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 October 3, 2010
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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 29, 2010 2,746,253,692 shares of Common Stock, $1.00 par value, were outstanding.
JOHNSON & JOHNSON AND SUBSIDIARIES
TABLE OF CONTENTS
2
Part I FINANCIAL INFORMATION
Item 1 FINANCIAL STATEMENTS
JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited; Dollars in Millions)
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October 3, 2010 |
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January 3, 2010 |
ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
14,338 |
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$ |
15,810 |
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Marketable securities |
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7,788 |
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3,615 |
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Accounts receivable, trade, less
allowances for doubtful accounts
$360 (2009, $333) |
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10,290 |
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9,646 |
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Inventories (Note 2) |
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5,409 |
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5,180 |
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Deferred taxes on income |
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2,418 |
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2,793 |
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Prepaid expenses and other receivables |
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2,474 |
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2,497 |
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Total current assets |
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42,717 |
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39,541 |
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Property, plant and equipment at cost |
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29,927 |
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29,251 |
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Less: accumulated depreciation |
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(15,567 |
) |
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(14,492 |
) |
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Property, plant and equipment, net |
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14,360 |
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14,759 |
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Intangible assets, net (Note 3) |
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17,068 |
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16,323 |
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Goodwill, net (Note 3) |
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15,375 |
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14,862 |
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Deferred taxes on income |
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5,175 |
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5,507 |
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Other assets |
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3,552 |
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|
3,690 |
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|
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|
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|
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Total assets |
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$ |
98,247 |
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$ |
94,682 |
|
See Notes to Consolidated Financial Statements
3
JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited; Dollars in Millions)
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October 3, 2010 |
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January 3, 2010 |
LIABILITIES AND SHAREHOLDERS EQUITY |
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Current liabilities: |
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Loans and notes payable |
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$ |
2,843 |
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$ |
6,318 |
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Accounts payable |
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5,477 |
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5,541 |
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Accrued liabilities |
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4,333 |
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5,796 |
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Accrued rebates, returns and
promotions |
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2,666 |
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|
2,028 |
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|
|
|
|
|
|
|
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Accrued salaries, wages and
commissions |
|
|
1,314 |
|
|
|
1,606 |
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|
|
|
|
|
|
|
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Accrued taxes on income |
|
|
781 |
|
|
|
442 |
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|
|
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|
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Total current liabilities |
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17,414 |
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21,731 |
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Long-term debt |
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9,182 |
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8,223 |
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Deferred taxes on income |
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1,725 |
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1,424 |
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Employee related obligations |
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6,409 |
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6,769 |
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Other liabilities |
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6,226 |
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5,947 |
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Total liabilities |
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40,956 |
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44,094 |
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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) |
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3,120 |
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|
3,120 |
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|
|
|
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Accumulated other comprehensive
income (Note 7) |
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|
(2,924 |
) |
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(3,058 |
) |
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|
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Retained earnings |
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77,272 |
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|
70,306 |
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Less: common stock held in treasury,
at cost (372,132,000 and 365,522,000
shares) |
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20,177 |
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|
19,780 |
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|
|
|
|
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Total shareholders equity |
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|
57,291 |
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|
50,588 |
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|
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Total liabilities and
shareholders equity |
|
$ |
98,247 |
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|
$ |
94,682 |
|
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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Fiscal Quarters Ended |
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Oct. 3, |
|
Percent |
|
Sept. 27, |
|
Percent |
|
|
2010 |
|
to Sales |
|
2009 |
|
to Sales |
Sales to customers (Note 9) |
|
$ |
14,982 |
|
|
|
100.0 |
% |
|
$ |
15,081 |
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|
100.0 |
% |
|
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|
|
|
|
|
|
|
|
|
|
|
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Cost of products sold |
|
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4,594 |
|
|
|
30.7 |
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|
4,434 |
|
|
|
29.4 |
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|
|
|
|
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|
|
|
|
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Gross profit |
|
|
10,388 |
|
|
|
69.3 |
|
|
|
10,647 |
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|
|
70.6 |
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|
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|
|
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|
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Selling, marketing and
administrative expenses |
|
|
4,709 |
|
|
|
31.4 |
|
|
|
4,767 |
|
|
|
31.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Research expense |
|
|
1,657 |
|
|
|
11.1 |
|
|
|
1,617 |
|
|
|
10.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Interest income |
|
|
(13 |
) |
|
|
(0.1 |
) |
|
|
(28 |
) |
|
|
(0.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Interest expense, net of
portion capitalized |
|
|
108 |
|
|
|
0.7 |
|
|
|
142 |
|
|
|
0.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (income)expense, net |
|
|
(292 |
) |
|
|
(2.0 |
) |
|
|
(96 |
) |
|
|
(0.6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings before provision for
taxes on income |
|
|
4,219 |
|
|
|
28.2 |
|
|
|
4,245 |
|
|
|
28.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for taxes on income
(Note 5) |
|
|
802 |
|
|
|
5.4 |
|
|
|
900 |
|
|
|
6.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET EARNINGS |
|
$ |
3,417 |
|
|
|
22.8 |
% |
|
$ |
3,345 |
|
|
|
22.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET EARNINGS PER SHARE (Note 8) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
1.24 |
|
|
|
|
|
|
$ |
1.21 |
|
|
|
|
|
Diluted |
|
$ |
1.23 |
|
|
|
|
|
|
$ |
1.20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH DIVIDENDS PER SHARE |
|
$ |
0.54 |
|
|
|
|
|
|
$ |
0.49 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AVG. SHARES OUTSTANDING |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
2,751.6 |
|
|
|
|
|
|
|
2,756.3 |
|
|
|
|
|
Diluted |
|
|
2,786.4 |
|
|
|
|
|
|
|
2,793.0 |
|
|
|
|
|
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 |
|
|
Oct. 3, |
|
Percent |
|
Sept. 27, |
|
Percent |
|
|
2010 |
|
to Sales |
|
2009 |
|
to Sales |
Sales to customers (Note 9) |
|
$ |
45,943 |
|
|
|
100.0 |
% |
|
$ |
45,346 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
13,752 |
|
|
|
29.9 |
|
|
|
13,135 |
|
|
|
29.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
32,191 |
|
|
|
70.1 |
|
|
|
32,211 |
|
|
|
71.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, marketing and
administrative expenses |
|
|
14,244 |
|
|
|
31.0 |
|
|
|
14,172 |
|
|
|
31.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research expense |
|
|
4,862 |
|
|
|
10.6 |
|
|
|
4,773 |
|
|
|
10.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
(83 |
) |
|
|
(0.2 |
) |
|
|
(78 |
) |
|
|
(0.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net of
portion capitalized |
|
|
317 |
|
|
|
0.7 |
|
|
|
358 |
|
|
|
0.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (income)expense, net |
|
|
(1,868 |
) |
|
|
(4.0 |
) |
|
|
(165 |
) |
|
|
(0.4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings before provision for
taxes on income |
|
|
14,719 |
|
|
|
32.0 |
|
|
|
13,151 |
|
|
|
29.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for taxes on income
(Note 5) |
|
|
3,327 |
|
|
|
7.2 |
|
|
|
3,091 |
|
|
|
6.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET EARNINGS |
|
$ |
11,392 |
|
|
|
24.8 |
% |
|
$ |
10,060 |
|
|
|
22.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET EARNINGS PER SHARE (Note 8) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
4.14 |
|
|
|
|
|
|
$ |
3.64 |
|
|
|
|
|
Diluted |
|
$ |
4.08 |
|
|
|
|
|
|
$ |
3.61 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH DIVIDENDS PER SHARE |
|
$ |
1.57 |
|
|
|
|
|
|
$ |
1.44 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AVG. SHARES OUTSTANDING |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
2,754.2 |
|
|
|
|
|
|
|
2,760.0 |
|
|
|
|
|
Diluted |
|
|
2,792.0 |
|
|
|
|
|
|
|
2,787.9 |
|
|
|
|
|
See Notes to Consolidated Financial Statements
6
JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited; Dollars in Millions)
|
|
|
|
|
|
|
|
|
|
|
Fiscal Nine Months Ended |
|
|
Oct. 3, |
|
Sept. 27, |
|
|
2010 |
|
2009 |
CASH FLOW FROM OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
Net earnings |
|
$ |
11,392 |
|
|
$ |
10,060 |
|
Adjustments to reconcile net earnings to cash
flows from operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization of
property and intangibles |
|
|
2,170 |
|
|
|
2,030 |
|
Stock based compensation |
|
|
474 |
|
|
|
499 |
|
Decrease in deferred tax provision |
|
|
644 |
|
|
|
541 |
|
Accounts receivable allowances |
|
|
30 |
|
|
|
39 |
|
Changes in assets and liabilities, net of
effects from acquisitions: |
|
|
|
|
|
|
|
|
Increase in accounts receivable |
|
|
(585 |
) |
|
|
(61 |
) |
Increase in inventories |
|
|
(197 |
) |
|
|
(250 |
) |
Decrease in accounts payable
and accrued liabilities |
|
|
(1,552 |
) |
|
|
(1,830 |
) |
Increase in other current and non-current
assets |
|
|
(310 |
) |
|
|
(35 |
) |
Increase in other current and
non-current liabilities |
|
|
495 |
|
|
|
291 |
|
|
|
|
|
|
|
|
|
|
NET CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
12,561 |
|
|
|
11,284 |
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
Additions to property, plant and equipment |
|
|
(1,425 |
) |
|
|
(1,521 |
) |
Proceeds from the disposal of assets |
|
|
324 |
|
|
|
12 |
|
Acquisitions, net of cash acquired |
|
|
(1,269 |
) |
|
|
(2,337 |
) |
Purchases of investments |
|
|
(10,679 |
) |
|
|
(5,922 |
) |
Sales of investments |
|
|
6,669 |
|
|
|
4,697 |
|
Other |
|
|
(70 |
) |
|
|
(163 |
) |
|
|
|
|
|
|
|
|
|
NET CASH USED BY INVESTING ACTIVITIES |
|
|
(6,450 |
) |
|
|
(5,234 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
Dividends to shareholders |
|
|
(4,323 |
) |
|
|
(3,974 |
) |
Repurchase of common stock |
|
|
(1,512 |
) |
|
|
(1,172 |
) |
Proceeds from short-term debt |
|
|
1,896 |
|
|
|
3,903 |
|
Retirement of short-term debt |
|
|
(5,390 |
) |
|
|
(4,012 |
) |
Proceeds from long-term debt |
|
|
1,079 |
|
|
|
9 |
|
Retirement of long-term debt |
|
|
(21 |
) |
|
|
(224 |
) |
Proceeds from the exercise of stock
options/excess tax benefits |
|
|
685 |
|
|
|
300 |
|
|
|
|
|
|
|
|
|
|
NET CASH USED BY FINANCING ACTIVITIES |
|
|
(7,586 |
) |
|
|
(5,170 |
) |
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and
cash equivalents |
|
|
3 |
|
|
|
208 |
|
(Decrease)/Increase in cash and cash
equivalents |
|
|
(1,472 |
) |
|
|
1,088 |
|
Cash and Cash equivalents, beginning of period |
|
|
15,810 |
|
|
|
10,768 |
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS, END OF PERIOD |
|
$ |
14,338 |
|
|
$ |
11,856 |
|
|
|
|
|
|
|
|
|
|
Acquisitions |
|
|
|
|
|
|
|
|
Fair value of assets acquired |
|
$ |
1,321 |
|
|
$ |
3,193 |
|
Fair value of liabilities assumed and
non-controlling interests |
|
|
(52 |
) |
|
|
(856 |
) |
Net cash paid for acquisitions |
|
$ |
1,269 |
|
|
$ |
2,337 |
|
See Notes to Consolidated Financial Statements
7
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 January 3, 2010. 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.
The Financial Accounting Standards Board (FASB) issued guidance and amendments to the criteria for
separating consideration in multiple-deliverable revenue arrangements, which the Company adopted in
the fiscal first quarter of 2010. The guidance also (a) provides principles and application
guidance on whether multiple deliverables exist, how the arrangement should be separated, and the
consideration allocated; (b) requires an entity to allocate revenue in an arrangement using
estimated selling prices of deliverables if a vendor does not have vendor-specific objective
evidence or third-party evidence of selling price; and(c) eliminates the use of the residual method
and requires an entity to allocate the revenue using the relative selling price method. The
adoption did not have a material impact on the Companys results of operations, cash flows or
financial position however it will expand the disclosures for multiple-deliverable revenue
arrangements.
During the fiscal first quarter of 2010 the Company adopted the FASB standard related to variable
interest entities. The adoption of this standard did not have an impact on the Companys results of
operations, cash flows or financial position.
During the fiscal first quarter of 2010 the Company adopted the new accounting guidance on fair
value measurements and disclosures. This guidance requires the Company to disclose the amount of
significant transfers between Level 1 and Level 2 inputs and the reasons for these transfers as
well as the reasons for any transfers in or out of Level 3 of the fair value hierarchy. In
addition, the guidance clarifies certain existing disclosure requirements. The adoption of this
standard did not have a material impact on the Companys results of operations, cash flows or
financial position.
During the fiscal second quarter of 2010 the FASB issued an accounting standard update related to
revenue recognition under the milestone method. The objective of the accounting standard update is
to provide guidance on defining a milestone and determining when it may be appropriate to apply the
milestone
8
method of revenue recognition for research or development transactions. This update is
effective on a prospective basis for
milestones achieved in fiscal years, and interim periods within those years, beginning on or after
June 15, 2010. The adoption of this standard is not expected to have a material impact on the
Companys results of operations, cash flows or financial position.
NOTE 2 INVENTORIES
|
|
|
|
|
|
|
|
|
(Dollars in Millions) |
|
October 3, 2010 |
|
|
January 3, 2010 |
|
Raw materials and supplies |
|
$ |
1,123 |
|
|
$ |
1,144 |
|
Goods in process |
|
|
1,548 |
|
|
|
1,395 |
|
Finished goods |
|
|
2,738 |
|
|
|
2,641 |
|
Inventories |
|
$ |
5,409 |
|
|
$ |
5,180 |
|
NOTE 3 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 2009. Future impairment tests for goodwill and indefinite lived
intangible assets will be performed annually in the fiscal fourth quarter, or sooner if warranted.
|
|
|
|
|
|
|
|
|
|
|
October 3, |
|
January 3, |
(Dollars in Millions) |
|
2010 |
|
2010 |
Intangible assets with definite lives: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents and trademarks gross |
|
$ |
6,729 |
|
|
$ |
5,697 |
|
Less accumulated amortization |
|
|
2,529 |
|
|
|
2,177 |
|
Patents and trademarks net |
|
|
4,200 |
|
|
|
3,520 |
|
|
|
|
|
|
|
|
|
|
Other intangibles gross |
|
|
7,748 |
|
|
|
7,808 |
|
Less accumulated amortization |
|
|
2,810 |
|
|
|
2,680 |
|
Other intangibles net |
|
|
4,938 |
|
|
|
5,128 |
|
|
|
|
|
|
|
|
|
|
Total intangible assets with definite lives gross |
|
|
14,477 |
|
|
|
13,505 |
|
Less accumulated amortization |
|
|
5,339 |
|
|
|
4,857 |
|
Total intangible assets with definite lives net |
|
|
9,138 |
|
|
|
8,648 |
|
|
|
|
|
|
|
|
|
|
Intangible assets with indefinite lives: |
|
|
|
|
|
|
|
|
Trademarks |
|
|
5,971 |
|
|
|
5,938 |
|
Purchased in-process research and development* |
|
|
1,959 |
|
|
|
1,737 |
|
Total intangible assets with indefinite lives |
|
|
7,930 |
|
|
|
7,675 |
|
|
|
|
|
|
|
|
|
|
Total intangible assets net |
|
$ |
17,068 |
|
|
$ |
16,323 |
|
|
|
|
* |
|
Purchased in-process research and development is accounted for as an indefinite-lived intangible
asset until the underlying project is completed or abandoned. |
Goodwill as of October 3, 2010 was allocated by segment of business as follows:
9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Med Dev |
|
|
(Dollars in Millions) |
|
Consumer |
|
Pharm |
|
& Diag |
|
Total |
Goodwill, net
at January 3, 2010 |
|
$ |
8,074 |
|
|
$ |
1,244 |
|
|
$ |
5,544 |
|
|
$ |
14,862 |
|
Acquisitions |
|
|
|
|
|
|
|
|
|
|
400 |
|
|
|
400 |
|
Currency translation/Other |
|
|
140 |
|
|
|
(11 |
) |
|
|
(16 |
) |
|
|
113 |
|
Goodwill, net as of
October 3, 2010 |
|
$ |
8,214 |
|
|
$ |
1,233 |
|
|
$ |
5,928 |
|
|
$ |
15,375 |
|
The weighted average amortization periods for patents and trademarks and other intangible assets
are 17 years and 28 years, respectively. The amortization expense of amortizable intangible assets
for the fiscal nine months ended October 3, 2010 was $528 million, and the estimated amortization
expense for the five succeeding years approximates $700 million, per year.
NOTE 4 FAIR VALUE MEASUREMENTS
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 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 October 3, 2010, the Company had notional amounts outstanding for
forward foreign exchange contracts and cross currency interest rate swaps of $23 billion and $3
billion, respectively.
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
10
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)/expense, net, and was not material for the
fiscal quarters and fiscal nine months ended October 3, 2010 and September 27, 2009. Refer to Note
7 for disclosures of movements in Accumulated Other Comprehensive Income.
As of October 3, 2010, the balance of deferred net gains on derivatives included in accumulated
other comprehensive income was $51 million after-tax. For additional information, see Note 7. The
Company expects that substantially all of the amounts 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 excluding interest rate swaps. 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.
The following table is a summary of the activity related to designated derivatives for the fiscal
third quarters in 2010 and 2009:*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain/(Loss) |
|
|
|
|
|
|
Gain/(Loss) |
|
|
reclassified |
|
|
Gain/(Loss) |
|
|
|
recognized in |
|
|
from |
|
|
recognized in |
|
|
|
Accumulated |
|
|
Accumulated OCI |
|
|
other |
|
|
|
OCI(1) |
|
|
into income(1) |
|
|
income/expense(2) |
|
|
|
Fiscal |
|
|
Fiscal |
|
|
Fiscal |
|
|
Fiscal |
|
|
Fiscal |
|
|
Fiscal |
|
|
|
third |
|
|
third |
|
|
third |
|
|
third |
|
|
third |
|
|
third |
|
(Dollars in Millions) |
|
quarter |
|
|
quarter |
|
|
quarter |
|
|
quarter |
|
|
quarter |
|
|
quarter |
|
Cash Flow Hedges |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Foreign exchange
contracts |
|
$ |
45 |
|
|
$ |
27 |
|
|
$ |
(12 |
) |
|
$ |
(6 |
) (A) |
|
$ |
18 |
|
|
$ |
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange
contracts |
|
|
(7 |
) |
|
|
(124 |
) |
|
|
(106 |
) |
|
|
3 |
(B) |
|
|
121 |
|
|
|
(2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange
contracts |
|
|
(46 |
) |
|
|
(23 |
) |
|
|
20 |
|
|
|
|
(C) |
|
|
(11 |
) |
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cross currency
interest rate swaps |
|
|
(24 |
) |
|
|
(49 |
) |
|
|
(1 |
) |
|
|
(14 |
) (D) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange
contracts |
|
|
(63 |
) |
|
|
(11 |
) |
|
|
9 |
|
|
|
(3 |
) (E) |
|
|
(17 |
) |
|
|
(11 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
(95 |
) |
|
$ |
(180 |
) |
|
$ |
(90 |
) |
|
$ |
(20 |
) |
|
$ |
111 |
|
|
$ |
(10 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11
|
|
|
* |
|
All amounts shown in the table above are net of tax. |
The following table is a summary of the activity related to designated derivatives for the first
fiscal nine months ended in 2010 and 2009:*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain/(Loss) |
|
|
|
|
|
|
Gain/(Loss) |
|
|
reclassified |
|
|
Gain/(Loss) |
|
|
|
recognized in |
|
|
from |
|
|
recognized in |
|
|
|
Accumulated |
|
|
Accumulated OCI |
|
|
other |
|
|
|
OCI(1) |
|
|
into income(1) |
|
|
income/expense(2) |
|
|
|
Fiscal |
|
|
Fiscal |
|
|
Fiscal |
|
|
Fiscal |
|
|
Fiscal |
|
|
Fiscal |
|
|
|
nine |
|
|
nine |
|
|
nine |
|
|
nine |
|
|
nine |
|
|
nine |
|
(Dollars in Millions) |
|
months |
|
|
months |
|
|
months |
|
|
months |
|
|
months |
|
|
months |
|
Cash Flow Hedges |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Foreign exchange
contracts |
|
$ |
(39 |
) |
|
$ |
(19 |
) |
|
$ |
(41 |
) |
|
$ |
(14 |
) (A) |
|
$ |
(3 |
) |
|
$ |
(2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange
contracts |
|
|
(213 |
) |
|
|
(189 |
) |
|
|
(204 |
) |
|
|
37 |
(B) |
|
|
(33 |
) |
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange
contracts |
|
|
27 |
|
|
|
(7 |
) |
|
|
41 |
|
|
|
22 |
(C) |
|
|
5 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cross currency
interest rate swaps |
|
|
(73 |
) |
|
|
144 |
|
|
|
10 |
|
|
|
(21 |
) (D) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange
contracts |
|
|
18 |
|
|
|
22 |
|
|
|
8 |
|
|
|
- |
(E) |
|
|
3 |
|
|
|
(10 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
(280 |
) |
|
$ |
(49 |
) |
|
$ |
(186 |
) |
|
$ |
24 |
|
|
$ |
(28 |
) |
|
$ |
(5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
All amounts shown in the table above are net of tax. |
|
(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 third quarters ended October 3, 2010 and September 27, 2009, gains of $119 million
and $16 million, respectively, were recognized in Other (income)/expense, net, relating to foreign
exchange contracts not designated as hedging instruments.
For the first fiscal nine months ended October 3, 2010 and September 27, 2009, gains of $50 million
and $20 million, respectively, were recognized in Other (income)/expense, net, relating to foreign
exchange contracts not designated as hedging instruments.
Fair value is 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
12
within the hierarchy are described 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 following three levels of inputs are used to measure fair value:
Level 1 Quoted prices in active markets for identical assets and liabilities.
Level 2 Significant other observable inputs.
Level 3 Significant unobservable inputs.
The Companys significant financial assets and liabilities measured at fair value as of October 3,
2010 and January 3, 2010 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
October 3, 2010 |
|
January 3, 2010 |
(Dollars in Millions) |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
|
Total(1) |
Derivatives designated as
hedging instruments : |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
$ |
387 |
|
|
|
|
|
|
|
387 |
|
|
|
436 |
|
Cross currency interest rate
swaps(2) |
|
|
|
|
|
|
9 |
|
|
|
|
|
|
|
9 |
|
|
|
126 |
|
Total |
|
|
|
|
|
|
396 |
|
|
|
|
|
|
|
396 |
|
|
|
562 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
912 |
|
|
|
|
|
|
|
912 |
|
|
|
608 |
|
Cross currency interest rate
swaps(3) |
|
|
|
|
|
|
559 |
|
|
|
|
|
|
|
559 |
|
|
|
571 |
|
Total |
|
|
|
|
|
|
1,471 |
|
|
|
|
|
|
|
1,471 |
|
|
|
1,179 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives not designated as
hedging instruments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
106 |
|
|
|
|
|
|
|
106 |
|
|
|
33 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
58 |
|
|
|
|
|
|
|
58 |
|
|
|
40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Investments(4) |
|
$ |
1,160 |
|
|
|
|
|
|
|
|
|
|
|
1,160 |
|
|
|
1,134 |
|
13
|
|
|
(1) |
|
As of January 3, 2010, these assets and liabilities are classified as Level 2 with the exception
of other investments of $1,134 which are classified as Level 1. |
|
(2) |
|
Includes $6 million and $119 million of non-current assets for October 3, 2010 and January 3,
2010, respectively. |
|
(3) |
|
Includes $529 million and $517 million of non-current liabilities for October 3, 2010 and
January 3, 2010, respectively. |
|
(4) |
|
Classified as non-current other assets. |
Financial Instruments not measured at Fair Value:
The following financial assets and liabilities are held at carrying amount on the consolidated
balance sheet as of October 3, 2010:
|
|
|
|
|
|
|
|
|
|
|
Carrying |
|
|
Estimated |
|
(Dollars in Millions) |
|
Amount |
|
|
Fair Value |
|
Financial Assets |
|
|
|
|
|
|
|
|
Current Investments |
|
|
|
|
|
|
|
|
Cash |
|
$ |
2,121 |
|
|
|
2,121 |
|
Government securities
and obligations |
|
|
16,480 |
|
|
|
16,479 |
|
Corporate debt securities |
|
|
756 |
|
|
|
756 |
|
Money market funds |
|
|
1,685 |
|
|
|
1,685 |
|
Time deposits |
|
|
1,084 |
|
|
|
1,084 |
|
|
|
|
|
|
|
|
|
|
Total cash, cash
equivalents and current
marketable securities |
|
$ |
22,126 |
|
|
|
22,125 |
|
|
|
|
|
|
|
|
|
|
Fair value of government securities
and obligations and non-current
marketable securities was estimated
using quoted broker prices in active
markets.
|
|
|
|
|
|
|
|
|
Financial Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Debt |
|
$ |
2,843 |
|
|
$ |
2,843 |
|
Non-Current Debt |
|
|
|
|
|
|
|
|
5.15% Debentures due 2012 |
|
|
599 |
|
|
|
651 |
|
3.80% Debentures due 2013 |
|
|
500 |
|
|
|
539 |
|
5.55% Debentures due 2017 |
|
|
1,000 |
|
|
|
1,200 |
|
5.15% Debentures due 2018 |
|
|
898 |
|
|
|
1,050 |
|
4.75% Notes due 2019 (1B
Euro 1.3669) |
|
|
1,359 |
|
|
|
1,580 |
|
3% Zero Coupon Convertible Subordinated
Debentures due in 2020 |
|
|
193 |
|
|
|
231 |
|
2.95% Debentures due 2020 |
|
|
541 |
|
|
|
550 |
|
6.73% Debentures due 2023 |
|
|
250 |
|
|
|
338 |
|
5.50% Notes due 2024
(500 GBP 1.5819) |
|
|
784 |
|
|
|
889 |
|
6.95% Notes due 2029 |
|
|
294 |
|
|
|
392 |
|
4.95% Debentures due 2033 |
|
|
500 |
|
|
|
532 |
|
5.95% Notes due 2037 |
|
|
995 |
|
|
|
1,211 |
|
5.86% Debentures due 2038 |
|
|
700 |
|
|
|
850 |
|
4.50% Debentures due 2040 |
|
|
538 |
|
|
|
544 |
|
Other (Includes
Industrial Revenue
Bonds) |
|
|
31 |
|
|
|
31 |
|
|
|
|
|
|
|
|
|
|
Total Non-Current Debt |
|
$ |
9,182 |
|
|
$ |
10,588 |
|
14
The weighted average effective rate on non-current debt is 5.25%.
On August 12, 2010 the Company issued an aggregate of $1.1 billion in long-term notes. There were
approximately $0.5 billion of 2.95% Notes issued due in 2020 and approximately $0.5 billion of
4.50% Notes issued due in 2040. The proceeds of the notes are expected to be used for general
corporate purposes.
Fair value of the non-current debt was estimated using market prices, which were corroborated by
quoted broker prices in active markets.
NOTE 5 INCOME TAXES
The worldwide effective income tax rates for the first fiscal nine months of 2010 and 2009 were
22.6% and 23.5%, respectively. The lower effective tax rate was primarily due to a decline in
taxable income in higher tax jurisdictions relative to taxable income in lower tax jurisdictions
partially offset by the U.S. Research and Development tax credit which was not in effect for the
first fiscal nine months of 2010.
NOTE 6 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 2010 and 2009 include the following components:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Retirement Plans |
|
Other Benefit Plans |
|
|
Fiscal Quarters Ended |
|
|
Oct. 3, |
|
Sept. 27, |
|
Oct. 3, |
|
Sept. 27, |
(Dollars in Millions) |
|
2010 |
|
2009 |
|
2010 |
|
2009 |
Service cost |
|
$ |
125 |
|
|
$ |
114 |
|
|
|
33 |
|
|
|
33 |
|
Interest cost |
|
|
198 |
|
|
|
188 |
|
|
|
52 |
|
|
|
43 |
|
Expected return on
plan assets |
|
|
(251 |
) |
|
|
(240 |
) |
|
|
|
|
|
|
|
|
Amortization of prior
service cost |
|
|
1 |
|
|
|
4 |
|
|
|
(2 |
) |
|
|
(2 |
) |
Recognized actuarial
losses |
|
|
59 |
|
|
|
35 |
|
|
|
12 |
|
|
|
13 |
|
Curtailments and
Settlements |
|
|
|
|
|
|
(11 |
) |
|
|
|
|
|
|
|
|
Net periodic benefit cost |
|
$ |
132 |
|
|
|
90 |
|
|
|
95 |
|
|
|
87 |
|
15
Net periodic benefit cost for the Companys defined benefit retirement plans and other benefit
plans for the fiscal nine months of 2010 and 2009 include the following components:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Retirement Plans |
|
Other Benefit Plans |
|
|
Fiscal Nine Months Ended |
|
|
Oct. 3, |
|
Sept. 27, |
|
Oct. 3, |
|
Sept. 27, |
(Dollars in Millions) |
|
2010 |
|
2009 |
|
2010 |
|
2009 |
Service cost |
|
$ |
372 |
|
|
$ |
348 |
|
|
|
100 |
|
|
|
103 |
|
Interest cost |
|
|
592 |
|
|
|
555 |
|
|
|
152 |
|
|
|
128 |
|
Expected return on
plan assets |
|
|
(751 |
) |
|
|
(695 |
) |
|
|
(1 |
) |
|
|
(1 |
) |
Amortization of prior
service cost |
|
|
7 |
|
|
|
9 |
|
|
|
(4 |
) |
|
|
(4 |
) |
Amortization of net
transition asset |
|
|
1 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
Recognized actuarial
losses |
|
|
176 |
|
|
|
117 |
|
|
|
37 |
|
|
|
41 |
|
Curtailments and
Settlements |
|
|
|
|
|
|
(11 |
) |
|
|
|
|
|
|
|
|
Net periodic benefit cost |
|
$ |
397 |
|
|
|
324 |
|
|
|
284 |
|
|
|
267 |
|
Company Contributions
For the fiscal nine months ended October 3, 2010, the Company contributed $603 million and $17
million to its U.S. and international retirement plans, respectively. 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 7 ACCUMULATED OTHER COMPREHENSIVE INCOME
Total comprehensive income for the first fiscal nine months ended October 3, 2010 was $11.5
billion, compared with $12.3 billion for the same period a year ago. Total comprehensive income for
the fiscal third quarter ended October 3, 2010 was $6.2 billion, compared with $5.1 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.
16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
For. |
|
|
|
|
|
|
|
|
|
|
|
|
|
Accum |
|
|
Cur. |
|
Gains/ |
|
Employee |
|
Deriv. |
|
Other |
|
|
Trans. |
|
(Losses) |
|
Benefit |
|
& |
|
Comp. Inc/ |
(Dollars in Millions) |
|
(Loss) |
|
on Sec. |
|
Plans |
|
Hedges |
|
(Loss) |
January 3, 2010 |
|
$ |
(508 |
) |
|
|
(30 |
) |
|
|
(2,665 |
) |
|
|
145 |
|
|
|
(3,058 |
) |
2010 nine months change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) |
|
|
|
|
|
|
91 |
|
|
|
|
|
|
|
(280 |
) |
|
|
|
|
Net amount reclassed to
net earnings |
|
|
|
|
|
|
(46 |
) |
|
|
|
|
|
|
186 |
* |
|
|
|
|
Net nine months change |
|
|
65 |
|
|
|
45 |
|
|
|
118 |
|
|
|
(94 |
) |
|
|
134 |
|
October 3, 2010 |
|
$ |
(443 |
) |
|
|
15 |
|
|
|
(2,547 |
) |
|
|
51 |
|
|
|
(2,924 |
) |
|
|
|
* |
|
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 8 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 October 3, 2010 and September 27, 2009.
|
|
|
|
|
|
|
|
|
|
|
Fiscal Quarters Ended |
|
|
Oct. 3, |
|
Sept. 27, |
(Shares in Millions) |
|
2010 |
|
2009 |
Basic net earnings per share |
|
$ |
1.24 |
|
|
$ |
1.21 |
|
Average shares outstanding basic |
|
|
2,751.6 |
|
|
|
2,756.3 |
|
Potential shares exercisable under stock
option plans |
|
|
149.6 |
|
|
|
174.5 |
|
Less: shares which could be repurchased under
treasury stock method |
|
|
(118.4 |
) |
|
|
(141.4 |
) |
Convertible debt shares |
|
|
3.6 |
|
|
|
3.6 |
|
Average shares outstanding diluted |
|
|
2,786.4 |
|
|
|
2,793.0 |
|
Diluted earnings per share |
|
$ |
1.23 |
|
|
$ |
1.20 |
|
The diluted earnings per share calculation for both fiscal third quarters ended October 3, 2010 and
September 27, 2009 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 quarters ended October 3, 2010 and
September 27, 2009, excluded 86 million and 77 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.
17
The following is a reconciliation of basic net earnings per share to diluted net earnings per share
for the fiscal nine months ended October 3, 2010 and September 27, 2009.
|
|
|
|
|
|
|
|
|
|
|
Fiscal Nine Months Ended |
|
|
Oct. 3, |
|
Sept. 27, |
(Shares in Millions) |
|
2010 |
|
2009 |
Basic net earnings per share |
|
$ |
4.14 |
|
|
$ |
3.64 |
|
Average shares outstanding basic |
|
|
2,754.2 |
|
|
|
2,760.0 |
|
Potential shares exercisable under stock
option plans |
|
|
149.9 |
|
|
|
103.9 |
|
Less: shares which could be repurchased
under treasury stock method |
|
|
(115.7 |
) |
|
|
(79.6 |
) |
Convertible debt shares |
|
|
3.6 |
|
|
|
3.6 |
|
Average shares outstanding diluted |
|
|
2,792.0 |
|
|
|
2,787.9 |
|
Diluted earnings per share |
|
$ |
4.08 |
|
|
$ |
3.61 |
|
The diluted earnings per share calculation for both the fiscal nine months ended October 3, 2010
and September 27, 2009, 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 October 3, 2010 and
September 27, 2009 excluded 85 million and 148 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 9 SEGMENTS OF BUSINESS AND GEOGRAPHIC AREAS
SALES BY SEGMENT OF BUSINESS (1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Quarters Ended |
|
|
Oct. 3, |
|
Sept. 27, |
|
Percent |
(Dollars in Millions) |
|
2010 |
|
2009 |
|
Change |
Consumer |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
$ |
1,277 |
|
|
$ |
1,691 |
|
|
|
(24.5 |
)% |
International |
|
|
2,290 |
|
|
|
2,298 |
|
|
|
(0.3 |
) |
Total |
|
|
3,567 |
|
|
|
3,989 |
|
|
|
(10.6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceutical |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
3,054 |
|
|
|
2,857 |
|
|
|
6.9 |
|
International |
|
|
2,441 |
|
|
|
2,392 |
|
|
|
2.0 |
|
Total |
|
|
5,495 |
|
|
|
5,249 |
|
|
|
4.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medical Devices & Diagnostics |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
2,800 |
|
|
|
2,766 |
|
|
|
1.2 |
|
International |
|
|
3,120 |
|
|
|
3,077 |
|
|
|
1.4 |
|
Total |
|
|
5,920 |
|
|
|
5,843 |
|
|
|
1.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Worldwide |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
7,131 |
|
|
|
7,314 |
|
|
|
(2.5 |
) |
International |
|
|
7,851 |
|
|
|
7,767 |
|
|
|
1.1 |
|
Total |
|
$ |
14,982 |
|
|
$ |
15,081 |
|
|
|
(0.7 |
)% |
18
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Nine Months Ended |
|
|
Oct. 3, |
|
Sept. 27, |
|
Percent |
(Dollars in Millions) |
|
2010 |
|
2009 |
|
Change |
Consumer |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
$ |
4,300 |
|
|
$ |
5,125 |
|
|
|
(16.1 |
)% |
International |
|
|
6,680 |
|
|
|
6,429 |
|
|
|
3.9 |
|
Total |
|
|
10,980 |
|
|
|
11,554 |
|
|
|
(5.0 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceutical |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
9,370 |
|
|
|
9,703 |
|
|
|
(3.4 |
) |
International |
|
|
7,316 |
|
|
|
6,824 |
|
|
|
7.2 |
|
Total |
|
|
16,686 |
|
|
|
16,527 |
|
|
|
1.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medical Devices & Diagnostics |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
8,551 |
|
|
|
8,194 |
|
|
|
4.4 |
|
International |
|
|
9,726 |
|
|
|
9,071 |
|
|
|
7.2 |
|
Total |
|
|
18,277 |
|
|
|
17,265 |
|
|
|
5.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Worldwide |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
22,221 |
|
|
|
23,022 |
|
|
|
(3.5 |
) |
International |
|
|
23,722 |
|
|
|
22,324 |
|
|
|
6.3 |
|
Total |
|
$ |
45,943 |
|
|
$ |
45,346 |
|
|
|
1.3 |
% |
|
|
|
(1) |
|
Export sales are not significant. |
OPERATING PROFIT BY SEGMENT OF BUSINESS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Quarters Ended |
|
|
Oct. 3, |
|
Sept. 27, |
|
Percent |
(Dollars in Millions) |
|
2010 |
|
2009 |
|
Change |
Consumer |
|
$ |
501 |
|
|
$ |
812 |
|
|
|
(38.3 |
)% |
Pharmaceutical |
|
|
1,858 |
|
|
|
1,637 |
|
|
|
13.5 |
|
Medical Devices
& Diagnostics |
|
|
2,002 |
|
|
|
2,016 |
|
|
|
(0.7 |
) |
Segments total |
|
|
4,361 |
|
|
|
4,465 |
|
|
|
(2.3 |
) |
Expense not allocated to
segments (2) |
|
|
(142 |
) |
|
|
(220 |
) |
|
|
|
|
Worldwide total |
|
$ |
4,219 |
|
|
$ |
4,245 |
|
|
|
(0.6 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Nine Months Ended |
|
|
Oct. 3, |
|
Sept. 27, |
|
Percent |
(Dollars in Millions) |
|
2010 |
|
2009 |
|
Change |
Consumer |
|
$ |
1,955 |
|
|
$ |
2,307 |
|
|
|
(15.3 |
)% |
Pharmaceutical (3) |
|
|
5,661 |
|
|
|
5,595 |
|
|
|
1.2 |
|
Medical Devices
& Diagnostics (4) |
|
|
7,580 |
|
|
|
5,891 |
|
|
|
28.7 |
|
Segments total |
|
|
15,196 |
|
|
|
13,793 |
|
|
|
10.2 |
|
Expense not allocated to
segments (2) |
|
|
(477 |
) |
|
|
(642 |
) |
|
|
|
|
Worldwide total |
|
$ |
14,719 |
|
|
$ |
13,151 |
|
|
|
11.9 |
% |
19
|
|
|
(2) |
|
Amounts not allocated to segments include interest income/(expense), non-controlling interests
and general corporate income/(expense). |
|
(3) |
|
Includes net litigation expense of $202 million recorded in the fiscal nine months of 2010. |
|
(4) |
|
Includes net litigation income of $1,542 million recorded in the fiscal nine months of 2010. |
SALES BY GEOGRAPHIC AREA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Quarters Ended |
|
|
Oct. 3, |
|
Sept. 27, |
|
Percent |
(Dollars in Millions) |
|
2010 |
|
2009 |
|
Change |
U.S. |
|
$ |
7,131 |
|
|
$ |
7,314 |
|
|
|
(2.5 |
)% |
Europe |
|
|
3,629 |
|
|
|
3,879 |
|
|
|
(6.4 |
) |
Western Hemisphere, excluding U.S. |
|
|
1,424 |
|
|
|
1,338 |
|
|
|
6.4 |
|
Asia-Pacific, Africa |
|
|
2,798 |
|
|
|
2,550 |
|
|
|
9.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
14,982 |
|
|
$ |
15,081 |
|
|
|
(0.7 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Nine Months Ended |
|
|
Oct. 3, |
|
Sept. 27, |
|
Percent |
(Dollars in Millions) |
|
2010 |
|
2009 |
|
Change |
U.S. |
|
$ |
22,221 |
|
|
$ |
23,022 |
|
|
|
(3.5 |
)% |
Europe |
|
|
11,563 |
|
|
|
11,522 |
|
|
|
0.4 |
|
Western Hemisphere, excluding U.S. |
|
|
4,079 |
|
|
|
3,615 |
|
|
|
12.8 |
|
Asia-Pacific, Africa |
|
|
8,080 |
|
|
|
7,187 |
|
|
|
12.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
45,943 |
|
|
$ |
45,346 |
|
|
|
1.3 |
% |
NOTE 10 BUSINESS COMBINATIONS AND DIVESTITURES
During the fiscal third quarter of 2010, the Company acquired Micrus Endovascular Corporation, a
global developer and manufacturer of minimally invasive devices to address hemorrhagic and ischemic
stroke for a net purchase price of approximately $0.4 billion. The purchase price for the
acquisition was allocated primarily to amortizable intangible assets for $0.3 billion.
During the fiscal third quarter of 2010, the Company completed the divestiture of the Breast Care
business of Ethicon Endo-Surgery, Inc., to Devicor Medical Products, Inc.
During the fiscal second quarter of 2010, the Company acquired RespiVert Ltd., a privately held
drug discovery company focused on
20
developing small-molecule, inhaled therapies for the treatment of
pulmonary diseases.
During the fiscal first quarter of 2010, the Company acquired Acclarent, Inc., a medical technology
company dedicated to designing, developing and commercializing devices that address conditions
affecting the ear, nose and throat, for a net purchase price of $0.8 billion. The purchase price
for the acquisition was allocated primarily to amortizable intangible assets for $0.7 billion.
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.
NOTE 11 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
21
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. There are a significant number of claimants who have pending lawsuits or
claims regarding injuries allegedly due to ORTHO EVRA®, RISPERDAL®, LEVAQUIN®, DURAGESIC®, the
CHARITÉ Artificial Disc, CYPHER® Stent, and ASR Hip. These claimants seek substantial
compensatory and, where available, punitive damages.
With respect to RISPERDAL®, the Attorneys General of multiple 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,
damages for overpayments by the state and others, 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 pursue a coordinated civil investigation of OMJPI regarding
potential consumer fraud actions in connection with the marketing of RISPERDAL®. 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. One of these has been dismissed on Summary
Judgment. 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 filed an appeal. The West Virginia Supreme Court
accepted Janssens appeal from that Judgment and the appeal was argued in September 2010. In
September and October 2010 a false claim suit brought under a Louisiana statute was tried. The jury
returned a verdict of $257.7 million in favor of that States Attorney General and against Janssen
and the Company. Post-trial motions challenging the verdict will be filed and if unsuccessful, will
be followed by an appeal. The Company believes that it has strong arguments supporting an appeal.
Since the Company believes that the potential for an unfavorable outcome is not probable, it has
not established a reserve with respect to the verdict. In the Commonwealth of Pennsylvania suit
against Janssen, trial commenced in June 2010. The Judge dismissed the case after the close of the
plaintiffs evidence. The Commonwealth has filed post-trial motions which are pending. Other cases
scheduled for trial are in South Carolina, currently scheduled in February 2011, and Texas
scheduled in June 2011.
22
In
August 2010, DePuy Orthopedics, Inc. (DePuy) announced a
world-wide voluntary recall of
its ASR XL Acetabular System and DePuy ASR Hip Resurfacing System used in hip replacement
surgery. Claims for personal injury have been made against the company. The Company has received
limited information to date with respect to potential claims and other costs associated with this
recall. Accordingly, a reasonable estimate of any future potential liability cannot be estimated at
this time.
PATENT LITIGATION
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.
On January 29, 2010, Cordis Corporation (Cordis) settled a patent infringement action against
Boston Scientific Corporation (Boston Scientific) in Delaware Federal District Court accusing its
Express2, Taxus® and Liberte® stents of infringing the Palmaz and Gray patents. Under the terms of
the settlement Boston Scientific dropped its lawsuit in which Cordis Cypher stent was found to
have infringed their Jang patent and paid Cordis $1.0 billion on February 1, 2010. Boston
Scientific also agreed to pay Cordis an additional $725 million plus interest by January 3, 2011.
On August 2, 2010, Boston Scientific paid the full $725 million plus interest. The Company
recorded the $1.7 billion in the fiscal first quarter of 2010. Cordis granted Boston Scientific a
worldwide license under the Palmaz and Gray patents and Boston Scientific granted Cordis a
worldwide license under the Jang patents for all stents sold by Cordis except the 2.25mm size
Cypher.
Cordis has several pending lawsuits in the New Jersey and Delaware Federal District Courts,
against Guidant Corporation (Guidant), Abbott Laboratories, Inc. (Abbott), Boston Scientific and
Medtronic Ave, Inc. (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. On January 20, 2010, in one of the cases against Boston Scientific, alleging that sales of
their Promus stent infringed Wright and Falotico patents, the District Court in Delaware found the
Wright/Falotico patent invalid for lack of written description and/or lack of enablement. Cordis
has appealed this ruling.
In October 2004, Tyco Healthcare Group, LP, (Tyco) and U.S. Surgical Corporation sued Ethicon
Endo-Surgery (EES) alleging that several features of EESs harmonic scalpel infringed four Tyco
patents. In October 2007, the court granted in part and denied in part cross-motions for summary
judgment. As a result of the opinion, a number of claims have been found invalid and a number have
been found infringed. No claim has been found valid and infringed. Trial commenced in December
2007, and the court dismissed the case without prejudice on grounds that Tyco did not own the
patents in suit. The dismissal without prejudice was affirmed on appeal. In January 2010, Tyco
filed another complaint in the District of Connecticut asserting three of the four patents
23
from the previous suit and adding new products. The case is scheduled to be trial ready by June
2011.
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. Genentech has dropped all its other claims that the manufacture of REMICADE®, STELARA,
SIMPONI and ReoPro® also infringes one of its other patents relating to the purification of
antibodies made through recombinant DNA techniques. The court conducted a hearing on Summary
Judgment Motions in August 2010. Shortly thereafter the parties settled this case with Centocor
receiving license under the Cabilly II patent.
In April 2009, a bench trial was held before the Federal District Court for the Middle
District of Florida on the liability phase of CIBA VISION Corporations (CIBA) patent infringement
lawsuit alleging that Johnson & Johnson Vision Care, Inc.s (JJVC) ACUVUE® OASYS lenses infringe
three of their Nicholson patents. In August 2009, the District Court found two of these patents
valid and infringed and entered judgment against JJVC. JJVC has appealed that judgment to the Court
of Appeals for the Federal Circuit. On April 27, 2010, the District Court denied CIBAs motion to
permanently enjoin the infringing lenses. Ciba appealed this ruling and its appeal has been
consolidated with JJVCs appeal on the merits. If the judgment is upheld on appeal the Court will
schedule another trial to determine damages and willfulness and, depending on the outcome of CIBAs
appeal, possibly injunctive relief. Ciba has also brought suit against JJVC under its counterparts
to the Nicholson patents in various European countries. In Holland and France the patents were
found valid and infringed and JJVC has been enjoined from selling Oasys. Both those decisions were
appealed. In France the appeal was denied. In Holland the appeal remains pending. CIBAs patents
were found to be invalid in Germany, the UK and Austria and CIBA is appealing those decisions.
In May 2009, Abbott Biotechnology Ltd. (Abbott) 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, infringes Abbotts 394
patent (the Salfeld patent). The case was stayed pending the resolution of an arbitration filed by
Centocor directed to its claim that it is licensed under the 394 patent. In June 2010, the
Arbitrator ruled that Centocor did not have a license to the patents-in-suit. The matter will
proceed before the District Court of Massachusetts on the issues of infringement and validity of
the Abbott patents.
In August 2009, Abbott GmbH & Co. (Abbott GmbH) and Abbott Bioresearch Center filed a patent
infringement lawsuit against Centocor (now COBI) in the United States District Court for the
24
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 infringement suit in Canada alleging that
STELARA infringes Abbott GmbHs Canadian patent. The cases filed by COBI in the District of
Columbia have been transferred to the District of Massachusetts.
In August 2009, Bayer Healthcare LLC (Bayer) filed suit against COBI in Massachusetts District
Court alleging infringement by COBIs SIMPONI product of its patent relating to human anti-TNF
antibodies. Bayer has also filed suit under its European counterpart to these patents in Germany
and the Netherlands. The court in the Netherlands held the Dutch patent invalid in a parallel case
Bayer brought against Abbott.
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. A bench trial on
Abbotts defenses, of inequitable conduct and prosecution laches, was held in August 2009, and the
District Court decided these issues in favor of Centocor. All of Abbotts post trial motions have
been denied except that the District Court granted Abbotts motion to overturn the jury finding of
willfulness. Judgment in the amount of $1.9 billion was entered in favor of Centocor in December
2009 and Abbott filed an appeal to the Court of Appeals for the Federal Circuit, therefore the
Company has not reflected any of the $1.9 billion in its consolidated financial statements. The
oral argument on appeal was held on November 2, 2010. Centocor has also filed a new lawsuit in the
Eastern District of Texas seeking damages for infringement of the 775 patent attributable to sales
of HUMIRA® subsequent to the jury verdict in June 2009.
The following chart summarizes various patent lawsuits concerning products of the Companys
subsidiaries that have yet to proceed to trial:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Plaintiff/ |
|
|
|
Trial |
|
Date |
J&J Product |
|
Company |
|
Patents |
|
Patent Holder |
|
Court |
|
Date** |
|
Filed |
|
|
|
CYPHER® Stent |
|
Cordis |
|
Wall |
|
Wall |
|
E.D. TX |
|
Q2/11 |
|
11/07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
CYPHER® Stent |
|
Cordis |
|
Saffran |
|
Saffran |
|
E.D. TX |
|
Q1/11 |
|
10/07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood
Glucose Meters and Strips |
|
LifeScan |
|
Wilsey |
|
Roche Diagnostics |
|
D. DE |
|
* |
|
11/07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
REMICADE®, ustekinumab, golimumab, ReoPro® |
|
Centocor/COBI |
|
Cabilly II |
|
Genentech |
|
C.D. CA |
|
* |
|
05/08 |
25
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Plaintiff/ |
|
|
|
Trial |
|
Date |
J&J Product |
|
Company |
|
Patents |
|
Patent Holder |
|
Court |
|
Date** |
|
Filed |
|
|
|
SIMPONI |
|
Centocor/COBI |
|
Salfeld |
|
Abbott Laboratories |
|
MA |
|
* |
|
05/09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
SIMPONI |
|
Centocor/COBI |
|
Boyle |
|
Bayer Healthcare |
|
MA |
|
* |
|
08/09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
STELARA |
|
Centocor/COBI |
|
Salfeld |
|
Abbott GmbH |
|
MA |
|
* |
|
08/09 |
|
|
|
* |
|
Trial date to be scheduled. |
|
** |
|
Q reflects the Companys fiscal quarter. |
LITIGATION AGAINST FILERS OF ABBREVIATED NEW DRUG APPLICATIONS (ANDAs)
The following chart indicates lawsuits pending against generic firms that filed Abbreviated New
Drug Applications (ANDAs) seeking to market generic forms of products sold by various subsidiaries
of the Company prior to expiration of the applicable patents covering those products. These ANDAs
typically include allegations of non-infringement, invalidity and unenforceability of these
patents. In the event the subsidiary of the Company involved is not successful in these actions, or
the statutory 30-month stay expires before a ruling from the District Court is obtained, the firms
involved will have the ability, upon FDA approval, to introduce generic versions of the product at
issue resulting in very substantial market share and revenue losses for the product of the
Companys subsidiary.
As noted in the following chart, 30-month stays expired during 2009, and will expire in 2010,
2011 and 2012 with respect to ANDA challenges regarding various products:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
30-Month |
Brand Name |
|
Patent/NDA |
|
Generic |
|
|
|
Trial |
|
Date |
|
Stay |
Product |
|
Holder |
|
Challenger |
|
Court |
|
Date** |
|
Filed |
|
Expiration |
|
|
|
CONCERTA®
18, 27, 36 and 54 mg controlled release tablet |
|
Ortho-McNeil-Janssen |
|
Andrx |
|
D. DE |
|
Q4/07 |
|
09/05 |
|
None |
|
ALZA |
|
KUDCO |
|
D. DE |
|
* |
|
01/10 |
|
05/12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
LEVAQUIN® 250, 500, 750 mg tablet |
|
Ortho-McNeil |
|
Lupin |
|
D. NJ |
|
* |
|
10/06 |
|
03/09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
ORTHO
TRI-CYCLEN® LO 0.18 mg/0.025 mg, 0.215 mg/0.025 mg and 0.25 mg/0.025 mg
|
|
Ortho-McNeil |
|
Watson |
|
D. NJ |
|
* |
|
10/08 |
|
03/11 |
|
|
|
Sandoz |
|
D. NJ |
|
* |
|
|
|
10/11 |
|
|
|
Lupin |
|
D. NJ |
|
* |
|
01/10 |
|
06/12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
ULTRAM
ER® 100, 200, 300 mg tablet |
|
Ortho-McNeil/Biovail |
|
Par |
|
D. DE |
|
Q2/09 |
|
05/07 |
|
09/09 |
|
|
|
|
|
|
|
|
|
|
06/07 |
|
11/09 |
|
|
|
|
|
|
|
|
|
|
10/07 |
|
03/10 |
26
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
30-Month |
Brand Name |
|
Patent/NDA |
|
Generic |
|
|
|
Trial |
|
Date |
|
Stay |
Product |
|
Holder |
|
Challenger |
|
Court |
|
Date** |
|
Filed |
|
Expiration |
|
|
|
ULTRAM
ER® 100, 200, 300 mg tablet |
|
Ortho-McNeil/Biovail |
|
Impax |
|
D. DE |
|
|
|
08/08 |
|
01/11 |
|
|
|
|
|
|
|
|
|
|
11/08 |
|
03/11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
ULTRAM
ER® 100, 200, 300 mg tablet |
|
Ortho-McNeil/Biovail |
|
Paddock |
|
D.DRD. Minn. |
|
* |
|
09/09 |
|
01/12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
ULTRAM
ER® 100, 200, 300 mg tablet |
|
Ortho-McNeil/Biovail |
|
Cipher |
|
D. DE |
|
* |
|
10/09 |
|
03/12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
ULTRAM
ER® 100, 200, 300 mg tablet |
|
Ortho-McNeil/Biovail |
|
Lupin |
|
D. DE |
|
* |
|
01/10 |
|
06/12 |
|
|
|
* |
|
Trial date to be scheduled. |
|
** |
|
Q reflects the Companys fiscal quarter. |
In October 2008, the Companys subsidiary Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI)
filed suit in Federal District Court in New Jersey against Watson Laboratories, Inc. (Watson) in
response to Watsons ANDA regarding ORTHO TRI-CYCLEN® LO. In June 2009, OMJPI filed suit in Federal
District Court in New Jersey against Sandoz Laboratories, Inc. (Sandoz) in response to Sandozs
ANDA regarding ORTHO TRI-CYCLEN® LO. The Sandoz and Watson cases have been consolidated. In
September 2010, OMJPI entered into a settlement agreement with Sandoz.
In January 2010, the Companys subsidiary OMJPI filed suit in Federal District Court in New
Jersey against Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively Lupin) in response to
Lupins ANDA regarding ORTHO TRI-CYCLEN® LO. The Lupin case has been consolidated with the Watson
case (discussed above).
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 CONCERTA® patents, a five-day
non-jury trial was held in the Federal District Court in Delaware in December 2007. In March 2009,
the court ruled that one CONCERTA® 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 in May 2009. The appeals court heard argument on February 3, 2010. On
April 26, 2010, the court of appeals affirmed the judgment of the district court that the patent is
invalid because it is not enabled. The court did not reach the issue of infringement.
ALZA and OMJPI filed suit in Federal District Court in Delaware against Kremers-Urban, LLC and
KUDCO Ireland, Ltd. (KUDCO) in January 2010 in response to KUDCOs ANDA challenge regarding
CONCERTA® tablets. In its notice letter, KUDCO contends that two ALZA patents for CONCERTA® are
invalid and not infringed by a KUDCO generic.
In the action against Lupin Pharmaceuticals, Inc. (Lupin) regarding its ANDA
concerning LEVAQUIN®, Lupin contended that the U.S. 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 alleged that the active
ingredient in LEVAQUIN® was the subject of prior marketing, and
27
therefore was not eligible for the patent term extension. Lupin conceded 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
in September 2009. In May 2010, the Court of Appeals affirmed the judgment of the trial court in
favor of Ortho-McNeil and Daiichi that the patent term extension covering LEVAQUIN®(levofloxacin)
is valid. Thereafter, Lupin requested rehearing en banc, which was denied.
In the ULTRAM® ER actions, Ortho-McNeil Pharmaceutical, Inc. (Ortho-McNeil) (now OMJPI), filed
lawsuits (each for different dosages) against Par Pharmaceuticals, Inc. and Par Pharmaceuticals
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 in April 2009. In August 2009, the Court issued a decision finding the
patents-in-suit invalid. Purdue has appealed that decision. In November 2009, the case against
Impax was stayed with the consent of all parties. 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. In June 2010, the Federal Circuit Court affirmed
the District Courts decision in the Par case. The case against Cipher Impax and Paddock were
dismissed based on the collateral estoppel effect of the Par decision.
In January 2010, Purdue filed a suit against Lupin Ltd. (Lupin) on its Tramadol ER formulation
patents.
GENERAL LITIGATION
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 opposed. The
district court heard oral argument on plaintiffs motion in July 2010. The court subsequently ruled
by denying plaintiffs motion for certification of the modified class.
28
In September 2009, Centocor Ortho Biotech Products, L.P. (COBI) intervened in an inventorship
dispute between Kansas University Center for Research (KUCR) involving certain U.S.
Government-owned VELCADE® formulation patents. KUCR brought this action against the U.S. government
in the District of Kansas seeking to add two Kansas University scientists to the patents. The U.S.
government licensed the patents (and their foreign counterparts) to Millennium Pharmaceuticals,
Inc., who in turn sublicensed the patents (and their foreign counterparts) to COBI for commercial
marketing outside the U.S. If KUCR succeeds in its co-inventorship claim and establishes
co-ownership in the U.S. VELCADE® formulation patents, there is a potential for the same issue to
arise with respect to the foreign counterparts of the patents. If KUCR is successful, this may
adversely affect COBIs license rights in those countries. In May 2010, the parties reached an
agreement to resolve the disputes in this case and will submit the inventorship issue to
arbitration, and the case has been stayed pending the arbitration. If KUCR wins the arbitration,
the parties will request that the Court issue an order to correct inventorship on the relevant
patents; if the U.S. Government, COBI, and MPI prevail, the case will be dismissed with prejudice.
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
Cefto-biprole 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
significant damages and a declaration that the Company materially breached the agreement. Post
hearing briefs have been submitted and a decision is expected in the fourth quarter 2010.
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 REMICADE® and SIMPONI worldwide, except within the United States, Japan,
Taiwan, Indonesia, and the Peoples Republic of China (including Hong Kong) (the Territory). COBI
distributes REMICADE® and SIMPONI, the next generation treatment, within the United States. In the
arbitration, COBI seeks a declaration that the agreement and 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 REMICADE® and SIMPONI within the
Territory. Schering-Plough has filed a response to COBIs arbitration demand that denies that it
has undergone a change of control. The arbitrators were selected and the evidentiary portion of the
hearing was concluded in October 2010. Oral argument is scheduled for late 2010. A decision is
expected during the first half of 2011.
In December 2009, the State of Israel (Sheba Medical Center) filed suit against the Companys
subsidiary, Omrix, and its affiliates. In the lawsuit, the State claims that an employee of a
29
government-owned hospital was the inventor on several patents related to fibrin glue
technology, that he developed while he was a government employee. The State claims that he had no
right to transfer any intellectual property to Omrix because it belongs to the State. The State is
seeking damages plus royalty on QUIXIL and EVICEL or, alternatively, transfer of the patents to
the State.
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. Two state cases against certain of the Companys subsidiaries
have been set for trial: Idaho in October 2011, and Kentucky in January 2012. In addition, the
state of Pennsylvania commenced trial in Commonwealth Court in October 2010. Other state cases are
likely to be set for trial in the coming year.
In April 2010, a lawsuit was filed in the United States District Court for the Northern
District of California. The complaint alleges that the Company, together with co-defendant
Omnicare, Inc. and other unidentified companies or individuals, engaged in a conspiracy to restrain
trade and in unlawful, unfair and fraudulent business acts or practices in violation of California
Business and Professions Code. The Company filed a motion to dismiss. Plaintiffs then filed an
amended complaint. The Company has moved to dismiss the amended complaint. A hearing on the
Companys motion to dismiss is scheduled for December 2010.
30
Johnson & Johnson has been named the nominal defendant in six shareholder derivative lawsuits
in the U.S. District Court for the District of New Jersey on behalf of Company shareholders against
certain current and former directors and officers of the Company derivatively on behalf of the
Company: Calamore v. Coleman et. al., filed April 21, 2010; Carpenters Pension Fund of West
Virginia v. Weldon, et. al., filed May 5, 2010; Feldman v. Coleman, et. al., filed May 6, 2010;
Hawaii Laborers Pension Fund v. Weldon, et. al., filed May 14, 2010; Ryan v. Weldon, et. al., filed
June 18, 2010; and Minneapolis Firefighters Relief Association, NECA-IBEW Pension Trust Fund, and
NECA-IBEW Welfare Trust Fund v. Weldon, et. al., filed June 24, 2010. These actions were
consolidated on August 17, 2010 into one lawsuit: In re Johnson & Johnson Shareholder Derivative
Litigation. An amended consolidated complaint is expected to be filed in November 2010.
Additionally, Johnson & Johnson has been named the nominal defendant in a shareholder derivative
lawsuit in New Jersey Superior Court on behalf of Company shareholders against certain current and
former directors and officers of the Company derivatively on behalf of the Company: Wolin v.
Johnson & Johnson, filed September 23, 2010. Each of these shareholder derivative actions is
similar in its claims and collectively they assert a variety of alleged breaches of fiduciary
duties, including, among other things, that the defendants allegedly engaged in, approved of, or
failed to remedy or prevent defective medical devices, improper pharmaceutical rebates, improper
off-label marketing of pharmaceutical and medical device products, violations of current good
manufacturing practice regulations that resulted in product recalls, and failed to disclose the
aforementioned alleged misconduct in the Companys filings under the Securities Exchange Act of
1934. Each complaint seeks a variety of relief, including monetary damages and corporate
governance reforms. Motions to consolidate these shareholder derivative actions are pending.
On July 27, 2010, a complaint was filed by a shareholder of the Company in New Jersey Superior
Court, Chancery Division, Middlesex County (Lipschutz v. Johnson & Johnson) seeking to compel
inspection of Company books and records with respect to certain product recalls and various
manufacturing plants. This lawsuit was dismissed on October 7, 2010.
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 TOPAMAX® (topiramate). In the fiscal second
31
quarter of 2010, OMJPI entered into a settlement agreement resolving the federal governments
investigation. The settlement includes total payments of $81.5 million plus interest, an amount
previously reserved. As one part of the resolution, Ortho-McNeil Pharmaceutical, LLC, a subsidiary
of OMJPI, has agreed to plead guilty to a single misdemeanor violation of the Food, Drug and
Cosmetic Act and to pay a $6.1 million criminal fine. OMJPI denies it engaged in any wrongful
conduct, beyond acknowledging the limited conduct of Ortho-McNeil Pharmaceutical, LLC, that is the
basis of the misdemeanor plea. The balance of the total settlement amount is a civil payment, part
of which was paid to the federal government and part of which was paid or set aside for payment to
states for their Medicaid programs.
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, RISPERDAL® (risperidone) from 1997 to 2002. Documents subsequent to 2002 have also been
requested. An additional subpoena seeking information about marketing of and adverse reactions to
RISPERDAL® was received from the U.S. 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. The government is continuing to actively investigate this matter. In February 2010, the
government served Civil Investigative Demands seeking additional information relating to sales and
marketing of RISPERDAL® and sales and marketing of INVEGA®. Discussions are ongoing in an effort to
resolve potential criminal and civil litigation arising from these matters. Whether a resolution
can be reached and on what terms is uncertain.
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 PROCRIT® (Epoetin alfa) from 1997 to the present, as well as to dealings
with U.S. Oncology Inc., a healthcare services network for oncologists. Ortho Biotech (now COBI)
has responded to the subpoena.
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 has responded 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 NATRECOR®. Scios responded 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
32
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 filed a motion to dismiss the qui tam complaint filed by the government, and that motion
was denied. The criminal investigation is continuing and discussions are underway in an effort to
settle this matter. Whether a settlement can be reached and on what terms is uncertain.
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., (Omnicare) a manager of pharmaceutical benefits for long-term care facilities. The Companys
subsidiaries involved responded to the subpoena. Several employees of the Companys pharmaceutical
subsidiaries were 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 related to
marketing of prescription drugs to Omnicare, Inc. On January 15, 2010, the government filed a
complaint intervening in the cases. The complaint asserts claims under the federal False Claims Act
and a related state law claim in connection with the marketing of several drugs to Omnicare. The
complaints allege that Johnson & Johnson provided Omnicare, Inc. with rebates and other alleged
kickbacks, and in so doing, caused Omnicare to file false claims with Medicaid and other government
programs. Subsequently, the Commonwealth of Massachusetts, Virginia, and Kentucky, and the States
of California and Indiana intervened in the action. The Companys motion to dismiss the
governments and relatorscomplaints, the governments and relators oppositions, and the Companys
reply brief have been filed. A hearing on the Companys motion to dismiss was held on October 7,
2010. The court has not ruled on the motion.
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 information.
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
33
referenced above, but whether agreement can be reached and on what terms is uncertain.
In May 2007, the New York State Attorney General issued a subpoena seeking information
relating to the marketing and safety of PROCRIT®. The Company has responded to these requests.
In April 2007, the Company received two subpoenas from the Office of the Attorney General of
the State of Delaware. The subpoenas seek documents and information relating to nominal pricing
agreements. For purposes of the subpoenas, nominal pricing agreements are defined as agreements
under which the Company agreed to provide a pharmaceutical product for less than ten percent of the
Average Manufacturer Price for the product. The Company responded to these requests.
In 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 responded to the request.
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. A False Claims Act complaint was
filed in Dallas relating to similar issues. The U.S. Department of Justice and several states have
declined to intervene at this time. A motion to dismiss the Texas qui tam case is pending.
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. The Company has responded to this request.
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 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 the financial interest of clinical investigators who performed
clinical studies for DePuy Orthopaedics, Inc. and DePuy Spine, Inc. DePuy Orthopaedics has
responded to these requests.
In May 2010, the Company received a letter from the United States House of Representatives
Committee on Oversight and Government Reform (Committee) requesting information and
34
documents regarding the April 2010 recall of various infants and childrens liquid products
by McNeil Consumer Healthcare. The Company produced documents and other information in response to
these requests. In May 2010, the Committee conducted a public hearing. Thereafter, the Company
received additional information requests from the Committee, including requests regarding the
recall of certain Motrin products by McNeil Consumer Healthcare. The Company produced documents
and other information in response to these requests. The Committee held another public hearing on
September 30, 2010, and the Company continues to cooperate fully with the Committees ongoing
information requests.
In addition, McNeil Consumer Healthcare, and certain affiliates including Johnson & Johnson
(the Companies), received grand jury subpoenas from the United States Attorneys Office for the
Eastern District of Pennsylvania requesting documents broadly relating to recent recalls of various
products of McNeil Consumer Healthcare, and the FDA inspections of the Fort Washington,
Pennsylvania and Lancaster, Pennsylvania manufacturing facilities. The Companies are cooperating
with the United States Attorneys Office in responding to these subpoenas.
The Companies have also received Civil Investigative Demands (CID) from multiple State
Attorneys General Offices broadly relating to the McNeil recall issues. The Companies continue to
produce documents in response to these CIDs and otherwise cooperate with these inquiries.
Furthermore, a lawsuit was filed by a shareholder in the United States District Court for the
District of New Jersey: Monk v. Johnson & Johnson. The complaint seeks class certification based
upon the anti-fraud provisions of the federal securities laws related to the McNeil manufacturing
facilities. More specifically, this complaint alleges that the Companies and certain individuals,
including officers and employees, failed to disclose that a number of manufacturing facilities were
failing to maintain current good manufacturing practices (cGMPs) and, as a result, the price of the
Companys stock has declined significantly.
Multiple complaints seeking class action certification related to the McNeil recalls have been
filed in the United States District Court for the Eastern District of Pennsylvania, the Northern
District of Illinois, the Central District of California, and the Southern District of Ohio. These
consumer complaints allege generally that purchasers of McNeils childrens medicines are owed
money damages and penalties because they paid premium prices for defective medications rather than
less expensive alternative medications. Each complaint seeks certification of a nation-wide class
of purchasers of childrens medicines. On October 8, 2010, the Judicial Panel on Multidistrict
Litigation consolidated these consumer complaints: Haviland v. McNeil (E.D. Pa.); Smith v. McNeil
(N.D. Ill.); Burrell v. McNeil (N.D. Ill.); DeGroot v. McNeil (N.D. Ill.); Michaud v. McNeil, (N.D.
Ill.); Nguyen v. McNeil (N.D. Ill.); Roberson v. McNeil (N.D. Ill.); Rivera v. Johnson & Johnson
(C.D. Cal.)for pretrial proceedings in
35
the United States District Court for the Eastern District of Pennsylvania. Defendants have
requested that the more recently filed case of Coleman v. McNeil (S.D. Ohio) be transferred to that
same court.
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 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 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 material impact on the Companys results of operations and cash flows for that
period.
36
NOTE 12 RESTRUCTURING
In the fourth quarter of 2009, the Company announced global restructuring initiatives designed to
strengthen the Companys position as one of the worlds leading global health care companies. This
program will allow the Company 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.
During the fiscal fourth quarter of 2009, the Company recorded $1.2 billion in related pre-tax
charges, of which approximately $830 million of the pre-tax restructuring charges are expected to
require cash payments. The $1.2 billion of restructuring charges consists of severance costs of
$748 million, asset write-offs of $362 million and $76 million related to leasehold and contract
obligations. The $362 million of asset write-offs relate to inventory of $113 million (recorded in
cost of products sold), property, plant and equipment of $107 million, intangible assets of $81
million and other assets of $61 million. The asset write-offs and leasehold and contract
obligations have been substantially completed. Additionally, as part of this program the Company
plans to eliminate approximately 7,500 positions of which approximately 4,300 have been eliminated
since the restructuring was announced.
The following table summarizes the severance related reserves and the associated spending under
this initiative through the fiscal third quarter of 2010:
|
|
|
|
|
(Dollars in Millions) |
|
Severance |
Reserve balance as of: |
|
|
|
|
January 3, 2010 |
|
$ |
686 |
|
Cash outlays |
|
|
(253 |
) |
October 3, 2010* |
|
$ |
433 |
|
|
|
|
* |
|
Cash outlays for severance are expected to be paid out over the next 12 to 15 months in accordance
with the Companys plans and local laws. |
NOTE 13 SUBSEQUENT EVENT
On October 6, 2010 the Company announced a definitive agreement with Crucell N.V. to acquire the
remaining 81.6% of outstanding equity of Crucell N.V. that it does not already own for
approximately euro 1.75 billion in a cash tender offer. Crucell is a global biopharmaceutical
company focused on the research & development, production and marketing of vaccines and antibodies
against infectious disease worldwide.
|
|
|
Item 2 |
|
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
Results of Operations
Analysis of Consolidated Sales
37
For the fiscal nine months of 2010, worldwide sales were $45.9 billion, an increase of 1.3% as
compared to 2009 fiscal nine months sales of $45.3 billion. Currency fluctuations had a positive
impact of 1.3% and operational growth was flat for the fiscal nine months of 2010.
Sales by U.S. companies were $22.2 billion in the fiscal nine months of 2010, which represented a
decrease of 3.5% as compared to the same period last year. Sales by international companies were
$23.7 billion, which represented a total increase of 6.3% including an operational increase of
3.7%, and a positive impact from currency of 2.6% as compared to the fiscal nine months sales of
2009.
Sales by companies in Europe achieved growth of 0.4%, including operational growth of 2.6% and a
negative impact from currency of 2.2%. Sales by companies in the Western Hemisphere, excluding the
U.S., achieved growth of 12.8% including operational growth of 2.5% and a positive impact from
currency of 10.3%. Sales by companies in the Asia-Pacific, Africa region achieved sales growth of
12.4%, including operational growth of 5.9% and an increase of 6.5% related to the positive impact
of currency.
For the fiscal third quarter of 2010, worldwide sales were $15.0 billion, a decrease of 0.7%
including an operational increase of 0.1% as compared to 2009 fiscal third quarter sales of $15.1
billion. Currency translation negatively impacted sales by 0.8% for the fiscal third quarter of
2010.
Sales by U.S. companies were $7.1 billion in the fiscal third quarter of 2010, which represented a
decrease of 2.5% as compared to the same period last year. Sales by international companies were
$7.9 billion, which represented a total increase of 1.1% including an operational increase of 2.6%,
and a negative impact from currency of 1.5% as compared to the fiscal third quarter sales of 2009.
Sales by companies in Europe experienced a sales decline of 6.4%, including operational growth of
1.8% and a negative impact from currency of 8.2%. Sales by companies in the Western Hemisphere,
excluding the U.S., achieved growth of 6.4% including operational growth of 1.7% and a positive
impact from currency of 4.7%. Sales by companies in the Asia-Pacific, Africa region achieved growth
of 9.7%, including operational growth of 4.1% and a positive impact from currency of 5.6%.
U.S. Health Care Reform
The Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act
of 2010 were signed into law during March 2010. The newly enacted health care reform legislation
included an increase in the minimum Medicaid rebate rate from 15.1% to 23.1% and also extended the
rebate to drugs provided through Medicaid managed care organizations. The Company has estimated the
total year 2010 impact will be an increase in sales rebates estimated at approximately $400
million, of which
38
$260 million and $110 million impacted the Companys fiscal nine months and fiscal third quarter of
2010, respectively.
Beginning in 2011, companies that sell branded prescription drugs to specified U.S. Government
programs will pay an annual non-tax deductible fee based on an allocation of the Companys market
share of branded prior year sales. Additionally, in 2011, discounts will be provided on the
Companys brand-name drugs to patients who fall within the Medicare Part D coverage gap, donut
hole. Beginning in 2013, the Company will record the tax deductible 2.3% excise tax imposed on the
sale of certain medical devices.
Puerto Rico Income and Excise Tax Legislation
On
October 25, 2010, the Commonwealth of Puerto Rico enacted a law effective January 1, 2011 that
imposes a tax on corporations that transact business with companies operating in Puerto Rico. A 4%
excise tax will be imposed on purchases from Puerto Rico in excess of $75 million in a year. Under
the new law, the tax rate will decline gradually each year to a level of 1% in 2016. The Company is
currently assessing the impact of the new tax bill.
Analysis of Sales by Business Segments
Consumer
Consumer segment sales in the fiscal nine months of 2010 were $11.0 billion, a decrease of 5.0% as
compared to the same period a year ago, including an operational decline of 6.9% and a positive
currency impact of 1.9%. U.S. Consumer segment sales declined by 16.1% while international sales
growth of 3.9%, included operational growth of 0.5% and a positive currency impact of 3.4%.
Major Consumer Franchise Sales Fiscal Nine Months
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oct. 3, |
|
Sept. 27, |
|
Total |
|
Operations |
|
Currency |
(Dollars in Millions) |
|
2010 |
|
2009 |
|
Change |
|
Change |
|
Change |
OTC Pharm & Nutr |
|
$ |
3,457 |
|
|
$ |
4,056 |
|
|
|
(14.8 |
)% |
|
|
(16.1 |
)% |
|
|
1.3 |
% |
Skin Care |
|
|
2,563 |
|
|
|
2,517 |
|
|
|
1.8 |
|
|
|
0.2 |
|
|
|
1.6 |
|
Baby Care |
|
|
1,632 |
|
|
|
1,541 |
|
|
|
5.9 |
|
|
|
2.5 |
|
|
|
3.4 |
|
Womens Health |
|
|
1,394 |
|
|
|
1,406 |
|
|
|
(0.9 |
) |
|
|
(3.1 |
) |
|
|
2.2 |
|
Oral Care |
|
|
1,137 |
|
|
|
1,161 |
|
|
|
(2.1 |
) |
|
|
(4.8 |
) |
|
|
2.7 |
|
Wound Care/Other |
|
|
797 |
|
|
|
873 |
|
|
|
(8.7 |
) |
|
|
(10.4 |
) |
|
|
1.7 |
|
Total |
|
$ |
10,980 |
|
|
$ |
11,554 |
|
|
|
(5.0 |
)% |
|
|
(6.9 |
)% |
|
|
1.9 |
% |
Consumer segment sales in the fiscal third quarter of 2010 were $3.6 billion, a decrease of
10.6% over the same period a year ago, including an operational decline of 10.2% and a negative
currency impact of 0.4%. U.S. Consumer segment sales declined by 24.5%. International Consumer
segment sales declined by 0.3%, including operational growth of 0.4%, and a negative currency
impact of 0.7%.
39
Major Consumer Franchise Sales Fiscal Third Quarters
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oct. 3, |
|
Sept. 27, |
|
Total |
|
Operations |
|
Currency |
(Dollars in Millions) |
|
2010 |
|
2009 |
|
Change |
|
Change |
|
Change |
OTC Pharm & Nutr |
|
$ |
1,109 |
|
|
$ |
1,398 |
|
|
|
(20.7 |
)% |
|
|
(19.4 |
)% |
|
|
(1.3 |
)% |
Skin Care |
|
|
800 |
|
|
|
842 |
|
|
|
(5.0 |
) |
|
|
(4.9 |
) |
|
|
(0.1 |
) |
Baby Care |
|
|
566 |
|
|
|
544 |
|
|
|
4.0 |
|
|
|
3.3 |
|
|
|
0.7 |
|
Womens Health |
|
|
459 |
|
|
|
502 |
|
|
|
(8.6 |
) |
|
|
(7.9 |
) |
|
|
(0.7 |
) |
Oral Care |
|
|
384 |
|
|
|
410 |
|
|
|
(6.3 |
) |
|
|
(6.8 |
) |
|
|
0.5 |
|
Wound Care/Other |
|
|
249 |
|
|
|
293 |
|
|
|
(15.0 |
) |
|
|
(15.0 |
) |
|
|
0.0 |
|
Total |
|
$ |
3,567 |
|
|
$ |
3,989 |
|
|
|
(10.6 |
)% |
|
|
(10.2 |
)% |
|
|
(0.4 |
)% |
The OTC Pharmaceuticals and Nutritionals franchise experienced an operational decline of 19.4%
as compared to prior year fiscal third quarter. Sales were negatively impacted by the voluntary
recalls of certain OTC products announced earlier in the year and suspension of production at
McNeil Consumer Healthcares Fort Washington, Pennsylvania facility. The Companys Canadian
affiliate has begun to ship small quantities for a limited number of the products that were
previously produced at the McNeil Consumer Healthcares Fort Washington, Pennsylvania facility. The
impact to 2010 annual sales from not shipping products produced at this facility is estimated at
approximately $600 million.
Alternate supply of the remainder of these products is projected to start in the first quarter of
2011 and continue to expand throughout the year. McNeil Consumer Healthcare submitted its
comprehensive action plan to the Food and Drug Administration (FDA) on July 15, 2010, which
encompasses, among other items, training, resources and capital investments in quality and
manufacturing systems across the McNeil organization. The Company continues to communicate with
the FDA on remediation actions.
The Skin Care franchise experienced an operational decline of 4.9% due in part to a temporary
product supply issue in the Neutrogena product line.
The Baby Care franchise achieved operational growth of 3.3% over the prior year fiscal third
quarter primarily due to growth in the Asia Pacific region.
The Womens Health Franchise experienced an operational decline of 7.9% as compared to prior year
fiscal third quarter primarily due to increased competitive pressures.
The Oral Care franchise experienced an operational decline of 6.8% primarily due to the
divestiture of the EFFERDENT®/Effergrip® brands in the fiscal fourth quarter of 2009 and lower
sales of toothbrushes.
Pharmaceutical
Pharmaceutical segment sales in the fiscal nine months of 2010 were $16.7 billion, an increase of
1.0% as compared to the same period a year ago with an operational increase of 0.2% and an increase
of 0.8% related to the positive impact of currency. U.S. Pharmaceutical sales declined by 3.4% as
compared to the same period a year ago. International Pharmaceutical sales growth of
40
7.2%, included
an operational increase of 5.3%, and an increase of 1.9% related to the positive impact of
currency.
Major Pharmaceutical Product Revenues Fiscal Nine Months*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oct. 3, |
|
Sept. 27, |
|
Total |
|
Operations |
|
Currency |
(Dollars in Millions) |
|
2010 |
|
2009 |
|
Change |
|
Change |
|
Change |
REMICADE® |
|
$ |
3,545 |
|
|
$ |
3,166 |
|
|
|
12.0 |
% |
|
|
12.0 |
% |
|
|
|
% |
PROCRIT®/EPREX® |
|
|
1,455 |
|
|
|
1,669 |
|
|
|
(12.8 |
) |
|
|
(12.9 |
) |
|
|
0.1 |
|
RISPERDALâ CONSTAâ |
|
|
1,112 |
|
|
|
1,026 |
|
|
|
8.4 |
|
|
|
8.2 |
|
|
|
0.2 |
|
LEVAQUIN®/FLOXIN® |
|
|
957 |
|
|
|
1,098 |
|
|
|
(12.8 |
) |
|
|
(12.9 |
) |
|
|
0.1 |
|
CONCERTAâ |
|
|
951 |
|
|
|
945 |
|
|
|
0.6 |
|
|
|
(0.6 |
) |
|
|
1.2 |
|
ACIPHEX®/PARIETâ |
|
|
754 |
|
|
|
784 |
|
|
|
(3.8 |
) |
|
|
(4.2 |
) |
|
|
0.4 |
|
TOPAMAX® |
|
|
417 |
|
|
|
959 |
|
|
|
(56.5 |
) |
|
|
(56.8 |
) |
|
|
0.3 |
|
Other Pharmaceuticals |
|
|
7,495 |
|
|
|
6,880 |
|
|
|
8.9 |
|
|
|
7.3 |
|
|
|
1.6 |
|
Total |
|
$ |
16,686 |
|
|
$ |
16,527 |
|
|
|
1.0 |
% |
|
|
0.2 |
% |
|
|
0.8 |
% |
|
|
|
* |
|
Prior year amounts have been reclassified to conform to current year presentation. |
Pharmaceutical segment sales in the fiscal third quarter of 2010 were $5.5 billion, a total
increase of 4.7% as compared to the same period a year ago with an operational increase of 5.9% and
a decrease of 1.2% due to the negative impact of currency. U.S. Pharmaceutical sales achieved sales
growth of 6.9% as compared to the same period a year ago. International Pharmaceutical sales
achieved sales growth of 2.0%, including operational growth of 4.6%, and a decrease of 2.6% related
to the negative impact of currency.
Major Pharmaceutical Product Revenues Fiscal Third Quarters*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oct. 3, |
|
Sept. 27, |
|
Total |
|
Operations |
|
Currency |
(Dollars in Millions) |
|
2010 |
|
2009 |
|
Change |
|
Change |
|
Change |
REMICADE® |
|
$ |
1,229 |
|
|
$ |
1,036 |
|
|
|
18.6 |
% |
|
|
18.6 |
% |
|
|
|
% |
PROCRIT®/EPREX® |
|
|
406 |
|
|
|
542 |
|
|
|
(25.1 |
) |
|
|
(22.9 |
) |
|
|
(2.2 |
) |
RISPERDALâ CONSTAâ |
|
|
378 |
|
|
|
353 |
|
|
|
7.1 |
|
|
|
11.0 |
|
|
|
(3.9 |
) |
CONCERTAâ |
|
|
299 |
|
|
|
284 |
|
|
|
5.3 |
|
|
|
5.8 |
|
|
|
(0.5 |
) |
LEVAQUIN®/FLOXIN® |
|
|
286 |
|
|
|
311 |
|
|
|
(8.0 |
) |
|
|
(8.1 |
) |
|
|
0.1 |
|
ACIPHEX®/PARIETâ |
|
|
240 |
|
|
|
261 |
|
|
|
(8.0 |
) |
|
|
(5.3 |
) |
|
|
(2.7 |
) |
TOPAMAX® |
|
|
127 |
|
|
|
175 |
|
|
|
(27.4 |
) |
|
|
(25.4 |
) |
|
|
(2.0 |
) |
Other Pharmaceuticals |
|
|
2,530 |
|
|
|
2,287 |
|
|
|
10.6 |
|
|
|
11.7 |
|
|
|
(1.1 |
) |
Total |
|
$ |
5,495 |
|
|
$ |
5,249 |
|
|
|
4.7 |
% |
|
|
5.9 |
% |
|
|
(1.2 |
)% |
|
|
|
* |
|
Prior year amounts have been reclassified to conform to current year presentation. |
REMICADE® (infliximab), a biologic approved for the treatment of a number of immune-mediated
inflammatory diseases, achieved operational growth of 18.6% over prior year fiscal third quarter.
Growth was primarily driven by market growth partially offset by lower market share due to
increased competition, including the Companys other immunology products, SIMPONI® (golimumab) and
STELARA® (ustekinumab). U.S. export sales grew 75.5% versus the prior year fiscal third quarter
primarily driven by an increase in customer production planning needs. REMICADE® is competing in a
41
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
22.9%, as compared to the prior year fiscal third quarter. The decline in PROCRITâ sales was due
to the declining U.S. market for Erythropoiesis Stimulating Agents (ESAs) and the impact of the
recall announced by the Companys supplier, Amgen, in September. The decline in EPREXâ sales was due to
increased competition and a slowdown in certain European markets.
RISPERDAL® CONSTA® (risperidone), a long-acting injectable antipsychotic, achieved operational
growth of 11.0% over the fiscal third quarter of 2009 due to growth outside the U.S. Sales in the
U.S. were primarily impacted by lower market share due to increased competition including sales of
the Companys long-acting injectable, INVEGA® SUSTENNA.
CONCERTAâ (methylphenidate HCl), a product for the treatment of attention deficit
hyperactivity disorder, achieved operational sales growth of 5.8% as compared to the prior year
fiscal third quarter due to market growth. Sales growth in the U.S. was partially offset by the health
care reform legislation enacted in March 2010 resulting from changes to rebates to Medicaid
managed care organizations. On November 2, 2010, the Company entered into a U.S. supply and
distribution agreement with Watson Laboratories, Inc. to distribute an authorized generic version of
CONCERTAâ beginning May 1, 2011. 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.
LEVAQUIN® (levofloxacin)/FLOXINâ (ofloxacin), an anti-infective, experienced an operational
decline of 8.1% as compared to the prior year fiscal third quarter primarily due to the decline in the
market and increased penetration of generics. Market exclusivity in the U.S. expires in June 2011.
The expiration of a products market exclusivity is likely to result in a significant reduction in
sales.
ACIPHEXâ/PARIETâ, experienced an operational decline of 5.3% as compared to the fiscal
third quarter of 2009 primarily due to generic competition in the U.S.
TOPAMAX® (topiramate), experienced an operational decline of 25.4% as compared to prior year fiscal
third quarter. Market exclusivity for TOPAMAX® (topiramate) expired in March 2009 in the U.S. and
in September 2009 in most European countries. Multiple generics have entered the market. Loss of
market exclusivity for the TOPAMAX® patent has resulted in the significant reduction of sales in
the U.S. and Europe.
42
In the fiscal third quarter of 2010, Other Pharmaceutical sales achieved operational growth of
11.7% over the prior year fiscal third quarter. Contributors to the increase were sales of
VELCADEâ (bortezomib), SIMPONI® (golimumab), STELARA® (ustekinumab), PREZISTA® (darunavir),
INTELENCE® (etravirine), NUCYNTA® (tapentadol) and INVEGA SUSTENNA® (paliperidone palmitate).
Additionally, growth of ORTHO TRI-CYCLEN® LO was impacted by a generic version shipped by a
competitor in the prior year fiscal third quarter. Subsequently, the generic manufacturer
recognized the validity of the patent, paid damages for its infringing sales and ceased further
shipments of the product. This growth was partially offset by lower sales of DURAGESIC®/Fentanyl
Transdermal (fentanyl transdermal system) and RISPERDALâ/risperidone due to
continued generic competition.
Medical Devices and Diagnostics
Medical Devices and Diagnostics segment sales in the fiscal nine months of 2010 were $18.2 billion,
an increase of 5.9% as compared to the same period a year ago, with 4.5% of this change due to
operational increases and an increase of 1.4% related to the positive impact of currency. The U.S.
Medical Devices and Diagnostics sales increase was 4.4% as compared to the prior year.
International Medical Devices and Diagnostics sales increase of 7.2% included operational increases
of 4.5% and an increase of 2.7% related to the positive impact of currency.
Major Medical Devices and Diagnostics Franchise Sales Fiscal Nine Months
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oct. 3, |
|
Sept. |
|
Total |
|
Operations |
|
Currency |
(Dollars in Millions) |
|
2010 |
|
27, 2009 |
|
Change |
|
Change |
|
Change |
DEPUY® |
|
$ |
4,138 |
|
|
$ |
3,899 |
|
|
|
6.1 |
% |
|
|
4.8 |
% |
|
|
1.3 |
% |
ETHICON ENDO-SURGERY® |
|
|
3,501 |
|
|
|
3,236 |
|
|
|
8.2 |
|
|
|
6.5 |
|
|
|
1.7 |
|
ETHICON® |
|
|
3,351 |
|
|
|
3,013 |
|
|
|
11.2 |
|
|
|
9.7 |
|
|
|
1.5 |
|
Vision Care |
|
|
2,021 |
|
|
|
1,888 |
|
|
|
7.0 |
|
|
|
4.0 |
|
|
|
3.0 |
|
CORDIS® |
|
|
1,923 |
|
|
|
1,982 |
|
|
|
(3.0 |
) |
|
|
(4.4 |
) |
|
|
1.4 |
|
Diabetes Care |
|
|
1,826 |
|
|
|
1,785 |
|
|
|
2.3 |
|
|
|
2.9 |
|
|
|
(0.6 |
) |
ORTHO-CLINICAL
DIAGNOSTICS® |
|
|
1,517 |
|
|
|
1,462 |
|
|
|
3.8 |
|
|
|
2.6 |
|
|
|
1.2 |
|
Total |
|
$ |
18,277 |
|
|
$ |
17,265 |
|
|
|
5.9 |
% |
|
|
4.5 |
% |
|
|
1.4 |
% |
Medical Devices and Diagnostics segment sales in the fiscal third quarter of 2010 were $5.9
billion, an increase of 1.3% as compared to the same period a year ago, with 1.9% of this change
due to operational increases and a negative currency impact of 0.6%. The U.S. Medical Devices and
Diagnostics sales growth was 1.2% and the increase in international Medical Devices and Diagnostics
sales was 1.4%, which included operational increases of 2.6% and a negative currency impact of
1.2%.
43
Major Medical Devices and Diagnostics Franchise Sales Fiscal Third Quarters
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oct. 3, |
|
Sept. 27, |
|
Total |
|
Operations |
|
Currency |
(Dollars in Millions) |
|
2010 |
|
2009 |
|
Change |
|
Change |
|
Change |
DEPUY® |
|
$ |
1,309 |
|
|
$ |
1,284 |
|
|
|
1.9 |
% |
|
|
2.6 |
|
|
|
(0.7 |
)% |
ETHICON ENDO-SURGERY® |
|
|
1,137 |
|
|
|
1,106 |
|
|
|
2.8 |
|
|
|
3.3 |
|
|
|
(0.5 |
) |
ETHICON® |
|
|
1,072 |
|
|
|
1,019 |
|
|
|
5.2 |
|
|
|
6.0 |
|
|
|
(0.8 |
) |
Vision Care |
|
|
695 |
|
|
|
659 |
|
|
|
5.5 |
|
|
|
3.1 |
|
|
|
2.4 |
|
Diabetes Care |
|
|
613 |
|
|
|
634 |
|
|
|
(3.3 |
) |
|
|
1.0 |
|
|
|
(4.3 |
) |
CORDIS® |
|
|
596 |
|
|
|
640 |
|
|
|
(6.9 |
) |
|
|
(6.6 |
) |
|
|
(0.3 |
) |
ORTHO-CLINICAL
DIAGNOSTICS® |
|
|
498 |
|
|
|
501 |
|
|
|
(0.6 |
) |
|
|
(0.4 |
) |
|
|
(0.2 |
) |
Total |
|
$ |
5,920 |
|
|
$ |
5,843 |
|
|
|
1.3 |
% |
|
|
1.9 |
% |
|
|
(0.6 |
)% |
The DePuy franchise achieved operational growth of 2.6% over the same period a year ago. This
growth was primarily due to an increase in the knee and Mitek sports medicine product line and
growth of the hip product line outside the U.S. Pressure on pricing continued as a result of
economic trends, however new product launches have mitigated some of the impact.
The Ethicon Endo-Surgery franchise achieved operational growth of 3.3% over the prior year fiscal
third quarter. This was attributable to growth in the Endoscopic, HARMONICä, SurgRx Enseal
and Advanced Sterilization product lines. The growth was partially offset by the divestiture of the
breast care business in the third quarter of 2010.
The Ethicon franchise achieved operational growth of 6.0% over the prior year fiscal third quarter.
This was attributable to sales of newly acquired products from the Acclarent acquisition in the
fiscal first quarter of 2010 in addition to growth in the sutures, biosurgicals, meshes and Mentor
product lines.
The Vision Care franchise achieved operational sales growth of 3.1% over the prior year fiscal
third quarter. Growth was primarily driven by 1-DAY ACUVUE® TruEyeTM, ACUVUE® OASYS for
Astigmatism and 1-DAY ACUVUE®DEFINETM partially offset by lower sales of reusable
lenses.
The Diabetes Care franchise achieved operational sales growth of 1.0% over the prior year fiscal
third quarter. This was primarily attributable to base business growth in the U.S. and Asia Pacific
region as well as growth of the Animas business primarily outside the U.S.
The Cordis franchise experienced an operational sales decline of 6.6% as compared to the fiscal
third quarter of 2009. The decline was caused by lower sales of the CYPHER® Sirolimus-eluting
Coronary Stent due to increased competition. The decline was partially offset by strong growth in
the Biosense Webster business.
The Ortho-Clinical Diagnostics franchise experienced an operational sales decline of 0.4% as
compared to the fiscal third quarter of 2009. Growth of VITROS® 5600 and 3600 was offset by lower
sales in donor screening primarily due to more selective screening for Chagas testing in the U.S.
44
Cost of Products Sold and Selling, Marketing and Administrative Expenses
Consolidated costs of products sold for the fiscal nine months of 2010 increased to 29.9% from
29.0% of sales in the same period a year ago. The major contributors to the increase as a percent
to sales were costs associated with the impact of the OTC recall and remediation efforts in the
Consumer business, lower selling prices in the Pharmaceutical business due to U.S. health care
reform and price reductions in certain Medical Devices and Diagnostics
businesses. Additionally, unfavorable product mix attributable to the loss of market exclusivity
for TOPAMAX® contributed to the increase. The cost of products sold for the fiscal third quarter of
2010 increased to 30.7% from 29.4% of sales as compared to the same period a year ago. The major
contributors to the increase as a percent to sales were costs associated with the impact of the OTC
recall and remediation efforts in the Consumer business, lower selling prices in the Pharmaceutical
business due to U.S. health care reform and price reductions in
certain Medical Devices and Diagnostics businesses.
Consolidated selling, marketing and administrative expenses for the fiscal nine months of 2010
decreased to 31.0% from 31.3% of sales as compared to the same period a year ago. Consolidated
selling, marketing and administrative expenses for the fiscal third quarter of 2010 decreased to
31.4% from 31.6% of sales as compared to the same period a year ago. The decrease in both the
fiscal third quarter and fiscal nine months was primarily due to cost containment initiatives principally resulting from the restructuring plan recorded in 2009. The decrease was partially offset by lower selling prices in the
Pharmaceutical business due to U.S. health care reform and price reductions in certain Medical
Devices and Diagnostics businesses.
Research & Development
Research and development 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 2010 were $4.9
billion, an increase of 0.1% to sales as compared to the same period a year ago. Worldwide
costs of research activities for the fiscal third quarter of 2010 were $1.7 billion, an increase of
0.4% to sales as compared to the prior fiscal period. The increases as a percent to sales in the
quarterly and nine month periods were primarily due to changes in the mix of businesses and timing
of project spend. Additionally lower selling prices in the Pharmaceutical business due to U.S.
health care reform and price reductions in certain Medical Devices and
Diagnostics businesses contributed to the increases as a percent to sales.
45
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.
Other (income) expense, net for the fiscal nine months of 2010 was favorable $1.7 billion as
compared to the same period a year ago primarily due to a net gain of $1.3 billion from net
litigation matters, the gain on the divestiture of the breast care business of Ethicon
Endo-Surgery, Inc. and portfolio gains from the Johnson & Johnson Development Corporation. The
change in other (income) expense, net for the fiscal third quarter of 2010 was favorable $0.2
billion as compared to the same period a year ago. In the fiscal third quarter of 2010 the Company
recorded the gain on the divestiture of the breast care business of Ethicon Endo-Surgery, Inc. and
portfolio gains from the Johnson & Johnson Development Corporation. The fiscal third quarter of
2009 included a net settlement payment received from Medtronic AVE, Inc.
OPERATING PROFIT BY SEGMENT
Consumer Segment
Operating profit for the Consumer segment as a percent to sales in the fiscal nine months of 2010
was 17.8% versus 20.0% for the same period a year ago. Operating profit for the Consumer segment as
a percent to sales in the fiscal third quarter of 2010 was 14.0% versus 20.4% for the same period a
year ago. The primary driver of the decline in operating profit for both the first fiscal nine
months and the fiscal third quarter of 2010 was due to lower sales and costs associated with the
recall of certain OTC products and the suspension of production at McNeil Consumer Healthcares
Fort Washington, Pennsylvania facility.
Pharmaceutical Segment
Operating profit for the Pharmaceutical segment as a percent to sales was 33.9% in both the fiscal
nine months of 2010 and 2009. The fiscal nine months of 2010 was impacted by the U.S. health care
reform legislation and $0.2 billion of expense related to litigation matters. This was offset by
lower manufacturing costs and benefits from cost improvement initiatives related to the
restructuring plan recorded in 2009. The operating profit for the fiscal nine months of 2009 was
negatively impacted due to the loss of market exclusivity of the TOPAMAX® patent in March of 2009.
Operating profit for the Pharmaceutical segment as a percent to sales in the fiscal third quarter
of 2010 was 33.8% versus 31.2% for the same period a year ago. The primary driver of the
improvement in the operating profit margin for the fiscal third quarter of 2010 was due to lower
manufacturing costs and benefits from cost improvement initiatives related to the restructuring
plan recorded in 2009 and favorable product mix, partially offset by the impact of the newly enacted U.S.
health care reform legislation.
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 2010 was 41.5%
46
versus 34.1% for the same period a year ago. The primary drivers of the improvement in the
operating profit margin in the Medical Devices and Diagnostics segment for the fiscal nine months
was due to a $1.5 billion gain from net litigation matters and the gain on the divestiture of the
breast care business recorded in 2010. Price reductions in certain
Medical Devices and Diagnostics businesses impacted the operating profit. The fiscal nine months of
2009 include net settlement payments of $0.4 billion received from Medtronic AVE, Inc. which was
partially offset by asset write-downs and other charges. Operating profit for the Medical Devices
and Diagnostics segment as a percent to sales in the fiscal third quarter of 2010 was 33.8% versus
34.5% for the same period a year ago. The fiscal third quarter of 2010 included the gain on the
divestiture of the breast care business offset by price reductions in
certain Medical Devices and Diagnostics businesses. The fiscal third quarter of 2009 included a net
settlement payment received from Medtronic AVE, Inc.
Interest (Income) Expense
Interest income decreased in the fiscal third quarter due to lower rates of interest earned,
despite higher average cash balances. Interest income increased for the fiscal nine months 2010 as
compared to the same period a year ago. The ending balance of cash, cash equivalents and marketable
securities, was $22.1 billion at the end of the fiscal third quarter of 2010. This is an increase
of $7.7 billion from the same period a year ago. The increase was primarily due to cash generated
from operating activities, net cash proceeds from litigation matters and divestitures and lower
spending on acquisition activity versus 2009.
Interest expense decreased in both the fiscal nine months and the fiscal third quarter of 2010 as
compared to the same period a year ago. At the end of the fiscal third quarter of 2010 the
Companys debt position was $12.0 billion compared to $11.6 billion from the same period a year
ago. The Company increased borrowings, capitalizing on favorable terms in the capital markets. The
proceeds of the notes are expected to be used for general corporate purposes.
Provision for Taxes on Income
The worldwide effective income tax rates for the first fiscal nine months of 2010 and 2009 were
22.6% and 23.5%, respectively. The lower effective tax rate was primarily due to a decline in
taxable income in higher tax jurisdictions relative to taxable income in lower tax jurisdictions
partially offset by the U.S. Research and Development tax credit which was not in effect for the
first fiscal nine months of 2010.
As of October 3, 2010 the Company had approximately $2.5 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.
47
See Note 8 to the Consolidated Financial Statements in the Annual Report on Form 10-K for the
fiscal year ended January 3, 2010 for more detailed information regarding unrecognized tax
benefits.
LIQUIDITY AND CAPITAL RESOURCES
Cash Flows
Cash and cash equivalents were $14.3 billion at the end of the fiscal third quarter of 2010 as
compared with $15.8 billion at the fiscal year end of 2009. The primary uses of cash that
contributed to the $1.5 billion decrease were $6.5 billion net cash used by investing activities,
primarily the purchase of short-term marketable securities, and $7.6 billion used by financing
activities partially offset by $12.6 billion generated from operating activities.
Cash flow from operations of $12.6 billion was the result of $11.4 billion of net earnings and
$3.3 billion of non cash charges related to depreciation and amortization, stock based
compensation and deferred tax provision partially offset by $2.1 billion related to changes in
assets and liabilities, net of effects from acquisitions.
Investing activities use of $6.5 billion was due to net investments in marketable securities of
$4.0 billion, acquisitions of $1.3 billion and $1.4 billion for additions to property, plant and
equipment, reduced by $0.3 billion of proceeds from asset sales.
Financing activities use of $7.6 billion was primarily for dividends to shareholders of $4.3
billion, $2.4 billion net retirement of short and long-term debt and a net of $0.8 billion for
repurchase of common stock net of proceeds from stock options exercised.
In the fiscal third quarter of 2010 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. However the Company monitors the global capital markets on an
ongoing basis and from time to time may raise capital when market conditions are favorable.
Dividends
On July 19, 2010, the Board of Directors declared a regular cash dividend of $0.540 per share,
payable on September 14, 2010 to shareholders of record as of August 31, 2010.
On October 21, 2010, the Board of Directors declared a regular cash dividend of $0.540 per share,
payable on December 14, 2010 to shareholders of record as of November 30, 2010. The Company expects
to continue the practice of paying regular quarterly cash dividends.
OTHER INFORMATION
48
New Accounting Standards
The Financial Accounting Standards Board (FASB) issued guidance and amendments to the criteria for
separating consideration in multiple-deliverable revenue arrangements, which the Company adopted in
the fiscal first quarter of 2010. The guidance also (a) provides principles and application
guidance on whether multiple deliverables exist, how the arrangement should be separated, and the
consideration allocated; (b) requires an entity to allocate revenue in an arrangement using
estimated selling prices of deliverables if a vendor does not have vendor-specific objective
evidence or third-party evidence of selling price; and (c) eliminates the use of the residual method
and requires an entity to allocate the revenue using the relative selling price method. The
adoption did not have a material impact on the Companys results of operations, cash flows or
financial position however it will expand the disclosures for multiple-deliverable revenue
arrangements.
During the fiscal first quarter of 2010 the Company adopted the FASB standard related to variable
interest entities. The adoption of this standard did not have an impact on the Companys results of
operations, cash flows or financial position.
During the fiscal first quarter of 2010 the Company adopted the new accounting guidance on fair
value measurements and disclosures. This guidance requires the Company to disclose the amount of
significant transfers between Level 1 and Level 2 inputs and the reasons for these transfers as
well as the reasons for any transfers in or out of Level 3 of the fair value hierarchy. In
addition, the guidance clarifies certain existing disclosure requirements. The adoption of this
standard did not have a material impact on the Companys results of operations, cash flows or
financial position.
During the fiscal second quarter of 2010 the FASB issued an accounting standard update related to
revenue recognition under the milestone method. The objective of the accounting standard update is
to provide guidance on defining a milestone and determining when it may be appropriate to apply the
milestone method of revenue recognition for research or development transactions. This update is
effective on a prospective basis for milestones achieved in fiscal years, and interim periods
within those years, beginning on or after June 15, 2010. The adoption of this standard is not
expected to have a material impact on the Companys results of operations, cash flows or financial
position.
Economic and Market Factors
Johnson & Johnson is aware that its products are used in an environment where, for more than a
decade, policymakers, consumers and businesses have expressed concern about the rising cost of
health care. Johnson & Johnson has a long-standing policy of pricing products responsibly. For the
period 1999 through 2009 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).
49
The Company operates in certain countries where the economic conditions continue to present
significant challenges. The Company continues to monitor these situations and take appropriate
actions. 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 11.
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
50
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 January 3, 2010 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 January 3, 2010.
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.
51
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 11 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 2010. Common Stock purchases on the open market are made as
part of a systematic plan to meet the needs of the Companys compensation programs.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 (2) |
|
or Programs (3) |
July 5, 2010
through August 1,
2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
August 2, 2010
through August 29,
2010 |
|
|
4,567,400 |
|
|
$ |
58.80 |
|
|
|
4,496,500 |
|
|
|
|
|
August 30, 2010
through October 3,
2010 |
|
|
7,766,139 |
|
|
$ |
59.78 |
|
|
|
6,073,548 |
|
|
|
|
|
Total |
|
|
12,333,539 |
|
|
|
|
|
|
|
10,570,048 |
|
|
|
5,998,121 |
|
|
|
|
(1) |
|
During the fiscal third quarter of 2010, the Company repurchased an aggregate of 10,570,048 shares of Johnson & Johnson |
52
|
|
|
|
|
Common Stock pursuant to the repurchase program that was publicly announced on July 9, 2007 and an
aggregate of 1,763,491 shares in open-market transactions outside of the program. The repurchase
program has no time limit and may be suspended for periods or discontinued at any time. |
|
(2) |
|
As of October 3, 2010, an aggregate of 152,422,148 shares were purchased for a total of $9.6
billion since the inception of the repurchase program announced on July 9, 2007. |
|
(3) |
|
As of October 3, 2010, based on the closing price of the Companys Common Stock on the New York
Stock Exchange on October 1, 2010 of $61.75 per share. |
Item 6 EXHIBITS
Exhibit 10.1 Compensation Arrangements for Non-Employee Directors
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 October 3, 2010, 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.
|
|
|
|
|
JOHNSON & JOHNSON |
|
|
(Registrant) |
|
|
|
Date:
November 10, 2010
|
|
By /s/ D. J. CARUSO |
|
|
D. J. CARUSO |
|
|
Vice President, Finance; |
|
|
Chief Financial Officer |
|
|
(Principal Financial Officer) |
|
|
|
Date:
November 10, 2010
|
|
By /s/ S. J. COSGROVE |
|
|
S. J. COSGROVE |
|
|
Controller |
|
|
(Principal Accounting Officer) |
54