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 September 30, 2010
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 1-4448
BAXTER INTERNATIONAL INC.
(Exact name of registrant as specified in its charter)
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Delaware
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36-0781620 |
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(State or other jurisdiction of
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 o |
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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
October 28, 2010 was 582,727,249 shares.
BAXTER INTERNATIONAL INC.
FORM 10-Q
For the quarterly period ended September 30, 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 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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23 |
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Item 3. |
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Quantitative and Qualitative Disclosures About Market Risk |
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34 |
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Item 4. |
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Controls and Procedures |
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35 |
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Review by Independent Registered Public Accounting Firm |
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36 |
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Report of Independent Registered Public Accounting Firm |
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37 |
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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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38 |
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Item 2. |
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Unregistered Sales of Equity Securities and Use of Proceeds |
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39 |
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Item 6. |
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Exhibits |
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40 |
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Signature |
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41 |
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PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Baxter International Inc.
Condensed Consolidated Statements of Income
(unaudited)
(in millions, except per share data)
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Three months ended |
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Nine months ended |
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September 30, |
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September 30, |
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2010 |
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2009 |
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2010 |
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2009 |
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Net sales |
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$ |
3,224 |
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$ |
3,145 |
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$ |
9,345 |
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$ |
9,092 |
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Cost of sales |
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1,565 |
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1,513 |
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5,005 |
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4,334 |
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Gross margin |
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1,659 |
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1,632 |
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4,340 |
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4,758 |
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Marketing and administrative expenses |
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670 |
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672 |
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2,074 |
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1,943 |
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Research and development expenses |
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207 |
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228 |
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653 |
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671 |
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Net interest expense |
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24 |
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23 |
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68 |
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73 |
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Other expense, net |
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117 |
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51 |
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122 |
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52 |
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Income before income taxes |
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641 |
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658 |
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1,423 |
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2,019 |
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Income tax expense |
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117 |
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126 |
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422 |
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380 |
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Net income |
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524 |
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532 |
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1,001 |
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1,639 |
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Less: Noncontrolling interests |
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(1 |
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2 |
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4 |
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6 |
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Net income attributable to Baxter
International Inc. (Baxter) |
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$ |
525 |
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$ |
530 |
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$ |
997 |
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$ |
1,633 |
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Net income attributable to Baxter per common share |
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Basic |
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$ |
0.90 |
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$ |
0.88 |
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$ |
1.68 |
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$ |
2.68 |
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Diluted |
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$ |
0.89 |
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$ |
0.87 |
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$ |
1.67 |
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$ |
2.66 |
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Weighted-average number of common shares outstanding |
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Basic |
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584 |
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605 |
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593 |
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608 |
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Diluted |
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587 |
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612 |
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597 |
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615 |
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Cash dividends declared per common share |
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$ |
0.29 |
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$ |
0.26 |
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$ |
0.87 |
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$ |
0.78 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
2
Baxter International Inc.
Condensed Consolidated Balance Sheets
(unaudited)
(in millions, except shares)
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September 30, |
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December 31, |
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2010 |
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2009 |
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Current assets |
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Cash and equivalents |
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$ |
2,788 |
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$ |
2,786 |
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Accounts and other current receivables |
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2,205 |
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2,302 |
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Inventories |
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2,500 |
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2,557 |
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Prepaid expenses and other |
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647 |
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626 |
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Total current assets |
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8,140 |
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8,271 |
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Property, plant and equipment, net |
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5,208 |
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5,159 |
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Other assets |
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Goodwill |
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2,027 |
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1,825 |
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Other intangible assets, net |
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518 |
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513 |
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Other |
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1,670 |
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1,586 |
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Total other assets |
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4,215 |
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3,924 |
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Total assets |
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$ |
17,563 |
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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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508 |
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682 |
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Accounts payable and accrued liabilities |
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3,676 |
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3,753 |
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Total current liabilities |
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4,199 |
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4,464 |
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Long-term debt and lease obligations |
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4,360 |
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3,440 |
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Other long-term liabilities |
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2,241 |
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2,030 |
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Commitments and contingencies |
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Equity |
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Common stock, $1 par value, authorized
2,000,000,000 shares, issued 683,494,944 shares
in 2010 and 2009 |
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683 |
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683 |
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Common stock in treasury, at cost,
101,905,194 shares in 2010 and 82,523,243
shares in 2009 |
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(5,627 |
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(4,741 |
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Additional contributed capital |
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5,729 |
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5,683 |
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Retained earnings |
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7,717 |
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7,343 |
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Accumulated other comprehensive loss |
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(1,971 |
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(1,777 |
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Total Baxter shareholders equity |
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6,531 |
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7,191 |
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Noncontrolling interests |
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232 |
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229 |
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Total equity |
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6,763 |
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7,420 |
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Total liabilities and equity |
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$ |
17,563 |
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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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Nine months ended |
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September 30, |
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2010 |
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2009 |
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Cash flows from operations |
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Net income |
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$ |
1,001 |
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$ |
1,639 |
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Adjustments |
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Depreciation and amortization |
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506 |
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466 |
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Deferred income taxes |
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169 |
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188 |
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Stock compensation |
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92 |
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106 |
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Realized excess tax benefits from
stock issued under employee benefit plans |
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(35 |
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(88 |
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Infusion pump charges |
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588 |
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27 |
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Impairment charges |
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112 |
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54 |
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Other |
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56 |
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35 |
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Changes in balance sheet items |
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Accounts and other current receivables |
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(27 |
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(108 |
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Inventories |
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(94 |
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(116 |
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Accounts payable and accrued liabilities |
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(57 |
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(163 |
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Restructuring and cost optimization payments |
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(43 |
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(35 |
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Other, including pension contributions |
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(200 |
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(82 |
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Cash flows from operations |
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2,068 |
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1,923 |
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Cash flows from investing activities |
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Capital expenditures |
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(699 |
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(634 |
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Acquisitions of and investments in businesses
and technologies |
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(274 |
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(156 |
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Other |
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37 |
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Cash flows from investing activities |
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(973 |
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(753 |
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Cash flows from financing activities |
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Issuances of debt |
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610 |
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862 |
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Payments of obligations |
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(21 |
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(193 |
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Decrease in debt with original maturities of three
months or less, net |
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(200 |
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Cash dividends on common stock |
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(519 |
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(475 |
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Proceeds and realized excess tax benefits from
stock issued under employee benefit plans |
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269 |
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289 |
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Purchases of treasury stock |
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(1,273 |
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(966 |
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Other |
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(44 |
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Cash flows from financing activities |
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(978 |
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(683 |
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Effect of currency exchange rate changes on cash and equivalents |
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(115 |
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(47 |
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Increase in cash and equivalents |
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2 |
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440 |
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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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$ |
2,788 |
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$ |
2,571 |
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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
Accounts and other current receivables
The company recorded a charge of $28 million in the second quarter of 2010 to write down its
accounts receivable in Greece principally as a result of the Greek governments announcement of a
plan to convert certain past due receivables into non-interest bearing bonds with maturities of one
to three years. The charge, computed by taking into consideration, among other factors, the
imputed discount of the outstanding receivables based upon publicly traded Greek government bonds
with similar terms, was included in marketing and administrative expenses. As it relates to these
and other receivables, changes in economic conditions and customer-specific factors may require the
company to re-evaluate the collectability of its receivables and the company could potentially
incur additional charges.
Net pension and other postemployment benefits cost
The following is a summary of net periodic benefit cost relating to the companys pension and other
postemployment benefit (OPEB) plans.
5
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Three months ended |
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Nine months ended |
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September 30, |
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September 30, |
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(in millions) |
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2010 |
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2009 |
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2010 |
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2009 |
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Pension benefits |
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Service cost |
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$ |
24 |
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$ |
22 |
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$ |
74 |
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$ |
65 |
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Interest cost |
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57 |
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55 |
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171 |
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164 |
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Expected return on plan assets |
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(70 |
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(63 |
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(211 |
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(188 |
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Amortization of net losses and other deferred
amounts |
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29 |
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25 |
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93 |
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74 |
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Net periodic pension benefit cost |
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$ |
40 |
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$ |
39 |
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$ |
127 |
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$ |
115 |
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OPEB |
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Service cost |
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$ |
1 |
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$ |
2 |
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$ |
4 |
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$ |
4 |
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Interest cost |
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7 |
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7 |
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22 |
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23 |
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Amortization of prior service credit and net loss |
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(1 |
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(1 |
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(4 |
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(2 |
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Net periodic OPEB cost |
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$ |
7 |
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$ |
8 |
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$ |
22 |
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$ |
25 |
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The company made first quarter discretionary cash contributions to its pension plan in the United
States totaling $300 million and $100 million in 2010 and 2009, respectively.
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Net interest expense
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Three months ended |
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Nine months ended |
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September 30, |
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September 30, |
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(in millions) |
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2010 |
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2009 |
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2010 |
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2009 |
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Interest expense, net of capitalized interest |
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$ |
30 |
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$ |
27 |
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$ |
88 |
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$ |
87 |
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Interest income |
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(6 |
) |
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(4 |
) |
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(20 |
) |
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(14 |
) |
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Net interest expense |
|
$ |
24 |
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$ |
23 |
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$ |
68 |
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$ |
73 |
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Comprehensive income
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Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
Comprehensive income |
|
$ |
901 |
|
|
$ |
677 |
|
|
$ |
810 |
|
|
$ |
1,918 |
|
Less: Comprehensive (loss) income
attributable
to noncontrolling interests |
|
|
(1 |
) |
|
|
4 |
|
|
|
7 |
|
|
|
9 |
|
|
Comprehensive income attributable to Baxter |
|
$ |
902 |
|
|
$ |
673 |
|
|
$ |
803 |
|
|
$ |
1,909 |
|
|
The increase in comprehensive income attributable to Baxter for the three months ended September
30, 2010 was principally due to favorable movements in currency translation adjustments, which
resulted in a $381 million gain in 2010 compared to a $166 million gain in 2009. The decrease in
comprehensive income attributable to Baxter for the nine months ended September 30, 2010 was
principally due to unfavorable movements in currency translation adjustments, which resulted in a
$306 million loss in 2010 compared to a $276 million gain in 2009, and lower net income,
principally due to a $588 million charge in the first quarter of 2010 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.
Effective tax rate
The companys effective income tax rate was 18.3% and 19.1% in the third quarters of 2010 and 2009,
respectively, and 29.7% and 18.8% in the nine-month periods ended September 30, 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 decrease in the effective
tax rate in the three-month period ended September 30, 2010 was due primarily to the tax benefit of
an impairment charge of $112 million in the third quarter of 2010 associated with the companys
agreement to divest
6
its generic injectables business, which was at the U.S. tax rate, partially offset by a change in
the earnings mix between lower tax and higher tax rate jurisdictions compared to the prior year
period. The increase in the effective tax rate in the nine-month period ended September 30, 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, 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, and a change in the earnings mix between lower tax and
higher tax rate jurisdictions compared to the prior year period, which were partially offset by the
tax benefit from the generic injectables business impairment charge.
Earnings per share
The numerator for both basic and diluted earnings per share (EPS) is net income attributable to
Baxter. The denominator for basic EPS is the weighted-average number of common shares outstanding
during the period. The dilutive effect of outstanding employee stock options, performance share
units and restricted stock units is reflected in the denominator for diluted EPS using the treasury
stock method.
The following is a reconciliation of basic shares to diluted shares.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
Basic shares |
|
|
584 |
|
|
|
605 |
|
|
|
593 |
|
|
|
608 |
|
Effect of dilutive securities |
|
|
3 |
|
|
|
7 |
|
|
|
4 |
|
|
|
7 |
|
|
Diluted shares |
|
|
587 |
|
|
|
612 |
|
|
|
597 |
|
|
|
615 |
|
|
The computation of diluted EPS excluded employee stock options to purchase 31 million and 14
million shares for the three months ended September 30, 2010 and 2009, respectively, and 28 million
and 16 million shares for the nine months ended September 30, 2010 and 2009, respectively, because
the effect would have been anti-dilutive.
Inventories
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
Raw materials |
|
$ |
550 |
|
|
$ |
598 |
|
Work in process |
|
|
863 |
|
|
|
842 |
|
Finished goods |
|
|
1,087 |
|
|
|
1,117 |
|
|
Inventories |
|
$ |
2,500 |
|
|
$ |
2,557 |
|
|
Property, plant and equipment, net
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
Property, plant and equipment, at cost |
|
$ |
10,450 |
|
|
$ |
10,060 |
|
Accumulated depreciation and amortization
|
|
|
(5,242 |
) |
|
|
(4,901 |
) |
|
Property, plant and equipment (PP&E), net |
|
$ |
5,208 |
|
|
$ |
5,159 |
|
|
Goodwill
The following is a reconciliation of goodwill by business segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medication |
|
|
|
|
|
|
|
(in millions) |
|
BioScience |
|
|
Delivery |
|
|
Renal |
|
|
Total |
|
|
Balance as of December 31, 2009 |
|
|
$595 |
|
|
$ |
1,043 |
|
|
$ |
187 |
|
|
$ |
1,825 |
|
Additions |
|
|
226 |
|
|
|
6 |
|
|
|
22 |
|
|
|
254 |
|
Currency translation and other adjustments |
|
|
(7 |
) |
|
|
(37 |
) |
|
|
(8 |
) |
|
|
(52 |
) |
|
Balance as of September 30, 2010 |
|
|
$814 |
|
|
$ |
1,012 |
|
|
$ |
201 |
|
|
$ |
2,027 |
|
|
7
Goodwill additions in 2010 principally related to the first quarter acquisition of ApaTech Limited
(ApaTech) and a second quarter payment related to the companys collaboration agreement for the
development of a home hemodialysis machine with HHD, LLC and DEKA Products Limited Partnership and
DEKA Research and Development Corp. (collectively, DEKA), in the BioScience and Renal segments,
respectively. 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 DEKA. As of September 30, 2010, there were no accumulated goodwill
impairment losses.
Other intangible assets, net
The following is a summary of the companys intangible assets.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Developed |
|
|
|
|
|
|
|
|
|
technology, |
|
|
|
|
|
|
|
(in millions) |
including patents |
|
|
Other |
|
|
Total |
|
|
September 30, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
Gross other intangible assets |
|
$ |
915 |
|
|
$ |
140 |
|
|
$ |
1,055 |
|
Accumulated amortization |
|
|
(503 |
) |
|
|
(65 |
) |
|
|
(568 |
) |
|
Other intangible assets, net |
|
$ |
412 |
|
|
$ |
75 |
|
|
$ |
487 |
|
|
December 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
Gross other intangible assets |
|
$ |
904 |
|
|
$ |
125 |
|
|
$ |
1,029 |
|
Accumulated amortization |
|
|
(489 |
) |
|
|
(58 |
) |
|
|
(547 |
) |
|
Other intangible assets, net |
|
$ |
415 |
|
|
$ |
67 |
|
|
$ |
482 |
|
|
The amortization expense for these intangible assets was $18 million and $17 million for the three
months ended September 30, 2010 and 2009, respectively, and $55 million and $45 million for the
nine months ended September 30, 2010 and 2009, respectively. The anticipated annual amortization
expense for intangible assets recorded as of September 30, 2010 is $71 million in 2010, $65 million
in 2011, $62 million in 2012, $61 million in 2013, $58 million in 2014 and $55 million in 2015.
The increase in other intangible assets, net primarily related to the acquisition of ApaTech in the
first quarter of 2010 and the agreement with Kamada Ltd. (Kamada) in the third quarter of 2010,
partially offset by the third quarter of 2010 impairment charge associated with the companys
agreement to divest its generic injectables business. The manufacturing, supply and distribution
agreement with Kamada for GLASSIATM [Alpha1-Proteinase Inhibitor (Human)], the only
liquid alpha1-proteinase inhibitor, provides the company with the exclusive distribution rights in
the United States, Australia, New Zealand and Canada. This BioScience segment arrangement included
an up-front payment of $20 million, which is included in the Other intangible asset category and is
being amortized on a straight-line basis over an estimated useful life of five years. Refer to the
discussions below for further information regarding ApaTech and the generic injectables business
impairment charge. Additionally, as of September 30, 2010 and December 31, 2009, the company had
$31 million of intangible assets not subject to amortization, which included trademarks and certain
acquired in-process research and development that have not yet received regulatory approval.
Variable interest entities
The condensed 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 nine months
ended September 30, 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 September 30, 2010, the
carrying amounts of the consolidated VIEs assets and liabilities were not material to Baxters
consolidated financial statements. Refer to Note 4 to the companys consolidated financial
statements in 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 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
8
Germany. This acquisition complements the companys existing commercial and technical capabilities
in regenerative medicine. The total purchase price of up to $337 million is comprised of $247
million in up-front payments, 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 $12 |
|
$ |
31 |
|
Property, plant and equipment, net |
|
|
13 |
|
Goodwill |
|
|
226 |
|
Other intangible assets |
|
|
77 |
|
Other assets |
|
|
7 |
|
|
|
|
|
|
Liabilities |
|
|
|
|
Accounts payable and accrued liabilities |
|
|
15 |
|
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. As of September 30, 2010, the estimated fair value of the contingent payments was $74
million, with changes in the estimated fair value recognized 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.
Generic injectables business impairment charge
On October 29, 2010, the company entered into a definitive agreement to divest its U.S. generic
injectables business to Hikma Pharmaceuticals PLC (Hikma). The consideration for the divestiture
arrangement totals approximately $112 million, subject to closing adjustments, resulting in a $112
million impairment charge in the third quarter of 2010. Hikma will acquire Baxters high-volume,
generic injectable products in vials and ampoules, including chronic pain, anti-infective and
anti-emetic products, along with a manufacturing facility located in Cherry Hill, New Jersey, and a
warehouse and distribution center located in Memphis, Tennessee. Approximately 750 employees will
also transfer as part of the transaction. The determination to sell this business was based on the
companys strategic decision to redirect resources toward its proprietary, enhanced packaging
offerings and formulation technologies, consistent with the companys focus on product
differentiation. The transaction, which is subject to customary closing conditions, is expected to
close within the next few months.
The charge principally related to impairments of PP&E and intangible assets (primarily developed
technology) to reflect the fair values of these assets based on the expected sale price of the
business.
Net sales relating to the generic injectables business, which are reported in the Medication
Delivery segment, were $57 million and $38 million for the three months ended September 30, 2010
and 2009, respectively and $143 million and $127 million for the nine months ended September 30,
2010 and 2009, respectively. The impairment charge was included in other expense, net in the
companys consolidated statement of income, and was included in the Medication Delivery segments
pre-tax income.
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
9
acceptance of these new or modified products. The company may not be able to realize the
expected returns from these investments, potentially resulting in asset impairments in the future.
3. INFUSION PUMP AND OTHER CHARGES
Infusion pump charges
In July 2005, the company stopped shipment of COLLEAGUE infusion pumps in the United States.
Following a number of Class I recalls relating to the performance of the pumps, as well as the
seizure litigation described in Note 6, the company entered into a Consent Decree with the U.S.
Food and Drug Administration (the FDA) in June 2006. Additional Class I recalls related to
remediation and repair and maintenance activities were addressed by the company in 2007 and 2009.
On July 13, 2010, the FDA issued a final order requiring the company to recall its approximately
200,000 COLLEAGUE infusion pumps currently in use in the U.S. market. Pursuant to the terms of the
order, Baxter will offer replacement infusion pumps or monetary consideration to owners of
COLLEAGUE pumps and will execute the recall through July 13, 2012 to minimize disruption to patient
care. Under the replacement option, customers may receive SIGMA SPECTRUM infusion pumps in
exchange for COLLEAGUE infusion pumps.
In the first quarter of 2010, following the FDAs issuance of its initial order dated April 30,
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 are being 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 additional cash and non-cash charges may be
required in future periods based on new information, changes in estimates, the implementation of
the recall in the United States, and other actions the company may be required to undertake in
markets outside the United States.
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 in 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 estimated expenditures for
the materials, labor and freight costs expected to be incurred to remediate the design issues,
customer accommodations, and 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, 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 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 September 30, 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 |
|
|
(19 |
) |
|
Reserves at September 30, 2010 |
|
$ |
526 |
|
|
The remaining infusion pump reserves are expected to be substantially utilized by the end of 2012.
10
Refer to Note 5 to the companys consolidated financial statements in the 2009 Annual Report for
further information regarding the COLLEAGUE and SYNDEO infusion pumps.
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 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 September 30, 2010 was $39 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 September 30, 2010 was $30 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
For trade receivables originated in Japan, the company has entered into agreements with financial
institutions in which the entire interest in and ownership of the receivable is sold.
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 following is a summary of the activity relating to the securitization arrangement.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
Sold receivables at beginning of period |
|
$ |
129 |
|
|
$ |
128 |
|
|
$ |
147 |
|
|
$ |
154 |
|
Proceeds from sales of receivables |
|
|
145 |
|
|
|
131 |
|
|
|
394 |
|
|
|
384 |
|
Cash collections (remitted to the owners
of the receivables) |
|
|
(144 |
) |
|
|
(135 |
) |
|
|
(408 |
) |
|
|
(407 |
) |
Effect of currency exchange rate changes |
|
|
8 |
|
|
|
5 |
|
|
|
5 |
|
|
|
(2 |
) |
|
Sold receivables at end of period |
|
$ |
138 |
|
|
$ |
129 |
|
|
$ |
138 |
|
|
$ |
129 |
|
|
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
11
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.
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
condensed 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 $1.4 billion and $500 million,
respectively, as of September 30, 2010 and $1.2 billion and $500 million, respectively, as of
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 is being 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 September 30, 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 loss or gain on the
12
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 September 30, 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 loss
or income recognition of the underlying hedged items. If the company terminates a fair value
hedge, an amount equal to the cumulative fair value adjustment to the hedged items at the date of
termination is amortized to earnings over the remaining term of the hedged item. There were no
hedge dedesignations in the first nine months 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 $437 million as of
September 30, 2010 and $419 million as of December 31, 2009.
Gains and Losses on Derivative Instruments
The following tables summarize the gains and losses on the companys derivative instruments for the
three months ended September 30, 2010 and 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain (loss) reclassified from |
|
|
|
Gain (loss) recognized in OCI |
|
|
Location of gain (loss) |
|
AOCI into income |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
in income statement |
|
2010 |
|
|
2009 |
|
|
Cash flow hedges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts |
|
$ |
|
|
|
$ |
(5 |
) |
|
Net interest expense |
|
$ |
|
|
|
$ |
(1 |
) |
Foreign exchange contracts |
|
|
|
|
|
|
(2 |
) |
|
Net sales |
|
|
(1 |
) |
|
|
1 |
|
Foreign exchange contracts |
|
|
(25 |
) |
|
|
(31 |
) |
|
Cost of sales |
|
|
2 |
|
|
|
4 |
|
Foreign exchange contracts |
|
|
(31 |
) |
|
|
(33 |
) |
|
Other expense, net |
|
|
(29 |
) |
|
|
(30 |
) |
|
Total |
|
$ |
(56 |
) |
|
$ |
(71 |
) |
|
|
|
|
|
$ |
(28 |
) |
|
$ |
(26 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Location of gain (loss) in |
|
Gain (loss) recognized in income |
|
(in millions) |
|
|
|
|
|
|
|
|
|
income statement |
|
2010 |
|
|
2009 |
|
|
Fair value hedges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts |
|
|
|
|
|
|
|
|
|
Net interest expense |
|
$ |
45 |
|
|
$ |
31 |
|
|
Undesignated derivative
instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
|
|
|
Other expense, net |
|
$ |
(2 |
) |
|
$ |
(3 |
) |
|
13
The following tables summarize the gains and losses on the companys derivative instruments
for the nine months ended September 30, 2010 and 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain (loss) reclassified from |
|
|
|
Gain (loss) recognized in OCI |
|
|
Location of gain (loss) |
|
AOCI into income |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
in income statement |
|
2010 |
|
|
2009 |
|
|
Cash flow hedges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts |
|
$ |
(7 |
) |
|
$ |
71 |
|
|
Net interest expense |
|
$ |
1 |
|
|
$ |
(2 |
) |
Foreign exchange contracts |
|
|
(2 |
) |
|
|
(3 |
) |
|
Net sales |
|
|
(3 |
) |
|
|
5 |
|
Foreign exchange contracts |
|
|
8 |
|
|
|
(49 |
) |
|
Cost of sales |
|
|
(5 |
) |
|
|
48 |
|
Foreign exchange contracts |
|
|
53 |
|
|
|
(52 |
) |
|
Other expense, net |
|
|
57 |
|
|
|
(36 |
) |
|
Total |
|
$ |
52 |
|
|
$ |
(33 |
) |
|
|
|
|
|
$ |
50 |
|
|
$ |
15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Location of gain (loss) in |
|
Gain (loss) recognized in income |
|
(in millions) |
|
|
|
|
|
|
|
|
|
income statement |
|
2010 |
|
|
2009 |
|
|
Fair value hedges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts |
|
|
|
|
|
|
|
|
|
Net interest expense |
|
$ |
130 |
|
|
$ |
(52 |
) |
|
Undesignated derivative
instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
|
|
|
Other expense, net |
|
$ |
(7 |
) |
|
$ |
(47 |
) |
|
For the companys fair value hedges, equal and offsetting losses of $45 million and $130
million were recognized in net interest expense in the third quarter and first nine months of 2010,
respectively, and an equal and offsetting loss of $31 million and gain of $52 million were
recognized in net interest expense in the third quarter and first nine months of 2009,
respectively, as adjustments to the underlying hedged item, fixed-rate debt. Ineffectiveness
related to the companys cash flow and fair value hedges for the nine months ended September 30,
2010 was not material.
As of September 30, 2010, $3 million of deferred, net after-tax losses 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 values of derivative instruments
reported in the condensed consolidated balance sheet as of September 30, 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 |
|
|
$189 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
|
|
Foreign exchange contracts |
|
Prepaid expenses and other |
|
|
21 |
|
|
and accrued liabilities |
|
|
$56 |
|
Foreign exchange contracts |
|
Other long-term assets |
|
|
3 |
|
|
Other long-term liabilities |
|
|
3 |
|
|
Total derivative
instruments designated as
hedges |
|
|
|
|
|
|
$213 |
|
|
|
|
|
|
|
$59 |
|
|
Undesignated derivative
instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
|
|
Foreign exchange contracts |
|
Prepaid expenses and other |
|
|
$ |
|
|
and accrued liabilities |
|
|
$ |
|
|
Total derivative instruments |
|
|
|
|
|
|
$213 |
|
|
|
|
|
|
|
$59 |
|
|
14
The following table summarizes the classification and fair values of derivative instruments
reported in the condensed 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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
|
|
Foreign exchange contracts |
|
Prepaid expenses and other |
|
|
20 |
|
|
and accrued liabilities |
|
|
112 |
|
|
Total derivative
instruments designated as
hedges |
|
|
|
|
|
|
$105 |
|
|
|
|
|
|
|
$113 |
|
|
Undesignated derivative
instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
|
|
Foreign exchange contracts |
|
Prepaid expenses and other |
|
|
$ |
|
|
and accrued liabilities |
|
|
$ |
|
|
Total derivative instruments |
|
|
|
|
|
|
$105 |
|
|
|
|
|
|
|
$113 |
|
|
Fair value measurements
The following tables summarize the bases used to measure financial assets and liabilities that are
carried at fair value on a recurring basis in the condensed 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) |
|
September 30, 2010 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency hedges |
|
|
$24 |
|
|
|
$ |
|
|
|
$24 |
|
|
|
$ |
|
Interest rate hedges |
|
|
189 |
|
|
|
|
|
|
|
189 |
|
|
|
|
|
Equity securities |
|
|
17 |
|
|
|
17 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
|
$230 |
|
|
|
$17 |
|
|
|
$213 |
|
|
|
$ |
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency hedges |
|
|
$59 |
|
|
|
$ |
|
|
|
$59 |
|
|
|
$ |
|
Contingent payments
related to
acquisitions and
investments |
|
|
126 |
|
|
|
|
|
|
|
|
|
|
|
126 |
|
|
Total liabilities |
|
|
$185 |
|
|
|
$ |
|
|
|
$59 |
|
|
|
$126 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
acquisitions and
investments |
|
|
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.
15
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 acquisitions and
investments.
|
|
|
|
|
(in millions) |
|
|
|
|
|
Fair value as of January 1, 2010 |
|
$ |
59 |
|
Additions, net of payments |
|
|
60 |
|
Unrealized loss recognized in earnings |
|
|
7 |
|
|
Fair value as of September 30, 2010 |
|
$ |
126 |
|
|
The unrealized loss recognized in earnings relates to liabilities held at September 30, 2010 and is
reported in cost of sales and R&D expenses. The addition during the first nine months of 2010
principally relates to 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 condensed 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 values recognized on the condensed consolidated
balance sheets and the approximate fair values as of September 30, 2010 and December 31, 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Book values |
|
|
Approximate fair values |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term insurance receivables |
|
$ |
39 |
|
|
$ |
49 |
|
|
$ |
38 |
|
|
$ |
47 |
|
Investments |
|
|
31 |
|
|
|
31 |
|
|
|
32 |
|
|
|
31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term debt |
|
|
15 |
|
|
|
29 |
|
|
|
15 |
|
|
|
29 |
|
Current maturities of long-term
debt and lease obligations |
|
|
508 |
|
|
|
682 |
|
|
|
509 |
|
|
|
697 |
|
Other long-term debt and lease
obligations |
|
|
4,360 |
|
|
|
3,440 |
|
|
|
4,833 |
|
|
|
3,568 |
|
Long-term litigation liabilities |
|
|
45 |
|
|
|
45 |
|
|
|
44 |
|
|
|
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 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 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 $29 million and $32 million for the three months ended September
30, 2010 and 2009, respectively, and $92 million and $106 million for the nine months ended
September 30, 2010 and 2009,
16
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
compensation grants made in the second and third quarters of 2010 were not material.
Stock Options
The weighted-average assumptions used in estimating the fair value of stock options granted during
the period, along with the weighted-average grant-date fair values, were as follows.
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
September 30, |
|
|
|
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 was $4 million and $27 million during the
three months ended September 30, 2010 and 2009, respectively, and was $83 million and $72 million
during the nine months ended September 30, 2010 and 2009, respectively.
As of September 30, 2010, $92 million of unrecognized compensation cost related to all unvested
stock options is expected to be recognized as expense over a weighted-average period of 1.9 years.
Performance Share and Restricted Stock Units
The weighted-average assumptions used in estimating the fair value of PSUs granted during the
period, along with the weighted-average grant-date fair values, were as follows.
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
September 30, |
|
|
|
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 |
|
|
$63 |
|
|
|
$65 |
|
|
As of September 30, 2010, unrecognized compensation cost related to all unvested PSUs of $38
million is expected to be recognized as expense over a weighted-average period of 1.8 years, and
unrecognized compensation cost related to all unvested restricted stock units of $9 million is
expected to be recognized as expense over a weighted-average period of 2.4 years.
Stock repurchases
As authorized by the board of directors, from time to time the company repurchases its stock
depending upon the companys cash flows, net debt level and market conditions. During the three-
and nine-month periods ended September 30, 2010, the company repurchased 3.6 million shares and
26.3 million shares for $161 million and $1.3 billion, respectively, under the board of directors
July 2009 $2.0 billion share repurchase authorization. At September 30, 2010, $677 million
remained available under this authorization.
6. LEGAL PROCEEDINGS
Baxter is involved in product liability, patent, commercial, and other legal matters 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.
17
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 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 governmental and regulatory matters, these
actions may lead to product recalls, injunctions, and other restrictions on the companys
operations and monetary sanctions, including significant civil or criminal penalties. 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. Abbotts request for reconsideration of this ruling was denied in September
2010. 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 alleged that Fresenius sale of
the Liberty Cycler peritoneal dialysis systems and related disposable items and equipment infringed
nine U.S. patents, which are owned by Baxter or exclusively licensed in the peritoneal dialysis
field to Baxter from DEKA. During the pendency of the litigation, Fresenius agreed to remove
certain functionality from the Liberty Cycler and the parties agreed to stay or dismiss seven of
the patents. In July 2010, a jury in the U.S.D.C. for the Northern District of California found
that the remaining two patents were not infringed by Fresenius.
Hemodialysis Litigation
Since April 2003, Baxter has been pursuing a patent infringement action against Fresenius Medical
Care Holdings, Inc. for infringement of certain Baxter patents. The patents cover Fresenius 2008K
hemodialysis instrument. In 2007, the court entered judgment in Baxters favor holding the patents
valid and infringed, and a jury assessed damages at $14 million for past sales only. In April
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. In September 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.
18
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 board denied
a request for reconsideration and the company has appealed 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. Summary judgment in the companys favor was granted by the trial
court in May 2010. The plaintiffs have appealed the decision to the U.S. Court of Appeals for the
Seventh Circuit.
In May 2010, a shareholder derivative action was brought on behalf of the company in the Circuit
Court of Lake County, Illinois against the companys board of directors, its Chief Executive
Officer and its then current Chief Financial Officer and President of Medication Delivery. The
complaint alleges that the defendants breached their fiduciary duties to the company and caused
substantial monetary losses to the company in connection with addressing the COLLEAGUE infusion
pump matter. In October 2010, a similar suit was filed in the U.S.D.C. for the Northern District
of Illinois against the companys board of directors, its Chief Executive Officer and its then
current President of Medication Delivery.
In September 2010, a purported class action was filed in the U.S.D.C. for the Northern District of
Illinois against the company and certain of its current executive officers. The complaint alleges
that, during the period between September 17, 2009 and May 3, 2010 inclusive, the defendants issued
materially false and misleading statements regarding the companys plasma-based therapies business
and the companys remediation of its COLLEAGUE infusion pumps causing the companys common stock to
trade at artificially high levels.
In October 2005, the United States filed a complaint in the U.S.D.C. for the Northern District of
Illinois to effect the seizure of COLLEAGUE and SYNDEO infusion pumps that were on hold in Northern
Illinois. Customer-owned pumps were not affected. In June 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, on July 13, 2010 the FDA issued a
final order regarding the recall of the companys COLLEAGUE infusion pumps currently in use in the
United States. The company will execute the recall through July 13, 2012 by offering its customers
an option to replace their COLLEAGUE infusion pumps or receive monetary consideration. The company
will permit lessees to terminate their leases without penalty and refund any prepaid, unused lease
portion upon the return of the devices. 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 for 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 seventeen 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 2003. 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 750 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
March 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.
19
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 next trial is scheduled for
November 2010.
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 (AWP) 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
2011. Baxter has also resolved a number of other AWP 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.
The company has received a letter request from the Office of the United States Attorney for the
Eastern District of Pennsylvania to produce documents related to the
companys contracting, marketing and promotional, and
historical government price reporting practices in the United States. In addition, the company
received a request from the Office of the United States Attorney for the Northern District of
California to produce documents related to the companys marketing and promotional practices,
including relationships between the company and specialty pharmacies. The company is fully
cooperating with both of these requests.
The company has received an inquiry from the U.S. Department of Justice and the U.S. Securities and
Exchange Commission requesting that the company voluntarily provide information about its business
activities in a number of countries. The company is fully cooperating with the agencies and
understands that this inquiry is part of a broader review of industry practices for compliance with
the U.S. Foreign Corrupt Practices Act.
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, alpha1-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.
20
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 condensed 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, the Greece receivable charge, 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 2 for further information regarding the
Greece receivable charge and Note 3 to the companys consolidated financial statements in the 2009
Annual Report for further information regarding the TT divestiture.
The Medication Delivery segments pre-tax income in the third quarter and first nine months of 2010
included an impairment charge of $112 million associated with the companys agreement to divest its
generic injectables business. Included in the Medication Delivery segments net sales and pre-tax
income in the first nine months of 2010 was a first quarter charge of $588 million related to the
recall of COLLEAGUE infusion pumps from the U.S. market. Of the total charge, $213 million was
recorded as a reduction of net sales and $375 million was recorded in cost of sales. Included in
the Medication Delivery segments pre-tax income in 2009 were third quarter charges of $54 million
associated with the discontinuation of the companys SOLOMIX drug delivery system in development
and $27 million related to planned retirement costs associated with SYNDEO and additional charges
related to the COLLEAGUE infusion pump. Refer to Note 3 for further information regarding the
COLLEAGUE and SYNDEO infusion pump charges, Note 2 for further information regarding the generic
injectables business impairment charge and Note 5 to the companys consolidated financial
statements in the 2009 Annual Report for further information regarding the SOLOMIX charge.
Financial information for the companys segments is as follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
Net sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BioScience |
|
$ |
1,387 |
|
|
$ |
1,385 |
|
|
$ |
4,107 |
|
|
$ |
4,055 |
|
Medication Delivery |
|
|
1,230 |
|
|
|
1,168 |
|
|
|
3,438 |
|
|
|
3,337 |
|
Renal |
|
|
594 |
|
|
|
576 |
|
|
|
1,763 |
|
|
|
1,641 |
|
Transition services to Fenwal |
|
|
13 |
|
|
|
16 |
|
|
|
37 |
|
|
|
59 |
|
|
Total |
|
$ |
3,224 |
|
|
$ |
3,145 |
|
|
$ |
9,345 |
|
|
$ |
9,092 |
|
|
Pre-tax income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BioScience |
|
$ |
569 |
|
|
$ |
580 |
|
|
$ |
1,638 |
|
|
$ |
1,654 |
|
Medication Delivery |
|
|
150 |
|
|
|
147 |
|
|
|
93 |
|
|
|
522 |
|
Renal |
|
|
88 |
|
|
|
85 |
|
|
|
260 |
|
|
|
212 |
|
|
Total pre-tax income from segments |
|
$ |
807 |
|
|
$ |
812 |
|
|
$ |
1,991 |
|
|
$ |
2,388 |
|
|
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.
21
The following is a reconciliation of segment pre-tax income to income before income taxes per the
condensed consolidated statements of income.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
Total pre-tax income from segments |
|
$ |
807 |
|
|
$ |
812 |
|
|
$ |
1,991 |
|
|
$ |
2,388 |
|
Unallocated amounts |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock compensation |
|
|
(29 |
) |
|
|
(32 |
) |
|
|
(92 |
) |
|
|
(106 |
) |
Net interest expense |
|
|
(24 |
) |
|
|
(23 |
) |
|
|
(68 |
) |
|
|
(73 |
) |
Certain foreign currency
fluctuations and hedging activities |
|
|
17 |
|
|
|
19 |
|
|
|
36 |
|
|
|
95 |
|
Other Corporate items |
|
|
(130 |
) |
|
|
(118 |
) |
|
|
(444 |
) |
|
|
(285 |
) |
|
Income before income taxes |
|
$ |
641 |
|
|
$ |
658 |
|
|
$ |
1,423 |
|
|
$ |
2,019 |
|
|
22
|
|
|
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 and nine months ended September
30, 2010.
RESULTS OF OPERATIONS
NET SALES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
Percent |
|
|
September 30, |
|
|
Percent |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
change |
|
|
2010 |
|
|
2009 |
|
|
change |
|
|
BioScience |
|
$ |
1,387 |
|
|
$ |
1,385 |
|
|
|
|
|
|
$ |
4,107 |
|
|
$ |
4,055 |
|
|
|
1% |
|
Medication Delivery |
|
|
1,230 |
|
|
|
1,168 |
|
|
|
5% |
|
|
|
3,438 |
|
|
|
3,337 |
|
|
|
3% |
|
Renal |
|
|
594 |
|
|
|
576 |
|
|
|
3% |
|
|
|
1,763 |
|
|
|
1,641 |
|
|
|
7% |
|
Transition services to Fenwal Inc. |
|
|
13 |
|
|
|
16 |
|
|
|
(19% |
) |
|
|
37 |
|
|
|
59 |
|
|
|
(37% |
) |
|
Total net sales |
|
$ |
3,224 |
|
|
$ |
3,145 |
|
|
|
3% |
|
|
$ |
9,345 |
|
|
$ |
9,092 |
|
|
|
3% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
Percent |
|
|
September 30, |
|
|
Percent |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
change |
|
|
2010 |
|
|
2009 |
|
|
change |
|
|
International |
|
$ |
1,835 |
|
|
$ |
1,813 |
|
|
|
1% |
|
|
$ |
5,521 |
|
|
$ |
5,194 |
|
|
|
6% |
|
United States |
|
|
1,389 |
|
|
|
1,332 |
|
|
|
4% |
|
|
|
3,824 |
|
|
|
3,898 |
|
|
|
(2% |
) |
|
Total net sales |
|
$ |
3,224 |
|
|
$ |
3,145 |
|
|
|
3% |
|
|
$ |
9,345 |
|
|
$ |
9,092 |
|
|
|
3% |
|
|
Foreign currency unfavorably impacted net sales by 1 percentage point in the three-month period
ended September 30, 2010 and favorably impacted net sales by 2 percentage points in the nine-month
period ended September 30, 2010, due to changes in the value of the U.S. Dollar relative to other
currencies, principally the Euro, the Australian and Canadian Dollars, and the Japanese Yen.
Total net sales growth through the nine-month period ended September 30, 2010 was unfavorably
impacted by 2 percentage points due to the companys first quarter charge related to the recall of
COLLEAGUE infusion pumps from the U.S. market. The $588 million charge, which was included in the
Medication Delivery segment, reduced net sales by $213 million. Refer to Note 3 for further
information regarding the COLLEAGUE infusion pump charge. In addition, healthcare reform has unfavorably impacted sales growth
in the three- and nine-month periods ended
September 30, 2010 by approximately 0.4 and 0.5 percentage points, respectively. Healthcare reform legislation
enacted in the United States in the first quarter of 2010 has increased Medicaid rebates and expanded the 340B
Drug Pricing Program in the United States, primarily impacting the Recombinants, Plasma Proteins and Antibody
Therapy product categories in the BioScience segment. Similar actions undertaken by governments outside the
United States have also unfavorably impacted sales growth.
23
BioScience
The following is a summary of sales by product category in the BioScience segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
Percent |
|
|
September 30, |
|
|
Percent |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
change |
|
|
2010 |
|
|
2009 |
|
|
change |
|
|
Recombinants |
|
$ |
526 |
|
|
$ |
528 |
|
|
|
|
|
|
$ |
1,561 |
|
|
$ |
1,494 |
|
|
|
4% |
|
Plasma Proteins |
|
|
346 |
|
|
|
331 |
|
|
|
5% |
|
|
|
952 |
|
|
|
958 |
|
|
|
(1% |
) |
Antibody Therapy |
|
|
336 |
|
|
|
336 |
|
|
|
|
|
|
|
968 |
|
|
|
1,017 |
|
|
|
(5% |
) |
Regenerative Medicine |
|
|
130 |
|
|
|
109 |
|
|
|
19% |
|
|
|
382 |
|
|
|
317 |
|
|
|
21% |
|
Other |
|
|
49 |
|
|
|
81 |
|
|
|
(40% |
) |
|
|
244 |
|
|
|
269 |
|
|
|
(9% |
) |
|
Total net sales |
|
$ |
1,387 |
|
|
$ |
1,385 |
|
|
|
|
|
|
$ |
4,107 |
|
|
$ |
4,055 |
|
|
|
1% |
|
|
Net sales in the BioScience segment were flat and increased 1% during the three- and nine-month
periods ended September 30, 2010, respectively. Foreign currency had a 3 percentage point
unfavorable impact in the third quarter of 2010 and a 1 percentage point favorable impact in the
nine-month period ended September 30, 2010. Excluding the impact of foreign currency, sales growth
in the Recombinants product category in both periods was the result of increased sales of the
companys advanced recombinant therapy, ADVATE [Antihemophilic Factor (Recombinant),
Plasma/Albumin-Free Method], which was partially offset by lower U.K. tender sales and a reduction
in RECOMBINATE distributor inventory levels in the United States during the third quarter of 2010.
Sales in the Plasma Proteins product category in both periods of 2010 reflected increased demand
for FEIBA (an anti-inhibitor coagulant complex) and for ARALAST NP [Alpha1-Proteinase Inhibitor
(Human)]. Partially offsetting this growth in the three-month period and more than offsetting it
in the nine-month period were lower sales of albumin in the United States and of plasma-derived
factor VIII globally. Excluding the impact of foreign currency, sales in Antibody Therapy
increased in the third quarter of 2010 driven by increased demand for GAMMAGARD LIQUID [Immune
Globulin Intravenous (Human)] (marketed as KIOVIG outside of the United States), the liquid
formulation of the antibody-replacement therapy IGIV (immune globulin intravenous). Antibody
Therapy sales for the nine-month period declined as a result of slower U.S. market growth, U.S.
share loss versus the prior year periods and pricing actions taken in 2010. Also unfavorably
impacting Antibody Therapy net sales in both periods of 2010 was the impact of lower WinRho SDF
[Rho(D) Immune Globulin Intravenous (Human)] sales due to the termination of a distribution
agreement effective July 1, 2010. While sequential improvement occurred in the United States
during the third quarter, the company may continue to experience volatility in the Antibody Therapy
product category due to potential market and broader economic pressures. Revenues in Regenerative
Medicine increased due to sales of ACTIFUSE (a silicate substituted calcium phosphate synthetic
bone graft material), a product obtained with the acquisition of ApaTech Limited (ApaTech) in the
first quarter of 2010, as well as increased sales of the companys biosurgery products, including
FLOSEAL, COSEAL and TISSEEL. Sales in the Other product category declined as a result of a
reduction in advanced purchase pandemic vaccine agreement revenues and lower revenues from
FSME-IMMUN (a tick-borne encephalitis vaccine) and NEISVAC-C (for the prevention of meningitis C)
in international markets. Partially offsetting the decline in the first nine months of 2010 was
the first quarter benefit from CELVAPAN H1N1 pandemic vaccine sales in select international
markets.
24
Medication Delivery
The following is a summary of sales by product category in the Medication Delivery segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
Percent |
|
|
September 30, |
|
|
Percent |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
change |
|
|
2010 |
|
|
2009 |
|
|
change |
|
|
IV Therapies |
|
$ |
417 |
|
|
$ |
396 |
|
|
|
5% |
|
|
$ |
1,226 |
|
|
$ |
1,124 |
|
|
|
9% |
|
Global Injectables |
|
|
469 |
|
|
|
433 |
|
|
|
8% |
|
|
|
1,392 |
|
|
|
1,222 |
|
|
|
14% |
|
Infusion Systems |
|
|
213 |
|
|
|
208 |
|
|
|
2% |
|
|
|
425 |
|
|
|
612 |
|
|
|
(31% |
) |
Anesthesia |
|
|
127 |
|
|
|
123 |
|
|
|
3% |
|
|
|
384 |
|
|
|
352 |
|
|
|
9% |
|
Other |
|
|
4 |
|
|
|
8 |
|
|
|
(50% |
) |
|
|
11 |
|
|
|
27 |
|
|
|
(59% |
) |
|
Total net sales |
|
$ |
1,230 |
|
|
$ |
1,168 |
|
|
|
5% |
|
|
$ |
3,438 |
|
|
$ |
3,337 |
|
|
|
3% |
|
|
Net sales in the Medication Delivery segment increased 5% and 3% during the three- and nine-month
periods ended September 30, 2010, respectively. Foreign currency had a 2 percentage point
unfavorable impact in the third quarter of 2010 and a 3 percentage point favorable impact in the
nine-month period ended September 30, 2010. Intravenous (IV) Therapies sales growth was driven by
improved pricing and increased demand for IV solutions and nutritional products, particularly in
the United States as the company benefited from competitor supply issues. Within the Global
Injectables product category, sales growth in both periods was driven by increased demand for
certain enhanced packaging products, select pre-mixed drugs and multi-source generic products in
the United States, and strong sales in the international pharmacy compounding business. Also
contributing to growth in Global Injectables in the nine-month period were increased sales in the
U.S. pharmaceutical partnering business. In the Infusion Systems product category, net sales
declined in the first nine months of 2010 as a result of the unfavorable impact of the $213 million
charge in the first quarter of 2010 related to the recall of COLLEAGUE infusion pumps. Excluding
the impact of the COLLEAGUE charge, sales growth in Infusion Systems in both periods was due to
increased sales of Sigma International General Medical Apparatus, LLC (SIGMA) SPECTRUM infusion
pumps partially offset by lower COLLEAGUE and disposable tubing set revenues. Sales growth in the
Anesthesia product category was driven by increased demand and improved pricing for SUPRANE
(desflurane) and increased demand for sevoflurane.
Renal
The following is a summary of sales by product category in the Renal segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
Percent |
|
|
September 30, |
|
|
Percent |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
change |
|
|
2010 |
|
|
2009 |
|
|
change |
|
|
PD Therapy |
|
$ |
487 |
|
|
$ |
473 |
|
|
|
3% |
|
|
$ |
1,441 |
|
|
$ |
1,347 |
|
|
|
7% |
|
HD Therapy |
|
|
107 |
|
|
|
103 |
|
|
|
4% |
|
|
|
322 |
|
|
|
294 |
|
|
|
10% |
|
|
Total net sales |
|
$ |
594 |
|
|
$ |
576 |
|
|
|
3% |
|
|
$ |
1,763 |
|
|
$ |
1,641 |
|
|
|
7% |
|
|
Net sales in the Renal segment increased 3% and 7% during the three- and nine-month periods ended
September 30, 2010, respectively. Foreign currency had no impact in the third quarter of 2010 and
a 4 percentage point favorable impact in the nine-month period ended September 30, 2010. Net sales
in both periods of 2010 grew due to an increase in the number of peritoneal dialysis (PD) patients,
particularly in the United States, Latin America, and Asia, including double-digit growth in China.
Net sales growth in the Hemodialysis (HD) Therapy product category in both periods was driven by
Continuous Renal Replacement Therapy sales related to the companys acquisition of certain assets
of the Edwards Lifesciences Corporation hemofiltration business late in the third quarter of 2009.
Transition services to Fenwal Inc.
Net sales in this category represent revenues associated with manufacturing, distribution and other
services provided by the company to Fenwal Inc. (Fenwal) subsequent to the divestiture of the
Transfusion Therapies (TT) business in 2007. Refer to Note 3 to the companys consolidated
financial statements in the 2009 Annual Report for additional information regarding the TT
divestiture.
25
GROSS MARGIN AND EXPENSE RATIOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
September 30, |
|
|
|
|
(as a percentage of net sales) |
|
2010 |
|
|
2009 |
|
|
Change |
|
|
2010 |
|
|
2009 |
|
|
Change |
|
|
Gross margin |
|
|
51.5% |
|
|
|
51.9% |
|
|
(0.4 pts |
) |
|
|
46.4% |
|
|
|
52.3% |
|
|
(5.9 pts |
) |
Marketing and administrative expenses |
|
|
20.8% |
|
|
|
21.4% |
|
|
(0.6 pts |
) |
|
|
22.2% |
|
|
|
21.4% |
|
|
0.8 pts |
|
|
Gross Margin
The gross margin percentage declined in the third quarter and first nine months of 2010.
In both periods, improvements in sales for select higher margin products in the BioScience segment were more than
offset by cost inefficiencies driven by lower volume throughput for plasma-based therapies and
vaccines, and the impact of U.S. healthcare reform legislation. The first nine months of 2010 were
also unfavorably impacted by an increase in inventory reserves and a $588 million charge in the
first quarter of 2010 related to the recall of COLLEAGUE infusion pumps from the U.S. market, which
unfavorably impacted the year-to-date gross margin by 5.2 percentage points. Included in the
companys gross margin in the third quarter of 2009 was a $27 million charge related to planned
retirement costs associated with the SYNDEO PCA Syringe Pump and additional costs related to the
COLLEAGUE infusion pumps which negatively impacted gross margin by 0.9 and 0.3 percentage points in
the third quarter and first nine months of 2009, respectively. Refer to Note 3 for further
information on the COLLEAGUE and SYNDEO charges.
Marketing and Administrative Expenses
Marketing and administrative expenses were $670 million in the third quarter of 2010, a slight
decrease compared to the $672 million reported in the third quarter of 2009, and $2.1 billion in
the first nine months of 2010, an increase of 7% over the $1.9 billion reported in the first nine
months of 2009. The increase in the first nine months of 2010 was driven by the unfavorable impact
of foreign currency, the expansion of the sales force, and increased spending on new marketing and
promotional programs, partially offset by the impact of the companys continued focus on
controlling discretionary spending. In addition, the increase in the marketing and administrative
expense ratio in the first nine months of 2010 was impacted by 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 0.5 percentage points, and a $28 million charge in
the second quarter of 2010 to write down accounts receivable in Greece. Refer to Note 2 for
further information regarding the Greece receivable charge.
RESEARCH AND DEVELOPMENT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
Percent |
|
|
September 30, |
|
|
Percent |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
change |
|
|
2010 |
|
|
2009 |
|
|
change |
|
|
Research and development expenses |
|
|
$207 |
|
|
|
$228 |
|
|
|
(9% |
) |
|
|
$653 |
|
|
|
$671 |
|
|
|
(3% |
) |
As a percentage of net sales |
|
|
6.4% |
|
|
|
7.2% |
|
|
|
|
|
|
|
7.0% |
|
|
|
7.4% |
|
|
|
|
|
|
Research and development (R&D) expenses decreased in the third quarter and first nine months of
2010. Impacting both periods in 2010 was a reduction in R&D expenses due to the completion of
clinical work on late-stage programs, lower milestone payments to partners and efforts to
reposition projects to gain organizational efficiencies. Also impacting R&D expenses for the three
months ended September 30, 2010 was the favorable 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, R&D expenses are expected to be lower for the full-year compared to 2009. Refer to the
2009 Annual Report for a discussion of the companys R&D pipeline.
NET INTEREST EXPENSE
Net interest expense was $24 million and $23 million in the third quarters of 2010 and 2009,
respectively, and $68 million and $73 million in the first nine months of 2010 and 2009,
respectively. The decrease in the first nine months of 2010 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.
26
OTHER EXPENSE, NET
Other expense, net was $117 million and $51 million in the third quarters of 2010 and 2009,
respectively, and $122 million and $52 million in the first nine months of 2010 and 2009,
respectively. Included in both periods were amounts related to foreign currency fluctuations,
principally relating to intercompany receivables, payables and loans denominated in a foreign
currency. Included in other expense, net was a third quarter of 2010 impairment charge of $112
million associated with the companys agreement to divest its generic injectables business. Refer
to Note 2 for further information regarding the generic injectables business impairment charge.
Included in other expense, net, in 2009 was a third quarter charge of $54 million associated with
the discontinuation of the companys SOLOMIX drug delivery system in development. Refer to Note 5
to the companys consolidated financial statements in the 2009 Annual Report for further
information on the SOLOMIX charge.
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.
BioScience
Pre-tax income decreased 2% and 1% for the three- and nine-month periods ended September 30, 2010,
respectively. Sales growth for select higher margin products in both periods was more than offset
by cost inefficiencies for plasma-based therapies and vaccines, the impact of U.S. healthcare
reform legislation, the expansion of the sales force, and increased spending on new marketing and
promotional programs. Also unfavorably impacting the nine-month period ended September 30, 2010
was an increase in inventory reserves. Foreign currency unfavorably impacted the three-month and
favorably impacted the nine-month periods ended September 30, 2010.
Medication Delivery
Pre-tax income increased 2% and decreased 82% for the three- and nine-month periods ended September
30, 2010, respectively. The decrease for the nine-month period ended September 30, 2010 was
primarily due to the COLLEAGUE charge in the first quarter of 2010 totaling $588 million and an
impairment charge of $112 million in the third quarter of 2010 associated with the companys
agreement to divest its generic injectables business. Impacting both periods of 2010 and partially
offsetting the negative impact of the first quarter of 2010 COLLEAGUE charge and the third quarter
of 2010 generic injectables business impairment charge were sales growth across multiple product
categories, gross margin improvements, and a reduction in R&D spending. Foreign currency
unfavorably impacted the three-month and favorably impacted the nine-month periods ended September
30, 2010. Included in pre-tax income in the third quarter of 2009 were charges of $54 million
associated with the discontinuation of the companys SOLOMIX drug delivery system in development
and $27 million related to planned retirement costs associated with SYNDEO pumps and additional
costs related to the COLLEAGUE pumps.
Renal
Pre-tax income increased 4% and 23% for the three- and nine-month periods ended September 30, 2010,
respectively. The increase in both periods of 2010 was primarily due to the continued increases in
PD Therapy patients, improved gross margins and the favorable impact of foreign currency, partially
offset by increased R&D spending.
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, the
Greece receivable charge, 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,
Note 2 for further information on the Greece receivable charge and the previous discussion for
further information regarding net interest expense.
27
INCOME TAXES
The companys effective income tax rate was 18.3% and 19.1% in the third quarters of 2010 and 2009,
respectively, and 29.7% and 18.8% in the nine-month periods ended September 30, 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 decrease in the effective
tax rate in the three-month period ended September 30, 2010 was due primarily to the tax benefit of
an impairment charge of $112 million in the third quarter of 2010 associated with the companys
agreement to divest its generic injectables business, which was at the U.S. tax rate, partially
offset by a change in the earnings mix between lower tax and higher tax rate jurisdictions compared
to the prior year period. The increase in the effective tax rate in the nine-month period ended
September 30, 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, 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 and a change in the earnings mix between
lower tax and higher tax rate jurisdictions compared to the prior year period, which were partially
offset by the tax benefit from the generic injectables business impairment charge.
The company anticipates that the effective tax rate for the full-year 2010 will be approximately
20.0%, excluding the impact of audit developments and other special items, such as the items in the
first nine months of 2010 noted above.
INCOME AND EARNINGS PER DILUTED SHARE
Net income attributable to Baxter was $525 million and $530 million for the three months ended
September 30, 2010 and 2009, respectively, and $997 million and $1.6 billion for the nine months
ended September 30, 2010 and 2009, respectively. Net income attributable to Baxter per diluted
share was $0.89 and $0.87 for the three months ended September 30, 2010 and 2009, respectively, and
$1.67 and $2.66 for the nine months ended September 30, 2010 and 2009, respectively. 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 nine months of 2010 as compared to the prior
year, totaling $2.1 billion in 2010 and $1.9 billion in 2009. The increase in cash flows from
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 nine months of 2010 and 2009
were outflows of $35 million and $88 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 outflows relating to accounts receivable decreased $81 million during the first nine months of
2010 as compared to the prior year. Days sales outstanding decreased from 58.4 days at September
30, 2009 to 56.2 days at September 30, 2010, primarily due to the favorable impact of foreign
currency and decreases in collection periods in certain international markets as well as in the
United States where the days sales outstanding were less than 30 days.
28
Inventories
Cash outflows relating to inventories decreased $22 million in 2010 as compared to the prior year.
The following is a summary of inventories at September 30, 2010 and December 31, 2009, as well as
annualized inventory turns for the three months ended September 30, 2010 and 2009, by segment. The
higher inventory turns for the total company were principally due to higher sales of select
products within the BioScience and Medication Delivery segments, as well as a reduction in vaccines
inventories.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Annualized inventory |
|
|
|
Inventories |
|
|
turns for the three |
|
|
|
September 30, |
|
|
December 31, |
|
|
months ended September 30, |
|
(in millions, except inventory turn data) |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
BioScience |
|
$ |
1,575 |
|
|
$ |
1,592 |
|
|
|
1.33 |
|
|
|
1.30 |
|
Medication Delivery |
|
|
633 |
|
|
|
705 |
|
|
|
4.30 |
|
|
|
3.33 |
|
Renal |
|
|
289 |
|
|
|
257 |
|
|
|
3.96 |
|
|
|
4.09 |
|
Other |
|
|
3 |
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
Total company |
|
$ |
2,500 |
|
|
$ |
2,557 |
|
|
|
2.39 |
|
|
|
2.19 |
|
|
Other
Cash outflows related to liabilities, restructuring and cost optimization payments and other
increased $20 million in the first nine months of 2010 as compared to the prior year. Higher first
quarter discretionary cash contributions to the companys pension plan in the United States, which
were $300 million and $100 million in 2010 and 2009, respectively, were partially offset by lower
outflows relating to accounts payable and accrued liabilities.
Cash flows from investing activities
Capital Expenditures
Capital expenditures increased $65 million for the nine months ended September 30, 2010, from $634
million in 2009 to $699 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. The increase in capital expenditures was also due to the
companys multi-year initiative to implement a global enterprise resource planning system that will
consolidate and standardize business processes, data and systems.
Acquisitions of and Investments in Businesses and Technologies
Cash outflows relating to acquisitions of and investments in businesses and technologies of $274
million in the first nine months of 2010 related primarily to a net cash outflow of $235 million
related to the acquisition of ApaTech Limited, an orthobiologic products company based in the
United Kingdom. In the second quarter of 2010, Baxter made an $18 million payment related to the
companys collaboration agreement for the development of a home hemodialysis machine with HHD, LLC
and DEKA Products Limited Partnership and DEKA Research and Development Corp. (collectively, DEKA).
Additionally, in the third quarter of 2010, Baxter made a $20 million payment related to a
manufacturing, supply and distribution agreement with Kamada Ltd. (Kamada) for GLASSIATM
[Alpha1-Proteinase Inhibitor (Human)], the only liquid alpha1-proteinase inhibitor, for the
exclusive distribution rights in the United States and other select markets. Cash outflows
relating to acquisitions of and investments in businesses and technologies of $156 million in the
first nine months of 2009 principally related to an agreement with SIGMA for the exclusive
distribution of SIGMAs infusion pumps in the United States and international markets, a 40 percent
equity stake in SIGMA, and an option to purchase the remaining portion of SIGMA. Additionally, in
August 2009 the company acquired certain assets of Edwards Lifesciences Corporation related to
their hemofiltration product line, also known as Continuous Renal Replacement Therapy (Edwards
CRRT), for $56 million. Refer to Note 2 for further information about the acquisition of ApaTech
and the Kamada arrangement and Note 4 to the companys consolidated financial statements in the
2009 Annual Report for further information related to DEKA, SIGMA and Edwards CRRT.
Other
Cash flows relating to other investing activities in the first nine months of 2009 included cash
collected from customers relating to previously securitized receivables.
29
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 $469
million in the first nine months 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 nine months 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 August 2009 issuance of $500 million of senior unsecured notes,
which mature in August 2019 and bear a 4.5% coupon rate. Partially offsetting the issuances in
2009 was the repayment of $200 million of outstanding commercial paper, and the repayment of
approximately $160 million of outstanding borrowings related to the companys Euro-denominated
credit facility.
Other Financing Activities
Cash dividend payments totaled $519 million and $475 million in the first nine months 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 July 2010, the board of directors
declared a quarterly dividend of $0.29 per share, payable on October 1, 2010 to shareholders of
record on September 10, 2010.
Proceeds and realized excess tax benefits from stock issued under employee benefit plans decreased
by $20 million, from $289 million in the first nine months of 2009 to $269 million in the first
nine months of 2010, primarily due to a decrease in realized excess tax benefits (as further
discussed above), partially offset by an increase in stock option exercises.
Stock repurchases totaled $1.3 billion and $966 million in the first nine months 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 September 30, 2010, $677 million remained available under this authorization.
CREDIT FACILITIES, ACCESS TO CAPITAL AND CREDIT RATINGS
Credit facilities
The companys primary revolving credit facility has a maximum capacity of $1.5 billion and matures
in December 2011. The company also maintains a credit facility denominated in Euros with a maximum
capacity of approximately $408 million at September 30, 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 September 30, 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 September 30, 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 $2.8 billion of cash and equivalents at September 30, 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.
30
The company continues to do business with foreign governments that have recently experienced credit
rating downgrades and may become unable to pay for the companys products or services. The company
recorded a charge of $28 million in the second quarter of 2010 to write down its accounts
receivable in Greece principally as a result of the Greek governments announcement of a plan to
convert certain past due receivables into non-interest bearing bonds with maturities of one to
three years. The charge, computed by taking into consideration, among other factors, the imputed
discount of the outstanding receivables based upon publicly traded Greek government bonds with
similar terms, was included in marketing and administrative expenses. As it relates to these and
other receivables, changes in economic conditions and customer-specific factors may require the
company to re-evaluate the collectability of its receivables and the company could potentially
incur additional charges.
Credit ratings
There were no changes in the companys credit ratings in the first nine months of 2010. Standard &
Poors downgraded the companys outlook from Positive to Stable in the second quarter 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 generally accepted accounting principles
(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 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 July 2010 the FDA issued a final
order regarding the recall of the companys COLLEAGUE infusion pumps currently in use in the United
States. The company will execute the recall over the two years following the final order by
offering its customers an option to replace their COLLEAGUE infusion pumps or receive monetary
consideration. Under the replacement option, the companys customers may receive SIGMA SPECTRUM
infusion pumps in exchange for their COLLEAGUE infusion pumps. Alternatively, COLLEAGUE pump
owners may receive the lesser of the pumps depreciated value, which will be no less than $1,500
per single-channel pump and $3,000 per triple-channel pump, or the purchase price. The company
will permit lessees to terminate their leases without penalty and will refund any prepaid, unused
lease portion upon the return of the devices. As discussed in Note 3, following the FDAs issuance
of its initial order dated April 30, 2010, the company recorded a charge in the first quarter of
2010 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 additional cash and
31
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 markets outside of the United States.
In June 2010, the company received a Warning Letter from the FDA in connection with an inspection
of its Renal businesss McGaw Park, Illinois headquarters facility. The Warning Letter pertains to
the processes by which the company analyzes and addresses product complaints through corrective and
preventative actions, and reports relevant information to the FDA. The company is working with the
FDA to resolve these matters.
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 regulation will not be introduced that may adversely affect
the companys operations and consolidated financial statements. 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.
32
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,
the anticipated closing of the sale of the companys generic
injectables business,
credit exposure to foreign governments, expectations with respect to
volatility in results for certain plasma-based therapies, estimates of liabilities, expectations
with respect to the companys hedging activities including its exposure to financial market
volatility and foreign currency risk, geographic expansion, future capital and R&D
expenditures, expectations with respect to the impact of healthcare reform legislation, 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:
|
|
|
demand for and market acceptance risks for new and existing products, such as ADVATE and
plasma-based therapies (including Antibody Therapy), and other therapies; |
|
|
|
|
fluctuations in supply and demand and the pricing of plasma-based therapies; |
|
|
|
|
healthcare reform legislation in the United States including its effect
on pricing, reimbursement, taxation and rebate policies; |
|
|
|
|
future actions of governmental authorities and other third parties including third party
payers as healthcare reform legislation and similar measures are implemented in the United
States and globally; |
|
|
|
|
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; |
|
|
|
|
the companys ability to identify business development and growth opportunities for
existing products; |
|
|
|
|
product quality or patient safety issues, leading to product recalls, withdrawals,
launch delays, sanctions, seizures, litigation, or declining sales; |
|
|
|
|
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; |
|
|
|
|
implementation of the FDAs final July 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; |
|
|
|
|
the companys ability to fulfill demand for its SIGMA SPECTRUM infusion pump; |
|
|
|
|
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; |
|
|
|
|
product development risks, including satisfactory clinical performance, the ability to
manufacture at appropriate scale, and the general unpredictability associated with the
product development cycle; |
|
|
|
|
the ability to enforce the companys patent rights or patents of third parties
preventing or restricting the companys manufacture, sale or use of affected products or
technology; |
|
|
|
|
the impact of geographic and product mix on the companys sales; |
|
|
|
|
the impact of competitive products and pricing, including generic competition, drug
reimportation and disruptive technologies; |
|
|
|
|
inventory reductions or fluctuations in buying patterns by wholesalers or distributors; |
|
|
|
|
the availability and pricing of acceptable raw materials and component supply; |
|
|
|
|
global regulatory, trade and tax policies; |
|
|
|
|
any changes in law concerning the taxation of income, including income earned outside
the United States; |
|
|
|
|
actions by tax authorities in connection with ongoing tax audits; |
|
|
|
|
the companys ability to realize the anticipated benefits of restructuring and
optimization initiatives; |
|
|
|
|
the companys ability to realize the anticipated benefits from its joint product
development and commercialization arrangements, including the SIGMA transaction; |
|
|
|
|
changes in credit agency ratings; |
|
|
|
|
any impact of the commercial and credit environment on the company and its customers and
suppliers; and |
|
|
|
|
other factors identified elsewhere in this report and other filings with the Securities
and Exchange Commission, including those factors described under the caption Item 1A. Risk
Factors in the companys Form 10-K for the year ended December 31, 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.
33
|
|
|
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 September 30, 2010 is 15 months. The company also uses
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 September 30, 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 $27 million with respect to those contracts
would increase by $74 million.
The sensitivity analysis model recalculates the fair value of the foreign exchange option, forward
and cross-currency swap contracts outstanding at September 30, 2010 by replacing the actual
exchange rates at September 30, 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 September 30, 2010.
34
|
|
|
Item 4. |
|
Controls and Procedures |
Evaluation of Disclosure Controls and Procedures
Baxter carried out an evaluation, under the supervision and with the participation of its
Disclosure Committee and management, including the Chief Executive Officer and Chief Financial
Officer, of the effectiveness of Baxters disclosure controls and procedures (as defined in Rules
13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the Exchange Act))
as of September 30, 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 September 30, 2010.
Changes in Internal Control over Financial Reporting
In the second quarter of 2010, the company began the implementation of a new global enterprise
resource planning system. In addition, the company is consolidating and outsourcing certain
computer operations and application support activities. These multi-year initiatives will be
conducted in phases and include modifications to the design and operation of controls over
financial reporting. The company is testing internal controls over financial reporting for design
effectiveness prior to implementation of each phase, and has monitoring controls in place over the
implementation of these changes. There have been no other changes in Baxters internal control
over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the
Exchange Act) during the quarter ended September 30, 2010 that have materially affected, or are
reasonably likely to materially affect, Baxters internal control over financial reporting.
35
Review by Independent Registered Public Accounting Firm
Reviews of the interim condensed consolidated financial information included in this Quarterly
Report on Form
10-Q for the three and nine months ended September 30, 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.
36
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders of Baxter International Inc.:
We have reviewed the accompanying condensed consolidated balance sheet of Baxter International Inc.
and its subsidiaries as of September 30, 2010, and the related condensed consolidated statements of
income for each of the three- and nine-month periods ended September 30, 2010 and 2009 and the
condensed consolidated statements of cash flows for the nine-month periods ended September 30, 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
November 3, 2010
37
PART II. OTHER INFORMATION
|
|
|
Item 1. |
|
Legal Proceedings |
The information in Part I, Item 1, Note 6 is incorporated herein by reference.
38
|
|
|
Item 2. |
|
Unregistered Sales of Equity Securities and Use of Proceeds |
The following table includes information about the companys common stock repurchases during the
three-month period ended September 30, 2010.
Issuer Purchases of Equity Securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total number |
|
|
|
|
|
|
Total number of shares |
|
|
Approximate dollar value of |
|
|
|
of shares |
|
|
Average price |
|
|
purchased as part of publicly |
|
|
shares that may yet be purchased |
|
Period |
|
purchased(1) |
|
|
paid per share |
|
|
announced program(1) |
|
|
under the program(1) |
|
|
July 1, 2010
through July 31, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
August 1, 2010
through August 31, 2010 |
|
|
1,749,685 |
|
|
$ |
44.87 |
|
|
|
1,749,685 |
|
|
|
|
|
September 1, 2010
through September 30, 2010 |
|
|
1,812,700 |
|
|
$ |
45.68 |
|
|
|
1,812,700 |
|
|
|
|
|
|
Total |
|
|
3,562,385 |
|
|
$ |
45.29 |
|
|
|
3,562,385 |
|
|
|
$676,663,385 |
|
|
|
|
|
(1) |
|
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 third
quarter of 2010, the company repurchased 3.6 million shares for $161 million under this
program. This program does not have an expiration date. |
39
Exhibit Index:
|
|
|
Exhibit |
|
|
Number |
|
Description |
15
|
|
Letter Re Unaudited Interim Financial Information |
|
|
|
31.1
|
|
Certification of Chief Executive Officer Pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934 |
|
|
|
31.2
|
|
Certification of Chief Financial Officer Pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934 |
|
|
|
32.1
|
|
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350 |
|
|
|
32.2
|
|
Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350 |
|
|
|
101.INS*
|
|
XBRL Instance Document |
|
|
|
101.SCH*
|
|
XBRL Taxonomy Extension Schema Document |
|
|
|
101.CAL*
|
|
XBRL Taxonomy Extension Calculation Linkbase Document |
|
|
|
101.LAB*
|
|
XBRL Taxonomy Extension Label Linkbase Document |
|
|
|
101.PRE*
|
|
XBRL Taxonomy Extension Presentation Linkbase Document |
|
|
|
101.DEF*
|
|
XBRL Taxonomy Extension Definition Linkbase Document |
40
Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
|
BAXTER INTERNATIONAL INC.
|
|
|
|
|
|
|
|
(Registrant) |
|
|
|
|
|
|
|
Date: November 3, 2010 |
By: |
/s/ Robert J. Hombach
|
|
|
|
Robert J. Hombach |
|
|
|
Corporate Vice President, Chief Financial Officer
and Treasurer (duly authorized officer and principal financial officer) |
|
|
41