|In millions of CHF||As % of sales||% change|
|2015||2014||2015||2014||At CER||In CHF|
|- United States||13,047||11,528||37||33||+7||+13|
* Asia–Pacific, EEMEA (Eastern Europe, Middle East, Africa), Latin America, Canada, Others
Commenting on the Group's first nine months, Roche CEO Severin Schwan said: "With sales continuing to grow strongly, we are raising our outlook for the full year. I am very pleased about the positive newsflow coming from our product pipeline. This includes data on our cancer immunotherapy medicine atezolizumab in bladder and lung cancer and, in particular, strong data on ocrelizumab in both relapsing and primary progressive forms of MS. These medicines have the potential to make a big difference to people living with these terrible diseases."
Group demonstrated continued strong growth
Sales of the Roche Group increased 6% to CHF 35.5 billion in the first nine months. Growth was driven by all regions in the Pharmaceuticals Division and Professional Diagnostics' sales.
The Swiss franc strengthened considerably against the euro during the first nine months of 2015, whilst weakening against the US dollar. The Japanese yen continued to weaken against the Swiss franc, as did Latin American and most European currencies. Overall, there was a negative currency impact of four percentage points on sales growth.
The DJSI again recognised Roche as the most sustainable company in the healthcare industry for the seventh consecutive year. Roche scored highest in the management of environmental and social topics, and with more than 100 new business partnerships established last year, DJSI also noted Roche's strong culture of collaboration, broad approach to innovation, and commitment to furthering patient access to healthcare.
HER2 franchise, Avastin and Esbriet driving growth in the Pharmaceuticals Division
In Pharmaceuticals, the oncology and immunology products drove the division's sales for the first nine months. Sales of the HER2-positive breast cancer medicines, Herceptin, Perjeta and Kadcyla, grew 19%. The outlook for this franchise was further strengthened in July after the European Commission approved Perjeta combination therapy for use before surgery. Avastin (+9%) and MabThera/Rituxan (+5%) also recorded continued strong growth.
In immunology, Actemra/RoActemra (+22%), which is used mainly to treat rheumatoid arthritis, and Xolair (+25%), which is now used in the treatment of chronic hives as well as asthma, grew again significantly. Sales of anti-viral medicine Valcyte and oral chemotherapy Xeloda declined as these medicines are no longer patent protected. Sales of hepatitis medicine Pegasys and eye treatment Lucentis dropped as a result of increased competition.
Strong demand for Esbriet, a treatment for idiopathic pulmonary fibrosis (IPF), a fatal lung disease, continued throughout the third quarter and sales totalled CHF 386 million in the first nine months. In September, additional data were presented from a pooled analysis of three phase III studies that suggested a reduction in treatment-emergent risk of death for IPF patients on Esbriet for more than two years.2 In the same month, Esbriet received approval in Switzerland.
Recently, key milestones were achieved for Roche's Cotellic (cobimetinib) for use in combination with Zelboraf in advanced melanoma. The company announced final phase III data showing a significant increase in overall survival, and in September, the Committee for Medicinal Products for Human Use (CHMP) recommended EU approval for Cotellic plus Zelboraf for the treatment of patients with BRAF V600 mutation-positive metastatic melanoma. This combination therapy was approved in Switzerland in August and a US FDA decision is anticipated by the end of the year.
Laboratory business main growth contributor in Diagnostics Division
Sales of the Diagnostics Division increased 6%, driven primarily by immunodiagnostic products from the Professional Diagnostics business area (+7%). The Molecular and Tissue Diagnostics business areas also performed well, with sales up 10% and 12%, respectively. Sales in Diabetes Care declined 3% due to ongoing challenging market conditions.
With four instruments and four test approvals and launches this year, the Diagnostics Division further broadened its industry leading product portfolio. Roche recently launched the cobas EGFR Mutation Test v2 that utilises plasma and/or tumour tissue for non-small cell lung cancer diagnosis and treatment monitoring.
Significant clinical data released at key medical meetings
At this year's European Cancer Congress (ECC), results were presented from several clinical studies that are supporting regulatory discussions on alectinib, atezolizumab and Cotellic, plus data on earlier-stage cancer immunotherapies. Roche is studying more than 20 medicines in cancer immunotherapy, eight of which are in clinical trials.
At the congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), Roche presented positive phase III data for ocrelizumab in people with relapsing forms of MS and in primary progressive MS. Ocrelizumab is the first medicine to show a clinically meaningful impact on the progression of disability in people with primary progressive MS (PPMS) in a pivotal phase III trial. In this study, the proportion of patients with adverse events and serious adverse events was similar in the ocrelizumab and placebo groups. In two studies in people with the most common form of the disease, relapsing MS, ocrelizumab was superior to high-dose interferon beta-1a in reducing key markers of MS activity over the two-year controlled treatment period: annualised relapse rate, disability progression, and areas of MS-related inflammation and brain injury. The proportion of patients with adverse events and serious adverse events was similar in the ocrelizumab and interferon beta-1a groups. Roche will submit these data to global health authorities in 2016 to seek approval of ocrelizumab for relapsing forms of MS and PPMS.
In September, the US FDA granted Breakthrough Therapy Designation for ACE910 to prevent bleeding episodes in hemophilia A patients aged 12 and older. This is now the ninth Breakthrough Therapy Designation granted for a Roche medicine.
Raised outlook for 2015
Based on the strong performance recorded in the first nine months of 2015, Roche now expects sales growth in the mid-single digit range, at constant exchange rates. Core earnings per share are targeted to grow ahead of sales at constant exchange rates3. 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-nine 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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1 Unless otherwise stated, all growth rates in this document are at constant exchange rates (CER: average full-year 2014).
2 Nathan SJ et al. Effect of Pirfenidone on Treatment-emergent (TE) All-cause Mortality (ACM) in Patients with Idiopathic Pulmonary Fibrosis (IPF): Pooled Data Analysis from ASCEND and CAPACITY. Abstract presented at ERS 2015.
3 This outlook excludes the one-time benefit of CHF 428 million before tax 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.