e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
|
|
|
þ |
|
Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
|
|
|
|
|
for the quarterly period ended April 3, 2011 |
or
|
|
|
o |
|
Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
|
|
|
|
|
for the transition period from to |
Commission file number 1-3215
(Exact name of registrant as specified in its charter)
|
|
|
NEW JERSEY
|
|
22-1024240 |
(State or other jurisdiction of
|
|
(I.R.S. Employer |
incorporation or organization)
|
|
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 definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act.
|
|
|
|
|
|
|
Large accelerated filer þ
|
|
Accelerated filer o
|
|
Non-accelerated filer o
(Do not check if a smaller reporting company)
|
|
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 April 29, 2011 2,741,143,427 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 Except Share and Per
Share Data)
|
|
|
|
|
|
|
|
|
|
|
April 3, 2011 |
|
|
January 2, 2011 |
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
22,356 |
|
|
$ |
19,355 |
|
|
|
|
|
|
|
|
|
|
Marketable securities |
|
|
4,511 |
|
|
|
8,303 |
|
|
|
|
|
|
|
|
|
|
Accounts receivable, trade, less
allowances for doubtful accounts
$339 (2010, $340) |
|
|
10,861 |
|
|
|
9,774 |
|
|
|
|
|
|
|
|
|
|
Inventories (Note 2) |
|
|
6,200 |
|
|
|
5,378 |
|
|
|
|
|
|
|
|
|
|
Deferred taxes on income |
|
|
2,272 |
|
|
|
2,224 |
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and other receivables |
|
|
3,021 |
|
|
|
2,273 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
49,221 |
|
|
|
47,307 |
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment at cost |
|
|
31,805 |
|
|
|
30,426 |
|
|
|
|
|
|
|
|
|
|
Less: accumulated depreciation |
|
|
(16,721 |
) |
|
|
(15,873 |
) |
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
15,084 |
|
|
|
14,553 |
|
|
|
|
|
|
|
|
|
|
Intangible assets, net (Note 3) |
|
|
18,687 |
|
|
|
16,716 |
|
|
|
|
|
|
|
|
|
|
Goodwill, net (Note 3) |
|
|
16,126 |
|
|
|
15,294 |
|
|
|
|
|
|
|
|
|
|
Deferred taxes on income |
|
|
5,327 |
|
|
|
5,096 |
|
|
|
|
|
|
|
|
|
|
Other assets |
|
|
3,705 |
|
|
|
3,942 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
108,150 |
|
|
$ |
102,908 |
|
See Notes to Consolidated Financial Statements
3
JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited; Dollars in Millions Except Share and Per
Share Data)
|
|
|
|
|
|
|
|
|
|
|
April 3, 2011 |
|
|
January 2, 2011 |
|
LIABILITIES AND SHAREHOLDERS EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Loans and notes payable |
|
$ |
8,575 |
|
|
$ |
7,617 |
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
5,701 |
|
|
|
5,623 |
|
|
|
|
|
|
|
|
|
|
Accrued liabilities |
|
|
4,093 |
|
|
|
4,100 |
|
|
|
|
|
|
|
|
|
|
Accrued rebates, returns and promotions |
|
|
2,858 |
|
|
|
2,512 |
|
|
|
|
|
|
|
|
|
|
Accrued compensation and employee
related obligations |
|
|
1,777 |
|
|
|
2,642 |
|
|
|
|
|
|
|
|
|
|
Accrued taxes on income |
|
|
1,007 |
|
|
|
578 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
24,011 |
|
|
|
23,072 |
|
|
|
|
|
|
|
|
|
|
Long-term debt |
|
|
9,255 |
|
|
|
9,156 |
|
|
|
|
|
|
|
|
|
|
Deferred taxes on income |
|
|
1,895 |
|
|
|
1,447 |
|
|
|
|
|
|
|
|
|
|
Employee related obligations |
|
|
6,125 |
|
|
|
6,087 |
|
|
|
|
|
|
|
|
|
|
Other liabilities |
|
|
7,001 |
|
|
|
6,567 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
48,287 |
|
|
|
46,329 |
|
|
|
|
|
|
|
|
|
|
Shareholders equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock par value $1.00 per
share (authorized 4,320,000,000 shares;
issued 3,119,843,000 shares) |
|
|
3,120 |
|
|
|
3,120 |
|
|
|
|
|
|
|
|
|
|
Accumulated other comprehensive income
(Note 7) |
|
|
(2,020 |
) |
|
|
(3,531 |
) |
|
|
|
|
|
|
|
|
|
Retained earnings |
|
|
79,515 |
|
|
|
77,773 |
|
|
|
|
|
|
|
|
|
|
Less: common stock held in treasury, at
cost (381,389,000 and 381,746,000
shares) |
|
|
20,752 |
|
|
|
20,783 |
|
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
59,863 |
|
|
|
56,579 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and
shareholders equity |
|
$ |
108,150 |
|
|
$ |
102,908 |
|
See Notes to Consolidated Financial Statements
4
JOHNSON
& JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF EARNINGS
(Unaudited; Dollars & Shares in Millions Except Per Share Amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Quarters Ended |
|
|
|
April 3, |
|
|
Percent |
|
|
April 4, |
|
|
Percent |
|
|
|
2011 |
|
|
to Sales |
|
|
2010 |
|
|
to Sales |
|
Sales to customers (Note 9) |
|
$ |
16,173 |
|
|
|
100.0 |
% |
|
$ |
15,631 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
4,778 |
|
|
|
29.5 |
|
|
|
4,528 |
|
|
|
29.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
11,395 |
|
|
|
70.5 |
|
|
|
11,103 |
|
|
|
71.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, marketing and
administrative expenses |
|
|
5,056 |
|
|
|
31.3 |
|
|
|
4,779 |
|
|
|
30.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expense |
|
|
1,738 |
|
|
|
10.8 |
|
|
|
1,557 |
|
|
|
10.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
(21 |
) |
|
|
(0.1 |
) |
|
|
(27 |
) |
|
|
(0.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net of
portion capitalized |
|
|
125 |
|
|
|
0.7 |
|
|
|
108 |
|
|
|
0.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
(income) expense, net |
|
|
(13 |
) |
|
|
(0.1 |
) |
|
|
(1,594 |
) |
|
|
(10.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings before provision for
taxes on income |
|
|
4,510 |
|
|
|
27.9 |
|
|
|
6,280 |
|
|
|
40.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for taxes on income
(Note 5) |
|
|
1,034 |
|
|
|
6.4 |
|
|
|
1,754 |
|
|
|
11.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET EARNINGS |
|
$ |
3,476 |
|
|
|
21.5 |
% |
|
$ |
4,526 |
|
|
|
29.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET EARNINGS PER SHARE (Note 8) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
1.27 |
|
|
|
|
|
|
$ |
1.64 |
|
|
|
|
|
Diluted |
|
$ |
1.25 |
|
|
|
|
|
|
$ |
1.62 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH DIVIDENDS PER SHARE |
|
$ |
0.540 |
|
|
|
|
|
|
$ |
0.490 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AVG. SHARES OUTSTANDING |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
2,738.4 |
|
|
|
|
|
|
|
2,755.4 |
|
|
|
|
|
Diluted |
|
|
2,772.7 |
|
|
|
|
|
|
|
2,797.3 |
|
|
|
|
|
See Notes to Consolidated Financial Statements
5
JOHNSON
& JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited; Dollars in Millions)
|
|
|
|
|
|
|
|
|
|
|
Fiscal Three Months |
|
|
|
Ended |
|
|
|
April 3, |
|
|
April 4, |
|
|
|
2011 |
|
|
2010 |
|
CASH FLOW FROM OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
Net earnings |
|
$ |
3,476 |
|
|
$ |
4,526 |
|
Adjustments to reconcile net earnings to cash
flows from operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization of
property and intangibles |
|
|
755 |
|
|
|
734 |
|
Stock based compensation |
|
|
152 |
|
|
|
157 |
|
Deferred tax provision |
|
|
(4 |
) |
|
|
960 |
|
Accounts receivable allowances |
|
|
(16 |
) |
|
|
78 |
|
Changes in assets and liabilities, net of
effects from acquisitions: |
|
|
|
|
|
|
|
|
Increase in accounts receivable |
|
|
(609 |
) |
|
|
(529 |
) |
Increase in inventories |
|
|
(452 |
) |
|
|
(193 |
) |
Decrease in accounts payable
and accrued liabilities |
|
|
(1,127 |
) |
|
|
(1,651 |
) |
Increase in other current and non-current
assets |
|
|
(970 |
) |
|
|
(1,088 |
) |
Increase in other current and
non-current liabilities |
|
|
1,111 |
|
|
|
696 |
|
|
NET CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
2,316 |
|
|
|
3,690 |
|
|
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
Additions to property, plant and equipment |
|
|
(436 |
) |
|
|
(397 |
) |
Proceeds from the disposal of assets |
|
|
121 |
|
|
|
102 |
|
Acquisitions, net of cash acquired |
|
|
(2,049 |
) |
|
|
(772 |
) |
Purchases of investments |
|
|
(1,036 |
) |
|
|
(3,246 |
) |
Sales of investments |
|
|
4,897 |
|
|
|
2,440 |
|
Other |
|
|
(57 |
) |
|
|
(9 |
) |
|
|
|
|
|
|
|
|
|
NET CASH FROM/(USED BY) INVESTING ACTIVITIES |
|
|
1,440 |
|
|
|
(1,882 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
Dividends to shareholders |
|
|
(1,480 |
) |
|
|
(1,350 |
) |
Repurchase of common stock |
|
|
(435 |
) |
|
|
(383 |
) |
Proceeds from short-term debt |
|
|
3,644 |
|
|
|
715 |
|
Retirement of short-term debt |
|
|
(2,744 |
) |
|
|
(3,043 |
) |
Proceeds from long-term debt |
|
|
8 |
|
|
|
|
|
Retirement of long-term debt |
|
|
(3 |
) |
|
|
(8 |
) |
Proceeds from the exercise of stock
options/excess tax benefits |
|
|
185 |
|
|
|
247 |
|
|
|
|
|
|
|
|
|
|
NET CASH USED BY FINANCING ACTIVITIES |
|
|
(825 |
) |
|
|
(3,822 |
) |
6
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
Fiscal Three Months |
|
|
|
Ended |
|
|
|
April 3, |
|
|
April 4, |
|
|
|
2011 |
|
|
2010 |
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and
cash equivalents |
|
|
70 |
|
|
|
(53 |
) |
Increase/(Decrease) in cash and cash
equivalents |
|
|
3,001 |
|
|
|
(2,067 |
) |
Cash and Cash equivalents, beginning of period |
|
|
19,355 |
|
|
|
15,810 |
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS, END OF PERIOD |
|
$ |
22,356 |
|
|
$ |
13,743 |
|
|
|
|
|
|
|
|
|
|
Acquisitions |
|
|
|
|
|
|
|
|
Fair value of assets acquired |
|
$ |
2,245 |
|
|
$ |
808 |
|
Fair value of liabilities assumed and
non-controlling interests |
|
|
(196 |
) |
|
|
(36 |
) |
Net cash paid for acquisitions |
|
$ |
2,049 |
|
|
$ |
772 |
|
See Notes to Consolidated Financial Statements
7
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
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 2, 2011. The unaudited interim financial
statements include all adjustments (consisting only of normal recurring adjustments) and accruals
necessary in the judgment of management for a fair statement of the results for the periods
presented.
During the fiscal first quarter of 2011, the Company adopted the Financial Accounting Standards
Board (FASB) guidance and amendments issued 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 did not have a material impact on the
Companys results of operations, cash flows or financial position.
During the fiscal first quarter of 2011,
the Company adopted the FASB
guidance on how pharmaceutical companies should recognize and classify
in the Companys financial statements, the non deductible annual fee
paid to the Government in accordance with the Patient Protection and
Affordable Care Act as amended by the Health Care and Education
Reconciliation Act. This fee is based on an allocation of a companys
market share of total branded prescription drug sales from the prior
year. The estimated fee was recorded as a selling, marketing and
administrative expense in the Companys financial statement and will
be amortized on a straight-line basis for the year as per the FASB
guidance. The adoption of this standard did not have a material impact
on the Companys results of operations, cash flows or financial
position.
NOTE 2 INVENTORIES
(Dollars in Millions)
|
|
|
|
|
|
|
|
|
|
|
April 3, 2011 |
|
|
January 2, 2011 |
|
Raw materials and supplies |
|
$ |
1,258 |
|
|
|
1,073 |
|
Goods in process |
|
|
1,652 |
|
|
|
1,460 |
|
Finished goods |
|
|
3,290 |
|
|
|
2,845 |
|
Total inventories |
|
$ |
6,200 |
|
|
|
5,378 |
|
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 2010. Future impairment tests for goodwill and indefinite lived
intangible assets will be performed annually in the fiscal fourth quarter, or sooner if warranted.
8
|
|
|
|
|
|
|
|
|
(Dollars in Millions) |
|
April 3, 2011 |
|
|
January 2, 2011 |
|
Intangible assets with definite lives: |
|
|
|
|
|
|
|
|
Patents and trademarks gross |
|
$ |
7,424 |
|
|
|
6,660 |
|
Less accumulated amortization |
|
|
2,705 |
|
|
|
2,629 |
|
Patents and trademarks net |
|
|
4,719 |
|
|
|
4,031 |
|
|
|
|
|
|
|
|
|
|
Other intangibles gross |
|
|
7,824 |
|
|
|
7,674 |
|
Less accumulated amortization |
|
|
3,028 |
|
|
|
2,880 |
|
Other intangibles net |
|
|
4,796 |
|
|
|
4,794 |
|
|
|
|
|
|
|
|
|
|
Intangible assets with indefinite lives: |
|
|
|
|
|
|
|
|
Trademarks |
|
|
6,082 |
|
|
|
5,954 |
|
Purchased in-process research and development |
|
|
3,090 |
|
|
|
1,937 |
|
Total intangible assets with indefinite lives |
|
|
9,172 |
|
|
|
7,891 |
|
|
Total intangible assets net |
|
$ |
18,687 |
|
|
|
16,716 |
|
Goodwill as of April 3, 2011 was allocated by segment of business as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Dollars in Millions) |
|
Consumer |
|
|
Pharm |
|
|
Med Dev & Diag |
|
|
Total |
|
Goodwill, net
at January 2, 2011 |
|
$ |
8,144 |
|
|
$ |
1,225 |
|
|
$ |
5,925 |
|
|
$ |
15,294 |
|
Acquisitions |
|
|
|
|
|
|
474 |
|
|
|
|
|
|
|
474 |
|
Currency translation/Other |
|
|
305 |
|
|
|
33 |
|
|
|
20 |
|
|
|
358 |
|
Goodwill, net as of
April 3, 2011 |
|
$ |
8,449 |
|
|
$ |
1,732 |
|
|
$ |
5,945 |
|
|
$ |
16,126 |
|
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 first quarter ended April 3, 2011 was $190 million, and the estimated amortization
expense for the five succeeding years approximates $730 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
9
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 April 3, 2011,
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 recorded on the balance sheet at fair value. Changes in the fair
value of derivatives are recorded each period in current earnings or other comprehensive income,
depending on whether the derivative is designated as part of a hedge transaction, and if so, the
type of hedge transaction.
The designation as a cash flow hedge is made at the entrance date into the derivative contract. At
inception, all derivatives are expected to be highly effective. Changes in the fair value of a
derivative that is designated as a cash flow hedge and is highly effective are recorded in
accumulated other comprehensive income until the underlying transaction affects earnings, and are
then reclassified to earnings in the same account as the hedged transaction. Gains/losses on net
investment hedges are accounted for through the currency translation account and are insignificant.
On an ongoing basis, the Company assesses whether each derivative continues to be highly effective
in offsetting changes in the cash flows of hedged items. If and when a derivative is no longer
expected to be highly effective, hedge accounting is discontinued. Hedge ineffectiveness, if any,
is included in current period earnings in other (income)/expense, net, and was not material for the
fiscal quarters ended April 3, 2011 and April 4, 2010. Refer to Note 7 for disclosures of movements
in Accumulated Other Comprehensive Income.
As of April 3, 2011, the balance of deferred net gains on derivatives included in accumulated other
comprehensive income was $188 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
first quarters in 2011 and 2010:
10
(Dollars in Millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain/(Loss) recognized in Accumulated |
|
|
Gain/(Loss) reclassified from Accumulated |
|
|
Gain/(Loss) recognized in other |
|
Cash Flow Hedges |
|
OCI(1) |
|
|
OCI into income(1) |
|
|
income/expense(2) |
|
|
|
Fiscal first |
|
|
Fiscal first |
|
|
Fiscal first |
|
|
Fiscal first |
|
|
Fiscal first |
|
|
Fiscal first |
|
|
|
quarter 2011 |
|
|
quarter 2010 |
|
|
quarter 2011 |
|
|
quarter 2010 |
|
|
quarter 2011 |
|
|
quarter 2010 |
|
Foreign exchange
contracts |
|
$ |
27 |
|
|
$ |
(31 |
) |
|
$ |
(10 |
) |
|
$ |
(20 |
) (A) |
|
$ |
(2 |
) |
|
$ |
(1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange
contracts |
|
|
80 |
|
|
|
(104 |
) |
|
|
(62 |
) |
|
|
(22 |
) (B) |
|
|
(3 |
) |
|
|
(5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange
contracts |
|
|
(36 |
) |
|
|
29 |
|
|
|
1 |
|
|
|
1 |
(C) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cross currency
interest rate swaps |
|
|
(9 |
) |
|
|
33 |
|
|
|
(2 |
) |
|
|
- |
(D) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange
contracts |
|
|
(52 |
) |
|
|
46 |
|
|
|
(5 |
) |
|
|
(1 |
) (E) |
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
10 |
|
|
$ |
(27 |
) |
|
$ |
(78 |
) |
|
$ |
(42 |
) |
|
$ |
(3 |
) |
|
$ |
(6 |
) |
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 and development expense |
|
(D) |
|
Included in Interest (income)/Interest expense, net |
|
(E) |
|
Included in Other (income)/expense, net |
For the fiscal first quarters ended April 3, 2011 and April 4, 2010, a gain of $15 million and a
loss of $48 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 is determined using assumptions that
market participants would use in pricing an asset or liability. The authoritative literature
establishes a three-level hierarchy to prioritize the inputs used in measuring fair value. The
levels within the hierarchy are described 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 or 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
11
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 because 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 April 3,
2011 and January 2, 2011 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
April 3, 2011 |
|
|
January 2, 2011 |
|
(Dollars in Millions) |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
|
Total(1) |
|
Derivatives designated as
hedging instruments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
$ |
464 |
|
|
|
|
|
|
|
464 |
|
|
|
321 |
|
Cross currency interest rate
swaps(2) |
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
3 |
|
|
|
17 |
|
Total |
|
|
|
|
|
|
467 |
|
|
|
|
|
|
|
467 |
|
|
|
338 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
796 |
|
|
|
|
|
|
|
796 |
|
|
|
586 |
|
Cross currency interest rate
swaps(3) |
|
|
|
|
|
|
404 |
|
|
|
|
|
|
|
404 |
|
|
|
502 |
|
Total |
|
|
|
|
|
|
1,200 |
|
|
|
|
|
|
|
1,200 |
|
|
|
1,088 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives not designated as
hedging instruments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
25 |
|
|
|
|
|
|
|
25 |
|
|
|
19 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
24 |
|
|
|
|
|
|
|
24 |
|
|
|
39 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Investments(4) |
|
$ |
858 |
|
|
|
|
|
|
|
|
|
|
|
858 |
|
|
|
1,165 |
|
|
|
|
(1) |
|
As of January 2, 2011, these assets and liabilities are classified as Level 2 with the
exception of Other Investments of $1,165 which are classified as Level 1. |
12
|
|
|
(2) |
|
Includes $3 million and $14 million of non-current assets for April 3, 2011 and January 2, 2011,
respectively. |
|
(3) |
|
Includes $404 million and $502 million of non-current liabilities for April 3, 2011 and January
2, 2011, 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 April 3, 2011:
|
|
|
|
|
|
|
|
|
|
|
Carrying |
|
|
Estimated |
|
(Dollars in Millions) |
|
Amount |
|
|
Fair Value |
|
Financial Assets |
|
|
|
|
|
|
|
|
Current Investments |
|
|
|
|
|
|
|
|
Cash |
|
$ |
2,729 |
|
|
|
2,729 |
|
Government securities
and obligations |
|
|
21,243 |
|
|
|
21,243 |
|
Corporate debt securities |
|
|
510 |
|
|
|
510 |
|
Money market funds |
|
|
1,848 |
|
|
|
1,848 |
|
Time deposits |
|
|
537 |
|
|
|
537 |
|
|
|
|
|
|
|
|
|
|
Total cash, cash
equivalents and current
marketable securities |
|
$ |
26,867 |
|
|
|
26,867 |
|
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 |
|
$ |
8,575 |
|
|
|
8,575 |
|
Non-Current Debt |
|
|
|
|
|
|
|
|
5.15% Debentures due 2012 |
|
|
599 |
|
|
|
636 |
|
3.80% Debentures due 2013 |
|
|
500 |
|
|
|
530 |
|
5.55% Debentures due 2017 |
|
|
1,000 |
|
|
|
1,148 |
|
5.15% Debentures due 2018 |
|
|
898 |
|
|
|
1,009 |
|
4.75% Notes due 2019 (1B
Euro 1.4167) |
|
|
1,410 |
|
|
|
1,510 |
|
3% Zero Coupon Convertible Subordinated
Debentures due in 2020 |
|
|
194 |
|
|
|
221 |
|
2.95% Debentures due 2020 |
|
|
541 |
|
|
|
513 |
|
6.73% Debentures due 2023 |
|
|
250 |
|
|
|
308 |
|
5.50% Notes due 2024 (500 GBP
1.601) |
|
|
796 |
|
|
|
848 |
|
6.95% Notes due 2029 |
|
|
294 |
|
|
|
362 |
|
4.95% Debentures due 2033 |
|
|
500 |
|
|
|
503 |
|
5.95% Notes due 2037 |
|
|
995 |
|
|
|
1,123 |
|
5.86% Debentures due 2038 |
|
|
700 |
|
|
|
781 |
|
4.50% Debentures due 2040 |
|
|
539 |
|
|
|
515 |
|
Other (Includes Industrial
Revenue Bonds) |
|
|
39 |
|
|
|
38 |
|
|
Total Non-Current Debt |
|
$ |
9,255 |
|
|
|
10,045 |
|
13
The weighted average effective rate on non-current debt is 5.25%.
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 fiscal first quarters of 2011 and 2010 were 22.9%
and 27.9%, respectively. The lower effective tax rate was due to lower income in higher tax
jurisdictions and the U.S. Research and Development tax credit, which was not in effect for the
fiscal first quarter of 2010. Additionally, the net litigation gain of $1.5 billion recorded at a
39.0% tax rate in the fiscal first quarter of 2010, added 3.5 percentage points to the worldwide
effective income tax rate.
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 first quarters of 2011 and 2010 include the following components:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Retirement Plans |
|
|
Other Benefit Plans |
|
|
|
Fiscal Quarters Ended |
|
(Dollars in Millions) |
|
April 3, 2011 |
|
|
April 4, 2010 |
|
|
April 3, 2011 |
|
|
April 4, 2010 |
|
Service cost |
|
$ |
143 |
|
|
|
126 |
|
|
|
37 |
|
|
|
34 |
|
Interest cost |
|
|
213 |
|
|
|
200 |
|
|
|
48 |
|
|
|
50 |
|
Expected return on
plan assets |
|
|
(278 |
) |
|
|
(252 |
) |
|
|
|
|
|
|
|
|
Amortization of prior
service cost |
|
|
3 |
|
|
|
3 |
|
|
|
(1 |
) |
|
|
(1 |
) |
Recognized actuarial
losses |
|
|
96 |
|
|
|
58 |
|
|
|
11 |
|
|
|
12 |
|
Net periodic benefit cost |
|
$ |
177 |
|
|
|
135 |
|
|
|
95 |
|
|
|
95 |
|
Company Contributions
For the fiscal quarters ended April 3, 2011, the Company contributed $84 million and $8 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.
14
NOTE 7 ACCUMULATED OTHER COMPREHENSIVE INCOME
Total comprehensive income for the fiscal first quarter ended April 3, 2011 was $5.0 billion,
compared with $3.7 billion for the same period a year ago. Total comprehensive income included net
earnings, net unrealized currency gains and losses on translation, net unrealized gains and losses
on securities available for sale, adjustments related to employee benefit plans, 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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Accum Other |
|
Gains/(Losses) |
|
Currency |
|
|
Securities |
|
|
Employee Benefit |
|
Deriv. |
|
|
Comp. Income/ |
|
(Dollars in Millions) |
|
Translation |
|
|
Available for sale |
|
|
Plans |
|
|
& Hedges |
|
|
(Loss) |
|
January 2, 2011 |
|
$ |
(969 |
) |
|
|
24 |
|
|
|
(2,686 |
) |
|
|
100 |
|
|
|
(3,531 |
) |
2011 three months change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) |
|
|
|
|
|
|
113 |
|
|
|
|
|
|
|
10 |
|
|
|
|
|
Net amount reclassed to
net earnings |
|
|
|
|
|
|
(135 |
) |
|
|
|
|
|
|
78 |
* |
|
|
|
|
Net three months change |
|
|
1,373 |
|
|
|
(22 |
) |
|
|
72 |
|
|
|
88 |
|
|
|
1,511 |
|
April 3, 2011 |
|
$ |
404 |
|
|
|
2 |
|
|
|
(2,614 |
) |
|
|
188 |
|
|
|
(2,020 |
) |
|
|
|
* |
|
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 first quarters ended April 3, 2011 and April 4, 2010.
|
|
|
|
|
|
|
|
|
|
|
Fiscal Quarters Ended |
|
(Shares in Millions) |
|
April 3, 2011 |
|
|
April 4, 2010 |
|
Basic net earnings per share |
|
$ |
1.27 |
|
|
$ |
1.64 |
|
Average shares outstanding basic |
|
|
2,738.4 |
|
|
|
2,755.4 |
|
Potential shares exercisable under
stock option plans |
|
|
138.5 |
|
|
|
193.4 |
|
Less: shares which could be repurchased
under treasury stock method |
|
|
(107.8 |
) |
|
|
(155.1 |
) |
Convertible debt shares |
|
|
3.6 |
|
|
|
3.6 |
|
Average shares outstanding diluted |
|
|
2,772.7 |
|
|
|
2,797.3 |
|
Diluted earnings per share |
|
$ |
1.25 |
|
|
$ |
1.62 |
|
15
The diluted earnings per share calculation for both fiscal first quarters ended April 3, 2011 and
April 4, 2010 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 first quarters ended April 3, 2011 and
April 4, 2010, excluded 93 million and 55 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 |
|
(Dollars in Millions) |
|
April 3, 2011 |
|
|
April 4, 2010 |
|
|
Percent Change |
|
Consumer |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
$ |
1,345 |
|
|
$ |
1,560 |
|
|
|
(13.8 |
)% |
International |
|
|
2,337 |
|
|
|
2,206 |
|
|
|
5.9 |
|
Total |
|
|
3,682 |
|
|
|
3,766 |
|
|
|
(2.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceutical |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
3,391 |
|
|
|
3,206 |
|
|
|
5.8 |
|
International |
|
|
2,668 |
|
|
|
2,432 |
|
|
|
9.7 |
|
Total |
|
|
6,059 |
|
|
|
5,638 |
|
|
|
7.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medical Devices &
Diagnostics |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
2,872 |
|
|
|
2,886 |
|
|
|
(0.5 |
) |
International |
|
|
3,560 |
|
|
|
3,341 |
|
|
|
6.6 |
|
Total |
|
|
6,432 |
|
|
|
6,227 |
|
|
|
3.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Worldwide |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
7,608 |
|
|
|
7,652 |
|
|
|
(0.6 |
) |
International |
|
|
8,565 |
|
|
|
7,979 |
|
|
|
7.3 |
|
Total |
|
$ |
16,173 |
|
|
$ |
15,631 |
|
|
|
3.5 |
% |
|
|
|
(1) |
|
Export sales are not significant. |
OPERATING PROFIT BY SEGMENT OF BUSINESS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Quarters Ended |
|
(Dollars in Millions) |
|
April 3, 2011 |
|
|
April 4, 2010 |
|
|
Percent Change |
|
Consumer |
|
$ |
573 |
|
|
$ |
785 |
|
|
|
(27.0 |
)% |
Pharmaceutical (2) |
|
|
2,209 |
|
|
|
1,970 |
|
|
|
12.1 |
|
Medical Devices
& Diagnostics (3) |
|
|
1,944 |
|
|
|
3,702 |
|
|
|
(47.5 |
) |
Segments total |
|
|
4,726 |
|
|
|
6,457 |
|
|
|
(26.8 |
) |
Expense not allocated to
segments (4) |
|
|
(216 |
) |
|
|
(177 |
) |
|
|
|
|
Worldwide total |
|
$ |
4,510 |
|
|
$ |
6,280 |
|
|
|
(28.2 |
)% |
16
|
|
|
(2) |
|
Includes litigation expense of $250 million partially offset by the gain related to the
Companys earlier investment in Crucell recorded in the fiscal first quarter of 2011. Includes
litigation expense of $87 million recorded in the fiscal first quarter of 2010. |
|
(3) |
|
Includes litigation expense of $41 million and additional DePuy ASR Hip recall costs of $55
million recorded in the fiscal first quarter of 2011. Includes net litigation income of $1,584
million recorded in the fiscal first quarter of 2010. |
|
(4) |
|
Amounts not allocated to segments include interest income/(expense), non-controlling interests
and general corporate income/(expense). |
SALES BY GEOGRAPHIC AREA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Quarters Ended |
|
(Dollars in Millions) |
|
April 3, 2011 |
|
|
April 4, 2010 |
|
|
Percent Change |
|
U.S. |
|
$ |
7,608 |
|
|
$ |
7,652 |
|
|
|
(0.6 |
)% |
Europe |
|
|
4,183 |
|
|
|
4,102 |
|
|
|
2.0 |
|
Western Hemisphere,
excluding U.S. |
|
|
1,436 |
|
|
|
1,280 |
|
|
|
12.2 |
|
Asia-Pacific, Africa |
|
|
2,946 |
|
|
|
2,597 |
|
|
|
13.4 |
|
|
Total |
|
$ |
16,173 |
|
|
$ |
15,631 |
|
|
|
3.5 |
% |
NOTE 10 BUSINESS COMBINATIONS AND DIVESTITURES
During the fiscal first quarter of 2011, the Company acquired substantially all of the outstanding
equity of Crucell N.V. that it did not already own. Crucell is a global biopharmaceutical company
focused on the research and development, production and marketing of vaccines and antibodies
against infectious disease worldwide. The net purchase price of $2.0 billion was allocated
primarily to non-amortizable intangible assets for $1.1 billion, amortizable intangible assets for
$0.7 billion and goodwill for $0.5 billion.
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.
17
NOTE 11 LEGAL PROCEEDINGS
Johnson & Johnson (the Company) and certain of its subsidiaries are involved in various lawsuits
and claims, regarding product liability, intellectual property, commercial and other matters;
governmental investigations; and other legal proceedings that arise from time to time in the
ordinary course of their business.
The Company records accruals for such contingencies when it is probable that a liability will be
incurred and the amount of the loss can be reasonably estimated. Legal defense costs expected to be
incurred in connection with a loss contingency are accrued when probable and reasonably estimable.
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 Companys subsidiaries are 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. The Company has established product liability reserves based on currently
available information, which in some cases may be limited, and changes to the reserves may be
required in the future as additional information becomes available.
Multiple products of the Companys 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®/fentanyl
patches, pelvic meshes, the CHARITÉ Artificial Disc, CYPHER® Stent, and ASR Hip. These claimants seek
substantial compensatory and, where available, punitive damages.
In August 2010, DePuy Orthopaedics, Inc. (DePuy) announced a worldwide 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 DePuy and the Company. The Company has received limited
information to date with respect to potential claims and other costs associated with this recall.
The Companys product liability reserve has been increased in part due to anticipated product
liability expense, and costs associated with the DePuy ASR Hip recall. Changes to the reserve may
be required in the future as additional information becomes available.
INTELLECTUAL PROPERTY
Certain of the Companys subsidiaries are subject, from time to time, to legal proceedings and
claims related to patent, trademark and other intellectual property matters arising out of their
business. The most significant of these matters are described below.
18
PATENT INFRINGEMENT
Certain of the Companys subsidiaries are involved in lawsuits challenging the coverage and/or
validity of the patents on their products. Although the Companys subsidiaries believe that they
have substantial defenses to these challenges with respect to all material patents, there can be no
assurance as to the outcome of these matters, and a loss in any of these cases could potentially
adversely affect the ability of the Companys subsidiaries to sell their products, or require the
payment of past damages and future royalties.
MEDICAL DEVICES & DIAGNOSTICS
In October 2004, Tyco Healthcare Group, LP, (Tyco) and U.S. Surgical Corporation filed a lawsuit
against Ethicon Endo-Surgery, Inc. (EES) in the United States District Court for the District of
Connecticut alleging that several features of EESs HARMONIC® scalpel infringed four
Tyco patents. In October 2007, on motions for summary judgment prior to the initial trial, a number
of claims were found invalid and a number were found infringed. However, no claim was found both
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 United States District
Court for the District of Connecticut asserting infringement of three of the four patents from the
previous suit and adding new products. Tyco is seeking monetary damages and injunctive relief.
This case is scheduled to be tried in October 2011.
Starting in March 2006, Cordis Corporation (Cordis) filed patent infringement lawsuits in the
United States District Courts for the Districts of New Jersey and Delaware, against Guidant
Corporation (Guidant), Abbott Laboratories, Inc. (Abbott), Boston Scientific Corporation (Boston
Scientific) and Medtronic Ave, Inc. (Medtronic) alleging that the Xience V (Abbott), Promus
(Boston Scientific) and Endeavor® (Medtronic) drug eluting stents infringe several of Cordiss
Wright/Falotico patents. Cordis is seeking monetary relief. On January 20, 2010, in one of the
cases against Boston Scientific, the United States District Court for the District of Delaware
found the Wright/Falotico patents invalid for lack of written description and/or lack of
enablement. Cordis has appealed this ruling.
In October 2007, Bruce Saffran (Saffran) filed a patent infringement lawsuit against the Company
and Cordis in the United States District Court for the Eastern District of Texas alleging
infringement on U.S. Patent No. 5,653,760. In January 2011, a jury returned a verdict finding that
Cordiss sales of its CYPHER® stent willfully infringed a patent issued to Saffran. The jury
awarded Saffran $482 million. In March 2011, the Court denied all of Cordiss post-trial motions to
overturn the verdict and entered judgment against Cordis in the amount of $593 million representing
the jury verdict, plus $111 million in pre-judgment interest.
19
Cordis will appeal the judgment. Because the Company believes that the potential for an unfavorable
outcome is not probable, it has not established a reserve with respect to the case.
In November 2007, Roche Diagnostics Operations, Inc., et al. (Roche) filed a patent infringement
lawsuit against LifeScan, Inc. (LifeScan) in the United States District Court for the District of
Delaware, accusing LifeScans entire ONETOUCH® line of blood glucose monitoring systems of
infringement of two patents related to the use of microelectrode sensors. In September 2009,
LifeScan obtained a favorable ruling on claim construction that precluded a finding of
infringement. The Court entered judgment against Roche in July 2010 and Roche appealed. Briefing
on appeal issues is to be completed by May 27, 2011. Oral argument will be held in fall 2012.
Roche is seeking monetary damages and injunctive relief.
Starting in February 2008, Cordis filed patent infringement lawsuits in the United States District
Court for the District of New Jersey against Guidant, Abbott, Boston Scientific and Medtronic
alleging that the Xience V (Abbott), Promus (Boston Scientific) and Endeavor® (Medtronic) drug
eluting stents infringe several of Wyeths
(now
Pfizer Inc.)
Morris patents, which have been licensed to Cordis.
Cordis is seeking monetary relief. Trial is scheduled for September 2011.
In June 2009, Rembrandt Vision Technologies, L.P. (Rembrandt) filed a patent infringement lawsuit
against Johnson & Johnson Vision Care, Inc. (JJVC) in the United States District Court for the
Eastern District of Texas alleging that JJVCs manufacture and sale of its ACUVUE ADVANCE® and
ACUVUE® OASYS HYDROGEL contact lenses infringe their U.S. Patent No. 5,712,327 (the Chang patent).
Rembrandt is seeking monetary relief. The case is scheduled for trial in May 2012.
PHARMACEUTICAL
In May 2009, Abbott Biotechnology Ltd. (Abbott) filed a patent infringement lawsuit against
Centocor, Inc. (Centocor) (now Centocor Ortho Biotech Inc. (COBI)) in the United States District
Court for the District of Massachusetts alleging that SIMPONI® infringes Abbotts U.S. Patent Nos.
7,223,394 and 7,451,031 (the Salfeld patents). Abbott is seeking monetary damages and injunctive
relief. No trial date has been set.
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
District of Massachusetts alleging that STELARA® infringes two United States patents assigned to
Abbott GmbH. COBI filed a complaint in the United States District Court for the District of
Columbia for a declaratory judgment of non-infringement and invalidity of the Abbott GmbH patents,
as well as a Complaint for Review of a Patent Interference Decision that granted priority of
invention on one of the two asserted patents to Abbott GmbH. The cases have been transferred from
the District of Columbia to the District of Massachusetts. Discovery in these cases is ongoing. No trial date has been set. Also in
August 2009, Abbott GmbH and
20
Abbott Laboratories Limited brought a patent infringement lawsuit in The Federal Court of Canada
alleging that STELARA® infringes Abbott GmbHs Canadian patent. The Canadian case is scheduled to
be tried in October 2012. In each of these cases, Abbott is seeking monetary damages and injunctive
relief.
In August 2009, Bayer HealthCare LLC (Bayer) filed a patent infringement lawsuit against COBI in
United States District Court for the District of Massachusetts alleging that the manufacture and
sale by COBI of SIMPONI® infringes a Bayer patent relating to human anti-TNF antibodies. In
January 2011, the court issued judgment dismissing Bayers infringement claims. Bayer has appealed
this ruling. In addition, in November 2009, Bayer also filed lawsuit 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 Laboratories, Inc. The Dutch court
subsequently entered judgment in favor of COBIs European affiliate, Janssen Biologics B.V., and
Bayer appealed that judgment in the Netherlands. The infringement trial in Germany is scheduled to
begin in August of 2011. In the lawsuits described above, Bayer is seeking monetary relief. In
addition, in March 2010, Janssen-Cilag NV filed a revocation action in the High Court in London
seeking to invalidate Bayers UK patent relating to human anti-TNF antibodies. Trial is scheduled
to begin June 8, 2011.
In April 2007, Centocor (now COBI) filed a patent infringement lawsuit against Abbott Laboratories,
Inc. (Abbott) in the United States District Court for the Eastern District of Texas alleging that
Abbotts HUMIRA® anti-TNF alpha product infringes Centocors U.S. Patent 7,070,775. In June 2009,
a jury returned a verdict finding the patent valid and infringed, and awarded COBI damages of
approximately $1.7 billion. In February 2011, the Court of Appeals reversed the June 2009 decision
and the judgment of the District Court. COBI has filed a petition for rehearing and rehearing en
banc.
LITIGATION AGAINST FILERS OF ABBREVIATED NEW DRUG APPLICATIONS (ANDAs)
The following summarizes lawsuits pending against generic companies 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 District Court ruling is obtained, the
companies involved will have the ability, upon approval of the United States Food and Drug
Administration (FDA), 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.
21
CONCERTA®
In January 2010, ALZA Corporation (ALZA) and Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI)
filed a patent infringement lawsuit in the United States District Court for the District of
Delaware against Kremers-Urban, LLC and KUDCO Ireland, Ltd. (collectively, KUDCO) in response to
KUDCOs ANDA seeking approval to market a generic version of CONCERTA® before the expiration of two
of ALZA and OMJPIs patents relating to CONCERTA®. KUDCO filed counterclaims alleging
non-infringement and invalidity.
In November 2010, ALZA and OMJPI filed a patent infringement lawsuit in the United States District
Court for the District of Delaware against Impax Laboratories, Inc. (Impax), Teva Pharmaceuticals
USA, Inc., and Teva Pharmaceutical Industries Ltd. (collectively, Teva) in response to Impax and
Tevas filing of a major amendment to its ANDA seeking approval to market a generic version of
CONCERTA® before the expiration of ALZA and OMJPIs patent relating to CONCERTA®. Impax and Teva
filed counterclaims alleging non-infringement and invalidity.
In May 2011,
Alza and OMJPI filed a second lawsuit against Teva in response to Tevas
filing of a second major amendment to its ANDA seeking approval to
market additional dosage strengths of its generic CONCERTA® product
before the expiration of Alza and OMJPIs patent relating to CONCERTA®.
In each of the above cases, ALZA and
OMJPI are seeking an Order enjoining the defendants from marketing its generic version of CONCERTA®
prior to the expiration of ALZA and OMJPIs CONCERTA® patent.
ORTHO TRI-CYLEN®LO
In October 2008, OMJPI and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (JJPRD)
filed a patent infringement lawsuit against Watson Laboratories, Inc. and Watson Pharmaceuticals,
Inc. (collectively, Watson) in the United States District Court for the District of New Jersey in
response to Watsons ANDA seeking approval to market a generic version of OMJPIs product prior to
the expiration of OMJPIs patent relating to ORTHO TRI-CYCLEN® LO (the OTCLO patent). Watson filed
a counterclaim alleging invalidity of the patent. In addition, in January 2010, OMJPI filed a
patent infringement lawsuit against Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively,
Lupin) in the United States District Court for the District of New Jersey in response to Lupins
ANDA seeking approval to market a generic version of ORTHO TRI-CYCLEN® LO prior to the expiration
of the OTCLO patent. Lupin filed a counterclaim alleging invalidity of the patent. The Lupin and
Watson cases have been consolidated.
In November 2010, OMJPI filed a patent infringement lawsuit against Mylan Inc. and Mylan
Pharmaceuticals, Inc. (collectively, Mylan), and Famy Care, Ltd. (Famy Care) in the United States
District Court for the District of New Jersey in response to Famy Cares ANDA seeking approval to
market a generic version of ORTHO TRI-CYCLEN® LO prior to the expiration of the OTCLO patent.
Mylan and Famy Care filed counterclaims alleging invalidity of the patent. In each of the above
cases, JJPRD and/or OMJPI are seeking an Order enjoining the defendants from marketing their
generic versions of ORTHO TRI-CYLCEN® LO before the expiration of the OTCLO patent.
22
PREZISTA®
In November 2010, Tibotec, Inc. and Tibotec Pharmaceuticals, Inc. (collectively, Tibotec) filed a
patent infringement lawsuit against Lupin, Ltd., Lupin Pharmaceuticals, Inc. (collectively, Lupin),
Mylan, Inc. and Mylan Pharmaceuticals, Inc. (collectively, Mylan) in the United States District
Court for the District of New Jersey in response to Lupins and Mylans respective ANDAs seeking
approval to market generic versions of Tibotecs PREZISTA® product before the expiration of
Tibotecs patent relating to PREZISTA®. Lupin and Mylan each filed counterclaims alleging
non-infringement and invalidity.
In March 2011, Tibotec and G.D. Searle & Company (G.D. Searle) filed a patent infringement lawsuit
against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals, Ltd. (collectively, Teva) in the
United States District Court for the District of New Jersey in response to Tevas ANDA seeking
approval to market a generic version of PREZISTA® before the expiration of certain patents relating
to PREZISTA® that Tibotec either owns or exclusively licenses from G.D. Searle.
In March 2011, Tibotec filed a patent infringement lawsuit against Hetero Drugs, Ltd. Unit III and
Hetero USA Inc. (collectively, Hetero) in the United States District Court for the District of New
Jersey in response to Heteros ANDA seeking approval to market a generic version of PREZISTA®
before the expiration of certain patents relating to PREZISTA® that Tibotec exclusively licenses
from G.D. Searle. In each of the above lawsuits, Tibotec is seeking an Order enjoining the
defendants from marketing their generic versions of PREZISTA® before the expiration of the relevant
patents.
OTHER INTELLECTUAL PROPERTY MATTERS
In September 2009, Centocor Ortho Biotech Products, L.P. (COBLP) intervened in an inventorship
lawsuit filed by the University of Kansas Center for Research, Inc. (KUCR) against the United
States of America (USA) in the United States District Court for the District of Kansas. KUCR
alleges that two KUCR scientists should be added as inventors on two USA-owned patents relating to
VELCADE®. The USA licensed the patents (and their foreign counterparts) to Millennium
Pharmaceuticals, Inc. (MPI), who in turn sublicensed the patents (and their foreign counterparts)
to COBLP for commercial marketing outside the United States. In July 2010, the parties reached a
settlement agreement to resolve the disputes in this case and will submit the inventorship issue to
arbitration. The case has been stayed pending the arbitration. As a result of the settlement
agreement, the outcome of the arbitration regarding inventorship will determine whether
pre-specified payments will be made to KUCR, but will not affect COBLPs right to market VELCADE®.
In December 2009, the State of Israel filed a lawsuit in the District Court in Tel Aviv Jaffa
against various affiliates of
23
Omrix Biopharmaceuticals, Inc. (Omrix). In the lawsuit, the State claims that an employee of a
government-owned hospital was the inventor on several patents related to fibrin glue technology
that the employee 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 royalties on QUIXIL and EVICEL or, alternatively, transfer of the patents to
the State.
In January 2011, Genentech, Inc. initiated an arbitration against UCB Celltech (Celltech) seeking
damages for allegedly cooperating with Centocor (now COBI) to improperly terminate a prior
agreement in which COBI was sublicensed under Genentechs Cabilly patents. COBI has an indemnity
agreement with Celltech, and Celltech has asserted that COBI is liable for any damages Celltech may
be required to pay Genentech in that arbitration.
GOVERNMENT PROCEEDINGS
Like other companies in the pharmaceutical and medical devices and diagnostics industries, the
Company and certain of its subsidiaries are subject to extensive regulation by national, state and
local government agencies in the United States and other countries in which they operate. As a
result, interaction with government agencies is ongoing. The most significant litigation brought
by, and investigations conducted by, government agencies are listed below. It is possible that
criminal charges and substantial fines and/or civil penalties or damages could result from
government investigations or litigation.
AVERAGE WHOLESALE PRICE (AWP) LITIGATION
The Company and several of its pharmaceutical subsidiaries (the J&J AWP defendants), 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.
Payors alleged that they used those AWPs in calculating provider reimbursement levels. Many of
these cases, both federal actions and state actions removed to federal court, were consolidated for
pre-trial purposes in a Multi-District Litigation (MDL) in the United States District Court for the
District of Massachusetts.
The plaintiffs in these cases included three 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. In June 2007, after a trial on the
merits, the MDL Court dismissed the claims of two of the plaintiff classes against the J&J AWP
defendants from the case regarding all claims of Classes 2 and 3. In March 2011, the Court
dismissed the claims of the third class against the J&J AWP defendants without prejudice.
24
AWP cases brought by various Attorneys General have proceeded to trial against other manufacturers.
Three state cases against certain of the Companys subsidiaries have been set for trial: Idaho in
October 2011, Kentucky in January 2012 and Kansas in March 2013. Other state cases are likely to
be set for trial in the coming year. In addition, an AWP case against the J&J AWP defendants
brought by the State of Pennsylvania was tried in Commonwealth Court in October and November 2010.
The Court found in the States favor with regard to certain of its claims under the Pennsylvania
Unfair Trade Practices and Consumer Protection Law, entered an injunction, and awarded $45 million
in restitution and $6.5 million in civil penalties. The Court found in the J&J AWP defendants
favor on the States claims of unjust enrichment, misrepresentation/fraud, civil conspiracy, and on
certain of the States claims under the Pennsylvania Unfair Trade Practices and Consumer Protection
Law. The parties are currently engaged in post trial motions, which will be followed by an appeal
to the Pennsylvania Supreme Court, if necessary. The Company believes that it has strong arguments
supporting an appeal. Because the Company believes that the potential for an unfavorable outcome is
not probable, it has not established a reserve with respect to the verdict.
RISPERDAL®
In January 2004, Janssen Pharmaceutica Inc. (Janssen) (now Ortho-McNeil-Janssen Pharmaceuticals,
Inc. (OMJPI)) received a subpoena from the Office of the Inspector General of the United States
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® from 1997 to 2002. Documents subsequent to 2002 have also been requested by the
Department of Justice. An additional subpoena seeking information about marketing of, and adverse
reactions to, RISPERDAL® was received from the United States Attorneys Office for the Eastern
District of Pennsylvania in November 2005. Numerous subpoenas seeking testimony from various
witnesses before a grand jury were also received. OMJPI cooperated in responding to these requests
for documents and witnesses. The United States Department of Justice and the United States
Attorneys Office for the Eastern District of Pennsylvania (the Government) are continuing to
actively pursue both criminal and civil actions. 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®. The focus of these matters is the alleged promotion of
RISPERDAL® and INVEGA® for off-label uses. The Government has notified OMJPI that there are also
pending qui tam actions alleging off-label promotion of RISPERDAL®. The Government informed OMJPI
that it will intervene in these qui tam actions and file a superseding complaint.
Discussions are ongoing in an effort to resolve
criminal
penalties under the Food Drug and Cosmetic Act and civil claims under
the False Claims Act (the qui tam actions) related to the promotion
of RISPERDAL®.
During the quarter ended April 3, 2011, OMJPI recorded a reserve for
a potential settlement of the
penalties under the Food Drug and Cosmetic Act. No complaint asserting
civil False Claims Act claims has yet been served and no reserve has
been established with respect to the civil False Claims Act claims.
If a negotiated resolution cannot be reached, criminal and civil litigation relating
to the allegations of off-
25
label promotion of RISPERDAL® and/or INVEGA® is likely. The ultimate resolution of these matters is
not expected to have a material adverse effect on the Companys financial position, although the
resolution in any reporting period could have a material impact on the Companys results of
operations and cash flows for that period.
The Attorneys General of multiple states and the Office of General Counsel of the Commonwealth of
Pennsylvania filed actions against Janssen (now OMJPI) 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. The trial of the Texas
action is scheduled to commence in October 2011. Certain of these actions also seek injunctive
relief relating to the promotion of RISPERDAL®. The Attorneys General of approximately 40 other
states have indicated a potential interest in pursuing similar litigation against 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®.
The Attorney General of West Virginia commenced suit in 2004 against Janssen (now OMJPI) based on
claims of alleged consumer fraud as to DURAGESIC®, as well as RISPERDAL®. OMJPI was found liable
and damages were assessed at $4.5 million. OMJPI filed an appeal, and in November 2010, the West
Virginia Supreme Court reversed the trial courts decision. In December 2010, the Attorney General
of West Virginia dismissed the case as it related to RISPERDAL® without any payment. Thereafter,
OMJPI settled the case insofar as it related to DURAGESIC®.
In 2004, the Attorney General of Louisiana filed a multi-count Complaint against Janssen (now
OMJPI). The Company was later added as a defendant. The case was tried in October 2010. The
issue tried to the jury was whether the Company or OMJPI had violated the States Medicaid Fraud
Act (the Act) through misrepresentations allegedly made in the mailing of a November 2003 Dear
Health Care Provider letter. The jury returned a verdict that OMJPI and the Company had violated
the Act and awarded $257.7 million in damages. The trial judge subsequently awarded the Attorney
General counsel fees and expenses in the amount of $73 million. The Company and OMJPIs motion for
a new trial was denied. The Company and OMJPI intend to file an appeal and believe that they have
strong arguments supporting the appeal. They believe that the potential for an unfavorable outcome
is not probable. Therefore, the Company has not established a reserve with respect to the verdict.
In 2007, The Office of General Counsel of the Commonwealth of Pennsylvania filed a lawsuit against
Janssen (now OMJPI) on a multi-Count Complaint related to Janssens sale of RISPERDAL® to the States Medicaid program. The
trial occurred in June 2010.
26
The trial judge dismissed the case after the close of the plaintiffs evidence. The Commonwealths
post-trial motions were denied. The Commonwealth filed an appeal in April 2011.
In 2007, the Attorney General of South Carolina filed a lawsuit against the Company and Janssen
(now OMJPI) on several counts. In March 2011, the matter was tried on liability only, at which
time the suit was limited to claims of violation of the South Carolina Unfair Trade Practice Act,
including, among others, questions of whether the Company or OMJPI engaged in unfair or deceptive
acts or practices in the conduct of any trade or commerce by distributing the November 2003 Dear
Doctor letter or in their use of the FDA-approved label. The jury found in favor of the Company
and against OMJPI. The penalty
hearing was held
in April 2011, and the parties are
awaiting the Courts decision.
MCNEIL CONSUMER HEALTHCARE
Starting in June 2010, McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. (McNeil Consumer
Healthcare), and certain affiliates, including the Company (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. In addition, in February 2011, the government served
McNEIL-PPC, Inc. (McNEIL-PPC) with a Civil Investigative Demand seeking records relevant to its
investigation to determine if there was a violation of the False Claims Act. The Companies are
cooperating with the United States Attorneys Office in responding to these subpoenas.
The Companies have also received Civil Investigative Demands (CIDs) 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. In January 2011,
the Oregon Attorney General filed a civil complaint against the Company, McNEIL-PPC and McNeil
Healthcare LLC in state court alleging civil violations of the Oregon unlawful trade practices act
relating to an earlier recall of a McNeil OTC product. The Companies removed this case to federal
court and have sought transfer of the case to the United States District Court for the Eastern
District of Pennsylvania. Currently, the case has been stayed pending a decision on transfer.
On March 10, 2011, the United States filed a complaint for injunctive relief in the United States
District Court for the Eastern District of Pennsylvania against McNEIL-PPC and two of its
employees, alleging that McNEIL-PPC is in violation of FDA regulations regarding the manufacture of
drugs at the facilities it operates in Lancaster, Pennsylvania, Fort Washington, Pennsylvania, and
Las Piedras, Puerto Rico. On the same day, the parties filed a consent decree of permanent
injunction resolving the claims set forth in the complaint. The Court approved and entered the consent decree on March
16, 2011.
27
The decree, which is subject to ongoing enforcement by the court, requires McNEIL-PPC to take
enhanced measures to remediate the three facilities. The Fort Washington facility, which the
company voluntarily shut down in April 2010, will remain shut down until a third-party consultant
certifies that its operations will be in compliance with applicable law, and FDA concurs with the
third party certification. The Lancaster and Las Piedras facilities may continue to manufacture
and distribute drugs, provided that a third party reviews manufacturing records for selected
batches of drugs released from the facilities, and certifies that any deviations reviewed do not
adversely affect the quality of the selected batches. McNEIL-PPC must further submit a workplan
(with deadlines) to FDA for remediation of the Lancaster and Las Piedras facilities; that plan is
subject to FDA approval. After completion of the workplan, third-party batch record review may
cease if FDA has stated that the facilities appear to be in compliance with applicable law. Each
facility is subject to a five-year audit period by a third party after the facility has been deemed
by FDA to be in apparent compliance with applicable law.
OMNICARE
In September 2005, the Company received a subpoena from the United States Attorneys Office,
District of Massachusetts, seeking documents related to the sales and marketing of eight drugs to
Omnicare, Inc. (Omnicare), a manager of pharmaceutical benefits for long-term care facilities. In
April 2009, the Company and certain of its pharmaceutical subsidiaries were served in two civil qui
tam cases asserting claims under the Federal False Claims Act and related state law claims alleging
that the defendants provided Omnicare with rebates and other alleged kickbacks, causing Omnicare to
file false claims with Medicaid and other government programs. In January 2010, the government
intervened in both of these cases, naming the Company, Ortho-McNeil-Janssen Pharmaceuticals, Inc.,
and Johnson & Johnson Health Care Systems Inc. as defendants. Subsequently, the Commonwealth of
Massachusetts, Virginia, and Kentucky, and the States of California and Indiana intervened in the
action. The defendants moved to dismiss the Complaints, and in February 2011, the United States
District Court for the District of Massachusetts dismissed one qui tam case entirely and dismissed
the other case in part, rejecting allegations that the defendants had violated its obligation to
report its best price to health care program officials. The defendants subsequently moved the
Court to reconsider its decision not to dismiss the second case in its entirety. The Court has yet
to rule on that motion. The claims of the United States and individual States remain pending.
In November 2005, a lawsuit was filed under seal by Scott Bartz, a former employee, in the United
States District Court for the Eastern District of Pennsylvania against the Company and certain of
its pharmaceutical subsidiaries (the J&J Defendants), along with co-defendants McKesson Corporation
and Omnicare, Inc. The Bartz complaint raises many issues in common with the Omnicare-related litigation discussed above
already pending before the
28
United States District Court for the District of Massachusetts, such as best price and a number of
kickback allegations. After investigation, the United States declined to intervene. The case was
subsequently unsealed in January 2011. In February 2011, the plaintiff filed an amended complaint,
which was placed under seal. Thereafter, on the J&J Defendants motion, the case was transferred
to the United States District Court for the District of Massachusetts, where it is currently
pending. In April 2011, the amended complaint was ordered unsealed and alleges a variety of causes
of action under the federal False Claims Act and corresponding state and local statutes, including
that the J&J Defendants engaged in various improper transactions that were allegedly designed to
report false prescription drug prices to the federal government in order to reduce the J&J
Defendants Medicaid rebate obligations. The complaint further alleges that the J&J Defendants
improperly retaliated against the plaintiff for having raised these allegations internally. Bartz
seeks multiple forms of relief, including damages and reinstatement to a position with the same
seniority status. The J&J Defendants have not yet responded to this amended complaint, but
anticipates filing a motion to dismiss.
OTHER
In July 2003, Centocor, Inc. (Centocor) (now Centocor Ortho Biotech Inc. (COBI)), received a
request that it voluntarily provide documents and information to the criminal division of the
United States 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
United States Attorneys Office. Both the Company and COBI have responded to these requests for
documents and information.
In July 2005, Scios Inc. (Scios) received a subpoena from the United States Attorneys Office,
District of Massachusetts, seeking documents related to the sales and marketing of NATRECOR®. In
August 2005, Scios was advised that the investigation would be handled by the United States
Attorneys Office for the Northern District of California in San Francisco. In February 2009, two
qui tam complaints were unsealed in the United States District Court for the Northern District of
California, alleging, among other things, improper activities in the promotion of NATRECOR®. In
June 2009, the United States government intervened in one of the qui tam actions, and filed a
complaint against Scios and the Company seeking relief under the False Claims Act and asserting a
claim of unjust enrichment. 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 February 2007, the Company voluntarily disclosed to the United States Department of Justice
(DOJ) and the United States Securities & Exchange Commission (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
29
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 were brought
to the attention of the agencies by the Company. Law enforcement agencies of a number of other
countries are pursuing investigations of matters voluntarily disclosed by the Company to the DOJ
and SEC. In addition, in February 2006, the Company received a subpoena from the SEC requesting
documents relating to the participation by several Company subsidiaries in the United Nations Iraq
Oil for Food Program. On April 8, 2011, the Company resolved the FCPA and Oil for Food matters
through settlements with the DOJ, SEC and United Kingdom Serious Fraud Office. These settlements
required payments of approximately $78 million in financial penalties. As part of the settlement
with the DOJ, the Company entered into a Deferred Prosecution Agreement that requires the Company
to complete a three-year term of enhanced compliance practices.
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 May 2007, the New York State Attorney General issued a subpoena to the Company seeking
information relating to the marketing, sale, reimbursement and safety of PROCRIT®. The Company has
responded to the subpoena.
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 Cordis. Cordis is
currently cooperating in responding to the subpoena. In addition, in January 2010, a complaint
was unsealed in the United States District Court for the Northern District of Texas seeking damages
against Cordis for alleged violations of the federal False Claims Act and several similar state
laws in connection with the marketing of biliary stents. The United States Department of Justice
and several states have declined to intervene at this time. In April 2011, the District Court for
the Northern District of Texas dismissed the complaint without prejudice.
In April 2009, Ortho-Clinical Diagnostics, Inc. (OCD) received a grand jury subpoena from the
United States 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. OCD complied with the
subpoena. In February 2011, OCD received a letter from the Antitrust Division indicating that it
had closed its investigation in November 2010. In June 2009, following the public announcement
that OCD had received a grand jury subpoena, multiple class action complaints
seeking damages for alleged price fixing were filed against OCD. The various cases were
consolidated for pre-trial purposes in the
30
United States District Court for the Eastern District of Pennsylvania. Discovery is ongoing.
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, Inc. has responded
to these requests.
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.
GENERAL LITIGATION
In September 2004, Plaintiffs, in an employment discrimination litigation initiated against the
Company in 2001 in the United States District Court for the District of New Jersey, moved to
certify a class of all African American and Hispanic salaried employees of the Company and its
affiliates in the United States, 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 denied Plaintiffs motion in July
2010, and the Court of Appeals denied Plaintiffs request for leave to appeal the denial of
certification of the modified class. The Company will continue to defend against Plaintiffs
individual claims of discrimination.
Starting in July 2006, five suits were filed in United States District Court for the District of
New Jersey by various employers and employee benefit plans and funds seeking to recover amounts
they paid for RISPERDAL® for plan participants. In general, Plaintiffs allege that the Company and
certain of its pharmaceutical subsidiaries engaged in off-label marketing of RISPERDAL® in
violation of the federal and New Jersey RICO statutes. In addition, Plaintiffs asserted various
state law claims. All of the cases were consolidated into one case seeking class action status, but
shortly thereafter, one action was voluntarily dismissed. In December 2008, the Court dismissed the
actions of the four remaining plaintiffs. In April 2010, those plaintiffs filed a new consolidated
class action against the Company and Janssen, L.P. (now OMJPI); and in March 2011, that action was
dismissed. In April 2011, one of those plaintiffs filed a notice of appeal with the United States
Court of Appeals for the Third Circuit.
31
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
(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). COBI distributes REMICADE® and SIMPONI® the
next generation treatment, within the United States. In the arbitration, COBI sought a declaration
that the agreement and merger between Merck & Co., Inc. (Merck) and Schering-Plough constituted a
change of control under the terms of the Distribution Agreements that permitted COBI to terminate
the Agreements. On April 15, 2011, the Company, COBI and Merck announced an agreement to amend
the Distribution Agreements. This agreement concluded the arbitration proceeding.
Under the terms of the amended Distribution Agreements, effective July 1, 2011, Mercks subsidiary,
Schering-Plough (Ireland) will relinquish exclusive marketing rights for REMICADE® and SIMPONI® to
the Companys Janssen pharmaceutical companies in territories including Canada, Central and South
America, the Middle East, Africa and Asia Pacific (relinquished territories). (Note, in Japan,
Indonesia, and Taiwan, COBI will continue to license distribution rights to REMICADE® and SIMPONI®
to Mitsubishi Tanabe Pharma Corporation). Merck will retain exclusive marketing rights throughout
Europe, Russia and Turkey (retained territories). The retained territories represent approximately
70 percent of Mercks 2010 revenue of approximately $2.8 billion from REMICADE® and SIMPONI®, while
the relinquished territories represent approximately 30 percent. In addition, beginning July 1,
2011, all profit derived from Mercks exclusive distribution of the two products in the retained
territories will be equally divided between Merck and COBI. Under the prior terms of the
distribution agreement, the contribution income (profit) split, which is currently at 58 percent to
Merck and 42 percent to COBI, would have declined for Merck and increased for COBI each year until
2014, when it would have been equally divided. COBI also received a one-time payment of $500
million in April 2011.
In April 2010, a putative class action lawsuit was filed in the United States District Court for
the Northern District of California by representatives of nursing home residents or their estates
against the Company, Omnicare, Inc. (Omnicare), and other unidentified companies or individuals.
In February 2011, plaintiffs filed a second amended complaint asserting that certain rebate
agreements between the Company and Omnicare increased the amount of money spent on pharmaceuticals
by the nursing home residents and violated the Sherman Act and the California Business &
Professions Code. The second amended complaint also asserts a claim of unjust enrichment.
Plaintiffs seek multiple forms of monetary and injunctive relief. The Company moved to dismiss the
second amended complaint in March 2011.
Starting in April 2010, a number of shareholder derivative lawsuits were filed in the United States
District Court for the
32
District of New Jersey against certain current and former directors and officers of the Company.
The Company is named as a nominal defendant. These actions were consolidated on August 17, 2010
into one lawsuit: In re Johnson & Johnson Shareholder Derivative Litigation. An amended
consolidated complaint was filed on December 17, 2010. Additionally, in September 2010, another
shareholder derivative lawsuit was filed in New Jersey Superior Court against certain current and
former directors and officers of the Company. The Company is named as a nominal defendant in this
action as well. The parties to this action have stipulated that it shall be stayed until the In re
Johnson & Johnson Shareholder Derivative Litigation is completely resolved.
These shareholder derivative actions are similar in their 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. In February 2011, the Company moved to dismiss
these actions on the grounds, inter alia, that the plaintiffs failed to make a demand upon the
Board of Directors.
Starting in May 2010, multiple complaints seeking class action certification related to the McNeil
recalls have been filed against McNeil Consumer Healthcare and certain affiliates, including the
Company, in the United States District Court for the Eastern District of Pennsylvania, the Northern
District of Illinois, the Central District of California, the Southern District of Ohio and the
Eastern District of Missouri. These consumer complaints allege generally that purchasers of various
McNeil medicines are owed monetary damages and penalties because they paid premium prices for
defective medications rather than less expensive alternative medications. All but one complaint
seeks certification of a nation-wide class of purchasers of these medicines, whereas one complaint,
the Harvey case, seeks certification of a class of Motrin® IB purchasers in Missouri. In October
2010, the Judicial Panel on Multidistrict Litigation (JPML) consolidated all of the consumer
complaints, except for the Harvey case, which was consolidated in March 2011, for pretrial
proceedings in the United States District Court for the Eastern District of Pennsylvania. The
plaintiffs in all of the cases except the Harvey case filed a Consolidated Amended Civil Consumer
Class Action Complaint (CAC) naming additional parties and claims on January 2011. Defendants
have filed a motion to dismiss the CAC, which motion is scheduled to be heard on June 29, 2011.
In September 2010, a shareholder, Ronald Monk, filed a lawsuit in the United States District Court
for the District of New Jersey seeking class certification and alleging that the Company and certain individuals, including
executive officers and employees of
33
the Company, failed to disclose that a number of manufacturing facilities were failing to maintain
current good manufacturing practices, and that as a result, the price of the Companys stock has
declined significantly. Plaintiffs seek to pursue remedies under the Securities Exchange Act of
1934 to recover their alleged economic losses.
In April 2011, OMJ Pharmaceuticals, Inc. (OMJ PR) filed suit against the United States in United
States District Court for the District of Puerto Rico alleging overpayment of federal income taxes
for the tax years ended November 30, 1999 and November 30, 2000. OMJ PR alleges that the Internal
Revenue Service erroneously calculated OMJ PRs tax credits under Section 936 of the Tax Code.
In May 2011, an additional
derivative lawsuit was filed by Sandra
Wollman and Gila Heimowitz in the United States District Court for the
District of New Jersey naming the Company as the nominal defendant and
the Companys current directors as defendants. The complaint alleges
breaches of fiduciary duties related to the Companys compliance with
the Foreign Corrupt Practices Act and participation in the United
Nations Iraq Oil For Food Program, that the Company has suffered damages
as a result of those alleged breaches, and that the defendants failed
to disclose the alleged misconduct in the Companys filings under the
Securities Exchange Act of 1934. Plaintiffs seek monetary damages.
Although the Company has not yet been served with the complaint, the
Company intends to move to dismiss it on the grounds, inter
alia, that
the plaintiffs failed to make a demand upon the Board of Directors.
The Company is a party to a number of proceedings brought under the Comprehensive Environmental
Response, Compensation, and Liability Act, commonly known as Superfund, and other state, local or
foreign laws in which the primary relief sought is the cost of past and/or future remediation.
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. There can be no assurance that
there will not be an increase in the scope of pending matters or that any future lawsuits, claims,
government investigations, or other legal proceedings will not be material.
The ultimate legal and financial liability of the Company in respect to all claims, lawsuits and
proceedings referred to above often cannot be reasonably estimated. 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
position, 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.
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
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
34
$830 million of the pre-tax restructuring charges 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. Additionally, as part of this
program the Company planned to eliminate approximately 7,500 positions, of which approximately
5,500 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 first quarter of 2011:
|
|
|
|
|
(Dollars in Millions) |
|
Severance |
|
Reserve balance as of: |
|
|
|
|
January 2, 2011 |
|
$ |
345 |
|
Cash outlays |
|
|
(41 |
) |
April 3, 2011* |
|
$ |
304 |
|
|
|
|
* |
|
Remaining cash outlays for severance are expected to be paid out in accordance with the Companys
plans and local laws. |
NOTE 13 SUBSEQUENT EVENT
On April 27, 2011 the Company entered into a definitive agreement to acquire Synthes, Inc. for
approximately $21.3 billion, approximately
$19.3 billion net of cash acquired. Synthes, Inc. is a premier global developer and manufacturer of
orthopaedics devices.
|
|
|
Item 2 |
|
MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
RESULTS OF OPERATIONS
Analysis of Consolidated Sales
For the fiscal first quarter of 2011, worldwide sales were $16.2 billion, an increase of 3.5%,
including an operational increase of 1.8% as compared to 2010 fiscal first quarter sales of $15.6
billion. Currency fluctuations had a positive impact of 1.7% for the fiscal first quarter of 2011.
Sales by U.S. companies were $7.6 billion in the fiscal first quarter of 2011, which represented a
decrease of 0.6% as compared to the same period last year. Sales by international companies were
$8.6 billion, which represented a total increase of 7.3%, including an operational increase of
4.1%, and a positive impact from currency of 3.2% as compared to the fiscal first quarter sales of
2010.
Sales by companies in Europe achieved growth of 2.0%, including operational growth of 1.9% and a
positive impact from currency of 0.1%. Sales by companies in the Western Hemisphere, excluding the
U.S., achieved growth of 12.2%, including operational growth of 7.3%, and a positive impact from currency of 4.9%. Sales by companies in the Asia-Pacific, Africa
region achieved sales growth
35
of 13.4%, including operational growth of 6.3%, and an increase of 7.1% related to the
positive impact of currency.
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 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 2011 full year impact to sales
rebates, thereby reducing sales revenue, is estimated to be $400 $500 million of which
approximately $120 million impacted the Companys fiscal first quarter of 2011. In the fiscal first
quarter of 2010, that amount was approximately $60 million.
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 total branded prescription drug sales from the prior year. The 2011 full year impact to
selling, marketing and administrative expenses is estimated to be $150 $200 million.
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 be
required to pay a tax deductible 2.3% excise tax imposed on the sale of certain medical devices.
ANALYSIS OF SALES BY BUSINESS SEGMENTS
Consumer
Consumer segment sales in the fiscal first quarter of 2011 were $3.7 billion, a decrease of 2.2%
over the same period a year ago, including an operational decline of 4.1%, and a positive currency
impact of 1.9%. U.S. Consumer segment sales declined by 13.8% while international sales achieved
sales growth of 5.9%, including operational growth of 2.6%, and a positive currency impact of 3.3%.
Major Consumer Franchise Sales Fiscal First Quarters
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
April 3, |
|
|
April 4, |
|
|
Total |
|
|
Operations |
|
|
Currency |
|
(Dollars in Millions) |
|
2011 |
|
|
2010 |
|
|
Change |
|
|
Change |
|
|
Change |
|
OTC Pharm & Nutr |
|
$ |
1,129 |
|
|
$ |
1,207 |
|
|
|
(6.5 |
)% |
|
|
(8.2 |
)% |
|
|
1.7 |
% |
Skin Care |
|
|
899 |
|
|
|
920 |
|
|
|
(2.3 |
) |
|
|
(3.7 |
) |
|
|
1.4 |
|
Baby Care |
|
|
561 |
|
|
|
529 |
|
|
|
6.0 |
|
|
|
3.1 |
|
|
|
2.9 |
|
Womens Health |
|
|
459 |
|
|
|
469 |
|
|
|
(2.1 |
) |
|
|
(4.0 |
) |
|
|
1.9 |
|
Oral Care |
|
|
391 |
|
|
|
381 |
|
|
|
2.6 |
|
|
|
0.2 |
|
|
|
2.4 |
|
Wound Care/Other |
|
|
243 |
|
|
|
260 |
|
|
|
(6.5 |
) |
|
|
(8.4 |
) |
|
|
1.9 |
|
Total |
|
$ |
3,682 |
|
|
$ |
3,766 |
|
|
|
(2.2 |
)% |
|
|
(4.1 |
)% |
|
|
1.9 |
% |
The OTC Pharmaceuticals and Nutritionals franchise experienced an operational decline of 8.2%
as compared to the prior year fiscal first quarter. Sales in the U.S. were negatively impacted by
the
36
suspension of production at McNeil Consumer Healthcares Fort Washington, Pennsylvania facility as
well as the impact on production volumes related to ongoing efforts to enhance quality and
manufacturing systems. Sales outside the U.S. grew primarily due to strong market growth in certain
regions.
During the quarter a consent decree was signed with the U.S. Food and Drug Administration (FDA),
which will govern certain McNeil Consumer Healthcare division manufacturing operations. The consent
decree identifies procedures that will help provide additional assurance of product quality to the
FDA. The consent decree recognizes the work already initiated by McNeil under the Comprehensive
Action Plan (CAP).
The Skin Care franchise experienced an operational decline of 3.7% due in part to a temporary
product supply issue in the Neutrogena product line due to manufacturing enhancements.
The Baby Care franchise achieved operational growth of 3.1% as compared to the prior year primarily
due to growth in cleansers, wipes and powders outside the U.S.
The Womens Health Franchise experienced an operational decline of 4.0% as compared to the prior
year primarily due to lower sales of sanitary protection and K-Y® products.
The Oral Care franchise achieved operational growth of 0.2% as compared to the prior year. Sales in
the U.S. declined, reflecting the impact of competition, including private label products, for
certain products. Sales growth outside the U.S. was due to increased sales of
LISTERINE®.
Pharmaceutical
Pharmaceutical segment sales in the fiscal first quarter of 2011 were $6.1 billion, a total
increase of 7.5% as compared to the same period a year ago with an operational increase of 6.4% and
an increase of 1.1% related to the positive impact of currency. U.S. Pharmaceutical sales increased
by 5.8% as compared to the same period a year ago. International Pharmaceutical sales achieved
sales growth of 9.7%, including operational growth of 7.3%, and an increase of 2.4% related to the
positive impact of currency.
Major Pharmaceutical Product Revenues Fiscal First Quarters*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
April 3, |
|
|
April 4, |
|
|
Total |
|
|
Operations |
|
|
Currency |
|
(Dollars in Millions) |
|
2011 |
|
|
2010 |
|
|
Change |
|
|
Change |
|
|
Change |
|
REMICADE® |
|
$ |
1,285 |
|
|
$ |
1,186 |
|
|
|
8.3 |
% |
|
|
8.3 |
% |
|
|
|
% |
LEVAQUIN®/FLOXIN® |
|
|
434 |
|
|
|
371 |
|
|
|
17.0 |
|
|
|
16.9 |
|
|
|
0.1 |
|
RISPERDAL® CONSTA® |
|
|
404 |
|
|
|
379 |
|
|
|
6.6 |
|
|
|
5.5 |
|
|
|
1.1 |
|
PROCRIT®/EPREX® |
|
|
397 |
|
|
|
523 |
|
|
|
(24.1 |
) |
|
|
(24.6 |
) |
|
|
0.5 |
|
CONCERTA® |
|
|
362 |
|
|
|
329 |
|
|
|
10.0 |
|
|
|
8.8 |
|
|
|
1.2 |
|
VELCADE® |
|
|
280 |
|
|
|
261 |
|
|
|
7.3 |
|
|
|
5.6 |
|
|
|
1.7 |
|
ACIPHEX®/PARIET® |
|
|
239 |
|
|
|
260 |
|
|
|
(8.1 |
) |
|
|
(8.6 |
) |
|
|
0.5 |
|
Other Pharmaceuticals |
|
|
2,658 |
|
|
|
2,329 |
|
|
|
14.1 |
|
|
|
12.1 |
|
|
|
2.0 |
|
Total |
|
$ |
6,059 |
|
|
$ |
5,638 |
|
|
|
7.5 |
% |
|
|
6.4 |
% |
|
|
1.1 |
% |
37
* 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 8.3% over prior year fiscal first quarter.
Growth was primarily driven by an increase in U.S. export sales due to market growth. On April 15,
2011 the Company announced it reached an agreement with Merck to amend distribution rights to
REMICADE® and SIMPONI® whereby, effective July 1, 2011, certain territories
will be transferred to the Company. On July 1, 2011, the Company will record sales of product from
certain territories, including Canada, Brazil, Australia and Mexico, previously supplied by Merck.
In addition, effective July 1, 2011, the division of contribution income split will increase to 50%
for the territories that Merck will retain. REMICADE® is competing in a market that is experiencing
increased competition due to new entrants and the expansion of indications for existing
competitors.
LEVAQUIN® (levofloxacin)/FLOXIN®(ofloxacin), an anti-infective, achieved operational growth
of 16.9% as compared to the prior year fiscal first quarter primarily
due to higher
incidence of respiratory illness and flu. Market exclusivity in the U.S. expires in June 2011. The
expiration of a products market exclusivity will result in a significant reduction in
sales.
RISPERDAL® CONSTA® (risperidone), a long-acting injectable antipsychotic, achieved operational
growth of 5.5% as compared to the prior year fiscal first quarter. Sales in the U.S. declined,
however the total U.S. sales of the Companys long-acting injectables, including INVEGA® SUSTENNA
(paliperidone palmitate), increased by double digits versus a year ago due to an increase in
combined market share. Sales outside the U.S. increased with strong growth in most major regions.
PROCRIT® (Epoetin alfa)/EPREX® (Epoetin alfa), experienced an operational sales decline
of 24.6%, as compared to the prior year fiscal first quarter. The decline was primarily due to
softening of the market for Erythropoiesis Stimulating Agents (ESAs) and increased competition.
CONCERTA® (methylphenidate HCl), a product for the treatment of attention deficit
hyperactivity disorder, achieved operational sales growth of 8.8% as compared to the prior year
fiscal first quarter, due to market growth, partially offset by market share loss and the full
quarter impact of the health care reform legislation enacted in March 2010, resulting in changes to
rebates to Medicaid managed care organizations. On November 1, 2010, the Company entered into a
U.S. Supply and Distribution Agreement with Watson Laboratories, Inc. to distribute an authorized
generic version of
CONCERTA® beginning
May 1, 2011. This authorized generic launch will
result in a significant reduction in CONCERTA® sales.
38
VELCADE® (bortezomib), a product for the treatment for multiple myeloma, for which the Company
has commercial rights in Europe and the rest of the world outside the U.S., achieved operational
sales growth of 5.6% as compared to the prior year fiscal first quarter. Slower sales in Europe
due to pricing pressure and increased competition were offset by strong growth in other regions.
ACIPHEX®/PARIET® experienced an operational decline of 8.6% as compared to the
prior year fiscal first quarter primarily due to increased generic competition in the category.
In the fiscal first quarter of 2011, Other Pharmaceutical sales achieved operational growth of
12.1% over the prior year fiscal first quarter. Contributors to the increase were sales of STELARA®
(ustekinumab), PREZISTA® (darunavir), CAELYX®(pegylated liposomal doxorubicin hydrochloride)
SIMPONI® (golimumab), INVEGA® SUSTENNA (paliperidone palmitate), NUCYNTA® (tapentadol)
and
INTELENCE® (etravirine). This growth was partially offset by lower sales of DURAGESIC®/Fentanyl
Transdermal (fentanyl transdermal system), TOPAMAX® (topiramate) and RISPERDAL®/risperidone
due to continued generic competition.
Medical Devices and Diagnostics
Medical Devices and Diagnostics segment sales in the fiscal first quarter of 2011 were $6.4
billion, an increase of 3.3% as compared to the same period a year ago, including an operational
increase of 1.3% and a positive currency impact of 2.0%. The U.S. Medical Devices and Diagnostics
sales declined 0.5%. The increase in international Medical Devices and Diagnostics sales was 6.6%,
which included operational increases of 3.0% and a positive currency impact of 3.6%.
Major Medical Devices and Diagnostics Franchise Sales Fiscal First Quarters
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
April 3, |
|
|
April 4, |
|
|
Total |
|
|
Operations |
|
|
Currency |
|
(Dollars in Millions) |
|
2011 |
|
|
2010 |
|
|
Change |
|
|
Change |
|
|
Change |
|
DEPUY® |
|
$ |
1,503 |
|
|
$ |
1,454 |
|
|
|
3.4 |
% |
|
|
1.7 |
% |
|
|
1.7 |
% |
ETHICON ENDO-SURGERY® |
|
|
1,221 |
|
|
|
1,168 |
|
|
|
4.5 |
|
|
|
2.4 |
|
|
|
2.1 |
|
ETHICON® |
|
|
1,193 |
|
|
|
1,147 |
|
|
|
4.0 |
|
|
|
2.3 |
|
|
|
1.7 |
|
Vision Care |
|
|
722 |
|
|
|
664 |
|
|
|
8.7 |
|
|
|
4.7 |
|
|
|
4.0 |
|
Diabetes Care |
|
|
637 |
|
|
|
597 |
|
|
|
6.7 |
|
|
|
6.0 |
|
|
|
0.7 |
|
CORDIS® |
|
|
635 |
|
|
|
672 |
|
|
|
(5.5 |
) |
|
|
(7.5 |
) |
|
|
2.0 |
|
ORTHO-CLINICAL DIAGNOSTICS® |
|
|
521 |
|
|
|
525 |
|
|
|
(0.8 |
) |
|
|
(2.5 |
) |
|
|
1.7 |
|
Total |
|
$ |
6,432 |
|
|
$ |
6,227 |
|
|
|
3.3 |
% |
|
|
1.3 |
% |
|
|
2.0 |
% |
The DePuy franchise achieved operational growth of 1.7% as compared to the same period a year
ago. This growth was primarily due to sales of newly acquired products from Micrus and the Mitek
sports medicine product line.
39
The Ethicon Endo-Surgery franchise achieved operational growth of 2.4% as compared to the prior
year fiscal first quarter. Growth in the U.S. was attributable to the Advanced Sterilization and
HARMONIC® Scalpel products. Outside the U.S., the Endo mechanical and Energy based product lines
were contributors to the growth. Total growth was impacted by the divestiture of the breast care
business in the third quarter of 2010.
The Ethicon franchise achieved operational growth of 2.3% as compared to the prior year fiscal
first quarter. The primary drivers of the growth were attributable to sales of sutures, womens
health and Acclarent products.
The Vision Care franchise achieved operational sales growth of 4.7% as compared to the prior year
fiscal first quarter. ACUVUE® TruEye and the astigmatism lenses were strong
contributors to the growth in the quarter.
The Diabetes Care franchise achieved operational sales growth of 6.0% as compared to the prior year
fiscal first quarter. The growth was primarily due to sales of the One Touch product line.
The Cordis franchise experienced an operational sales decline of 7.5% as compared to the prior year
fiscal first quarter. 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 Companys electrophysiology business.
The Ortho-Clinical Diagnostics franchise experienced an operational sales decline of 2.5% as
compared to the prior year fiscal first quarter attributable to lower sales of donor screening due
to the move to selective testing in the U.S. for Chagas disease. This was partially offset by the
continued growth in clinical labs due to the strength of the VITROS® 5600 and 3600
analyzers.
Cost of Products Sold and Selling, Marketing and Administrative Expenses
Consolidated costs of products sold for the fiscal first quarter of 2011 increased to 29.5% from
29.0% of sales as compared to the same period a year ago, primarily due to ongoing remediation
costs in the Consumer business, which was partially offset by favorable product mix due to a change
in the mix of businesses.
Consolidated selling, marketing and administrative expenses for the fiscal first quarter of 2011
increased to 31.3% from 30.5% of sales as compared to the same period a year ago. The increase was
primarily due to investment spending in the Medical Devices and Diagnostics business as well as the
fee on branded pharmaceutical products incurred due to the U.S. health care reform legislation.
40
Research & Development
Research & 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 & development activities for the fiscal first quarter of 2011
were $1.7 billion, which was an increase of 11.6% in spending as compared to the prior year fiscal
first quarter. The increase was primarily due to the timing of milestone payments in the
Pharmaceutical business.
Other (Income) Expense, Net
Other (income) expense, net is the account where the Company records gains and losses related to
the sale and write-down of certain equity securities of the Johnson & Johnson Development
Corporation, gains and losses on the disposal of fixed assets, currency gains and losses, gains and
losses relating to non-controlling interests, litigation settlements, as well as royalty income.
The change in other (income) expense, net for the fiscal first quarter of 2011, was unfavorable as
compared to the same period a year ago. The fiscal first quarter of 2011 included $0.3 billion
related to litigation expense and additional DePuy ASR Hip recall costs partially offset by the
gain related to the Companys earlier investment in Crucell versus a net gain of $1.5 billion from
litigation matters recorded in the fiscal first quarter of 2010.
OPERATING PROFIT BY SEGMENT
Consumer Segment
Operating profit for the Consumer segment as a percent to sales in the fiscal first quarter of 2011
was 15.6% versus 20.8% for the same period a year ago. The primary drivers of the decline in
operating profit were unfavorable product mix and remediation costs associated with the recall of
certain OTC products.
Pharmaceutical Segment
Operating profit for the Pharmaceutical segment as a percent to sales in the fiscal first quarter
of 2011 was 36.5% versus 34.9% for the same period a year ago. The primary drivers of the increase
in the operating profit margin were the gain related to the Companys earlier investment in Crucell
and lower manufacturing costs, partially offset by the impact of the health care reform legislation
and litigation expense recorded in 2011. The fiscal first quarter of 2010 was negatively impacted
by unfavorable product mix due to the loss of market exclusivity for TOPAMAX® and litigation
expense.
Medical Devices and Diagnostics Segment
Operating profit for the Medical Devices and Diagnostics segment as a percent to sales in the
fiscal first quarter of 2011 was 30.2% versus 59.5% for the same period a year ago. The primary
driver of the decline in the operating profit margin in the Medical Devices and Diagnostics segment
was $0.1 billion related to litigation expense and additional DePuy ASR Hip recall costs
41
recorded in the fiscal first quarter of 2011. The fiscal first quarter of 2010 included a $1.6
billion gain from net litigation matters.
Interest (Income) Expense
Interest income decreased slightly in the fiscal first quarter of 2011 as compared to the same
period a year ago, due to lower rates of interest earned despite higher average cash balances. The
ending balance of cash, cash equivalents and marketable securities, was $26.9 billion at the end of
the fiscal first quarter of 2011. This is an increase of $8.9 billion from the same period a year
ago. The increase was primarily due to cash generated from operating activities.
Interest expense increased in the fiscal first quarter of 2011 as compared to the same period a
year ago due to a higher average debt balance. At the end of the fiscal first quarter of 2011, the
Companys debt position was $17.8 billion compared to $12.1 billion from the same period a year
ago. The Company increased borrowings in 2010, capitalizing on favorable terms in the capital
markets. The proceeds of the debt were used for general corporate purposes.
Provision for Taxes on Income
The worldwide effective income tax rates for the fiscal first quarters of 2011 and 2010 were 22.9%
and 27.9%, respectively. The lower effective tax rate was due to lower income in higher tax
jurisdictions and the U.S. Research and Development tax credit, which was not in effect for the
fiscal first quarter of 2010. Additionally, the net litigation gain of $1.5 billion recorded at a
39.0% tax rate in the fiscal first quarter of 2010, added 3.5 percentage points to the worldwide
effective income tax rate.
As of April 3, 2011, the Company had approximately $2.4 billion of liabilities from unrecognized
tax benefits. The Company does not expect that the total amount of unrecognized tax benefits will
change significantly during the next twelve months.
See Note 8 to the Consolidated Financial Statements in the Annual Report on Form 10-K for the
fiscal year ended January 2, 2011 for more detailed information regarding unrecognized tax
benefits.
LIQUIDITY AND CAPITAL RESOURCES
Cash Flows
Cash and cash equivalents were $22.4 billion at the end of the fiscal first quarter of 2011 as
compared with $19.4 billion at the fiscal year end of 2010. The primary sources of cash that
contributed to the $3.0 billion increase were $2.3 billion generated from operating activities and
$1.4 billion net cash from investing activities offset by $0.8 billion used by financing
activities.
42
Cash flow from operations of $2.3 billion was the result of $3.5 billion of net earnings and
$0.9 billion of non cash charges related to depreciation and amortization and stock based
compensation reduced by $2.1 billion related to changes in assets and liabilities, net of effects
from acquisitions.
Cash from investing activities of $1.4 billion was due to proceeds from asset sales and net
sale of investments in marketable securities of $3.9 billion partially offset by acquisitions of
$2.1 billion and $0.4 billion used for additions to property, plant and equipment.
Financing activities use of $0.8 billion was primarily for dividends to shareholders of $1.5
billion and $0.2 billion for repurchase of common stock net of proceeds from stock options
exercised partially offset by $0.9 billion net proceeds of short and long-term debt.
In the fiscal first quarter of 2011, 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 January 3, 2011, the Board of Directors declared a regular quarterly cash dividend of
$0.540 per share, payable on March 15, 2011, to shareholders of record as of March 1, 2011.
On April 28, 2011, the Board of Directors declared a regular cash dividend of $0.570 per share,
payable on June 14, 2011 to shareholders of record as of May 31, 2011. This represented an increase
of 5.6% in the quarterly dividend rate and was the 49th consecutive year of cash dividend
increases. The Company expects to continue the practice of paying regular quarterly cash dividends.
OTHER INFORMATION
New Accounting Standards
During the fiscal first quarter of 2011, the Company adopted the Financial Accounting Standards
Board (FASB) guidance and amendments issued 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 did not have a material impact on the
Companys results of operations, cash flows or financial position.
During the fiscal first
quarter of 2011, the Company adopted the FASB
guidance on how pharmaceutical companies should recognize and classify
in the Companys financial statements, the non deductible annual fee
paid to the Government in accordance with the Patient Protection and
Affordable Care Act as amended by the Health Care and Education
Reconciliation Act. This fee is based on an allocation of a companys
market share of total branded prescription drug sales from the prior
year. The estimated fee was recorded as a selling, marketing and
administrative expense in the Companys financial statement and will
be amortized on a straight-line basis for the year as per the FASB
guidance. The adoption of this standard did not have a material impact
on the Companys results of operations, cash flows or financial
position.
43
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 2000 through 2010 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).
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
44
growth, product development, regulatory approval, market position and expenditures.
Forward-looking statements are based on current expectations of future events. The Company cannot
guarantee that any forward- looking statement will be accurate, although the Company believes that
it has been reasonable in its expectations and assumptions. Investors should realize that if
underlying assumptions prove inaccurate or that unknown risks or uncertainties materialize, actual
results could vary materially from the Companys expectations and projections. Investors are
therefore cautioned not to place undue reliance on any forward-looking statements. The Company does
not undertake to update any forward-looking statements as a result of new information or future
events or developments.
Risks and uncertainties include, but are not limited to, general industry conditions and
competition; economic factors, such as 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;
significant litigation adverse to the Company; impact to business combinations; financial distress
and bankruptcies experienced by significant customers and suppliers; changes to governmental laws
and regulations and U.S. and foreign health care reforms; trends toward healthcare cost
containment; increased scrutiny of the health care industry by government agencies; changes in
behavior and spending patterns of healthcare products and services; manufacturing difficulties or
delays; 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 2, 2011 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 2, 2011.
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
45
forms. Disclosure controls and procedures include, without limitation, controls and procedures
designed to ensure that information required to be disclosed by the Company in the reports that it
files or submits under the Securities Exchange Act is accumulated and communicated to the Companys
management, including its principal executive and principal financial officers, or persons
performing similar functions, as appropriate to allow timely decisions regarding required
disclosure. William C. Weldon, Chairman and Chief Executive Officer, and Dominic J. Caruso, Vice
President, Finance and Chief Financial Officer, reviewed and participated in this evaluation.
Based on this evaluation, Messrs. Weldon and Caruso concluded that, as of the end of the period
covered by this report, the Companys disclosure controls and procedures were effective.
Internal control. During the period covered by this report, there were no changes in the Companys
internal control over financial reporting that have materially affected, or are reasonably likely
to materially affect, the Companys internal control over financial reporting.
Part II OTHER INFORMATION
Item 1 LEGAL PROCEEDINGS
The information called for by this item is incorporated herein by reference to Note 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 first quarter of 2011. 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 |
|
|
Average |
|
|
|
of Shares |
|
|
Price Paid |
|
Fiscal Month |
|
Purchased |
|
|
per Share |
|
January 3, 2011 through January 30, 2011 |
|
|
2,630,613 |
|
|
$ |
62.59 |
|
January 31, 2011 through February 27, 2011 |
|
|
1,745,764 |
|
|
$ |
60.41 |
|
February 28, 2011 through April 3, 2011 |
|
|
2,771,478 |
|
|
$ |
59.65 |
|
Total |
|
|
7,147,855 |
|
|
|
|
|
46
Item 6 EXHIBITS
Exhibit 31.1 Certifications under Rule 13a-14(a) of the
Securities Exchange Act pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002 Filed with this document.
Exhibit 32.1 Certifications pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002 Furnished with this document.
Exhibit 101 XBRL (Extensible Business Reporting Language)
The following materials from Johnson & Johnsons Quarterly Report on Form 10-Q for the
quarter ended April 3, 2011, 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.
47
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: May 10, 2011 |
By |
/s/ D. J. CARUSO
|
|
|
|
D. J. CARUSO |
|
|
|
Vice President, Finance;
Chief Financial Officer
(Principal Financial Officer) |
|
|
|
|
|
Date: May 10, 2011 |
By |
/s/ S. J. COSGROVE
|
|
|
|
S. J. COSGROVE |
|
|
|
Controller
(Principal Accounting Officer) |
|
|
48