Basel, 21 July 2016
Roche delivers continued growth in the first half of 2016
- Group sales increased by 5%1 at constant exchange rates, 6% in Swiss francs
- Pharmaceuticals Division sales up 4%, driven by oncology and immunology medicines
- Diagnostics Division sales grew 6%, driven primarily by immunodiagnostic products; challenging market conditions in Diabetes Care
- Core earnings per share grew slightly faster than sales at 5% at constant exchange rates, 7% in Swiss francs
- OCREVUS filed in US and EU for relapsing and primary progressive forms of multiple sclerosis; FDA granted priority review
- Cancer immunotherapy medicine Tecentriq received accelerated FDA approval in bladder cancer in the US
- cobas e801 immunodiagnostic module launched for high-volume testing
- Outlook for 2016 confirmed
|In millions of CHF||% change|
|Core operating profit|
|Core EPS-diluted (CHF)|
|IFRS net income|
Commenting on the Group’s results, Roche CEO Severin Schwan said: “In the first half of the year, both our Pharmaceuticals and Diagnostics Divisions showed good growth across all regions. The launch of our first cancer immunotherapy medicine Tecentriq is off to a strong start. We also completed the US and EU filings of OCREVUS, which brings us an important step closer toward launching this promising multiple sclerosis medicine. Based on our half year performance, I am confident that we will meet our full-year targets for 2016.”
Strong performance in both divisions
In the first half of 2016, Group sales rose 4.8% at constant exchange rates to CHF 25.0 billion. Core EPS grew 5.2% at constant exchange rates, slightly faster than sales. Core EPS growth reflects the good underlying business performance, investments into the launch of new products and the product pipeline, the one-off accounting impact of changes to the Group's Swiss pension plans, as well as an early bond redemption.
IFRS net income was up 3% at constant exchange rates and 4% in Swiss francs. The positive currency effect was driven by the weakening of the Swiss franc against the US dollar, the yen and the euro, partly offset by a strengthening of Latin American currencies.
Sales in the Pharmaceuticals Division were up 4% to CHF 19.5 billion, driven by demand for oncology and immunology medicines. Sales in the US increased 4%, led by immunology treatments Xolair and Esbriet, as well as Herceptin and Perjeta against HER2-positive breast cancer. There was high demand for Alecensa, which was recently launched in the US for a specific type of lung cancer. Sales of Lucentis and Tarceva declined due to the continued impact of competition. In Europe (+5%), Perjeta, MabThera/Rituxan and Actemra/RoActemra recorded strong sales growth, especially in Germany and France. In the International region (+4%), growth was driven by HER2 medicines, Avastin and MabThera/Rituxan. This growth was partly offset by lower Pegasys sales due to competition from a new generation of hepatitis C treatments. In Japan, sales rose 2% driven by HER2 medicines, Alecensa and Actemra/RoActemra.
Sales in the Diagnostics Division grew 6% to CHF 5.6 billion. All regions contributed to this growth, particularly Asia-Pacific (+17%). Professional and Tissue Diagnostics grew strongly. Diabetes Care sales were impacted by continued challenging market conditions, especially in North America.
In the second quarter, Roche achieved several key regulatory milestones. In April, Venclexta (venetoclax) received accelerated approval in the US for a specific form of leukemia. This medicine was jointly developed with AbbVie. In May, the FDA granted cancer immunotherapy Tecentriq (atezolizumab) accelerated approval in the US for a specific type of bladder cancer. Also in May, the subcutaneous formulation of MabThera/Rituxan received approval in the EU for people with chronic lymphocytic leukaemia. In June, the European Commission approved Gazyva/Gazyvaro plus bendamustine for the second-line treatment of follicular lymphoma. The EU authorities also approved the combination of Avastin and Tarceva for the treatment of people with a specific type of lung cancer.
Strong Pharma pipeline
Roche made significant progress in late-stage development. In June, the European Medicines Agency (EMA) and the FDA confirmed that the data submission for OCREVUS (ocrelizumab) is complete, and the marketing applications for both relapsing and progressive multiple sclerosis are being reviewed. In addition, the FDA granted priority review for the US application with an action date of 28 December 2016.
In the same month, the largest clinical trial ever conducted in giant cell arteritis (GCA), a serious inflammatory disease of blood vessels, showed positive results. Initially combined with a six-month steroid regimen, Actemra/RoActemra more effectively sustained remission through one year compared to a 6- or 12-month steroid-only regimen in people with newly diagnosed and relapsing GCA.
At the American Society of Clinical Oncology (ASCO) annual meeting in June, Roche presented an updated clinical analysis for Tecentriq in previously treated lung cancer. Overall survival benefit was seen regardless of Programmed Death-Ligand 1 (PD-L1) expression compared to chemotherapy. In addition, Roche shared encouraging results from clinical trials with Tecentriq in combination with chemotherapy, targeted anti-cancer medicines and other cancer immunotherapy agents in several tumour types.
In May, a phase III study (J-ALEX) by Chugai found that Alecensa significantly reduced the risk of disease worsening or death compared to crizotinib. This trial in a Japanese patient population with advanced or recurrent ALK-positive non-small cell lung cancer was stopped early after a pre-planned interim analysis.
Roche recently provided an update on the phase III study of Gazyva/Gazyvaro in previously untreated diffuse large B-cell lymphoma (GOYA). The study did not meet its primary goal of extending the time patients live without their disease advancing. In May, another phase III study of Gazyva/Gazyvaro (GALLIUM) was stopped early after a pre-planned interim analysis showed positive results in the first-line treatment of follicular lymphoma. In both studies, Gazyva/Gazyvaro plus chemotherapy was tested head-to-head with MabThera/Rituxan combined with chemotherapy. The GALLIUM data will be submitted to health authorities for approval consideration. Gazyva/Gazyvaro is already approved for previously treated follicular lymphoma.
Portfolio progress in Diagnostics
In May, Roche launched the CoaguChek INRange, the first Bluetooth enabled home device, allowing patients and their healthcare providers greater control over their coagulation status. In June, Roche launched the cobas e801 module in countries accepting the CE Mark. As part of the cobas 8000 analyzer, this module provides increased immunochemistry testing capacity and an extensive test menu to laboratories with high testing volumes. Also in June, the cobas liquid biopsy test for the detection of specific mutations of the epidermal growth factor receptor (EGFR) gene became the first FDA approved liquid biopsy test. It can support therapy guidance in non-small cell lung cancer (NSCLC) via the analysis of a simple blood sample; and it complements the existing tissue-based EGFR test.
Outlook for 2016 confirmed
Roche continues to expect sales to grow low- to mid-single digit at constant exchange rates in 2016. Core earnings per share are targeted to grow ahead of sales at constant exchange rates. Roche expects to further increase its dividend in Swiss francs.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry seven years in a row by the Dow Jones Sustainability Indices.
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
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1) Unless otherwise stated, all growth rates in this document are at constant exchange rates (CER: average 2015).
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