UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(X) Quarterly
Report Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934 for the quarterly period ended September
28, 2008
or
( )
Transition Report Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934 for the transition period
from to
Commission
file number 1-3215
(Exact
name of registrant as specified in its charter)
NEW
JERSEY
(State or
other jurisdiction of
incorporation
or organization)
|
22-1024240
|
One
Johnson & Johnson Plaza
New
Brunswick, New Jersey 08933
(Address
of principal executive offices)
Registrant's
telephone number, including area code (732) 524-0400
Indicate
by check mark whether the registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing
requirements for the past 90
days. (X)
Yes ( )No
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
definitions of “large accelerated filer”, “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. Large accelerated filer
(X)Accelerated filer ( ) Non-accelerated filer ( ) Smaller
reporting company ( )
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).( ) Yes(X) No
Indicate
the number of shares outstanding of each of the issuer's classes of common
stock, as of the latest practicable date.
On
October 26, 2008 2,774,568,107 shares of Common Stock, $1.00 par
value, were outstanding.
JOHNSON
& JOHNSON AND SUBSIDIARIES
TABLE
OF CONTENTS
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
|
Part I -
FINANCIAL INFORMATION
Item 1 –
FINANCIAL STATEMENTS
JOHNSON
& JOHNSON AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(Unaudited;
Dollars in Millions)
ASSETS
|
|
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 |
|
See Notes
to Consolidated Financial Statements
JOHNSON
& JOHNSON AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(Unaudited;
Dollars in Millions)
LIABILITIES
AND SHAREHOLDERS' EQUITY
|
|
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 |
|
See Notes
to Consolidated Financial Statements
JOHNSON
& JOHNSON AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF EARNINGS
(Unaudited;
dollars & shares in millions
except
per share amounts)
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See Notes
to Consolidated Financial Statements
JOHNSON
& JOHNSON AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF EARNINGS
(Unaudited;
dollars & shares in millions
except
per share amounts)
|
|
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 |
|
|
|
|
|
See
Notes to Consolidated Financial Statements
JOHNSON
& JOHNSON AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(Unaudited;
Dollars in Millions)
|
|
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 |
|
See Notes
to Consolidated Financial Statements
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 -
The accompanying unaudited interim consolidated financial statements and related
notes should be read in conjunction with the audited Consolidated Financial
Statements of Johnson & Johnson and its Subsidiaries (the "Company") and
related notes as contained in the Company’s Annual Report on Form 10-K for the
fiscal year ended December 30, 2007. The unaudited interim financial statements
include all adjustments (consisting only of normal recurring adjustments) and
accruals necessary in the judgment of management for a fair statement of the
results for the periods presented.
During
the fiscal first quarter of 2008, the Company adopted Statement of Financial
Accounting Standards (SFAS) No. 157, Fair
Value Measurements. This statement defines fair value, establishes a
framework for measuring fair value in generally accepted accounting principles,
and expands disclosures about fair value measurements. This statement was
adopted in the fiscal first quarter of 2008 except for non-financial assets and
liabilities recognized or disclosed at fair value on a non-recurring basis, for
which the effective date is fiscal years beginning after November 15, 2008. See
Note 13 for more details.
During
the fiscal first quarter of 2008, the Company adopted SFAS No. 159, Fair
Value Option for Financial Assets and Financial Liabilities, which
permits an entity to measure financial assets and financial liabilities at fair
value. See Note 13 for more details.
During
the fiscal first quarter of 2008, the Company adopted EITF Issue 07-03 Accounting
for Nonrefundable Advance Payments for Goods or Services Received for Use in
Future Research and Development Activities. This issue requires
nonrefundable advance payments for research and development to be capitalized
and recognized as an expense as related goods are delivered or services are
performed. The adoption of EITF Issue 07-03 did not have a significant impact on
the Company’s results of operation, cash flows or financial
position.
NOTE 2 -
FINANCIAL INSTRUMENTS
The
Company follows the provisions of Statement of Financial Accounting Standards
(SFAS) 133, SFAS 138 and SFAS 149 requiring that all derivative instruments be
recorded on the balance sheet at fair value.
As of
September 28, 2008, the balance of deferred net gains on derivatives included in
accumulated other comprehensive income was $64 million after-tax. For additional
information, see Note 8. The Company expects that substantially all of this
amount will be reclassified into earnings over the next 12 months as a result of
transactions that are expected to occur over that period. The amount ultimately
realized in earnings will differ as foreign exchange rates change. Realized
gains and losses are ultimately determined by actual exchange rates at maturity
of the derivative. Transactions with third parties will cause the amount in
accumulated other comprehensive income to affect net earnings. The length of
time over which the Company is hedging typically does not exceed 18
months. The Company also uses currency swaps to manage currency risk
primarily related to borrowings, which may exceed 18 months.
For the
fiscal third quarters ended September 28, 2008 and September 30, 2007, the net
impact of the hedges' ineffectiveness, transactions not qualifying for hedge
accounting and discontinuance of hedges, to the Company's financial statements
was insignificant. Refer to Note 8 for disclosures of movements in Accumulated
Other Comprehensive Income.
NOTE 3 -
INCOME TAXES
The
worldwide effective income tax rates for the first fiscal nine months of 2008
and 2007 were 23.7% and 25.1%, respectively. The decrease in the effective tax
rate was primarily due to the lower in-process research and development
(IPR&D) charge of $40 million with no tax benefit recorded in the first
fiscal nine months of 2008 versus the IPR&D charge of $807 million with no
tax benefit recorded in the first fiscal nine months of 2007. This benefit
is reduced by higher taxes in 2008 due to the expiration of the Research
and Development (R&D) credit at the end of 2007. The R&D credit
was extended as part of the Emergency Economic Stabilization Act of 2008,
signed in October of 2008 but is not included in the results of the first
fiscal nine months of 2008.
NOTE 4 -
INVENTORIES
(Dollars
in Millions)
|
|
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 |
|
NOTE 5 -
INTANGIBLE ASSETS AND GOODWILL
Intangible
assets that have finite useful lives are amortized over their estimated useful
lives. Goodwill and indefinite lived intangible assets are assessed annually for
impairment. The latest impairment assessment of goodwill and indefinite lived
intangible assets was completed in the fiscal fourth quarter of 2007. Future
impairment tests will be performed annually in the fiscal fourth quarter, or
sooner if warranted.
(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 |
|
Goodwill
as of September 28, 2008 as allocated by segment of business is as
follows:
(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 |
|
The
weighted average amortization periods for patents and trademarks and other
intangible assets are 16 years and 28 years, respectively. The
amortization expense of amortizable intangible assets for the fiscal nine months
ended September 28, 2008 was $593 million and the estimated amortization expense
for the five succeeding years approximates $750 million, per year.
NOTE 6 -
SEGMENTS OF BUSINESS AND GEOGRAPHIC AREAS
(Dollars
in Millions)
SALES BY
SEGMENT OF BUSINESS (1)
|
|
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 |
% |
(1)
Export sales are not significant.
OPERATING
PROFIT BY SEGMENT OF BUSINESS
|
|
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 |
% |
(1)
Includes restructuring charges of $15 million recorded in the fiscal third
quarter and the first fiscal nine months of 2007.
(2)
Includes restructuring charges of $429 million recorded in the fiscal third
quarter and the first fiscal nine months of 2007.
(3) Includes restructuring
charges of $301 million recorded in the fiscal
third quarter and the first fiscal nine months of
2007.
(4)
Amounts not allocated to segments include interest income/(expense), minority
interest and general corporate income/(expense).
(5)
Includes $40 million and $807 million of IPR&D charges related to
acquisitions completed in the first fiscal nine months of 2008 and first fiscal
nine months of 2007, respectively.
SALES BY
GEOGRAPHIC AREA
(Dollars
in Millions)
|
|
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 |
% |
NOTE 7 -
EARNINGS PER SHARE
The
following is a reconciliation of basic net earnings per share to diluted net
earnings per share for the fiscal third quarters ended September 28, 2008 and
September 30, 2007.
(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 |
|
The
diluted earnings per share calculation included the dilutive effect of
convertible debt that was offset by the related reduction in interest expense of
$1 million for both the fiscal third quarters ended September 28, 2008 and
September 30, 2007.
The
diluted earnings per share calculation for the fiscal third quarter ended
September 30, 2007, excluded 66 million shares related to stock options as the
exercise price of these options was greater than their average market value,
which would result in an anti-dilutive effect on diluted earnings per share. For
the fiscal third quarter ended September 28, 2008 the number of shares related
to stock options for which the exercise price of these options was greater than
their average market value was insignificant.
The
following is a reconciliation of basic net earnings per share to
diluted net earnings per share for the fiscal nine months ended September 28,
2008 and September 30, 2007.
(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 |
|
The
diluted earnings per share calculation included the dilutive effect of
convertible debt that was offset by the related reduction in interest expense of
$3 million for both the fiscal nine months ended September 28, 2008 and
September 30, 2007.
The
diluted earnings per share calculation for the first fiscal nine months ended
September 28, 2008 and September 30, 2007, excluded 1 million and 65 million
shares, respectively, related to stock options as the exercise price of these
options was greater than their average market value, which would result in an
anti-dilutive effect on diluted earnings per share.
NOTE 8 -
ACCUMULATED OTHER COMPREHENSIVE INCOME
Total
comprehensive income for the first fiscal nine months ended September 28, 2008
was $10.0 billion, compared with $8.8 billion for the same period a year ago.
Total comprehensive income for the fiscal third quarter ended September 28, 2008
was $1.8 billion, compared with $2.9 billion for the same period a year ago.
Total comprehensive income included net earnings, net unrealized currency gains
and losses on translation, adjustments related to Employee Benefit Plans,
net unrealized gains and losses on securities available for sale and net gains
and losses on derivative instruments qualifying and designated as cash flow
hedges. The following table sets forth the components of accumulated other
comprehensive income.
(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 |
) |
Amounts
in accumulated other comprehensive income are presented net of the related tax
impact. Foreign currency translation adjustments are not currently
adjusted for income taxes, as they relate to permanent investments in
international subsidiaries.
*Substantially
offset in net earnings by changes in value of the underlying
transactions.
NOTE 9 –
MERGERS, ACQUISITIONS AND DIVESTITURES
During
the fiscal third quarter of 2008 the Company acquired Beijing Dabao Cosmetics
Co., Ltd., a company that sells personal care brands in China.
During
the fiscal third quarter of 2008 the Company entered into a definitive agreement
to sell Ethicon’s Professional Wound Care business. The divestiture is expected
to close in the fiscal fourth quarter of 2008.
During
the fiscal second quarter of 2008 the Company acquired Amic AB, a Swedish
developer of in vitro diagnostic technologies for use in point-of-care and
near-patient settings (outside the physical facilities of the clinical
laboratory). An in-process research & development (IPR&D) charge of $40
million before and after tax was recorded related to the acquisition of Amic
AB.
During
the fiscal first quarter of 2007, the Company acquired Conor Medsystems, Inc.
for a purchase price of $1.4 billion in cash. Conor Medsystems, Inc., is a
cardiovascular device company, with new drug delivery technology. An
IPR&D charge of $807 million before and after tax was recorded related to
the acquisition of Conor
Medsystems, Inc.
During
the fiscal first quarter of 2007, the Company completed the divestiture of the
KAOPECTATE®,
UNISOM®,
CORTIZONE®,
BALMEX® and
ACT® consumer
products to Chattem, Inc. for $410 million in cash.
NOTE 10 –
PENSIONS AND OTHER POSTRETIREMENT BENEFITS
Components
of Net Periodic Benefit Cost
Net
periodic benefit cost for the Company’s defined benefit retirement plans and
other benefit plans for the fiscal third quarters of 2008 and 2007 include the
following components:
|
|
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 |
|
Net
periodic benefit cost for the Company’s defined benefit retirement plans and
other benefit plans for the first fiscal nine months of 2008 and 2007 include
the following components:
|
|
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 |
|
Company
Contributions
For the
fiscal nine months ended September 28, 2008, the Company contributed $21 million
and $17 million to its U.S. and international retirement plans, respectively.
The Company is not required to fund the U.S. retirement plans due to minimum
statutory funding requirements for its U.S. retirement plans in 2008. Additional
contributions may be made when deemed appropriate. International plans are
funded in accordance with local regulations.
NOTE 11 –
RESTRUCTURING
In the
third quarter of 2007, the Company announced restructuring initiatives in an
effort to improve its overall cost structure. This action was taken to offset
the anticipated negative impacts associated with generic competition in the
Pharmaceutical segment and challenges in the drug-eluting stent market. The
Company's Pharmaceuticals segment is reducing its cost base by consolidating
certain operations, while continuing to invest in recently launched products and
its late-stage pipeline of new products. The Cordis franchise is moving to a
more integrated business model to address the market changes underway with
drug-eluting stents and to better serve the broad spectrum of its patients'
cardiovascular needs, while reducing its cost base. Additionally, as part of
this initiative the Company plans to eliminate approximately 4,400 positions of
which 3,300 have been eliminated since this restructuring initiative was
announced. The Company is also accelerating steps to standardize and streamline
certain aspects of its enterprise-wide functions such as human resources,
finance and information technology to support growth across the business, while
also leveraging its scale more effectively in areas such as procurement to
benefit its operating companies.
During
the fiscal third quarter of 2007, the Company recorded $745 million in pre-tax
charges of which, approximately, $500 million of the pre-tax restructuring
charges are expected to require cash payments. The $745 million of restructuring
charges consists of severance costs of $450 million, asset write-offs of
$272 million and $23 million related to leasehold obligations. The $272 million
of asset write-offs relate to property, plant and equipment of $166 million,
intangible assets of $48 million and other assets of $58 million.
The
following table summarizes the severance reserve and the associated spending
under this initiative through the third quarter of 2008:
(Dollars in
Millions)
Reserve balance as of:
December 30, 2007
Cash outlays*
September 28, 2008
|
Severance
$404
(195)
$209
|
*Cash
outlays for severance are expected to be substantially paid out over the next
9-12 months in accordance with the Company’s plans and local laws.
NOTE 12 -
LEGAL PROCEEDINGS
PRODUCT
LIABILITY
The
Company is involved in numerous product liability cases in the United States,
many of which concern adverse reactions to drugs and medical devices. The
damages claimed are substantial, and while the Company is confident of the
adequacy of the warnings and instructions for use that accompany such products,
it is not feasible to predict the ultimate outcome of litigation. However, the
Company believes that if any product liability results from such cases, it will
be substantially covered by existing amounts accrued in the Company’s balance
sheet and, where available, by third-party product liability
insurance.
Multiple
products of Johnson & Johnson subsidiaries are subject to numerous product
liability claims and lawsuits, including ORTHO EVRA®, RISPERDAL®, DURAGESIC® and
the CHARITÉ™ Artificial Disc. There are approximately 1,200 claimants who have
pending lawsuits or claims regarding injuries allegedly due to ORTHO EVRA®, 535
with respect to RISPERDAL®, 288 with respect to CHARITÉ™ and 100 with respect to
DURAGESIC®. These claimants seek substantial compensatory and, where available,
punitive damages.
With
respect to RISPERDAL®, the Attorneys General of eight states and the Office of
General Counsel of the Commonwealth of Pennsylvania have filed actions seeking
reimbursement of Medicaid or other public funds for RISPERDAL® prescriptions
written for off-label use, compensation for treating their citizens for alleged
adverse reactions to RISPERDAL®, civil fines or penalties, punitive damages, or
other relief. The Attorney General of Texas has joined a qui tam action in that
state seeking similar relief. Certain of these actions also seek injunctive
relief relating to the promotion of RISPERDAL®. The Attorneys General of more
than 40 other states have indicated a potential interest in pursuing similar
litigation against the Company’s Janssen subsidiary, and have obtained a tolling
agreement staying the running of the statute of limitations while they inquire
into the issues. In addition, there are six cases filed by union health plans
seeking damages for alleged overpayments for RISPERDAL®, several of which seek
certification as class actions. In the case brought by the Attorney
General of West Virginia, based on claims for alleged consumer fraud as to
DURAGESIC® as well as RISPERDAL®, Janssen was found liable on motion, and
damages are likely to be assessed at less than $20 million. Janssen
intends to appeal.
Numerous
claims and lawsuits in the United States relating to the drug PROPULSID®,
withdrawn from general sale by the Company’s Janssen subsidiary in 2000, have
been resolved or are currently enrolled in settlement programs with an aggregate
cap below $100 million. Litigation concerning PROPULSID® is pending in Canada,
where a class action of persons alleging adverse reactions to the drug has been
certified.
AFFIRMATIVE
STENT PATENT LITIGATION
In patent
infringement actions tried in Delaware Federal District Court in late 2000,
Cordis Corporation (Cordis), a subsidiary of Johnson & Johnson, obtained
verdicts of infringement and patent validity, and damage awards against Boston
Scientific Corporation (Boston Scientific) and Medtronic AVE, Inc. (Medtronic)
based on a number of Cordis vascular stent patents. In December 2000, the jury
in the damage action against Boston Scientific returned a verdict of $324
million and the jury in the Medtronic action returned a verdict of $271 million.
The Court of Appeals for the Federal Circuit has upheld liability in these
cases, and on September 30, 2008, the district court entered judgments,
including interest, in the amounts of $702 million and $521 million against
Boston Scientific and Medtronic, respectively. Boston Scientific has
appealed the judgment, but Medtronic paid $472 million in October 2008,
representing the judgment, net of amounts exchanged in settlement of a number of
other litigations between the companies.
Cordis
also has two arbitrations against Medtronic seeking royalties for the sale of
stent products introduced by Medtronic subsequent to December 2000 pursuant to a
1997 cross-license agreement between Cordis and Medtronic. The
hearing on the first of these arbitrations will take place in March
2009.
In
January 2003, Cordis filed a patent infringement action against Boston
Scientific in Delaware Federal District Court accusing its Express2™, Taxus® and
Liberte® stents of infringing the Palmaz patent that expired in November 2005.
The Liberte® stent was also accused of infringing Cordis’ Gray patent that
expires in 2016. In June 2005, a jury found that the Express2™, Taxus® and
Liberte® stents infringed the Palmaz patent and that the Liberte® stent also
infringed the Gray patent. Boston Scientific has appealed to the U.S. Court of
Appeals for the Federal Circuit.
Cordis
has filed several lawsuits in New Jersey Federal District Court against Guidant
Corporation, Abbott Laboratories, Inc., Boston Scientific and Medtronic alleging
that the Xience V™ (Abbott), Promus™ (Boston Scientific) and Endeavor®
(Medtronic) drug eluting stents infringe several patents owned by or licensed to
Cordis. In October 2008, Cordis filed suit against Boston Scientific in Delaware
Federal Court accusing the Taxus® Liberte® stent of infringing the Gray
patent.
PATENT
LITIGATION AGAINST VARIOUS JOHNSON & JOHNSON SUBSIDIARIES
The
products of various Johnson & Johnson subsidiaries are the subject of
various patent lawsuits, the outcomes of which could potentially adversely
affect the ability of those subsidiaries to sell those products, or require the
payment of past damages and future royalties.
In July
2005, a jury in Federal District Court in Delaware found that the Cordis CYPHER®
Stent infringed Boston Scientific’s Ding ’536 patent and that the Cordis CYPHER®
and BX VELOCITY® Stents also infringed Boston Scientific’s Jang ’021 patent. The
jury also found both of those patents valid. Boston Scientific seeks substantial
damages and an injunction in that action. The District Court denied motions by
Cordis to overturn the jury verdicts or grant a new trial. Cordis has appealed
to the Court of Appeals for the Federal Circuit. The District Court indicated it
will consider damages, willfulness and injunctive relief after the appeals have
been decided.
Boston
Scientific has brought actions in Belgium, the Netherlands, Germany, France and
Italy under its Kastenhofer patent, which purports to cover two-layer catheters
such as those used to deliver the CYPHER® Stent, to enjoin the manufacture and
sale of allegedly infringing catheters in those countries, and to recover
damages. A decision by the lower court in the Netherlands in Boston Scientific’s
favor was reversed on appeal in April 2007. Boston Scientific has filed an
appeal to the Dutch Supreme Court. In October 2007, Boston Scientific prevailed
in the nullity action challenging the validity of the Kastenhofer patent filed
by Cordis in Germany. Cordis has appealed. No substantive hearings
have been scheduled in the French or Italian actions.
Trial in
Boston Scientific’s U.S. case based on the Kastenhofer patent in Federal
District Court in California concluded in October 2007 with a jury finding that
the patent was invalid. The jury also found for Cordis on its
counterclaim that sale by Boston Scientific of its balloon catheters and stent
delivery systems infringe Cordis’ Fontirroche patent. The Court has
denied Boston Scientific’s post trial motions and is considering the appropriate
remedy for future infringement.
In
Germany, Boston Scientific has several actions based on its Ding patents pending
against the Cordis CYPHER® Stent. Cordis was successful in these actions at the
trial level, but Boston Scientific has appealed.
The
following chart summarizes various patent lawsuits concerning products of
Johnson & Johnson subsidiaries that have yet to proceed to
trial:
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 |
|
*
Trial date to be scheduled.
LITIGATION
AGAINST FILERS OF ABBREVIATED NEW DRUG APPLICATIONS (ANDAs)
The
following chart indicates lawsuits pending against generic firms that filed
Abbreviated New Drug Applications (ANDAs) seeking to market generic forms of
products sold by various subsidiaries of the Company prior to expiration of the
applicable patents covering those products. These ANDAs typically include
allegations of non-infringement, invalidity and unenforceability of these
patents. In the event the subsidiary of the Company involved is not successful
in these actions, or the statutory 30-month stay expires before a ruling from
the district court is obtained, the firms involved will have the ability, upon
FDA approval, to introduce generic versions of the product at issue resulting in
very substantial market share and revenue losses for the product of the
Company’s subsidiary.
As noted
in the following chart, 30-month stays expired during 2006 and 2007, and will
expire in 2008, 2009, 2010 and 2011 with respect to ANDA challenges regarding
various products:
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 |
|
* Trial
date to be scheduled.
In the
action against Barr regarding ORTHO TRICYCLEN® LO, on January 22, 2008, the
Company’s subsidiary Ortho Women’s Health & Urology, a Division of
Ortho-McNeil-Janssen Pharmaceuticals, Inc., and Barr agreed to a non-binding
term sheet to settle the litigation, which settlement discussions are still
underway. The trial court postponed the January 22, 2008 trial
without setting a new trial date.
On
October 16, 2008, the Company’s subsidiary Ortho-McNeil-Janssen Pharmaceuticals,
Inc. (OMJPI) filed suit in Federal District Court in New Jersey against Watson
Laboratories, Inc. in response to Watson’s ANDA regarding Ortho TriCyclen
Lo.
In the
action against Barr and AlphaPharm with respect to their ANDA challenges to the
RAZADYNE® patent that Janssen licenses from Synaptech, a four-day non-jury trial
was held in the Federal District Court in Delaware in May 2007. On August 27,
2008, the court held that the patent was invalid because it was not
enabled. Janssen and Synaptech have appealed the decision. Since the
court’s decision, three generic companies have received final approvals for
their products and two companies, Barr and Alphapharm (Mylan), have launched “at
risk” pending appeal. Additional generic approvals and launches could
occur at any time.
On August
13, 2008, the Company’s subsidiary OMJPI, and Synaptech filed suit in Federal
District Court in Delaware against Sandoz, Inc. in response to Sandoz’s ANDA
regarding RAZADYNE® tablets. Sandoz seeks to bring its generic
version of RAZADYNE® to market, before expiration of the patent that OMJPI
licenses from Synaptech, in December 2008. In light of the court’s
decision in the actions against Barr and Alphapharm, it is expected that the
court will enter judgment for Sandoz shortly.
In the
action against Andrx with respect to its ANDA challenge to the CONCERTA®
patents, a five-day non-jury trial was held in the Federal District Court in
Delaware in December 2007. The Court has yet to issue its ruling in that
action.
In the
action against Sandoz with respect to its ANDA challenge to a RAZADYNE® ER
patent that Janssen licenses from Synaptech, the action has been stayed pending
the outcome of the appeal in the above litigation in Delaware Federal District
Court. Sandoz originally challenged only one of two patents for RAZADYNE® ER,
and certified that it will await expiration of the second patent in 2019 before
marketing its generic version of RAZADYNE® ER. In April 2008, Sandoz notified
Janssen that it has now challenged the second patent in its ANDA and seeks to
market the product before that patent expires in 2019. An
infringement action was brought against Sandoz based on the second patent in the
District of New Jersey in June 2008.
In the
action against Barr with respect to its ANDA challenge to the RAZADYNE® ER patent
that Janssen licenses from Synaptech, the action was stayed pending the outcome
in the above litigation against Barr in Delaware Federal District
Court. In September 2008, the Delaware decision invalidating the
patent resulted in entry of judgment for Barr on that patent. Litigation against
Barr as to another patent regarding RAZADYNE® ER will
proceed, but no stay of generic entry applies to Barr as to that
patent.
McNEIL-PPC,
Inc. filed suit in April 2008 in Federal District Court in New Jersey against
Perrigo Company with respect to its ANDA regarding MONISTAT® 1 Combination
Pack. In September 2008, a Joint Voluntary Stipulation of Dismissal
was entered.
In the
Ultracet actions, Ortho-McNeil filed suit against Kali/Par in 2002, separately
against Caraco in 2004, and separately against Teva/Barr in 2004 based on
the patent then in force. In October 2005, Caraco’s motion for summary
judgment of non-infringement of the original patent was granted and subsequently
affirmed by the Federal Circuit. In August 2006, the PTO granted a reissue
patent. Ortho-McNeil thereafter amended its pending claims against Kali/Par and
Teva/Barr to assert claim 6 of the reissue patent. Ortho-McNeil also
brought a new lawsuit against Kali/Par, Caraco, and Teva/Barr based on
other claims of the reissue patent. In April 2007, certain of Kali/Par's
and Teva/Barr’s motions for summary judgment of invalidity of the original
patent were granted. In July 2007 Kali/Par settled all pending
claims, acknowledging that the asserted claims of the reissue patent are
valid, enforceable, and infringed. Also in July 2007, Ortho-McNeil filed
suit against Apotex on the reissue patent. In March 2008, Ortho-McNeil
filed suit against Mylan and AlphaPharm on the reissue patent. In April
2008, Caraco’s motion for summary judgment of invalidity of the reissue patent
was granted. The Mylan/AlphaPharm case was dismissed on collateral
estoppel grounds in light of the summary judgment finding of invalidity of
the reissue patent in the Caraco case, and Apotex has filed a motion for summary
judgment on similar grounds. Ortho-McNeil intends to appeal the summary
judgment decision invalidating the claims of the reissue patent.
In the
action against Lupin Pharmaceuticals, Inc. (Lupin) regarding its ANDA concerning
LEVAQUIN®, Lupin contends that the United States Patent and Trademark Office
improperly granted a patent term extension to the patent that Ortho-McNeil
licenses from Daiichi Pharmaceuticals, Inc. Lupin alleges that the
active ingredient in LEVAQUIN® was the subject of prior marketing, and therefore
was not eligible for the patent term extension. Lupin concedes validity and that
its product would violate the patent if marketed prior to the expiration of the
original patent term.
AVERAGE
WHOLESALE PRICE (AWP) LITIGATION
Johnson
& Johnson and several of its pharmaceutical subsidiaries, along with
numerous other pharmaceutical companies, are defendants in a series of lawsuits
in state and federal courts involving allegations that the pricing and marketing
of certain pharmaceutical products amounted to fraudulent and otherwise
actionable conduct because, among other things, the companies allegedly reported
an inflated Average Wholesale Price (AWP) for the drugs at issue. Most of these
cases, both federal actions and state actions removed to federal court, have
been consolidated for pre-trial purposes in a Multi-District Litigation (MDL) in
Federal District Court in Boston, Massachusetts. The plaintiffs in these cases
include classes of private persons or entities that paid for any portion of the
purchase of the drugs at issue based on AWP, and state government entities that
made Medicaid payments for the drugs at issue based on AWP.
The MDL
Court identified classes of Massachusetts-only private insurers providing
“Medi-gap” insurance coverage and private payers for physician-administered
drugs where payments were based on AWP (“Class 2” and “Class 3”), and a national
class of individuals who made co-payments for physician-administered drugs
covered by Medicare (“Class 1”). A trial of the two Massachusetts-only class
actions concluded before the MDL Court in December 2006. In June 2007, the MDL
Court issued post-trial rulings, dismissing the Johnson & Johnson defendants
from the case regarding all claims of Classes 2 and 3, and subsequently of Class
1 as well. AWP cases brought by various Attorneys General are expected to be set
for trial in 2009.
OTHER
In July
2003, Centocor Inc., a Johnson & Johnson subsidiary, received a request that
it voluntarily provide documents and information to the criminal division of the
U.S. Attorney’s Office, District of New Jersey, in connection with its
investigation into various Centocor marketing practices. Subsequent requests for
documents have been received from the U.S. Attorney’s Office. Both the Company
and Centocor have responded to these requests for documents and
information.
In
December 2003, Ortho-McNeil received a subpoena from the U.S. Attorney’s Office
in Boston, Massachusetts seeking documents relating to the marketing, including
alleged off-label marketing, of the drug TOPAMAX® (topiramate). Additional
subpoenas for documents have been received, and current and former employees
have testified before a grand jury. Discussions are underway in an
effort to resolve this matter, but whether agreement can be reached and on what
terms is uncertain.
In
January 2004, Janssen received a subpoena from the Office of the Inspector
General of the U.S. Office of Personnel Management seeking documents concerning
sales and marketing of, any and all payments to physicians in connection with
sales and marketing of, and clinical trials for, RISPERDAL® (risperidone) from
1997 to 2002. Documents subsequent to 2002 have also been requested. An
additional subpoena seeking information about marketing of and adverse reactions
to RISPERDAL® was received from the U.S. Attorney’s Office for the Eastern
District of Pennsylvania in November 2005. Subpoenas seeking testimony from
various witnesses before a grand jury have also been received. Janssen is
cooperating in responding to these subpoenas.
In August
2004, Johnson & Johnson Health Care Systems, Inc. (HCS), a Johnson &
Johnson subsidiary, received a subpoena from the Dallas, Texas U.S. Attorney’s
Office seeking documents relating to the relationships between the group
purchasing organization, Novation, and HCS and other Johnson & Johnson
subsidiaries. The Company’s subsidiaries involved have responded to the
subpoena.
In
September 2004, Ortho Biotech Inc. (Ortho Biotech), received a subpoena from the
U.S. Office of Inspector General’s Denver, Colorado field office seeking
documents directed to sales and marketing of PROCRIT® (Epoetin alfa) from 1997
to the present, as well as to dealings with U.S. Oncology Inc., a healthcare
services network for oncologists. Ortho Biotech has responded to the
subpoena.
In
September 2004, plaintiffs in an employment discrimination litigation initiated
against the Company in 2001 in Federal District Court in New Jersey moved to
certify a class of all African American and Hispanic salaried employees of the
Company and its affiliates in the U.S., who were employed at any time from
November 1997 to the present. Plaintiffs seek monetary damages for the period
1997 through the present (including punitive damages) and equitable relief. The
Court denied plaintiffs’ class certification motion in December 2006 and their
motion for reconsideration in April 2007. Plaintiffs sought to appeal these
decisions and, in April 2008, the Court of Appeals ruled that plaintiffs’ appeal
of the denial of class certification was untimely. Plaintiffs are now
engaged in further discovery of individual plaintiffs’ claims.
In March
2005, DePuy Orthopaedics, Inc. (DePuy), a Johnson & Johnson subsidiary,
received a subpoena from the U.S. Attorney’s Office, District of New Jersey,
seeking records concerning contractual relationships between DePuy and surgeons
or surgeons-in-training involved in hip and knee replacement and reconstructive
surgery. This investigation was resolved by DePuy and the four other leading
suppliers of hip and knee implants in late September 2007 by agreements with the
U.S. Attorney’s Office for the District of New Jersey. The settlements include
an 18-month Deferred Prosecution Agreement (DPA), acceptance by each company of
a monitor to assure compliance with the DPA and, with respect to four of the
five companies, payment of settlement monies and entry into five year Corporate
Integrity Agreements. DePuy paid $85 million as its settlement. In
November 2007, the Attorney General of the Commonwealth of Massachusetts issued
a civil investigative demand to DePuy seeking information regarding financial
relationships between a number of Massachusetts-based orthopedic surgeons and
providers and DePuy, which relationships had been publicly disclosed by DePuy
pursuant to the DPA. In February 2008, DePuy received a written request for
information from the U.S. Senate Special Committee on Aging, as a follow-up to
earlier inquiries, concerning a number of aspects of the DPA.
In June
2005, the U.S. Senate Committee on Finance requested the Company to produce
information regarding use by several of its pharmaceutical subsidiaries of
educational grants. A similar request was sent to other major pharmaceutical
companies. In July 2005, the Committee specifically requested information about
educational grants in connection with the drug PROPULSID®. A follow up request
was received from the Committee for additional information in January 2006. On
October 30, 2007 another letter was received from the U.S. Senate Committee on
Finance requesting information concerning payments to a list of physicians, and
specification as to whether any such payments were for continuing medical
education, honoraria, research support, etc. The Company has responded to these
requests.
In July
2005, Scios Inc. (Scios), a Johnson & Johnson subsidiary, received a
subpoena from the U.S. Attorney’s Office, District of Massachusetts, seeking
documents related to the sales and marketing of NATRECOR®. Scios is responding
to the subpoena. In early August 2005, Scios was advised that the investigation
would be handled by the U.S. Attorney’s Office for the Northern District of
California in San Francisco. Additional requests for documents have
been received and responded to and former and current Scios employees have
testified before a grand jury in San Francisco.
In
September 2005, Johnson & Johnson received a subpoena from the U.S.
Attorney’s Office, District of Massachusetts, seeking documents related to sales
and marketing of eight drugs to Omnicare, Inc., a manager of pharmaceutical
benefits for long-term care facilities. The Johnson & Johnson subsidiaries
involved responded to the subpoena. Several employees of the Company’s
pharmaceutical subsidiaries have been subpoenaed to testify before a grand jury
in connection with this investigation.
In
November 2005, Amgen filed suit against Hoffmann-LaRoche, Inc. in the U.S.
District Court for the District of Massachusetts seeking a declaration that the
Roche product CERA, which Roche has indicated it would seek to introduce into
the United States, infringes a number of Amgen patents concerning EPO. Amgen
licenses EPO for sale in the United States to Ortho Biotech for non-dialysis
indications. Trial in this action concluded in October 2007 with a verdict in
Amgen’s favor, finding the patents valid and infringed. The judge
issued a preliminary injunction blocking the CERA launch, but said he was
considering modifying that injunction to grant Roche a compulsory license that
would allow it to launch in the U.S. if it paid a 22.5 percent
royalty. Before the judge decided whether to grant Roche the
compulsory license, however, Roche appealed the original granting of the
preliminary injunction to the U.S. Court of Appeals for the Federal
Circuit. In a subsequent decision, the district judge indicated he
would not grant Roche a compulsory license.
In late
December 2005 and early 2006, three purported class actions were filed on behalf
of purchasers of endo-mechanical instruments against the Company and its
wholly-owned subsidiaries, Ethicon, Inc., Ethicon Endo-Surgery, Inc., and
Johnson & Johnson Health Care Systems, Inc. These cases challenge suture and
endo-mechanical contracts with Group Purchasing Organizations and hospitals, in
which discounts are predicated on a hospital achieving specified market share
targets for both categories of products. These actions are in the process of
being settled for approximately $14 million.
In
February 2006, Johnson & Johnson received a subpoena from the U.S.
Securities & Exchange Commission (SEC) requesting documents relating to the
participation by several Johnson & Johnson subsidiaries in the United
Nations Iraq Oil for Food Program. The subsidiaries are cooperating
with the SEC and U.S. Department of Justice (DOJ) in producing responsive
documents.
In
September 2006, Janssen received a subpoena from the Attorney General of the
State of California seeking documents regarding sales and marketing and
side-effects of RISPERDAL®, as well as interactions with State officials
regarding the State’s formulary for Medicaid-reimbursed drugs. Janssen has
responded to the subpoena.
In
February 2007, Johnson & Johnson voluntarily disclosed to the DOJ and the
SEC that subsidiaries outside the United States are believed to have made
improper payments in connection with the sale of medical devices in two
small-market countries, which payments may fall within the jurisdiction of the
Foreign Corrupt Practices Act (FCPA). In the course of continuing dialogues with
the agencies, other issues potentially rising to the level of FCPA violations in
additional markets have been brought to the attention of the agencies by the
Company. The Company has provided and will continue to provide additional
information to DOJ and SEC, and will cooperate with the agencies’ reviews of
these matters. Law enforcement agencies of a number of other
countries are also pursuing investigations of matters voluntarily disclosed by
the Company to DOJ and SEC.
In March
2007, Cordis received a letter request for documents from the Committee on
Oversight and Government Reform of the U.S. House of Representatives regarding
marketing and safety of drug-eluting stents. Cordis has responded to the
request.
In March
2007, the Company received separate subpoenas from the U.S. Attorney’s Office in
Philadelphia, the U.S. Attorney’s Office in Boston and the U.S. Attorney’s
Office in San Francisco. The subpoenas relate to investigations by these three
offices referenced above concerning, respectively, sales and marketing of
RISPERDAL® by Janssen, TOPAMAX® by Ortho-McNeil and NATRECOR® by Scios. The
subpoenas request information regarding the Company’s corporate supervision and
oversight of these three subsidiaries, including their sales and marketing of
these drugs. The Company responded to these requests. In addition,
the U.S. Attorney’s office in Boston has issued subpoenas for grand jury
testimony to several employees of Johnson & Johnson.
In March
2007, the Company received a letter from the Committee on Energy and Commerce of
the U.S. House of Representatives seeking answers to several questions regarding
marketing and safety of PROCRIT®, the erythropoietin product sold by
Ortho-Biotech. In March 2008, the Committee on Energy and Commerce sent the
Company a second letter focused on direct-to-consumer advertising for
PROCRIT®. In May
2007, Senator Grassley, the ranking member of the U.S. Senate Committee on
Finance, sent the Company a letter seeking information relating to PROCRIT®. The
Company provided its initial response in July 2007. By letter dated
February 11, 2008, the Senate Finance Committee requested further rebate
information for Ortho Biotech’s five largest physicians and/or group practices
in each state. In May 2007, the New York State Attorney General
issued a subpoena seeking information relating to PROCRIT®. Like the House and
Senate requests, the subpoena asks for materials relating to PROCRIT® safety,
marketing and pricing. The Company is responding to these requests.
In April
2007, the Company received two subpoenas from the Office of the Attorney General
of the State of Delaware. The subpoenas seek documents and information relating
to nominal pricing agreements. For purposes of the subpoenas, nominal pricing
agreements are defined as agreements under which the Company agreed to provide a
pharmaceutical product for less than ten percent of the Average Manufacturer
Price for the product. The Company responded to these requests.
In August
2007, the Company received a request for documents and interviews of witnesses
from the Committee on Energy and Commerce of the U.S. House of Representatives
concerning GMP (Good Manufacturing Practice) issues involving the CYPHER® Stent.
The letter states that FDA inspectors in 2003 identified “numerous systemic
violations” of GMP’s in connection with CYPHER® manufacturing but nonetheless
allowed Cordis to continue marketing CYPHER® Stents. Cordis has responded to
this request.
In
October 2007, the Company received a request for documents from Senator Grassley
on behalf of the Committee on Finance of the U.S. Senate concerning continuing
medical education payments to specific physicians. The Company responded to this
request.
In
November 2007, the Company received a request from United States Senators Byron
Dorgan and Olympia Snowe seeking information relating to the Company’s oversight
of foreign manufacturing facilities. The Company responded in January
2008.
In
December 2007, the Company and its subsidiary Janssen received a request from
Senator Grassley on behalf of the Committee on Finance of the U.S. Senate for
documents and information concerning the marketing and promotion of RISPERDAL®
for use by nursing home patients. The companies responded to this
request.
In
January 2008, the European Commission (“EC”) began an industry-wide antitrust
inquiry concerning competitive conditions within the pharmaceutical
sector. Because this is a sector inquiry, it is not based on any
specific allegation that the company has violated EC competition
law. The inquiry began with unannounced raids of a substantial number
of pharmaceutical companies throughout Europe, including Johnson & Johnson
affiliates. In March 2008, the EC issued detailed questionnaires to
approximately 100 companies, including Johnson & Johnson
affiliates.
In March
2008, the Company received a letter request from the Attorney General of the
State of Michigan. The request seeks documents and information relating to
nominal price transactions. The Company is responding to the request
and will cooperate with the inquiry.
In June 2008, Johnson
& Johnson received a subpoena from the United States Attorneys Office for
the District of Massachusetts relating to the marketing of biliary stents by the
company’s Cordis subsidiary. Cordis is cooperating in responding to
the subpoena.
In
September 2008, Multilan AG, an indirect subsidiary of Schering-Plough
Corporation, commenced arbitration against Janssen Pharmaceutica NV for an
alleged wrongful termination of an agreement relating to payments in connection
with termination of certain marketing rights. Multilan seeks declaratory relief,
specific performance and damages. Multilan alleges that damages exceed €700
million. The parties are in the process of selecting an arbitral
tribunal.
On
October 16, 2008, the Company received a letter from the Senate Committee on
Finance and the Senate Subcommittee on Aging requesting information regarding
the relationship between certain doctors and organizations and J&J,
principally relating to the CYPHER®
stent. The Company is in the process of responding to these
inquiries.
On
October 23, 2008, the Company received a letter from the Senate Committee on
Finance requesting information on any payments or benefits to a number of
specified psychiatrists associated with psychiatric professional associations or
otherwise authorities in their field. The Company is in the process of
responding to the request.
With
respect to all the above matters, the Company and its subsidiaries are
vigorously contesting the allegations asserted against them and otherwise
pursuing defenses to maximize the prospect of success. The Company and its
subsidiaries involved in these matters continually evaluate their strategies in
managing these matters and, where appropriate, pursue settlements and other
resolutions where those are in the best interest of the Company.
The
Company is also involved in a number of other patent, trademark and other
lawsuits incidental to its business. The ultimate legal and financial liability
of the Company in respect to all claims, lawsuits and proceedings referred to
above cannot be estimated with any certainty. However, in the Company’s opinion,
based on its examination of these matters, its experience to date and
discussions with counsel, the ultimate outcome of legal proceedings, net of
liabilities accrued in the Company’s balance sheet, is not expected to have a
material adverse effect on the Company’s financial position, although the
resolution in any reporting period of one or more of these matters could have a
significant impact on the Company’s results of operations and cash flows for
that period.
NOTE 13
Fair Value Measurements
During
the fiscal first quarter of 2008, the Company adopted SFAS No. 157, Fair
Value Measurements, except for non-financial assets and liabilities
recognized or disclosed at fair value on a non-recurring basis, for which the
effective date is fiscal years beginning after November 15,
2008. SFAS No. 157 defines fair value, establishes a framework for
measuring fair value, and expands disclosures about fair value measurements.
During the fiscal first quarter of 2008, the Company adopted SFAS No. 159, Fair
Value Option for Financial Assets and Financial Liabilities. SFAS No. 159
permits the Company to measure certain financial assets and financial
liabilities at fair value. The Company assessed the fair value option made
available upon adopting SFAS No. 159, and has elected not to apply the fair
value option to any financial instruments that were not already recognized at
fair value.
SFAS No.
157 defines fair value as the exit price that would be received to sell an asset
or paid to transfer a liability. Fair value is a market-based measurement that
should be determined using assumptions that market participants would use in
pricing an asset or liability. The statement establishes a three-level hierarchy
to prioritize the inputs used in measuring fair value. The levels
within the hierarchy are described in the table below with level 1 having the
highest priority and level 3 having the lowest.
The
following table provides a summary of the significant assets and liabilities
that are measured at fair value as of September 28, 2008.
(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 |
|
|
The
Company uses forward exchange contracts to manage its exposure to the
variability of cash flows, primarily related to the foreign exchange rate
changes on future intercompany and third party purchases of raw materials
denominated in foreign currency. The Company also uses currency swaps
to manage currency risk primarily related to borrowings. The fair value of
derivative instruments is the aggregation, by currency, of all future cash flows
discounted to present value at prevailing market interest rates, and
subsequently converted to the United States dollar at the current spot foreign
exchange rate. The Company does not believe that fair values of these derivative
instruments materially differs from the amounts that could be realized upon
settlement or maturity, or that the changes in fair value will have a material
effect on the Company’s results of operations, cash flows or financial
position.
The
Company did not have any other significant financial assets or liabilities,
which would require revised valuations under SFAS No. 157 that are recognized at
fair value.
NOTE 14
Subsequent Events
On
October 16, 2008 the Company completed the acquisition of SurgRx, Inc. SurgRx,
Inc. is a privately held developer of the advanced bipolar tissue sealing system
used in the ENSEAL® family of devices.
September
30, 2008, the district court entered judgments, including interest, in the
amounts of $702 million and $521 million against Boston Scientific and
Medtronic, respectively. Boston Scientific has appealed the judgment,
but Medtronic paid $472 million in October 2008, representing the judgment, net
of amounts exchanged in settlement of a number of other litigations between the
companies.
October
27, 2008, the Company completed the acquisition of HealthMedia, Inc. a privately
held company that creates web-based behavior change interventions.
Item 2 -
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Results
of Operations
Analysis
of Consolidated Sales
For the
first fiscal nine months of 2008, worldwide sales were $48.6 billion, a total
increase of 7.6% including an operational increase of 3.0% over 2007 first
fiscal nine months sales of $45.1 billion. Currency had a positive impact of
4.6% for the period.
Sales by
U.S. companies were $24.6 billion in the first fiscal nine months of 2008, which
represented an increase of 1.8% over the same period last year. Sales
by international companies were $23.9 billion, which represented a total
increase of 14.3% including an operational increase of 4.3%, and a positive
impact from currency of 10.0% over the first fiscal nine months of
2007.
Sales by
companies in Europe achieved total growth of 12.6%, including an operational
growth of 1.4% and a positive impact from currency of 11.2%. Sales by
companies in the Western Hemisphere, excluding the U.S., achieved total growth
of 18.2% including operational growth of 8.4% and a positive impact from
currency of 9.8%. Sales by companies in the Asia-Pacific, Africa region posted
sales growth of 15.5%, with operational growth of 7.8% and a positive impact
from currency of 7.7%.
For the
fiscal third quarter of 2008, worldwide sales were $15.9 billion, a total
increase of 6.4% and an operational increase of 3.3%, over 2007 fiscal third
quarter sales of $15.0 billion. Currency fluctuations positively
impacted sales by 3.1% for the period.
Sales by
U.S. companies were $7.9 billion in the fiscal third quarter of 2008, which
represented an increase of 0.4%. Sales by international companies were $8.0
billion, which represented a total increase of 13.1%, including an operational
increase of 6.5%, and a positive impact from currency of 6.6% over the fiscal
third quarter of 2007.
Sales by
companies in Europe achieved total growth of 8.3%, with operational growth of
1.0% and a positive impact from currency of 7.3%. Sales by companies
in the Western Hemisphere, excluding the U.S., achieved total growth of 22.3%,
operational growth of 15.3% and a positive impact from currency of
7.0%. Sales by companies in the Asia-Pacific, Africa region posted
sales growth of 16.5%, with operational growth of 11.3% and a positive impact
from currency of 5.2%.
Analysis
of Sales by Business Segments
Consumer
Consumer
segment sales in the first fiscal nine months of 2008 were $12.2 billion, an
increase of 14.2% over the same period a year ago, with 8.7% of operational
growth and a positive currency impact of 5.5%. U.S. Consumer segment sales
increased by 10.5% while international sales achieved growth of 17.2%,
representing an operational increase of 7.3%, with a positive currency impact of
9.9%.
Major
Consumer Franchise Sales – First Fiscal Nine Months
|
|
|
|
(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 |
% |
Consumer
segment sales in the fiscal third quarter of 2008 were $4.1 billion,
an increase of 13.1% over the same period a year ago with 9.4% of operational
growth and a positive currency impact of 3.7%. U.S. Consumer segment sales
increased by 11.2% while international sales achieved growth of 14.7%,
representing an operational increase of 8.1%, with a positive currency impact of
6.6%.
Major
Consumer Franchise Sales – Fiscal Third Quarter
|
|
|
|
(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 |
% |
The OTC
Pharmaceuticals and Nutritionals franchise achieved operational growth of 11.3%
over prior year fiscal third quarter. A major contributor was the continued
success of over-the-counter ZYRTEC® in the U.S., which was launched during the fiscal first quarter
of 2008. On October 7, 2008 the Company announced a voluntary labeling change on
children’s cough and cold medicines regarding usage for children under the age
of 4 years, to encourage the safe, effective use of these products. These
actions will not have a significant impact on sales for the OTC Pharmaceuticals
and Nutritionals franchise.
The Skin
Care franchise achieved operational growth of 12.0% over prior year fiscal third
quarter. Strong growth was driven by NEUTROGENA®, CLEAN & CLEAR®, AVEENO® and Johnson’s Adult product lines
due to new product launches and strength in the core business. Additionally,
newly acquired products from the acquisition of Beijing Dabao Cosmetics Co.,
Ltd. contributed to the growth in the fiscal third quarter.
The Baby
Care franchise operational growth of 9.4% over prior year fiscal third quarter
was the result of strong sales performance by wipes, haircare and powder product
lines primarily in sales outside the U.S.
The
Women’s Health franchise operational growth of 5.5% over the prior year fiscal
third quarter was primarily due to the successful launch of new products in the
U.S.
The Oral
Care franchise operational growth of 6.7% was driven by the strong growth of
LISTERINE®
mouthwash. The launch of the dissolvable whitening strips in the third
quarter of 2007 impacted the U.S. growth comparisons for the
quarter.
Pharmaceutical
Pharmaceutical
segment sales in the first fiscal nine months of 2008 were $18.9 billion, a
total increase of 2.2% over the same period a year ago with an operational
decline of 1.5% and an increase of 3.7% related to the positive impact of
currency. The U.S. Pharmaceutical sales decreased by 2.2% over the same period a
year ago. Total growth in international Pharmaceutical sales was 9.9%, an
increase related to the positive impact of currency.
Major
Pharmaceutical Product Revenues* – First Fiscal Nine Months
(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 |
% |
*Prior
year amounts have been reclassified to conform to current
presentation.
Pharmaceutical
segment sales in the fiscal third quarter of 2008 were $6.1 billion, a total
increase of 0.2% over the same period a year ago with an operational decline of
2.5% and an increase of 2.7% related to the positive impact of currency. U.S.
Pharmaceutical sales decreased by 6.0% over the same period a year ago. Total
growth in international Pharmaceutical sales was 10.3%, representing an
operational increase of 3.3% with a positive currency impact of
7.0%.
Major
Pharmaceutical Product Revenues* – Fiscal Third Quarter
(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 |
% |
*Prior
year amounts have been reclassified to conform to current
presentation.
REMICADE®
(infliximab), a biologic approved for the treatment of Crohn’s disease,
ankylosing spondylitis, psoriasis, psoriatic arthritis, ulcerative colitis and
use in the treatment of rheumatoid arthritis, achieved operational growth of
19.4% over prior year fiscal third quarter. The U.S. sales growth was driven by
market growth. An increase in export sales is due to the increased demand
outside the U.S. and customer production planning needs. REMICADE® is competing
in a market which is experiencing increased competition due to new entrants and
the expansion of indications for existing competitors.
TOPAMAX®
(topiramate), which has been approved for adjunctive and monotherapy use in
epilepsy, as well as for the prophylactic treatment of migraines, achieved
strong operational growth of 17.6% as compared to prior year fiscal third
quarter. The growth was primarily due to increases in the migraine category
partially offset by generic competition in certain markets outside the U.S. The
patent for TOPAMAX® (topiramate) in the U.S. expired in September 2008. In July
2008, the U.S. Food and Drug Administration (FDA) granted pediatric exclusivity
for TOPAMAX®, which
extends market exclusivity in the U.S. until March 2009. The expiration of a
product patent or loss of market exclusivity is likely to result in a
significant reduction in sales. In the first fiscal nine months of 2008, U.S.
sales of TOPAMAX® were $1.7 billion.
PROCRIT® (Epoetin
alfa)/EPREX® (Epoetin alfa) experienced an operational sales decline of
11.9%, as compared to prior year fiscal third quarter. The decline in
PROCRIT® sales was due to the declining markets for Erythropoiesis
Stimulating Agents (ESAs) in the U.S. Outside the U.S., new competition and
label reviews have contributed to the lower sales results for EPREX®.
Discussions with European regulators regarding changes to the label for ESAs,
including EPREX®, are underway. The FDA issued an order requiring a labeling
supplement making specific revisions to the label for ESAs, including
PROCRIT®. The label for PROCRIT® was
updated July 30, based on review of emerging safety data for the use of ESAs in
patients with cancer.
CONCERTA®
(methylphenidate HCl), a product for the treatment of attention deficit
hyperactivity disorder, achieved operational sales growth of 66.4% over the
fiscal third quarter of 2007. Sales results in the fiscal third quarter of 2008
were favorably impacted by approximately $135 million, related to a change in
the estimate of accrued rebates. Of the $135 million, $115 million relates
to amounts recorded in prior years. An additional contributor to the sales
growth was market growth. Although the original CONCERTA® patent
expired in 2004, the FDA has not approved any generic version that is
substitutable for CONCERTA®. Two
parties have filed Abbreviated New Drug Applications (ANDAs) for generic
versions of CONCERTA®, which are pending and may be approved at any time.
RISPERDAL®
CONSTA® (risperidone), a long acting injectable for the treatment of
schizophrenia, achieved operational growth of 9.8% over the fiscal third quarter
of 2007. Strong growth was due to a positive shift from oral to injectable
therapies outside the U.S.
LEVAQUIN®(levofloxacin)/FLOXIN®,
RISPERDAL®(risperidone), ACIPHEX®/PARIET® and
DURAGESIC®/Fentanyl Transdermal (fentanyl transdermal system) experienced
operational declines of 10.4%, 63.0%, 19.0% and 20.7% respectively, versus the
prior year. Generic competition continued to negatively impact the sales of
these products.
Market
exclusivity for RISPERDAL® oral in the U.S. expired on June 29, 2008 and
Janssen, a Johnson & Johnson subsidiary, launched an authorized generic
version of RISPERDAL® oral on June 30, 2008. Loss of market exclusivity for the
RISPERDAL® oral patent has resulted in a significant reduction in sales in the
U.S.
In the
fiscal third quarter of 2008, Other Pharmaceutical sales achieved operational
growth of 10.7% versus the prior year. The biggest contributor to the increase
was VELCADE®, a treatment for relapse multiple myeloma, which was
co-developed with Millenium Pharmaceuticals, Inc.
Medical
Devices and Diagnostics
Medical
Devices and Diagnostics segment sales in the first fiscal nine months of 2008
were $17.5 billion, an increase of 9.4% over the same period a year ago, with
4.3% of this change due to operational increases and the remaining 5.1% increase
related to the positive impact of currency. The U.S. Medical Devices
and Diagnostics sales increase was 2.4% and the growth in international Medical
Devices and Diagnostics sales was 16.0%, which included operational increases of
6.0% and an increase of 10.0% related to the positive impact of
currency.
Major
Medical Devices and Diagnostics Franchise Sales* – First Fiscal Nine
Months
(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 |
% |
*Prior
year amounts have been reclassified to conform to current
presentation.
Medical
Devices and Diagnostics segment sales in the fiscal third quarter of 2008 were
$5.7 billion, an increase of 8.8% over the same period a year ago, with 5.6% of
this change due to operational growth and the remaining 3.2% increase related to
the positive impact of currency. The U.S. Medical Devices and
Diagnostics sales increase was 3.1% and the growth in international Medical
Devices and Diagnostics sales was 14.3%, which included operational growth of
8.0% and an increase of 6.3% related to the positive impact of
currency.
Major
Medical Devices and Diagnostics Franchise Sales* – Fiscal Third
Quarter
(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®
|
|
|
1,042 |
|
|
|
922 |
|
|
|
13.0 |
|
|
|
9.5 |
|
|
|
3.5 |
|
ETHICON®
|
|
|
957 |
|
|
|
881 |
|
|
|
8.6 |
|
|
|
5.2 |
|
|
|
3.4 |
|
CORDIS®
|
|
|
726 |
|
|
|
777 |
|
|
|
(6.6 |
) |
|
|
(10.2 |
) |
|
|
3.6 |
|
Diabetes
Care
|
|
|
667 |
|
|
|
585 |
|
|
|
14.0 |
|
|
|
10.3 |
|
|
|
3.7 |
|
Vision
Care
|
|
|
652 |
|
|
|
577 |
|
|
|
13.0 |
|
|
|
9.0 |
|
|
|
4.0 |
|
ORTHO-CLINICAL
DIAGNOSTICS®
|
|
|
470 |
|
|
|
420 |
|
|
|
11.9 |
|
|
|
9.0 |
|
|
|
2.9 |
|
Total
|
|
$ |
5,709 |
|
|
$ |
5,248 |
|
|
|
8.8 |
% |
|
|
5.6 |
% |
|
|
3.2 |
% |
*Prior
year amounts have been reclassified to conform to current
presentation.
The DePuy
franchise achieved operational growth of 8.0% over the same period a year ago.
This growth was primarily due to strong performance by the hip product line. An
additional contributor to the growth was strong performance in the Mitek sports
medicine product line primarily due to new product launches.
The
Ethicon Endo-Surgery franchise achieved operational growth of 9.5% over prior
year fiscal third quarter. This growth was mainly driven by the HARMONIC™ business due to
the success of newly launched products. Additional contributors to the growth
were the REALIZE® Gastric Band in
the U.S. and endoscopy products outside the U.S.
The
Ethicon franchise achieved operational growth of 5.2% from the same period in
the prior year resulting from solid growth in Hemostasis and
biosurgicals.
The
Cordis franchise experienced an operational sales decline of 10.2% over the
fiscal third quarter of 2007. This decline was caused by lower sales of the
CYPHER® Sirolimus-eluting Coronary Stent. Loss of market share for the CYPHER®
Sirolimus-eluting Coronary Stent is due to increased competition on a global
basis. These results were partially offset by growth of the Biosense Webster
business.
The
Diabetes Care franchise achieved operational growth of 10.3% over the fiscal
third quarter of 2007 reflecting the continued success of the ONETOUCH® ULTRA® product lines and
the growth of the Animas business.
The
Vision Care franchise achieved operational sales growth of 9.0%. ACUVUE® OASYS™,
1-DAY ACUVUE®MOIST™,
and ACUVUE® lenses for Astigmatism were the major contributors to
this growth.
The
Ortho-Clinical Diagnostics franchise achieved operational growth of 9.0% over
the fiscal third quarter of 2007 resulting from strong growth in
Immunohematology and Immunodiagnostics products.
Cost of
Products Sold and Selling, Marketing and Administrative Expenses
Consolidated
costs of products sold for the first fiscal nine months of 2008 increased to
29.1% from 28.8% of sales as compared to the same period a year
ago. The cost of products sold for the fiscal third quarter of 2008
increased to 30.0% from 28.5% of sales in the same period a year ago. The
increase in both the first fiscal nine months and the fiscal third quarter was
primarily due to the change in the mix of businesses, with stronger sales growth
in the Consumer business and lower sales growth in the Pharmaceutical business,
as well as inventory write-offs in the Pharmaceutical business.
Consolidated
selling, marketing and administrative expenses were 32.6% for both the first
fiscal nine months of 2008 and 2007. Consolidated selling, marketing and
administrative expenses for the fiscal third quarter of 2008 decreased to 32.6%
from 32.7% of sales in the same period a year ago. Decreases
in the fiscal third quarter were primarily due to cost containment efforts
offsetting the impact of the change in the mix of businesses.
Research
& Development
Research
activities represent a significant part of the Company’s
business. These expenditures relate to the development of new
products, improvement of existing products, technical support of products and
compliance with governmental regulations for the protection of the consumer.
Worldwide costs of research activities, for the first fiscal nine months of 2008
were $5.5 billion, an increase of 2.2% over the same period a year
ago. Research and development spending in the fiscal third quarter of
2008 was $1.9 billion, an increase of 1.5% over the fiscal third quarter of
2007. As a percent to sales, the level of research and development spending
decreased for both the fiscal third quarter and the first fiscal nine months of
2008 as compared to the same period a year ago. The decreases as a percent to
sales in the quarterly and nine month periods were primarily due to changes to
the mix of businesses and increased efficiencies in the Pharmaceutical research
and development support.
In-Process
Research & Development(IPR&D)
In the
fiscal third quarter of 2008, the Company had no IPR&D charges. IPR&D
charges of $40 million before and after tax were recorded during the first
fiscal nine months of 2008 related to the acquisition of Amic AB.
In the
fiscal third quarter of 2007, the Company had no IPR&D charges. IPR&D
charges of $807 million before and after tax were recorded during the first
fiscal nine months of 2007 related to the acquisitions of Conor Medsystems
Inc.
Other
(Income) Expense, Net
Other (income)
expense, net is the account where the Company records gains and losses related
to the sale and write-down of certain equity securities of the Johnson &
Johnson Development Corporation, gains and losses on the disposal of fixed
assets, currency gains and losses, minority interests, litigation settlements,
as well as royalty income. The favorable change in other (income) expense, net
for the fiscal third quarter of 2008 as compared to the fiscal third quarter of
2007 was primarily due to a settlement payment of $200 million received from
Amgen in the fiscal third quarter of 2008. The favorable change in other
(income) expense, net for the first fiscal nine months of 2008 as compared to
the same period a year ago was $34 million. This was primarily due to the
settlement payment of $200 million received from Amgen in the fiscal third
quarter of 2008 versus the net gain of $175 million related to the divestiture
of certain consumer brands recorded in the fiscal first quarter of
2007.
OPERATING
PROFIT BY SEGMENT
Consumer
Segment
Operating
profit for the Consumer segment as a percent to sales in the first fiscal nine
months of 2008 was 17.8% versus 17.1% over the same period a year ago. Operating
profit as a percent to sales in the fiscal third quarter of 2008 was 18.6%
versus 16.2% over the same period a year ago. The increase in both the fiscal
nine months and the fiscal third quarter was due to cost synergies, lower
integration costs in 2008 related to the acquisition of the Consumer Healthcare
Business of Pfizer Inc. and other cost containment initiatives.
Pharmaceutical
Segment
Operating
profit for the Pharmaceutical segment as a percent to sales in the first fiscal
nine months of 2008 was 34.5% versus 32.5% over the same period a year ago.
Operating profit as a percent to sales in the fiscal third quarter of 2008 was
32.8% versus 26.1% over the same period a year ago. For both periods in 2008,
operating profit increased, as compared to the same periods a year ago. This was
due to the restructuring charges of $429 million recorded during the fiscal
third quarter of 2007 offset by the change in product mix, primarily due to the
RISPERDAL® oral loss
of exclusivity during 2008. The fiscal third quarter of 2008 included a
settlement of $200 million received from Amgen partially offset by inventory
write-offs.
Medical
Devices and Diagnostics Segment
Operating
profit for the Medical Devices and Diagnostics segment as a percent to sales in
the first fiscal nine months of 2008 was 29.5% versus 21.1% over the same period
a year ago. Operating profit as a percent to sales in the fiscal third quarter
of 2008 was 29.0% versus 21.7% over the same period a year ago. The primary
driver of the improvement in the operating profit margin in the Medical Devices
and Diagnostics segment for both periods in 2008 versus the same period a year
ago was due to favorable mix and manufacturing efficiencies in 2008 as well as
the restructuring charges of $301 million recorded during the fiscal third
quarter of 2007. Additionally, the first fiscal nine months of 2007 included
acquisition related IPR&D charges of $807 million versus lower IPR&D
charges of $40 million incurred during the fiscal nine months of
2008.
Interest
(Income) Expense
Interest
income decreased in both the first fiscal nine months and fiscal third quarter
of 2008 as compared to the same periods a year ago, due to lower rates of
interest earned, despite higher average cash balances. The ending balance of
cash, cash equivalents and marketable securities, was $14.8 billion at the end
of the fiscal third quarter of 2008. This is an increase of $6.5 billion from
the same period a year ago. The increase was primarily due to cash generated
from operating activities.
Interest
expense increased in both the first fiscal nine months and fiscal third quarter
of 2008 as compared to the same periods a year ago, due to a higher debt
position of $14.6 billion at the end of the fiscal third quarter of 2008,
compared to $7.9 billion from the same period a year ago. The higher debt
balance was due to increased borrowings primarily to purchase common stock under
the ongoing Common Stock repurchase program announced on July 9,
2007.
Provision
For Taxes on Income
The
worldwide effective income tax rates for the first fiscal nine months of 2008
and 2007 were 23.7% and 25.1%, respectively. The decrease in the effective tax
rate of 1.4% was primarily due to the lower in-process research and development
(IPR&D) charge of $40 million with no tax benefit recorded in the first
fiscal nine months of 2008 versus the higher IPR&D charges of $807 million
with no tax benefit recorded in the first fiscal nine months of
2007. This benefit is reduced by higher taxes in 2008 due to
the expiration of the Research and Development (R&D) credit at the end of
2007. The R&D credit was extended as part of the Emergency Economic
Stabilization Act of 2008, signed in October of 2008 but is not included in
the results of the first fiscal nine months of 2008.
At
September 28, 2008 the Company had approximately $1.7 billion of liabilities
from unrecognized tax benefits. During the third quarter of 2008, the U.S.
Internal Revenue Service (IRS) completed its audit for the years 2000 through
2002. The Company’s audit settlement with the IRS resulted in a reduction
of the unrecognized tax benefits by approximately $150 million and had minimal
impact on the effective tax rate. However, the years 2000 through 2002 remain
open for a limited number of issues to be considered at the IRS appeals level.
The Company does not expect that the total amount of unrecognized tax benefits
will change significantly during the next twelve months.
See Note
8 to the Consolidated Financial Statements in the Annual Report on Form 10-K for
the fiscal year ended December 30, 2007 for more detailed information regarding
unrecognized tax benefits.
LIQUIDITY
AND CAPITAL RESOURCES
Cash
Flows
Cash
generated from business operations provided the major sources of funds for the
growth of the business, including working capital, capital expenditures, and
acquisitions. In the first fiscal nine months of 2008, cash flow from operations
was $11.0 billion, an increase of $0.1 million over the same period a year ago.
This was a result of growth in net income of $2.0 billion offset by reduced
IPR&D charges of $0.8 billion. The changes in current and non current assets
and liabilities were $1.1 billion unfavorable. The major changes decreasing cash
flow were related to $0.8 billion in accounts payable, $1.2 billion in accrued
liabilities, and long term liabilities of $0.6 billion, which were partially
offset by favorable changes in current and non current assets of $1.0 billion
and deferred taxes of $0.5 billion versus the same period a year ago. Net cash
used by investing activities decreased by $3.1 billion primarily due to a
decrease of $1.0 billion in acquisition activity and an increase of $2.4 billion
in the maturity and sales of investments, net of purchases. This decrease was
partially offset by a $0.2 billion decrease in proceeds from the disposal of
assets versus the same period a year ago which included the divestitures of
certain consumer products related to the acquisition of Consumer Healthcare
business of Pfizer Inc. in the first quarter of 2007. Net cash used by financing
activities decreased by $0.9 billion versus the same period a year ago. The
decrease was primarily due to an increase of $3.9 billion in net proceeds from
short and long-term debt and an increase of $0.4 billion in proceeds from the
exercise of stock options partially offset by an increase of $0.3 million in
dividends and an increase of $3.2 billion for the repurchase of common stock
primarily associated with the stock repurchase program announced on July 9,
2007. Cash and current marketable securities were $14.8 billion at the end of
the fiscal third quarter of 2008 as compared with $8.3 billion at fiscal third
quarter of 2007, an increase of $6.5 billion, primarily due to cash generated
from operating activities. At the end of September, the Company renewed its
expiring 364-day credit facility for $6.3 billion. In addition the Company
signed a new five-year credit facility for $1.4 billion to replace an existing
one, both of which had AAA credit ratings affirmed.
Dividends
On July
21, 2008, the Board of Directors declared a regular cash dividend of $0.460 per
share, which was paid on September 9, 2008 to shareholders of record as of
August 26, 2008.
On
October 16, 2008, the Board of Directors declared a regular cash dividend of
$0.460 per share, payable on December 9, 2008 to shareholders of record as of
November 25, 2008. The Company expects to continue the practice of paying
regular quarterly cash dividends.
OTHER
INFORMATION
New
Accounting Standards
During
the fiscal first quarter of 2008, the Company adopted Statement of Financial
Accounting Standards (SFAS) No. 157, Fair
Value Measurements. This statement defines fair value, establishes a
framework for measuring fair value in generally accepted accounting principles,
and expands disclosures about fair value measurements. This statement was
adopted in the fiscal first quarter of 2008 except for non-financial assets and
liabilities recognized or disclosed at fair value on a non-recurring basis, for
which the effective date is fiscal years beginning after November 15, 2008. See
Note 13 for more details.
During
the fiscal first quarter of 2008, the Company adopted SFAS No.159, Fair
Value Option for Financial Assets and Financial Liabilities, which
permits an entity to measure financial assets and financial liabilities at fair
value. See Note 13 for more details.
During
the fiscal first quarter of 2008, the Company adopted EITF Issue 07-03 Accounting
for Nonrefundable Advance Payments for Goods or Services Received for Use in
Future Research and Development Activities. This issue requires
nonrefundable advance payments for research and development to be capitalized
and recognized as an expense as related goods are delivered or services are
performed. The adoption of EITF Issue 07-03 did not have a significant impact on
the Company’s results of operation, cash flows or financial
position.
In
December 2007, the Financial Accounting Standards Board (FASB) issued SFAS
Statements No.141(R), Business
Combinations, and No. 160, Noncontrolling
Interests in Consolidated Financial Statements. These statements aim to
improve, simplify, and converge internationally the accounting for business
combinations and the reporting of noncontrolling interests in consolidated
financial statements. These statements are effective for fiscal years beginning
after December 15, 2008. SFAS No.141(R) will have a significant impact on the
manner in which the Company accounts for future acquisitions beginning in the
fiscal year 2009. Significant changes include the capitalization of IPR&D,
expensing of acquisition related restructuring actions and transaction related
costs and the recognition of contingent purchase price consideration at fair
value at the acquisition date. In addition, changes in accounting for deferred
tax asset valuation allowances and acquired income tax uncertainties after the
measurement period will be recognized in earnings rather than as an adjustment
to the cost of acquisition. This accounting treatment is applicable to
acquisitions that occurred both prior and subsequent to the adoption of SFAS No.
141(R). The Company believes that the adoption of SFAS No. 141(R) and SFAS
No.160 will not have a material effect on its results of operations, cash flows
or financial position.
In March
2008, the FASB issued SFAS Statement No. 161, Disclosures
About Derivative Instruments and Hedging Activities, to enhance the
disclosure regarding the Company’s derivative and hedging activities to improve
the transparency of financial reporting. This statement is effective for fiscal
years beginning after November 15, 2008. The adoption of SFAS No. 161 is not
expected to have a significant impact on the Company’s results of operations,
cash flow or financial position.
EITF
Issue 07-01:
Accounting
for Collaborative Arrangements Related to the Development and Commercialization
of Intellectual Property. This issue is effective for financial
statements issued for fiscal years beginning after December 15, 2008. This issue
addresses the income statement classification of payments made between parties
in a collaborative arrangement. The adoption of EITF 07-01 is not expected to
have a significant impact on the Company’s results of operations, cash flows or
financial position.
Economic
and Market Factors
Johnson
& Johnson is aware that its products are used in an environment where, for
more than a decade, policymakers, consumers and businesses have expressed
concern about the rising cost of health care. Johnson & Johnson
has a long-standing policy of pricing products responsibly. For the period 1997
through 2007 in the United States, the weighted average compound annual growth
rate of Johnson & Johnson price increases for health care products
(prescription and over-the-counter drugs, hospital and professional products)
was below the U.S. Consumer Price Index (CPI).
Inflation
rates continue to have an effect on worldwide economies and, consequently, on
the way companies operate. In the face of increasing costs, the Company strives
to maintain its profit margins through cost reduction programs, productivity
improvements and periodic price increases. The Company faces various
worldwide health care changes that may result in pricing pressures that include
health care cost containment and government legislation relating to sales,
promotions and reimbursement.
The
Company also operates in an environment increasingly hostile to intellectual
property rights. Generic drug firms have filed Abbreviated New Drug Applications
seeking to market generic forms of most of the Company's key pharmaceutical
products, prior to expiration of the applicable patents covering those products.
In the event the Company is not successful in defending a lawsuit resulting from
an Abbreviated New Drug Application filing, the generic firms will then
introduce generic versions of the product at issue, resulting in very
substantial market share and revenue losses. For further information see the
discussion on “Litigation Against Filers of Abbreviated New Drug Applications”
included in Item 1. Financial Statements (unaudited)- Notes to Consolidated
Financial Statements, Note 12.
CAUTIONARY
FACTORS THAT MAY AFFECT FUTURE RESULTS
This Form
10-Q contains forward-looking statements. Forward- looking statements do not
relate strictly to historical or current facts and anticipate results based on
management's plans that are subject to uncertainty. Forward-looking statements
may be identified by the use of words like "plans," "expects," "will,"
"anticipates," "estimates" and other words of similar meaning in conjunction
with, among other things, discussions of future operations, financial
performance, the Company's strategy for growth, product development, regulatory
approval, market position and expenditures.
Forward-looking
statements are based on current expectations of future events. The Company
cannot guarantee that any forward- looking statement will be accurate, although
the Company believes that it has been reasonable in its expectations and
assumptions. Investors should realize that if underlying assumptions prove
inaccurate or that unknown risks or uncertainties materialize, actual results
could vary materially from the Company's expectations and projections. Investors
are therefore cautioned not to place undue reliance on any forward-looking
statements. The Company does not undertake to update any
forward-looking statements as a result of new information or future events
or developments.
Risks and
uncertainties include general industry conditions and competition; economic
conditions; interest rate and currency exchange rate fluctuations; technological
advances, new products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory approvals; challenges
to patents; U.S. and foreign health care reforms and governmental laws and
regulations; trends toward health care cost containment; increased scrutiny of
the health care industry by government agencies; product efficacy or safety
concerns resulting in product recalls or regulatory action.
The
Company's Annual Report on Form 10-K for the fiscal year ended December 30, 2007
contains, as an Exhibit, a discussion of additional factors that could cause
actual results to differ from expectations. The Company notes these factors as
permitted by the Private Securities Litigation Reform Act of 1995.
Item 3 –
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
There has
been no material change in the Company's assessment of its
sensitivity to market risk since its presentation set forth in Item
7A, "Quantitative and Qualitative Disclosures About Market
Risk," in
its Annual Report on Form 10-K for the fiscal year ended December
30, 2007.
Item 4 -
CONTROLS AND PROCEDURES
Disclosure
controls and procedures. At the end of the period covered by this report, the
Company evaluated the effectiveness of the design and operation of its
disclosure controls and procedures. The Company’s disclosure controls
and procedures are designed to ensure that information required to be disclosed
by the Company in the reports that it files or submits under the Securities
Exchange Act is recorded, processed, summarized and reported, within the time
periods specified in the SEC’s rules and forms. Disclosure controls
and procedures include, without limitation, controls and procedures designed to
ensure that information required to be disclosed by the Company in the reports
that it files or submits under the Securities Exchange Act is accumulated and
communicated to the Company’s management, including its principal executive and
principal financial officers, or persons performing similar functions, as
appropriate to allow timely decisions regarding required
disclosure. William C. Weldon, Chairman and Chief Executive Officer,
and Dominic J. Caruso, Vice President, Finance and Chief Financial
Officer, reviewed and participated in this
evaluation. Based on this evaluation, Messrs. Weldon and Caruso
concluded that, as of the end of the period covered by this report, the
Company's disclosure controls and procedures were effective.
Internal
control. During the period covered by this report, there were no
changes in the Company's internal control over financial reporting that have
materially affected, or are reasonably likely to materially affect, the
Company’s internal control over financial reporting.
Part II –
OTHER INFORMATION
Item 1 –
LEGAL PROCEEDINGS
The
information called for by this item is incorporated herein by reference to Note
12 included in Part I, Item 1, Financial Statements (unaudited) - Notes to
Consolidated Financial Statements.
Item 2 –
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
(c)
Purchases of Equity Securities by the Issuer and Affiliated
Purchasers.
The
following table provides information with respect to Common Stock purchases by
the Company during the fiscal third quarter of 2008. Common Stock
purchases on the open market are made as part of a systematic plan related to
the Company’s compensation programs.
Fiscal
Month
|
|
Total
Number of Shares Purchased (1)
|
|
|
Average
Price Paid per Share
|
|
|
Total
Number of Shares Purchased as Part of Publicly Announced Plans or
Programs
|
|
|
Remaining
Maximum Number of Shares that May Be Purchased Under the Plans or Programs
(2)
|
|
June
30, 2008 through July 27, 2008
|
|
|
6,933,200 |
|
|
$ |
65.25 |
|
|
|
3,113,000 |
|
|
|
|
July
28, 2008 through August 24, 2008
|
|
|
7,884,188 |
|
|
$ |
70.10 |
|
|
|
- |
|
|
|
|
August
25, 2008 through September 28, 2008
|
|
|
16,324,800 |
|
|
$ |
70.51 |
|
|
|
10,881,100 |
|
|
|
|
Total
|
|
|
31,142,188 |
|
|
|
|
|
|
|
13,994,100 |
(3) |
|
|
37,350,014 |
|
(1)
During the fiscal third quarter of 2008, the Company repurchased an aggregate of
13,994,100 shares of Johnson & Johnson Common Stock pursuant to the
repurchase program that was publicly announced on July 9, 2007 and an aggregate
of 17,148,088 shares in open-market transactions outside of the program. The
repurchase program has no time limit and may be suspended for periods or
discontinued at any time.
(2) As of
September 28, 2008, based on the closing price of the Company’s Common Stock on
the New York Stock Exchange on September 26, 2008 of $69.40 per
share.
(3) As of
September 28, 2008, an aggregate of 113,763,400 shares were purchased for a
total of $7.4 billion since the inception of the repurchase program announced on
July 9, 2007.
Item 6 –
EXHIBITS
Exhibit
31.1 Certifications under Rule 13a-14(a) of the Securities
Exchange Act pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002 – Filed with this document.
Exhibit
32.1 Certifications pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 – Furnished with
this document.
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its
behalf by the undersigned thereunto duly authorized.
JOHNSON
& JOHNSON
(Registrant)
Date: November
4, 2008
By /s/ D. J.
CARUSO
D.
J. CARUSO
Vice
President, Finance;
Chief
Financial Officer
|
(Principal Financial Officer)
|
Date: November
4, 2008 By /s/
S. J. COSGROVE
S.
J. COSGROVE
Controller
|
(Principal Accounting
Officer)
|