|In millions of CHF||As % of sales||% change|
* Asia–Pacific, EEMEA (Eastern Europe, Middle East, Africa), Latin America, Canada, Others
Commenting on the Group's results, Roche CEO Severin Schwan said: "We started the year with strong growth and good uptake of new products. In particular, I am pleased to see continued strong demand for Perjeta for breast cancer, as well as Esbriet, which was recently approved in the US for idiopathic pulmonary fibrosis. During the first quarter, the FDA also granted a second Breakthrough Therapy Designation for our cancer immunotherapy medicine anti-PDL1, for a specific type of lung cancer, in addition to bladder cancer. In Diagnostics, we further broadened the menu for the recently launched cobas 6800/8800 instrument platform. Overall, we are on track to reach our full-year targets for 2015."
The Roche Group posted strong sales growth in the first three months in both divisions, with demand for oncology and immunology medicines driving growth in Pharmaceuticals, and immunodiagnostics products driving growth in Diagnostics.
In Pharmaceuticals, medicines for HER2-positive breast cancer (Herceptin, Perjeta, Kadcyla) saw very strong growth of 23% as the combination of Perjeta and Herceptin in treatment becomes increasingly widespread. Avastin (+6%), which is used to treat seven different cancers, also continued to grow strongly, with increased use in two recently approved indications, ovarian and cervical cancer, as well as breast and lung cancer. MabThera/Rituxan (+5%), used in treatment for blood cancer and rheumatoid arthritis, also made a significant contribution to growth. Actemra/RoActemra (+27%), for rheumatoid arthritis, benefited from increased demand in early stage treatment and in monotherapy, as well as with the new subcutaneous formulation. Xolair (+28%) continued to grow significantly after its approval for an additional indication, chronic hives, in 2014. There was strong uptake of new products, in particular the newly-acquired medicine Esbriet for idiopathic pulmonary fibrosis and Gazyva/Gazyvaro for chronic lymphocytic leukemia. Generic competition impacted two medicines, Xeloda, a chemotherapy drug and Valcyte, an antiviral medicine. Pegasys, a medicine for hepatitis also declined in the quarter, as a result of competition from a newer generation of treatment.
In Diagnostics, sales increased 6% in the first quarter, with Professional Diagnostics (+6%) driving growth from its immunodiagnostics business. Sales were up 10% in Molecular Diagnostics, 14% in Tissue Diagnostics and 1% in Diabetes Care.
The Swiss franc appreciated against a number of currencies, in particular the euro, after the Swiss National Bank lifted its exchange rate peg in January. The impact of the weaker euro was more than offset by the stronger US dollar. The Japanese yen continued to weaken against the Swiss franc, as did a number of Latin American and other European currencies. Overall, exchange rates had a negative impact of 2 percentage points on first quarter sales growth.
Product approvals and positive data from the pipeline
There were a number of key pipeline milestones in the quarter, notably very positive results from the phase III GADOLIN study of Gazyva/Gazyvaro in refractory indolent non-Hodgkin's lymphoma. The study met its primary endpoint and was stopped early, having shown that the patients treated with Gazyva/Gazyvaro lived significantly longer without their disease worsening. In cancer immunotherapy, the FDA granted a second Breakthrough Therapy Designation for the investigational medicine anti-PDL1 in non-small cell lung cancer. Anti-PDL1 received its first Breakthrough Therapy Designation for bladder cancer in 2014. In addition, the FDA approved eye medicine Lucentis in a new indication, the treatment of diabetic retinopathy in people with diabetic macular edema. The FDA also granted Priority Review for cobimetinib, in combination with Zelboraf, for treatment of advanced BRAF-mutated melanoma. Avastin in combination with chemotherapy received EU approval for use in advanced cervical cancer.
Diagnostic product launches to strengthen key growth areas
Two new tests were launched in CE mark countries in the first quarter: the cobas DPX test, a real-time PCR duplex test for parvovirus B19 and hepatitis A virus in human plasma and the cobas HBV quantitative nucleic acid test. Both tests are for use on the cobas 6800/8800 systems, which were launched in 2014, and there was good uptake in the markets.
Building the portfolio with strategic acquisitions
Roche established a strategic partnership with Foundation Medicine in molecular information and genomic analysis. This collaboration aims to advance personalised healthcare, by making use of molecular information and genomic profiles to better target cancer tumours. The transaction was completed in April 2015. Roche also made a number of strategic acquisitions, including Ariosa Diagnostics to enter the non-invasive prenatal and cell-free DNA testing markets; Signature Diagnostics to advance translation research for next generation sequencing diagnostics; CAPP Medical which provides a technology to isolate circulating tumour DNA from blood for sequencing; and Trophos to expand into neuromuscular disease.
Outlook for 2015
In 2015, Roche continues to expect sales to grow low- to mid-single digit, at constant exchange rates2. 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.
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, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.
In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D and posted sales of 47.5 billion Swiss francs. 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 roche.com.
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1Unless otherwise stated, all growth rates in this document are at constant exchange rates (CER: average full-year 2014).
2This outlook excludes the benefit of 428m Swiss francs related to the divestment of filgrastim rights in 2014.
Disclaimer: Cautionary statement regarding forward-looking statements
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