Annual Report Key Figures 2012 Group sales 45,499 millions of CHF +4% (CER) 1 Core operating profit 17,160 millions of CHF +11% (CER) Core earnings per share 13.62 CHF +10% (CER) Operating free cash flow 15,389 millions of CHF +10% (CER) R & D investment 8,475 millions of CHF +2% (CER) Dividend 2 7.35 CHF +8% (CER) Total Shareholder Return 2012 The value of CHF 100 3 invested 1/1/2012, for the period ending 31/12/2012 125 121 120 118 117 115 110 105 100 95 90 Dec Mar Jun Sep Dec 2011 2012 Roche GS, Price = 184.00 Roche B, Price = 186.90 Peer Set Index Patients on clinical trials 326,642 patients +10.4% Number of employees 4 82,089 employees +2.4% 1 CER: Constant exchange rates (average full-year 2011). 2 Proposed by the Board of Directors. 3 Prices translated at constant CHF exchange rates: USD=0.90; EUR=1.20; 100 JPY=1.10; GBP=1.40. 4 Full-time equivalents. Key Events 2012 Roche Group At the Roche Annual General Management changes: 3% Meeting in 2012, shareholders Daniel O’Day, former Head authorised a 3% dividend of Roche Diagnostics, was Daniel O’Day Daniel increase to CHF 6.80 per appointed the new Head of share and non-voting equity. Roche Pharma. Roland DiggelmannRoland It was the company’s 25 th Diggelmann has assumed dividend increase in as many the position of Head of years. Roche Diagnostics. Roche continued to streamline Our late-stage pipeline its research and develop- made considerable progress ment activities, taking the in 2012, with 11 out of 14 clini- decision to close its site in cal trials delivering positive Nutley, New Jersey, USA. results, underpinning the The respective R & D activities strength of our innovation are being consolidated in strategy. Switzerland and Germany. Pharmaceuticals The FDA approved The FDA approved Perjeta Erivedge (vismodegib), (pertuzumab) for patients a first-in-class Hedgehog with HER2-positive meta- Pathway Inhibitor for static breast cancer. This new adults with advanced personalised medicine gives basal cell carcinoma. patients more time without their disease worsening. New data from the Phase III After the second interim EMILIA study showed that data analysis of the Roche’s trastuzumab dal-OUTCOMES trial, Roche emtansine (T–DM1) decided to discontinue the significantly improved survival development of dalcetrapib, of people with HER2-positive a medicine to lower cardio- metastatic breast cancer. vascular risks. Roche has filed for approval at the FDA and the EMA. Corporate Sustainability In 2012 we reduced our The second Transnet- water consumption by 8.6% Phelophepa Healthcare and our greenhouse gas Train was inaugurated in emissions by 2.6%. With this, South Africa. Roche doubled we are well on track to reach its support, now reaching our five-year goal of a 10% over 550,000 people a year in improvement in efficiency by rural South Africa through 2014. the train’s various services. Roche has been recognised Roche has been named as a great place to work, Healthcare Supersector achieving top rankings in Leader in the Dow Jones prestigious award listings Sustainability Indexes (DJSI) worldwide in 2012. for the fourth consecutive year. The ranking is a confir- mation of Roche’s commit- ment to long-term sustainable value creation. Diagnostics New US guidelines recognise The FDA cleared the the benefit of genotyping Accu-Chek Combo the human papillomavirus system, Roche’s new inter- (HPV) 16 and 18, the active insulin pump system principal causes of cervical for people with diabetes, cancer in women. and the Accu-Chek Nano SmartView system. Roche Applied Science Roche launched GUIDE-IT, and Diabetes Care initiated a clinical trial involving the restructuring measures cardiac marker NT-proBNP to sustain long-term profit- to guide therapy in heart ability. failure patients. The value of innovation ROCHE AT A GLANCE Who we are At Roche, we focus on fitting treatments to patients through innovative medicines and diagnostic tests. A global leader in innovation A sustainable company A great workplace Roche is a leader in research-focused We are committed to sustainability and to We are driven by a shared set of stan- healthcare with combined strengths in running our business in a way that is dards of integrity, the courage to reach pharmaceuticals and diagnostics. ethical, responsible and creates long-term beyond boundaries and a passion for value. what we do. 150+ 18,000,01 00 82,0892 countries patients treated employees 18 326,642 26 research centres patients in clinical trials manufacturing sites #1 in biotech #1 in oncology #1 in in vitro diagnostics #1 in hospital market What we do Pharmaceuticals Diagnostics We are the world’s largest biotech company with a product We are the global leader in in vitro diagnostic testing for portfolio of truly differentiated therapies and a robust pipeline early detection, evaluation and monitoring of disease. of investigational new medicines. We are also a frontrunner in the management of diabetes. Sales by therapeutic area 2012 (CER) 3 Sales by business area 2012 (CER) 3 61% Oncology (+9%) 51% Professional Diagnostics (+8%) 9% Virology (+14%) 25% Diabetes Care (–4%) Inflammation/Autoimmune/ 9% Transplantation (+5%) 11% Molecular Diagnostics (+4%) 5% Metabolism/Bone (–23%) 7% Applied Science (–3%) 4% Ophthalmology (–8%) 6% Tissue Diagnostics (+12%) 3% Respiratory diseases (+9%) 3% Cardiovascular diseases (+6%) 2% Renal anemia (–16%) 2% Central nervous system (+1%) 1% Infectious diseases (–1%) 1% Other therapeutic areas (–14%) Pharmaceuticals Sales 35.2 billion CHF Diagnostics Sales 10.3 billion CHF Roche Group Sales 45.5 billion CHF 1 With one of Roche’s 25 top-selling products. 2 Full-time equivalents (FTE). 3 CER: Constant Exchange Rates (average full-year 2011). Our strategic priorities Patients in need We strive to help patients in need with truly differ- cancer 29 million entiated diagnostics and medicines. Our focus lies in five disease areas with unmet medical need, hepatitis C 70 million oncology, inflammation, infectious disease, metabolism and the central nervous system. 24 million schizophrenia 235 million asthma 346 million diabetes Personalised Healthcare Personalised Healthcare at Roche is about providing the right therapy for the right group of patients at PERSONALISED Pharmaceuticals Diagnostics the right time. We provide medicines and diagnostics HEALTHCARE that optimise patient care, enabling tangible improve- ments in health, quality of life and survival. Excellence in science Roche is a highly innovative healthcare company, IN-HOUSE CUTTING EDGE SCIENCE with a robust R & D foundation. We have three autono- mous research units, as well as 150 partnerships OPTIMAL RESOURCE ALLOCATION all over the world, to foster diversity of research and translate science into medicines. EXTERNAL INNOVATION Innovative pricing models E STABLISHED Roche aims to bring its medicines and diagnostic marKETS Pressure from more tests to as many patients in need as possible. active payers To do this, we explore innovative pricing models and patient access schemes targeted to individual markets. E MERGING marKETS Build-up of healthcare systems with tight cost parameters Stakeholder value By discovering and developing innovative products, PATIENTS EMPLOYEES we aim to provide value to all our stakeholders, be they patients, doctors, employees, investors or value FOR society as a whole. ALL staKEHOLDERS SHAREHOLDERS PROVIDERS TP O -SELLING pharmaceuticals in millions of CHF 6,707 5,889 5,764 1,649 1,523 Product MabThera/ Herceptin Avastin Pegasys Xeloda Rituxan Sales growth (CER) 1 +9% +11% +6% +12% +9% Active substance rituximab trastuzumab bevacizumab peginterferon alfa-2a capecitabine Indications non-Hodgkin’s lymphoma, HER2-positive breast colorectal cancer, breast hepatitis B and C colorectal cancer, chronic lymphocytic cancer, advanced HER2- cancer, non-small cell colon cancer, leukemia, rheumatoid positive stomach cancer lung cancer, kidney breast cancer arthritis, ANCA-asso- cancer, ovarian cancer, ciated vasculitis glioblastoma 1 CER: Constant exchange rates (average full-year 2011). TP O -SELLING diagnostics in millions of CHF Accu-Chek Nano SmartView cobas e 602 cobas c 502 cobas TaqMan 48 Ventana IHC reagents 2,346 2,321 1,514 562 518 Product Accu-Chek cobas e modules, cobas c modules, Cobas AmpliPrep/ immunohistochemistry monitoring systems Modular Analytics, Modular Analytics, Cobas TaqMan and in situ hybridisation Elecsys Cobas Integra Sales growth (CER) 1 –5% +15% +5% +2% +13% Market segment Blood glucose monitoring Immunoassays Clinical chemistry Virology (hepatitis B, Advanced tissue staining hepatitis C, HIV) Business area Diabetes Care Professional Diagnostics Professional Diagnostics Molecular Diagnostics Tissue Diagnostics The Value of Innovation Roche is a global leader in innovation for medicines and diagnostic testing. This annual report highlights how inno- vation brings value to patients, prescribers, healthcare reimbursement and society as a whole. 16 58 70 A possible new medicine Actemra/Roactemra High-sensitivity for HER2-positive meta- Relief for the agony of childhood cardiac test static breast cancer arthritis Precise testing for life or A new generation of cancer death decisions treatment 78 88 98 Accurate diagnosis and Working with the insurance cobas HPV and CINtec personalised healthcare industry in China tests Focusing healthcare budgets Improving health insurance Better screening for cervical on targeted treatments coverage for cancer patients cancer 106 120 Special Feature The fight against cancer goes on From mining to biotech - Innovation in the pharma- 50 years of cancer research at Roche One in three people will develop cancer during their lifetime. From the start, our aim was to advance the treatment of cancer. And yet the challenge to find a cure remains elusive. One of the As a result, Roche later developed several successor drugs Roche Penzberg ceutical industry reasons it is so difficult to treat is that cancer is, strictly speak- with the aim of preferentially generating the cytotoxin 5-FU in ing, not just one disease but a group of different diseases.