UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2011
¨ | 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)
Delaware |
36-0781620 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
One Baxter Parkway, Deerfield, Illinois |
60015-4633 | |
(Address of principal executive offices) | (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 ¨
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 ¨
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.
Large accelerated filer þ | Accelerated filer ¨ | Non-accelerated filer ¨ | Smaller reporting company ¨ | |||
(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 ¨ No þ
The number of shares of the registrants Common Stock, par value $1.00 per share, outstanding as of October 28, 2011 was 563,866,130 shares.
FORM 10-Q
For the quarterly period ended September 30, 2011
TABLE OF CONTENTS
Page Number | ||||||
PART I. | ||||||
Item 1. | ||||||
2 | ||||||
3 | ||||||
4 | ||||||
5 | ||||||
Item 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations |
23 | ||||
Item 3. | 34 | |||||
Item 4. |
35 | |||||
36 | ||||||
Report of Independent Registered Public Accounting Firm | 37 | |||||
PART II. | ||||||
Item 1. | 38 | |||||
Item 2. | 39 | |||||
Item 6. |
40 | |||||
41 |
Condensed Consolidated Statements of Income Condensed Consolidated Statements of Income (unaudited)
(in millions, except per share data)
Three months ended September 30, |
Nine months ended September 30, |
|||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Net sales |
$3,479 | $3,224 | $10,299 | $9,345 | ||||||||||||
Cost of sales |
1,708 | 1,565 | 5,018 | 5,005 | ||||||||||||
Gross margin |
1,771 | 1,659 | 5,281 | 4,340 | ||||||||||||
Marketing and administrative expenses |
787 | 670 | 2,268 | 2,074 | ||||||||||||
Research and development expenses |
239 | 207 | 692 | 653 | ||||||||||||
Net interest expense |
14 | 24 | 39 | 68 | ||||||||||||
Other expense, net |
4 | 117 | 21 | 122 | ||||||||||||
Income before income taxes |
727 | 641 | 2,261 | 1,423 | ||||||||||||
Income tax expense |
149 | 117 | 477 | 422 | ||||||||||||
Net income |
578 | 524 | 1,784 | 1,001 | ||||||||||||
Less: Noncontrolling interests |
2 | (1 | ) | 23 | 4 | |||||||||||
Net income attributable to Baxter International Inc. (Baxter) |
$ 576 | $ 525 | $ 1,761 | $ 997 | ||||||||||||
Net income attributable to Baxter per common share |
||||||||||||||||
Basic |
$ 1.02 | $ 0.90 | $ 3.08 | $ 1.68 | ||||||||||||
Diluted |
$ 1.01 | $ 0.89 | $ 3.06 | $ 1.67 | ||||||||||||
Weighted-average number of common shares outstanding |
||||||||||||||||
Basic |
566 | 584 | 571 | 593 | ||||||||||||
Diluted |
571 | 587 | 575 | 597 | ||||||||||||
Cash dividends declared per common share |
$ 0.31 | $ 0.29 | $ 0.93 | $ 0.87 | ||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
Condensed Consolidated Balance Sheets Condensed Consolidated Balance Sheets (unaudited)
(in millions, except shares)
September 30, 2011 |
December 31, 2010 |
|||||||||
Current assets | Cash and equivalents |
$ 2,338 | $ 2,685 | |||||||
Accounts and other current receivables |
2,347 | 2,265 | ||||||||
Inventories |
2,621 | 2,371 | ||||||||
Prepaid expenses and other |
696 | 668 | ||||||||
Total current assets |
8,002 | 7,989 | ||||||||
Property, plant and equipment, net |
5,426 | 5,260 | ||||||||
Other assets | Goodwill |
2,119 | 2,015 | |||||||
Other intangible assets, net |
710 | 500 | ||||||||
Other |
1,586 | 1,725 | ||||||||
Total other assets |
4,415 | 4,240 | ||||||||
Total assets | $17,843 | $17,489 | ||||||||
Current liabilities | Short-term debt |
$ 87 | $ 15 | |||||||
Current maturities of long-term debt and lease obligations |
8 | 9 | ||||||||
Accounts payable and accrued liabilities |
4,070 | 4,017 | ||||||||
Total current liabilities |
4,165 | 4,041 | ||||||||
Long-term debt and lease obligations | 4,447 | 4,363 | ||||||||
Other long-term liabilities |
2,041 | 2,289 | ||||||||
Commitments and contingencies |
||||||||||
Equity | Common stock, $1 par value, authorized 2,000,000,000 shares, issued 683,494,944 shares in 2011 and 2010 |
683 | 683 | |||||||
Common stock in treasury, at cost, 120,356,510 shares in 2011 and 102,761,588 shares in 2010 |
(6,608 | ) | (5,655 | ) | ||||||
Additional contributed capital |
5,772 | 5,753 | ||||||||
Retained earnings |
9,154 | 7,925 | ||||||||
Accumulated other comprehensive loss |
(2,049 | ) | (2,139 | ) | ||||||
Total Baxter shareholders equity |
6,952 | 6,567 | ||||||||
Noncontrolling interests |
238 | 229 | ||||||||
Total equity |
7,190 | 6,796 | ||||||||
Total liabilities and equity | $17,843 | $17,489 | ||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
Condensed Consolidated Statements of Cash Flows Condensed Consolidated Statements of Cash Flows (unaudited)
(in millions)
Nine months ended September 30, |
||||||||||
2011 | 2010 | |||||||||
Cash flows from operations |
Net income |
$ 1,784 | $ 1,001 | |||||||
Adjustments |
||||||||||
Depreciation and amortization |
503 | 506 | ||||||||
Deferred income taxes |
218 | 169 | ||||||||
Stock compensation |
94 | 92 | ||||||||
Realized excess tax benefits from stock issued under employee benefit plans |
(17 | ) | (35 | ) | ||||||
Infusion pump charge |
| 588 | ||||||||
Impairment charge |
| 112 | ||||||||
Other |
103 | 56 | ||||||||
Changes in balance sheet items |
||||||||||
Accounts and other current receivables |
(102 | ) | (27 | ) | ||||||
Inventories |
(272 | ) | (94 | ) | ||||||
Accounts payable and accrued liabilities |
(90 | ) | (38 | ) | ||||||
Infusion pump and business optimization payments |
(258 | ) | (62 | ) | ||||||
Other, including pension contributions |
(38 | ) | (200 | ) | ||||||
Cash flows from operations |
1,925 | 2,068 | ||||||||
Cash flows from investing activities |
Capital expenditures |
(643 | ) | (699 | ) | |||||
Acquisitions and investments |
(229 | ) | (274 | ) | ||||||
Divestiture and other |
106 | | ||||||||
Cash flows from investing activities |
(766 | ) | (973 | ) | ||||||
Cash flows from financing activities |
Issuances of debt |
4 | 610 | |||||||
Payments of obligations |
(9 | ) | (21 | ) | ||||||
Increase in debt with original maturities of three months or less, net |
75 | | ||||||||
Cash dividends on common stock |
(534 | ) | (519 | ) | ||||||
Proceeds and realized excess tax benefits from stock issued under employee |
405 | 269 | ||||||||
Purchases of treasury stock |
(1,413 | ) | (1,273 | ) | ||||||
Other |
(20 | ) | (44 | ) | ||||||
Cash flows from financing activities |
(1,492 | ) | (978 | ) | ||||||
Effect of currency exchange rate changes on cash and equivalents |
(14 | ) | (115 | ) | ||||||
(Decrease) increase in cash and equivalents | (347 | ) | 2 | |||||||
Cash and equivalents at beginning of period |
2,685 | 2,786 | ||||||||
Cash and equivalents at end of period |
$ 2,338 | $ 2,788 | ||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
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.
Three months ended September 30, |
Nine months ended September 30, |
|||||||||||||||
(in millions) | 2011 | 2010 | 2011 | 2010 | ||||||||||||
Pension benefits |
||||||||||||||||
Service cost |
$ 28 | $ 24 | $ 84 | $ 74 | ||||||||||||
Interest cost |
60 | 57 | 178 | 171 | ||||||||||||
Expected return on plan assets |
(76 | ) | (70 | ) | (228 | ) | (211 | ) | ||||||||
Amortization of net losses and other deferred amounts |
44 | 29 | 132 | 93 | ||||||||||||
Net periodic pension benefit cost |
$ 56 | $ 40 | $ 166 | $ 127 | ||||||||||||
OPEB |
||||||||||||||||
Service cost |
$ 2 | $ 1 | $ 5 | $ 4 | ||||||||||||
Interest cost |
7 | 7 | 21 | 22 | ||||||||||||
Amortization of prior service credit and net loss |
(1 | ) | (1 | ) | (2 | ) | (4 | ) | ||||||||
Net periodic OPEB cost |
$ 8 | $ 7 | $ 24 | $ 22 | ||||||||||||
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
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
(in millions) | 2011 | 2010 | 2011 | 2010 | ||||||||||||
Interest expense, net of capitalized interest |
$23 | $30 | $ 67 | $ 88 | ||||||||||||
Interest income |
(9 | ) | (6 | ) | (28 | ) | (20 | ) | ||||||||
Net interest expense |
$14 | $24 | $ 39 | $ 68 | ||||||||||||
5
Comprehensive income
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
(in millions) | 2011 | 2010 | 2011 | 2010 | ||||||||||||
Comprehensive income |
$295 | $901 | $1,865 | $810 | ||||||||||||
Less: Comprehensive (loss) income attributable to noncontrolling interests |
(4 | ) | (1 | ) | 14 | 7 | ||||||||||
Comprehensive income attributable to Baxter |
$299 | $902 | $1,851 | $803 | ||||||||||||
The decrease in comprehensive income attributable to Baxter for the three months ended September 30, 2011 was principally due to unfavorable movements in currency translation adjustments (CTA), which resulted in a $316 million loss in 2011 compared to a $381 million gain in 2010, partially offset by higher net income attributable to Baxter. The increase in comprehensive income attributable to Baxter for the nine months ended September 30, 2011 was primarily due to 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, and favorable movements in CTA, which resulted in a $17 million gain in 2011 compared to a $306 million loss in 2010. Refer to Note 3 for further information regarding the COLLEAGUE infusion pump charge.
Effective tax rate
The companys effective income tax rate was 20.5% and 18.3% in the third quarters of 2011 and 2010, respectively, and 21.1% and 29.7% for the nine months ended September 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 third quarter of 2011 was primarily due to the tax benefit from the third quarter 2010 impairment charge of $112 million associated with the divestiture of the U.S. multi-source generic injectables business. The effective income tax rate also increased due to a change in the earnings mix from lower to higher tax rate jurisdictions compared to the prior year period and an increase in a tax reserve associated with one of the companys joint ventures. This increase was partially offset by the tax benefit from the $79 million charge in the third quarter of 2011 related to the resolution of litigation pertaining to average wholesale prices (AWP) and certain rebate and discount adjustments related to historical price reporting submissions.
The decrease in the effective income tax rate in the nine months ended September 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. This decrease was partially offset by the tax benefit from the third quarter 2010 U.S. multi-source generic injectables business impairment charge.
Refer to the discussion below for further information regarding the U.S. multi-source generic injectables business divestiture, Note 6 for further information regarding the AWP litigation and historical price reporting charge, and Note 3 for further information regarding the COLLEAGUE infusion pump 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.
6
The following is a reconciliation of basic shares to diluted shares.
Three months ended September 30, |
Nine months ended September 30, |
|||||||||||||||
(in millions) | 2011 | 2010 | 2011 | 2010 | ||||||||||||
Basic shares |
566 | 584 | 571 | 593 | ||||||||||||
Effect of dilutive securities |
5 | 3 | 4 | 4 | ||||||||||||
Diluted shares |
571 | 587 | 575 | 597 | ||||||||||||
The computation of diluted EPS excluded employee stock options to purchase 18 million and 31 million shares for the three months ended September 30, 2011 and 2010, respectively, and 18 million and 28 million shares for the nine months ended September 30, 2011 and 2010, respectively, because their inclusion would have had an anti-dilutive effect on diluted EPS.
Inventories
(in millions) | September 30, 2011 |
December 31, 2010 |
||||||
Raw materials |
$ 587 | $ 536 | ||||||
Work in process |
910 | 787 | ||||||
Finished goods |
1,124 | 1,048 | ||||||
Inventories |
$2,621 | $2,371 | ||||||
Property, plant and equipment, net
(in millions) | September 30, 2011 |
December 31, 2010 |
||||||
Property, plant and equipment, at cost |
$10,794 | $10,591 | ||||||
Accumulated depreciation and amortization |
(5,368 | ) | (5,331 | ) | ||||
Property, plant and equipment (PP&E), net |
$ 5,426 | $ 5,260 | ||||||
Goodwill
The following is a summary of goodwill by business segment.
(in millions) | BioScience | Medical Products |
Total | |||||||||
Balance as of December 31, 2010 |
$809 | $1,206 | $2,015 | |||||||||
Additions |
1 | 100 | 101 | |||||||||
Currency translation and other adjustments |
2 | 1 | 3 | |||||||||
Balance as of September 30, 2011 |
$812 | $1,307 | $2,119 | |||||||||
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. Prism and HHD are within the Medical Products segment. Refer to the discussion below for further information regarding Prism and HHD. As of September 30, 2011, there were no accumulated goodwill impairment losses.
7
Other intangible assets, net
The following is a summary of the companys intangible assets subject to amortization at September 30, 2011 and December 31, 2010.
(in millions) | Developed technology, including patents |
Other | Total | |||||||||
September 30, 2011 |
||||||||||||
Gross other intangible assets |
$1,099 | $147 | $1,246 | |||||||||
Accumulated amortization |
(493 | ) | (78 | ) | (571 | ) | ||||||
Other intangible assets, net |
$ 606 | $ 69 | $ 675 | |||||||||
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 $21 million and $18 million for the three months ended September 30, 2011 and 2010, respectively, and $58 million and $55 million for the nine months ended September 30, 2011 and 2010, respectively. The anticipated annual amortization expense for intangible assets recorded as of September 30, 2011 is $80 million in 2011, $84 million in 2012, $81 million in 2013, $78 million in 2014, $76 million in 2015, and $73 million in 2016.
The increase in other intangible assets, net in the first nine months of 2011 primarily related to $225 million from the second quarter acquisition of Prism and $38 million from an arrangement with Ceremed, Inc. (Ceremed) related to Ceremeds OSTENE brand bone hemostasis product line, as well as its AOC PolymerBlend technology, which is used in manufacturing Baxters ACTIFUSE product, a silicate substituted calcium phosphate synthetic bone graft material. Refer to the discussion below for further information regarding the Prism acquisition.
Additionally, as of September 30, 2011 and December 31, 2010, the 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 nine months ended September 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 September 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.
Acquisitions and investments
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) container 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 expands 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.
8
The following table summarizes the preliminary allocation of the fair value of assets acquired and liabilities assumed at the acquisition date. The final allocation of the purchase price may result in 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. As of September 30, 2011, the estimated fair value of the contingent payments was $72 million, with changes in the estimated fair value recognized in earnings. 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.
Baxa Corporation
In August 2011, the company entered into a definitive agreement to acquire privately-held Baxa Corporation (Baxa), which manufactures and markets devices, systems and software for the safe and efficient preparation, handling, packaging and administration of fluid medications. Upon completion of the acquisition, Baxter will acquire product lines that include devices that automate multi-ingredient nutritional solution compounding, such as the EXACTAMIX Compounder, filling and packaging systems for oral and enteral syringes, automated dose filling systems, and the DoseEdge Pharmacy Workflow Manager, an integrated system for managing IV and oral dose preparation activities. The addition of Baxas product lines will complement Baxters portfolio of nutrition products and drug delivery systems, and will provide Baxter with a comprehensive solution to fulfill the majority of patients nutritional requirements and increase efficiency in the pharmacy. The transaction is expected to close in the fourth quarter of 2011, subject to customary closing conditions including applicable regulatory approvals. Under the terms of the agreement, Baxter will provide Baxa with an upfront cash payment of $380 million at closing. The acquisition is not expected to have a material impact on Baxters 2011 financial statements.
Divestiture of U.S. multi-source generic injectables business
In May 2011, the company completed the divestiture of its U.S. multi-source 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. An impairment charge of $112 million, primarily related to PP&E and intangible assets, was recorded in the third quarter of 2010 to reflect the fair values of these assets based on the expected sale price of the business. Refer to the 2010 Annual Report for further information about this divestiture.
Net sales relating to the U.S. multi-source generic injectables business, which were reported in the Medical Products segment prior to the divestiture, were $57 million in the third quarter of 2010 and $58 million and $143 million in the first nine 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
9
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 (SIGMA) 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 September 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 |
(175 | ) | ||
Reserves as of September 30, 2011 |
$ | 338 | ||
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.
10
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 |
(83 | ) | ||
CTA |
| |||
Reserves as of September 30, 2011 |
$ 97 | |||
The company believes that these reserves are adequate and expects that the reserves will be substantially utilized by the end of 2012. 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 September 30, | Nine months ended September 30, | |||||||||||||||
(in millions) | 2011 | 2010 | 2011 | 2010 | ||||||||||||
Sold receivables at beginning of period |
$ 148 | $ 129 | $ 157 | $ 147 | ||||||||||||
Proceeds from sales of receivables |
155 | 145 | 443 | 394 | ||||||||||||
Cash collections (remitted to the owners |
(161 | ) | (144 | ) | (464 | ) | (408 | ) | ||||||||
Effect of currency exchange rate changes |
7 | 8 | 13 | 5 | ||||||||||||
Sold receivables at end of period |
$ 149 | $ 138 | $ 149 | $ 138 | ||||||||||||
Credit facility and commercial paper
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 previous credit facility. Commitment fees under the new credit facility are not material. As of September 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.
During the first nine months of 2011, the company issued and redeemed commercial paper, of which $75 million was outstanding as of September 30, 2011, with a weighted-average interest rate of 0.14%.
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 was computed by taking into consideration, among other factors, the imputed discount of the outstanding receivables based upon
11
publicly traded Greek government bonds with similar terms and 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. Refer to the discussion below for information regarding the Greek government bonds held by the company at September 30, 2011. 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 anticipated issuances of debt and, in the prior year, 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 deferred in accumulated other comprehensive income (AOCI) and then recognized in earnings consistent with the underlying hedged item. Option premiums or net premiums paid are initially recorded as assets and reclassified to other comprehensive income (OCI) over the life of the option, and then recognized in earnings consistent with the underlying hedged item. Cash flow hedges are 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.
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The notional amounts of foreign exchange contracts were $1.5 billion and $1.6 billion as of September 30, 2011 and December 31, 2010, respectively. The notional amount of interest rate contracts designated as cash flow hedges was $200 million as of September 30, 2011. There were no interest rate contracts designated as cash flow hedges outstanding as of December 31, 2010.
The maximum term over which the company has cash flow hedge contracts in place related to foreign currency forecasted transactions at September 30, 2011 is 15 months.
Fair Value Hedges
The company uses interest rate swaps to convert a portion of its fixed-rate debt into variable-rate debt. These instruments hedge the companys earnings from changes in the fair value of debt due to fluctuations in the designated benchmark interest rate. For each derivative instrument that is designated and effective as a fair value hedge, the gain or loss on the derivative is recognized immediately to earnings, and offsets the loss or gain on the 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 $900 million as of September 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 and third quarters of 2011, the company terminated $600 million and $850 million, respectively, of interest rate contracts that had been designated as fair value hedges, which resulted in net gains of $46 million and $49 million, respectively, that have been deferred and are being amortized as a reduction of net interest expense over the remaining terms of the underlying debt. There were no hedge dedesignations in the first nine months 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 $360 million as of September 30, 2011 and $445 million as of December 31, 2010.
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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 September 30, 2011 and 2010.
Gain (loss) recognized in OCI | Location of gain (loss) in income statement |
Gain (loss) reclassified from AOCI into income |
||||||||||||||||
(in millions) | 2011 | 2010 | 2011 | 2010 | ||||||||||||||
Cash flow hedges |
||||||||||||||||||
Interest rate contracts |
$(8 | ) | $ | Net interest expense | $ | $ | ||||||||||||
Foreign exchange contracts |
(1 | ) | | Net sales | | (1 | ) | |||||||||||
Foreign exchange contracts |
7 | (25 | ) | Cost of sales | (10 | ) | 2 | |||||||||||
Foreign exchange contracts |
| (31 | ) | Other expense, net | | (29 | ) | |||||||||||
Total |
$(2 | ) | $(56 | ) | $(10 | ) | $(28 | ) | ||||||||||
Location of gain (loss) in income statement |
Gain (loss) recognized in income | |||||||||||||||||
(in millions) | 2011 | 2010 | ||||||||||||||||
Fair value hedges |
||||||||||||||||||
Interest rate contracts |
Net interest expense | $53 | $45 | |||||||||||||||
Undesignated derivative instruments |
||||||||||||||||||
Foreign exchange contracts |
Other expense, net | $ 2 | $ (2 | ) | ||||||||||||||
The following table summarizes the income statement locations and gains and losses on the companys derivative instruments for the nine months ended September 30, 2011 and 2010.
|
| |||||||||||||||||
Gain (loss) recognized in OCI | Location of gain (loss) in income statement |
Gain (loss) reclassified from AOCI into income |
||||||||||||||||
(in millions) | 2011 | 2010 | 2011 | 2010 | ||||||||||||||
Cash flow hedges |
||||||||||||||||||
Interest rate contracts |
$ (8 | ) | $ (7 | ) | Net interest expense | $ | $ 1 | |||||||||||
Foreign exchange contracts |
| (2 | ) | Net sales | (1 | ) | (3 | ) | ||||||||||
Foreign exchange contracts |
(24 | ) | 8 | Cost of sales | (25 | ) | (5 | ) | ||||||||||
Foreign exchange contracts |
| 53 | Other expense, net | | 57 | |||||||||||||
Total |
$(32 | ) | $52 | $(26 | ) | $50 | ||||||||||||
Location of gain (loss) in income statement |
Gain (loss) recognized in income | |||||||||||||||||
(in millions) | 2011 | 2010 | ||||||||||||||||
Fair value hedges |
||||||||||||||||||
Interest rate contracts |
Net interest expense | $65 | $130 | |||||||||||||||
Undesignated derivative instruments |
||||||||||||||||||
Foreign exchange contracts |
Other expense, net | $ (6 | ) | $ (7 | ) | |||||||||||||
For the companys fair value hedges, equal and offsetting losses of $53 million and $65 million were recognized in net interest expense in the third quarter and first nine months of 2011, respectively, and equal and offsetting losses of $45 million and $130 million were recognized in net interest expense in the third quarter and first nine months of 2010, respectively, as adjustments to the underlying hedged item, fixed-rate debt. Ineffectiveness related to the companys cash flow and fair value hedges for the nine months ended September 30, 2011 was not material.
As of September 30, 2011, $11 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.
14
Fair Values of Derivative Instruments
The following table summarizes the classification and fair values of derivative instruments reported in the condensed consolidated balance sheet as of September 30, 2011.
(in millions) |
Derivatives in asset positions | Derivatives in liability positions | ||||||||||||||
Balance sheet location | Fair value | Balance sheet location | Fair value | |||||||||||||
Derivative instruments designated as hedges |
||||||||||||||||
Interest rate contracts |
Other long-term assets | $106 | Other long-term liabilities | $ 8 | ||||||||||||
Foreign exchange contracts |
Prepaid expenses and other | 42 |
|
Accounts payable and accrued liabilities |
|
11 | ||||||||||
Foreign exchange contracts |
Other long-term assets | 10 | Other long-term liabilities | 1 | ||||||||||||
Total derivative instruments designated as hedges |
$158 | $20 | ||||||||||||||
Undesignated derivative instruments |
||||||||||||||||
Foreign exchange contracts |
Prepaid expenses and other | $ | |
Accounts payable and accrued liabilities |
|
$ | ||||||||||
Total derivative instruments |
$158 | $20 | ||||||||||||||
The following table summarizes the classification and fair values of derivative instruments reported in the consolidated balance sheet as of December 31, 2010.
(in millions) |
Derivatives in asset positions | Derivatives in liability positions | ||||||||||||||
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 | ||||||||||||||
15
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.
(in millions) |
Balance at September 30, 2011 |
Basis of fair value measurement | ||||||||||||||
Quoted prices in (Level 1) |
Significant other (Level 2) |
Significant inputs (Level 3) |
||||||||||||||
Assets |
||||||||||||||||
Foreign currency hedges |
$ 52 | $ | $ 52 | $ | ||||||||||||
Interest rate hedges |
106 | | 106 | | ||||||||||||
Equity securities |
14 | 14 | | | ||||||||||||
Total assets |
$172 | $14 | $158 | $ | ||||||||||||
Liabilities |
||||||||||||||||
Foreign currency hedges |
$ 12 | $ | $ 12 | $ | ||||||||||||
Interest rate hedges |
8 | | 8 | | ||||||||||||
Contingent payments related to acquisitions and investments |
219 | | | 219 | ||||||||||||
Total liabilities |
$239 | $ | $ 20 | $219 | ||||||||||||
(in millions) |
Balance at |
Basis of fair value measurement | ||||||||||||||
Quoted prices in (Level 1) |
Significant other (Level 2) |
Significant inputs (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 of $10 |
86 | |||
Unrealized loss recognized in earnings |
8 | |||
Fair value as of September 30, 2011 |
$219 | |||
The unrealized loss recognized in earnings relates to liabilities held as of September 30, 2011 and is reported in cost of sales and research and development (R&D) expenses. The additions during the first nine months of 2011 principally related to the fair value of contingent payments associated with the companys second quarter acquisition of Prism and third quarter arrangement with Ceremed. Refer to Note 2 for information on the Prism acquisition and Ceremed arrangement.
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.
16
Book Values and Fair Values of Financial Instruments
In addition to the financial instruments that the company is required to recognize at fair value on the condensed consolidated balance sheets, the company has certain financial instruments that are recognized at historical cost or some basis other than fair value. For these financial instruments, the following table provides the values recognized on the condensed consolidated balance sheets and the approximate fair values as of September 30, 2011 and December 31, 2010.
(in millions) |
Book values | Approximate fair values | ||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Assets |
||||||||||||||||
Long-term insurance receivables |
$ 32 | $ 31 | $ 31 | $ 30 | ||||||||||||
Investments |
128 | 32 | 90 | 32 | ||||||||||||
Liabilities |
||||||||||||||||
Short-term debt |
87 | 15 | 87 | 15 | ||||||||||||
Current maturities of long-term debt and lease obligations |
8 | 9 | 8 | 9 | ||||||||||||
Long-term debt and lease obligations |
4,447 | 4,363 | 4,976 | 4,666 | ||||||||||||
Long-term litigation liabilities |
66 | 76 | 64 | 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 2010 and 2011, certain past due receivables with the Greek government were converted into non-interest bearing bonds with maturities of one to three years. Refer to the 2010 Annual Report for more information on the Greek governments settlement plan. As of September 30, 2011, the bonds, which are classified as held-to-maturity, had a book value and fair value of $78 million and $40 million, respectively. The first tranche of Greek government bonds, which will mature in December 2011, had a book value and fair value of $16 million and $12 million, respectively, as of September 30, 2011. The fair value of these bonds was calculated using a discounted cash flow model that incorporates observable inputs, including interest rate yields.
During the third quarter of 2011, Baxter made an $18 million investment in the common stock of Enobia Pharma Corporation, a privately-held company that develops therapies to treat serious genetic bone disorders for which there are no approved treatments, which has been classified as a cost method investment. 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 and $29 million for the three months ended September 30, 2011 and 2010, respectively, and $94 million and $92 million for the nine months ended September 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 R&D 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 and third quarters of 2011 were not material.
17
Stock Options
The weighted-average assumptions used in estimating the fair value of stock options granted during the period, along with the weighted-average grant-date fair values, were as follows.
Nine months ended September 30, | ||||
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 $23 million and $4 million during the three months ended September 30, 2011 and 2010, respectively, and was $85 million and $83 million during the nine months ended September 30, 2011 and 2010, respectively.
As of September 30, 2011, $74 million of unrecognized compensation cost related to all unvested stock options is expected to be recognized as expense over a weighted-average period of 1.8 years.
Performance Share and Restricted Stock Units
The weighted-average assumptions used in estimating the fair value of PSUs granted during the period, along with the weighted-average grant-date fair values, were as follows.
Nine months ended September 30, | ||||
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 September 30, 2011, unrecognized compensation cost related to all unvested PSUs of $32 million is expected to be recognized as expense over a weighted-average period of 1.7 years, and unrecognized compensation cost related to all unvested RSUs of $45 million is expected to be recognized as expense over a weighted-average period of 2.5 years.
Stock repurchases
As authorized by the board of directors, from time to time the company repurchases its stock depending upon the companys cash flows, net debt level and market conditions. During the three- and nine-month periods ended September 30, 2011, the company repurchased 5.5 million shares and 26.3 million shares for $298 million and $1.4 billion, respectively, under the board of directors July 2009 $2.0 billion and December 2010 $2.5 billion share repurchase authorizations. As of September 30, 2011, $1.6 billion remained available under the December 2010 authorization. There was no remaining availability under the July 2009 authorization as of September 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 September 30, 2011, the companys total recorded reserves with respect to legal matters were $239 million and the total related insurance receivables were $67 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
18
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, more than 600 lawsuits are pending 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 and in some cases McKesson Corporation (as the distributors) improperly designed, manufactured and sold large vials of propofol to these endoscopy centers. In the first three cases, juries have awarded the plaintiffs $39 million in compensatory damages and $751 million in punitive damages ($505 million against Teva, $229 million against the company and $17 million against McKesson Corporation). The company is entitled to indemnity in these matters pursuant to an indemnity agreement entered into with Teva in 2009.
19
SIGMA Litigation
In February 2010, CareFusion 303, Inc., a subsidiary of CareFusion Corporation, filed a patent infringement action against SIGMA in the U.S.D.C. for the Southern District of California. CareFusion has alleged that SIGMA Spectrum infusion pumps infringe a CareFusion force sensor patent and is seeking reasonable royalties, lost profits and an injunction to prevent the manufacture of SIGMA Spectrum infusion pumps. In October 2011, SIGMA filed motions for summary judgment with respect to the infringement and lost profits claims. A trial is scheduled for January 2012.
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 alleged violations of the Employee Retirement Income Security Act of 1974, as amended. Plaintiff alleged 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 October 2011, the parties agreed to a non-monetary settlement ending the litigation.
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 and certain current and former executive officers. 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. These suits have been consolidated for further proceedings.
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, as subsequently amended, alleges that, from June 10, 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. An additional suit has 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 and 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.
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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, including a qui tam action which was settled and fully reserved for in September 2011.
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 engaged in an internal review of its historical price reporting submissions during the period of 2008 through 2010. As a result of this review, the company is making certain historical rebate and discount adjustments and expects to submit these adjustments in the fourth quarter of 2011. Such adjustments are reflected in the charge recorded by the company in the third quarter. The company has also 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 and has produced documents and information in each case, there can be no assurance that the scope of either matter will not be expanded or that either matter will not result in civil or criminal penalties or otherwise adversely affect the companys business, financial condition or results of operations.
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. multi-source 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.
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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 AWP litigation and historical price reporting charge, 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, Note 6 for further information regarding the AWP litigation and historical price reporting 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 third quarter and first nine months of 2010 was an impairment charge of $112 million associated with the divestiture of the U.S. multi-source generic injectables business. Included in the Medical Products segments net sales and pre-tax income in the first nine months of 2010 was a first quarter charge of $588 million (with $213 million recorded as a reduction of net sales and $375 million recorded in cost of sales) related to the recall of COLLEAGUE infusion pumps from the U.S. market. Refer to Note 2 for further information regarding the divestiture and Note 3 for further information regarding the COLLEAGUE infusion pump charge.
Financial information for the companys segments is as follows.
Three months
ended September 30, |
Nine months
ended September 30, |
|||||||||||||||
(in millions) | 2011 | 2010 | 2011 | 2010 | ||||||||||||
Net sales |
||||||||||||||||
BioScience |
$1,517 | $1,387 | $ 4,478 | $4,107 | ||||||||||||
Medical Products |
1,950 | 1,824 | 5,791 | 5,201 | ||||||||||||
Transition services to Fenwal |
12 | 13 | 30 | 37 | ||||||||||||
Total |
$3,479 | $3,224 | $10,299 | $9,345 | ||||||||||||
Pre-tax income |
||||||||||||||||
BioScience |
$ 584 | $ 569 | $ 1,784 | $1,638 | ||||||||||||
Medical Products |
403 | 238 | 1,157 | 353 | ||||||||||||
Total pre-tax income from segments |
$ 987 | $ 807 | $ 2,941 | $1,991 | ||||||||||||
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 September 30, |
Nine months
ended September 30, |
|||||||||||||||
(in millions) | 2011 | 2010 | 2011 | 2010 | ||||||||||||
Total pre-tax income from segments |
$987 | $807 | $2,941 | $1,991 | ||||||||||||
Unallocated amounts |
||||||||||||||||
Stock compensation |
(33 | ) | (29 | ) | (94 | ) | (92 | ) | ||||||||
Net interest expense |
(14 | ) | (24 | ) | (39 | ) | (68 | ) | ||||||||
Certain foreign currency fluctuations and hedging activities |
(5 | ) | 17 | (21 | ) | 36 | ||||||||||
AWP litigation and historical price reporting charge |
(79 | ) | | (79 | ) | | ||||||||||
Greece receivable charge |
| | | (28 | ) | |||||||||||
Other Corporate items |
(129 | ) | (130 | ) | (447 | ) | (416 | ) | ||||||||
Income before income taxes |
$727 | $641 | $2,261 | $1,423 | ||||||||||||
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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 nine months ended September 30, 2011.
RESULTS OF OPERATIONS
NET SALES
Three months ended September 30, |
Percent change |
Nine months
ended September 30, |
Percent change |
|||||||||||||||||||||
(in millions) | 2011 | 2010 | 2011 | 2010 | ||||||||||||||||||||
BioScience |
$1,517 | $1,387 | 9% | $4,478 | $4,107 | 9% | ||||||||||||||||||
Medical Products |
1,950 | 1,824 | 7% | 5,791 | 5,201 | 11% | ||||||||||||||||||
Transition services to Fenwal Inc. |
12 | 13 | (8% | ) | 30 | 37 | (19% | ) | ||||||||||||||||
Total net sales |
$3,479 | $3,224 | 8% | $10,299 | $9,345 | 10% | ||||||||||||||||||
Three months ended September 30, |
Percent change |
Nine months
ended September 30, |
Percent change |
|||||||||||||||||||||
(in millions) | 2011 | 2010 | 2011 | 2010 | ||||||||||||||||||||
International |
$2,076 | $1,835 | 13% | $6,056 | $5,521 | 10% | ||||||||||||||||||
United States |
1,403 | 1,389 | 1% | 4,243 | 3,824 | 11% | ||||||||||||||||||
Total net sales |
$3,479 | $3,224 | 8% | $10,299 | $9,345 | 10% | ||||||||||||||||||
Foreign currency favorably impacted net sales by 5 and 3 percentage points in the three- and nine-month periods ended September 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 nine months 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 total net sales growth in the nine-month period ended September 30, 2011 by 2 percentage points. Refer to Note 3 for further information regarding the COLLEAGUE infusion pump charge.
Additionally, included in net sales in the Medical Products segment are sales of $57 million in the third quarter of 2010 and $58 million and $143 million in the nine months ended September 30, 2011 and 2010, respectively, related to the U.S. multi-source generic injectables business, which was divested by the company in May 2011. The divestiture of this business unfavorably impacted total net sales growth by 2 and 1 percentage points in the three- and nine-month periods ended September 30, 2011, respectively. Refer to Note 2 for further information regarding this divestiture.
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BioScience
The following is a summary of sales by product category in the BioScience segment.
Three months ended September 30, |
Percent change |
Nine months ended September 30, |
Percent change |
|||||||||||||||||||||
(in millions) | 2011 | 2010 | 2011 | 2010 | ||||||||||||||||||||
Recombinants |
$ 552 | $ 526 | 5% | $1,634 | $1,561 | 5% | ||||||||||||||||||
Plasma Proteins |
372 | 346 | 8% | 1,043 | 952 | 10% | ||||||||||||||||||
Antibody Therapy |
380 | 336 | 13% | 1,135 | 968 | 17% | ||||||||||||||||||
Regenerative Medicine |
143 | 130 | 10% | 430 | 382 | 13% | ||||||||||||||||||
Other |
70 | 49 | 43% | 236 | 244 | (3% | ) | |||||||||||||||||
Total net sales |
$1,517 | $1,387 | 9% | $4,478 | $4,107 | 9% | ||||||||||||||||||
Net sales in the BioScience segment increased 9% during both the three- and nine-month periods ended September 30, 2011 (including a 5 and 3 percentage point benefit from foreign currency in the three- and nine-month periods ended September 30, 2011, respectively). Excluding the benefit of foreign currency, the principal drivers were the following:
| For the Recombinants product category, sales in both periods benefited from improved sales of recombinant therapies in the United States, but were unfavorably impacted by lower sales in Europe and lower tender-related sales in the United Kingdom and Australia. |
| 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, partially offset by lower U.S. sales of albumin in the third quarter of 2011 as a result of supply constraints. |
| Sales growth in the Antibody Therapy product category 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 demand and incremental volume resulting from a competitor being out of the market during the first nine months of 2011. |
| In the Regenerative Medicine product category, sales growth in both periods was driven by increased sales of the fibrin sealant products FLOSEAL and TISSEEL. U.S. sales of ACTIFUSE (a product obtained with the acquisition of ApaTech in the first quarter of 2010) were negatively impacted during the third quarter of 2011 by a temporary disruption resulting from the planned transition to a direct sales model from ApaTechs former distributor model, which partially offset sales growth in both periods. |
| In the third quarter of 2011, sales in the Other product category increased due to strong international demand for FSME-IMMUN (a tick-borne encephalitis vaccine) and revenues associated with the companys development, license, and technology transfer agreement with Takeda Pharmaceutical Company Limited. In the nine-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. |
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Medical Products
The following is a summary of sales by product category in the Medical Products segment.
Three months ended September 30, |
Percent change |
Nine months ended September 30, |
Percent change |
|||||||||||||||||||||
(in millions) | 2011 | 2010 | 2011 | 2010 | ||||||||||||||||||||
Renal |
$ 646 | $ 594 | 9% | $1,866 | $1,763 | 6% | ||||||||||||||||||
Global Injectables |
494 | 469 | 5% | 1,517 | 1,392 | 9% | ||||||||||||||||||
IV Therapies |
453 | 417 | 9% | 1,333 | 1,226 | 9% | ||||||||||||||||||
Infusion Systems |
222 | 213 | 4% | 666 | 425 | 57% | ||||||||||||||||||
Anesthesia |
129 | 127 | 2% | 390 | 384 | 2% | ||||||||||||||||||
Other |
6 | 4 | 40% | 19 | 11 | 73% | ||||||||||||||||||
Total net sales |
$1,950 | $1,824 | 7% | $5,791 | $5,201 | 11% | ||||||||||||||||||
Net sales in the Medical Products segment increased 7% and 11% during the three- and nine-month periods ended September 30, 2011, respectively (including a 6 and 4 percentage point benefit from foreign currency in the three- and nine-month periods ended September 30, 2011, respectively). Excluding the benefit of foreign currency, the principal drivers were the following:
| In the Renal product category, growth in the number of peritoneal dialysis (PD) patients globally was partially offset, for both periods, by PD patient losses in the United States to another service provider and lower sales of hemodialysis products. |
| Within the Global Injectables product category, the divestiture of the U.S. multi-source generic injectables business unfavorably impacted total net sales growth by 14 and 7 percentage points in the three- and nine-month periods ended September 30, 2011, respectively. Refer to Note 2 for further information regarding this divestiture. Excluding the impact of this divestiture, 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 injectable drugs. |
| Intravenous (IV) Therapies sales growth in both periods was driven by increased demand for IV solutions and sales for nutritional products. |
| In the Infusion Systems product category, sales growth in the third quarter and first nine months of 2011 reflected increased sales of the Sigma International General Medical Apparatus, LLC (SIGMA) Spectrum infusion pumps, partially offset by lower global sales of access sets in the third quarter. Sales growth in the nine-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. |
| Within the Anesthesia product category, sales in both periods were unfavorably impacted by lower demand for inhaled anesthetics in the United States resulting from declines in surgical procedures in the marketplace, as well as competitive pricing pressures for generic sevoflurane. These factors were partially offset by continued expansion in international markets. |
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.
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GROSS MARGIN AND EXPENSE RATIOS
Three months ended September 30, |
Change |
Nine months ended September 30, |
Change |
|||||||||||||||||||||
(as a percentage of net sales) | 2011 | 2010 | 2011 | 2010 | ||||||||||||||||||||
Gross margin |
50.9% | 51.5% | (0.6 pts | ) | 51.3% | 46.4% | 4.9 pts | |||||||||||||||||
Marketing and administrative expenses |
22.6% | 20.8% | 1.8 pts | 22.0% | 22.2% | (0.2 pts | ) | |||||||||||||||||
Gross Margin
The gross margin percentage decreased during the third quarter of 2011 and increased during the first nine months of 2011. In the third quarter of 2011, the unfavorable impacts of foreign currency and costs associated with manufacturing issues at the companys Castlebar, Ireland facility were partially offset by sales growth of select higher margin products in the BioScience and Medical Products segments and improved margins for plasma-based therapies.
During the first nine months of 2011, the improvement in the gross margin percentage was primarily driven by the $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 percentage by 5.2 percentage points. Also contributing to the improvement was sales growth of select higher margin products in the BioScience and Medical Products segments, as well as the impact of cost inefficiencies and increased inventory reserves related to vaccine products in the prior year, which unfavorably impacted the gross margin percentage in the first nine months of 2010. These items were partially offset by costs associated with manufacturing issues at the Castlebar, Ireland facility.
Marketing and Administrative Expenses
The marketing and administrative expense ratio in both the third quarter and first nine months of 2011 included the third quarter 2011 charge of $79 million related to the resolution of litigation pertaining to average wholesale prices (AWP) and certain rebate and discount adjustments related to historical price reporting submissions, which unfavorably impacted the marketing and administrative expense ratio by 2.2 and 0.7 percentage points for the third quarter and first nine months of 2011, respectively. Additionally, the marketing and administrative expense ratio in the first nine months of 2010 included the first quarter 2010 charge to net sales related to the recall of COLLEAGUE infusion pumps and the second quarter 2010 charge to write down accounts receivable in Greece, which, in total, unfavorably impacted the marketing and administrative expense ratio by 0.8 percentage points in the first nine months of 2010.
The ratio in both periods was favorably impacted by leverage from higher sales and the companys continued focus on controlling discretionary spending, offset by increased spending related to certain marketing and promotional programs and increased pension expense.
Refer to Note 6 for further information regarding the AWP litigation and historical price reporting charge, Note 4 for further information regarding the Greece receivable charge, and Note 3 for further information regarding the COLLEAGUE infusion pump charge.
RESEARCH AND DEVELOPMENT
Three months
ended September 30, |
Percent change |
Nine months
ended September 30, |
Percent change |
|||||||||||||||||||||
(in millions) | 2011 | 2010 | 2011 | 2010 | ||||||||||||||||||||
Research and development expenses |
$239 | $207 | 15% | $692 | $653 | 6% | ||||||||||||||||||
As a percentage of net sales |
6.9% | 6.4% | 6.7% | 7.0% | ||||||||||||||||||||
Research and development (R&D) expenses increased in the third quarter and first nine months of 2011, as the company continues to invest in a number of late-stage 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 0.2 percentage points in the prior year. Refer to the 2010 Annual Report for a discussion of the companys R&D pipeline.
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NET INTEREST EXPENSE
Net interest expense was $14 million and $24 million in the third quarters of 2011 and 2010, respectively, and $39 million and $68 million in the first nine months 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.
OTHER EXPENSE, NET
Other expense, net was $4 million and $117 million in the third quarters of 2011 and 2010, respectively, and $21 million and $122 million during the first nine months 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. Included in other expense, net in 2010 was a third quarter impairment charge of $112 million associated with the companys divestiture of its U.S. multi-source generic injectables business, which was subsequently completed in May 2011. Refer to Note 2 for further information regarding this divestiture.
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 3% and 9% for the third quarter and first nine months of 2011, respectively. In both periods, the impact from sales growth for certain higher margin products and improved margins on plasma-based therapies were partially offset by an increase in spending on new marketing and promotional programs. Also contributing to the increase in pre-tax income for both periods was a prior year increase in inventory reserves related to vaccine products, which unfavorably impacted pre-tax income in the three- and nine-month periods ended September 30, 2010.
Medical Products
Pre-tax income increased 69% in the third quarter of 2011. Pre-tax income in the first nine months of 2011 was $1.2 billion, compared to $353 million in the first nine months 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 and the third quarter 2010 U.S. multi-source generic injectables business impairment charge of $112 million. Pre-tax income in both the third quarter and the first nine months of 2011 benefited from sales growth for certain higher margin products, which was partially offset by increased R&D spending and costs associated with manufacturing issues at the companys Castlebar, Ireland facility.
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 AWP litigation and historical price reporting charge, 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 for further information regarding stock compensation expense, Note 6 for further information regarding the AWP litigation and historical price reporting charge, 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 20.5% and 18.3% in the third quarters of 2011 and 2010, respectively, and 21.1% and 29.7% for the nine months ended September 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
27
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 third quarter of 2011 was primarily due to the tax benefit from the third quarter 2010 impairment charge of $112 million associated with the divestiture of the U.S. multi-source generic injectables business. The effective income tax rate also increased due to a change in the earnings mix from lower to higher tax rate jurisdictions compared to the prior year period and an increase in a tax reserve associated with one of the companys joint ventures. This increase was partially offset by the tax benefit from the $79 million charge in the third quarter of 2011 related to the resolution of litigation pertaining to AWP and certain rebate and discount adjustments related to historical price reporting submissions.
The decrease in the effective income tax rate in the nine months ended September 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. This decrease was partially offset by the tax benefit from the third quarter 2010 U.S. multi-source generic injectables business impairment charge.
The company anticipates that the effective tax rate for the full-year 2011 will approximate 21.5%, excluding the impact of audit developments and other special items.
Refer to Note 2 for further information regarding the U.S. multi-source generic injectables business divestiture, Note 6 for further information regarding the AWP litigation and historical price reporting charge, and Note 3 for further information regarding the COLLEAGUE infusion pump charge.
INCOME AND EARNINGS PER DILUTED SHARE
Net income attributable to Baxter was $576 million and $525 million for the three months ended September 30, 2011 and 2010, respectively, and $1.8 billion and $997 million for the nine months ended September 30, 2011 and 2010, respectively. Net income attributable to Baxter per diluted share was $1.01 and $0.89 for the three months ended September 30, 2011 and 2010, respectively, and $3.06 and $1.67 for the nine months ended September 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 5.5 million and 26.3 million shares during the third quarter and first nine months 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 during the first nine months of 2011 as compared to the prior year, totaling $1.9 billion in 2011 and $2.1 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 nine months of 2011 as compared to the prior year. Days sales outstanding decreased from 56.2 days at September 30, 2010 to 54.5 days at September 30, 2011, with the impact of longer collection periods more than offset by the favorable impact from foreign currency. Outstanding receivables from customers outside of the United States were approximately 80% of total accounts receivable at both September 30, 2011 and December 31, 2010.
28
Inventories
Cash outflows relating to inventories increased in 2011 as compared to the prior year. The following is a summary of inventories as of September 30, 2011 and December 31, 2010, as well as annualized inventory turns for the three months ended September 30, 2011 and 2010, by segment.
Inventories | Annualized inventory turns for the three months ended September 30, |
|||||||||||||||
(in millions, except inventory turn data) |
September 30, | December 31, | ||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
BioScience |
$1,617 | $1,455 | 1.50 | 1.33 | ||||||||||||
Medical Products |
1,004 | 914 | 4.07 | 4.19 | ||||||||||||
Other |
| 2 | | | ||||||||||||
Total company |
$2,621 | $2,371 | 2.48 | 2.39 | ||||||||||||
The increase in inventories in the first nine months 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 $62 million in the first nine months of 2010 to $258 million in the first nine months 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 $200 million in the first nine months of 2010 to $38 million in the first nine months of 2011, principally due to lower discretionary pension contributions to the U.S. pension plan and cash inflows related to the termination of interest rate swaps.
Cash flows from investing activities
Capital Expenditures
Capital expenditures decreased $56 million for the nine months ended September 30, 2011, from $699 million in 2010 to $643 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 $229 million in the first nine months 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 nine months 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). Additionally, cash outflows in the first nine months of 2011 included an $18 million investment in the common stock of Enobia Pharma Corporation and a $10 million payment related to the arrangement with Ceremed, Inc. (Ceremed). Refer to Note 2 for further information about the Prism acquisition, the DEKA agreement, and the Ceremed arrangement.
Cash outflows relating to acquisitions and investments of $274 million in the first nine months 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. Additionally, in the third quarter of 2010, Baxter made a $20 million payment related to a manufacturing, supply and distribution agreement with Kamada Ltd. for GLASSIA [Alpha1-Proteinase Inhibitor (Human)], the only liquid alpha1-proteinase inhibitor, for the exclusive distribution rights in the Unites States and other select markets.
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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. multi-source 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 inflows related to debt and other financing obligations totaled $70 million in the first nine months of 2011, as compared to net cash inflows of $589 million in the first nine months of 2010. During the third quarter of 2011, the company issued and redeemed commercial paper, of which $75 million was outstanding as of September 30, 2011, with a weighted-average interest rate of 0.14%. 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 $534 million and $519 million in the first nine months 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 July 2011, the board of directors declared a quarterly dividend of $0.31 per share, which was paid 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 $136 million, from $269 million in the first nine months of 2010 to $405 million in the first nine months 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 $17 million and $35 million in the first nine months 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 $1.4 billion and $1.3 billion in the first nine months of 2011 and 2010, respectively. As authorized by the board of directors, from time to time the company repurchases its stock depending upon the companys cash flows, net debt level and market conditions. In July 2009 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 September 30, 2011, $1.6 billion 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 prior 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 $410 million at September 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 September 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 September 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 $2.3 billion of cash and equivalents at September 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
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positions fluctuate, a significant portion of the companys cash and equivalents is 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 the demand for the companys products or the solvency of its customers or suppliers materially declines, the companys key financial ratios or credit ratings deteriorate or other significantly unfavorable changes in conditions occur. 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 was 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 and 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 nine months 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 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 nine 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 2010, the U.S. Food and Drug Administration (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. As discussed in Note 3, 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. It is possible that substantial additional cash and non-cash charges, including significant asset impairments related to the COLLEAGUE infusion pumps and
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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. Refer to Certain Regulatory Matters in the Managements Discussion and Analysis of Financial Condition and Results of Operations section in the companys Annual Report on Form 10-K for the year ended December 31, 2010 for more information regarding the COLLEAGUE matter.
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. In September 2011, the Committee for Medicinal Products for Human Use issued a positive opinion on the actions the company has taken to resolve the matter and recommended to the EMA that the respective Article 31 Referral Procedure of the EU Commission be closed. The company continues to supply the European Union with these products through other Baxter manufacturing facilities.
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.
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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 Baxa acquisition, 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:
| demand for and market acceptance risks for new and existing products, such as ADVATE and plasma-based therapies (including Antibody Therapy), and other therapies; |
| fluctuations in supply and demand and the pricing of plasma-based therapies; |
| healthcare reform legislation in the United States including its effect on pricing, reimbursement, taxation and rebate policies; |
| future actions of governmental authorities and other third parties including third party payers as healthcare reform legislation and other similar measures are implemented in the United States and globally; |
| additional legislation, regulation and other governmental pressures in the United States or globally, which may affect pricing, reimbursement, taxation and rebate policies of government agencies and private payers or other elements of the company's business; |
| the companys ability to identify business development and growth opportunities for new and existing products; |
| product quality or patient safety issues, leading to product recalls, withdrawals, launch delays, sanctions, seizures, litigation, or declining sales; |
| future actions of the FDA, 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; |
| implementation of the FDAs final July 2010 order to recall all of the companys COLLEAGUE infusion pumps currently in use in the United States as well as any additional actions required globally; |
| the companys ability to fulfill demand for SIGMAs Spectrum infusion pump; |
| foreign currency fluctuations, particularly due to reduced benefits from the companys natural hedges and limitations on the ability to cost-effectively hedge resulting from financial market and currency volatility; |
| product development risks, including satisfactory clinical performance, the ability to manufacture at appropriate scale, and the general unpredictability associated with the product development cycle; |
| the ability to enforce the companys patent rights or patents of third parties preventing or restricting the companys manufacture, sale or use of affected products or technology; |
| the impact of geographic and product mix on the companys sales; |
| the impact of competitive products and pricing, including generic competition, drug reimportation and disruptive technologies; |
| inventory reductions or fluctuations in buying patterns by wholesalers or distributors; |
| the availability and pricing of acceptable raw materials and component supply; |
| global regulatory, trade and tax policies; |
| any changes in law concerning the taxation of income, including income earned outside the United States; |
| actions by tax authorities in connection with ongoing tax audits; |
| the companys ability to realize the anticipated benefits of restructuring and optimization initiatives; |
| the successful implementation of the companys global enterprise resource planning system; |
| the companys ability to realize the anticipated benefits from its joint product development and commercialization arrangements, including the SIGMA transaction; |
| changes in credit agency ratings; |
| any impact of the commercial and credit environment on the company and its customers and suppliers; and |
| other factors identified elsewhere in this report and other filings with the Securities and Exchange Commission, including those factors described 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.
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Item 3. Quantitative and Qualitative Disclosures about Market Risk
Currency Risk
The company is primarily exposed to foreign exchange risk with respect to recognized assets and liabilities, forecasted transactions and net assets denominated in the Euro, Japanese Yen, British Pound, Australian Dollar, Canadian Dollar, Brazilian Real and Colombian Peso. The company manages its foreign currency exposures on a consolidated basis, which allows the company to net exposures and take advantage of any natural offsets. In addition, the company uses derivative and nonderivative financial instruments to further reduce the net exposure to foreign exchange. Gains and losses on the hedging instruments offset losses and gains on the hedged transactions and reduce the earnings and shareholders equity volatility relating to foreign exchange. Financial market and currency volatility may reduce the benefits of the companys natural hedges and limit the companys ability to cost-effectively hedge these exposures.
The company uses options 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 September 30, 2011 is 15 months. The company also uses derivative instruments to hedge certain intercompany and third-party receivables and payables and debt denominated in foreign currencies.
Currency restrictions enacted in Venezuela require Baxter to obtain approval from the Venezuelan government to exchange Venezuelan Bolivars for U.S. Dollars and requires such exchange to be made at the official exchange rate established by the government. On January 8, 2010, the Venezuelan government devalued the official exchange rate 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 September 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 $25 million with respect to those contracts would decrease by $46 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 September 30, 2011 by replacing the actual exchange rates at September 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 September 30, 2011.
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Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Baxter carried out an evaluation, under the supervision and with the participation of its Disclosure Committee and management, including the Chief Executive Officer and Chief Financial Officer, of the effectiveness of Baxters disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the Exchange Act)) as of September 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 September 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 September 30, 2011 that have materially affected, or are reasonably likely to materially affect, Baxters internal control over financial reporting.
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Review by Independent Registered Public Accounting Firm
A review of the interim condensed consolidated financial information included in this Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2011 and 2010 has 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.
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Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders of Baxter International Inc.:
We have reviewed the accompanying condensed consolidated balance sheet of Baxter International Inc. and its subsidiaries as of September 30, 2011, and the related condensed consolidated statements of income for each of the three- and nine-month periods ended September 30, 2011 and 2010 and the condensed consolidated statements of cash flows for the nine-month periods ended September 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
November 2, 2011
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The information in Part I, Item 1, Note 6 is incorporated herein by reference.
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
The following table includes information about the companys common stock repurchases during the three-month period ended September 30, 2011.
Issuer Purchases of Equity Securities
Period |
Total number of
shares |
Average price paid per share |
Total number of shares purchased as part of publicly announced program(1) |
Approximate dollar value of shares that may yet be purchased under the program(1) |
||||||||||||
July 1, 2011 through July 31, 2011 |
| | | |||||||||||||
August 1, 2011 through August 31, 2011 |
3,783,500 | $53.13 | 3,783,500 | |||||||||||||
September 1, 2011 through |
1,759,604 | $54.88 | 1,759,604 | |||||||||||||
Total |
5,543,104 | $53.69 | 5,543,104 | $1,583,499,030 | ||||||||||||
(1) | 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 third quarter of 2011, the company repurchased approximately 5.5 million shares for $298 million under this program. This program does not have an expiration date. |
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Exhibit Index:
Exhibit Number |
Description | |
15 | Letter Re Unaudited Interim Financial Information | |
31.1 | Certification of Chief Executive Officer Pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934 | |
31.2 | Certification of Chief Financial Officer Pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934 | |
32.1 | Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350 | |
32.2 | Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350 | |
101.INS | XBRL Instance Document | |
101.SCH | XBRL Taxonomy Extension Schema Document | |
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | |
101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | |
101.LAB | XBRL Taxonomy Extension Label Linkbase Document | |
101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document |
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
BAXTER INTERNATIONAL INC. | ||||||
(Registrant) | ||||||
Date: November 2, 2011 | By: | /s/ Robert J. Hombach | ||||
Robert J. Hombach | ||||||
Corporate Vice President and Chief Financial Officer (duly authorized officer and principal financial officer) |
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