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 4, 2010
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. (Check one):
|
|
|
|
|
|
|
Large accelerated filer þ
|
|
Accelerated filer o
|
|
Non-accelerated filer o
|
|
Smaller reporting company o |
|
|
|
|
(Do not check if a smaller reporting company) |
|
|
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 May 2, 2010 2,758,069,561 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)
ASSETS
|
|
|
|
|
|
|
|
|
|
|
April 4, 2010 |
|
January 3, 2010 |
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
13,743 |
|
|
$ |
15,810 |
|
|
|
|
|
|
|
|
|
|
Marketable securities |
|
|
4,267 |
|
|
|
3,615 |
|
|
|
|
|
|
|
|
|
|
Accounts receivable, trade, less
allowances for doubtful accounts
$408 (2009, $333) |
|
|
10,018 |
|
|
|
9,646 |
|
|
|
|
|
|
|
|
|
|
Inventories (Note 2) |
|
|
5,308 |
|
|
|
5,180 |
|
|
|
|
|
|
|
|
|
|
Deferred taxes on income |
|
|
2,232 |
|
|
|
2,793 |
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and other receivables |
|
|
3,293 |
|
|
|
2,497 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
38,861 |
|
|
|
39,541 |
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment at cost |
|
|
28,963 |
|
|
|
29,251 |
|
|
|
|
|
|
|
|
|
|
Less: accumulated depreciation |
|
|
(14,686 |
) |
|
|
(14,492 |
) |
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
14,277 |
|
|
|
14,759 |
|
|
|
|
|
|
|
|
|
|
Intangible assets, net (Note 3) |
|
|
16,799 |
|
|
|
16,323 |
|
|
|
|
|
|
|
|
|
|
Goodwill, net (Note 3) |
|
|
14,977 |
|
|
|
14,862 |
|
|
|
|
|
|
|
|
|
|
Deferred taxes on income |
|
|
4,905 |
|
|
|
5,507 |
|
|
|
|
|
|
|
|
|
|
Other assets |
|
|
3,622 |
|
|
|
3,690 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
93,441 |
|
|
$ |
94,682 |
|
See Notes to Consolidated Financial Statements
3
JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited; Dollars in Millions)
LIABILITIES AND SHAREHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
|
|
April 4, 2010 |
|
January 3, 2010 |
Current liabilities: |
|
|
|
|
|
|
|
|
Loans and notes payable |
|
$ |
4,044 |
|
|
$ |
6,318 |
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
5,126 |
|
|
|
5,541 |
|
|
|
|
|
|
|
|
|
|
Accrued liabilities |
|
|
4,415 |
|
|
|
5,796 |
|
|
|
|
|
|
|
|
|
|
Accrued rebates, returns and promotions |
|
|
2,487 |
|
|
|
2,028 |
|
|
|
|
|
|
|
|
|
|
Accrued salaries, wages and commissions |
|
|
1,054 |
|
|
|
1,606 |
|
|
|
|
|
|
|
|
|
|
Accrued taxes on income |
|
|
1,373 |
|
|
|
442 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
18,499 |
|
|
|
21,731 |
|
|
|
|
|
|
|
|
|
|
Long-term debt |
|
|
8,059 |
|
|
|
8,223 |
|
|
|
|
|
|
|
|
|
|
Deferred taxes on income |
|
|
1,672 |
|
|
|
1,424 |
|
|
|
|
|
|
|
|
|
|
Employee related obligations |
|
|
6,254 |
|
|
|
6,769 |
|
|
|
|
|
|
|
|
|
|
Other liabilities |
|
|
6,043 |
|
|
|
5,947 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
40,527 |
|
|
|
44,094 |
|
|
|
|
|
|
|
|
|
|
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) |
|
|
(3,837 |
) |
|
|
(3,058 |
) |
|
|
|
|
|
|
|
|
|
Retained earnings |
|
|
73,184 |
|
|
|
70,306 |
|
|
|
|
|
|
|
|
|
|
Less: common stock held in treasury, at
cost (362,009,000 and 365,522,000
shares) |
|
|
19,553 |
|
|
|
19,780 |
|
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
52,914 |
|
|
|
50,588 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and
shareholders equity |
|
$ |
93,441 |
|
|
$ |
94,682 |
|
See Notes to Consolidated Financial Statements
4
JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF EARNINGS
(Unaudited; dollars & shares in millions
except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Quarters Ended |
|
|
|
|
|
|
Percent |
|
|
|
|
|
Percent |
|
|
April 4, |
|
to |
|
March 29, |
|
to |
|
|
2010 |
|
Sales |
|
2009 |
|
Sales |
Sales to customers (Note 9) |
|
$ |
15,631 |
|
|
|
100.0 |
% |
|
$ |
15,026 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
4,528 |
|
|
|
29.0 |
|
|
|
4,251 |
|
|
|
28.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
11,103 |
|
|
|
71.0 |
|
|
|
10,775 |
|
|
|
71.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, marketing and
administrative expenses |
|
|
4,779 |
|
|
|
30.5 |
|
|
|
4,608 |
|
|
|
30.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research expense |
|
|
1,557 |
|
|
|
10.0 |
|
|
|
1,518 |
|
|
|
10.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
(27 |
) |
|
|
(0.2 |
) |
|
|
(25 |
) |
|
|
(0.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net of
portion capitalized |
|
|
108 |
|
|
|
0.7 |
|
|
|
106 |
|
|
|
0.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
(1,594 |
) |
|
|
(10.2 |
) |
|
|
(75 |
) |
|
|
(0.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings before provision for
taxes on income |
|
|
6,280 |
|
|
|
40.2 |
|
|
|
4,643 |
|
|
|
30.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for taxes on income
(Note 5) |
|
|
1,754 |
|
|
|
11.2 |
|
|
|
1,136 |
|
|
|
7.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET EARNINGS |
|
$ |
4,526 |
|
|
|
29.0 |
% |
|
$ |
3,507 |
|
|
|
23.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET EARNINGS PER SHARE (Note 8) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
1.64 |
|
|
|
|
|
|
$ |
1.27 |
|
|
|
|
|
Diluted |
|
$ |
1.62 |
|
|
|
|
|
|
$ |
1.26 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH DIVIDENDS PER SHARE |
|
$ |
0.490 |
|
|
|
|
|
|
$ |
0.460 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AVG. SHARES OUTSTANDING |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
2,755.4 |
|
|
|
|
|
|
|
2,765.9 |
|
|
|
|
|
Diluted |
|
|
2,797.3 |
|
|
|
|
|
|
|
2,789.8 |
|
|
|
|
|
See Notes to Consolidated Financial Statements
5
JOHNSON & JOHNSON AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited; Dollars in Millions)
|
|
|
|
|
|
|
|
|
|
|
Fiscal Quarters Ended |
|
|
April 4, |
|
March 29, |
|
|
2010 |
|
2009 |
CASH FLOW FROM OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
Net earnings |
|
$ |
4,526 |
|
|
$ |
3,507 |
|
Adjustments to reconcile net earnings to cash
flows from operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization of
property and intangibles |
|
|
734 |
|
|
|
676 |
|
Stock based compensation |
|
|
157 |
|
|
|
159 |
|
Decrease in deferred tax provision |
|
|
960 |
|
|
|
1,212 |
|
Accounts receivable allowances |
|
|
78 |
|
|
|
22 |
|
Changes in assets and liabilities, net of
effects from acquisitions: |
|
|
|
|
|
|
|
|
Increase in accounts receivable |
|
|
(529 |
) |
|
|
(86 |
) |
Increase in inventories |
|
|
(193 |
) |
|
|
(336 |
) |
Decrease in accounts payable
and accrued liabilities |
|
|
(1,651 |
) |
|
|
(2,155 |
) |
Increase in other current and non-current
assets |
|
|
(1,088 |
) |
|
|
(39 |
) |
Increase/(Decrease) in other current and
non-current liabilities |
|
|
696 |
|
|
|
(133 |
) |
|
|
|
|
|
|
|
|
|
NET CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
3,690 |
|
|
|
2,827 |
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
Additions to property, plant and equipment |
|
|
(397 |
) |
|
|
(435 |
) |
Proceeds from the disposal of assets |
|
|
102 |
|
|
|
6 |
|
Acquisitions, net of cash acquired |
|
|
(772 |
) |
|
|
(1,291 |
) |
Purchases of investments |
|
|
(3,246 |
) |
|
|
(1,440 |
) |
Sales of investments |
|
|
2,440 |
|
|
|
2,150 |
|
Other |
|
|
(9 |
) |
|
|
(66 |
) |
|
|
|
|
|
|
|
|
|
NET CASH USED BY INVESTING ACTIVITIES |
|
|
(1,882 |
) |
|
|
(1,076 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
Dividends to shareholders |
|
|
(1,350 |
) |
|
|
(1,273 |
) |
Repurchase of common stock |
|
|
(383 |
) |
|
|
(834 |
) |
Proceeds from short-term debt |
|
|
715 |
|
|
|
3,276 |
|
Retirement of short-term debt |
|
|
(3,043 |
) |
|
|
(1,057 |
) |
Proceeds from long-term debt |
|
|
|
|
|
|
2 |
|
Retirement of long-term debt |
|
|
(8 |
) |
|
|
(9 |
) |
Proceeds from the exercise of stock
options/excess tax benefits |
|
|
247 |
|
|
|
27 |
|
|
|
|
|
|
|
|
|
|
NET CASH(USED BY)/FROM FINANCING ACTIVITIES |
|
|
(3,822 |
) |
|
|
132 |
|
Effect of exchange rate changes on cash and
cash equivalents |
|
|
(53 |
) |
|
|
(62 |
) |
(Decrease)/Increase in cash and cash
equivalents |
|
|
(2,067 |
) |
|
|
1,821 |
|
Cash and Cash equivalents, beginning of period |
|
|
15,810 |
|
|
|
10,768 |
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS, END OF PERIOD |
|
$ |
13,743 |
|
|
$ |
12,589 |
|
|
|
|
|
|
|
|
|
|
Acquisitions |
|
|
|
|
|
|
|
|
Fair value of assets acquired |
|
$ |
808 |
|
|
$ |
1,519 |
|
Fair value of liabilities assumed |
|
|
(36 |
) |
|
|
(228 |
) |
Net cash paid for acquisitions |
|
$ |
772 |
|
|
$ |
1,291 |
|
See Notes to Consolidated Financial Statements
6
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 The accompanying unaudited interim consolidated financial statements and related notes
should be read in conjunction with the audited Consolidated Financial Statements of Johnson &
Johnson and its Subsidiaries (the Company) and related notes as contained in the Companys Annual
Report on Form 10-K for the fiscal year ended January 3, 2010. The unaudited interim financial
statements include all adjustments (consisting only of normal recurring adjustments) and accruals
necessary in the judgment of management for a fair statement of the results for the periods
presented.
The Financial Accounting Standards Board (FASB) issued guidance and amendments to the criteria for
separating consideration in multiple-deliverable revenue arrangements, which the Company adopted in
the fiscal first quarter of 2010. The guidance also (a) provides principles and application
guidance on whether multiple deliverables exist, how the arrangement should be separated, and the
consideration allocated; (b) requires an entity to allocate revenue in an arrangement using
estimated selling prices of deliverables if a vendor does not have vendor-specific objective
evidence or third-party evidence of selling price; and(c) eliminates the use of the residual method
and requires an entity to allocate the revenue using the relative selling price method. The
adoption did not have a material impact on the Companys results of operations, cash flows or
financial position however it will expand the disclosures for multiple-deliverable revenue
arrangements.
During the fiscal first quarter of 2010 the Company adopted the FASB standard related to variable
interest entities. The adoption of this standard did not have a significant impact on the Companys
results of operations, cash flows or financial position.
During the fiscal first quarter of 2010 the Company adopted the new accounting guidance on fair
value measurements and disclosures. This guidance requires the Company to disclose the amount of
significant transfers between Level 1 and Level 2 inputs and the reasons for these transfers as
well as the reasons for any transfers in or out of Level 3 of the fair value hierarchy. In
addition, the guidance clarifies certain existing disclosure requirements. The adoption of this
standard did not have a significant impact on the Companys results of operations, cash flows or
financial position.
During the fiscal second quarter of 2010 the FASB issued an accounting standard update related to
revenue recognition under the milestone method. The objective of the accounting standard update is
to provide guidance on defining a milestone and determining when it may be appropriate to apply the
milestone method of revenue recognition for research or development transactions. This update is
effective on a prospective basis for milestones achieved in fiscal years, and interim periods
within
7
those years, beginning on or after June 15, 2010. The adoption of this standard is not expected to
have a significant impact on the Companys results of operations, cash flows or financial position.
NOTE 2 INVENTORIES
|
|
|
|
|
|
|
|
|
|
|
April 4, |
|
January 3, |
(Dollars in Millions) |
|
2010 |
|
2010 |
Raw materials and supplies |
|
$ |
1,002 |
|
|
$ |
1,144 |
|
Goods in process |
|
|
1,467 |
|
|
|
1,395 |
|
Finished goods |
|
|
2,839 |
|
|
|
2,641 |
|
Total |
|
$ |
5,308 |
|
|
$ |
5,180 |
|
NOTE 3 INTANGIBLE ASSETS AND GOODWILL
Intangible assets that have finite useful lives are amortized over their estimated useful lives.
The latest impairment assessment of goodwill and indefinite lived intangible assets was completed
in the fiscal fourth quarter of 2009. Future impairment tests for goodwill and indefinite lived
intangible assets will be performed annually in the fiscal fourth quarter, or sooner if warranted.
|
|
|
|
|
|
|
|
|
|
|
April 4, |
|
January 3, |
(Dollars in Millions) |
|
2010 |
|
2010 |
Intangible assets with definite lives: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents and trademarks gross |
|
$ |
6,456 |
|
|
$ |
5,697 |
|
Less accumulated amortization |
|
|
2,354 |
|
|
|
2,177 |
|
Patents and trademarks net |
|
|
4,102 |
|
|
|
3,520 |
|
|
|
|
|
|
|
|
|
|
Other intangibles gross |
|
|
7,654 |
|
|
|
7,808 |
|
Less accumulated amortization |
|
|
2,646 |
|
|
|
2,680 |
|
Other intangibles net |
|
|
5,008 |
|
|
|
5,128 |
|
|
|
|
|
|
|
|
|
|
Total intangible assets with definite lives gross |
|
|
14,110 |
|
|
|
13,505 |
|
Less accumulated amortization |
|
|
5,000 |
|
|
|
4,857 |
|
Total intangible assets with definite lives net |
|
|
9,110 |
|
|
|
8,648 |
|
|
|
|
|
|
|
|
|
|
Intangible assets with indefinite lives: |
|
|
|
|
|
|
|
|
Trademarks |
|
|
5,879 |
|
|
|
5,938 |
|
Purchased in-process research and development* |
|
|
1,810 |
|
|
|
1,737 |
|
Total intangible assets with indefinite lives |
|
|
7,689 |
|
|
|
7,675 |
|
|
|
|
|
|
|
|
|
|
Total intangible assets net |
|
$ |
16,799 |
|
|
$ |
16,323 |
|
|
|
|
* |
|
Purchased in-process research and development is accounted for as an indefinite-lived intangible
asset until the underlying project is completed or abandoned. |
8
Goodwill as of April 4, 2010 was allocated by segment of business as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Med Dev |
|
|
(Dollars in Millions) |
|
Consumer |
|
Pharm |
|
& Diag |
|
Total |
Goodwill, net
at January 3, 2010 |
|
$ |
8,074 |
|
|
$ |
1,244 |
|
|
$ |
5,544 |
|
|
$ |
14,862 |
|
Acquisitions |
|
|
|
|
|
|
|
|
|
|
233 |
|
|
|
233 |
|
Currency translation/Other |
|
|
(87 |
) |
|
|
(15 |
) |
|
|
(16 |
) |
|
|
(118 |
) |
Goodwill, net as of
April 4, 2010 |
|
$ |
7,987 |
|
|
$ |
1,229 |
|
|
$ |
5,761 |
|
|
$ |
14,977 |
|
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 4, 2010 was $180 million, and the estimated amortization
expense for the five succeeding years approximates $700 million, per year.
NOTE 4 FAIR VALUE MEASUREMENTS
The Company uses forward exchange contracts to manage its exposure to the variability of cash
flows, primarily related to the foreign exchange rate changes of future intercompany product and
third- party purchases of raw materials denominated in foreign currency. The Company also uses
cross currency interest rate swaps to manage currency risk primarily related to borrowings. Both
types of derivatives are designated as cash flow hedges. The Company also uses forward exchange
contracts to manage its exposure to the variability of cash flows for repatriation of foreign
dividends. These contracts are designated as net investment hedges. Additionally, the Company
uses forward exchange contracts to offset its exposure to certain foreign currency assets and
liabilities. These forward exchange contracts are not designated as hedges and therefore, changes
in the fair values of these derivatives are recognized in earnings, thereby offsetting the current
earnings effect of the related foreign currency assets and liabilities. The Company does not enter
into derivative financial instruments for trading or speculative purposes, or contain credit risk
related contingent features or requirements to post collateral. On an ongoing basis the Company
monitors counterparty credit ratings. The Company considers credit non-performance risk to be low,
because the Company enters into agreements with commercial institutions that have at least an A (or
equivalent) credit rating. As of April 4, 2010, the Company had notional amounts outstanding for
forward foreign exchange contracts and cross currency interest rate swaps of $22 billion and $4
billion, respectively.
As required by U.S. GAAP for derivative instruments and hedging activities, all derivative
instruments are to be recorded on the balance sheet at fair value. Changes in the fair value of
derivatives are recorded each period in current earnings or other comprehensive income, depending
on whether the derivative is designated as part of a hedge transaction, and if so, the type of
hedge transaction.
9
The designation as a cash flow hedge is made at the entrance date into the derivative contract. At
inception, all derivatives are expected to be highly effective. Changes in the fair value of a
derivative that is designated as a cash flow hedge and is highly effective are recorded in
accumulated other comprehensive income until the underlying transaction affects earnings, and are
then reclassified to earnings in the same account as the hedged transaction. Gains/losses on net
investment hedges are accounted for through the currency translation account and are insignificant.
On an ongoing basis, the Company assesses whether each derivative continues to be highly effective
in offsetting changes in the cash flows of hedged items. If and when a derivative is no longer
expected to be highly effective, hedge accounting is discontinued. Hedge ineffectiveness, if any,
is included in current period earnings in other (income) and expense, net, and was insignificant
for the fiscal quarters ended April 4, 2010 and March 29, 2009. Refer to Note 7 for disclosures of
movements in Accumulated Other Comprehensive Income.
As of April 4, 2010, the balance of deferred net gains on derivatives included in accumulated other
comprehensive income was $160 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:*
(Dollars in Millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain/(Loss) |
|
Gain/(Loss) |
|
|
|
|
|
Gain/(Loss) |
|
|
recognized in |
|
reclassified from |
|
|
|
|
|
recognized in |
|
|
Accumulated |
|
Accumulated OCI |
|
|
|
|
|
other |
Cash Flow Hedges |
|
OCI(1) |
|
into income(1) |
|
|
|
|
|
income/expense(2) |
|
|
Fiscal |
|
Fiscal |
|
Fiscal |
|
Fiscal |
|
|
|
|
|
Fiscal |
|
Fiscal |
|
|
first |
|
year |
|
first |
|
first |
|
|
|
|
|
first |
|
first |
|
|
quarter |
|
end |
|
quarter |
|
quarter |
|
|
|
|
|
quarter |
|
quarter |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
|
|
|
2010 |
|
2009 |
Foreign exchange contracts |
|
$ |
(31 |
) |
|
$ |
(63 |
) |
|
$ |
(20 |
) |
|
$ |
5 |
|
|
|
(A) |
|
|
$ |
(1 |
) |
|
$ |
(2 |
) |
Foreign exchange contracts |
|
|
(104 |
) |
|
|
(173 |
) |
|
|
(22 |
) |
|
|
19 |
|
|
|
(B) |
|
|
|
(5 |
) |
|
|
5 |
|
Foreign exchange contracts |
|
|
29 |
|
|
|
5 |
|
|
|
1 |
|
|
|
10 |
|
|
|
(C) |
|
|
|
|
|
|
|
|
|
Cross currency interest rate swaps |
|
|
33 |
|
|
|
241 |
|
|
|
|
|
|
|
(6 |
) |
|
|
(D) |
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
46 |
|
|
|
28 |
|
|
|
(1 |
) |
|
|
(3 |
) |
|
|
(E) |
|
|
|
|
|
|
|
1 |
|
Total |
|
$ |
(27 |
) |
|
$ |
38 |
|
|
$ |
(42 |
) |
|
$ |
25 |
|
|
|
|
|
|
$ |
(6 |
) |
|
$ |
4 |
|
|
|
|
* |
|
All amounts shown in the table above are net of tax. |
10
|
|
|
(1) |
|
Effective portion |
|
(2) |
|
Ineffective portion |
|
(A) |
|
Included in Sales to customer |
|
(B) |
|
Included in Cost of products sold |
|
(C) |
|
Included in Research expense |
|
(D) |
|
Included in Interest (income)/Interest expense, net |
|
(E) |
|
Included in Other (income)/expense, net |
For the fiscal first quarters ended April 4, 2010 and March 29, 2009, a loss of $48 million and $6
million, respectively, was recognized in Other (income)/expense, net, relating to foreign exchange
contracts not designated as hedging instruments.
Fair value is the exit price that would be received to sell an asset or paid to transfer a
liability. Fair value is a market-based measurement that should be determined using assumptions
that market participants would use in pricing an asset or liability. The authoritative literature
establishes a three-level hierarchy to prioritize the inputs used in measuring fair value. The
levels within the hierarchy are described below with Level 1 having the highest priority and Level
3 having the lowest.
The fair value of a derivative financial instrument (i.e. forward exchange contract, currency swap)
is the aggregation by currency of all future cash flows discounted to its present value at the
prevailing market interest rates and subsequently converted to the U.S. dollar at the current spot
foreign exchange rate. The Company does not believe that fair values of these derivative
instruments materially differ from the amounts that could be realized upon settlement or maturity,
or that the changes in fair value will have a material effect on the Companys results of
operations, cash flows or financial position. The Company also holds equity investments which are
classified as Level 1 since they are traded in an active exchange market. The Company did not have
any other significant financial assets or liabilities which would require revised valuations under
this standard that are recognized at fair value.
The following three levels of inputs are used to measure fair value:
Level 1 Quoted prices in active markets for identical assets and liabilities.
Level 2 Significant other observable inputs
Level 3 Significant unobservable inputs
The Companys significant financial assets and liabilities measured at fair value as of April 4,
2010 and January 3, 2010 were as follows:
11
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
April 4, 2010 |
|
|
|
|
|
January 3, 2010 |
(Dollars in Millions) |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
|
Total(1) |
Derivatives designated as
hedging instruments : |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
$ |
360 |
|
|
|
|
|
|
|
360 |
|
|
|
436 |
|
Cross currency interest rate
swaps(2) |
|
|
|
|
|
|
15 |
|
|
|
|
|
|
|
15 |
|
|
|
126 |
|
Total |
|
|
|
|
|
|
375 |
|
|
|
|
|
|
|
375 |
|
|
|
562 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
475 |
|
|
|
|
|
|
|
475 |
|
|
|
608 |
|
Cross currency interest rate
swaps(3) |
|
|
|
|
|
|
509 |
|
|
|
|
|
|
|
509 |
|
|
|
571 |
|
Total |
|
|
|
|
|
|
984 |
|
|
|
|
|
|
|
984 |
|
|
|
1,179 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives not designated as
hedging instruments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
26 |
|
|
|
|
|
|
|
26 |
|
|
|
33 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts |
|
|
|
|
|
|
55 |
|
|
|
|
|
|
|
55 |
|
|
|
40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Investments(4) |
|
$ |
1,263 |
|
|
|
|
|
|
|
|
|
|
|
1,263 |
|
|
|
1,134 |
|
|
|
|
(1) |
|
As of January 3, 2010, these assets and liabilities are classified as Level 2 with the
exception of other investments of $1,134 which are classified as Level 1. |
|
(2) |
|
Includes $10 million and $119 million of non-current assets for April 4, 2010 and January 3,
2010, respectively. |
|
(3) |
|
Includes $483 million and $517 million of non-current liabilities for April 4, 2010 and January
3, 2010, respectively. |
|
(4) |
|
Classified as non-current 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 4, 2010:
|
|
|
|
|
|
|
|
|
|
|
Carrying |
|
Estimated |
(Dollars in Millions) |
|
Amount |
|
Fair Value |
Financial Assets |
|
|
|
|
|
|
|
|
Current Investments |
|
|
|
|
|
|
|
|
Cash |
|
$ |
2,320 |
|
|
|
2,320 |
|
|
Government securities
and obligations |
|
|
12,680 |
|
|
|
12,680 |
|
Corporate debt securities |
|
|
315 |
|
|
|
315 |
|
Money market funds |
|
|
1,785 |
|
|
|
1,785 |
|
Time deposits |
|
|
910 |
|
|
|
910 |
|
|
Total cash, cash
equivalents and current
marketable securities |
|
$ |
18,010 |
|
|
|
18,010 |
|
12
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 |
|
$ |
4,044 |
|
|
|
4,044 |
|
Non-Current Debt |
|
|
|
|
|
|
|
|
5.15% Debentures due 2012 |
|
|
599 |
|
|
|
655 |
|
3.80% Debentures due 2013 |
|
|
500 |
|
|
|
532 |
|
5.55% Debentures due 2017 |
|
|
1,000 |
|
|
|
1,134 |
|
5.15% Debentures due 2018 |
|
|
898 |
|
|
|
975 |
|
4.75% Notes due 2019 (1B
Euro 1.349) |
|
|
1,340 |
|
|
|
1,477 |
|
3% Zero Coupon Convertible Subordinated
Debentures due in 2020 |
|
|
190 |
|
|
|
244 |
|
6.73% Debentures due 2023 |
|
|
250 |
|
|
|
306 |
|
5.50% Notes due 2024
(500 GBP 1.5237) |
|
|
755 |
|
|
|
792 |
|
6.95% Notes due 2029 |
|
|
294 |
|
|
|
357 |
|
4.95% Debentures due 2033 |
|
|
500 |
|
|
|
496 |
|
5.95% Notes due 2037 |
|
|
995 |
|
|
|
1,077 |
|
5.86% Debentures due 2038 |
|
|
700 |
|
|
|
747 |
|
Other (Includes
Industrial Revenue Bonds) |
|
|
38 |
|
|
|
38 |
|
Total Non-Current Debt |
|
$ |
8,059 |
|
|
$ |
8,830 |
|
The weighted average effective rate on non-current debt is 5.43%.
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 2010 and 2009 were 27.9%
and 24.5%, respectively. The higher effective tax rate was due to the net litigation gain of $1.5
billion recorded in the fiscal first quarter of 2010, which was recorded at 39.0% tax rate and
resulted in an additional 3.5 percentage points added to the worldwide effective income tax rate.
13
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 2010 and 2009 include the following components:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Retirement Plans |
|
Other Benefit Plans |
|
|
Fiscal Quarters Ended |
|
|
April 4, |
|
March 29, |
|
April 4, |
|
March 29, |
(Dollars in Millions) |
|
2010 |
|
2009 |
|
2010 |
|
2009 |
Service cost |
|
$ |
126 |
|
|
|
118 |
|
|
|
34 |
|
|
|
34 |
|
Interest cost |
|
|
200 |
|
|
|
185 |
|
|
|
50 |
|
|
|
43 |
|
Expected return on
plan assets |
|
|
(252 |
) |
|
|
(228 |
) |
|
|
|
|
|
|
(1 |
) |
Amortization of prior
service cost |
|
|
3 |
|
|
|
2 |
|
|
|
(1 |
) |
|
|
(1 |
) |
Recognized actuarial
losses |
|
|
58 |
|
|
|
41 |
|
|
|
12 |
|
|
|
14 |
|
|
Net periodic benefit cost |
|
$ |
135 |
|
|
|
118 |
|
|
|
95 |
|
|
|
89 |
|
Company Contributions
For the fiscal three months ended April 4, 2010, the Company contributed $508 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.
NOTE 7 ACCUMULATED OTHER COMPREHENSIVE INCOME
Total comprehensive income for the fiscal first quarter ended April 4, 2010 was $3.7 billion,
compared with $3.3 billion for the same period a year ago. Total comprehensive income included net
earnings, net unrealized currency gains and losses on translation, adjustments related to Employee
Benefit Plans, net unrealized gains and losses on securities available for sale and net gains and
losses on derivative instruments qualifying and designated as cash flow hedges. The following table
sets forth the components of accumulated other comprehensive income.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
For. |
|
|
|
|
|
|
|
|
|
Gains/ |
|
Accum |
|
|
Cur. |
|
Gains/ |
|
Employee |
|
(Losses) |
|
Other Comp. |
|
|
Trans. |
|
(Losses) |
|
Benefit |
|
on Deriv. |
|
Inc/ |
(Dollars in Millions) |
|
(Loss) |
|
on Sec. |
|
Plans |
|
& Hedges |
|
(Loss) |
January 3, 2010 |
|
$ |
(508 |
) |
|
|
(30 |
) |
|
|
(2,665 |
) |
|
|
145 |
|
|
|
(3,058 |
) |
2010 three months change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) |
|
|
|
|
|
|
104 |
|
|
|
|
|
|
|
(27 |
) |
|
|
|
|
Net amount reclassed to
net earnings |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
42 |
* |
|
|
|
|
Net three months change |
|
|
(945 |
) |
|
|
104 |
|
|
|
47 |
|
|
|
15 |
|
|
|
(779 |
) |
April 4, 2010 |
|
$ |
(1,453 |
) |
|
|
74 |
|
|
|
(2,618 |
) |
|
|
160 |
|
|
|
(3,837 |
) |
14
|
|
|
* |
|
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 4, 2010 and March 29, 2009.
|
|
|
|
|
|
|
|
|
|
|
Fiscal Quarters Ended |
|
|
April 4, |
|
March 29, |
(Shares in Millions) |
|
2010 |
|
2009 |
Basic net earnings per share |
|
$ |
1.64 |
|
|
$ |
1.27 |
|
Average shares outstanding basic |
|
|
2,755.4 |
|
|
|
2,765.9 |
|
Potential shares exercisable under stock
option plans |
|
|
193.4 |
|
|
|
109.8 |
|
Less: shares which could be repurchased under
treasury stock method |
|
|
(155.1 |
) |
|
|
(89.5 |
) |
Convertible debt shares |
|
|
3.6 |
|
|
|
3.6 |
|
Average shares outstanding diluted |
|
|
2,797.3 |
|
|
|
2,789.8 |
|
Diluted earnings per share |
|
$ |
1.62 |
|
|
$ |
1.26 |
|
The diluted earnings per share calculation for both fiscal first quarters ended April 4, 2010 and
March 29, 2009 included the dilutive effect of convertible debt that was offset by the related
reduction in interest expense.
The diluted earnings per share calculation for the fiscal first quarters ended April 4, 2010 and
March 29, 2009 excluded 55 million and 153 million shares related to stock options, as the exercise
price of these options was greater than their average market value, which would result in an
anti-dilutive effect on diluted earnings per share.
NOTE 9 SEGMENTS OF BUSINESS AND GEOGRAPHIC AREAS
(Dollars in Millions)
SALES BY SEGMENT OF BUSINESS (1)
15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Quarters Ended |
|
|
April 4, |
|
March 29, |
|
Percent |
(Dollars in Millions) |
|
2010 |
|
2009 |
|
Change |
Consumer |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
$ |
1,560 |
|
|
$ |
1,726 |
|
|
|
(9.6 |
)% |
International |
|
|
2,206 |
|
|
|
1,985 |
|
|
|
11.1 |
|
Total |
|
|
3,766 |
|
|
|
3,711 |
|
|
|
1.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceutical |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
3,206 |
|
|
|
3,674 |
|
|
|
(12.7 |
) |
International |
|
|
2,432 |
|
|
|
2,106 |
|
|
|
15.5 |
|
Total |
|
|
5,638 |
|
|
|
5,780 |
|
|
|
(2.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Medical Devices &
Diagnostics |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
2,886 |
|
|
|
2,652 |
|
|
|
8.8 |
|
International |
|
|
3,341 |
|
|
|
2,883 |
|
|
|
15.9 |
|
Total |
|
|
6,227 |
|
|
|
5,535 |
|
|
|
12.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Worldwide |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
7,652 |
|
|
|
8,052 |
|
|
|
(5.0 |
) |
International |
|
|
7,979 |
|
|
|
6,974 |
|
|
|
14.4 |
|
Total |
|
$ |
15,631 |
|
|
$ |
15,026 |
|
|
|
4.0 |
% |
|
|
|
(1) |
|
Export sales are not significant. |
OPERATING PROFIT BY SEGMENT OF BUSINESS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Quarters Ended |
|
|
April 4, |
|
March 29, |
|
Percent |
(Dollars in Millions) |
|
2010 |
|
2009 |
|
Change |
Consumer |
|
$ |
785 |
|
|
$ |
800 |
|
|
|
(1.9 |
)% |
Pharmaceutical |
|
|
1,970 |
|
|
|
2,257 |
|
|
|
(12.7 |
) |
Medical Devices
& Diagnostics |
|
|
3,702 |
|
|
|
1,787 |
|
|
|
107.2 |
|
Segments total |
|
|
6,457 |
|
|
|
4,844 |
|
|
|
33.3 |
|
Expense not allocated to segments (2) |
|
|
(177 |
) |
|
|
(201 |
) |
|
|
|
|
Worldwide total |
|
$ |
6,280 |
|
|
$ |
4,643 |
|
|
|
35.3 |
% |
|
|
|
(2) |
|
Amounts not allocated to segments include interest income/(expense) , non-controlling interests
and general corporate income/(expense). |
SALES BY GEOGRAPHIC AREA
(Dollars in Millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Quarters Ended |
|
|
April 4, |
|
March 29, |
|
Percent |
(Dollars in Millions) |
|
2010 |
|
2009 |
|
Change |
U.S. |
|
$ |
7,652 |
|
|
$ |
8,052 |
|
|
|
(5.0 |
)% |
Europe |
|
|
4,102 |
|
|
|
3,671 |
|
|
|
11.7 |
|
Western Hemisphere, excluding U.S. |
|
|
1,280 |
|
|
|
1,062 |
|
|
|
20.5 |
|
Asia-Pacific, Africa |
|
|
2,597 |
|
|
|
2,241 |
|
|
|
15.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
15,631 |
|
|
$ |
15,026 |
|
|
|
4.0 |
% |
NOTE 10 BUSINESS COMBINATIONS AND DIVESTITURES
During the fiscal first quarter of 2010, the Company acquired Acclarent, Inc., a medical technology
company dedicated to
16
designing, developing and commercializing devices that address conditions
affecting the ear, nose and throat, for a net purchase price of $0.8 billion. The purchase price
for the acquisition was
allocated primarily to amortizable intangible assets for $0.7 billion.
During the fiscal first quarter of 2009, the Company acquired Mentor Corporation, a leading
supplier of medical products for the global aesthetic market, for a net purchase price of $1.1
billion. The purchase price for the acquisition was allocated primarily to amortizable intangible
assets for $0.9 billion and goodwill for $0.4 billion.
NOTE 11 LEGAL PROCEEDINGS
PRODUCT LIABILITY
The Companys subsidiaries are involved in numerous product liability cases in the United States,
many of which concern alleged adverse reactions to drugs and medical devices. The damages claimed
are substantial, and while the Company is confident of the adequacy of the warnings and
instructions for use that accompany such products, it is not feasible to predict the ultimate
outcome of litigation. However, the Company believes that if any product liability results from
such cases, it will be substantially covered by existing amounts accrued in the Companys balance
sheet and, where available, by third-party product liability insurance.
Multiple products of Johnson & Johnson subsidiaries are subject to numerous product liability
claims and lawsuits. There are a significant number of claimants who have pending lawsuits or
claims regarding injuries allegedly due to ORTHO EVRA®, RISPERDAL®, LEVAQUIN®, DURAGESIC®, the
CHARITÉ Artificial Disc and CYPHER® Stent. These claimants seek substantial compensatory and,
where available, punitive damages.
With respect to RISPERDAL®, the Attorneys General of seven states and the Office of General
Counsel of the Commonwealth of Pennsylvania have filed actions seeking reimbursement of Medicaid or
other public funds for RISPERDAL® prescriptions written for off-label use, compensation for
treating their citizens for alleged adverse reactions to RISPERDAL®, civil fines or penalties,
punitive damages, or other relief. The Attorney General of Texas has joined a qui tam action in
that state seeking similar relief. Certain of these actions also seek injunctive relief relating to
the promotion of RISPERDAL®. The Attorneys General of more than 40 other states have indicated a
potential interest in pursuing similar litigation against the Companys subsidiary, Janssen
Pharmaceutica Inc. (Janssen) (now Ortho-McNeil-Janssen Pharmaceuticals Inc. (OMJPI)), and have
obtained a tolling agreement staying the running of the statute of limitations while they inquire
into the issues. In addition, there are six cases filed by union health plans seeking damages for
alleged overpayments for RISPERDAL®, several of which seek certification as class actions. In the
case brought by the Attorney General of West Virginia, based on claims for alleged consumer fraud
as to
17
DURAGESIC® as well as RISPERDAL®, Janssen (now OMJPI) was found liable and damages were
assessed at $4.5 million. OMJPI has filed an appeal.
PATENT LITIGATION
The products of various Johnson & Johnson subsidiaries are the subject of various patent lawsuits,
the outcomes of which could potentially adversely affect the ability of those subsidiaries to sell
those products, or require the payment of past damages and future royalties.
On January 29, 2010, Cordis Corporation (Cordis) settled a patent infringement action against
Boston Scientific Corporation (Boston Scientific) in Delaware Federal District Court accusing its
Express2, Taxus® and Liberte® stents of infringing the Palmaz and Gray patents. Under the terms of
the settlement Boston Scientific dropped its lawsuit in which Cordis Cypher stent was found to
have infringed their Jang patent and paid Cordis $1.0 billion on February 1, 2010. Boston
Scientific will also pay Cordis an additional $725 million plus interest on January 3, 2011. The
Company recorded the $1.7 billion in the fiscal first quarter of 2010. Cordis granted Boston
Scientific a worldwide license under the Palmaz and Gray patents and Boston Scientific granted
Cordis a worldwide license under the Jang patents for all stents sold by Cordis except the 2.25mm
size Cypher.
Cordis has several pending lawsuits in New Jersey and Delaware Federal District Court against
Guidant Corporation (Guidant), Abbott Laboratories, Inc. (Abbott), Boston Scientific and Medtronic
Ave, Inc. (Medtronic) alleging that the Xience V (Abbott), Promus (Boston Scientific) and
Endeavor® (Medtronic) drug eluting stents infringe several patents owned by or licensed to Cordis.
In one of the cases against Boston Scientific, alleging that sales of their Promus stent infringed
Wright and Falotico patents, on January 20, 2010 the District Court in Delaware found the
Wright/Falotico patent invalid for lack of written description and/or lack of enablement. Cordis
has appealed this ruling.
In May 2008, Centocor, Inc. (Centocor) (now Centocor Ortho Biotech Inc. (COBI)) filed a
lawsuit against Genentech, Inc. (Genentech) in U.S. District Court for the Central District of
California seeking to invalidate the Cabilly II patent. Prior to filing suit, Centocor had a
sublicense under this patent from Celltech (who was licensed by Genentech) for REMICADE® and had
been paying royalties to Celltech. Centocor has terminated that sublicense and stopped paying
royalties. Genentech has filed a counterclaim alleging that REMICADE® infringes its Cabilly II
patents. Genentech has dropped all its other claims that the manufacture of REMICADE®, STELARA,
SIMPONI and ReoPro® also infringes one of its other patents relating to the purification of
antibodies made through recombinant DNA techniques. The court has scheduled a hearing for Summary
Judgment Motions in August 2010.
In April 2009, a bench trial was held before the Federal District Court for the Middle
District of Florida on the liability phase of CIBA VISION Corporations (CIBA) patent infringement
lawsuit alleging that Johnson & Johnson Vision Care, Inc.s (JJVC) ACUVUE® OASYS lenses infringe
three of their Nicholson patents. In August 2009, the District Court found two of these
18
patents
valid and infringed and entered judgment against JJVC. JJVC has appealed that judgment to the Court
of Appeals for the Federal Circuit. On March 22, 2010, the District Court held a hearing on
CIBAs motion for a permanent injunction, and on April 27, 2010, denied the motion for an
injunction. If the judgment is upheld on appeal the Court will schedule another trial to determine
damages and willfulness.
In May 2009, Abbott Biotechnology Ltd. (Abbott) filed a patent infringement lawsuit against
Centocor (now COBI) in the United States District Court for the District of Massachusetts. The suit
alleges that Centocors SIMPONI product, a human anti-TNF alpha antibody, infringes Abbotts 394
patent (the Salfeld patent). The case has been stayed pending the resolution of an arbitration
filed by Centocor directed to its claim that it is licensed under the 394 patent. The arbitration
is scheduled for May 2010.
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. The suit alleges that COBIs STELARA product infringes two U.S. patents
assigned to Abbott GmbH. In August 2009, COBI filed a complaint for a declaratory judgment of
non-infringement and invalidity of the Abbott GmbH patents in the United States District Court for
the District of Columbia. On the same date, also in the United States District Court for the
District of Columbia, COBI filed a Complaint for Review of a Patent Interference Decision granting
priority of invention on one of the two asserted patents to Abbott GmbH. In August 2009, Abbott
GmbH and Abbott Laboratories Limited brought a patent infringement suit in Canada alleging that
STELARA infringes Abbott GmbHs Canadian patent. The cases filed by COBI in the District of
Columbia have been transferred to the District of Massachusetts.
In August 2009, Bayer Healthcare LLC (Bayer) filed suit against COBI in Massachusetts District
Court alleging infringement by COBIs SIMPONI product of its patent relating to human anti-TNF
antibodies. Bayer has also filed suit under its European counterpart to these patents in Germany
and the Netherlands.
In June 2009, Centocors (now COBI) lawsuit alleging that Abbotts HUMIRA® anti-TNF alpha
product infringes Centocors 775 patent went to trial in Federal District Court in the Eastern
District of Texas. On June 28, 2009 a jury returned a verdict finding the patent valid and
willfully infringed, and awarded Centocor damages of approximately $1.7 billion. A bench trial on
Abbotts defenses, of inequitable conduct and prosecution laches, was held in August 2009, and the
District Court decided these issues in favor of Centocor. All of Abbotts post trial motions have
been denied except that the District Court granted Abbotts motion to overturn the jury finding of
willfulness. Judgment in the amount of $1.9 billion was entered in favor of Centocor in December
2009 and Abbott has filed an appeal to the Court of Appeals for the Federal Circuit therefore, the
Company has not reflected any of the $1.9 billion in its consolidated financial statements.
Centocor has also filed a new lawsuit in the Eastern District of Texas seeking damages for
infringement of the 775 patent attributable to sales of HUMIRA® subsequent to the jury verdict in
June 2009.
19
The following chart summarizes various patent lawsuits concerning products of the Companys
subsidiaries that have yet to proceed to trial:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Plaintiff/ |
|
|
|
Trial |
|
Date |
J&J Product |
|
Company |
|
Patents |
|
Patent Holder |
|
Court |
|
Date** |
|
Filed |
CYPHER® Stent |
|
Cordis |
|
Wall |
|
Wall |
|
E.D. TX |
|
Q2/11 |
|
11/07 |
CYPHER® Stent |
|
Cordis |
|
Saffran |
|
Saffran |
|
E.D. TX |
|
Q2/11 |
|
10/07 |
Blood Glucose Meters and
Strips |
|
LifeScan |
|
Wilsey |
|
Roche Diagnostics |
|
D. DE |
|
* |
|
11/07 |
REMICADE®, ustekinumab,
golimumab, ReoPro® |
|
Centocor/COBI |
|
Cabilly II |
|
Genentech |
|
C.D. CA |
|
* |
|
05/08 |
SIMPONI |
|
Centocor/COBI |
|
Salfeld |
|
Abbott Laboratories |
|
MA |
|
* |
|
05/09 |
SIMPONI |
|
Centocor/COBI |
|
Boyle |
|
Bayer Healthcare |
|
MA |
|
* |
|
08/09 |
STELARA |
|
Centocor/COBI |
|
Salfeld |
|
Abbott GmbH |
|
MA |
|
* |
|
08/09 |
|
|
|
* |
|
Trial date to be scheduled. |
|
** |
|
Q reflects the Companys fiscal quarter. |
LITIGATION AGAINST FILERS OF ABBREVIATED NEW DRUG APPLICATIONS (ANDAs)
The following chart indicates lawsuits pending against generic firms that filed Abbreviated New
Drug Applications (ANDAs) seeking to market generic forms of products sold by various subsidiaries
of the Company prior to expiration of the applicable patents covering those products. These ANDAs
typically include allegations of non-infringement, invalidity and unenforceability of these
patents. In the event the subsidiary of the Company involved is not successful in these actions, or
the statutory 30-month stay expires before a ruling from the district court is obtained, the firms
involved will have the ability, upon FDA approval, to introduce generic versions of the product at
issue resulting in very substantial market share and revenue losses for the product of the
Companys subsidiary.
As noted in the following chart, 30-month stays expired during 2009, and will expire in 2010,
2011 and 2012 with respect to ANDA challenges regarding various products:
20
|
|
|
|
|
|
|
|
|
|
|
|
|
Brand Name |
|
Patent/NDA |
|
Generic |
|
|
|
Trial |
|
Date |
|
30-Month |
Product |
|
Holder |
|
Challenger |
|
Court |
|
Date** |
|
Filed |
|
Stay Expiration |
CONCERTA® 18, 27, 36 and 54 mg controlled release tablet |
|
McNeil-PPC
ALZA |
|
Andrx |
|
D. DE |
|
Q4/07 |
|
09/05 |
|
None |
|
|
KUDCO |
|
D. DE |
|
* |
|
01/10 |
|
05/12 |
LEVAQUIN® 250, 500, 750 mg tablet |
|
Ortho-McNeil |
|
Lupin |
|
D. NJ |
|
* |
|
10/06 |
|
03/09 |
ORTHO TRI-CYCLEN® LO 0.18 mg/0.025 mg, 0.215 mg/0.025 mg and 0.25 mg/0.025 mg |
|
Ortho-McNeil |
|
Watson Sandoz |
|
D. NJ
D. NJ |
|
*
* |
|
10/08
06/09 |
|
03/11
10/11 |
|
|
|
|
Lupin |
|
D. NJ |
|
* |
|
|
|
06/12 |
ULTRAM ER® 100, 200, 300 mg tablet |
|
Ortho-McNeil/Biovail |
|
Par |
|
D. DE |
|
Q2/09 |
|
05/07 |
|
09/09 |
|
|
|
|
|
|
|
|
|
|
06/07 |
|
11/09 |
|
|
|
|
|
|
|
|
|
|
10/07 |
|
03/10 |
ULTRAM ER® 100, 200, 300 mg tablet |
|
Ortho-McNeil/Biovail |
|
Impax |
|
D. DE |
|
Q2/10 |
|
08/08 |
|
01/11 |
|
|
|
|
|
|
|
|
|
|
11/08 |
|
03/11 |
ULTRAM ER® 100, 200, 300 mg tablet |
|
Ortho-McNeil/Biovail |
|
Paddock |
|
D.DRD. Minn. |
|
* |
|
09/09 |
|
01/12 |
ULTRAM ER® 100, 200, 300 mg tablet |
|
Ortho-McNeil/Biovail |
|
Cipher |
|
D. DE |
|
* |
|
10/09 |
|
03/12 |
ULTRAM ER® 100, 200, 300 mg tablet |
|
Ortho-McNeil/Biovail |
|
Lupin |
|
D. DE |
|
* |
|
01/10 |
|
06/12 |
|
|
|
* |
|
Trial date to be scheduled. |
|
** |
|
Q reflects the Companys fiscal quarter. |
In October 2008, the Companys subsidiary Ortho-McNeil-Janssen Pharmaceuticals, Inc.
(OMJPI) filed suit in Federal District Court in New Jersey against Watson Laboratories, Inc.
(Watson) in response to Watsons ANDA regarding ORTHO TRI-CYCLEN® LO. In June 2009, OMJPI filed
suit in Federal District Court in New Jersey against Sandoz Laboratories, Inc. (Sandoz) in response
to Sandozs ANDA regarding ORTHO TRI-CYCLEN® LO. The Sandoz and Watson cases have been
consolidated.
In January 2010, the Companys subsidiary OMJPI filed suit in Federal District Court in New
Jersey against Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively Lupin) in response to
Lupins ANDA regarding ORTHO TRI-CYCLEN® LO.
In the action by McNEIL-PPC, Inc. (McNeil-PPC) and ALZA Corporation (ALZA) against Andrx
Corporation (Andrx) with respect to its ANDA challenge to the CONCERTA® patents, a five-day
non-jury trial was held in the Federal District Court in Delaware in December 2007. In March 2009,
the court ruled that one CONCERTA® patent would not be infringed by Andrxs proposed generic
product and that the patent was invalid because it was not enabled. The court dismissed without
prejudice Andrxs declaratory judgment suit on a second patent for lack of jurisdiction. McNeil-PPC
and ALZA filed an appeal in May 2009. The appeals court heard argument on February 3, 2010. On
April 26, 2010, the court of appeals affirmed the judgment of the district court that the patent is
invalid because it is not enabled. The court did not reach the issue of infringement.
21
ALZA and OMJPI filed a second suit in Federal District Court in Delaware against
Kremers-Urban, LLC and KUDCO Ireland, Ltd. (KUDCO) in January 2010 in response to KUDCOs ANDA
challenge regarding CONCERTA® tablets. In its notice letter, KUDCO contends that two ALZA patents
for CONCERTA® are invalid and not infringed by a KUDCO generic.
In the action against Lupin Pharmaceuticals, Inc. (Lupin) regarding its ANDA concerning
LEVAQUIN®, Lupin contends that the U.S. Patent and Trademark Office improperly granted a patent
term extension to the patent that Ortho-McNeil (now Ortho-McNeil-Janssen Pharmaceuticals, Inc.
(OMJPI)) licenses from Daiichi Pharmaceuticals, Inc. (Daiichi). Lupin alleges that the active
ingredient in LEVAQUIN® was the subject of prior marketing, and therefore was not eligible for the
patent term extension. Lupin concedes validity and that its product would violate the patent if
marketed prior to the expiration of the original patent term. Summary judgment against Lupin was
granted in May 2009 and Lupin appealed. Oral argument was held in September 2009. A decision is
pending.
In the ULTRAM® ER actions, Ortho-McNeil Pharmaceutical, Inc. (Ortho-McNeil) (now OMJPI), filed
lawsuits (each for different dosages) against Par Pharmaceuticals, Inc. and Par Pharmaceuticals
Companies, Inc. (Par) in May, June and October 2007 on two Tramadol ER formulation patents owned by
Purdue Pharma Products L.P. (Purdue) and Napp Pharmaceutical Group Ltd. (Napp). OMJPI also filed
lawsuits (each for different dosages) against Impax Laboratories, Inc. (Impax) on a Tramadol ER
formulation patent owned by Purdue and Napp in August and November 2008. Purdue, Napp and Biovail
Laboratories International SRL (Biovail) (the NDA holder) joined as co-plaintiffs in the lawsuits
against Par and Impax, but Biovail and OMJPI were subsequently dismissed for lack of standing. The
trial against Par took place in April 2009. In August 2009, the Court issued a decision finding the
patents-in-suit invalid. Purdue has appealed that decision. The trial against Impax is scheduled
for June 2010. In November 2009, the case against Impax was stayed with the consent of all parties.
In September and October 2009, respectively, Purdue filed suits against Paddock Laboratories, Inc.
(Paddock) and Cipher Pharmaceuticals Inc. (Cipher) on its Tramadol ER formulation patents.
In January 2010, Purdue filed a suit against Lupin Ltd. (Lupin) on its Tramadol ER formulation
patents.
GENERAL LITIGATION
In September 2004, plaintiffs in an employment discrimination litigation initiated against the
Company in 2001 in Federal District Court in New Jersey moved to certify a class of all African
American and Hispanic salaried employees of the Company and its affiliates in the U.S., who were
employed at any time from November 1997 to the present. Plaintiffs seek monetary damages for the
period 1997 through the present (including punitive damages) and equitable relief. The Court denied
plaintiffs class certification motion in December 2006 and their motion for reconsideration in
April 2007. Plaintiffs sought to appeal these
22
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 is opposing.
The parties are engaged in expert discovery and briefing. The hearing on plaintiffs motion for
class certification is scheduled for July 2010.
In September 2009, Centocor Ortho Biotech Products, L.P. (COBI, LP) intervened in an
inventorship dispute between Kansas University Center for Research (KUCR) involving certain U.S.
government-owned VELCADE® formulation patents. KUCR brought this action against the U.S. government
in the District of Kansas seeking to add two Kansas University scientists to the patents. The U.S.
government licensed the patents (and their foreign counterparts) to Millennium Pharmaceuticals,
Inc., who in turn sublicensed the patents (and their foreign counterparts) to COBI, LP for
commercial marketing outside the U.S. If KUCR succeeds in its co-inventorship claim and establishes
co-ownership in the U.S. VELCADE® formulation patents, we anticipate that KUCR will
initiate actions to establish co-inventorship and co-ownership with respect to the foreign
counterpart patents in the countries where COBI, LP has commercial marketing rights. If KUCR in
Kansas is successful, this may adversely affect COBI, LPs license rights in those countries.
In February 2009, Basilea Pharmaceutica AG (Basilea) brought an arbitration against the
Company and various affiliates alleging that the Company breached the 2005 License Agreement for
Cefto-biprole by, among other things, failing to secure FDA approval of the cSSSI (skin) indication
and allegedly failing to properly develop the pneumonia indication. Basilea is seeking to recover
damages and a declaration that the Company materially breached the agreement. This matter has been
scheduled for an arbitration hearing commencing in June 2010 followed by post-trial submissions.
In May 2009, COBI commenced an arbitration proceeding before the American Arbitration
Association against Schering-Plough Corporation and its subsidiary Schering-Plough (Ireland)
Company (collectively, Schering-Plough). COBI and Schering-Plough are parties to a series of
agreements (the Distribution Agreements) that grant Schering-Plough the exclusive right to
distribute the drugs REMICADE® and SIMPONI worldwide, except within the United States, Japan,
Taiwan, Indonesia, and the Peoples Republic of China (including Hong Kong) (the Territory). COBI
distributes REMICADE® and SIMPONI, the next generation treatment, within the United States. In the
arbitration, COBI seeks a declaration that the agreement and merger between Merck & Co., Inc.
(Merck) and Schering-Plough constitutes a change of control under the terms of the Distribution
Agreements that permits COBI to terminate the Agreements. The termination of the Distribution
Agreements would return to COBI the right to distribute REMICADE® and SIMPONI within the
Territory. Schering-Plough has filed a response to COBIs arbitration demand that denies that it
has undergone a change of control. The arbitrators have been selected and the matter will be
proceeding to arbitration in late September 2010.
23
In December 2009, the State of Israel (Sheba Medical Center) filed a lawsuit against three
Omrix entities. 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 he developed while he
was a government employee. The State claims that he had no right to transfer any intellectual
property to Omrix because it belongs to the State. The State is seeking damages plus royalty on
QUIXIL and EVICEL or, alternatively, transfer of the patents to the State.
Average Wholesale Price (AWP) Litigation Johnson & Johnson and several of its pharmaceutical
subsidiaries, along with numerous other pharmaceutical companies, are defendants in a series of
lawsuits in state and federal courts involving allegations that the pricing and marketing of
certain pharmaceutical products amounted to fraudulent and otherwise actionable conduct because,
among other things, the companies allegedly reported an inflated Average Wholesale Price (AWP) for
the drugs at issue. Many of these cases, both federal actions and state actions removed to federal
court, have been consolidated for pre-trial purposes in a
Multi-District Litigation (MDL) in Federal District Court in Boston, Massachusetts. The plaintiffs
in these cases include classes of private persons or entities that paid for any portion of the
purchase of the drugs at issue based on AWP, and state government entities that made Medicaid
payments for the drugs at issue based on AWP.
The MDL Court identified classes of Massachusetts-only private insurers providing Medi-gap
insurance coverage and private payers for physician-administered drugs where payments were based on
AWP (Class 2 and Class 3), and a national class of individuals who made co-payments for
physician-administered drugs covered by Medicare (Class 1). A trial of the two Massachusetts-only
class actions concluded before the MDL Court in December 2006. In June 2007, the MDL Court issued
post-trial rulings, dismissing the Johnson & Johnson defendants from the case regarding all claims
of Classes 2 and 3, and subsequently of Class 1 as well. Plaintiffs appealed the Class 1 judgment
and, in September 2009, the Court of Appeals vacated the judgment and remanded for further
proceedings in the District Court. AWP cases brought by various Attorneys General have proceeded to
trial against other manufacturers. One state case against certain of the Companys subsidiaries has
been set for trial in late 2010, and other state cases are likely to be set for trial thereafter.
On April 2, 2010, a lawsuit was filed in the United States District Court for the Northern
District of California. The complaint alleges that the company, together with co-defendant
Omnicare, Inc. and other unidentified companies or individuals, engaged in a conspiracy to restrain
trade and in unlawful, unfair and fraudulent business acts or practices in violation of California
Business and Professions Code. The Companys answer or other pleading in response to the complaint
is due on June 30, 2010.
On April 21, 2010, a lawsuit was filed in the United States District Court for the District of
New Jersey on behalf of a
24
Company shareholder, seeking to sue certain Company directors, officers, and employees
derivatively on behalf of the Company. The shareholder derivative complaint alleges that the
defendants breached their fiduciary duties to the Company, in that they allegedly declined to stop
or prevent what are described as kickback charges, violations of the False Claims Act, off-label
drug promotion, failure to warn and cGMP (current Good Manufacturing Practices) violations in
connection with the recall of over-the-counter (OTC) products.
On May 5, 2010, a lawsuit was filed in the United States District Court for the District of
New Jersey on behalf of a Company shareholder, seeking to sue certain current and former Company
directors and officers derivatively on behalf of the Company. The shareholder derivative complaint
alleges that the defendants breached their fiduciary duties to the Company, wasted Company assets,
unjustly enriched themselves, and caused the Company to issue allegedly inaccurate and incomplete
proxy statements, in that they allegedly declined to stop or prevent what are described as kickback
schemes, violations of the False Claims Act, and off-label drug promotion, and failed to inform
Company shareholders of the alleged wrongdoing or the extent of the liabilities allegedly facing
the Company as a result.
On May 6, 2010, a lawsuit was filed in the United States District Court for the District of
New Jersey on behalf of a Company shareholder, seeking to sue certain current Company directors and
officers derivatively on behalf of the Company. The shareholder derivative complaint alleges that
the defendants breached their fiduciary duties to the Company and wasted corporate assets, in that
they allegedly declined to stop or prevent what are described as violations of current Good
Manufacturing Practices and FDA regulations, which allegedly resulted in certain product recalls.
OTHER
In July 2003, Centocor (now COBI), a Johnson & Johnson subsidiary, received a request that it
voluntarily provide documents and information to the criminal division of the U.S. Attorneys
Office, District of New Jersey, in connection with its investigation into various Centocor
marketing practices. Subsequent requests for documents have been received from the U.S. Attorneys
Office. Both the Company and Centocor have responded to these requests for documents and
information.
In December 2003, Ortho-McNeil (now OMJPI) received a subpoena from the U.S. Attorneys
Office in Boston, Massachusetts seeking documents relating to the marketing, including alleged
off-label marketing, of the drug TOPAMAX® (topiramate). In the fiscal second quarter of 2010, OMJPI
entered into a settlement agreement resolving the federal governments investigation. The
settlement includes total payments of $81.5 million plus interest, an amount previously reserved.
As one part of the resolution, Ortho-McNeil Pharmaceutical, L.L.C., a subsidiary of OMJPI, has
agreed to plead guilty to a single misdemeanor violation of the Food, Drug and Cosmetic Act and to
pay a $6.1 million criminal
25
fine. OMJPI denies it engaged in any wrongful conduct, beyond acknowledging the limited conduct of
Ortho-McNeil Pharmaceutical, L.L.C. that is the basis of the misdemeanor plea. The balance of the
total settlement amount is a civil payment, part of which will be paid to the federal government
and part of which will be made available to states for their Medicaid programs.
In January 2004, Janssen (now OMJPI) received a subpoena from the Office of the Inspector
General of the U.S. Office of Personnel Management seeking documents concerning sales and marketing
of, any and all payments to physicians in connection with sales and marketing of, and clinical
trials for, RISPERDAL® (risperidone) from 1997 to 2002. Documents subsequent to 2002 have also been
requested. An additional subpoena seeking information about marketing of and adverse reactions to
RISPERDAL® was received from the U.S. Attorneys Office for the Eastern District of Pennsylvania in
November 2005. Subpoenas seeking testimony from various witnesses before a grand jury have also
been received. Janssen is cooperating in responding to ongoing requests for documents and
witnesses. The government is continuing to actively investigate this matter. In February 2010, the
government served Civil Investigative Demands seeking additional information relating to sales and
marketing of RISPERDAL® and sales and marketing of INVEGA®.
In September 2004, Ortho Biotech Inc. (Ortho Biotech) (now COBI), received a subpoena from the
U.S. Office of Inspector Generals Denver, Colorado field office seeking documents directed to the
sales and marketing of PROCRIT® (Epoetin alfa) from 1997 to the present, as well as to dealings
with U.S. Oncology Inc., a healthcare services network for oncologists. Ortho Biotech (now COBI)
has responded to the subpoena.
In November 2007, the Attorney General of the Commonwealth of Massachusetts issued a Civil
Investigative Demand to DePuy seeking information regarding financial relationships between a
number of Massachusetts-based orthopedic surgeons and providers and DePuy. DePuy is responding to
Massachusetts additional requests.
In July 2005, Scios Inc. (Scios), a Johnson & Johnson subsidiary, received a subpoena from the
U.S. Attorneys Office, District of Massachusetts, seeking documents related to the sales and
marketing of NATRECOR®. Scios responded to the subpoena. In early August 2005, Scios was advised
that the investigation would be handled by the U.S. Attorneys Office for the Northern District of
California in San Francisco. Additional requests for documents have been received and responded to
and former Scios employees have testified before a grand jury in San Francisco. The qui tam
complaints were unsealed on February 19, 2009. The U.S. government has intervened in one of the qui
tam actions, and filed a complaint against Scios and the Company in June 2009. Scios and Johnson &
Johnson have filed a motion to dismiss the qui tam complaint filed by the government, and that
motion was denied. The criminal investigation is continuing and discussions are underway in an
effort to settle this matter. Whether a settlement can be reached and on what terms is uncertain.
26
In September 2005, the Company received a subpoena from the U.S. Attorneys Office,
District of Massachusetts, seeking documents related to sales and marketing of eight drugs to
Omnicare, Inc., (Omnicare) a manager of pharmaceutical benefits for long-term care facilities. The
Companys subsidiaries involved responded to the subpoena. Several employees of the Companys
pharmaceutical subsidiaries have been subpoenaed to testify before a grand jury in connection with
this investigation. In April 2009, the Company was served with the complaints in two civil qui tam
cases related to marketing of prescription drugs to Omnicare, Inc. On January 15, 2010, the
government filed a complaint intervening in the cases. The complaint asserts claims under the
federal False Claims Act and a related state law claim in connection with the marketing of several
drugs to Omnicare. The complaints allege that J&J provided Omnicare, Inc. with rebates and other
alleged kickbacks, and in so doing, caused Omnicare to file false claims with Medicaid and other
government programs. Massachusetts, Virginia, and Kentucky have provided notice of their intent to
intervene.
In February 2006, the Company received a subpoena from the U.S. Securities & Exchange
Commission (SEC) requesting documents relating to the participation by several Johnson & Johnson
subsidiaries in the United Nations Iraq Oil for Food Program. The subsidiaries are cooperating with
the SEC and U.S. Department of Justice (DOJ) in producing responsive documents.
In February 2007, the Company voluntarily disclosed to the DOJ and the SEC that subsidiaries
outside the United States are believed to have made improper payments in connection with the sale
of medical devices in two small-market countries, which payments may fall within the jurisdiction
of the Foreign Corrupt Practices Act (FCPA). In the course of continuing dialogues with the
agencies, other issues potentially rising to the level of FCPA violations in additional markets
have been brought to the attention of the agencies by the Company. The Company has provided and
will continue to provide additional information to the DOJ and SEC, and will cooperate with the
agencies reviews of these matters. Law enforcement agencies of a number of other countries are
also pursuing investigations of matters voluntarily disclosed by the Company to the DOJ and SEC.
Discussions are underway in an effort to resolve these matters, and the Iraq Oil for Food matter
referenced above, but whether agreement can be reached and on what terms is uncertain.
In May 2007, the New York State Attorney General issued a subpoena seeking information
relating to the marketing and safety of PROCRIT®. The Company is responding to these requests.
In April 2007, the Company received two subpoenas from the Office of the Attorney General of
the State of Delaware. The subpoenas seek documents and information relating to nominal pricing
agreements. For purposes of the subpoenas, nominal pricing agreements are defined as agreements
under which the Company agreed to provide a pharmaceutical product for less than ten percent of the
Average Manufacturer Price for the product. The Company responded to these requests.
27
In March 2008, the Company received a letter request from the Attorney General of the State of
Michigan. The request seeks documents and information relating to nominal price transactions. The
Company responded to the request and will cooperate with the inquiry. In June 2008, the Company
received a subpoena from the United States Attorneys Office for the District of Massachusetts
relating to the marketing of biliary stents by the Companys Cordis subsidiary. Cordis is
cooperating in responding to the subpoena. A False Claims Act complaint was filed in Dallas
relating to similar issues. The U.S. Department of Justice and several states have declined to
intervene at this time.
In April 2009, the Company received a HIPPA subpoena from the U.S. Attorneys Office for the
District of Massachusetts (Boston) seeking information regarding the Companys financial
relationship with several psychiatrists. The Company is responding to this request.
In April 2009, Ortho-Clinical Diagnostics, Inc. (OCD) received a grand jury subpoena from the
U.S. Department of Justice, Antitrust Division, requesting documents and information for the period
beginning September 1, 2000 through the present, pertaining to an investigation of alleged
violations of the antitrust laws in the blood reagents industry. The Company is in the process of
complying with the subpoena. In the weeks following the public announcement that OCD had received a
subpoena from the Antitrust Division, multiple class action complaints were filed. The various
cases were consolidated for pre-trial purposes in the Eastern District of Pennsylvania.
In May 2009, the New Jersey Attorney General issued a subpoena to DePuy Orthopaedics,
Inc., seeking information regarding the financial interest of clinical investigators who performed
clinical studies for DePuy Orthopaedics, Inc. and DePuy Spine, Inc. DePuy Othropaedics is
responding 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.
With respect to all the above matters, the Company and its subsidiaries are vigorously
contesting the allegations asserted against them and otherwise pursuing defenses to maximize the
prospect of success. The Company and its subsidiaries involved in these matters continually
evaluate their strategies in managing these matters and, where appropriate, pursue settlements and
other resolutions where those are in the best interest of the Company.
The Company is also involved in a number of other patent, trademark and other lawsuits
incidental to its business. The ultimate legal and financial liability of the Company in respect to
all claims, lawsuits and proceedings referred to above cannot be estimated with any certainty.
However, in the Companys opinion, based on its examination of these matters, its experience to
date and discussions with counsel, the ultimate outcome of legal proceedings, net of liabilities
accrued in the Companys balance sheet, is not expected to have a material adverse effect on the
Companys financial condition, although the resolution in
28
any reporting period of one or more of these matters could have a significant impact on the
Companys results of operations and cash flows for that period.
NOTE 12 RESTRUCTURING
In the fourth quarter of 2009, the Company announced global restructuring initiatives designed to
strengthen the Companys position as one of the worlds leading global health care companies. This
program will allow the Company to invest in new growth platforms; ensure the successful launch of
its many new products and continued growth of its core businesses; and provide flexibility to
adjust to the changed and evolving global environment.
During the fiscal fourth quarter of 2009, the Company recorded $1.2 billion in related pre-tax
charges, of which approximately $830 million of the pre-tax restructuring charges are expected to
require cash payments. The $1.2 billion of restructuring charges consists of severance costs of
$748 million, asset write-offs of $362 million and $76 million related to leasehold and contract
obligations. The $362 million of asset write-offs relate to inventory of $113 million (recorded in
cost of products sold), property, plant and equipment of $107 million, intangible assets of $81
million and other assets of $61 million. The asset write-offs and leasehold and contract
obligations have been substantially completed. Additionally, as part of this program the Company
plans to eliminate approximately 7,500 positions of which approximately 3,000 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 2010:
|
|
|
|
|
(Dollars in Millions) |
|
Severance |
Reserve balance as of: January 3, 2010 |
|
$ |
686 |
|
Cash outlays |
|
|
(89 |
) |
April 4, 2010* |
|
$ |
597 |
|
|
|
|
* |
|
Cash outlays for severance are expected to be paid out over the next 12 to 18 months in accordance
with the Companys plans and local laws. |
|
|
|
Item 2 |
|
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
Results of Operations
Analysis of Consolidated Sales
29
For the fiscal first quarter of 2010, worldwide sales were $15.6 billion, an increase of 4.0% with
an operational decline of 0.1% as compared to 2009 fiscal first quarter sales of $15.0 billion.
Currency fluctuations had a positive impact of 4.1% for the fiscal first quarter of 2010.
Sales by U.S. companies were $7.6 billion in the fiscal first quarter of 2010, which represented a
decrease of 5.0% as compared to the same period last year. Sales by international companies were
$8.0 billion, which represented a total increase of 14.4% including an operational increase of
5.5%, and a positive impact from currency of 8.9% as compared to the fiscal first quarter sales of
2009.
Sales by companies in Europe achieved growth of 11.7%, including operational growth of 4.6% and a
positive impact from currency of 7.1%. Sales by companies in the Western Hemisphere, excluding the
U.S., achieved growth of 20.5% including operational growth of 3.5% and a positive impact from
currency of 17.0%. Sales by companies in the Asia-Pacific, Africa region achieved sales growth of
15.9%, including operational growth of 7.8% and an increase of 8.1% related to the positive impact
of currency.
Health Care Reform
The Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act
of 2010 were signed into law during March 2010. The newly enacted health care reform legislation
included an increase in the minimum Medicaid rebate rate from 15.1% to 23.1% and also extended the
rebate to drugs provided through Medicaid managed care organizations. The Company has estimated the
total year 2010 impact will be an increase in sales rebates in the range of $400-$500 million of
which $60 million impacted the Companys fiscal first quarter of 2010.
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 Companies market share of
branded prior year sales. Additionally, in 2011, discounts will be provided on the Companys
brand-name drugs to patients who fall within the Medicare Part D coverage gap, donut hole.
Beginning in 2013, the Company will record the 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 2010 were $3.8 billion, an increase of 1.5%
over the same period a year ago, including an operational decline of 3.7% and a positive currency
impact of 5.2%. U.S. Consumer segment sales declined by 9.6% while international sales achieved
sales growth of 11.1%, including operational growth of 1.4%, and a positive currency impact of
9.7%.
30
Major Consumer Franchise Sales Fiscal First Quarters
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
April 4, |
|
March 29, |
|
Total |
|
Operations |
|
Currency |
(Dollars in Millions) |
|
2010 |
|
2009 |
|
Change |
|
Change |
|
Change |
OTC Pharm & Nutr |
|
$ |
1,207 |
|
|
$ |
1,348 |
|
|
|
(10.5 |
)% |
|
|
(15.0 |
)% |
|
|
4.5 |
% |
Skin Care |
|
|
920 |
|
|
|
842 |
|
|
|
9.3 |
|
|
|
4.6 |
|
|
|
4.7 |
|
Baby Care |
|
|
529 |
|
|
|
489 |
|
|
|
8.2 |
|
|
|
1.2 |
|
|
|
7.0 |
|
Womens Health |
|
|
469 |
|
|
|
423 |
|
|
|
10.9 |
|
|
|
4.4 |
|
|
|
6.5 |
|
Oral Care |
|
|
381 |
|
|
|
365 |
|
|
|
4.4 |
|
|
|
(1.3 |
) |
|
|
5.7 |
|
Wound Care/Other |
|
|
260 |
|
|
|
244 |
|
|
|
6.6 |
|
|
|
2.1 |
|
|
|
4.5 |
|
Total |
|
$ |
3,766 |
|
|
$ |
3,711 |
|
|
|
1.5 |
% |
|
|
(3.7 |
)% |
|
|
5.2 |
% |
The OTC Pharmaceuticals and Nutritionals franchise experienced an operational decline of 15.0%
as compared to prior year fiscal first quarter. Sales were negatively impacted by the voluntary
recall of certain OTC products announced in January 2010, compounded by a less severe cold and flu
season. This was partially offset by growth in the ZYRTEC® product line primarily due to the U.S.
launch of liquid gels.
On April 30, 2010 McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., voluntarily recalled
all lots that have not yet expired of certain over-the-counter (OTC) Childrens and Infants liquid
products manufactured in the U.S. The Company temporarily suspended production at the manufacturing
facility. The timing of resumption of production and shipment is
not known at this time and is dependent on a number of factors. The recall did not have a
significant impact on the results of operations in the fiscal first quarter of 2010.
The Skin Care franchise achieved operational growth of 4.6%. Sales growth was driven by AVEENO®,
NEUTROGENA®, JOHNSONs Adult and PETIT MARSEILLAIS® product lines.
The Baby Care franchise achieved operational growth of 1.2% over prior year fiscal first quarter.
This was primarily due to growth in Latin America markets.
The Womens Health Franchise operational growth of 4.4% was primarily attributable to growth in the
sanitary protection product line outside the U.S. due to both sales of products from the
acquisition of a joint venture partner in France in 2009 and growth in the core business.
The Oral Care franchise experienced an operational decline of 1.3% primarily due to the divestiture
of the EFFERDENT®/Effergrip® brands in the fiscal fourth quarter of 2009 partially offset by growth
of LISTERINEâ mouthwash outside the U.S.
The Wound Care/Other franchise operational growth of 2.1% was primarily due to growth in the
BAND-AID® brand and NEOSPORIN® product lines.
Pharmaceutical
Pharmaceutical segment sales in the fiscal first quarter of 2010 were $5.6 billion, a total
decrease of 2.5% as compared to the same period a year ago with an operational decline of 5.7% and
an increase of 3.2% related to the positive impact of currency. U.S.
31
Pharmaceutical sales decreased by 12.7% as compared to the same period a year ago. International
Pharmaceutical sales achieved sales growth of 15.5%, including operational growth of 6.6%, and an
increase of 8.9% related to the positive impact of currency.
Major Pharmaceutical Product Revenues Fiscal First Quarters*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
April 4, |
|
March 29, |
|
Total |
|
Operations |
|
Currency |
(Dollars in Millions) |
|
2010 |
|
2009 |
|
Change |
|
Change |
|
Change |
REMICADE® |
|
$ |
1,186 |
|
|
$ |
1,028 |
|
|
|
15.4 |
% |
|
|
15.4 |
% |
|
|
|
% |
PROCRIT®/EPREX® |
|
|
523 |
|
|
|
550 |
|
|
|
(4.9 |
) |
|
|
(8.2 |
) |
|
|
3.3 |
|
RISPERDALâ CONSTAâ |
|
|
379 |
|
|
|
325 |
|
|
|
16.6 |
|
|
|
10.3 |
|
|
|
6.3 |
|
LEVAQUIN®/FLOXIN® |
|
|
371 |
|
|
|
425 |
|
|
|
(12.7 |
) |
|
|
(12.8 |
) |
|
|
0.1 |
|
CONCERTAâ |
|
|
329 |
|
|
|
344 |
|
|
|
(4.4 |
) |
|
|
(7.3 |
) |
|
|
2.9 |
|
ACIPHEX®/PARIETâ |
|
|
260 |
|
|
|
263 |
|
|
|
(1.1 |
) |
|
|
(5.7 |
) |
|
|
4.6 |
|
TOPAMAX® |
|
|
148 |
|
|
|
602 |
|
|
|
(75.4 |
) |
|
|
(76.6 |
) |
|
|
1.2 |
|
Other Pharmaceuticals |
|
|
2,442 |
|
|
|
2,243 |
|
|
|
8.9 |
|
|
|
3.6 |
|
|
|
5.3 |
|
Total |
|
$ |
5,638 |
|
|
$ |
5,780 |
|
|
|
(2.5 |
)% |
|
|
(5.7 |
)% |
|
|
3.2 |
% |
|
|
|
* |
|
Prior year amounts have been reclassified to conform to current year presentation. |
REMICADE® (infliximab), a biologic approved for the treatment of a number of immune-mediated
inflammatory diseases, achieved operational growth of 15.4% over prior year fiscal first quarter.
Growth was primarily driven by market growth in both the U.S. and U.S. export markets. REMICADE® is
competing in a market which is experiencing increased competition due to new entrants and the
expansion of indications for existing competitors.
PROCRITâ (Epoetin alfa)/EPREXâ (Epoetin alfa), experienced an operational sales decline
of 8.2%, as compared to the prior year fiscal first quarter. The decline in PROCRITâ and
EPREXâ sales was due to the declining markets for Erythropoiesis Stimulating Agents (ESAs).
RISPERDAL® CONSTA®
(risperidone), a long-acting injectable antipsychotic, achieved operational
growth of 10.3% over the fiscal first quarter of 2009 due to growth outside the U.S.
LEVAQUIN® (levofloxacin)/FLOXINâ
(ofloxacin), an anti-infective, experienced an operational
decline of 12.8% as compared to the prior year fiscal first quarter primarily due to a lower
incident of respiratory illness and flu.
CONCERTAâ (methylphenidate HCl), a product for the treatment of attention deficit
hyperactivity disorder, experienced an operational sales decline of 7.3% as compared to the prior
year fiscal first quarter. U.S. sales were adversely impacted by the newly enacted health care
reform legislation due to changes to rebates to Medicaid managed care organizations. The decline
was partially offset by sales growth outside the U.S. Although the original CONCERTAâ patent
expired in 2004, the FDA has not approved any generic version that is substitutable for
CONCERTAâ. Parties have filed Abbreviated New Drug Applications (ANDAs) for
32
generic versions of CONCERTAâ, which are pending and may be approved at any time.
ACIPHEXâ/PARIETâ, experienced an operational decline of 5.7% as compared to the fiscal
first quarter of 2009 primarily due to generic competition in the U.S.
TOPAMAX® (topiramate), experienced an operational decline of 76.6% as compared to prior year fiscal
first quarter. Market exclusivity for TOPAMAX® (topiramate) in the U.S. expired in March 2009 and
multiple generics have entered the market. Loss of market exclusivity for the TOPAMAX® patent has
resulted in a significant reduction in sales in the U.S. In 2009, full year U.S. sales of TOPAMAX®
were $0.7 billion. U.S. sales of TOPAMAX® were $0.5 billion in the first quarter of 2009 and $0.2
billion for the remainder of the 2009 fiscal year.
In the fiscal first quarter of 2010, Other Pharmaceutical sales achieved operational growth of 3.6%
over the prior year fiscal first quarter. Contributors to the increase were sales of VELCADEâ
(bortezomib), a product for the treatment of multiple myeloma, and recent pharmaceutical launches
such as SIMPONI®, STELARA®, NUCYNTA® and INVEGA SUSTENNA®. The growth was partially offset by lower
sales of DURAGESIC®/Fentanyl Transdermal (fentanyl transdermal system) and
RISPERDALâ/risperidone due to continued generic competition.
Medical Devices and Diagnostics
Medical Devices and Diagnostics segment sales in the fiscal first quarter of 2010 were $6.2
billion, an increase of 12.5% as compared to the same period a year ago, with 8.1% of this change
due to operational increases and a positive currency impact of 4.4%. The U.S. Medical Devices and
Diagnostics sales growth was 8.8% and the increase in international Medical Devices and Diagnostics
sales was 15.9%, which included operational increases of 7.5% and a positive currency impact of
8.4%.
Major Medical Devices and Diagnostics Franchise Sales Fiscal First Quarters
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
April 4, |
|
March 29, |
|
Total |
|
Operations |
|
Currency |
(Dollars in Millions) |
|
2010 |
|
2009 |
|
Change |
|
Change |
|
Change |
DEPUY® |
|
$ |
1,454 |
|
|
$ |
1,292 |
|
|
|
12.5 |
% |
|
|
8.2 |
% |
|
|
4.3 |
% |
ETHICON ENDO-SURGERY® |
|
|
1,168 |
|
|
|
1,015 |
|
|
|
15.1 |
|
|
|
10.0 |
|
|
|
5.1 |
|
ETHICON® |
|
|
1,147 |
|
|
|
953 |
|
|
|
20.4 |
|
|
|
15.5 |
|
|
|
4.9 |
|
CORDIS® |
|
|
672 |
|
|
|
668 |
|
|
|
0.6 |
|
|
|
(3.3 |
) |
|
|
3.9 |
|
Vision Care |
|
|
664 |
|
|
|
599 |
|
|
|
10.9 |
|
|
|
6.8 |
|
|
|
4.1 |
|
Diabetes Care |
|
|
597 |
|
|
|
541 |
|
|
|
10.4 |
|
|
|
6.4 |
|
|
|
4.0 |
|
ORTHO-CLINICAL
DIAGNOSTICS® |
|
|
525 |
|
|
|
467 |
|
|
|
12.4 |
|
|
|
8.9 |
|
|
|
3.5 |
|
Total |
|
$ |
6,227 |
|
|
$ |
5,535 |
|
|
|
12.5 |
% |
|
|
8.1 |
% |
|
|
4.4 |
% |
The DePuy franchise achieved operational growth of 8.2% over the same period a year ago. This was
primarily due to growth in the
33
hip and knee product lines and new product launches in the Mitek sports medicine product line.
The Ethicon Endo-Surgery franchise achieved operational growth of 10.0% over the prior year fiscal
first quarter. This was attributable to growth in the Endo-Mechanical, HARMONICä and Advanced
Sterilization product lines.
The Ethicon franchise achieved operational growth of 15.5% over the prior year fiscal first
quarter. This was attributable to growth in the sutures, biosurgical and mesh product lines in
addition to sales of acquired products from the acquisitions of Mentor Corporation and Acclarent,
Inc.
The Cordis franchise experienced an operational sales decline of 3.3% as compared to the fiscal
first quarter of 2009. The decline was caused by lower sales of the CYPHER® Sirolimus-eluting
Coronary Stent due to increased global competition. The decline was partially offset by growth in
the Biosense Webster business.
The Vision Care franchise achieved operational sales growth of 6.8% over the prior year fiscal
first quarter. ACUVUE® OASYS for Astigmatism, 1-DAY ACUVUE® MOISTTM and 1-DAY ACUVUE®
TruEyeTM outside the U.S. were the major contributors to this growth driven by the
strength of the underlying platform and new product launches.
The Diabetes Care franchise achieved operational sales growth of 6.4% over the prior year fiscal
first quarter. This was attributable to growth of the Animas business resulting from new product
launches and the continued development of the international markets.
The Ortho-Clinical Diagnostics franchise achieved operational growth of 8.9% over the fiscal first
quarter of 2009. This growth was primarily attributable to sales of the VITROS 3600 and 5600
analyzers.
Cost of Products Sold and Selling, Marketing and Administrative Expenses
Consolidated costs of products sold for the fiscal first quarter of 2010 increased to 29.0% from
28.3% of sales as compared to the same period a year ago. The Pharmaceutical business was impacted
by unfavorable product mix, primarily due to the loss of market exclusivity for TOPAMAX®, as well
as the impact of the newly enacted health care reform legislation. The Consumer business was
impacted by unfavorable product mix due to the recall of certain OTC products announced in January
of 2010.
Consolidated selling, marketing and administrative expenses for the fiscal first quarter of 2010
decreased to 30.5% from 30.7% of sales as compared to the same period a year ago. The decrease was
primarily due to cost containment initiatives.
34
Research & Development
Research activities represent a significant part of the Companys business. These expenditures
relate to the development of new products, improvement of existing products, technical support of
products and compliance with governmental regulations for the protection of the consumer. Worldwide
costs of research activities, for the fiscal first quarter of 2010 were $1.6 billion,
which was a slight increase in spending as compared to the prior fiscal period but a decrease of
0.1% of sales as compared to the same period a year ago. The decrease was primarily due to a change
in the mix of businesses.
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 2010 was favorable as
compared to the same periods a year ago. In the fiscal first quarter of 2010 the Company recorded a
net gain of $1.5 billion from litigation matters.
OPERATING PROFIT BY SEGMENT
Consumer Segment
Operating profit for the Consumer segment as a percent to sales in the fiscal first quarter of 2010
was 20.8% versus 21.6% for the same period a year ago. The primary driver of the decline in
operating profit was due to unfavorable product mix due to the recall of certain OTC products
announced in January of 2010.
Pharmaceutical Segment
Operating profit for the Pharmaceutical segment as a percent to sales in the fiscal first quarter
of 2010 was 34.9% versus 39.0% for the same period a year ago. Unfavorable product mix due to the
loss of market exclusivity for TOPAMAX®, $0.1 billion of expense related to litigation matters and
the impact of the newly enacted health care reform legislation were the primary drivers of the
decreased operating profit.
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 2010 was 59.5% versus 32.3% for the same period a year ago. The primary
driver of the improvement in the operating profit margin in the Medical Devices and Diagnostics
segment was due to a $1.6 billion gain from net litigation matters and favorable product mix.
Interest (Income) Expense
Interest income was the same in the fiscal first quarter of 2010 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
35
$18.0 billion at the end of the fiscal first quarter of 2010. This is an increase of $4.1 billion
from the same period a year ago. The increase was primarily due to cash generated from operating
activities and net cash proceeds from litigation matters.
Interest expense was flat in the fiscal first quarter of 2010 as compared to the same period a year
ago. At the end of the fiscal first quarter of 2010 the Companys debt position was $12.1 billion
compared to $14.1 billion from the same period a year ago. The reduction in current debt in the
first quarter was primarily due to a reduction in Commercial Paper issued.
Provision for Taxes on Income
The worldwide effective income tax rates for the fiscal first quarter of 2010 and 2009 were 27.9%
and 24.5%, respectively. The higher effective tax rate was due to the net litigation gain of $1.5
billion recorded in the fiscal first quarter of 2010, which was recorded at 39.0% tax rate and
resulted in an additional 3.5 percentage points added to the worldwide effective income tax rate.
As of April 4, 2010 the Company had approximately $2.5 billion of liabilities from unrecognized tax
benefits. The Company does not expect that the total amount of unrecognized tax benefits will
change significantly during the next twelve months.
See Note 8 to the Consolidated Financial Statements in the Annual Report on Form 10-K for the
fiscal year ended January 3, 2010 for more detailed information regarding unrecognized tax
benefits.
LIQUIDITY AND CAPITAL RESOURCES
Cash Flows
Cash and cash equivalents were $13.7 billion at the end of the fiscal first quarter of 2010 as
compared with $15.8 billion at the fiscal year end of 2009. The primary uses of cash that
contributed to the $2.1 billion decrease were $3.7 billion generated from operating activities
offset by $1.9 billion net cash used by investing activities and $3.8 billion used by financing
activities.
Cash flow from operations of $3.7 billion was the result of $4.5 billion of net earnings and $1.9
billion of non cash charges related to depreciation and amortization, stock based compensation
and deferred tax provision partially offset by $2.8 billion related to changes in assets and
liabilities net of effects from acquisitions.
Investing activities use of $1.9 billion cash related to net investments in marketable securities
of $0.8 billion, acquisitions of $0.8 billion and $0.4 billion for additions to property, plant
and equipment, reduced by $0.1 billion of proceeds from asset sales.
36
The use of $3.8 billion in financing activities was primarily for dividends to shareholders of
$1.4 billion, $2.3 billion net retirement of short-term debt and a net of $0.1 billion for
repurchase of common stock net of proceeds from stock options exercised.
In the fiscal first quarter of 2010 the Company continued to have access to liquidity through the
commercial paper market. The Company anticipates that operating cash flows, existing credit
facilities and access to the commercial paper markets will continue to provide sufficient
resources to fund operating needs.
Dividends
On January 4, 2010, the Board of Directors declared a regular quarterly cash dividend of $0.490 per
share, payable on March 9, 2010, to shareholders of record as of February 23, 2010.
On April 22, 2010, the Board of Directors declared a regular cash dividend of $0.540 per share,
payable on June 15, 2010 to shareholders of record as of June 1, 2010. This represented an increase
of 10.2% in the quarterly dividend rate and was the 48th consecutive year of cash dividend
increases. The Company expects to continue the practice of paying regular quarterly cash dividends.
OTHER INFORMATION
New Accounting Standards
The Financial Accounting Standards Board (FASB) issued guidance and amendments to the criteria for
separating consideration in multiple-deliverable revenue arrangements, which the Company adopted in
the fiscal first quarter of 2010. The guidance also (a) provides principles and application
guidance on whether multiple deliverables exist, how the arrangement should be separated, and the
consideration allocated; (b) requires an entity to allocate revenue in an arrangement using
estimated selling prices of deliverables if a vendor does not have vendor-specific objective
evidence or third-party evidence of selling price; and(c) eliminates the use of the residual method
and requires an entity to allocate the revenue using the relative selling price method. The
adoption did not have a material impact on the Companys results of operations, cash flows or
financial position however it will expand the disclosures for multiple-deliverable revenue
arrangements.
During the fiscal first quarter of 2010 the Company adopted the FASB standard related to variable
interest entities. The adoption of this standard did not have a significant impact on the Companys
results of operations, cash flows or financial position.
During the fiscal first quarter of 2010 the Company adopted the new accounting guidance on fair
value measurements and disclosures. This guidance requires the Company to disclose the
37
amount of significant transfers between Level 1 and Level 2 inputs and the reasons for these
transfers as well as the reasons for any transfers in or out of Level 3 of the fair value
hierarchy. In addition, the guidance clarifies certain existing disclosure requirements. The
adoption of this standard did not have a significant impact on the Companys results of operations,
cash flows or financial position.
During the fiscal second quarter of 2010 the FASB issued an accounting standard update related to
revenue recognition under the milestone method. The objective of the accounting standard update is
to provide guidance on defining a milestone and determining when it may be appropriate to apply the
milestone method of revenue recognition for research or development transactions. This update is
effective on a prospective basis for milestones achieved in fiscal years, and interim periods
within those years, beginning on or after June 15, 2010. The adoption of this standard is not
expected to have a significant impact on the Companys results of operations, cash flows or
financial position.
Economic and Market Factors
Johnson & Johnson is aware that its products are used in an environment where, for more than a
decade, policymakers, consumers and businesses have expressed concern about the rising cost of
health care. Johnson & Johnson has a long-standing policy of pricing products responsibly. For the
period 1999 through 2009 in the United States, the weighted average compound annual growth rate of
Johnson & Johnson price increases for health care products (prescription and over-the-counter
drugs, hospital and professional products) was below the U.S. Consumer Price Index (CPI).
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
38
at issue, resulting in very substantial market share and revenue losses. For further information
see the discussion on Litigation Against Filers of Abbreviated New Drug Applications included in
Item 1. Financial Statements (unaudited)- Notes to Consolidated Financial Statements, Note 11.
CAUTIONARY FACTORS THAT MAY AFFECT FUTURE RESULTS
This Form 10-Q contains forward-looking statements. Forward- looking statements do not relate
strictly to historical or current facts and anticipate results based on managements plans that are
subject to uncertainty. Forward-looking statements may be identified by the use of words like
plans, expects, will, anticipates, estimates and other words of similar meaning in
conjunction with, among other things, discussions of future operations, financial performance, the
Companys strategy for growth, product development, regulatory approval, market position and
expenditures.
Forward-looking statements are based on current expectations of future events. The Company cannot
guarantee that any forward- looking statement will be accurate, although the Company believes that
it has been reasonable in its expectations and assumptions. Investors should realize that if
underlying assumptions prove inaccurate or that unknown risks or uncertainties materialize, actual
results could vary materially from the Companys expectations and projections. Investors are
therefore cautioned not to place undue reliance on any forward-looking statements. The Company does
not undertake to update any forward-looking statements as a result of new information or future
events or developments.
Risks and uncertainties include general industry conditions and competition; economic conditions;
interest rate and currency exchange rate fluctuations; technological advances, new products and
patents attained by competitors; challenges inherent in new product development, including
obtaining regulatory approvals; challenges to patents; U.S. and foreign health care reforms and
governmental laws and regulations; trends toward health care cost containment; increased scrutiny
of the health care industry by government agencies; product efficacy or safety concerns resulting
in product recalls or regulatory action.
The Companys Annual Report on Form 10-K for the fiscal year ended January 3, 2010 contains, as an
Exhibit, a discussion of additional factors that could cause actual results to differ from
expectations. The Company notes these factors as permitted by the Private Securities Litigation
Reform Act of 1995.
|
|
|
Item 3 |
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
There has been no material change in the Companys assessment of
its sensitivity to market risk since its presentation set forth in
Item 7A, Quantitative and Qualitative Disclosures About Market
Risk, in its Annual Report on Form 10-K for the fiscal year ended
January 3, 2010.
39
|
|
|
Item 4 |
|
CONTROLS AND PROCEDURES |
Disclosure controls and procedures. At the end of the period covered by this report, the Company
evaluated the effectiveness of the design and operation of its disclosure controls and procedures.
The Companys disclosure controls and procedures are designed to ensure that information required
to be disclosed by the Company in the reports that it files or submits under the Securities
Exchange Act is recorded, processed, summarized and reported, within the time periods specified in
the SECs rules and forms. Disclosure controls and procedures include, without limitation, controls
and procedures designed to ensure that information required to be disclosed by the Company in the
reports that it files or submits under the Securities Exchange Act is accumulated and communicated
to the Companys management, including its principal executive and principal financial officers, or
persons performing similar functions, as appropriate to allow timely decisions regarding required
disclosure. William C. Weldon, Chairman and Chief Executive Officer, and Dominic J. Caruso, Vice
President, Finance and Chief Financial Officer, reviewed and participated in this evaluation.
Based on this evaluation, Messrs. Weldon and Caruso concluded that, as of the end of the period
covered by this report, the Companys disclosure controls and procedures were effective.
Internal control. During the period covered by this report, there were no changes in the Companys
internal control over financial reporting that have materially affected, or are reasonably likely
to materially affect, the Companys internal control over financial reporting.
Part II OTHER INFORMATION
|
|
|
Item 1 |
|
LEGAL PROCEEDINGS |
The information called for by this item is incorporated herein by reference to Note 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 2010. Common Stock purchases on the open market are made as
part
40
of a systematic plan to meet the needs of the Companys compensation programs.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Number of |
|
Remaining |
|
|
|
|
|
|
|
|
|
|
Shares Purchased |
|
Maximum Number |
|
|
|
|
|
|
Average |
|
as Part of |
|
of Shares that |
|
|
Total Number |
|
Price |
|
Publicly |
|
May Be Purchased |
|
|
of Shares |
|
Paid per |
|
Announced Plans |
|
Under the Plans |
Fiscal Month |
|
Purchased (1) |
|
Share |
|
or Programs(2) |
|
or Programs (3) |
January 4, 2010
through January 31,
2010 |
|
|
2,209,400 |
|
|
$ |
64.27 |
|
|
|
|
|
|
|
|
|
February 1, 2010
through February
28, 2010 |
|
|
3,104,600 |
|
|
$ |
62.91 |
|
|
|
|
|
|
|
|
|
March 1, 2010
through April 4,
2010 |
|
|
725,700 |
|
|
$ |
64.23 |
|
|
|
|
|
|
|
|
|
Total |
|
|
6,039,700 |
|
|
|
|
|
|
|
|
|
|
|
16,419,761 |
|
|
|
|
(1) |
|
During the fiscal first quarter of 2010, the Company repurchased an aggregate of 6,039,700
shares of Johnson & Johnson Common Stock in open-market transactions. There were no purchases in
the first quarter of 2010 pursuant to the repurchase program that was publicly announced on July 9,
2007. The repurchase program has no time limit and may be suspended for periods or discontinued at
any time. |
|
(2) |
|
As of April 4, 2010, an aggregate of 140,377,700 shares were purchased for a total of $8.9
billion since the inception of the repurchase program announced on July 9, 2007. |
|
(3) |
|
As of April 4, 2010, based on the closing price of the Companys Common Stock on the New York
Stock Exchange on April 1, 2010 of $65.77 per share. |
|
|
|
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 4, 2010, formatted in Extensive Business Reporting Language (XBRL),
(i)consolidated balance sheets, (ii) consolidated statements of earnings, (iii)
consolidated statements of cash flows, and (iv) the notes to the consolidated financial
statements. |
41
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, 2010 |
By |
/s/ D. J. CARUSO
|
|
|
|
D. J. CARUSO |
|
|
|
Vice President, Finance;
Chief Financial Officer (Principal Financial Officer) |
|
|
Date: May 10, 2010 |
By |
/s/ S. J. COSGROVE
|
|
|
|
S. J. COSGROVE |
|
|
|
Controller
(Principal Accounting Officer) |
|
|
42