Media Release
Basel, 2 February 2005
Roche
in 2004: Net income doubled — further significant improvement in operating profitability
and financial position
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Roche
Group in 2004
• Sales show double-digit increase of 12% in local currencies (9%
in Swiss francs; 18% in US dollars) to 29.5 billion Swiss francs* — growth well above the market average
• Operating profit increases 24% in local currencies (20% in Swiss francs) to nearly
7 billion Swiss francs**
• Operating profit margin improves for third consecutive year:
up 2.2 percentage points to 23.5%**
• Net income more than doubles to 6.6 billion Swiss
francs
• Board to propose 18th consecutive dividend increase, 21% to 2 Swiss francs
•
Substantial increase in net liquidity, from 5.9 to 11.7 billion Swiss francs
• Sale of
Consumer Health completes strategic refocusing process
Roche
Pharmaceuticals in 2004
• Sales increase 13% in local currencies (10% in Swiss
francs), well ahead of the global market
• Operating profit margin (before exceptional
items) up 1.9 percentage points to 25.7%
• Strong demand for Avastin and established
oncology products
Roche Diagnostics in 2004
•
Market share expanded further as sales grow 8% in local currencies (6% in Swiss francs)
•
Operating profit margin (before exceptional items) increases by a substantial 2.4 percentage points
to 21.4%
• Roche becomes first company to launch chip-based test for broad diagnostic
use
Outlook
• Roche expects local-currency
sales in both divisions to continue to outpace market growth in 2005
• Pharma: operating
profit margin for 2005 (before exceptional items) expected to be broadly in line with that in 2004,
despite investments in product launches (Avastin, Tarceva, Boniva) and significant development activities
•
Diagnostics: additional progress towards achieving an operating profit margin of around 23% (before
exceptional items) in 2006
• A balanced financial income in 2005
* Basis: continuing businesses / ** Basis: continuing businesses before exceptional items
Commenting on the full-year results for 2004, Roche Chairman and CEO Franz B. Humer said, ‘We achieved — and in some cases even exceeded — our ambitious goals for the year. Our operating profit was the highest ever in Roche’s history. We gained marketing approvals for two breakthrough anticancer medicines. And we intensified the focus on our core capabilities. Thanks to a very strong operating performance and the gain from the sale of our consumer health business, net income more than doubled, reaching 6.6 billion Swiss francs. Given the tremendous need for new and better medical solutions and the explosive progress of science and technology, the outlook for continued growth is good despite today’s challenging marketplace. We thus expect sales in both divisions to continue to grow faster than the market this year.’
Key figures in millions of CHF
Roche | Group | Continuing businesses a) | ||||||
% change | % change | % change | % change |
|||||
2004 | 2003 | in CHF | in local cur. | 2004 | 2003 | in CHF | in local cur. |
|
Sales | 31,273 | 31,220 | 0 | 3 | 29,522 | 27,190 | 9 | 12 |
EBITDAb) | 9,566 | 8,609 | 11 | 15 | 9,231 | 8,038 | 15 | 19 |
Operating profit before exceptional items | 7,254 | 6,268 | 16 | 20 | 6,950 | 5,793 | 20 | 24 |
Operating profit | 8,979 | 5,592 | 61 | 65 | 6,179 | 5,520 | 12 | 16 |
Net income before exceptional items | - | - | - | - | 4,343 | 3,371 | 29 | - |
Net income | 6,641 | 3,069 | 116 | - | 4,339 | 3,074 | 41 | - |
Research and Development | 5,093 | 4,766 | 7 | 11 | 5,053 | 4,624 | 9 | 14 |
Additions to property, plant and equipment | 2,357 | 2,265 | 4 | 8 | 2,351 | 2,080 | 13 | 17 |
Diluted earnings per share and non-voting equity security (in CHF) | 7.81 | 3.61 | 116 | - | 5.09 | 3.62 | 41 | - |
Dividend per share and non-voting equity security (in CHF)c) | 2.00 | 1.65 | 21 | - | - | - | - | - |
Employees | 64,703 | 65,357 | -1 | 64,594 | 63,267 | 2 |
a)
Continuing businesses includes the Pharmaceuticals and Diagnostics businesses, treasury and other corporate
activities. Consumer Health (OTC) and Vitamins and Fine Chemicals are reported as discontinuing businesses.
b)
EBITDA: Earnings before exceptional items and before interest and other financial income, tax, depreciation
and amortisation, including impairment. This corresponds to operating profit before exceptional items
and before depreciation and amortisation, including impairment.
c) 2004 dividend as proposed
by the Board of Directors.
Roche Group
Sales revenues from the Group’s continuing businesses
rose to 29.5 billion Swiss francs in 2004, an increase of 12% in local currencies (9% in Swiss francs)
and 18% in US dollars; these results exclude the consumer health (OTC) businesses and the vitamins and
fine chemicals business, which was sold in 2003. Both Roche divisions, Pharmaceuticals and Diagnostics,
grew significantly faster than the global market. Prescription drug sales advanced 13% in local currencies
(10% in Swiss francs), with positive contributions to growth coming from the Roche Prescription subdivision
(+8% in local currencies) and from the strategic alliances with Genentech in the United States (+45%
in US dollars) and Chugai in Japan (+3% in Japanese yen). In the Diagnostics Division sales rose 8%
in local currencies (6% in Swiss francs), led by the division’s diabetes care, molecular diagnostics
and immunochemistry businesses, which grew significantly ahead of their markets.
Significant
improvement in operating profit and operating margins
Operating profit from continuing
businesses was up substantially for the year, advancing 24% in local currencies (20% in Swiss francs)
to nearly 7 billion Swiss francs (before exceptional items). The operating profit margins in both divisions
again increased sharply. In the Pharmaceuticals Division it rose 1.9 percentage points to 25.7%, while
the margin in the Diagnostics Division gained 2.4 percentage points to reach 21.4%. Strong sales growth,
productivity improvements and the gains realised on the disposal of non-core products and technologies
as Roche continued to realign its product portfolio were major contributors to the Group’s improved
profitability. Together these factors more than offset increased costs for new product launches, investments
in the Group’s R&D pipeline and expenditures on in-licensing agreements for products and technologies.
Even excluding gains from the disposal of products, the operating margin improved significantly.
Significant
increase in net liquidity and equity-to-assets ratio
Thanks to the strong operating
performances of the Group’s continuing businesses, EBITDA from these businesses increased 15% to 9.2
billion Swiss francs. The EBITDA margin in the Pharmaceuticals Division reached 32.6%, compared with
31.5% the year before, and in the Diagnostics Division it advanced 2.7 percentage points to 31.2%. The
Group’s net liquidity nearly doubled, from 5.9 to 11.7 billion Swiss francs, thanks to the strong positive
cash flows from the divisions, the sale of the consumer health (OTC) businesses and the conversion of
the ‘LYONs IV’ notes. The ratio of equity to total assets rose significantly, from 49% to 57%. The sale
of the OTC businesses (Roche and Chugai) resulted in an exceptional pre-tax gain totalling 2.3 billion
Swiss francs. The Group also completed a major acquisition during the year, purchasing Igen in the United
States in early 2004 for a total consideration of 1.8 billion Swiss francs.
Further
improvement in financial income
Financial income showed further improvement compared
with the previous year, with the Group recording a net financial expense of 359 million Swiss francs
for 2004 (after an expense of 667 million Swiss francs in 2003). Group debt was reduced by a further
6.3 billion Swiss francs, to 9 billion Swiss francs, resulting in a decrease in interest expense. The
conditions are thus now in place for a balanced financial income in 2005. The conversion and redemption
of debt instruments yielded an exceptional pre-tax gain of 908 million Swiss francs. Including this
exceptional gain, financial income for 2004 was positive.
Net
income doubled
Net income increased 116% (or 3.6 billion Swiss francs) to 6.6 billion
Swiss francs thanks to the further improvement in the Group’s operating results and the gains from the
sale of the OTC businesses and the conversion and redemption of debt instruments. Even excluding exceptional
items and the Group’s discontinuing businesses, net income showed an increase of 972 million Swiss francs,
or 29%.
Outlook positive
In 2005 the
results in the Pharmaceuticals Division will be influenced by the expiry of the US patent for Rocephin
and by costs for product launches in key markets and significant development activities. As an overall
outcome the division anticipates local-currency sales growth above the world market and an operating
profit margin (before exceptional items) broadly in line with that for 2004. In 2005 Roche Diagnostics
expects to outgrow the world market again in terms of local-currency sales. The division also expects
further progress towards its goal of an operating profit margin (before exceptional items) of around
23% in 2006. In addition, Roche expects a balanced financial income in 2005.
Eighteenth
consecutive annual dividend increase
In view of the strong increases in operating
profit and net income, the Board of Directors will propose a dividend increase of 21%, to 2 Swiss francs
per share and non-voting equity security, at the Annual General Meeting on 28 February 2005. If approved,
this will be Roche’s eighteenth consecutive dividend increase.
Pharmaceuticals
Division
Growth well above the market average
Key figures | in millions of CHF | % change in CHF | % change in local currencies | as % of sales |
Sales | 21,695 | 10 | 13 | 100 |
EBITDA | 7,079 | 14 | 18 | 32.6 |
Operating profit* | 5,573 | 19 | 23 | 25.7 |
Research and development | 4,355 | 12 | 17 | 20.1 |
*Before exceptional items
Roche Pharmaceuticals — including Genentech
and Chugai — continued to deliver strong performance in 2004, recording total sales of 21,695 million
Swiss francs. This represents an increase over the previous year of 13% in local currencies, well ahead
of the global market. Once again, growth was driven by the Group’s oncology, virology and transplantation
franchises. Operating profit (before exceptional items) increased further, advancing 23% in local currencies
and 19% in Swiss francs to 5,573 million Swiss francs. Despite a sustained high level of investment
in R&D and product launch activities, the division posted another significant increase in profitability,
recording an operating profit margin (before exceptional items) of 25.7%, compared with 23.8% in 2003.
EBITDA totalled 7,079 million Swiss francs or 32.6% of sales, compared with 31.5% the previous year.
Market
share gains in the United States
All regions contributed to growth in 2004. Sales
growth weakened slightly during the fourth quarter of 2004 compared with the record highs of the prior-year
period. This was primarily due to the late start of the 2004/2005 influenza season. Excluding this effect,
fourth-quarter sales growth was in the double digits.
Sales by Roche and Genentech in
North America were up 20% (all growth rates are based on local currencies) in 2004, well ahead of the
market (8%), fuelled primarily by strong demand for Avastin, established oncology brands and the hepatitis
combination Pegasys and Copegus. The oncology and hepatitis franchises were also the main contributors
to above-market growth in Europe (12% vs a 7% market average). Sales by Chugai in Japan rose 3%, compared
with local market growth of 2%. In Latin America the division recorded double-digit sales growth against
a background of steady market recovery. Growth in the markets of the Asia–Pacific region was strong,
while in the Middle East and Africa it held up well despite political and economic turbulence.
Oncology
— further innovative products launched
In 2004 the Roche Group’s oncology portfolio
earned revenues of 7.7 billion Swiss francs and posted a gain of 32%. Roche is the only pharmaceuticals
group offering five anticancer medicines that can help extend the lives of cancer patients.
MabThera/Rituxan,
the world’s first therapeutic monoclonal antibody for indolent and aggressive forms of non-Hodgkin’s
lymphoma (NHL), delivered strong growth in 2004, particularly in Europe and Japan. Sales of the product
benefited from its approval last August in Europe for first-line use in indolent NHL; new data show
a survival benefit for this group of patients. In addition, two large clinical trials have shown that
maintenance treatment with MabThera/Rituxan over two years is highly effective in patients with indolent
NHL.
Herceptin, a monoclonal antibody for the targeted treatment of breast
cancer, generated sales of almost 1.5 billion Swiss francs, with solid gains in all major markets. Adoption
of the drug as first-line therapy received a major boost in June 2004, when the combination of Herceptin
plus Taxotere was approved for this indication in the European Union.
Total
sales of Xeloda, for colorectal and breast cancer, rose 7% in 2004, with growth outside the United States
an impressive 31%. Although sales growth in the United States was impacted in the first half of the
year by a number of important changes in the marketplace, prescription figures continued to show increasing
adoption of the product. In August Roche filed applications with the EU and US authorities for approval
of Xeloda in a new indication, adjuvant treatment of colon cancer patients following surgery.
In
February Genentech received approval for Avastin in the United States for use in combination with chemotherapy
in patients with previously untreated metastatic cancer of the colon or rectum. After an extremely successful
launch, demand for the product in its first market has been strong, resulting in sales of almost 700
million Swiss francs in less than 12 months. In January 2005 Avastin also received marketing approval
in the European Union. In December Avastin was approved in Switzerland, which also opens the way to
registration of the medicine in over 90 countries. Clinical trials have repeatedly demonstrated that
Avastin, when added to chemotherapy, significantly prolongs survival in patients with metastatic colorectal
cancer, regardless of the chemotherapy used.
Tarceva, a breakthrough
anticancer drug developed by Genentech, OSI Pharmaceuticals and Roche, was approved by the US Food and
Drug Administration (FDA) in November as monotherapy for advanced non-small cell lung cancer (NSCLC).
Approval, which followed a priority review, was based on the results of a phase III trial showing that
the drug extends overall survival in patients with pretreated lung cancer. An application for marketing
authorisation is being evaluated by the EU authorities. Data from another phase III study showed that
Tarceva increases the survival of patients with metastatic pancreatic cancer when added to chemotherapy.
Tarceva is currently being investigated in a variety of malignant diseases.
Kytril,
used to control nausea and vomiting in patients receiving chemo- or radiation therapy or who have undergone
surgery, continued to perform well in a highly competitive marketplace.
Anemia
– new pre-filled syringe for NeoRecormon patients
Against a background of continued
price pressure in the anemia market as a whole, Roche’s NeoRecormon and Chugai’s Epogin posted combined
sales of 2.1 billion Swiss francs. Sales of NeoRecormon in cancer-related anemia grew by 14%, driven
by the successful launch and penetration of a new once-weekly 30,000 IU pre-filled syringe that offers
patients high efficacy plus convenient dosing.
Transplantation — global
market leadership achieved
Roche is now the global market leader in transplantation medicines.
In 2004 the Group’s transplantation portfolio posted sales of 1.8 billion Swiss francs, an increase
of 11%, with Roche’s flagship transplantation drug CellCept showing solid growth. While CellCept remains
the leading branded immunosuppressant in the United States, with total prescriptions up by 24%, US sales
were negatively impacted in the second half of the year by changes in wholesaler buying patterns, the
effects of which are expected to disappear during the first half of 2005.
Combined sales
of Valcyte and Cymevene showed solid growth of 22% in 2004 as Valcyte became the global market leader
for the prevention of cytomegalovirus infection (CMV).
Virology
— Pegasys gains additional market share
In 2004 Roche enhanced its leadership position
in hepatitis C, with sales of its combination therapy Pegasys plus Copegus advancing to over 1.5 billion
Swiss francs. At year end Pegasys accounted for over 60% of both the US and global pegylated interferon
markets. During the year new data demonstrated the significant benefits of Pegasys plus Copegus in two
hepatitis C patient subgroups: patients co-infected with HIV, and patients with persistently normal
liver enzymes (normal ALT), a subgroup that would traditionally not be considered for treatment. Roche
received marketing authorisation in Europe for the normal ALT indication in November. Regulatory filings
for approval of the combination in HIV–HCV co-infection were submitted in mid-2004 in the European Union
and in the United States. Roche received a positive opinion from the EU authorities in December, and
the US filing has been granted priority review. Roche has completed its development programme for Pegasys
in chronic hepatitis B, with extensive clinical trial data supporting its use as a first-line treatment
of the disease. Marketing applications have now been filed in Europe, the United States and elsewhere.
In January 2005 the EU authorities recommended approval.
Sales of Fuzeon, for the treatment
of HIV, improved steadily in 2004, reaching 168 million Swiss francs at year end. Roche and Trimeris
are working to accelerate the uptake of Fuzeon through major physician and patient education initiatives.
Other
major products — Rocephin sales remain stable
Global sales of Xenical were down
slightly in a market that is still in overall decline. While US sales fell significantly, the product
experienced steady growth elsewhere.
Rocephin remained the world’s leading injectable
antibiotic in 2004, posting total sales of over 1 billion Swiss francs. Rocephin had a strong year in
the United States, with sales growing 8%.
Due to a relatively mild influenza season,
sales of Tamiflu declined despite initial orders of pandemic readiness supplies. Preclinical tests have
shown Tamiflu to be effective against the highly pathogenic human and avian H5N1 influenza virus, considered
the most likely source of a pandemic strain.
Boniva/Bonviva is being developed as the
first once-monthly oral treatment for postmenopausal osteoporosis. One-year data from a two-year multinational
study show that once-monthly oral Boniva is an effective, well-tolerated and convenient alternative
to current daily and weekly oral bisphosphonate regimens and has the potential to improve long-term
treatment adherence. In addition, new data from a multinational study of injectable Boniva have shown
it to be the first injectable bisphosphonate that is effective when administered once every two or three
months. The once-monthly oral formulation has already been filed in the United States, the European
Union and Switzerland. A marketing application for Boniva two-monthly or three-monthly intravenous injection
was submitted to the US FDA at the end of 2004.
Research
and development — 64 new molecular entities
Roche Pharmaceuticals invested 4.4
billion Swiss francs in R&D in 2004. At 20.1% of sales, this again puts Roche above the industry
average and shows its strong commitment to innovation.
The Pharmaceuticals Division R&D
pipeline currently includes 64 new molecular entities (NMEs), of which 13 are in phase 0, 30 in phase
I, 13 in phase II and eight in phase III or filed.
In the division’s main growth area,
oncology, Roche Research and Development increased the number of projects to 60, twelve more than at
the end of 2003. Roche currently has 107 research projects across seven therapeutic areas and 79 development
projects in eight therapeutic areas.
Development of CERA, the first continuous erythropoietin
receptor activator, for the treatment of renal and cancer-related anemia is progressing on track. CERA
represents a major advance in anemia management. Recruitment into global phase III renal anemia studies
is advancing well, and phase III studies in cancer-related anemia are scheduled to begin in the second
half of 2005. Roche plans to file marketing applications in the United States and elsewhere in 2006.
Roche,
Genentech and Biogen Idec are developing MabThera/Rituxan for the treatment of rheumatoid arthritis
(RA). It is the first B-cell depleting agent to be studied in this disease. Development is progressing
on track and global filings for an initial indication — in patients with an inadequate response to currently
prescribed biologics — are planned for the second half of 2005. Development of MRA for the treatment
of RA is also progressing on track. Phase III studies of this novel biopharmaceutical in RA commenced
in Europe and the United States at the end of 2004.
Work is continuing on development
of the insulin sensitiser R483 in the treatment of type 2 diabetes. Following new guidance by the FDA
on data requirements for the class of drugs to which R483 belongs, Roche has decided to wait for the
results of ongoing long-term toxicity studies before starting phase III clinical trials. The toxicity
studies will be completed in the first half of 2005.
Diagnostics
Division
Above-market growth in all business areas
Key figures | in millions of CHF | % change in CHF | % change in local currencies | as % of sales |
Sales | 7,827 | 6 | 8 | 100 |
- Diabetes Care | 2,895 | 7 | 10 | 37 |
- Near Patient Testing | 554 | 1 | 3 | 7 |
- Centralized Diagnostics | 2,743 | 4 | 5 | 35 |
- Molecular Diagnostics | 1,104 | 8 | 11 | 14 |
- Applied Science | 531 | 5 | 7 | 7 |
EBITDA | 2,444 | 16 | 17 | 31.2 |
Operating profit* | 1,675 | 19 | 21 | 21.4 |
Research and development | 698 | -4 | -2 | 8.9 |
*Before exceptional items
Roche Diagnostics remained on the growth track, with sales advancing 8% in local currencies and 6% in Swiss francs. Sales grew significantly faster than the market in all five of the division’s business areas, led by particularly strong gains in the diabetes care, molecular diagnostics and immunochemistry segments. As a result, the division reinforced its position as the global market leader. Profitability also improved further. The division’s operating profit margin (before exceptional items) reached 21.4%, and the EBITDA margin climbed 2.7 percentage points to 31.2%. These figures set a new industry benchmark. Operating profit (before exceptional items) increased 19% to 1,675 million Swiss francs, while the division’s EBITDA rose 16% to 2,444 million Swiss francs.Roche Diagnostics invested 698 million Swiss francs in research and development, significantly more than any competitor. The division is concentrating its research efforts primarily on its three fastest-growing segments — molecular diagnostics, diabetes and immunochemistry.
Double-digit growth rates sustained in Asia
Roche Diagnostics outpaced the market in all regions. Once again, sales advanced at double-digit rates in Iberia/Latin America (14%) and the Asia-Pacific region (13%). The division continued to expand its market leadership in both these regions. Sales increased 11% in Japan, helped by the success of the division’s diabetes care, blood screening and immunochemistry businesses. After adjusting for the sale of several product lines in 2003, North American sales rose 8% on a comparable basis, an increase well above the market growth rate. Diabetes management products, molecular diagnostics and immunochemistry were the biggest growth segments in Europe. Sales in this market region (which includes the Middle East and Africa) advanced 7% for the year, and thus also grew significantly faster than the market.
Diabetes Care — new and established products on the success track
Roche Diabetes Care remained the leading provider of solutions for better diabetes management, with sales growing 10% in local currencies. Once again, the Accu-Chek Advantage and Accu-Chek Compact blood glucose meters were among the top-selling products. The state-of-the-art Accu-Chek D-TRONplus insulin pump — the first pump to carry the Accu-Chek name — was launched in 2004. Also new is Accu-Chek Pocket Compass 2.0, a diabetes management software package for personal digital assistants that completes the ‘circle of care’ by allowing users to record and track data from both a blood glucose meter and an insulin pump.
2004 also saw the launch of Accu-Chek Multiclix, the world’s first lancing device to use an integrated lancet drum. Multiclix offers enhanced hygiene and safety because lancets automatically retract into the six-lancet drum immediately after use.
In mid-2003 the FDA issued a letter citing certain deficiencies in manufacturing processes and documentation at Disetronic, the insulin pump manufacturer acquired by Roche earlier that same year. The procedures and processes in question have since been modified to conform to the Roche Group’s worldwide quality standards. Roche is working closely with FDA officials in preparation for the pending FDA re-audit of the Burgdorf production site in Switzerland. Following successful completion of the re-audit, Roche will move quickly to start sales of its new-generation insulin pumps in the United States.
Near Patient Testing — coagulation portfolio posts strong results
Sales in this business area grew 3% in local currencies in 2004. Sales of coagulation monitoring products — a segment in which Roche has by far the largest market share — grew by more than 16%, with demand fuelled mainly by the continuing trend to systematic anticoagulation management. More and more European health insurers have begun reimbursing the costs of patient self-monitoring now that the benefits have been documented in several international clinical trials. Self-monitoring has been shown, for example, to significantly reduce the risk of thrombosis in patients with artificial heart valves.
Roche Diagnostics is also the leader in the hospital point-of-care segment (rapid testing products for use in hospitals and at accident scenes). Placements of OMNI S multifunctional blood gas analysers showed a fourfold increase over 2003.
Centralized Diagnostics — moving towards leadership in immunochemistry
Roche Centralized Diagnostics reported above-market sales growth of 5% in local currencies. Performance in this business area was largely driven by a strong rise in immunochemistry sales, with the acquisition of Igen providing an important additional stimulus to growth. Completed in February 2004, this strategic transaction secures Roche’s rights to the electrochemiluminescence (ECL) technology underlying the Elecsys line of immunochemistry products. From 2001 to 2003 this product line consistently achieved sales growth above 20%. In 2004 new placements of Elecsys systems reached a record high, and sales rose another 21%. In the medium term Roche Diagnostics aims to become the leader in immunochemistry, a growth market currently valued at 8.6 billion Swiss francs.
In the cardiovascular testing segment, Centralized Diagnostics has increased the availability of NT-proBNP — a key marker for heart failure — through out-licensing agreements, and last year also expanded its own product portfolio further by in-licensing the marker hsCRP (high sensitivity C-reactive protein).
Molecular Diagnostics — first AmpliChip test launched
Sales of diagnostic products were up 12% in local currencies, while sales of enzymes to industrial customers, which account for a smaller percentage of revenues, showed a gain of 8%. Blood screening and women’s health products were the main growth drivers. Sales in the blood screening segment advanced by an impressive 32%. Roche’s viral tests are used to screen more units of blood worldwide than any other nucleic acid-based (NAT) testing system. 2004 saw the signing of three major agreements in this area. One of the agreements extends Roche’s exclusive contract with the Japanese Red Cross for an additional four years, while another provides for the Korean Red Cross to use Roche tests to screen 70% of its blood donations. The third agreement, with the German Red Cross, marks Roche’s entry into the German blood screening market.
In addition, an application for clearance of Cobas AmpliScreen HBV Test for screening donor blood for the hepatitis B virus was submitted to the FDA. Filings have also been submitted to the FDA for expanded indications of the Cobas AmpliScreen HIV and HCV products for NAT testing of cadaveric fluid for HIV and hepatitis C virus. Clearance of the products for these indications will help increase the safety of organ and tissue donations.
In 2004 the division added another important test to its women’s health portfolio with the successful European rollout of Amplicor HPV Test. HPV (human papillomavirus) infection is recognised as the leading cause of cervical cancer. Tests for chlamydial infections and gonorrhea, which are among the most common sexually transmitted diseases, posted double-digit sales growth. In 2004 Roche Molecular Diagnostics maintained its leading position in the fiercely competitive virology market. The business area’s quantitative test for hepatitis B and qualitative test for hepatitis C were two of the major growth drivers.
Sales in the genomics segment showed double-digit growth. This strong gain was due in part to AmpliChip CYP450 Test — the world’s first microarray-based test for clinical diagnostic use — which was launched during the year in Europe. Since January 2005 it has also been cleared for marketing in the United States. This novel test provides valuable information for assessing the body’s ability to metabolise medications, which can vary greatly between individuals.
Applied Science — LightCycler instruments on growth track
Sales in this business rose 7% in local currencies. Growth was led by sales of LightCycler reagents and by Applied Science’s industrial business, with a major contribution coming from new placements of LightCycler instruments. Placements of this DNA amplification system continue to increase steadily, particularly in high-growth markets in the Asia–Pacific region.
Annex
Additional information:
- Annual Report 2004: www.roche.com/fig_annualrep_2004.htm
- Presentations / live media conference broadcast (starting at 10 am CET): www.roche.com/med_events_bmk05.htm
- Photographs of the media conference (starting at 2:00 pm CET): www.roche.com/pages/downloads/photosel/050202/
- First-quarter sales 2005: 19 April (tentative)
- First-half results 2005: 20 July (tentative)
- Nine-month sales 2005: 19 October (tentative)
Disclaimer
This
release contains certain forward-looking statements. These forward-looking statements may be identified
by words such as “believes”, “expects”, “anticipates”, “projects”, “intends”, “should”, “seeks”, “estimates”,
“future” or similar expressions or by discussion of strategy, goals, plans or intentions. Various factors
may cause actual results to differ materially in the future from those reflected in forward-looking
statements contained in this presentation among others: (1) pricing and product initiatives of competitors;
(2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining
regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and
general financial market conditions; (5) uncertainties in the discovery, development or marketing of
new products or new uses of existing products; (6) increased government pricing pressures; (7) interruptions
in production; (8) loss of or inability to obtain adequate protection for intellectual property rights;
(9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity or news coverage.