e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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þ |
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Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
for the quarterly period ended September 27, 2009
or
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o |
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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)
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NEW JERSEY
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22-1024240 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
One Johnson & Johnson Plaza
New Brunswick, New Jersey 08933
(Address of principal executive offices)
Registrants 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.
þ Yes o No
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files). þ Yes o No
Indicate by check mark whether the
registrant is a large accelerated filer, an accelerated filer, a non-accelerated
filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
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Large accelerated filer þ |
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Accelerated filer o
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Non-accelerated filer o (Do not check if a smaller reporting
company) |
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Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). o Yes þ No
Indicate the number of shares outstanding of each of the issuers classes of common stock, as
of the latest practicable
date.
On October 25, 2009 2,759,099,726 shares of Common Stock, $1.00 par value, were outstanding.
JOHNSON & JOHNSON AND SUBSIDIARIES
TABLE OF CONTENTS
2
Part I FINANCIAL INFORMATION
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Item 1 |
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FINANCIAL STATEMENTS |
JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited; Dollars in Millions)
ASSETS
|
|
|
|
|
|
|
|
|
|
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September 27, 2009 |
|
December 28, 2008 |
Current assets: |
|
|
|
|
|
|
|
|
Cash & cash equivalents |
|
$ |
11,856 |
|
|
$ |
10,768 |
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|
Marketable securities |
|
|
2,481 |
|
|
|
2,041 |
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Accounts receivable, trade, less
allowances for doubtful accounts
$316 (2008,$268) |
|
|
10,279 |
|
|
|
9,719 |
|
|
Inventories (Note 4) |
|
|
5,568 |
|
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|
5,052 |
|
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Deferred taxes on income |
|
|
2,650 |
|
|
|
3,430 |
|
|
Prepaid expenses and other
receivables |
|
|
2,768 |
|
|
|
3,367 |
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Total current assets |
|
|
35,602 |
|
|
|
34,377 |
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Marketable securities, non-current |
|
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19 |
|
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|
4 |
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|
Property, plant and equipment at
cost |
|
|
29,452 |
|
|
|
27,392 |
|
|
Less: accumulated depreciation |
|
|
(14,637 |
) |
|
|
(13,027 |
) |
|
Property, plant and equipment, net |
|
|
14,815 |
|
|
|
14,365 |
|
|
Intangible assets, net (Note 5) |
|
|
16,636 |
|
|
|
13,976 |
|
|
Goodwill, net (Note 5) |
|
|
15,017 |
|
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|
13,719 |
|
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Deferred taxes on income |
|
|
5,888 |
|
|
|
5,841 |
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Other assets |
|
|
3,581 |
|
|
|
2,630 |
|
|
Total assets |
|
$ |
91,558 |
|
|
$ |
84,912 |
|
See Notes to Consolidated Financial Statements
3
JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited; Dollars in Millions)
LIABILITIES AND SHAREHOLDERS EQUITY
|
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|
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September 27, 2009 |
|
December 28, 2008 |
Current liabilities: |
|
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|
|
|
|
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Loans and notes payable |
|
$ |
3,341 |
|
|
$ |
3,732 |
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Accounts payable |
|
|
6,419 |
|
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|
7,503 |
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Accrued liabilities |
|
|
4,862 |
|
|
|
5,531 |
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Accrued rebates, returns and
promotions |
|
|
2,123 |
|
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|
2,237 |
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|
Accrued salaries, wages and
commissions |
|
|
1,471 |
|
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|
1,432 |
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|
Accrued taxes on income |
|
|
1,029 |
|
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|
417 |
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|
Total current liabilities |
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|
19,245 |
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|
20,852 |
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Long-term debt |
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|
8,259 |
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|
8,120 |
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Deferred taxes on income |
|
|
1,505 |
|
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|
1,432 |
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Employee related obligations |
|
|
7,111 |
|
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|
7,791 |
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Other liabilities |
|
|
5,054 |
|
|
|
4,206 |
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Total liabilities |
|
|
41,174 |
|
|
|
42,401 |
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Shareholders equity: |
|
|
|
|
|
|
|
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|
Common stock par value $1.00 per
share (authorized 4,320,000,000
shares; issued 3,119,843,000 shares) |
|
|
3,120 |
|
|
|
3,120 |
|
|
Accumulated other comprehensive
income (Note 8) |
|
|
(2,661 |
) |
|
|
(4,955 |
) |
|
Retained earnings |
|
|
69,471 |
|
|
|
63,379 |
|
|
Less: common stock held in treasury,
at cost (361,821,040 and 350,665,000
shares) |
|
|
19,546 |
|
|
|
19,033 |
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|
Total shareholders equity |
|
|
50,384 |
|
|
|
42,511 |
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|
Total liabilities and
shareholders equity |
|
$ |
91,558 |
|
|
$ |
84,912 |
|
See Notes to Consolidated Financial Statements
4
JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF EARNINGS
(Unaudited; dollars & shares in millions
except per share amounts)
|
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|
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Fiscal Quarters Ended |
|
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Percent |
|
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|
Percent |
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|
Sept. 27, |
|
to |
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Sept. 28, |
|
to |
|
|
2009 |
|
Sales |
|
2008 |
|
Sales |
Sales to customers (Note 6) |
|
$ |
15,081 |
|
|
|
100.0 |
% |
|
$ |
15,921 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
4,434 |
|
|
|
29.4 |
|
|
|
4,774 |
|
|
|
30.0 |
|
|
|
|
|
|
|
|
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|
|
|
|
|
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Gross profit |
|
|
10,647 |
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|
70.6 |
|
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|
11,147 |
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|
70.0 |
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
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Selling, marketing and
administrative expenses |
|
|
4,767 |
|
|
|
31.6 |
|
|
|
5,195 |
|
|
|
32.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Research expense |
|
|
1,617 |
|
|
|
10.7 |
|
|
|
1,861 |
|
|
|
11.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Interest income |
|
|
(28 |
) |
|
|
(0.2 |
) |
|
|
(97 |
) |
|
|
(0.6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net of
portion capitalized |
|
|
142 |
|
|
|
0.9 |
|
|
|
122 |
|
|
|
0.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Other income, net |
|
|
(96 |
) |
|
|
(0.6 |
) |
|
|
(224 |
) |
|
|
(1.4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Earnings before provision for
taxes on income |
|
|
4,245 |
|
|
|
28.2 |
|
|
|
4,290 |
|
|
|
26.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for taxes on income
(Note 3) |
|
|
900 |
|
|
|
6.0 |
|
|
|
980 |
|
|
|
6.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET EARNINGS |
|
$ |
3,345 |
|
|
|
22.2 |
% |
|
$ |
3,310 |
|
|
|
20.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
NET EARNINGS PER SHARE (Note 7) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
1.21 |
|
|
|
|
|
|
$ |
1.19 |
|
|
|
|
|
Diluted |
|
$ |
1.20 |
|
|
|
|
|
|
$ |
1.17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
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|
CASH DIVIDENDS PER SHARE |
|
$ |
0.490 |
|
|
|
|
|
|
$ |
0.460 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AVG. SHARES OUTSTANDING |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
2,756.3 |
|
|
|
|
|
|
|
2,790.9 |
|
|
|
|
|
Diluted |
|
|
2,793.0 |
|
|
|
|
|
|
|
2,831.3 |
|
|
|
|
|
See Notes to Consolidated Financial Statements
5
JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF EARNINGS
(Unaudited; dollars & shares in millions
except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Nine Months Ended |
|
|
|
|
|
|
Percent |
|
|
|
|
|
Percent |
|
|
Sept. 27, |
|
to |
|
Sept. 28, |
|
to |
|
|
2009 |
|
Sales |
|
2008 |
|
Sales |
Sales to customers (Note 6) |
|
$ |
45,346 |
|
|
|
100.0 |
% |
|
$ |
48,565 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
13,135 |
|
|
|
29.0 |
|
|
|
14,139 |
|
|
|
29.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
32,211 |
|
|
|
71.0 |
|
|
|
34,426 |
|
|
|
70.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, marketing and
administrative expenses |
|
|
14,172 |
|
|
|
31.3 |
|
|
|
15,825 |
|
|
|
32.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research expense |
|
|
4,773 |
|
|
|
10.5 |
|
|
|
5,469 |
|
|
|
11.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In-process research &
development (IPR&D) |
|
|
|
|
|
|
|
|
|
|
40 |
|
|
|
0.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
(78 |
) |
|
|
(0.2 |
) |
|
|
(268 |
) |
|
|
(0.6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net of
portion capitalized |
|
|
358 |
|
|
|
0.8 |
|
|
|
325 |
|
|
|
0.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
(165 |
) |
|
|
(0.4 |
) |
|
|
(377 |
) |
|
|
(0.8 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings before provision for
taxes on income |
|
|
13,151 |
|
|
|
29.0 |
|
|
|
13,412 |
|
|
|
27.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for taxes on income
(Note 3) |
|
|
3,091 |
|
|
|
6.8 |
|
|
|
3,177 |
|
|
|
6.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET EARNINGS |
|
$ |
10,060 |
|
|
|
22.2 |
% |
|
$ |
10,235 |
|
|
|
21.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET EARNINGS PER SHARE (Note 7) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
3.64 |
|
|
|
|
|
|
$ |
3.64 |
|
|
|
|
|
Diluted |
|
$ |
3.61 |
|
|
|
|
|
|
$ |
3.60 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH DIVIDENDS PER SHARE |
|
$ |
1.44 |
|
|
|
|
|
|
$ |
1.335 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AVG. SHARES OUTSTANDING |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
2,760.0 |
|
|
|
|
|
|
|
2,811.9 |
|
|
|
|
|
Diluted |
|
|
2,787.9 |
|
|
|
|
|
|
|
2,847.8 |
|
|
|
|
|
See Notes to Consolidated Financial Statements
6
JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited; Dollars in Millions)
|
|
|
|
|
|
|
|
|
|
|
Fiscal Nine Months Ended |
|
|
Sept. 27, |
|
Sept. 28, |
|
|
2009 |
|
2008 |
CASH FLOW FROM OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
Net earnings |
|
$ |
10,060 |
|
|
$ |
10,235 |
|
Adjustments to reconcile net earnings to cash
flows from operating activities: |
|
|
|
|
|
|
|
|
Depreciation
and amortization of property
and intangibles |
|
|
2,030 |
|
|
|
2,117 |
|
Stock based compensation |
|
|
499 |
|
|
|
524 |
|
Purchased in-process research and development |
|
|
|
|
|
|
40 |
|
Decrease/(Increase) in deferred tax provision |
|
|
541 |
|
|
|
(354 |
) |
Accounts receivable allowances |
|
|
39 |
|
|
|
62 |
|
Changes in assets and liabilities, net of
effects from acquisitions: |
|
|
|
|
|
|
|
|
Increase in accounts receivable |
|
|
(61 |
) |
|
|
(790 |
) |
Increase in inventories |
|
|
(250 |
) |
|
|
(348 |
) |
Decrease in accounts payable
and accrued liabilities |
|
|
(1,830 |
) |
|
|
(1,103 |
) |
Increase in other current and non-current
assets |
|
|
(35 |
) |
|
|
(2 |
) |
Increase in other current and non-current
liabilities |
|
|
291 |
|
|
|
590 |
|
|
|
|
|
|
|
|
|
|
NET CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
11,284 |
|
|
|
10,971 |
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
Additions to property, plant and equipment |
|
|
(1,521 |
) |
|
|
(1,938 |
) |
Proceeds from the disposal of assets |
|
|
12 |
|
|
|
56 |
|
Acquisitions, net of cash acquired |
|
|
(2,337 |
) |
|
|
(400 |
) |
Purchases of investments |
|
|
(5,922 |
) |
|
|
(1,434 |
) |
Sales of investments |
|
|
4,697 |
|
|
|
2,079 |
|
Other |
|
|
(163 |
) |
|
|
(36 |
) |
|
|
|
|
|
|
|
|
|
NET CASH USED BY INVESTING ACTIVITIES |
|
|
(5,234 |
) |
|
|
(1,673 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
Dividends to shareholders |
|
|
(3,974 |
) |
|
|
(3,750 |
) |
Repurchase of common stock |
|
|
(1,172 |
) |
|
|
(5,773 |
) |
Proceeds from short-term debt |
|
|
3,903 |
|
|
|
5,194 |
|
Retirement of short-term debt |
|
|
(4,012 |
) |
|
|
(1,649 |
) |
Proceeds from long-term debt |
|
|
9 |
|
|
|
1,640 |
|
Retirement of long-term debt |
|
|
(224 |
) |
|
|
(16 |
) |
Proceeds from the exercise of stock
options/excess tax benefits |
|
|
300 |
|
|
|
1,360 |
|
|
|
|
|
|
|
|
|
|
NET CASH USED BY FINANCING ACTIVITIES |
|
|
(5,170 |
) |
|
|
(2,994 |
) |
7
|
|
|
|
|
|
|
|
|
|
|
Fiscal Nine Months Ended |
|
|
Sept. 27, |
|
Sept. 28, |
|
|
2009 |
|
2008 |
Effect of exchange rate changes on cash and
cash equivalents |
|
|
208 |
|
|
|
(56 |
) |
Increase in cash and cash equivalents |
|
|
1,088 |
|
|
|
6,248 |
|
Cash and Cash equivalents, beginning of period |
|
|
10,768 |
|
|
|
7,770 |
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS, END OF PERIOD |
|
$ |
11,856 |
|
|
$ |
14,018 |
|
|
|
|
|
|
|
|
|
|
Acquisitions |
|
|
|
|
|
|
|
|
Fair value of assets acquired |
|
$ |
3,193 |
|
|
$ |
416 |
|
Fair value of liabilities assumed and noncontrolling interests |
|
|
(856 |
) |
|
|
(16 |
) |
Net cash paid for acquisitions |
|
$ |
2,337 |
|
|
$ |
400 |
|
See Notes to Consolidated Financial Statements
8
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 Companys Annual
Report on Form 10-K for the fiscal year ended December 28, 2008. 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 third quarter of 2009, the Company adopted The FASB Accounting Standards
Codification (ASC or Codification) and the Hierarchy of Generally Accepted Accounting Principles
(GAAP) which establishes the Codification as the sole source for authoritative U.S. GAAP and will
supersede all accounting standards in U.S. GAAP, aside from those issued by the SEC. The adoption
of the Codification did not have an impact on the Companys results of operations, cash flows or
financial position. Since the adoption of the Accounting Standards Codification (ASC) the Companys
notes to the consolidated financial statements will no longer make reference to Statement of
Financial Accounting Standards (SFAS) or other U.S. GAAP pronouncements.
During the fiscal second quarter of 2009, in accordance with U.S. GAAP, the Company adopted the
standards on subsequent events. This pronouncement establishes standards of accounting for and
disclosure of events that occur after the balance sheet date but before financial statements are
issued. See Note 13 for additional information.
During the fiscal first quarter of 2009, in accordance with U.S. GAAP, the Company adopted the
standards on business combinations and 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 have a significant impact on the manner in which the Company accounts
for acquisitions beginning in the fiscal year 2009. Significant changes include the capitalization
of in process research and development (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 for taxes is applicable to acquisitions that occurred
9
both prior and subsequent to the adoption of the standard. Operating profit attributable to noncontrolling
interests are reported in Other (Income)Expense, net and the related tax impact to the Provision
for Taxes. Additionally, equity attributable to noncontrolling interests is recorded in Other
Non-Current liabilities. Noncontrolling interests as related to the Companys financial statements
are immaterial and therefore, not separately disclosed. The adoption of these standards did not
have a material impact on the Companys results of operations, cash flows or financial position.
During the fiscal first quarter of 2009, in accordance with U.S. GAAP, the Company adopted the
standard related to disclosures about derivative instruments and hedging activities, to enhance the
disclosure regarding the Companys derivative and hedging activities to improve the transparency of
financial reporting. The adoption of this standard did not have a significant impact on the Companys results of operations, cash flows or
financial position. See Note 2 for enhanced disclosures.
During the fiscal first quarter of 2009, in accordance with U.S. GAAP, the Company adopted the
standard on collaborative arrangements related to the development and commercialization of
intellectual property. This standard addresses the income statement classification of payments made
between parties in a collaborative arrangement.
The Company enters into collaborative arrangements, typically with other pharmaceutical or
biotechnology companies, to develop and commercialize drug candidates or intellectual property.
These arrangements typically involve two (or more) parties who are active participants in the
collaboration and are exposed to significant risks and rewards dependent on the commercial success
of the activities. These collaborations usually involve various activities by one or more parties,
including research and development, marketing and selling and distribution. Often, these
collaborations require upfront, milestone and royalty or profit share payments, contingent upon the
occurrence of certain future events linked to the success of the asset in development. Amounts due
from collaborative partners related to development activities are generally reflected as a
reduction of research and development expense because the performance of contract development
services is not central to the Companys operations. In general, the income statement presentation
for these collaborations is as follows:
|
|
|
Nature / Type of Collaboration
|
|
Statement of Earnings Presentation |
|
|
|
Third party sale of product
|
|
Sales to customers |
|
|
|
Royalties / milestones paid to
collaborative partner (post-regulatory
approval)*
|
|
Cost of goods sold |
|
|
|
Royalties received from collaborative partner
|
|
Other income (expense), net |
|
|
|
Upfront payments & milestones paid to
collaborative partner (pre-regulatory
approval)
|
|
Research expense |
10
|
|
|
Nature / Type of Collaboration
|
|
Statement of Earnings Presentation |
|
Research and development payments to
collaborative partner
|
|
Research expense |
|
|
|
Research and development payments
received from collaborative partner
|
|
Reduction of Research expense |
|
|
|
* |
|
Milestones are capitalized as intangible assets and amortized to cost of goods sold over the
useful life. |
The impact of the adoption of this standard related to all collaboration agreements that existed as
of September 27, 2009 and December 28, 2008 was immaterial to the Companys results of operations,
cash flows or financial position.
During the fiscal first quarter of 2009, in accordance with U.S. GAAP, the Company adopted the
standard related to defensive intangible assets. This standard applies to
acquired intangible assets in situations in which an entity does not intend to actively use the
asset but intends to hold the asset to prevent others from obtaining access to the asset, except
for intangible assets that are used in research and development activities. The adoption of this
standard did not have a significant impact on the Companys results of operations, cash flows or
financial position.
During the fiscal first quarter of 2008, in accordance with U.S. GAAP, the Company adopted the
standard related to fair value measurements except for non-financial assets and liabilities
recognized or disclosed at fair value on a non-recurring basis, which became effective during the
first fiscal quarter of 2009. The effect of adoption on December 29, 2008 of this standard for
non-financial assets and liabilities recorded at fair value on a nonrecurring basis did not have a
material impact on the Companys financial position and results of operations.
NOTE 2 FINANCIAL INSTRUMENTS
During the fiscal first quarter of 2009, in accordance with U.S. GAAP the Company adopted the
standard related to disclosures about derivative instruments and hedging activities. This standard
requires qualitative disclosures about objectives and strategies for using derivatives,
quantitative disclosures about fair value amounts of gain and losses on derivative instruments, and
disclosures about credit-risk-related contingent features in derivative agreements.
The Company uses forward exchange contracts to manage its exposure to the variability of cash
flows, primarily related to the foreign exchange rate changes of future intercompany product and
third- party purchases of raw materials denominated in foreign currency. The Company also uses
cross currency interest rate swaps to manage currency risk primarily related to borrowings. Both
types of derivatives are designated as cash flow hedges. The Company also uses forward exchange
contracts to manage its exposure to the variability of cash flows for repatriation of foreign
dividends. These contracts are designated as net investment hedges. Additionally, the Company
uses forward exchange contracts to
11
offset its exposure to certain foreign currency assets and
liabilities. These forward exchange contracts are not designated as hedges and therefore, changes
in the fair values of these derivatives are recognized in earnings, thereby offsetting the current
earnings effect of the related foreign currency assets and liabilities. The Company does not enter
into derivative financial instruments for trading or speculative purposes, or contain credit risk
related contingent features or requirements to post collateral. On an ongoing basis the Company
monitors counterparty credit ratings. The Company considers credit non-performance risk to be low,
because the Company enters into agreements with commercial institutions that have at least an A (or
equivalent) credit rating. As of September 27, 2009, the Company had notional amounts outstanding
for forward foreign exchange contracts and cross currency interest rate swaps of $23 billion and $4
billion, respectively.
As
required by the ASC for derivative instruments and hedging activities, all derivative instruments
are to be recorded on the balance sheet at fair value. Changes in the fair value of derivatives are
recorded each period in current earnings or other comprehensive income, depending on whether the
derivative is designated as part of a hedge transaction, and if so, the type of hedge transaction.
The designation as a cash flow hedge is made at the entrance date into the derivative contract. At
inception, all derivatives are expected to be highly effective. Changes in the fair value of a
derivative that is designated as a cash flow hedge and is highly effective are recorded in
accumulated other comprehensive income until the underlying transaction affects earnings, and are
then reclassified to earnings in the same account as the hedged transaction. Gains/losses on net
investment hedges are accounted for through the currency translation account and are insignificant.
On an ongoing basis, the Company assesses whether each derivative continues to be highly effective
in offsetting changes in the cash flows of hedged items. If and when a derivative is no longer
expected to be highly effective, hedge accounting is discontinued. Hedge ineffectiveness, if any,
is included in current period earnings in other (income) and expense, net, and was insignificant
for the fiscal quarters and fiscal nine months ended September 27, 2009 and September 28, 2008.
Refer to Note 8 for disclosures of movements in Accumulated Other Comprehensive Income.
As of September 27, 2009, the balance of deferred net gains on derivatives included in accumulated
other comprehensive income was $48 million after-tax. For additional information, see Note 8. The
Company expects that substantially all of the amount related to foreign exchange contracts will be
reclassified into earnings over the next 12 months as a result of transactions that are expected to
occur over that period. The maximum length of time over which the Company is hedging transaction
exposure is 18 months. 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.
12
The following table is a summary of the activity for the fiscal third quarter and fiscal nine
months ended September 27, 2009 related to designated derivatives as defined in the codification:
(Dollars in Millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain/ (Loss) |
|
Gain/ (Loss) |
|
|
|
|
|
|
|
|
|
|
|
|
recognized in |
|
reclassed from |
|
|
|
|
|
Gain/ (Loss) |
|
|
|
|
|
|
Accumulated |
|
Accumulated OCI |
|
|
|
|
|
recognized in |
|
|
|
|
Cash Flow Hedges |
|
OCI (1) |
|
into income (1) |
|
|
|
|
|
income (2) |
|
|
|
|
|
|
|
|
|
|
Nine |
|
|
|
|
|
Nine |
|
|
|
|
|
|
|
|
|
Nine |
|
|
|
|
|
|
Quarter |
|
Months |
|
Quarter |
|
Months |
|
|
|
|
|
Quarter |
|
Months |
|
|
|
|
|
|
ended |
|
Ended |
|
ended |
|
Ended |
|
|
|
|
|
ended |
|
Ended |
|
|
|
|
Foreign exchange contracts |
|
$ |
27 |
|
|
$ |
(19 |
) |
|
$ |
(6 |
) |
|
$ |
(14 |
) |
|
|
(A) |
|
|
$ |
2 |
|
|
$ |
(2 |
) |
|
|
(E) |
|
Foreign exchange contracts |
|
|
(124 |
) |
|
|
(189 |
) |
|
|
3 |
|
|
|
37 |
|
|
|
(B) |
|
|
|
(2 |
) |
|
|
6 |
|
|
|
(E) |
|
Foreign exchange contracts |
|
|
(23 |
) |
|
|
(7 |
) |
|
|
|
|
|
|
22 |
|
|
|
(C) |
|
|
|
1 |
|
|
|
1 |
|
|
|
(E) |
|
Cross currency interest rate swaps |
|
|
(49 |
) |
|
|
144 |
|
|
|
(14 |
) |
|
|
(21 |
) |
|
|
(D) |
|
|
|
|
|
|
|
|
|
|
|
(E) |
|
Foreign exchange contracts |
|
|
(11 |
) |
|
|
22 |
|
|
|
(3 |
) |
|
|
|
|
|
|
(E) |
|
|
|
(11 |
) |
|
|
(10 |
) |
|
|
(E) |
|
Total |
|
$ |
(180 |
) |
|
$ |
(49 |
) |
|
$ |
(20 |
) |
|
$ |
24 |
|
|
|
|
|
|
$ |
(10 |
) |
|
$ |
(5 |
) |
|
|
|
|
|
|
|
(1) |
|
Effective portion |
|
(2) |
|
Ineffective portion |
|
(A) |
|
Included in Sales to customer |
|
(B) |
|
Included in Cost of products sold |
|
(C) |
|
Included in Research expense |
|
(D) |
|
Included in Interest (Income)/Interest Expense, net |
|
(E) |
|
Included in Other (Income)/Expense, net |
For the fiscal quarter and the fiscal nine months ended September 27, 2009, a gain of $16 million
and $20 million, respectively, was recognized in Other (income)/expense, net, relating to foreign
exchange contracts not designated as hedging instruments under the codification.
During the fiscal first quarter of 2008, in accordance with U.S. GAAP, the Company adopted the
standard related to fair value measurements except for non-financial assets and liabilities
recognized or disclosed at fair value on a non-recurring basis, which became effective during the
first fiscal quarter of 2009. The effect of adoption on December 29, 2008 of this standard for
non-financial assets and liabilities recorded at fair value on a nonrecurring basis did not have a
material impact on the Companys financial position and results of operations. This standard
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 the standard
related to fair value option for financial assets and financial liabilities. This
standard permits the Company to
13
measure certain financial assets and financial liabilities at fair
value. The Company assessed the fair value option made available upon adopting this standard, and
has elected not to apply the fair value option to any financial instruments that were not already
recognized at fair value.
The ASC 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 authoritative
literature 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 fair value of a derivative financial instrument (i.e. forward exchange contract, currency swap)
is the aggregation by currency of all future cash flows discounted to its present value at the
prevailing market interest rates and subsequently converted to the U.S. dollar at the current spot
foreign exchange rate. The Company does not believe that fair values of these derivative
instruments materially differ 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 Companys results of
operations, cash flows or financial position. The Company also holds equity investments which are
classified as level 1 since they are traded in an active exchange market. The Company did not have
any other significant financial assets or liabilities which would require revised valuations under
this standard that are recognized at fair value.
The Companys significant financial assets and liabilities measured at fair value as of September
27, 2009 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted prices |
|
|
|
|
|
|
in active |
|
Significant |
|
|
|
|
markets for |
|
other |
|
Significant |
|
|
identical |
|
observable |
|
unobservable |
|
|
assets |
|
inputs |
|
inputs |
(Dollars in Millions) |
|
Level 1 |
|
Level 2 |
|
Level 3 |
Derivatives designated as hedging instruments : |
|
|
|
|
|
|
|
|
|
|
|
|
Other Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
$ |
511 |
|
|
|
|
|
Cross currency interest rate swaps |
|
|
|
|
|
|
144 |
|
|
|
|
|
Total |
|
|
|
|
|
|
655 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
906 |
|
|
|
|
|
Cross currency interest rate swaps |
|
|
|
|
|
|
749 |
|
|
|
|
|
Total |
|
|
|
|
|
|
1,655 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives not designated as hedging instruments : |
|
|
|
|
|
|
|
|
|
|
|
|
14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted prices |
|
|
|
|
|
|
in active |
|
Significant |
|
|
|
|
markets for |
|
other |
|
Significant |
|
|
identical |
|
observable |
|
unobservable |
|
|
assets |
|
inputs |
|
inputs |
(Dollars in Millions) |
|
Level 1 |
|
Level 2 |
|
Level 3 |
Other Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
52 |
|
|
|
|
|
|
Other Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
53 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Equity Investments |
|
$ |
821 |
|
|
|
|
|
|
|
|
|
Financial Instruments not measured at Fair Value:
The
following financial assets and liabilities are held at carrying amount on the consolidated
balance sheet:
|
|
|
|
|
|
|
|
|
|
|
Carrying |
|
Estimated |
(Dollars in Millions) |
|
Amount |
|
Fair Value |
Financial Assets |
|
|
|
|
|
|
|
|
Current Investments |
|
|
|
|
|
|
|
|
Cash |
|
$ |
3,356 |
|
|
$ |
3,356 |
|
|
Government securities and obligations |
|
|
8,571 |
|
|
|
8,572 |
|
Corporate debt securities |
|
|
268 |
|
|
|
268 |
|
Money market funds |
|
|
1,359 |
|
|
|
1,359 |
|
Time deposits |
|
|
783 |
|
|
|
783 |
|
|
|
|
|
|
|
|
|
|
Total cash, cash equivalents and current marketable securities |
|
$ |
14,337 |
|
|
$ |
14,338 |
|
|
|
|
|
|
|
|
|
|
Non-Current Investments |
|
|
|
|
|
|
|
|
Marketable securities |
|
$ |
19 |
|
|
$ |
19 |
|
|
|
|
|
|
|
|
|
|
Financial Liabilities |
|
|
|
|
|
|
|
|
Current Debt |
|
$ |
3,341 |
|
|
$ |
3,341 |
|
Non-Current Debt |
|
|
|
|
|
|
|
|
5.15% Debentures due 2012 |
|
|
600 |
|
|
|
658 |
|
3.80% Debentures due 2013 |
|
|
500 |
|
|
|
534 |
|
5.55% Debentures due 2017 |
|
|
1,000 |
|
|
|
1,127 |
|
5.15% Debentures due 2018 |
|
|
898 |
|
|
|
995 |
|
4.75% Notes due 2019 (1B Euro 1.4796) |
|
|
1,470 |
|
|
|
1,574 |
|
3% Zero Coupon Convertible Subordinated Debentures due in 2020 |
|
|
188 |
|
|
|
229 |
|
6.73% Debentures due 2023 |
|
|
250 |
|
|
|
299 |
|
5.50% Notes
due 2024 (500 GBP 1.6210) |
|
|
803 |
|
|
|
878 |
|
6.95% Notes due 2029 |
|
|
294 |
|
|
|
363 |
|
4.95% Debentures due 2033 |
|
|
500 |
|
|
|
470 |
|
5.95% Notes due 2037 |
|
|
995 |
|
|
|
1,175 |
|
5.86% Debentures due 2038 |
|
|
700 |
|
|
|
792 |
|
Other (Includes Industrial Revenue Bonds) |
|
|
61 |
|
|
|
61 |
|
Total Non-Current Debt |
|
$ |
8,259 |
|
|
$ |
9,155 |
|
15
The weighted average effective rate on non-current debt is 5.42%.
Fair value of government securities and obligations and non-current marketable securities was
estimated using quoted broker prices in active markets.
Fair value of the non-current debt was estimated using market prices, which were corroborated by
quoted broker prices in active markets.
NOTE 3 INCOME TAXES
The worldwide effective income tax rates for the fiscal nine months of 2009 and 2008 were 23.5% and
23.7%, respectively. The lower effective tax rate was primarily due to the U.S. Research tax
credit which was not in effect in the first fiscal nine months of 2008.
NOTE 4 INVENTORIES
|
|
|
|
|
|
|
|
|
|
|
September 27, |
|
December 28, |
(Dollars in Millions) |
|
2009 |
|
2008 |
Raw materials and supplies |
|
$ |
824 |
|
|
$ |
839 |
|
Goods in process |
|
|
1,554 |
|
|
|
1,372 |
|
Finished goods |
|
|
3,190 |
|
|
|
2,841 |
|
Total |
|
$ |
5,568 |
|
|
$ |
5,052 |
|
NOTE 5 INTANGIBLE ASSETS AND GOODWILL
Intangible assets that have finite useful lives are amortized over their estimated useful lives.
The latest impairment assessment of goodwill and indefinite lived intangible assets was completed
in the fiscal fourth quarter of 2008. Future impairment tests for goodwill and indefinite lived
intangible assets will be performed annually in the fiscal fourth quarter, or sooner if warranted.
16
|
|
|
|
|
|
|
|
|
|
|
September 27, |
|
December 28, |
(Dollars in Millions) |
|
2009 |
|
2008 |
Trademarks
(non-amortizable) gross |
|
$ |
6,128 |
|
|
$ |
5,879 |
|
Less accumulated amortization |
|
|
147 |
|
|
|
145 |
|
Trademarks
(non-amortizable) net |
|
|
5,981 |
|
|
|
5,734 |
|
|
Patents and trademarks gross |
|
|
5,704 |
|
|
|
5,119 |
|
Less accumulated amortization |
|
|
2,106 |
|
|
|
1,820 |
|
Patents and
trademarks net |
|
|
3,598 |
|
|
|
3,299 |
|
|
Other amortizable intangibles gross |
|
|
8,090 |
|
|
|
7,376 |
|
Less accumulated amortization |
|
|
2,701 |
|
|
|
2,433 |
|
Other
intangibles net |
|
|
5,389 |
|
|
|
4,943 |
|
|
Purchased in process research and
development (nonamortizable) gross* |
|
|
1,668 |
|
|
|
|
|
|
Total intangible assets gross |
|
|
21,590 |
|
|
|
18,374 |
|
Less accumulated amortization |
|
|
4,954 |
|
|
|
4,398 |
|
Total intangible assets net |
|
$ |
16,636 |
|
|
$ |
13,976 |
|
|
|
|
* |
|
Purchased in process research and development will be accounted for as an indefinite-lived
intangible asset until regulatory approval or discontinuation. |
Goodwill as of September 27, 2009 was allocated by segment of business as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Med Dev |
|
|
(Dollars in Millions) |
|
Consumer |
|
Pharm |
|
& Diag |
|
Total |
Goodwill, net
at December 28, 2008 |
|
$ |
7,474 |
|
|
$ |
963 |
|
|
$ |
5,282 |
|
|
$ |
13,719 |
|
Acquisitions |
|
|
|
|
|
|
284 |
|
|
|
376 |
|
|
|
660 |
|
Translation & Other** |
|
|
754 |
|
|
|
17 |
|
|
|
(133 |
) |
|
|
638 |
|
Goodwill, net as of
September 27, 2009 |
|
$ |
8,228 |
|
|
$ |
1,264 |
|
|
$ |
5,525 |
|
|
$ |
15,017 |
|
|
|
|
** |
|
Includes currency translation, reclassification between segments and other adjustments. |
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 27, 2009 was $509 million, and the estimated
amortization expense for the five succeeding years approximates
$750 million, per year.
17
NOTE 6 SEGMENTS OF BUSINESS AND GEOGRAPHIC AREAS
(Dollars in Millions)
SALES BY SEGMENT OF BUSINESS (1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Quarters Ended |
|
|
Sept. 27, |
|
Sept. 28, |
|
Percent |
(Dollars in Millions) |
|
2009 |
|
2008 |
|
Change |
Consumer |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
$ |
1,691 |
|
|
$ |
1,769 |
|
|
|
(4.4 |
)% |
International |
|
|
2,298 |
|
|
|
2,330 |
|
|
|
(1.4 |
) |
Total |
|
|
3,989 |
|
|
|
4,099 |
|
|
|
(2.7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceutical |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
2,857 |
|
|
|
3,538 |
|
|
|
(19.2 |
) |
International |
|
|
2,392 |
|
|
|
2,575 |
|
|
|
(7.1 |
) |
Total |
|
|
5,249 |
|
|
|
6,113 |
|
|
|
(14.1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Medical Devices &
Diagnostics |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
2,766 |
|
|
|
2,648 |
|
|
|
4.5 |
|
International |
|
|
3,077 |
|
|
|
3,061 |
|
|
|
0.5 |
|
Total |
|
|
5,843 |
|
|
|
5,709 |
|
|
|
2.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Worldwide |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
7,314 |
|
|
|
7,955 |
|
|
|
(8.1 |
) |
International |
|
|
7,767 |
|
|
|
7,966 |
|
|
|
(2.5 |
) |
Total |
|
$ |
15,081 |
|
|
$ |
15,921 |
|
|
|
(5.3 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Nine Months Ended |
|
|
Sept. 27, |
|
Sept. 28, |
|
Percent |
(Dollars in Millions) |
|
2009 |
|
2008 |
|
Change |
Consumer |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
$ |
5,125 |
|
|
$ |
5,282 |
|
|
|
(3.0 |
)% |
International |
|
|
6,429 |
|
|
|
6,917 |
|
|
|
(7.1 |
) |
Total |
|
|
11,554 |
|
|
|
12,199 |
|
|
|
(5.3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceutical |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
9,703 |
|
|
|
11,401 |
|
|
|
(14.9 |
) |
International |
|
|
6,824 |
|
|
|
7,481 |
|
|
|
(8.8 |
) |
Total |
|
|
16,527 |
|
|
|
18,882 |
|
|
|
(12.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Medical Devices &
Diagnostics |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
8,194 |
|
|
|
7,959 |
|
|
|
3.0 |
|
International |
|
|
9,071 |
|
|
|
9,525 |
|
|
|
(4.8 |
) |
Total |
|
|
17,265 |
|
|
|
17,484 |
|
|
|
(1.3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Worldwide |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
23,022 |
|
|
|
24,642 |
|
|
|
(6.6 |
) |
International |
|
|
22,324 |
|
|
|
23,923 |
|
|
|
(6.7 |
) |
Total |
|
$ |
45,346 |
|
|
$ |
48,565 |
|
|
|
(6.6 |
)% |
|
|
|
(1) |
|
Export sales are not significant. |
18
OPERATING PROFIT BY SEGMENT OF BUSINESS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Quarters Ended |
|
|
Sept. 27, |
|
Sept. 28, |
|
Percent |
(Dollars in Millions) |
|
2009 |
|
2008 |
|
Change |
Consumer |
|
$ |
812 |
|
|
$ |
764 |
|
|
|
6.3 |
% |
Pharmaceutical |
|
|
1,637 |
|
|
|
2,003 |
|
|
|
(18.3 |
) |
Medical Devices
& Diagnostics |
|
|
2,016 |
|
|
|
1,657 |
|
|
|
21.7 |
|
Segments total |
|
|
4,465 |
|
|
|
4,424 |
|
|
|
(0.9 |
) |
Expense not allocated to
segments (2) |
|
|
(220 |
) |
|
|
(134 |
) |
|
|
|
|
Worldwide total |
|
$ |
4,245 |
|
|
$ |
4,290 |
|
|
|
(1.0 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Nine Months Ended |
|
|
Sept. 27, |
|
Sept. 28, |
|
Percent |
(Dollars in Millions) |
|
2009 |
|
2008 |
|
Change |
Consumer |
|
$ |
2,307 |
|
|
$ |
2,175 |
|
|
|
6.1 |
% |
Pharmaceutical |
|
|
5,595 |
|
|
|
6,513 |
|
|
|
(14.1 |
) |
Medical Devices
& Diagnostics (1) |
|
|
5,891 |
|
|
|
5,159 |
|
|
|
14.2 |
|
Segments total |
|
|
13,793 |
|
|
|
13,847 |
|
|
|
(0.4 |
) |
Expense not allocated to
segments (2) |
|
|
(642 |
) |
|
|
(435 |
) |
|
|
|
|
Worldwide total |
|
$ |
13,151 |
|
|
$ |
13,412 |
|
|
|
(1.9 |
)% |
|
|
|
(1) |
|
Includes $40 million of in-process research and development (IPR&D) charges related to the
acquisition of Amic AB completed in the fiscal second quarter of 2008. |
|
(2) |
|
Amounts not allocated to segments include interest income/(expense) and general corporate
income/(expense). |
SALES BY GEOGRAPHIC AREA
(Dollars in Millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Quarters Ended |
|
|
Sept. 27, |
|
Sept. 28, |
|
Percent |
(Dollars in Millions) |
|
2009 |
|
2008 |
|
Change |
U.S. |
|
$ |
7,314 |
|
|
$ |
7,955 |
|
|
|
(8.1 |
)% |
Europe |
|
|
3,879 |
|
|
|
4,076 |
|
|
|
(4.8 |
) |
Western Hemisphere,
excluding U.S. |
|
|
1,338 |
|
|
|
1,461 |
|
|
|
(8.4 |
) |
Asia-Pacific, Africa |
|
|
2,550 |
|
|
|
2,429 |
|
|
|
5.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
15,081 |
|
|
$ |
15,921 |
|
|
|
(5.3 |
)% |
19
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Nine Months Ended |
|
|
Sept. 27, |
|
Sept. 28, |
|
Percent |
(Dollars in Millions) |
|
2009 |
|
2008 |
|
Change |
U.S. |
|
$ |
23,022 |
|
|
$ |
24,642 |
|
|
|
(6.6 |
)% |
Europe |
|
|
11,522 |
|
|
|
12,931 |
|
|
|
(10.9 |
) |
Western Hemisphere,
excluding U.S. |
|
|
3,615 |
|
|
|
3,986 |
|
|
|
(9.3 |
) |
Asia-Pacific, Africa |
|
|
7,187 |
|
|
|
7,006 |
|
|
|
2.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
45,346 |
|
|
$ |
48,565 |
|
|
|
(6.6 |
)% |
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 27, 2009 and September 28, 2008.
|
|
|
|
|
|
|
|
|
|
|
Fiscal Quarters Ended |
|
|
September 27, |
|
September 28, |
(Shares in Millions) |
|
2009 |
|
2008 |
Basic net earnings per share |
|
$ |
1.21 |
|
|
$ |
1.19 |
|
Average
shares outstanding basic |
|
|
2,756.3 |
|
|
|
2,790.9 |
|
Potential shares exercisable under
stock option plans |
|
|
174.5 |
|
|
|
242.0 |
|
Less: shares which could be
repurchased under treasury stock
method |
|
|
(141.4 |
) |
|
|
(205.3 |
) |
Convertible debt shares |
|
|
3.6 |
|
|
|
3.7 |
|
Average
shares outstanding diluted |
|
|
2,793.0 |
|
|
|
2,831.3 |
|
Diluted earnings per share |
|
$ |
1.20 |
|
|
$ |
1.17 |
|
The diluted earnings per share calculation for the fiscal third quarters ended September 27, 2009
and September 28, 2008 included the dilutive effect of convertible debt that was offset by the
related reduction in interest expense.
The diluted earnings per share calculation for the fiscal third quarter ended September 27, 2009
excluded 77 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 27, 2009 and September 28, 2008.
20
|
|
|
|
|
|
|
|
|
|
|
Fiscal Nine Months Ended |
|
|
September 27, |
|
September 28, |
(Shares in Millions) |
|
2009 |
|
2008 |
Basic net earnings per share |
|
$ |
3.64 |
|
|
$ |
3.64 |
|
Average
shares outstanding basic |
|
|
2,760.0 |
|
|
|
2,811.9 |
|
Potential shares exercisable under
stock option plans |
|
|
103.9 |
|
|
|
241.5 |
|
Less: shares which could be
repurchased under treasury stock
method |
|
|
(79.6 |
) |
|
|
(209.3 |
) |
Convertible debt shares |
|
|
3.6 |
|
|
|
3.7 |
|
Average
shares outstanding diluted |
|
|
2,787.9 |
|
|
|
2,847.8 |
|
Diluted earnings per share |
|
$ |
3.61 |
|
|
$ |
3.60 |
|
The diluted earnings per share calculation for both the fiscal nine months ended September 27, 2009
and September 28, 2008 included the dilutive effect of convertible debt that was offset by the
related reduction in interest expense.
The diluted earnings per share calculation for the fiscal nine months ended September 27, 2009 and
September 28, 2008, excluded 148 million shares and 1 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 fiscal nine months ended September 27, 2009 was $12.3 billion,
compared with $10.0 billion for the same period a year ago. Total comprehensive income for the
fiscal third quarter ended September 27, 2009 was $5.1 billion, compared with $1.8 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.
21
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
Unrld |
|
|
|
|
|
Gains/ |
|
Accum |
|
|
For. |
|
Gains/ |
|
Employee |
|
(Losses) |
|
Other Comp |
|
|
Cur. |
|
(Losses) |
|
Benefit |
|
on Deriv |
|
Inc/ |
(Dollars in Millions) |
|
Trans. |
|
on Sec |
|
Plans |
|
& Hedges |
|
(Loss) |
December 28, 2008 |
|
$ |
(1,871 |
) |
|
|
25 |
|
|
|
(3,230 |
) |
|
|
121 |
|
|
|
(4,955 |
) |
2009 nine months change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change associated
with current period
hedging transactions |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(28 |
) |
|
|
|
|
Net amount reclassed to
net earnings |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(45 |
) * |
|
|
|
|
Net nine months change |
|
|
2,268 |
|
|
|
(10 |
) |
|
|
109 |
|
|
|
(73 |
) |
|
|
2,294 |
|
September 27, 2009 |
|
$ |
397 |
|
|
|
15 |
|
|
|
(3,121 |
) |
|
|
48 |
|
|
|
(2,661 |
) |
|
|
|
* |
|
Substantially offset in net earnings by changes in value of the underlying transactions. |
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.
NOTE 9 BUSINESS COMBINATIONS AND DIVESTITURES
During the
fiscal third quarter of 2009, the Company acquired
substantially all of the assets and
rights of Elans Alzheimers Immunotherapy Program through a newly formed company, of which Johnson
& Johnson owns 50.1% and Elan owns 49.9%. In addition, the
Company purchased approximately 107 million newly issued American
Depositary Receipts (ADRs) of Elan, representing 18.4% of Elans
outstanding ordinary shares. As part of this transaction, Johnson
& Johnson paid $0.9 billion to Elan and committed to fund up to
$0.2 billion of Elans share of research and development
spending by the newly formed company. Of this total consideration of
$1.1 billion, $0.8 billion represents the fair value of the 18.4%
investment in Elan based on Elans share price in an actively
traded market as of the date of this transaction. The remaining $0.3
billion represents the consideration for Johnson &
Johnsons 50.1% interest in the newly formed company. This
transaction resulted in acquired in-process research and development
(IPR&D) for $0.7 billion and a noncontrolling interest of $0.6
billion, which Johnson & Johnson has recorded in other
non-current liabilities.
During the fiscal third quarter of 2009, the Company acquired Cougar Biotechnology, Inc., a
development stage biopharmaceutical company with specific focus on oncology, for a net purchase
price of $1.0 billion. The purchase price for the acquisition was allocated primarily to purchased
IPR&D for $1.0 billion, goodwill for $0.3 billion and deferred tax liability for $0.3 billion.
During the fiscal first quarter of 2009, the Company acquired Mentor Corporation, a leading
supplier of medical products for the global aesthetic market, for a net purchase price of $1.1
billion. The purchase price for the acquisition was allocated primarily to amortizable intangible
assets for $0.9 billion and goodwill for $0.4 billion.
During the fiscal third quarter of 2008 the Company acquired Beijing Dabao Cosmetics Co., Ltd., a
company that sells personal care brands in China.
22
During the fiscal second quarter of 2008, the Company acquired Amic AB for a purchase price of $44
million in cash and debt. Amic AB is 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.
NOTE 10 PENSIONS AND OTHER POSTRETIREMENT BENEFITS
Components of Net Periodic Benefit Cost
Net periodic benefit cost for the Companys defined benefit retirement plans and other benefit
plans for the fiscal third quarters of 2009 and 2008 include the following components:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Retirement Plans |
|
Other Benefit Plans |
|
|
Fiscal Quarters Ended |
|
|
Sept. 27, |
|
Sept. 28, |
|
Sept. 27, |
|
Sept. 28, |
(Dollars in Millions) |
|
2009 |
|
2008 |
|
2009 |
|
2008 |
Service cost |
|
$ |
114 |
|
|
|
126 |
|
|
|
33 |
|
|
|
35 |
|
Interest cost |
|
|
188 |
|
|
|
177 |
|
|
|
43 |
|
|
|
43 |
|
Expected return on
plan assets |
|
|
(240 |
) |
|
|
(220 |
) |
|
|
|
|
|
|
(1 |
) |
Amortization of prior
service cost |
|
|
4 |
|
|
|
2 |
|
|
|
(2 |
) |
|
|
(1 |
) |
Recognized actuarial
losses |
|
|
35 |
|
|
|
16 |
|
|
|
13 |
|
|
|
15 |
|
Curtailments and
settlements |
|
|
(11 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net periodic benefit cost |
|
$ |
90 |
|
|
|
101 |
|
|
|
87 |
|
|
|
91 |
|
Net periodic benefit cost for the Companys defined benefit retirement plans and other benefit
plans for the fiscal nine months of 2009 and 2008 include the following components:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Retirement Plans |
|
Other Benefit Plans |
|
|
Fiscal Nine Months Ended |
|
|
Sept. 27, |
|
Sept. 28, |
|
Sept. 27, |
|
Sept. 28, |
(Dollars in Millions) |
|
2009 |
|
2008 |
|
2009 |
|
2008 |
Service cost |
|
$ |
348 |
|
|
|
381 |
|
|
|
103 |
|
|
|
106 |
|
Interest cost |
|
|
555 |
|
|
|
534 |
|
|
|
128 |
|
|
|
126 |
|
Expected return on
plan assets |
|
|
(695 |
) |
|
|
(666 |
) |
|
|
(1 |
) |
|
|
(2 |
) |
Amortization of prior
service cost |
|
|
9 |
|
|
|
8 |
|
|
|
(4 |
) |
|
|
(4 |
) |
Amortization of net
transition asset |
|
|
1 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
Recognized actuarial
losses |
|
|
117 |
|
|
|
47 |
|
|
|
41 |
|
|
|
48 |
|
Curtailments and
settlements |
|
|
(11 |
) |
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net periodic benefit cost |
|
$ |
324 |
|
|
|
309 |
|
|
|
267 |
|
|
|
274 |
|
23
Company Contributions
For the fiscal nine months ended September 27, 2009, the Company contributed $828 million and $19
million to its U.S. and international retirement plans, respectively. In 2006, Congress passed the
Pension Protection Act of 2006. The Act amended the Employee Retirement Income Security Act (ERISA)
for plan years beginning after 2007 and established new minimum funding standards for U.S. employer
defined benefit plans. The Company plans to continue to fund its U.S. defined benefit plans to
comply with the Pension Protection Act of 2006. 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 Companys Pharmaceuticals segment has reduced 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 has moved 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. This program allowed
the Company to accelerate 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. Additionally, as part of this initiative, the
Company eliminated approximately 4,200 positions.
The Company recorded $745 million in pre-tax charges during the fiscal third quarter of 2007, of
which, approximately, $500 million of the pre-tax restructuring charges required cash payments. The
$745 million of restructuring charges included 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 related 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 2009:
|
|
|
|
|
(Dollars in Millions) |
|
Severance |
Reserve balance as of: |
|
|
|
|
December 28, 2008 |
|
$ |
178 |
|
Cash outlays |
|
|
(108 |
) |
September 27, 2009* |
|
$ |
70 |
|
24
|
|
|
* |
|
Substantially all cash outlays related to the remaining reserve balance for severance is expected
to be paid out in the fourth quarter of 2009 in accordance with the Companys plans and local laws. |
NOTE 12 LEGAL PROCEEDINGS
PRODUCT LIABILITY
The Companys subsidiaries are involved in numerous product liability cases in the United States,
many of which concern alleged 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 Companys 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®, LEVAQUIN®, the CYPHER® Stent
and the CHARITÉ Artificial Disc. There are approximately 467 claimants who have pending lawsuits
or claims regarding injuries allegedly due to ORTHO EVRA®, 425 with respect to RISPERDAL®, 280
with respect to CHARITÉ, 276 with respect to LEVAQUIN®, 110 with respect to DURAGESIC® and 63 with
respect to CYPHER®. 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 Companys subsidiary, Janssen
Pharmaceutica Inc. (Janssen) (now Ortho-McNeil-Janssen Pharmaceuticals Inc. (OMJPI)), 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 (now OMJPI) was found liable and damages were
assessed at $4.5 million. OMJPI has filed an appeal.
25
Numerous claims and lawsuits in the United States relating to the drug PROPULSID®, withdrawn from
general sale by the Companys Janssen (now OMJPI) subsidiary in 2000, have been resolved or are
currently enrolled in settlement programs with an aggregate cap below $100 million. Similar
litigation concerning PROPULSID® is pending in Canada, where a national class action of persons
alleging adverse reactions to the drug has been certified and a settlement program instituted with
an aggregate cap below $10 million.
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. 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. The net settlement of $472 million was recorded as a credit to other
(income) expense, net in the 2008 consolidated statement of earnings. On September 29, 2009, Cordis
settled this case with Boston Scientific together with the Kasenthofer/Fontirroche and Ding cases
described below, for a net payment of $716 million which will be recorded in the fiscal fourth
quarter of 2009. As part of that settlement Boston Scientific received a paid up license to the
Fontirroche family of patents worldwide and Cordis received a paid license to the Kastenhofer and
Ding families of patents worldwide. In addition, in May 2009, Medtronic paid $270 million to
settle additional patent infringement claims asserted by Cordis based on its vascular stent
patents, which was recorded as a credit to other (income) expense, net in the fiscal second quarter
of 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. On March 31, 2009, the U.S. Court of Appeals for the Federal Circuit affirmed this
judgment. The case has been remanded to the district court for a trial on damages and willfulness.
Cordis also filed a lawsuit in Delaware Federal District Court in October of 2008 alleging that
Boston
26
Scientifics sale of Taxus® Liberte® since June of 2005 infringes Cordis Gray patent.
Cordis has pending several lawsuits in New Jersey and Delaware Federal District Court against
Guidant Corporation (Guidant), Abbott Laboratories, Inc. (Abbott), 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.
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 Scientifics Ding 536 patent and that the Cordis CYPHER® and BX VELOCITY® Stents
also infringed Boston Scientifics Jang 021 patent. The jury also found both of those patents
valid. Boston Scientific seeks substantial damages and an injunction in those actions. Cordis
appealed. On January 15, 2009, the Court of Appeals for the Federal Circuit held the Ding patent
invalid. In March of 2009, the Court of Appeals for the Federal Circuit denied Boston Scientifics
motion for reconsideration. On March 31, 2009, the Court of Appeals for the Federal Circuit upheld
the judgment that Cordis CYPHER® stent infringed Boston Scientifics Jang patent. The Court of
Appeals denied Cordis application for reconsideration. The case has been remanded for a trial on
the issues of damages and willfulness. Boston Scientific is not seeking injunctive relief.
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. 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 Scientifics 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. These cases have been settled as part of the September 29, 2009 settlement
described above.
Trial in Boston Scientifics 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
27
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 Scientifics post trial motions. On April 9, 2009, the Court ruled that Boston Scientific
will be required to pay Cordis a royalty of 5.1% of all infringing sales of catheters and stent
delivery systems from October 2007 as long as they practice the patented invention. The Court
entered judgment against Boston Scientific in the amount of $26 million. Boston Scientific has
filed an appeal. This case was settled as part of the September 29, 2009 settlement described
above.
In May 2008, Centocor, Inc. (Centocor) (now Centocor Ortho Biotech Inc. (COBI)) filed a lawsuit
against Genentech, Inc. (Genentech) in U.S. District Court for the Central District of California
seeking to invalidate the Cabilly II patent. Prior to filing suit, Centocor had a sublicense under
this patent from Celltech (who was licensed by Genentech) for REMICADE® and had been paying
royalties to Celltech. Centocor has terminated that sublicense and stopped paying royalties.
Genentech has filed a counterclaim alleging that REMICADE® infringes its Cabilly II patents and
that the manufacture of REMICADE®, ustekinumab, golimumab and ReoPro infringe one of its patents
relating to the purification of antibodies made through recombinant DNA techniques. The court has
scheduled a hearing for Summary Judgment Motions in August 2010.
In April 2009, a bench trial was held before the Federal District Court for the Middle District of
Florida on the liability phase of Cibas patent infringement lawsuit alleging that Johnson &
Johnson Vision Care, Inc.s ACUVUE® OASYS lenses infringe three of their Nicholson patents. In
August 2009, the District Court found two of these patents valid and infringed. On October 12,
2009, Ciba asked the Court to schedule another trial to determine damages and Cibas request for a
permanent injunction.
In May 2009, Abbott Biotechnology Ltd. filed a patent infringement lawsuit against Centocor (now
COBI) in the United States District Court for the District of Massachusetts. The suit alleges that
Centocors SIMPONI® product, a human anti TNF alpha antibody, which was recently approved by the
FDA, infringes Abbotts 394 patent (the Salfeld patent). The case has been stayed pending the
resolution of an arbitration filed by Centocor directed to its claim that it is licensed under the
394 patent.
In August 2009, Abbott GmbH & Co. (Abbott GmbH) and Abbott Bioresearch Center filed a patent
infringement lawsuit against COBI in the United States District Court for the District of
Massachusetts. The suit alleges that COBIs STELARA® product infringes two U.S. Patents assigned
to Abbott GmbH. In August 2009, COBI filed a complaint for a declaratory judgment of
non-infringement and invalidity of the Abbott GmbH patents in the United States District Court for
the District of Columbia. On the same date, also in the United States District Court for the
District of Columbia, COBI filed a Complaint for Review of a Patent Interference Decision granting
priority of invention on one of the two asserted patents to Abbott GmbH. In August 2009, Abbott
GmbH and Abbott Laboratories Limited brought a patent
28
infringement suit in Canada alleging that STELARAâ infringes Abbott GmbHs Canadian patent.
In August 2009, Bayer Healthcare LLC filed suit against COBI in Massachusetts District Court
alleging infringement by COBIs SIMPONIâ product of its patent relating to human anti-TNF
antibodies. To date, Bayer has not served the complaint on COBI.
In June 2009, Centocors (now COBI) lawsuit alleging that Abbotts HUMIRA anti TNF alpha product
infringes Centocors 775 patent went to trial in Federal District Court in the Eastern District of
Texas. On June 28, 2009 a jury returned a verdict finding the patent valid and willfully infringed,
and awarded Centocor damages of approximately $1.7 billion. All of Abbotts post trial motions have
been denied except that the district court granted Abbotts motion to overturn the jury finding of
willfulness. A bench trial on Abbotts defenses, of inequitable conduct and prosecution laches, was
held on August 4, 2009, and the parties are awaiting decision as to these issues.
The following chart summarizes various patent lawsuits concerning products of Johnson & Johnson
subsidiaries that have yet to proceed to trial:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Plaintiff/ |
|
|
|
Trial |
|
Date |
J&J Product |
|
Company |
|
Patents |
|
Patent Holder |
|
Court |
|
Date |
|
Filed |
CYPHERâ Stent |
|
Cordis |
|
Wall |
|
Wall |
|
E.D. TX |
|
04/11 |
|
11/07 |
CYPHERâ Stent |
|
Cordis |
|
Saffran |
|
Saffran |
|
E.D. TX |
|
06/11 |
|
10/07 |
Blood Glucose
Meters and Strips |
|
Lifescan |
|
Wilsey |
|
Roche Diagnostics |
|
D. DE |
|
* |
|
11/07 |
REMICADEâ,
ustekinumab,
golimumab, ReoPro |
|
Centocor/ COBI |
|
Cabilly II |
|
Genentech |
|
C.D. CA |
|
* |
|
05/08 |
SIMPONIâ |
|
Centocor/ COBI |
|
Salfeld |
|
Abbott Laboratories |
|
MA |
|
* |
|
05/09 |
SIMPONIâ |
|
Centocor/ COBI |
|
Boyle |
|
Bayer Healthcare |
|
MA |
|
* |
|
08/09 |
STELARAâ |
|
Centocor/ COBI |
|
Salfeld |
|
Abbott GmbH |
|
MA/DC |
|
* |
|
08/09 |
|
|
|
* |
|
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
29
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 Companys
subsidiary.
As noted in the following chart, 30-month stays expired during 2006, 2007 and 2008, and will expire
in 2009, 2010 and 2011 with respect to ANDA challenges regarding various products:
|
|
|
|
|
|
|
|
|
|
|
|
|
Brand Name |
|
Patent/NDA |
|
Generic |
|
|
|
Trial |
|
Date |
|
30-Month |
Product |
|
Holder |
|
Challenger |
|
Court |
|
Date |
|
Filed |
|
Stay Expiration |
CONCERTAâ
18, 27, 36 and 54 mg
controlled release tablet |
|
McNeil-PPC ALZA |
|
Andrx |
|
D. DE |
|
12/07 |
|
09/05 |
|
None |
LEVAQUINâ 250, 500, 750 mg tablet |
|
Ortho-McNeil |
|
Lupin |
|
D. NJ |
|
* |
|
10/06 |
|
03/09 |
ORTHO TRI-CYCLENâ LO
0.18 mg/0.025 mg, 0.215 mg/ |
|
Ortho-McNeil |
|
Watson |
|
D. NJ |
|
* |
|
10/08 |
|
03/11 |
0.025 mg and
0.25 mg/ 0.025 mg |
|
|
|
Sandoz |
|
D. NJ |
|
* |
|
06/09 |
|
10/11 |
ULTRAMâ ER 100, 200, 300 mg tablet |
|
Ortho- |
|
Par |
|
D. DE |
|
01/09 |
|
05/07 |
|
09/09 |
|
|
McNeil/Biovail |
|
|
|
|
|
|
|
06/07 |
|
11/09 |
|
|
|
|
|
|
|
|
|
|
10/07 |
|
03/10 |
ULTRAMâ ER 100, 200, 300 mg tablet |
|
Ortho- |
|
Impax |
|
D. DE |
|
06/10 |
|
08/08 |
|
01/11 |
|
|
McNeil/Biovail |
|
|
|
|
|
|
|
11/08 |
|
03/11 |
|
|
|
* |
|
Trial date to be scheduled. |
In the action against Barr Pharmaceuticals, Inc. (Barr)(now a wholly-owned subsidiary of Teva
Pharmaceutical Industries LTD.) regarding ORTHO TRI-CYCLENâ LO, on January 22, 2008, the Companys
subsidiary Ortho Womens 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 June 30, 2009, Barr launched its generic product at risk before
trial. OMJPI sought a preliminary injunction and recall of Barr product which the Court granted on
July 21, 2009. On July 23, 2009, the parties entered into a definitive agreement to settle the
lawsuit. Under the terms of the settlement, Barr obtained a release for its sales of its generic
product in exchange for an undisclosed royalty payment. Barr also obtained a non-exclusive,
royalty-bearing license to re-enter the market on December 31, 2015, or earlier in certain limited
circumstances.
In October 2008, the Companys subsidiary OMJPI filed suit in Federal District Court in New Jersey
against Watson Laboratories, Inc. (Watson) in response to Watsons ANDA regarding ORTHO
TRI-CYCLENâ LO.
30
In June 2009, the Companys subsidiary OMJPI filed suit in Federal District Court in New Jersey
against Sandoz Laboratories, Inc. (Sandoz) in response to Sandozs ANDA regarding ORTHO
TRI-CYCLENâ LO.
In the action against Barr and AlphaPharm with respect to their ANDA challenges to the RAZADYNEâ
patent that Janssen (now OMJPI) licenses from Synaptech, Inc. (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 (OMJPI) and Synaptech
have appealed the decision. Since the courts decision, multiple generic companies have received
final approvals for their products and have launched at risk pending appeal. Additional generic
approvals and launches could occur at any time. On September 25, 2009, the Court of Appeals
affirmed the judgment that the patent is invalid.
In the action by McNEIL-PPC, Inc. (McNeil-PPC) and ALZA Corporation (ALZA) against Andrx
Corporation (Andrx) with respect to its ANDA challenge to the CONCERTAâ patents, a five-day
non-jury trial was held in the Federal District Court in Delaware in December 2007. On March 30,
2009, the court ruled that one CONCERTAâ patent would not be infringed by Andrxs proposed generic
product and that the patent was invalid because it was not enabled. The court dismissed without
prejudice Andrxs declaratory judgment suit on a second patent for lack of
jurisdiction. McNeil-PPC and ALZA filed an appeal on May 7, 2009.
In the RAZADYNEâ ER cases, a lawsuit was filed against Barr on the RAZADYNEâ use patent that
Janssen (now OMJPI) licenses from Synaptech in June 2006. In September 2008, the above-discussed
Delaware decision invalidating the RAZADYNEâ use patent resulted in entry of judgment for Barr on
that patent, but the case will be reopened if Janssen (now OMJPI) and Synaptech win on appeal. Barr
has received FDA approval of its product and has launched at risk. On September 25, 2009, the
Federal Circuit affirmed the Delaware decision invalidating the Razadyneâ use patent. As a result,
this case will not be reopened.
In the action against Lupin Pharmaceuticals, Inc. (Lupin) regarding its ANDA concerning LEVAQUINâ,
Lupin contends that the United States Patent and Trademark Office improperly granted a patent term
extension to the patent that Ortho-McNeil (now Ortho-McNeil-Janssen Pharmaceuticals, Inc.
(OMJPI)) licenses from Daiichi Pharmaceuticals, Inc. (Daiichi). Lupin alleges that the active
ingredient in LEVAQUINâ 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. Summary judgment against Lupin was
granted in May 2009 and Lupin appealed. Oral argument was held on September 8, 2009.
In the ULTRAMâ ER actions, Ortho-McNeil Pharmaceutical, Inc. (Ortho-McNeil) (now OMJPI), filed
lawsuits (each for different dosages) against Par Pharmaceuticals, Inc. and Par Pharmaceuticals
31
Companies, Inc. (Par) in May, June and October 2007 on two
Tramadol ER formulation patents owned by Purdue Pharma Products L.P. (Purdue) and Napp
Pharmaceutical Group Ltd. (Napp). OMJPI also filed lawsuits (each for different dosages) against
Impax Laboratories, Inc. (Impax) on a Tramadol ER formulation patent owned by Purdue and Napp in
August and November 2008. Purdue, Napp and Biovail Laboratories International SRL (Biovail)(the NDA
holder) joined as co-plaintiffs in the lawsuits against Par and Impax, but Biovail and OMJPI were
subsequently dismissed for lack of standing. The trial against Par took place on April 16-22, 2009.
On August 14, 2009, the Court issued a decision finding the patents-in-suit invalid. Purdue has
appealed that decision. The trial against Impax is scheduled for June 2010. In September and
October 2009, respectively, Purdue filed suits against Paddock Laboratories, Inc. (Paddock) and
Cipher Pharmaceuticals Inc. (Cipher) on its tramadol ER formulation patents.
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. Many 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. Plaintiffs appealed the Class 1 judgment
and, in September 2009, the Court of Appeals vacated the judgment and remanded for further
proceedings in the District Court. AWP cases brought by various Attorneys General have proceeded to
trial against other manufacturers. Cases including Johnson & Johnson subsidiaries have been set for
trial in 2010 and thereafter.
32
OTHER
In July 2003, Centocor (now COBI), a Johnson & Johnson subsidiary, received a request that it
voluntarily provide documents and information to the criminal division of the U.S. Attorneys
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. Attorneys
Office. Both the Company and Centocor have responded to these requests for documents and
information.
In December 2003, Ortho-McNeil (now OMJPI) received a subpoena from the U.S. Attorneys Office in
Boston, Massachusetts seeking documents relating to the marketing, including alleged off-label
marketing, of the drug TOPAMAXâ (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 are uncertain.
In January 2004, Janssen (now OMJPI) 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,
RISPERDALâ (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 RISPERDALâ
was received from the U.S. Attorneys 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 ongoing requests for documents and
witnesses.
In September 2004, Ortho Biotech Inc. (Ortho Biotech)(now COBI), received a subpoena from the U.S.
Office of Inspector Generals Denver, Colorado field office seeking documents directed to the sales
and marketing of PROCRITâ (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 (now COBI) 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. In July 2009,
plaintiffs filed a motion for certification of a modified class, which the Company will oppose.
Plaintiffs are engaged in further discovery of individual plaintiffs claims.
33
In March 2005, DePuy Orthopaedics, Inc. (DePuy), a Johnson & Johnson subsidiary, received a
subpoena from the U.S. Attorneys 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.
Attorneys Office for the District of New Jersey. The settlements included 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. The term of the
Monitorship under the Deferred Prosecution Agreement concluded on March 27, 2009, and an order
dismissing all charges was entered on March 30, 2009.
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. DePuy is responding to
Massachusetts additional requests.
In July 2005, Scios Inc. (Scios), a Johnson & Johnson subsidiary, received a subpoena from the U.S.
Attorneys Office, District of Massachusetts, seeking documents related to the sales and marketing
of NATRECORâ. Scios is responding to the subpoena. In early August 2005, Scios was advised that the
investigation would be handled by the U.S. Attorneys Office for the Northern District of
California in San Francisco. Additional requests for documents have been received and responded to
and former Scios employees have testified before a grand jury in San Francisco. The qui tam
complaints were unsealed on February 19, 2009. The U.S. government has intervened in one of the qui
tam actions, and filed a complaint against Scios and the Company in June 2009. Scios and Johnson &
Johnson have filed a motion to dismiss the qui tam complaint filed by the government, and that
motion is pending.
In September 2005, the Company received a subpoena from the U.S. Attorneys 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 Companys pharmaceutical
subsidiaries have been subpoenaed to testify before a grand jury in connection with this
investigation. In April 2009, the Company was served with the complaints in two civil qui
tam cases relating to marketing of prescription drugs to Omnicare, Inc. The complaints assert
claims under the federal False Claims Act and related state statutes in connection with
the marketing of several drugs to Omnicare. The government has not yet announced whether it will
intervene in these cases.
34
In November 2005, Amgen Inc. (Amgen) filed suit against Hoffmann-LaRoche, Inc. (Roche) 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 (now COBI) for non-dialysis
indications. Trial in this action concluded in October 2007 with a verdict in Amgens favor,
finding the patents valid and infringed. The judge issued a preliminary injunction blocking the
CERA launch, and subsequently made the injunction permanent. The Federal Circuit upheld the
entry of a permanent injunction.
In February 2006, the Company 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 February 2007, the Company 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 the 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 the DOJ and SEC.
Discussions are underway in an effort to resolve these matters, and the Iraq Oil for Food matter
referenced above, but whether agreement can be reached and on what terms is uncertain.
In March 2007, the Company received separate subpoenas from the U.S. Attorneys Office in
Philadelphia, the U.S. Attorneys Office in Boston and the U.S. Attorneys Office in San Francisco.
The subpoenas relate to investigations by these three offices referenced above concerning,
respectively, sales and marketing of RISPERDALâ by Janssen (now OMJPI), TOPAMAXâ by Ortho-McNeil
(now OMJPI) and NATRECORâ by Scios. The subpoenas request information regarding the Companys
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. Attorneys
office in Boston has issued subpoenas for grand jury testimony to several employees of Johnson &
Johnson.
In May 2007, the New York State Attorney General issued a subpoena seeking information relating to
the marketing and safety of PROCRITâ. 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
35
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 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 November 2008, the EC
issued a preliminary report summarizing its findings. The final report was issued on July 8, 2009.
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, the Company received a subpoena from the United States Attorneys Office for the
District of Massachusetts relating to the marketing of biliary stents by the Companys Cordis
subsidiary. Cordis is cooperating in responding to the subpoena.
In September 2008, Multilan AG (Multilan), 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. A hearing on the matter is scheduled for January 2010.
In February 2009, Basilea Pharmaceutica AG (Basilea) brought an arbitration against the Company and
various affiliates alleging that the Company breached the 2005 License Agreement for ceftobiprole
by, among other things, failing to secure FDA approval of the cSSSI (skin) indication and allegedly
failing to properly develop the pneumonia indication. Basilea is seeking to recover damages and a
declaration that the Company materially breached the agreement.
In April 2009, the Company received a HIPPA subpoena from the U.S. Attorneys Office for the
District of Massachusetts (Boston) seeking information regarding the Companys financial
relationship with several psychiatrists.
In April 2009, Ortho-Clinical Diagnostics, Inc. (OCD) received a grand jury subpoena from the U.S.
Department of Justice, Antitrust Division, requesting documents and information for the period
beginning September 1, 2000 through the present, pertaining to an
36
investigation of alleged
violations of the antitrust laws in the blood reagents industry. The company is in the process of
complying with the subpoena. In the weeks following the public announcement that OCD had received a
subpoena from the Antitrust Division, multiple class action complaints were filed. The various
cases were consolidated for pre-trial purposes in the Eastern District of Pennsylvania.
In May 2009, the New Jersey Attorney General issued a subpoena to DePuy Orthopaedics, Inc., seeking
information regarding financial interest of clinical investigators who performed clinical studies
for DePuy Orthopaedics, Inc. and DePuy Spine, Inc.
In May 2009, COBI commenced an arbitration proceeding before the American Arbitration Association
against Schering-Plough Corporation and its subsidiary Schering-Plough (Ireland) Company
(collectively, Schering-Plough). COBI and Schering-Plough are parties to a series of agreements
(the Distribution Agreements) that grant Schering-Plough the exclusive right to distribute the
drugs REMICADEâ and SIMPONI worldwide, except within the United States, Japan, Taiwan, Indonesia,
and the Peoples Republic of China (including Hong Kong) (the Territory). COBI distributes
REMICADEâ and SIMPONIâ, the next generation treatment, within the United States. In the
arbitration, COBI seeks a declaration that the agreement and plan of merger between Merck & Co.,
Inc. (Merck) and Schering-Plough constitutes a change of control under the terms of the
Distribution Agreements that permits COBI to terminate the Agreements. The termination of the
Distribution Agreements would return to COBI the right to distribute REMICADEâ and SIMPONI within
the Territory. Schering-Plough has filed a response to COBIs arbitration demand that denies both
that it has undergone a change of control and that it will undergo a change of control upon the
completion of the merger with Merck. The arbitrators have been selected and the matter will be
proceeding to arbitration.
In recent years the Company has received numerous requests from a variety of United States
Congressional Committees to produce information relevant to ongoing congressional inquiries. It is
the Companys policy to cooperate with these inquiries by producing the requested information.
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 Companys opinion, based on its examination of these matters, its experience to date and
discussions with counsel, the ultimate outcome of
37
legal proceedings, net of liabilities accrued in
the Companys balance sheet, is not expected to have a material adverse effect
on the Companys financial condition, although the resolution in any reporting period of one or
more of these matters could have a significant impact on the Companys results of operations and
cash flows for that period.
NOTE 13-SUBSEQUENT EVENTS
On November 3, 2009 the Company announced global restructuring
initiatives that are expected to generate pre-tax, annual cost
savings of $1.4-$1.7 billion when fully implemented in 2011, with
$0.8-$0.9 billion expected to be achieved in 2010. The associated
savings will provide additional resources to invest in new growth
platforms; ensure the successful launch of its many new products and
continued growth of its core businesses; and provide flexibility to
adjust to the changed and evolving global environment. The Company
expects to take associated pre-tax, restructuring charges in the
range of $1.1-$1.3 billion in the fourth quarter of 2009.
On October 1, 2009 the Company received $716 million from Boston Scientific to settle several stent
patent litigations. See note 12 for additional details.
On September 28, 2009 the Company, through its affiliate, has entered into a strategic
collaboration with Crucell N.V. which will focus on the discovery, development and
commercialization of monoclonal antibodies and vaccines for the treatment and prevention of
influenza and other infectious and non-infectious diseases. In addition, Johnson & Johnson, through
its affiliate, purchased approximately 18% of Crucells outstanding ordinary shares for an
aggregate purchase price of $448 million.
The Company has performed an evaluation of subsequent events through November 4, 2009, the date the
Company issued these financial statements.
|
|
|
Item 2 |
|
MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
Results of Operations
Analysis of Consolidated Sales
For the fiscal nine months of 2009, worldwide sales were $45.3 billion, a decrease of 6.6%
including an operational decrease of 1.8% as compared to 2008 fiscal nine months sales of $48.6
billion. Currency had a negative impact of 4.8% on total reported fiscal nine months 2009 sales.
Sales by U.S. companies were $23.0 billion in the fiscal nine months of 2009, which represented a
decrease of 6.6% as compared to the same period last year. Sales by international companies were
$22.3 billion, which represented a total decrease of 6.7% including an operational increase of
3.1%, and a negative impact from currency of 9.8% as compared to the fiscal nine months sales of
2008.
Sales by companies in Europe experienced a sales decline of 10.9%, including operational growth of
1.2% and a negative impact from currency of 12.1%. Sales by companies in the Western Hemisphere,
excluding the U.S., experienced a sales decline of 9.3% including operational growth of 5.8% and a
negative impact from currency of 15.1%. Sales by companies in the Asia-Pacific, Africa region
achieved sales growth of 2.6%, including operational growth of 5.1% and a negative impact from
currency of 2.5%.
For the fiscal third quarter of 2009, worldwide sales were $15.1 billion, a decrease of 5.3%
including an operational decrease of
38
2.8% as compared to 2008 fiscal third quarter sales of $15.9
billion. Currency negatively impacted sales by 2.5% for the fiscal third quarter of 2009.
Sales by U.S. companies were $7.3 billion in the fiscal third quarter of 2009, which represented a
decrease of 8.1% as compared to the same period last year. Sales by international companies were
$7.8 billion, which represented a total decrease of 2.5% including an operational increase of 2.4%,
and a negative impact from currency of 4.9% as compared to the fiscal third quarter sales of 2008.
Sales by companies in Europe experienced a sales decline of 4.8%, including operational growth of
2.1% and a negative impact from currency of 6.9%. Sales by companies in the Western Hemisphere,
excluding the U.S., experienced a sales decline of 8.4% including operational growth of 1.5% and a
negative impact from currency of 9.9%. Sales by companies in the Asia-Pacific, Africa region
achieved sales growth of 5.0%, including operational growth of 3.5% and an increase of 1.5% related
to the positive impact of currency.
Analysis of Sales by Business Segments
Consumer
Consumer segment sales in the fiscal nine months of 2009 were $11.5 billion, a decrease of 5.3% as
compared to the same period a year ago, including operational growth of 1.0% and a negative
currency impact of 6.3%. U.S. Consumer segment sales declined by 3.0% while international sales
experienced an overall sales decline of 7.1%, including operational growth of 4.1% and a negative
currency impact of 11.2%.
Major Consumer Franchise Sales Fiscal Nine Months
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sept. 27, |
|
Sept. 28, |
|
Total |
|
Operations |
|
Currency |
(Dollars in Millions) |
|
2009 |
|
2008 |
|
Change |
|
Change |
|
Change |
OTC Pharm & Nutr |
|
$ |
4,056 |
|
|
$ |
4,438 |
|
|
|
(8.6 |
)% |
|
|
(2.8 |
)% |
|
|
(5.8 |
)% |
Skin Care |
|
|
2,517 |
|
|
|
2,537 |
|
|
|
(0.8 |
) |
|
|
5.0 |
|
|
|
(5.8 |
) |
Baby Care |
|
|
1,541 |
|
|
|
1,691 |
|
|
|
(8.9 |
) |
|
|
(1.4 |
) |
|
|
(7.5 |
) |
Womens Health |
|
|
1,406 |
|
|
|
1,475 |
|
|
|
(4.7 |
) |
|
|
3.1 |
|
|
|
(7.8 |
) |
Oral Care |
|
|
1,161 |
|
|
|
1,228 |
|
|
|
(5.5 |
) |
|
|
1.1 |
|
|
|
(6.6 |
) |
Wound Care/Other |
|
|
873 |
|
|
|
830 |
|
|
|
5.2 |
|
|
|
10.5 |
|
|
|
(5.3 |
) |
Total |
|
$ |
11,554 |
|
|
$ |
12,199 |
|
|
|
(5.3 |
)% |
|
|
1.0 |
% |
|
|
(6.3 |
)% |
Consumer segment sales in the fiscal third quarter of 2009 were $4.0 billion, a decrease of
2.7% over the same period a year ago, including operational growth of 1.1% and a negative currency
impact of 3.8%. U.S. Consumer segment sales declined by 4.4% while international sales experienced
an overall sales decline of 1.4%, including operational growth of 5.2%, and a negative currency
impact of 6.6%.
39
Major
Consumer Franchise Sales Fiscal Third Quarters
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sept. 27, |
|
Sept. 28, |
|
Total |
|
Operations |
|
Currency |
(Dollars in Millions) |
|
2009 |
|
2008 |
|
Change |
|
Change |
|
Change |
OTC Pharm & Nutr |
|
$ |
1,398 |
|
|
$ |
1,439 |
|
|
|
(2.8 |
)% |
|
|
0.5 |
% |
|
|
(3.3 |
)% |
Skin Care |
|
|
842 |
|
|
|
858 |
|
|
|
(1.9 |
) |
|
|
1.3 |
|
|
|
(3.2 |
) |
Baby Care |
|
|
544 |
|
|
|
586 |
|
|
|
(7.2 |
) |
|
|
(2.6 |
) |
|
|
(4.6 |
) |
Womens Health |
|
|
502 |
|
|
|
510 |
|
|
|
(1.6 |
) |
|
|
3.6 |
|
|
|
(5.2 |
) |
Oral Care |
|
|
410 |
|
|
|
434 |
|
|
|
(5.5 |
) |
|
|
(1.4 |
) |
|
|
(4.1 |
) |
Wound Care/Other |
|
|
293 |
|
|
|
272 |
|
|
|
7.7 |
|
|
|
10.5 |
|
|
|
(2.8 |
) |
Total |
|
$ |
3,989 |
|
|
$ |
4,099 |
|
|
|
(2.7 |
)% |
|
|
1.1 |
% |
|
|
(3.8 |
)% |
The OTC Pharmaceuticals and Nutritionals franchise achieved operational growth of 0.5% as
compared to prior year fiscal third quarter. Increased sales in anticipation of the flu season have
been partially offset by lower seasonal trade inventory builds in allergy. Increased competitive
pressures including private label have negatively impacted sales. The U.S. Food and Drug
Administration (FDA) is currently considering certain recommendations made by its advisory
committee for reducing the potential for overdose with acetaminophen, the active ingredient in
TYLENOLâ. The Company has provided the FDA with its own recommendations and will continue to be
actively engaged with the FDA on this topic.
The Skin Care franchise achieved operational growth of 1.3%. Sales grew in the AVEENOâ,
Dabao and Vendome product lines.
The Baby Care franchise experienced an operational decline of 2.6% over prior year fiscal third
quarter. This was primarily due to lower sales for Babycenter.com as a result of exiting the online
retail business. This was partially offset by growth in the haircare and baby oil product lines
outside the U.S.
The Womens Health Franchise operational growth of 3.6% was primarily due to sales associated with
the buyout of a joint venture partner in France in the fiscal first quarter of 2009. Prior to the
buyout of the joint venture partner, sales by the joint venture were not recorded as part of the
Companys sales to customers.
The Oral Care franchise experienced an operational decline of 1.4% due to softness in the category
in the U.S. partially offset by growth of LISTERINEâ mouthwash outside the U.S.
The Wound Care/Other franchise operational growth of 10.5% was primarily due to the recent
acquisitions in the Wellness and Prevention platform and sales associated with the buyout of a
joint venture partner in France in the fiscal first quarter of 2009. Prior to the buyout of the
joint venture partner, sales by the joint venture were not recorded as part of the Companys sales
to customers.
Pharmaceutical
Pharmaceutical segment sales in the fiscal nine months of 2009 were $16.5 billion, a total decrease
of 12.5% as compared to the same period a year ago with an operational decline of 8.5% and a
decrease of 4.0% related to the negative impact of currency. U.S. Pharmaceutical sales declined by
14.9% as compared to the same period a year ago. International Pharmaceutical sales experienced a
sales decline of 8.8%, representing an operational increase of
40
1.4%, and a decrease of 10.2%
related to the negative impact of currency.
Major
Pharmaceutical Product Revenues Fiscal Nine Months
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sept. 27, |
|
Sept. 28, |
|
Total |
|
Operations |
|
Currency |
(Dollars in Millions) |
|
2009 |
|
2008 |
|
Change |
|
Change |
|
Change |
REMICADEâ |
|
$ |
3,166 |
|
|
$ |
2,862 |
|
|
|
10.6 |
% |
|
|
10.6 |
% |
|
|
|
% |
PROCRITâ/EPREXâ |
|
|
1,669 |
|
|
|
1,900 |
|
|
|
(12.2 |
) |
|
|
(7.6 |
) |
|
|
(4.6 |
) |
LEVAQUINâ/FLOXINâ |
|
|
1,098 |
|
|
|
1,180 |
|
|
|
(6.9 |
) |
|
|
(6.0 |
) |
|
|
(0.9 |
) |
RISPERDALâ CONSTAâ |
|
|
1,026 |
|
|
|
990 |
|
|
|
3.6 |
|
|
|
13.0 |
|
|
|
(9.4 |
) |
TOPAMAXâ |
|
|
959 |
|
|
|
2,051 |
|
|
|
(53.2 |
) |
|
|
(50.9 |
) |
|
|
(2.3 |
) |
CONCERTAâ |
|
|
945 |
|
|
|
967 |
|
|
|
(2.3 |
) |
|
|
1.3 |
|
|
|
(3.6 |
) |
ACIPHEXâ/PARIETâ |
|
|
784 |
|
|
|
884 |
|
|
|
(11.3 |
) |
|
|
(5.3 |
) |
|
|
(6.0 |
) |
RISPERDALâ/Risperidone |
|
|
706 |
|
|
|
1,841 |
|
|
|
(61.7 |
) |
|
|
(60.4 |
) |
|
|
(1.3 |
) |
DURAGESICâ/Fentanyl
Transdermal |
|
|
655 |
|
|
|
764 |
|
|
|
(14.3 |
) |
|
|
(8.0 |
) |
|
|
(6.3 |
) |
Other |
|
|
5,519 |
|
|
|
5,443 |
|
|
|
1.4 |
|
|
|
8.1 |
|
|
|
(6.7 |
) |
Total |
|
$ |
16,527 |
|
|
$ |
18,882 |
|
|
|
(12.5 |
)% |
|
|
(8.5 |
)% |
|
|
(4.0 |
)% |
Pharmaceutical segment sales in the fiscal third quarter of 2009 were $5.3 billion, a total
decrease of 14.1% over the same period a year ago with an operational decline of 11.9% and a
decrease of 2.2% related to the negative impact of currency. U.S. Pharmaceutical sales decreased by
19.2% over the same period a year ago. International Pharmaceutical sales experienced a sales
decline of 7.1%, representing an operational decline of 1.9%, and a decrease of 5.2% related to the
negative impact of currency.
Major Pharmaceutical Product Revenues Fiscal Third Quarters
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sept. 27, |
|
Sept. 28, |
|
Total |
|
Operations |
|
Currency |
(Dollars in Millions) |
|
2009 |
|
2008 |
|
Change |
|
Change |
|
Change |
REMICADEâ |
|
$ |
1,036 |
|
|
$ |
978 |
|
|
|
5.9 |
% |
|
|
5.9 |
% |
|
|
|
% |
PROCRITâ/EPREXâ |
|
|
542 |
|
|
|
619 |
|
|
|
(12.4 |
) |
|
|
(10.0 |
) |
|
|
(2.4 |
) |
RISPERDALâ CONSTAâ |
|
|
353 |
|
|
|
338 |
|
|
|
4.4 |
|
|
|
9.9 |
|
|
|
(5.5 |
) |
LEVAQUINâ/FLOXINâ |
|
|
311 |
|
|
|
333 |
|
|
|
(6.6 |
) |
|
|
(5.7 |
) |
|
|
(0.9 |
) |
CONCERTAâ |
|
|
284 |
|
|
|
398 |
|
|
|
(28.6 |
) |
|
|
(27.2 |
) |
|
|
(1.4 |
) |
ACIPHEXâ/PARIETâ |
|
|
261 |
|
|
|
282 |
|
|
|
(7.4 |
) |
|
|
(4.4 |
) |
|
|
(3.0 |
) |
DURAGESICâ/Fentanyl
Transdermal |
|
|
206 |
|
|
|
259 |
|
|
|
(20.5 |
) |
|
|
(18.3 |
) |
|
|
(2.2 |
) |
RISPERDALâ/Risperidone |
|
|
192 |
|
|
|
320 |
|
|
|
(40.0 |
) |
|
|
(40.4 |
) |
|
|
0.4 |
|
TOPAMAXâ |
|
|
175 |
|
|
|
728 |
|
|
|
(76.0 |
) |
|
|
(74.7 |
) |
|
|
(1.3 |
) |
Other |
|
|
1,889 |
|
|
|
1,858 |
|
|
|
1.7 |
|
|
|
5.5 |
|
|
|
(3.8 |
) |
Total |
|
$ |
5,249 |
|
|
$ |
6,113 |
|
|
|
(14.1 |
)% |
|
|
(11.9 |
)% |
|
|
(2.2 |
)% |
REMICADEâ (infliximab), a biologic approved for the treatment of Crohns disease, ankylosing
spondylitis, psoriasis, psoriatic arthritis, ulcerative colitis and use in the treatment of
rheumatoid arthritis, achieved operational growth of 5.9% over prior year fiscal third quarter.
Sales in the U.S. market grew 5.7% versus the prior year primarily driven by market growth. U.S.
export sales grew 5.1% versus the prior year fiscal third quarter primarily driven by increased
demand outside the U.S. and inventory adjustments based on customer production planning needs.
41
U.S. export sales operational growth for the fiscal nine months of 2009 versus the same period
a year ago was 14.3%, which the Company believes is more reflective of actual consumption in the
three fiscal quarters of 2009. REMICADE® is competing in a market which is experiencing increased
competition due to new entrants and the expansion of indications for existing competitors.
PROCRITâ
(Epoetin alfa) /EPREXâ (Epoetin alfa), experienced an operational sales decline
of 10.0%, as compared to prior year fiscal third quarter. The decline in PROCRITâ sales was
due to the declining markets for Erythropoiesis Stimulating Agents (ESAs) in the U.S. Outside the
U.S., increased competition has contributed to the lower sales results for EPREXâ.
RISPERDAL® CONSTA® (risperidone), a long-acting injectable for the treatment of schizophrenia,
achieved operational growth of 9.9% over the fiscal third quarter of 2008. The growth was primarily
due to increased share and the launch of RISPERDAL® CONSTA® in Japan earlier in the year.
LEVAQUIN®(levofloxacin)/FLOXINâ(ofloxacin), experienced an operational decline of 5.7% over
the fiscal third quarter of 2008 primarily due to increased competition from generic products.
CONCERTAâ (methylphenidate HCl), a product for the treatment of attention deficit
hyperactivity disorder, experienced an operational sales decline of 27.2% over the fiscal third
quarter of 2008 primarily due to a reserve reversal of $135 million in the third quarter of 2008
related to sales outside the U.S. Growth in the U.S. was due to market growth. Although the
original CONCERTAâ patent expired in 2004, the FDA has not approved any generic version that
is substitutable for CONCERTAâ. Parties have filed Abbreviated New Drug Applications (ANDAs)
for generic versions of CONCERTAâ, which are pending and may be approved at any time.
ACIPHEXâ/PARIETâ, experienced an operational decline of 4.4% over the fiscal third
quarter of 2008 primarily due to generic competition.
DURAGESIC®/Fentanyl Transdermal (fentanyl transdermal system), experienced an operational decline
of 18.3% due to continued generic competition.
RISPERDAL®(risperidone), a medication that treats the symptoms of schizophrenia, bipolar mania and
irritability associated with autistic behavior in indicated patients, experienced an operational
decline of 40.4% in the fiscal third quarter of 2009 versus the same period in the prior year.
Market exclusivity for RISPERDAL® oral in the U.S. expired on June 29, 2008. Loss of market
exclusivity for the RISPERDAL® oral patent has resulted in a significant reduction in sales in the
U.S. In 2008, full year U.S. sales of RISPERDAL® oral were $1.3 billion. U.S. sales of RISPERDAL®
oral were $1.1 billion and $0.2 billion in the first half and the second half of the 2008 fiscal
year, respectively,
42
and $0.2 billion in the fiscal nine months of the 2009 fiscal year.
TOPAMAX® (topiramate), which has been approved for adjunctive and monotherapy use in epilepsy, as
well as for the prophylactic treatment of migraines, experienced an operational decline of 74.7% as
compared to prior year fiscal third quarter. Marketing exclusivity for TOPAMAX® (topiramate) in the
U.S. expired in March 2009 and multiple generics have entered the market. Loss of market
exclusivity for the TOPAMAX® patent has resulted in a significant reduction in sales in the U.S. In
2008, full year U.S. sales of TOPAMAX® were $2.3 billion. U.S. sales of TOPAMAX® were $0.5 billion
and $0.6 billion in the fiscal first quarter and the fiscal nine months of 2009 respectively.
In the fiscal third quarter of 2009, Other Pharmaceutical sales achieved operational growth of 5.5%
versus the prior year. Contributors to the increase were sales of VELCADEâ (bortezomib), a
treatment for multiple myeloma, PREZISTAâ (darunavir), for the treatment of HIV/AIDS patients
and INVEGAâ (paliperidone), a once-daily atypical antipsychotic. The growth was partially
offset by the impact of a generic version of ORTHO TRI-CYCLEN® LO shipped by a competitor.
Subsequently, the generic manufacturer recognized the validity of the patent, paid damages for its
infringing sales and ceased further shipments of the product.
Medical Devices and Diagnostics
Medical Devices and Diagnostics segment sales in the fiscal nine months of 2009 were $17.3
billion, a decrease of 1.3% as compared to the same period a year ago, with 3.3% of this change due
to operational increases and a decrease of 4.6% related to the negative impact of currency. The
U.S. Medical Devices and Diagnostics sales increase was 3.0% and the decline in international
Medical Devices and Diagnostics sales was 4.8%, which included operational increases of 3.7% and a
decrease of 8.5% related to the negative impact of currency.
Major Medical Devices and Diagnostics Franchise Sales* Fiscal Nine Months
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sept. 27, |
|
Sept. 28, |
|
Total |
|
Operations |
|
Currency |
(Dollars in Millions) |
|
2009 |
|
2008 |
|
Change |
|
Change |
|
Change |
DEPUY® |
|
$ |
3,899 |
|
|
$ |
3,846 |
|
|
|
1.4 |
% |
|
|
6.7 |
% |
|
|
(5.3 |
)% |
ETHICON ENDO-SURGERY® |
|
|
3,236 |
|
|
|
3,169 |
|
|
|
2.1 |
|
|
|
7.7 |
|
|
|
(5.6 |
) |
ETHICON® |
|
|
3,013 |
|
|
|
2,922 |
|
|
|
3.1 |
|
|
|
9.3 |
|
|
|
(6.2 |
) |
CORDIS® |
|
|
1,982 |
|
|
|
2,304 |
|
|
|
(14.0 |
) |
|
|
(10.9 |
) |
|
|
(3.1 |
) |
Vision Care |
|
|
1,888 |
|
|
|
1,898 |
|
|
|
(0.5 |
) |
|
|
0.9 |
|
|
|
(1.4 |
) |
Diabetes Care |
|
|
1,785 |
|
|
|
1,956 |
|
|
|
(8.7 |
) |
|
|
(4.1 |
) |
|
|
(4.6 |
) |
ORTHO-CLINICAL
DIAGNOSTICS® |
|
|
1,462 |
|
|
|
1,389 |
|
|
|
5.3 |
|
|
|
9.3 |
|
|
|
(4.0 |
) |
Total |
|
$ |
17,265 |
|
|
$ |
17,484 |
|
|
|
(1.3 |
)% |
|
|
3.3 |
% |
|
|
(4.6 |
)% |
43
|
|
|
* |
|
Prior year amounts have been reclassified to conform to current presentation. |
Medical Devices and Diagnostics segment sales in the fiscal third quarter of 2009 were $5.8
billion, an increase of 2.3% as compared to the same period a year ago, with 4.1% of this change
due to operational increases and a decrease of 1.8% related to the negative impact of currency. The
U.S. Medical Devices and Diagnostics sales growth was 4.5% and the increase in international
Medical Devices and Diagnostics sales was 0.5%, which included operational increases of 3.8% and a
decrease of 3.3% related to the negative impact of currency.
Major Medical Devices and Diagnostics Franchise Sales* Fiscal Third Quarters
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sept. 27, |
|
Sept. 28, |
|
Total |
|
Operations |
|
Currency |
(Dollars in Millions) |
|
2009 |
|
2008 |
|
Change |
|
Change |
|
Change |
DEPUY® |
|
$ |
1,284 |
|
|
$ |
1,231 |
|
|
|
4.3 |
% |
|
|
6.7 |
% |
|
|
(2.4 |
)% |
ETHICON ENDO-SURGERY® |
|
|
1,106 |
|
|
|
1,042 |
|
|
|
6.1 |
|
|
|
8.4 |
|
|
|
(2.3 |
) |
ETHICON® |
|
|
1,019 |
|
|
|
957 |
|
|
|
6.5 |
|
|
|
9.4 |
|
|
|
(2.9 |
) |
Vision Care |
|
|
659 |
|
|
|
652 |
|
|
|
1.1 |
|
|
|
0.2 |
|
|
|
0.9 |
|
CORDIS® |
|
|
640 |
|
|
|
690 |
|
|
|
(7.2 |
) |
|
|
(6.6 |
) |
|
|
(0.6 |
) |
Diabetes Care |
|
|
634 |
|
|
|
667 |
|
|
|
(4.9 |
) |
|
|
(2.7 |
) |
|
|
(2.2 |
) |
ORTHO-CLINICAL
DIAGNOSTICS® |
|
|
501 |
|
|
|
470 |
|
|
|
6.6 |
|
|
|
8.2 |
|
|
|
(1.6 |
) |
Total |
|
$ |
5,843 |
|
|
$ |
5,709 |
|
|
|
2.3 |
% |
|
|
4.1 |
% |
|
|
(1.8 |
)% |
|
|
|
* |
|
Prior year amounts have been reclassified to conform to current presentation. |
The DePuy franchise achieved operational growth of 6.7% over the same period a year ago. This was
primarily due to growth in the spine, hip and knee product lines. Additionally, new product
launches in the Mitek sports medicine product line contributed to the growth.
The Ethicon Endo-Surgery franchise achieved operational growth of 8.4% over prior year fiscal third
quarter. This was attributable to growth in the Endo-Mechanical, HARMONICä, ENSEALâ and
Advanced Sterilization product lines.
The Ethicon franchise achieved operational growth of 9.4% over prior year fiscal third quarter.
This was attributable to growth in the biosurgical and mesh product lines in addition to sales of
newly acquired products from the acquisitions of Omrix Biopharmaceuticals, Inc. and Mentor
Corporation. The growth was partially offset by the divestiture of the Professional Wound Care
business of Ethicon, Inc. in the fiscal fourth quarter of 2008.
The Vision Care franchise achieved operational sales growth of 0.2%. ACUVUE® OASYS,
ACUVUE® OASYS for Astigmatism and 1-DAY ACUVUE® TruEyeTM outside
the U.S. were the major contributors to
44
this growth offset by slowing category growth due to declines in consumer spending.
The Cordis franchise experienced an operational sales decline of 6.6% as compared to the fiscal
third quarter of 2008. This decline was caused by lower sales of the CYPHER® Sirolimus-eluting
Coronary Stent due to increased global competition. This decline was partially offset by growth in
balloons and the Biosense Webster business.
The Diabetes Care franchise experienced an operational sales decline of 2.7% as compared to the
fiscal third quarter of 2008. This decline reflects the overall decrease in consumer spending.
These results were partially offset by growth of the Animas business, an insulin delivery business.
The Ortho-Clinical Diagnostics franchise achieved operational growth of 8.2% over the fiscal third
quarter of 2008. This growth was primarily attributable to the recent launch of the VITROS 3600 and
5600 analyzers.
Cost of Products Sold and Selling, Marketing and Administrative Expenses
Consolidated costs of products sold for the fiscal nine months of 2009 decreased to 29.0% from
29.1% of sales as compared to the same period a year ago. The costs of products sold for the fiscal
third quarter of 2009 decreased to 29.4% from 30.0% of sales in the same period a year ago.
Decreases in the quarterly and nine month periods were due to cost containment initiatives across
all the businesses partially offset by the negative impact of product mix. Additionally, the fiscal
third quarter of 2008 included inventory write-offs in the Pharmaceutical business.
Consolidated selling, marketing and administrative expenses for the fiscal nine months of 2009
decreased to 31.3% from 32.6% of sales as compared to the same period a year ago. Consolidated
selling, marketing and administrative expenses for the fiscal third quarter of 2009 decreased to
31.6% from 32.6% of sales as compared to the same period a year ago. Decreases in the quarterly and
nine month periods were due to cost containment efforts across all the businesses.
Research & Development
Research activities represent a significant part of the Companys 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 fiscal nine months of 2009 were $4.8 billion, a
decrease of 12.7% over the same period a year ago. Research and development spending in the
fiscal third quarter of 2009 was $1.6 billion, a decrease of 13.1% over the fiscal third quarter of
2008. The decreases as a percent to sales in the quarterly and nine month periods were primarily
due to changes in
45
the mix of businesses and increased efficiencies in Pharmaceutical research and development
activities.
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 fiscal nine months of 2008 related to the acquisition
of Amic AB.
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, gains and
losses relating to non-controlling interests, litigation settlements, as well as royalty income.
The change in other (income) expense, net for the fiscal nine months and the fiscal third quarter
of 2009 was unfavorable as compared to the same periods a year ago. The Company received a
settlement payment of $200 million from Amgen Inc. in the fiscal third quarter of 2008. The Company
recorded a net settlement payment of $115 million from Medtronic AVE, Inc. during the fiscal third
quarter of 2009 which was partially offset by other Corporate charges. A $270 million settlement
payment from Medtronic AVE, Inc. during the fiscal second quarter of 2009 was offset by several
smaller litigation matters as well as asset write-downs and other charges.
OPERATING PROFIT BY SEGMENT
Consumer Segment
Operating profit for the Consumer segment as a percent to sales in the fiscal nine months of 2009
was 20.0% versus 17.8% for the same period a year ago. Operating profit for the Consumer segment as
a percent to sales in the fiscal third quarter of 2009 was 20.4% versus 18.6% for the same period a
year ago. The primary driver of the improved operating profit for both the fiscal nine months and
the fiscal third quarter of 2009 was due to cost containment initiatives related to selling,
marketing and administrative expenses.
Pharmaceutical Segment
Operating profit for the Pharmaceutical segment as a percent to sales in the fiscal nine months of
2009 was 33.9% versus 34.5% for the same period a year ago. Operating profit for the Pharmaceutical
segment as a percent to sales in the fiscal third quarter of 2009 was 31.2% versus 32.8% for the
same period a year ago. For both periods in 2009, operating profit decreased, as compared to the
same periods a year ago. The negative impact of product mix due to the loss of exclusivity of the
TOPAMAX® patent and the RISPERADAL® oral patent was the primary
driver of the decreased operating profit. Additionally, the fiscal third quarter of 2008 included a
settlement of $200 million received from Amgen partially offset by inventory write-offs.
46
Medical Devices and Diagnostics Segment
Operating profit for the Medical Devices and Diagnostics segment as a percent to sales in the
fiscal nine months of 2009 was 34.1% versus 29.5% for the same period a year ago. Operating profit
for the Medical Devices and Diagnostics segment as a percent to sales in the fiscal third quarter
of 2009 was 34.5% versus 29.0% for 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 2009 was due to favorable product mix, manufacturing efficiencies and cost containment
initiatives related to selling, marketing and administrative expenses. The fiscal third quarter of
2009 recorded a net settlement payment of $115 million from Medtronic AVE, Inc. Additionally, the
Company received a $270 million settlement payment from Medtronic AVE, Inc., which was partially
offset by asset write-downs and other charges in the fiscal second quarter of 2009.
Interest (Income) Expense
Interest income decreased in both the fiscal nine months and third quarter of 2009 as compared to
the same periods a year ago, due to lower rates of interest earned. The ending balance of cash,
cash equivalents and marketable securities, was $14.4 billion at the end of the fiscal third
quarter of 2009. This is a decrease of $0.4 billion from the same period a year ago. The decrease
was primarily due to acquisition activity.
Interest expense increased in both the fiscal nine months and fiscal third quarter of 2009 as
compared to the same period a year ago. At the end of the fiscal third quarter of 2009 the
Companys debt position was $11.6 billion compared to $14.6 billion from the same period a year
ago. The reduction in current debt in the third quarter was primarily due to a reduction in
Commercial Paper issued.
Provision for Taxes on Income
The worldwide effective income tax rates for the fiscal nine months of 2009 and 2008 were 23.5% and
23.7%, respectively. The lower effective tax rate was primarily due to the U.S. Research tax credit
which was not in effect in the fiscal nine months of 2008.
As of September 27, 2009 the Company had approximately $2.3 billion of liabilities from
unrecognized tax benefits. 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 28, 2008 for more detailed information regarding unrecognized tax
benefits.
LIQUIDITY AND CAPITAL RESOURCES
Cash Flows
Cash and cash equivalents were $11.9 billion at the end of the fiscal third quarter of 2009 as
compared with $10.8 billion at the fiscal year end of 2008. The primary sources of cash that
47
contributed to the $1.1 billion increase were $11.3 billion generated from operating activities
offset by $5.2 billion net cash used by investing activities and $5.2 billion used by financing
activities.
Cash flow from operations of $11.3 billion was the result of $10.1 billion of net earnings and
$3.1 billion of non cash charges related to depreciation and amortization, stock based
compensation and deferred tax provision offset by $1.9 billion related to changes in assets and
liabilities net of effects from acquisitions.
Investing activities use of $5.2 billion cash related to net investments in marketable securities
of $1.2 billion, acquisitions of $2.3 billion and $1.5 billion for additions to property, plant
and equipment.
The use of $5.2 billion in financing activities was primarily for dividends to shareholders of
$4.0 billion and $1.2 billion for repurchase of common stock.
In the fiscal third quarter of 2009 the Company continued to have access to liquidity through the
commercial paper market. The Company anticipates that operating cash flows, existing credit
facilities and access to the commercial paper markets will continue to provide sufficient
resources to fund operating needs.
Dividends
On July 20, 2009, the Board of Directors declared a regular cash dividend of $0.490 per share,
payable on September 8, 2009 to shareholders of record as of August 25, 2009.
On October 22, 2009, the Board of Directors declared a regular cash dividend of $0.490 per share,
payable on December 8, 2009 to shareholders of record as of November 24, 2009. The Company expects
to continue the practice of paying regular quarterly cash dividends.
OTHER INFORMATION
New Accounting Standards
During the fiscal third quarter of 2009, the Company adopted The FASB Accounting Standards
Codification (ASC or codification) and the Hierarchy of Generally Accepted Accounting Principles
(GAAP) which establishes the Codification as the sole source for authoritative U.S. GAAP and will
supersede all accounting standards in U.S. GAAP, aside from those issued by the SEC. The adoption
of the Codification did not have an impact on the Companys results of operations, cash flows or
financial position. Since the adoption of the Accounting Standards Codification (ASC) the Companys
notes to the consolidated financial statements will no longer make reference to Statement of
Financial Accounting Standards (SFAS) or other U.S. GAAP pronouncements.
During the fiscal second quarter of 2009, in accordance with U.S. GAAP, the Company adopted the
standards on subsequent events. This pronouncement establishes standards of accounting for and
48
disclosure of events that occur after the balance sheet date but before financial statements are
issued. See Note 13 for additional information.
During the fiscal first quarter of 2009, in accordance with U.S. GAAP, the Company adopted the
standards on business combinations and 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 have a significant impact on the manner in which the Company accounts
for acquisitions beginning in the fiscal year 2009. Significant changes include the capitalization
of in process research and development (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 for taxes is applicable to acquisitions that occurred both prior and
subsequent to the adoption of the standard. Operating profit attributable to noncontrolling
interests are reported in Other (Income)Expense, net and the related tax impact to the provision
for taxes. Additionally, equity attributable to noncontrolling interests is recorded in Other
Non-Current liabilities. Noncontrolling interests as related to the Companys financial statements
are immaterial and therefore, not separately disclosed. The adoption of these standards did not
have a material impact on the Companys results of operations, cash flows or financial position.
During the fiscal first quarter of 2009, in accordance with U.S. GAAP, the Company adopted the
standard related to disclosures about derivative instruments and hedging activities, to enhance the
disclosure regarding the Companys derivative and hedging activities to improve the transparency of
financial reporting. The adoption of this standard did not have a significant impact on the
Companys results of operations, cash flows or financial position. See Note 2 for enhanced
disclosures.
During the fiscal first quarter of 2009, in accordance with U.S. GAAP, the Company adopted the
standard on collaborative arrangements related to the development and commercialization of
intellectual property. This standard addresses the income statement classification of payments made
between parties in a collaborative arrangement. The impact of the adoption of this standard related
to all collaboration agreements that existed as of September 27, 2009 and December 28, 2008 was
immaterial to the Companys results of operations, cash flows or financial position.
During the fiscal first quarter of 2009, in accordance with U.S. GAAP, the Company adopted the
standard related to defensive intangible assets. This standard applies to
acquired intangible assets in situations in which an entity does not intend to actively use the
asset but intends to hold the asset to prevent
49
others from obtaining access to the asset, except for intangible assets that are used in research
and development activities. The adoption of this standard did not have a significant impact on the
Companys results of operations, cash flows or financial position.
During the fiscal first quarter of 2008, in accordance with U.S. GAAP, the Company adopted the
standard related to fair value measurements except for non-financial assets and liabilities
recognized or disclosed at fair value on a non-recurring basis, which became effective during the
first fiscal quarter of 2009. The effect of adoption on December 29, 2008 of this standard for
non-financial assets and liabilities recorded at fair value on a nonrecurring basis did not have a
material impact on the Companys financial position and results of operations.
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 1998 through 2008 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 continue to result in pricing
pressures that include health care cost containment and government legislation relating to sales,
promotions and reimbursement.
Changes in the behavior and spending patterns of consumers of health care products and services,
including delaying medical procedures, rationing prescription medications, reducing the frequency
of physician visits and foregoing health care insurance coverage, as a result of a prolonged
global economic downturn will continue to impact the Companys businesses.
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 Companys 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.
50
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 managements 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
Companys 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 Companys 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 Companys Annual Report on Form 10-K for the fiscal year ended December 28, 2008 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 Companys 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 28, 2008.
51
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 Companys 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 SECs 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 Companys 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 Companys disclosure controls and procedures were effective.
Internal control. During the period covered by this report, there were no changes in the Companys
internal control over financial reporting that have materially affected, or are reasonably likely
to materially affect, the Companys 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 2009. Common Stock purchases on the open market are made as
part of a systematic plan to meet the needs of the Companys compensation programs.
52
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Number of |
|
Remaining |
|
|
|
|
|
|
|
|
|
|
Shares Purchased |
|
Maximum Number |
|
|
|
|
|
|
Average |
|
as Part of |
|
of Shares that |
|
|
Total Number |
|
Price |
|
Publicly |
|
May Be Purchased |
|
|
of Shares |
|
Paid per |
|
Announced Plans |
|
Under the Plans |
Fiscal Month |
|
Purchased (1) |
|
Share |
|
or Programs (3) |
|
or Programs (2) |
June 29, 2009
through July 26,
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
July 27, 2009
through August 23,
2009 |
|
|
343,100 |
|
|
$ |
60.07 |
|
|
|
|
|
|
|
|
|
August 24, 2009
through September
27, 2009 |
|
|
472,300 |
|
|
$ |
60.06 |
|
|
|
|
|
|
|
|
|
Total |
|
|
815,400 |
|
|
|
|
|
|
|
|
|
|
|
17,814,709 |
|
|
|
|
(1) |
|
During the fiscal third quarter of 2009, the Company repurchased an aggregate of 815,400 shares
of Johnson & Johnson Common Stock in open-market transactions. There were no purchases in the third
quarter of 2009 pursuant to the repurchase program that was publicly announced on July 9, 2007. The
repurchase program has no time limit and may be suspended for periods or discontinued at any time. |
|
(2) |
|
As of September 27, 2009, based on the closing price of the Companys Common Stock on the New
York Stock Exchange on September 25, 2009 of $60.62 per share. |
|
(3) |
|
As of September 27, 2009, an aggregate of 140,377,700 shares were purchased for a total of $8.9
billion since the inception of the repurchase program announced on July 9, 2007. |
Item 5
Other Information
(a)
Costs Associated with Exit or Disposal Activities.
On
November 3, 2009, the Company announced certain global restructuring
initiatives. The Companys plans are expected to increase its
operational efficiency and generate annualized, pre-tax cost savings
of $1.4-$1.7 billion when fully implemented in 2011, with $0.8-$0.9
billion expected to be achieved in 2010. The associated savings will
provide additional resources to invest in new growth platforms;
ensure the successful launch of its many new products and continued
growth of its core businesses; and provide flexibility to adjust to
the changed and evolving global environment. The Company expects to
record an associated pre-tax, restructuring charge in the range of
$1.1-$1.3 billion in the fourth quarter of 2009. Cost savings will be
achieved primarily by reducing layers of management, increasing
individual spans of control, and simplifying business structures and
processes across the companys global operations. The Company
estimates that position eliminations will be in a range of 6-7
percent of its global workforce, subject to any consultation
procedures on these plans in countries where required.
Item 6 EXHIBITS
Exhibit 10.1
Johnson & Johnson 2009 Certificates of Long-term Performance Plan
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.
Exhibit 101 XBRL (Extensible Business Reporting Language)
The following materials from Johnson & Johnsons Quarterly Report on Form 10-Q for the
quarter ended September 27, 2009, formatted in Extensive Business Reporting Language
(XBRL), (i)consolidated balance sheets, (ii) consolidated statements of earnings, (iii)
consolidated statements of cash flows, and (iv) the notes to the consolidated financial
statements.
53
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.
|
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JOHNSON & JOHNSON
(Registrant)
|
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Date: November 4, 2009 |
By /s/ D. J. CARUSO
|
|
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D. J. CARUSO |
|
|
Vice President, Finance;
Chief Financial Officer
(Principal Financial Officer) |
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|
|
Date: November 4, 2009 |
By /s/ S. J. COSGROVE
|
|
|
S. J. COSGROVE |
|
|
Controller
(Principal Accounting Officer) |
|
|
54