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Roche Group
- High growth rate of 17%* maintained in third quarter despite expiry of US Rocephin patent
- Group sales for first nine months up 17% (+16% in Swiss francs)
- Acquisition of GlycArt completed
Pharmaceuticals Division
- Sales growth remains strong at 22% (+20% in Swiss francs) - sales advance more than three times as fast as the market
- Strong demand for cancer medicines; sales of Avastin already passed billion-franc mark; Tarceva launched in Europe
- Tamiflu sales show further significant growth, driven by orders for pandemic readiness supplies
- Bonviva launches under way in Europe
- MabThera/Rituxan filed in US and EU for rheumatoid arthritis
- Compelling data from several large clinical trials show Herceptin effective in early-stage HER2-positive breast cancer
Diagnostics Division
- Sales growth in the third quarter accelerates by 2 percentage points to 6%
- Nine-month sales up 4% (+4% in Swiss francs)
- Molecular diagnostics, immunodiagnostics and diabetes care businesses post solid gains
- Innovative new diabetes management products successfully launched in all major markets
- World's largest manufacturing facility for PCR-based products opened in Branchburg (USA)
* Unless otherwise stated, all percentage changes are period-over-period changes and are based on results in local currencies.
Commenting on the Group's performance in the first nine months of 2005, Roche Chairman and CEO Franz B. Humer said, 'Roche posted significant double-digit gains in the third quarter, maintaining the strong sales growth of the first half-year. Our Pharmaceuticals Division gained additional market share, with all major products contributing to this strong performance, particularly our new cancer medicines. Roche Diagnostics has now rolled out its new Accu-Chek products in all major markets, enhancing its competitive diabetes management portfolio. This helped accelerate divisional sales growth in the third quarter.'
Roche Group
Roche posted sales of 25.4 billion Swiss francs in the first nine months of 2005, an increase of 17% (+16% in Swiss francs; +20% in US dollars) over the same period last year. The Group thus maintained the high growth rates reported for the first half-year. Nine-month sales in the Pharmaceuticals Division increased 22% (+20% in Swiss francs), more than three times as fast as the global market. The Diagnostics Division maintained its leading market position with sales growth of 4% (+4% in Swiss francs).
The GlycArt acquisition, completed in July, has strengthened Roche's expertise in therapeutic antibody research and added new, cutting-edge technologies and products to Roche's R&D organisation and pipeline. In September Roche was reselected as an index component of the Dow Jones Sustainability World Indexes (DJSI World) and Dow Jones STOXX Sustainability Indexes (DJSI STOXX). In addition, Roche again met the FTSE4Good criteria, and thus continues to be a member of the FTSE4Good Index series.
Pharmaceuticals Division
The Pharmaceuticals Division achieved impressive growth in the first nine months of 2005, with sales up 22% in local currencies (+20% in Swiss francs; +24% in US dollars). Regional sales growth significantly outpaced the market average in each of the division's major markets: North America, Europe and Japan. Growth was driven by continued strong demand for the division's oncology products. The anti-influenza drug Tamiflu, which a number of governments are stockpiling as part of pandemic readiness programmes, also contributed to growth.
Oncology - continued strong sales growth The division's oncology portfolio achieved an outstanding growth of 37%, reinforcing Roche's position as the world's leading provider of cancer medications.
Worldwide sales of Avastin, a new breakthrough in cancer therapy, totalled 1.1 billion Swiss francs. Indicated for the first-line treatment of patients with advanced colorectal cancer, Avastin is being steadily rolled out in Europe and other countries. Recent phase III results have revealed Avastin's benefits in other tumour types; for example, a survival advantage with the drug has been seen both in advanced non-small cell lung cancer and in metastatic breast cancer. Regulatory filings for these new indications are planned for next year.
Sales of MabThera/Rituxan, for non-Hodgkin's lymphoma (NHL), increased 22%, putting total nine-month sales over the 3-billion-franc mark.
This strong growth was driven by the steady rise in prescriptions of the drug for indolent and aggressive NHL in Europe. During the third quarter Genentech and Biogen Idec submitted a filing to the FDA for use in aggressive NHL. Roche intends to submit a marketing application to the European authorities later this year for MabThera as maintenance therapy in indolent NHL.
Herceptin, the only targeted treatment for HER2-positive breast cancer, posted significant sales growth in all key markets (+38%). Four large-scale phase III trials investigating Herceptin in patients with early-stage HER2-positive breast cancer have shown that adding Herceptin to chemotherapy significantly reduces the risk of cancer recurrence in this population. Roche plans to file for this new indication early next year.
Xeloda sales achieved strong worldwide growth of 47%. Sales advanced impressively both in the United States (+64%) and in Europe/Rest of World (+39%), fuelled by recent US and EU approvals for the use of Xeloda for the adjuvant (post surgery) treatment of colon cancer.
Sales of Tarceva, a novel targeted drug for advanced non-small cell lung cancer, reached 234 million Swiss francs in the United States after just 11 months on the US market. Tarceva received approval for this indication in the European Union in September, and the market roll-out there is already under way. In addition, the FDA has voted in favour of recommending approval of Tarceva for the treatment of advanced pancreatic cancer in previously untreated patients. A filing for the pancreatic cancer indication was recently submitted to EU regulators.
Anemia - leadership maintained
Combined sales of NeoRecormon and Epogin were up 7% with growth seen in both the renal and oncology indication. NeoRecormon sales for cancer-related anemia are expected to grow steadily, helped by continued uptake of the new once weekly pre-filled syringe. Sales will also be strengthened by a recent update of the product label, as a result of which NeoRecormon is now also indicated for the correction of anemia in patients with solid and lymphoid tumours receiving any form of chemotherapy.
Transplantation - CellCept number one worldwide Thanks to strong, double-digit sales growth (+18%), CellCept remained the world's top-selling branded immunosuppressant for use in transplantation. Sales were up by double digits in the United States, Europe and Japan.
Virology - Tamiflu sales surge forward
Worldwide sales of Tamiflu rose to 859 million Swiss francs, mainly as a result of increased orders for pandemic readiness supplies. Roche has donated 3 million packs of Tamiflu to the World Health Organisation (WHO) for use as a rapid response stockpile in the event of an outbreak of a pandemic strain of influenza. The Group has already significantly expanded its Tamiflu production capacity several times, and Roche will continue to take action, both on its own and with a significant number of suppliers, to increase production capacity for Tamiflu to meet seasonal and pandemic needs.
Sales of Pegasys, the market-leading pegylated interferon for hepatitis C, showed double-digit growth (+17%), with demand running especially strong in Europe/Rest of World (+24%) and Japan (+37%). Sales were driven primarily by three new indications approved over the course of this year: use in patients co-infected with hepatitis C and HIV, treatment of hepatitis B and treatment of hepatitis C in patients with normal liver enzymes. Pegasys is already approved for hepatitis B in over 50 countries - including the United States, the European Union and China. A Japanese filing for Pegasys plus Copegus in hepatitis C has been granted priority review status.
Sales of the anti-HIV medicine Fuzeon were up significantly for the period, rising 49% to 178 million Swiss francs. This reflects the continued flow of impressive new efficacy data in treatment-experienced patients with HIV/AIDS.
Other major products - Bonviva approved for once monthly oral use in Europe Bonviva/Boniva, the first once monthly oral bisphosphonate for the treatment and prevention of osteoporosis, was recently approved in the European Union and Switzerland. In the United States, where the product has been available since April, patient acceptance has been good, both among previously untreated women and among women switching to Boniva from other treatments.
Global sales of Xenical grew 4%. The labelling for Xenical has been expanded to include clinical trial data on the use of the product in obese adolescents, making it the first and only weight loss medication in the United States and Europe to contain such information in the label. GlaxoSmithKline has filed with the FDA for approval of an OTC formulation of orlistat.
Total Rocephin sales declined in line with expectations (-21%) following expiry of the US patent in July. Third-quarter sales were down more than 50% from the year before.
Major development activities in the third quarter - first filings in rheumatoid arthritis The US and EU filings for MabThera/Rituxan in its first rheumatoid arthritis indication represent a significant milestone for the product. The filings are for use in patients who have failed to respond adequately to current biologic therapies - the rheumatoid arthritis patients most difficult to treat. Positive outcomes have also been seen in clinical trials with patients who had previously failed treatment with one or more disease-modifying anti-rheumatic drugs.
Development of Actemra (formerly known as MRA) for rheumatoid arthritis is progressing well. Data from a phase III programme in Japan will be presented later this year, and patient recruitment for international phase III trials in rheumatoid arthritis is proceeding as planned.
Diagnostics Division
Sales growth in line with the market
In the first nine months of 2005 Roche Diagnostics posted sales of 6 billion Swiss francs, an increase of 4% (+4% in Swiss francs; +7% in US dollars) over the year-earlier period. Third-quarter sales growth accelerated to 6%. Molecular diagnostics, immunodiagnostics and diabetes care continue to be the main contributors of growth. Sales in Japan showed a high single-digit increase, while growth in the EMEA region (Europe, Middle East, Africa) was in the mid single digits, slightly above the market average. The division posted double-digit gains in Asia-Pacific and Iberia/Latin America, outpacing the market in both regions. Substantial investments were made in ongoing product launches in the United States, where the new Accu-Chek Aviva device has been very well received by the market.
Diabetes Care - new portfolio rolled out Roche Diabetes Care posted sales growth of 4%. The global launch of Accu-Chek Aviva was successfully completed. The new Accu-Chek Spirit insulin pump is now available in 21 countries and accounts for 40% of all Roche insulin pump sales.
Near Patient Testing - strong growth in coagulation monitoring segment Roche Near Patient Testing reported overall sales growth of 4%. In the coagulation business, growth was well into the double digits, while the Cardiac Reader segment posted high single-digit gains. The Roche Cardiac proBNP test was launched worldwide for use on the Cardiac Reader, making it the first point-of-care NT proBNP assay for heart failure to reach the market. Cardiac Reader placements were up 6% from the previous year, and during the first nine months the 10,000th Cardiac Reader was manufactured. In the blood gas/electrolyte analyser segment, Roche Diagnostics placed 65% more Roche Omni S instruments than during the same period last year.
Centralized Diagnostics - growth above the market Sales by Roche Centralized Diagnostics increased 5% in a market estimated to be growing at a rate of 3%. This dynamic performance was driven mainly by a record number of placements of Cobas Integra and Elecsys systems (+23% and +29%, respectively). Thanks to Elecsys proBNP, Roche Diagnostics is now the number-one supplier of cardiac biomarker assays. This brings Roche another step closer to its goal of achieving market leadership in immunodiagnostics.
Molecular Diagnostics - market leadership maintained Roche Molecular Diagnostics maintained its leading market share of over 40%, as sales rose 6%. This business area's largest segments, virology and blood screening, continued to grow in line with the market. The new automated virology systems and real-time PCR-based tests have been well received in European markets, where they were recently launched. In the blood screening segment, Roche received FDA clearance for a new hepatitis B test for screening organ and tissue donations. Roche's established blood screening tests remain the market leaders, providing a strong platform for future launches of the highly automated blood screening systems currently in development at Roche.
At its Branchburg site (USA), Roche opened the world's largest PCR production facility in July to meet the rising demand for its PCR-based products.
Applied Science - market position stabilised Roche Applied Science consolidated its position (+1%) in an increasingly competitive market. The launch of a new ultra-fast nanotechnology-based DNA sequencing system at the end of September and the new LightCycler 480 DNA amplification system in early October will significantly reinforce Roche Applied Science's position as a provider of superior bioanalytical systems.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet at www.roche.com.
All trademarks used or mentioned in this release are protected by law.
Additional information
- Media release with sales tables: www.roche.com/med-cor-2005-10-19
- Full-year report for 2005: 1 February 2006
Roche Group Media Office
Phone: +41 61 688 8888 / E-Mail: basel.mediaoffice@roche.com
- Baschi Dürr
- Alexander Klauser
- Daniel Piller (Head of Roche Group Media Office)
- Katja Prowald (Head of Science Communications)
- Martina Rupp
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.
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