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Download1 MB Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer London, September 2015 This presentation 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 presentation, 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. Any statements 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 this year or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. For marketed products discussed in this presentation, please see full prescribing information on our website – www.roche.com All mentioned trademarks are legally protected 2 Performance update Improving the standard of care Outlook 3 Q2 2015: Sales growth for fifth consecutive year 10% 8% 8% 7% 7% 6% 6% 6% 6% 6% 5% 5% 4% 5% 4% 4% 4% 4% 2% 2% 0% 0% 1% 0% Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 11 11 11 11 12 12 12 12 13 13 13 13 14 14 14 14 15 15 All growth rates at Constant Exchange Rates (CER) 4 HY 2015: Strong underlying Group core operating profit & margin % of sales 40.7% 41.0% 39.2% (+0.4%p 38.5% excl. filgrastim*) 38.1% +2% at CER (+7%*) CHFbn 9.5 9.4 9.2 8.3 8.6 HY 2011 HY 2012 HY 2013 HY 2014 HY 2015 CER=Constant Exchange Rates 5 * Excluding sale of filgrastim rights in 2014 at CER 2014: Dividend and payout ratio further increased CHF Dividend payout ratio (%) 10.00 56.0 55.3 54.7 9.00 54.5 8.00 8.00 51.6 2014 payout ratio: 56.0% 48.6 7.00 44.8 6.00 38.8 34.5 5.00 31.9 4.00 3.00 2.00 1.00 0.00 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014 Payout ratio calculated as dividend per share divided by core earnings per share (diluted); Note: For 1995, a special dividend was paid 6 1 out compoundto mark F. Hoffmann annual growth-La Roche’s rate 100th anniversary in 1996 Performance update Improving the standard of care Outlook 7 Roche strategy: Focused on medically differentiated therapies Regulators: Pharma Dia Optimised benefit / risk ratio Payors: Focus Optimised benefit / cost ratio MedTech Premium for innovation for Premium OTC Generics Differentiation 8 Roche’s approach in specialty care: First and best in class necessary for success Market share* Undifferentiated products Modest differentiation Medical breakthroughs Years post launch Data source: Evaluate Pharma, Decision Resources, Roche/Genentech PMR launch trackers Note: *Market shares represent either % sales of target product relative to sales competing products in similar indications or patient shares from Roche PMR trackers; sales data are actuals (≤ 2013) + consensus broker forecasts (2013-2020) where applicable 9 Roche: Making progress in advancing patient care Recognising innovation 2013-15 Breakthrough Therapy 9 Designations Actemra (Systemic sclerosis) Rank Company # Venetoclax (R/R CLL 17p) YTD 2015 1 Roche 9 Atezolizumab (NSCLC) ACE 910 (Hemophilia) 2 GSK 5 Esbriet (IPF) 2 Novartis 5 2014 Lucentis (DR) 3 Merck 4 Atezolizumab (bladder) 3 JNJ 4 Alectinib (2L ALK+ NSCLC) 3 BMS 4 2013 Gazyva (1L CLL) Source: http://www.focr.org/breakthrough-therapies; CLL=Chronic Lymphocytic Leukemia; NSCLC=Non-Small Cell Lung Cancer; IPF=Idiopathic Pulmonary Hypertension; DR=Diabetic Retinopathy 10 Progressing in Personalised Healthcare 60% of phase 2 & 3 products have PHC component Phase 2 Phase 3/Registration Marketed FIXa/FX bispecific MAb MAO-B inh PD-L1 MAb Tarceva® SERD GABRA5 NAM venetoclax (Bcl-2 inh) Zelboraf® CSF-1R MAb bitopertin alectinib (ALK inh) Erivedge® Ang2-VEGF MAb basimglurant taselisib Rituxan® ipatasertib V1 receptor antag cobimetinib Gazyva® polatuzumab vedotin crenezumab lebrikizumab Herceptin® lifastuzumab vedotin olesoxime etrolizumab Perjeta® gantenerumab glypican-3 MAb danoprevir Kadcyla® Flu A MAb ocrelizumab Avastin® LptD antibiotic lampalizumab Xeloda® Esbriet® Pulmozyme® Oncology Molecular Diagnostics Xolair® Immunology Tissue Diagnostics Infectious Diseases Actemra® Professional Diagnostics Neuroscience Lucentis® Ophthalmology 11 Progressing in Personalised Healthcare 60% of phase 2 & 3 products have PHC component Phase 2 Phase 3/Registration Marketed FIXa/FX bispecific MAb MAO-B inh PD-L1 MAb Tarceva® SERD GABRA5 NAM venetoclax (Bcl-2 inh) Zelboraf® CSF-1R MAb bitopertin alectinib (ALK inh) Erivedge® Ang2-VEGF MAb basimglurant taselisib Rituxan® ipatasertib V1 receptor antag cobimetinib Gazyva® polatuzumab vedotin crenezumab lebrikizumab Herceptin® lifastuzumab vedotin olesoxime etrolizumab Perjeta® gantenerumab glypican-3 MAb danoprevir Kadcyla® Flu A MAb ocrelizumab Avastin® LptD antibiotic lampalizumab Xeloda® Esbriet® Pulmozyme® Oncology Molecular Diagnostics Xolair® Immunology Tissue Diagnostics Infectious Diseases Actemra® Professional Diagnostics Neuroscience Lucentis® Ophthalmology 12 POPLAR: Atezolizumab increased OS by 7.7 mo in IC2/3 or TC2/3 subgroup TC3 or IC3 (n = 47) TC2/3 or IC2/3 (n = 105) HRa = 0.49 (0.22, 1.07) HRa = 0.54 (0.33, 0.89) P value = 0.068 P value = 0.014 Median 11.1 mo Median 15.5 mo Median 7.4 mo Median 15.1 mo (6.7, 14.4) (9.8, NE) (6.0, 12.5) (8.4, NE) TC1/2/3 or IC3 (n = 195) TC0 and IC0 (n = 92) HRa = 0.59 (0.40, 0.85) HRa = 1.04 (0.62, 1.75) P value = 0.005 P value = 0.871 Median 9.2 mo Median 15.5 mo Median 9.7 mo Median 9.7 mo (7.3, 12.8) (11.0, NE) (8.6, 12.0) (6.7, 12.0) Atezolizumab Docetaxel + Censored 13 aUnstratified HR. Data cut-off May 8, 2015. Atezolizumab and chemo-combos Deep and ongoing effects Arm C – cb/pac (n=8) Arm D – cb/pem (n=17) Arm E – cb/nab (n=16) 100 100 100 Complete response Complete response Complete response Partial response Partial response Partial response Progressive disease 50 50 Progressive disease 50 Progressive disease Stable disease Stable disease Stable disease 0 0 0 9 11 9 –16 –7 –12 –17 baseline (%) baseline baseline (%) baseline baseline (%) baseline –22 –23 –25 –31 –31 –21 –21 –22 –50 –43 –50 –38 –50 –45 –41 –42 –47 –43 –50 –53 Maximum SLD reduction from Maximum SLD reduction from Maximum SLD reduction from –57 –57 –57 –58 –64 –69 –67 –72 –72 –76 –100 –84 –100 –100 –86 –87 100 PR/CR (n=4) 100 PD (n=2) 100 PD (n=2) –100 –100 80 SD (n=4) 80 PR/CR (n=13) 80 PR/CR (n=9) Progression* SD (n=1) SD (n=4) 60 Discontinued 60 Progression* 60 Progression* 40 New lesion 40 Discontinued 40 Discontinued 20 20 New lesion 20 New lesion 0 0 0 –20 –20 –20 –40 –40 –40 –60 –60 –60 Change in SLD from SLD (%)baseline Change in –80 –80 from SLD (%)Changebaseline in –80 Change in SLD from SLD (%)baseline Change in –100 –100 –100 0 42 84 126 168 210 252 294 336 378 420 450 0 42 84 126 168 210 252 294 336 378 420 450 0 42 84 126 168 210 252 294 336 378 420 450 Time on study (days) Time on study (days) Time on study (days) 14 Includes all patients dosed by 10 Nov 2014; data cut-off: 10 Feb 2015; SLD, sum of longest diameters; *PD for reasons other than new lesions The 7 steps of the Cancer-Immunity Cycle guide our prioritization framework for Atezolizumab Step 1: Release of Cancer Cell antigens: - ex: Atezo + chemo, Gazyva, aCD40 Step 2 & 3: Cancer antigen presentation & priming and activation - ex: Atezo + interferon, OX40 Steps 4 & 5: Trafficking & inflitration of T cells to tumours - ex: Atezo + Avastin, aCSF1R, Steps 6 & 7: Recognition of cancer cells by T cells & killing of cancer cells - ex: Atezo + Meki, IDOi, aOX40 Chen and Mellman. Immunity 2013 15 Progressing in Personalised Healthcare 60% of phase 2 & 3 products have PHC component Phase 2 Phase 3/Registration Marketed FIXa/FX bispecific MAb MAO-B inh PD-L1 MAb Tarceva® SERD GABRA5 NAM venetoclax (Bcl-2 inh) Zelboraf® CSF-1R MAb bitopertin alectinib (ALK inh) Erivedge® Ang2-VEGF MAb basimglurant taselisib Rituxan® ipatasertib V1 receptor antag cobimetinib Gazyva® polatuzumab vedotin crenezumab lebrikizumab Herceptin® lifastuzumab vedotin olesoxime etrolizumab Perjeta® gantenerumab glypican-3 MAb danoprevir Kadcyla® Flu A MAb ocrelizumab Avastin® LptD antibiotic lampalizumab Xeloda® Esbriet® Pulmozyme® Oncology Molecular Diagnostics Xolair® Immunology Tissue Diagnostics Infectious Diseases Actemra® Professional Diagnostics Neuroscience Lucentis® Ophthalmology 16 Three major types of Multiple Sclerosis Relapse-Remitting (RRMS) Mainly inflammatory (60-65%) Clearly defined relapses (attacks) with remissions initially returning • High unmet need: to baseline but gradually result in sustained disability • high efficacy therapies have major safety issues • diagnosis and classification is Inflammatory / Degenerative Secondary Progressive difficult, often retrospective and (SPMS) (20-25%) can take 2-5 years Initial RRMS followed by disability accumulation.
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