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| JNJ > SEC Filings for JNJ > Form 10-Q on 4-Nov-2009 | All Recent SEC Filings |
4-Nov-2009
Quarterly Report
Results of Operations
Analysis of Consolidated Sales
For the fiscal nine months of 2009, worldwide sales were $45.3 billion, a
decrease of 6.6% including an operational decrease of 1.8% as compared to 2008
fiscal nine months sales of $48.6 billion. Currency had a negative impact of
4.8% on total reported fiscal nine months 2009 sales.
Sales by U.S. companies were $23.0 billion in the fiscal nine months of 2009,
which represented a decrease of 6.6% as compared to the same period last year.
Sales by international companies were $22.3 billion, which represented a total
decrease of 6.7% including an operational increase of 3.1%, and a negative
impact from currency of 9.8% as compared to the fiscal nine months sales of
2008.
Sales by companies in Europe experienced a sales decline of 10.9%, including
operational growth of 1.2% and a negative impact from currency of 12.1%. Sales
by companies in the Western Hemisphere, excluding the U.S., experienced a sales
decline of 9.3% including operational growth of 5.8% and a negative impact from
currency of 15.1%. Sales by companies in the Asia-Pacific, Africa region
achieved sales growth of 2.6%, including operational growth of 5.1% and a
negative impact from currency of 2.5%.
For the fiscal third quarter of 2009, worldwide sales were $15.1 billion, a
decrease of 5.3% including an operational decrease of
2.8% as compared to 2008 fiscal third quarter sales of $15.9 billion. Currency negatively impacted sales by 2.5% for the fiscal third quarter of 2009.
Sales by U.S. companies were $7.3 billion in the fiscal third quarter of 2009,
which represented a decrease of 8.1% as compared to the same period last year.
Sales by international companies were $7.8 billion, which represented a total
decrease of 2.5% including an operational increase of 2.4%, and a negative
impact from currency of 4.9% as compared to the fiscal third quarter sales of
2008.
Sales by companies in Europe experienced a sales decline of 4.8%, including
operational growth of 2.1% and a negative impact from currency of 6.9%. Sales by
companies in the Western Hemisphere, excluding the U.S., experienced a sales
decline of 8.4% including operational growth of 1.5% and a negative impact from
currency of 9.9%. Sales by companies in the Asia-Pacific, Africa region achieved
sales growth of 5.0%, including operational growth of 3.5% and an increase of
1.5% related to the positive impact of currency.
Analysis of Sales by Business Segments
Consumer
Consumer segment sales in the fiscal nine months of 2009 were $11.5 billion, a
decrease of 5.3% as compared to the same period a year ago, including
operational growth of 1.0% and a negative currency impact of 6.3%. U.S. Consumer
segment sales declined by 3.0% while international sales experienced an overall
sales decline of 7.1%, including operational growth of 4.1% and a negative
currency impact of 11.2%.
Major Consumer Franchise Sales - Fiscal Nine Months
Sept. 27, Sept. 28, Total Operations Currency
(Dollars in Millions) 2009 2008 Change Change Change
OTC Pharm & Nutr $ 4,056 $ 4,438 (8.6 )% (2.8 )% (5.8 )%
Skin Care 2,517 2,537 (0.8 ) 5.0 (5.8 )
Baby Care 1,541 1,691 (8.9 ) (1.4 ) (7.5 )
Women's Health 1,406 1,475 (4.7 ) 3.1 (7.8 )
Oral Care 1,161 1,228 (5.5 ) 1.1 (6.6 )
Wound Care/Other 873 830 5.2 10.5 (5.3 )
Total $ 11,554 $ 12,199 (5.3 )% 1.0 % (6.3 )%
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Consumer segment sales in the fiscal third quarter of 2009 were $4.0 billion, a decrease of 2.7% over the same period a year ago, including operational growth of 1.1% and a negative currency impact of 3.8%. U.S. Consumer segment sales declined by 4.4% while international sales experienced an overall sales decline of 1.4%, including operational growth of 5.2%, and a negative currency impact of 6.6%.
Major Consumer Franchise Sales - Fiscal Third Quarters
Sept. 27, Sept. 28, Total Operations Currency
(Dollars in Millions) 2009 2008 Change Change Change
OTC Pharm & Nutr $ 1,398 $ 1,439 (2.8 )% 0.5 % (3.3 )%
Skin Care 842 858 (1.9 ) 1.3 (3.2 )
Baby Care 544 586 (7.2 ) (2.6 ) (4.6 )
Women's Health 502 510 (1.6 ) 3.6 (5.2 )
Oral Care 410 434 (5.5 ) (1.4 ) (4.1 )
Wound Care/Other 293 272 7.7 10.5 (2.8 )
Total $ 3,989 $ 4,099 (2.7 )% 1.1 % (3.8 )%
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The OTC Pharmaceuticals and Nutritionals franchise achieved operational growth
of 0.5% as compared to prior year fiscal third quarter. Increased sales in
anticipation of the flu season have been partially offset by lower seasonal
trade inventory builds in allergy. Increased competitive pressures including
private label have negatively impacted sales. The U.S. Food and Drug
Administration (FDA) is currently considering certain recommendations made by
its advisory committee for reducing the potential for overdose with
acetaminophen, the active ingredient in TYLENOLâ. The Company has provided the
FDA with its own recommendations and will continue to be actively engaged with
the FDA on this topic.
The Skin Care franchise achieved operational growth of 1.3%. Sales grew in the
AVEENOâ, Dabao and Vendome product lines.
The Baby Care franchise experienced an operational decline of 2.6% over prior
year fiscal third quarter. This was primarily due to lower sales for
Babycenter.com as a result of exiting the online retail business. This was
partially offset by growth in the haircare and baby oil product lines outside
the U.S.
The Women's Health Franchise operational growth of 3.6% was primarily due to
sales associated with the buyout of a joint venture partner in France in the
fiscal first quarter of 2009. Prior to the buyout of the joint venture partner,
sales by the joint venture were not recorded as part of the Company's sales to
customers.
The Oral Care franchise experienced an operational decline of 1.4% due to
softness in the category in the U.S. partially offset by growth of LISTERINEâ
mouthwash outside the U.S.
The Wound Care/Other franchise operational growth of 10.5% was primarily due to
the recent acquisitions in the Wellness and Prevention platform and sales
associated with the buyout of a joint venture partner in France in the fiscal
first quarter of 2009. Prior to the buyout of the joint venture partner, sales
by the joint venture were not recorded as part of the Company's sales to
customers.
Pharmaceutical
Pharmaceutical segment sales in the fiscal nine months of 2009 were
$16.5 billion, a total decrease of 12.5% as compared to the same period a year
ago with an operational decline of 8.5% and a decrease of 4.0% related to the
negative impact of currency. U.S. Pharmaceutical sales declined by 14.9% as
compared to the same period a year ago. International Pharmaceutical sales
experienced a sales decline of 8.8%, representing an operational increase of
1.4%, and a decrease of 10.2% related to the negative impact of currency. Major Pharmaceutical Product Revenues - Fiscal Nine Months
Sept. 27, Sept. 28, Total Operations Currency
(Dollars in Millions) 2009 2008 Change Change Change
REMICADEâ $ 3,166 $ 2,862 10.6 % 10.6 % - %
PROCRITâ/EPREXâ 1,669 1,900 (12.2 ) (7.6 ) (4.6 )
LEVAQUINâ/FLOXINâ 1,098 1,180 (6.9 ) (6.0 ) (0.9 )
RISPERDALâ CONSTAâ 1,026 990 3.6 13.0 (9.4 )
TOPAMAXâ 959 2,051 (53.2 ) (50.9 ) (2.3 )
CONCERTAâ 945 967 (2.3 ) 1.3 (3.6 )
ACIPHEXâ/PARIETâ 784 884 (11.3 ) (5.3 ) (6.0 )
RISPERDALâ/Risperidone 706 1,841 (61.7 ) (60.4 ) (1.3 )
DURAGESICâ/Fentanyl Transdermal 655 764 (14.3 ) (8.0 ) (6.3 )
Other 5,519 5,443 1.4 8.1 (6.7 )
Total $ 16,527 $ 18,882 (12.5 )% (8.5 )% (4.0 )%
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Pharmaceutical segment sales in the fiscal third quarter of 2009 were
$5.3 billion, a total decrease of 14.1% over the same period a year ago with an
operational decline of 11.9% and a decrease of 2.2% related to the negative
impact of currency. U.S. Pharmaceutical sales decreased by 19.2% over the same
period a year ago. International Pharmaceutical sales experienced a sales
decline of 7.1%, representing an operational decline of 1.9%, and a decrease of
5.2% related to the negative impact of currency.
Major Pharmaceutical Product Revenues - Fiscal Third Quarters
Sept. 27, Sept. 28, Total Operations Currency
(Dollars in Millions) 2009 2008 Change Change Change
REMICADEâ $ 1,036 $ 978 5.9 % 5.9 % - %
PROCRITâ/EPREXâ 542 619 (12.4 ) (10.0 ) (2.4 )
RISPERDALâ CONSTAâ 353 338 4.4 9.9 (5.5 )
LEVAQUINâ/FLOXINâ 311 333 (6.6 ) (5.7 ) (0.9 )
CONCERTAâ 284 398 (28.6 ) (27.2 ) (1.4 )
ACIPHEXâ/PARIETâ 261 282 (7.4 ) (4.4 ) (3.0 )
DURAGESICâ/Fentanyl Transdermal 206 259 (20.5 ) (18.3 ) (2.2 )
RISPERDALâ/Risperidone 192 320 (40.0 ) (40.4 ) 0.4
TOPAMAXâ 175 728 (76.0 ) (74.7 ) (1.3 )
Other 1,889 1,858 1.7 5.5 (3.8 )
Total $ 5,249 $ 6,113 (14.1 )% (11.9 )% (2.2 )%
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REMICADEâ (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 5.9% over prior year fiscal third quarter. Sales in the U.S. market grew 5.7% versus the prior year primarily driven by market growth. U.S. export sales grew 5.1% versus the prior year fiscal third quarter primarily driven by increased demand outside the U.S. and inventory adjustments based on customer production planning needs.
U.S. export sales operational growth for the fiscal nine months of 2009 versus
the same period a year ago was 14.3%, which the Company believes is more
reflective of actual consumption in the three fiscal quarters of 2009. REMICADE®
is competing in a market which is experiencing increased competition due to new
entrants and the expansion of indications for existing competitors.
PROCRITâ (Epoetin alfa) /EPREXâ (Epoetin alfa), experienced an operational sales
decline of 10.0%, as compared to prior year fiscal third quarter. The decline in
PROCRITâ sales was due to the declining markets for Erythropoiesis Stimulating
Agents (ESAs) in the U.S. Outside the U.S., increased competition has
contributed to the lower sales results for EPREXâ.
RISPERDAL® CONSTA® (risperidone), a long-acting injectable for the treatment of
schizophrenia, achieved operational growth of 9.9% over the fiscal third quarter
of 2008. The growth was primarily due to increased share and the launch of
RISPERDAL® CONSTA® in Japan earlier in the year.
LEVAQUIN®(levofloxacin)/FLOXINâ(ofloxacin), experienced an operational decline
of 5.7% over the fiscal third quarter of 2008 primarily due to increased
competition from generic products.
CONCERTAâ (methylphenidate HCl), a product for the treatment of attention
deficit hyperactivity disorder, experienced an operational sales decline of
27.2% over the fiscal third quarter of 2008 primarily due to a reserve reversal
of $135 million in the third quarter of 2008 related to sales outside the U.S.
Growth in the U.S. was due to market growth. Although the original CONCERTAâ
patent expired in 2004, the FDA has not approved any generic version that is
substitutable for CONCERTAâ. Parties have filed Abbreviated New Drug
Applications (ANDAs) for generic versions of CONCERTAâ, which are pending and
may be approved at any time.
ACIPHEXâ/PARIETâ, experienced an operational decline of 4.4% over the fiscal
third quarter of 2008 primarily due to generic competition.
DURAGESIC®/Fentanyl Transdermal (fentanyl transdermal system), experienced an
operational decline of 18.3% due to continued generic competition.
RISPERDAL®(risperidone), a medication that treats the symptoms of schizophrenia,
bipolar mania and irritability associated with autistic behavior in indicated
patients, experienced an operational decline of 40.4% in the fiscal third
quarter of 2009 versus the same period in the prior year. Market exclusivity for
RISPERDAL® oral in the U.S. expired on June 29, 2008. Loss of market exclusivity
for the RISPERDAL® oral patent has resulted in a significant reduction in sales
in the U.S. In 2008, full year U.S. sales of RISPERDAL® oral were $1.3 billion.
U.S. sales of RISPERDAL®oral were $1.1 billion and $0.2 billion in the first
half and the second half of the 2008 fiscal year, respectively,
and $0.2 billion in the fiscal nine months of the 2009 fiscal year.
TOPAMAX® (topiramate), which has been approved for adjunctive and monotherapy
use in epilepsy, as well as for the prophylactic treatment of migraines,
experienced an operational decline of 74.7% as compared to prior year fiscal
third quarter. Marketing exclusivity for TOPAMAX® (topiramate) in the U.S.
expired in March 2009 and multiple generics have entered the market. Loss of
market exclusivity for the TOPAMAX® patent has resulted in a significant
reduction in sales in the U.S. In 2008, full year U.S. sales of TOPAMAX® were
$2.3 billion. U.S. sales of TOPAMAX® were $0.5 billion and $0.6 billion in the
fiscal first quarter and the fiscal nine months of 2009 respectively.
In the fiscal third quarter of 2009, Other Pharmaceutical sales achieved
operational growth of 5.5% versus the prior year. Contributors to the increase
were sales of VELCADEâ (bortezomib), a treatment for multiple myeloma, PREZISTAâ
(darunavir), for the treatment of HIV/AIDS patients and INVEGAâ (paliperidone),
a once-daily atypical antipsychotic. The growth was partially offset by the
impact of a generic version of ORTHO TRI-CYCLEN® LO shipped by a competitor.
Subsequently, the generic manufacturer recognized the validity of the patent,
paid damages for its infringing sales and ceased further shipments of the
product.
Medical Devices and Diagnostics
Medical Devices and Diagnostics segment sales in the fiscal nine months of 2009
were $17.3 billion, a decrease of 1.3% as compared to the same period a year
ago, with 3.3% of this change due to operational increases and a decrease of
4.6% related to the negative impact of currency. The U.S. Medical Devices and
Diagnostics sales increase was 3.0% and the decline in international Medical
Devices and Diagnostics sales was 4.8%, which included operational increases of
3.7% and a decrease of 8.5% related to the negative impact of currency.
Major Medical Devices and Diagnostics Franchise Sales* - Fiscal Nine Months
Sept. 27, Sept. 28, Total Operations Currency
(Dollars in Millions) 2009 2008 Change Change Change
DEPUY® $ 3,899 $ 3,846 1.4 % 6.7 % (5.3 )%
ETHICON ENDO-SURGERY® 3,236 3,169 2.1 7.7 (5.6 )
ETHICON® 3,013 2,922 3.1 9.3 (6.2 )
CORDIS® 1,982 2,304 (14.0 ) (10.9 ) (3.1 )
Vision Care 1,888 1,898 (0.5 ) 0.9 (1.4 )
Diabetes Care 1,785 1,956 (8.7 ) (4.1 ) (4.6 )
ORTHO-CLINICAL DIAGNOSTICS® 1,462 1,389 5.3 9.3 (4.0 )
Total $ 17,265 $ 17,484 (1.3 )% 3.3 % (4.6 )%
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* Prior year amounts have been reclassified to conform to current presentation.
Medical Devices and Diagnostics segment sales in the fiscal third quarter of 2009 were $5.8 billion, an increase of 2.3% as compared to the same period a year ago, with 4.1% of this change due to operational increases and a decrease of 1.8% related to the negative impact of currency. The U.S. Medical Devices and Diagnostics sales growth was 4.5% and the increase in international Medical Devices and Diagnostics sales was 0.5%, which included operational increases of 3.8% and a decrease of 3.3% related to the negative impact of currency. Major Medical Devices and Diagnostics Franchise Sales* - Fiscal Third Quarters
Sept. 27, Sept. 28, Total Operations Currency
(Dollars in Millions) 2009 2008 Change Change Change
DEPUY® $ 1,284 $ 1,231 4.3 % 6.7 % (2.4 )%
ETHICON ENDO-SURGERY® 1,106 1,042 6.1 8.4 (2.3 )
ETHICON® 1,019 957 6.5 9.4 (2.9 )
Vision Care 659 652 1.1 0.2 0.9
CORDIS® 640 690 (7.2 ) (6.6 ) (0.6 )
Diabetes Care 634 667 (4.9 ) (2.7 ) (2.2 )
ORTHO-CLINICAL DIAGNOSTICS® 501 470 6.6 8.2 (1.6 )
Total $ 5,843 $ 5,709 2.3 % 4.1 % (1.8 )%
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* Prior year amounts have been reclassified to conform to current presentation.
The DePuy franchise achieved operational growth of 6.7% over the same period a
year ago. This was primarily due to growth in the spine, hip and knee product
lines. Additionally, new product launches in the Mitek sports medicine product
line contributed to the growth.
The Ethicon Endo-Surgery franchise achieved operational growth of 8.4% over
prior year fiscal third quarter. This was attributable to growth in the
Endo-Mechanical, HARMONICä, ENSEALâ and Advanced Sterilization product lines.
The Ethicon franchise achieved operational growth of 9.4% over prior year fiscal
third quarter. This was attributable to growth in the biosurgical and mesh
product lines in addition to sales of newly acquired products from the
acquisitions of Omrix Biopharmaceuticals, Inc. and Mentor Corporation. The
growth was partially offset by the divestiture of the Professional Wound Care
business of Ethicon, Inc. in the fiscal fourth quarter of 2008.
The Vision Care franchise achieved operational sales growth of 0.2%. ACUVUE®
OASYS™, ACUVUE® OASYS™ for Astigmatism and 1-DAY ACUVUE® TruEyeTM outside the
U.S. were the major contributors to
this growth offset by slowing category growth due to declines in consumer
spending.
The Cordis franchise experienced an operational sales decline of 6.6% as
compared to the fiscal third quarter of 2008. This decline was caused by lower
sales of the CYPHER® Sirolimus-eluting Coronary Stent due to increased global
competition. This decline was partially offset by growth in balloons and the
Biosense Webster business.
The Diabetes Care franchise experienced an operational sales decline of 2.7% as
compared to the fiscal third quarter of 2008. This decline reflects the overall
decrease in consumer spending. These results were partially offset by growth of
the Animas business, an insulin delivery business.
The Ortho-Clinical Diagnostics franchise achieved operational growth of 8.2%
over the fiscal third quarter of 2008. This growth was primarily attributable to
the recent launch of the VITROS 3600 and 5600 analyzers.
Cost of Products Sold and Selling, Marketing and Administrative Expenses
Consolidated costs of products sold for the fiscal nine months of 2009 decreased
to 29.0% from 29.1% of sales as compared to the same period a year ago. The
costs of products sold for the fiscal third quarter of 2009 decreased to 29.4%
from 30.0% of sales in the same period a year ago. Decreases in the quarterly
and nine month periods were due to cost containment initiatives across all the
businesses partially offset by the negative impact of product mix. Additionally,
the fiscal third quarter of 2008 included inventory write-offs in the
Pharmaceutical business.
Consolidated selling, marketing and administrative expenses for the fiscal nine
months of 2009 decreased to 31.3% from 32.6% of sales as compared to the same
period a year ago. Consolidated selling, marketing and administrative expenses
for the fiscal third quarter of 2009 decreased to 31.6% from 32.6% of sales as
compared to the same period a year ago. Decreases in the quarterly and nine
month periods were due to cost containment efforts across all the businesses.
Research & Development
Research activities represent a significant part of the 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 fiscal nine months of 2009 were $4.8 billion, a
decrease of 12.7% over the same period a year ago. Research and development
spending in the fiscal third quarter of 2009 was $1.6 billion, a decrease of
13.1% over the fiscal third quarter of 2008. The decreases as a percent to sales
in the quarterly and nine month periods were primarily due to changes in
the mix of businesses and increased efficiencies in Pharmaceutical research and
development activities.
In-Process Research & Development(IPR&D)
In the fiscal third quarter of 2008, the Company had no IPR&D charges. IPR&D
charges of $40 million before and after tax were recorded during the fiscal nine
months of 2008 related to the acquisition of Amic AB.
Other (Income) Expense, Net
Other (income) expense, net is the account where the Company records gains and
losses related to the sale and write-down of certain equity securities of the
Johnson & Johnson Development Corporation, gains and losses on the disposal of
fixed assets, currency gains and losses, gains and losses relating to
non-controlling interests, litigation settlements, as well as royalty income.
The change in other (income) expense, net for the fiscal nine months and the
fiscal third quarter of 2009 was unfavorable as compared to the same periods a
year ago. The Company received a settlement payment of $200 million from Amgen
Inc. in the fiscal third quarter of 2008. The Company recorded a net settlement
payment of $115 million from Medtronic AVE, Inc. during the fiscal third quarter
of 2009 which was partially offset by other Corporate charges. A $270 million
settlement payment from Medtronic AVE, Inc. during the fiscal second quarter of
2009 was offset by several smaller litigation matters as well as asset
write-downs and other charges.
OPERATING PROFIT BY SEGMENT
Consumer Segment
Operating profit for the Consumer segment as a percent to sales in the fiscal
nine months of 2009 was 20.0% versus 17.8% for the same period a year ago.
Operating profit for the Consumer segment as a percent to sales in the fiscal
third quarter of 2009 was 20.4% versus 18.6% for the same period a year ago. The
primary driver of the improved operating profit for both the fiscal nine months
and the fiscal third quarter of 2009 was due to cost containment initiatives
related to selling, marketing and administrative expenses.
Pharmaceutical Segment
Operating profit for the Pharmaceutical segment as a percent to sales in the
fiscal nine months of 2009 was 33.9% versus 34.5% for the same period a year
ago. Operating profit for the Pharmaceutical segment as a percent to sales in
the fiscal third quarter of 2009 was 31.2% versus 32.8% for the same period a
year ago. For both periods in 2009, operating profit decreased, as compared to
the same periods a year ago. The negative impact of product mix due to the loss
of exclusivity of the TOPAMAX® patent and the RISPERADAL® oral patent was the
primary driver of the decreased operating profit. Additionally, the fiscal third
quarter of 2008 included a settlement of $200 million received from Amgen
partially offset by inventory write-offs.
Medical Devices and Diagnostics Segment
Operating profit for the Medical Devices and Diagnostics segment as a percent to
sales in the fiscal nine months of 2009 was 34.1% versus 29.5% for the same
period a year ago. Operating profit for the Medical Devices and Diagnostics
segment as a percent to sales in the fiscal third quarter of 2009 was 34.5%
versus 29.0% for the same period a year ago. The primary driver of the
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