NEW
JERSEY
(State or
other jurisdiction of
incorporation
or organization)
|
22-1024240
(I.R.S.
Employer
Identification
No.)
|
Part I - Financial Information |
Page
No.
|
Item 1. Financial Statements (unaudited) | |
Consolidated Balance Sheets - September 28, 2008 and December 30, 2007 |
3
|
Consolidated Statements of Earnings for the Fiscal Third Quarters Ended September 28, 2008 and September 30, 2007 |
5
|
Consolidated Statements of Earnings for the Fiscal Nine Months Ended September 28, 2008 and September 30, 2007 |
6
|
Consolidated Statements of Cash Flows for the Fiscal Nine Months Ended September 28, 2008 and September 30, 2007 |
7
|
Notes to Consolidated Financial Statements |
9
|
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations |
33
|
Item 3. Quantitative and Qualitative Disclosures About Market Risk |
46
|
Item 4. Controls and Procedures |
46
|
Part II - Other Information | |
Item 1 - Legal Proceedings |
47
|
Item 2 – Unregistered Sales of Equity Securities and Use of Proceeds |
47
|
Item 6 - Exhibits |
48
|
Signatures |
49
|
September
28, 2008
|
December
30, 2007
|
|||||||
Current
assets:
|
||||||||
Cash
& cash equivalents
|
$
|
14,018 |
$
|
7,770 | ||||
Marketable
securities
|
781 | 1,545 | ||||||
Accounts
receivable, trade, less allowances for doubtful accounts
$254
(2007,$193)
|
10,156 | 9,444 | ||||||
Inventories
(Note 4)
|
5,473 | 5,110 | ||||||
Deferred
taxes on income
|
2,584 | 2,609 | ||||||
Prepaid
expenses and other receivables
|
3,578 | 3,467 | ||||||
Total
current assets
|
36,590 | 29,945 | ||||||
Marketable
securities, non-current
|
2 | 2 | ||||||
Property,
plant and equipment at cost
|
27,601 | 26,466 | ||||||
Less:
accumulated depreciation
|
(13,246 | ) | (12,281 | ) | ||||
Property,
plant and equipment, net
|
14,355 | 14,185 | ||||||
Intangible
assets, net (Note 5)
|
14,296 | 14,640 | ||||||
Goodwill,
net (Note 5)
|
14,275 | 14,123 | ||||||
Deferred
taxes on income
|
5,191 | 4,889 | ||||||
Other
assets
|
3,015 | 3,170 | ||||||
Total
assets
|
$
|
87,724 |
$
|
80,954 |
September
28, 2008
|
December
30, 2007
|
|||||||
Current
liabilities:
|
||||||||
Loans
and notes payable
|
$
|
6,245 |
$
|
2,463 | ||||
Accounts
payable
|
6,384 | 6,909 | ||||||
Accrued
liabilities
|
5,521 | 6,412 | ||||||
Accrued
rebates, returns and promotions
|
2,609 | 2,318 | ||||||
Accrued
salaries, wages and commissions
|
1,513 | 1,512 | ||||||
Accrued
taxes on income
|
458 | 223 | ||||||
Total
current liabilities
|
22,730 | 19,837 | ||||||
Long-term
debt
|
8,395 | 7,074 | ||||||
Deferred
taxes on income
|
1,384 | 1,493 | ||||||
Employee
related obligations
|
5,533 | 5,402 | ||||||
Other
liabilities
|
3,948 | 3,829 | ||||||
Total
liabilities
|
41,990 | 37,635 | ||||||
Shareholders’
equity:
|
||||||||
Common
stock – par value $1.00 per share (authorized 4,320,000,000 shares; issued
3,119,842,548 shares)
|
3,120 | 3,120 | ||||||
Accumulated
other comprehensive income (Note 8)
|
(930 | ) | (693 | ) | ||||
Retained
earnings
|
61,878 | 55,280 | ||||||
Less:
common stock held in treasury, at cost (339,515,000 and 279,620,000
shares)
|
18,334 | 14,388 | ||||||
Total
shareholders’ equity
|
45,734 | 43,319 | ||||||
Total
liabilities and shareholders’ equity
|
$
|
87,724 |
$
|
80,954 |
Fiscal
Quarters Ended
|
||||||||||||||||
Sept.
28, 2008
|
Percent
to Sales
|
Sept.
30, 2007
|
Percent
to Sales
|
|||||||||||||
Sales
to customers (Note 6)
|
$ | 15,921 | 100.0 | % | $ | 14,970 | 100.0 | % | ||||||||
Cost
of products sold
|
4,774 | 30.0 | 4,274 | 28.5 | ||||||||||||
Gross
profit
|
11,147 | 70.0 | 10,696 | 71.5 | ||||||||||||
Selling,
marketing and
administrative
expenses
|
5,195 | 32.6 | 4,899 | 32.7 | ||||||||||||
Research
expense
|
1,861 | 11.7 | 1,834 | 12.3 | ||||||||||||
Restructuring
(Note 11)
|
- | - | 745 | 5.0 | ||||||||||||
Interest
income
|
(97 | ) | (0.6 | ) | (134 | ) | (0.9 | ) | ||||||||
Interest
expense, net of portion capitalized
|
122 | 0.8 | 82 | 0.6 | ||||||||||||
Other
(income)expense, net
|
(224 | ) | (1.4 | ) | 2 | - | ||||||||||
Earnings
before provision for taxes on income
|
4,290 | 26.9 | 3,268 | 21.8 | ||||||||||||
Provision
for taxes on income (Note 3)
|
980 | 6.1 | 720 | 4.8 | ||||||||||||
NET
EARNINGS
|
$ | 3,310 | 20.8 | % | $ | 2,548 | 17.0 | % | ||||||||
`
NET
EARNINGS PER SHARE (Note 7)
|
||||||||||||||||
Basic
|
$ | 1.19 | $ | 0.88 | ||||||||||||
Diluted
|
$ | 1.17 | $ | 0.88 | ||||||||||||
CASH
DIVIDENDS PER SHARE
|
$ | 0.460 | $ | 0.415 | ||||||||||||
AVG.
SHARES OUTSTANDING
|
||||||||||||||||
Basic
|
2,790.9 | 2,887.7 | ||||||||||||||
Diluted
|
2,831.3 | 2,912.9 | ||||||||||||||
Fiscal
Nine Months Ended
|
||||||||||||||||
Sept.
28, 2008
|
Percent
to Sales
|
Sept.
30, 2007
|
Percent
to Sales
|
|||||||||||||
Sales
to customers (Note 6)
|
$ | 48,565 | 100.0 | % | $ | 45,138 | 100.0 | % | ||||||||
Cost
of products sold
|
14,139 | 29.1 | 13,017 | 28.8 | ||||||||||||
Gross
profit
|
34,426 | 70.9 | 32,121 | 71.2 | ||||||||||||
Selling,
marketing and
administrative
expenses
|
15,825 | 32.6 | 14,730 | 32.6 | ||||||||||||
Research
expense
|
5,469 | 11.3 | 5,352 | 11.9 | ||||||||||||
In-process
research & development (IPR&D)
|
40 | 0.1 | 807 | 1.8 | ||||||||||||
Restructuring
(Note 11)
|
- | - | 745 | 1.7 | ||||||||||||
Interest
income
|
(268 | ) | (0.6 | ) | (324 | ) | (0.7 | ) | ||||||||
Interest
expense, net of portion capitalized
|
325 | 0.7 | 203 | 0.4 | ||||||||||||
Other
(income)expense, net
|
(377 | ) | (0.8 | ) | (343 | ) | (0.8 | ) | ||||||||
Earnings
before provision for taxes on income
|
13,412 | 27.6 | 10,951 | 24.3 | ||||||||||||
Provision
for taxes on income (Note 3)
|
3,177 | 6.5 | 2,749 | 6.1 | ||||||||||||
NET
EARNINGS
|
$ | 10,235 | 21.1 | % | $ | 8,202 | 18.2 | % | ||||||||
NET
EARNINGS PER SHARE (Note 7)
|
||||||||||||||||
Basic
|
$ | 3.64 | $ | 2.84 | ||||||||||||
Diluted
|
$ | 3.60 | $ | 2.81 | ||||||||||||
CASH
DIVIDENDS PER SHARE
|
$ | 1.335 | $ | 1.205 | ||||||||||||
AVG.
SHARES OUTSTANDING
|
||||||||||||||||
Basic
|
2,811.9 | 2,892.0 | ||||||||||||||
Diluted
|
2,847.8 | 2,919.3 |
Fiscal
Nine Months Ended
|
||||||||
Sept.
28, 2008
|
Sept.
30, 2007
|
|||||||
CASH
FLOW FROM OPERATING ACTIVITIES
|
||||||||
Net
earnings
|
$ | 10,235 | $ | 8,202 | ||||
Adjustment
to reconcile net earnings to cash flows from operating
activities:
|
||||||||
Depreciation
and amortization of property and intangibles
|
2,117 | 1,902 | ||||||
Stock
based compensation
|
524 | 537 | ||||||
Purchased
in-process research and development
|
40 | 807 | ||||||
Deferred
tax provision
|
(354 | ) | (900 | ) | ||||
Accounts
receivable allowances
|
62 | 13 | ||||||
Changes
in assets and liabilities, net of effects from
acquisitions:
|
||||||||
Increase
in accounts receivable
|
(790 | ) | (407 | ) | ||||
Increase
in inventories
|
(348 | ) | (309 | ) | ||||
(Decrease)/Increase
in accounts payable and accrued
liabilities
|
(1,103 | ) | 933 | |||||
Increase
in other current and non-current assets
|
(2 | ) | (1,007 | ) | ||||
Increase
in other current and non-current liabilities
|
590 | 1,154 | ||||||
NET
CASH FLOWS FROM OPERATING ACTIVITIES
|
10,971 | 10,925 | ||||||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
||||||||
Additions
to property, plant and equipment
|
(1,938 | ) | (1,704 | ) | ||||
Proceeds
from the disposal of assets
|
56 | 214 | ||||||
Acquisitions,
net of cash acquired
|
(400 | ) | (1,378 | ) | ||||
Purchases
of investments
|
(1,434 | ) | (8,475 | ) | ||||
Sales
of investments
|
2,079 | 6,706 | ||||||
Other
(primarily intangibles)
|
(36 | ) | (101 | ) | ||||
NET
CASH USED BY INVESTING ACTIVITIES
|
(1,673 | ) | (4,738 | ) | ||||
CASH
FLOWS FROM FINANCING ACTIVITIES
|
||||||||
Dividends
to shareholders
|
(3,750 | ) | (3,486 | ) | ||||
Repurchase
of common stock
|
(5,773 | ) | (2,581 | ) | ||||
Proceeds
from short-term debt
|
5,194 | 20,124 | ||||||
Retirement
of short-term debt
|
(1,649 | ) | (21,461 | ) | ||||
Proceeds
from long-term debt
|
1,640 | 2,605 | ||||||
Retirement
of long-term debt
|
(16 | ) | (12 | ) | ||||
Proceeds
from the exercise of stock options/excess
tax benefits
|
1,360 | 961 | ||||||
NET
CASH USED BY FINANCING ACTIVITIES
|
(2,994 | ) | (3,850 | ) |
Effect
of exchange rate changes on cash and cash equivalents
|
(56 | ) | 220 | |||||
Increase/(decrease)
in cash and cash equivalents
|
6,248 | 2,557 | ||||||
Cash
and Cash equivalents, beginning of period
|
7,770 | 4,083 | ||||||
CASH
AND CASH EQUIVALENTS, END OF PERIOD
|
$ | 14,018 | $ | 6,640 | ||||
Acquisitions
|
||||||||
Fair
value of assets acquired
|
$ | 416 | $ | 1,609 | ||||
Fair
value of liabilities assumed
|
(16 | ) | (231 | ) | ||||
Net
cash paid for acquisitions
|
$ | 400 | $ | 1,378 |
September
28, 2008
|
December
30, 2007
|
|||||||
Raw
materials and supplies
|
$
|
943 |
$
|
905 | ||||
Goods
in process
|
1,655 | 1,384 | ||||||
Finished
goods
|
2,875 | 2,821 | ||||||
Total
|
$
|
5,473 |
$
|
5,110 |
(Dollars
in Millions)
|
September
28, 2008
|
December
30, 2007
|
||||||
Trademarks
(non-amortizable)
|
$
|
6,223 |
$
|
6,457 | ||||
Less
accumulated amortization
|
147 | 144 | ||||||
Trademarks
(non-amortizable)- net
|
6,076 | 6,313 | ||||||
Patents
and trademarks
|
4,746 | 4,597 | ||||||
Less
accumulated amortization
|
1,758 | 1,615 | ||||||
Patents
and trademarks – net
|
2,988 | 2,982 | ||||||
Other
amortizable intangibles
|
7,594 | 7,399 | ||||||
Less
accumulated amortization
|
2,362 | 2,054 | ||||||
Other
intangibles – net
|
5,232 | 5,345 | ||||||
Total
intangible assets - gross
|
18,563 | 18,453 | ||||||
Less
accumulated amortization
|
4,267 | 3,813 | ||||||
Total
intangible assets - net
|
14,296 | 14,640 | ||||||
Goodwill
– gross
|
15,014 | 14,866 | ||||||
Less
accumulated amortization
|
739 | 743 | ||||||
Goodwill
– net
|
$
|
14,275 |
$
|
14,123 |
(Dollars
in Millions)
|
Consumer
|
Pharm
|
Med
Dev & Diag
|
Total
|
||||||||||||
Goodwill,
net of accumulated amortization at December 30, 2007
|
$ | 8,125 | $ | 964 | $ | 5,034 | $ | 14,123 | ||||||||
Acquisitions
|
190 | - | 6 | 196 | ||||||||||||
Translation
& Other
|
(61 | ) | 11 | 6 | (44 | ) | ||||||||||
Goodwill,
net as of September
28, 2008
|
$ | 8,254 | $ | 975 | $ | 5,046 | $ | 14,275 |
Fiscal
Quarters Ended
|
||||||||||||
(Dollars
in Millions)
|
Sept.
28, 2008
|
Sept.
30, 2007
|
Percent
Change
|
|||||||||
Consumer
|
||||||||||||
U.S.
|
$ | 1,769 | $ | 1,591 | 11.2 | % | ||||||
International
|
2,330 | 2,032 | 14.7 | |||||||||
Total
|
4,099 | 3,623 | 13.1 | |||||||||
Pharmaceutical
|
||||||||||||
U.S.
|
3,538 | 3,765 | (6.0 | ) | ||||||||
International
|
2,575 | 2,334 | 10.3 | |||||||||
Total
|
6,113 | 6,099 | 0.2 | |||||||||
Medical
Devices & Diagnostics
|
||||||||||||
U.S.
|
2,648 | 2,569 | 3.1 | |||||||||
International
|
3,061 | 2,679 | 14.3 | |||||||||
Total
|
5,709 | 5,248 | 8.8 | |||||||||
Worldwide
|
||||||||||||
U.S.
|
7,955 | 7,925 | 0.4 | |||||||||
International
|
7,966 | 7,045 | 13.1 | |||||||||
Total
|
$ | 15,921 | $ | 14,970 | 6.4 | % |
Fiscal
Nine Months Ended
|
||||||||||||
(Dollars
in Millions)
|
Sept.
28, 2008
|
Sept.
30, 2007
|
Percent
Change
|
|||||||||
Consumer
|
||||||||||||
U.S.
|
$ | 5,282 | $ | 4,782 | 10.5 | % | ||||||
International
|
6,917 | 5,901 | 17.2 | |||||||||
Total
|
12,199 | 10,683 | 14.2 | |||||||||
Pharmaceutical
|
||||||||||||
U.S.
|
11,401 | 11,659 | (2.2 | ) | ||||||||
International
|
7,481 | 6,810 | 9.9 | |||||||||
Total
|
18,882 | 18,469 | 2.2 | |||||||||
Medical
Devices & Diagnostics
|
||||||||||||
U.S.
|
7,959 | 7,772 | 2.4 | |||||||||
International
|
9,525 | 8,214 | 16.0 | |||||||||
Total
|
17,484 | 15,986 | 9.4 | |||||||||
Worldwide
|
||||||||||||
U.S.
|
24,642 | 24,213 | 1.8 | |||||||||
International
|
23,923 | 20,925 | 14.3 | |||||||||
Total
|
$ | 48,565 | $ | 45,138 | 7.6 | % |
Fiscal
Quarters Ended
|
||||||||||||
(Dollars
in Millions)
|
Sept.
28, 2008
|
Sept.
30, 2007
|
Percent
Change
|
|||||||||
Consumer
(1)
|
$ | 764 | $ | 586 | 30.4 | % | ||||||
Pharmaceutical
(2)
|
2,003 | 1,594 | 25.7 | |||||||||
Medical
Devices & Diagnostics (3)
|
1,657 | 1,140 | 45.4 | |||||||||
Segments
total
|
4,424 | 3,320 | 33.3 | |||||||||
Expense
not allocated to segments (4)
|
(134 | ) | (52 | ) | ||||||||
Worldwide
total
|
$ | 4,290 | $ | 3,268 | 31.3 | % |
Fiscal
Nine Months Ended
|
||||||||||||
(Dollars
in Millions)
|
Sept.
28, 2008
|
Sept.30,
2007
|
Percent
Change
|
|||||||||
Consumer
(1)
|
$ | 2,175 | $ | 1,828 | 19.0 | % | ||||||
Pharmaceutical
(2)
|
6,513 | 6,006 | 8.4 | |||||||||
Medical
Devices & Diagnostics(3)(5)
|
5,159 | 3,378 | 52.7 | |||||||||
Segments
total
|
13,847 | 11,212 | 23.5 | |||||||||
Expense
not allocated to segments (4)
|
(435 | ) | (261 | ) | ||||||||
Worldwide
total
|
$ | 13,412 | $ | 10,951 | 22.5 | % |
Fiscal
Quarters Ended
|
||||||||||||
(Dollars
in Millions)
|
Sept.
28, 2008
|
Sept.
30, 2007
|
Percent
Change
|
|||||||||
U.S.
|
$ | 7,955 | $ | 7,925 | 0.4 | % | ||||||
Europe
|
4,076 | 3,765 | 8.3 | |||||||||
Western
Hemisphere, excluding U.S.
|
1,461 | 1,195 | 22.3 | |||||||||
Asia-Pacific,
Africa
|
2,429 | 2,085 | 16.5 | |||||||||
Total
|
$ | 15,921 | $ | 14,970 | 6.4 | % |
Fiscal
Nine Months Ended
|
||||||||||||
(Dollars
in Millions)
|
Sept.
28, 2008
|
Sept.
30, 2007
|
Percent
Change
|
|||||||||
U.S.
|
$ | 24,642 | $ | 24,213 | 1.8 | % | ||||||
Europe
|
12,931 | 11,485 | 12.6 | |||||||||
Western
Hemisphere, excluding U.S.
|
3,986 | 3,372 | 18.2 | |||||||||
Asia-Pacific,
Africa
|
7,006 | 6,068 | 15.5 | |||||||||
Total
|
$ | 48,565 | $ | 45,138 | 7.6 | % |
(Shares
in Millions)
|
Fiscal
Quarters Ended
|
|||||||
Sept.
28, 2008
|
Sept.
30, 2007
|
|||||||
Basic
net earnings per share
|
$ | 1.19 | $ | 0.88 | ||||
Average
shares outstanding – basic
|
2,790.9 | 2,887.7 | ||||||
Potential
shares exercisable under stock option plans
|
242.0 | 192.0 | ||||||
Less:
shares which could be repurchased under treasury stock
method
|
(205.3 | ) | (170.6 | ) | ||||
Convertible
debt shares
|
3.7 | 3.8 | ||||||
Average
shares outstanding – diluted
|
2,831.3 | 2,912.9 | ||||||
Diluted
earnings per share
|
$ | 1.17 | $ | 0.88 |
(Shares
in Millions)
|
Fiscal
Nine Months Ended
|
|||||||
Sept.
28, 2008
|
Sept.
30, 2007
|
|||||||
Basic
net earnings per share
|
$ | 3.64 | $ | 2.84 | ||||
Average
shares outstanding – basic
|
2,811.9 | 2,892.0 | ||||||
Potential
shares exercisable under stock option plans
|
241.5 | 192.3 | ||||||
Less:
shares which could be repurchased under treasury stock
method
|
(209.3 | ) | (168.8 | ) | ||||
Convertible
debt shares
|
3.7 | 3.8 | ||||||
Average
shares outstanding – diluted
|
2,847.8 | 2,919.3 | ||||||
Diluted
earnings per share
|
$ | 3.60 | $ | 2.81 |
(Dollars
in Millions)
|
For. Cur.
Trans.
|
Unrld
Gains/
(Losses)
on Sec
|
Employee
Benefit Plans
|
Gains/(Losses)
on Deriv & Hedges
|
Total
Accum Other Comp Inc/(Loss)
|
|
||||||||||||
December
30, 2007
|
$ | 628 | 84 | (1,360 | ) |
(45
|
) | (693 | ) | |||||||||
2008 nine
months changes
|
||||||||||||||||||
Net
change associated
with
current period
hedging
transactions
|
4
|
|||||||||||||||||
Net
amount reclassed to
net
earnings
|
105
|
* | ||||||||||||||||
Net nine
months changes
|
(406 | ) | (47 | ) | 107 |
109
|
(237 | ) | ||||||||||
September 28,
2008
|
$ | 222 | 37 | (1,253 | ) |
64
|
(930 | ) |
Retirement
Plans
|
Other
Benefit Plans
|
|||||||||||||||
Fiscal
Quarters Ended
|
||||||||||||||||
(Dollars
in Millions)
|
Sept.
28, 2008
|
Sept.
30, 2007
|
Sept.
28, 2008
|
Sept.
30, 2007
|
||||||||||||
Service
cost
|
$ | 126 | 148 | 35 | 34 | |||||||||||
Interest
cost
|
177 | 169 | 43 | 37 | ||||||||||||
Expected
return on plan
assets
|
(220 | ) | (208 | ) | (1 | ) | (1 | ) | ||||||||
Amortization
of prior service cost
|
2 | 2 | (1 | ) | (1 | ) | ||||||||||
Amortization
of net transition asset
|
- | 1 | - | - | ||||||||||||
Recognized
actuarial losses
|
16 | 47 | 15 | 17 | ||||||||||||
Curtailments
and settlements
|
- | (2 | ) | - | - | |||||||||||
Net
periodic benefit cost
|
$ | 101 | 157 | 91 | 86 |
Retirement
Plans
|
Other
Benefit Plans
|
|||||||||||||||
Fiscal
Nine Months Ended
|
||||||||||||||||
(Dollars
in Millions)
|
Sept.
28, 2008
|
Sept.
30, 2007
|
Sept.
28, 2008
|
Sept.
30, 2007
|
||||||||||||
Service
cost
|
$ | 381 | 417 | 106 | 104 | |||||||||||
Interest
cost
|
534 | 489 | 126 | 111 | ||||||||||||
Expected
return on plan
assets
|
(666 | ) | (603 | ) | (2 | ) | (2 | ) | ||||||||
Amortization
of prior service cost
|
8 | 7 | (4 | ) | (4 | ) | ||||||||||
Amortization
of net transition asset
|
1 | 1 | - | - | ||||||||||||
Recognized
actuarial losses
|
47 | 142 | 48 | 50 | ||||||||||||
Curtailments
and settlements
|
4 | (2 | ) | - | - | |||||||||||
Net
periodic benefit cost
|
$ | 309 | 451 | 274 | 259 |
(Dollars in
Millions)
Reserve balance as of:
December 30, 2007
Cash outlays*
September 28, 2008
|
Severance
$404
(195)
$209
|
J&J
Product
|
Company
|
Patents
|
Plaintiff/Patent
Holder
|
Court
|
Trial
Date
|
Date
Filed
|
||||||
Two-layer
Catheters
|
Cordis
|
Kasten-hofer
|
Boston
Scientific Corp.
|
Multiple
European
|
* | 09/07 | ||||||
Contact
Lenses
|
Vision
Care
|
Nicolson
|
CIBA Vision
|
M.D.FL
Multiple
European
|
03/09
*
|
09/03 | ||||||
CYPHER®
Stent
|
Cordis
|
Wall
|
Wall
|
E.D.
TX
|
* | 11/07 | ||||||
CYPHER®
Stent
|
Cordis
|
Bonutti
|
MarcTec
|
S.D.
IL
|
* | 11/07 | ||||||
CYPHER®
Stent
|
Cordis
|
Saffran
|
Saffran
|
E.D.
TX
|
* | 10/07 | ||||||
Stent/Catheter
Delivery
Systems
|
Cordis/
Ethicon
|
Schock
|
Cardio
Access LLC
|
E.D.
TX
|
* | 06/08 | ||||||
LISTERINE®
Tooth Whitening Strips
|
McNeil-PPC
|
Sagel
|
Procter
& Gamble
|
W.D.
WI
|
* | 05/08 | ||||||
Blood
Glucose Meters and Strips
|
Lifescan
|
Wilsey
|
Roche
Diagnostics
|
D.
DE
|
* | 11/07 |
Brand
Name Product
|
Patent/NDA
Holder
|
Generic
Challenger
|
Court
|
Trial
Date
|
Date
Filed
|
30-Month
Stay Expiration
|
|||||||||
CONCERTA®
|
McNeil-PPC
|
Andrx
|
D.
DE
|
12/07 | 09/05 |
None
|
|||||||||
18,27,36
and 54 mg controlled release tablet
|
ALZA
|
||||||||||||||
LEVAQUIN® 250,
500, 750 mg tablets
|
Ortho-McNeil
|
Lupin
|
D.
NJ
|
* | 10/06 | 03/09 | |||||||||
ORTHO
TRI CYCLEN® LO
|
Ortho-McNeil
|
Barr
|
D.
NJ
|
* | 10/03 | 02/06 | |||||||||
0.18
mg/0.025 mg
0.215
mg/0.025 mg and
0.25
mg/0.025 mg
|
Watson
|
D.
NJ
|
* | 10/08 | 03/11 | ||||||||||
RAZADYNE(TM)
|
Janssen
|
Teva
|
D.
DE
|
05/07 | 07/05 | 08/08 | |||||||||
Mylan
|
D.
DE
|
05/07 | 07/05 | 08/08 | |||||||||||
Dr. Reddy's
|
D.
DE
|
05/07 | 07/05 | 08/08 | |||||||||||
Purepac
|
D.
DE
|
05/07 | 07/05 | 08/08 | |||||||||||
Barr
|
D.
DE
|
05/07 | 07/05 | 08/08 | |||||||||||
AlphaPharm
|
D.
DE
|
05/07 | 07/05 | 08/08 | |||||||||||
Sandoz
|
D.
DE
|
* | 08/08 |
None
|
|||||||||||
RAZADYNE™ ER
|
Janssen
|
Barr
|
D.
NJ
|
* | 06/06 |
None
|
|||||||||
Sandoz
|
D.
NJ
|
* | 05/07 |
None
|
|||||||||||
KV
Pharma
|
D.
NJ
|
* | 12/07 | 05/10 | |||||||||||
ULTRACET
|
Ortho-McNeil
|
Apotex
|
N.D.
IL
|
* | 07/07 | 12/09 | |||||||||
ULTRAM
ER®
100,
200, 300 mg tablet
|
Ortho-McNeil
|
Par
|
D.
DE
|
01/09 | 05/07 | 09/09 | |||||||||
ULTRAM
ER®
100
mg tablet
|
Ortho-McNeil-Janssen
|
Impax
|
D.
DE
|
* | 08/08 | 01/11 |
(Dollars
in Millions)
|
Quoted
prices in active markets for identical assets
|
Significant
other observable inputs
|
Significant
unobservable inputs
|
|||||||
September
28, 2008
|
Level
1
|
Level
2
|
Level
3
|
|||||||
Assets
|
||||||||||
Derivative
instruments
|
$ | 1,044 | $ | 1,044 | ||||||
Liabilities
|
||||||||||
Derivative
instruments
|
$ | 1,600 | $ | 1,600 |
(Dollars
in Millions)
|
Sept.
28, 2008
|
Sept.
30, 2007
|
Total
Change
|
Operations
Change
|
Currency
Change
|
|||||||||||||||
OTC
Pharm & Nutr
|
$ | 4,438 | $ | 3,727 | 19.1 | % | 14.2 | % | 4.9 | % | ||||||||||
Skin
Care
|
2,537 | 2,258 | 12.4 | 6.9 | 5.5 | |||||||||||||||
Baby
Care
|
1,691 | 1,445 | 17.0 | 9.8 | 7.2 | |||||||||||||||
Women’s
Health
|
1,475 | 1,345 | 9.7 | 2.9 | 6.8 | |||||||||||||||
Oral
Care
|
1,228 | 1,109 | 10.7 | 6.4 | 4.3 | |||||||||||||||
Wound
Care/Other
|
830 | 799 | 3.9 | (0.3 | ) | 4.2 | ||||||||||||||
Total
|
$ | 12,199 | $ | 10,683 | 14.2 | % | 8.7 | % | 5.5 | % |
(Dollars
in Millions)
|
Sept.
28, 2008
|
Sept.
30, 2007
|
Total
Change
|
Operations
Change
|
Currency
Change
|
|||||||||||||||
OTC
Pharm & Nutr
|
$ | 1,439 | $ | 1,264 | 13.8 | % | 11.3 | % | 2.5 | % | ||||||||||
Skin
Care
|
858 | 737 | 16.4 | 12.0 | 4.4 | |||||||||||||||
Baby
Care
|
586 | 511 | 14.7 | 9.4 | 5.3 | |||||||||||||||
Women’s
Health
|
510 | 461 | 10.6 | 5.5 | 5.1 | |||||||||||||||
Oral
Care
|
434 | 396 | 9.6 | 6.7 | 2.9 | |||||||||||||||
Wound
Care/Other
|
272 | 254 | 7.1 | 4.2 | 2.9 | |||||||||||||||
Total
|
$ | 4,099 | $ | 3,623 | 13.1 | % | 9.4 | % | 3.7 | % |
(Dollars
in Millions)
|
Sept.
28, 2008
|
Sept.
30, 2007
|
Total
Change
|
Operations
Change
|
Currency
Change
|
|||||||||||||||
REMICADE®
|
$ | 2,862 | $ | 2,419 | 18.3 | % | 18.3 | % | - | % | ||||||||||
TOPAMAX®
|
2,051 | 1,801 | 13.9 | 12.1 | 1.8 | |||||||||||||||
PROCRIT®/EPREX®
|
1,900 | 2,257 | (15.8 | ) | (19.8 | ) | 4.0 | |||||||||||||
RISPERDAL®/Risperidone
|
1,841 | 2,546 | (27.7 | ) | (30.0 | ) | 2.3 | |||||||||||||
LEVAQUIN®/FLOXIN®
|
1,180 | 1,214 | (2.8 | ) | (3.0 | ) | 0.2 | |||||||||||||
RISPERDAL® CONSTA®
|
990 | 833 | 18.8 | 11.2 | 7.6 | |||||||||||||||
CONCERTA®
|
967 | 739 | 30.9 | 27.3 | 3.6 | |||||||||||||||
ACIPHEX®/PARIET®
|
884 | 1,010 | (12.5 | ) | (16.9 | ) | 4.4 | |||||||||||||
DURAGESIC®/Fentanyl Transdermal
|
764 | 900 | (15.1 | ) | (21.0 | ) | 5.9 | |||||||||||||
Other
|
5,443 | 4,750 | 14.6 | 8.2 | 6.4 | |||||||||||||||
Total
|
$ | 18,882 | $ | 18,469 | 2.2 | % | (1.5 | )% | 3.7 | % |
(Dollars
in Millions)
|
Sept.
28, 2008
|
Sept.
30, 2007
|
Total
Change
|
Operations
Change
|
Currency
Change
|
|||||||||||||||
REMICADE®
|
$ | 978 | $ | 819 | 19.4 | % | 19.4 | % | - | % | ||||||||||
TOPAMAX®
|
728 | 613 | 18.8 | 17.6 | 1.2 | |||||||||||||||
PROCRIT®/EPREX®
|
619 | 682 | (9.2 | ) | (11.9 | ) | 2.7 | |||||||||||||
CONCERTA®
|
398 | 231 | 72.3 | 66.4 | 5.9 | |||||||||||||||
RISPERDAL®
CONSTA®
|
338 | 294 | 15.0 | 9.8 | 5.2 | |||||||||||||||
LEVAQUIN®/FLOXIN®
|
333 | 371 | (10.2 | ) | (10.4 | ) | 0.2 | |||||||||||||
RISPERDAL®/Risperidone
|
320 | 831 | (61.5 | ) | (63.0 | ) | 1.5 | |||||||||||||
ACIPHEX®/PARIET®
|
282 | 338 | (16.6 | ) | (19.0 | ) | 2.4 | |||||||||||||
DURAGESIC®/Fentanyl
Transdermal
|
259 | 309 | (16.2 | ) | (20.7 | ) | 4.5 | |||||||||||||
Other
|
1,858 | 1,611 | 15.3 | 10.7 | 4.6 | |||||||||||||||
Total
|
$ | 6,113 | $ | 6,099 | 0.2 | % | (2.5 | )% | 2.7 | % |
(Dollars
in Millions)
|
Sept.
28, 2008
|
Sept.
30, 2007
|
Total
Change
|
Operations
Change
|
Currency
Change
|
|||||||||||||||
DEPUY®
|
$ | 3,737 | $ | 3,378 | 10.6 | % | 6.7 | % | 3.9 | % | ||||||||||
ETHICON
ENDO-SURGERY®
|
3,169 | 2,770 | 14.4 | 8.7 | 5.7 | |||||||||||||||
ETHICON®
|
2,922 | 2,659 | 9.9 | 4.1 | 5.8 | |||||||||||||||
CORDIS®
|
2,413 | 2,557 | (5.6 | ) | (10.7 | ) | 5.1 | |||||||||||||
Diabetes
Care
|
1,956 | 1,730 | 13.1 | 7.6 | 5.5 | |||||||||||||||
Vision
Care
|
1,898 | 1,643 | 15.5 | 9.6 | 5.9 | |||||||||||||||
ORTHO-CLINICAL
DIAGNOSTICS®
|
1,389 | 1,249 | 11.2 | 6.6 | 4.6 | |||||||||||||||
Total
|
$ | 17,484 | $ | 15,986 | 9.4 | % | 4.3 | % | 5.1 | % |
(Dollars
in Millions)
|
Sept.
28, 2008
|
Sept.
30, 2007
|
Total
Change
|
Operations
Change
|
Currency
Change
|
|||||||||||||||
DEPUY®
|
$ | 1,195 | $ | 1,086 | 10.0 | % | 8.0 | % | 2.0 | % | ||||||||||
ETHICON
ENDO-SURGERY®
|