10-Q
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, 2008
|
|
|
o |
|
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 o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
|
|
|
|
|
|
|
Large accelerated filer þ |
|
Accelerated filer o |
|
Non-accelerated filer o (Do not check if a smaller reporting company) |
|
Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
The number of shares of the registrants Common Stock, par value $1.00 per share, outstanding as of
October 28, 2008 was 620,171,069 shares.
BAXTER INTERNATIONAL INC.
FORM 10-Q
For the quarterly period ended September 30, 2008
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Baxter International Inc.
Condensed Consolidated Statements of Income (unaudited)
(in millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
Net sales |
|
$ |
3,151 |
|
|
$ |
2,750 |
|
|
$ |
9,217 |
|
|
$ |
8,254 |
|
Costs and expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
1,630 |
|
|
|
1,374 |
|
|
|
4,689 |
|
|
|
4,220 |
|
Marketing and administrative expenses |
|
|
681 |
|
|
|
663 |
|
|
|
2,024 |
|
|
|
1,867 |
|
Research and development expenses |
|
|
230 |
|
|
|
203 |
|
|
|
642 |
|
|
|
539 |
|
Restructuring charge |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
70 |
|
Net interest expense |
|
|
20 |
|
|
|
6 |
|
|
|
62 |
|
|
|
10 |
|
Other expense, net |
|
|
32 |
|
|
|
21 |
|
|
|
36 |
|
|
|
28 |
|
|
Total costs and expenses |
|
|
2,593 |
|
|
|
2,267 |
|
|
|
7,453 |
|
|
|
6,734 |
|
|
Income before income taxes |
|
|
558 |
|
|
|
483 |
|
|
|
1,764 |
|
|
|
1,520 |
|
Income tax expense |
|
|
86 |
|
|
|
88 |
|
|
|
319 |
|
|
|
291 |
|
|
Net income |
|
$ |
472 |
|
|
$ |
395 |
|
|
$ |
1,445 |
|
|
$ |
1,229 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.76 |
|
|
$ |
0.62 |
|
|
$ |
2.30 |
|
|
$ |
1.90 |
|
|
Diluted |
|
$ |
0.74 |
|
|
$ |
0.61 |
|
|
$ |
2.26 |
|
|
$ |
1.87 |
|
|
Weighted average number of common
shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
625 |
|
|
|
641 |
|
|
|
628 |
|
|
|
647 |
|
|
Diluted |
|
|
638 |
|
|
|
651 |
|
|
|
640 |
|
|
|
657 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividends declared per common
share |
|
$ |
0.218 |
|
|
$ |
0.168 |
|
|
$ |
0.653 |
|
|
$ |
0.503 |
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
Baxter International Inc.
Condensed Consolidated Balance Sheets (unaudited)
(in millions, except shares)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
|
|
2008 |
|
|
2007 |
|
|
Current assets |
|
Cash and equivalents |
|
$ |
2,191 |
|
|
$ |
2,539 |
|
|
|
Accounts and other current receivables |
|
|
2,101 |
|
|
|
2,026 |
|
|
|
Inventories |
|
|
2,520 |
|
|
|
2,334 |
|
|
|
Other current assets |
|
|
625 |
|
|
|
656 |
|
|
|
|
|
|
Total current assets |
|
|
7,437 |
|
|
|
7,555 |
|
|
Property, plant and equipment, net |
|
|
4,598 |
|
|
|
4,487 |
|
|
Other assets |
|
Goodwill |
|
|
1,703 |
|
|
|
1,690 |
|
|
|
Other intangible assets, net |
|
|
417 |
|
|
|
455 |
|
|
|
Other |
|
|
1,054 |
|
|
|
1,107 |
|
|
|
|
|
|
Total other assets |
|
|
3,174 |
|
|
|
3,252 |
|
|
Total assets |
|
$ |
15,209 |
|
|
$ |
15,294 |
|
|
Current liabilities |
|
Short-term debt |
|
$ |
230 |
|
|
$ |
45 |
|
|
|
Current maturities of long-term debt and
lease obligations |
|
|
5 |
|
|
|
380 |
|
|
|
Accounts payable and accrued liabilities |
|
|
3,089 |
|
|
|
3,387 |
|
|
|
|
|
|
Total current liabilities |
|
|
3,324 |
|
|
|
3,812 |
|
|
Long-term debt and lease obligations |
|
|
3,185 |
|
|
|
2,664 |
|
|
Other long-term liabilities |
|
|
1,641 |
|
|
|
1,902 |
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
Shareholders equity |
|
Common stock, $1 par value, authorized
2,000,000,000 shares, issued 683,494,944 shares
in 2008 and 2007 |
|
|
683 |
|
|
|
683 |
|
|
|
Common stock in treasury, at cost,
60,665,621 shares in 2008 and 49,857,061
shares in 2007 |
|
|
(3,491 |
) |
|
|
(2,503 |
) |
|
|
Additional contributed capital |
|
|
5,418 |
|
|
|
5,297 |
|
|
|
Retained earnings |
|
|
5,415 |
|
|
|
4,379 |
|
|
|
Accumulated other comprehensive loss |
|
|
(966 |
) |
|
|
(940 |
) |
|
|
|
|
|
Total shareholders equity |
|
|
7,059 |
|
|
|
6,916 |
|
|
Total liabilities and shareholders equity |
|
$ |
15,209 |
|
|
$ |
15,294 |
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
Baxter International Inc.
Condensed Consolidated Statements of Cash Flows (unaudited)
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
September 30, |
|
|
|
|
|
2008 |
|
|
2007 |
|
|
Cash flows from operating activities |
|
Net income |
|
$ |
1,445 |
|
|
$ |
1,229 |
|
|
|
Adjustments |
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
481 |
|
|
|
428 |
|
|
|
Deferred income taxes |
|
|
164 |
|
|
|
32 |
|
|
|
Stock compensation |
|
|
111 |
|
|
|
99 |
|
|
|
Restructuring and infusion pump charges |
|
|
125 |
|
|
|
70 |
|
|
|
Impairment charge |
|
|
31 |
|
|
|
|
|
|
|
Average wholesale pricing litigation charge |
|
|
|
|
|
|
56 |
|
|
|
In-process research and development charges |
|
|
12 |
|
|
|
46 |
|
|
|
Other |
|
|
27 |
|
|
|
53 |
|
|
|
Changes in balance sheet items |
|
|
|
|
|
|
|
|
|
|
Accounts and other current receivables |
|
|
(86 |
) |
|
|
(114 |
) |
|
|
Inventories |
|
|
(207 |
) |
|
|
(261 |
) |
|
|
Accounts payable and accrued liabilities |
|
|
(236 |
) |
|
|
(85 |
) |
|
|
Restructuring payments |
|
|
(35 |
) |
|
|
(20 |
) |
|
|
Other |
|
|
63 |
|
|
|
21 |
|
|
|
|
|
|
Cash flows from operating activities |
|
|
1,895 |
|
|
|
1,554 |
|
|
Cash flows from investing activities |
|
Capital expenditures |
|
|
(615 |
) |
|
|
(424 |
) |
|
|
Acquisitions of and investments in businesses
and technologies |
|
|
(73 |
) |
|
|
(83 |
) |
|
|
Divestitures and other |
|
|
45 |
|
|
|
490 |
|
|
|
|
|
|
Cash flows from investing activities |
|
|
(643 |
) |
|
|
(17 |
) |
|
Cash flows from financing activities |
|
Issuances of debt |
|
|
518 |
|
|
|
73 |
|
|
|
Payments of obligations |
|
|
(942 |
) |
|
|
(501 |
) |
|
|
Increase in debt with original maturities of
three months or less, net |
|
|
192 |
|
|
|
|
|
|
|
Cash dividends on common stock |
|
|
(411 |
) |
|
|
(598 |
) |
|
|
Proceeds and excess tax benefits from
stock issued under employee benefit plans |
|
|
547 |
|
|
|
500 |
|
|
|
Purchases of treasury stock |
|
|
(1,522 |
) |
|
|
(1,641 |
) |
|
|
|
|
|
Cash flows from financing activities |
|
|
(1,618 |
) |
|
|
(2,167 |
) |
|
Effect of currency exchange rate changes on cash and equivalents |
|
|
18 |
|
|
|
(37 |
) |
|
Decrease in cash and equivalents |
|
|
(348 |
) |
|
|
(667 |
) |
Cash and equivalents at beginning of period |
|
|
2,539 |
|
|
|
2,485 |
|
|
Cash and equivalents at end of period |
|
$ |
2,191 |
|
|
$ |
1,818 |
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
Baxter International Inc.
Notes to Condensed Consolidated Financial Statements (unaudited)
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The unaudited interim condensed consolidated financial statements of Baxter International Inc. and
its subsidiaries (the company or Baxter) have been prepared pursuant to the rules and regulations
of the Securities and Exchange Commission (SEC). Accordingly, certain information and footnote
disclosures normally included in financial statements prepared in accordance with generally
accepted accounting principles in the United States have been condensed or omitted. These interim
condensed consolidated financial statements should be read in conjunction with the consolidated
financial statements and notes included in the companys 2007 Annual Report to Shareholders (2007
Annual Report).
In the opinion of management, the interim condensed consolidated financial statements reflect all
adjustments necessary for a fair presentation of the interim periods. All such adjustments,
unless otherwise noted herein, are of a normal, recurring nature. The results of operations for
the interim period are not necessarily indicative of the results of operations to be expected for
the full year.
Adoption of new accounting standards
SFAS No. 159
On January 1, 2008, the company adopted Statement of Financial Accounting Standards (SFAS) No.
159, The Fair Value Option for Financial Assets and Financial Liabilities, Including an amendment
of FASB Statement No. 115 (SFAS No. 159). SFAS No. 159 permits entities to choose to measure
many financial instruments and certain other items at fair value, which are not otherwise
currently required to be measured at fair value. Under SFAS No. 159, the decision to measure
items at fair value is made at specified election dates on an instrument-by-instrument basis and
is irrevocable. Entities electing the fair value option are required to recognize changes in fair
value in earnings and to expense upfront costs and fees associated with the item for which the
fair value option is elected. The new standard did not impact the companys consolidated
financial statements as the company did not elect the fair value option for any instruments
existing as of the adoption date. However, the company will evaluate the fair value measurement
election with respect to financial instruments the company enters into in the future.
Issued but not yet effective accounting standards
SFAS No. 161
In March 2008, the Financial Accounting Standards Board (FASB) issued SFAS No. 161, Disclosures
about Derivative Instruments and Hedging Activities, an amendment of FASB Statement No. 133 (SFAS
No. 161). The standard expands the disclosure requirements of SFAS No. 133, Accounting for
Derivative Instruments and Hedging Activities, and requires qualitative disclosures about the
objectives and strategies for using derivatives, quantitative disclosures about the fair value
amounts of and gains and losses on derivative instruments, and disclosures about
credit-risk-related contingent features in derivative agreements. The company is in the process of
analyzing this new standard, which will be effective for disclosures made by the company in the
first quarter of 2009.
SFAS No. 160
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated Financial
Statements, an amendment of ARB No. 51 (SFAS No. 160). The new standard changes the accounting
and reporting of noncontrolling interests, which have historically been referred to as minority
interests. SFAS No. 160 requires that noncontrolling interests be presented in the consolidated
balance sheets within shareholders equity, but separate from the parents equity, and that the
amount of consolidated net income attributable to the parent and to the noncontrolling interest be
clearly identified and presented in the consolidated statements of income. Any losses in excess of
the noncontrolling interests equity interest will continue to be allocated to the noncontrolling
interest. Purchases or sales of equity interests that do not result in a change of control will be
accounted for as equity transactions. Upon a loss of control, the interest sold, as well as any
interest retained, will be measured at fair value, with any gain or loss recognized in earnings.
In partial acquisitions, when control is obtained, the acquiring company will recognize, at fair
value, 100% of the assets and liabilities, including goodwill, as if the entire target company had
been acquired. SFAS No. 160 is effective for fiscal years, and interim periods within those fiscal
years, beginning on or after December 15, 2008, with early adoption prohibited. The new standard
will be applied prospectively, except for the presentation and disclosure requirements, which will
be applied retrospectively for all periods presented. The company is in the process of analyzing the standard, which will be adopted
by the company at the beginning of 2009.
5
SFAS No. 141-R
In December 2007, the FASB issued SFAS No. 141 (revised 2007), Business Combinations (SFAS No.
141-R). The new standard changes the accounting for business combinations in a number of
significant respects. The key changes include the expansion of transactions that will qualify as
business combinations, the capitalization of in-process research and development as an
indefinite-lived asset, the recognition of certain acquired contingent assets and liabilities at
fair value, the expensing of acquisition costs, the expensing of costs associated with
restructuring the acquired company, the recognition of contingent consideration at fair value on
the acquisition date, and the recognition of post-acquisition date changes in deferred tax asset
valuation allowances and acquired income tax uncertainties as income tax expense or benefit. SFAS
No. 141-R is effective for business combinations that close in years beginning on or after December
15, 2008, with early adoption prohibited. The company will adopt this standard at the beginning of
2009.
Partial adoption of SFAS No. 157
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS No. 157), which
clarifies the definition of fair value whenever another standard requires or permits assets or
liabilities to be measured at fair value. Specifically, the standard clarifies that fair value
should be based on the assumptions market participants would use when pricing the asset or
liability, and establishes a fair value hierarchy that prioritizes the information used to develop
those assumptions. SFAS No. 157 does not expand the use of fair value to any new circumstances,
and must be applied on a prospective basis except in certain cases. The standard also requires
expanded financial statement disclosures about fair value measurements, including disclosure of
the methods used and the effect on earnings.
In February 2008, FASB Staff Position (FSP) FAS No. 157-2, Effective Date of FASB Statement No.
157 (FSP No. 157-2) was issued. FSP No. 157-2 defers the effective date of SFAS No. 157 to
fiscal years beginning after December 15, 2008, and interim periods within those fiscal years, for
all nonfinancial assets and liabilities, except those that are recognized or disclosed at fair
value in the financial statements on a recurring basis (at least annually). Examples of items
within the scope of FSP No. 157-2 are nonfinancial assets and nonfinancial liabilities initially
measured at fair value in a business combination (but not measured at fair value in subsequent
periods), and long-lived assets, such as property, plant and equipment and intangible assets
measured at fair value for an impairment assessment under SFAS No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets.
The partial adoption of SFAS No. 157 on January 1, 2008 with respect to financial assets and
financial liabilities recognized or disclosed at fair value in the financial statements on a
recurring basis did not have a material impact on the companys consolidated financial statements.
See Note 5 for the fair value measurement disclosures for these assets and liabilities. The
company is in the process of analyzing the potential impact of SFAS No. 157 relating to its
planned January 1, 2009 adoption of the remainder of the standard.
2. SUPPLEMENTAL FINANCIAL INFORMATION
Net pension and other postemployment benefits expense
The following is a summary of net expense relating to the companys pension and other
postemployment benefit (OPEB) plans.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
Pension benefits |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service cost |
|
$ |
22 |
|
|
$ |
22 |
|
|
$ |
65 |
|
|
$ |
65 |
|
Interest cost |
|
|
51 |
|
|
|
47 |
|
|
|
153 |
|
|
|
139 |
|
Expected return on plan assets |
|
|
(58 |
) |
|
|
(54 |
) |
|
|
(174 |
) |
|
|
(161 |
) |
Amortization of net loss, prior service cost
and transition obligation |
|
|
19 |
|
|
|
24 |
|
|
|
59 |
|
|
|
73 |
|
|
Net pension plan expense |
|
$ |
34 |
|
|
$ |
39 |
|
|
$ |
103 |
|
|
$ |
116 |
|
|
6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
OPEB |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service cost |
|
$ |
2 |
|
|
$ |
1 |
|
|
$ |
4 |
|
|
$ |
4 |
|
Interest cost |
|
|
7 |
|
|
|
8 |
|
|
|
22 |
|
|
|
23 |
|
Amortization of net loss and prior service cost |
|
|
|
|
|
|
1 |
|
|
|
|
|
|
|
3 |
|
|
Net OPEB plan expense |
|
$ |
9 |
|
|
$ |
10 |
|
|
$ |
26 |
|
|
$ |
30 |
|
|
The companys funding policy for its pension plans is to contribute amounts sufficient to meet
legal funding requirements, plus any additional amounts that the company may determine to be
appropriate considering the funded status of the plans, tax deductibility, the cash flows
generated by the company and other factors. Continued volatility in the global financial markets
could have an unfavorable impact on future funding requirements.
Net interest expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
Interest expense, net of capitalized interest |
|
$ |
37 |
|
|
$ |
30 |
|
|
$ |
113 |
|
|
$ |
90 |
|
Interest income |
|
|
(17 |
) |
|
|
(24 |
) |
|
|
(51 |
) |
|
|
(80 |
) |
|
Net interest expense |
|
$ |
20 |
|
|
$ |
6 |
|
|
$ |
62 |
|
|
$ |
10 |
|
|
Comprehensive income
Total comprehensive income was $217 million and $429 million for the three months ended September
30, 2008 and 2007, respectively, and $1,419 million and $1,394 million for the nine months ended
September 30, 2008 and 2007, respectively. The decrease in comprehensive income in the third
quarter of 2008 was principally due to unfavorable movements in foreign currency translation
adjustments, partially offset by higher net income. The increase in the first nine months of 2008
was principally due to higher net income, partially offset by unfavorable movements in foreign
currency translation adjustments.
Effective tax rate
The companys effective income tax rates were 15.4% and 18.2% in the third quarters of 2008 and
2007, respectively, and were 18.1% and 19.1% in the nine-month periods ended September 30, 2008 and
2007, respectively.
The effective tax rates in the third quarters and first nine months of 2008 and 2007 were impacted
by reductions of $29 million and $57 million, respectively, of valuation allowances on net
operating loss carryforwards in foreign jurisdictions due to profitability improvements, and $14
million and $84 million, respectively, of additional U.S. income tax expense related to foreign earnings which
are no longer considered indefinitely reinvested outside of the United States because management
planned to remit these earnings to the United States in the foreseeable future. Also impacting the
tax rate in the 2007 year-to-date period was the extension of tax incentives and the settlement of
tax audits in jurisdictions outside of the United States.
Earnings per share
The numerator for both basic and diluted earnings per share (EPS) is net income. 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, restricted stock
units and restricted stock is reflected in the denominator for diluted EPS principally using the
treasury stock method.
The computation of diluted EPS excludes employee stock options to purchase 7 million and 11 million
shares for the third quarters of 2008 and 2007, respectively, and 8 million and 11 million shares
for the nine-month periods ended September 30, 2008 and 2007, respectively, because the assumed
proceeds were greater than the average market price of the companys common stock, resulting in an
anti-dilutive effect on diluted EPS.
7
The following is a reconciliation of basic shares to diluted shares.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
Basic shares |
|
|
625 |
|
|
|
641 |
|
|
|
628 |
|
|
|
647 |
|
Effect of employee stock options
and other dilutive securities |
|
|
13 |
|
|
|
10 |
|
|
|
12 |
|
|
|
10 |
|
|
Diluted shares |
|
|
638 |
|
|
|
651 |
|
|
|
640 |
|
|
|
657 |
|
|
Inventories
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
Raw materials |
|
$ |
634 |
|
|
$ |
624 |
|
Work in process |
|
|
776 |
|
|
|
695 |
|
Finished products |
|
|
1,110 |
|
|
|
1,015 |
|
|
Total inventories |
|
$ |
2,520 |
|
|
$ |
2,334 |
|
|
Property, plant and equipment, net
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
Property, plant and equipment, at cost |
|
$ |
9,189 |
|
|
$ |
8,824 |
|
Accumulated depreciation and amortization |
|
|
(4,591 |
) |
|
|
(4,337 |
) |
|
Property, plant and equipment, net |
|
$ |
4,598 |
|
|
$ |
4,487 |
|
|
Goodwill
Goodwill at September 30, 2008 totaled $596 million for the BioScience segment, $952 million for
the Medication Delivery segment and $155 million for the Renal segment. Goodwill at December 31,
2007 totaled $587 million for the BioScience segment, $948 million for the Medication Delivery
segment and $155 million for the Renal segment. The increase in the goodwill balance was due to
several small acquisitions completed in the first quarter of 2008, partially offset by the impact
of foreign currency fluctuations.
Other intangible assets, net
The following is a summary of the companys intangible assets subject to amortization at September
30, 2008 and December 31, 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Developed |
|
|
|
|
|
|
|
|
|
technology, |
|
|
|
|
|
|
|
(in millions) |
|
including patents |
|
|
Other |
|
|
Total |
|
|
September 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
Gross other intangible assets |
|
$ |
802 |
|
|
$ |
123 |
|
|
$ |
925 |
|
Accumulated amortization |
|
|
(446 |
) |
|
|
(69 |
) |
|
|
(515 |
) |
|
Other intangible assets, net |
|
$ |
356 |
|
|
$ |
54 |
|
|
$ |
410 |
|
|
December 31, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
Gross other intangible assets |
|
$ |
848 |
|
|
$ |
130 |
|
|
$ |
978 |
|
Accumulated amortization |
|
|
(458 |
) |
|
|
(72 |
) |
|
|
(530 |
) |
|
Other intangible assets, net |
|
$ |
390 |
|
|
$ |
58 |
|
|
$ |
448 |
|
|
The amortization expense for these intangible assets was $13 million and $14 million for the three
months ended September 30, 2008 and 2007, respectively, and $40 million and $43 million for the
nine months ended September 30, 2008 and 2007, respectively. The anticipated annual amortization
expense for intangible assets recorded as of September 30, 2008 is $52 million in 2008, $51 million
in 2009, $49 million in 2010, $44 million in 2011, $41 million in 2012 and $37 million in 2013.
8
Securitization arrangements
The companys securitization arrangements resulted in net cash outflows of $2 million and $23
million for the three months ended September 30, 2008 and 2007, respectively, and $12 million and
$31 million for the nine months ended September 30, 2008 and 2007, respectively. A summary of the
activity is as follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
(in millions) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
Sold receivables at beginning of period |
|
$ |
124 |
|
|
$ |
337 |
|
|
$ |
129 |
|
|
$ |
348 |
|
Proceeds from sales of receivables |
|
|
112 |
|
|
|
402 |
|
|
|
332 |
|
|
|
1,172 |
|
Cash collections (remitted to the
owners of the receivables) |
|
|
(114 |
) |
|
|
(425 |
) |
|
|
(344 |
) |
|
|
(1,203 |
) |
Effect of currency exchange rate changes |
|
|
2 |
|
|
|
13 |
|
|
|
7 |
|
|
|
10 |
|
|
Sold receivables at end of period |
|
$ |
124 |
|
|
$ |
327 |
|
|
$ |
124 |
|
|
$ |
327 |
|
|
Investment in technologies
In July 2008, the company entered into an in-licensing agreement with Innocoll Pharmaceuticals Ltd.
(Innocoll), a division of Innocoll, Inc., granting Baxter exclusive rights to market and distribute
Innocolls gentamicin surgical implant in the United States. The gentamicin surgical implant is a
biodegradable, leave-behind antibiotic surgical sponge used as an adjunct (add-on) therapy for the
prevention and treatment of surgical site infections. This BioScience segment arrangement included
an up-front cash obligation of $12 million, which was expensed as in-process research and
development (IPR&D) as the licensed technology had not received regulatory approval in the United
States and had no alternative future use. The company will also contribute to the funding of
Innocolls clinical trial costs. In addition, the company may be required to make additional
payments of up to $89 million based on the successful completion of specified development,
regulatory and sales milestones.
3. SALE OF TRANSFUSION THERAPIES BUSINESS
On February 28, 2007, the company divested substantially all of the assets and liabilities of its
Transfusion Therapies (TT) business to an affiliate of TPG Capital, L.P., which established the new
company as Fenwal Inc. (Fenwal), for $540 million. Prior to the divestiture, the TT business was
part of the BioScience business. Refer to the 2007 Annual Report for further information.
Under transition agreements, the company is providing manufacturing and support services to Fenwal
for a period of time after divestiture, which varies based on the product or service provided and
other factors, but generally approximates two years. Due to the companys actual and expected
significant continuing cash flows associated with this business, the company continued to include
the results of operations of TT in the companys results of continuing operations through the
February 28, 2007 sale date. No facts or circumstances arose subsequent to the divestiture date
that changed the initial expectation of significant continuing cash flows. Revenues associated
with the manufacturing, distribution and other transition services provided by the company, which
were $47 million and $44 million in the three months ended September 30, 2008 and 2007,
respectively, and $133 million and $100 million in the nine months ended September 30, 2008 and
2007, respectively, are reported at the corporate headquarters level and not allocated to a
segment. Included in these revenues were $5 million and $19 million in the third quarter and first
nine months of 2008, respectively, of deferred revenue related to the manufacturing, distribution
and other transition agreements. As of September 30, 2008, deferred revenue that will be
recognized in the future as the services under these arrangements are performed totaled $10
million.
In the first quarter of 2007, the company recorded a pre-tax gain on the sale of the TT business of
$58 million. In the first quarter of 2008, the company recorded an income adjustment to the gain
of $16 million as a result of the finalization of the net assets transferred in the divestiture.
In connection with the TT divestiture, in the first quarter of 2007, the company recorded a $35
million pre-tax charge principally associated with severance and other employee-related costs.
Reserve utilization through September 30, 2008 was $10 million. The reserve is expected to be
substantially utilized by the end of 2009, and the company believes that the reserves are adequate.
However, adjustments may be recorded in the future as the transition is completed.
The gain on the sale of the TT business and the related charges and adjustments in 2008 and 2007
were recorded in other expense, net on the consolidated statements of income.
9
4. RESTRUCTURING AND OTHER SPECIAL CHARGES
Restructuring charges
The following is a summary of restructuring charges recorded in 2007 and 2004. Refer to the 2007
Annual Report for additional information about these charges.
2007
In 2007, the company recorded a restructuring charge of $70 million principally associated with the
consolidation of certain commercial and manufacturing operations outside of the United States.
Based on a review of current and future capacity needs, the company decided to integrate several
facilities to reduce the companys cost structure and optimize operations, principally in the
Medication Delivery segment.
Included in the charge was $17 million related to asset impairments, principally to write down
property, plant and equipment (PP&E) based on market data for the assets. Also included in the
charge was $53 million for cash costs, principally pertaining to severance and other
employee-related costs associated with the elimination of approximately 550 positions, or
approximately 1% of the companys total workforce.
2004
In 2004, the company recorded a $543 million restructuring charge principally associated with
managements decision to implement actions to reduce the companys overall cost structure and to
drive sustainable improvements in financial performance. Included in the 2004 charge was $196
million relating to asset impairments, almost all of which was to write down PP&E. Also included
in the 2004 charge was $347 million for cash costs, principally pertaining to severance and other
employee-related costs.
Restructuring reserves
The following table summarizes cash activity in the companys 2007 and 2004 restructuring charges.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee- |
|
|
Contractual |
|
|
|
|
|
|
related |
|
|
and other |
|
|
|
|
(in millions) |
|
costs |
|
|
costs |
|
|
Total |
|
|
2004 Charge |
|
$ |
212 |
|
|
$ |
135 |
|
|
$ |
347 |
|
Utilization and adjustments in 2004, 2005 and 2006 |
|
|
(198 |
) |
|
|
(94 |
) |
|
|
(292 |
) |
|
Reserve at December 31, 2006 |
|
|
14 |
|
|
|
41 |
|
|
|
55 |
|
2007 Charge |
|
|
46 |
|
|
|
7 |
|
|
|
53 |
|
Utilization |
|
|
(15 |
) |
|
|
(12 |
) |
|
|
(27 |
) |
|
Reserve at December 31, 2007 |
|
|
45 |
|
|
|
36 |
|
|
|
81 |
|
Utilization |
|
|
(6 |
) |
|
|
(6 |
) |
|
|
(12 |
) |
|
Reserve at March 31, 2008 |
|
|
39 |
|
|
|
30 |
|
|
|
69 |
|
Utilization |
|
|
(6 |
) |
|
|
(5 |
) |
|
|
(11 |
) |
|
Reserve at June 30, 2008 |
|
|
33 |
|
|
|
25 |
|
|
|
58 |
|
Utilization |
|
|
(3 |
) |
|
|
(3 |
) |
|
|
(6 |
) |
|
Reserve at September 30, 2008 |
|
$ |
30 |
|
|
$ |
22 |
|
|
$ |
52 |
|
|
Restructuring reserve utilization in the third quarter of 2008 totaled $6 million, with $3 million
relating to the 2007 program and $3 million relating to the 2004 program. The 2007 and 2004
reserves are expected to be substantially utilized by the end of 2009. The company believes that
the reserves are adequate. However, adjustments may be recorded in the future as the programs are
completed.
Other charges
The COLLEAGUE infusion pump and heparin charges discussed below were classified in cost of goods
sold in the companys consolidated statements of income, and were reflected in the Medication
Delivery segments pre-tax income. The actual costs relating to these matters may differ from the
companys estimates; with respect to
COLLEAGUE, while the companys estimates are based on the information available to the company at
this time, the company remains in a dialogue with the U.S. Food and Drug Administration, the
outcome of which dialogue may impact the nature and timing of the companys actions, which, in
turn, may significantly impact these estimates. It is possible that additional charges may be
required in future periods, based on new information or changes in estimates.
10
While the company continues to work to resolve the issues associated with COLLEAGUE infusion pumps
and its heparin products described below, 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, or that sales of any other product may not be adversely affected.
COLLEAGUE Infusion Pumps
The company began to hold shipments of COLLEAGUE infusion pumps in July 2005 and continues to hold
shipments of new pumps in the United States. Please refer to the companys 2007 Annual Report for
further information.
The company recorded charges of $171 million ($157 million for cash costs and $14 million for asset
impairments) in 2006 and 2005 related to issues associated with its COLLEAGUE infusion pumps. The
reserve for cash costs represented an estimate of the cash expenditures for the materials, labor
and freight costs expected to be incurred to remediate the design issues, customer accommodations,
and warranty and other commitments made to customers. In 2007, the company increased its reserve
for cash costs by $14 million as estimates were refined based on the companys experience executing
the remediation plan.
As a result of delays in the remediation plan, principally due to additional software modifications
and validation and testing required to remediate the pumps, and other changes in the estimated
costs to execute the remediation plan, the company recorded a charge associated with the COLLEAGUE
infusion pump of $53 million in the first quarter of 2008. This charge consisted of $39 million
for cash costs and $14 million principally relating to asset impairments. The reserve for cash
costs principally related to customer accommodations, including extended warranties, and other
costs associated with the delay in the recommercialization timeline.
In the third quarter of 2008, as a result of the companys decision to upgrade the global pump base
to a standard software platform and other changes in the estimated costs to execute the remediation
plan, the company recorded a charge of $72 million. This charge consisted of $46 million for cash
costs and $26 million principally relating to asset impairments and inventory used in the
remediation plan. The reserve for cash costs primarily consisted of costs associated with the
deployment of the new software and additional repair and warranty costs.
The following table summarizes cash activity in the companys COLLEAGUE infusion pump reserves
through September 30, 2008.
|
|
|
|
|
(in millions) |
|
|
|
|
|
Charges in 2005 and 2006 |
|
$ |
157 |
|
Utilization and adjustments in 2005 through 2007 |
|
|
(87 |
) |
|
Reserve at December 31, 2007 |
|
|
70 |
|
Charge |
|
|
39 |
|
Utilization |
|
|
(12 |
) |
|
Reserve at March 31, 2008 |
|
|
97 |
|
Utilization |
|
|
(11 |
) |
|
Reserve at June 30, 2008 |
|
|
86 |
|
Charge |
|
|
46 |
|
Utilization |
|
|
(8 |
) |
|
Reserve at September 30, 2008 |
|
$ |
124 |
|
|
The majority of the remaining infusion pump reserves are expected to be utilized by 2010.
Heparin
During the first quarter of 2008, the company recorded a charge of $19 million related to the
companys recall of its heparin sodium injection products in the United States. During the first
quarter of 2008, the company identified an
increasing level of allergic-type and hypotensive adverse reactions occurring in patients using its
heparin sodium injection products in the United States, and initiated a field corrective action
with respect to these products.
Included in the charge were $14 million of asset impairments, primarily heparin inventory that will
not be sold, and $5 million of cash costs related to the recall. The reserve for cash costs has
been substantially utilized as of September 30, 2008.
11
The companys sales of these heparin products totaled approximately $30 million in 2007.
CLEARSHOT Pre-Filled Syringes
During the third quarter of 2008, the company recorded a $31 million charge related to the
companys decision to discontinue its CLEARSHOT pre-filled syringe program based on
managements assessment of the market demand and expected profitability for this product.
Substantially all of the charge related to asset impairments, principally to write off
equipment used to manufacture the CLEARSHOT syringes. The charge was recorded in other
expense, net on the consolidated statement of income, and was reflected in the Medication
Delivery segments pre-tax income.
5. DEBT, NET INVESTMENT HEDGES AND FAIR VALUE MEASUREMENTS
Debt
The company repaid its 5.196% notes, which approximated $250 million, upon their maturity in
February 2008. In May 2008, the company issued $500 million of senior unsecured notes, maturing in
June 2018 and bearing a 5.375% coupon rate. The net proceeds were used for general corporate
purposes, including the settlement of cross-currency swaps (including swaps originally designated
as net investment hedges and mirror, or offsetting, swaps), as further described below. In
addition, during the third quarter of 2008, the company issued commercial paper, of which $192
million was outstanding as of September 30, 2008, with a weighted-average interest rate of 2.8%.
Net Investment Hedges
During the first nine months of 2008 and 2007, the company terminated certain cross-currency and
mirror swaps, resulting in net settlement payments of $528 million and $227 million, respectively.
As a result, as of the end of the third quarter of 2008, the company has completely terminated its
net investment hedge portfolio, and, therefore, is no longer party to any agreement whereby the
counterparty financial institution can terminate or accelerate the maturity date of a financial
instrument due solely to unfavorable changes in the companys credit ratings. Refer to the 2007
Annual Report for further information regarding these swaps.
In accordance with SFAS No. 149, Amendment of Statement 133 on Derivative Instruments and Hedging
Activities, when the cross-currency swaps are settled, the cash flows are reported within the
financing section of the consolidated statement of cash flows. When the mirror swaps are settled,
the cash flows are reported in the operating section of the consolidated statement of cash flows.
Of the $528 million of net settlement payments in the first nine months of 2008, $540 million of
cash outflows were included in the financing section and $12 million of cash inflows were included
in the operating section. Of the $227 million of net settlement payments in the first nine months
of 2007, $196 million of cash outflows were included in the financing section and $31 million of
cash outflows were included in the operating section.
Fair Value Measurements
The following table summarizes the bases used to measure financial assets and liabilities that are
carried at fair value on a recurring basis in the balance sheet.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basis of Fair Value Measurement |
|
|
|
|
|
|
|
Quoted Prices in |
|
|
|
|
|
|
Significant |
|
|
|
|
|
|
|
Active Markets for |
|
|
Significant Other |
|
|
Unobservable |
|
|
|
Balance at |
|
|
Identical Assets |
|
|
Observable Inputs |
|
|
Inputs |
|
(in millions) |
|
September 30, 2008 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency hedges |
|
|
$70 |
|
|
|
$ |
|
|
|
$70 |
|
|
|
$ |
|
Interest rate hedges |
|
|
10 |
|
|
|
|
|
|
|
10 |
|
|
|
|
|
Equity securities |
|
|
16 |
|
|
|
16 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
|
$96 |
|
|
|
$16 |
|
|
|
$80 |
|
|
|
$ |
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency hedges |
|
|
$94 |
|
|
|
$ |
|
|
|
$94 |
|
|
|
$ |
|
|
Total liabilities |
|
|
$94 |
|
|
|
$ |
|
|
|
$94 |
|
|
|
$ |
|
|
12
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, which are observable, depend on the type of derivative, and include
contractual terms, counterparty credit risk, interest rate yield curves, foreign exchange rates
and volatility.
6. COMMON STOCK
Stock-based compensation plans
Stock compensation expense totaled $38 million and $36 million for the three months ended September
30, 2008 and 2007, respectively, and $111 million and $99 million for the nine months ended
September 30, 2008 and 2007, respectively. Approximately three-quarters of stock compensation
expense is classified in marketing and administrative expenses, with the remainder classified in
cost of goods sold and research and development expenses.
In March 2008, the company made its annual stock compensation grants, which consisted of
approximately 7.0 million stock options and 0.7 million performance share units (PSUs). Stock
compensation grants made in the second and third quarters of 2008 were not material.
Stock options
The weighted-average assumptions used in estimating the fair value of stock options granted during
the periods, along with the weighted-average fair values, were as follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
Expected volatility |
|
|
23.7% |
|
|
|
23.4% |
|
Expected life (in years) |
|
|
4.5 |
|
|
|
4.5 |
|
Risk-free interest rate |
|
|
2.5% |
|
|
|
4.5% |
|
Dividend yield |
|
|
1.5% |
|
|
|
1.2% |
|
Fair value per stock option |
|
|
$12 |
|
|
|
$13 |
|
|
|
The total intrinsic value of stock options exercised was $174 million and $37 million during the
three months ended September 30, 2008 and 2007, respectively, and $306 million and $225 million
during the nine months ended September 30, 2008 and 2007, respectively.
|
|
As of September 30, 2008, $108 million of pre-tax unrecognized compensation cost related to all
unvested stock options is expected to be recognized as expense over a weighted-average period of
1.9 years. |
|
Performance share and restricted stock units
|
|
The assumptions used in estimating the fair value of PSUs granted during the periods, along with
the fair values, were as follows. |
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
|
September 30, |
|
|
2008 |
|
|
2007 |
|
|
Baxter volatility |
|
|
19.7% |
|
|
|
17.8% |
|
Peer group volatility |
|
|
12.4%-37.1% |
|
|
|
13.0%-38.6% |
|
Correlation of returns |
|
|
0.12-0.40 |
|
|
|
0.09-0.34 |
|
Risk-free interest rate |
|
|
1.9% |
|
|
|
4.5% |
|
Dividend yield |
|
|
1.5% |
|
|
|
1.2% |
|
Fair value per PSU |
|
|
$64 |
|
|
|
$64 |
|
|
As of September 30, 2008, pre-tax unrecognized compensation cost related to all unvested PSUs of
$39 million is expected to be recognized as expense over a weighted-average period of 1.9 years,
and pre-tax unrecognized compensation cost related to all unvested restricted stock units of $18
million is expected to be recognized as expense over a weighted-average period of 1.8 years.
13
Realized excess income tax benefits
Realized excess tax benefits associated with stock-based compensation are required to be presented
on the statement of cash flows as an outflow within the operating section and an inflow within the
financing section. Realized excess tax benefits for the nine-month period ended September 30, 2008
were $28 million. No income tax benefits were realized from stock-based compensation during 2007.
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 current market conditions. During the
three- and nine-month periods ended September 30, 2008, the company repurchased 8.5 million shares
and 24.0 million shares in open market purchases for $589 million and $1,522 million,
respectively, under stock repurchase programs authorized by the board of directors. In March
2008, the board of directors authorized the repurchase of up to an additional $2.0 billion of the
companys common stock. At September 30, 2008, $1.6 billion remained available under the March
2008 authorization.
7. LEGAL PROCEEDINGS
Baxter is involved in product liability, patent, commercial, and other legal proceedings that arise
in the normal course of the companys business. The company records a liability when a loss is
considered probable and the amount can be reasonably estimated. If the reasonable estimate of a
probable loss is a range, and no amount within the range is a better estimate, the minimum amount
in the range is accrued. If a loss is not probable or a probable loss cannot be reasonably
estimated, no liability is recorded.
Baxter has established reserves for certain of the matters discussed below. The company is not
able to estimate the amount or range of any loss for certain of the legal contingencies for which
there is no reserve or additional loss for matters already reserved. While the liability of the
company in connection with the claims cannot be estimated with any certainty and although the
resolution in any reporting period of one or more of these matters could have a significant impact
on the companys results of operations for that period, the outcome of these legal proceedings is
not expected to have a material adverse effect on the companys consolidated financial position.
While the company believes that it has valid defenses in these matters, litigation is inherently
uncertain, excessive verdicts do occur, and the company may in the future incur material judgments
or enter into material settlements of claims.
In addition to the matters described below, the company remains subject to other potential
administrative and legal actions. With respect to regulatory matters, these actions may lead to
product recalls, injunctions to halt manufacture and distribution, and other restrictions on the
companys operations and monetary sanctions. With respect to intellectual property, the company
may be exposed to significant litigation concerning the scope of the companys and others rights.
Such litigation could result in a loss of patent protection or the ability to market products,
which could lead to a significant loss of sales, or otherwise materially affect future results of
operations.
Patent Litigation
Sevoflurane Litigation
In September 2005, the U.S.D.C. for the Northern District of Illinois ruled that a patent owned by
Abbott Laboratories and the Central Glass Company, U.S. Patent No. 5,990,176, was not infringed by
Baxters generic version of sevoflurane. Abbott and Central Glass appealed and Baxter filed a
cross-appeal as to the validity of the patent. In November 2006, the Court of Appeals for the
Federal Circuit granted Baxters cross-appeal and held Abbotts patent invalid. Abbotts motions
to have that appeal re-heard were denied in January 2007.
Related actions are pending in various jurisdictions in the United States and abroad. Another
patent infringement action against Baxter remains pending in the U.S.D.C. for the Northern District
of Illinois on a related patent owned by Abbott and Central Glass. Baxter has filed a motion
asserting that judgment of non-infringement and invalidity should be entered based in part on
findings made in the earlier case. In May 2005, Abbott and Central Glass filed suit in the Tokyo
District Court on a counterpart Japanese patent and in September 2006, the Tokyo District Court
ruled in favor of Abbott and Central Glass on this matter. Baxter has appealed this decision. In
June 2005, Baxter filed suit in the High Court of Justice in London, England seeking revocation of
the U.K. part of the related European patent and a declaration of non-infringement. In March 2007,
the High Court ruled in Baxters favor, concluding that the U.K. patent was invalid. In 2007,
Abbott brought a patent infringement action against Baxter in the Cali Circuit Court of Colombia
based on a Colombian counterpart patent, and obtained an injunction preliminarily prohibiting the
approval of Baxters generic sevoflurane in Colombia during the pendency of the
14
infringement suit. In May 2008, the Court issued a decision maintaining the injunction, but
suspending it during an appeal of the Courts decision, which appeal was immediately granted.
Parallel opposition proceedings in the European and Japanese Patent Offices, or on appeal from
those Offices, seeking to revoke certain versions of the patent are also pending. A decision in
the European opposition proceeding is expected from the Board of Appeals in December 2008.
Peritoneal Dialysis Litigation
On October 16, 2006, Baxter Healthcare Corporation and DEKA Products Limited Partnership (DEKA)
filed a patent infringement lawsuit against Fresenius Medical Care Holdings, Inc. and Fresenius
USA, Inc. The complaint alleges that Freseniuss sale of the Liberty Cycler peritoneal dialysis
systems and related disposable items and equipment infringes nine U.S. patents owned by Baxter, as
to which DEKA has granted Baxter an exclusive license in the peritoneal dialysis field. The case
is pending in the U.S.D.C. for the Northern District of California with a trial date scheduled for
April 2009.
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 Freseniuss
2008K hemodialysis instrument. In 2007, the court entered judgment in Baxters favor holding the
patents valid and infringed, and a jury assessed damages at $14 million for past sales only. On
April 4, 2008, the U.S.D.C. for the Northern District of California granted Baxters motion for
permanent injunction, and granted Baxters request for royalties on Freseniuss sales of the 2008K
hemodialysis machines during a nine-month transition period before the permanent injunction takes
effect. The order also granted a royalty on disposables, which Fresenius has appealed. A decision
is expected in the second quarter of 2009.
Securities Laws
In October 2004, a purported class action was filed in the U.S.D.C. for the Northern District of
Illinois against Baxter and its current Chief Executive Officer and then current Chief Financial
Officer and their predecessors for alleged violations of the Employee Retirement Income Security
Act of 1974, as amended. Plaintiff alleges that these defendants, along with the Administrative
and Investment Committees of the companys 401(k) plans, breached their fiduciary duties to the
plan participants by offering Baxter common stock as an investment option in each of the plans
during the period of January 2001 to October 2004. In March 2006, the trial court certified a
class of plan participants who elected to acquire Baxter common stock through the plans between
January 2001 and the present. In April 2008, the Court of Appeals for the Seventh Circuit denied
Baxters interlocutory appeal and upheld the trial courts denial of Baxters motion to dismiss.
Baxter has filed a motion for judgment on the pleadings. Discovery has been completed in this
matter.
Other
On October 12, 2005 the United States filed a complaint in the U.S.D.C. for the Northern District
of Illinois to effect the seizure of COLLEAGUE and SYNDEO pumps that were on hold in Northern
Illinois. Customer-owned pumps were not affected. On June 29, 2006, Baxter Healthcare
Corporation, a direct wholly-owned subsidiary of Baxter, entered into a Consent Decree for
Condemnation and Permanent Injunction with the United States to resolve this seizure litigation.
The Consent Decree also outlines the steps the company must take to resume sales of new pumps in
the United States. Additional third party claims may be filed in connection with the COLLEAGUE
matter.
In connection with the recall of heparin products in the United States described in Note 4,
approximately 50 lawsuits, some of which are purported class actions, have been filed alleging that
plaintiffs suffered allergic or hypotensive symptoms following the administration of heparin, 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. These cases are each in their
earliest stages of litigation.
The company is a defendant, along with others, in over 50 lawsuits brought in various state and
U.S. federal courts, which allege that Baxter and other defendants reported artificially inflated
average wholesale prices for Medicare and Medicaid eligible drugs. These cases have been brought
by private parties on behalf of various purported classes of purchasers of Medicare and Medicaid
eligible drugs, as well as by state attorneys general. A number of these cases were consolidated
in the U.S.D.C. for the District of Massachusetts for pretrial case management under Multi District
Litigation rules. In April 2008, the court preliminarily approved a class settlement resolving
Medicare Part B claims and independent health plan claims against Baxter and others, which had
previously been reserved for
15
by the company. Final approval of this settlement is expected later this year. Remaining lawsuits
against Baxter include a number of cases brought by state attorneys general and New York entities,
which seek unspecified damages, injunctive relief, civil penalties, disgorgement, forfeiture and
restitution. Various state and federal agencies are conducting civil investigations into the
marketing and pricing practices of Baxter and others with respect to Medicare and Medicaid
reimbursement. These investigations may result in additional cases being filed by various state
attorneys general.
Baxter currently is a defendant in a number of lawsuits and subject to additional claims brought by
individuals who have hemophilia and their families, all seeking damages for injuries allegedly
caused by anti-hemophilic factor concentrates VIII or IX derived from human blood plasma (factor
concentrates) processed by the company and other acquired entities from the late 1970s to the
mid-1980s. The typical case or claim alleges that the individual was infected with the HIV or HCV
virus by factor concentrates that contained one or the other or both viruses. None of these cases
involves factor concentrates currently processed by the company.
As of September 30, 2008, the company has been named as a defendant, along with others, in
approximately 125 lawsuits filed in various state and U.S. federal courts, seeking damages,
injunctive relief and medical monitoring for claimants alleged to have contracted autism or
attention deficit disorders as a result of exposure to vaccines for childhood diseases containing
the preservative, thimerosal. These vaccines were formerly manufactured and sold by North
American Vaccine, Inc., which was acquired by Baxter in June 2000, as well as by other companies.
8. SEGMENT INFORMATION
Baxter operates in three segments, each of which is a strategic business that is managed separately
because each business develops, manufactures and sells distinct products and services. The
segments and a description of their products and services are as follows:
The BioScience business manufactures recombinant and plasma-based proteins to treat hemophilia and
other bleeding disorders, plasma-based therapies to treat immune deficiencies, biosurgery and other
products for regenerative medicine and vaccines. Prior to the divestiture of the TT business on
February 28, 2007, the business also manufactured manual and automated blood and blood-component
separation and collection systems.
The Medication Delivery business manufactures intravenous (IV) solutions and administration sets,
premixed drugs and drug-reconstitution systems, pre-filled vials and syringes for injectable drugs,
IV nutrition products, infusion pumps, and inhalation anesthetics, as well as products and services
related to drug formulation and enhanced packaging technologies.
The Renal business provides products to treat end-stage renal disease, or irreversible kidney
failure. The business manufactures solutions and other products for peritoneal dialysis, a
home-based therapy, and also distributes products for hemodialysis, which is a therapy generally
conducted in a hospital or clinic.
The company uses more than one measurement and multiple views of data to measure segment
performance and to allocate resources to the segments. However, the dominant measurements are
consistent with the companys consolidated financial statements and, accordingly, are reported on
the same basis herein. The company evaluates the performance of its segments and allocates
resources to them primarily based on pre-tax income along with cash flows and overall economic
returns. Intersegment sales are generally accounted for at amounts comparable to sales to
unaffiliated customers and are eliminated in consolidation.
Certain items are maintained at the corporate level and are not allocated to the segments. They
primarily include most of the companys debt and cash and equivalents and related net interest
expense, certain foreign exchange fluctuations and the majority of the foreign currency and
interest rate 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, IPR&D charges, 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.
The third quarter 2008 IPR&D charge of $12 million related to the companys in-licensing
arrangement with Innocoll was not allocated to a segment. Special charges that were not allocated
to a segment for the third quarter and nine months ended September 30, 2007 were a third quarter
2007 charge of $56 million related to the average wholesale pricing (AWP) litigation and IPR&D
charges totaling $46 million, with $25 million relating to the
16
companys third quarter 2007 collaboration with HHD, LLC, $10 million related to the companys
third quarter 2007 in-licensing arrangement with Halozyme Therapeutics, Inc. (Halozyme), and $11
million related to the second quarter 2007 acquisition of certain assets of MAAS Medical, LLC (MAAS
Medical). Refer to Note 2 for additional information on the arrangement with Innocoll and the 2007
Annual Report for a discussion of the AWP litigation, the arrangements with Halozyme and HHD, LLC,
and the acquisition of MAAS Medical.
Included in the Medication Delivery segments pre-tax income in 2008 were charges of $125 million
related to COLLEAGUE infusion pumps, which consisted of a charge of $53 million in the first
quarter and a charge of $72 million in the third quarter of 2008. Also included in pre-tax income
for the Medication Delivery segment in the third quarter of 2008 was an impairment charge of $31
million associated with the discontinuation of the CLEARSHOT pre-filled syringe program. Refer to
Note 4 for additional information on these charges.
Financial information for the companys segments for the three and nine months ended September 30
is as follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
Net sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BioScience |
|
$ |
1,354 |
|
|
$ |
1,099 |
|
|
$ |
3,949 |
|
|
$ |
3,440 |
|
Medication Delivery |
|
|
1,157 |
|
|
|
1,047 |
|
|
|
3,386 |
|
|
|
3,076 |
|
Renal |
|
|
593 |
|
|
|
560 |
|
|
|
1,749 |
|
|
|
1,638 |
|
Transition services to Fenwal |
|
|
47 |
|
|
|
44 |
|
|
|
133 |
|
|
|
100 |
|
|
Total net sales |
|
$ |
3,151 |
|
|
$ |
2,750 |
|
|
$ |
9,217 |
|
|
$ |
8,254 |
|
|
Pre-tax income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BioScience |
|
$ |
548 |
|
|
$ |
464 |
|
|
$ |
1,613 |
|
|
$ |
1,338 |
|
Medication Delivery |
|
|
96 |
|
|
|
183 |
|
|
|
396 |
|
|
|
508 |
|
Renal |
|
|
86 |
|
|
|
91 |
|
|
|
246 |
|
|
|
280 |
|
|
Total pre-tax income from segments |
|
$ |
730 |
|
|
$ |
738 |
|
|
$ |
2,255 |
|
|
$ |
2,126 |
|
|
Net sales and pre-tax income for the BioScience segment include sales of TT products until the
completion of the sale of the TT business on February 28, 2007. Transition services to Fenwal
represent revenues associated with manufacturing, distribution and other services provided by the
company to Fenwal subsequent to the divestiture. Refer to Note 3 for further information.
The following is a reconciliation of segment pre-tax income to income before income taxes per the
consolidated income statements.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
Total pre-tax income from segments |
|
$ |
730 |
|
|
$ |
738 |
|
|
$ |
2,255 |
|
|
$ |
2,126 |
|
Unallocated amounts |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest expense |
|
|
(20 |
) |
|
|
(6 |
) |
|
|
(62 |
) |
|
|
(10 |
) |
Restructuring charge |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(70 |
) |
Certain foreign currency fluctuations
and hedging activities |
|
|
20 |
|
|
|
(2 |
) |
|
|
30 |
|
|
|
(11 |
) |
AWP litigation charge |
|
|
|
|
|
|
(56 |
) |
|
|
|
|
|
|
(56 |
) |
IPR&D charges |
|
|
(12 |
) |
|
|
(35 |
) |
|
|
(12 |
) |
|
|
(46 |
) |
Stock compensation |
|
|
(38 |
) |
|
|
(36 |
) |
|
|
(111 |
) |
|
|
(99 |
) |
Other corporate expenses, net |
|
|
(122 |
) |
|
|
(120 |
) |
|
|
(336 |
) |
|
|
(314 |
) |
|
Income before income taxes |
|
$ |
558 |
|
|
$ |
483 |
|
|
$ |
1,764 |
|
|
$ |
1,520 |
|
|
17
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Refer to
the 2007 Annual Report to Shareholders (2007 Annual Report) for managements discussion and analysis of the financial condition
and results of operations of the company for the year ended December 31, 2007. 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, 2008.
RESULTS OF OPERATIONS
NET SALES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
Percent |
|
|
September 30, |
|
|
Percent |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
change |
|
|
2008 |
|
|
2007 |
|
|
change |
|
|
BioScience |
|
$ |
1,354 |
|
|
$ |
1,099 |
|
|
|
23% |
|
|
$ |
3,949 |
|
|
$ |
3,440 |
|
|
|
15% |
|
Medication Delivery |
|
|
1,157 |
|
|
|
1,047 |
|
|
|
11% |
|
|
|
3,386 |
|
|
|
3,076 |
|
|
|
10% |
|
Renal |
|
|
593 |
|
|
|
560 |
|
|
|
6% |
|
|
|
1,749 |
|
|
|
1,638 |
|
|
|
7% |
|
Transition services to Fenwal Inc. |
|
|
47 |
|
|
|
44 |
|
|
|
7% |
|
|
|
133 |
|
|
|
100 |
|
|
|
33% |
|
|
Total net sales |
|
$ |
3,151 |
|
|
$ |
2,750 |
|
|
|
15% |
|
|
$ |
9,217 |
|
|
$ |
8,254 |
|
|
|
12% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
Percent |
|
|
September 30, |
|
|
Percent |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
change |
|
|
2008 |
|
|
2007 |
|
|
change |
|
|
International |
|
$ |
1,879 |
|
|
$ |
1,539 |
|
|
|
22% |
|
|
$ |
5,525 |
|
|
$ |
4,708 |
|
|
|
17% |
|
United States |
|
|
1,272 |
|
|
|
1,211 |
|
|
|
5% |
|
|
|
3,692 |
|
|
|
3,546 |
|
|
|
4% |
|
|
Total net sales |
|
$ |
3,151 |
|
|
$ |
2,750 |
|
|
|
15% |
|
|
$ |
9,217 |
|
|
$ |
8,254 |
|
|
|
12% |
|
|
Foreign currency fluctuations benefited sales growth by 6 and 7 percentage points in the three- and
nine-month periods ended September 30, 2008, respectively, principally due to the weakening of the
U.S. Dollar relative to the Euro in both periods.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
Percent |
|
|
September 30, |
|
|
Percent |
(in millions) |
|
2008 |
|
|
2007 |
|
|
change |
|
|
2008 |
|
|
2007 |
|
|
change |
|
Total net sales |
|
$ |
3,151 |
|
|
$ |
2,750 |
|
|
|
15% |
|
|
$ |
9,217 |
|
|
$ |
8,254 |
|
|
|
12 |
% |
Pre-divestiture sales of Transfusion
Therapies products (included in
BioScience segment through the
February 28, 2007 divestiture date) |
|
|
|
|
|
|
|
|
|
|
N/A |
|
|
|
|
|
|
|
79 |
|
|
|
(100 |
%) |
Transition services to Fenwal Inc.
(subsequent to the February 28, 2007
divestiture date) |
|
|
47 |
|
|
|
44 |
|
|
|
7% |
|
|
|
133 |
|
|
|
100 |
|
|
|
33 |
% |
|
Total net sales excluding
Transfusion Therapies |
|
$ |
3,104 |
|
|
$ |
2,706 |
|
|
|
15% |
|
|
$ |
9,084 |
|
|
$ |
8,075 |
|
|
|
12 |
% |
|
Net sales excluding Transfusion Therapies (TT) increased 15% and 12% in the three- and nine-month
periods ended September 30, 2008 (including a 6 percentage point favorable impact from foreign
currency fluctuations for both the three- and nine-month periods ended September 30, 2008).
Management believes that net sales and sales growth excluding TT facilitates a more meaningful
analysis of the companys net sales growth due to the divestiture of this business in 2007. See
Note 3 for further information regarding the divestiture of the TT business.
BioScience
Net sales in the BioScience segment increased 23% and 15% for the three- and nine-month periods
ended September 30, 2008 (including a 6 and 7 percentage point favorable impact from foreign
currency fluctuations in the three- and nine-month periods ended September 30, 2008, respectively).
The following is a summary of sales by significant product line.
18
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
Percent |
|
|
September 30, |
|
|
Percent |
(in millions) |
|
2008 |
|
|
2007 |
|
|
change |
|
|
2008 |
|
|
2007 |
|
|
change |
|
Recombinants |
|
$ |
516 |
|
|
$ |
432 |
|
|
|
19% |
|
|
$ |
1,460 |
|
|
$ |
1,251 |
|
|
|
17 |
% |
Plasma Proteins |
|
|
338 |
|
|
|
246 |
|
|
|
37% |
|
|
|
889 |
|
|
|
714 |
|
|
|
25 |
% |
Antibody Therapy |
|
|
307 |
|
|
|
245 |
|
|
|
25% |
|
|
|
908 |
|
|
|
705 |
|
|
|
29 |
% |
Regenerative Medicine |
|
|
104 |
|
|
|
82 |
|
|
|
27% |
|
|
|
307 |
|
|
|
251 |
|
|
|
22 |
% |
Transfusion Therapies |
|
|
|
|
|
|
|
|
|
|
N/A |
|
|
|
|
|
|
|
79 |
|
|
|
(100 |
%) |
Other |
|
|
89 |
|
|
|
94 |
|
|
|
(5% |
) |
|
|
385 |
|
|
|
440 |
|
|
|
(13 |
%) |
|
Total net sales |
|
$ |
1,354 |
|
|
$ |
1,099 |
|
|
|
23% |
|
|
$ |
3,949 |
|
|
$ |
3,440 |
|
|
|
15 |
% |
|
Recombinants
The primary driver of sales growth in the Recombinants product line during the third quarter and
first nine months of 2008 was increased sales volume of recombinant factor VIII therapies. Factor
VIII products are used in the treatment of hemophilia A, which is a bleeding disorder caused by a
deficiency in blood clotting factor VIII. Sales growth was fueled by the continuing adoption by
customers of the advanced recombinant therapy, ADVATE (Antihemophilic Factor (Recombinant),
Plasma/Albumin-Free Method) rAHF-PFM, with strong patient conversion in both the United States and
international markets, and increased demand for new dosage forms that reduce both the volume of
drug and infusion time required for hemophilia patients needing high doses of factor VIII.
Plasma Proteins
Plasma Proteins include specialty therapeutics, such as FEIBA, an anti-inhibitor coagulant complex,
and ARALAST (alpha 1-proteinase inhibitor (human)) for the treatment of hereditary emphysema,
plasma-derived hemophilia treatments and albumin. Sales growth in the third quarter and first nine
months of 2008 was driven by growth across all plasma protein products, including albumin, FEIBA,
plasma-derived factor VIII and ARALAST, as a result of strong demand and pricing improvements,
primarily for albumin, as well as the timing of international tenders.
Antibody Therapy
Higher sales of IGIV (immune globulin intravenous), which is used in the treatment of immune
deficiencies, fueled sales growth during the third quarter and first nine months of 2008, with
increased volume, continuing improvements in pricing in the United States, and continuing customer
conversions to the liquid formulation of the product. Because it does not need to be reconstituted
prior to infusion, the higher-yielding liquid formulation offers added convenience for clinicians
and patients.
Regenerative Medicine
This product line principally includes plasma-based and non-plasma-based biosurgery products for
hemostasis (the stoppage of bleeding) and wound-sealing. Growth in the third quarter and first
nine months of 2008 was driven by increased sales volume of the companys portfolio of fibrin
sealant products, FLOSEAL, COSEAL and TISSEEL.
Transfusion Therapies
The Transfusion Therapies product line included products and systems for use in the collection and
preparation of blood and blood components. See Note 3 for information regarding the companys
February 28, 2007 sale of substantially all of the assets and liabilities of this business.
Other
Other BioScience products primarily consist of vaccines and sales of plasma to third parties. The
decrease in sales in this product line in the third quarter of 2008 was primarily due to the impact
of lower milestone revenue associated with the development of a candidate pandemic vaccine and a
seasonal influenza vaccine for the U.S. government. The decrease in sales in this product line in
the first nine months of 2008 was primarily due to the transfer of marketing and distribution
rights for recombinant FIX (BeneFIX) back to Wyeth effective June 30, 2007. Sales of BeneFIX were
approximately $110 million through the June 30, 2007 transition date. Also contributing to the
decrease in sales in the year-to-date period were significant shipments of candidate H5N1 influenza
vaccine to various governments worldwide in the first quarter of 2007. Partially offsetting these
declines in the first nine months of 2008 were strong international sales of FSME Immun (for the
prevention of tick-borne encephalitis), due to both volume and pricing improvements. Sales of
vaccines may fluctuate from period to period based on the seasonal nature of demand, timing of
government tenders and new supply agreements.
19
Medication Delivery
Net sales in the Medication Delivery segment increased 11% and 10% for the three- and nine-month
periods ended September 30, 2008 (including a 5 percentage point favorable impact from foreign
currency fluctuations for both the three- and nine-month periods ended September 30, 2008).
The following is a summary of sales by significant product line.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
Percent |
|
|
September 30, |
|
|
Percent |
(in millions) |
|
2008 |
|
|
2007 |
|
|
change |
|
|
2008 |
|
|
2007 |
|
|
change |
|
IV Therapies |
|
$ |
403 |
|
|
$ |
346 |
|
|
|
16% |
|
|
$ |
1,182 |
|
|
$ |
1,012 |
|
|
|
17 |
% |
Global Injectables |
|
|
403 |
|
|
|
372 |
|
|
|
8% |
|
|
|
1,164 |
|
|
|
1,114 |
|
|
|
4 |
% |
Infusion Systems |
|
|
235 |
|
|
|
207 |
|
|
|
14% |
|
|
|
684 |
|
|
|
624 |
|
|
|
10 |
% |
Anesthesia |
|
|
112 |
|
|
|
111 |
|
|
|
1% |
|
|
|
333 |
|
|
|
296 |
|
|
|
13 |
% |
Other |
|
|
4 |
|
|
|
11 |
|
|
|
(64% |
) |
|
|
23 |
|
|
|
30 |
|
|
|
(23 |
%) |
|
Total net sales |
|
$ |
1,157 |
|
|
$ |
1,047 |
|
|
|
11% |
|
|
$ |
3,386 |
|
|
$ |
3,076 |
|
|
|
10 |
% |
|
IV Therapies
This product line principally consists of intravenous (IV) solutions and nutritional products.
Growth for the third quarter and first nine months of 2008 was principally driven by increased
demand for IV therapy products in Europe, Latin America, and Asia, and strong international sales
of nutritional products. Also impacting sales growth in the third quarter and first nine months of
2008 were pricing improvements for IV therapy products in the United States.
Global Injectables
This product line primarily consists of the companys pharmaceutical company partnering business,
enhanced packaging, premixed drugs and generic injectables. Sales growth in the third quarter and
first nine months of 2008 was driven by strong international sales in the pharmacy-compounding
business, partially offset by lower sales of generic injectables. In the year-to-date period,
lower sales of generic injectables was principally driven by the transfer of marketing and
distribution rights for generic propofol back to Teva Pharmaceutical Industries Ltd. effective July
1, 2007. Sales of propofol totaled approximately $35 million in the first nine months of 2007.
Infusion Systems
Sales growth in the third quarter and first nine months of 2008 was driven by increased revenues
relating to COLLEAGUE infusion pumps which remain in use as the remediation plan is executed and
increased sales of disposable tubing sets used in the administration of IV solutions. Refer to
Note 4 and the Certain Regulatory Matters section below for additional information related to the
COLLEAGUE infusion pump.
Anesthesia
Sales in this product line in the third quarter of 2008 benefited from strong international sales
of SUPRANE (desflurane, USP) and sevoflurane. However, sales growth of SUPRANE in the United
States in the third quarter of 2008 was negatively impacted by wholesaler purchasing patterns.
Sales growth in the first nine months of 2008 was driven by the launch of sevoflurane in additional
geographic markets and strong global sales of SUPRANE.
Renal
Net sales in the Renal segment increased 6% and 7% for the three- and nine-month periods ended
September 30, 2008 (including a 7 and 8 percentage point favorable impact from foreign currency
fluctuations in the three- and nine-month periods ended September 30, 2008, respectively).
The following is a summary of sales by significant product line.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
Percent |
|
|
September 30, |
|
|
Percent |
(in millions) |
|
2008 |
|
|
2007 |
|
|
change |
|
|
2008 |
|
|
2007 |
|
|
change |
|
PD Therapy |
|
$ |
480 |
|
|
$ |
448 |
|
|
|
7% |
|
|
$ |
1,404 |
|
|
$ |
1,310 |
|
|
|
7 |
% |
HD Therapy |
|
|
113 |
|
|
|
112 |
|
|
|
1% |
|
|
|
345 |
|
|
|
328 |
|
|
|
5 |
% |
|
Total net sales |
|
$ |
593 |
|
|
$ |
560 |
|
|
|
6% |
|
|
$ |
1,749 |
|
|
$ |
1,638 |
|
|
|
7 |
% |
|
20
PD Therapy
Peritoneal dialysis, or PD Therapy, is a home dialysis treatment for end-stage renal disease. PD
Therapy uses the peritoneal membrane, or abdominal lining, as a natural filter to remove waste from
the bloodstream. Excluding the impact of foreign currency, sales were flat in the third quarter
and declined slightly in the first nine months of 2008, as increased numbers of patients in Asia
(particularly in China), the United States, and Central and Eastern Europe were more than offset by
the loss of a government tender in Mexico in the first quarter of 2008. Increased penetration of
PD Therapy products continues to be strong in emerging markets, where many people with end-stage
renal disease are currently under-treated.
HD Therapy
Hemodialysis, or HD Therapy, is another form of end-stage renal disease dialysis therapy that is
generally performed in a hospital or outpatient center. In HD Therapy, the patients blood is
pumped outside the body to be cleansed of wastes and fluid using a machine and an external filter,
also known as a dialyzer. The favorable impact of foreign currency fluctuations in the third
quarter and first nine months of 2008 were partially offset by lower saline sales.
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
TT business on February 28, 2007. See Note 3 for further information.
GROSS MARGIN AND EXPENSE RATIOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
2008 |
|
|
2007 |
|
|
Change |
|
|
2008 |
|
|
2007 |
|
|
Change |
|
|
Gross margin |
|
|
48.3% |
|
|
|
50.0% |
|
|
(1.7 pts |
) |
|
|
49.1% |
|
|
|
48.9% |
|
|
0.2 pts |
|
Marketing and
administrative expenses |
|
|
21.6% |
|
|
|
24.1% |
|
|
(2.5 pts |
) |
|
|
22.0% |
|
|
|
22.6% |
|
|
(0.6 pts |
) |
|
Gross Margin
The gross margin in both the third quarter and the first nine months of 2008 benefited from
continued customer conversion to ADVATE and the liquid formulation of IGIV, manufacturing
efficiencies and improved volumes and pricing for certain plasma protein and other products.
Included in the companys gross margin in 2008 were charges of $125 million related to COLLEAGUE
infusion pumps (with $72 million recorded in the third quarter and $53 million recorded in the
first quarter) and a $19 million charge in the first quarter related to the companys recall of its
heparin products in the United States. These charges decreased the gross margin by 2.3 percentage
points in the third quarter and 1.6 percentage points in the year-to-date period. Refer to Note 4
for further information on these charges. Also negatively impacting the gross margin in both
periods were increased raw material costs.
Marketing and Administrative Expenses
The decline in the marketing and administrative expense ratios for the third quarter and first nine
months of 2008 was principally due to leverage from higher sales, stronger cost controls and the
impact of the third quarter 2007 charge of $56 million to establish reserves related to the average
wholesale pricing (AWP) litigation, partially offset by an increase in stock compensation costs and
spending related to certain marketing programs, particularly in the BioScience segment.
RESEARCH AND DEVELOPMENT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 30, |
|
|
Percent |
|
|
September 30, |
|
|
Percent |
|
(in millions) |
|
2008 |
|
|
2007 |
|
|
change |
|
|
2008 |
|
|
2007 |
|
|
change |
|
|
Research and development (R&D) expenses |
|
|
$230 |
|
|
|
$203 |
|
|
|
13% |
|
|
|
$642 |
|
|
|
$539 |
|
|
|
19% |
|
As a percent of sales |
|
|
7.3% |
|
|
|
7.4% |
|
|
|
|
|
|
|
7.0% |
|
|
|
6.5% |
|
|
|
|
|
|
R&D expenses increased during the third quarter and first nine months of 2008 with strong growth in
spending on R&D projects across all three of the companys businesses, particularly BioScience,
reflecting the companys
21
commitment to accelerate R&D investments. Foreign currency fluctuations also contributed to the
increase in R&D expenses in both periods.
Included in R&D expenses in the third quarter of 2008 was a $12 million in-process R&D (IPR&D)
charge related to an in-licensing agreement with Innocoll Pharmaceuticals Ltd. (Innocoll) to market
and distribute Innocolls gentamicin surgical implant in the United States upon receipt of
regulatory approval. Included in R&D expenses in the third quarter of 2007 was a $25 million IPR&D
charge related to a collaboration for the development of a next-generation home HD machine with
HHD, LLC, and a $10 million IPR&D charge related to an in-licensing arrangement with Halozyme
Therapeutics, Inc. (Halozyme). The nine months ended September 30, 2007 also included an $11
million IPR&D charge relating to the acquisition of certain assets of MAAS Medical, LLC (MAAS
Medical). Refer to Note 2 for additional information regarding the companys in-licensing
agreement with Innocoll and the 2007 Annual Report for a discussion of the companys R&D pipeline,
arrangements with HHD, LLC and Halozyme and the acquisition of MAAS Medical.
2007 RESTRUCTURING CHARGE
During 2007, the company recorded a restructuring charge of $70 million principally associated
with the consolidation of certain commercial and manufacturing operations outside of the United
States. Based upon a review of current and future capacity needs, the company decided to
integrate several facilities in order to reduce the companys cost structure and optimize the
companys operations.
Included in the charge was $17 million related to asset impairments and $53 million for cash
costs, principally pertaining to severance and other employee-related costs. The reserve for cash
costs is expected to be substantially utilized by the end of 2009. Refer to Note 4 for further
information, including reserve utilization through September 30, 2008. The company believes that
the reserves are adequate. However, adjustments may be recorded in the future as the programs are
completed. Cash expenditures are being funded with cash generated from operations.
NET INTEREST EXPENSE
Net interest expense was $20 million and $6 million in the third quarters of 2008 and 2007,
respectively, and $62 million and $10 million for the nine months ended September 30, 2008 and
2007, respectively. The increased expense was driven by lower interest rates and higher average
debt levels, principally due to the December 2007 issuance of $500 million of senior unsecured
notes and the May 2008 issuance of $500 million of senior unsecured notes. The increase in net
interest expense for the nine months ended September 30, 2008 was also driven by lower average cash
balances.
OTHER EXPENSE, NET
Other expense, net was $32 million and $21 million in the third quarters of 2008 and 2007,
respectively, and $36 million and $28 million for the nine-month periods ended September 30, 2008
and 2007, respectively. Other expense, net in both periods included amounts relating to foreign
exchange, minority interests and equity method investments. Included in other expense, net for the
three and nine months ended September 30, 2008 was a third quarter 2008 charge of $31 million
associated with the discontinuation of the companys CLEARSHOT pre-filled syringe program. Also
included in other expense, net for the nine months ended September 30, 2008 and 2007 was income
recognized in the first quarter of 2007 related to the divestiture of the TT business, which
included a gain on the sale of the TT business of $58 million less related charges of $35 million,
and $16 million of income in the first quarter of 2008 related to the finalization of the net
assets transferred in the TT divestiture. See Note 3 for further information on the TT business
divestiture and Note 4 for further information on the CLEARSHOT charge.
PRE-TAX INCOME
Refer to Note 8 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 18% and 21% for the three- and nine-month periods ended September 30,
2008, respectively. The primary drivers of the increase in both periods were the continued
customer conversion to ADVATE and the liquid formulation of IGIV, improved pricing of certain
plasma protein products, manufacturing
22
efficiencies and the favorable impact of foreign currency fluctuations. Partially offsetting this
growth was higher spending on new marketing programs and increased R&D spending related to product
development and milestone payments to partners.
Medication Delivery
Pre-tax income decreased 48% and 22% for the three- and nine-month periods ended September 30,
2008, respectively. The improvements in product mix, with increased sales of certain higher-margin
products such as SUPRANE, sevoflurane and nutritional products, as well as the favorable impact of
foreign currency fluctuations, were more than offset by the impact of special charges and increased
spending on R&D. The nine months ended September 30, 2008 included $125 million of charges related
to the COLLEAGUE infusion pump (with $72 million recorded in the third quarter and $53 million
recorded in the first quarter), a third quarter 2008 charge of $31 million related to the
discontinuation of the CLEARSHOT pre-filled syringe program and a first quarter 2008 charge of $19
million related to the companys recall of its heparin products in the United States. See Note 4
for further information about these charges.
Renal
Pre-tax income decreased 5% and 12% for the three- and nine-month periods ended September 30, 2008,
respectively. The decrease in both periods was principally due to the loss of a PD tender in
Mexico, and increased spending on new product development, including a next-generation home HD
machine, partially offset by the favorable impact of foreign currency fluctuations.
Other
Certain items are maintained at the companys corporate level and are not allocated to the
segments. These items primarily include net interest expense, certain foreign currency
fluctuations and the majority of the foreign currency and interest rate hedging activities, stock
compensation expense, income and expense related to certain non-strategic investments, corporate
headquarters costs, certain employee benefit plan costs, certain nonrecurring gains and losses,
IPR&D charges and income related to the manufacturing, distribution and other transition agreements
with Fenwal. Refer to Note 8 for a reconciliation of segment pre-tax income to income before
income taxes per the consolidated income statements. The significant factors impacting these other
items are described below.
Refer to the discussion above regarding net interest expense, the 2007 restructuring charge, the
AWP charge and IPR&D charges.
The increase in stock compensation expense in the quarter and year-to-date period was principally
due to changes in the companys stock compensation programs, including the granting of performance
share units beginning in 2007 and an amendment to the companys employee stock purchase plan
effective January 1, 2008. Refer to the 2007 Annual Report for further information regarding these
changes.
The increase in other corporate expenses, net in the first nine months of 2008 was primarily driven
by increased legal and other costs held at corporate and the impact of the income in the first
quarter of 2007 related to the divestiture of the TT business, partially offset by income in the
first quarter of 2008 related to the finalization of the net assets transferred in the divestiture
of the TT business. Refer to Note 3 for further information regarding the divestiture of the TT
business.
INCOME TAXES
The companys effective income tax rates were 15.4% and 18.2% in the third quarters of 2008 and
2007, respectively, and were 18.1% and 19.1% in the nine-month periods ended September 30, 2008 and
2007, respectively.
The effective tax rates in the third quarters and first nine months of 2008 and 2007 were impacted
by reductions of $29 million and $57 million, respectively, of valuation allowances on net
operating loss carryforwards in foreign jurisdictions due to profitability improvements, and $14
million and $84 million, respectively, of additional U.S. income tax expense related to foreign earnings which
are no longer considered indefinitely reinvested outside of the United States because management
planned to remit these earnings to the United States in the foreseeable future. Also impacting the
tax rate in the 2007 year-to-date period was the extension of tax incentives and the settlement of
tax audits in jurisdictions outside of the United States.
23
INCOME AND EARNINGS PER DILUTED SHARE
Net income was $472 million and $395 million for the three months ended September 30, 2008 and
2007, respectively, and $1,445 million and $1,229 million for the nine months ended September 30,
2008 and 2007, respectively. Net income per diluted share was $0.74 and $0.61 for the three months
ended September 30, 2008 and 2007, respectively, and $2.26 and $1.87 for the nine months ended
September 30, 2008 and 2007, respectively. The significant factors and events contributing to the
changes are discussed above.
CRITICAL ACCOUNTING POLICIES
The preparation of financial statements in accordance with generally accepted accounting principles
in the United States 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 as of December 31, 2007 is included in Note 1 to the companys consolidated
financial statements in the 2007 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 2007 Annual Report.
LIQUIDITY AND CAPITAL RESOURCES
CASH FLOWS
Cash flows from operating activities
Cash flows from operating activities increased during the first nine months of 2008 as compared to
the prior year, totaling $1,895 million in 2008 and $1,554 million in 2007. The increase in cash
flows was primarily due to higher earnings (before non-cash items) and the other factors discussed
below.
Accounts Receivable
Cash outflows relating to accounts receivable decreased during the first nine months of 2008 as
compared to the prior year. Days sales outstanding improved from 58.7 days at September 30, 2007
to 55.6 days at September 30, 2008, primarily due to improved collection periods in the United
States and certain international locations, partially offset by a decrease in cash proceeds from
the securitization and factoring of receivables, principally due to the termination of the European
securitization arrangement in the fourth quarter of 2007. See the 2007 Annual Report for further
information.
Inventories
Cash outflows relating to inventories decreased in 2008. The following is a summary of inventories
at September 30, 2008 and December 31, 2007, as well as inventory turns for the nine months ended
September 30, 2008 and 2007, by segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Annualized inventory |
|
|
|
Inventories |
|
|
turns for the nine |
|
|
|
September 30, |
|
|
December 31, |
|
|
months ended September 30, |
|
(in millions, except inventory turn data) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
BioScience |
|
$ |
1,368 |
|
|
$ |
1,234 |
|
|
|
1.61 |
|
|
|
1.43 |
|
Medication Delivery |
|
|
857 |
|
|
|
826 |
|
|
|
3.08 |
|
|
|
2.85 |
|
Renal |
|
|
262 |
|
|
|
236 |
|
|
|
4.28 |
|
|
|
4.55 |
|
Other |
|
|
33 |
|
|
|
38 |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
2,520 |
|
|
$ |
2,334 |
|
|
|
2.40 |
|
|
|
2.28 |
|
|
Liabilities, Restructuring Payments and Other
Cash outflows related to liabilities, restructuring payments and other increased in the first nine
months of 2008 as compared to the prior year period, principally driven by the timing of payment of
trade accounts payable and increased payments related to the companys restructuring programs.
Also contributing to the increase in cash outflows were the impact of cash inflows in the first
quarter of 2007 of $52 million resulting from a prepayment relating to the Fenwal manufacturing,
distribution and other transition agreements. Refer to Note 3 for further
24
information regarding the agreements with Fenwal. Further contributing to the increase in cash
outflows were realized excess tax benefits of $28 million associated with stock-based compensation.
Excess tax benefits are presented as an outflow within the operating section and an inflow within
the financing section of the statement of cash flows. No income tax benefits were realized from
stock-based compensation during the first nine months of 2007.
Partially offsetting these increases in cash outflows were the settlements of mirror cross-currency
swaps, which resulted in operating cash inflows of $12 million in the first nine months of 2008 as
compared to cash outflows of $31 million in the first nine months of 2007. Refer to Note 5 for
further information regarding these swaps.
Cash flows from investing activities
Capital Expenditures
Capital expenditures increased $191 million for the nine months ended September 30, 2008, from $424
million in 2007 to $615 million in 2008. The company is investing in various multi-year capital
projects across its three segments, including ongoing projects to upgrade facilities or increase
manufacturing capacity for global injectables, plasma-based (including antibody therapy) and other
products. Foreign currency fluctuations also contributed to the increase in capital expenditures
in both periods.
Acquisitions of and Investments in Businesses and Technologies
Cash outflows relating to acquisitions of and investments in businesses and technologies of $73
million in the first nine months of 2008 principally related to an IV solutions business in China,
the companys in-licensing agreement to market and distribute Innocolls gentamicin surgical
implant in the United States upon receipt of regulatory approval and certain smaller acquisitions
and investments. Also included in the cash outflows in the first nine months of 2008 were payments
related to the companys fourth quarter 2007 agreement with Nycomed Pharma AS (Nycomed) to market
and distribute Nycomeds TachoSil surgical patch in the United States, and a fourth quarter 2007
amendment of the companys exclusive R&D, license and manufacturing agreement with Nektar
Therapeutics (Nektar) to include the use of Nektars proprietary PEGylation technology in the
development of longer-acting forms of blood clotting proteins.
Cash outflows relating to the acquisitions of and investments in businesses and technologies of $83
million in the first nine months of 2007 included $30 million related to the expansion of the
companys existing agreements with Halozyme to include the use of HYLENEX recombinant
(hyaluronidase human injection) with the companys proprietary and non-proprietary small molecule
drugs, $25 million related to the companys collaboration with HHD, LLC for the development of a
next-generation home HD machine, $11 million for the acquisition of certain assets of MAAS Medical,
a company that specializes in infusion systems technology, and $10 million related to an
in-licensing arrangement to apply Halozymes Enhanze technology to the development of a
subcutaneous route of administration for Baxters liquid formulation of IGIV. Refer to the 2007
Annual Report for a discussion of the 2007 arrangements.
Divestitures and Other
Cash inflows relating to divestitures and other in the first nine months of 2008 principally
consisted of cash collections from customers relating to previously securitized receivables. In
the fourth quarter of 2007, the company repurchased the third party interest in receivables
previously sold under the European securitization arrangement, and the European facility was not
renewed. Refer to the 2007 Annual Report for further information.
Cash inflows in the first nine months of 2007 principally related to cash proceeds from the
divestiture of the TT business. Refer to Note 3 for further information. Cash inflows in both
2008 and 2007 also included collections on retained interests associated with securitization
arrangements.
Cash flows from financing activities
Debt Issuances and Payments of Obligations
Net cash outflows relating to debt issuances and payments of obligations in the first nine months
of 2008 totaled $232 million, as compared to $428 million in the prior year period. Debt issuances
in the first nine months of 2008 principally related to the May 2008 issuance of $500 million of
senior unsecured notes, maturing in June 2018 and bearing a 5.375% coupon rate. The net proceeds
were used for general corporate purposes, including the settlement of cross-currency swaps, as
further described below. In addition, during the third quarter of 2008, the company issued
commercial paper, of which $192 million was outstanding as of September 30, 2008.
25
Financing cash outflows for payments of obligations included the settlement of certain
cross-currency swaps of $540 million and $196 million during the first nine months of 2008 and
2007, respectively. Refer to Note 5 and the 2007 Annual Report for further information regarding
these swaps. Payments of obligations for the nine months ended September 30, 2008 also included
the repayment of the companys 5.196% notes, which approximated $250 million, upon their maturity
in February 2008. Financing cash outflows in the first nine months of 2008 and 2007 included other
payments of obligations totaling $152 million and $305 million, respectively.
Other Financing Activities
Cash dividend payments totaled $411 million in the first nine months of 2008 and $598 million in
the first nine months of 2007. Beginning in 2007, the company converted from an annual to a
quarterly dividend payment and increased the dividend by 15% on an annualized basis, to $0.1675 per
share per quarter. The final annual dividend of $380 million was paid in January 2007, and the
first quarterly dividend of $109 million was paid in the second quarter of 2007. In the first nine
months of 2008, the company paid quarterly dividends of $0.2175 per share ($0.87 per share on an
annualized basis), which represented an increase of 30% over the previous quarterly rate of $0.1675
per share.
Cash proceeds from stock issued under employee benefit plans increased by $47 million, from $500
million in the first nine months of 2007 to $547 million in the first nine months of 2008,
primarily driven by an increased participation in the companys employee stock purchase plans in
2008 and an increase in excess tax benefits related to stock options.
Stock repurchases totaled $1.52 billion in the first nine months of 2008 as compared to $1.64
billion in the prior year period. 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 current
market conditions. In March 2008, the board of directors authorized the repurchase of up to an
additional $2.0 billion of the companys common stock. At September 30, 2008, $1.6 billion
remained available under the March 2008 authorization.
CREDIT FACILITIES, ACCESS TO CAPITAL AND CREDIT RATINGS
Credit facilities
The companys primary revolving credit facility has a maximum capacity of $1.5 billion and matures
in December 2011. The company also maintains a credit facility denominated in Euros with a maximum
capacity of approximately $435 million at September 30, 2008, which matures in January 2013. The
companys 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, 2008, 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,
2008. 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 the
2007 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 $2.2 billion of cash and equivalents at September 30, 2008. The company invests its
excess cash in certificates of deposit and money market funds, and diversifies the concentration of
cash among different financial institutions.
The global financial markets have recently experienced unprecedented levels of volatility. The
companys ability to generate cash flows from operations, issue debt or enter into other financing
arrangements on acceptable terms could be adversely affected if there is a material decline in the
demand for the companys products or in the solvency of its customers or suppliers, deterioration
in the companys key financial ratios or credit ratings, or other significantly unfavorable changes
in conditions. In addition, continuing volatility in the global financial markets could increase
borrowing costs or affect the companys ability to access the capital markets. However, the
company believes it has sufficient financial flexibility in the future to issue debt, enter into
other financing arrangements, and attract long-term capital on acceptable terms to support the
companys growth objectives.
26
Credit ratings
There were no changes in the companys debt ratings in the first nine months of 2008. As a result
of the termination of the companys remaining net investment hedge portfolio in the third quarter
of 2008, the company is no longer party to any agreement whereby the counterparty financial
institution can terminate or accelerate the maturity date of a financial instrument solely due to
unfavorable changes in the companys credit ratings. Refer to Note 5 for further information
regarding the companys net investment hedges.
LEGAL CONTINGENCIES
Refer to Note 7 for a discussion of the companys legal contingencies. Upon resolution of any of
these uncertainties, the company may incur charges in excess of presently established liabilities.
While the liability of the company in connection with the claims cannot be estimated with any
certainty, and although the resolution in any reporting period of one or more of these matters
could have a significant impact on the companys results of operations 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
The company began to hold shipments of COLLEAGUE infusion pumps in July 2005, and continues to hold
shipments of new pumps in the United States. Following a number of Class I recalls (recalls at the
highest priority level for the U.S. Food and Drug Administration (FDA)) relating to the performance
of the pumps, as well as the seizure litigation described in Note 7, the company entered into a
Consent Decree in June 2006 outlining the steps the company must take to resume sales of new pumps
in the United States. Additional Class I recalls related to remediation and repair and maintenance
activities were addressed by the company in 2007. The Consent Decree provides for reviews of the
companys facilities, processes and controls by the companys outside expert, followed by the FDA.
In December 2007, following the outside experts review, the FDA inspected and remains in a
dialogue with the company with respect to observations from its inspection as well as the
validation of modifications to the pump required to be completed in order to secure approval for
recommercialization.
As previously disclosed, the company received a Warning Letter from the FDA in March 2005 regarding
observations, primarily related to dialysis equipment, that arose from the FDAs inspection of the
companys manufacturing facility located in Largo, Florida. During 2007, the FDA re-inspected the
Largo manufacturing facility and, in a follow-up regulatory meeting, indicated that a number of
observations remain open.
In the first quarter of 2008, the company identified an increasing level of allergic-type and
hypotensive adverse reactions occurring in patients using its heparin sodium injection products in
the United States. The company initiated a field corrective action with respect to the products;
however, due to users needs for the products, the company and the FDA concluded that public health
considerations warranted permitting selected dosages of the products to remain in distribution for
use where medically necessary until alternate sources became available in the quarter, at which
time the companys products were removed from distribution.
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 any other product may not be
adversely affected, or that additional legislation or regulation will not be introduced that may
adversely affect the companys operations. Please see Item 1A. Risk Factors in the companys
Form 10-K for the year ended December 31, 2007 for additional discussion of regulatory matters.
NEW ACCOUNTING STANDARDS
SFAS No. 161
In March 2008, the Financial Accounting Standards Board (FASB) issued Statement of Financial
Accounting Standards (SFAS) No. 161, Disclosures about Derivative Instruments and Hedging
Activities, an amendment of FASB Statement No. 133 (SFAS No. 161). The standard expands the
disclosure requirements of SFAS No. 133, Accounting for Derivative Instruments and Hedging
Activities, and requires qualitative disclosures about the objectives and strategies for using
derivatives, quantitative disclosures about the fair value amounts of and gains and losses on
derivative instruments, and disclosures about credit-risk-related contingent features in derivative
27
agreements. The company is in the process of analyzing this new standard, which will be effective
for disclosures made by the company in the first quarter of 2009.
SFAS No. 160
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated Financial
Statements, an amendment of ARB No. 51 (SFAS No. 160). The new standard changes the accounting
and reporting of noncontrolling interests, which have historically been referred to as minority
interests. SFAS No. 160 requires that noncontrolling interests be presented in the consolidated
balance sheets within shareholders equity, but separate from the parents equity, and that the
amount of consolidated net income attributable to the parent and to the noncontrolling interest be
clearly identified and presented in the consolidated statements of income. Any losses in excess of
the noncontrolling interests equity interest will continue to be allocated to the noncontrolling
interest. Purchases or sales of equity interests that do not result in a change of control will be
accounted for as equity transactions. Upon a loss of control, the interest sold, as well as any
interest retained, will be measured at fair value, with any gain or loss recognized in earnings.
In partial acquisitions, when control is obtained, the acquiring company will recognize, at fair
value, 100% of the assets and liabilities, including goodwill, as if the entire target company had
been acquired. SFAS No. 160 is effective for fiscal years, and interim periods within those fiscal
years, beginning on or after December 15, 2008, with early adoption prohibited. The new standard
will be applied prospectively, except for the presentation and disclosure requirements, which will
be applied retrospectively for all periods presented. The company is in the process of analyzing
the standard, which will be adopted by the company at the beginning of 2009.
SFAS No. 141-R
In December 2007, the FASB issued SFAS No. 141 (revised 2007), Business Combinations (SFAS No.
141-R). The new standard changes the accounting for business combinations in a number of
significant respects. The key changes include the expansion of transactions that will qualify as
business combinations, the capitalization of IPR&D as an indefinite-lived asset, the recognition
of certain acquired contingent assets and liabilities at fair value, the expensing of acquisition
costs, the expensing of costs associated with restructuring the acquired company, the recognition
of contingent consideration at fair value on the acquisition date, and the recognition of
post-acquisition date changes in deferred tax asset valuation allowances and acquired income tax
uncertainties as income tax expense or benefit. SFAS No. 141-R is effective for business
combinations that close in years beginning on or after December 15, 2008, with early adoption
prohibited. The company will adopt this standard at the beginning of 2009.
SFAS No. 157
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS No. 157), which
clarifies the definition of fair value whenever another standard requires or permits assets or
liabilities to be measured at fair value. Specifically, the standard clarifies that fair value
should be based on the assumptions market participants would use when pricing the asset or
liability, and establishes a fair value hierarchy that prioritizes the information used to develop
those assumptions. SFAS No. 157 does not expand the use of fair value to any new circumstances,
and must be applied on a prospective basis except in certain cases. The standard also requires
expanded financial statement disclosures about fair value measurements, including disclosure of
the methods used and the effect on earnings.
In February 2008, FASB Staff Position (FSP) FAS No. 157-2, Effective Date of FASB Statement No.
157 (FSP No. 157-2) was issued. FSP No. 157-2 defers the effective date of SFAS No. 157 to
fiscal years beginning after December 15, 2008, and interim periods within those fiscal years, for
all nonfinancial assets and liabilities, except those that are recognized or disclosed at fair
value in the financial statements on a recurring basis (at least annually). Examples of items
within the scope of FSP No. 157-2 are nonfinancial assets and nonfinancial liabilities initially
measured at fair value in a business combination (but not measured at fair value in subsequent
periods), and long-lived assets, such as property, plant and equipment and intangible assets
measured at fair value for an impairment assessment under SFAS No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets.
The partial adoption of SFAS No. 157 on January 1, 2008 with respect to financial assets and
financial liabilities recognized or disclosed at fair value in the financial statements on a
recurring basis did not have a material impact on the companys consolidated financial statements.
See Note 5 for the fair value measurement disclosures for these assets and liabilities. The
company is in the process of analyzing the potential impact of SFAS No. 157 relating to its
planned January 1, 2009 adoption of the remainder of the standard.
28
FORWARD-LOOKING INFORMATION
This quarterly report includes forward-looking statements, including accounting estimates and
assumptions, litigation outcomes, statements with respect to infusion pumps, heparin and other
regulatory matters, expectations with respect to restructuring and acquisition activities,
strategic plans, sales and pricing forecasts, estimates of liabilities, management of currency
risk, future capital and R&D expenditures, the sufficiency of the companys financial flexibility
and the adequacy of reserves, statements with respect to ongoing cash flows from the TT business,
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
IGIV, and other therapies; |
|
|
|
|
the companys ability to identify business development and growth opportunities for
existing products and to exit low-margin businesses or products; |
|
|
|
|
product quality or patient safety issues, leading to product recalls, withdrawals,
launch delays, sanctions, seizures, litigation, or declining sales, including with respect
to the companys heparin products; |
|
|
|
|
future actions of regulatory bodies and other government authorities 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 pumps; |
|
|
|
|
fluctuations in the balance between supply and demand with respect to the market for
plasma protein products; |
|
|
|
|
reimbursement policies of government agencies and private payers; |
|
|
|
|
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; |
|
|
|
|
foreign currency fluctuations, particularly due to reduced benefits from the companys
natural hedges and limitations on the ability to cost-effectively hedge resulting from the
recent financial market and currency volatility; |
|
|
|
|
global regulatory, trade and tax policies; |
|
|
|
|
actions by tax authorities in connection with ongoing tax audits; |
|
|
|
|
the companys ability to realize the anticipated benefits of restructuring initiatives; |
|
|
|
|
change in credit agency ratings; |
|
|
|
|
any impact of the commercial and credit environment on the company and its customers; |
|
|
|
|
continued developments in the market for transfusion therapies products and Fenwals
ability to execute with respect to the acquired business; and |
|
|
|
|
other factors identified elsewhere in this report and other filings with the Securities
and Exchange Commission, including those factors described under the caption Item 1A. Risk
Factors in the companys Form 10-K for the year ended December 31, 2007, 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.
29
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Currency Risk
The company is primarily exposed to foreign exchange risk with respect to firm commitments,
forecasted transactions and net assets denominated in the Euro, Japanese Yen, British Pound, Swiss
Franc, Australian Dollar, Brazilian Real, Colombian Peso and Mexican 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 earnings and
shareholders equity volatility relating to foreign exchange.
The company uses option and forward contracts to hedge the foreign exchange risk to earnings
relating to firm commitments and forecasted transactions denominated in foreign currencies. The
company enters into derivative instruments to hedge certain intercompany and third-party
receivables, payables and debt denominated in foreign currencies. The company has also
historically hedged certain of its net investments in international affiliates, using a combination
of debt denominated in foreign currencies and cross-currency swap agreements. As further discussed
in Note 5, in the third quarter of 2008, the company terminated all of its remaining net investment
hedges. The recent 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.
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 hedge contracts outstanding
at September 30, 2008, while not predictive in nature, indicated that if the U.S. Dollar uniformly
fluctuated unfavorably by 10% against all currencies, on a net-of-tax basis, the net liability
balance of $25 million, which principally related to a hedge of U.S. Dollar-denominated debt issued
by a foreign subsidiary, would increase by $82 million.
The sensitivity analysis model recalculates the fair value of the foreign currency option, forward
and cross-currency swap contracts outstanding at September 30, 2008 by replacing the actual
exchange rates at September 30, 2008 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 Financial Instrument Market Risk in the companys 2007 Annual Report. There
were no significant changes during the quarter ended September 30, 2008.
30
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, 2008. Baxters disclosure controls and procedures are designed to ensure that
information required to be disclosed by Baxter in the reports it files or submits under the
Exchange Act is recorded, processed, summarized and reported on a timely basis and that such
information is communicated to management, including the Chief Executive Officer, Chief Financial
Officer and its Board of Directors to allow timely decisions regarding required disclosure.
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, 2008.
Changes in Internal Control over Financial Reporting
There has been no change in Baxters internal control over financial reporting (as such term is
defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended September
30, 2008 that has materially affected, or is reasonably likely to materially affect, Baxters
internal control over financial reporting.
31
Review by Independent Registered Public Accounting Firm
Reviews of the interim condensed consolidated financial information included in this Quarterly
Report on Form 10-Q for the three and nine months ended September 30, 2008 and 2007, respectively,
have been performed by PricewaterhouseCoopers LLP, the companys independent registered public
accounting firm. Its report on the interim condensed consolidated financial information follows.
This report is not considered a report within the meaning of Sections 7 and 11 of the Securities
Act of 1933 and therefore, the independent accountants liability under Section 11 does not extend
to it.
32
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, 2008, and the related condensed consolidated statements of
income for each of the three-month and nine-month periods ended September 30, 2008 and 2007 and the
condensed consolidated statements of cash flows for the nine-month periods ended September 30, 2008
and 2007. 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, 2007, and the related
consolidated statements of income, cash flows and shareholders equity and comprehensive income for
the year then ended, and in our report dated February 26, 2008, we expressed an unqualified opinion
on those consolidated financial statements. The consolidated financial statements referred to
above are not presented herein. In our opinion, the information set forth in the accompanying
condensed consolidated balance sheet as of December 31, 2007, 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
October 31, 2008
33
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
The information in Part I, Item 1, Note 7 is incorporated herein by reference.
34
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, 2008.
Issuer Purchases of Equity Securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Approximate Dollar Value of |
|
|
|
Total Number |
|
|
|
|
|
|
Total Number of Shares |
|
|
Shares that May Yet Be |
|
|
|
of Shares |
|
|
Average Price |
|
|
Purchased as Part of Publicly |
|
|
Purchased Under the |
|
Period |
|
Purchased (1)(2) |
|
|
Paid per Share |
|
|
Announced Programs (1)(2) |
|
|
Program (2) |
|
|
July 1, 2008
through July 31, 2008 |
|
|
1,343,559 |
|
|
$ |
65.86 |
|
|
|
1,343,559 |
|
|
|
|
|
August 1, 2008
through August 31, 2008 |
|
|
5,736,344 |
|
|
|
69.73 |
|
|
|
5,736,344 |
|
|
|
|
|
September 1, 2008
through September 30, 2008 |
|
|
1,462,297 |
|
|
|
68.38 |
|
|
|
1,462,297 |
|
|
|
|
|
|
Total |
|
|
8,542,200 |
|
|
$ |
68.89 |
|
|
|
8,542,200 |
|
|
$ |
1,629,437,930 |
|
|
|
|
|
(1) |
|
On March 13, 2007, the company announced that its board of directors authorized the company
to repurchase up to $2.0 billion of its common stock on the open market. During the third
quarter of 2008, the company repurchased 3.2 million shares in open market purchases for $218
million under this program. No amount remains under this authorization at September 30, 2008. |
|
(2) |
|
On March 18, 2008, the company announced that its board of directors authorized the company
to repurchase up to an additional $2.0 billion of its common stock on the open market. During
the third quarter of 2008, the company repurchased 5.3 million shares in open market purchases
for $371 million under this program, and the remaining authorization totaled $1.6 billion at
September 30, 2008. This program does not have an expiration date. |
35
Item 6. Exhibits
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 |
36
Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
|
|
|
|
|
BAXTER INTERNATIONAL INC. |
|
|
|
|
|
|
|
|
|
|
|
|
|
(Registrant) |
|
|
|
|
|
|
|
|
|
Date: October 31, 2008
|
|
By:
|
|
/s/ Robert M. Davis |
|
|
|
|
|
|
|
|
|
|
|
|
|
Robert M. Davis |
|
|
|
|
|
|
Corporate Vice President and Chief Financial Officer |
|
|
|
|
|
|
(duly authorized officer and principal financial officer)
|
|
|
37