Attached files
file | filename |
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8-K - FORM 8K DATED DECEMBER 10, 2009 - BOSTON SCIENTIFIC CORP | form8-k_16657.htm |
EX-23 - CONSENT OF ERNST & YOUNG LLP - BOSTON SCIENTIFIC CORP | exhibit23_16657.htm |
EX-99.2 - ITEM 7. MD&A - BOSTON SCIENTIFIC CORP | exhibit99-2_16657.htm |
EX-99.1 - ITEM 1. BUSINESS - BOSTON SCIENTIFIC CORP | exhibit99-1_16657.htm |
EXHIBIT
99.3
Report
of Independent Registered Public Accounting Firm
The
Board of Directors and Shareholders of Boston Scientific
Corporation
We
have audited the accompanying consolidated balance sheets of Boston Scientific
Corporation as of December 31, 2008 and 2007, and the related consolidated
statements of operations, stockholders’ equity, and cash flows for each of the
three years in the period ended December 31, 2008. Our audits also
included the accompanying financial statement schedule. These
financial statements and schedule are the responsibility of the Company's
management. Our responsibility is to express an opinion on these
financial statements and schedule based on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In
our opinion, the financial statements referred to above present fairly, in all
material respects, the consolidated financial position of Boston Scientific
Corporation at December 31, 2008 and 2007, and the consolidated results of its
operations and its cash flows for each of the three years in the period ended
December 31, 2008, in conformity with U.S. generally accepted accounting
principles. Also in our opinion, the related financial statement
schedule, when considered in relation to the basic financial statements taken as
a whole, presents fairly in all material respects the information set forth
therein.
As
discussed in Note K to the accompanying consolidated financial statements,
effective January 1, 2007, the Company adopted Financial Accounting
Standards Board (FASB) Interpretation No. 48, Accounting for
Uncertainty in Income Taxes.
We
also have audited, in accordance with the standards of the Public Company
Accounting Oversight Board (United States), Boston Scientific Corporation’s
internal control over financial reporting as of December 31, 2008, based on
criteria established in Internal Control-Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission and our report
dated February 24, 2009, expressed an unqualified opinion thereon.
/s/
Ernst & Young LLP
Boston,
Massachusetts
February
24, 2009
except
for Notes E and P, as to which
the
date is November 25, 2009
ITEM
8.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
CONSOLIDATED STATEMENTS OF
OPERATIONS
(in
millions, except per share data)
|
Year
Ended December 31,
|
|||||||||||
2008
|
2007
|
2006
|
||||||||||
Net
sales
|
$ | 8,050 | $ | 8,357 | $ | 7,821 | ||||||
Cost
of products sold
|
2,469 | 2,342 | 2,207 | |||||||||
Gross
profit
|
5,581 | 6,015 | 5,614 | |||||||||
Operating
expenses:
|
||||||||||||
Selling,
general and administrative expenses
|
2,589 | 2,909 | 2,675 | |||||||||
Research
and development expenses
|
1,006 | 1,091 | 1,008 | |||||||||
Royalty
expense
|
203 | 202 | 231 | |||||||||
Amortization
expense
|
543 | 620 | 474 | |||||||||
Goodwill
and intangible asset impairment charges
|
2,790 | 21 | 56 | |||||||||
Acquisition-related
milestone
|
(250 | ) | ||||||||||
Purchased
research and development
|
43 | 85 | 4,119 | |||||||||
Gain
on divestitures
|
(250 | ) | ||||||||||
Loss
on assets held for sale
|
560 | |||||||||||
Restructuring
charges
|
78 | 176 | ||||||||||
Litigation-related
charges
|
334 | 365 | ||||||||||
7,086 | 6,029 | 8,563 | ||||||||||
Operating
loss
|
(1,505 | ) | (14 | ) | (2,949 | ) | ||||||
Other
income (expense)
|
||||||||||||
Interest
expense
|
(468 | ) | (570 | ) | (435 | ) | ||||||
Fair-value
adjustment for the sharing of proceeds feature of
the Abbott Laboratories stock purchase
|
(8 | ) | (95 | ) | ||||||||
Other,
net
|
(58 | ) | 23 | (56 | ) | |||||||
Loss
before income taxes
|
(2,031 | ) | (569 | ) | (3,535 | ) | ||||||
Income
tax expense (benefit)
|
5 | (74 | ) | 42 | ||||||||
Net
loss
|
$ | (2,036 | ) | $ | (495 | ) | $ | (3,577 | ) | |||
Net
loss per common share
|
||||||||||||
Basic
|
$ | (1.36 | ) | $ | (0.33 | ) | $ | (2.81 | ) | |||
Assuming
dilution
|
$ | (1.36 | ) | $ | (0.33 | ) | $ | (2.81 | ) | |||
Weighted-average
shares outstanding:
|
||||||||||||
Basic
|
1,498.5 | 1,486.9 | 1,273.7 | |||||||||
Assuming
dilution
|
1,498.5 | 1,486.9 | 1,273.7 | |||||||||
(See
notes to the consolidated financial statements)
CONSOLIDATED BALANCE
SHEETS
As
of December 31,
|
||||||||
(in
millions)
|
2008
|
2007
|
||||||
ASSETS
|
||||||||
Current
assets
|
||||||||
Cash
and cash equivalents
|
$ | 1,641 | $ | 1,452 | ||||
Trade
accounts receivable, net
|
1,402 | 1,502 | ||||||
Inventories
|
853 | 725 | ||||||
Deferred
income taxes
|
911 | 679 | ||||||
Assets
held for sale
|
13 | 1,119 | ||||||
Prepaid
expenses and other current assets
|
632 | 464 | ||||||
Total
current assets
|
$ | 5,452 | $ | 5,941 | ||||
Property,
plant and equipment, net
|
1,728 | 1,715 | ||||||
Investments
|
113 | 317 | ||||||
Other
assets
|
181 | 157 | ||||||
Intangible
assets
|
||||||||
Goodwill
|
12,421 | 15,103 | ||||||
Core
and developed technology, net
|
6,363 | 6,978 | ||||||
Patents,
net
|
300 | 322 | ||||||
Other
intangible assets, net
|
581 | 664 | ||||||
Total
intangible assets
|
19,665 | 23,067 | ||||||
Total
assets
|
$ | 27,139 | $ | 31,197 | ||||
(See
notes to the consolidated financial statements)
CONSOLIDATED BALANCE
SHEETS
As
of December 31,
|
||||||||
(in
millions, except share data)
|
2008
|
2007
|
||||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||||||
Current
liabilities
|
||||||||
Current
debt obligations
|
$ | 2 | $ | 256 | ||||
Accounts
payable
|
239 | 139 | ||||||
Accrued
expenses
|
2,612 | 2,541 | ||||||
Income
taxes payable
|
161 | 122 | ||||||
Liabilities
associated with assets held for sale
|
39 | |||||||
Other
current liabilities
|
219 | 153 | ||||||
Total
current liabilities
|
$ | 3,233 | $ | 3,250 | ||||
Long-term
debt
|
6,743 | 7,933 | ||||||
Deferred
income taxes
|
2,262 | 2,284 | ||||||
Other
long-term liabilities
|
1,727 | 2,633 | ||||||
Commitments
and contingencies
|
||||||||
Stockholders’
equity
|
||||||||
Preferred
stock, $ .01 par value — authorized 50,000,000 shares,
none issued and outstanding
|
||||||||
Common
stock, $ .01 par value — authorized 2,000,000,000 shares and
issued 1,501,635,679 at December
31, 2008 and 1,491,234,911 shares
at December 31, 2007
|
15 | 15 | ||||||
Additional
paid-in capital
|
15,944 | 15,788 | ||||||
Deferred
cost, ESOP
|
(22 | ) | ||||||
Retained
deficit
|
(2,732 | ) | (693 | ) | ||||
Accumulated
other comprehensive income (loss), net of tax
|
||||||||
Foreign
currency translation adjustment
|
(13 | ) | 54 | |||||
Unrealized
gain on available-for-sale securities
|
16 | |||||||
Unrealized
loss on derivative financial instruments
|
(26 | ) | (59 | ) | ||||
Unrealized
costs associated with certain retirement plans
|
(14 | ) | (2 | ) | ||||
Total
stockholders’ equity
|
13,174 | 15,097 | ||||||
$ | 27,139 | $ | 31,197 |
(See
notes to the consolidated financial statements)
CONSOLIDATED STATEMENTS OF
STOCKHOLDERS’ EQUITY (in millions, except share data)
Common
Stock
|
Additional
Paid-In
|
Deferred
|
Deferred
Cost, ESOP
|
Treasury
|
Retained
Earnings
|
Accumulated
Other
Comprehensive
|
Comprehensive
Income
|
|||||||||||||||||||||||||||||||||
Shares
Issued
|
Par
Value
|
Capital
|
Compensation
|
Shares
|
Amount
|
Stock
|
(Deficit)
|
Income
(Loss)
|
(Loss)
|
|||||||||||||||||||||||||||||||
Balance
at January 1, 2006
|
844,565,292 | $ | 8 | $ | 1,658 | $ | (98 | ) | $ | (717 | ) | $ | 3,410 | $ | 21 | |||||||||||||||||||||||||
Comprehensive
income
|
||||||||||||||||||||||||||||||||||||||||
Net
loss
|
(3,577 | ) | $ | (3,577 | ) | |||||||||||||||||||||||||||||||||||
Other
comprehensive income (loss), net of tax
|
||||||||||||||||||||||||||||||||||||||||
Foreign
currency translation adjustment
|
87 | 87 | ||||||||||||||||||||||||||||||||||||||
Net
change in available-for-sale investments
|
(10 | ) | (10 | ) | ||||||||||||||||||||||||||||||||||||
Net
change in derivative financial instruments
|
(35 | ) | (35 | ) | ||||||||||||||||||||||||||||||||||||
Net
change in certain retirement amounts
|
(6 | ) | (6 | ) | ||||||||||||||||||||||||||||||||||||
Issuance
of shares of common stock for Guidant acquisition
|
577,206,996 | 6 | 12,508 | |||||||||||||||||||||||||||||||||||||
Conversion
of outstanding Guidant stock options
|
450 | |||||||||||||||||||||||||||||||||||||||
Issuance
of shares of common stock to Abbott
|
64,631,157 | 1 | 1,399 | |||||||||||||||||||||||||||||||||||||
Impact
of stock-based compensation plans, net of tax
|
(214 | ) | 98 | 383 | ||||||||||||||||||||||||||||||||||||
Step-up
accounting adjustment for certain investments
|
(7 | ) | ||||||||||||||||||||||||||||||||||||||
Acquired
401(k) ESOP for legacy Guidant employees
|
3,794,965 | $ | (86 | ) | ||||||||||||||||||||||||||||||||||||
401(k)
ESOP transactions
|
(9 | ) | (1,237,662 | ) | 28 | |||||||||||||||||||||||||||||||||||
Balance
at December 31, 2006
|
1,486,403,445 | $ | 15 | $ | 15,792 | $ | — | 2,557,303 | $ | (58 | ) | $ | (334 | ) | $ | (174 | ) | $ | 57 | $ | (3,541 | ) | ||||||||||||||||||
Comprehensive
income
|
||||||||||||||||||||||||||||||||||||||||
Net
loss
|
(495 | ) | $ | (495 | ) | |||||||||||||||||||||||||||||||||||
Other
comprehensive income (loss), net of tax
|
||||||||||||||||||||||||||||||||||||||||
Foreign
currency translation adjustment
|
38 | 38 | ||||||||||||||||||||||||||||||||||||||
Net
change in derivative financial instruments
|
(91 | ) | (91 | ) | ||||||||||||||||||||||||||||||||||||
Net
change in certain retirement amounts
|
5 | 5 | ||||||||||||||||||||||||||||||||||||||
Cumulative
effect adjustment for adoption of
Interpretation
No. 48
|
(26 | ) | ||||||||||||||||||||||||||||||||||||||
Common
stock issued for acquisitions
|
(52 | ) | 142 | |||||||||||||||||||||||||||||||||||||
Impact
of stock-based compensation plans, net of tax
|
4,831,466 | 61 | 192 | |||||||||||||||||||||||||||||||||||||
401(k)
ESOP transactions
|
(13 | ) | (1,605,737 | ) | 36 | |||||||||||||||||||||||||||||||||||
Other
|
2 | |||||||||||||||||||||||||||||||||||||||
Balance
at December 31, 2007
|
1,491,234,911 | $ | 15 | $ | 15,788 | 951,566 | $ | (22 | ) | $ | — | $ | (693 | ) | $ | 9 | $ | (543 | ) | |||||||||||||||||||||
Comprehensive
income
|
||||||||||||||||||||||||||||||||||||||||
Net
loss
|
(2,036 | ) | $ | (2,036 | ) | |||||||||||||||||||||||||||||||||||
Other
comprehensive income (loss), net of tax
|
||||||||||||||||||||||||||||||||||||||||
Foreign
currency translation adjustment
|
(67 | ) | (67 | ) | ||||||||||||||||||||||||||||||||||||
Net
change in available-for-sale investments
|
(16 | ) | (16 | ) | ||||||||||||||||||||||||||||||||||||
Net
change in derivative financial instruments
|
33 | 33 | ||||||||||||||||||||||||||||||||||||||
Net
change in certain retirement amounts
|
(12 | ) | (12 | ) | ||||||||||||||||||||||||||||||||||||
Impact
of stock-based compensation plans, net of tax
|
10,400,768 | 166 | ||||||||||||||||||||||||||||||||||||||
401(k)
ESOP transactions
|
(10 | ) | (951,566 | ) | 22 | |||||||||||||||||||||||||||||||||||
Other
|
(3 | ) | ||||||||||||||||||||||||||||||||||||||
Balance
at December 31, 2008
|
1,501,635,679 | $ | 15 | $ | 15,944 | — | $ | — | $ | (2,732 | ) | $ | (53 | ) | $ | (2,098 | ) |
(See
notes to the consolidated financial statements)
CONSOLIDATED
STATEMENTS OF CASH FLOWS
Year
Ended December 31,
|
||||||||||||
in
millions
|
2008
|
2007
|
2006
|
|||||||||
Operating
Activities
|
||||||||||||
Net
loss
|
$ | (2,036 | ) | $ | (495 | ) | $ | (3,577 | ) | |||
Adjustments
to reconcile net loss to cash provided by operating
activities:
|
||||||||||||
Depreciation
and amortization
|
864 | 918 | 725 | |||||||||
Deferred
income taxes
|
(334 | ) | (386 | ) | (420 | ) | ||||||
Stock-based
compensation expense
|
138 | 122 | 113 | |||||||||
Net
loss on investments and notes recievable
|
78 | 54 | 109 | |||||||||
Goodwill
and intangible asset impairments
|
2,790 | 21 | 56 | |||||||||
Purchased
research and development
|
43 | 85 | 4,119 | |||||||||
Gain
on divestitures
|
(250 | ) | ||||||||||
Loss
on assets held for sale
|
560 | |||||||||||
Fair-value
adjustment for sharing of proceeds feature of Abbott stock
purchase
|
8 | 95 | ||||||||||
Step-up
value of acquired inventory sold
|
267 | |||||||||||
Increase
(decrease) in cash flows from operating assets and liabilities,
excluding the effect of acquisitions and assets held for
sale:
|
||||||||||||
Trade
accounts receivable
|
96 | (72 | ) | 64 | ||||||||
Inventories
|
(120 | ) | (30 | ) | (53 | ) | ||||||
Prepaid
expenses and other assets
|
(21 | ) | (43 | ) | 79 | |||||||
Accounts
payable and accrued expenses
|
392 | 45 | (1 | ) | ||||||||
Income
taxes payable and other liabilities
|
(416 | ) | 125 | 234 | ||||||||
Other,
net
|
(8 | ) | 22 | 35 | ||||||||
Cash
provided by operating activities
|
1,216 | 934 | 1,845 | |||||||||
Investing
Activities
|
||||||||||||
Property,
plant and equipment
|
||||||||||||
Purchases
|
(362 | ) | (363 | ) | (341 | ) | ||||||
Proceeds
on disposals
|
2 | 30 | 18 | |||||||||
Acquisitions
|
||||||||||||
Payments
for acquisitions of businesses, net of cash acquired
|
(21 | ) | (13 | ) | (8,686 | ) | ||||||
Payments
relating to prior period acquisitions
|
(675 | ) | (248 | ) | (397 | ) | ||||||
Other
investing activity
|
||||||||||||
Proceeds
from business divestitures
|
1,287 | |||||||||||
Payments
for investments in privately held companies and acquisitions of certain
technologies
|
(56 | ) | (123 | ) | (98 | ) | ||||||
Proceeds
from sales of investments in, and collections of notes receivable from,
investment portfolio companies
|
149 | 243 | 33 | |||||||||
Proceeds
from maturities of marketable securities
|
159 | |||||||||||
Cash
provided by (used for) investing activities
|
324 | (474 | ) | (9,312 | ) | |||||||
Financing
Activities
|
||||||||||||
Debt
|
||||||||||||
Payments
on notes payable, capital leases and long-term borrowings
|
(1,175 | ) | (1,000 | ) | (1,510 | ) | ||||||
Net
(payments on) proceeds from borrowings on credit and security
facilities
|
(250 | ) | 246 | 3 | ||||||||
Proceeds
from notes payable and long-term borrowings, net of debt issuance
costs
|
8,544 | |||||||||||
Net
payments on commercial paper
|
(149 | ) | ||||||||||
Equity
|
||||||||||||
Proceeds
from issuances of shares of common stock
|
71 | 132 | 145 | |||||||||
Excess
tax benefit relating to stock options
|
4 | 2 | 7 | |||||||||
(Payments)
proceeds related to issuance of shares of common stock to
Abbott
|
(60 | ) | 1,400 | |||||||||
Other,
net
|
(1 | ) | ||||||||||
Cash
(used for) provided by financing activities
|
(1,350 | ) | (680 | ) | 8,439 | |||||||
Effect
of foreign exchange rates on cash
|
(1 | ) | 4 | 7 | ||||||||
Net
increase (decrease) in cash and cash equivalents
|
189 | (216 | ) | 979 | ||||||||
Cash
and cash equivalents at beginning of year
|
1,452 | 1,668 | 689 | |||||||||
Cash
and cash equivalents at end of year
|
$ | 1,641 | $ | 1,452 | $ | 1,668 |
Year
Ended December 31,
|
||||||||||||
SUPPLEMENTAL
INFORMATION:
|
2008
|
2007
|
2006
|
|||||||||
Cash
paid for income taxes
|
$ | 468 | $ | 475 | $ | 199 | ||||||
Cash
paid for interest
|
414 | 543 | 383 | |||||||||
Non-cash investing
activities:
|
||||||||||||
Stock
and stock equivalents issued for acquisitions
|
$ | 90 | $ | 12,964 | ||||||||
Non-cash financing
activities:
|
||||||||||||
Capital
lease arrangements
|
$ | 31 |
(See
notes to the consolidated financial statements)
Principles
of Consolidation
Our
consolidated financial statements include the accounts of Boston Scientific
Corporation and our subsidiaries, all of which we wholly own. We consider the
principles of Financial Accounting Standards Board (FASB) Interpretation
No. 46(R), Consolidation
of Variable Interest Entities; Accounting Research Bulletin No. 51,
Consolidation of Financial
Statements, and FASB Statement No. 94, Consolidation of All Majority-Owned
Subsidiaries, when evaluating whether an entity is subject to
consolidation. We assess the terms of our investment interests in entities to
determine if any of our investees meet the definition of a variable interest
entity (VIE) under Interpretation No. 46(R). We consolidate any VIEs in which we
are the primary beneficiary. Our evaluation considers both qualitative and
quantitative factors and various assumptions, including expected losses and
residual returns. As of December 31, 2008, we did not consolidate any VIEs. We
account for investments in companies over which we have the ability to exercise
significant influence under the equity method if we hold 50 percent or less
of the voting stock.
In the
first quarter of 2008, we completed the divestiture of certain non-strategic
businesses. Our operating results for the years ended December 31, 2007 and 2006
include a full year of results of these businesses. Our operating results for
the year ended December 31, 2008 include the results of these businesses through
the date of separation. Refer to Note F – Divestitures and Assets
Held for Sale for a description of these business
divestitures.
On April
21, 2006, we consummated the acquisition of Guidant Corporation. Our operating
results for the years ended December 31, 2008 and 2007 each include a full year
of results of our cardiac rhythm management (CRM) business that we acquired from
Guidant. Our operating results for the year ended December 31, 2006 include the
results of the CRM business beginning on the date of acquisition. Refer to Note D- Acquisitions for further
details on the Guidant acquisition, as well as supplemental pro forma financial
information which gives effect to the acquisition as though it had occurred at
the beginning of 2006.
Reclassifications
We have
reclassified certain prior year amounts to conform to the current year’s
presentation, including amounts for prior years included in our consolidated
statements of operations with respect to intangible asset impairment charges,
and amounts included in our consolidated balance sheets with respect to assets
held for sale, as well as within Note P – Segment
Reporting.
Accounting
Estimates
To
prepare our consolidated financial statements in accordance with U.S. generally
accepted accounting principles, management makes estimates and assumptions that
may affect the reported amounts of our assets and liabilities, the disclosure of
contingent assets and liabilities at the date of our financial statements and
the reported amounts of our revenues and expenses during the reporting period.
Our actual results may differ from these estimates.
Cash,
Cash Equivalents and Marketable Securities
We record
cash and cash equivalents in our consolidated balance sheets at cost, which
approximates fair value. We consider all highly liquid investments purchased
with a remaining maturity of three months or less at the time of acquisition to
be cash equivalents.
We record
available-for-sale investments at fair value. We exclude unrealized gains and
temporary losses on available-for-sale securities from earnings and report such
gains and losses, net of tax, as a separate component of stockholders’ equity
until realized. We compute realized gains and losses on sales of
available-for-sale securities based on the average cost method, adjusted for any
other-than-temporary declines in fair
value. We
record held-to-maturity securities at amortized cost and adjust for amortization
of premiums and accretion of discounts to maturity. We classify investments in
debt securities or equity securities that have a readily determinable fair value
that we purchase and hold principally for selling them in the near term as
trading securities. All of our cash investments at December 31, 2008 and 2007
had maturity dates at date of purchase of less than three months and,
accordingly, we have classified them as cash and cash equivalents.
Concentrations
of Credit Risk
Financial
instruments that potentially subject us to concentrations of credit risk consist
primarily of cash and cash equivalents, marketable securities, derivative
financial instrument contracts and accounts and notes receivable. Our investment
policy limits exposure to concentrations of credit risk and changes in market
conditions. Counterparties to financial instruments expose us to credit-related
losses in the event of nonperformance. We transact our financial instruments
with a diversified group of major financial institutions and actively monitor
outstanding positions to limit our credit exposure.
We
provide credit, in the normal course of business, to hospitals, healthcare
agencies, clinics, doctors’ offices and other private and governmental
institutions and generally do not require collateral. We perform on-going credit
evaluations of our customers and maintain allowances for potential credit
losses.
Revenue
Recognition
We
generate revenue primarily from the sale of single-use medical devices. We
consider revenue to be realized or realizable and earned when all of the
following criteria are met: persuasive evidence of a sales arrangement exists;
delivery has occurred or services have been rendered; the price is fixed or
determinable; and collectibility is reasonably assured. We generally meet these
criteria at the time of shipment, unless a consignment arrangement exists or we
are required to provide additional services. We recognize revenue from
consignment arrangements based on product usage, or implant, which indicates
that the sale is complete. For our other transactions, we recognize revenue when
our products are delivered and risk of loss transfers to the customer, provided
there are no substantive remaining performance obligations required of us
or any matters requiring customer acceptance, and provided we can form an
estimate for sales returns. For multiple-element arrangements, where the sale of
devices is combined with future service obligations, as with our LATITUDE®
Patient Management System, we defer revenue on the undelivered element based on
verifiable objective evidence of fair value, and recognize the associated
revenue over the related service period. We present revenue net of sales taxes
in our consolidated statements of operations.
We
generally allow our customers to return defective, damaged and, in certain
cases, expired products for credit. We base our estimate for sales returns upon
historical trends and record the amount as a reduction to revenue when we
sell the initial product. In addition, we may allow customers to return
previously purchased products for next-generation product offerings; for these
transactions, we defer recognition of revenue based upon an estimate of the
amount of product to be returned when the next-generation products are shipped
to the customer.
We offer
sales rebates and discounts to certain customers. We treat sales rebates and
discounts as a reduction of revenue and classify the corresponding liability as
current. We estimate rebates for products where there is sufficient historical
information available to predict the volume of expected future rebates. If we
are unable to estimate the expected rebates reasonably, we record a liability
for the maximum rebate percentage offered. We have entered certain agreements
with group purchasing organizations to sell our products to participating
hospitals at negotiated prices. We recognize revenue from these agreements
following the same revenue recognition criteria discussed above.
Inventories
We state
inventories at the lower of first-in, first-out cost or market. We base our
provisions for excess and obsolete inventory primarily on our estimates of
forecasted net sales. A significant change in the timing or
level of
demand for our products as compared to forecasted amounts may result in
recording additional provisions for excess and obsolete inventory in the future.
The industry in which we participate is characterized by rapid product
development and frequent new product introductions. Uncertain timing of
next-generation product approvals, variability in product launch strategies,
product recalls and variation in product utilization all affect our estimates
related to excess and obsolete inventory. We record provisions for inventory
located in our manufacturing and distribution facilities as cost of products
sold. We charge consignment inventory write-downs to selling, general and
administrative (SG&A) expense. These write-downs were $16 million in 2008,
$35 million in 2007, and $24 million in 2006. Inventories under consignment
arrangements were $121 million at December 31, 2008 and $78 million at December
31, 2007.
Property,
Plant and Equipment
We state
property, plant, equipment, and leasehold improvements at historical cost. We
charge expenditures for maintenance and repairs to expense and capitalize
additions and improvements. We generally provide for depreciation using the
straight-line method at rates that approximate the estimated useful lives of the
assets. We depreciate buildings and improvements over a 20 to 40 year life;
equipment, furniture and fixtures over a three to seven year life; and
leasehold improvements over the shorter of the useful life of the improvement or
the term of the lease. We present assets under capital lease arrangements with
property, plant and equipment in the accompanying consolidated balance
sheets.
Valuation
of Business Combinations
We record
intangible assets acquired in business combinations under the purchase method of
accounting. We allocate the amounts we pay for each acquisition to the assets we
acquire and liabilities we assume based on their fair values at the dates of
acquisition in accordance with FASB Statement No. 141, Business Combinations,
including identifiable intangible assets and purchased research and development
which either arise from a contractual or legal right or are separable from
goodwill. We base the fair value of identifiable intangible assets and purchased
research and development on detailed valuations that use information and
assumptions provided by management. We allocate any excess purchase price over
the fair value of the net tangible and identifiable intangible assets acquired
to goodwill. The use of alternative valuation assumptions, including estimated
cash flows and discount rates, and alternative estimated useful life assumptions
could result in different purchase price allocations, purchased research and
development charges, and intangible asset amortization expense in current and
future periods.
In
circumstances where the amounts assigned to assets acquired and liabilities
assumed exceeds the cost of the acquired entity and the purchase agreement does
not provide for contingent consideration that might result in an additional
element of cost of the acquired entity that equals or exceeds the excess of fair
value over cost, the excess is allocated as a pro rata reduction of the amounts
that otherwise would have been assigned to all of the acquired assets, including
purchased research and development, except for a) financial assets other than
investments accounted for under the equity method, b) assets to be disposed of
by sale, c) deferred tax assets, d) prepaid assets relating to pension or other
postretirement benefit plans and e) any other current assets. In
those circumstances where an acquisition involves contingent consideration, we
recognize an amount equal to the lesser of the maximum amount of the contingent
payment or the excess of fair value over cost as a
liability.
Purchased
Research and Development
Our
purchased research and development represents the value of acquired in-process
projects that have not yet reached technological feasibility and have no
alternative future uses as of the date of acquisition. The primary basis for
determining the technological feasibility of these projects is obtaining
regulatory approval to market the underlying products in an applicable
geographic region. Through December 31, 2008, we have expensed the value
attributable to these in-process projects at the time of the acquisition in
accordance with accounting standards effective through that date. If the
projects are not successful or completed in a timely manner, we may not realize
the financial benefits expected for these projects or for the acquisition as a
whole. In addition, we record certain costs associated with our alliances as
purchased research and development.
We use
the income approach to determine the fair values of our purchased research and
development. This approach calculates fair value by estimating the after-tax
cash flows attributable to an in-process project over its useful life and then
discounting these after-tax cash flows back to a present value. We base our
revenue assumptions on estimates of relevant market sizes, expected market
growth rates, expected trends in technology and expected levels of market share.
In arriving at the value of the in-process projects, we consider, among other
factors: the in-process projects’ stage of completion; the complexity of the
work completed as of the acquisition date; the costs already incurred; the
projected costs to complete; the contribution of core technologies and other
acquired assets; the expected introduction date; and the estimated useful life
of the technology. We base the discount rate used to arrive at a present value
as of the date of acquisition on the time value of money and medical technology
investment risk factors. For the in-process projects acquired in connection with
our recent acquisitions, we used the following ranges of risk-adjusted discount
rates to discount our projected cash flows: 34 percent in 2008, 19 percent in
2007, and 13 percent to 17 percent in 2006. We believe that the estimated
in-process research and development amounts so determined represent the fair
value at the date of acquisition and do not exceed the amount a third party
would pay for the projects.
Amortization
and Impairment of Intangible Assets
We record
intangible assets at historical cost and amortize them over their estimated
useful lives. We use a straight-line method of amortization, unless a
method that better reflects the pattern in which the economic benefits of the
intangible asset are consumed or otherwise used up can be reliably determined.
The approximate useful lives for amortization of our intangible assets is as
follows: patents and licenses, two to 20 years; definite-lived core and
developed technology, five to 25 years; customer relationships, five to 25
years; other intangible assets, various.
We review
intangible assets subject to amortization quarterly to determine if any adverse
conditions exist or a change in circumstances has occurred that would indicate
impairment or a change in the remaining useful life. Conditions that may
indicate impairment include, but are not limited to, a significant adverse
change in legal factors or business climate that could affect the value of an
asset, a product recall, or an adverse action or assessment by a regulator. If
an impairment indicator exists, we test the intangible asset for
recoverability. For purposes of the recoverability test, we group our
intangible assets with other assets and liabilities at the lowest level of
identifiable cash flows if the intangible asset does not generate cash flows
independent of other assets and liabilities. If the carrying value of the
intangible asset (asset group) exceeds the undiscounted cash flows expected to
result from the use and eventual disposition of the intangible asset (asset
group), we will write the carrying value down to the fair
value in the period identified. In addition, we review our indefinite-lived
intangible assets at least annually for impairment and reassess their
classification as indefinite-lived assets. To test for impairment, we calculate
the fair value of our indefinite-lived intangible assets and compare the
calculated fair values to the respective carrying values. If the
carrying value exceeds the fair value of the indefinite-lived intangible asset,
the carrying value is written down to the fair value.
We
generally calculate fair value of our intangible assets as the present value of
estimated future cash flows we expect to generate from the asset using a
risk-adjusted discount rate. In determining our estimated future cash
flows associated with our intangible assets, we use estimates
and assumptions about future revenue contributions, cost structures and
remaining useful lives of the asset (asset group). The use of alternative
assumptions, including estimated cash flows, discount rates, and alternative
estimated remaining useful lives could result in different
calculations of impairment. See Note E - Goodwill and
Other Intangible Assets for more information related to impairment
of intangible assets during 2008, 2007 and 2006.
For
patents developed internally, we capitalize costs incurred to obtain patents,
including attorney fees, registration fees, consulting fees, and other
expenditures directly related to securing the patent. We amortize these costs
generally over a period of 17 years utilizing the straight-line method,
commencing when the related patent is issued. Legal costs incurred in connection
with the successful defense of both internally developed patents and those
obtained through our acquisitions are capitalized and amortized over the
remaining amortizable life of the related patent.
Goodwill
Impairment
We test
our goodwill balances as of April 1 during the second quarter of each year for
impairment. We test our goodwill balances more frequently if indicators are
present or changes in circumstances suggest that impairment may exist. In
performing the test, we utilize the two-step approach prescribed under FASB
Statement No. 142, Goodwill and Other Intangible
Assets. The first step requires a comparison of the carrying value of the
reporting units, as defined, to the fair value of these units. We have
identified our domestic divisions, which in aggregate make up the U.S.
reportable segment, and our two international operating segments as our
reporting units for purposes of the goodwill impairment test. To
derive the carrying value of our reporting units at the time of acquisition, we
assign goodwill to the reporting units that we expect to benefit from the
respective business combination. In addition, for purposes of performing our
annual goodwill impairment test, assets and liabilities, including corporate
assets, which relate to a reporting unit’s operations, and would be considered
in determining fair value, are allocated to the individual reporting units. We
allocate assets and liabilities not directly related to a specific reporting
unit, but from which the reporting unit benefits, based primarily on the
respective revenue contribution of each reporting unit. If the carrying value of
a reporting unit exceeds its fair value, we will perform the second step of the
goodwill impairment test to measure the amount of impairment loss, if
any.
The
second step of the goodwill impairment test compares the implied fair value of a
reporting unit’s goodwill to its carrying value. If we were unable to complete
the second step of the test prior to the issuance of our financial statements
and an impairment loss was probable and could be reasonably estimated, we would
recognize our best estimate of the loss in our current period financial
statements and disclose that the amount is an estimate. We would then
recognize any adjustment to that estimate in subsequent reporting periods, once
we have finalized the second step of the impairment test.
During
the fourth quarter of 2008, we recorded a $2.613 billion goodwill impairment
charge associated with our acquisition of Guidant. The decline in our stock
price and our market capitalization during the fourth quarter created an
indication of potential impairment of our goodwill balance; therefore, we
performed an interim impairment test. Key factors contributing to the impairment
charge included disruptions in the credit and equity market, and the resulting
impacts to weighted-average costs of capital, and changes in CRM market demand
relative to our original assumptions at the time of the acquisition. Refer to
Note E – Goodwill and Other
Intangible Assets for more information.
Investments
in Publicly Traded and Privately Held Entities
We
account for our publicly traded investments as available-for-sale securities
based on the quoted market price at the end of the reporting period. We compute
realized gains and losses on sales of available-for-sale securities based on the
average cost method, adjusted for any other-than-temporary declines in fair
value. We account for our investments for which fair value is not readily
determinable in accordance with Accounting Principles Board (APB) Opinion
No. 18, The Equity Method
of Accounting for Investments in Common Stock, Emerging Issues Task Force
(EITF) Issue No. 02-14, Whether an Investor Should Apply the
Equity Method of Accounting to Investments other than Common Stock and
FASB Staff Position Nos. 115-1 and 124-1, The Meaning of Other-Than-Temporary
Impairment and Its Application to Certain Investments.
We
account for investments in entities over which we have the ability to exercise
significant influence under the equity method if we hold 50 percent or less
of the voting stock and the entity is not a variable interest entity in which we
are the primary beneficiary. We account for investments in entities over which
we do not have the ability to exercise significant influence under the cost
method. Our determination of whether we have the ability to exercise significant
influence over an entity requires judgment. We consider the guidance
in Opinion No. 18, EITF Issue No. 03-16, Accounting for Investments in
Limited Liability Companies, and EITF Topic D-46, Accounting for Limited Partnership
Investments, in determining whether we have the ability to exercise
significant influence over an entity.
For
investments accounted for under the equity method, we record the investment
initially at cost, and adjust the carrying amount to reflect our share of the
earnings or losses of the investee, including all adjustments similar to those
made in preparing consolidated financial statements.
Each
reporting period, we evaluate our investments to determine if there are any
events or circumstances that are likely to have a significant adverse effect on
the fair value of the investment. Examples of such impairment indicators
include, but are not limited to: a significant deterioration in earnings
performance; recent financing rounds at reduced valuations; a significant
adverse change in the regulatory, economic or technological environment of an
investee; or a significant doubt about an investee’s ability to continue as a
going concern. If we identify an impairment indicator, we will estimate the fair
value of the investment and compare it to its carrying value. Our estimation of
fair value considers all available financial information related to the
investee, including valuations based on recent third-party equity investments in
the investee. If the fair value of the investment is less than its carrying
value, the investment is impaired and we make a determination as to whether the
impairment is other-than-temporary. We deem impairment to be
other-than-temporary unless we have the ability and intent to hold an investment
for a period sufficient for a market recovery up to the carrying value of the
investment. Further, evidence must indicate that the carrying value of the
investment is recoverable within a reasonable period. For other-than-temporary
impairments, we recognize an impairment loss equal to the difference between an
investment’s carrying value and its fair value. Impairment losses on our
investments are included in other, net in our consolidated statements of
operations.
Income
Taxes
We
utilize the asset and liability method of accounting for income taxes. Under
this method, we determine deferred tax assets and liabilities based on
differences between the financial reporting and tax bases of our assets and
liabilities. We measure deferred tax assets and liabilities using the enacted
tax rates and laws that will be in effect when we expect the differences to
reverse.
We
recognized net deferred tax liabilities of $1.351 billion at December 31, 2008
and $1.605 billion at December 31, 2007. The liabilities relate primarily
to deferred taxes associated with our acquisitions. The assets relate primarily
to the establishment of inventory and product-related reserves, litigation and
product liability reserves, purchased research and development, investment
write-downs, net operating loss carryforwards and tax credit carryforwards. In
light of our historical financial performance, we believe we will recover
substantially all of these assets. We reduce our deferred tax assets by a
valuation allowance if, based upon the weight of available evidence, it is more
likely than not that we will not realize some portion or all of the deferred tax
assets. We consider relevant evidence, both positive and negative, to determine
the need for a valuation allowance. Information evaluated includes our financial
position and results of operations for the current and preceding years, as well
as an evaluation of currently available information about future
years.
We do not
provide income taxes on unremitted earnings of our foreign subsidiaries where we
have indefinitely reinvested such earnings in our foreign operations. It is not
practical to estimate the amount of income taxes payable on the earnings that
are indefinitely reinvested in foreign operations. Unremitted earnings of our
foreign subsidiaries that we have indefinitely reinvested offshore are $9.327
billion at December 31, 2008 and $7.804 billion at December 31,
2007.
We
provide for potential amounts due in various tax jurisdictions. In the ordinary
course of conducting business in multiple countries and tax jurisdictions, there
are many transactions and calculations where the ultimate tax outcome is
uncertain. Judgment is required in determining our worldwide income tax
provision. In our opinion, we have made adequate provisions for income taxes for
all years subject to audit. Although we believe our estimates are reasonable, we
can make no assurance that the final tax outcome of these matters will not be
different from that which we have reflected in our historical income tax
provisions and accruals. Such differences could have a material impact on our
income tax provision and operating results in the period in which we make such
determination.
Legal,
Product Liability Costs and Securities Claims
We are
involved in various legal and regulatory proceedings, including intellectual
property, breach of contract, securities litigation and product liability suits.
In some cases, the claimants seek damages, as well as other relief, which, if
granted, could require significant expenditures or impact our ability to sell
our products. We are substantially self-insured with respect to product
liability claims. We maintain insurance policies providing limited coverage
against securities claims. We generally record losses for claims in excess of
purchased insurance in earnings at the time and to the extent they are probable
and estimable. In accordance with FASB Statement No. 5, Accounting for
Contingencies, we accrue anticipated costs of settlement, damages, losses
for product liability claims and, under certain conditions, costs of defense,
based on historical experience or to the extent specific losses are probable and
estimable. Otherwise, we expense these costs as incurred. If the estimate of a
probable loss is a range and no amount within the range is more likely, we
accrue the minimum amount of the range. See Note L - Commitments and
Contingencies for further discussion of our individual material legal
proceedings.
Warranty
Obligations
We
estimate the costs that we may incur under our warranty programs based on
historical experience and record a liability at the time our products are sold.
Factors that affect our warranty liability include the number of units sold, the
historical and anticipated rates of warranty claims and the cost per claim. We
record a reserve equal to the costs to repair or otherwise satisfy the claim. We
regularly assess the adequacy of our recorded warranty liabilities and adjust
the amounts as necessary. Changes in our product warranty obligations during
2008 consisted of the following (in millions):
Balance
as of December 31, 2007
|
$ | 66 | ||
Warranty
claims provision
|
35 | |||
Settlements
made
|
(39 | ) | ||
Balance
as of December 31, 2008
|
$ | 62 |
Costs
Associated with Exit Activities
We record
employee termination costs in accordance with FASB Statement No. 112, Employer’s Accounting for
Postemployment Benefits, if we pay the benefits as part of an on-going
benefit arrangement, which includes benefits provided as part of our domestic
severance policy or that we provide in accordance with international statutory
requirements. We accrue employee termination costs associated with an on-going
benefit arrangement if the obligation is attributable to prior services
rendered, the rights to the benefits have vested and the payment is probable and
we can reasonably estimate the liability. We account for employee termination
benefits that represent a one-time benefit in accordance with FASB Statement
No. 146, Accounting for
Costs Associated with Exit or Disposal Activities. We record such costs
into expense over the employee’s future service period, if any, in accordance
with the Statement No. 146 criteria. In addition, in conjunction with an exit
activity, we may offer voluntary termination benefits to employees. These
benefits are recorded when the employee accepts the termination benefits and the
amount can be reasonably estimated. Other costs associated with exit activities
may include contract termination costs, including costs related to leased
facilities to be abandoned or subleased, and long-lived asset impairments. In
addition, through December 31, 2008, we have accounted for costs to exit an
activity of an acquired company, costs for involuntary employee termination
benefits and relocation costs associated with acquired businesses in
accordance with EITF Issue No. 95-3, Recognition of Liabilities in
Connection with a Purchase Business
Combination. We include exit costs in the
purchase price allocation of the acquired business if a plan to exit an activity
of an acquired company exists, in accordance with the Issue No. 95-3 criteria,
and if those costs have no future economic benefit to us and will
be incurred as a direct result of the exit plan; or the exit costs represent
amounts to be incurred by us under a contractual obligation of the acquired
entity that existed prior to the acquisition date.
Translation
of Foreign Currency
We
translate all assets and liabilities of foreign subsidiaries at the year-end
exchange rate and translate sales and expenses at the average exchange rates in
effect during the year. We show the net effect of these translation adjustments
in the accompanying consolidated financial statements as a component of
stockholders’ equity. Foreign currency transaction gains and losses are included
in other, net in our consolidated statements of operations net of losses and
gains from any related derivative financial instruments. These amounts were not
material to our consolidated statements of operations for 2008, 2007, and
2006.
Financial
Instruments
We
recognize all derivative financial instruments in our consolidated financial
statements at fair value in accordance with FASB Statement No. 133, Accounting for Derivative
Instruments and Hedging Activities. We record changes in the fair value
of derivative instruments in earnings unless we meet deferred hedge accounting
criteria. For derivative instruments designated as fair value hedges, we record
the changes in fair value of both the derivative instrument and the hedged item
in earnings. For derivative instruments designated as cash flow hedges, we
record the effective portions of changes in fair value, net of tax, in other
comprehensive income until the related hedged third party transaction occurs.
For derivative instruments designated as net investment hedges, we record the
effective portion of changes in fair value in other comprehensive income as part
of the cumulative translation adjustment. We recognize any ineffective portion
of our hedges in earnings.
Shipping
and Handling Costs
We
generally do not bill customers for shipping and handling of our products.
Shipping and handling costs of $72 million in 2008, $79 million in 2007, and
$85 million in 2006 are included in selling, general and administrative
expenses in the accompanying consolidated statements of operations.
Research
and Development
We
expense research and development costs, including new product development
programs, regulatory compliance and clinical research as incurred. Refer to
Purchased Research and
Development for our policy regarding in-process research and development
acquired in connection with our business combinations.
Employee
Retirement Plans
Defined Benefit
Plans
In
connection with our acquisition of Guidant, we sponsor the Guidant Retirement
Plan, a frozen noncontributory defined benefit plan covering a select group of
current and former employees. The funding policy for the plan is consistent with
U.S. employee benefit and tax-funding regulations. Plan assets, which we
maintain in a trust, consist primarily of equity and fixed-income instruments.
We also sponsor the Guidant Excess Benefit Plan, a frozen nonqualified plan for
certain former officers and employees of Guidant. The Guidant Excess Benefit
Plan was funded through a Rabbi Trust that contains segregated company assets
used to pay the benefit obligations related to the plan. In addition, certain
current and former U.S. and Puerto Rico employees of Guidant are eligible to
receive a portion of their healthcare retirement benefits under a frozen defined
benefit plan.
We
maintain an Executive Retirement Plan, which covers executive officers and
division presidents. The plan provides retiring executive officers and division
presidents with a lump sum benefit of 1.5 to 2.5 months of salary for each
completed year of service, up to a maximum of 36 months’ pay for executive
officers and 24 months’ pay for division presidents. Participants may retire
with unreduced benefits once retirement conditions have been satisfied. In order
to meet the retirement definition under the Executive Retirement Plan, an
employee’s age in addition to his or her years of service with Boston Scientific
must be at least 65 years, the employee must be at least
55 years old and have been with Boston Scientific for at least
five years. In addition, we maintain defined benefit retirement plans
covering certain international employees.
In
accordance with FASB Statement No. 158, Employer’s Accounting for Defined
Benefit Pension and Other Postretirement Plans, we use a December 31
measurement date for these plans and record the underfunded portion as a
liability, and recognize changes in the funded status through
other comprehensive income. The outstanding obligation as of December 31,
2008 is as follows:
(in
millions)
|
Projected
Benefit
Obligation
(PBO)
|
Less:
Fair
value of
Plan
Assets
|
Underfunded
PBO Recognized
|
|||||||||
Executive
Retirement Plan
|
$ | 16 | $ | 16 | ||||||||
Guidant
Retirement Plan (frozen)
|
90 | $ | 54 | 36 | ||||||||
Guidant
Excess Benefit Plan (frozen)
|
28 | 28 | ||||||||||
Guidant
Healthcare Retirement Benefit Plan (frozen)
|
15 | 15 | ||||||||||
International
Retirement Plans
|
52 | 22 | 30 | |||||||||
$ | 201 | $ | 76 | $ | 125 |
The net
decrease in the funded status of our plans at December 31, 2008, as compared to
December 31, 2007, reported as a reduction to accumulated other comprehensive
income was $12 million.
The
weighted average assumptions used to determine benefit obligations at December
31, 2008 are as follows:
Discount
Rate
|
Expected
Return
on
Plan Assets
|
Healthcare
Cost
Trend
Rate
|
Rate
of
Compensation
Increase
|
|
Executive
Retirement Plan
|
6.25%
|
4.50%
|
||
Guidant
Retirement Plan (frozen)
|
6.25%
|
7.75%
|
||
Guidant
Excess Benefit Plan (frozen)
|
6.25%
|
|||
Healthcare
Retirement Benefit Plan (frozen)
|
6.00%
|
5.00%
|
||
International
Retirement Plans
|
2.00%
- 6.00%
|
2.00%
- 4.10%
|
3.00%
- 5.40%
|
Defined Contribution
Plans
We
sponsor a voluntary 401(k) Retirement Savings Plan for eligible employees.
Participants may contribute between one percent and twenty-five percent of his
or her compensation on an pre-tax basis, and between one percent and ten percent
on an after-tax basis, up to established federal limits. We match employee
contributions equal to 200 percent for employee contributions up to two percent
of employee compensation, and fifty percent for employee contributions greater
than two percent, but not exceeding six percent, of pre-tax employee
compensation. Participants age 50 and older may also contribute up to an
additional $5,000 per year in pre-tax contributions, which we do not match.
Total expense for our matching contributions to the plan was $63 million in
2008, $64 million in 2007, and $48 million in 2006.
In
connection with our acquisition of Guidant, we sponsored the Guidant Employee
Savings and Stock Ownership Plan, which allowed for employee contributions of a
percentage of pre-tax earnings, up to established federal limits. Our
matching contributions to the plan were in the form of shares of stock,
allocated from the Employee Stock Ownership Plan (ESOP). Refer to Note N – Stock Ownership Plans
for more information on the ESOP. Total expense for our matching
contributions to the plan was $12 million in 2008, $23 million in 2007 and $19
million in 2006. Effective June 1, 2008, this plan was merged into our 401(k)
Retirement Savings Plan.
Net
Income (Loss) per Common Share
We base
net income (loss) per common share upon the weighted-average number of common
shares and common stock equivalents outstanding each year. Potential common
stock equivalents are determined using the treasury stock method. We exclude
stock options whose effect would be anti-dilutive from the
calculation.
Note B—Supplemental
Balance Sheet Information
Components
of selected captions in our accompanying consolidated balance sheets are as
follows:
As
of December 31,
|
||||||||
2008
|
2007
|
|||||||
Trade
accounts receivable, net
|
||||||||
Accounts
receivable
|
$ | 1,533 | $ | 1,639 | ||||
Less:
allowances
|
131 | 137 | ||||||
$ | 1,402 | $ | 1,502 | |||||
Inventories
|
||||||||
Finished
goods
|
$ | 555 | $ | 454 | ||||
Work-in-process
|
135 | 132 | ||||||
Raw
materials
|
163 | 139 | ||||||
$ | 853 | $ | 725 |
Sales
of the PROMUS® everolimus-eluting stent systems represented approximately
four percent of our total net sales in 2008. We are reliant on Abbott
Laboratories for our supply of PROMUS® stent systems. Any production or capacity
issues that affect Abbott’s manufacturing capabilities or the process for
forecasting, ordering and receiving shipments may impact our ability to increase
or decrease the level of supply to us in a timely manner; therefore, our supply
of PROMUS® stent systems may not align with customer demand, which could have an
adverse effect on our operating results. At present, we believe that our supply
of PROMUS® stent systems from Abbott is sufficient to meet our current customer
demand.
Further,
the price we pay Abbott for our supply of PROMUS® stent systems is determined by
our contracts with them. Our cost is based, in part, on previously
fixed estimates of Abbott’s manufacturing costs for PROMUS® stent systems and
third-party reports of our average selling price of PROMUS® stent systems.
Amounts paid pursuant to this pricing arrangement are subject to a retroactive
adjustment at pre-determined intervals based on Abbott’s actual costs to
manufacture these stent systems for us and our average selling price of PROMUS®
stent systems. During 2009, we may make a payment to or receive a payment from
Abbott based on the differences between their actual manufacturing costs and the
contractually stipulated manufacturing costs and differences between our actual
average selling price and third-party reports of our average selling price, in
each case, with respect to our purchases of PROMUS® stent systems from Abbott
during 2008, 2007 and 2006.
As
of December 31,
|
||||||||
2008
|
2007
|
|||||||
Property,
plant and equipment, net
|
||||||||
Land
|
$ | 116 | $ | 116 | ||||
Buildings
and improvements
|
865 | 801 | ||||||
Equipment,
furniture and fixtures
|
1,824 | 1,671 | ||||||
Capital
in progess
|
305 | 304 | ||||||
3,110 | 2,892 | |||||||
Less:
accumulated depreciation
|
1,382 | 1,177 | ||||||
$ | 1,728 | $ | 1,715 | |||||
Accrued
expenses
|
||||||||
Legal
reserves
|
$ | 924 | $ | 499 | ||||
Acquisition-related
obligations
|
520 | 699 | ||||||
Payroll
and related liabilities
|
438 | 515 | ||||||
Restructuring
liabilities
|
42 | 137 | ||||||
Other
|
688 | 691 | ||||||
$ | 2,612 | $ | 2,541 | |||||
Other
long-term liabilities
|
||||||||
Acquisition-related
obligations
|
$ | 465 | ||||||
Legal
reserves
|
$ | 165 | 495 | |||||
Accrued
income taxes
|
1,100 | 1,344 | ||||||
Other
long-term liabilities
|
462 | 329 | ||||||
$ | 1,727 | $ | 2,633 |
See Note E - Goodwill and Other
Intangible Assets for details on our intangible assets and Note F – Divestitures and Assets
Held for Sale for the components of those assets and associated
liabilities classified as held for sale in our consolidated balance
sheets.
Note
C – Fair Value Measurements
We
adopted FASB Statement No. 157, Fair Value Measurements, as
of January 1, 2008. Statement No. 157 defines fair value, establishes a
framework for measuring fair value in accordance with U.S. GAAP, and expands
disclosures about fair value measurements. Statement No. 157 does not require
any new fair value measurements; rather, it applies to other accounting
pronouncements that require or permit fair value measurements. In February 2008,
the FASB released Staff Position No. 157-2, Effective Date of FASB Statement
No. 157, which delays the effective date of Statement No. 157
for all nonfinancial assets and nonfinancial liabilities, except for those that
are recognized or disclosed at fair value in the financial statements on a
recurring basis. In accordance with Staff Position No. 157-2, we have not
applied the provisions of Statement No. 157 to the following nonfinancial assets
and nonfinancial liabilities:
•
|
Nonfinancial
assets and nonfinancial liabilities initially measured at fair value in a
business combination or other new basis event, but not measured at fair
value in subsequent reporting
periods;
|
•
|
Reporting
units and nonfinancial assets and nonfinancial liabilities measured at
fair value for our goodwill assessments in accordance with FASB Statement
No. 142, Goodwill and
Other Intangible Assets;
|
•
|
Indefinite-lived
intangible assets measured at fair value for impairment assessment in
accordance with Statement No. 142;
|
•
|
Nonfinancial
long-lived assets or asset groups measured at fair value for impairment
assessment or disposal under FASB Statement No. 144, Accounting for the Impairment
or Disposal of Long-Lived Assets; and
|
•
|
Nonfinancial
liabilities associated with exit or disposal activities initially measured
at fair value under FASB Statement No. 146, Accounting for Costs
Associated with Exit or Disposal
Activities.
|
We will
be required to apply the provisions of Statement No. 157 to these nonfinancial
assets and nonfinancial liabilities as of January 1, 2009 and are currently
evaluating the impact of the application of Statement No. 157 as it
pertains to these items. The application of Statement No. 157 for financial
assets and financial liabilities did not have a material impact on our financial
position, results of operations or cash flows.
On a
recurring basis, we measure certain financial assets and financial liabilities
at fair value, including our money market funds, available-for-sale investments,
interest rate derivative instruments and foreign currency derivative contracts.
Statement No. 157 defines fair value as the price that would be received to sell
an asset or paid to transfer a liability in an orderly transaction between
market participants at the measurement date. As such, fair value is a
market-based measurement that should be determined based on assumptions that
market participants would use in pricing an asset or liability. We base fair
value upon quoted market prices, where available. Where quoted market prices or
other observable inputs are not available, we apply valuation techniques to
estimate fair value.
Statement
No. 157 establishes a three-level valuation hierarchy for disclosure of fair
value measurements. The categorization of financial assets and financial
liabilities within the valuation hierarchy is based upon the lowest level of
input that is significant to the measurement of fair value. The three levels of
the hierarchy are defined as follows:
•
|
Level
1 – Inputs to the valuation methodology are quoted market prices for
identical assets or liabilities.
|
•
|
Level
2 – Inputs to the valuation methodology are other observable inputs,
including quoted market prices for similar assets or liabilities and
market-corroborated inputs.
|
•
|
Level
3 – Inputs to the valuation methodology are unobservable inputs based on
management’s best estimate of inputs market participants would use in
pricing the asset or liability at the measurement date, including
assumptions about risk.
|
Our
investments in money market funds, as well as available-for-sale
investments carried at fair value, are generally classified within Level 1
of the fair value hierarchy because they are valued using quoted market prices.
Our money market funds are classified as cash and cash equivalents within our
accompanying condensed consolidated balance sheets, in accordance with our
accounting policies, as these funds are highly liquid and readily convertible to
known amounts of cash.
During
2008, certain of our publicly traded available-for-sale investments were
classified within Level 3 of the fair value hierarchy as they were subject to
lock-up agreements. We used an option pricing model to determine the
liquidity discount associated with these lock-up restrictions as a part of our
fair value measurement within the framework of Statement No. 157. In
addition, certain of our publicly traded available-for-sale investments were
classified within Level 3, as they were marked to fair value based on agreements
to sell those investments to a third party. During 2008, we completed
the sale of these investments to the third party (see Note G – Investments and Notes
Receivable for further discussion); in addition, none of our
available-for-sale securities were subject to lock-up agreements as of December
31, 2008. Therefore, as of December 31, 2008, none of our investments
in available-for-sale securities were classified within Level 3. Our cost method
investments are adjusted to fair value only when impairment
charges
are recorded for other-than-temporary declines in value and are determined using
fair value criteria within the framework of Statement No. 157. As the
inputs utilized for the impairment assessment are not based on observable market
data, these cost method investments are classified within Level 3 of the fair
value hierarchy on a non-recurring basis.
We
recognize all derivative financial instruments in our consolidated financial
statements at fair value in accordance with FASB Statement No. 133, Accounting for Derivative
Instruments and Hedging Activities. We determine the fair
value of these instruments using the framework prescribed by Statement No. 157,
by considering the estimated amount we would receive to sell or transfer these
agreements at the reporting date and by taking into account current interest
rates, current currency exchange rates, the creditworthiness of the counterparty
for assets, and our creditworthiness for liabilities. In certain
instances, we may utilize financial models to measure fair value. Generally, we
use inputs that include quoted prices for similar assets or liabilities in
active markets; quoted prices for identical or similar assets or liabilities in
markets that are not active; other observable inputs for the asset or liability;
and inputs derived principally from, or corroborated by, observable market data
by correlation or other means. We have classified our derivative assets and
liabilities within Level 2 of the fair value hierarchy because these observable
inputs are available for substantially the full term of our derivative
instruments.
Fair Value Measured on a
Recurring Basis
Financial
assets and financial liabilities measured at fair value on a recurring basis
consist of the following as of December 31, 2008:
(in
millions)
|
Level
1
|
Level
2
|
Level
3
|
Total
|
||||||||||||
Assets
|
||||||||||||||||
Money
market funds
|
$ | 690 | $ | 690 | ||||||||||||
Available-for-sale
investments
|
1 | 1 | ||||||||||||||
Currency
exchange contracts
|
$ | 132 | 132 | |||||||||||||
Interest
rate swap contracts
|
||||||||||||||||
$ | 691 | $ | 132 | $ | 823 | |||||||||||
Liabilities
|
||||||||||||||||
Currency
exchange contracts
|
$ | 195 | $ | 195 | ||||||||||||
Interest
rate swap contracts
|
46 | 46 | ||||||||||||||
$ | 241 | $ | 241 |
In
addition to $690 million invested in money market funds as of December 31, 2008,
we had $781 million of cash invested in short-term time deposits, and $170
million in interest bearing and non-interest bearing bank accounts.
For
assets measured at fair value using significant unobservable inputs (Level 3) as
of December 31, 2008, the following table summarizes the change in balances
during the year ended December 31, 2008 (in millions):
Balance
as of January 1, 2008
|
$ | 30 | ||
Net
transfers into Level 3
|
31 | |||
Net
sales
|
(44 | ) | ||
Realized
losses related to investment impairments
|
(1 | ) | ||
Change
in unrealized gains/losses related to market prices
|
(16 | ) | ||
Balance
as of December 31, 2008
|
$ | — |
Unrealized
gains/losses are included in other comprehensive income in our accompanying
condensed consolidated balance sheets.
Derivative
Instruments and Hedging Activities
We
develop, manufacture and sell medical devices globally and our earnings and cash
flows are exposed to market risk from changes in currency exchange rates and
interest rates. We address these risks through a risk management program that
includes the use of derivative financial instruments. We operate the program
pursuant to documented corporate risk management policies. We do not enter into
derivative transactions for speculative purposes.
Currency
Hedging
We manage
our exposure to foreign currency denominated monetary assets and liabilities on
a consolidated basis to take advantage of offsetting transactions. We may use
foreign currency denominated borrowings and currency forward contracts to manage
the majority of the remaining transaction exposure. These currency forward
contracts are not designated as cash flow, fair value or net investment hedges
under Statement No. 133; are marked-to-market with changes in fair value
recorded to earnings; and are entered into for periods consistent with currency
transaction exposures, generally one to six months. These derivative instruments
do not subject our earnings or cash flows to material risk since gains and
losses on these derivatives generally offset losses and gains on the assets and
liabilities being hedged. In addition, changes in
currency exchange rates related to any unhedged transactions may impact our
earnings and cash flows.
We also
use currency forward and option contracts to reduce the risk that our earnings
and cash flows, associated with forecasted foreign currency denominated
intercompany and third-party transactions, will be affected by currency exchange
rate changes. These contracts are designated as foreign currency cash flow
hedges under Statement No. 133. We record the effective portion of
any change in the fair value of the foreign currency cash flow hedges in other
comprehensive income until the related third-party transaction occurs. Once the
related third-party transaction occurs, we reclassify the effective portion of
any related gain or loss on the foreign currency cash flow hedge from other
comprehensive income to earnings. In the event the hedged forecasted transaction
does not occur, or it becomes probable that it will not occur, we would
reclassify the effective portion of any gain or loss on the related cash flow
hedge from other comprehensive income to earnings at that time. Gains and losses
from hedge ineffectiveness were immaterial in 2008, 2007 and 2006. We recognized
in earnings net losses of $67 million in 2008, net gains of $20 million during
2007, and net gains of $38 million during 2006 on currency derivative
instruments. All cash flow hedges outstanding at December 31, 2008 mature
within 36 months. As of December 31, 2008, $6 million of net losses
are recorded in other comprehensive income, net of tax, to recognize the
effective portion of the fair value of any currency derivative instruments that
are, or previously were, designated as foreign currency cash flow hedges, as
compared to $58 million at December 31, 2007. At December 31, 2008, $1
million of net gains, net of tax, may be reclassified to earnings within the
next twelve months. The success of the hedging program depends, in part, on
forecasts of transaction activity in various currencies (primarily Japanese yen,
Euro, British pound sterling, Australian dollar and Canadian dollar). We may
experience unanticipated currency exchange gains or losses to the extent that
there are differences between forecasted and actual activity during periods of
currency volatility. Changes in currency exchange rates related to
any unhedged transactions may impact our earnings and cash flows.
Interest
Rate Hedging
We use
interest rate derivative instruments to manage our exposure to interest rate
movements and to reduce borrowing costs by converting floating-rate debt into
fixed-rate debt or fixed-rate debt into floating-rate debt. We designate these
derivative instruments either as fair value or cash flow hedges under Statement
No. 133. We record changes in the fair value of fair value
hedges in other income (expense), which is offset by changes in the fair value
of the hedged debt obligation to the extent the hedge is effective. Interest
expense includes interest payments made or received under interest rate
derivative instruments. We record the effective
portion
of any change in the fair value of cash flow hedges as other comprehensive
income, net of tax, until the hedged cash flow occurs, at which point the
effective portion of any gain or loss is reclassified to earnings.
Prior to
2006, we entered into fixed-to-floating interest rate swaps indexed to six-month
LIBOR to hedge against potential changes in the fair value of certain of our
senior notes. We designated these interest rate swaps as fair value hedges under
Statement No. 133 with changes in fair value recorded to earnings offset by
changes in the fair value of our hedged senior notes. We terminated these hedges
during 2006 and realized a net loss of $14 million, which we recorded to the
carrying amount of certain of our senior notes and which are being amortized
into earnings over the remaining term of the hedged debt. As of December 31,
2008, the carrying amount of certain of our senior notes included $3 million of
unamortized gains and $11 million of unamortized losses related to these
interest rate swaps, as compared to $4 million of unamortized gains and
$13 million of unamortized losses at December 31, 2007.
During
2005 and 2006, we entered floating-to-fixed treasury locks to hedge potential
changes in future cash flows of certain senior note issuances. The objective of
these hedges was to reduce potential variability of interest payments on the
forecasted senior notes issuance. We designated these treasury locks as cash
flow hedges under Statement No. 133. Upon termination of the treasury locks in
2006, we realized net gains of $21 million. At December 31, 2008, we had $8
million of unamortized gain, net of tax, recorded in accumulated other
comprehensive income, which we are amortizing into earnings over the term of the
hedged debt. At December 31, 2007, we had $10 million of unamortized
gain, net of tax, recorded in accumulated other comprehensive
income.
We had
floating-to-fixed interest rate swaps indexed to three-month LIBOR outstanding
in the notional amount of $4.9 billion at December 31, 2008 and $1.5 billion at
December 31, 2007. The objective of these derivative instruments is to hedge
against variability in our future interest payments on our LIBOR-indexed
floating-rate loans as a result of changes in LIBOR. Three-month LIBOR
approximated 1.425 percent at December 31, 2008 and 4.70 percent at December 31,
2007. We designated these interest rate swaps as cash flow hedges under
Statement No. 133, and record fluctuations in the fair value of these derivative
instruments as unrealized gains or losses in other comprehensive income, net of
tax, until the hedged cash flow occurs. At December 31, 2008, we recorded a net
unrealized loss of $28 million, net of tax, in other comprehensive income to
recognize the fair value of these interest rate derivative instruments, as
compared to $11 million of net unrealized losses at December 31,
2007.
We
recognized $20 million of net losses in earnings related to all current and
prior interest rate derivative contracts in 2008 as compared to net losses of $2
million in 2007, and net gains of $2 million in 2006. At December 31, 2008,
$26 million of net losses, net of tax, may be reclassified to earnings within
the next twelve months.
Fair Value Measured on a
Non-Recurring Basis
During
2008, we recorded impairment charges on certain of our cost method investments
and adjusted the carrying amount of those investments to fair value, as we
deemed the decline in the value of those assets to be
other-than-temporary. These impairment charges relate primarily to
our investments in, and notes receivable from, certain entities that we agreed
to sell during the second quarter of 2008. See Note G – Investments and Notes
Receivable for further discussion. These cost method investments fall
within Level 3 of the fair value hierarchy, due to the use of significant
unobservable inputs to determine fair value, as the investments are in privately
held entities without quoted market prices. To determine the fair
value of those investments, we used all available financial information related
to the entities, including information based on recent third-party equity
investments in these entities and information from our agreements to sell
certain of these investments. The following summarizes changes to the
carrying amount of these investments during the year ended December 31, 2008 (in
millions):
Balance
at January 1, 2008
|
$ | 24 | ||
Net
transfers into Level 3
|
156 | |||
Net
sales
|
(48 | ) | ||
Other-than-temporary
impairments
|
(112 | ) | ||
Balance
at December 31, 2008
|
$ | 20 |
Other Fair Value
Disclosures
The fair
value of our long-term debt obligations was $6.184 billion at December 31, 2008
and $7.603 billion at December 31, 2007. Refer to Note I – Borrowings and Credit
Arrangements for a discussion of our debt obligations.
Note
D—Acquisitions
During
2008, we paid approximately $40 million in cash to acquire CryoCor, Inc. and
Labcoat, Ltd. During 2007, we paid approximately $100 million through a
combination of cash and common stock to acquire EndoTex Interventional Systems,
Inc. and $70 million in cash to acquire Remon Medical Technologies,
Inc. During 2006, we paid $28.4 billion to acquire Guidant through a
combination of cash, common stock, and fully vested stock options.
Our
consolidated financial statements include the operating results for each
acquired entity from its respective date of acquisition. Pro forma information
for 2006 related to our acquisition of Guidant is included in the section that
follows. We do not present pro forma information for our other acquisitions
given the immateriality of their results to our consolidated financial
statements.
2008
Acquisitions
In
December 2008, we completed the acquisition of the assets of Labcoat, Ltd., for
a purchase price of $17 million, net of cash acquired. We may also be required
to make future payments contingent upon Labcoat achieving certain performance
milestones. Labcoat is developing a novel technology for coating drug-eluting
stents. We intend to use this technology in future generations of our
drug-eluting stent products.
In May
2008, we completed our acquisition of 100 percent of the fully diluted equity of
CryoCor, Inc., and paid a cash purchase price of $21 million, net of cash
acquired. CryoCor is developing products using cryogenic technology for use in
treating atrial fibrillation. The acquisition was intended to allow us to
further pursue therapeutic solutions for atrial fibrillation in order to advance
our existing CRM and Electrophysiology product lines.
2007
Acquisitions
In
January 2007, we completed our acquisition of 100 percent of the fully diluted
equity of EndoTex Interventional Systems, Inc., a developer of stents used
in the treatment of stenotic lesions in the carotid arteries. We issued
approximately five million shares of our common stock valued at $90 million and
paid approximately $10 million in cash, in addition to our previous investments
of approximately $40 million, to acquire the remaining interests of
EndoTex. In addition, we may be required to pay future consideration
that is contingent upon EndoTex achieving certain performance-related
milestones. The acquisition was intended to expand our carotid artery disease
technology portfolio.
In August
2007, we completed our acquisition of 100 percent of the fully diluted equity of
Remon Medical Technologies, Inc. Remon is a development-stage company
focused on creating communication technology for medical device applications. We
paid approximately $70 million in cash, net of cash acquired, in addition to our
previous investments of $3 million, to acquire the remaining interests of Remon.
We may also be
required
to make future payments contingent upon Remon achieving certain performance
milestones. The acquisition was intended to expand our sensor and wireless
communication technology portfolio and complement our existing CRM product
line.
2006
Acquisitions
On April
21, 2006, we acquired 100 percent of the fully diluted equity of Guidant
Corporation for a purchase price of $21.7 billion, net of cash acquired, which
included: $7.8 billion in cash; 577 million shares of our common stock at an
estimated fair value of $12.5 billion; approximately 40 million of our fully
vested stock options granted to Guidant employees at an estimated fair value of
$450 million; $97 million associated with the buyout of options of certain
former vascular intervention and endovascular solutions Guidant employees; and
$770 million of direct acquisition costs, including a $705 million payment made
to Johnson & Johnson in connection with the termination of its merger
agreement with Guidant. Partially offsetting the purchase price was $6.7 billion
of cash that we acquired, including $4.1 billion in connection with Guidant’s
prior sale of its vascular intervention and endovascular solutions businesses to
Abbott Laboratories. The remaining cash relates to cash on hand at the time of
closing. There is no potential contingent consideration payable to the
former Guidant shareholders.
Upon the
closing of the acquisition, each share of Guidant common stock (other than
shares owned by Guidant and Boston Scientific) was converted into (i) $42.00 in
cash, (ii) 1.6799 shares of Boston Scientific common stock, and (iii) $0.0132 in
cash per share for each day beginning on April 1 through the closing date of
April 21, representing an additional $0.28 per share. The number of Boston
Scientific shares issued for each Guidant share was based on an exchange ratio
determined by dividing $38.00 by the average closing price of Boston Scientific
common stock during the 20 consecutive trading day period ending three days
prior to the closing date, so long as the average closing price during that
period was between $22.62 and $28.86. If the average closing price during that
period was below $22.62, the merger agreement specified a fixed exchange ratio
of 1.6799 shares of Boston Scientific common stock for each share of Guidant
common stock. Because the average closing price of Boston Scientific common
stock during that period was less than $22.62, Guidant shareholders received
1.6799 Boston Scientific shares for each share of Guidant common
stock.
We
measured the fair value of the 577 million shares of our common stock issued as
consideration in conjunction with our acquisition of Guidant under Statement No.
141, and EITF Issue No. 99-12, Determination of the Measurement
Date for the Market Price of Acquirer Securities Issued in a Purchase Business
Combination. We determined the measurement date to be April 17, 2006, the
first date on which the average 20-day closing price fell below $22.62 and the
number of Boston Scientific shares to be issued according to the exchange ratio
became fixed without subsequent revision. We valued the securities based on
average market prices a few days before and after the measurement date
(beginning on April 12 and ending on April 19), which did not include any dates
after the April 21 closing date of the acquisition. The weighted-average stock
price so determined was $21.68.
To
finance the cash portion of the Guidant acquisition, we borrowed $6.6 billion
consisting of a $5.0 billion five-year term loan and a $700 million 364-day
interim credit facility loan from a syndicate of commercial and investment
banks, as well as a $900 million subordinated loan from Abbott. See Note I - Borrowings and Credit
Arrangements for further details regarding the debt issued to finance the
cash portion of the Guidant acquisition.
We made
our offer to acquire Guidant after the execution of a merger agreement between
Guidant and Johnson & Johnson. On January 25, 2006, Guidant
terminated the Johnson & Johnson merger agreement and, in connection
with the termination, Guidant paid Johnson & Johnson a termination fee
of $705 million. We then reimbursed Guidant for the full amount of the
termination fee paid to Johnson & Johnson.
Abbott
Transaction
On April
21, 2006, before the closing of the Boston Scientific-Guidant transaction,
Abbott acquired Guidant’s vascular intervention and endovascular solutions
businesses for:
•
|
an
initial payment of $4.1 billion in cash at the Abbott transaction
closing;
|
•
|
a
milestone payment of $250 million upon receipt of an approval from
the U.S. Food and Drug Administration (FDA) within ten years after the
Abbott transaction closing to market and sell an everolimus-eluting stent
in the U.S.; and
|
•
|
a
milestone payment of $250 million upon receipt of an approval from the
Japanese Ministry of Health, Labor and Welfare within ten years after
the Abbott transaction closing to market and sell an everolimus-eluting
stent in Japan.
|
Further,
Abbott purchased from us approximately 65 million shares of our common stock for
$1.4 billion, or $21.66 per share. Abbott agreed not to sell any of these
shares of common stock for six months following the transaction closing
unless the average price per share of our common stock over any consecutive
20-day trading period during that six-month period exceeded $30.00. In addition,
during the 18-month period following the transaction closing, Abbott was
precluded from, in any one-month period, selling more than 8.33 percent of these
shares of our common stock. Abbott was required to sell all of these shares of
our common stock no later than 30 months following the April 21, 2006
acquisition date, and apply a portion of the net proceeds from its sale of these
shares of our common stock in excess of specified amounts, if any, to reduce the
principal amount of the loan from Abbott to us (sharing of proceeds feature). As
of the first quarter of 2008, Abbott had sold all of its shares of our common
stock, and no amounts were applied as a reduction of the loan.
We
determined the fair value of the sharing of proceeds feature of the Abbott stock
purchase as of April 21, 2006 to be $103 million and recorded this amount as an
asset received in connection with the sale of the Guidant vascular intervention
and endovascular solutions business to Abbott. We revalued this instrument each
reporting period, and recorded net expense of approximately $8 million during
2007 and $95 million during 2006 to reflect a decrease in fair value. There
was no income or expense associated with this instrument in 2008 prior to Abbott
selling all of its shares of our common stock.
We used a
Monte Carlo simulation methodology in determining the value of the sharing of
proceeds feature. We estimated the fair value on April 21, 2006 using the
following assumptions.
BSX
stock price
|
$ | 22.49 | ||
Expected
volatility
|
30% | |||
Risk-free
interest rate
|
4.9% | |||
Credit
spread
|
0.35% | |||
Expected
dividend yield
|
0% | |||
Contractual
term to expiration (years)
|
2.5 | |||
Notional
shares
|
64,635,272 |
In
connection with the Abbott transaction, we agreed to issue Abbott additional
shares of our common stock having an aggregate value of up to $60 million
eighteen months following the transaction closing to reimburse Abbott for a
portion of its cost of borrowing $1.4 billion to purchase the shares of our
common stock. We recorded the $60 million obligation as a liability assumed in
connection with the sale of Guidant’s vascular intervention and endovascular
solutions businesses to Abbott. In October 2007, we modified our agreement with
Abbott, and paid this obligation in cash, rather than in shares of our common
stock.
Prior to
the Abbott transaction closing, Boston Scientific and Abbott entered transition
services agreements under which (i) we were to provide or make available to the
Guidant vascular and endovascular solutions businesses acquired by Abbott those
services, rights, properties and assets of Guidant that were not included in the
assets purchased by Abbott and that are reasonably required by Abbott to enable
them to conduct the Guidant vascular and endovascular solutions businesses
substantially as conducted at the time of the Abbott transaction closing; and
(ii) Abbott was to provide or make available to us those services, rights,
properties and assets reasonably required by Boston Scientific to enable it to
conduct the business conducted by
Guidant,
other than the Guidant vascular and endovascular solutions businesses, in
substantially the same manner as conducted as of the Abbott transaction closing,
to the extent those services, rights, properties and assets were included in the
assets purchased by Abbott. As of December 31, 2008, all but one of these
transition services agreements had expired; the remaining agreement will expire
at the end of 2009.
Purchase
Price
We
accounted for the acquisition of Guidant as a purchase under U.S. GAAP. Under
the purchase method of accounting, we recorded the assets and liabilities of
Guidant as of the acquisition date at their respective fair values, and
consolidated them with those of legacy Boston Scientific. The preparation
of the valuation required the use of significant assumptions and estimates.
Critical estimates included, but were not limited to, future expected cash flows
and the applicable discount rates as of the date of the
acquisition.
The
purchase price, net of cash acquired, is as follows (in millions):
Consideration to
Guidant
|
||||
Cash
portion of consideration
|
$ | 14,527 | ||
Fair
value of Boston Scientific common stock
|
12,514 | |||
Fair
value of Boston Scientific options exchanged for Guidant stock
options
|
450 | |||
Buyout
of options for certain former employees
|
97 | |||
27,588 | ||||
Other
acquisition-related costs
|
||||
Johnson
& Johnson termination fee
|
705 | |||
Other
direct acquisition costs
|
65 | |||
Total
purchase price
|
28,358 | |||
Less:
cash acquired
|
6,708 | |||
Purchase
price, net of cash acquired
|
$ | 21,650 |
The fair
value of the Boston Scientific stock options exchanged for Guidant options was
included in the purchase price due to the fact that the options were fully
vested. We estimated the fair value of these options using a Black-Scholes
option-pricing model. We estimated the fair value of the stock options assuming
no expected dividends and the following weighted-average
assumptions:
Expected
term (in years)
|
2.4
|
Expected
volatility
|
30%
|
Risk-free
interest rate
|
4.9%
|
Stock
price on date of grant
|
$22.49
|
Weighted-average
exercise price
|
$13.11
|
Purchase
Price Allocation
The
following summarizes the Guidant purchase price allocation (in
millions):
Cash
|
$ | 6,708 | ||
Intangible
assets subject to amortization
|
7,719 | |||
Goodwill
|
12,516 | |||
Other
assets
|
2,400 | |||
Purchased
research and development
|
4,169 | |||
Current
liabilities
|
(1,881 | ) | ||
Net
deferred income taxes
|
(2,497 | ) | ||
Exit
costs
|
(161 | ) | ||
Other
long-term liabilities
|
(701 | ) | ||
Deferred
cost, ESOP
|
86 | |||
Total
purchase price
|
28,358 | |||
Less:
cash acquired
|
6,708 | |||
Purchase
price, net of cash acquired
|
$ | 21,650 |
We
allocated the purchase price to specific intangible asset categories as
follows:
Amount
Assigned
(in
millions)
|
Weighted
Average Amortization Period
(in
years)
|
Risk-Adjusted
Discount Rates used in Purchase Price Allocation
|
||||||||||
Amortizable
intangible assets
|
||||||||||||
Technology
- core
|
$ | 6,142 | 25 |
10%-16%
|
||||||||
Technology
- developed
|
885 | 6 |
10%
|
|
||||||||
Customer
relationships
|
688 | 15 |
10%-13%
|
|||||||||
Other
|
4 | 10 |
10%
|
|||||||||
$ | 7,719 | 22 | ||||||||||
Purchased
research and development
|
$ | 4,169 |
13%-17%
|
|||||||||
Goodwill
|
$ | 12,516 |
We
believe that the estimated intangible assets and purchased research and
development so determined represent the fair value at the date of acquisition
and do not exceed the amount a third party would pay for the assets. We used the
income approach to determine the fair value of the amortizable intangible assets
and purchased research and development. We valued and accounted for the
identified intangible assets and purchased research and development in
accordance with our policy as described in Note A - Significant Accounting
Policies.
The core
technology consists of technical processes, intellectual property, and
institutional understanding with respect to products or processes that were
developed by Guidant and that we will leverage in future products or processes.
Core technology represents know-how, patented and unpatented technology, testing
methodologies and hardware that will be carried forward from one product
generation to the next. Over 90 percent of the value assigned to core technology
is associated with Guidant’s CRM products and includes battery and capacitor
technology, lead technology, software algorithms, and interfacing for shocking
and pacing.
The
developed technology acquired from Guidant represents the value associated with
marketed products that had received FDA approval as of the acquisition date.
Guidant’s marketed products as of the acquisition date included:
•
|
Implantable
cardioverter defibrillator (ICD) systems used to detect and treat
abnormally fast heart rhythms (tachycardia) that could result in sudden
cardiac death, including implantable cardiac resynchronization therapy
defibrillator (CRT-D) systems used to treat heart
failure;
|
•
|
Implantable
pacemaker systems used to manage slow or irregular heart rhythms
(bradycardia), including implantable cardiac resynchronization therapy
pacemaker (CRT-P) systems used to treat heart failure;
and
|
•
|
Cardiac
surgery systems used to perform cardiac surgical ablation, endoscopic vein
harvesting and clampless beating-heart bypass
surgery.
|
We sold
the Cardiac Surgery business we acquired with Guidant in a separate transaction
in 2008. Refer to Note F– Divestitures and Assets Held for
Sale for further information.
Customer
relationships represent the estimated fair value of the non-contractual customer
relationships Guidant had with physician customers as of the acquisition date.
The primary physician users of Guidant’s largest selling products include
electrophysiologists, implanting cardiologists, cardiovascular surgeons, and
cardiac surgeons. These relationships were valued separately from goodwill as
Guidant (i) had information about and had regular contact with its physician
customers and (ii) the physician customers had the ability to make direct
contact with Guidant. We used the income approach to estimate the fair value of
customer relationships as of the acquisition date.
Various
factors contributed to the establishment of goodwill, including: the strategic
benefit of entering the CRM market and diversifying our product portfolio; the
value of Guidant’s highly trained assembled workforce as of the acquisition
date; the expected revenue growth over time that is attributable to expanded
indications and increased market penetration from future products and customers;
the incremental value to our existing Interventional Cardiology business from
having two drug-eluting stent platforms; and the synergies expected to result
from combining infrastructures, reducing combined operational spend and program
reprioritization. During 2008, we recorded a $2.613 billion goodwill impairment
charge associated with our acquisition of Guidant. Refer to Note E – Goodwill and Other Intangible Assets
for more information.
Pro
Forma Results of Operations
The
following unaudited pro forma information presents a summary of consolidated
results of our operations and Guidant’s, as if the acquisition, the Abbott
transaction and the financing for the acquisition had occurred at the beginning
of 2006. We have adjusted the historical consolidated financial information to
give effect to pro forma events that are (i) directly attributable to the
acquisition and (ii) factually supportable. We present the unaudited pro
forma condensed consolidated financial information for informational purposes
only. The pro forma information is not necessarily indicative of what the
financial position or results of operations actually would have been had the
acquisition, the sale of the Guidant vascular intervention and endovascular
solutions businesses to Abbott and the financing transactions with Abbott and
other lenders been completed at the beginning of the period. Pro forma
adjustments are tax-effected at our effective tax rate.
Year
Ended
|
|||||
in
millions, except per share data
|
December
31, 2006
|
||||
(unaudited)
|
|||||
Net
sales
|
$ | 8,533 | |||
Net
loss
|
(3,916 | ) | |||
Net
loss per share - basic
|
$ | (2.66 | ) | ||
Net
loss per share - assuming dilution
|
$ | (2.66 | ) |
The
unaudited pro forma net loss includes $480 million for the amortization of
purchased intangible assets, as well as the following non-recurring charges:
purchased research and development of $4.169 billion; $267 million associated
with the step-up value of acquired inventory sold; a tax charge for the
drug-eluting stent license right obtained from Abbott; and $95 million for the
fair value adjustment related to the sharing of proceeds feature of the Abbott
stock purchase. In connection with the accounting for the acquisition of
Guidant, we wrote up inventory acquired from manufacturing cost to fair
value.
Included
in the final Guidant purchase price allocation is $161 million associated with
exit activities accrued pursuant to Issue No. 95-3. As of the acquisition date,
management began to assess and formulate plans to exit certain Guidant
activities. As a result of these exit plans, we made severance,
relocation and change-in-control payments. The majority of the exit costs relate
to our first quarter 2007 reduction of the acquired CRM workforce. The
affected workforce included primarily research and development employees,
although employees within sales and marketing and certain other functions were
also impacted. We also made smaller workforce reductions
internationally across multiple functions in order to eliminate duplicate
facilities and rationalize our distribution network in certain
countries. During 2007 and 2008, we reduced our estimate for
Guidant-related exit costs in accordance with Issue No. 95-3. A rollforward of
the components of our accrual for Guidant-related and other exit costs is as
follows:
Workforce
Reductions
|
Relocation
Costs
|
Contractual
Commitments
|
Total
|
|||||||||||||
Balance
as of January 1, 2006
|
||||||||||||||||
Purchase
price adjustments
|
$ | 190 | $ | 15 | $ | 30 | $ | 235 | ||||||||
Charges
utilized
|
(27 | ) | (5 | ) | (5 | ) | (37 | ) | ||||||||
Balance
as of December 31, 2006
|
163 | 10 | 25 | 198 | ||||||||||||
Purchase
price adjustments
|
(63 | ) | (2 | ) | (7 | ) | (72 | ) | ||||||||
Charges
utilized
|
(85 | ) | (6 | ) | (9 | ) | (100 | ) | ||||||||
Balance
as of December 31, 2007
|
15 | 2 | 9 | 26 | ||||||||||||
Purchase
price adjustments
|
(1 | ) | (1 | ) | (2 | ) | ||||||||||
Charges
utilized
|
(4 | ) | (1 | ) | (3 | ) | (8 | ) | ||||||||
Balance
as of December 31, 2008
|
$ | 10 | $ | — | $ | 6 | $ | 16 |
Payments
Related to Prior Period Acquisitions
During
2008, we paid $675 million related to prior period acquisitions, consisting
primarily of a $650 million fixed payment made to the principal former
shareholders of Advanced Bionics Corporation in connection with our 2007
amendment to the original merger agreement, which was accrued at December 31,
2007. During 2007, we paid $248 million for acquisition-related payments
associated primarily with Advanced Bionics, of which approximately $220 million
was accrued at December 31, 2006. During 2006, we paid $397 million for
acquisition-related payments associated primarily with Advanced Bionics,
CryoVascular Systems, Inc. and Smart Therapeutics, Inc.
Certain
of our acquisitions involve the payment of contingent consideration. Payment of
the additional consideration is generally contingent on the acquired company
reaching certain performance milestones, including attaining specified revenue
levels, achieving product development targets or obtaining regulatory approvals.
In August 2007, we entered an agreement to amend our 2004 merger agreement with
the principal former shareholders of Advanced Bionics Corporation. Previously,
we were obligated to pay future consideration contingent primarily on the
achievement of future performance milestones. The amended agreement provides a
new schedule of consolidated, fixed payments, consisting of $650 million that
was paid in January 2008, and $500 million payable in March 2009. The fair value
of these payments, determined to be $1.115 billion, was accrued at December 31,
2007. As of December 31, 2008, we have accrued $497 million
representing
the fair value of the payment to be made in March 2009. These payments will be
the final payments made to Advanced Bionics. See Note F – Divestitures and Assets
Held for Sale for further discussion of the amendment. As of December 31,
2008, the estimated maximum potential amount of future contingent consideration
(undiscounted) that we could be required to make associated with our other
business combinations, excluding Advanced Bionics, some of which may be payable
in common stock, is approximately $650 million. The milestones associated with
the contingent consideration must be reached in certain future periods ranging
from 2009 through 2022. The estimated cumulative specified revenue level
associated with these maximum future contingent payments is approximately $2.4
billion.
Purchased Research and
Development
In 2008,
we recorded $43 million of purchased research and development charges, including
$17 million associated with our acquisition of Labcoat, Ltd., $8 million
attributable to our acquisition of CryoCor, Inc., and $18 million associated
with entering certain licensing and development arrangements.
The $17
million of in-process research and development associated with our acquisition
of Labcoat, Ltd. relates to their in-process coating technology for drug-eluting
stents. The $8 million of purchased research and development associated with
CryoCor relates to their cryogenic technology for use in the treatment of atrial
fibrillation.
In 2007,
we recorded $85 million of purchased research and development, including $75
million associated with our acquisition of Remon Medical Technologies, Inc., $13
million resulting from the application of equity method accounting for one of
our strategic investments, and $12 million associated with payments made for
certain early-stage CRM technologies. Additionally, in June 2007, we terminated
our product development agreement with Aspect Medical Systems relating to brain
monitoring technology that Aspect has been developing to aid the diagnosis and
treatment of depression, Alzheimer’s disease and other neurological conditions.
As a result, we recognized a credit to purchased research and development of
approximately $15 million during 2007, representing future payments that we
would have been obligated to make prior to the termination of the agreement. We
do not expect the termination of the agreement to impact our future operations
or cash flows materially.
The $75
million of in-process research and development acquired with Remon relates to
their pressure-sensing system development project, which we intend to combine
with our existing CRM devices. As of December 31, 2008, we estimate that the
total cost to complete the development project is between $75 million and $80
million. We expect to launch devices using pressure-sensing technology in 2012
in our EMEA region and certain Inter-Continental countries, in the U.S. in
2015, and Japan in 2016, subject to regulatory approvals. We expect material net
cash inflows from such products to commence in 2015, following the launch of
this technology in the U.S.
In 2006,
we recorded $4.119 billion of purchased research and development, including a
charge of approximately $4.169 billion associated with the in-process research
and development obtained in conjunction with the Guidant acquisition; a credit
of $67 million resulting primarily from the reversal of accrued contingent
payments due to the cancellation of the TriVascular AAA program; and an expense
of $17 million resulting primarily from the application of equity method
accounting for one of our investments.
The
$4.169 billion of purchased research and development associated with the Guidant
acquisition consists primarily of approximately $3.26 billion for acquired
CRM-related technology and $540 million for drug-eluting stent technology shared
with Abbott. The purchased research and development value associated with the
Guidant acquisition also includes $369 million representing the estimated fair
value of the potential milestone payments of up to $500 million that we may
receive from Abbott upon its receipt of regulatory approvals for certain
products. We recorded the amounts as purchased research and development at the
acquisition date because the receipt of the payments was dependent on future
research and development activity and regulatory approvals, and the asset had no
alternative future use as of the acquisition date. In 2008, Abbott received FDA
approval and launched its XIENCE V™ everolimus-eluting coronary stent system in
the U.S.,
and paid
us $250 million, which we recognized as a gain in our consolidated financial
statements. Under the terms of the agreement, we are entitled to receive a
second milestone payment of $250 million from Abbott upon receipt of an approval
from the Japanese Ministry of Health, Labour and Welfare to market the
XIENCE V™ stent system in Japan. If received, we will record this receipt as a
gain in our consolidated financial statements at the time of
receipt.
The most
significant in-process purchased research and development projects acquired from
Guidant included the next-generation CRM pulse generator platform and rights to
the everolimus-eluting stent technology that we share with Abbott. The
next-generation pulse generator platform incorporates new components and
software while leveraging certain existing intellectual property, technology,
manufacturing know-how and institutional knowledge of Guidant. We expect to
leverage this platform across all CRM product families, including ICD systems,
cardiac resynchronization therapy (CRT) devices and pacemaker systems, to treat
electrical dysfunction in the heart. During 2008, we substantially completed the
in-process CRM pulse generator project with the regulatory approval and launch
of the COGNIS® CRT-D and TELIGEN® ICD devices in the U.S., our EMEA region and
certain Inter-Continental countries. We expect to launch the INGENIO™ pacemaker
system, utilizing this platform in both EMEA and the U.S. in the first half of
2011. As of December 31, 2008, we estimate that the total cost to complete the
INGENIO™ technology is between $30 million and $35 million and expect material
net cash inflows from the INGENIO™ device to commence in the second half of
2011.
The $540
million attributable to everolimus-eluting stent technology represents the
estimated fair value of the rights to Guidant’s everolimus-based drug-eluting
stent technology we share with Abbott. In December 2006, we launched the PROMUS®
everolimus-eluting coronary stent system, supplied to us by Abbott, in certain
European countries. In 2007, we expanded our launch in Europe, as well as in key
countries in other regions and, in July 2008, launched in the U.S. We expect to
launch an internally developed and manufactured next-generation everolimus-based
stent in late 2009 and in the U.S. and Japan in mid-2012. We expect
that net cash inflows from our internally developed and manufactured
everolimus-based drug-eluting stent, the PROMUS® Element™, will commence in
2010. As of December 31, 2008, we estimate that the cost to complete our
internally manufactured next-generation everolimus-eluting stent technology
project is between $150 million and $175 million.
Note E—Goodwill
and Other Intangible Assets
The gross
carrying amount of goodwill and other intangible assets and the related
accumulated amortization for intangible assets subject to amortization is as
follows:
As
of December 31, 2008
|
As
of December 31, 2007
|
|||||||||||||||
(in
millions)
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
||||||||||||
Amortizable
intangible assets
|
||||||||||||||||
Technology
- core
|
$ | 6,564 | $ | 854 | $ | 6,596 | $ | 526 | ||||||||
Technology
- developed
|
1,026 | 664 | 1,096 | 515 | ||||||||||||
Patents
|
564 | 264 | 579 | 257 | ||||||||||||
Other
intangible assets
|
791 | 210 | 806 | 142 | ||||||||||||
$ | 8,945 | $ | 1,992 | $ | 9,077 | $ | 1,440 | |||||||||
Unamortizable
intangible assets
|
||||||||||||||||
Goodwill
|
$ | 12,421 | $ | 15,103 | ||||||||||||
Technology
- core
|
291 | 327 | ||||||||||||||
$ | 12,712 | $ | 15,430 |
During
the fourth quarter of 2008, we performed an interim goodwill impairment test on
our U.S. CRM reporting unit, acquired with Guidant, and recorded a $2.613
billion goodwill impairment charge. The interim test was performed because the
decline in our stock price and corresponding market capitalization during the
fourth quarter created an indication of potential impairment of our goodwill
balance. As the majority of the goodwill associated with our acquisition of
Guidant is allocated to the U.S. CRM reporting unit, this unit is most impacted
by subsequent changes in fair value. The key factors that contributed to the
U.S. CRM goodwill impairment charge included disruptions in the credit and
equity markets, and the resulting increase to weighted-average costs of capital;
and reductions in CRM market demand relative to our assumptions at the time of
the Guidant acquisition. At the time of the Guidant acquisition in 2006, we
expected average U.S. net sales growth rates in the mid-teens. Due to changes in
end market demand, we now expect average U.S. net sales growth rates in the mid
to high single digits.
We used
the income approach to determine the fair value of the U.S. CRM reporting unit
acquired as part of the Guidant transaction and the amount of the goodwill
impairment charge. This approach calculates fair value by estimating the
after-tax cash flows attributable to a reporting unit and then discounting these
after-tax cash flows to a present value using a risk-adjusted discount
rate. This methodology is consistent with how we estimate the fair
value of our reporting units during our annual goodwill impairment tests. In
applying the income approach to calculate the fair value of the U.S. CRM
reporting unit, we used reasonable estimates and assumptions about future
revenue contributions and cost structures. In addition, the application of the
income approach requires judgment in determining a risk-adjusted discount rate;
at the reporting unit level, we based this determination on estimates of
weighted-average costs of capital of a market participant. We performed a peer
company analysis and considered the industry weighted-average return on debt and
equity from a market participant perspective. Given the disruptions in the
credit and equity markets, this weighted-average return increased 150 basis
points between our annual test performed in the second quarter of 2008, and the
interim test performed during the fourth quarter. The long-term growth rates for
our U.S. CRM reporting unit underlying our interim test at December 31, 2008 are
largely consistent with those applied in the annual test during the second
quarter of 2008.
To
calculate the amount of the goodwill impairment charge, we allocated the fair
value of the U.S. CRM reporting unit to all of its assets and liabilities,
including certain unrecognized intangible assets, in order to determine the
implied fair value of goodwill at December 31, 2008. This allocation process
required judgment and the use of additional valuation assumptions in deriving
the individual fair values of our U.S. CRM reporting unit’s assets and
liabilities as if the U.S. CRM reporting unit had been acquired in a business
combination. We believe our determined fair values and the resulting goodwill
impairment charge are based on reasonable assumptions and represent the best
estimate of these amounts at December 31, 2008. The goodwill impairment charge
has been excluded from the determination of segment income considered by
management.
In
addition, during 2008, we reduced our future revenue and cash flow forecasts
associated with certain of our Peripheral Interventions-related intangible
assets, primarily as a result of a recall of one of our
products. Therefore, we tested these intangible assets for
impairment, in accordance with our accounting policies, and determined that
these assets were impaired, resulting in a $131 million charge to write down
these intangible assets to their fair value. Further, as a result of
significantly lower than forecasted sales of certain of our Urology products,
due to lower than anticipated market penetration, we determined that certain of
our Urology-related intangible assets were impaired, resulting in a $46 million
charge to write down these intangible assets to their fair value. These amounts
have been excluded from the determination of segment income considered by
management.
The
intangible asset category and associated write down is as follows (in
millions):
Technology
- core
|
$ | 126 | ||
Other
intangible assets
|
51 | |||
$ | 177 |
In 2007,
we recorded intangible asset impairment charges of $21 million associated with
our acquisition of Advanced Stent Technologies (AST), due to our decision to
suspend further significant funding of R&D with respect to the Petal™
bifurcation stent. In 2006, we
recorded intangible asset impairment charges of $23 million attributable to the
cancellation of the AAA stent-graft program we acquired with TriVascular, Inc.
In addition, we recorded intangible asset write-offs of $21 million associated
with developed technology obtained as part of our 2005 acquisition of Rubicon
Medical Corporation, and $12 million associated with our Real-time Position
Management® System (RPM)™ technology, due to our decision to cease investment in
these technologies.
Our core
technology that is not subject to amortization represents technical processes,
intellectual property and/or institutional understanding acquired through
business combinations that is fundamental to the on-going operations of our
business and has no limit to its useful life. Our core technology that is not
subject to amortization is comprised primarily of certain purchased stent and
balloon technology, which is foundational to our continuing operations within
the Cardiovascular market and other markets within interventional medicine. We
amortize all other core technology over its estimated useful life.
Estimated
amortization expense for each of the five succeeding fiscal years based upon our
intangible asset portfolio at December 31, 2008 is as follows:
Fiscal
Year
|
Estimated
Amortization
Expense
(in
millions)
|
||||
2009
|
$ | 491 | |||
2010
|
478 | ||||
2011
|
387 | ||||
2012
|
343 | ||||
2013
|
334 |
Goodwill
as of December 31 as allocated to our U.S., EMEA, Japan and
Inter-Continental segments for purposes of our goodwill impairment testing is
presented below. Our U.S. goodwill is further allocated to our U.S. reporting
units for our goodwill testing in accordance with Statement No. 142. During the
first quarter of 2009, we reorganized our international business, and therefore,
revised our reportable segments to reflect the way we currently manage and view
our business. Refer to Note P
– Segment Reporting for more information on our reporting structure and
segment results. We have reclassified previously reported 2007 and 2006 goodwill
balances and activity by segment to be consistent with the 2008
presentation.
(in
millions)
|
United
States
|
EMEA
|
Japan
|
Inter-
Continental
|
Total
|
|||||||||||||||
Balance
as of January 1, 2007
|
$ | 9,529 | $ | 3,955 | $ | 575 | $ | 569 | $ | 14,628 | ||||||||||
Purchase
price adjustments
|
77 | 54 | 6 | 5 | 142 | |||||||||||||||
Goodwill
acquired
|
34 | 10 | 4 | 4 | 52 | |||||||||||||||
Contingent
consideration
|
924 | 139 | 42 | 41 | 1,146 | |||||||||||||||
Goodwill
reclassified to assets held for sale
|
(311 | ) | (1 | ) | (1 | ) | (313 | ) | ||||||||||||
Goodwill
written off
|
(478 | ) | (46 | ) | (14 | ) | (14 | ) | (552 | ) | ||||||||||
Balance
as of December 31, 2007
|
$ | 9,775 | $ | 4,111 | $ | 612 | $ | 605 | $ | 15,103 | ||||||||||
Purchase
price adjustments
|
(7 | ) | (38 | ) | (15 | ) | (14 | ) | (74 | ) | ||||||||||
Contingent
consideration
|
5 | 5 | ||||||||||||||||||
Goodwill
written off
|
(2,613 | ) | (2,613 | ) | ||||||||||||||||
Balance
as of December 31, 2008
|
$ | 7,160 | $ | 4,073 | $ | 597 | $ | 591 | $ | 12,421 | ||||||||||
During
2007, we determined that certain of our businesses were no longer strategic to
our on-going operations. Therefore, in conjunction with the anticipated sales of
our Auditory, Cardiac Surgery and Vascular Surgery businesses, we recorded $552
million of goodwill write-downs in 2007 in accordance with FASB Statement No.
142, Goodwill and Other
Intangible Assets, and FASB Statement No. 144, Accounting for the Impairment or
Disposal of Long-lived Assets. In addition, in accordance with
Statement No. 144, we present separately the assets of the disposal groups,
including the related goodwill, as ‘assets held for sale’ within our
consolidated balance sheets. Refer to Note F – Divestitures and Assets
Held for Sale for more information regarding these transactions, and for
the major classes of assets, including goodwill, classified as held for
sale.
The 2007
and 2008 purchase price adjustments related primarily to adjustments in taxes
payable and deferred income taxes, including changes in the liability for
unrecognized tax benefits in accordance with FASB Interpretation No. 48, Accounting for Uncertainty in Income
Taxes; as well as reductions in our estimate for Guidant-related exit
costs. In addition, the 2007 purchase price adjustments included
changes in our estimates for the costs associated with Guidant product liability
claims and litigation.
Note F—Divestitures
and Assets Held for Sale
During
2007, we determined that our Auditory, Cardiac Surgery, Vascular Surgery, Venous
Access, and Fluid Management businesses, as well as our TriVascular
Endovascular Aortic Repair (EVAR) program, were no longer strategic to our
on-going operations. Therefore, we initiated the process of selling these
businesses in 2007, and completed their sale in the first quarter of 2008, as
discussed below. We received gross proceeds of approximately $1.3 billion from
these divestitures. The sale of these disposal groups has helped allow us to
focus on our core businesses and priorities. Management committed to a plan to
sell each of these businesses in 2007 and, pursuant to Statement No. 144, we
adjusted the carrying value of the disposal groups to their fair value, less
cost to sell (if lower than the carrying value) during 2007, and presented
separately the assets of the disposal groups as ‘assets held for sale’ and the
liabilities of the disposal groups as ‘liabilities associated with assets held
for sale’ in our consolidated balance sheets.
In
addition, in 2008 we committed to the sale of certain of our owned properties
and, in accordance with Statement No. 144, have presented separately the
carrying value, less cost to sell, of the properties as ‘assets held for sale’
in our consolidated balance sheets.
Auditory
In August
2007, we entered an agreement to amend our 2004 merger agreement with the
principal former shareholders of Advanced Bionics Corporation. The
acquisition of Advanced Bionics included potential earnout payments that were
contingent primarily on the achievement of future performance milestones, with
certain milestones tied to profitability. The amended agreement provides for a
new schedule of consolidated,
fixed
payments to the former Advanced Bionics shareholders, consisting of $650 million
that was paid upon closing in January 2008, and $500 million payable in March
2009. These payments will be the final payments made to Advanced Bionics. The
former shareholders of Advanced Bionics approved the amended merger agreement in
September 2007. Following the approval by the former shareholders, we accrued
the fair value of these payments in accordance with Statement No. 141, as the
payment of this consideration was determinable beyond a reasonable doubt. The
fair value of these payments, determined to be $1.115 billion, was recorded as
an increase to goodwill. At December 31, 2008, we have accrued $497 million,
representing the present value of the final payment to be made in March
2009.
In
conjunction with the amended merger agreement, in January 2008, we completed the
sale of a controlling interest in our Auditory business and drug pump
development program, acquired with Advanced Bionics in 2004, to entities
affiliated with the principal former shareholders of Advanced Bionics for an
aggregate purchase price of $150 million in cash. To adjust the carrying
value of the disposal group to its fair value, less costs to sell, we recorded a
loss of approximately $367 million (pre-tax) in 2007, representing primarily a
write-down of goodwill. In addition, we recorded a tax benefit of $7 million
during 2008 in connection with the closing of the transaction. Under the terms
of the agreement, we retained an equity interest in the limited liability
companies formed for purposes of operating the Auditory business and drug pump
development program. In accordance with EITF Issue No. 03-16, Accounting for Investments in
Limited Liability Companies, we are accounting for these investments
under the equity method of accounting.
Cardiac
Surgery and Vascular Surgery
In
January 2008, we completed the sale of our Cardiac Surgery and Vascular Surgery
businesses to the Getinge Group for net cash proceeds of approximately $700
million. To adjust the carrying value of the Cardiac Surgery and Vascular
Surgery disposal group to its fair value, less costs to sell, we recorded a loss
of approximately $193 million in 2007, representing primarily the write-down of
goodwill. In addition, we recorded a tax expense of $19 million during 2008 in
connection with the closing of the transaction. We acquired the
Cardiac Surgery business in April 2006 as part of the Guidant transaction (refer
to Note D –
Acquisitions) and acquired the Vascular Surgery business in
1995.
Fluid
Management and Venous Access
In
February 2008, we completed the sale of our Fluid Management and Venous Access
businesses to Navylist Medical (affiliated with Avista Capital Partners) for net
cash proceeds of approximately $400 million. We did not adjust the carrying
value of the Fluid Management and Venous Access disposal group as of December
31, 2007, because the fair value of the disposal group, less costs to sell,
exceeded its carrying value. We recorded a pre-tax gain of $234 million ($161
million after-tax) during 2008 associated with this transaction. We acquired the
Fluid Management business as part of our acquisition of Schneider Worldwide in
1998. The Venous Access business was previously a component of our Oncology
business.
TriVascular
EVAR Program
In March
2008, we sold our EVAR program obtained in connection with our 2005 acquisition
of TriVascular, Inc. for $30 million in cash. We discontinued our EVAR program
in 2006. In connection with the sale, we recorded a pre-tax gain of $16 million
($36 million after-tax) during 2008.
The
combined assets held for sale and liabilities associated with the assets held
for sale included in the accompanying consolidated balance sheets consist of the
following:
As
of December 31,
|
||||||||
(in
millions)
|
2008
|
2007
|
||||||
Trade
accounts receivable, net
|
$ | 41 | ||||||
Inventories
|
71 | |||||||
Prepaid
expenses and other current assets
|
3 | |||||||
Property,
plant and equipment, net
|
$ | 13 | 107 | |||||
Goodwill
|
313 | |||||||
Other
intangible assets, net
|
581 | |||||||
Other
long-term assets
|
3 | |||||||
Assets
held for sale
|
$ | 13 | $ | 1,119 | ||||
Accounts
payable and accrued expenses
|
$ | 32 | ||||||
Other
current liabilities
|
6 | |||||||
Other
non-current liabilities
|
1 | |||||||
Liabilities
associated with assets held for sale
|
$ | 39 |
The
tangible assets and liabilities presented in the table above are primarily U.S.
assets and liabilities and are included in our United States reportable
segment.
The
combined 2007 revenues associated with the disposal groups were $553 million, or
seven percent of our net sales.
Note
G – Investments and Notes Receivable
We have
historically entered a significant number of alliances with publicly traded
and privately held entities in order to broaden our product technology
portfolio and to strengthen and expand our reach into existing and new markets.
During 2007, in connection with our strategic initiatives, we announced our
intent to sell the majority of our investment portfolio in order to monetize
those investments determined to be non-strategic.
In June
2008, we signed definitive agreements with Saints Capital and Paul Capital
Partners to sell the majority of our investments in, and notes receivable from,
certain publicly traded and privately held entities for gross proceeds of
approximately $140 million. In connection
with these agreements we have received proceeds of $95 million as of December
31, 2008. In addition, we received proceeds of $54 million from other
transactions to monetize certain other non-strategic investments and notes
receivable during 2008.
We
recorded total other-than-temporary impairments of $130 million during 2008,
including $127 million related to non-strategic investments and notes
receivable, which we have sold or intend to sell, and $3 million related to our
strategic equity investments. Our 2008 other-than-temporary impairments included
$112 million of impairments related to privately held entities, and $18 million
of impairments related to publicly traded entities. In addition, we recorded
gains of $52 million on the sale of non-strategic investments during 2008. We
also recognized other costs of $5 million associated with the Saints and Paul
agreements. During 2007, we recorded other-than-temporary impairments of $119
million related to our investments and notes receivable, and recorded gains of
$65 million associated with the sale of equity investments and collection of
notes receivable. During 2006, we recorded $122 million of total
other-than-temporary impairments of our investments and notes receivable and
recorded gains of $13 million associated with the sale of equity investments.
Losses and gains associated with our investments and notes receivable are
recorded in Other, net within our consolidated statements of
operations.
Many of
our alliances involve equity investments in privately held equity securities or
investments where an observable quoted market value does not exist. Many of
these companies are in the developmental stage and
have not
yet commenced their principal operations. Our exposure to losses related to our
alliances is generally limited to our equity investments and notes receivable
associated with these alliances. Our equity investments in alliances consist of
the following:
As
of December 31,
|
||||||||
(in
millions)
|
2008
|
2007
|
||||||
Available-for-sale
investments
|
||||||||
Carrying
value
|
$ | 1 | $ | 18 | ||||
Gross
unrealized gains
|
26 | |||||||
Gross
unrealized losses
|
||||||||
Fair
value
|
1 | 44 | ||||||
Equity
method investments
|
||||||||
Carrying
value
|
45 | 60 | ||||||
Cost
method investments
|
||||||||
Carrying
value
|
67 | 213 | ||||||
$ | 113 | $ | 317 |
As of
December 31, 2008, we held $45 million of investments that we accounted for
under the equity method. Our ownership percentages in these entities ranges from
approximately five percent to 18 percent. In accordance with EITF
Issue No. 03-16, Accounting
for Investments in Limited Liability Companies, and EITF Topic D-46,
Accounting for Limited
Partnership Investments, we account for these investments under the
equity method of accounting. We recorded losses of $10 million, reported in
Other, net, associated with the application of the equity method of accounting
to these investments in 2008. We recorded $13 million of purchased research and
development associated with the initial application of the equity method of
accounting to certain investments in 2007; other income (expense) associated
with equity method adjustments in 2007 was less than $1 million in the
aggregate.
We had
notes receivable of approximately $46 million at December 31, 2008 and $61
million at December 31, 2007 due from certain companies. In addition, we
had approximately $20 million of cost method investments recorded in other
current assets in our consolidated balance sheets as of December 31, 2008 as
these investments will be monetized in 2009 pursuant to our definitive agreement
with Saints.
Note
H – Restructuring-related Activities
In
October 2007, our Board of Directors approved, and we committed to, an expense
and head count reduction plan, which resulted in the elimination of
approximately 2,300 positions worldwide. We are providing affected employees
with severance packages, outplacement services and other appropriate assistance
and support. The plan is intended to bring expenses in line with
revenues as part of our initiatives to enhance short- and long-term shareholder
value. Key activities under the plan include the restructuring of several
businesses, corporate functions and product franchises in order to better
utilize resources, strengthen competitive positions, and create a more
simplified and efficient business model; the elimination, suspension or
reduction of spending on certain R&D projects; and the transfer of certain
production lines from one facility to another. We initiated these activities in
the fourth quarter of 2007 and expect to be substantially complete worldwide in
2010.
We expect
that the execution of this plan will result in total pre-tax expenses of
approximately $425 million to $450 million. We are recording a
portion of these expenses as restructuring charges and the remaining portion
through other lines within our consolidated statements of operations. We
expect the plan to result in cash payments of approximately $395 million to $415
million. The following provides a summary of our expected total costs
associated with the plan by major type of cost:
Type
of cost
|
Total
estimated amount expected to be incurred
|
Restructuring
charges:
|
|
Termination
benefits
|
$225
million to $230 million
|
Fixed
asset write-offs
|
$20
million
|
Other
(1)
|
$65
million to $70 million
|
Restructuring-related
expenses:
|
|
Retention
incentives
|
$75
million to $80 million
|
Accelerated
depreciation
|
$10
million to $15 million
|
Transfer
costs (2)
|
$30
million to $35 million
|
$425
million to $450 million
|
(1) | Consists primarily of consulting fees and contractual cancellations. | |
|
(2)
|
Consists
primarily of costs to transfer product lines from one facility to another,
including costs of transfer teams, freight and product line
validations.
|
During
2008, we recorded $78 million of restructuring charges. In addition,
we recorded $55 million of expenses within other lines of our consolidated
statements of operations related to our restructuring initiatives. The following
presents these costs by major type and line item within our consolidated
statements of operations:
(in
millions)
|
Termination
Benefits
|
Retention
Incentives
|
Asset
Write-offs
|
Accelerated
Depreciation
|
Transfer
Costs
|
Other
|
Total
|
|||||||||||||||||||||
Restructuring
charges
|
$ | 34 | $ | 10 | $ | 34 | $ | 78 | ||||||||||||||||||||
Restructuring-related
expenses:
|
||||||||||||||||||||||||||||
Cost
of products sold
|
$ | 9 | $ | 4 | $ | 4 | 17 | |||||||||||||||||||||
Selling,
general and administrative expenses
|
27 | 4 | 31 | |||||||||||||||||||||||||
Research
and development expenses
|
7 | 7 | ||||||||||||||||||||||||||
43 | 8 | 4 | 55 | |||||||||||||||||||||||||
$ | 34 | $ | 43 | $ | 10 | $ | 8 | $ | 4 | $ | 34 | $ | 133 |
During
2007, we recorded $176 million of restructuring charges, and $8 million of
restructuring-related expenses within other lines of our consolidated statements
of operations. The following presents these costs by major type and line item
within our consolidated statements of operations:
(in
millions)
|
Termination
Benefits
|
Retention
Incentives
|
Asset
Write-offs
|
Accelerated
Depreciation
|
Transfer
Costs
|
Other
|
Total
|
|||||||||||||||||||||
Restructuring
charges
|
$ | 158 | $ | 8 | $ | 10 | $ | 176 | ||||||||||||||||||||
Restructuring-related
expenses:
|
||||||||||||||||||||||||||||
Cost
of products sold
|
$ | 1 | $ | 1 | 2 | |||||||||||||||||||||||
Selling,
general and administrative expenses
|
2 | $ | 2 | 4 | ||||||||||||||||||||||||
Research
and development expenses
|
2 | 2 | ||||||||||||||||||||||||||
5 | 3 | 8 | ||||||||||||||||||||||||||
$ | 158 | $ | 5 | $ | 8 | $ | 3 | $ | 10 | $ | 184 |
The
termination benefits recorded during 2008 and 2007 represent amounts incurred
pursuant to our on-going benefit arrangements and amounts for “one-time”
involuntary termination benefits, and have been recorded in accordance with FASB
Statement No. 112, Employer’s
Accounting for Postemployment Benefits and FASB Statement No. 146, Accounting for Costs Associated with
Exit or Disposal Activities. We expect to record the additional
termination benefits in 2009 when we identify with more specificity the job
classifications, functions and locations of the remaining head count to be
eliminated. Retention incentives represent cash incentives, which are
being recorded over the future service period during which eligible employees
must remain employed with us in order to retain the payment. The
other restructuring costs, which, in 2008 and 2007, represented primarily
consulting fees, are being recognized and measured at their fair value in the
period in which the liability is incurred in accordance with FASB Statement No.
146.
We have incurred cumulative restructuring and restructuring-related costs of $317 million since we committed to the plan in October 2007. The following presents these costs by major type (in millions):
Termination
benefits
|
$ | 192 | ||
Retention
incentives
|
48 | |||
Fixed
asset write-offs
|
18 | |||
Accelerated
depreciation
|
11 | |||
Transfer
costs
|
4 | |||
Other
|
44 | |||
$ | 317 |
In 2008,
we made cash payments of approximately $185 million associated with our
restructuring initiatives, which related to termination benefits and retention
incentives paid and other restructuring charges. We have made
cumulative cash payments of approximately $230 million since we committed to our
restructuring initiatives in October 2007. These payments were made using cash
generated from our operations. We expect to record the remaining
costs associated with these restructuring initiatives through 2009 and make the
remaining cash payments throughout 2009 and 2010 using cash generated from
operations.
Costs
associated with restructuring and restructuring-related activities are excluded
from the determination of segment income, as they do not reflect expected
on-going future operating expenses and are not considered by management when
assessing operating performance.
The
following is a rollforward of the liability associated with our restructuring
initiatives since the inception of the plan in the fourth quarter of 2007, which
is reported as a component of accrued expenses included in our accompanying
consolidated balance sheets.
(in
millions)
|
Termination
Benefits
|
Other
|
Total
|
|||||||||
Charges
|
$ | 158 | $ | 10 | $ | 168 | ||||||
Cash
payments
|
(23 | ) | (8 | ) | (31 | ) | ||||||
Balance
at December 31, 2007
|
135 | 2 | 137 | |||||||||
Charges
|
34 | 34 | 68 | |||||||||
Cash
payments
|
(128 | ) | (35 | ) | (163 | ) | ||||||
Balance
at December 31, 2008
|
$ | 41 | $ | 1 | $ | 42 |
In
addition to the amounts in the rollforward above, we have incurred cumulative
charges of $81 million associated with retention incentives, product transfer
costs, asset write-offs and accelerated depreciation; and have made cumulative
cash payments of $32 million associated with retention incentives and $4 million
associated with product transfer costs.
Plant
Network Optimization
On
January 27, 2009, our Board of Directors approved, and we committed to, a plant
network optimization plan, which is intended to simplify our manufacturing plant
structure by transferring certain production lines from one facility to another
and by closing certain facilities. The plan is a complement to our previously
announced expense and head count reduction plan, and is intended to improve
overall gross profit margins. Activities under the plan will be initiated in
2009 and are expected to be substantially completed by the end of
2011.
We
estimate that the plan will result in total pre-tax charges of approximately
$135 million to $150 million, and that approximately $120 million to $130
million of these charges will result in future cash outlays. The
following provides a summary of our estimates of costs associated with the plan
by major type of cost:
Type
of cost
|
Total
estimated amount expected to be incurred
|
Restructuring
charges:
|
|
Termination
benefits
|
$45
million to $50 million
|
Restructuring-related
expenses:
|
|
Accelerated
depreciation
|
$15
million to $20 million
|
Transfer
costs (1)
|
$75
million to $80 million
|
$135
million to $150 million
|
(1)
|
Consists
primarily of costs to transfer product lines from one facility to another,
including costs of transfer teams, freight and product line
validations.
|
The
estimated restructuring charges relate primarily to termination benefits to be
recorded pursuant to FASB Statement No. 112, Employer’s Accounting for
Postemployment Benefits and FASB Statement No. 146, Accounting for Costs Associated with
Exit or Disposal Activities. The accelerated depreciation will be
recorded through cost of products sold over the new remaining useful life of the
related assets and the production line transfer costs will be recorded through
cost of products sold as incurred.
Note I—Borrowings
and Credit Arrangements
We had
total debt of $6.745 billion at December 31, 2008 at an average interest rate of
5.65 percent, as compared to total debt of $8.189 billion at December 31,
2007 at an average interest rate of 6.36 percent. Our borrowings consist of
the following:
As
of December 31,
|
||||||||
(in
millions)
|
2008
|
2007
|
||||||
Current debt
obligations
|
||||||||
Credit
and security facility
|
$ | 250 | ||||||
Other
|
$ | 2 | 6 | |||||
2 | 256 | |||||||
Long-term debt
obligations
|
||||||||
Term
loan
|
2,825 | 4,000 | ||||||
Abbott
loan
|
900 | 900 | ||||||
Senior
notes
|
3,050 | 3,050 | ||||||
Fair
value adjustment (1)
|
(8 | ) | (9 | ) | ||||
Discounts
|
(30 | ) | (42 | ) | ||||
Capital
leases
|
28 | |||||||
Other
|
6 | 6 | ||||||
6,743 | 7,933 | |||||||
$ | 6,745 | $ | 8,189 |
(1)
|
Represents
unamortized losses related to interest rate swaps used to hedge the fair
value of certain of our senior
notes. See Note
C - Fair Value Measurements for further discussion regarding
the accounting treatment of
our interest rate
swaps.
|
In April
2006, to finance the cash portion of our acquisition of Guidant, we borrowed
$6.6 billion, consisting of a $5.0 billion five-year term loan and a $700
million 364-day interim credit facility loan from a syndicate of commercial and
investment banks, as well as a $900 million subordinated loan from Abbott. In
addition, we terminated our existing revolving credit facilities and established
a new $2.0 billion revolving credit facility. In May 2006, we repaid and
terminated the $700 million 364-day interim credit facility loan and terminated
the credit facility. Additionally, in June 2006, under our shelf registration
previously filed with the SEC, we issued $1.2 billion of publicly registered
senior notes. Refer to the Senior Notes section below
for the terms of this issuance.
As of
December 31, 2008, the debt maturity schedule for our term loan, as well as
scheduled maturities of the other significant components of our debt
obligations, is as follows:
(in
millions)
|
2009
|
2010
|
2011
|
2012
|
2013
|
Thereafter
|
Total
|
|||||||||||||||||||||
Term
loan
|
$ | 825 | $ | 2,000 | $ | 2,825 | ||||||||||||||||||||||
Abbott
loan
|
900 | 900 | ||||||||||||||||||||||||||
Senior
notes
|
850 | $ | 2,200 | 3,050 | ||||||||||||||||||||||||
$ | $ | 825 | $ | 3,750 | $ | $ | $ | 2,200 | $ | 6,775 |
|
Note:
|
The
table above does not include discounts associated with our Abbott loan and
senior notes, or amounts related to interest rate swaps used to hedge the
fair value of certain of our senior
notes.
|
Term
Loan and Revolving Credit Facility
In April
2006, we established our $2.0 billion, five-year revolving credit facility. Use
of the borrowings is unrestricted and the borrowings are unsecured. In October
of 2008, we issued a $717 million surety bond backed by a $702 million letter of
credit and $15 million of cash to secure a damage award related to the Johnson
& Johnson patent infringement case pending appeal, described in Note L – Commitments and
Contingencies, reducing the credit availability under the revolving
facility. There were no
amounts borrowed under this facility as of December 31, 2008 and
2007.
We are
permitted to prepay the term loan prior to maturity with no penalty or premium.
During 2007, we prepaid $1.0 billion of our five-year term loan, using $750
million of cash on hand and $250 million in borrowings against our credit
facility secured by our U.S. trade receivables (refer to Other Credit Facilities
section for more information on this facility). During 2008, we made
prepayments of $1.175 billion. These additional prepayments satisfied the
remaining $300 million of our term loan due in 2009 and $875 million of our term
loan due in 2010.
In
February 2009, we amended our term loan and revolving credit facility agreement
to increase flexibility under our financial covenants. The amendment
provides for an exclusion from the calculation of consolidated EBITDA, as
defined by the amended agreement, through the credit agreement maturity in
April 2011, of up to $346 million in restructuring charges to support our
plant network optimization and other expense reduction initiatives; an
exclusion for any litigation-related charges and credits until such items are
paid or received; and an exclusion of up to $1.137 billion of any cash
payments for litigation settlements or damage awards (net of any litigation
payments received), and all cash payments (net of cash receipts) related to
amounts that were recorded in the financial statements before January 1,
2009. At the same
time, we prepaid $500 million of our term loan and reduced our
revolving credit facility by $250 million. As a result, our next debt
maturity of $325 million is due in April 2010. In addition, the
agreement provides for an increase in interest rates on our term loan borrowings
from LIBOR plus 1.00 percent to LIBOR plus 1.75 percent at current credit
ratings. Further, the interest rate on unused facilities increases from 0.175
percent to 0.500 percent.
Abbott
Loan
The $900
million loan from Abbott bears interest at a fixed 4.0 percent rate, payable
semi-annually. The loan is subordinated to our senior, unsecured,
subsidiary indebtedness. We are permitted to prepay the Abbott loan prior
to maturity with no penalty or premium. We determined that an appropriate fair
market interest rate on the loan from Abbott was 5.25 percent per annum. We
recorded the loan at a discount of approximately $50 million at the inception of
the loan and are recording interest at an imputed rate of 5.25 percent over the
term of the loan. The remaining discount as of December 31, 2008 is $24
million.
Other
Credit Facilities
We
maintain a $350 million credit and security facility secured by our U.S. trade
receivables. Use of the borrowings is unrestricted. Borrowing availability under
this facility changes based upon the amount of eligible receivables,
concentration of eligible receivables and other factors. Certain significant
changes in the quality of our receivables may require us to repay borrowings
immediately under the facility. The credit agreement required us to create a
wholly owned entity, which we consolidate. This entity purchases our U.S. trade
accounts receivable and then borrows from two third-party financial institutions
using these receivables as collateral. The receivables and related borrowings
remain on our consolidated balance sheets because we have the right to prepay
any borrowings and effectively retain control over the receivables. Accordingly,
pledged receivables are included as trade accounts receivable, net, while the
corresponding borrowings are included as debt on our consolidated balance
sheets. There were $250 million in borrowings outstanding under this facility at
December 31, 2007. During 2008, we repaid those amounts outstanding and extended
the maturity of this facility to August 2009. There were no amounts outstanding
under this facility at December 31, 2008.
Further,
we have uncommitted credit facilities with two commercial Japanese banks that
provide for borrowings and promissory notes discounting of up to 18.5 billion
Japanese yen (translated to approximately $205 million at December 31,
2008). During 2008, we increased available borrowings under this facility from
15 billion Japanese yen (translated to $133 million at December 31, 2007). We
discounted $190 million of notes receivable as of December 31, 2008 at an
average interest rate of 1.13 percent and $109 million of notes receivable
as of December 31, 2007 at an average interest rate of 1.15 percent.
Discounted notes receivable are excluded from accounts receivable in the
accompanying consolidated balance sheets.
At
December 31, 2008, we had outstanding letters of credit of approximately $819
million, as compared to approximately $110 million at December 31, 2007, which
consisted primarily of bank guarantees and collateral for workers’
compensation programs. The increase is due primarily to a $702
million letter of credit entered into in 2008 in conjunction with the Johnson
& Johnson patent infringement case. We have accrued amounts associated with
this case in our accompanying consolidated balance sheets. As of December 31,
2008, none of the beneficiaries had drawn upon the letters of credit or
guarantees. Accordingly, we have not recognized a related liability in our
consolidated balance sheets as of December 31, 2008 or 2007. We believe we
have sufficient cash on hand and intend to fund these payments without drawing
on the letters of credit.
Senior
Notes
We had
senior notes of $3.050 billion outstanding at December 31, 2008 and
2007. These notes are publicly registered securities, are redeemable prior to
maturity and are not subject to any sinking fund requirements. Our senior notes
are unsecured, unsubordinated obligations and rank on a parity with each other.
These notes are effectively junior to borrowings under our credit and
security facility and liabilities of our subsidiaries, including our term loan
and the Abbott loan. Our senior notes consist of the
following:
Amount
(in
millions)
|
Issuance
Date
|
Maturity
Date
|
Semi-annual
Coupon
Rate
|
|||||
January
2011 Notes
|
$ 250
|
November
2004
|
January
2011
|
4.250%
|
||||
June
2011 Notes
|
600
|
June
2006
|
June
2011
|
6.000%
|
||||
June
2014 Notes
|
600
|
June
2004
|
June
2014
|
5.450%
|
||||
November
2015 Notes
|
400
|
November
2005
|
November
2015
|
5.500%
|
||||
June
2016 Notes
|
600
|
June
2006
|
June
2016
|
6.400%
|
||||
January
2017 Notes
|
250
|
November
2004
|
January
2017
|
5.125%
|
||||
November
2035 Notes
|
350
|
November
2005
|
November
2035
|
6.250%
|
||||
$ 3,050
|
||||||||
In April
2006, we increased the interest rate payable on our November 2015 Notes and
November 2035 Notes by 0.75 percent to 6.25 percent and 7.0 percent,
respectively, in connection with credit ratings changes as a result of our
acquisition of Guidant. Rating changes throughout 2007 and 2008 had no
additional impact on the interest rates associated with our senior notes. At
December 31, 2008, our credit ratings from Standard & Poor’s Rating Services
(S&P) and Fitch Ratings were BB+, and our credit rating from Moody’s
Investor Service was Ba1. These ratings are below investment grade and the
ratings outlook by S&P and Moody’s is currently negative. During 2008, Fitch
increased our rating from negative outlook to stable. Credit rating changes may
impact our borrowing cost, but do not require the repayment of borrowings.
These credit rating changes have not materially increased the cost of our
existing borrowings. Subsequent rating improvements may result in a
decrease in the adjusted interest rate to the extent that our lowest credit
rating is above BBB- or Baa3. The interest rates on our November 2015 and
November 2035 Notes will be permanently reinstated to the issuance rate if the
lowest credit ratings assigned to these senior notes is either A- or A3 or
higher.
Debt
Covenants
Our term
loan and revolving credit facility agreement requires that we maintain certain
financial covenants, including a ratio of total debt to EBITDA, as defined by
the agreement, as amended, for the preceding four consecutive
fiscal quarters of less than or equal to 4.5 to 1.0 through December 31,
2008. The maximum permitted ratio of total debt to EBITDA steps-down to 4.0 to
1.0 on March 31, 2009 and to 3.5 to 1.0 on September 30, 2009. The agreement
also requires that we maintain a ratio of EBITDA, as defined by the agreement,
as amended, to interest expense for the preceding four consecutive
fiscal quarters of greater than or equal to 3.0 to 1.0. As of December 31,
2008, we were in compliance with the required covenants. Our ratio of total debt
to EBITDA was approximately 2.7 to 1.0 and our ratio of EBITDA to interest
expense was
approximately
5.4 to 1.0 as of December 31, 2008. If at any time we are not able to maintain
these covenants, we could be required to seek to renegotiate the terms of our
credit facilities or seek waivers from compliance with these covenants, both of
which could result in additional borrowing costs. Further, there can be no
assurance that our lenders would grant such waivers.
Note J—Leases
Rent
expense amounted to $92 million in 2008, $72 million in 2007, and $80 million in
2006.
Our
obligations under noncancelable capital leases were not material as of
December 31, 2008. Future minimum rental commitments at December 31,
2008 under other noncancelable lease agreements are as follows (in
millions):
2009
|
$ | 64 | ||
2010
|
56 | |||
2011
|
45 | |||
2012
|
35 | |||
2013
|
26 | |||
Thereafter
|
57 | |||
$ | 283 |
Note
K – Income Taxes
Our
(loss) income before income taxes consisted of the following:
Year
Ended December 31,
|
||||||||||||
(in
millions)
|
2008
|
2007
|
2006
|
|||||||||
Domestic
|
$ | (3,018 | ) | $ | (1,294 | ) | $ | (4,535 | ) | |||
Foreign
|
987 | 725 | 1,000 | |||||||||
$ | (2,031 | ) | $ | (569 | ) | $ | (3,535 | ) |
The
related provision for income taxes consists of the following:
Year
Ended December 31,
|
||||||||||||
(in
millions)
|
2008
|
2007
|
2006
|
|||||||||
Current
|
||||||||||||
Federal
|
$ | 110 | $ | 99 | $ | 375 | ||||||
State
|
27 | 46 | 53 | |||||||||
Foreign
|
189 | 167 | 34 | |||||||||
326 | 312 | 462 | ||||||||||
Deferred
|
||||||||||||
Federal
|
(279 | ) | (345 | ) | (421 | ) | ||||||
State
|
(20 | ) | (20 | ) | (24 | ) | ||||||
Foreign
|
(22 | ) | (21 | ) | 25 | |||||||
(321 | ) | (386 | ) | (420 | ) | |||||||
$ | 5 | $ | (74 | ) | $ | 42 |
2008
|
2007
|
2006
|
||||||||||
U.S.
federal statutory income tax rate
|
(35.0 | ) % | (35.0 |
)
%
|
(35.0 | ) % | ||||||
State
income taxes, net of federal benefit
|
0.4 |
%
|
4.0 |
%
|
0.5 |
%
|
||||||
Effect
of foreign taxes
|
(5.9 | ) % | (41.9 |
)
%
|
(6.1 | ) % | ||||||
Non-deductible
acquisition expenses
|
0.5 |
%
|
5.4 |
%
|
40.8 |
%
|
||||||
Research
credit
|
(0.5 | ) % | (2.4 |
)
%
|
(0.6 | ) % | ||||||
Valuation
allowance
|
2.9 |
%
|
19.6 |
%
|
2.2 |
%
|
||||||
Divestitures
|
(9.9 | ) % | 33.2 |
%
|
||||||||
Intangible
asset impairments
|
46.5 |
%
|
||||||||||
Section
199
|
(2.2 |
)
%
|
(0.5 | ) % | ||||||||
Tax
liability release on unremitted earnings
|
(3.8 | ) % | ||||||||||
Sale
of intangible assets
|
3.3 |
%
|
||||||||||
Other,
net
|
1.2 |
%
|
6.3 |
%
|
0.4 |
%
|
||||||
0.2 |
%
|
(13.0 |
)
%
|
1.2 |
%
|
Significant
components of our deferred tax assets and liabilities are as
follows:
As
of December 31,
|
||||||||
(in
millions)
|
2008
|
2007
|
||||||
Deferred
tax assets
|
||||||||
Inventory
costs, intercompany profit and related reserves
|
$ | 297 | $ | 250 | ||||
Tax
benefit of net operating loss, capital loss and tax
credits
|
294 | 267 | ||||||
Reserves
and accruals
|
392 | 573 | ||||||
Restructuring-
and acquisition-related charges, including purchased
research and development
|
115 | 112 | ||||||
Litigation
and product liability reserves
|
188 | 82 | ||||||
Unrealized
losses on derivative financial instruments
|
15 | 34 | ||||||
Investment
writedown
|
59 | 107 | ||||||
Stock-based
compensation
|
86 | 84 | ||||||
Federal
benefit of uncertain tax positions
|
117 | 114 | ||||||
Other
|
34 | 17 | ||||||
1,597 | 1,640 | |||||||
Less:
valuation allowance on deferred tax assets
|
252 | 193 | ||||||
1,345 | 1,447 | |||||||
Deferred
tax liabilities
|
||||||||
Property,
plant and equipment
|
52 | 51 | ||||||
Intangible
assets
|
2,617 | 2,967 | ||||||
Litigation
settlement
|
25 | 24 | ||||||
Unrealized
gains on available-for-sale securities
|
10 | |||||||
Other
|
2 | |||||||
2,696 | 3,052 | |||||||
$ | (1,351 | ) | $ | (1,605 | ) |
At
December 31, 2008, we had U.S. tax net operating loss, capital loss and tax
credit carryforwards, the tax effect of which was $45 million, as compared to
$79 million at December 31, 2007. In addition, we had foreign tax net operating
loss carryforwards, the tax effect of which was $249 million at December
31, 2008, as compared to $188 million at December 31, 2007. These carryforwards
will expire periodically beginning in 2009. We established a valuation allowance
of $252 million against these carryforwards as of December 31, 2008 and
$193 million as of December 31, 2007, due to our determination, after
consideration of all positive and negative evidence, that it is more likely than
not a portion of the carryforwards will not be realized. The increase in the
valuation allowance at December 31, 2008 as compared to December 31, 2007 is
attributable primarily to foreign net operating losses generated during the
year.
The
income tax impact of the unrealized gain or loss component of other
comprehensive income was a provision of less than $1 million in 2008, a benefit
of $53 million in 2007, and a benefit of $27 million in
2006.
We do not
provide income taxes on unremitted earnings of our foreign subsidiaries where we
have indefinitely reinvested such earnings in our foreign operations. It is not
practical to estimate the amount of income taxes payable on the earnings that
are indefinitely reinvested in foreign operations. Unremitted earnings of our
foreign subsidiaries that we have indefinitely reinvested offshore are $9.327
billion at December 31, 2008 and $7.804 billion at December 31,
2007.
Effective
January 1, 2007, we adopted the provisions of FASB Interpretation No. 48, Accounting for Uncertainty in Income
Taxes. At December 31, 2008, we had $1.107 billion of gross unrecognized
tax benefits, $978 million of which, if recognized, would affect our effective
tax rate. At December 31, 2007, we had $1.180 billion of gross unrecognized tax
benefits, $415 million of which, if recognized, would affect our effective tax
rate. The gross unrecognized tax benefits decreased at December 31, 2008, as
compared to December 31, 2007, due principally to the resolution of federal,
state and foreign examinations for both Boston Scientific and Guidant for the
years 1998 through 2005, as discussed below. The unrecognized tax benefits
which, if recognized, would impact our effective rate increased at December 31,
2008, as compared to December 31, 2007 due to the adoption of FASB Statement
No. 141(R), Business
Combinations, as of January 1, 2009, which requires that we recognize
changes in acquired income tax uncertainties (applied to acquisitions before and
after the adoption date) as income tax expense or benefit. A
reconciliation of the beginning and ending amount of unrecognized tax benefits
is as follows (in millions):
2008
|
2007
|
|||||||
Balance
as of January 1
|
$ | 1,180 | $ | 1,155 | ||||
Additions
based on positions related to the current year
|
128 | 80 | ||||||
Additions
for tax positions of prior years
|
48 | 60 | ||||||
Reductions
for tax positions of prior years
|
(161 | ) | (47 | ) | ||||
Settlements
with Taxing Authorities
|
(82 | ) | (61 | ) | ||||
Statute
of limitation expirations
|
(6 | ) | (7 | ) | ||||
Balance
as of December 31
|
$ | 1,107 | $ | 1,180 |
We are
subject to U.S. federal income tax as well as income tax of multiple state and
foreign jurisdictions. We have concluded all U.S. federal income tax
matters through 2000. Substantially all material state, local, and
foreign income tax matters have been concluded for all years though
2001.
During
2008, we resolved certain matters in federal, state, and foreign jurisdictions
for Guidant and Boston Scientific for the years 1998 to 2005. We
settled multiple federal issues at the IRS examination and Appellate levels,
including issues related to Guidant’s acquisition of Intermedics, Inc., and
various litigation settlements. We also received favorable foreign court
decisions and a favorable outcome related to our foreign research credit
claims. As a result of these audit activities, we decreased our
reserve for uncertain tax positions, excluding tax payments, by $156 million,
inclusive of $37 million of interest and penalties during 2008. During 2007, we
settled several audits, obtained an Advance Pricing Agreement between the U.S.
and Japan, and received a favorable appellate court decision on a previously
outstanding Japan matter with respect to the 1995 to 1998 tax
periods. As a result of settlement of these matters, we decreased our
reserve for uncertain tax positions, excluding tax payments, by $31 million,
inclusive of $29 million of interest and penalties.
During
2008, we received the Revenue Agent’s Report for Guidant’s federal examination
covering years 2001 through 2003, which contained significant proposed
adjustments related primarily to the allocation of income between our U.S. and
foreign affiliates. We disagree with the proposed adjustment and we
intend to contest this matter through applicable IRS and judicial procedures, as
appropriate. Although the final resolution of the proposed
adjustments is uncertain, we believe that our income tax reserves are adequate
and that the resolution will not have a material impact on our financial
condition or results of operations.
It is
reasonably possible that within the next 12 months we will resolve multiple
issues including transfer pricing, research and development credit and
transactional related issues, with foreign, federal and state taxing
authorities, in which case we could record a reduction in our balance of
unrecognized tax benefits of up to approximately $176 million.
Our
historical practice was and continues to be to recognize interest and penalties
related to income tax matters in income tax expense (benefit). We had
$268 million accrued for gross interest and penalties at December 31, 2008 and
$264 million at December 31, 2007. The increase in gross interest and
penalties was a result of $43 million recognized in our consolidated statements
of operations, partially offset by a $39 million reduction, due primarily to
payments. The total amount of interest and penalties recognized in our
consolidated statements of operations in 2007 was $76 million.
Note L—Commitments
and Contingencies
The
medical device market in which we primarily participate
is largely technology driven. Physician customers, particularly in
interventional cardiology, have historically moved quickly to new products and
new technologies. As a result, intellectual property rights, particularly
patents and trade secrets, play a significant role in product development and
differentiation. However, intellectual property litigation to defend or create
market advantage is inherently complex and unpredictable. Furthermore, appellate
courts frequently overturn lower court patent decisions.
In
addition, competing parties frequently file multiple suits to leverage patent
portfolios across product lines, technologies and geographies and to balance
risk and exposure between the parties. In some cases, several competitors are
parties in the same proceeding, or in a series of related proceedings, or
litigate multiple features of a single class of devices. These forces frequently
drive settlement not only of individual cases, but also of a series of pending
and potentially related and unrelated cases. In addition, although monetary and
injunctive relief is typically sought, remedies and restitution are generally
not determined until the conclusion of the proceedings and are frequently
modified on appeal. Accordingly, the outcomes of individual cases are difficult
to time, predict or quantify and are often dependent upon the outcomes of other
cases in other geographies.
Several
third parties have asserted that our current and former stent systems infringe
patents owned or licensed by them. We have similarly asserted that stent systems
or other products sold by our competitors infringe patents owned or licensed by
us. Adverse outcomes in one or more of the proceedings against us could limit
our ability to sell certain stent products in certain jurisdictions, or reduce
our operating margin on the sale of these products and could have a material
adverse effect on our financial position, results of operations or
liquidity.
In
particular, we are engaged in significant patent litigation with Johnson
& Johnson relating to stent systems, balloon catheters and stent delivery
systems. We have each asserted that products of the other infringe patents
owned or exclusively licensed by each of us. Adverse outcomes in one or
more of these matters could have a material adverse effect on our ability to
sell certain products and on our operating margins, financial position, results
of operation or liquidity.
In the
normal course of business, product liability and securities claims are asserted
against us. In addition, requests for information from governmental entities
have increased in recent years which may evolve into legal proceedings. Product
liability and securities claims may be asserted against us and requests for
information may be received in the future related to events not known to
management at the present time. We are substantially self-insured with respect
to product liability claims, and maintain an insurance policy providing limited
coverage against securities claims. The absence of significant third-party
insurance coverage increases our potential exposure to unanticipated claims or
adverse decisions. Product liability
claims,
product recalls, securities litigation, requests for information and other legal
proceedings in the future, regardless of their outcome, could have a material
adverse effect on our financial position, results of operations or
liquidity.
Our
accrual for legal matters that are probable and estimable was $1.089 billion at
December 31, 2008 and $994 million at December 31, 2007, and includes
estimated costs of settlement, damages and defense. The increase in
our accrual is due primarily to a pre-tax charge of $334 million resulting from
a ruling by a federal judge in a patent infringement case brought against us by
Johnson & Johnson, which we recorded during the third quarter of 2008.
Partially offsetting this increase was a reduction of $187 million as result of
payments made during the fourth quarter of 2008 related to the Guidant
multi-district litigation (MDL) settlement. In the first quarter of 2009, we
made an additional MDL payment of approximately $13 million, and anticipate
making the remaining payments of $20 million during the first half of 2009.
These amounts were both accrued as of December 31, 2008. We continue to assess
certain litigation and claims to determine the amounts that
management believes will be paid as a result of such claims and litigation
and, therefore, additional losses may be accrued in the future, which could
adversely impact our operating results, cash flows and our ability to comply
with our debt covenants. See Note A - Significant Accounting
Policies for further discussion on our policy for accounting for legal,
product liability and security claims.
In
management’s opinion, we are not currently involved in any legal proceedings
other than those specifically identified below which, individually or in the
aggregate, could have a material effect on our financial condition, operations
and/or cash flows. Unless included in our accrual as of December 31, 2008 or
otherwise indicated below, a range of loss associated with any individual
material legal proceeding can not be estimated.
Litigation
with Johnson & Johnson
On
October 22, 1997, Cordis Corporation, a subsidiary of Johnson &
Johnson, filed a suit for patent infringement against us and Boston Scientific
Scimed, Inc. (f/k/a SCIMED Life Systems, Inc.), our wholly owned
subsidiary, alleging that the importation and use of the NIR® stent infringes
two patents owned by Cordis. On April 13, 1998, Cordis filed another suit
for patent infringement against Boston Scientific Scimed and us, alleging that
our NIR® stent infringes two additional patents owned by Cordis. The suits were
filed in the U.S. District Court for the District of Delaware seeking monetary
damages, injunctive relief and that the patents be adjudged valid, enforceable
and infringed. A jury trial on both actions found that the NIR® stent infringed
one claim of one Cordis patent and awarded damages of approximately
$324 million to Cordis. On May 16, 2002, the Court set
aside the verdict of infringement, requiring a new trial. On March 24,
2005, in a second trial, a jury found that a single claim of the Cordis patent
was valid and infringed. Our appeals of the infringement decision were denied.
On September 30, 2008, the District Court entered final judgment against us and
awarded Cordis $702 million in damages and interest. On October 10, 2008, we
appealed the damage award. As a result of the Court’s ruling, we increased our
accrual for litigation-related matters by $334 million in the third quarter of
2008. This accrual is in addition to $368 million of previously established
accruals related to this matter.
On
April 2, 1997, Ethicon and other Johnson & Johnson subsidiaries
filed a cross-border proceeding in The Netherlands alleging that the NIR® stent
infringes a European patent licensed to Ethicon. In January 1999,
Johnson & Johnson amended the claims of the patent and changed the
action from a cross-border case to a Dutch national action. The Dutch Court
asked the Dutch Patent Office for technical advice on the validity of the
amended patent. On August 31, 2005, the Dutch Patent Office issued its
technical advice that the amended patent was valid and on October 8, 2008, the
Dutch Court found the patent valid.
On
August 22, 1997, Johnson & Johnson filed a suit for patent
infringement against us alleging that the sale of the NIR® stent infringes
certain Canadian patents owned by Johnson & Johnson. Suit was filed in
the federal court of Canada seeking a declaration of infringement, monetary
damages and injunctive relief. On April 30, 2008, the Court found that the
NIR® stent
did not infringe one patent of Johnson & Johnson and that the other Johnson
& Johnson patent was invalid. On May 30, 2008, Cordis filed an
appeal.
On
February 14, 2002, we, and certain of our subsidiaries, filed suit for
patent infringement against Johnson & Johnson and Cordis alleging that
certain balloon catheters and stent delivery systems sold by Johnson &
Johnson and Cordis infringe five U.S. patents owned by us. The complaint was
filed in the U.S. District Court for the Northern District of California seeking
monetary and injunctive relief. On October 15, 2002, Cordis filed a
counterclaim alleging that certain balloon catheters and stent delivery systems
sold by us infringe three U.S. patents owned by Cordis and seeking monetary and
injunctive relief. On December 6, 2002, we filed an amended complaint
alleging that two additional patents owned by us are infringed by the Cordis’
products. On October 31, 2007, a jury found that we infringe a patent of Cordis.
The jury also found four of our patents invalid and infringed by Cordis. No
damages were determined because the judge found that Cordis failed to submit
evidence sufficient to enable a jury to make a damage assessment. A hearing
on prospective relief was held on October 3, 2008, and an evidentiary hearing on
February 2, 2009.
On
March 26, 2002, we and our wholly owned subsidiary, Target
Therapeutics, Inc., filed suit for patent infringement against Cordis
alleging that certain detachable coil delivery systems infringe three U.S.
patents, owned by or exclusively licensed to Target. The complaint was filed in
the U.S. District Court for the Northern District of California seeking monetary
and injunctive relief. Summary judgment motions with respect to one of the
patents were filed by both parties and on March 21, 2008, the Court found
infringement. Also, on January 18, 2008, the Court granted our motion for
summary judgment that Cordis infringes a second patent in the suit. Based
on this order, we have filed a motion for summary judgment of infringement of
the third patent in the suit, as well as a request to add infringement of
certain additional claims of the second patent. On August 15, 2008, the Court
granted our motion for summary judgment relating to infringement. Trial on
validity and damages is scheduled to begin on March 4, 2009.
On
January 13, 2003, Cordis filed suit for patent infringement against Boston
Scientific Scimed and us alleging that our Express2®
coronary stent infringes a U.S. patent owned by Cordis. The suit was filed in
the U.S. District Court for the District of Delaware seeking monetary and
injunctive relief. We answered the complaint, denying the allegations and filed
a counterclaim alleging that certain Cordis products infringe a patent owned by
us. On August 4, 2004, the Court granted a Cordis motion to add our
Liberté® coronary stent and two additional patents to the complaint. On
June 21, 2005, a jury found that our TAXUS® Express2®,
Express2®,
Express®
Biliary, and Liberté® stents infringe a Johnson & Johnson patent and
that the Liberté® stent infringes a second Johnson & Johnson patent.
The jury only determined liability; monetary damages would be determined at a
later trial. With respect to our counterclaim, a jury found on July 1,
2005, that Johnson & Johnson’s Cypher®, Bx Velocity®, Bx Sonic® and
Genesis™ stents infringe our patent. Both parties appealed and a hearing was
held on December 2, 2008.
On
March 13, 2003, Boston Scientific Scimed and we filed suit for patent
infringement against Johnson & Johnson and Cordis, alleging that its
Cypher® drug-eluting stent infringes one of our patents. The suit was filed in
the U.S. District Court for the District of Delaware seeking monetary and
injunctive relief. Cordis answered the complaint, denying the allegations, and
filed a counterclaim against us alleging that the patent is not valid and is
unenforceable. On July 1, 2005, a jury found that Johnson &
Johnson’s Cypher® drug-eluting stent infringes the original patent and upheld
the validity of the patent. The jury determined liability only; any monetary
damages would be determined at a later trial. On January 15, 2009, the U.S.
Court of Appeals reversed the lower Court’s decision and found the patent
invalid. On February 12, 2009, we filed a request for a rehearing and a
rehearing en banc with the U.S. Court of Appeals.
On
August 5, 2004, we (through our subsidiary Schneider Europe GmbH) filed
suit in the District Court of Brussels, Belgium against the Belgian subsidiaries
of Johnson & Johnson, Cordis and Janssen Pharmaceutica alleging that
Cordis’ Bx Velocity® stent, Bx Sonic® stent, Cypher® stent, Cypher® Select
stent, Aqua T3™ balloon and U-Pass balloon infringe one of our European patents
and seeking injunctive and monetary relief. On September 12, 2008, the District
Court issued a decision and ruled that a technical expert be appointed. On
December 1, 2008, we filed a partial appeal of the decision in the Brussels
Court of Appeals. In December 2005, the Johnson & Johnson
subsidiaries filed a nullity action in France. On January 25, 2008, we filed a
counterclaim infringement action in France, and a hearing is scheduled for
December 1, 2009. In
January 2006,
the same Johnson & Johnson subsidiaries filed nullity actions in Italy
and Germany. On October 23, 2007, the German Federal Patent Court found the
patent valid. We then filed a counterclaim infringement action in Italy and an
infringement action in Germany. On February 10, 2009, the District Court of
Dusseldorf issued an oral decision dismissing the German infringement
action.
On
May 12, 2004, we filed suit against two of Johnson &
Johnson’s Dutch subsidiaries, alleging that Cordis’ Bx Velocity® stent, Bx
Sonic® stent, Cypher® stent, Cypher® Select stent, and Aqua T3 balloon delivery
systems for those stents, and U-Pass angioplasty balloon catheters infringe one
of our European patents. The suit was filed in the District Court of The Hague
in The Netherlands seeking injunctive and monetary relief. On June 8, 2005,
the Court found the Johnson & Johnson products infringe our patent. An
appeal decision was received on March 15, 2007, finding the patent valid but not
infringed. We appealed the finding and a decision on our appeal is expected
during the second quarter of 2009.
On
September 27, 2004, Boston Scientific Scimed filed suit against a German
subsidiary of Johnson & Johnson alleging the Cypher® drug-eluting stent
infringes one of our European patents. The suit was filed in Mannheim, Germany
seeking monetary and injunctive relief. A hearing was held on September 21,
2007, in Mannheim, Germany, and a decision has not yet been
rendered.
On
November 29, 2007, Boston Scientific Scimed filed suit against a German
subsidiary of Johnson & Johnson alleging the Cypher® and Cypher® Select
drug-eluting stents infringe one of our European patents. The suit was filed in
Mannheim, Germany seeking monetary and injunctive relief. On October 17,
2008, the Court ruled that a technical expert be appointed to evaluate
infringement. A hearing has been scheduled for April 17, 2009.
On
September 25, 2006, Johnson & Johnson filed a lawsuit against us, Guidant
and Abbott in the U.S. District Court for the Southern District of New York. The
complaint alleges that Guidant breached certain provisions of the amended merger
agreement between Johnson & Johnson and Guidant (Merger Agreement) as well
as the implied duty of good faith and fair dealing. The complaint further
alleges that Abbott and we tortiously interfered with the Merger Agreement by
inducing Guidant’s breach. The complaint seeks certain factual findings, damages
in an amount no less than $5.5 billion and attorneys’ fees and costs. On
August 29, 2007, the judge dismissed the tortious interference claims against us
and Abbott and the implied duty of good faith and fair dealing claim against
Guidant. On February 20, 2009, Johnson & Johnson filed a motion to
amend its complaint to reinstate its tortious interference claims against us and
Abbott. We have not yet responded to the motion. A trial date
has not yet been scheduled.
On each
of May 25, June 1, June 22 and November 27, 2007, Boston Scientific Scimed and
we filed suit against Johnson & Johnson and Cordis in the U.S. District
Court for the District of Delaware seeking a declaratory judgment of invalidity
of a U.S. patent owned by them and of non-infringement of the patent by our
PROMUS® coronary stent system. On February 21, 2008, Cordis answered the
complaints, denying the allegations, and filed counterclaims for infringement
seeking an injunction and a declaratory judgment of validity. Trials on all
four suits are scheduled to begin on February 8, 2010.
On
January 15, 2008, Johnson & Johnson Inc. filed a suit for patent
infringement against us alleging that the sale of the Express®, Express2® and
TAXUS® Express2®
stent delivery systems infringe two Canadian patents owned by Johnson &
Johnson. Suit was filed in The Federal Court of Canada seeking a
declaration of infringement, monetary damages and injunctive relief. On January
7, 2009, we answered the complaint denying the allegations.
On
February 1, 2008, Wyeth and Cordis Corporation filed an amended complaint
against Abbott Laboratories, adding us and Boston Scientific Scimed as
additional defendants to the complaint. The suit alleges that our PROMUS®
coronary stent system, upon launch in the United States, will infringe
three U.S. patents owned by Wyeth and licensed to Cordis. The suit was
filed in the United States District Court for the District of New Jersey seeking
monetary and injunctive relief. On May 23, 2008, we answered denying
allegations of the complaint and asserting a counterclaim of invalidity. A trial
has not yet been scheduled.
On
October 17, 2008, Cordis Corporation filed a complaint for patent infringement
against us alleging that our TAXUS® Liberté® stent product, when launched in the
United States, will infringe a U.S. patent owned by them. The suit was
filed in the United States District Court of Delaware seeking monetary and
injunctive relief. A preliminary injunction hearing is scheduled for March 23,
2009.
Litigation
with Medtronic, Inc.
On
December 17, 2007, Medtronic, Inc. filed a declaratory judgment action in the
District Court for Delaware against us, Guidant Corporation (Guidant), and
Mirowski Family Ventures L.L.C. (Mirowski), challenging its obligation to pay
royalties to Mirowski on certain cardiac resynchronization therapy devices by
alleging non-infringement and invalidity of certain claims of two patents owned
by Mirowski and exclusively licensed to Guidant and sublicensed to Medtronic. On
November 21, 2008, Medtronic filed an amended complaint adding unenforceability
of the patents. We answered the complaint on December 1, 2008.
Litigation with
St. Jude Medical, Inc.
Guidant
Sales Corp., Cardiac Pacemakers, Inc. (CPI) and Mirowski are plaintiffs in a
patent infringement suit originally filed against St. Jude Medical, Inc. and its
affiliates in November 1996 in the District Court in Indianapolis. On March 1,
2006, the District Court issued a ruling related to damages which granted St.
Jude’s motion to limit damages to a subset of the accused products but which
denied their motion to limit damages to only U.S. sales. On March 26, 2007, the
District Court issued a ruling which found the patent infringed but invalid. On
December 18, 2008, the Court of Appeals upheld the District Court’s ruling of
infringement and overturned the invalidity ruling. St. Jude and we have filed
requests for rehearing with the Court of Appeals.
Litigation
with Medinol Ltd.
On
September 25, 2002, we filed suit against Medinol alleging Medinol’s
NIRFlex™ and NIRFlex™ Royal products infringe a patent owned by us. The suit was
filed in the District Court of The Hague, The Netherlands seeking cross-border,
monetary and injunctive relief. On September 10, 2003, the Dutch Court
ruled that the patent was invalid. On December 14, 2006, an appellate decision
was rendered upholding the trial court ruling. We appealed the Court’s decision
on March 14, 2007. We expect a decision on our appeal during the second quarter
of 2009.
On August
3, 2007, Medinol submitted a request for arbitration against us, and our wholly
owned subsidiaries Boston Scientific Ltd. and Boston Scientific
Scimed, Inc., under the Arbitration Rules of the World Intellectual
Property Organization pursuant to a settlement agreement between Medinol and us
dated September 21, 2005. The request for arbitration alleges that our
PROMUS® coronary stent system infringes five U.S. patents, three European
patents and two German patents owned by Medinol. Medinol is seeking to have the
patents declared valid and enforceable and a reasonable royalty. The September
2005 settlement agreement provides, among other things, that Medinol may only
seek reasonable royalties and is specifically precluded from seeking injunctive
relief. On June 29, 2008, the parties agreed that we can sell PROMUS® stent
systems in the United States supplied to us by Abbott. A hearing on the European
and German patents is scheduled to begin May 11, 2009.
On
December 12, 2008, we submitted a request for arbitration against Medinol with
the American Arbitration Association in New York. We are asking the Arbitration
panel to enforce a contract between Medinol and us to have Medinol contribute to
the final damage award owed to Johnson & Johnson for damages related to the
sales of the NIR stent supplied to us by Medinol.
Other
Stent System Patent Litigation
On
April 4, 2005, Angiotech and we filed suit against Sahajanand Medical
Technologies Pvt. Ltd. in The Hague, The Netherlands seeking a declaration
that Sahajanand’s drug-eluting stent products infringe patents owned by
Angiotech and licensed to us. On May 3, 2006, the Court found that the asserted
patents were
infringed
and valid, and provided for injunctive and monetary relief. On January 27, 2009,
the Court of Appeals affirmed that the patent was valid and infringed by
Sahajanand.
On
November 26, 2005, Angiotech and we filed suit against Occam International,
BV in The Hague, The Netherlands seeking a preliminary injunction against
Occam’s drug-eluting stent products based on infringement of patents owned by
Angiotech and licensed to us. On January 27, 2006, the Court denied our
request for a preliminary injunction. Angiotech and we have appealed the Court’s
decision, and the parties agreed to pursue normal infringement proceedings
against Occam in The Netherlands.
On
May 19, 2005, G. David Jang, M.D. filed suit against us alleging breach of
contract relating to certain patent rights covering stent technology. The suit
was filed in the U.S. District Court, Central District of California seeking
monetary damages and rescission of the contract. After a Markman ruling relating
to the Jang patent rights, Dr. Jang stipulated to the dismissal of certain
claims alleged in the complaint with a right to appeal. In February 2007, the
parties agreed to settle the other claims of the case. On May 23, 2007, Jang
filed an appeal with respect to the remaining patent claims. On July 11, 2008,
the Court of Appeals vacated the District Court’s consent judgment and remanded
the case back to the District Court for further clarification.
On
December 16, 2005, Bruce N. Saffran, M.D., Ph.D. filed suit against us
alleging that our TAXUS® Express® coronary stent system infringes a patent owned
by Dr. Saffran. The suit was filed in the U.S. District Court for the
Eastern District of Texas and seeks monetary and injunctive relief. On February
11, 2008, the jury found that our TAXUS® Express® and TAXUS® Liberté® stent
products infringe Dr. Saffran’s patent and that the patent is valid. No
injunction was requested, but the jury awarded damages of $431 million. The
District Court awarded Dr. Saffran $69 million in pre-judgment interest and
entered judgment in his favor. On August 5, 2008, we filed an appeal with the
U.S. Court of Appeals for the Federal Circuit in Washington, D.C. A hearing
is set for March 2, 2009. On February 21, 2008, Dr. Saffran filed a new
complaint alleging willful infringement by the continued sale of the TAXUS®
stent products and on March 12, 2008, we answered denying the
allegations.
On
December 11, 2007, Wall Cardiovascular Technologies LLC filed suit against us
alleging that our TAXUS® Express® coronary stent system infringes a patent owned
by them. The complaint also alleges that Cordis Corporation’s drug-eluting
stent system infringes the patent. The suit was filed in the Eastern District
Court of Texas and seeks monetary and injunctive relief. Wall Cardiovascular
Technologies later amended its complaint to add Medtronic, Inc. to the suit with
respect to Medtronic’s drug-eluting stent system. A Markman hearing has been
scheduled for November 3, 2010. Trial is scheduled to begin on April 4,
2011.
On August
6, 2008, Boston Scientific Scimed and we filed suit against Wall Cardiovascular
Technologies, in the U.S. District Court for the District of Delaware
seeking a declaratory judgment of invalidity and unenforceability due to
inequitable conduct and prosecution history laches of a U.S. patent owned by
them, and of non-infringement of the patent by our PROMUS® coronary stent
system. On October 9, 2008, Wall filed a motion to dismiss. On January 2, 2009,
we filed an amended complaint to include noninfringement of the patent by our
TAXUS® Liberté® stent delivery system and to add Cardio Holdings LLC as a
defendant.
Other
Patent Litigation
On August
7, 2008, Thermal Scalpel LLC filed suit against us and numerous other medical
device companies alleging infringement of a patent related to an electrically
heated surgical cutting instrument exclusively licensed to them. The suit was
filed in the U.S. District Court for the Eastern District of Texas seeking
monetary and other further relief. A trial has been scheduled for March
2011.
CRM
Litigation
Approximately
76 product liability class action lawsuits and more than 2,250 individual
lawsuits involving approximately 5,554 individual plaintiffs are pending in
various state and federal jurisdictions against
Guidant
alleging personal injuries associated with defibrillators or pacemakers involved
in the 2005 and 2006 product communications. The majority of the cases in the
United States are pending in federal court but approximately 244 cases are
currently pending in state courts. On November 7, 2005, the Judicial Panel
on Multi-District Litigation established MDL-1708 (MDL) in the United States
District Court for the District of Minnesota and appointed a single judge to
preside over all the cases in the MDL. In April 2006, the personal injury
plaintiffs and certain third-party payors served a Master Complaint in the MDL
asserting claims for class action certification, alleging claims of strict
liability, negligence, fraud, breach of warranty and other common law and/or
statutory claims and seeking punitive damages. The majority of claimants allege
no physical injury, but are suing for medical monitoring and anxiety. On
July 12, 2007, we reached an agreement to settle certain claims associated with
the 2005 and 2006 product communications, which was amended on November 19,
2007. Under the terms of the amended agreement, subject to certain conditions,
we will pay a total of up to $240 million covering up to 8,550 patient claims,
including all of the claims that have been consolidated in the MDL as well as
other filed and unfiled claims throughout the United States. On June 13, 2006,
the Minnesota Supreme Court appointed a single judge to preside over all
Minnesota state court lawsuits involving cases arising from the product
communications. The plaintiffs in those cases are eligible to participate in the
settlement, and activities in all Minnesota State court cases are currently
stayed pending individual plaintiff’s decisions whether to participate in the
settlement. We have made payments of approximately $220 million related to the
MDL settlement and, if certain agreed-upon requirements are met, may make
substantially all of the remaining $20 million payment during the first half of
2009.
We are
aware of more than 18 Guidant product liability lawsuits pending internationally
associated with defibrillators or pacemakers involved in the 2005 and 2006
product communications. Six of those suits pending in Canada are putative class
actions. On April 10, 2008, the Court certified a class of all persons in
whom defibrillators were implanted in Canada and a class of family members with
derivative claims. The second of these putative class actions encompasses all
persons in whom pacemakers were implanted in Canada. A hearing on whether the
pacemaker putative class action concluded on February 12, 2009.
Guidant
is a defendant in a complaint in which the plaintiff alleges a right of recovery
under the Medicare secondary payer (or MSP) private right of action, as well as
related claims. Plaintiff claims as damages double the amount paid by Medicare
in connection with devices that were the subject of the product communications.
The case is pending in the MDL in the United States District Court for the
District of Minnesota, subject to the general stay order imposed by the MDL
presiding judge.
Guidant or
its affiliates are defendants in two separate actions brought by private
third-party providers of health benefits or health insurance (TPPs). In these
cases, plaintiffs allege various theories of recovery, including derivative tort
claims, subrogation, violation of consumer protection statutes and unjust
enrichment, for the cost of healthcare benefits they allegedly paid for in
connection with the devices that have been the subject of Guidant’s product
communications. The TPP actions are pending in state court in
Minnesota, and are part of the coordinated state court proceeding ordered
by the Minnesota Supreme Court. The plaintiffs in one of these cases are a
number of Blue Cross & Blue Shield plans, while the plaintiffs in the other
case are a national health insurer and its affiliates. A hearing was held on
June 18, 2007, and a decision has not yet been rendered.
In
January 2006, Guidant was served with a civil False Claims Act qui tam
lawsuit filed in the U.S. District Court for the Middle District of
Tennessee in September 2003 by Robert Fry, a former employee alleged to
have worked for Guidant from 1981 to 1997. The lawsuit claims that Guidant
violated federal law and the laws of the States of Tennessee, Florida and
California, by allegedly concealing limited warranty and other credits for
upgraded or replacement medical devices, thereby allegedly causing hospitals to
file reimbursement claims with federal and state healthcare programs for amounts
that did not reflect the providers’ true costs for the devices. On October 16,
2006, the United States filed a motion to intervene in this action, which was
approved by the Court on November 2, 2006.
Securities
Related Litigation
On
September 23, 2005, Srinivasan Shankar, on behalf of himself and all others
similarly situated, filed a purported securities class action suit in the U.S.
District Court for the District of Massachusetts on behalf of those who
purchased or otherwise acquired our securities during the period March 31,
2003 through August 23, 2005, alleging that we and certain of our officers
violated certain sections of the Securities Exchange Act of 1934. Four other
plaintiffs, on behalf of themselves and all others similarly situated, each
filed additional purported securities class action suits in the same Court on
behalf of the same purported class. On February 15, 2006, the Court
ordered that the five class actions be consolidated and appointed the
Mississippi Public Employee Retirement System Group as lead plaintiff. A
consolidated amended complaint was filed on April 17, 2006. The consolidated
amended complaint alleges that we made material misstatements and omissions by
failing to disclose the supposed merit of the Medinol litigation and DOJ
investigation relating to the 1998 NIR ON® Ranger with Sox stent recall,
problems with the TAXUS® drug-eluting coronary stent systems that led to product
recalls, and our ability to satisfy FDA regulations concerning medical device
quality. The consolidated amended complaint seeks unspecified damages, interest,
and attorneys’ fees. The defendants filed a motion to dismiss the consolidated
amended complaint on June 8, 2006, which was granted by the Court on March 30,
2007. On April 16, 2008, the First Circuit reversed the dismissal of only
plaintiff’s TAXUS® stent recall related claims and remanded the matter for
further proceedings. On November 6, 2008, plaintiff filed a motion for class
certification and on February 25, 2009, the Court certified the class. A trial
has not yet been scheduled.
On
January 19, 2006, George Larson filed a purported class action complaint in
the U.S. District Court for the District of Massachusetts on behalf of
participants and beneficiaries of our 401(k) Retirement Savings Plan (401(k)
Plan) and GESOP alleging that we and certain of our officers and employees
violated certain provisions under the Employee Retirement Income Security Act of
1974, as amended (ERISA), and Department of Labor Regulations. Other similar
actions were filed in early 2006. On April 3, 2006, the Court issued an order
consolidating the actions. On August 23, 2006, plaintiffs filed a consolidated
purported class action complaint on behalf of all participants and beneficiaries
of our 401(k) Plan during the period May 7, 2004 through January 26, 2006
alleging that we, our 401(k) Administrative and Investment Committee (the
Committee), members of the Committee, and certain directors violated certain
provisions of ERISA (the “Consolidated ERISA Complaint”). The Consolidated ERISA
Complaint alleges, among other things, that the defendants breached their
fiduciary duties to the 401(k) Plan’s participants because they knew or should
have known that the value of the Company’s stock was artificially inflated and
was not a prudent investment for the 401(k) Plan. The Consolidated ERISA
Complaint seeks equitable and monetary relief. On June 30, 2008, Robert
Hochstadt (who previously had withdrawn as an interim lead plaintiff) filed a
motion to intervene to serve as a proposed class representative. On
November 3, 2008, the Court denied Plaintiffs’ motion to certify a class, denied
Hochstadt’s motion to intervene, and dismissed the action. On December 2, 2008,
plaintiffs filed a notice of appeal.
On
December 24, 2008, Robert Hochstadt and Edward Hazelrig, Jr. filed a purported
class action complaint in the U.S. District Court for the District of
Massachusetts on behalf of all participants and beneficiaries of our 401(k) Plan
during the period May 7, 2004 through January 26, 2006. This new complaint
repeats the allegations of the August 23, 2006, Consolidated ERISA Complaint. On
February 24, 2009, we responded to the complaint.
In July
2005, a purported class action complaint was filed on behalf of participants in
Guidant’s employee pension benefit plans. This action was filed in the U.S.
District Court for the Southern District of Indiana against Guidant and its
directors. The complaint alleges breaches of fiduciary duty under
ERISA. Specifically, the complaint alleges that Guidant fiduciaries
concealed adverse information about Guidant’s defibrillators and imprudently
made contributions to Guidant’s 401(k) plan and employee stock ownership plan in
the form of Guidant stock. The complaint seeks class certification, declaratory
and injunctive relief, monetary damages, the imposition of a constructive trust,
and costs and attorneys’ fees. In September 2007, we filed a motion to
dismiss the complaint for failure to state a claim. In June 2008, the District
Court dismissed the complaint in part, but ruled that certain of the plaintiffs’
claims may go forward to discovery. On October 29, 2008, the Magistrate Judge
ruled that discovery should be limited, in the first instance, to alleged
damages-related issues.
On
November 3, 2005, a securities class action complaint was filed on behalf
of purchasers of Guidant stock between December 1, 2004 and October 18, 2005, in
the U.S. District Court for the Southern District of Indiana, against Guidant
and several of its officers and directors. The complaint alleges that the
defendants concealed adverse information about Guidant’s defibrillators and
pacemakers and sold stock in violation of federal securities laws. The complaint
seeks a declaration that the lawsuit can be maintained as a class action,
monetary damages, and injunctive relief. Several additional, related securities
class actions were filed in November 2005 and January 2006. The Court issued an
order consolidating the complaints and appointed the Iron Workers of Western
Pennsylvania Pension Plan and David Fannon as lead plaintiffs. Lead plaintiffs
filed a consolidated amended complaint. In August 2006, the defendants moved to
dismiss the complaint. On February 27, 2008, the District Court granted the
motion to dismiss and entered final judgment in favor of all defendants. On
March 13, 2008, the plaintiffs filed a motion seeking to amend the final
judgment to permit the filing of a further amended complaint. On May 21, 2008,
the District Court denied plaintiffs motion to amend the judgment. On June 6,
2008, plaintiffs appealed the judgment to the United States Court of Appeals for
the Seventh Circuit. On January 16, 2009, the appeal was argued before a panel
of the Court.
Governmental
Proceedings – BSC
In
December 2007, we were informed by the Department of Justice that it is
conducting an investigation of allegations that we and other suppliers
improperly promoted biliary stents for off-label uses. On June 26, 2008,
the Department of Justice issued a subpoena to us under the Health Insurance
Portability & Accountability Act of 1996 requiring the production of
documents to the United States Attorney’s Office in the District of
Massachusetts. We are cooperating with the investigation.
On
February 26, 2008, fifteen pharmaceutical and medical device manufacturers,
including Boston Scientific, received a letter from Senator Charles E. Grassley,
ranking member of the United States Senate Committee on Finance regarding their
plans to enhance the transparency of financial relationships with physicians and
medical organizations. On March 7, 2008, we responded to the
Senator.
On June
27, 2008, the Republic of Iraq filed a complaint against us and ninety-two other
defendants in the U.S. District Court of the Southern District of New York. The
complaint alleges that the defendants acted improperly in connection with the
sale of products under the United Nations Oil for Food Program. The complaint
alleges RICO violations, conspiracy to commit fraud and the making of false
statements and improper payments, and seeks monetary and punitive damages. We
intend to vigorously defend against its allegations.
On
October 16, 2008, we received a letter from Senator Charles E. Grassley, ranking
member of the United States Senate Committee on Finance and Senator Herb
Kohl, Chairman, United States Senate Special Committee on Aging,
requesting information regarding payments made to the Cardiovascular
Research Foundation, Columbia University and certain affiliated
individuals. Additionally, the letter requests information regarding the COURAGE
trial. We are cooperating with the request.
On July
14, 2008, we received a subpoena from the State of New Hampshire, Office of the
Attorney General, requesting information in connection with our refusal to sell
medical devices or equipment intended to be used in the administration of spinal
cord stimulation trials to practitioners other than practicing medical doctors.
We are cooperating with the request.
On
November 13, 2008, we received a subpoena from the Attorney General of the State
of New York requesting
documents and information related to hedges and forward contracts primarily
concerning our executive officers and directors. We are cooperating with the
request.
Governmental
Proceedings – Guidant
On
November 2, 2005, the Attorney General of the State of New York filed a
civil complaint against Guidant pursuant to the New York’s Consumer Protection
Law. In the complaint, the Attorney General alleges that Guidant concealed from
physicians and patients a design flaw in its PRIZM 1861 defibrillator from
approximately February of 2002 until May 23, 2005. The complaint further
alleges that due to Guidant’s concealment of this information, Guidant has
engaged in repeated and persistent fraudulent conduct in violation of the law.
The Attorney General is seeking permanent injunctive relief, restitution for
patients in whom a PRIZM 1861 defibrillator manufactured before April 2002 was
implanted, disgorgement of profits, and all other proper relief. This case is
currently pending in the MDL in the United States District Court for the
District of Minnesota.
In
October 2005, Guidant received administrative subpoenas from the U.S. Department
of Justice U.S. Attorney’s offices in Boston and Minneapolis, issued under
the Health Insurance Portability & Accountability Act of 1996. The
subpoena from the U.S. Attorney’s office in Boston requests documents concerning
marketing practices for pacemakers, implantable cardioverter defibrillators,
leads and related products. The subpoena from the U.S. Attorney’s office in
Minneapolis requests documents relating to Guidant’s VENTAK PRIZM® 2 and CONTAK
RENEWAL® and CONTAK RENEWAL 2 devices. Guidant is cooperating with the
requests.
On
January 16, 2007, the French Competition Council (Conseil de la Concurrence
which is one of the bodies responsible for the enforcement of
antitrust/competition law in France) issued a Statement of Objections alleging
that Guidant France SAS (“Guidant France”) had agreed with the four other main
suppliers of implantable cardiac defibrillators (“ICDs”) in France to
collectively refrain from responding to a 2001 tender for ICDs conducted by a
group of seventeen (17) University Hospital Centers in France. This alleged
collusion is alleged to be contrary to the French Commercial Code and Article 81
of the European Community Treaty. On December 19, 2007, the Council found
that the suppliers had violated competition law and assessed monetary fines,
however, each of the suppliers were fined amounts considerably less than
originally recommended. The French Ministry of the Economy and Finance filed an
incidental recourse seeking aggravated sanctions against all defendants. On
January 14, 2009, Guidant filed its rejoinder with the Paris Court of Appeals. A
trial was held on February 17, 2009, and a decision is expected on April 8,
2009.
On July
1, 2008, Guidant Sales Corporation received a subpoena from the Maryland office
of the Department of Health and Human Services, Office of Inspector General.
This subpoena seeks information concerning payments to physicians, primarily
related to the training of sales representatives. We are cooperating with this
request.
On
October 17, 2008, we received a subpoena from the U.S. Department of Health and
Human Services, Office of the Inspector General, requesting information related
to the alleged use of a skin adhesive in certain of our products. We are
cooperating with the request.
On October 24, 2008, we
received a letter from the U.S. Department of Justice (“DOJ”) informing us of an
investigation relating to surgical cardiac ablation system devices to treat
atrial fibrillation. We are cooperating with the investigation.
On
November 7, 2008, Guidant/Boston Scientific received a request from the
Department of Defense, Defense Criminal Investigative Service and the Department
of the Army, Criminal Investigation Command seeking information concerning sales
and marketing interactions with physicians at
Madigan Army Medical Center in Tacoma, Washington. We are
cooperating with the request.
Other
Proceedings
On
July 28, 2000, Dr. Tassilo Bonzel filed a complaint naming certain
of our Schneider Worldwide subsidiaries and Pfizer Inc. and certain of
its affiliates as defendants, alleging that Pfizer failed to pay Dr. Bonzel
amounts owed under a license agreement involving Dr. Bonzel’s patented
Monorail® balloon catheter technology. This and similar suits were dismissed in
state and federal courts in Minnesota. On April 24, 2007, we received a letter
from Dr. Bonzel’s counsel alleging that the 1995 license agreement with Dr.
Bonzel may have been invalid under German law. On October 5, 2007,
Dr. Bonzel filed a complaint against us in Kassel, Germany, alleging the
1995 license agreement is invalid under German law and seeking monetary
damages. On May 16, 2008, we answered denying the allegations in the
complaint. A hearing has been scheduled for May 8, 2009.
As of
June 2003, Guidant had outstanding fourteen suits alleging product liability
related causes of action relating to the ANCURE Endograft System for the
treatment of abdominal aortic aneurysms. Subsequently, Guidant was notified of
additional claims and served with additional complaints relating to the ANCURE
System. From time to time, Guidant has settled certain of the individual claims
and suits for amounts that were not material to Guidant. Recently, Guidant
resolved 8 filed lawsuits pending in the United States District Court for the
District of Minnesota, subject to final dismissal. Guidant also has four cases
pending in State Court in California. These cases have been dismissed on summary
judgment and are pending appeal. Additionally, Guidant has been notified of over
130 potential unfiled claims alleging product liability relating to the ANCURE
System. The claimants generally allege that they or their relatives suffered
injuries, and in certain cases died, as a result of purported defects in the
device or the accompanying warnings and labeling. It is uncertain how many of
these claims will actually be pursued against Guidant.
Although
insurance may reduce Guidant’s exposure with respect to ANCURE System claims,
one of Guidant’s carriers, Allianz Insurance Company (Allianz), filed suit in
the Circuit Court, State of Illinois, County of DuPage, seeking to rescind
or otherwise deny coverage and alleging fraud. Additional carriers have
intervened in the case and Guidant affiliates, including EVT, are also named as
defendants. Guidant and its affiliates also initiated suit against certain
of their insurers, including Allianz, in the Superior Court, State of
Indiana, County of Marion, in order to preserve Guidant’s rights to
coverage. On July 11, 2007, the Illinois court entered a final partial
summary judgment ruling in favor of Allianz. Following appeals, both lawsuits
are pending in the trial courts.
FDA
Warning Letters
In
January 2006, legacy Boston Scientific received a corporate warning letter from
the FDA notifying us of serious regulatory problems at three of our
facilities and advising us that our corporate-wide corrective action plan
relating to three site-specific warning letters issued to us in 2005 was
inadequate. We have identified solutions to the quality system issues cited by
the FDA and have made significant progress in transitioning our organization to
implement those solutions. The FDA reinspected a number of our facilities
and, in October 2008, informed us that our quality system is now in substantial
compliance with its Quality System Regulations. Between September and December
2008, the FDA approved all of our requests for final approval of Class III
submissions previously on hold due to the corporate warning letter and has
approved all eligible requests for Certificates to Foreign Governments (CFGs).
The corporate warning letter remains in place pending final remediation of
certain Medical Device Report (MDR) filing issues, which we are actively working
with the FDA to resolve.
Matters
Concluded Since January 1, 2008
On July
17, 2006, Carla Woods and Jeffrey Goldberg, as Trustees of the Bionics Trust and
Stockholders’ Representative, filed a lawsuit against us in the U.S. District
Court for the Southern District of New York. The complaint alleges that we
breached the Agreement and Plan of Merger among us, Advanced Bionics
Corporation, the Bionics Trust, Alfred E. Mann, Jeffrey H. Greiner, and David
MacCallum, collectively in their capacity as Stockholders’ Representative, and
others dated May 28, 2004 (the Merger Agreement) or, alternatively, the covenant
of good faith and fair dealing. The complaint seeks injunctive and other relief.
In
connection
with an amendment to the Merger Agreement and the execution of related
agreements in August 2007, the parties agreed to a resolution to this litigation
contingent upon the closing of the Amendment and related agreements. On January
3, 2008, the closing contemplated by the amendment and related agreements
occurred and on January 9, 2008, the District Court entered a joint stipulation
vacating the injunction and dismissed the case with prejudice.
On May 4,
2006, we filed suit against Conor Medsystems Ireland Ltd. alleging that its
Costar® paclitaxel-eluting coronary stent system infringes one of our balloon
catheter patents. The suit was filed in Ireland seeking monetary and injunctive
relief. On January 14, 2008, the case was dismissed pursuant to a
settlement agreement between the parties.
On
September 12, 2002, ev3 Inc. filed suit against The Regents of the
University of California and our wholly owned subsidiary, Boston Scientific
International, B.V., in the District Court of The Hague, The Netherlands,
seeking a declaration that ev3’s EDC II and VDS embolic coil products do not
infringe three patents licensed to us from The Regents. On October 30, 2007, we
reached an agreement in principle with ev3 to resolve this matter. On March 27,
2008, the parties signed a definitive settlement agreement and the case has been
formally dismissed.
On
March 29, 2005, we and Boston Scientific Scimed, filed suit against ev3 for
patent infringement, alleging that ev3’s SpideRX® embolic protection device
infringes four U.S. patents owned by us. The complaint was filed in the U.S.
District Court for the District of Minnesota seeking monetary and injunctive
relief. On October 30, 2007, we reached an agreement in principle with ev3 to
resolve this matter. On March 27, 2008, the parties signed a definitive
settlement agreement and the case has been formally dismissed.
On
December 16, 2003, The Regents of the University of
California filed suit against Micro Therapeutics, Inc., a subsidiary
of ev3, and Dendron GmbH alleging that Micro Therapeutics’ Sapphire detachable
coil delivery systems infringe twelve patents licensed to us and owned by The
Regents. The complaint was filed in the U.S. District Court for the Northern
District of California seeking monetary and injunctive relief. On October 30,
2007, we reached an agreement in principle with ev3 to resolve this matter. On
March 27, 2008, the parties signed a definitive settlement agreement and on
April 4, 2008, a Stipulation of Dismissal was filed with the Court and the case
was formally dismissed.
On
February 20, 2006, Medinol submitted a request for arbitration against us,
and our wholly owned subsidiaries Boston Scientific Ltd. and Boston
Scientific Scimed, Inc., under the Arbitration Rules of the World
Intellectual Property Organization pursuant to a settlement agreement between
Medinol and us dated September 21, 2005. The request for arbitration
alleges that our Liberté® coronary stent system infringes two U.S. patents and
one European patent owned by Medinol. On May 2, 2008, the World Intellectual
Property Organization panel held that the Medinol patents were valid but not
infringed by our Liberté® and TAXUS® Liberté® stent systems. On June 6, 2008,
the parties agreed not to appeal the decision.
On
June 12, 2003, Guidant announced that its subsidiary, EndoVascular
Technologies, Inc. (EVT), had entered into a plea agreement with the U.S.
Department of Justice relating to a previously disclosed investigation regarding
the ANCURE ENDOGRAFT System for the treatment of abdominal aortic aneurysms. In
connection with the plea agreement, EVT entered into a five year Corporate
Integrity Agreement (“CIA”) with the Office of the Inspector General of the
United States Department of Health and Human Services. A final annual report was
due on August 30, 2008, and was timely submitted. Subject to review of the final
annual report, the CIA effectively expired on June 30, 2008, in accordance with
its terms.
Shareholder
derivative suits relating to the ANCURE System were pending in the Southern
District of Indiana and in the Superior Court of the State of
Indiana, County of Marion. The suits, purportedly filed on behalf of
Guidant, initially alleged that Guidant’s directors breached their fiduciary
duties by taking improper steps or failing to take steps to prevent the ANCURE
and EVT related matters described above. The complaints sought damages and other
equitable relief. On March 9, 2007, the Superior Court granted the parties’
joint motion to dismiss the complaint with prejudice for lack of standing in one
of the pending state derivative actions. On March 27, 2008, the District Court
granted the motion to dismiss the federal action and entered judgment in favor
of all defendants. On July 11, 2008, the Superior Court granted the parties’
joint motion to dismiss the complaint with prejudice in the final state
derivative action.
On
September 8, 2005, the Laborers Local 100 and 397 Pension Fund initiated a
putative shareholder derivative lawsuit on our behalf in the Commonwealth of
Massachusetts Superior Court Department for Middlesex County against our
directors, certain of our current and former officers, and us as nominal
defendant. The complaint alleged, among other things, that with regard to
certain matters of regulatory compliance, the defendants breached their
fiduciary duties to us and our shareholders in the management and affairs of our
business and in the use and preservation of our assets. The complaint also
alleged that as a result of the alleged misconduct and the purported failure to
publicly disclose material information, certain directors and officers sold our
stock at inflated prices in violation of their fiduciary duties and were
unjustly enriched. The suit was dismissed on September 11, 2006. The Board of
Directors thereafter received two letters from the Laborers Local 100 and 397
Pension Fund dated February 21, 2007. One letter demanded that the Board of
Directors investigate and commence action against the defendants named in the
original complaint in connection with the matters alleged in the original
complaint. The second letter (as well as subsequent letters from the Pension
Fund) made a demand for an inspection of certain books and records for the
purpose of, among other things, the investigation of possible breaches of
fiduciary duty, misappropriation of information, abuse of control, gross
mismanagement, waste of corporate assets and unjust enrichment. On March 21,
2007, we rejected the request to inspect books and records on the ground that
Laborers Local 100 and 397 Pension Fund had not established a proper purpose for
the request. On July 31, 2008, the Board of Directors rejected the demand
in the first letter to commence action against the defendants.
In August
2007, we received a warning letter from the FDA regarding the conduct of
clinical investigations associated with our abdominal aortic aneurysm (AAA)
stent-graft program acquired from TriVascular, Inc. We implemented a
comprehensive plan of corrective actions regarding the conduct of our clinical
trials and informed the FDA that we have finalized commitments made as part of
our response. On July 31, 2008, the FDA notified Boston Scientific that no
further actions were required relative to this warning letter. We
terminated the TriVascular AAA development program in 2006.
On
October 15, 2004, Boston Scientific Scimed filed suit against a German
subsidiary of Johnson & Johnson alleging the Cypher® drug-eluting stent
infringes one of our German utility models. The suit was filed in
Mannheim, Germany seeking monetary and injunctive relief. On August 26,
2008, we withdrew the suit.
On
December 30, 2004, Boston Scientific Scimed filed suit against a German
subsidiary of Johnson & Johnson alleging the Cypher® drug-eluting stent
infringes one of our German utility models. The suit was filed in
Dusseldorf, Germany seeking monetary and injunctive relief. On August 26,
2008, we withdrew the suit.
On May 8,
2008, certain shareholders of CryoCor filed a lawsuit in the Superior Court of
the State of California, County of San Diego, against CryoCor, its
directors and us. The lawsuit alleged that the directors of CryoCor breached
their fiduciary duties to their shareholders by approving the sale of the
company to us and that we aided and abetted in the breach of fiduciary duties.
On September 19, 2008, the suit was dismissed by the Court. Plaintiffs have
agreed not to appeal the decision and we have agreed not to seek to recover
costs.
On
January 15, 2008, CryoCor, Inc. (acquired by Boston Scientific Scimed on May 28,
2008) (“CryoCor”) and AMS Research Corporation (“AMS”) filed a statement of
claim in Canada alleging that cryoablation catheters and cryoconsole of CryoCath
Technologies, Inc. (“CryoCath”) infringe certain Canadian patents licensed by
CryoCor. The suit seeks injunctive relief and monetary damages. On September 23,
2008, the parties signed a settlement agreement and on September 25, 2008, the
suit was dismissed.
On
January 15, 2008, CryoCor and AMS filed a suit for patent infringement against
CryoCath alleging that Cryocath’s cryosurgical products, including its
cryoconsole and cryoablation catheters, infringe three patents exclusively
licensed to CryoCor. The suit was filed in the U.S. District Court for the
District of Delaware, and seeks monetary damages and injunctive relief. On
February 4, 2008, CryoCath answered the complaint, denying the allegations and
counterclaiming for a declaratory judgment that the patents are invalid and
non-infringed, as well as alleging antitrust violations, deceptive and unfair
business practices and patent infringement by CryoCor of a CryoCath patent. On
September 23, 2008, the parties signed a settlement agreement and on September
25, 2008, the suit was dismissed.
On
September 27, 2004, Target Therapeutics and we filed suit for patent
infringement against Micrus Corporation alleging that certain detachable embolic
coil devices infringe two U.S. patents exclusively licensed to Target
Therapeutics. The complaint was filed in the U.S. District Court for the
Northern District of California seeking monetary and injunctive relief. On
August 6, 2008, we reached an agreement in principle with Micrus to resolve this
matter. On September 4, 2008, the parties signed a definitive settlement
agreement and on October 8, 2008, the case was formally dismissed.
On
February 28, 2008, CryoCor and AMS brought a complaint in the International
Trade Commission alleging that Cryocath’s cryosurgical products, including its
cryoconsole and cryoablation catheters, infringe three patents exclusively
licensed to CryoCor. CryoCor and AMS are seeking an order to exclude entry into
the United States of any of CryoCath’s products found to infringe the patents.
On September 23, 2008, the parties signed a settlement agreement. On
September 25, 2008, the parties filed a joint motion to terminate the action,
which became effective on November 6, 2008.
On
October 15, 2007, CryoCath filed suit for patent infringement against CryoCor
alleging that cryoconsoles and cryoablation catheters sold by CryoCor infringe
certain of CryoCath’s patents. The suit was filed in the U.S. District Court for
the District of Delaware and seeks monetary damages and injunctive relief. On
September 23, 2008, the parties signed a settlement agreement and on September
25, 2008, the suit was dismissed. Two of the patents asserted by CryoCath are
also involved in interference proceedings provoked by CryoCor. The interferences
are on-going at the U.S. Patent and Trademark Office.
On July
2, 2008, Cardio Access LLC filed suit against us alleging infringement of a
patent related to an intra-aortic balloon access cannula owned by them. The suit
was filed in the U.S. District Court for the Eastern District of Texas seeking
monetary and injunctive relief. On November 4, 2008, the case was
dismissed.
Between
March and July 2005, sixty-nine former employees filed charges against Guidant
with the U.S. Equal Employment Opportunity Commission (EEOC) alleging that
Guidant discriminated against the former employees on the basis of their age
when Guidant terminated their employment in the fall of 2004 as part of a
reduction in force. On March 24, 2008, the EEOC began dismissing the charges,
with the final charges dismissed on April 4, 2008, in light of the litigation
pending in Minnesota District Court described in the following
paragraph.
In 2005, the
Securities and Exchange Commission began a formal inquiry into issues related to
certain of Guidant’s product disclosures and trading in Guidant stock. Guidant
has cooperated with the inquiry. Since 2006, we have not received additional
requests for information on this matter.
On
October 23, 2008, we received a letter from Senator Charles E. Grassley, ranking
member of the United States Senate Committee on Finance, requesting certain
information regarding payments made to certain psychiatrists, including those
who may serve as leaders of professional societies or those who may serve as
authorities for developing and modifying the diagnostic criteria for mental
illness. We have cooperated with this request.
On
February 28, 2007, we received a letter from the Congressional Committee on
Oversight and Government Reform requesting information relating to our TAXUS®
stent systems. The Committee’s request expressly related to concerns about the
safety and off-label use of drug-eluting stents raised by a December 2006 FDA
panel. We provided documents in response to the Committee’s request and there
has been no further action from the Committee.
On March
1, 2006, Medtronic Vascular, Inc. filed suit against Boston Scientific Scimed
and us, alleging that our balloon products infringe four U.S. patents owned by
Medtronic Vascular. The suit was filed in the U.S. District Court for the
Eastern District of Texas seeking monetary and injunctive relief. On May 27,
2008, the Court found one of the patents not infringed. On the same date, the
jury found the other three patents valid and infringed, awarding Medtronic $250
million in damages. On July 11, 2008, the Court granted our motion that certain
accused products did not infringe one of the patents and ordered the parties to
submit a new damage calculation. On July 21, 2008, Medtronic and we agreed that
the Court’s ruling reduced the damages by approximately $64 million. On August
29, 2008, the Court found two Medtronic patents unenforceable for inequitable
conduct and set new damages at $19 million. On January 23, 2009, the parties
executed a settlement and stand-still agreement settling the
action.
On August
12, 2008, we filed suit for patent infringement against Medtronic, Inc. and
certain of its subsidiaries alleging that the sale of certain balloon catheters
and stent delivery systems infringe four U.S. patents owned by us. The complaint
was filed in the United States District Court for the Northern District of
California seeking monetary and injunctive relief. On January 23, 2009, the
parties executed a settlement and stand-still agreement and the case was
dismissed on January 29, 2009.
On July
25, 2007, the U.S. District Court for the Northern District of California
granted our motion to intervene in an action filed February 15, 2006 by
Medtronic Vascular and certain of its affiliates against Advanced Cardiovascular
Systems, Inc. and Abbott Laboratories. As a counterclaim plaintiff in this
litigation, we are seeking a declaratory judgment of patent invalidity and of
non-infringement by our PROMUS® coronary stent system relating to two U.S.
patents owned by Medtronic. On January 23, 2009, the parties executed a
settlement and stand-still agreement and the case was dismissed on January 30,
2009.
On August
12, 2008, we and Endovascular Technologies, Inc. filed suit for patent
infringement against Medtronic, Inc. and certain of its subsidiaries alleging
that the sale of Medtronic’s AAA products infringe ten U.S. patents owned by the
us. The complaint was filed in the United States District Court for the Eastern
District of Texas, Tyler Division, seeking monetary and injunctive relief. On
January 23, 2009, the parties executed a settlement and stand-still agreement
and the case was dismissed on February 2, 2009.
On August
13, 2008, Medtronic, Inc. and certain of its subsidiaries filed suit for patent
infringement against us, Boston Scientific Scimed, Inc., Abbott and certain of
Abbott’s subsidiaries alleging infringement of one U.S. patent owned by them.
The complaint was filed in the United States District Court for the Eastern
District of Texas, Marshall Division, seeking monetary and injunctive relief. On
September 2, 2008, Medtronic filed an amended complaint adding a second patent
to the suit. On January 23, 2009, the parties executed a settlement and
stand-still agreement and the case was dismissed on February 2,
2009.
On April
4, 2007, SciCo Tec GmbH filed suit against us alleging certain of our balloon
catheters infringe a U.S. patent owned by SciCo Tec GmbH. The suit was
filed in the U. S. District Court for the Eastern District of Texas seeking
monetary and injunctive relief. On May 10, 2007, SciCo Tec filed an amended
complaint alleging certain additional balloon catheters and stent delivery
systems infringe the same patent. On May 29, 2007, we responded to the amended
complaint and filed a counterclaim seeking declaratory judgment of invalidity
and non-infringement with respect to the patent at issue. On February 7,
2009, the parties settled this suit subject to negotiation of a definitive
settlement agreement.
On April
19, 2007, SciCo Tec GmbH, filed suit against us and our subsidiary, Boston
Scientific Medizintechnik GmbH, alleging certain of our balloon catheters
infringe a German patent owned by SciCo Tec GmbH. The suit was filed in
Mannheim, Germany. We answered the complaint, denying the allegations
and filed a nullity action against SciCo Tec relating to one of its German
patents. On February 7, 2009, the parties settled this suit subject
to negotiation of a definitive settlement agreement.
Litigation-related
Charges
We have
recorded certain significant litigation-related charges as a separate line item
in our accompanying consolidated statements of operations. In 2008, we recorded
a charge of $334 million as a result of a ruling by a federal judge in a patent
infringement case brought against us by Johnson & Johnson. In 2007, we
recorded a charge of $365 million associated with this case.
Note M—Stockholders’
Equity
Preferred
Stock
We are
authorized to issue 50 million shares of preferred stock in one or more
series and to fix the powers, designations, preferences and relative
participating, option or other rights thereof, including dividend rights,
conversion rights, voting rights, redemption terms, liquidation preferences and
the number of shares constituting any series, without any further vote or action
by our stockholders. At December 31, 2008 and 2007, we had no shares of
preferred stock issued or outstanding.
Common
Stock
We are
authorized to issue 2.0 billion shares of common stock, $.01 par value per
share. Holders of common stock are entitled to one vote per share. Holders of
common stock are entitled to receive dividends, if and when declared by the
Board of Directors, and to share ratably in our assets legally available for
distribution to our stockholders in the event of liquidation. Holders of common
stock have no preemptive, subscription, redemption, or conversion rights. The
holders of common stock do not have cumulative voting rights. The holders of a
majority of the shares of common stock can elect all of the directors and can
control our management and affairs.
We did
not repurchase any shares of our common stock during 2008, 2007 or 2006.
Approximately 37 million shares remain under previous share repurchase
authorizations. Repurchased shares are available for reissuance under our equity
incentive plans and for general corporate purposes, including acquisitions and
alliances. There were no shares in treasury at December 31, 2008 or
2007.
Note N—Stock
Ownership Plans
Employee
and Director Stock Incentive Plans
On May 6,
2008, our shareholders approved an amendment and restatement of our 2003
Long-Term Incentive Plan (LTIP), increasing the number of shares of our common
stock available for issuance under the plan by 70 million shares. Together with
our 2000 LTIP, the plans provide for the issuance of up to 160 million
shares of common stock. Shares reserved for future equity awards under
our stock incentive plans totaled approximately 82 million at
December 31, 2008. Together,
the Plans cover officers, directors, employees and consultants and provide for
the grant of various incentives, including qualified and nonqualified options,
deferred stock units, stock grants, share appreciation rights, performance-based
awards and market-based awards. The Executive Compensation and Human Resources
Committee of the Board of Directors, consisting of independent, non-employee
directors, may authorize the issuance of common stock and authorize cash awards
under the plans in recognition of the achievement of long-term performance
objectives established by the Committee.
Nonqualified
options issued to employees are generally granted with an exercise price equal
to the market price of our stock on the grant date, vest over a four-year
service period, and have a ten-year contractual life. In the case of qualified
options, if the recipient owns more than ten percent of the voting power of
all classes of stock, the option granted will be at an exercise price of
110 percent of the fair market value of our common stock on the date of
grant and will expire over a period not to exceed five years. Non-vested stock
awards (awards other than options) issued to employees are generally granted
with an exercise price of zero and typically vest in four to five equal
installments over a five-year service period. These awards represent our
commitment to issue shares to recipients after a vesting period. Upon each
vesting date, such awards are no longer subject to risk of forfeiture and we
issue shares of our common stock to the recipient. We generally issue shares for
option exercises and non-vested stock from our treasury, if
available.
During
2004, the FASB issued Statement No. 123(R), Share-Based Payment, which
is a revision of Statement No. 123, Accounting for Stock-Based
Compensation. Statement No. 123(R) supersedes APB Opinion
No. 25, Accounting for
Stock Issued to Employees, and amends Statement No. 95, Statement of Cash Flows. In
general, Statement No. 123(R) contains similar accounting concepts as those
described in Statement No. 123. However, Statement No. 123(R) requires
that we recognize all share-based payments to employees, including grants of
employee stock options, in our consolidated statements of operations based on
their fair values. Pro forma disclosure is no longer an
alternative.
The
following presents the impact of stock-based compensation on our consolidated
statements of operations for the years ended December 31, 2008, 2007 and 2006
for options and restricted stock awards:
Year
Ended December 31,
|
||||||||||||
(in
millions)
|
2008
|
2007
|
2006
|
|||||||||
Cost
of products sold
|
$ | 21 | $ | 19 | $ | 15 | ||||||
Selling,
general and administrative expenses
|
88 | 76 | 74 | |||||||||
Research
and development expenses
|
29 | 27 | 24 | |||||||||
138 | 122 | 113 | ||||||||||
Income
tax benefit
|
41 | 35 | 32 | |||||||||
$ | 97 | $ | 87 | $ | 81 | |||||||
Net
loss per common share - basic
|
$ | 0.06 | $ | 0.06 | $ | 0.06 | ||||||
Net
loss per common share - assuming dilution
|
$ | 0.06 | $ | 0.06 | $ | 0.06 | ||||||
Stock
Options
We
generally use the Black-Scholes option-pricing model to calculate the grant-date
fair value of our stock options granted to employees under our stock incentive
plans. In conjunction with the Guidant acquisition, we converted certain
outstanding Guidant options into approximately 40 million fully vested Boston
Scientific options. See Note D
- Acquisitions for further details regarding the fair value and valuation
assumptions related to those awards. We calculated the fair value for all other
options granted during 2008, 2007 and 2006 using the following estimated
weighted-average assumptions:
Year
Ended December 31,
|
||||||||||||
2008
|
2007
|
2006
|
||||||||||
Options
granted (in thousands)
|
4,905 | 1,969 | 5,438 | |||||||||
Weighted-average
exercise price
|
$ | 12.53 | $ | 15.55 | $ | 21.48 | ||||||
Weighted-average
grant-date fair value
|
$ | 4.44 | $ | 6.83 | $ | 7.61 | ||||||
Black-Scholes
Assumptions
|
||||||||||||
Expected volatility
|
35 | % | 35 | % | 30 | % | ||||||
Expected term (in years, weighted)
|
5.0 | 6.3 | 5.0 | |||||||||
Risk-free interest rate
|
2.77% - 3.77 | % | 4.05% - 4.96 | % | 4.26% - 5.18 | % |
Expected
Volatility
For
options granted prior to 2006, we used our historical volatility as a basis to
estimate expected volatility in our valuation of stock options. Upon adoption of
Statement No. 123(R), we changed our method of estimating expected volatility to
consider historical volatility and implied volatility.
Expected
Term
We
estimate the expected term of our options using historical exercise and
forfeiture data. We believe that this historical data is the best estimate of
the expected term of our new option grants. Approximately 75 percent of stock
options granted in 2007 related to a single grant to one member of our executive
management team. We performed a specific analysis for this grant and
determined that the grant had an expected term of 6.7
years. We determined that the other grants during 2007 had
an expected term of 5.0 years based on historical data.
Risk-Free Interest
Rate
We use
yield rates on U.S. Treasury securities for a period approximating the expected
term of the award to estimate the risk-free interest rate in our grant-date fair
value assessment.
Expected Dividend
Yield
We have
not historically paid dividends to our shareholders. We currently do not intend
to pay dividends, and intend to retain all of our earnings to repay indebtedness
and invest in the continued growth of our business. Therefore, we have assumed
an expected dividend yield of zero in our grant-date fair value
assessment.
Information
related to stock options for 2008, 2007 and 2006 under stock incentive plans is
as follows:
Options
(in
thousands)
|
Weighted
Average Exercise Price
|
Weighted Average Remaining
Contractual Life (in years)
|
Aggregate
Intrinsic Value
(in
millions)
|
|||||||||||||
Outstanding
at January 1, 2006
|
50,285 | $ | 20 | |||||||||||||
Guidant
converted options
|
39,649 | 13 | ||||||||||||||
Granted
|
5,438 | 21 | ||||||||||||||
Exercised
|
(10,548 | ) | 11 | |||||||||||||
Cancelled/forfeited
|
(1,793 | ) | 25 | |||||||||||||
Outstanding
at December 31, 2006
|
83,031 | $ | 18 | |||||||||||||
Granted
|
1,969 | 16 | ||||||||||||||
Exercised
|
(7,190 | ) | 12 | |||||||||||||
Exchanged
for DSUs
|
(6,599 | ) | 33 | |||||||||||||
Cancelled/forfeited
|
(2,470 | ) | 24 | |||||||||||||
Outstanding
at December 31, 2007
|
68,741 | $ | 17 | |||||||||||||
Granted
|
4,905 | 13 | ||||||||||||||
Exercised
|
(4,546 | ) | 8 | |||||||||||||
Cancelled/forfeited
|
(8,034 | ) | 19 | |||||||||||||
Outstanding
at December 31, 2008
|
61,066 | $ | 17 | 3.7 | $ | 2 | ||||||||||
Exercisable
at December 31, 2008
|
48,994 | $ | 16 | 2.7 | $ | 2 | ||||||||||
Expected
to vest as of December 31, 2008
|
55,824 | $ | 17 | 3.3 | $ | 2 | ||||||||||
On May
22, 2007, we extended an offer to our non-director and non-executive employees
to exchange certain outstanding stock options for deferred stock units (DSUs).
Stock options previously granted under our stock plans with an exercise price of
$25 or more per share were exchangeable for a smaller number of DSUs, based on
exchange ratios derived from the exercise prices of the surrendered
options. On June 20, 2007, following the expiration of the offer, our
employees exchanged approximately 6.6 million options for approximately 1.1
million DSUs, which were subject to additional vesting restrictions. We did not
record incremental stock compensation expense as a result of these exchanges
because the fair values of the options exchanged equaled the fair values of the
DSUs issued.
The total
intrinsic value of options exercised in 2008 was $19 million, as compared to $28
million in 2007 and $102 million in 2006.
Non-Vested
Stock
We value
restricted stock awards and DSUs based on the closing trading value of our
shares on the date of grant. Information related to non-vested stock
awards during 2008, 2007, and 2006, including those issued in connection
with our stock option exchange program discussed above, is as
follows:
Non-Vested
Stock Award Units
(in
thousands)
|
Weighted
Average Grant-Date Fair Value
|
|||||||
Balance
at January 1, 2006
|
3,834 | $ | 30 | |||||
Granted
|
6,580 | 23 | ||||||
Vested(1)
|
(52 | ) | 32 | |||||
Forfeited
|
(487 | ) | 28 | |||||
Balance
at December 31, 2006
|
9,875 | $ | 26 | |||||
Option
exchange grants
|
1,115 | 16 | ||||||
Other
grants
|
9,545 | 17 | ||||||
Vested
(1)
|
(778 | ) | 29 | |||||
Forfeited
|
(1,621 | ) | 22 | |||||
Balance
at December 31, 2007
|
18,136 | $ | 20 | |||||
Granted
|
13,557 | 12 | ||||||
Vested
(1)
|
(3,856 | ) | 21 | |||||
Forfeited
|
(3,183 | ) | 18 | |||||
Balance
at December 31, 2008
|
24,654 | $ | 16 | |||||
(1)
|
The number of restricted stock
units vested includes shares withheld on behalf of employees to satisfy
statutory tax withholding
requirements.
|
The total
vesting date fair value of stock award units that vested during 2008 was
approximately $47 million, as compared to $15 million in 2007 and $1 million in
2006.
CEO
Award
During
the first quarter of 2006, we granted a special market-based award of two
million deferred stock units to our chief executive officer. The attainment of
this award is based on the individual’s continued employment and our stock
reaching certain specified prices as of December 31, 2008 and December 31,
2009. We determined the fair value of the award to be approximately $15
million based on a Monte Carlo simulation, using the following
assumptions:
Stock
price on date of grant
|
$ | 24.42 | |||
Expected
volatility
|
30 | % | |||
Expected
term (in years)
|
3.84 | ||||
Risk-free
rate
|
4.64 | % | |||
We have been and will continue to recognize the expense in our consolidated statement of operations through 2009 using an accelerated attribution method.
Expense
Attribution
We
generally recognize compensation expense for our stock awards issued subsequent
to the adoption of Statement
No. 123(R) using a straight-line method over the substantive vesting period.
Prior to the adoption of Statement No. 123(R), we allocated the pro forma
compensation expense for stock option awards over the vesting period using an
accelerated attribution method. We continue to amortize compensation expense
related to stock option awards granted prior to the adoption of Statement No.
123(R) using an accelerated attribution method. Prior to the adoption of
Statement No. 123(R), we recognized compensation expense for non-vested stock
awards over the vesting period using a straight-line method. We continue to
amortize compensation expense related to non-vested stock awards granted prior
to the adoption of Statement No. 123(R) using a straight-line method. Most of
our stock awards provide for immediate vesting upon retirement, death or
disability of the participant. We expense stock-based awards over the period
between grant date and retirement eligibility or immediately if the employee is
retirement eligible at the date of grant.
We
recognize stock-based compensation expense for the value of the portion of
awards that are ultimately expected to vest. Statement No. 123(R) requires
forfeitures to be estimated at the time of grant and revised, if necessary, in
subsequent periods if actual forfeitures differ from those estimates. The term
“forfeitures” is distinct from “cancellations” or “expirations” and represents
only the unvested portion of the surrendered option. We have applied, based on
an analysis of our historical forfeitures, an annual forfeiture rate of
eight percent to all unvested stock awards as of December 31, 2008, which
represents the portion that we expect will be forfeited each year over the
vesting period. We will re-evaluate this analysis periodically and adjust the
forfeiture rate as necessary. Ultimately, we will only recognize
expense for those shares that vest.
Unrecognized
Compensation Cost
Under the
provisions of Statement No. 123(R), we expect to recognize the following
future expense for awards outstanding as of December 31, 2008:
Unrecognized
Compensation
Cost
(in
millions)(1)
|
Weighted
Average Remaining Vesting Period
(in
years)
|
|||||||
Stock
options
|
$ | 24 | ||||||
Non-vested
stock awards
|
184 | |||||||
$ | 208 | 3.1 | ||||||
(1) Amounts presented represent
compensation cost, net of estimated forfeitures.
Employee
Stock Purchase Plans
In 2006,
our stockholders approved and adopted a new global employee stock purchase plan,
which provides for the granting of options to purchase up to 20 million
shares of our common stock to all eligible employees. Under the employee stock
purchase plan, we grant each eligible employee, at the beginning of each
six-month offering period, an option to purchase shares of our common stock
equal to not more than ten percent of the employee’s eligible compensation
or the statutory limit under the U.S. Internal Revenue Code. Such options may be
exercised generally only to the extent of accumulated payroll deductions at the
end of the offering period, at a purchase price equal to 90 percent of the
fair market value of our common stock at the beginning or end of each offering
period, whichever is less. This discount was reduced from 15 percent to ten
percent effective for the offering period beginning July 1, 2007. At
December 31, 2008, there were approximately 13 million shares available for
future issuance under the employee stock purchase plan.
Information
related to shares issued or to be issued in connection with the employee stock
purchase plan based on employee contributions and the range of purchase prices
is as follows:
(shares
in thousands)
|
2008
|
2007
|
2006
|
|||||||||
Shares
issued or to be issued
|
3,505 | 3,418 | 2,765 | |||||||||
Range
of purchase prices
|
$ | 6.97 - $10.37 | $ | 10.47 - $13.04 | $ | 14.20 - $14.31 | ||||||
We use
the Black-Scholes option-pricing model to calculate the grant-date fair value of
shares issued under the employee stock purchase plan. We recognize expense
related to shares purchased through the employee stock purchase plan ratably
over the offering period. We recognized $7 million in expense associated with
our employee stock purchase plan in 2008, $13 million in 2007 and $12 million in
2006.
In
connection with our acquisition of Guidant, we assumed Guidant’s employee stock
ownership plan (ESOP), which matched employee 401(k) contributions in the form
of stock. As part of the Guidant purchase accounting, we recognized deferred
costs of $86 million for the fair value of the shares that were unallocated on
the date of acquisition. Common stock held by the ESOP was allocated among
participants’ accounts on a periodic basis until these shares were exhausted and
were treated as outstanding in the computation of earnings per share. As of
December 31, 2008, all of the common stock held by the ESOP had been
allocated to employee accounts. Allocated shares of the ESOP were charged to
expense based on the fair value of the common stock on the date of transfer. We
recognized compensation expense of $12 million in 2008, $23 million in 2007 and
$19 million in 2006 related to the plan. Effective June 1, 2008, this plan was
merged into our 401(k) Retirement Savings Plan.
Note O—Weighted-Average
Shares Outstanding
The
following is a reconciliation of weighted-average shares outstanding for basic
and diluted loss per share computations:
Year
Ended December 31,
|
||||||||||||
(in
millions)
|
2008
|
2007
|
2006
|
|||||||||
Weighted-average
shares outstanding - basic
|
1,498.5 | 1,486.9 | 1,273.7 | |||||||||
Net
effect of common stock equivalents
|
||||||||||||
Weighted-average
shares outstanding - assuming dilution
|
1,498.5 | 1,486.9 | 1,273.7 | |||||||||
Weighted-average
shares outstanding, assuming dilution, excludes the impact of 50.7 million stock
options for 2008, 42.5 million stock options for 2007, and 30.3 million for
2006, due to the exercise prices of these stock options being greater than the
average fair market value of our common stock during the
year.
In
addition, weighted-average shares outstanding, assuming dilution, excludes
common stock equivalents of 5.8 million for 2008, 13.1 million for 2007 and 15.6
million for 2006 due to our net loss position for those years.
Note P—Segment
Reporting
Each of
our reportable segments generates revenues from the sale of medical devices.
During
the first quarter of 2009, we reorganized our international structure to provide
more direct sales focus in the marketplace. As of January 1, 2009, we had four
reportable segments based on geographic regions: the United States; EMEA,
consisting of Europe, the Middle East and Africa; Japan; and Inter-Continental,
consisting of Asia Pacific and the Americas. Accordingly,
we have revised our reportable segments to reflect the way we currently manage
and view our business. The reportable segments represent an aggregate of all
operating divisions within each segment. We measure and evaluate our reportable
segments based on segment income. We exclude from segment income certain
corporate and manufacturing-related expenses, as our corporate and manufacturing
functions do not meet the definition of a segment, as defined by FASB Statement
No. 131, Disclosures about
Segments of an Enterprise
and Related Information. In
addition, certain transactions or adjustments that our Chief Operating Decision
Maker considers to be non-recurring and/or non-operational, such as amounts
related to acquisitions, divestitures, litigation, restructuring activities, and
goodwill and intangible asset impairment charges, as well as amortization
expense, are excluded from segment income. Although we exclude these
amounts from segment income, they are included in reported consolidated net
income (loss) and are included in the reconciliation below.
We manage
our international operating segments on a constant currency basis. Sales
generated from reportable segments and divested businesses, as well as operating
results of reportable segments and expenses from manufacturing operations, are
based on internally derived standard currency exchange rates, which may differ
from year to year, and do not include intersegment profits. We have restated the
segment information for 2007 and 2006 net sales and operating results based on
our standard currency exchange rates used for 2008 in order to remove the impact
of currency fluctuations. In addition, we have reclassified previously reported
2007 and 2006 segment results to be consistent with the 2008 presentation.
Because of the interdependence of the reportable segments, the operating profit
as presented may not be representative of the geographic distribution that would
occur if the segments were not interdependent. A reconciliation of the totals
reported for the reportable segments to the applicable line items in our
consolidated statements of operations is as follows:
Year
Ended December 31,
|
||||||||||||
(in
millions)
|
2008
|
2007
|
2006
|
|||||||||
(restated)
|
||||||||||||
Net sales
|
||||||||||||
United
States
|
$ | 4,487 | $ | 4,522 | $ | 4,415 | ||||||
EMEA
|
1,816 | 1,783 | 1,725 | |||||||||
Japan
|
807 | 826 | 596 | |||||||||
Inter-Continental
|
667 | 677 | 779 | |||||||||
Net
sales allocated to reportable segments
|
7,777 | 7,808 | 7,515 | |||||||||
Sales
generated from divested businesses
|
66 | 555 | 492 | |||||||||
Impact
of foreign currency fluctuations
|
207 | (6 | ) | (186 | ) | |||||||
$ | 8,050 | $ | 8,357 | $ | 7,821 | |||||||
Depreciation expense
|
||||||||||||
United
States
|
$ | 62 | $ | 39 | $ | 30 | ||||||
EMEA
|
24 | 12 | 8 | |||||||||
Japan
|
13 | 12 | 9 | |||||||||
Inter-Continental
|
9 | 5 | 4 | |||||||||
Depreciation
expense allocated to reportable segments
|
108 | 68 | 51 | |||||||||
Manufacturing
operations
|
148 | 151 | 125 | |||||||||
Corporate
expenses and foreign exchange
|
65 | 79 | 75 | |||||||||
$ | 321 | $ | 298 | $ | 251 | |||||||
Loss before income taxes
|
||||||||||||
United
States
|
$ | 1,000 | $ | 1,214 | $ | 1,679 | ||||||
EMEA
|
865 | 923 | 777 | |||||||||
Japan
|
488 | 520 | 386 | |||||||||
Inter-Continental
|
286 | 276 | 220 | |||||||||
Operating
income allocated to reportable segments
|
2,639 | 2,933 | 3,062 | |||||||||
Manufacturing
operations
|
(407 | ) | (621 | ) | (577 | ) | ||||||
Corporate
expenses and currency exchange
|
(394 | ) | (462 | ) | (376 | ) | ||||||
Goodwill
and intangible asset impairment charges and acquisition-,
divestiture-, litigation-, and restructuring-related
net charges
|
(2,800 | ) | (1,244 | ) | (4,584 | ) | ||||||
Amortization
expense
|
(543 | ) | (620 | ) | (474 | ) | ||||||
Operating
loss
|
(1,505 | ) | (14 | ) | (2,949 | ) | ||||||
Other
expense, met
|
(526 | ) | (555 | ) | (586 | ) | ||||||
$ | (2,031 | ) | $ | (569 | ) | $ | (3,535 | ) |
As
of December 31,
|
||||||||||||
Total assets
|
2008
|
2007
|
||||||||||
United
States
|
$ | 2,455 | $ | 2,168 | ||||||||
EMEA
|
1,643 | 1,551 | ||||||||||
Japan
|
357 | 422 | ||||||||||
Inter-Continental
|
266 | 311 | ||||||||||
Total
assets allocated to reportable segments
|
4,721 | 4,452 | ||||||||||
Goodwill
and other intangible assets
|
19,665 | 23,067 | ||||||||||
All
other corporate and manufacturing operations assets
|
2,753 | 3,678 | ||||||||||
$ | 27,139 | $ | 31,197 |
Enterprise-Wide
Information
Net
sales
|
||||||||||||
Year
Ended December, 31
|
||||||||||||
(in
millions)
|
2008
|
2007
|
2006
|
|||||||||
Cardiovascular
|
$ | 3,468 | $ | 3,613 | $ | 4,133 | ||||||
CRM/
Electrophysiology
|
2,439 | 2,271 | 1,505 | |||||||||
Neurovascular
|
455 | 447 | 413 | |||||||||
Cardiovascular
group
|
6,362 | 6,331 | 6,051 | |||||||||
Endoscopy
|
943 | 866 | 777 | |||||||||
Urology
|
431 | 403 | 371 | |||||||||
Endosurgery
group
|
1,374 | 1,269 | 1,148 | |||||||||
Neuromodulation
|
245 | 204 | 146 | |||||||||
7,981 | 7,804 | 7,345 | ||||||||||
Divested
businesses
|
69 | 553 | 476 | |||||||||
$ | 8,050 | $ | 8,357 | $ | 7,821 | |||||||
United
States
|
$ | 4,487 | $ | 4,522 | $ | 4,415 | ||||||
Japan
|
861 | 797 | 560 | |||||||||
Other
foreign countries
|
2,633 | 2,525 | 2,370 | |||||||||
7,981 | 7,804 | 7,345 | ||||||||||
Divested
businesses
|
69 | 553 | 476 | |||||||||
$ | 8,050 | $ | 8,357 | $ | 7,821 | |||||||
As
of December 31,
|
||||||||||||
Long-lived
assets
|
2008
|
2007
|
||||||||||
United
States
|
$ | 1,159 | $ | 1,342 | ||||||||
Ireland
|
246 | 235 | ||||||||||
Other
foreign countries
|
323 | 138 | ||||||||||
Property,
plant and equipment, net
|
1,728 | 1,715 | ||||||||||
Goodwill
and other intangible assets
|
19,665 | 23,067 | ||||||||||
$ | 21,393 | $ | 24,782 | |||||||||
Note Q
- New Accounting Standards
Standards
Implemented
Interpretation
No. 48
In July
2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in
Income Taxes, to create a single model to address accounting for
uncertainty in tax positions. We adopted Interpretation No. 48 as of the first
quarter of 2007. Interpretation No. 48 requires the use of a two-step approach
for recognizing and measuring tax benefits taken or expected to be taken in a
tax return, as well as enhanced disclosures regarding uncertainties in income
tax positions, including a roll forward of tax benefits taken that do not
qualify for financial statement recognition. Refer to Note K – Income Taxes to our
2008 consolidated financial statements included in Item 8 of this Annual Report
for more information regarding our application of Interpretation No. 48 and its
impact on our consolidated financial statements.
Statement
No. 157
In
September 2006, the FASB issued Statement No. 157, Fair Value Measurements.
Statement No. 157 defines fair value, establishes a framework for measuring fair
value in accordance with U.S. GAAP, and expands disclosures about fair value
measurements. Statement No. 157 does not require any new fair value
measurements; rather, it applies to other accounting pronouncements that require
or permit fair value measurements. We adopted the provisions of Statement No.
157 for financial assets and financial liabilities as of January 1, 2008, and
will apply those provisions to nonfinancial assets and nonfinancial liabilities
as of January 1, 2009. Refer to Note C – Fair Value Measurements
to our consolidated financial statements contained in Item 8 of this
Annual Report for a discussion of our adoption of Statement No. 157 and its
impact on our financial statements.
Statement
No. 158
In
September 2006, the FASB issued Statement No. 158, Employers’ Accounting for Defined
Benefit Pension and Other Postretirement Plans, which amends Statements
Nos. 87, 88, 106 and 132(R). Statement No. 158 requires recognition of the
funded status of a benefit plan in the consolidated statements of financial
position, as well as the recognition of certain gains and losses that arise
during the period, but are deferred under pension accounting rules, in other
comprehensive income (loss). Additionally, Statement No. 158 requires that,
beginning with fiscal years ending after December 15, 2008, a business entity
measure plan assets and benefit obligations as of its fiscal year-end statement
of financial position. We adopted the measurement-date requirement in 2008 and
the other provisions of Statement No. 158 in 2006. Refer to Note A – Significant Accounting
Policies to our 2008 consolidated financial statements included in Item 8
of this Annual Report for more information on our pension and other
postretirement plans.
Statement
No. 159
In
February 2007, the FASB issued Statement No. 159, The Fair Value Option for Financial
Assets and Financial Liabilities, which allows an entity to elect to
record financial assets and financial liabilities at fair value upon their
initial recognition on a contract-by-contract basis. We adopted Statement No.
159 as of January 1, 2008 and did not elect the fair value option for our
eligible financial assets and financial liabilities.
New Standards to be
Implemented
Statement
No. 161
In March
2008, the FASB issued Statement No. 161, Disclosures about Derivative
Instruments and Hedging Activities, which amends Statement No. 133 by
requiring expanded disclosures about an entity’s derivative instruments and
hedging activities. Statement No. 161 requires increased qualitative,
quantitative, and credit-risk disclosures, including (a) how and why an entity
uses derivative instruments, (b) how derivative instruments and related hedged
items are accounted for under Statement No. 133 and its related interpretations,
and (c) how derivative instruments and related hedged items affect an entity’s
financial position, financial performance, and cash flows. We are
required to adopt Statement No. 161 for our first quarter ending March 31,
2009.
Staff
Position No. 157-2
In
February 2008, the FASB released Staff Position No. 157-2, Effective Date of FASB Statement
No. 157, which delays the effective date of Statement No. 157
for all nonfinancial assets and nonfinancial liabilities, except for those that
are recognized or disclosed at fair value in the financial statements on a
recurring basis. We are required to apply the provisions of Statement No. 157 to
nonfinancial assets and nonfinancial liabilities as of January 1, 2009. We do
not believe the adoption of Staff Position No. 157-2 will have a material impact
on our future results of operations or financial position.
Statement
No. 141(R)
In
December 2007, the FASB issued Statement No. 141(R), Business Combinations, a
replacement for Statement No. 141. Statement No. 141(R) retains the fundamental
requirements of Statement No. 141, but requires the recognition of all assets
acquired and liabilities assumed in a business combination at their fair values
as of the acquisition date. It also requires the recognition of assets acquired
and liabilities assumed arising from contractual contingencies at their
acquisition date fair values. Additionally, Statement No. 141(R) supersedes FASB
Interpretation No. 4, Applicability of FASB Statement No.
2 to Business Combinations Accounted for by the Purchase Method, which
required research and development assets acquired in a business combination that
had no alternative future use to be measured at their fair values and expensed
at the acquisition date. Statement No. 141(R) now requires that purchased
research and development be recognized as an intangible asset. We are required
to adopt Statement No. 141(R) prospectively for any acquisitions on or after
January 1, 2009, except for changes in tax assets and liabilities associated
with prior acquisitions.
QUARTERLY
RESULTS OF OPERATIONS
(in
millions, except per share data)
(unaudited)
Three
Months Ended
|
||||||||||||||||
March
31,
|
June
30,
|
Sept
30,
|
Dec
31,
|
|||||||||||||
2008
|
||||||||||||||||
Net
sales
|
$ | 2,046 | $ | 2,024 | $ | 1,978 | $ | 2,002 | ||||||||
Gross
profit
|
1,466 | 1,420 | 1,323 | 1,372 | ||||||||||||
Operating
income (loss)
|
580 | 303 | 28 | (2,416 | ) | |||||||||||
Net
income (loss)
|
322 | 98 | (62 | ) | (2,394 | ) | ||||||||||
Net
income (loss) per common share - basic
|
$ | 0.22 | $ | 0.07 | $ | (0.04 | ) | $ | (1.59 | ) | ||||||
Net
income (loss) per common share - assuming dilution
|
$ | 0.21 | $ | 0.07 | $ | (0.04 | ) | $ | (1.59 | ) | ||||||
2007
|
||||||||||||||||
Net
sales
|
$ | 2,086 | $ | 2,071 | $ | 2,048 | $ | 2,152 | ||||||||
Gross
profit
|
1,518 | 1,508 | 1,473 | 1,517 | ||||||||||||
Operating
income (loss)
|
282 | 280 | (147 | ) | (430 | ) | ||||||||||
Net
income (loss)
|
120 | 115 | (272 | ) | (458 | ) | ||||||||||
Net
income (loss) per common share - basic
|
$ | 0.08 | $ | 0.08 | $ | (0.18 | ) | $ | (0.31 | ) | ||||||
Net
income (loss) per common share - assuming dilution
|
$ | 0.08 | $ | 0.08 | $ | (0.18 | ) | $ | (0.31 | ) | ||||||
Our
reported results for 2008 included goodwill and intangible asset impairment
charges; acquisition-, divestiture-, litigation- and restructuring-related
amounts and discrete tax items (after tax) of: $74 million of net credits in the
first quarter, $98 million of net charges in the second quarter,
$202 million of net charges in the third quarter and $2.570 billion of net
charges in the fourth quarter. These charges consisted of: goodwill and
intangible asset impairment charges, associated primarily with a write-down of
goodwill; a gain related to the receipt of an acquisition-related milestone
payment from Abbott Laboratories; purchased research and development charges,
attributable primarily with the acquisitions of Labcoat, Ltd. and CryoCor, Inc.;
restructuring charges associated with our on-going expense and head count
reduction initiatives; a gain associated with the sale of certain non-strategic
businesses; losses associated with the sale of certain non-strategic
investments; litigation-related charges resulting primarily from a ruling by a
federal judge in a patent infringement case brought against us by Johnson &
Johnson; and discrete tax benefits related to certain tax positions associated
with prior period acquisition-, divestiture-, litigation- and
restructuring-related charges.
During
2007, we recorded intangible asset impairments and acquisition-, divestiture-,
litigation- and restructuring-related charges (after tax) of: $20 million of net
charges in the first quarter, $1 million of net charges in the second
quarter, $435 million of net charges in the third quarter and $654 million
of net charges in the fourth quarter. These charges consisted of: intangible
asset impairments associated with our decision to suspend further significant
funding of the Petal™ bifurcation project acquired with Advanced Stent
Technologies; a charge attributable to estimated losses associated with
litigation; restructuring charges associated with our expense and head count
reduction initiatives; losses associated with the write-down of assets held for
sale attributable to the sale of certain of our businesses; charges for
purchased research and development costs related to certain acquisitions and
strategic alliances; and Guidant integration costs.
Schedule
II
VALUATION
AND QUALIFYING ACCOUNTS (in millions)
Description
|
Balance
Beginning of Year
|
Charges
to Costs and Expenses
|
Deductions
to Allowances for Uncollectible Accounts (a)
|
Charges
to (Deductions from) Other
Accounts
(b)
|
Balance
at End of Year
|
|||||||||||||||
Year
Ended December 31, 2008:
|
||||||||||||||||||||
Allowances
for uncollectible accounts and sales returns and
allowances
|
$ | 137 | $ | 8 | $ | (11 | ) | $ | (3 | ) | $ | 131 | ||||||||
Year
Ended December 31, 2007:
|
||||||||||||||||||||
Allowances
for uncollectible accounts and sales returns and
allowances
|
$ | 135 | 15 | (13 | ) | $ | 137 | |||||||||||||
Year
Ended December 31, 2006:
|
||||||||||||||||||||
Allowances
for uncollectible accounts and sales returns and
allowances
|
$ | 83 | 27 | (7 | ) | 32 | $ | 135 | ||||||||||||
(a)
Uncollectible amounts written off.
|
||||||||||||||||||||
(b)
Represents charges for sales returns and allowances, net of actual sales
returns.
|