In the first nine months of 2011 Roche reported positive data from seven clinical studies, several of which have already formed the basis for regulatory filings and approvals in the third quarter:
- Zelboraf for metastatic melanoma and companion diagnostic cobas BRAF Mutation Test approved and launched in the US (approval based on BRIM2 and BRIM3 studies)
- Tarceva approved in the EU for EGFR-mutated non-small cell lung cancer(based on EURTAC study)
- vismodegib filed in the US for treatment of basal cell carcinoma (supported by ERIVANCE study).
- primary objective achieved in phase III registration study with pertuzumab for HER2-positive metastatic breast cancer (CLEOPATRA)
Commenting on the Group's 2011 performance to date, Roche CEO Severin Schwan said: "Roche's solid sales performance in the third quarter is in line with our expectations. We're on track to achieve our targets for 2011. The successful US launch of our new melanoma medicine Zelboraf and the diagnostic cobas BRAF test has strengthened our leading position in personalised healthcare. The good results we have achieved with new medicines in seven late-stage clinical trials so far this year further enhance our prospects for future growth."
Growth in sales of key medicines led by Latin America and Asia–Pacific
Sales by the Pharmaceuticals Division, excluding Tamiflu, grew 1% in the first nine months of 2011. Including Tamiflu, sales declined by 1% at constant exchange rates (-14% in Swiss francs; +4% in US dollars) to 24.4 billion Swiss francs. Sales reflected solid growth of most key medicines, including recently launched products. Negative impacts included expected decreases in sales of Avastin (due to uncertainty around the metastatic breast cancer indication in the US), Tamiflu, Bonviva/Boniva and CellCept, and sustained competitive pressure on the NeoRecormon/Epogin franchise.
In the regions, growth of 1% in US pharmaceutical sales was driven mainly by demand for Lucentis, Rituxan and Actemra. Sales in Western Europe decreased by 4%, primarily due to government austerity measures. Excluding Tamiflu, sales in the International region grew 6%, helped by increasing demand for key products in certain Latin American and Asia–Pacific countries, notably China (+28%), Venezuela (+88%) and Brazil (+16%). A decrease of 2% in sales in Japan, excluding Tamiflu, was due primarily to ongoing effects following the disastrous earthquake in March.
Diagnostics business continues to outpace the market
Diagnostics Division sales continued to grow faster than the global in vitro diagnostics market, advancing 6% at constant exchange rates (-8% in Swiss francs, +11% in US dollars). Growth was led by Professional Diagnostics (+9%), fuelled by continued strong growth in immunoassays and solid instrument placements, and by Tissue Diagnostics (+15%). Sales grew in all regions, with the largest gains in Asia–Pacific (+17%). These reflect the strong overall demand for immunoassays and in particular the division's performance in China, where sales increased 25%. In the third quarter Roche Diagnostics launched 17 new products in key markets.
Roche Group again recognised as global sustainability leader in healthcare
In September Roche was named Supersector Leader in Healthcare in the Dow Jones Sustainability Indexes (DJSI) for the third year in a row. This top ranking among the world's leading sustainability-driven healthcare companies is a reflection of Roche's commitment to its employees, communities and the environment, and positions Roche as a global leader in sustainable business practices.
Full-year outlook confirmed
Roche confirms its full-year outlook for 2011 on the basis of the positive nine-month sales performance. Barring unforeseen events, Group and Pharmaceuticals sales (excluding Tamiflu) are expected to grow at low single-digit rates at constant exchange rates, reflecting the impact of US healthcare reforms and European austerity measures. Pharmaceuticals sales are thus expected to grow in line with the market. In 2011 Diagnostics sales are again expected to grow significantly ahead of the market, driven by further rollouts of new products in all business areas. Thanks to ongoing cost savings and productivity gains, Roche is targeting Core EPS growth of around 10% at constant exchange rates for 2011, in spite of a more challenging environment and the introduction of an excise tax in the United States. Roche aims to grow the dividend in line with Core EPS growth, and will at least maintain last year's dividend in Swiss francs.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80,000 employees worldwide and invested over 9 billion Swiss francs in R&D (core basis). The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan.