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, 2011
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the
transition period from
to
Commission file number 1-4448
BAXTER INTERNATIONAL INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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36-0781620 |
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(State or other jurisdiction of |
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(I.R.S. Employer |
incorporation or organization) |
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Identification No.) |
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One Baxter Parkway, Deerfield, Illinois |
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60015-4633 |
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(Address of principal executive offices) |
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(Zip Code) |
847-948-2000
(Registrants
telephone number,
including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files).
Yes 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, 2011 was 568,256,444 shares.
BAXTER INTERNATIONAL INC.
FORM 10-Q
For the quarterly period ended June 30, 2011
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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2011 |
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2010 |
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2011 |
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2010 |
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Net sales |
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$ |
3,536 |
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$ |
3,194 |
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$ |
6,820 |
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$ |
6,121 |
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Cost of sales |
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1,701 |
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1,556 |
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3,310 |
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3,440 |
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Gross margin |
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1,835 |
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1,638 |
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3,510 |
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2,681 |
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Marketing and administrative expenses |
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765 |
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721 |
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1,481 |
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1,404 |
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Research and development expenses |
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239 |
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219 |
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453 |
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446 |
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Net interest expense |
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15 |
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25 |
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25 |
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44 |
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Other expense, net |
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13 |
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3 |
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17 |
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5 |
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Income before income taxes |
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803 |
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670 |
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1,534 |
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782 |
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Income tax expense |
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174 |
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133 |
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328 |
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305 |
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Net income |
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629 |
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537 |
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1,206 |
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477 |
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Less: Noncontrolling interests |
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14 |
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2 |
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21 |
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5 |
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Net income attributable to Baxter
International Inc. (Baxter) |
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$ |
615 |
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$ |
535 |
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$ |
1,185 |
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$ |
472 |
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Net income attributable to Baxter per common share |
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Basic |
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$ |
1.08 |
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$ |
0.90 |
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$ |
2.07 |
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$ |
0.79 |
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Diluted |
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$ |
1.07 |
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$ |
0.90 |
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$ |
2.05 |
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$ |
0.78 |
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Weighted-average number of common shares outstanding |
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Basic |
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570 |
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593 |
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573 |
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597 |
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Diluted |
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575 |
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596 |
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578 |
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602 |
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Cash dividends declared per common share |
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$ |
0.31 |
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$ |
0.29 |
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$ |
0.62 |
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$ |
0.58 |
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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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2011 |
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2010 |
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Current assets |
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Cash and equivalents |
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$ |
2,018 |
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$ |
2,685 |
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Accounts and other current receivables |
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2,491 |
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2,265 |
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Inventories |
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2,648 |
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2,371 |
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Prepaid expenses and other |
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652 |
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668 |
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Total current assets |
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7,809 |
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7,989 |
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Property, plant and equipment, net |
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5,481 |
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5,260 |
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Other assets |
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Goodwill |
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2,168 |
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2,015 |
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Other intangible assets, net |
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702 |
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500 |
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Other |
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1,581 |
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1,725 |
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Total other assets |
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4,451 |
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4,240 |
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Total assets |
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$ |
17,741 |
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$ |
17,489 |
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Current liabilities |
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Short-term debt |
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$ |
13 |
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$ |
15 |
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Current maturities of long-term debt and
lease obligations |
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9 |
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9 |
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Accounts payable and accrued liabilities |
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4,009 |
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4,017 |
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Total current liabilities |
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4,031 |
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4,041 |
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Long-term debt and lease obligations |
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4,378 |
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4,363 |
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Other long-term liabilities |
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2,088 |
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2,289 |
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Commitments and contingencies |
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Equity |
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Common stock, $1 par value, authorized
2,000,000,000 shares,
issued 683,494,944 shares in 2011 and 2010 |
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683 |
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683 |
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Common stock in treasury, at cost,
116,875,826 shares in 2011
and 102,761,588 shares in 2010 |
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(6,419 |
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(5,655 |
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Additional contributed capital |
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5,751 |
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5,753 |
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Retained earnings |
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8,754 |
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7,925 |
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Accumulated other comprehensive loss |
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(1,772 |
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(2,139 |
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Total Baxter shareholders equity |
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6,997 |
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6,567 |
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Noncontrolling interests |
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247 |
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229 |
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Total equity |
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7,244 |
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6,796 |
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Total liabilities and equity |
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$ |
17,741 |
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$ |
17,489 |
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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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2011 |
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2010 |
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Cash flows from operations |
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Net income |
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$ |
1,206 |
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$ |
477 |
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Adjustments |
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Depreciation and amortization |
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327 |
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335 |
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Deferred income taxes |
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160 |
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120 |
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Stock compensation |
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61 |
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63 |
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Realized excess tax benefits from
stock issued under employee benefit plans |
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(13 |
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(34 |
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Infusion pump charge |
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588 |
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Other |
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18 |
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33 |
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Changes in balance sheet items |
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Accounts and other current receivables |
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(157 |
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(38 |
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Inventories |
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(214 |
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(119 |
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Accounts payable and accrued liabilities |
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(124 |
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(152 |
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Infusion pump and business optimization
payments |
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(147 |
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(41 |
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Other, including pension contributions |
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(114 |
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(170 |
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Cash flows from operations |
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1,003 |
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1,062 |
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Cash flows from investing activities |
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Capital expenditures |
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(408 |
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(467 |
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Acquisitions and investments |
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(202 |
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(254 |
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Divestiture and other |
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106 |
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Cash flows from investing activities |
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(504 |
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(721 |
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Cash flows from financing activities |
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Issuances of debt |
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4 |
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604 |
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Payments of obligations |
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(7 |
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(17 |
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Cash dividends on common stock |
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(358 |
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(348 |
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Proceeds and realized excess tax benefits from
stock issued
under employee benefit plans |
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304 |
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235 |
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Purchases of treasury stock |
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(1,115 |
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(1,112 |
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Other |
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(14 |
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(32 |
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Cash flows from financing activities |
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(1,186 |
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(670 |
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Effect of currency exchange rate changes on cash and equivalents |
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20 |
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(157 |
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Decrease in cash and equivalents |
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(667 |
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(486 |
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Cash and equivalents at beginning of period |
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2,685 |
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2,786 |
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Cash and equivalents at end of period |
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$ |
2,018 |
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$ |
2,300 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
Baxter International Inc.
Notes to Condensed Consolidated Financial Statements (unaudited)
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The unaudited interim condensed consolidated financial statements of Baxter International Inc. and
its subsidiaries (the company or Baxter) have been prepared pursuant to the rules and regulations
of the Securities and Exchange Commission (SEC). Accordingly, certain information and footnote
disclosures normally included in financial statements prepared in accordance with generally
accepted accounting principles in the United States have been condensed or omitted. These
unaudited 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, 2010 (2010 Annual Report).
In the opinion of management, the unaudited 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 unaudited interim period are not necessarily indicative of the results of
operations to be expected for the full year.
Certain reclassifications have been made to conform the prior period unaudited interim condensed
consolidated financial statements and notes to the current period presentation.
2. SUPPLEMENTAL FINANCIAL INFORMATION
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.
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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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2011 |
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2010 |
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2011 |
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2010 |
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Pension benefits |
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Service cost |
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$ |
28 |
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$ |
25 |
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$ |
56 |
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$ |
50 |
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Interest cost |
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59 |
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56 |
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118 |
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114 |
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Expected return on plan assets |
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(76 |
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(70 |
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(152 |
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(141 |
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Amortization of net losses and other deferred
amounts |
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44 |
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33 |
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88 |
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64 |
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Net periodic pension benefit cost |
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$ |
55 |
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$ |
44 |
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$ |
110 |
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$ |
87 |
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OPEB |
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Service cost |
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$ |
1 |
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$ |
2 |
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$ |
3 |
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$ |
3 |
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Interest cost |
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7 |
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7 |
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14 |
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15 |
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Amortization of prior service credit and net loss |
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(2 |
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(1 |
) |
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(3 |
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Net periodic OPEB cost |
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$ |
8 |
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$ |
7 |
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$ |
16 |
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$ |
15 |
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The company made discretionary cash contributions to its pension plan in the United States
totaling $150 million and $300 million in the first quarters of 2011 and 2010, respectively.
Net interest expense
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Three months ended |
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Six months ended |
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June 30, |
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June 30, |
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(in millions) |
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2011 |
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2010 |
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2011 |
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2010 |
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Interest expense, net of capitalized interest |
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$ |
22 |
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$ |
30 |
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$ |
44 |
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$ |
58 |
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Interest income |
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(7 |
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(5 |
) |
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(19 |
) |
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(14 |
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Net interest expense |
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$ |
15 |
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$ |
25 |
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$ |
25 |
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$ |
44 |
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5
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) |
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2011 |
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2010 |
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2011 |
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2010 |
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Comprehensive income (loss) |
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$ |
728 |
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$ |
226 |
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$ |
1,570 |
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$ |
(91 |
) |
Less: Comprehensive income attributable to
noncontrolling interests |
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10 |
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6 |
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18 |
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8 |
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Comprehensive income (loss) attributable to Baxter |
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$ |
718 |
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$ |
220 |
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$ |
1,552 |
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$ |
(99 |
) |
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The increase in comprehensive income attributable to Baxter for the three months ended June 30,
2011 was principally due to favorable movements in currency translation adjustments (CTA), which
resulted in a $74 million gain in 2011 compared to a $355 million loss in 2010, and higher net
income attributable to Baxter. The change in comprehensive income (loss) attributable to Baxter
for the six months ended June 30, 2011 was principally due to favorable movements in CTA, which
resulted in a $333 million gain in 2011 compared to a $687 million loss in 2010, and higher net
income attributable to Baxter, 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 21.7% and 19.9% in the second quarters of 2011 and
2010, respectively, and 21.4% and 39.0% in the six-month periods ended June 30, 2011 and 2010,
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 from the U.S. federal statutory rate. In addition, the effective
tax rate can be affected each period by discrete factors and events. The increase in the effective
income tax rate in the second quarter of 2011 was primarily due to a change in the earnings mix
from lower to higher tax rate jurisdictions compared to the prior year period, as well as the
impact of the pharmaceutical products fee, which became effective in the first quarter of 2011 and
is not deductible. The decrease in the effective income tax rate in the six-month period ended
June 30, 2011 was principally due to the first quarter 2010 charge of $588 million related to the
recall of COLLEAGUE infusion pumps from the U.S. market, for which there was no net tax benefit
recognized, and a $39 million write-off of a deferred tax asset in the first quarter of 2010 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 enacted in the United States.
Refer to Note 3 for further information regarding the COLLEAGUE charge.
Earnings per share
The numerator for both basic and diluted earnings per share (EPS) is net income attributable to
Baxter. The denominator for basic EPS is the weighted-average number of common shares outstanding
during the period. The dilutive effect of outstanding employee stock options, performance share
units and restricted stock units is reflected in the denominator for diluted EPS using the treasury
stock method.
The following is a reconciliation of basic shares to diluted shares.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
(in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Basic shares |
|
|
570 |
|
|
|
593 |
|
|
|
573 |
|
|
|
597 |
|
Effect of dilutive securities |
|
|
5 |
|
|
|
3 |
|
|
|
5 |
|
|
|
5 |
|
|
Diluted shares |
|
|
575 |
|
|
|
596 |
|
|
|
578 |
|
|
|
602 |
|
|
The computation of diluted EPS excluded employee stock options to purchase 18 million and 30
million shares for the three months ended June 30, 2011 and 2010, respectively, and 20 million and
23 million shares for the six months ended June 30, 2011 and 2010, respectively, because their
inclusion would have had an anti-dilutive effect on diluted EPS.
6
Inventories
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
(in millions) |
|
2011 |
|
|
2010 |
|
|
Raw materials |
|
$ |
580 |
|
|
$ |
536 |
|
Work in process |
|
|
894 |
|
|
|
787 |
|
Finished goods |
|
|
1,174 |
|
|
|
1,048 |
|
|
Inventories |
|
$ |
2,648 |
|
|
$ |
2,371 |
|
|
Property, plant and equipment, net
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
(in millions) |
|
2011 |
|
|
2010 |
|
|
Property, plant and equipment, at cost |
|
$ |
10,846 |
|
|
$ |
10,591 |
|
Accumulated depreciation and amortization |
|
|
(5,365 |
) |
|
|
(5,331 |
) |
|
Property, plant and equipment (PP&E), net |
|
$ |
5,481 |
|
|
$ |
5,260 |
|
|
Goodwill
The following is a summary of goodwill by business segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medical |
|
|
|
|
(in millions) |
BioScience |
|
|
Products |
|
|
Total |
|
|
Balance as of December 31, 2010 |
|
$ |
809 |
|
|
$ |
1,206 |
|
|
$ |
2,015 |
|
Additions |
|
|
|
|
|
|
100 |
|
|
|
100 |
|
Currency translation and other adjustments |
|
|
10 |
|
|
|
43 |
|
|
|
53 |
|
|
Balance as of June 30, 2011 |
|
$ |
819 |
|
|
$ |
1,349 |
|
|
$ |
2,168 |
|
|
Goodwill additions in 2011 principally related to the second quarter acquisition of Prism
Pharmaceuticals, Inc. (Prism) and the second quarter exercise of an option related to the companys
collaboration agreement for the development of a home hemodialysis machine with HHD, LLC (HHD),
DEKA Products Limited Partnership and DEKA Research and Development Corp. Both Prism and HHD are
within the Medical Products segment. Refer to the discussion below for further information
regarding Prism and HHD. As of June 30, 2011, 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,
2011 and December 31, 2010.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Developed |
|
|
|
|
|
|
|
|
technology, |
|
|
|
|
|
|
|
(in millions) |
including patents |
|
|
Other |
|
|
Total |
|
|
June 30, 2011 |
|
|
|
|
|
|
|
|
|
|
|
|
Gross other intangible assets |
|
$ |
1,077 |
|
|
$ |
152 |
|
|
$ |
1,229 |
|
Accumulated amortization |
|
|
(484 |
) |
|
|
(78 |
) |
|
|
(562 |
) |
|
Other intangible assets, net |
|
$ |
593 |
|
|
$ |
74 |
|
|
$ |
667 |
|
|
December 31, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
Gross other intangible assets |
|
$ |
916 |
|
|
$ |
144 |
|
|
$ |
1,060 |
|
Accumulated amortization |
|
|
(522 |
) |
|
|
(69 |
) |
|
|
(591 |
) |
|
Other intangible assets, net |
|
$ |
394 |
|
|
$ |
75 |
|
|
$ |
469 |
|
|
The amortization expense for these intangible assets was $20 million for both the three months
ended June 30, 2011 and 2010 and $37 million for both the six months ended June 30, 2011 and 2010.
The increase in other intangible assets, net primarily related to the acquisition of Prism in the
second quarter of 2011. Refer to the discussion below for further information regarding this
acquisition. The anticipated annual amortization expense for intangible assets recorded as of June
30, 2011 is $78 million in 2011, $81 million in 2012, $78 million in 2013, $75 million in 2014, $73
million in 2015, and $70 million in 2016. Additionally, as of June 30, 2011 and December 31, 2010,
the
7
company had $35 million and $31 million, respectively, of intangible assets not subject to
amortization, which included a trademark with an indefinite life and certain acquired in-process
research and development (IPR&D) associated with products that have not yet received regulatory
approval.
Variable interest entities
The unaudited interim condensed consolidated financial statements include the accounts of variable
interest entities (VIEs) in which Baxter is the primary beneficiary. During the six months ended
June 30, 2011, the company did not enter into any new arrangements in which it determined that the
company is the primary beneficiary of a VIE. During the second quarter of 2011, the company
exercised an option to acquire the assets of HHD, an entity whose financial results were already
consolidated by Baxter because Baxter had been determined to be the primary beneficiary of this
VIE. As of June 30, 2011, 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 2010 Annual Report for further information about the VIEs
consolidated by the company.
Acquisition of Prism Pharmaceuticals
In May 2011, the company acquired privately-held Prism, a specialty pharmaceutical company. As a
result of this acquisition, Baxter acquired NEXTERONE (amiodarone HCl), an antiarrhythmic agent
used for ventricular tachyarrhythmias, or fast forms of irregular heartbeat. The NEXTERONE product
portfolio includes the first and only ready-to-use premixed intravenous (IV) bag formulations, as
well as vials and a pre-filled syringe, all of which have received U.S. Food and Drug
Administration (FDA) approval. This acquisition will expand Baxters existing portfolio of
premixed drugs and solutions for use in the acute care setting. Total consideration of up to $338
million consisted of an upfront cash payment of $170 million at closing and contingent payments of
up to $168 million, which are associated with the achievement of specified sales milestones through
2017.
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 an adjustment to the recognized amounts of assets and liabilities; however, no material
adjustments are anticipated.
|
|
|
|
|
(in millions) |
|
|
|
|
|
Assets |
|
|
|
|
Goodwill |
|
$ |
81 |
|
IPR&D |
|
|
4 |
|
Other intangible assets |
|
|
225 |
|
Other assets |
|
|
3 |
|
|
|
|
|
|
Liabilities |
|
|
|
|
Contingent payments |
|
|
67 |
|
Other long-term liabilities |
|
|
76 |
|
|
Goodwill includes expected synergies and other benefits the company believes will result from the
acquisition. The other intangible assets relate to developed technology and are being amortized on
a straight-line basis over an estimated average useful life of 14 years. The contingent payments
of up to $168 million were recorded at their estimated fair value of $67 million, principally taking into account the estimated
probability of achieving the specified sales milestones. Changes in the
estimated fair value of the contingent payments will be recognized in earnings in future
periods. The results of operations, assets and liabilities of Prism are included in the Medical
Products segment, and the goodwill is also included in this reporting unit. The goodwill is not
deductible for tax purposes. The pro forma impact of the Prism acquisition was not significant to
the results of operations of the company.
Divestiture of generic injectables business
In May 2011, the company completed the divestiture of its U.S. generic injectables business to
Hikma Pharmaceuticals PLC (Hikma). The consideration for the divestiture arrangement totaled $104
million, after closing-related adjustments. Hikma acquired Baxters high-volume, generic
injectable products in vials and ampoules, including chronic pain, anti-infective and anti-emetic
products, along with a manufacturing facility located in Cherry Hill, New Jersey, and a warehouse
and distribution center located in Memphis, Tennessee. Refer to the 2010 Annual Report for further
information about this divestiture.
8
Net sales relating to the generic injectables business, which were reported in the Medical Products
segment, were approximately $20 million and $50 million in the second quarters of 2011 and 2010,
respectively, and approximately $60 million and $90 million in the first six months of 2011 and
2010, respectively.
Asset impairments
Baxter has made and continues to make significant investments in assets, including inventory and
PP&E, 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.
3. INFUSION PUMP AND BUSINESS OPTIMIZATION 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, on July 13, 2010, the FDA issued a final order requiring
the company to recall its approximately 200,000 COLLEAGUE infusion pumps then in use in the U.S.
market. Pursuant to the terms of the order, Baxter is offering replacement infusion pumps or
monetary consideration to owners of COLLEAGUE pumps and is executing the recall through July 13,
2012. Under the replacement option, customers may receive Sigma International General Medical
Apparatus, LLC Spectrum infusion pumps in exchange for COLLEAGUE infusion pumps. Refer to Note 5
to the companys consolidated financial statements in the 2010 Annual Report for further
information regarding the COLLEAGUE and SYNDEO 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 is undertaking outside of 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 2010, from 2005 through 2009, the company recorded charges and other costs
totaling $337 million related to its COLLEAGUE and SYNDEO infusion pumps. 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.
In aggregate, the total charges incurred from 2005 through 2010 included $716 million of cash costs
and $209 million principally related to asset impairments. The asset impairments related to
inventory, lease receivables and other assets relating to the recalled pumps. The reserve for cash
costs principally included an estimate of cash refunds or replacement infusion pumps that are being
offered to current owners in exchange for their COLLEAGUE infusion pumps. Cash costs also included
costs associated with the execution of the remediation and recall programs and customer
accommodations. While the company continues 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, 2011.
|
|
|
|
|
(in millions) |
|
|
|
|
|
Charges and adjustments in 2005 through 2010 |
|
$ |
716 |
|
Utilization in 2005 through 2010 |
|
|
(203 |
) |
|
Reserves as of December 31, 2010 |
|
|
513 |
|
Utilization |
|
|
(90 |
) |
|
Reserves as of June 30, 2011 |
|
$ |
423 |
|
|
9
The company believes that the remaining infusion pump reserves are adequate and expects that the
reserves will be substantially utilized by the end of 2012.
Business optimization charges
In 2010 and 2009, the company recorded charges of $257 million and $79 million, respectively,
primarily related to costs associated with optimizing its overall cost structure on a global basis,
as the company streamlines its international operations, rationalizes its manufacturing facilities
and enhances its general and administrative infrastructure. The charges included severance costs,
as well as asset impairments and contract terminations associated with discontinued products and
projects.
Included in the charges were cash costs of $253 million, principally pertaining to severance and
other employee-related costs in Europe and the United States. Also included in the charges were
asset impairments totaling $83 million, which related to fixed assets, inventory and other assets
associated with discontinued products and projects.
Refer to the 2010 Annual Report for further information about these charges.
The following summarizes cash activity in the reserves related to the companys business
optimization initiatives.
|
|
|
|
|
(in millions) |
|
|
|
|
|
Charges in 2010 and 2009 |
|
$ |
253 |
|
Utilization in 2010 and 2009 |
|
|
(73 |
) |
|
Reserves as of December 31, 2010 |
|
|
180 |
|
Utilization |
|
|
(57 |
) |
CTA |
|
|
5 |
|
|
Reserves as of June 30, 2011 |
|
$ |
128 |
|
|
The company believes that these reserves are adequate and expects that the reserves will be
substantially utilized by the end of 2011. However, adjustments may be recorded in the future as
the programs are completed.
4. DEBT, FINANCIAL INSTRUMENTS AND FAIR VALUE MEASUREMENTS
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) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Sold receivables at beginning of period |
|
$ |
144 |
|
|
$ |
120 |
|
|
$ |
157 |
|
|
$ |
147 |
|
Proceeds from sales of receivables |
|
|
147 |
|
|
|
132 |
|
|
|
288 |
|
|
|
249 |
|
Cash collections (remitted to the owners
of the receivables) |
|
|
(145 |
) |
|
|
(122 |
) |
|
|
(303 |
) |
|
|
(264 |
) |
Effect of currency exchange rate changes |
|
|
2 |
|
|
|
(1 |
) |
|
|
6 |
|
|
|
(3 |
) |
|
Sold receivables at end of period |
|
$ |
148 |
|
|
$ |
129 |
|
|
$ |
148 |
|
|
$ |
129 |
|
|
Credit facility
In the second quarter of 2011, the company refinanced its primary revolving credit facility
agreement, which was set to mature in December 2011. The key terms of the new credit facility,
which has a maximum capacity of $1.5 billion and matures in June 2015, are substantially the same
as the existing credit facility. Commitment fees under the new credit facility are not material.
As of June 30, 2011 and December 31, 2010, there were no outstanding borrowings under either credit
facility. Refer to Note 6 to the companys consolidated financial statements in the 2010 Annual Report for further discussion of the companys credit facilities.
10
Concentrations of credit risk
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.
The company continues to do business with foreign governments in certain countries, including
Greece, Spain, Portugal and Italy, that have experienced a deterioration in credit and economic
conditions. While the economic downturn has not significantly impacted the companys ability to
collect receivables, global economic conditions and liquidity issues in certain countries have
resulted, and may continue to result, in delays in the collection of receivables and credit losses.
Global economic conditions, governmental actions and customer-specific factors may require the
company to re-evaluate the collectibility and valuation of its receivables which could result in
additional credit losses.
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 related to forecasted intercompany sales denominated in foreign currencies and, in the
prior year, anticipated issuances of debt and a hedge of U.S. Dollar-denominated debt issued by a
foreign subsidiary.
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
11
consistent with the underlying hedged item. Cash flow hedges are principally classified in cost of
sales, net interest expense, and other expense, net, and primarily relate to forecasted
intercompany sales denominated in foreign currencies, anticipated issuances of debt, and a hedge of
U.S. Dollar-denominated debt issued by a foreign subsidiary, respectively.
The notional amounts of foreign exchange contracts were $1.7 billion and $1.6 billion as of June
30, 2011 and December 31, 2010, respectively. The maximum term over which the company has cash
flow hedge contracts in place related to forecasted transactions at June 30, 2011 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 $1.8
billion as of June 30, 2011 and $1.9 billion as of December 31, 2010.
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. In the second
quarter of 2011, the company terminated $600 million of interest rate contracts that had been
designated as fair value hedges, which resulted in a net gain of $46 million that was deferred and
is being amortized as a reduction of net interest expense over the remaining term of the underlying debt. There were no hedge
dedesignations in the first half of 2011 or 2010 resulting from changes in the companys assessment
of the probability that the hedged forecasted transactions would occur.
Undesignated Derivative Instruments
The company uses forward contracts to hedge earnings from the effects of foreign exchange relating
to certain of the companys intercompany and third-party receivables and payables denominated in a
foreign currency. These derivative instruments are generally not formally designated as hedges,
and the change in fair value, which substantially offsets the change in book value of the
hedged items, is recorded directly to other expense, net. The terms of these instruments generally
do not exceed one month.
The total gross notional amount of undesignated derivative instruments was $455 million as of June
30, 2011 and $445 million as of December 31, 2010.
12
Gains and Losses on Derivative Instruments
The following table summarizes the income statement locations and gains and losses on the companys
derivative instruments for the three months ended June 30, 2011 and 2010.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain (loss) reclassified from |
|
|
|
Gain (loss) recognized in OCI |
|
|
Location of gain (loss) |
|
AOCI into income |
|
(in millions) |
|
2011 |
|
|
2010 |
|
|
in income statement |
|
2011 |
|
|
2010 |
|
|
Cash flow hedges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts |
|
$ |
|
|
|
$ |
|
|
|
Net interest expense |
|
$ |
|
|
|
$ |
|
|
Foreign exchange contracts |
|
|
2 |
|
|
|
(1 |
) |
|
Net sales |
|
|
|
|
|
|
(1 |
) |
Foreign exchange contracts |
|
|
(5 |
) |
|
|
19 |
|
|
Cost of sales |
|
|
(10 |
) |
|
|
(2 |
) |
Foreign exchange contracts |
|
|
|
|
|
|
47 |
|
|
Other expense, net |
|
|
|
|
|
|
48 |
|
|
Total |
|
$ |
(3 |
) |
|
$ |
65 |
|
|
|
|
|
|
$ |
(10 |
) |
|
$ |
45 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Location of gain (loss) |
|
Gain (loss) recognized in income |
|
(in millions) |
|
|
|
|
|
|
|
|
|
in income statement |
|
2011 |
|
|
2010 |
|
|
Fair value hedges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts |
|
|
|
|
|
|
|
|
|
Net interest expense |
|
$ |
36 |
|
|
$ |
64 |
|
|
Undesignated derivative
instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
|
|
|
Other expense, net |
|
$ |
(8 |
) |
|
$ |
(4 |
) |
|
The following table summarizes the income statement locations and gains and losses on the
companys derivative instruments for the six months ended June 30, 2011 and 2010.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain (loss) reclassified from |
|
|
|
Gain (loss) recognized in OCI |
|
|
Location of gain (loss) |
|
AOCI into income |
|
(in millions) |
|
2011 |
|
|
2010 |
|
|
in income statement |
|
2011 |
|
|
2010 |
|
|
Cash flow hedges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts |
|
$ |
|
|
|
$ |
(7 |
) |
|
Net interest expense |
|
$ |
|
|
|
$ |
1 |
|
Foreign exchange contracts |
|
|
1 |
|
|
|
(2 |
) |
|
Net sales |
|
|
(1 |
) |
|
|
(2 |
) |
Foreign exchange contracts |
|
|
(31 |
) |
|
|
33 |
|
|
Cost of sales |
|
|
(15 |
) |
|
|
(7 |
) |
Foreign exchange contracts |
|
|
|
|
|
|
84 |
|
|
Other expense, net |
|
|
|
|
|
|
86 |
|
|
Total |
|
$ |
(30 |
) |
|
$ |
108 |
|
|
|
|
|
|
$ |
(16 |
) |
|
$ |
78 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Location of gain (loss) |
|
Gain (loss) recognized in income |
|
(in millions) |
|
|
|
|
|
|
|
|
|
in income statement |
|
2011 |
|
|
2010 |
|
|
Fair value hedges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts |
|
|
|
|
|
|
|
|
|
Net interest expense |
|
$ |
12 |
|
|
$ |
85 |
|
|
Undesignated derivative
instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
|
|
|
Other expense, net |
|
$ |
(8 |
) |
|
$ |
(5 |
) |
|
For the companys fair value hedges, equal and offsetting losses of $36 million and $12
million were recognized in net interest expense in the second quarter and first half of 2011,
respectively, and 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, 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, 2011 was not material.
As of June 30, 2011, $18 million of deferred, net after-tax losses on derivative instruments
included in AOCI are expected to be recognized in earnings during the next 12 months, coinciding
with when the hedged items are expected to impact earnings.
13
Fair Values of Derivative Instruments
The following table summarizes the classification and fair values of derivative instruments
reported in the condensed consolidated balance sheet as of June 30, 2011.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
$ |
102 |
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
Prepaid expenses and other |
|
|
31 |
|
|
Accounts payable
and accrued liabilities |
|
$ |
16 |
|
Foreign exchange contracts |
|
Other long-term assets |
|
|
14 |
|
|
Other long-term liabilities |
|
|
1 |
|
|
Total derivative instruments
designated as hedges |
|
|
|
|
|
$ |
147 |
|
|
|
|
|
|
$ |
17 |
|
|
Undesignated derivative
instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
Prepaid expenses and other |
|
$ |
|
|
|
Accounts payable and accrued liabilities |
|
$ |
|
|
|
Total derivative instruments |
|
|
|
|
|
$ |
147 |
|
|
|
|
|
|
$ |
17 |
|
|
The following table summarizes the classification and fair values of derivative instruments
reported in the consolidated balance sheet as of December 31, 2010.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives in asset positions |
|
|
Derivatives in liability positions |
|
(in millions) |
|
Balance sheet location |
Fair value |
|
|
Balance sheet location |
Fair value |
|
|
Derivative instruments
designated as hedges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts |
|
Other long-term assets |
|
$ |
136 |
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
Prepaid expenses and other |
|
|
23 |
|
|
Accounts payable
and accrued liabilities |
|
$ |
19 |
|
Foreign exchange contracts |
|
Other long-term assets |
|
|
8 |
|
|
Other long-term liabilities |
|
|
2 |
|
|
Total derivative instruments
designated as hedges |
|
|
|
|
|
$ |
167 |
|
|
|
|
|
|
$ |
21 |
|
|
Undesignated derivative
instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
Prepaid expenses and other |
|
$ |
|
|
|
Accounts payable and accrued liabilities |
|
$ |
|
|
|
Total derivative instruments |
|
|
|
|
|
$ |
167 |
|
|
|
|
|
|
$ |
21 |
|
|
14
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, 2011 |
|
(Level 1) |
|
(Level 2) |
|
(Level 3) |
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency hedges |
|
$ |
45 |
|
|
$ |
|
|
|
$ |
45 |
|
|
$ |
|
|
Interest rate hedges |
|
|
102 |
|
|
|
|
|
|
|
102 |
|
|
|
|
|
Equity securities |
|
|
17 |
|
|
|
17 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
164 |
|
|
$ |
17 |
|
|
$ |
147 |
|
|
$ |
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency hedges |
|
$ |
17 |
|
|
$ |
|
|
|
$ |
17 |
|
|
$ |
|
|
Contingent payments
related to
acquisitions and
investments |
|
|
182 |
|
|
|
|
|
|
|
|
|
|
|
182 |
|
|
Total liabilities |
|
$ |
199 |
|
|
$ |
|
|
|
$ |
17 |
|
|
$ |
182 |
|
|
|
|
|
|
|
|
|
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, 2010 |
|
(Level 1) |
|
(Level 2) |
|
(Level 3) |
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency hedges |
|
$ |
31 |
|
|
$ |
|
|
|
$ |
31 |
|
|
$ |
|
|
Interest rate hedges |
|
|
136 |
|
|
|
|
|
|
|
136 |
|
|
|
|
|
Equity securities |
|
|
18 |
|
|
|
18 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
185 |
|
|
$ |
18 |
|
|
$ |
167 |
|
|
$ |
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency hedges |
|
$ |
21 |
|
|
$ |
|
|
|
$ |
21 |
|
|
$ |
|
|
Contingent payments
related to
acquisitions and
investments |
|
|
125 |
|
|
|
|
|
|
|
|
|
|
|
125 |
|
|
Total liabilities |
|
$ |
146 |
|
|
$ |
|
|
|
$ |
21 |
|
|
$ |
125 |
|
|
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, 2011 |
|
$ |
125 |
|
Additions, net of payments |
|
|
57 |
|
Unrealized gain/loss recognized in earnings |
|
|
|
|
|
Fair value as of June 30, 2011 |
|
$ |
182 |
|
|
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.
15
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, 2011 and December 31, 2010.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Book values |
|
|
Approximate fair values |
|
(in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term insurance receivables |
|
$ |
37 |
|
|
$ |
31 |
|
|
$ |
36 |
|
|
$ |
30 |
|
Investments |
|
|
109 |
|
|
|
32 |
|
|
|
94 |
|
|
|
32 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term debt |
|
|
13 |
|
|
|
15 |
|
|
|
13 |
|
|
|
15 |
|
Current maturities of long-term debt and
lease obligations |
|
|
9 |
|
|
|
9 |
|
|
|
9 |
|
|
|
9 |
|
Other long-term debt and lease obligations |
|
|
4,378 |
|
|
|
4,363 |
|
|
|
4,717 |
|
|
|
4,666 |
|
Long-term litigation liabilities |
|
|
97 |
|
|
|
76 |
|
|
|
94 |
|
|
|
74 |
|
|
The
estimated fair values of long-term 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.
Investments principally represent held-to-maturity debt securities, as well as certain cost method
investments. In the first half of 2011, certain past due receivables with the Greek government
were converted into non-interest bearing bonds with maturities of one to three years. The fair
value of these bonds, which are classified as held-to-maturity, was calculated using a discounted
cash flow model that incorporates observable inputs, including interest rate yields. Refer to the
2010 Annual Report for more information on the Greek governments settlement plan. 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 estimated fair values of current and long-term debt were computed by multiplying price by the
notional amount of the respective debt instrument. Price is calculated using the stated terms of
the respective debt instrument and yield curves commensurate with the companys credit risk.
5. COMMON STOCK
Stock-based compensation plans
Stock compensation expense totaled $33 million for both the three months ended June 30, 2011 and
2010 and $61 million and $63 million for the six months ended June 30, 2011 and 2010, respectively.
Approximately 70% of stock compensation expense is classified in marketing and administrative
expenses with the remainder classified in cost of sales and research and development expenses.
In March 2011, the company awarded its annual stock compensation grants, which consisted of 5.7
million stock options, 1.1 million restricted stock units (RSUs) and 436,000 performance share
units (PSUs). Effective with this annual grant, the company changed the overall mix of stock
compensation by reducing the number of options and PSUs granted and introducing RSUs for
equity-eligible employees, except for the companys officers whose grants continue to include only
stock options and PSUs. Stock compensation grants made in the second quarter of 2011 were not
material.
16
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, |
|
|
|
2011 |
|
|
2010 |
|
|
Expected volatility |
|
|
25% |
|
|
|
22% |
|
Expected life (in years) |
|
|
5.0 |
|
|
|
4.5 |
|
Risk-free interest rate |
|
|
2.2% |
|
|
|
2.0% |
|
Dividend yield |
|
|
2.3% |
|
|
|
2.0% |
|
Fair value per stock option |
|
|
$10 |
|
|
|
$10 |
|
|
The total intrinsic value of stock options exercised was $41 million and $19 million during the
three months ended June 30, 2011 and 2010, respectively, and was $62 million and $79 million during
the six months ended June 30, 2011 and 2010, respectively.
As of June 30, 2011, $91 million of unrecognized compensation cost related to all unvested stock
options is expected to be recognized as expense over a weighted-average period of 2.0 years.
Performance Share and Restricted Stock Units
The weighted-average assumptions used in estimating the fair value of PSUs granted during the
period, along with the weighted-average grant-date fair values, were as follows.
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended |
|
|
|
June 30, |
|
|
|
2011 |
|
|
2010 |
|
|
Baxter volatility |
|
|
28% |
|
|
|
26% |
|
Peer group volatility |
|
|
19% - 55% |
|
|
|
20% - 59% |
|
Correlation of returns |
|
|
0.29 - 0.61 |
|
|
|
0.29 - 0.63 |
|
Risk-free interest rate |
|
|
1.2% |
|
|
|
1.3% |
|
Fair value per PSU |
|
|
$62 |
|
|
|
$63 |
|
|
The fair value per RSU is determined based on the quoted price of the companys common stock on the
date of the grant.
As of June 30, 2011, unrecognized compensation cost related to all unvested PSUs of $39 million is
expected to be recognized as expense over a weighted-average period of 1.9 years, and unrecognized
compensation cost related to all unvested RSUs of $50 million is expected to be recognized as
expense over a weighted-average period of 2.7 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, 2011, the company repurchased 8.3 million shares and 20.7
million shares for $478 million and $1.1 billion, respectively, under the board of directors July
2009 $2.0 billion and December 2010 $2.5 billion share repurchase authorizations. As of June 30,
2011, $1.9 billion remained available under the December 2010 authorization. No shares remained
available under the July 2009 authorization as of June 30, 2011.
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. As of June 30, 2011, the companys total recorded reserves
with respect to legal matters were $159 million and the total related insurance receivables were
$68 million.
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 contingencies for which there is no
reserve or additional loss for matters
17
already reserved. While the liability of the company in connection with the claims cannot be
estimated with any certainty and although the resolution in any reporting period of one or more of
these matters could have a significant impact on the companys results of operations and cash flows
for that period, the outcome of these legal proceedings is not expected to have a material adverse
effect on the companys consolidated financial position. While the company believes that it has
valid defenses in these matters, litigation is inherently uncertain, excessive verdicts do occur,
and the company may incur material judgments or enter into material settlements of claims.
In addition to the matters described below, the company remains subject to other potential
administrative and legal actions. With respect to governmental and regulatory matters, these
actions may lead to product recalls, injunctions, and other restrictions on the companys
operations and monetary sanctions, including significant civil or criminal penalties. With respect
to intellectual property, the company may be exposed to significant litigation concerning the scope
of the companys and others rights. Such litigation could result in a loss of patent protection
or the ability to market products, which could lead to a significant loss of sales, or otherwise
materially affect future results of operations.
Patent litigation
Hemodialysis Litigation
Since April 2003, Baxter has been pursuing a patent infringement action against Fresenius Medical
Care Holdings, Inc. for infringement of certain Baxter patents. The patents cover Fresenius 2008K
hemodialysis instrument. In 2007, the court entered judgment in Baxters favor holding the patents
valid and infringed, and a jury assessed damages at $14 million for past sales only. In April
2008, the U.S.D.C. for the Northern District of California granted Baxters motion for permanent
injunction, granted Baxters request for royalties on Fresenius sales of the 2008K hemodialysis
machines during a nine-month transition period before the permanent injunction took effect, and
granted a royalty on disposables. In September 2009, the appellate court affirmed Fresenius
liability for infringing valid claims of Baxters main patent, invalidated certain claims of other
patents, and remanded the case to the district court to finalize the scope of the injunction and
the amount of damages owed to Baxter. In November 2009, the appellate court denied Fresenius
petition for re-hearing of the appeal. In January 2010, Fresenius consented to reentry of the
injunction and sought a new trial to determine royalties, which the district court denied. A
hearing has been set for December 2011 to determine the amount of damages owed to Baxter. In March
2010, the United States Patent and Trademark Offices (USPTO) appellate board affirmed the previous
determination by the USPTO patent examiner that the remaining patent was invalid. The board denied
a request for reconsideration and the company has appealed the USPTOs decision to the same
appellate court that affirmed the validity of the patent in September 2009.
Product liability litigation
Heparin Litigation
In connection with the recall of heparin products in the United States, approximately 730 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. In September 2008, a number of state court cases were
consolidated in Cook County, Illinois for pretrial case management. In June 2011, the first of the
state court cases resulted in a verdict in favor of the plaintiffs with an award of $625,000 in
compensatory damages. In July 2011, the federal court ruled in Baxters favor on certain motions for summary judgment that are expected to result in the dismissal of a significant portion of the cases filed in that court. Additional trials are expected to be scheduled in federal and state court in
2012.
Propofol Litigation
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 have
appealed this decision. Additionally, Baxter is entitled to indemnity in these matters pursuant to
an indemnity agreement entered into with Teva in 2009. The next trial
is scheduled for August
2011.
General litigation
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
18
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 and plaintiffs
appealed the decision to the U.S. Court of Appeals for the Seventh
Circuit.
In May 2010, a shareholder derivative action was brought on behalf of the company in the Circuit
Court of Lake County, Illinois against the companys board of directors, its Chief Executive
Officer and its then current Chief Financial Officer and President of Medication Delivery. The
complaint alleges that the defendants breached their fiduciary duties to the company in connection
with addressing the COLLEAGUE infusion pump matter. Since October 2010, four additional derivative
actions have been filed on behalf of the company against the companys board of directors and
certain current and former executive officers in the U.S.D.C. for the Northern District of
Illinois. In January 2011, the Lake County action was stayed at the request of the Federal Court
plaintiffs. The complaints allege breach of fiduciary duties and substantial damage to the company
arising from the manner in which the COLLEAGUE matter and other quality issues have been addressed
under state law as well as in some cases violations of the federal securities laws. Plaintiffs
seek monetary damages for the company and corporate governance reform and attorneys fees.
In September 2010, a purported class action was filed in the U.S.D.C. for the Northern District of
Illinois against the company and certain of its current executive officers. The complaint alleges
that, from September 17, 2009 to May 3, 2010, the defendants issued materially false and misleading
statements regarding the companys plasma-based therapies business and the companys remediation of
its COLLEAGUE infusion pumps causing the companys common stock to trade at artificially high
levels. Two additional suits have subsequently been filed against the company and certain of its
executive officers in the U.S.D.C. for the Northern District of Illinois. These suits seek to
recover the lost value of investors stock as damages. These suits have been consolidated for
further proceedings.
The company is a defendant, along with others, in nineteen lawsuits brought in various U.S. federal
courts alleging that Baxter and certain of its competitors conspired to restrict output and
artificially increase the price of plasma-derived therapies since 2003. The complaints attempt to
state a claim for class action relief and in some cases demand treble damages. These cases have
been consolidated for pretrial proceedings before the U.S.D.C. for the Northern District of
Illinois. In February 2011, the court denied the companys motion to dismiss certain of the claims
and the parties are proceeding into discovery.
Other
In October 2005, the United States filed a complaint in the U.S.D.C. for the Northern District of
Illinois to effect the seizure of COLLEAGUE and SYNDEO infusion pumps that were on hold in Northern
Illinois. Customer-owned pumps were not affected. In June 2006, Baxter Healthcare Corporation
entered into a Consent Decree for Condemnation and Permanent Injunction with the United States to
resolve this seizure litigation. Pursuant to the Consent Decree, on July 13, 2010 the FDA issued a
final order regarding the recall of the companys COLLEAGUE infusion pumps currently in use in the
United States. The company is executing the recall through July 13, 2012 by offering its customers
an option to replace their COLLEAGUE infusion pumps or receive monetary consideration. The company
will permit lessees to terminate their leases without penalty and refund any prepaid, unused lease
portion upon the return of the devices. Additional third-party claims may be filed in connection
with the COLLEAGUE matter.
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. A class settlement resolving Medicare Part B claims
and independent health plan claims against Baxter and others has been preliminarily approved by
that court and final approval is expected in 2011. Baxter has also resolved a number of other AWP
cases brought by state attorneys general and other plaintiffs. The company remains subject to two
qui tam actions in which the government has declined to intervene and two additional lawsuits
brought by state attorneys general, in each case seeking unspecified damages, injunctive relief,
civil penalties, disgorgement, forfeiture and restitution.
The company has received a letter request from the Office of the United States Attorney for the
Eastern District of Pennsylvania to produce documents related to the companys contracting,
marketing and promotional, and historical government price reporting practices in the United
States. Independent of this request, the company has been
19
engaged in an internal review of its historical price reporting submissions and expects to complete
its internal review in 2011. In addition, the company received a request from the Office of the
United States Attorney for the Northern District of California to produce documents related to the
companys marketing and promotional practices, including relationships between the company and
specialty pharmacies. While the company is fully cooperating with both of these requests, there
can be no assurance that the scope of either matter will not be expanded.
The company has received an inquiry from the U.S. Department of Justice and the SEC requesting that
the company provide information about its business activities in a number of countries. The
company is fully cooperating with the agencies and understands that this inquiry is part of a
broader review of industry practices for compliance with the U.S. Foreign Corrupt Practices Act.
7. SEGMENT INFORMATION
Prior to 2011, the company operated in three segments: BioScience, Medication Delivery and Renal.
The company has combined its former Medication Delivery and Renal businesses into a single global
business unit to form the Medical Products business. Effective January 1, 2011, the company
changed its segment presentation to reflect this new structure, and recast all prior periods
presented to conform to the new presentation.
Baxters two segments, BioScience and Medical Products, are both strategic businesses that are
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 select vaccines.
The Medical Products business manufactures 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. The business also provides products and
services related to pharmacy compounding, drug formulation and packaging technologies. In
addition, the Medical Products business provides products and services 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. In May 2011, the company divested its U.S. generic
injectables business. Refer to Note 2 for further information regarding this divestiture.
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 Transfusion Therapies (TT) business. Refer to Note 4 for further
information regarding the Greece receivable charge, and Note 3 to the companys consolidated
financial statements in the 2010 Annual Report for further information regarding the TT
divestiture.
Included in the Medical Products segments pre-tax income in the first six months 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.
20
Financial information for the companys segments is as follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
(in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Net sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BioScience |
|
$ |
1,553 |
|
|
$ |
1,358 |
|
|
$ |
2,961 |
|
|
$ |
2,720 |
|
Medical Products |
|
|
1,973 |
|
|
|
1,824 |
|
|
|
3,841 |
|
|
|
3,377 |
|
Transition services to Fenwal |
|
|
10 |
|
|
|
12 |
|
|
|
18 |
|
|
|
24 |
|
|
Total |
|
$ |
3,536 |
|
|
$ |
3,194 |
|
|
$ |
6,820 |
|
|
$ |
6,121 |
|
|
Pre-tax income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BioScience |
|
$ |
621 |
|
|
$ |
515 |
|
|
$ |
1,200 |
|
|
$ |
1,069 |
|
Medical Products |
|
|
398 |
|
|
|
372 |
|
|
|
754 |
|
|
|
115 |
|
|
Total pre-tax income from segments |
|
$ |
1,019 |
|
|
$ |
887 |
|
|
$ |
1,954 |
|
|
$ |
1,184 |
|
|
Transition services to Fenwal represent revenues associated with manufacturing, distribution and
other services provided by the company to Fenwal subsequent to the divestiture of the TT business
in 2007.
The following is a reconciliation of segment pre-tax income to income before income taxes per the
condensed consolidated statements of income.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
(in millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Total pre-tax income from segments |
|
$ |
1,019 |
|
|
$ |
887 |
|
|
$ |
1,954 |
|
|
$ |
1,184 |
|
Unallocated amounts |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock compensation |
|
|
(33 |
) |
|
|
(33 |
) |
|
|
(61 |
) |
|
|
(63 |
) |
Net interest expense |
|
|
(15 |
) |
|
|
(25 |
) |
|
|
(25 |
) |
|
|
(44 |
) |
Certain foreign currency
fluctuations and hedging activities |
|
|
(13 |
) |
|
|
10 |
|
|
|
(16 |
) |
|
|
19 |
|
Greece receivable charge |
|
|
|
|
|
|
(28 |
) |
|
|
|
|
|
|
(28 |
) |
Other Corporate items |
|
|
(155 |
) |
|
|
(141 |
) |
|
|
(318 |
) |
|
|
(286 |
) |
|
Income before income taxes |
|
$ |
803 |
|
|
$ |
670 |
|
|
$ |
1,534 |
|
|
$ |
782 |
|
|
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, 2010 (2010 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,
2011.
RESULTS OF OPERATIONS
NET SALES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Six months ended |
|
|
|
|
|
|
June 30, |
|
|
Percent |
|
|
June 30, |
|
|
Percent |
|
(in millions) |
|
2011 |
|
|
2010 |
|
|
change |
|
|
2011 |
|
|
2010 |
|
|
change |
|
|
BioScience |
|
$ |
1,553 |
|
|
$ |
1,358 |
|
|
|
14% |
|
|
$ |
2,961 |
|
|
$ |
2,720 |
|
|
|
9% |
|
Medical Products |
|
|
1,973 |
|
|
|
1,824 |
|
|
|
8% |
|
|
|
3,841 |
|
|
|
3,377 |
|
|
|
14% |
|
Transition services
to Fenwal Inc. |
|
|
10 |
|
|
|
12 |
|
|
|
(17% |
) |
|
|
18 |
|
|
|
24 |
|
|
|
(25% |
) |
|
Total net sales |
|
$ |
3,536 |
|
|
$ |
3,194 |
|
|
|
11% |
|
|
$ |
6,820 |
|
|
$ |
6,121 |
|
|
|
11% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Six months ended |
|
|
|
|
|
|
June 30, |
|
|
Percent |
|
|
June 30, |
|
|
Percent |
|
(in millions) |
|
2011 |
|
|
2010 |
|
|
change |
|
|
2011 |
|
|
2010 |
|
|
change |
|
|
International |
|
$ |
2,118 |
|
|
$ |
1,839 |
|
|
|
15% |
|
|
$ |
3,980 |
|
|
$ |
3,686 |
|
|
|
8% |
|
United States |
|
|
1,418 |
|
|
|
1,355 |
|
|
|
5% |
|
|
|
2,840 |
|
|
|
2,435 |
|
|
|
17% |
|
|
Total net sales |
|
$ |
3,536 |
|
|
$ |
3,194 |
|
|
|
11% |
|
|
$ |
6,820 |
|
|
$ |
6,121 |
|
|
|
11% |
|
|
Foreign currency favorably impacted net sales by 5 and 2 percentage points in the three- and
six-month periods ended June 30, 2011, respectively, principally due to the weakening of the U.S.
Dollar relative to the Euro, the Australian Dollar and the Japanese Yen in both periods.
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 Medical Products segment, favorably impacted sales growth in
the six-month period ended June 30, 2011 by 3 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) |
|
2011 |
|
|
2010 |
|
|
change |
|
|
2011 |
|
|
2010 |
|
|
change |
|
|
Recombinants |
|
$ |
570 |
|
|
$ |
525 |
|
|
|
9% |
|
|
$ |
1,082 |
|
|
$ |
1,035 |
|
|
|
5% |
|
Plasma Proteins |
|
|
363 |
|
|
|
314 |
|
|
|
16% |
|
|
|
671 |
|
|
|
606 |
|
|
|
11% |
|
Antibody Therapy |
|
|
381 |
|
|
|
310 |
|
|
|
23% |
|
|
|
755 |
|
|
|
632 |
|
|
|
19% |
|
Regenerative Medicine |
|
|
147 |
|
|
|
133 |
|
|
|
11% |
|
|
|
287 |
|
|
|
252 |
|
|
|
14% |
|
Other |
|
|
92 |
|
|
|
76 |
|
|
|
21% |
|
|
|
166 |
|
|
|
195 |
|
|
|
(15% |
) |
|
Total net sales |
|
$ |
1,553 |
|
|
$ |
1,358 |
|
|
|
14% |
|
|
$ |
2,961 |
|
|
$ |
2,720 |
|
|
|
9% |
|
|
Net sales in the BioScience segment increased 14% and 9% during the three- and six-month periods
ended June 30, 2011, respectively (including a 4 and 2 percentage point benefit from foreign
currency in the three- and six-month periods ended June 30, 2011, respectively). Excluding the
benefit of foreign currency, the principal drivers were the following:
|
|
|
In the Recombinants product category, sales growth in both periods was the result of
increased demand for the companys advanced recombinant therapy, ADVATE [Antihemophilic
Factor (Recombinant), Plasma/Albumin-Free Method] and, in the second quarter, Recombinate
[Antihemophilic factor (Recombinant)]. Partially offsetting this growth, particularly in
the six-month period, were lower tender sales for ADVATE in the United Kingdom. |
|
|
|
|
Sales in the Plasma Proteins product category increased in both periods, driven by
strong international demand for FEIBA (an anti-inhibitor coagulant complex) and
plasma-derived factor VIII, and demand for albumin in the United States. Partially
offsetting this growth were lower U.S. sales of FEIBA as a result of higher Medicaid
rebates for this product. |
|
|
|
|
Sales growth in the Antibody Therapy product line was due to increased sales of
GAMMAGARD LIQUID, [Immune Globulin Intravenous (Human)] (marketed as KIOVIG outside of the
United States), the liquid formulation of the antibody-replacement therapy IGIV (immune
globulin intravenous), driven by improved market demand and incremental volume resulting
from a competitor being out of the market during the first half of 2011. This performance
was partially offset, particularly in the six-month period, by pricing actions implemented
by the company beginning in the second quarter of 2010. |
|
|
|
|
In the Regenerative Medicine product category, sales growth in both periods was driven
by increased sales of the fibrin sealant product FLOSEAL and, in the six-month period,
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. |
|
|
|
|
In the second quarter of 2011, sales in the Other product category increased due to
strong demand for FSME-IMMUN (a tick-borne encephalitis vaccine). In the six-month period,
strong sales of FSME-IMMUN were more than offset by lower influenza revenues, as the first
quarter of 2010 benefited from sales of CELVAPAN H1N1 pandemic vaccine. Lower demand for
NEISVAC-C (for the prevention of meningitis C) unfavorably impacted sales growth in both
periods. |
23
Medical Products
The following is a summary of sales by product category in the Medical Products segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Six months ended |
|
|
|
|
|
|
June 30, |
|
|
Percent |
|
|
June 30, |
|
|
Percent |
|
(in millions) |
|
2011 |
|
|
2010 |
|
|
change |
|
|
2011 |
|
|
2010 |
|
|
change |
|
|
Renal |
|
$ |
633 |
|
|
$ |
585 |
|
|
|
8% |
|
|
$ |
1,220 |
|
|
$ |
1,169 |
|
|
|
4% |
|
Global Injectables |
|
|
506 |
|
|
|
472 |
|
|
|
7% |
|
|
|
1,023 |
|
|
|
923 |
|
|
|
11% |
|
IV Therapies |
|
|
452 |
|
|
|
418 |
|
|
|
8% |
|
|
|
880 |
|
|
|
809 |
|
|
|
9% |
|
Infusion Systems |
|
|
233 |
|
|
|
216 |
|
|
|
8% |
|
|
|
444 |
|
|
|
212 |
|
|
|
110% |
|
Anesthesia |
|
|
143 |
|
|
|
130 |
|
|
|
10% |
|
|
|
261 |
|
|
|
257 |
|
|
|
2% |
|
Other |
|
|
6 |
|
|
|
3 |
|
|
|
100% |
|
|
|
13 |
|
|
|
7 |
|
|
|
86% |
|
|
Total net sales |
|
$ |
1,973 |
|
|
$ |
1,824 |
|
|
|
8% |
|
|
$ |
3,841 |
|
|
$ |
3,377 |
|
|
|
14% |
|
|
Net sales in the Medical Products segment increased 8% and 14% during the three- and six-month
periods ended June 30, 2011, respectively (including a 5 and 3 percentage point benefit from
foreign currency in the three- and six-month periods ended June 30, 2011, respectively). Excluding
the benefit of foreign currency, the principal drivers were the following:
|
|
|
In the Renal product line, growth in the number of peritoneal dialysis (PD) patients in
Asia, Latin America and the United States was partially offset, particularly in the
six-month period, by PD patient losses in the United States to another service provider and
lower sales of hemodialysis products. |
|
|
|
|
Within the Global Injectables product category, sales growth in both periods was driven
by strong sales in the U.S. pharmaceutical partnering and international pharmacy
compounding businesses, as well as strong demand for certain enhanced packaging products.
Partially offsetting this growth in both periods was the May 2011 divestiture of the U.S.
generic injectables business. Refer to Note 2 for further information regarding this
divestiture. |
|
|
|
|
Intravenous (IV) Therapies sales growth in both periods was driven by increased demand
for IV solutions and strong U.S. growth of nutritional products due to competitor supply
issues. |
|
|
|
|
In the Infusion Systems product category, sales growth in the second quarter and first
half of 2011 reflected increased sales of the Sigma International General Medical
Apparatus, LLC (SIGMA) Spectrum infusion pumps. Sales growth in the six-month period was
favorably impacted by the $213 million charge against sales 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 this charge. |
|
|
|
|
Sales growth in the Anesthesia product category in the second quarter was driven by
improved demand, particularly for SUPRANE (desflurane). Sales growth in the six-month
period was unfavorably impacted by a reduction in wholesaler inventory levels and, in both
periods, by competitive pricing pressures related to generic sevoflurane. |
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 2010 Annual Report for additional information regarding the TT
divestiture.
24
GROSS MARGIN AND EXPENSE RATIOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Six months ended |
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
June 30, |
|
|
|
|
(as a percentage of net sales) |
|
2011 |
|
|
2010 |
|
|
Change |
|
|
2011 |
|
|
2010 |
|
|
Change |
|
|
Gross margin |
|
|
51.9% |
|
|
|
51.3% |
|
|
|
0.6 pts |
|
|
|
51.5% |
|
|
|
43.8% |
|
|
|
7.7 pts |
|
Marketing and administrative
expenses |
|
|
21.6% |
|
|
|
22.6% |
|
|
|
(1.0 pt |
) |
|
|
21.7% |
|
|
|
22.9% |
|
|
|
(1.2 pts |
) |
|
Gross Margin
The increase in the gross margin percentage in both the second quarter and the first half of 2011
was primarily due to sales growth for select higher margin products in the BioScience and Medical
Products segments and the favorable impact of foreign currency, partially offset by costs
associated with manufacturing issues at the companys Castlebar, Ireland facility and cost
inefficiencies driven by lower volume throughput for plasma-based therapies during 2010, which
resulted in higher costs associated with plasma products sold in the second quarter and first half
of 2011.
Also contributing to the increase in the gross margin percentage in both periods were cost
inefficiencies and increased inventory reserves related to vaccine products in the prior year,
which unfavorably impacted the gross margin percentage in the second quarter and first half of
2010. 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 prior year-to-date gross margin rate by 7.8 percentage points.
Marketing and Administrative Expenses
The decrease in the marketing and administrative expense ratio in both periods was driven by
leverage from higher sales, the companys continued focus on controlling discretionary spending,
and the impact of a $28 million charge in the second quarter of 2010 to write down accounts
receivable in Greece. Partially offsetting these items in both periods were increased spending
related to certain marketing and promotional programs, increased pension expense, and the
pharmaceutical products fee, which became effective in the first quarter of 2011 under healthcare
reform legislation enacted in the United States in the first quarter of 2010. Refer to Note 4 for
further information regarding the Greece receivable charge.
Also contributing to the decrease in the marketing and administrative expense ratio in the first
half of 2011 was 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 in the first half of 2010. Refer to Note 3 for further information
regarding the COLLEAGUE charge.
RESEARCH AND DEVELOPMENT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Six months ended |
|
|
|
|
|
|
June 30, |
|
|
Percent |
|
|
June 30, |
|
|
Percent |
|
(in millions) |
|
2011 |
|
|
2010 |
|
|
change |
|
|
2011 |
|
|
2010 |
|
|
change |
|
|
Research and development expenses |
|
|
$239 |
|
|
|
$219 |
|
|
|
9% |
|
|
|
$453 |
|
|
|
$446 |
|
|
|
2% |
|
As a percentage of net sales |
|
|
6.8% |
|
|
|
6.9% |
|
|
|
|
|
|
|
6.6% |
|
|
|
7.3% |
|
|
|
|
|
|
Research and development (R&D) expenses increased in the second quarter and first half of 2011, as
the company continues to invest in key R&D programs across the product pipeline. Also contributing
to the increase in R&D expenses in both periods was the impact of foreign currency. The first
quarter of 2010 charge to net sales related to the recall of COLLEAGUE infusion pumps increased the
R&D expense ratio by 0.3 percentage points in the prior year. Refer to the 2010 Annual Report for
a discussion of the companys R&D pipeline.
NET INTEREST EXPENSE
Net interest expense was $15 million and $25 million in the second quarters of 2011 and 2010,
respectively, and $25 million and $44 million in the first half of 2011 and 2010, respectively.
The decrease in both periods was principally driven by lower interest rates on outstanding debt and
an increase in interest income.
25
OTHER EXPENSE, NET
Other expense, net was $13 million and $3 million in the second quarters of 2011 and 2010,
respectively, and $17 million and $5 million during the first half of 2011 and 2010, 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 increased 21% and 12% for the second quarter and first half of 2011, respectively.
In both periods, the impact from increased sales of certain higher-margin products and the
favorable impact of foreign currency were partially offset by cost inefficiencies driven by lower
volume throughput for plasma-based therapies during 2010, an increase in spending on new marketing
and promotional programs, as well as the pharmaceutical products fee that became effective in the
first quarter of 2011. Also contributing to the increase in pre-tax income for both periods was an
increase in inventory reserves related to vaccine products in the prior year, which unfavorably
impacted pre-tax income in the second quarter and first half of 2010.
Medical Products
Pre-tax income increased 7% in the second quarter of 2011. Pre-tax income in the first half of
2011 was $754 million, compared to $115 million in the first half of 2010. Included in pre-tax
income in the prior year was the first quarter 2010 charge of $588 million related to the recall of
COLLEAGUE infusion pumps from the U.S. market. Pre-tax income in both the second quarter and the
first half of 2011 benefited from strong sales growth, favorable product mix, and the favorable
impact of foreign currency, which was partially offset by increased R&D spending, costs associated
with manufacturing issues at the companys Castlebar, Ireland facility, and the pharmaceutical
products fee that became effective in the first quarter of 2011.
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 4 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 21.7% and 19.9% in the second quarters of 2011 and
2010, respectively, and 21.4% and 39.0% in the six-month periods ended June 30, 2011 and 2010,
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 from the U.S. federal statutory rate. In addition, the effective
tax rate can be affected each period by discrete factors and events. The increase in the effective
income tax rate in the second quarter of 2011 was primarily due to a change in the earnings mix
from lower to higher tax rate jurisdictions compared to the prior year period, as well as the
impact of the pharmaceutical products fee, which became effective in the first quarter of 2011 and
is not deductible. The decrease in the effective income tax rate in the six-month period ended
June 30, 2011 was principally due to the first quarter 2010 charge of $588 million related to the
recall of COLLEAGUE infusion pumps from the U.S. market, for which there was no net tax benefit
recognized, and a $39 million write-off of a deferred tax asset in the first quarter of 2010 as a
result of a change in the tax treatment of reimbursements under the Medicare Part D retiree
prescription drug
26
subsidy program under healthcare reform legislation enacted in the United States. Refer to Note 3
for further information regarding the COLLEAGUE charge.
The company anticipates that the effective tax rate for the full-year 2011 will be
approximately 21.0% to 21.5%, excluding the impact of audit developments and other special items.
INCOME AND EARNINGS PER DILUTED SHARE
Net income attributable to Baxter was $615 million and $535 million for the three months ended June
30, 2011 and 2010, respectively, and $1.2 billion and $472 million for the six months ended June
30, 2011 and 2010, respectively. Net income attributable to Baxter per diluted share was $1.07 and
$0.90 for the three months ended June 30, 2011 and 2010, respectively, and $2.05 and $0.78 for the
six months ended June 30, 2011 and 2010, respectively. The significant factors and events
contributing to the changes are discussed above. Additionally, net income attributable to Baxter
per diluted share was positively impacted by the repurchase of 8.3 million and 20.7 million shares
during the second quarter and first half of 2011, respectively. Refer to Note 5 for further
information regarding the companys stock repurchases.
LIQUIDITY AND CAPITAL RESOURCES
CASH FLOWS
Cash flows from operations
Cash flows from operations decreased slightly during the first half of 2011 as compared to the
prior year, totaling $1.0 billion in 2011 and $1.1 billion in 2010. The impact of higher earnings
(before non-cash items) was more than offset by the factors discussed below.
Accounts Receivable
Cash flows relating to accounts receivable decreased during the first half of 2011 as compared to
the prior year. Days sales outstanding increased from 54.3 days at June 30, 2010 to 57.8 days at
June 30, 2011 due to longer collection periods in certain international markets, as well as an
unfavorable impact from foreign currency. Outstanding receivables from customers outside of the
United States were approximately 80% of total accounts receivable at both June 30, 2011 and
December 31, 2010.
Inventories
Cash flows relating to inventories decreased in 2011 as compared to the prior year. The following
is a summary of inventories at June 30, 2011 and December 31, 2010, as well as annualized inventory
turns for the three months ended June 30, 2011 and 2010, by segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Annualized inventory |
|
|
|
Inventories |
|
|
turns for the three |
|
|
|
June 30, |
|
|
December 31, |
|
|
months ended June 30, |
|
(in millions, except inventory turn data) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
BioScience |
|
$ |
1,624 |
|
|
$ |
1,455 |
|
|
|
1.49 |
|
|
|
1.43 |
|
Medical Products |
|
|
1,023 |
|
|
|
914 |
|
|
|
3.97 |
|
|
|
4.29 |
|
Other |
|
|
1 |
|
|
|
2 |
|
|
|
|
|
|
|
|
|
|
Total company |
|
$ |
2,648 |
|
|
$ |
2,371 |
|
|
|
2.45 |
|
|
|
2.49 |
|
|
The increase in inventories in the first half of 2011 was principally due to higher plasma-related
inventories in the BioScience segment, as well as higher inventories of the SIGMA Spectrum infusion
pump and PD solutions in the Medical Products segment.
Other
Payments related to the execution of the COLLEAGUE infusion pump recall and the companys business
optimization initiatives increased from $41 million in the first half of 2010 to $147 million in
the first half of 2011. Refer to Note 3 for more information regarding the COLLEAGUE infusion pump
recall and the business optimization initiatives. Other cash outflows decreased from $170 million
in the first half of 2010 to $114 million in the first half of 2011, principally due to lower
discretionary pension contributions to the U.S. pension plan and a cash inflow related to the
termination of interest rate swaps.
27
Cash flows from investing activities
Capital Expenditures
Capital expenditures decreased $59 million for the six months ended June 30, 2011, from $467
million in 2010 to $408 million in 2011. The companys investments in capital expenditures are
focused on projects that enhance the companys cost structure and manufacturing capabilities and
support its strategy of geographic expansion with select investments in growing markets. In
addition, the company continues to invest to support the companys ongoing strategic focus on R&D
with the expansion of research facilities, pilot manufacturing sites and laboratories. Capital
expenditures also included the companys multi-year initiative to implement a global enterprise
resource planning system that will consolidate and standardize business processes, data and
systems.
Acquisitions and Investments
Cash outflows relating to acquisitions and investments of $202 million in the first half of 2011
primarily related to a cash outflow of $170 million associated with the acquisition of Prism
Pharmaceuticals, Inc. (Prism). Cash outflows in the first half of 2011 also included an $18
million payment to exercise an option related to the companys collaboration agreement for the
development of a home hemodialysis machine with HHD, LLC, DEKA Products Limited Partnership and
DEKA Research and Development Corp. (collectively, DEKA). Refer to Note 2 for further information
about the Prism acquisition and the DEKA agreement.
Cash outflows relating to acquisitions and investments of $254 million in the first half of 2010
primarily related to a net cash outflow of $235 million related to the acquisition of ApaTech, an
orthobiologic products company based in the United Kingdom, and an $18 million payment related to
the companys collaboration agreement for the development of a home hemodialysis machine with DEKA.
Refer to the 2010 Annual Report for further information about the ApaTech acquisition.
Divestiture and Other
Cash inflows relating to divestiture and other principally consisted of $104 million of cash
proceeds associated with the companys divestiture of its U.S. generic injectables business in the
second quarter of 2011. Refer to Note 2 for further information about this divestiture.
Cash flows from financing activities
Debt Issuances, Net of Payments of Obligations
Net cash outflows related to debt and other financing obligations totaled $3 million in the first
half of 2011, as compared to net cash inflows of $587 million in the first half of 2010. 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 were used for general corporate purposes,
including the refinancing of indebtedness.
Other Financing Activities
Cash dividend payments totaled $358 million and $348 million in the first half of 2011 and 2010,
respectively. The increase in cash dividend payments was primarily due to a 7% increase in the
quarterly dividend rate compared to the prior year, partially offset by the impact of a lower
number of common shares outstanding as a result of the companys stock repurchase programs. In May
2011, the board of directors declared a quarterly dividend of $0.31 per share, payable on July 1,
2011 to shareholders of record on June 10, 2011. In July 2011, the board of directors declared a
quarterly dividend of $0.31 per share, payable on October 3, 2011 to shareholders of record on
September 9, 2011.
Proceeds and realized excess tax benefits from stock issued under employee benefit plans increased
by $69 million, from $235 million in the first half of 2010 to $304 million in the first half of
2011, primarily due to an increase in stock option exercises, partially offset by a decrease in
realized excess tax benefits. Realized excess tax benefits, which were $13 million and $34 million
in the first half of 2011 and 2010, respectively, are presented in the condensed consolidated
statements of cash flows as an outflow in the operating section and an inflow in the financing
section.
Stock repurchases totaled $1.1 billion in both the first half of 2011 and 2010. 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 and December 2010, the
board of directors authorized the repurchase of up to $2.0 billion and $2.5 billion, respectively,
of the companys common stock. At June 30, 2011, $1.9 billion
28
remained available under the December 2010 authorization. There was no remaining availability
under the July 2009 authorization.
CREDIT FACILITIES, ACCESS TO CAPITAL AND CREDIT RATINGS
Credit facilities
In the second quarter of 2011, the company refinanced its primary revolving credit facility
agreement, which was set to mature in December 2011. The key terms of the new credit facility,
which has a maximum capacity of $1.5 billion and matures in June 2015, are substantially the same
as the existing credit facility. Commitment fees under the new credit facility are not material.
The company also maintains a credit facility denominated in Euros with a maximum capacity of
approximately $431 million at June 30, 2011, 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, 2011, 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, 2011. 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 2010 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 $2.0 billion of cash and equivalents at June 30, 2011. The company invests its excess cash in
certificates of deposit and money market funds, and diversifies the concentration of cash among
different financial institutions. While the companys cash positions fluctuate, a significant
portion of the companys cash and equivalents are generally held in foreign jurisdictions.
However, the company has adequate cash available to meet operating requirements in each
jurisdiction in which the company operates.
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.
The company continues to do business with foreign governments in certain countries, including
Greece, Spain, Portugal and Italy, that have experienced a deterioration in credit and economic
conditions. While the economic downturn has not significantly impacted the companys ability to
collect receivables, global economic conditions and liquidity issues in certain countries have
resulted, and may continue to result, in delays in the collection of receivables and credit losses.
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. Global economic
conditions, governmental actions and customer-specific factors may require the company to
re-evaluate the collectibility and valuation of its receivables which could result in additional
credit losses.
Credit ratings
There were no changes in the companys credit ratings in the first half of 2011. Refer to the 2010
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
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 2010 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
29
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 2010 Annual Report. There have been no significant changes in the companys application of its
critical accounting policies during the first six months of 2011.
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 any presently established
liabilities. While the liability of the company in connection with certain 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 (FDA)) relating to the performance of the pumps, as well as the seizure
litigation described in Note 6, the company entered into a Consent Decree in June 2006. Additional
Class I recalls related to remediation and repair and maintenance activities were addressed by the
company in 2007 and 2009. Pursuant to the Consent Decree, in July 2010 the FDA issued a final
order regarding the recall of the companys COLLEAGUE infusion pumps currently in use in the United
States. The company is executing the recall over the two years following the final order by
offering its customers an option to replace their COLLEAGUE infusion pumps or receive monetary
consideration. Under the replacement option, the companys customers may receive SIGMA Spectrum
infusion pumps in exchange for their COLLEAGUE infusion pumps. Alternatively, COLLEAGUE pump
owners may receive the lesser of the pumps depreciated value, which will be no less than $1,500
per single-channel pump and $3,000 per triple-channel pump, or the purchase price. The
company will permit lessees to terminate their leases without penalty and will refund any prepaid,
unused lease portion upon the return of the devices. As discussed in Note 3, following the FDAs
issuance of its initial order dated April 30, 2010, the company recorded a charge in the first
quarter of 2010 related to the FDAs order and other actions the company is undertaking 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 for the Northern District of Illinois relating to the COLLEAGUE infusion pump in
September 2009. It is possible that substantial additional cash and non-cash charges, including
significant asset impairments related to the COLLEAGUE infusion pumps and related businesses, may
be required in future periods based on new information, changes in estimates, the implementation of
the recall in the United States, and other actions the company may be required to undertake in
markets outside of the United States.
In June 2010, the company received a Warning Letter from the FDA in connection with an inspection
of its Renal businesss McGaw Park, Illinois headquarters facility. The Warning Letter pertains to
the processes by which the company analyzes and addresses product complaints through corrective and
preventative actions, and reports relevant information to the FDA. The company is working with the
FDA to resolve these matters.
In January 2011, the European Medicines Agency (EMA) announced the review of Dianeal, Extraneal and
Nutrineal peritoneal dialysis solutions manufactured in the companys Castlebar, Ireland facility
due to the potential presence of endotoxins in certain batches. The company continues to supply the European Union with these products through other Baxter manufacturing facilities. The company is working with the
EMA 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 of the
companys 2010 Annual Report 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, credit exposure to foreign governments, the impact of the acquisition of
Prism, contingent payments, estimates of liabilities, expectations with respect to the companys
hedging activities including its exposure to financial market volatility and foreign currency
risk, future capital and R&D expenditures, the sufficiency of the companys financial flexibility
and the adequacy of credit facilities and reserves, the effective tax rate in 2011, and all other
statements that do not relate to historical facts. The statements are based on assumptions about
many important factors, including assumptions concerning:
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demand for and market acceptance risks for new and existing products, such as ADVATE
and plasma-based therapies (including Antibody Therapy), and other therapies; |
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fluctuations in supply and demand and the pricing of plasma-based therapies; |
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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 healthcare reform legislation and other similar measures are implemented in the
United States and globally; |
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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 new
and 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, EMA or any other regulatory body or government authority that
could delay, limit or suspend product development, manufacturing or sale or result in
seizures, injunctions, monetary sanctions or criminal or civil liabilities, including any
sanctions available under the Consent Decree entered into with the FDA concerning the
COLLEAGUE and SYNDEO infusion pumps; |
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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 SIGMAs Spectrum infusion pump; |
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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 successful implementation of the companys global enterprise resource planning
system; |
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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 in Item 1A in the companys
Annual Report on Form 10-K for the year ended December 31, 2010, 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
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 and forwards 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, 2011 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 of 2.15 relative to the U.S. Dollar. The official
exchange rate for imported goods classified as essential, such as food and medicine, was changed to
2.6, while the rate for payments for non-essential goods was changed to 4.3. In 2010, the majority
of the companys products imported into Venezuela were classified as essential goods. Effective
January 1, 2011, the Venezuela government devalued the official currency for imported goods
classified as essential to 4.3. Since January 1, 2010, Venezuela has been designated as a highly
inflationary economy and as a result, the functional currency of the companys subsidiary in
Venezuela is 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 and forward
contracts outstanding at June 30, 2011, 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 $18 million with respect to those contracts would decrease by $47 million,
resulting in a net liability balance.
The sensitivity analysis model recalculates the fair value of the foreign exchange option and
forward contracts outstanding at June 30, 2011 by replacing the actual exchange rates at June 30,
2011 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 2010 Annual Report. There were no significant changes during the quarter
ended June 30, 2011.
32
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, 2011.
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, 2011.
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, 2011 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, 2011 and 2010 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, 2011, and the related condensed consolidated statements of
income for each of the three- and six-month periods ended June 30, 2011 and 2010 and the condensed
consolidated statements of cash flows for the six-month periods ended June 30, 2011 and 2010.
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, 2010, 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 23, 2011, 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, 2010, 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 2, 2011
35
PART II. OTHER INFORMATION
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, 2011.
Issuer Purchases of Equity Securities
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Total number |
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Total number of shares |
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Approximate dollar value of |
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of shares |
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Average price |
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purchased as part of publicly |
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shares that may yet be purchased |
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Period |
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purchased(1) |
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paid per share |
|
|
announced program(1) |
|
|
under the program(1) |
|
|
April 1, 2011
through April 30, 2011 |
|
|
2,004,800 |
|
|
$ |
54.10 |
|
|
|
2,004,800 |
|
|
|
|
|
May 1, 2011
through May 31, 2011 |
|
|
2,469,245 |
|
|
$ |
58.45 |
|
|
|
2,469,245 |
|
|
|
|
|
June 1, 2011
through June 30, 2011 |
|
|
3,836,600 |
|
|
$ |
58.65 |
|
|
|
3,836,600 |
|
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Total |
|
|
8,310,645 |
|
|
$ |
57.49 |
|
|
|
8,310,645 |
|
|
$ |
1,881,195,544 |
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(1) |
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In December 2010, the company announced that its board of directors authorized the company to
repurchase up to $2.5 billion of its common stock on the open market or in private
transactions. During the second quarter of 2011, the company repurchased approximately 8.3
million shares for $478 million under this program. This program does not have an expiration
date. |
37
Item 6. Exhibits
Exhibit Index:
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Exhibit |
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Number |
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Description |
15
|
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Letter Re Unaudited Interim Financial Information |
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31.1
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Certification of Chief Executive Officer Pursuant to Rule 13a-14(a)/15d-14(a) of the
Securities Exchange Act of 1934 |
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31.2
|
|
Certification of Chief Financial Officer Pursuant to Rule 13a-14(a)/15d-14(a) of the
Securities Exchange Act of 1934 |
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|
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32.1
|
|
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350 |
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|
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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.
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BAXTER INTERNATIONAL INC.
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(Registrant)
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Date: August 2, 2011 |
By: |
/s/ Robert J. Hombach
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Robert J. Hombach |
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Corporate Vice President and Chief Financial Officer
(duly authorized officer and principal financial officer) |
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39