ |
97 |
|
|
$ |
|
|
|
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.
13
5. COMMON STOCK
Stock-based compensation plans
Stock compensation expense totaled $38 million for both the three months ended March 31, 2009 and
2008. Approximately three-quarters of stock compensation expense is classified in marketing and
administrative expenses with the remainder classified in cost of sales and R&D expenses.
In March 2009, the company awarded its annual stock compensation grants, which consisted of
approximately 6.7 million stock options and 580,000 performance share units (PSUs).
Stock Options
The weighted-average assumptions used in estimating the fair value of stock options granted during
the period, along with the weighted-average grant date fair values, were as follows.
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
|
Expected volatility |
|
|
30% |
|
|
|
24% |
|
Expected life (in years) |
|
|
4.5 |
|
|
|
4.5 |
|
Risk-free interest rate |
|
|
1.8% |
|
|
|
2.4% |
|
Dividend yield |
|
|
2.0% |
|
|
|
1.5% |
|
Fair value per stock option |
|
| $12 |
|
|
| $12 |
|
|
|
The total intrinsic value of stock options exercised during the three months ended March 31, 2009
and 2008 was $29 million and $61 million, respectively. |
|
As of March 31, 2009, $138 million of 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, |
|
|
|
2009 |
|
|
2008 |
|
|
Baxter volatility |
|
25% |
|
|
20% |
|
Peer group volatility |
|
20% - 59% |
|
|
12% - 37% |
|
Correlation of returns |
|
0.30 - 0.61 |
|
|
0.12 - 0.40 |
|
Risk-free interest rate |
|
1.6% |
|
|
1.9% |
|
Fair value per PSU |
|
| $65 |
|
|
| $64 |
|
|
As of March 31, 2009, unrecognized compensation cost related to all unvested PSUs of $64 million is
expected to be recognized as expense over a weighted-average period of 2.1 years, and unrecognized
compensation cost related to all unvested restricted stock units of $12 million is expected to be
recognized as expense over a weighted-average period of 1.8 years.
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 market conditions. During the
three-month period ended March 31, 2009, the company repurchased 10.1 million shares for $566
million under the board of directors March 2008 $2.0 billion share repurchase authorization. At
March 31, 2009, $600 million remained available under this authorization.
6. 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
14
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 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, and 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
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 the patent invalid. Abbotts motions to have
that appeal re-heard were denied in January 2007.
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. portion of the European
patent was invalid. In December 2008, the Board of Appeals for the European Patent Office
similarly revoked this European patent in its entirety.
Related actions remain pending in the U.S., Japan and Colombia. Another patent infringement action
against Baxter is pending in the U.S.D.C. for the Northern District of Illinois on a second 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 appealed this decision, and in April 2009 the appellate court
reversed the District Court, lifting the injunction against
Baxters sales of sevoflurane in Japan. 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. In May 2008, the Court issued a decision maintaining the
injunction, but suspending it during an appeal of the Courts decision, which appeal is pending.
Peritoneal Dialysis Litigation
On October 16, 2006, Baxter Healthcare Corporation, a direct wholly-owned subsidiary of Baxter, and
DEKA Products Limited Partnership (DEKA) filed a patent infringement lawsuit against Fresenius
Medical Care Holdings, Inc. and Fresenius USA, Inc. The complaint alleges that Fresenius sale of
the Liberty Cycler peritoneal dialysis systems and related disposable items and equipment infringes
nine U.S. patents, which are owned by Baxter or exclusively
licensed in the peritoneal dialysis field to Baxter from DEKA. The case is pending in the U.S.D.C. for the Northern District of
California with a trial anticipated in mid 2010.
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 Fresenius 2008K
hemodialysis instrument. 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
Fresenius sales
15
of the 2008K hemodialysis machines during a nine-month transition period before
the permanent injunction took effect. The order also granted a royalty on disposables, which
Fresenius has appealed. A decision is expected in the second quarter of 2009.
Other
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. Fact discovery has been completed in this
matter and expert discovery is proceeding.
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 3,
approximately 135 lawsuits, some of which are purported class actions, have been filed alleging
that plaintiffs suffered various reactions to a heparin contaminant, in some cases resulting in
fatalities. In June 2008, a number of these federal cases were consolidated in the U.S.D.C. for
the Northern District of Ohio for pretrial case management under the Multi District Litigation
rules. In September 2008, a number of state court cases were consolidated in Cook County, Illinois
for pretrial case management. Discovery is ongoing.
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 in the
second quarter of 2009. 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 both viruses. None of these cases involves
factor concentrates currently processed by the company.
16
7. SEGMENT INFORMATION
Baxter operates in three segments, each of which is a strategic business that is managed separately
because each business develops, manufactures and markets 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, alpha 1-antitrypsin
deficiency, burns and shock, and other chronic and acute blood-related conditions; products for
regenerative medicine, such as biosurgery products and technologies used in adult stem-cell
therapies; and vaccines.
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 pharmacy compounding and pharmaceutical partnering, drug formulation and 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 (corporate) 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 (principally relating to intercompany
receivables, payables and loans denominated in a foreign currency) 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 Inc. (Fenwal) in connection
with the divestiture of the TT business.
Included in the Medication Delivery segments pre-tax income in the first quarter of 2008 was a
charge of $53 million related to COLLEAGUE infusion pumps and $19 million related to the companys
recall of its heparin sodium injection products in the United States. Refer to Note 3 for further
information on these charges.
Financial information for the companys segments for the three months ended March 31 is as follows.
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
(in millions) |
|
2009 |
|
|
2008 |
|
|
Net sales |
|
|
|
|
|
|
|
|
BioScience |
|
$ | 1,252 |
|
|
$ | 1,210 |
|
Medication Delivery |
|
|
1,035 |
|
|
|
1,065 |
|
Renal |
|
|
515 |
|
|
|
558 |
|
Transition services to Fenwal |
|
|
22 |
|
|
|
44 |
|
|
Total |
|
$ | 2,824 |
|
|
$ | 2,877 |
|
|
Pre-tax income |
|
|
|
|
|
|
|
|
BioScience |
|
$ | 509 |
|
|
$ | 500 |
|
Medication Delivery |
|
|
168 |
|
|
|
94 |
|
Renal |
|
|
50 |
|
|
|
78 |
|
|
Total pre-tax income from segments |
|
$ | 727 |
|
|
$ | 672 |
|
|
17
Transition services to Fenwal represent revenues associated with manufacturing, distribution and
other services provided by the company to Fenwal subsequent to the divestiture of the TT business
in 2007. Refer to Note 3 to the companys consolidated financial statements in the 2008 Annual
Report for further information regarding the TT divestiture.
The following is a reconciliation of segment pre-tax income to income before income taxes per the
consolidated statements of income.
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
(in millions) |
|
2009 |
|
|
2008 |
|
|
Total pre-tax income from segments |
|
$ |
727 |
|
|
$ |
672 |
|
Unallocated amounts |
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
(26 |
) |
|
|
(17 |
) |
Certain foreign currency fluctuations and hedging activities |
|
|
42 |
|
|
|
1 |
|
Stock compensation |
|
|
(38 |
) |
|
|
(38 |
) |
Other corporate items |
|
|
(68 |
) |
|
|
(81 |
) |
|
Income before income taxes |
|
$ |
637 |
|
|
$ |
537 |
|
|
8. SUBSEQUENT EVENT
On April 14, 2009, the company entered an exclusive three-year distribution agreement covering the
United States and international markets with SIGMA International General Medical Apparatus, LLC
(SIGMA) for infusion pumps. The agreement includes SIGMAs Spectrum large volume infusion pumps,
as well as access to SIGMAs product development pipeline. The arrangement includes an up-front
cash payment by Baxter of $100 million for the exclusive distribution rights, a 40 percent equity
stake in SIGMA, and an option to purchase the remaining portion of SIGMA, exercisable at any time
during the three-year term of the option. The $100 million payment was made in April 2009. Baxter
may make additional payments of up to $130 million for the exercise of its option to purchase the
remaining portion of SIGMA as well as for SIGMAs achievement of certain R&D, regulatory and
commercial milestones. Baxter will consolidate the financial statements of SIGMA from the date of
the agreement in accordance with GAAP. The agreement is not expected to have a material impact on
Baxters 2009 consolidated financial statements.
18
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Refer to the companys 2008 Annual Report to Shareholders (2008 Annual Report) for managements
discussion and analysis of the financial condition and results of operations of the company for the
year ended December 31, 2008. 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,
2009.
RESULTS OF OPERATIONS
NET SALES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
Percent |
|
(in millions) |
|
2009 |
|
|
2008 |
|
|
change |
|
|
BioScience |
|
$ |
1,252 |
|
|
$ |
1,210 |
|
|
|
3% |
|
Medication Delivery |
|
|
1,035 |
|
|
|
1,065 |
|
|
|
(3% |
) |
Renal |
|
|
515 |
|
|
|
558 |
|
|
|
(8% |
) |
Transition services to Fenwal Inc. |
|
|
22 |
|
|
|
44 |
|
|
|
(50% |
) |
|
Total net sales |
|
$ |
2,824 |
|
|
$ |
2,877 |
|
|
|
(2% |
) |
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
Percent |
|
(in millions) |
|
2009 |
|
|
2008 |
|
|
change |
|
|
International |
|
$ |
1,583 |
|
|
$ |
1,698 |
|
|
|
(7% |
) |
United States |
|
|
1,241 |
|
|
|
1,179 |
|
|
|
5% |
|
|
Total net sales |
|
$ |
2,824 |
|
|
$ |
2,877 |
|
|
|
(2% |
) |
|
During the first quarter of 2009, foreign currency unfavorably impacted net sales by 8 percentage
points, principally due to the strengthening of the U.S. Dollar relative to other currencies,
including the Euro and the British Pound.
|
BioScience
|
The following is a summary of sales by significant product line in the BioScience segment.
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
Percent |
|
(in millions) |
|
2009 |
|
|
2008 |
|
|
change |
|
|
Recombinants |
|
$ |
451 |
|
|
$ |
436 |
|
|
|
3% |
|
Plasma Proteins |
|
|
274 |
|
|
|
260 |
|
|
|
5% |
|
Antibody Therapy |
|
|
337 |
|
|
|
286 |
|
|
|
18% |
|
Regenerative Medicine |
|
|
99 |
|
|
|
94 |
|
|
|
5% |
|
Other |
|
|
91 |
|
|
|
134 |
|
|
|
(32% |
) |
|
Total net sales |
|
$ |
1,252 |
|
|
$ |
1,210 |
|
|
|
3% |
|
|
Net sales in the BioScience segment increased 3% during the first quarter of 2009 (including
an 8 percentage point unfavorable foreign currency impact). Excluding the impact of foreign
currency, net sales increased across the majority of the product lines. Increased sales in
Antibody Therapy were driven by demand and improved pricing for GAMMAGARD LIQUID (marketed as
KIOVIG in most markets outside the United States), the liquid formulation of the
antibody-replacement therapy IGIV (immune globulin intravenous). Recombinants sales growth
reflected increased demand for ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free
Method] fueled by continued customer adoption, with strong patient conversion in both the United
States and international markets, and increased demand for new dosage forms that provide more
precise dosing and convenience for patients. Sales growth in the Plasma Proteins product line was
driven by demand for albumin, FEIBA (an anti-inhibitor coagulant
complex), plasma-derived factor VIII and
ARALAST [alpha 1-proteinase inhibitor (human)], as well as improved
pricing for various plasma-derived products. Also contributing to the growth were increased sales
of FLOSEAL and COSEAL, fibrin sealant products in Regenerative Medicine. Partially offsetting this
sales growth were lower sales of FSME-IMMUN (a tick-borne encephalitis vaccine), reflected in the
Other product line, as a result of seasonal factors in Europe.
19
Medication Delivery
The following is a summary of sales by significant product line in the Medication Delivery segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
Percent |
|
(in millions) |
|
2009 |
|
|
2008 |
|
|
change |
|
|
IV Therapies |
|
|
$ 344 |
|
|
|
$ 371 |
|
|
|
(7% |
) |
Global Injectables |
|
|
371 |
|
|
|
368 |
|
|
|
1% |
|
Infusion Systems |
|
|
199 |
|
|
|
220 |
|
|
|
(10% |
) |
Anesthesia |
|
|
109 |
|
|
|
99 |
|
|
|
10% |
|
Other |
|
|
12 |
|
|
|
7 |
|
|
|
71% |
|
|
Total net sales |
|
|
$1,035 |
|
|
|
$1,065 |
|
|
|
(3% |
) |
|
Net sales for the Medication Delivery segment decreased 3% during the first quarter of 2009
(including a 9 percentage point unfavorable foreign currency impact). Excluding the impact of
foreign currency, net sales increased as a result of strong sales growth in the international
pharmacy compounding and the U.S. pharmaceutical partnering businesses in Global Injectables, and
increased sales of the companys anesthesia products, SUPRANE (desflurane) and sevoflurane. Also
contributing to the sales growth was increased demand in Intravenous (IV) Therapies for nutritional
products, particularly for the companys proprietary multi-chamber containers, and IV solutions,
particularly in Asia and Latin America.
|
Renal
|
The following is a summary of sales by significant product line in the Renal segment.
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
Percent |
|
(in millions) |
|
2009 |
|
|
2008 |
|
|
change |
|
|
PD Therapy |
|
|
$420 |
|
|
|
$445 |
|
|
|
(5% |
) |
HD Therapy |
|
|
95 |
|
|
|
113 |
|
|
|
(16% |
) |
|
Total net sales |
|
|
$515 |
|
|
|
$558 |
|
|
|
(8% |
) |
|
Net sales in the Renal segment decreased 8% during the first quarter of 2009 (including a 9
percentage point unfavorable foreign currency impact). Excluding the impact of foreign currency,
net sales increased due to an increase in the number of peritoneal dialysis (PD) patients in Asia
(particularly in China), Latin America and Eastern Europe. Penetration of PD Therapy
products continues to be strong in emerging markets where many people with end-stage renal disease
are currently under-treated. Partially offsetting the increase was a decline in Hemodialysis (HD)
Therapy sales from lower sales volumes of saline, principally in the United States.
|
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
Transfusion Therapies (TT) business in 2007. Refer to Note 3 to the companys consolidated
financial statements in the 2008 Annual Report for additional information regarding the TT
divestiture.
|
GROSS MARGIN AND EXPENSE RATIOS
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
|
|
(as a percentage of net sales) |
|
2009 |
|
|
2008 |
|
|
Change |
|
|
Gross margin |
|
|
52.7% |
|
|
|
48.0% |
|
|
4.7 pts |
|
Marketing and administrative expenses |
|
|
21.6% |
|
|
|
22.2% |
|
|
(0.6 pts |
) |
|
20
Gross Margin
The improvement in the gross margin in the first quarter of 2009 was principally driven by an
improvement in sales mix, with increased sales of higher-margin products, as well as manufacturing
and yield improvements. Contributing to the gross margin improvement was continued customer
conversion to ADVATE and GAMMAGARD LIQUID, improved volumes and pricing for certain plasma protein
and other products, and a favorable foreign currency impact.
Included in the companys gross margin in 2008 was a charge of $53 million related to COLLEAGUE
infusion pumps and $19 million related to the companys recall of its heparin sodium injection
products in the United States. These charges decreased the gross margin in the first quarter of
2008 by 2.5 percentage points. Refer to Note 3 for further information on the COLLEAGUE and
heparin charges.
Marketing and Administrative Expenses
The marketing and administrative expense ratio for the first quarter of 2009 decreased compared to
2008 as the company benefited from stronger cost controls and lower product distribution costs,
partially offset by an unfavorable foreign currency impact.
RESEARCH AND DEVELOPMENT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
Percent |
|
(in millions) |
|
2009 |
|
|
2008 |
|
|
change |
|
|
Research and development expenses |
|
|
$212 |
|
|
|
$190 |
|
|
|
12% |
|
As a percent of net sales |
|
|
7.5% |
|
|
|
6.6% |
|
|
|
|
|
|
Research and development (R&D) expenses increased during the first quarter of 2009, reflecting the
companys strategy to accelerate R&D investments with respect to both the companys internal
pipeline, including several clinical trials for the evaluation of GAMMAGARD LIQUID for a number of
potential indications, as well as collaborations with partners, including programs relating to the
development of tissue-repair products, longer-acting forms of blood clotting proteins to treat
hemophilia and a next-generation home HD device. Partially offsetting the increase in R&D spending
was a favorable foreign currency impact. Refer to the 2008 Annual Report for a discussion of the
companys R&D pipeline.
NET INTEREST EXPENSE
Net interest expense was $26 million in the first quarter of 2009, compared to $17 million in the
first quarter of 2008. The increase was principally driven by a reduction in interest income as a
result of lower interest rates and a lower average cash balance, and a higher average debt balance,
partially offset by lower weighted-average interest rates on outstanding debt.
OTHER EXPENSE (INCOME), NET
Other expense (income), net was $2 million of expense in the first quarter of 2009 compared to $4
million of income in the first quarter of 2008. Included in both periods were amounts related to
foreign currency fluctuations, principally relating to intercompany receivables, payables and loans
denominated in a foreign currency. 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.
Refer to Note 3 to the companys consolidated financial statements in the 2008 Annual Report for
further information regarding the TT divestiture.
PRE-TAX INCOME
Refer to Note 7 for a summary of financial results by segment. Certain items are maintained at the
companys corporate level and are not allocated to the segments. The following is a summary of
significant factors impacting the segments financial results.
BioScience
Pre-tax income increased 2% in the first quarter of 2009. Continued gross margin expansion
was driven by strong sales of higher-margin products, fueled by the continued customer adoption of
ADVATE and GAMMAGARD
21
LIQUID, improved pricing and volumes of certain plasma protein products, and continued
cost and yield improvements. Substantially offsetting this growth was the unfavorable impact of
foreign currency and an approximately 25% increase in R&D spending, particularly related to
several clinical trials for the evaluation of GAMMAGARD LIQUID for a number of potential
indications.
Medication Delivery
Pre-tax income increased 79% in the first quarter of 2009. Pre-tax income in the first
quarter of 2008 included charges of $53 million related to COLLEAGUE infusion pumps and $19 million
related to the companys recall of its heparin sodium injection products in the United States. See
Note 3 for further information about the COLLEAGUE and heparin charges. In addition, the gross
margin improvement resulting from favorable product mix was partially offset by the unfavorable
impact of foreign currency.
Renal
Pre-tax income decreased 36% in the first quarter of 2009. The decrease was primarily due to
lower sales of saline, increased costs, including R&D spending related to the development of the
next-generation home HD device, and an unfavorable impact from foreign currency, partially offset
by the continued increase in PD Therapy patients.
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 (principally relating to intercompany receivables, payables and loans denominated in a
foreign currency) and the majority of the foreign currency and interest rate hedging activities,
corporate headquarters costs, stock compensation expense, income and expense related to certain
non-strategic investments, certain employee benefit plan costs, certain nonrecurring gains and
losses and revenues and costs related to the manufacturing, distribution and other transition
agreements with Fenwal. Refer to Note 7 for a reconciliation of segment pre-tax income to income
before income taxes per the consolidated statements of income. Refer to the discussion above
regarding net interest expense and Note 5 regarding stock compensation expense.
INCOME TAXES
The companys effective income tax rate was 18.7% and 19.6% in the first quarters of 2009
and 2008, respectively. The effective tax rate in the first quarter of 2008 was higher due to a
lower tax rate associated with the COLLEAGUE infusion pump charge recorded in that period. Refer
to Note 3 for further information on the COLLEAGUE charge. The company anticipates that the
effective tax rate, calculated in accordance with generally accepted accounting principles (GAAP),
will be approximately 18.5% to 19.0% for the full-year 2009, excluding any impact from
additional audit developments and other special items.
INCOME AND EARNINGS PER DILUTED SHARE
Net income attributable to Baxter was $516 million, or $0.83 per diluted share, for the first
quarter of 2009 and $429 million, or $0.67 per diluted share, in the prior year quarter. The
significant factors and events contributing to the changes are discussed above.
LIQUIDITY AND CAPITAL RESOURCES
CASH FLOWS
Cash flows from operations
Cash flows from operations decreased during the first quarter of 2009 as compared to the prior
year, totaling $237 million in the first quarter of 2009 and $362 million in the first quarter of
2008. Higher earnings were more than offset by non-cash items and other factors discussed below,
resulting in a decrease in cash flows from operations. Included in cash flows from operations in
the first quarter of 2009 were outflows of $78 million related to realized excess tax benefits from
stock issued under employee benefit plans. Realized excess tax benefits are required to be
presented in the statement of cash flows as an outflow within the operating section and an inflow
within the financing section.
22
Accounts Receivable
Cash flows relating to accounts receivable increased during the first quarter of 2009 as compared
to the prior year. Days sales outstanding decreased from 56.3 days at March 31, 2008 to 52.1 days
at March 31, 2009, primarily due to improved collection periods in certain international locations
and the United States, partially offset by a decrease in cash proceeds from the factoring of
receivables.
Inventories
Cash outflows relating to inventories decreased in 2009. The following is a summary of inventories
at March 31, 2009 and December 31, 2008, as well as inventory turns for the three months ended
March 31, 2009 and 2008, by segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Annualized inventory |
|
|
|
Inventories |
|
|
turns for the three |
|
|
|
March 31, |
|
|
December 31, |
|
|
months ended March 31, |
|
(in millions, except inventory turn data) |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
BioScience |
|
$ |
1,406 |
|
|
$ |
1,346 |
|
|
|
1.28 |
|
|
|
1.44 |
|
Medication Delivery |
|
|
763 |
|
|
|
771 |
|
|
|
2.98 |
|
|
|
2.98 |
|
Renal |
|
|
235 |
|
|
|
227 |
|
|
|
4.16 |
|
|
|
4.18 |
|
Other |
|
|
17 |
|
|
|
17 |
|
|
|
|
|
|
|
|
|
|
Total company |
|
$ |
2,421 |
|
|
$ |
2,361 |
|
|
|
2.10 |
|
|
|
2.27 |
|
|
Inventory turns in the Medication Delivery and Renal segments were consistent with the prior year.
The lower inventory turns in the BioScience segment were the result of measured steps to provide
safe and reliable supplies of critical therapies for patients.
Other
Cash outflows related to liabilities, restructuring payments and other increased in the first three
months of 2009 as compared to the prior year period, principally driven by a planned discretionary
cash contribution of $100 million to the companys pension plan in the United States in the first
quarter of 2009. Also contributing to the increase in cash outflows were the timing of payment of
trade accounts payable and increased payments related to the companys restructuring programs.
Cash flows from investing activities
Capital Expenditures
Capital expenditures increased $14 million for the three months ended March 31, 2009, from $157
million in 2008 to $171 million in 2009. The company makes investments in capital expenditures at
a level sufficient to support the strategic and operating needs of the businesses and continues to
improve capital allocation discipline in making investments to enhance long-term growth.
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,
payments related to the companys fourth quarter 2007 agreements with Nycomed Pharma AS (Nycomed)
and Nektar Therapeutics (Nektar), and certain smaller acquisitions and investments. Refer to Note
4 to the companys consolidated financial statements in the 2008 Annual Report for further
information about the arrangements with Nycomed and Nektar.
Other
Cash flows relating to other investing activities in the first quarter of 2009 decreased as a
result of an increase in short-term investments and a reduction in the amount of cash collected
from customers relating to previously securitized receivables. In 2007, the company repurchased
the third party interest in receivables previously sold under the European securitization
arrangement, and the European facility was not renewed.
Cash flows from financing activities
Debt Issuances, Net of Payments of Obligations
Net cash inflows related to debt and other financing obligations in the first quarter of 2009
totaled $194 million. The company issued $350 million of senior unsecured notes, which mature in
March 2014 and bear a 4.0% coupon rate. The net proceeds from this issuance were used for
general corporate purposes, including the repayment of
23
approximately $160 million of outstanding borrowings related to its Euro-denominated credit
facility (further discussed below). Net cash outflows related to debt and other financing
obligations in the first quarter of 2008 totaled $455 million. Included in the cash outflows was
the repayment of the companys 5.196% notes, which approximated $250 million, upon their
maturity in February 2008. Also included in the financing cash outflows in 2008 were $169 million
of settlements related to certain cross-currency swaps. There were no settlements of net
investment cross-currency swaps in 2009, as all of the companys net investment hedges were settled
by the end of 2008. Refer to Note 7 to the companys consolidated financial statements in the 2008
Annual Report for further information regarding these swaps.
Other Financing Activities
Cash dividend payments totaled $160 million in the first quarter of 2009 and $138 million in the
first quarter of 2008. In February 2009, the board of directors declared a quarterly dividend of
$0.26 per share, payable on April 1, 2009 to shareholders of record on March 10, 2009.
Proceeds and realized excess tax benefits from stock issued under employee benefit plans increased
by $27 million, from $112 million in the first quarter of 2008 to $139 million in the first quarter
of 2009, primarily due to $78 million of realized excess tax benefits (as further discussed above),
partially offset by a decrease in stock option exercises. No excess tax benefits were realized
from stock issued under employee benefit plans during the first quarter of 2008.
Stock repurchases totaled $566 million in the first quarter of 2009 as compared to $545 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 market
conditions. 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, 2009, $600 million remained available
under this authorization.
CREDIT FACILITIES, ACCESS TO CAPITAL AND CREDIT RATINGS
Credit facilities
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 $400 million at March 31, 2009, which matures in January 2013. These
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, 2009, 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, 2009. The
non-performance of any financial institution supporting the credit facility would reduce the
maximum capacity of these facilities by each institutions respective commitment. Refer to Note 6
to the companys consolidated financial statements in the 2008 Annual Report for further discussion
of the companys credit facilities.
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. The
company had $1.7 billion of cash and equivalents at March 31, 2009. The company invests its excess
cash in certificates of deposit and money market funds, and diversifies the concentration of cash
among different financial institutions.
The global financial markets have recently experienced unprecedented levels of volatility. 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 or in the solvency of its customers or suppliers, deterioration
in the companys key financial ratios or credit ratings, or other significantly unfavorable changes
in conditions. In addition, continuing volatility in the global financial markets could increase
borrowing costs or affect the companys ability to access the capital markets. However, 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.
Credit ratings
There were no changes in the companys credit ratings in the first three months of 2009. Refer to
the 2008 Annual Report for further discussion of the companys credit ratings.
24
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 is included in Note 1 to the
companys consolidated financial statements in the 2008 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 2008 Annual Report.
LEGAL CONTINGENCIES
Refer to Note 6 for a discussion of the companys legal contingencies. Upon resolution of any of
these uncertainties, the company may incur charges in excess of presently established liabilities.
While the liability of the company in connection with the claims cannot be estimated 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 6, 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 and 2009. 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
re-commercialization. As discussed in Note 3, the company has recorded a number of charges in
connection with its COLLEAGUE infusion pumps. It is possible that additional charges related to
COLLEAGUE may be required in future periods, based on new information, changes in estimates, and
modifications to the current remediation plan as a result of ongoing dialogue with the FDA.
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 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, 2008 for additional discussion of regulatory matters.
25
NEW ACCOUNTING STANDARDS
SFAS No. 160
On January 1, 2009, the company adopted Statement of Financial Accounting Standards (SFAS) No. 160,
Noncontrolling Interests in Consolidated Financial Statements, an amendment of ARB No. 51 (SFAS
No. 160). The new standard changed 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 equity, but
separate from Baxter shareholders equity, and that the amount of consolidated net income
attributable to Baxter and to the noncontrolling interests 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, Baxter recognizes, at fair value, 100% of the assets and
liabilities, including goodwill, as if the entire target company had been acquired. The new
standard has been applied prospectively as of January 1, 2009, except for the presentation and
disclosure requirements, which have been applied retrospectively for prior periods presented.
Prior to the adoption of SFAS No. 160, the noncontrolling interests share of net income was
included in other expense (income), net in the consolidated statement of income and the
noncontrolling interests equity was included in other long-term liabilities in the consolidated
balance sheet.
FSP FAS No. 132(R)-1
In December 2008, the Financial Accounting Standards Board (FASB) issued FASB Staff Position (FSP)
FAS No. 132(R)-1, Employers Disclosures about Postretirement Benefit Plan Assets (FSP FAS No.
132(R)-1). This FSP expands the disclosure requirements relating to pension and other
postretirement benefits to require enhanced disclosures about how investment allocation decisions
are made and the investment policies and strategies that support those decisions, major categories
of plan assets, the input and valuation techniques used in measuring plan assets at fair value, and
significant concentrations of credit risk within plan assets. The company will include the
disclosures required by this standard beginning with its 2009 year-end consolidated financial
statements.
26
FORWARD-LOOKING INFORMATION
This quarterly report includes forward-looking statements, including statements with respect to
accounting estimates and assumptions, future litigation outcomes, the companys efforts to
remediate its infusion pumps and other regulatory matters, expectations with respect to
restructuring programs (including expected cost savings), strategic plans, product mix,
promotional efforts, geographic expansion, sales and pricing forecasts, expectations with respect
to business development activities, potential developments with respect to credit and credit
ratings, estimates of liabilities, ongoing tax audits and related tax
provisions, deferred tax assets, future pension plan expense, the companys hedging policy and
expectations with respect to the companys exposure to foreign currency and interest rate risk,
the companys internal R&D pipeline, future capital and R&D expenditures, the sufficiency of the
companys financial flexibility and the adequacy of credit facilities and reserves, the effective
tax rate in 2009, expected revenues from the Fenwal transition services agreements, 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; |
|
|
|
|
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; |
|
|
|
|
foreign currency fluctuations, particularly due to reduced benefits from the companys
natural hedges and limitations on the ability to cost-effectively hedge resulting from the
recent financial market and currency volatility; |
|
|
|
|
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; |
|
|
|
|
changes to the healthcare regulatory environment, including through healthcare reform in
the United States or globally; |
|
|
|
|
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 and pricing of acceptable raw materials and component supply; |
|
|
|
|
global regulatory, trade and tax policies; |
|
|
|
|
any changes in law concerning the taxation of income, including income earned outside
the United States; |
|
|
|
|
actions by tax authorities in connection with ongoing tax audits; |
|
|
|
|
the companys ability to realize the anticipated benefits of restructuring initiatives; |
|
|
|
|
the companys ability to realize the anticipated benefits from its joint product
development and commercialization arrangements, including the SIGMA transaction; |
|
|
|
|
changes in credit agency ratings; |
|
|
|
|
any impact of the commercial and credit environment on the company and its customers and
suppliers; |
|
|
|
|
continued developments in the market for transfusion therapies products and Fenwals
ability to execute with respect to the acquired business; 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, 2008, 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 is primarily exposed to foreign exchange risk with respect to recognized assets and
liabilities, forecasted transactions and net assets denominated in the Euro, Japanese Yen, British
Pound, Australian Dollar, Canadian Dollar and certain Latin American currencies. The company
manages its foreign currency exposures on a consolidated basis, which allows the company to net
exposures and take advantage of any natural offsets. In addition, the company uses derivative and
nonderivative financial instruments to further reduce the net exposure to foreign exchange. Gains
and losses on the hedging instruments offset losses and gains on the hedged transactions and
reduce the earnings and equity volatility relating to foreign exchange.
The company uses options, forwards and cross-currency swaps to hedge the foreign exchange risk to
earnings relating to forecasted transactions denominated in foreign currencies and recognized
assets and liabilities. The maximum term over which the company has cash flow hedge contracts in
place related to forecasted transactions at March 31, 2009 is 15 months. The company also enters
into undesignated derivative instruments to hedge certain intercompany and third-party receivables
and payables in foreign currencies. The recent financial market and currency volatility may
reduce the benefits of the companys natural hedges and limit the companys ability to
cost-effectively hedge these exposures.
As part of its risk-management program, the company performs sensitivity analyses to assess
potential changes in the fair value of its foreign exchange instruments relating to hypothetical
and reasonably possible near-term movements in foreign exchange rates.
A sensitivity analysis of changes in the fair value of foreign exchange option, forward and
cross-currency swap contracts outstanding at March 31, 2009, 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 asset balance of $23 million, which principally relates
to hedges of Euro forecasted transactions partially offset by U.S. Dollar-denominated debt issued
by a foreign subsidiary, would decrease by $79 million, resulting in a net liability position.
The sensitivity analysis model recalculates the fair value of the foreign exchange option, forward
and cross-currency swap contracts outstanding at March 31, 2009 by replacing the actual exchange
rates at March 31, 2009 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 Interest Rate and Other Risks in the Financial Instrument Market Risk
section of the companys 2008 Annual Report. There were no significant changes during the quarter
ended March 31, 2009.
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, 2009. 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, 2009.
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,
2009 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, 2009 and 2008 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, 2009, and the related condensed consolidated statements of
income for each of the three-month periods ended March 31, 2009 and 2008 and the condensed
consolidated statements of cash flows for the three-month periods ended March 31, 2009 and 2008.
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, 2008, 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 19, 2009, we expressed an unqualified opinion
on those consolidated financial statements. The consolidated financial statements referred to
above are not presented herein. As discussed in Note 1 to the accompanying condensed consolidated
financial statements, the company changed its method of accounting and reporting for noncontrolling
interests. The accompanying December 31, 2008 condensed consolidated balance sheet reflects this
change.
/s/ PricewaterhouseCoopers LLP
PricewaterhouseCoopers LLP
Chicago, Illinois
May 5, 2009
31
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
The information in Part I, Item 1, Note 6 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, 2009.
Issuer Purchases of Equity Securities
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Total number |
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|
|
|
Total number of shares |
|
|
Approximate dollar value of |
|
|
|
of shares |
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|
Average price |
|
|
purchased as part of publicly |
|
|
shares that may yet be purchased |
|
Period |
|
purchased (1) |
|
|
paid per share |
|
|
announced program (1) |
|
|
under the program (1) |
|
|
January 1, 2009
through January 31, 2009 |
|
|
3,017,276 |
|
|
$ |
54.72 |
|
|
|
3,017,276 |
|
|
|
|
|
February 1, 2009
through February 28, 2009 |
|
|
4,377,104 |
|
|
$ |
58.84 |
|
|
|
4,377,104 |
|
|
|
|
|
March 1, 2009
through March 31, 2009 |
|
|
2,717,800 |
|
|
$ |
52.60 |
|
|
|
2,717,800 |
|
|
|
|
|
|
Total |
|
|
10,112,180 |
|
|
$ |
55.93 |
|
|
|
10,112,180 |
|
|
$ |
600,133,457 |
|
|
(1) |
|
In March 2008, 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 2009, the company repurchased 10.1 million shares for $566 million under this
program, and the remaining authorization totaled $600 million at March 31, 2009. 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 5, 2009
|
|
By:
|
|
/s/ Robert M. Davis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Robert M. Davis |
|
|
|
|
|
|
Corporate Vice President and Chief Financial Officer |
|
|
|
|
|
|
(duly authorized officer and principal financial officer) |
|
|
35