Basel, 14 April 2011
Roche Group’s first-quarter 2011 sales on track for full-year targets – positive results in seven key clinical trials
- Group sales stable in local currencies (-9% in Swiss francs; +2% in US dollars) at 11.1 billion Swiss francs in first three months of 2011. Excluding Tamiflu, Group sales rise 2%1 (-7% in Swiss francs, +4% in US dollars).
- Negative exchange-rate impact of 1.1 billion Swiss francs or 9%, due primarily to significant weakening of US dollar and euro against Swiss franc.
- Roche confirms full-year targets — Group and Pharma (excluding Tamiflu) expected to grow at low single-digit rates, with Pharma growth in line with the market, Diagnostics to grow significantly above market, and Core EPS to grow at a high single-digit rate at constant exchange rates.
- Excluding Tamiflu, divisional sales rise 1% (-8% in Swiss francs, +3% in US dollars), on track to achieve Roche’s full-year targets. Including Tamiflu, with expected negative impact, sales declined 2% (-10% in Swiss francs, +1% in US dollars).
- Growth driven mainly by Lucentis, MabThera/Rituxan, Herceptin, Actemra/RoActemra, Activase/TNKase, Tarceva and Xeloda.
- Expected negative impact on Avastin sales of regulatory and reimbursement uncertainty in the US regarding the metastatic breast cancer indication; sales for other indications continue to grow, driven by International markets and Japan; positive clinical data from phase III OCEANS study in ovarian cancer further supports growth potential.
- Positive results announced in first quarter from six key clinical trials that are expected to support marketing applications for new medicines or additional indications for existing products.
- Exploratory phase II study demonstrates superiority of trastuzumab emtansine (T–DM1) monotherapy over Herceptin plus chemotherapy in first-line treatment of HER2-positive metastatic breast cancer.
- Divisional sales continue to grow ahead of the market, advancing 6% (-4% in Swiss francs, +7% in US dollars), driven by Professional Diagnostics and Tissue Diagnostics.
- Roche expands its portfolio of diagnostic tests for personalised healthcare: immunoassay for hepatitis B therapy monitoring launched; BRAF, KRAS and EGFR biomarkers on track for launch in 2011.
- Roche to acquire PVT, a market leader in automation and workflow solutions, to strengthen offering for clinical laboratories.
Barring unforeseen events.
1) Unless otherwise stated, growth rates are in local currencies
Commenting on the Group’s first-quarter 2011 performance, Roche CEO Severin Schwan said: ‘Based on our first-quarter sales, we are on track to achieve our targets for the full-year. And since the beginning of the year we have already announced positive results from seven key phase II or III clinical trials, further underscoring our growth prospects for the coming years.’
|Three months ended|
|2011||2010||In LC*||In CHF||In USD|
|- Excluding Tamiflu||8,460||9,210||+1||-8||+3|
|- Excluding Tamiflu||3,148||3,477||+2||-9||+2|
|- Excluding Tamiflu||2,201||2,594||-4||-15||-5|
|- Excluding Tamiflu||855||862||+1||-1||+11|
|- Excluding Tamiflu||2,256||2,277||+6||-1||+11|
|- Excluding Tamiflu||10,868||11,728||+2||-7||+4|
*LC= local currencies
**International: Asia–Pacific, CEMAI (Central and Eastern Europe, Middle East, Africa, Central Asia, Indian Subcontinent), Latin America, Canada, Others
See appendix to this media release for details of quarterly sales growth
Stable sales in first quarter
In the first three months of 2011 Group sales remained stable in local currencies (-9% in Swiss francs; +2% in US dollars) at 11.1 billion Swiss francs. Excluding Tamiflu sales, which as expected declined significantly compared with the prior-year period (from 517 million to 252 million francs), Group sales increased 2% (-7% in Swiss francs, +4% in US dollars). The Pharmaceuticals Division’s first-quarter sales totalled 8.7 billion Swiss francs, a decline of 2% in local currencies (-10% in Swiss francs; +1% in US dollars). Excluding Tamiflu, pharmaceutical sales advanced 1%. Sales by the Diagnostics Division continued to grow faster than the global in vitro diagnostics market, advancing 6% in local currencies (-4% in Swiss francs; +7% in US dollars) to 2.4 billion Swiss francs. The sales figures expressed in Swiss francs reflect a substantial negative exchange-rate impact due to the strength of the franc relative to all currencies relevant for Roche, in particular the US dollar and the euro, compared with the first quarter of 2010.
Positive results from seven key clinical trials
In the first quarter Roche announced positive results from seven key clinical trials, six of which are expected to support marketing applications for new medicines or additional indications for existing products:
- vemurafenib (metastatic melanoma)
- vismodegib (basal cell carcinoma)
- Avastin (ovarian cancer)
- Tarceva (EGFR-positive non-small cell lung cancer)
- Lucentis (diabetic macular edema — two studies)
- Trastuzumab emtansine (T-DM1; HER2-positive metastatic breast cancer)
Including these latest studies, 18 of the Group’s phase II or phase III trials have achieved positive results since last October. Roche and Genentech plan to submit the results of a number of these trials for presentation at medical meetings during 2011.
Full-year targets confirmed
Based on its first-quarter sales, Roche confirms its full-year outlook for 2011: Barring unforeseen events, Group and Pharmaceuticals sales (excluding Tamiflu) are expected to grow at low single-digit rates in local currencies, reflecting the impact of US healthcare reform 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 rollout of new products in all business areas. In spite of a more challenging environment and the introduction of an excise tax in the United States, Roche aims for Core Earnings per Share to grow at a high single-digit rate at constant exchange rates in 2011. Roche aims to increase the dividend in line with Core Earnings per Share. Based on the strong operating free cash flow, Roche expects to reduce debt progressively and to return to a net cash position by 2015.
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. 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. For more information: www.roche.com.
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This document 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, among other things, 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 document, 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, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed 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 and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for any current or future period will necessarily match or exceed the historical published earnings or earnings per share of Roche.