Roche delivers good sales growth in the first nine months of 2016 Basel, 20 October 2016 Group sales increase 4%1 at constant exchange rates, 6% in Swiss francs Pharmaceuticals Division sales up 4%, driven by oncology and immunology medicines Diagnostics Division sales grow 7%, primarily due to immunodiagnostic products US FDA approves Tecentriq, the first anti-PD-L1 cancer immunotherapy for metastatic non-small cell lung cancer Successful launch of cobas e 801, high-throughput immunodiagnostic module For the eighth year running, Roche ranked as the most sustainable healthcare company in the Dow Jones Sustainability Index (DJSI) Outlook for 2016 confirmed Commenting on the Group’s first nine months, Roche CEO Severin Schwan said: “We had continued good sales growth in both Pharmaceuticals and Diagnostics driven by our newly launched products, and our product pipeline is developing very well. Our cancer immunotherapy medicine Tecentriq has been performing strongly since May, when it was first approved in the US for people with advanced bladder cancer, and it has just received US FDA approval for previously treated metastatic non-small cell lung cancer. Based on our performance so far, I am confident that we will meet our full-year targets for 2016.” Group Both divisions showed continued growth Group sales increased 4% to CHF 37.5 billion. Sales in the Pharmaceuticals Division were up 4% to CHF 29.1 billion, driven by demand for breast cancer medicines Perjeta and Herceptin as well as for Actemra/RoActemra for rheumatoid arthritis. Sales in the US rose 3%, led by three immunology treatments Xolair, Esbriet and Actemra/RoActemra, as well as Activase/TNKase, and Perjeta and Herceptin for HER2-positive breast cancer. The recently launched medicines Tecentriq in bladder cancer and Alecensa in lung cancer have had a strong uptake. US growth was partly offset by a decline in sales of Tamiflu, Lucentis, Avastin and Tarceva. In Europe, sales increased 5% with Perjeta, Actemra/RoActemra and MabThera/Rituxan recording strong growth, especially in Germany and France. In the International region, the 4% growth was driven by the strategic cancer medicines portfolio. In Japan, sales were stable; mandated price cuts for reimbursed products were compensated by strong growth from Alecensa, HER2 cancer medicines and Actemra/RoActemra. Sales in the Diagnostics Division grew strongly (+7%) to CHF 8.4 billion. All regions contributed to this growth, particularly Asia-Pacific (+17%). Professional, Molecular and Tissue Diagnostics experienced continued good sales development. Diabetes Care sales continue to be impacted by challenging market conditions, especially in North America. Confirming data for key investigational Roche medicines Two Roche medicines were granted breakthrough therapy designations (BTD) by the US FDA in October. BTD was granted to Actemra/RoActemra for giant cell arteritis (GCA), a chronic, potentially life-threatening autoimmune condition. In addition, Alecensa received BTD for the treatment of adult patients with advanced ALK-positive non-small cell lung cancer (NSCLC) who have not received prior treatment with an ALK inhibitor. Also in October, the FDA approved the Lucentis prefilled syringe as a new method of administering the medicine to people with wet age-related macular degeneration and to people with macular edema after retinal vein occlusion. In September, Roche presented new post-hoc analyses from three pivotal Ocrevus (ocrelizumab) studies at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The new data showed that Ocrevus consistently increased disease control both in patients with the relapsing form of multiple sclerosis and in those with the primary progressive form. At the European Society for Medical Oncology (ESMO) annual meeting in October, Roche presented results from the phase III OAK trial with Tecentriq in metastatic NSCLC. The study met its primary endpoint, having established a survival benefit over chemotherapy, even in people with low or no observed levels of PD-L1 expression. These results add to the growing body of evidence that supported the FDA approval of Tecentriq as a new treatment for specific types of advanced NSCLC. In addition to OAK, Roche has seven phase III lung studies underway evaluating Tecentriq alone or in combination with other treatments in patients with early and advanced stages of lung cancer. Portfolio progress in Diagnostics In August, the FDA granted a premarket clearance and CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas Influenza A/B & RSV test for use on the cobas Liat System. This test also identifies the Respiratory Syncytial Virus (RSV), which causes more than 80% of acute lower respiratory tract infections in infants under one year old. The FDA also issued an Emergency Use Authorization for the LightMix Zika rRT-PCR test for use in patients meeting clinical and/or epidemiological criteria developed by the Center for Disease Control. These tests further expand the rich menu of Roche products. Also in August, the Accu-Chek Guide was launched in the EU. This next-generation blood glucose monitoring system is designed to make everyday blood glucose monitoring easier for people with diabetes. The Accu-Chek Guide system also provides advanced accuracy, which enables reliable diabetes management. Roche the most sustainable healthcare company The Dow Jones Sustainability Index (DJSI) recognised Roche as the most sustainable company in the healthcare industry for the eighth consecutive year. This year’s DJSI assessment emphasised that by focusing on access to healthcare, compliance and transparency, a diverse work culture and collaboration with a variety of partners, Roche is committed to creating value for all its stakeholders. Outlook for 2016 confirmed Roche expects 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. Read full Media Release About Roche 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 eight years in a row by the Dow Jones Sustainability Index. 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. All trademarks used or mentioned in this release are protected by law. References 1. Unless otherwise stated, all growth rates in this document are at constant exchange rates (CER: average 2015). 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 2015 or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche.