e10vq
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, 2010
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 1-4448
BAXTER INTERNATIONAL INC.
(Exact name of registrant as specified in its charter)
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Delaware
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36-0781620 |
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.) |
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One Baxter Parkway, Deerfield, Illinois
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60015-4633 |
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(Address of principal executive offices)
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(Zip Code) |
847-948-2000
(Registrants telephone number,
including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant 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 þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See 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
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Smaller reporting company |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes o No þ
The number of shares of the registrants Common Stock, par value $1.00 per share, outstanding as of
April 30, 2010 was 596,452,857 shares.
BAXTER INTERNATIONAL INC.
FORM 10-Q
For the quarterly period ended March 31, 2010
TABLE OF CONTENTS
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Page Number |
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PART I. |
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FINANCIAL INFORMATION |
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Item 1. |
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Financial Statements |
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Condensed
Consolidated Statements of (Loss) Income |
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2 |
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Condensed Consolidated Balance Sheets |
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3 |
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Condensed Consolidated Statements of Cash Flows |
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4 |
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Notes to Condensed Consolidated Financial Statements |
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5 |
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Item 2. |
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Managements Discussion and Analysis of Financial Condition and Results of Operations |
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20 |
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Item 3. |
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Quantitative and Qualitative Disclosures About Market Risk |
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28 |
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Item 4. |
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Controls and Procedures |
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29 |
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Review by Independent Registered Public Accounting Firm |
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30 |
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Report of Independent Registered Public Accounting Firm |
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31 |
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PART II. |
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OTHER INFORMATION |
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Item 1. |
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Legal Proceedings |
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32 |
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Item 2. |
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Unregistered Sales of Equity Securities and Use of Proceeds |
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33 |
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Item 6. |
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Exhibits |
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34 |
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Signature |
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35 |
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PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Baxter International Inc.
Condensed Consolidated Statements of (Loss) 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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2010 |
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2009 |
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Net sales |
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$ |
2,927 |
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$ |
2,824 |
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Cost of sales |
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1,884 |
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1,336 |
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Gross margin |
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1,043 |
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1,488 |
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Marketing and administrative expenses |
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683 |
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611 |
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Research and development expenses |
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227 |
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212 |
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Net interest expense |
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19 |
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26 |
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Other expense, net |
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2 |
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2 |
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Income before income taxes |
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112 |
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637 |
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Income tax expense |
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172 |
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119 |
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Net (loss) income |
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(60 |
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518 |
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Less: Noncontrolling interests |
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3 |
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2 |
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Net (loss) income attributable to Baxter International Inc. (Baxter) |
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$ |
(63 |
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$ |
516 |
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Net (loss) income attributable to Baxter per common share |
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Basic |
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$ |
(0.11 |
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$ |
0.84 |
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Diluted |
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$ |
(0.11 |
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$ |
0.83 |
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Weighted-average number of common shares outstanding |
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Basic |
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602 |
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613 |
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Diluted |
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602 |
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621 |
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Cash dividends declared per common share |
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$ |
0.290 |
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$ |
0.260 |
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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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2010 |
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2009 |
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Current assets |
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Cash and equivalents |
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$ |
2,673 |
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$ |
2,786 |
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Accounts and other current receivables |
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2,254 |
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2,302 |
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Inventories |
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2,477 |
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2,557 |
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Prepaid expenses and other |
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611 |
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626 |
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Total current assets |
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8,015 |
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8,271 |
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Property, plant and equipment, net |
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5,064 |
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5,159 |
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Other assets |
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Goodwill |
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2,002 |
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1,825 |
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Other intangible assets, net |
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556 |
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513 |
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Other |
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1,529 |
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1,586 |
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Total other assets |
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4,087 |
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3,924 |
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Total assets |
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$ |
17,166 |
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$ |
17,354 |
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Current liabilities |
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Short-term debt |
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$ |
15 |
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$ |
29 |
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Current
maturities of long-term debt and lease obligations |
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682 |
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682 |
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Accounts payable and accrued liabilities |
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3,587 |
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3,753 |
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Total current liabilities |
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4,284 |
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4,464 |
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Long-term debt and lease obligations |
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4,056 |
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3,440 |
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Other long-term liabilities |
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2,167 |
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2,030 |
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Commitments and contingencies |
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Equity |
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Common stock, $1 par value, authorized
2,000,000,000 shares, issued 683,494,944 shares
in 2010 and 2009 |
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683 |
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683 |
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Common stock in treasury, at cost,
85,602,245 shares in 2010 and 82,523,243
shares in 2009 |
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(4,926 |
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(4,741 |
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Additional contributed capital |
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5,675 |
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5,683 |
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Retained earnings |
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7,030 |
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7,343 |
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Accumulated other comprehensive loss |
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(2,033 |
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(1,777 |
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Total Baxter shareholders equity |
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6,429 |
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7,191 |
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Noncontrolling interests |
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230 |
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229 |
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Total equity |
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6,659 |
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7,420 |
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Total liabilities and equity |
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$ |
17,166 |
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$ |
17,354 |
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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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2010 |
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2009 |
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Cash flows from operations |
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Net (loss) income |
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$ |
(60) |
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$ |
518 |
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Adjustments |
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Depreciation and amortization |
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166 |
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148 |
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Deferred income taxes |
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91 |
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59 |
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Stock compensation |
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30 |
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38 |
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Realized
excess tax benefits from stock issued under employee benefit plans |
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(31 |
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(78 |
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Infusion
pump charge |
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588 |
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Other |
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9 |
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9 |
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Changes in balance sheet items |
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Accounts and other current receivables |
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(33 |
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45 |
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Inventories |
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(94 |
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(86 |
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Accounts payable and accrued liabilities |
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(107 |
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(304 |
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Restructuring and cost optimization payments |
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(17 |
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(21 |
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Other |
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(263 |
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(91 |
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Cash flows from operations |
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279 |
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237 |
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Cash flows from investing activities |
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Capital expenditures |
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(230 |
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(171 |
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Acquisitions
of and investments in businesses and technologies |
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(234 |
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Other |
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(25 |
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Cash flows from investing activities |
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(464 |
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(196 |
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Cash flows from financing activities |
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Issuances of debt |
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602 |
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358 |
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Payments of obligations |
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(13 |
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(164 |
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Cash dividends on common stock |
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(174 |
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(160 |
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Proceeds and
realized excess tax benefits from stock issued under employee benefit plans |
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171 |
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139 |
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Purchases of treasury stock |
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(435 |
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(566 |
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Other |
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(32 |
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Cash flows from financing activities |
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119 |
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(393 |
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Effect of currency exchange rate changes on cash and equivalents |
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(47 |
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(76 |
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Decrease in cash and equivalents |
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(113 |
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(428 |
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Cash and equivalents at beginning of period |
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2,786 |
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2,131 |
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Cash and equivalents at end of period |
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$ |
2,673 |
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$ |
1,703 |
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The accompanying notes are an integral part of these condensed consolidated financial
statements.
4
Baxter International Inc.
Notes to Condensed Consolidated Financial Statements (unaudited)
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The unaudited interim condensed consolidated financial statements of Baxter International Inc. and
its subsidiaries (the company or Baxter) have been prepared pursuant to the rules and regulations
of the Securities and Exchange Commission. Accordingly, certain information and footnote
disclosures normally included in financial statements prepared in accordance with generally
accepted accounting principles (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 Annual Report on Form 10-K
for the year ended December 31, 2009 (2009 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.
Changes in accounting standards
Transfers of Financial Assets
On January 1, 2010, the company adopted a new accounting standard relating to the accounting for
transfers of financial assets. The new standard eliminates the concept of a qualifying
special-purpose entity and clarifies existing GAAP as it relates to determining whether a
transferor has surrendered control over transferred financial assets. The standard limits the
circumstances in which a financial asset, or portion of a financial asset, should be derecognized
when the transferor has not transferred the entire original financial asset to an entity that is
not consolidated with the transferor in the financial statements presented and/or when the
transferor has continuing involvement with the transferred financial asset. The standard also
requires enhanced disclosures about transfers of financial assets and a transferors continuing
involvement with transferred financial assets. The new standard was applied prospectively on
January 1, 2010, except for the disclosure requirements, which have been applied retrospectively
for all periods presented. The new standard did not impact the companys consolidated financial
statements. Refer to Note 4 for disclosures provided in connection with this new standard.
Variable Interest Entities
On January 1, 2010, the company adopted a new standard that changes the consolidation model for
variable interest entities (VIEs). The new standard requires an enterprise to qualitatively assess
the determination of the primary beneficiary of a VIE as the enterprise that has both the power to
direct the activities of the VIE that most significantly impact the entitys economic performance
and has the obligation to absorb losses or the right to receive benefits from the entity that could
potentially be significant to the VIE. The standard requires ongoing reassessments of whether an
enterprise is the primary beneficiary of a VIE. The standard expands the disclosure requirements
for enterprises with a variable interest in a VIE. The new standard did not impact the companys
consolidated financial statements. Refer to Note 2 for disclosures provided in connection with
this new standard.
2. SUPPLEMENTAL FINANCIAL INFORMATION
Net pension and other postemployment benefits expense
The following is a summary of net expense relating to the companys pension and other
postemployment benefit (OPEB) plans.
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Three months ended |
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March 31, |
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(in millions) |
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2010 |
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2009 |
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Pension benefits |
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Service cost |
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$ |
25 |
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$ |
21 |
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Interest cost |
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58 |
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54 |
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Expected return on plan assets |
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(71 |
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(62 |
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Amortization of net losses and other deferred amounts |
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31 |
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25 |
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Net pension plan expense |
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$ |
43 |
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$ |
38 |
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OPEB |
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Service cost |
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$ |
1 |
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$ |
1 |
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Interest cost |
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8 |
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8 |
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Amortization of prior service cost and net loss |
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(1 |
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(1 |
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Net OPEB plan expense |
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$ |
8 |
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$ |
8 |
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5
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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2010 |
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2009 |
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Interest expense, net of capitalized interest |
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$ |
28 |
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$ |
31 |
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Interest income |
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(9 |
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(5 |
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Net interest expense |
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$ |
19 |
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$ |
26 |
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Comprehensive
(loss) income
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Three months ended |
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March 31, |
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(in millions) |
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2010 |
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2009 |
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Comprehensive
(loss) income |
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$ |
(317 |
) |
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$ |
422 |
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Less: Comprehensive income (loss)
attributable to noncontrolling interests |
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2 |
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(2 |
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Comprehensive
(loss) income attributable to Baxter |
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$ |
(319 |
) |
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$ |
424 |
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The
decrease in comprehensive (loss) income attributable to Baxter was
principally due to a $588 million charge related to the recall of
COLLEAGUE infusion pumps from the U.S. market and unfavorable
movements in currency translation adjustments. Refer to Note 3
for further information regarding the COLLEAGUE infusion pump charge.
Effective tax rate
The
companys effective income tax rate was 153.6% and 18.7% in the first quarters of 2010 and 2009,
respectively. The companys effective income tax rate differs from the U.S. federal statutory rate
each year due to certain operations that are subject to tax incentives, state and local taxes, and
foreign taxes that are different than the U.S. federal statutory rate. In addition, the effective
tax rate can be impacted each period by discrete factors and events.
The increase in the effective tax rate in the first quarter of 2010
was principally due to a $588 million charge related to the
recall of COLLEAGUE infusion pumps from the U.S. market for which
there was no net tax benefit recognized. The effective tax rate in the
first quarter of 2010 was also impacted by a $39 million write-off of a deferred tax asset as a result
of a change in the tax treatment of reimbursements under the Medicare Part D retiree prescription
drug subsidy program under healthcare reform legislation recently enacted in the United States.
Baxter expects to reduce the amount of its liability for uncertain tax positions within the next
12 months by $302 million due principally to the expiration of certain statutes of limitations
related to tax benefits recorded in respect of losses from restructuring certain international
operations and the settlements of certain multi-jurisdictional transfer pricing issues. While the
final outcome of these matters is inherently uncertain, the company believes it has made adequate
tax provisions for all years subject to examination.
Earnings
(loss) per share
The
numerator for both basic and diluted earnings (loss) per share
(EPS) is net (loss) 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 following is a reconciliation of basic shares to diluted shares.
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Three months ended |
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March 31, |
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(in millions) |
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2010 |
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|
2009 |
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Basic shares |
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602 |
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613 |
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Effect of dilutive securities |
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8 |
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Diluted shares |
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602 |
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|
621 |
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6
The
computation of diluted EPS excluded common stock equivalents of
7 million for the first quarter of 2010 because their inclusion would have an anti-dilutive effect on diluted EPS. The computation of diluted EPS also excluded employee stock options to purchase 8.6 million and 16.8
million shares for the first quarters of 2010 and 2009, 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.
Inventories
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March 31, |
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December 31, |
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(in millions) |
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2010 |
|
|
2009 |
|
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Raw materials |
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$ |
514 |
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$ |
598 |
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Work in process |
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850 |
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|
842 |
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Finished goods |
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1,113 |
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|
1,117 |
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|
Inventories |
|
$ |
2,477 |
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|
$ |
2,557 |
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|
Property, plant and equipment, net
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|
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|
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|
|
March 31, |
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|
December 31, |
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(in millions) |
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2010 |
|
|
2009 |
|
|
Property, plant and equipment, at cost |
|
$ |
9,950 |
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|
$ |
10,060 |
|
Accumulated depreciation and amortization |
|
|
(4,886 |
) |
|
|
(4,901 |
) |
|
Property, plant and equipment, net |
|
$ |
5,064 |
|
|
$ |
5,159 |
|
|
Goodwill
The following is a summary of the activity in goodwill by business segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medication |
|
|
|
|
|
|
|
(in millions) |
|
BioScience |
|
|
Delivery |
|
|
Renal |
|
|
Total |
|
|
Balance as of December 31, 2009 |
|
$ |
595 |
|
|
$ |
1,043 |
|
|
$ |
187 |
|
|
$ |
1,825 |
|
Additions and other adjustments |
|
|
223 |
|
|
|
6 |
|
|
|
1 |
|
|
|
230 |
|
Cumulative translation adjustment |
|
|
(11 |
) |
|
|
(33 |
) |
|
|
(9 |
) |
|
|
(53 |
) |
|
Balance as of March 31, 2010 |
|
$ |
807 |
|
|
$ |
1,016 |
|
|
$ |
179 |
|
|
$ |
2,002 |
|
|
Additional goodwill recognized in 2010 principally related to the acquisition of ApaTech Limited
(ApaTech) within the BioScience segment. In the Medication Delivery segment, a $6 million
adjustment was made to the goodwill recognized in connection with the consolidation of Sigma
International General Medical Apparatus, LLC (SIGMA). Refer to the discussion below for further
information regarding ApaTech and Note 4 to the companys consolidated financial statements in the
2009 Annual Report for further information related to SIGMA. As of March 31, 2010, there were no
accumulated goodwill impairment losses.
Other intangible assets, net
The following is a summary of the companys intangible assets subject to amortization at March 31,
2010 and December 31, 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Developed |
|
|
|
|
|
|
|
|
|
technology, |
|
|
|
|
|
|
|
(in millions) |
|
including patents |
|
|
Other |
|
|
Total |
|
|
March 31, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
Gross other intangible assets |
|
$ |
935 |
|
|
$ |
120 |
|
|
$ |
1,055 |
|
Accumulated amortization |
|
|
(471 |
) |
|
|
(59 |
) |
|
|
(530 |
) |
|
Other intangible assets, net |
|
$ |
464 |
|
|
$ |
61 |
|
|
$ |
525 |
|
|
December 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
Gross other intangible assets |
|
$ |
904 |
|
|
$ |
125 |
|
|
$ |
1,029 |
|
Accumulated amortization |
|
|
(489 |
) |
|
|
(58 |
) |
|
|
(547 |
) |
|
Other intangible assets, net |
|
$ |
415 |
|
|
$ |
67 |
|
|
$ |
482 |
|
|
7
The amortization expense for these intangible assets was $17 million and $12 million for the three
months ended March 31, 2010 and 2009, respectively. The anticipated annual amortization expense
for intangible assets recorded as of March 31, 2010 is
$73 million in 2010, $70 million in 2011,
$66 million in 2012, $63 million in 2013, $60 million in 2014 and $58 million in 2015. The
increase in other intangible assets, net primarily related to the acquisition of ApaTech in the
first quarter of 2010. Refer to the discussion below for further information regarding ApaTech.
Asset impairments
Baxter has made and continues to make significant investments in assets, including inventory and
property, plant and equipment, which relate to potential new products or modifications to existing
products. The companys ability to realize value from these investments is contingent on, among
other things, regulatory approval and market acceptance of these new products. The company may
not be able to realize the expected returns from these investments, potentially resulting in asset
impairments in the future.
Variable interest entities
The consolidated financial statements include the accounts of VIEs in which Baxter is the primary
beneficiary. With respect to the VIEs that were consolidated by the company as of December 31,
2009, the first quarter 2010 adoption of a new accounting standard on VIEs did not change the
companys determination that it is the primary beneficiary of those VIEs. During the first quarter
of 2010, the company did not enter into any new arrangements in which it determined that the
company is the primary beneficiary of a VIE. As of March 31, 2010, the carrying amounts of the
consolidated VIEs assets and liabilities were not material to Baxters consolidated financial
statements. Refer to the 2009 Annual Report for further information about the VIEs consolidated by
the company.
Acquisitions of and investments in businesses and technologies
In March 2010, Baxter acquired all of the outstanding equity of ApaTech, an orthobiologic products
company based in the United Kingdom. As a result of the acquisition, Baxter acquired ACTIFUSE, a
silicate substituted calcium phosphate synthetic bone graft material which is currently marketed in
the United States, Europe and other select markets around the world, and manufacturing and research
and development (R&D) facilities located in the United Kingdom, the United States and Germany.
This acquisition complements the companys existing commercial and technical capabilities in
regenerative medicine. The total purchase price of up to $335 million is comprised of a $245
million up-front payment, as adjusted for closing date cash and net working capital-related
adjustments, and contingent payments of up to $90 million, which are associated with the
achievement of specified commercial milestones.
The following table summarizes the preliminary allocation of the fair value of assets acquired and
liabilities assumed at the acquisition date. The final allocation of the purchase price may result
in adjustments to the recognized amounts of assets and liabilities.
|
|
|
|
|
(in millions) |
|
|
|
|
|
Assets |
|
|
|
|
Current assets, including cash of $11 |
|
$ |
31 |
|
Property, plant and equipment, net |
|
|
13 |
|
Goodwill |
|
|
223 |
|
Other intangible assets |
|
|
77 |
|
Other assets |
|
|
7 |
|
|
|
|
|
|
Liabilities |
|
|
|
|
Accounts payable and accrued liabilities |
|
|
14 |
|
Contingent payments |
|
|
70 |
|
Other long-term liabilities |
|
|
22 |
|
|
Goodwill includes expected synergies and other benefits the company believes will result from the
acquisition. The other intangible assets primarily relate to developed technology and are being
amortized on a straight-line basis over an estimated average useful life of nine years. The
contingent payments of up to $90 million were recorded at their estimated fair value of $70
million. Future changes in the estimated fair value of the contingent payments will be
8
recognized immediately in earnings. The results of operations and assets and liabilities of
ApaTech are included in the BioScience segment, and the goodwill is included in this reporting
unit. A majority of the goodwill is not deductible for tax purposes. The pro forma impact of the
ApaTech acquisition was not significant to the results of operations of the company.
3. INFUSION PUMP AND OTHER CHARGES
Infusion pump charges
The company stopped shipment of COLLEAGUE infusion pumps in July 2005 in the United States, and
entered into a Consent Decree with the U.S. Food and Drug
Administration (the FDA) in June 2006. Refer
to Note 5 to the companys consolidated financial statements in the 2009 Annual Report for further
information regarding the COLLEAGUE infusion pumps and the SYNDEO PCA Syringe Pump.
On
April 30, 2010, and pursuant to the Consent Decree, the FDA ordered the company to recall from the market its approximately 200,000
COLLEAGUE infusion pumps currently in use in the United States. The
company expects to provide its customers with replacement infusion pumps or monetary consideration
in exchange for their COLLEAGUE infusion pumps. The company anticipates that, among other
alternatives to be provided to customers, the company will offer its
SIGMA SPECTRUM infusion pump
as a replacement infusion pump without charge. As provided for in the Consent Decree, the company
intends to propose refinements to the FDAs recall order and is in active dialogue
with the FDA regarding the terms of the recall. The final terms of the recall and offer to
customers remain subject to that ongoing dialogue.
In the first quarter of 2010, the company recorded a charge of $588 million in connection with this
recall and other actions the company intends to undertake outside of the United States. Included
in the charge were $142 million relating to asset impairments and $446 million for cash costs. The
asset impairments principally related to inventory, lease receivables and other assets relating to
the recalled pumps. The reserve for cash costs included an estimate of cash refunds or replacement
infusion pumps that will be offered to current owners in exchange for their COLLEAGUE infusion
pumps. Cash costs also included costs associated with the execution of the recall program and
customer accommodations. It is possible that substantial cash and non-cash charges, including significant asset impairments
related to the COLLEAGUE infusion pumps and related businesses, may be required in future periods
based on new information, changes in estimates, the outcome of the current dialogue with the FDA
and modifications to the FDA order, and other actions the company may be required to undertake in
other global markets.
Of the total charge, $213 million was recorded as a reduction of net sales and $375 million was
recorded in cost of sales. The amount recorded against net sales principally related to estimated
cash payments to customers.
Prior to
the charge recorded in the first quarter of 2010, from 2005 through
2009, the company recorded charges and other
costs totaling $337 million related to its COLLEAGUE and SYNDEO infusion pumps. In aggregate,
these charges included $270 million of cash costs and $67 million principally related to asset
impairments. These 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.
While the company will continue to work to resolve the issues associated with COLLEAGUE infusion
pumps globally (including working with the FDA to finalize the terms of the order and thereafter to
implement the order), 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
other products may not be adversely affected, or that additional legislation or regulation will
not be introduced that may adversely affect the companys operations and consolidated financial
statements.
The following table summarizes cash activity in the companys COLLEAGUE and SYNDEO infusion pump
reserves through March 31, 2010.
|
|
|
|
|
(in millions) |
|
|
|
|
|
Charges and adjustments in 2005 through 2009 |
|
$ |
270 |
|
Utilization in 2005 through 2009 |
|
|
(171 |
) |
|
Reserves at December 31, 2009 |
|
|
99 |
|
Charge |
|
|
446 |
|
Utilization |
|
|
(6 |
) |
|
Reserves at March 31, 2010 |
|
$ |
539 |
|
|
The
company expects to begin to utilize the reserves during 2010;
however, it is uncertain when the reserves will be fully utilized.
Other charges
The following is a summary of the 2009 cost optimization charge and a charge recorded in connection
with the divestiture of the Transfusion Therapies (TT) business in 2007. Refer to the 2009 Annual
Report for further information about these charges. The company expects that these reserves will
be substantially utilized by the end of 2010. The company believes that the reserves are adequate.
However, adjustments may be recorded in the future as the programs are completed.
2009 Cost Optimization Charge
In the fourth quarter of 2009, the company recorded a charge of $79 million related to costs
associated with optimizing its overall cost structure on a global basis. Of the total charge, $30
million was recorded in cost of sales
9
and $49 million was recorded in marketing and administrative expenses. Refer to Note 5 to the
companys consolidated financial statements in the 2009 Annual Report for further information
related to the charge.
Included in the charge were asset impairments of $10 million, relating to inventory and fixed
assets associated with discontinued products and projects. Also included in the charge was $69
million of cash costs, principally pertaining to severance and other employee-related costs. Cash
cost reserve utilization through March 31, 2010 was $16 million.
Transfusion Therapies
In connection with the TT divestiture in the first quarter of 2007, the company recorded a $35
million charge principally associated with severance and other employee-related costs. Reserve
utilization through March 31, 2010 was $28 million.
4. DEBT, FINANCIAL INSTRUMENTS AND FAIR VALUE MEASUREMENTS
Significant debt issuances
In March 2010, the company issued $600 million of senior unsecured notes, with $300 million
maturing in March 2013 and bearing a 1.8% coupon rate, and $300 million maturing in March 2020 and
bearing a 4.25% coupon rate. The net proceeds are being used for general corporate purposes,
including the refinancing of indebtedness.
Securitization arrangement
Where economical, the company has entered into agreements with various financial institutions in
which the entire interest in and ownership of the receivable is sold, consisting of trade
receivables originated in Japan. The company continues to service the receivables in
its Japanese securitization arrangement. Servicing assets or liabilities are not recognized
because the company receives adequate compensation to service the sold receivables. The Japanese
securitization arrangement includes limited recourse provisions, which are not material.
The companys securitization arrangement resulted in net cash outflows of $25 million and $19
million for the three months ended March 31, 2010 and 2009, respectively. The following is a
summary of the activity relating to the securitization arrangement.
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
Sold receivables at beginning of period |
|
$ |
147 |
|
|
$ |
154 |
|
Proceeds from sales of receivables |
|
|
117 |
|
|
|
124 |
|
Cash collections (remitted to the owners of the receivables) |
|
|
(142 |
) |
|
|
(143 |
) |
Effect of currency exchange rate changes |
|
|
(2 |
) |
|
|
(8 |
) |
|
Sold receivables at end of period |
|
$ |
120 |
|
|
$ |
127 |
|
|
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, Brazilian Real and Colombian Peso. 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. Market volatility and currency
fluctuations may reduce the benefits of the companys natural hedges and limit the companys
ability to cost-effectively hedge these exposures.
10
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 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 may use 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) 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.
Cash flow hedges are classified in other expense, net, cost of sales, and net interest expense, and
primarily relate to a hedge of U.S. Dollar-denominated debt issued by a foreign subsidiary,
forecasted intercompany sales denominated in foreign currencies and anticipated issuances of debt,
respectively.
The notional amounts of foreign exchange contracts and cross-currency swaps (used to hedge U.S.
Dollar-denominated debt issued by a foreign subsidiary) were $1.2 billion and $500 million,
respectively, as of both March 31, 2010 and December 31, 2009. The notional amount of interest
rate contracts outstanding at December 31, 2009 was $200 million. In the first quarter of 2010,
in conjunction with the debt issuance disclosed above, these contracts were terminated, resulting
in a gain of $18 million that will be amortized to net interest expense over the life of the
related debt.
The maximum term over which the company has cash flow hedge contracts in place related to
forecasted transactions at March 31, 2010 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 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. Fair value
hedges are classified in net interest expense, as they hedge the interest rate risk associated with
certain of the companys fixed-rate debt.
The total notional amount of interest rate contracts designated as fair value hedges was $1.9
billion as of March 31, 2010 and $1.6 billion as of December 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
11
remaining term of the hedged item. There were no hedge dedesignations in the first quarters of
2010 or 2009 resulting from changes in the companys assessment of the probability that the hedged
forecasted transactions would occur.
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, which substantially offsets the change in book value of the
hedged items, is recorded directly to other expense, net. The terms of these instruments generally
do not exceed one month.
The total gross notional amount of undesignated derivative instruments was $453 million as of March
31, 2010 and $419 million as of December 31, 2009.
Gains and Losses on Derivative Instruments
The following tables summarize the income statement locations and gains and losses on the companys
derivative instruments for the three months ended March 31, 2010.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain (loss) reclassified |
|
|
|
|
|
|
|
Location of gain (loss) |
|
from AOCI into the |
|
(in millions) |
|
Gain (loss) recognized in OCI |
|
|
in the income statement |
|
income statement |
|
|
Cash flow hedges |
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts |
|
|
$ (7 |
) |
|
Net interest expense |
|
|
$ 1 |
|
Foreign exchange contracts |
|
|
(1 |
) |
|
Net sales |
|
|
(1 |
) |
Foreign exchange contracts |
|
|
14 |
|
|
Cost of sales |
|
|
(5 |
) |
Foreign exchange contracts |
|
|
37 |
|
|
Other expense, net |
|
|
38 |
|
|
Total |
|
|
$43 |
|
|
|
|
|
|
|
$33 |
|
|
|
|
|
|
|
|
|
|
|
|
Gain (loss) recognized |
|
|
|
|
|
|
|
Location of gain (loss) |
|
in the income |
|
(in millions) |
|
|
|
|
|
in the income statement |
|
statement |
|
|
Fair value hedges |
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts |
|
|
|
|
|
Net interest expense |
|
|
$21 |
|
|
Undesignated derivative instruments |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
Other expense, net |
|
|
$(1 |
) |
|
|
The following tables summarize the income statement locations and gains and losses on the
companys derivative instruments for the three months ended March 31, 2009. |
|
|
|
|
|
|
|
|
|
|
Gain (loss) reclassified |
|
|
|
|
|
|
|
Location of gain (loss) |
|
from AOCI into the |
|
(in millions) |
|
Gain (loss) recognized in OCI |
|
|
in the income statement |
|
income statement |
|
|
Cash flow hedges |
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts |
|
|
$20 |
|
|
Net interest expense |
|
|
$(1 |
) |
Foreign exchange contracts |
|
|
(1 |
) |
|
Net sales |
|
|
2 |
|
Foreign exchange contracts |
|
|
12 |
|
|
Cost of sales |
|
|
24 |
|
Foreign exchange contracts |
|
|
(2 |
) |
|
Other expense, net |
|
|
9 |
|
|
Total |
|
|
$29 |
|
|
|
|
|
|
|
$34 |
|
|
|
|
|
|
|
|
|
|
Location of loss in |
|
Loss recognized in |
|
(in millions) |
|
|
|
|
|
the income statement |
|
the income statement |
|
|
Fair value hedges |
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts |
|
|
|
|
|
Net interest expense |
|
|
$(17 |
) |
|
Undesignated derivative instruments |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
Other expense, net |
|
|
$(27 |
) |
|
For the companys fair value hedges, equal and offsetting losses of $21 million and gains of
$17 million were recognized in net interest expense in the first quarters of 2010 and 2009,
respectively, as adjustments to the
12
underlying hedged item, fixed-rate debt. Ineffectiveness related to the companys cash flow and
fair value hedges for the year ended March 31, 2010 was not material.
As of March 31, 2010, $1 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.
Fair Values of Derivative Instruments
The following table summarizes the classification and fair value amounts of derivative instruments
reported in the consolidated balance sheet as of March 31, 2010.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
$ |
82 |
|
|
Other long-term liabilities |
|
$ |
2 |
|
Foreign exchange contracts |
|
Prepaid expenses and other |
|
|
24 |
|
|
Accounts payable
and accrued liabilities |
|
|
61 |
|
Foreign exchange contracts |
|
Other long-term assets |
|
|
2 |
|
|
Other long-term liabilities |
|
|
1 |
|
|
Total derivative instruments
designated as hedges |
|
|
|
|
|
$ |
108 |
|
|
|
|
|
|
$ |
64 |
|
|
Undesignated derivative instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
Prepaid expenses and other |
|
$ |
|
|
|
Accounts payable
and accrued liabilities |
|
$ |
|
|
|
Total derivative instruments |
|
|
|
|
|
$ |
108 |
|
|
|
|
|
|
$ |
64 |
|
|
|
The following table summarizes the classification and fair value amounts of derivative
instruments reported in the consolidated balance sheet as of December 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 |
|
Prepaid expenses and other |
|
$ |
25 |
|
|
Other long-term liabilities |
|
$ |
1 |
|
Interest rate contracts |
|
Other long-term assets |
|
|
60 |
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
Prepaid expenses and other |
|
|
20 |
|
|
Accounts payable and accrued liabilities |
|
|
112 |
|
|
Total derivative instruments
designated as hedges |
|
|
|
|
|
$ |
105 |
|
|
|
|
|
|
$ |
113 |
|
|
Undesignated derivative instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
Prepaid expenses and other |
|
$ |
|
|
|
Accounts payable and accrued liabilities |
|
$ |
|
|
|
Total derivative instruments |
|
|
|
|
|
$ |
105 |
|
|
|
|
|
|
$ |
113 |
|
|
13
Fair value measurements
The following table summarizes the bases used to measure financial assets and liabilities that are
carried at fair value on a recurring basis in the consolidated balance sheets.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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, 2010 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency hedges |
|
$ |
26 |
|
|
$ |
|
|
|
$ |
26 |
|
|
$ |
|
|
Interest rate hedges |
|
|
82 |
|
|
|
|
|
|
|
82 |
|
|
|
|
|
Equity securities |
|
|
17 |
|
|
|
17 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
125 |
|
|
$ |
17 |
|
|
$ |
108 |
|
|
$ |
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency hedges |
|
$ |
62 |
|
|
$ |
|
|
|
$ |
62 |
|
|
$ |
|
|
Interest rate hedges |
|
|
2 |
|
|
|
|
|
|
|
2 |
|
|
|
|
|
Contingent payments related to business acquisitions |
|
|
131 |
|
|
|
|
|
|
|
|
|
|
|
131 |
|
|
Total liabilities |
|
$ |
195 |
|
|
$ |
|
|
|
$ |
64 |
|
|
$ |
131 |
|
|
|
|
|
|
|
|
|
|
Basis of fair value measurement |
|
|
|
|
|
|
|
Quoted prices in |
|
|
|
|
|
|
Significant |
|
|
|
|
|
|
|
active markets for |
|
|
Significant other |
|
|
unobservable |
|
|
|
Balance at |
|
|
identical assets |
|
|
observable inputs |
|
|
inputs |
|
(in millions) |
|
December 31, 2009 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency hedges |
|
$ |
20 |
|
|
$ |
|
|
|
$ |
20 |
|
|
$ |
|
|
Interest rate hedges |
|
|
85 |
|
|
|
|
|
|
|
85 |
|
|
|
|
|
Equity securities |
|
|
13 |
|
|
|
13 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
118 |
|
|
$ |
13 |
|
|
$ |
105 |
|
|
$ |
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency hedges |
|
$ |
112 |
|
|
$ |
|
|
|
$ |
112 |
|
|
$ |
|
|
Interest rate hedges |
|
|
1 |
|
|
|
|
|
|
|
1 |
|
|
|
|
|
Contingent payments
related to business
acquisitions |
|
|
59 |
|
|
|
|
|
|
|
|
|
|
|
59 |
|
|
Total liabilities |
|
$ |
172 |
|
|
$ |
|
|
|
$ |
113 |
|
|
$ |
59 |
|
|
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 are considered observable and vary depending on the type of derivative, and include
contractual terms, interest rate yield curves, foreign exchange rates and volatility. The
contingent payments are valued using a discounted cash flow technique that reflects managements
expectations about probability of payment.
The following table is a reconciliation of the fair value measurements that use significant
unobservable inputs (Level 3), which consist of contingent payments related to business
acquisitions.
|
|
|
|
|
(in millions) |
|
|
|
|
|
Fair value as of January 1, 2010 |
|
$ |
59 |
|
Unrealized loss recognized in earnings |
|
|
2 |
|
Addition relating to the ApaTech acquisition |
|
|
70 |
|
|
Fair value as of March 31, 2010 |
|
$ |
131 |
|
|
The amount of total loss for the period included in earnings attributable to the change in
unrealized loss relating to liabilities held at March 31, 2010 was $2 million, and is reported in
cost of sales and R&D expenses. The addition during the first quarter of 2010 represents the fair
value of contingent payments associated with the companys acquisition of ApaTech. Refer to Note 2
for more information regarding ApaTech.
As
discussed further in Note 3, the company recorded an asset
impairment charge related to the recall of COLLEAGUE infusion pumps
from the U.S. market in the first quarter of 2010. As the assets had
no alternative use and no salvage value, the fair value, measured
using significant unobservable inputs (Level 3), was assessed to
be zero.
Book Values and Fair Values of Financial Instruments
In addition to the financial instruments that the company is required to recognize at fair value on
the consolidated balance sheets, the company has certain financial instruments that are recognized
at historical cost or some basis other than fair value. For these financial instruments, the
following table provides the value recognized on the consolidated balance sheets and the
approximate fair value as of March 31, 2010 and December 31, 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Book values |
|
|
Approximate fair values |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term insurance receivables |
|
$ |
25 |
|
|
$ |
49 |
|
|
$ |
24 |
|
|
$ |
47 |
|
Investments |
|
|
31 |
|
|
|
31 |
|
|
|
32 |
|
|
|
31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term debt |
|
|
15 |
|
|
|
29 |
|
|
|
15 |
|
|
|
29 |
|
Current maturities of long-term debt and
lease obligations |
|
|
682 |
|
|
|
682 |
|
|
|
692 |
|
|
|
697 |
|
Other long-term debt and lease obligations |
|
|
4,056 |
|
|
|
3,440 |
|
|
|
4,205 |
|
|
|
3,568 |
|
Long-term litigation liabilities |
|
|
36 |
|
|
|
45 |
|
|
|
35 |
|
|
|
44 |
|
|
The estimated fair values of insurance receivables and long-term litigation liabilities were
computed by discounting the expected cash flows based on currently available information, which in
many cases does not include final orders
14
or settlement agreements. The discount factors used in the calculations reflect the
non-performance risk of the insurance providers and the company, respectively. The estimated fair
values of current and long-term debt and lease obligations were computed by multiplying price by
the notional amount of the respective debt instrument. Price is calculated using the stated terms
of the respective debt instrument and yield curves commensurate with the companys credit risk. In
determining the fair value of cost method investments, the company takes into consideration recent
transactions, as well as the financial information of the investee. The carrying values of the
other financial instruments approximate their fair values due to the short-term maturities of most
of these assets and liabilities.
5. COMMON STOCK
Stock-based compensation plans
Stock compensation expense totaled $30 million and $38 million for the three months ended March 31,
2010 and 2009, respectively. A majority 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 2010, the company awarded its annual stock compensation grants, which consisted of
approximately 8.0 million stock options and 574,000 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, |
|
|
|
2010 |
|
|
2009 |
|
|
Expected volatility |
|
|
22% |
|
|
|
30% |
|
Expected life (in years) |
|
|
4.5 |
|
|
|
4.5 |
|
Risk-free interest rate |
|
|
2.0% |
|
|
|
1.8% |
|
Dividend yield |
|
|
2.0% |
|
|
|
2.0% |
|
Fair value per stock option |
|
|
$10 |
|
|
|
$12 |
|
|
The total intrinsic value of stock options exercised during the three months ended March 31, 2010
and 2009 was $60 million and $29 million, respectively.
As of March 31, 2010, $129 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, |
|
|
|
2010 |
|
|
2009 |
|
|
Baxter volatility |
|
|
26% |
|
|
|
25% |
|
Peer group volatility |
|
|
20% - 59% |
|
|
|
20% - 59% |
|
Correlation of returns |
|
|
0.29 - 0.63 |
|
|
|
0.30 - 0.61 |
|
Risk-free interest rate |
|
|
1.3% |
|
|
|
1.6% |
|
Fair value per PSU |
|
|
$64 |
|
|
|
$65 |
|
|
As of March 31, 2010, unrecognized compensation cost related to all unvested PSUs of $58 million is
expected to be recognized as expense over a weighted-average period of 2.2 years, and unrecognized
compensation cost related to all unvested restricted stock units of $8 million is expected to be
recognized as expense over a weighted-average period of 2.1 years.
15
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, 2010, the company repurchased 7.5 million shares for $435
million under the board of directors July 2009 $2.0 billion share repurchase authorization. At
March 31, 2010, $1.5 billion 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 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 and cash flows 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
Since 2000, Baxters generic sevoflurane has been the subject of several patent infringement
actions initiated by Abbott Laboratories and Central Glass Company. The initial lawsuit in the
United States was resolved in Baxters favor in 2007 by the Court of Appeals for the Federal
Circuits decision that the asserted patent was invalid. In 2009, a lawsuit filed in Japan was
also resolved in Baxters favor by the appellate courts determination that Baxters generic
sevoflurane did not infringe the Japanese patent at issue.
Related actions remain pending in the U.S. and Colombia. A patent infringement action is pending in
the U.S.D.C. for the Northern District of Illinois on a second patent owned by Abbott and Central
Glass. In September 2009, the District Court granted summary judgment of non-infringement in favor
of Baxter. Abbott has requested reconsideration of this ruling. 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
In October 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
16
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, granted Baxters
request for royalties on Fresenius sales of the 2008K hemodialysis machines during a nine-month
transition period before the permanent injunction took effect, and granted a royalty on
disposables. On September 10, 2009, the appellate court affirmed Fresenius liability for
infringing valid claims of Baxters main patent, invalidated certain claims of other patents, and
remanded the case to the district court to finalize the scope of the injunction and the amount of
damages owed to Baxter. In November 2009, the appellate court denied Fresenius petition for
re-hearing of the appeal. In January 2010, Fresenius consented to reentry of the injunction and
sought a new trial to determine royalties, which the company is opposing. In March 2010, the
United States Patent and Trademark Offices (USPTO) appellate board affirmed the previous
determination by the USPTO patent examiner that the remaining patent was invalid. The company is
seeking reconsideration of that decision with the board, and if unsuccessful, will appeal the
USPTOs decision to the same appellate court that affirmed the validity of the patent in September
2009. Fresenius has asked the trial court to stay further court proceedings during the pendency of
the companys appeal of the USPTOs negative determination.
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.
On September 28, 2009, the trial court partially granted Baxters motion for judgment on the
pleadings, dismissing claims related to the 2004 time-frame. Fact and expert discovery has been
completed in this matter. Summary judgment in the company's favor was
granted in May 2010.
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 infusion pumps that were on hold in
Northern Illinois. Customer-owned pumps were not affected. On June 29, 2006, Baxter Healthcare
Corporation entered into a Consent Decree for Condemnation and Permanent Injunction with the United
States to resolve this seizure litigation. Pursuant to the Consent
Decree, in April 2010 the FDA ordered the company to recall all
of its COLLEAGUE infusion pumps currently in use in the United
States. Additional third-party claims may be filed in
connection with the COLLEAGUE matter. In September 2009, the company received a subpoena from the
Office of the United States Attorney of the Northern District of Illinois requesting production of
documents relating to the COLLEAGUE infusion pump. The company is fully cooperating with the
request.
The company is a defendant, along with others, in eleven lawsuits brought in various U.S. federal
courts alleging that Baxter and certain of its competitors conspired to restrict output and
artificially increase the price of plasma-derived therapies since 2004. The complaints attempt to
state a claim for class action relief and in some cases demand treble damages. These cases have
been consolidated for pretrial proceedings before the U.S.D.C. for the Northern District of
Illinois.
In connection with the recall of heparin products in the United States, approximately 740 lawsuits
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. A trial date for the first of these cases is scheduled for
early 2011. In September 2008, a number of state court cases were consolidated in Cook County,
Illinois for pretrial case management, with a scheduled trial date for the first of these cases in
May 2011. Discovery is ongoing with respect to these matters.
The company is a defendant, along with others, in numerous lawsuits filed in state court in
Las Vegas, Nevada. These lawsuits allege that health care workers improperly reused vials of
propofol during endoscopy procedures, which resulted in the transmission of Hepatitis C to
patients. These lawsuits allege that Teva Pharmaceuticals USA, Inc. (Teva) (as the manufacturer)
and the company (as the distributor) improperly designed, manufactured and sold larger vials of
propofol to these endoscopy centers. The first case went to trial against Teva and the company in
April 2010. The jury awarded the plaintiffs $5 million in compensatory damages and $500 million in
punitive damages ($356 million against Teva and $144 million against the company). Teva and the
company plan to appeal this decision. Additionally, Baxter believes it is entitled to indemnity in these matters pursuant to an indemnity
agreement entered into with Teva in 2009.
The company is a defendant, along with others, in less than a dozen lawsuits which allege that
Baxter and other defendants manipulated product reimbursements by, among other things, reporting
artificially inflated average wholesale prices for Medicare and Medicaid eligible drugs. The cases
have been consolidated for pretrial purposes before the U.S.D.C. for the District of Massachusetts.
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
17
of 2010. Baxter has also resolved a number of other cases brought by state attorneys general and
other plaintiffs. A small number of lawsuits against Baxter brought by relators, state attorneys
general and New York entities remain 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.
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. Baxter and other defendants have announced
a settlement offer with respect to these claims. The fully reserved settlement is contingent on
receiving acceptance from a significant percentage of the claimants in 2010.
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 processes 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 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, 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 in this report. 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 a segment.
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 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. Refer to Note 3 to the companys consolidated financial statements
in the 2009 Annual Report for further information regarding the TT divestiture.
Included
in the Medication Delivery segment's pre-tax loss in the first
quarter of 2010 was a $588 million charge related to the recall
of COLLEAGUE infusion pumps from the U.S. market. Refer to
Note 3 for further information regarding the COLLEAGUE infusion
pump charge.
18
Financial information for the companys segments is as follows.
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
Net sales |
|
|
|
|
|
|
|
|
BioScience |
|
$ |
1,362 |
|
|
$ |
1,252 |
|
Medication Delivery |
|
|
969 |
|
|
|
1,035 |
|
Renal |
|
|
584 |
|
|
|
515 |
|
Transition services to Fenwal |
|
|
12 |
|
|
|
22 |
|
|
Total |
|
$ |
2,927 |
|
|
$ |
2,824 |
|
|
Pre-tax
income (loss) |
|
|
|
|
|
|
|
|
BioScience |
|
$ |
554 |
|
|
$ |
509 |
|
Medication Delivery |
|
|
(342 |
) |
|
|
168 |
|
Renal |
|
|
85 |
|
|
|
50 |
|
|
Total pre-tax income from segments |
|
$ |
297 |
|
|
$ |
727 |
|
|
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.
The
following is a reconciliation of segment pre-tax income to income
before income taxes per the condensed consolidated statements of (loss) income.
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
Total pre-tax income from segments |
|
$ |
297 |
|
|
$ |
727 |
|
Unallocated amounts |
|
|
|
|
|
|
|
|
Stock compensation |
|
|
(30 |
) |
|
|
(38 |
) |
Net interest expense |
|
|
(19 |
) |
|
|
(26 |
) |
Certain foreign currency fluctuations and hedging activities |
|
|
9 |
|
|
|
42 |
|
Other Corporate items |
|
|
(145 |
) |
|
|
(68 |
) |
|
Income before income taxes |
|
$ |
112 |
|
|
$ |
637 |
|
|
19
|
|
|
Item 2.
|
|
Managements Discussion and Analysis of Financial Condition and Results of Operations |
Refer to the companys Annual Report on Form 10-K for the year ended December 31, 2009 (2009 Annual
Report) for managements discussion and analysis of the financial condition and results of
operations of the company. 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, 2010.
RESULTS OF OPERATIONS
NET SALES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
|
March 31, |
|
|
|
Percent |
|
(in millions) |
|
|
2010 |
|
|
|
2009 |
|
|
|
change |
|
|
BioScience |
|
$ |
1,362 |
|
|
$ |
1,252 |
|
|
|
9% |
|
Medication Delivery |
|
|
969 |
|
|
|
1,035 |
|
|
|
(6%) |
|
Renal |
|
|
584 |
|
|
|
515 |
|
|
|
13% |
|
Transition services to Fenwal Inc. |
|
|
12 |
|
|
|
22 |
|
|
|
(45% |
) |
|
Total net sales |
|
$ |
2,927 |
|
|
$ |
2,824 |
|
|
|
4% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
|
March 31, |
|
|
|
Percent |
|
(in millions) |
|
|
2010 |
|
|
|
2009 |
|
|
|
change |
|
|
International |
|
$ |
1,847 |
|
|
$ |
1,583 |
|
|
|
17% |
|
United States |
|
|
1,080 |
|
|
|
1,241 |
|
|
|
(13%) |
|
|
Total net sales |
|
$ |
2,927 |
|
|
$ |
2,824 |
|
|
|
4% |
|
|
Foreign currency favorably impacted net sales growth by 6 percentage points in the first quarter of
2010 principally due to the weakening of the U.S. Dollar relative to other currencies, including
the Euro, the Australian Dollar and the British Pound, during the same period in the prior year.
Healthcare reform legislation enacted in the United States in the first quarter of 2010 unfavorably
impacted sales growth in the quarter by approximately 0.5 percentage points, principally in the
BioScience segment. The company expects that the healthcare reform legislation will continue to
unfavorably impact sales growth throughout the remainder of 2010 as a result of an increase in
Medicaid rebates and the expansion of the 340B Drug Pricing Program.
Included
as a reduction to net sales in the first quarter of 2010 was $213 million of
the company's $588 million charge related to the recall of
COLLEAGUE infusion pumps from the U.S. market. The charge, included
in the Medication Delivery segment, unfavorably impacted sales growth
in the quarter by 7 percentage points. Refer to Note 3 for
further information regarding the COLLEAGUE infusion pump charge.
BioScience
The following is a summary of sales by product category in the BioScience segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
|
March 31, |
|
|
|
Percent |
|
(in millions) |
|
|
2010 |
|
|
|
2009 |
|
|
|
change |
|
|
Recombinants |
|
$ |
510 |
|
|
$ |
451 |
|
|
|
13% |
|
Plasma Proteins |
|
|
292 |
|
|
|
274 |
|
|
|
7% |
|
Antibody Therapy |
|
|
322 |
|
|
|
337 |
|
|
|
(4% |
) |
Regenerative Medicine |
|
|
119 |
|
|
|
99 |
|
|
|
20% |
|
Other |
|
|
119 |
|
|
|
91 |
|
|
|
31% |
|
|
Total net sales |
|
$ |
1,362 |
|
|
$ |
1,252 |
|
|
|
9% |
|
|
Net sales in the BioScience segment increased 9% during the first quarter of 2010 (including a 6
percentage point benefit from foreign currency). Overall sales growth in the BioScience segment
was unfavorably impacted by healthcare reform legislation enacted in the United States in the first
quarter of 2010, principally in the Antibody Therapy, Plasma Proteins and Recombinants product
categories. Sales growth in the Recombinants product category was the result of increased sales of
the companys advanced recombinant therapy, ADVATE [Antihemophilic Factor (Recombinant),
Plasma/Albumin-Free Method], due to continued customer adoption of this therapy and increased
demand for new dosage forms that provide more precise dosing and convenience for patients.
20
Excluding the impact of foreign currency, sales in the Plasma Proteins product category declined
slightly, as increased demand for FEIBA (an anti-inhibitor coagulant complex) and certain other
plasma-derived products, and improved demand in the United States for ARALAST [alpha 1-proteinase
inhibitor (human)],
were more than offset by reduced demand for albumin in the United States and decreased
international sales of plasma-derived factor VIII. Lower net sales in the Antibody Therapy product
category were due to lower overall market growth, share erosion, and increased Medicaid rebates,
principally 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), as
well as a decline in sales of WinRho SDF [Rho(D) Immune Globulin Intravenous (Human)]. The company
anticipates continuing near-term volatility in results for plasma-based therapies (Plasma Proteins
and Antibody Therapy), driven by market and broader economic pressures on pricing and unit demand.
Also driving the overall sales growth of the BioScience segment were increased sales of the
companys sealant products, FLOSEAL, COSEAL and TISSEEL, in the Regenerative Medicine product
category, and increased international sales of CELVAPAN H1N1 pandemic vaccine, which more than
offset the lower international demand for FSME-IMMUN (a tick-borne encephalitis vaccine), in the
Other product category.
Medication Delivery
The following is a summary of sales by product category in the Medication Delivery segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
|
March 31, |
|
|
|
Percent |
|
(in millions) |
|
|
2010 |
|
|
|
2009 |
|
|
|
change |
|
|
IV Therapies |
|
$ |
391 |
|
|
$ |
344 |
|
|
|
14% |
|
Global Injectables |
|
|
451 |
|
|
|
371 |
|
|
|
22% |
|
Infusion Systems |
|
|
(4) |
|
|
|
199 |
|
|
|
(102%) |
|
Anesthesia |
|
|
127 |
|
|
|
109 |
|
|
|
17% |
|
Other |
|
|
4 |
|
|
|
12 |
|
|
|
(67% |
) |
|
Total net sales |
|
$ |
969 |
|
|
$ |
1,035 |
|
|
|
(6%) |
|
|
Net sales
for the Medication Delivery segment decreased 6% during the first quarter of 2010
(including a 6 percentage point benefit from foreign currency) principally due to the unfavorable impact of a $213 million
charge related to the recall of COLLEAGUE infusion pumps from the
U.S. market. Intravenous (IV) Therapies sales growth was
driven by improved pricing and increased global demand for nutritional products and IV solutions.
Within the Global Injectables product category, sales growth was driven by strong sales in the
international pharmacy compounding and the U.S. pharmaceutical partnering businesses. In the
Infusion Systems product category, net sales declined as a result of
a charge
related to the recall of COLLEAGUE infusion pumps and lower sales of disposable tubing sets used in the
administration of IV solutions. The company anticipates that, among
other alternatives to be provided to customers, the company will
offer its available Sigma International General Medical Apparatus,
LLC (SIGMA) SPECTRUM infusion pumps as a replacement pump without
charge. Sales growth in the Anesthesia
product category was driven by
increased demand for SUPRANE (desflurane) and sevoflurane.
Renal
The following is a summary of sales by product category in the Renal segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
|
March 31, |
|
|
|
Percent |
|
(in millions) |
|
|
2010 |
|
|
|
2009 |
|
|
|
change |
|
|
PD Therapy |
|
$ |
474 |
|
|
$ |
420 |
|
|
|
13% |
|
HD Therapy |
|
|
110 |
|
|
|
95 |
|
|
|
16% |
|
|
Total net sales |
|
$ |
584 |
|
|
$ |
515 |
|
|
|
13% |
|
|
Net sales in the Renal segment increased 13% during the first quarter of 2010 (including an 8
percentage point benefit from foreign currency). Net sales increased due to an increase in the
number of peritoneal dialysis (PD) patients, particularly in the United States, Latin America and
Eastern Europe and double-digit growth across Asia. Penetration of PD Therapy products continues
to be strong in emerging markets where many people with end-stage renal disease are currently
under-treated. Net sales growth in the Hemodialysis (HD) Therapy product category was driven by
Continuous Renal Replacement Therapy sales related to the companys acquisition of certain assets
of the Edwards Lifesciences Corporation hemofiltration business in the third quarter of 2009.
21
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 2009 Annual Report for
additional information regarding the TT divestiture.
GROSS MARGIN AND EXPENSE RATIOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
(as a percent of net sales) |
|
|
2010 |
|
|
|
2009 |
|
|
|
Change |
|
|
Gross margin |
|
|
35.6% |
|
|
|
52.7% |
|
|
(17.1 pts |
) |
Marketing and administrative expenses |
|
|
23.3% |
|
|
|
21.6% |
|
|
1.7 pts |
|
|
Gross Margin
The gross margin percentage declined in the first quarter of 2010. Improvements in sales mix
across all three segments were more than offset by the impact of a
charge in the first quarter of 2010 totaling $588 million
related to the recall of COLLEAGUE infusion pumps from the U.S.
market, which unfavorably impacted the gross margin rate by 16.3 percentage
points, an increase in Medicaid rebates
resulting from healthcare reform legislation enacted in the United States in the first quarter and
increased inventory reserves relating to the companys CELVAPAN H1N1 pandemic vaccine. In
addition, the gross margin rate in the prior year was favorably impacted by foreign currency.
Marketing and Administrative Expenses
The increase in the marketing and administrative expense ratio in the first quarter of 2010 was
principally due to a charge to net sales in the first quarter of 2010
related to the recall of COLLEAGUE infusion pumps, which unfavorably
impacted the marketing and administrative expense ratio by 1.5
percentage points. Marketing and administrative expenses
were $683 million in the first quarter of 2010, an increase of 12% over the $611 million reported
in the first quarter of 2009. This increase was driven by increased
spending on new marketing programs, higher employee benefit costs
and the unfavorable impact of foreign currency, partially offset by
the impact of stronger cost controls.
RESEARCH AND DEVELOPMENT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
(in millions) |
|
|
2010 |
|
|
|
2009 |
|
|
|
Change |
|
|
Research and development expenses |
|
|
$227 |
|
|
|
$212 |
|
|
|
7% |
|
as a percent of net sales |
|
|
7.8% |
|
|
|
7.5% |
|
|
0.3 pts |
|
|
Research and development (R&D) expenses increased during the first quarter of 2010, principally
driven by continued investments in R&D in the BioScience segment and the unfavorable impact of
foreign currency. While the company will continue to invest in its R&D pipeline as part of the
execution of its long-term growth strategy, growth in R&D expenses is expected to be flat in 2010.
The first quarter of 2010 charge to net sales related to the recall
of COLLEAGUE infusion pumps unfavorably impacted the R&D expense
ratio by 0.6 percentage points. Refer to the 2009 Annual Report for a discussion of the companys R&D pipeline.
NET INTEREST EXPENSE
Net interest expense was $19 million in the first quarter of 2010, compared to $26 million in the
first quarter of 2009. The decrease was principally driven by an increase in interest income, with
the impact of a higher average cash balance more than offsetting the impact of lower interest
rates.
OTHER EXPENSE, NET
Other expense, net was $2 million in the first quarter of 2010 and the first quarter of 2009.
Included in both periods were amounts related to foreign currency fluctuations, principally
relating to intercompany receivables, payables and loans denominated in a foreign currency.
PRE-TAX INCOME
Refer to Note 7 for a summary of financial results by segment. The following is a summary of
significant factors impacting the segments financial results.
22
BioScience
Pre-tax income increased 9% in the first quarter of 2010. The impact of strong sales of
higher-margin products, fueled by the continued customer adoption of ADVATE therapy, and the
favorable impact of foreign currency were partially offset by an increase in Medicaid rebates
resulting from healthcare reform legislation enacted in the United States in the first quarter,
increased inventory reserves related to the companys CELVAPAN H1N1 pandemic vaccine, and increased
R&D
spending, particularly related to several clinical trials for the evaluation of GAMMAGARD LIQUID
therapy for a number of potential indications.
Medication Delivery
Pre-tax
loss was $342 million in the first quarter of 2010 compared to
pre-tax income of $168 million in the first quarter of 2009. The decrease was driven by a charge in the first quarter of 2010
totaling $588 million related to the recall of COLLEAGUE
infusion pumps from the U.S. market. Partially offsetting the impact
of the charge were strong sales
growth, gross margin improvement resulting from favorable product mix and manufacturing cost
improvements, and the favorable impact of foreign currency.
Renal
Pre-tax income increased 70% in the first quarter of 2010. The increase was primarily due to the
continued increases in PD Therapy patients, favorable product mix, and the favorable impact of
foreign currency.
Other
Certain items are maintained at the companys corporate level and are not allocated to the
segments. These amounts are detailed in the table in Note 7 and primarily include most of the
companys debt and cash and equivalents and related 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 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. Refer to Note 5 regarding stock compensation expense and the previous discussion for
further information regarding net interest expense.
INCOME TAXES
The
companys effective income tax rate was 153.6% and 18.7% in the first quarters of 2010 and 2009,
respectively. The companys effective income tax rate differs from the U.S. federal statutory rate
each year due to certain operations that are subject to tax incentives, state and local taxes, and
foreign taxes that are different than the U.S. federal statutory rate. In addition, the effective
tax rate can be impacted each period by discrete factors and events.
The increase in the effective tax rate in the first quarter of 2010
was principally due to a $588 million charge related to the
recall of COLLEAGUE infusion pumps from the U.S. market for which
there was no net tax benefit recognized. The effective tax rate in the
first quarter of 2010 was also impacted by a $39 million write-off of a deferred tax asset as a result
of a change in the tax treatment of reimbursements under the Medicare Part D retiree prescription
drug subsidy program under healthcare reform legislation recently enacted in the United States.
The company anticipates that the effective tax rate for the full-year 2010 will be approximately
19.5%, excluding the impact from audit developments and other special items, such as the item in
the first quarter of 2010 noted above.
(LOSS) INCOME
AND EARNINGS (LOSS) PER DILUTED SHARE
Net loss attributable to Baxter was $63 million, or $0.11 per diluted share, for the first quarter
of 2010, compared to net income attributable to Baxter of $516 million, or $0.83 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 increased during the first quarter of 2010 as compared to the prior
year, totaling $279 million in the first quarter of 2010 and $237 million in the first quarter of
2009. The increase in cash flows from
23
operations was primarily due to higher earnings (before
non-cash items) and the other factors discussed below. Included in cash flows from operations in
the first quarters of 2010 and 2009 were outflows of $31 million and $78 million, respectively,
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.
Accounts Receivable
Cash flows relating to accounts receivable decreased during the first quarter of 2010 as compared
to the prior year. Days sales outstanding increased from 52.1 days at March 31, 2009 to 58.5 days
at March 31, 2010, primarily due to the impact of the first quarter of 2010 charge related to the recall of COLLEAGUE infusion pumps, which increased days sales outstanding by 5.4 days.
Also impacting days sales outstanding was the geographic mix of sales and increased collection periods in
certain international locations, partially offset by improved collection periods in the United
States and an increase in the factoring of receivables.
Inventories
Cash outflows relating to inventories increased in 2010. The following is a summary of inventories
at March 31, 2010 and December 31, 2009, as well as annualized inventory turns for the three months
ended March 31, 2010 and 2009, by segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Annualized inventory |
|
|
|
Inventories |
|
|
turns for the three |
|
|
|
March 31, |
|
|
December 31, |
|
|
months ended March 31, |
|
(in millions, except inventory turn data) |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
BioScience |
|
$ |
1,568 |
|
|
$ |
1,592 |
|
|
|
1.29 |
|
|
|
1.28 |
|
Medication Delivery |
|
|
637 |
|
|
|
705 |
|
|
|
6.44 |
|
|
|
2.98 |
|
Renal |
|
|
268 |
|
|
|
257 |
|
|
|
4.16 |
|
|
|
4.16 |
|
Other |
|
|
4 |
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
Total company |
|
$ |
2,477 |
|
|
$ |
2,557 |
|
|
|
2.93 |
|
|
|
2.10 |
|
|
The higher inventory turns for the total company were principally due to the impact of the first
quarter of 2010 charge related to the recall of COLLEAGUE infusion pumps in the Medication Delivery segment. The COLLEAGUE infusion pump charge increased the Medication Delivery segment and total company inventory turns
by 2.84 and 0.69, respectively.
Other
Cash
outflows related to liabilities, restructuring and cost optimization payments and other decreased in the first three months of 2010. Higher discretionary cash contributions to the
companys pension plan in the United States, which were $300 million and $100 million in the first quarters of 2010 and 2009,
respectively, were more than offset by lower outflows relating to
accounts payable and accrued liabilities and decreased payments
related to the companys restructuring and cost optimization programs.
Cash flows from investing activities
Capital Expenditures
Capital expenditures increased $59 million in the first quarter of 2010, from $171 million in 2009
to $230 million in 2010. The companys investments in capital expenditures are focused on projects
that enhance the companys cost structure and manufacturing capabilities across the three
businesses. In addition, the company continues to invest to support its strategy of geographic
expansion with select investments in growing markets, and continues to invest to support the
companys ongoing strategic focus on R&D with the expansion of research facilities, pilot
manufacturing sites and laboratories.
Acquisitions of and Investments in Businesses and Technologies
Cash outflows relating to acquisitions of and investments in businesses and technologies of $234
million in the first quarter of 2010 related to the acquisition of all of the outstanding equity of
ApaTech Limited (ApaTech), an orthobiologic products company based in the United Kingdom. Cash
outflows in the first quarter of 2010 consisted of the $245 million up-front purchase price,
adjusted for closing date cash of $11 million. Refer to Note 2 for further information about the
acquisition of ApaTech.
Other
There were no cash flows relating to other investing activities in the first quarter of 2010. Cash
outflows in the first quarter of 2009 principally related to an increase in short-term investments.
24
Cash flows from financing activities
Debt Issuances, Net of Payments of Obligations
Net cash inflows related to debt and other financing obligations totaled $589 million and $194
million in the first quarters of 2010 and 2009, respectively. In March 2010, the company issued
$600 million of senior unsecured notes, with $300 million maturing in March 2013 and bearing a 1.8%
coupon rate, and $300 million maturing in March 2020 and bearing a 4.25% coupon rate. The net
proceeds from this issuance are being used for general corporate purposes, including the
refinancing of indebtedness. Included in the net cash inflows in the first quarter of 2009 was the
February 2009 issuance of $350 million of senior unsecured notes, which mature in March 2014 and
bear a 4.0% coupon rate, and the repayment of approximately $160 million of outstanding borrowings
related to its Euro-denominated credit facility.
Other Financing Activities
Cash dividend payments totaled $174 million and $160 million in the first quarters of 2010 and
2009, respectively. The increase in cash dividend payments was primarily due to a 12% increase in
the quarterly dividend rate compared to the prior year. In February 2010, the board of directors
declared a quarterly dividend of $0.29 per share, paid on April 1, 2010 to shareholders of record
on March 10, 2010.
Proceeds and realized excess tax benefits from stock issued under employee benefit plans increased
by $32 million, from $139 million in the first quarter of 2009 to $171 million in the first quarter
of 2010, primarily due to an increase in stock option exercises, partially offset by a decrease in
realized excess tax benefits (as further discussed above).
Stock repurchases totaled $435 million and $566 million in the first quarters of 2010 and 2009,
respectively. 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 July
2009, the board of directors authorized the repurchase of up to $2.0 billion of the companys
common stock. At March 31, 2010, $1.5 billion 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 $406 million at March 31, 2010, 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, 2010, 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, 2010. 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 2009 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 $2.7 billion of cash and equivalents at March 31, 2010. 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 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. 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.
While the current economic downturn has not meaningfully impacted the companys ability to collect
receivables, the company continues to do business with certain foreign governments which have
recently experienced credit rating downgrades and may become unable to pay for the companys
products or services.
25
Credit ratings
There were no changes in the companys credit ratings in the first three months of 2010. Refer to
the 2009 Annual Report for further discussion of the companys credit ratings.
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 2009 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 2009 Annual Report. Other than changes required
due to the issuance of new accounting pronouncements, there have been no significant changes in the
companys application of its critical accounting policies during 2010.
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 and cash flows 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
In July 2005, the company stopped shipment of COLLEAGUE infusion 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 (the 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. Additional
Class I recalls related to remediation and repair and maintenance activities were addressed by the
company in 2007 and 2009. Pursuant to the Consent Decree, in April 2010 the FDA ordered the company to recall COLLEAGUE infusion pumps currently in use in the
United States. As discussed in Note 3, the company has recorded a
charge against its first quarter results related to the FDAs
order and other actions the company intends to undertake outside the
United States, in addition to a number of earlier charges in connection
with its COLLEAGUE infusion pumps. As discussed in Note 6, the company received a subpoena from the Office of the United
States Attorney of the Northern District of Illinois relating to the COLLEAGUE infusion pump in
September 2009. It is possible that substantial cash and non-cash charges, including significant asset impairments related to the COLLEAGUE infusion pumps and related
businesses, may be required in future periods based on new information, changes in estimates, the outcome of the current dialogue with the FDA and modifications to the FDA order, and other
actions the company may be required to undertake in other global markets.
In March 2010, the FDA classified the companys Urgent Product Recall regarding Increased
Intraperitoneal Volume (IIPV), or overfill of the abdominal cavity, associated with the companys
HomeChoice and HomeChoice Pro peritoneal dialysis cyclers as a Class I recall. The company is
working with the FDA to address the recall.
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
other products 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, 2009 for additional discussion of regulatory matters.
26
FORWARD-LOOKING INFORMATION
This quarterly report includes forward-looking statements, including statements with respect to
accounting estimates and assumptions, including those made in
connection with the charges related to the recall of the companys COLLEAGUE infusion pumps, litigation related matters including outcomes, the companys
efforts to recall and remediate its COLLEAGUE infusion pumps and other regulatory matters, expectations with respect to
restructuring and cost optimization programs (including expected cost savings), strategic plans,
geographic expansion, credit exposure to foreign governments, expectations with respect to
business development activities, estimates of liabilities, ongoing tax audits and related tax
provisions, expectations with respect to the companys hedging activities including its exposure
to financial market volatility and foreign currency 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, repurchases of the companys common stock, the
effective tax rate in 2010, and all other statements that do not relate to historical facts. The
statements are based on assumptions about many important factors, including assumptions
concerning:
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demand for and market acceptance risks for new and existing products, such as
ADVATE and plasma-based therapies (including Antibody Therapy), and other therapies; |
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fluctuations in supply and demand and the pricing of plasma-based therapies; |
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recently enacted healthcare reform legislation in the United States including its effect
on pricing, reimbursement, taxation and rebate policies; |
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future actions of governmental authorities and other third parties including third party
payers as recently adopted healthcare reform legislation is implemented in the United
States; |
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additional legislation, regulation and other governmental pressures in the United States
or globally, which may affect pricing, reimbursement, taxation and rebate policies of
government agencies and private payers or other elements of the companys business; |
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the companys ability to identify business development and growth opportunities
for existing products; |
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product quality or patient safety issues, leading to product recalls, withdrawals,
launch delays, sanctions, seizures, litigation, or declining sales; |
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future actions of the FDA or any other regulatory body or government authority 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 infusion pumps; |
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final resolution of the FDAs April 2010 order to recall all of the companys COLLEAGUE infusion pumps currently
in use in the United States as well as any additional actions required globally; |
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the companys ability to fulfill demand for its SIGMA SPECTRUM infusion pump as a result of the recall of its COLLEAGUE infusion pumps currently in use in the United States; |
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foreign currency fluctuations, particularly due to reduced benefits from the companys
natural hedges and limitations on the ability to cost-effectively hedge resulting from
financial market and currency volatility; |
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reimbursement or rebate policies of government agencies and private payers; |
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product development risks, including satisfactory clinical performance, the ability to
manufacture at appropriate scale, and the general unpredictability associated with the
product development cycle; |
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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; |
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the impact of geographic and product mix on the companys sales; |
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the impact of competitive products and pricing, including generic competition, drug
reimportation and disruptive technologies; |
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inventory reductions or fluctuations in buying patterns by wholesalers or distributors; |
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the availability and pricing of acceptable raw materials and component supply; |
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global regulatory, trade and tax policies; |
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any changes in law concerning the taxation of income, including income earned outside
the United States; |
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actions by tax authorities in connection with ongoing tax audits; |
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the companys ability to realize the anticipated benefits of restructuring and
optimization initiatives; |
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the companys ability to realize the anticipated benefits from its joint product
development and commercialization arrangements, including the SIGMA transaction; |
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changes in credit agency ratings; |
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any impact of the commercial and credit environment on the company and its customers and
suppliers; and |
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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, 2009, 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, Brazilian Real and Colombian Peso. 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 shareholders equity volatility relating to foreign exchange. 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 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, 2010 is 15 months. The company also enters
into derivative instruments to hedge certain intercompany and third-party receivables and payables
and debt denominated in foreign currencies.
Currency restrictions enacted in Venezuela require Baxter to obtain approval from the Venezuelan
government to exchange Venezuelan Bolivars for U.S. Dollars and requires such exchange to be made
at the official exchange rate established by the government. On January 8, 2010, the Venezuelan
government devalued the official exchange rate. As of January 1, 2010, Venezuela has been
designated as a highly inflationary economy under GAAP and as a result, the functional currency of
the companys subsidiary in Venezuela became the U.S. Dollar. The devaluation of the Venezuelan
Bolivar and designation of Venezuela as highly inflationary did not have a material impact on the
financial results of the company.
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, 2010, while not predictive in nature,
indicated that if the U.S. Dollar uniformly fluctuated unfavorably by 10% against all currencies,
on a net-of-tax basis, the net liability balance of $29 million with respect to those contracts,
which principally related to a hedge of U.S. Dollar-denominated debt issued by a foreign
subsidiary, would increase by $62 million.
The sensitivity analysis model recalculates the fair value of the foreign exchange option, forward
and cross-currency swap contracts outstanding at March 31, 2010 by replacing the actual exchange
rates at March 31, 2010 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 2009 Annual Report. There were no significant changes during the quarter
ended March 31, 2010.
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, 2010.
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, 2010.
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,
2010 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, 2010 and 2009 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, 2010, and the related condensed consolidated statements of
(loss) income for each of the three-month periods ended March 31, 2010 and 2009 and the condensed
consolidated statements of cash flows for the three-month periods ended March 31, 2010 and 2009.
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, 2009, and the related
consolidated statements of income, of cash flows and of changes in equity and comprehensive income
for the year then ended, and in our report dated February 22, 2010, we expressed an unqualified
opinion on those consolidated financial statements. In our opinion, the information set forth in
the accompanying condensed consolidated balance sheet as of December 31, 2009, is fairly stated in
all material respects in relation to the consolidated balance sheet from which it has been derived.
/s/ PricewaterhouseCoopers LLP
PricewaterhouseCoopers LLP
Chicago, Illinois
May 10, 2010
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, 2010.
Issuer Purchases of Equity Securities
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Approximate dollar value of |
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Total number |
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Total number of shares |
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shares that may yet be |
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of shares |
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Average price |
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purchased as part of publicly |
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purchased under the |
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Period |
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purchased (1) |
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paid per share |
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announced program (1) |
|
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program (1) |
|
January 1, 2010
through January 31, 2010 |
|
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753,565 |
|
|
$ |
59.44 |
|
|
|
753,565 |
|
|
|
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|
February 1, 2010
through February 28, 2010 |
|
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3,470,345 |
|
|
$ |
56.93 |
|
|
|
3,470,345 |
|
|
|
|
|
March 1, 2010
through March 31, 2010 |
|
|
3,293,217 |
|
|
$ |
58.49 |
|
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3,293,217 |
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Total |
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|
7,517,127 |
|
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$ |
57.87 |
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|
|
7,517,127 |
|
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$ |
1,514,857,326 |
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(1) |
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In July 2009, 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 2010, the company repurchased 7.5 million shares for $435 million under this
program. This program does not have an expiration date. |
33
Item 6. Exhibits
Exhibit Index:
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Exhibit |
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Number |
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Description |
15 |
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Letter Re Unaudited Interim
Financial Information
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31.1 |
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Certification of Chief Executive Officer Pursuant to Rule 13a-14(a)/15d-14(a) of the
Securities Exchange Act of 1934
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31.2 |
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Certification of Chief Financial Officer Pursuant to Rule 13a-14(a)/15d-14(a) of the
Securities Exchange Act of 1934
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32.1 |
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Certification of Chief Executive
Officer Pursuant to 18 U.S.C. Section 1350
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32.2 |
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Certification of Chief Financial
Officer Pursuant to 18 U.S.C. Section 1350
|
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101.INS* |
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XBRL Instance Document
|
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101.SCH* |
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XBRL Taxonomy Extension Schema
Document
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101.CAL* |
|
XBRL Taxonomy Extension Calculation
Linkbase Document
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101.LAB* |
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XBRL Taxonomy Extension Label
Linkbase Document
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101.PRE* |
|
XBRL Taxonomy Extension
Presentation Linkbase Document
|
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.
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BAXTER INTERNATIONAL INC.
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(Registrant) |
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Date: May 10, 2010
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By:
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/s/ Robert M. Davis |
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Robert M. Davis |
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Corporate Vice President and Chief Financial Officer |
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(duly authorized officer and principal financial officer) |
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35