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| JNJ > SEC Filings for JNJ > Form 10-Q on 4-Aug-2009 | All Recent SEC Filings |
4-Aug-2009
Quarterly Report
Sales by companies in Europe experienced a sales decline of 12.6%, including
operational growth of 1.8% and a negative impact from currency of 14.4%. Sales
by companies in the Western Hemisphere, excluding the U.S., experienced a sales
decline of 5.1% including operational growth of 11.7% and a negative impact from
currency of 16.8%. Sales by companies in the Asia-Pacific, Africa region
experienced a sales decline of 0.7%, including operational growth of 3.7% and a
negative impact from currency of 4.4%.
Analysis of Sales by Business Segments
Consumer
Consumer segment sales in the first fiscal six months of 2009 were $7.6 billion,
a decrease of 6.6% as compared to the same period a year ago, including
operational growth of 1.0% and a negative currency impact of 7.6%. U.S. Consumer
segment sales declined by 2.2% while international sales experienced an overall
sales decline of 9.9%, including operational growth of 3.6% and a negative
currency impact of 13.5%.
Major Consumer Franchise Sales - Fiscal Six Months
June 28, June 29, Total Operations Currency
(Dollars in Millions) 2009 2008 Change Change Change
OTC Pharm & Nutr $ 2,658 $ 2,999 (11.4 )% (4.3 )% (7.1 )%
Skin Care 1,675 1,679 (0.2 ) 6.9 (7.1 )
Baby Care 997 1,105 (9.8 ) (0.7 ) (9.1 )
Women's Health 904 965 (6.3 ) 2.8 (9.1 )
Oral Care 751 794 (5.4 ) 2.6 (8.0 )
Wound Care/Other 580 558 3.9 10.4 (6.5 )
Total $ 7,565 $ 8,100 (6.6 )% 1.0 % (7.6 )%
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Consumer segment sales in the fiscal second quarter of 2009 were $3.8 billion, a
decrease of 4.5% over the same period a year ago, including operational growth
of 3.1% and a negative currency impact of 7.6%. U.S. Consumer segment sales
increased by 0.8% while international sales experienced an overall sales decline
of 8.4%, including operational growth of 4.7%, and a negative currency impact of
13.1%.
Major Consumer Franchise Sales - Fiscal Second Quarters
June 28, June 29, Total Operations Currency
(Dollars in Millions) 2009 2008 Change Change Change
OTC Pharm & Nutr $ 1,310 $ 1,405 (6.8 )% 0.3 % (7.1 )%
Skin Care 833 839 (0.7 ) 5.9 (6.6 )
Baby Care 508 572 (11.2 ) (2.2 ) (9.0 )
Women's Health 481 504 (4.6 ) 4.8 (9.4 )
Oral Care 386 408 (5.4 ) 2.4 (7.8 )
Wound Care/Other 336 308 9.1 15.7 (6.6 )
Total $ 3,854 $ 4,036 (4.5 )% 3.1 % (7.6 )%
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The OTC Pharmaceuticals and Nutritionals franchise achieved operational growth of 0.3% as compared to prior year fiscal second quarter. Increased competitive pressures including private label have negatively impacted sales. The U.S. Food and Drug Administration (FDA) is currently considering certain
recommendations made by its advisory committee for reducing the potential for
overdose with acetaminophen, the active ingredient in TYLENOL®. The Company has
provided the FDA with its own recommendations and will continue to be actively
engaged with the FDA on this topic.
The Skin Care franchise achieved operational growth of 5.9% which was primarily
due to growth in the Neutrogena and Aveeno product lines.
The Baby Care franchise experienced an operational decline of 2.2% over prior
year fiscal second quarter. This was due to increased private label competition
and lower sales for Babycenter.com primarily as a result of exiting the online
retail business. This was partially offset by growth in the haircare and powder
product lines outside the U.S.
The Women's Health Franchise operational growth of 4.8% was primarily due to
sales associated with the buyout of a joint venture partner in France. Prior to
the buyout of the joint venture partner, sales by the joint venture were not
recorded as part of the Company's sales to customers.
The Oral Care franchise operational growth of 2.4% was driven by the growth of
LISTERINEâmouthwash outside the U.S. partially offset by lower sales of
whitening strips and mouth fresheners on a global basis.
The Wound Care/Other franchise operational growth of 15.7% was primarily due to
the recent acquisitions in wellness and prevention and sales associated with the
buyout of a joint venture partner in France. Prior to the buyout of the joint
venture partner, sales by the joint venture were not recorded as part of the
Company's sales to customers.
Pharmaceutical
Pharmaceutical segment sales in the first fiscal six months of 2009 were
$11.3 billion, a total decrease of 11.7% as compared to the same period a year
ago with an operational decline of 6.8% and a decrease of 4.9% related to the
negative impact of currency. U.S. Pharmaceutical sales declined by 12.9% as
compared to the same period a year ago. International Pharmaceutical sales
experienced a sales decline of 9.7%, representing an operational increase of
3.1%, and a decrease of 12.8% related to the negative impact of currency.
Major Pharmaceutical Product Revenues - Fiscal Six Months
June 28, June 29, Total Operations Currency
(Dollars in Millions) 2009 2008 Change Change Change
REMICADE® $ 2,130 $ 1,884 13.1 % 13.1 % - %
PROCRIT®/EPREX® 1,127 1,281 (12.0 ) (6.3 ) (5.7 )
LEVAQUIN®/FLOXIN® 787 847 (7.1 ) (6.2 ) (0.9 )
TOPAMAX® 784 1,323 (40.7 ) (37.9 ) (2.8 )
RISPERDALâ CONSTAâ 673 652 3.2 14.6 (11.4 )
CONCERTAâ 661 569 16.2 21.4 (5.2 )
ACIPHEXâ/PARIETâ 523 602 (13.1 ) (5.7 ) (7.4 )
RISPERDALâ 514 1,521 (66.2 ) (64.5 ) (1.7 )
DURAGESIC®/Fentanyl Transdermal 449 505 (11.1 ) (2.7 ) (8.4 )
Other 3,630 3,585 1.3 9.4 (8.1 )
Total $ 11,278 $ 12,769 (11.7 )% (6.8 )% (4.9 )%
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Pharmaceutical segment sales in the fiscal second quarter of 2009 were
$5.5 billion, a total decrease of 13.3% over the same period a year ago with an
operational decline of 8.5% and a decrease of 4.8% related to the negative
impact of currency. U.S. Pharmaceutical sales decreased by 16.4% over the same
period a year ago. International Pharmaceutical sales experienced a sales
decline of 8.7%, representing an operational increase of 3.3%, and a decrease of
12.0% related to the negative impact of currency.
Major Pharmaceutical Product Revenues - Fiscal Second Quarters
June 28, June 29, Total Operations Currency
(Dollars in Millions) 2009 2008 Change Change Change
REMICADE® $ 1,102 $ 886 24.4 % 24.4 % - %
PROCRIT®/EPREX® 577 652 (11.5 ) (6.0 ) (5.5 )
LEVAQUIN®/FLOXIN® 362 351 3.1 4.1 (1.0 )
RISPERDALâ CONSTAâ 348 343 1.5 12.1 (10.6 )
CONCERTAâ 317 279 13.6 18.7 (5.1 )
ACIPHEX®/PARIETâ 260 325 (20.0 ) (13.3 ) (6.7 )
RISPERDALâ 239 712 (66.4 ) (64.8 ) (1.6 )
DURAGESIC®/Fentanyl Transdermal 218 272 (19.9 ) (12.3 ) (7.6 )
TOPAMAX® 182 677 (73.1 ) (70.4 ) (2.7 )
Other 1,893 1,843 2.7 10.5 (7.8 )
Total $ 5,498 $ 6,340 (13.3 )% (8.5 )% (4.8 )%
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REMICADE® (infliximab), a biologic approved for the treatment of Crohn's
disease, ankylosing spondylitis, psoriasis, psoriatic arthritis, ulcerative
colitis and use in the treatment of rheumatoid arthritis, achieved operational
growth of 24.4% over prior year fiscal second quarter. Sales in the U.S. market
grew 12.7% versus the prior year primarily driven by market growth. U.S. export
sales grew 63.5% versus the prior year fiscal second quarter primarily driven by
an increase in customer production planning needs. U.S. export sales operational
growth for the fiscal six months of 2009 versus the same period a year ago was
17.9%, which the Company believes is more reflective of actual consumption in
the first two fiscal quarters of 2009. REMICADE® is competing in a market which
is experiencing increased competition due to new entrants and the expansion of
indications for existing competitors.
PROCRITâ (Epoetin alfa)/EPREXâ (Epoetin alfa), experienced an operational sales
decline of 6.0%, as compared to prior year fiscal second quarter. The decline in
PROCRITâ sales was due to the declining markets for Erythropoiesis Stimulating
Agents (ESAs) in the U.S. The FDA issued an order requiring a labeling
supplement making specific revisions to the label for ESAs,
including PROCRITâ. The label for PROCRITâ was updated July 30, 2008 based on
review of emerging safety data for the use of ESAs in patients with cancer.
Outside the U.S., the emerging safety data issues have contributed to the lower
sales results for EPREXâ.
RISPERDAL® CONSTA® (risperidone), a long-acting injectable for the treatment of
schizophrenia, achieved operational growth of 12.1% over the fiscal second
quarter of 2008. Strong growth was due to a positive shift from daily therapies
to longer-acting RISPERDAL® CONSTA® and increased share.
CONCERTAâ (methylphenidate HCl), a product for the treatment of attention
deficit hyperactivity disorder, achieved operational sales growth of 18.7% over
the fiscal second quarter of 2008 due to market growth. Although the original
CONCERTAâ patent expired in 2004, the FDA has not approved any generic version
that is substitutable for CONCERTAâ. Parties have filed Abbreviated New Drug
Applications (ANDAs) for generic versions of CONCERTAâ, which are pending and
may be approved at any time.
ACIPHEXâ/PARIETâ, experienced an operational decline of 13.3% due in part to
generic competition.
RISPERDAL®(risperidone), a medication that treats the symptoms of schizophrenia,
bipolar mania and irritability associated with autistic behavior in indicated
patients, experienced an operational decline of 64.8% in the fiscal second
quarter of 2009 versus the same period in the prior year. Market exclusivity for
RISPERDAL® oral in the U.S. expired on June 29, 2008. Loss of market exclusivity
for the RISPERDAL® oral patent has resulted in a significant reduction in sales
in the U.S. In 2008, U.S. sales of RISPERDAL® oral were $1.3 billion. U.S. sales
of RISPERDAL® oral were $1.1 billion and $0.2 billion in the first half and the
second half of the 2008 fiscal year, respectively, and $0.2 billion in the first
half of the 2009 fiscal year.
DURAGESIC®/Fentanyl Transdermal (fentanyl transdermal system), experienced an
operational decline of 12.3% due to continued generic competition.
TOPAMAX® (topiramate), which has been approved for adjunctive and monotherapy
use in epilepsy, as well as for the prophylactic treatment of migraines,
experienced an operational decline of 70.4% as compared to prior year fiscal
second quarter. Marketing exclusivity for TOPAMAX® (topiramate) in the U.S.
expired in March 2009 and multiple generics have entered the market. Loss of
market exclusivity for the TOPAMAX® patent has resulted in a significant
reduction in sales in the U.S. In 2008, U.S. sales of TOPAMAX® were
$2.3 billion. U.S. sales of TOPAMAX® were $0.5 billion and $0.1 billion in the
fiscal first quarter and the fiscal second quarter of 2009 respectively.
In the fiscal second quarter of 2009, Other Pharmaceutical sales achieved
operational growth of 10.5% versus the prior year.
Contributors to the increase were sales of VELCADEâ (bortezomib), a treatment
for multiple myeloma, PREZISTAâ (darunavir), for the treatment of HIV/AIDS
patients and INVEGAâ(paliperidone), a once-daily atypical antipsychotic.
Medical Devices and Diagnostics
Medical Devices and Diagnostics segment sales in the first fiscal six months of
2009 were $11.4 billion, a decrease of 3.0% as compared to the same period a
year ago, with 3.0% of this change due to operational increases and a decrease
of 6.0% related to the negative impact of currency. The U.S. Medical Devices and
Diagnostics sales increase was 2.2% and the decline in international Medical
Devices and Diagnostics sales was 7.3%, which included operational increases of
3.6% and a decrease of 10.9% related to the negative impact of currency.
Major Medical Devices and Diagnostics Franchise Sales* - Fiscal Six Months
June 28, June 29, Total Operations Currency
(Dollars in Millions) 2009 2008 Change Change Change
DEPUY® $ 2,615 $ 2,615 - % 6.6 % (6.6 )%
ETHICON ENDO-SURGERY® 2,130 2,127 0.1 7.3 (7.2 )
ETHICON® 1,994 1,965 1.5 9.4 (7.9 )
CORDIS® 1,342 1,614 (16.9 ) (12.8 ) (4.1 )
Vision Care 1,229 1,246 (1.4 ) 1.3 (2.7 )
Diabetes Care 1,151 1,289 (10.7 ) (4.8 ) (5.9 )
ORTHO-CLINICAL DIAGNOSTICS® 961 919 4.6 9.7 (5.1 )
Total $ 11,422 $ 11,775 (3.0 )% 3.0 % (6.0 )%
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* Prior year amounts have been reclassified to conform to current presentation.
Medical Devices and Diagnostics segment sales in the fiscal second quarter of 2009 were $5.9 billion, a decrease of 3.1% as compared to the same period a year ago, with 2.9% of this change due to operational increases and a decrease of 6.0% related to the negative impact of currency. The U.S. Medical Devices and Diagnostics sales increase was 1.9% and the decline in international Medical Devices and Diagnostics sales was 7.2%, which included operational increases of 3.7% and a decrease of 10.9% related to the negative impact of currency. Major Medical Devices and Diagnostics Franchise Sales* - Fiscal Second Quarters
June 28, June 29, Total Operations Currency
(Dollars in Millions) 2009 2008 Change Change Change
DEPUY® $ 1,323 $ 1,328 (0.4 )% 6.0 % (6.4 )%
ETHICON ENDO-SURGERY® 1,115 1,124 (0.8 ) 6.3 (7.1 )
ETHICON® 1,041 1,020 2.1 9.7 (7.6 )
CORDIS® 674 813 (17.1 ) (12.6 ) (4.5 )
Vision Care 630 639 (1.4 ) 1.9 (3.3 )
Diabetes Care 610 674 (9.5 ) (3.7 ) (5.8 )
ORTHO-CLINICAL DIAGNOSTICS® 494 476 3.8 9.2 (5.4 )
Total $ 5,887 $ 6,074 (3.1 )% 2.9 % (6.0 )%
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* Prior year amounts have been reclassified to conform to current presentation.
The DePuy franchise achieved operational growth of 6.0% over the same period a
year ago. This was primarily due to growth in the spine, hip and knee product
lines. Additionally, new product launches in the Mitek sports medicine product
line contributed to the growth.
The Ethicon Endo-Surgery franchise achieved operational growth of 6.3% over
prior year fiscal second quarter. This growth was mainly driven by the HARMONICä
technology business due to the success of newly launched products and the
underlying strength of the technology. Additional contributors to the growth in
the U.S. were the REALIZEâ Gastric Band and newly acquired ENSEALâ products.
The Ethicon franchise achieved operational growth of 9.7% over prior year fiscal
second quarter. This was attributable to growth in the biosurgical, meshes and
women's health product lines in addition to sales of newly acquired products
from the acquisitions of Omrix Biopharmaceuticals, Inc. and Mentor Corporation.
The growth was partially offset by the divestiture of the Professional Wound
Care business in the fiscal fourth quarter of 2008.
The Cordis franchise experienced an operational sales decline of 12.6% as
compared to the fiscal second quarter of 2008. This decline was caused by lower
sales of the CYPHER® Sirolimus-eluting Coronary Stent due to increased global
competition. These results were partially offset by growth of the Biosense
Webster business.
The Vision Care franchise achieved operational sales growth of 1.9%. ACUVUE®
OASYS™, 1-DAY ACUVUE®MOISTTM, and ACUVUE® OASYS™ for Astigmatism were the major
contributors to this growth offset by slowing category growth due to declines in
consumer spending.
The Diabetes Care franchise experienced an operational sales decline of 3.7% as
compared to the fiscal second quarter of 2008. This decline reflects the overall
decrease in the market due to current economic conditions. These results were
partially offset by growth of the Animas business, an insulin delivery business.
The Ortho-Clinical Diagnostics franchise achieved operational growth of 9.2%
over the fiscal second quarter of 2008. This growth was primarily attributable
to the launch of new VITROS 3600 and 5600 analyzers and donor screening
products.
Cost of Products Sold and Selling, Marketing and Administrative Expenses
Consolidated costs of products sold for each of the first fiscal six months of
2009 and 2008 were 28.7% as a percent of sales. The costs of products sold for
the fiscal second quarter of 2009 increased to 29.2% from 28.9% of sales in the
same period a year
ago. The increase was primarily due to the negative impact of product mix,
partially offset by cost containment initiatives across all the businesses.
Consolidated selling, marketing and administrative expenses for the first fiscal
six months of 2009 decreased to 31.1% from 32.6% of sales as compared to the
same period a year ago. Consolidated selling, marketing and administrative
expenses for the fiscal second quarter of 2009 decreased to 31.5% from 33.5% of
sales as compared to the same period a year ago. Decreases in the quarterly and
six month period were due to cost containment efforts across all the businesses.
Research & Development
Research activities represent a significant part of the Company's business.
These expenditures relate to the development of new products, improvement of
existing products, technical support of products and compliance with
governmental regulations for the protection of the consumer. Worldwide costs of
research activities, for the first fiscal six months of 2009 were $3.2 billion,
a decrease of 12.5% over the same period a year ago. Research and development
spending in the fiscal second quarter of 2009 was $1.6 billion, a decrease of
13.6% over the fiscal second quarter of 2008. The decreases as a percent to
sales in the quarterly and six month period were primarily due to changes to the
mix of businesses and increased efficiencies in Pharmaceutical research and
development activities.
In-Process Research & Development(IPR&D)
In the fiscal second quarter and the first fiscal six months of 2008, the
Company had $40 million of IPR&D charges with no tax benefit associated with the
acquisition of Amic AB.
Other (Income) Expense, Net
Other (income) expense, net is the account where the Company records gains and
losses related to the sale and write-down of certain equity securities of the
Johnson & Johnson Development Corporation, gains and losses on the disposal of
fixed assets, currency gains and losses, gains and losses relating to
non-controlling interests, litigation settlements, as well as royalty income.
The change in other (income) expense, net for the first fiscal six months and
the fiscal second quarter of 2009 was unfavorable as compared to the same
periods a year ago. The Company received a $270 million settlement payment from
Medtronic AVE, Inc. during the fiscal second quarter which was offset by several
smaller litigation matters as well as asset write-downs and other charges.
OPERATING PROFIT BY SEGMENT
Consumer Segment
Operating profit for the Consumer segment as a percent to sales in the first
fiscal six months of 2009 was 19.8% versus 17.4% for the same period a year ago.
Operating profit for the Consumer segment as a percent to sales in the fiscal
second quarter of 2009 was 18.0% versus 16.9% for the same period a year ago.
The primary driver of the improved operating profit for both the first fiscal
six months and the fiscal second quarter of 2009 was due to cost
containment initiatives related to selling, marketing and administrative
expenses.
Pharmaceutical Segment
Operating profit for the Pharmaceutical segment as a percent to sales in the
first fiscal six months of 2009 was 35.1% versus 35.3% for the same period a
year ago. Operating profit for the Pharmaceutical segment as a percent to sales
in the fiscal second quarter of 2009 was 30.9% versus 33.8% for the same period
a year ago. For both periods in 2009, operating profit decreased, as compared to
the same periods a year ago. The negative impact of product mix due to the loss
of exclusivity of the TOPAMAX® patent was the primary driver 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 first fiscal six months of 2009 was 33.9% versus 29.7% for the same
period a year ago. Operating profit for the Medical Devices and Diagnostics
segment as a percent to sales in the fiscal second quarter of 2009 was 35.5%
versus 28.0% for the same period a year ago. The primary driver of the
improvement in the operating profit margin in the Medical Devices and
Diagnostics segment for both periods in 2009 was due to favorable product mix,
manufacturing efficiencies and cost containment initiatives related to selling,
marketing and administrative expenses. Additionally, the Company received a
$270 million settlement payment from Medtronic AVE, Inc., which was partially
offset by asset write-downs and other charges in the fiscal second quarter of
2009.
Interest (Income) Expense
Interest income decreased in both the first fiscal six months and second quarter
of 2009 as compared to the same periods a year ago, due to lower rates of
interest earned, despite higher average cash balances. The ending balance of
cash, cash equivalents and marketable securities, was $14.7 billion at the end
of the fiscal second quarter of 2009. This is an increase of $1.6 billion from
the same period a year ago. The increase was primarily due to cash generated
from operating activities.
Interest expense was relatively flat in both the first fiscal six months and
fiscal second quarter of 2009 as compared to the same period a year ago. At the
end of the fiscal second quarter of 2009 the Company's debt position was
$13.6 billion compared to $13.9 billion from the same period a year ago.
Provision For Taxes on Income
The worldwide effective income tax rates for the first fiscal six months of 2009
and 2008 were 24.6% and 24.1%, respectively. The increase in the effective tax
rate was primarily due to a decline in taxable income in lower tax jurisdictions
relative to taxable income in higher tax jurisdictions partially offset by the
U.S. Research and Development tax credit which was not in effect in the first
fiscal six months of 2008.
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