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 June 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) |
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
July 28, 2010 was 584,369,752 shares.
BAXTER INTERNATIONAL INC.
FORM 10-Q
For the quarterly period ended June 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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22 |
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Item 3. |
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Quantitative and Qualitative Disclosures About Market Risk |
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32 |
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Item 4. |
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Controls and Procedures |
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33 |
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Review by Independent Registered Public Accounting Firm |
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34 |
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Report of Independent Registered Public Accounting Firm |
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35 |
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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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36 |
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Item 2. |
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Unregistered Sales of Equity Securities and Use of Proceeds |
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37 |
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Item 6. |
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Exhibits |
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38 |
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Signature |
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39 |
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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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Six months ended |
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June 30, |
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June 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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$ |
3,194 |
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$ |
3,123 |
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$ |
6,121 |
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$ |
5,947 |
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Cost of sales |
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1,556 |
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1,485 |
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3,440 |
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2,821 |
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Gross margin |
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1,638 |
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1,638 |
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2,681 |
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3,126 |
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Marketing and administrative expenses |
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721 |
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660 |
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1,404 |
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1,271 |
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Research and development expenses |
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219 |
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231 |
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446 |
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443 |
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Net interest expense |
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25 |
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24 |
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44 |
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50 |
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Other expense (income), net |
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3 |
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(1 |
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5 |
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1 |
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Income before income taxes |
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670 |
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724 |
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782 |
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1,361 |
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Income tax expense |
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133 |
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135 |
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305 |
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254 |
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Net income |
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537 |
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589 |
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477 |
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1,107 |
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Less: Noncontrolling interests |
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2 |
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2 |
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5 |
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4 |
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Net income attributable to Baxter International Inc. (Baxter) |
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$ |
535 |
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$ |
587 |
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$ |
472 |
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$ |
1,103 |
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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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$ |
0.97 |
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$ |
0.79 |
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$ |
1.81 |
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Diluted |
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$ |
0.90 |
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$ |
0.96 |
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$ |
0.78 |
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$ |
1.79 |
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Weighted-average number of common shares outstanding |
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Basic |
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593 |
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607 |
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597 |
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610 |
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Diluted |
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596 |
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612 |
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602 |
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616 |
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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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$ |
0.58 |
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$ |
0.52 |
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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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June 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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$ |
2,300 |
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$ |
2,786 |
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Accounts and other current receivables |
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2,072 |
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2,302 |
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Inventories |
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2,384 |
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2,557 |
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Prepaid expenses and other |
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619 |
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626 |
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Total current assets |
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7,375 |
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8,271 |
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Property, plant and equipment, net |
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4,983 |
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5,159 |
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Other assets |
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Goodwill |
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1,956 |
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1,825 |
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Other intangible assets, net |
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522 |
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513 |
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Other |
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1,651 |
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1,586 |
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Total other assets |
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4,129 |
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3,924 |
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Total assets |
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$ |
16,487 |
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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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680 |
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682 |
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Accounts payable and accrued liabilities |
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3,390 |
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3,753 |
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Total current liabilities |
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4,085 |
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4,464 |
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Long-term debt and lease obligations |
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4,119 |
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3,440 |
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Other long-term liabilities |
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2,149 |
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2,030 |
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Commitments and contingencies |
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Equity |
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Common stock, $1 par value, authorized
2,000,000,000 shares, issued 683,494,944 shares
in 2010 and 2009 |
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683 |
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683 |
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Common stock in treasury, at cost,
99,215,562 shares in 2010 and 82,523,243
shares in 2009 |
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(5,515 |
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(4,741 |
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Additional contributed capital |
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5,702 |
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5,683 |
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Retained earnings |
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7,376 |
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7,343 |
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Accumulated other comprehensive loss |
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(2,348 |
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(1,777 |
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Total Baxter shareholders equity |
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5,898 |
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7,191 |
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Noncontrolling interests |
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236 |
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229 |
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Total equity |
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6,134 |
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7,420 |
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Total liabilities and equity |
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$ |
16,487 |
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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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Six months ended |
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June 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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$ |
477 |
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$ |
1,107 |
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Adjustments |
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Depreciation and amortization |
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335 |
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302 |
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Deferred income taxes |
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120 |
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135 |
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Stock compensation |
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63 |
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74 |
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Realized excess tax benefits from
stock issued under employee benefit plans |
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(34 |
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(81 |
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Infusion pump charge |
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588 |
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Other |
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33 |
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14 |
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Changes in balance sheet items |
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Accounts and other current receivables |
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(38 |
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(58 |
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Inventories |
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(119 |
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(85 |
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Accounts payable and accrued liabilities |
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(162 |
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(264 |
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Restructuring and cost optimization payments |
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(31 |
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(28 |
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Other |
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(170 |
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(68 |
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Cash flows from operations |
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1,062 |
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1,048 |
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Cash flows from investing activities |
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Capital expenditures |
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(467 |
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(387 |
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Acquisitions of and investments in businesses
and technologies |
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(254 |
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(102 |
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Other |
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(8 |
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Cash flows from investing activities |
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(721 |
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(497 |
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Cash flows from financing activities |
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Issuances of debt |
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604 |
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361 |
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Payments of obligations |
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(17 |
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(183 |
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Cash dividends on common stock |
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(348 |
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(318 |
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Proceeds and realized excess tax benefits from
stock issued under employee benefit plans |
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235 |
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204 |
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Purchases of treasury stock |
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(1,112 |
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(866 |
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Other |
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(32 |
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Cash flows from financing activities |
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(670 |
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(802 |
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Effect of currency exchange rate changes on cash and equivalents |
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(157 |
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(78 |
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Decrease in cash and equivalents |
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(486 |
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(329 |
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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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$ |
2,300 |
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$ |
1,802 |
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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 $28 million in the second quarter of 2010 to write down its
accounts receivable in Greece principally as a result of the Greek governments announcement of a
plan to convert certain past due receivables into non-interest bearing bonds with maturities of one
to three years. The charge, computed by taking into consideration, among other factors, the
imputed discount of the outstanding receivables based upon publicly traded Greek government bonds
with similar terms, was included in marketing and administrative expenses. As it relates to these
and other receivables, changes in economic conditions and customer-specific factors may require the
company to re-evaluate the collectability of its receivables and the company could potentially
incur additional charges.
Net pension and other postemployment benefits cost
The following is a summary of net periodic benefit cost relating to the companys pension and other
postemployment benefit (OPEB) plans.
5
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Three months ended |
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Six months ended |
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June 30, |
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June 30, |
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(in millions) |
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2010 |
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2009 |
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2010 |
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2009 |
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Pension benefits |
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Service cost |
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$ |
25 |
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$ |
22 |
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$ |
50 |
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$ |
43 |
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Interest cost |
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56 |
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55 |
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114 |
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109 |
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Expected return on plan assets |
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(70 |
) |
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(63 |
) |
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(141 |
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(125 |
) |
Amortization of net losses and other deferred
amounts |
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33 |
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24 |
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64 |
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49 |
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Net periodic pension benefit cost |
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$ |
44 |
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$ |
38 |
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$ |
87 |
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$ |
76 |
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OPEB |
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Service cost |
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$ |
2 |
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$ |
1 |
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$ |
3 |
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$ |
2 |
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Interest cost |
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7 |
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8 |
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15 |
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16 |
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Amortization of prior service credit and net loss |
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(2 |
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(3 |
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(1 |
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Net periodic OPEB cost |
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$ |
7 |
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$ |
9 |
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$ |
15 |
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$ |
17 |
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Net interest expense
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Three months ended |
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Six months ended |
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June 30, |
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June 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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$ |
29 |
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$ |
58 |
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$ |
60 |
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Interest income |
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(5 |
) |
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(5 |
) |
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(14 |
) |
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(10 |
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Net interest expense |
|
$ |
25 |
|
|
$ |
24 |
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$ |
44 |
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$ |
50 |
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Comprehensive income (loss)
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Three months ended |
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Six months ended |
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June 30, |
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June 30, |
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(in millions) |
|
2010 |
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2009 |
|
|
2010 |
|
|
2009 |
|
|
Comprehensive income (loss) |
|
$ |
226 |
|
|
$ |
819 |
|
|
$ |
(91 |
) |
|
$ |
1,241 |
|
Less: Comprehensive income attributable to
noncontrolling interests |
|
|
6 |
|
|
|
7 |
|
|
|
8 |
|
|
|
5 |
|
|
Comprehensive income (loss) attributable to Baxter |
|
$ |
220 |
|
|
$ |
812 |
|
|
$ |
(99 |
) |
|
$ |
1,236 |
|
|
The decrease in comprehensive income attributable to Baxter for the three months ended June 30,
2010 was principally due to unfavorable movements in currency translation adjustments, which
resulted in a $355 million loss in 2010 compared to a $215 million gain in 2009. The decrease in
comprehensive income attributable to Baxter for the six months ended June 30, 2010 was principally
due to unfavorable movements in currency translation adjustments, which resulted in a $687 million
loss in 2010 compared to a $109 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 19.9% and 18.6% in the second quarters of 2010 and
2009, respectively, and 39.0% and 18.7% in the six-month periods ended June 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 increase in the effective
tax rate in the three-month period ended June 30, 2010 was due primarily to a change in the
earnings mix between lower and higher tax rate jurisdictions compared to the prior year period.
The increase in the effective tax rate in the six-month period ended June 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
6
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 and higher tax rate jurisdictions compared to the prior year period.
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 |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
Basic shares |
|
|
593 |
|
|
|
607 |
|
|
|
597 |
|
|
|
610 |
|
Effect of dilutive securities |
|
|
3 |
|
|
|
5 |
|
|
|
5 |
|
|
|
6 |
|
|
Diluted shares |
|
|
596 |
|
|
|
612 |
|
|
|
602 |
|
|
|
616 |
|
|
The computation of diluted EPS excluded employee stock options to purchase 30 million and 23
million shares for the three months ended June 30, 2010 and 2009, respectively, and 23 million and
17 million shares for the six months ended June 30, 2010 and 2009, respectively, because the effect
would have been anti-dilutive.
Inventories
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
Raw materials |
|
$ |
469 |
|
|
$ |
598 |
|
Work in process |
|
|
858 |
|
|
|
842 |
|
Finished goods |
|
|
1,057 |
|
|
|
1,117 |
|
|
Inventories |
|
$ |
2,384 |
|
|
$ |
2,557 |
|
|
Property, plant and equipment, net
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
Property, plant and equipment, at cost |
|
$ |
9,868 |
|
|
$ |
10,060 |
|
Accumulated depreciation and amortization |
|
|
(4,885 |
) |
|
|
(4,901 |
) |
|
Property, plant and equipment, net |
|
$ |
4,983 |
|
|
$ |
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 |
|
|
|
18 |
|
|
|
250 |
|
Currency translation and other adjustments |
|
|
(25 |
) |
|
|
(75 |
) |
|
|
(19 |
) |
|
|
(119 |
) |
|
Balance as of June 30, 2010 |
|
$ |
796 |
|
|
$ |
974 |
|
|
$ |
186 |
|
|
$ |
1,956 |
|
|
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
7
statements in the 2009 Annual Report for further information related to DEKA. As of June 30, 2010,
there were no accumulated goodwill impairment losses.
Other intangible assets, net
The following is a summary of the companys intangible assets subject to amortization at June 30,
2010 and December 31, 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Developed |
|
|
|
|
|
|
|
|
technology, |
|
|
|
|
|
|
|
(in millions) |
including patents |
|
|
Other |
|
|
Total |
|
|
June 30, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
Gross other intangible assets |
|
$ |
912 |
|
|
$ |
113 |
|
|
$ |
1,025 |
|
Accumulated amortization |
|
|
(475 |
) |
|
|
(59 |
) |
|
|
(534 |
) |
|
Other intangible assets, net |
|
$ |
437 |
|
|
$ |
54 |
|
|
$ |
491 |
|
|
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 $20 million and $16 million for the three
months ended June 30, 2010 and 2009, respectively, and $37 million and $28 million for the six
months ended June 30, 2010 and 2009, respectively. The anticipated annual amortization expense for
intangible assets recorded as of June 30, 2010 is $70 million in 2010, $66 million in 2011, $64
million in 2012, $62 million in 2013, $58 million in 2014 and $57 million in 2015. The increase in
other intangible assets, net primarily related to the acquisition of ApaTech in the first quarter
of 2010. Refer to the discussion below for further information regarding ApaTech.
Asset impairments
Baxter has made and continues to make significant investments in assets, including inventory and
property, plant and equipment, which relate to potential new products or modifications to existing
products. The companys ability to realize value from these investments is contingent on, among
other things, regulatory approval and market acceptance of these new 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.
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 first half of
2010, the company did not enter into any new arrangements in which it determined that the company
is the primary beneficiary of a VIE. As of June 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 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.
8
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. Changes in the estimated fair value of the contingent payments are being recognized
immediately in earnings. The results of operations and assets and liabilities of ApaTech are
included in the BioScience segment, and the goodwill is included in this reporting unit. A
majority of the goodwill is not deductible for tax purposes. The pro forma impact of the ApaTech
acquisition was not significant to the results of operations of the company.
3. INFUSION PUMP AND OTHER CHARGES
Infusion pump charges
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 its 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 over the next two years 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 will be offered to current owners in exchange for their COLLEAGUE infusion pumps. Cash
costs also included costs associated with the execution of the recall program and customer
accommodations. It is possible that substantial 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
9
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 June 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 |
|
|
(10 |
) |
|
Reserves at June 30, 2010 |
|
$ |
535 |
|
|
The remaining infusion pump reserves are expected to be substantially utilized by the end of 2012.
Refer to Note 5 to the companys consolidated financial statements in the 2009 Annual Report for
further information regarding the COLLEAGUE infusion pumps and the SYNDEO PCA Syringe Pump.
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 June 30, 2010 was $29 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 June 30, 2010 was $28 million.
4. DEBT, FINANCIAL INSTRUMENTS AND FAIR VALUE MEASUREMENTS
Significant debt issuances
In March 2010, the company issued $600 million of senior unsecured notes, with $300 million
maturing in March 2013 and bearing a 1.8% coupon rate, and $300 million maturing in March 2020 and
bearing a 4.25% coupon rate. The net proceeds are being used for general corporate purposes,
including the refinancing of indebtedness.
10
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 |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
Sold receivables at beginning of period |
|
$ |
120 |
|
|
$ |
127 |
|
|
$ |
147 |
|
|
$ |
154 |
|
Proceeds from sales of receivables |
|
|
132 |
|
|
|
129 |
|
|
|
249 |
|
|
|
253 |
|
Cash collections (remitted to the owners
of the receivables) |
|
|
(122 |
) |
|
|
(129 |
) |
|
|
(264 |
) |
|
|
(272 |
) |
Effect of currency exchange rate changes |
|
|
(1 |
) |
|
|
1 |
|
|
|
(3 |
) |
|
|
(7 |
) |
|
Sold receivables at end of period |
|
$ |
129 |
|
|
$ |
128 |
|
|
$ |
129 |
|
|
$ |
128 |
|
|
Derivatives and hedging activities
The company operates on a global basis and is exposed to the risk that its earnings, cash flows and
equity could be adversely impacted by fluctuations in foreign exchange and interest rates. The
companys hedging policy attempts to manage these risks to an acceptable level based on the
companys judgment of the appropriate trade-off between risk, opportunity and costs.
The company is primarily exposed to foreign exchange risk with respect to recognized assets and
liabilities, forecasted transactions and net assets denominated in the Euro, Japanese Yen, British
Pound, Australian Dollar, Canadian Dollar, Brazilian Real and Colombian Peso. The company manages
its foreign currency exposures on a consolidated basis, which allows the company to net exposures
and take advantage of any natural offsets. In addition, the company uses derivative and
nonderivative instruments to further reduce the net exposure to foreign exchange. Gains and losses
on the hedging instruments offset losses and gains on the hedged transactions and reduce the
earnings and equity volatility resulting from foreign exchange. Market volatility and currency
fluctuations may reduce the benefits of the companys natural hedges and limit the companys
ability to cost-effectively hedge these exposures.
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.
11
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 (income), net, cost of sales, and net interest
expense, and primarily relate to a hedge of U.S. Dollar-denominated debt issued by a foreign
subsidiary, forecasted intercompany sales denominated in foreign currencies and anticipated
issuances of debt, respectively.
The notional amounts of foreign exchange contracts and cross-currency swaps (used to hedge U.S.
Dollar-denominated debt issued by a foreign subsidiary) were $1.2 billion and $500 million,
respectively, as of both June 30, 2010 and December 31, 2009. The notional amount of interest rate
contracts outstanding at December 31, 2009 was $200 million. In the first quarter of 2010, in
conjunction with the debt issuance disclosed above, these contracts were terminated, resulting in a
gain of $18 million that 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 June 30, 2010 is 18 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 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 June 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 half 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 (income), net. The terms of these instruments
generally do not exceed one month.
The total gross notional amount of undesignated derivative instruments was $425 million as of June
30, 2010 and $419 million as of December 31, 2009.
12
Gains and Losses on Derivative Instruments
The following tables summarize the income statement locations and gains and losses on the companys
derivative instruments for the three months ended June 30, 2010 and 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain (loss) reclassified from |
|
|
|
Gain (loss) recognized in OCI |
|
|
|
|
AOCI into income |
|
|
|
Three months ended June 30, |
|
|
Location of gain (loss) |
|
Three months ended June 30, |
|
(in millions) |
2010 |
|
2009 |
|
|
in income statement |
2010 |
|
2009 |
|
|
Cash flow hedges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts
|
|
$ |
|
|
|
$ |
56 |
|
|
Net interest expense
|
|
$ |
|
|
|
$ |
|
|
Foreign exchange contracts
|
|
|
(1 |
) |
|
|
|
|
|
Net sales
|
|
|
(1 |
) |
|
|
2 |
|
Foreign exchange contracts
|
|
|
19 |
|
|
|
(30 |
) |
|
Cost of sales
|
|
|
(2 |
) |
|
|
20 |
|
Foreign exchange contracts
|
|
|
47 |
|
|
|
(17 |
) |
|
Other expense (income), net
|
|
|
48 |
|
|
|
(15 |
) |
|
Total
|
|
$ |
65 |
|
|
$ |
9 |
|
|
|
|
$ |
45 |
|
|
$ |
7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain (loss) recognized in income |
|
|
|
|
|
|
|
|
|
|
|
Location of gain (loss) in |
|
Three months ended June 30, |
|
(in millions) |
|
|
|
|
|
income statement |
2010 |
|
2009 |
|
|
Fair value hedges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts
|
|
|
|
|
|
|
|
|
|
Net interest expense
|
|
$ |
64 |
|
|
$ |
(66 |
) |
|
Undesignated derivative instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts
|
|
|
|
|
|
|
|
|
|
Other expense (income), net
|
|
$ |
(4 |
) |
|
$ |
(17 |
) |
|
The following tables summarize the income statement locations and gains and losses on the
companys derivative instruments for the six months ended June 30, 2010 and 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain (loss) reclassified from |
|
|
|
Gain (loss) recognized in OCI |
|
|
|
|
AOCI into income |
|
|
|
Six months ended June 30, |
|
|
Location of gain (loss) |
|
Six months ended June 30, |
|
(in millions) |
2010 |
|
2009 |
|
|
in income statement |
2010 |
|
2009 |
|
|
Cash flow hedges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts |
|
$ |
(7 |
) |
|
$ |
76 |
|
|
Net interest expense
|
|
$ |
1 |
|
|
|
$ (1 |
) |
Foreign exchange contracts
|
|
|
(2 |
) |
|
|
(1 |
) |
|
Net sales
|
|
|
(2 |
) |
|
|
4 |
|
Foreign exchange contracts
|
|
|
33 |
|
|
|
(18 |
) |
|
Cost of sales
|
|
|
(7 |
) |
|
|
44 |
|
Foreign exchange contracts
|
|
|
84 |
|
|
|
(19 |
) |
|
Other expense (income), net
|
|
|
86 |
|
|
|
(6 |
) |
|
Total
|
|
$ |
108 |
|
|
$ |
38 |
|
|
|
|
$ |
78 |
|
|
|
$41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain (loss) recognized in income |
|
|
|
|
|
|
|
|
|
|
|
Location of gain (loss) in |
|
Six months ended June 30, |
|
(in millions) |
|
|
|
|
|
income statement |
2010 |
|
2009 |
|
|
Fair value hedges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts
|
|
|
|
|
|
|
|
|
|
Net interest expense
|
|
$ |
85 |
|
|
|
$(83 |
) |
|
Undesignated derivative instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts
|
|
|
|
|
|
|
|
|
|
Other expense (income), net
|
|
$ |
(5 |
) |
|
|
$(44 |
) |
|
For the companys fair value hedges, equal and offsetting losses of $64 million and $85
million were recognized in net interest expense in the second quarter and first half of 2010,
respectively, and equal and offsetting gains of $66 million and $83 million were recognized in net
interest expense in the second quarter and first half 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 six months ended June 30, 2010 was not material.
As of June 30, 2010, $12 million of deferred, net after-tax gains on derivative instruments
included in AOCI are expected to be recognized in earnings during the next 12 months, coinciding
with when the hedged items are expected to impact earnings.
13
Fair Values of Derivative Instruments
The following table summarizes the classification and fair value amounts of derivative instruments
reported in the condensed consolidated balance sheet as of June 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
|
|
|
$145 |
|
|
|
|
|
|
|
Foreign exchange contracts
|
|
Prepaid expenses and other
|
|
|
37 |
|
|
Accounts payable and accrued liabilities
|
|
|
$14 |
|
Foreign exchange contracts
|
|
Other long-term assets
|
|
|
1 |
|
|
Other long-term liabilities
|
|
|
1 |
|
|
Total derivative instruments designated as hedges
|
|
|
|
|
$183 |
|
|
|
|
|
$15 |
|
|
Undesignated derivative instruments |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts
|
|
Prepaid expenses and other
|
|
|
$ |
|
|
Accounts payable and accrued liabilities
|
|
|
$ |
|
|
Total derivative instruments
|
|
|
|
|
$183 |
|
|
|
|
|
$15 |
|
|
The following table summarizes the classification and fair value amounts 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 |
|
|
|
|
|
|
|
Foreign exchange contracts
|
|
Prepaid expenses and other
|
|
|
20 |
|
|
Accounts payable and accrued liabilities
|
|
|
112 |
|
|
Total derivative instruments designated as hedges
|
|
|
|
|
$105 |
|
|
|
|
|
$113 |
|
|
Undesignated derivative instruments |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts
|
|
Prepaid expenses and other
|
|
|
$ |
|
|
Accounts payable and accrued liabilities
|
|
|
$ |
|
|
Total derivative instruments
|
|
|
|
|
$105 |
|
|
|
|
|
$113 |
|
|
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) |
June 30, 2010 |
|
(Level 1) |
|
(Level 2) |
|
(Level 3) |
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency hedges |
|
|
$38 |
|
|
|
$ |
|
|
|
$38 |
|
|
|
$ |
|
Interest rate hedges |
|
|
145 |
|
|
|
|
|
|
|
145 |
|
|
|
|
|
Equity securities |
|
|
15 |
|
|
|
15 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
|
$198 |
|
|
|
$15 |
|
|
|
$183 |
|
|
|
$ |
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency hedges |
|
|
$15 |
|
|
|
$ |
|
|
|
$15 |
|
|
|
$ |
|
Contingent payments
related to
acquisitions and
investments |
|
|
126 |
|
|
|
|
|
|
|
|
|
|
|
126 |
|
|
Total liabilities |
|
|
$141 |
|
|
|
$ |
|
|
|
$15 |
|
|
|
$126 |
|
|
14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
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 |
|
|
65 |
|
Unrealized loss recognized in earnings |
|
|
2 |
|
|
Fair value as of June 30, 2010 |
|
$ |
126 |
|
|
The unrealized loss recognized in earnings relates to liabilities held at June 30, 2010 and is
reported in cost of sales and R&D expenses. The addition during the first half 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 June 30, 2010 and December 31, 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Book values |
|
|
Approximate fair values |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term insurance receivables |
|
$ |
35 |
|
|
$ |
49 |
|
|
$ |
34 |
|
|
$ |
47 |
|
Investments |
|
|
31 |
|
|
|
31 |
|
|
|
30 |
|
|
|
31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term debt |
|
|
15 |
|
|
|
29 |
|
|
|
15 |
|
|
|
29 |
|
Current maturities of long-term debt and lease obligations |
|
|
680 |
|
|
|
682 |
|
|
|
686 |
|
|
|
697 |
|
Other long-term debt and lease obligations |
|
|
4,119 |
|
|
|
3,440 |
|
|
|
4,469 |
|
|
|
3,568 |
|
Long-term litigation liabilities |
|
|
39 |
|
|
|
45 |
|
|
|
38 |
|
|
|
44 |
|
|
15
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 and lease obligations were
computed by multiplying price by the notional amount of the respective debt instrument. Price is
calculated using the stated terms of the respective debt instrument and yield curves commensurate
with the companys credit risk. In determining the fair value of cost method investments, the
company takes into consideration recent transactions, as well as the financial information of the
investee. The carrying values of the other financial instruments approximate their fair values due
to the short-term maturities of most of these assets and liabilities.
5. COMMON STOCK
Stock-based compensation plans
Stock compensation expense totaled $33 million and $36 million for the three months ended June 30,
2010 and 2009, respectively, and $63 million and $74 million for the six months ended June 30, 2010
and 2009, respectively. A majority of stock compensation expense is classified in marketing and
administrative expenses with the remainder classified in cost of sales and R&D expenses.
In March 2010, the company awarded its annual stock compensation grants, which consisted of
approximately 8.0 million stock options and 574,000 performance share units (PSUs). Stock
compensation grants made in the second quarter 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.
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended |
|
|
|
June 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 $19 million and $16 million during the
three months ended June 30, 2010 and 2009, respectively, and was $79 million and $45 million during
the six months ended June 30, 2010 and 2009, respectively.
As of June 30, 2010, $111 million of unrecognized compensation cost related to all unvested stock
options is expected to be recognized as expense over a weighted-average period of 2.1 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 fair values, were as follows.
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended |
|
|
|
June 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 June 30, 2010, unrecognized compensation cost related to all unvested PSUs of $49 million is
expected to be recognized as expense over a weighted-average period of 2.0 years, and unrecognized
compensation cost related to
16
all unvested restricted stock units of $10 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 six-month periods ended June 30, 2010, the company repurchased 15.2 million shares and 22.7
million shares for $677 million and $1.1 billion, respectively, under the board of directors July
2009 $2.0 billion share repurchase authorization. At June 30, 2010, $838 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.
Baxter has established reserves for certain of the matters discussed below. The company is not
able to estimate the amount or range of any loss for certain of the legal contingencies for which
there is no reserve or additional loss for matters already reserved. While the liability of the
company in connection with the claims cannot be estimated with any certainty and although the
resolution in any reporting period of one or more of these matters could have a significant impact
on the companys results of operations and cash flows for that period, the outcome of these legal
proceedings is not expected to have a material adverse effect on the companys consolidated
financial position. While the company believes that it has valid defenses in these matters,
litigation is inherently uncertain, excessive verdicts do occur, and the company may in the future
incur material judgments or enter into material settlements of claims.
In addition to the matters described below, the company remains subject to other potential
administrative and legal actions. With respect to 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. Abbott has requested reconsideration of this ruling. In 2007, Abbott brought
a patent infringement action against Baxter in the Cali Circuit Court of Colombia based on a
Colombian counterpart patent, and obtained an injunction preliminarily prohibiting the approval of
Baxters generic sevoflurane in Colombia during the pendency of the infringement suit. In May 2008,
the Court issued a decision maintaining the injunction, but suspending it during an appeal of the
Courts decision, which appeal is pending.
Peritoneal Dialysis Litigation
In October 2006, Baxter Healthcare Corporation, a direct wholly-owned subsidiary of Baxter, and
DEKA Products Limited Partnership (DEKA) filed a patent infringement lawsuit against Fresenius
Medical Care Holdings, Inc. and Fresenius USA, Inc. The complaint alleged that Fresenius sale of
the Liberty Cycler peritoneal dialysis systems and
17
related disposable items and equipment infringes nine U.S. patents, which are owned by Baxter or
exclusively licensed in the peritoneal dialysis field to Baxter from
DEKA. 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. On April 4,
2008, the U.S.D.C. for the Northern District of California granted Baxters motion for permanent
injunction, granted Baxters request for royalties on Fresenius sales of the 2008K hemodialysis
machines during a nine-month transition period before the permanent injunction took effect, and
granted a royalty on disposables. On September 10, 2009, the appellate court affirmed Fresenius
liability for infringing valid claims of Baxters main patent, invalidated certain claims of other
patents, and remanded the case to the district court to finalize the scope of the injunction and
the amount of damages owed to Baxter. In November 2009, the appellate court denied Fresenius
petition for re-hearing of the appeal. In January 2010, Fresenius consented to reentry of the
injunction and sought a new trial to determine royalties, which the company is opposing. In March
2010, the United States Patent and Trademark Offices (USPTO) appellate board affirmed the previous
determination by the USPTO patent examiner that the remaining patent was invalid. The company is
seeking reconsideration of that decision with the board, and if unsuccessful, will appeal the
USPTOs decision to the same appellate court that affirmed the validity of the patent in September
2009. Fresenius has asked the trial court to stay further court proceedings during the pendency of
the companys appeal of the USPTOs negative determination.
Other
In October 2004, a purported class action was filed in the U.S.D.C. for the Northern District of
Illinois against Baxter and its current Chief Executive Officer and then current Chief Financial
Officer and their predecessors for alleged violations of the Employee Retirement Income Security
Act of 1974, as amended. Plaintiff alleges that these defendants, along with the Administrative
and Investment Committees of the companys 401(k) plans, breached their fiduciary duties to the
plan participants by offering Baxter common stock as an investment option in each of the plans
during the period of January 2001 to October 2004. In March 2006, the trial court certified a
class of plan participants who elected to acquire Baxter common stock through the plans between
January 2001 and the present. 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 Chief Executive Officer, then current Chief
Financial Officer, Medication Delivery business President and board of directors. The complaint
alleges that the defendants breached their fiduciary duties to the company under Illinois law and
caused substantial monetary losses to the company in connection with addressing the COLLEAGUE
infusion pump matter.
On October 12, 2005 the United States filed a complaint in the U.S.D.C. for the Northern District
of Illinois to effect the seizure of COLLEAGUE and SYNDEO infusion pumps that were on hold in
Northern Illinois. Customer-owned pumps were not affected. On June 29, 2006, Baxter Healthcare
Corporation entered into a Consent Decree for Condemnation and Permanent Injunction with the United
States to resolve this seizure litigation. Pursuant to the Consent Decree, in July 2010 the FDA
issued its 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 next two years 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 of the Northern District of
Illinois requesting production of documents relating to the COLLEAGUE infusion pump. The company
is fully cooperating with the request.
The company is a defendant, along with others, in eleven lawsuits brought in various U.S. federal
courts alleging that Baxter and certain of its competitors conspired to restrict output and
artificially increase the price of plasma-derived therapies since 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.
18
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.
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
October 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 the
third quarter of 2010. 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.
Baxter currently is a defendant in a number of lawsuits and subject to additional claims brought by
individuals who have hemophilia and their families, all seeking damages for injuries allegedly
caused by anti-hemophilic factor concentrates VIII or IX derived from human blood plasma (factor
concentrates) processed by the company and other acquired entities from the late 1970s to the
mid-1980s. The typical case or claim alleges that the individual was infected with the HIV or HCV
virus by factor concentrates that contained one or both viruses. None of these cases involves
factor concentrates currently processed by the company. Baxter and other defendants have announced
a settlement offer with respect to these claims. The fully reserved settlement is contingent on
receiving acceptance from a significant percentage of the claimants in 2010.
7. SEGMENT INFORMATION
Baxter operates in three segments, each of which is a strategic business that is managed separately
because each business develops, manufactures and markets distinct products and services. The
segments and a description of their products and services are as follows.
The BioScience business processes recombinant and plasma-based proteins to treat hemophilia and
other bleeding disorders; plasma-based therapies to treat immune deficiencies, alpha 1-antitrypsin
deficiency, burns and shock, and other chronic and acute blood-related conditions; products for
regenerative medicine, such as biosurgery products; and vaccines.
The Medication Delivery business manufactures intravenous (IV) solutions and administration sets,
premixed drugs and drug-reconstitution systems, pre-filled vials and syringes for injectable drugs,
IV nutrition products, infusion pumps, and inhalation anesthetics, as well as products and services
related to pharmacy compounding, drug formulation and packaging technologies.
The Renal business provides products to treat end-stage renal disease, or irreversible kidney
failure. The business manufactures solutions and other products for peritoneal dialysis, a
home-based therapy, and also distributes products for hemodialysis, which is generally conducted in
a hospital or clinic.
19
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.
Included in the Medication Delivery segments pre-tax loss in the first half of 2010 was a first
quarter charge of $588 million 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.
Financial information for the companys segments is as follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
Net sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BioScience |
|
$ |
1,358 |
|
|
$ |
1,418 |
|
|
$ |
2,720 |
|
|
$ |
2,670 |
|
Medication Delivery |
|
|
1,239 |
|
|
|
1,134 |
|
|
|
2,208 |
|
|
|
2,169 |
|
Renal |
|
|
585 |
|
|
|
550 |
|
|
|
1,169 |
|
|
|
1,065 |
|
Transition services to Fenwal |
|
|
12 |
|
|
|
21 |
|
|
|
24 |
|
|
|
43 |
|
|
Total |
|
$ |
3,194 |
|
|
$ |
3,123 |
|
|
$ |
6,121 |
|
|
$ |
5,947 |
|
|
Pre-tax income (loss) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BioScience |
|
$ |
515 |
|
|
$ |
565 |
|
|
$ |
1,069 |
|
|
$ |
1,074 |
|
Medication Delivery |
|
|
285 |
|
|
|
207 |
|
|
|
(57 |
) |
|
|
375 |
|
Renal |
|
|
87 |
|
|
|
77 |
|
|
|
172 |
|
|
|
127 |
|
|
Total pre-tax income from segments |
|
$ |
887 |
|
|
$ |
849 |
|
|
$ |
1,184 |
|
|
$ |
1,576 |
|
|
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.
20
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 |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
Total pre-tax income from segments |
|
$ |
887 |
|
|
$ |
849 |
|
|
$ |
1,184 |
|
|
$ |
1,576 |
|
Unallocated amounts |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock compensation |
|
|
(33 |
) |
|
|
(36 |
) |
|
|
(63 |
) |
|
|
(74 |
) |
Net interest expense |
|
|
(25 |
) |
|
|
(24 |
) |
|
|
(44 |
) |
|
|
(50 |
) |
Certain foreign currency
fluctuations and hedging activities |
|
|
10 |
|
|
|
34 |
|
|
|
19 |
|
|
|
76 |
|
Other Corporate items |
|
|
(169 |
) |
|
|
(99 |
) |
|
|
(314 |
) |
|
|
(167 |
) |
|
Income before income taxes |
|
$ |
670 |
|
|
$ |
724 |
|
|
$ |
782 |
|
|
$ |
1,361 |
|
|
21
|
|
|
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 six months ended June 30,
2010.
RESULTS OF OPERATIONS
NET SALES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Six months ended |
|
|
|
|
|
|
June 30, |
|
|
Percent |
|
|
June 30, |
|
|
Percent |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
change |
|
|
2010 |
|
|
2009 |
|
|
change |
|
|
BioScience |
|
$ |
1,358 |
|
|
$ |
1,418 |
|
|
|
(4% |
) |
|
$ |
2,720 |
|
|
$ |
2,670 |
|
|
|
2% |
|
Medication Delivery |
|
|
1,239 |
|
|
|
1,134 |
|
|
|
9% |
|
|
|
2,208 |
|
|
|
2,169 |
|
|
|
2% |
|
Renal |
|
|
585 |
|
|
|
550 |
|
|
|
6% |
|
|
|
1,169 |
|
|
|
1,065 |
|
|
|
10% |
|
Transition services
to Fenwal Inc. |
|
|
12 |
|
|
|
21 |
|
|
|
(43% |
) |
|
|
24 |
|
|
|
43 |
|
|
|
(44% |
) |
|
Total net sales |
|
$ |
3,194 |
|
|
$ |
3,123 |
|
|
|
2% |
|
|
$ |
6,121 |
|
|
$ |
5,947 |
|
|
|
3% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Six months ended |
|
|
|
|
|
|
June 30, |
|
|
Percent |
|
|
June 30, |
|
|
Percent |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
change |
|
|
2010 |
|
|
2009 |
|
|
change |
|
|
International |
|
$ |
1,839 |
|
|
$ |
1,798 |
|
|
|
2% |
|
|
$ |
3,686 |
|
|
$ |
3,381 |
|
|
|
9% |
|
United States |
|
|
1,355 |
|
|
|
1,325 |
|
|
|
2% |
|
|
|
2,435 |
|
|
|
2,566 |
|
|
|
(5% |
) |
|
Total net sales |
|
$ |
3,194 |
|
|
$ |
3,123 |
|
|
|
2% |
|
|
$ |
6,121 |
|
|
$ |
5,947 |
|
|
|
3% |
|
|
Foreign currency favorably impacted net sales by 2 and 4 percentage points in the three- and
six-month periods ended June 30, 2010, respectively, principally due to the weakening of the U.S.
Dollar relative to other currencies, including the Australian and Canadian Dollar in both periods
and the Euro in the six-month period ended June 30, 2010.
Healthcare reform legislation enacted in the United States in the first quarter of 2010 unfavorably
impacted sales growth in the three- and six-month periods ended June 30, 2010 by approximately 0.6
percentage points, principally in the BioScience segment. The company expects that U.S.
healthcare reform legislation will continue to unfavorably impact sales growth throughout the
remainder of 2010 as a result of an increase in Medicaid rebates and the expansion of the 340B Drug
Pricing Program with respect to the increase in both the number of eligible entities and the
discounts that the company may provide.
Included as a reduction to net sales in the first half of 2010 was $213 million of the companys
$588 million first quarter charge related to the recall of COLLEAGUE infusion pumps from the U.S.
market. The charge, included in the Medication Delivery segment, unfavorably impacted sales growth
in the six-month period ended June 30, 2010 by 4 percentage points. Refer to Note 3 for further
information regarding the COLLEAGUE infusion pump charge.
22
BioScience
The following is a summary of sales by product category in the BioScience segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Six months ended |
|
|
|
|
|
|
June 30, |
|
|
Percent |
|
|
June 30, |
|
|
Percent |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
change |
|
|
2010 |
|
|
2009 |
|
|
change |
|
|
Recombinants |
|
$ |
525 |
|
|
$ |
515 |
|
|
|
2% |
|
|
$ |
1,035 |
|
|
$ |
966 |
|
|
|
7% |
|
Plasma Proteins |
|
|
314 |
|
|
|
353 |
|
|
|
(11% |
) |
|
|
606 |
|
|
|
627 |
|
|
|
(3% |
) |
Antibody Therapy |
|
|
310 |
|
|
|
344 |
|
|
|
(10% |
) |
|
|
632 |
|
|
|
681 |
|
|
|
(7% |
) |
Regenerative Medicine |
|
|
133 |
|
|
|
109 |
|
|
|
22% |
|
|
|
252 |
|
|
|
208 |
|
|
|
21% |
|
Other |
|
|
76 |
|
|
|
97 |
|
|
|
(22% |
) |
|
|
195 |
|
|
|
188 |
|
|
|
4% |
|
|
Total net sales |
|
$ |
1,358 |
|
|
$ |
1,418 |
|
|
|
(4% |
) |
|
$ |
2,720 |
|
|
$ |
2,670 |
|
|
|
2% |
|
|
Net sales in the BioScience segment decreased 4% and increased 2% during the three- and six-month
periods ended June 30, 2010, respectively (including a 1 and 3 percentage point benefit from
foreign currency in the three- and six-month periods ended June 30, 2010, respectively). Sales in
the BioScience segment in both periods were unfavorably impacted by U.S. healthcare reform
legislation that affected the Antibody Therapy, Recombinants and Plasma Proteins product
categories. Sales growth in the Recombinants product category was the result of increased sales of
the companys advanced recombinant therapy, ADVATE [Antihemophilic Factor (Recombinant),
Plasma/Albumin-Free Method], which was partially offset by lower U.K. tender sales in the second
quarter of 2010. Sales in the Plasma Proteins product category declined in both periods as
increased demand for ARALAST NP [alpha 1-proteinase inhibitor (human)] in the United States and for
FEIBA (an anti-inhibitor coagulant complex) outside the United States, were more than offset by
lower sales of albumin in the United States and of plasma-derived factor VIII from international
tenders. Antibody Therapy sales declined due to slower market growth, share loss versus the prior
year periods, and pricing actions implemented in the second quarter of 2010 pertaining to GAMMAGARD
LIQUID, the liquid formulation of the antibody-replacement therapy IGIV (immune globulin
intravenous). The company may continue to experience volatility in results for certain
plasma-based therapies (Plasma Proteins and Antibody Therapy) as a
result of 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 broad portfolio of sealant products, including FLOSEAL,
COSEAL and TISSEEL. Excluding the impact of foreign currency in both periods, sales in the Other
product category declined as a result of a reduction in advanced purchase agreement revenues and
lower demand for FSME-IMMUN (a tick-borne encephalitis vaccine) and NEISVAC-C (for the prevention
of meningitis C) in international markets. Partially offsetting the decline for the six months
ended June 30, 2010 were first quarter sales of the CELVAPAN H1N1 pandemic vaccine in select
international markets.
Medication Delivery
The following is a summary of sales by product category in the Medication Delivery segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Six months ended |
|
|
|
|
|
|
June 30, |
|
|
Percent |
|
|
June 30, |
|
|
Percent |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
change |
|
|
2010 |
|
|
2009 |
|
|
change |
|
|
IV Therapies |
|
$ |
418 |
|
|
$ |
384 |
|
|
|
9% |
|
|
$ |
809 |
|
|
$ |
728 |
|
|
|
11% |
|
Global Injectables |
|
|
472 |
|
|
|
418 |
|
|
|
13% |
|
|
|
923 |
|
|
|
789 |
|
|
|
17% |
|
Infusion Systems |
|
|
216 |
|
|
|
205 |
|
|
|
5% |
|
|
|
212 |
|
|
|
404 |
|
|
|
(48% |
) |
Anesthesia |
|
|
130 |
|
|
|
120 |
|
|
|
8% |
|
|
|
257 |
|
|
|
229 |
|
|
|
12% |
|
Other |
|
|
3 |
|
|
|
7 |
|
|
|
(57% |
) |
|
|
7 |
|
|
|
19 |
|
|
|
(63% |
) |
|
Total net sales |
|
$ |
1,239 |
|
|
$ |
1,134 |
|
|
|
9% |
|
|
$ |
2,208 |
|
|
$ |
2,169 |
|
|
|
2% |
|
|
Net sales for the Medication Delivery segment increased 9% and 2% during the three- and six-month
periods ended June 30, 2010, respectively (including a 3 and 5 percentage point benefit from
foreign currency in the three- and six-month periods ended June 30, 2010, respectively).
Intravenous (IV) Therapies sales growth was driven by improved pricing and increased global demand
for nutritional products and IV solutions. Within the Global Injectables
23
product category, sales growth in both periods was driven by strong sales in the U.S.
pharmaceutical partnering and international pharmacy compounding businesses and growth for certain
pre-mixed drugs, particularly in the United States, as well as increased demand in the second
quarter for select multi-source generic products. In the Infusion Systems product category, net
sales declined in the first half 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 from the U.S.
market. Increased sales of the Sigma International General Medical Apparatus, LLC (SIGMA) SPECTRUM
infusion pumps partially offset the impact of the COLLEAGUE charge in the first half of 2010, and
contributed to the growth in the second quarter of 2010. In connection with the implementation of
the COLLEAGUE recall, customers may receive SIGMA SPECTRUM infusion pumps in exchange for their
COLLEAGUE infusion pumps. 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 |
|
|
|
|
|
|
Six months ended |
|
|
|
|
|
|
June 30, |
|
|
Percent |
|
|
June 30, |
|
|
Percent |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
change |
|
|
2010 |
|
|
2009 |
|
|
change |
|
|
PD Therapy |
|
$ |
480 |
|
|
$ |
454 |
|
|
|
6% |
|
|
$ |
954 |
|
|
$ |
874 |
|
|
|
9% |
|
HD Therapy |
|
|
105 |
|
|
|
96 |
|
|
|
9% |
|
|
|
215 |
|
|
|
191 |
|
|
|
13% |
|
|
Total net sales |
|
$ |
585 |
|
|
$ |
550 |
|
|
|
6% |
|
|
$ |
1,169 |
|
|
$ |
1,065 |
|
|
|
10% |
|
|
Net sales in the Renal segment increased 6% and 10% during the three- and six-month periods ended
June 30, 2010, respectively (including a 5 and 7 percentage point benefit from foreign currency in
the three- and six-month periods ended June 30, 2010, respectively). Net sales in both periods
grew due to an increase in the number of peritoneal dialysis (PD) patients, particularly in the
United States and Latin America, and double-digit growth in Asia (particularly 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 in the third quarter of 2009.
Transition services to Fenwal Inc.
Net sales in this category represents revenues associated with manufacturing, distribution and
other services provided by the company to Fenwal Inc. (Fenwal) subsequent to the divestiture of the
Transfusion Therapies (TT) business in 2007. Refer to Note 3 to the companys consolidated
financial statements in the 2009 Annual Report for additional information regarding the TT
divestiture.
GROSS MARGIN AND EXPENSE RATIOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Six months ended |
|
|
|
|
|
|
June 30, |
|
|
Percent |
|
|
June 30, |
|
|
Percent |
|
(as a percentage of net sales) |
|
2010 |
|
|
2009 |
|
|
Change |
|
|
2010 |
|
|
2009 |
|
|
Change |
|
|
Gross margin |
|
|
51.3% |
|
|
|
52.4% |
|
|
(1.1 pts |
) |
|
|
43.8% |
|
|
|
52.6% |
|
|
(8.8 pts |
) |
Marketing and administrative
expenses |
|
|
22.6% |
|
|
|
21.1% |
|
|
1.5 pts |
|
|
|
22.9% |
|
|
|
21.4% |
|
|
1.5 pts |
|
|
Gross Margin
The gross margin percentage declined in the second quarter and first half of 2010. Improvements in
sales mix in both periods in the Medication Delivery and Renal segments, as well as for select
products in the BioScience segment, were more than offset by the impact of U.S. healthcare reform
legislation and cost inefficiencies driven by lower volume throughput for plasma-based therapies
and vaccines, and increases in vaccines inventory reserves. The first half of 2010 was also
impacted by 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 rate
by 7.8 percentage points.
24
Marketing and Administrative Expenses
Marketing and administrative expenses were $721 million in the second quarter of 2010, an increase
of 9% over the $660 million reported in the second quarter of 2009, and $1.4 billion in the first
half of 2010, an increase of 10% over the $1.3 billion reported in the first half of 2009. These
increases were driven by the unfavorable impact of foreign currency, a $28 million charge in the
second quarter of 2010 to write down accounts receivable in Greece, and increased spending on new
marketing and promotional programs, which were partially offset by the companys focus on
controlling discretionary spending. In addition, the increase in the marketing and administrative
expense ratio in the first half 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 0.7 percentage points. As a
result of an increased focus on managing costs, the company expects a
decline from the prior year in the marketing and administrative
expenses incurred during the full-year 2010. Refer to Note 2 for further information regarding the
Greece receivable charge.
RESEARCH AND DEVELOPMENT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Six months ended |
|
|
|
|
|
|
June 30, |
|
|
Percent |
|
|
June 30, |
|
|
Percent |
|
(in millions) |
|
2010 |
|
|
2009 |
|
|
change |
|
|
2010 |
|
|
2009 |
|
|
change |
|
|
Research and development expenses |
|
|
$219 |
|
|
|
$231 |
|
|
|
(5% |
) |
|
|
$446 |
|
|
|
$443 |
|
|
|
1% |
|
As a percentage of net sales |
|
|
6.9% |
|
|
|
7.4% |
|
|
|
|
|
|
|
7.3% |
|
|
|
7.4% |
|
|
|
|
|
|
Research and development (R&D) expenses decreased in the second quarter of 2010 and increased
slightly during the first half of 2010. Impacting both periods was a reduction in R&D expenses due
to the completion of clinical work on late-stage programs and efforts to reposition projects to
gain organizational efficiencies. Also impacting R&D expenses for the six months ended June 30,
2010 was the unfavorable impact of foreign currency. While the company will continue to invest in
its R&D pipeline as part of the execution of its long-term growth strategy, 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 $25 million and $24 million in the second quarters of 2010 and 2009,
respectively, and $44 million and $50 million in the first half of 2010 and 2009, respectively.
The decrease in the first six 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.
OTHER EXPENSE (INCOME), NET
Other expense (income), net was $3 million of expense and $1 million of income in the second
quarters of 2010 and 2009, respectively, and $5 million and $1 million of expense during the first
half 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.
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 9% and was flat for the three- and six-month periods ended June 30, 2010,
respectively. The impact from increased sales of certain higher-margin products and the favorable
impact of foreign currency were more than offset by the reduction in sales and cost inefficiencies
for plasma-based therapies and vaccines, and increases in Medicaid rebates, vaccines inventory
reserves, spending on R&D and new marketing and promotional programs.
25
Medication Delivery
Pre-tax income increased 38% and decreased 115% for the three- and six-month periods ended June 30,
2010, respectively. The decrease for the six-month period ended June 30, 2010 was primarily due to
the COLLEAGUE charge in the first quarter of 2010 totaling $588 million. Partially offsetting the
impact of the first half decrease and favorably impacting the second quarter were strong sales
growth, gross margin improvement resulting from favorable product mix, a reduction in R&D spending
and the favorable impact of foreign currency.
Renal
Pre-tax income increased 13% and 35% for the three- and six-month periods ended June 30, 2010,
respectively. The increase in both periods 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.
INCOME TAXES
The companys effective income tax rate was 19.9% and 18.6% in the second quarters of 2010 and
2009, respectively, and 39.0% and 18.7% in the six-month periods ended June 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 increase in the effective
tax rate in the three-month period ended June 30, 2010 was due primarily to a change in the
earnings mix between lower and higher tax rate jurisdictions compared to the prior year period.
The increase in the effective tax rate in the six-month period ended June 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 and higher tax rate jurisdictions
compared to the prior year period.
The company anticipates that the effective tax rate for the full-year 2010 will be approximately
19.5%, excluding the impact from audit developments and other special items, such as the items in
the first half of 2010 noted above.
INCOME AND EARNINGS PER DILUTED SHARE
Net income attributable to Baxter was $535 million and $587 million for the three months ended June
30, 2010 and 2009, respectively, and $472 million and $1.1 billion for the six months ended June
30, 2010 and 2009, respectively. Net income attributable to Baxter per diluted share was $0.90 and
$0.96 for the three months ended June 30, 2010 and 2009, respectively, and $0.78 and $1.79 for the
six months ended June 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 half of 2010 as compared to the prior year,
totaling $1,062 million in 2010 and $1,048 million in 2009. The increase in cash flows from
operations was primarily due to higher
26
earnings (before non-cash items) and the other factors discussed below. Included in cash flows
from operations in the first half of 2010 and 2009 were outflows of $34 million and $81 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 during the first half of 2010 as compared
to the prior year. Days sales outstanding increased from 53.9 days at June 30, 2009 to 54.3 days
at June 30, 2010, primarily due to a modest increase in collection periods in the United States.
Inventories
Cash outflows relating to inventories increased in 2010 as compared to the prior year. The
following is a summary of inventories at June 30, 2010 and December 31, 2009, as well as annualized
inventory turns for the three months ended June 30, 2010 and 2009, by segment. The higher
inventory turns for the total company were principally due to the favorable impact of foreign
currency.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Annualized inventory |
|
|
|
Inventories |
|
|
turns for the three |
|
|
|
June 30, |
|
December 31, |
|
|
months ended June 30, |
|
(in millions, except inventory turn data) |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
BioScience |
|
$ |
1,502 |
|
|
$ |
1,592 |
|
|
|
1.43 |
|
|
|
1.48 |
|
Medication Delivery |
|
|
609 |
|
|
|
705 |
|
|
|
4.40 |
|
|
|
3.18 |
|
Renal |
|
|
270 |
|
|
|
257 |
|
|
|
4.04 |
|
|
|
4.09 |
|
Other |
|
|
3 |
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
Total company |
|
$ |
2,384 |
|
|
$ |
2,557 |
|
|
|
2.49 |
|
|
|
2.27 |
|
|
Other
Cash outflows related to liabilities, restructuring and cost optimization payments and other
increased slightly in the first six 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 $80 million for the six months ended June 30, 2010, from $387
million in 2009 to $467 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, as well as the impact of foreign
currency.
Acquisitions of and Investments in Businesses and Technologies
Cash outflows relating to acquisitions of and investments in businesses and technologies of $254
million in the first half 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. Additionally, 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). Cash outflows relating to acquisitions of and investments in businesses and
technologies of $102 million in the first half 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. Refer to Note 2 for further information about the acquisition of ApaTech and
Note 4 to the companys consolidated financial statements in the 2009 Annual Report for further
information related to DEKA and SIGMA.
27
Other
Cash outflows in the first half of 2009 principally related to an increase in short-term
investments.
Cash flows from financing activities
Debt
Issuances, Net of Payments of Obligations
Net cash inflows related to debt and other financing obligations totaled $587 million and $178
million in the first half 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 half of 2009 was the
February 2009 issuance of $350 million of senior unsecured notes, which mature in March 2014 and
bear a 4.0% coupon rate, and the repayment of approximately $160 million of outstanding borrowings,
related to the companys Euro-denominated credit facility.
Other
Financing Activities
Cash dividend payments totaled $348 million and $318 million in the first half 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 May 2010, the board of directors declared a
quarterly dividend of $0.29 per share, payable on July 1, 2010 to shareholders of record on June
10, 2010. 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 increased
by $31 million, from $204 million in the first half of 2009 to $235 million in the first half of
2010, primarily due to an increase in stock option exercises, partially offset by a decrease in
realized excess tax benefits (as further discussed above).
Stock repurchases totaled $1.1 billion and $866 million in the first half 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 June 30, 2010, $838 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 $370 million at June 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 June 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 June 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 $2.3 billion of cash and equivalents at June 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.
28
The company continues to do business with certain foreign governments which have recently
experienced credit rating downgrades and may become unable to pay for the companys products or
services. 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 half 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 in the future incur material judgments or enter into material settlements of claims.
CERTAIN REGULATORY MATTERS
In July 2005, the company stopped shipment of COLLEAGUE infusion pumps in the United States.
Following a number of Class I recalls (recalls at the highest priority level for the U.S. Food and
Drug Administration (the FDA)) relating to the performance of the pumps, as well as the seizure
litigation described in Note 6, the company entered into a Consent Decree in June 2006. Additional
Class I recalls related to remediation and repair and maintenance activities were addressed by the
company in 2007 and 2009. Pursuant to the Consent Decree, in July 2010 the FDA issued its 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 next two years 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 non-cash
29
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 March 2010, the FDA classified the companys Urgent Product Recall regarding Increased
Intraperitoneal Volume, or overfill of the abdominal cavity, associated with the companys
HomeChoice and HomeChoice Pro peritoneal dialysis cyclers as a Class I recall. The company is
working with the FDA to address the recall.
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.
30
FORWARD-LOOKING INFORMATION
This quarterly report includes forward-looking statements, including statements with respect to
accounting estimates and assumptions, including those made in connection with the charges related
to the recall of the companys COLLEAGUE infusion pumps, litigation related matters including
outcomes, the companys efforts to recall and remediate its COLLEAGUE infusion pumps and other
regulatory matters, expectations with respect to restructuring and cost optimization programs
(including expected cost savings), strategic plans, geographic expansion, credit exposure to
foreign governments, expectations with respect to business development activities, 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, the companys internal R&D pipeline, future
capital, R&D and marketing and administrative 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; |
|
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|
fluctuations in supply and demand and the pricing of plasma-based therapies; |
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|
recently enacted healthcare reform legislation in the United States including its effect
on pricing, reimbursement, taxation and rebate policies; |
|
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|
future actions of governmental authorities and other third parties including third party
payers as recently adopted healthcare reform legislation is implemented in the United
States; |
|
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|
|
additional legislation, regulation and other governmental pressures in the United States
or globally, which may affect pricing, reimbursement, taxation and rebate policies of
government agencies and private payers or other elements of the companys business; |
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|
the companys ability to identify business development and growth opportunities for
existing products; |
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|
product quality or patient safety issues, leading to product recalls, withdrawals,
launch delays, sanctions, seizures, litigation, or declining sales; |
|
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|
future actions of the FDA or any other regulatory body or government authority that
could delay, limit or suspend product development, manufacturing or sale or result in
seizures, injunctions, monetary sanctions or criminal or civil liabilities, including any
sanctions available under the Consent Decree entered into with the FDA concerning the
COLLEAGUE and SYNDEO infusion pumps; |
|
|
|
|
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; |
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|
the companys ability to fulfill demand for its SIGMA SPECTRUM infusion pump as a result
of the recall of its COLLEAGUE infusion pumps currently in use in the United States; |
|
|
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|
foreign currency fluctuations, particularly due to reduced benefits from the companys
natural hedges and limitations on the ability to cost-effectively hedge resulting from
financial market and currency volatility; |
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|
product development risks, including satisfactory clinical performance, the ability to
manufacture at appropriate scale, and the general unpredictability associated with the
product development cycle; |
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|
the ability to enforce the companys patent rights or patents of third parties
preventing or restricting the companys manufacture, sale or use of affected products or
technology; |
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|
the impact of geographic and product mix on the companys sales; |
|
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|
the impact of competitive products and pricing, including generic competition, drug
reimportation and disruptive technologies; |
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|
inventory reductions or fluctuations in buying patterns by wholesalers or distributors; |
|
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|
the availability and pricing of acceptable raw materials and component supply; |
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|
global regulatory, trade and tax policies; |
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|
any changes in law concerning the taxation of income, including income earned outside
the United States; |
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actions by tax authorities in connection with ongoing tax audits; |
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|
the companys ability to realize the anticipated benefits of restructuring and
optimization initiatives; |
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|
the companys ability to realize the anticipated benefits from its joint product
development and commercialization arrangements, including the SIGMA transaction; |
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changes in credit agency ratings; |
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|
any impact of the commercial and credit environment on the company and its customers and
suppliers; and |
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|
other factors identified elsewhere in this report and other filings with the Securities
and Exchange Commission, including those factors described under the caption Item 1A. Risk
Factors in the companys Form 10-K for the year ended December 31, 2009, all of which are
available on the companys website. |
Actual results may differ materially from those projected in the forward-looking statements.
The company does not undertake to update its forward-looking statements.
31
|
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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 June 30, 2010 is 18 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 June 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 asset balance of $13 million with respect to those contracts would
decrease by $66 million, resulting in a net liability balance.
The sensitivity analysis model recalculates the fair value of the foreign exchange option, forward
and cross-currency swap contracts outstanding at June 30, 2010 by replacing the actual exchange
rates at June 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 June 30, 2010.
32
|
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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 June 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 June 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 June 30, 2010 that have materially affected, or are
reasonably likely to materially affect, Baxters internal control over financial reporting.
33
Review by Independent Registered Public Accounting Firm
Reviews of the interim condensed consolidated financial information included in this Quarterly
Report on Form 10-Q for the three and six months ended June 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.
34
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders of Baxter International Inc.:
We have reviewed the accompanying condensed consolidated balance sheet of Baxter International Inc.
and its subsidiaries as of June 30, 2010, and the related condensed consolidated statements of
income for each of the three- and six-month periods ended June 30, 2010 and 2009 and the condensed
consolidated statements of cash flows for the six-month periods ended June 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
August 4, 2010
35
PART II. OTHER INFORMATION
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|
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Item 1. |
|
Legal Proceedings |
The information in Part I, Item 1, Note 6 is incorporated herein by reference.
36
|
|
|
Item 2. |
|
Unregistered Sales of Equity Securities and Use of Proceeds |
The following table includes information about the companys common stock repurchases during the
three-month period ended June 30, 2010.
Issuer Purchases of Equity Securities
|
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|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
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) |
|
|
April 1, 2010
through April 30, 2010 |
|
|
2,606,000 |
|
|
$ |
49.09 |
|
|
|
2,606,000 |
|
|
|
|
|
May 1, 2010
through May 31, 2010 |
|
|
7,791,400 |
|
|
$ |
44.84 |
|
|
|
7,791,400 |
|
|
|
|
|
June 1, 2010
through June 30, 2010 |
|
|
4,765,200 |
|
|
$ |
41.81 |
|
|
|
4,765,200 |
|
|
|
|
|
|
Total |
|
|
15,162,600 |
|
|
$ |
44.62 |
|
|
|
15,162,600 |
|
|
|
$838,058,628 |
|
|
|
|
|
(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 second
quarter of 2010, the company repurchased 15.2 million shares for $677 million under this
program. This program does not have an expiration date. |
37
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.DEF*
|
|
XBRL Taxonomy Extension Definition Linkbase Document |
|
|
|
101.LAB*
|
|
XBRL Taxonomy Extension Label Linkbase Document |
|
|
|
101.PRE*
|
|
XBRL Taxonomy Extension Presentation Linkbase Document |
38
Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
|
BAXTER INTERNATIONAL INC. |
|
|
|
|
|
|
|
(Registrant) |
|
|
|
|
|
|
|
Date: August 4, 2010 |
By: |
/s/ Robert J. Hombach |
|
|
|
Robert J. Hombach |
|
|
|
Corporate Vice President, Chief Financial Officer
and Treasurer
(duly authorized officer and principal financial officer) |
|
|
39