|
Quotes & Info
|
| JNJ > SEC Filings for JNJ > Form 10-Q on 4-Nov-2008 | All Recent SEC Filings |
4-Nov-2008
Quarterly Report
Results of Operations
Analysis of Consolidated Sales
For the first fiscal nine months of 2008, worldwide sales were $48.6 billion, a
total increase of 7.6% including an operational increase of 3.0% over 2007 first
fiscal nine months sales of $45.1 billion. Currency had a positive impact of
4.6% for the period.
Sales by U.S. companies were $24.6 billion in the first fiscal nine months of 2008, which represented an increase of 1.8% over the same period last year. Sales by international companies were $23.9 billion, which represented a total increase of 14.3% including an operational increase of 4.3%, and a positive impact from currency of 10.0% over the first fiscal nine months of 2007.
Sales by companies in Europe achieved total growth of 12.6%, including an operational growth of 1.4% and a positive impact from currency of 11.2%. Sales by companies in the Western Hemisphere, excluding the U.S., achieved total growth of 18.2% including operational growth of 8.4% and a positive impact from currency of 9.8%. Sales by companies in the Asia-Pacific, Africa region posted sales growth of 15.5%, with operational growth of 7.8% and a positive impact from currency of 7.7%.
For the fiscal third quarter of 2008, worldwide sales were $15.9 billion, a total increase of 6.4% and an operational increase of 3.3%, over 2007 fiscal third quarter sales of $15.0 billion. Currency fluctuations positively impacted sales by 3.1% for the period.
Sales by U.S. companies were $7.9 billion in the fiscal third quarter of 2008, which represented an increase of 0.4%. Sales by international companies were $8.0 billion, which represented a total increase of 13.1%, including an operational increase of 6.5%, and a positive impact from currency of 6.6% over the fiscal third quarter of 2007.
Sales by companies in Europe achieved total growth of 8.3%, with operational growth of 1.0% and a positive impact from currency of 7.3%. Sales by companies in the Western Hemisphere, excluding the U.S., achieved total growth of 22.3%, operational growth of 15.3% and a positive impact from currency of 7.0%. Sales by companies in the Asia-Pacific, Africa region posted sales growth of 16.5%, with operational growth of 11.3% and a positive impact from currency of 5.2%.
Analysis of Sales by Business Segments
Consumer
Consumer segment sales in the first fiscal nine months of 2008 were $12.2
billion, an increase of 14.2% over the same period a year ago, with 8.7% of
operational growth and a positive currency impact of 5.5%. U.S. Consumer segment
sales increased by 10.5% while international sales achieved growth of 17.2%,
representing an operational increase of 7.3%, with a positive currency impact of
9.9%.
Major Consumer Franchise Sales - First Fiscal Nine Months
Operations
(Dollars in Millions) Sept. 28, 2008 Sept. 30, 2007 Total Change Change Currency Change
OTC Pharm & Nutr $ 4,438 $ 3,727 19.1 % 14.2 % 4.9 %
Skin Care 2,537 2,258 12.4 6.9 5.5
Baby Care 1,691 1,445 17.0 9.8 7.2
Women's Health 1,475 1,345 9.7 2.9 6.8
Oral Care 1,228 1,109 10.7 6.4 4.3
Wound Care/Other 830 799 3.9 (0.3 ) 4.2
Total $ 12,199 $ 10,683 14.2 % 8.7 % 5.5 %
|
Consumer segment sales in the fiscal third quarter of 2008 were $4.1 billion, an increase of 13.1% over the same period a year ago with 9.4% of operational growth and a positive currency impact of 3.7%. U.S. Consumer segment sales increased by 11.2% while international sales achieved growth of 14.7%, representing an operational increase of 8.1%, with a positive currency impact of 6.6%.
Major Consumer Franchise Sales - Fiscal Third Quarter
Operations
(Dollars in Millions) Sept. 28, 2008 Sept. 30, 2007 Total Change Change Currency Change
OTC Pharm & Nutr $ 1,439 $ 1,264 13.8 % 11.3 % 2.5 %
Skin Care 858 737 16.4 12.0 4.4
Baby Care 586 511 14.7 9.4 5.3
Women's Health 510 461 10.6 5.5 5.1
Oral Care 434 396 9.6 6.7 2.9
Wound Care/Other 272 254 7.1 4.2 2.9
Total $ 4,099 $ 3,623 13.1 % 9.4 % 3.7 %
|
The OTC Pharmaceuticals and Nutritionals franchise achieved operational growth of 11.3% over prior year fiscal third quarter. A major contributor was the continued success of over-the-counter ZYRTEC® in the U.S., which was launched during the fiscal first quarter of 2008. On October 7, 2008 the Company announced a voluntary labeling change on children's cough and cold medicines regarding usage for children under the age of 4 years, to encourage the safe, effective use of these products. These actions will not have a significant impact on sales for the OTC Pharmaceuticals and Nutritionals franchise.
The Baby Care franchise operational growth of 9.4% over prior year fiscal third quarter was the result of strong sales performance by wipes, haircare and powder product lines primarily in sales outside the U.S.
The Women's Health franchise operational growth of 5.5% over the prior year fiscal third quarter was primarily due to the successful launch of new products in the U.S.
The Oral Care franchise operational growth of 6.7% was driven by the strong growth of LISTERINE® mouthwash. The launch of the dissolvable whitening strips in the third quarter of 2007 impacted the U.S. growth comparisons for the quarter.
Pharmaceutical
Pharmaceutical segment sales in the first fiscal nine months of 2008 were $18.9
billion, a total increase of 2.2% over the same period a year ago with an
operational decline of 1.5% and an increase of 3.7% related to the positive
impact of currency. The U.S. Pharmaceutical sales decreased by 2.2% over the
same period a year ago. Total growth in international Pharmaceutical sales was
9.9%, an increase related to the positive impact of currency.
Major Pharmaceutical Product Revenues* - First Fiscal Nine Months
Operations
(Dollars in Millions) Sept. 28, 2008 Sept. 30, 2007 Total Change Change Currency Change
REMICADE® $ 2,862 $ 2,419 18.3 % 18.3 % - %
TOPAMAX® 2,051 1,801 13.9 12.1 1.8
PROCRIT®/EPREX® 1,900 2,257 (15.8 ) (19.8 ) 4.0
RISPERDAL®/Risperidone 1,841 2,546 (27.7 ) (30.0 ) 2.3
LEVAQUIN®/FLOXIN® 1,180 1,214 (2.8 ) (3.0 ) 0.2
RISPERDAL® CONSTA® 990 833 18.8 11.2 7.6
CONCERTA® 967 739 30.9 27.3 3.6
ACIPHEX®/PARIET® 884 1,010 (12.5 ) (16.9 ) 4.4
DURAGESIC®/Fentanyl Transdermal 764 900 (15.1 ) (21.0 ) 5.9
Other 5,443 4,750 14.6 8.2 6.4
Total $ 18,882 $ 18,469 2.2 % (1.5 )% 3.7 %
|
*Prior year amounts have been reclassified to conform to current presentation.
Pharmaceutical segment sales in the fiscal third quarter of 2008 were $6.1 billion, a total increase of 0.2% over the same period a year ago with an operational decline of 2.5% and an increase of 2.7% related to the positive impact of currency. U.S. Pharmaceutical sales decreased by 6.0% over the same period a year ago. Total growth in international Pharmaceutical sales was 10.3%, representing an operational increase of 3.3% with a positive currency impact of 7.0%.
Major Pharmaceutical Product Revenues* - Fiscal Third Quarter
Operations
(Dollars in Millions) Sept. 28, 2008 Sept. 30, 2007 Total Change Change Currency Change
REMICADE® $ 978 $ 819 19.4 % 19.4 % - %
TOPAMAX® 728 613 18.8 17.6 1.2
PROCRIT®/EPREX® 619 682 (9.2 ) (11.9 ) 2.7
CONCERTA® 398 231 72.3 66.4 5.9
RISPERDAL® CONSTA® 338 294 15.0 9.8 5.2
LEVAQUIN®/FLOXIN® 333 371 (10.2 ) (10.4 ) 0.2
RISPERDAL®/Risperidone 320 831 (61.5 ) (63.0 ) 1.5
ACIPHEX®/PARIET® 282 338 (16.6 ) (19.0 ) 2.4
DURAGESIC®/Fentanyl Transdermal 259 309 (16.2 ) (20.7 ) 4.5
Other 1,858 1,611 15.3 10.7 4.6
Total $ 6,113 $ 6,099 0.2 % (2.5 )% 2.7 %
|
*Prior year amounts have been reclassified to conform to current presentation.
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 19.4% over prior year fiscal third quarter. The U.S. sales growth was driven by market growth. An increase in export sales is due to the increased demand outside the U.S. and customer production planning needs. REMICADE® is competing in a market which is experiencing increased competition due to new entrants and the expansion of indications for existing competitors.
TOPAMAX® (topiramate), which has been approved for adjunctive and monotherapy use in epilepsy, as well as for the prophylactic treatment of migraines, achieved strong operational growth of 17.6% as compared to prior year fiscal third quarter. The growth was primarily due to increases in the migraine category partially offset by generic competition in certain markets outside the U.S. The patent for TOPAMAX® (topiramate) in the U.S. expired in September 2008. In July 2008, the U.S. Food and Drug Administration (FDA) granted pediatric exclusivity for TOPAMAX®, which extends market exclusivity in the U.S. until March 2009. The expiration of a product patent or loss of market exclusivity is likely to result in a significant reduction in sales. In the first fiscal nine months of 2008, U.S. sales of TOPAMAX® were $1.7 billion.
PROCRIT® (Epoetin alfa)/EPREX® (Epoetin alfa) experienced an operational sales decline of 11.9%, as compared to prior year fiscal third quarter. The decline in PROCRIT® sales was due to the declining markets for Erythropoiesis Stimulating Agents (ESAs) in the U.S. Outside the U.S., new competition and label reviews have contributed to the lower sales results for EPREX®. Discussions with European regulators regarding changes to the label for ESAs, including EPREX®, are underway. The FDA issued an order requiring a labeling supplement making specific revisions to the label for ESAs, including PROCRIT®. The label for PROCRIT® was updated July 30, based on review of emerging safety data for the use of ESAs in patients with cancer.
CONCERTA® (methylphenidate HCl), a product for the treatment of attention deficit hyperactivity disorder, achieved operational sales growth of 66.4% over the fiscal third quarter of 2007. Sales results in the fiscal third quarter of 2008 were favorably impacted by approximately $135 million, related to a change in the estimate of accrued rebates. Of the $135 million, $115 million relates to amounts recorded in prior years. An additional contributor to the sales growth was market growth. Although the original CONCERTA® patent expired in 2004, the FDA has not approved any generic version that is substitutable for CONCERTA®. Two parties have filed Abbreviated New Drug Applications (ANDAs) for generic versions of CONCERTA®, which are pending and may be approved at any time.
RISPERDAL® CONSTA® (risperidone), a long acting injectable for the treatment of schizophrenia, achieved operational growth of 9.8% over the fiscal third quarter of 2007. Strong growth was due to a positive shift from oral to injectable therapies outside the U.S.
LEVAQUIN®(levofloxacin)/FLOXIN®, RISPERDAL®(risperidone), ACIPHEX®/PARIET® and DURAGESIC®/Fentanyl Transdermal (fentanyl transdermal system) experienced operational declines of 10.4%, 63.0%, 19.0% and 20.7% respectively, versus the prior year. Generic competition continued to negatively impact the sales of these products.
Market exclusivity for RISPERDAL® oral in the U.S. expired on June 29, 2008 and Janssen, a Johnson & Johnson subsidiary, launched an authorized generic version of RISPERDAL® oral on June 30, 2008. Loss of market exclusivity for the RISPERDAL® oral patent has resulted in a significant reduction in sales in the U.S.
In the fiscal third quarter of 2008, Other Pharmaceutical sales achieved operational growth of 10.7% versus the prior year. The biggest contributor to the increase was VELCADE®, a treatment for relapse multiple myeloma, which was co-developed with Millenium Pharmaceuticals, Inc.
Medical Devices and Diagnostics
Medical Devices and Diagnostics segment sales in the first fiscal nine months of
2008 were $17.5 billion, an increase of 9.4% over the same period a year ago,
with 4.3% of this change due to operational increases and the remaining 5.1%
increase related to the positive impact of currency. The U.S. Medical Devices
and Diagnostics sales increase was 2.4% and the growth in international Medical
Devices and Diagnostics sales was 16.0%, which included operational increases of
6.0% and an increase of 10.0% related to the positive impact of currency.
Major Medical Devices and Diagnostics Franchise Sales* - First Fiscal Nine
Months
Operations
(Dollars in Millions) Sept. 28, 2008 Sept. 30, 2007 Total Change Change Currency Change
DEPUY® $ 3,737 $ 3,378 10.6 % 6.7 % 3.9 %
ETHICON ENDO-SURGERY® 3,169 2,770 14.4 8.7 5.7
ETHICON® 2,922 2,659 9.9 4.1 5.8
CORDIS® 2,413 2,557 (5.6 ) (10.7 ) 5.1
Diabetes Care 1,956 1,730 13.1 7.6 5.5
Vision Care 1,898 1,643 15.5 9.6 5.9
ORTHO-CLINICAL DIAGNOSTICS® 1,389 1,249 11.2 6.6 4.6
Total $ 17,484 $ 15,986 9.4 % 4.3 % 5.1 %
|
*Prior year amounts have been reclassified to conform to current presentation.
Medical Devices and Diagnostics segment sales in the fiscal third quarter of 2008 were $5.7 billion, an increase of 8.8% over the same period a year ago, with 5.6% of this change due to operational growth and the remaining 3.2% increase related to the positive impact of currency. The U.S. Medical Devices and Diagnostics sales increase was 3.1% and the growth in international Medical Devices and Diagnostics sales was 14.3%, which included operational growth of 8.0% and an increase of 6.3% related to the positive impact of currency.
Major Medical Devices and Diagnostics Franchise Sales* - Fiscal Third Quarter
Operations
(Dollars in Millions) Sept. 28, 2008 Sept. 30, 2007 Total Change Change Currency Change
DEPUY® $ 1,195 $ 1,086 10.0 % 8.0 % 2.0 %
ETHICON ENDO-SURGERY® 1,042 922 13.0 9.5 3.5
ETHICON® 957 881 8.6 5.2 3.4
CORDIS® 726 777 (6.6 ) (10.2 ) 3.6
Diabetes Care 667 585 14.0 10.3 3.7
Vision Care 652 577 13.0 9.0 4.0
ORTHO-CLINICAL DIAGNOSTICS® 470 420 11.9 9.0 2.9
Total $ 5,709 $ 5,248 8.8 % 5.6 % 3.2 %
|
*Prior year amounts have been reclassified to conform to current presentation.
The DePuy franchise achieved operational growth of 8.0% over the same period a year ago. This growth was primarily due to strong performance by the hip product line. An additional contributor to the growth was strong performance in the Mitek sports medicine product line primarily due to new product launches.
The Ethicon Endo-Surgery franchise achieved operational growth of 9.5% over prior year fiscal third quarter. This growth was mainly driven by the HARMONIC™ business due to the success of newly launched products. Additional contributors to the growth were the REALIZE® Gastric Band in the U.S. and endoscopy products outside the U.S.
The Ethicon franchise achieved operational growth of 5.2% from the same period in the prior year resulting from solid growth in Hemostasis and biosurgicals.
The Cordis franchise experienced an operational sales decline of 10.2% over the fiscal third quarter of 2007. This decline was caused by lower sales of the CYPHER® Sirolimus-eluting Coronary Stent. Loss of market share for the CYPHER® Sirolimus-eluting Coronary Stent is due to increased competition on a global basis. These results were partially offset by growth of the Biosense Webster business.
The Diabetes Care franchise achieved operational growth of 10.3% over the fiscal third quarter of 2007 reflecting the continued success of the ONETOUCH® ULTRA® product lines and the growth of the Animas business.
The Vision Care franchise achieved operational sales growth of 9.0%. ACUVUE® OASYS™, 1-DAY ACUVUE®MOIST™, and ACUVUE® lenses for Astigmatism were the major contributors to this growth.
The Ortho-Clinical Diagnostics franchise achieved operational growth of 9.0% over the fiscal third quarter of 2007 resulting from strong growth in Immunohematology and Immunodiagnostics products.
Cost of Products Sold and Selling, Marketing and Administrative Expenses Consolidated costs of products sold for the first fiscal nine months of 2008 increased to 29.1% from 28.8% of sales as compared to the same period a year ago. The cost of products sold for the fiscal third quarter of 2008 increased to 30.0% from 28.5% of sales in the same period a year ago. The increase in both the first fiscal nine months and the fiscal third quarter was primarily due to the change in the mix of businesses, with stronger sales growth in the Consumer business and lower sales growth in the Pharmaceutical business, as well as inventory write-offs in the Pharmaceutical business.
Consolidated selling, marketing and administrative expenses were 32.6% for both the first fiscal nine months of 2008 and 2007. Consolidated selling, marketing and administrative expenses for the fiscal third quarter of 2008 decreased to 32.6% from 32.7% of sales in the same period a year ago. Decreases in the fiscal third quarter were primarily due to cost containment efforts offsetting the impact of the change in the mix of 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 nine months of 2008 were
$5.5 billion, an increase of 2.2% over the same period a year ago. Research and
development spending in the fiscal third quarter of 2008 was $1.9 billion, an
increase of 1.5% over the fiscal third quarter of 2007. As a percent to sales,
the level of research and development spending decreased for both the fiscal
third quarter and the first fiscal nine months of 2008 as compared to the same
period a year ago. The decreases as a percent to sales in the quarterly and nine
month periods were primarily due to changes to the mix of businesses and
increased efficiencies in the Pharmaceutical research and development support.
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 first fiscal nine months of 2008 related to the acquisition of Amic AB.
In the fiscal third quarter of 2007, the Company had no IPR&D charges. IPR&D charges of $807 million before and after tax were recorded during the first fiscal nine months of 2007 related to the acquisitions of Conor Medsystems Inc.
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, minority interests, litigation
settlements, as well as royalty income. The favorable change in other (income)
expense, net for the fiscal third quarter of 2008 as compared to the fiscal
third quarter of 2007 was primarily due to a settlement payment of $200 million
received from Amgen in the fiscal third quarter of 2008. The favorable change in
other (income) expense, net for the first fiscal nine months of 2008 as compared
to the same period a year ago was $34 million. This was primarily due to the
settlement payment of $200 million received from Amgen in the fiscal third
quarter of 2008 versus the net gain of $175 million related to the divestiture
of certain consumer brands recorded in the fiscal first quarter of 2007.
Pharmaceutical Segment
Operating profit for the Pharmaceutical segment as a percent to sales in the
first fiscal nine months of 2008 was 34.5% versus 32.5% over the same period a
year ago. Operating profit as a percent to sales in the fiscal third quarter of
2008 was 32.8% versus 26.1% over the same period a year ago. For both periods in
2008, operating profit increased, as compared to the same periods a year ago.
This was due to the restructuring charges of $429 million recorded during the
fiscal third quarter of 2007 offset by the change in product mix, primarily due
to the RISPERDAL® oral loss of exclusivity during 2008. 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 first fiscal nine months of 2008 was 29.5% versus 21.1% over the
same period a year ago. Operating profit as a percent to sales in the fiscal
third quarter of 2008 was 29.0% versus 21.7% over 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 2008 versus the same
period a year ago was due to favorable mix and manufacturing efficiencies in
2008 as well as the restructuring charges of $301 million recorded during the
. . .
|
|