Positive clinical and regulatory news flow continues
In the first quarter of 2012 Roche achieved several important regulatory milestones with novel medicines: Erivedge (basal cell carcinoma) was approved in the US, Zelboraf (metastatic melanoma) received marketing approval in the EU, and the US Food and Drug Administration (FDA) has granted pertuzumab priority review for HER2-positive breast cancer. The strength of Roche's pipeline was further underscored by continued positive results from five out of five late-stage clinical trials in the fields of cancer and arthritis.
Pharmaceuticals: growth in sales of key medicines led by US
The main contributors to sales growth in the Pharmaceuticals Division were Pegasys (hepatitis C) and cancer medicines MabThera/Rituxan, Herceptin and Xeloda. Additional major growth contributions came from continued strong uptake of Actemra/RoActemra (rheumatoid arthritis), as well as from recently launched Zelboraf (metastatic melanoma). These factors more than offset the decline of NeoRecormon/Epogin (anemia) due to competitive pressure, Bonviva/Boniva (osteoporosis), Tamiflu (influenza) and CellCept (transplantation). Sales of Avastin advanced moderately (+1%), with continued growth expected following the approval of the ovarian cancer indication in Europe at the end of 2011.
Of the regions the US (+6%) was the greatest contributor to growth, led by Pegasys and Rituxan. In Western Europe (-4%) sales were impacted by continued pricing pressure. Sales growth in Japan (+1%) was led by Tamiflu and Mircera. Sales in the International region (+2%) reflect good growth in Latin America (+9%) and Asia-Pacific (+7%), offsetting uneven purchasing patterns and price pressure in countries of the CEMAI region (-1%).
Strong growth in laboratory diagnostics
Diagnostics sales growth was driven by strong above-market growth of Professional Diagnostics (+9%) and Tissue Diagnostics (+18%), supported by Molecular Diagnostics (+8%). Sales performance reflects continued demand for these business areas’ broad product offerings for large private, hospital, histopathology and molecular laboratories, and for near-patient-testing. These gains were partly offset by lower Diabetes Care sales (-7%), which were impacted primarily by reimbursement changes in key European and other markets; Roche expects the launch of key diabetes care products in 2012 to create new growth momentum.
Sales in the EMEA region decreased slightly (-1%), mainly due to the decline of Diabetes Care, while all other regions continued to grow. The greatest contributions to growth came from North America (+7%), where Roche Diagnostics substantially outpaced the market, and Asia–Pacific (+13%), led by China (+27%).
Roche increases offer price for Illumina
Following discussions with Illumina shareholders, Roche has increased its offer price for all outstanding publicly-held shares of Illumina to 51.00 US dollars per share in cash. The offer is scheduled to expire on April 20. Illumina's sequencing systems and microarrays would complement Roche Diagnostics' offering in genomics research and diagnostics.
Full-year targets confirmed
Roche confirms its full-year outlook for 2012. Barring unforeseen events, Roche expects low to mid-single-digit sales growth at constant exchange rates for the Group and the Pharmaceuticals Division in 2012. Pharma sales growth is expected to accelerate, driven by the strength of its established product portfolio, as well as planned new product launches. Sales by the Diagnostics Division are expected to again outpace the market. Despite a challenging market environment, based on the expected sales growth and continued efficiency improvements, Roche is aiming for a high single-digit increase in Core Earnings per Share at constant exchange rates. Roche will continue its attractive dividend policy.
Roche CEO Severin Schwan commenting on the Group's first quarter 2012 performance: "With sales advancing 2% in the first three months, we remain on track to achieve our targets for the full-year. After the rapid approvals of Zelboraf and Erivedge we can now make these innovative medicines available to patients suffering from severe forms of skin cancer. The ongoing positive newsflow on our product pipeline underscores our growth prospects for the coming years: since the beginning of the year we have announced positive results from five out of five key late-stage clinical trials."