Improving the standard of care

Transcription

1 Improving the standard of care Bill Anderson Head of Global Product Strategy and Chief Marketing Officer London, September 2015

2 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 All mentioned trademarks are legally protected 2

3 Performance update Improving the standard of care Outlook 3

4 Q2 2015: Sales growth for fifth consecutive year 10% 8% 6% 6% 6% 6% 8% 7% 5% 5% 6% 7% 4% 4% 4% 4% 4% 5% 2% 2% 0% 0% 0% 1% Q1 11 Q2 11 Q3 11 Q4 11 Q1 12 Q2 12 Q3 12 Q4 12 Q1 13 Q2 13 Q3 13 Q4 13 Q1 14 Q2 14 Q3 14 Q4 14 Q1 15 Q2 15 All growth rates at Constant Exchange Rates (CER) 4

5 HY 2015: Strong underlying Group core operating profit & margin 40.7% 41.0% % of sales 38.1% 38.5% 39.2% (+0.4%p excl. filgrastim*) +2% at CER (+7%*) CHFbn HY 2011 HY 2012 HY 2013 HY 2014 HY 2015 CER=Constant Exchange Rates * Excluding sale of filgrastim rights in 2014 at CER 5

6 2014: Dividend and payout ratio further increased CHF payout ratio: 56.0% Dividend payout ratio (%) Payout ratio calculated as dividend per share divided by core earnings per share (diluted); Note: For 1995, a special dividend was paid 1 out compound to mark F. Hoffmann-La annual growth Roche s rate 100th anniversary in

7 Performance update Improving the standard of care Outlook 7

8 Roche strategy: Focused on medically differentiated therapies Premium for innovation Generics OTC Pharma Dia Focus MedTech Regulators: Optimised benefit / risk ratio Payors: Optimised benefit / cost ratio Differentiation 8

9 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 ( ) where applicable 9

10 Roche: Making progress in advancing patient care Recognising innovation Breakthrough Therapy Designations Rank Company # 1 Roche 9 2 GSK 5 2 Novartis 5 3 Merck 4 3 JNJ 4 3 BMS 4 YTD Actemra (Systemic sclerosis) Venetoclax (R/R CLL 17p) Atezolizumab (NSCLC) ACE 910 (Hemophilia) Esbriet (IPF) Lucentis (DR) Atezolizumab (bladder) Alectinib (2L ALK+ NSCLC) Gazyva (1L CLL) Source: CLL=Chronic Lymphocytic Leukemia; NSCLC=Non-Small Cell Lung Cancer; IPF=Idiopathic Pulmonary Hypertension; DR=Diabetic Retinopathy 10

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 glypican-3 MAb danoprevir gantenerumab Kadcyla Flu A MAb ocrelizumab Avastin LptD antibiotic lampalizumab Xeloda Esbriet Pulmozyme Oncology Immunology Infectious Diseases Neuroscience Ophthalmology Molecular Diagnostics Tissue Diagnostics Professional Diagnostics Xolair Actemra Lucentis 11

12 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 glypican-3 MAb danoprevir gantenerumab Kadcyla Flu A MAb ocrelizumab Avastin LptD antibiotic lampalizumab Xeloda Esbriet Pulmozyme Oncology Immunology Infectious Diseases Neuroscience Ophthalmology Molecular Diagnostics Tissue Diagnostics Professional Diagnostics Xolair Actemra Lucentis 12

13 POPLAR: Atezolizumab increased OS by 7.7 mo in IC2/3 or TC2/3 subgroup TC3 or IC3 (n = 47) HR a = 0.49 (0.22, 1.07) P value = TC2/3 or IC2/3 (n = 105) HR a = 0.54 (0.33, 0.89) P value = Median 11.1 mo (6.7, 14.4) Median 15.5 mo (9.8, NE) Median 7.4 mo (6.0, 12.5) Median 15.1 mo (8.4, NE) TC1/2/3 or IC3 (n = 195) HR a = 0.59 (0.40, 0.85) P value = TC0 and IC0 (n = 92) HR a = 1.04 (0.62, 1.75) P value = Median 9.2 mo (7.3, 12.8) Median 15.5 mo (11.0, NE) Median 9.7 mo (8.6, 12.0) Median 9.7 mo (6.7, 12.0) a Unstratified HR. Data cut-off May 8, Atezolizumab Docetaxel + Censored 13

14 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) Maximum SLD reduction from baseline (%) Change in SLD from baseline (%) Complete response Partial response Progressive disease Stable disease PR/CR (n=4) 80 SD (n=4) Progression* 60 Discontinued 40 New lesion Maximum SLD reduction from baseline (%) Change in SLD from baseline (%) Complete response Partial response Progressive disease Stable disease PD (n=2) PR/CR (n=13) SD (n=1) Progression* Discontinued New lesion Maximum SLD reduction from baseline (%) Change in SLD from baseline (%) PD (n=2) PR/CR (n=9) SD (n=4) Progression* Discontinued New lesion Complete response Partial response Progressive disease Stable disease Time on study (days) Time on study (days) Time on study (days) 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 14

15 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

16 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 glypican-3 MAb danoprevir gantenerumab Kadcyla Flu A MAb ocrelizumab Avastin LptD antibiotic lampalizumab Xeloda Esbriet Pulmozyme Oncology Immunology Infectious Diseases Neuroscience Ophthalmology Molecular Diagnostics Tissue Diagnostics Professional Diagnostics Xolair Actemra Lucentis 16

17 Three major types of Multiple Sclerosis Disability Mainly inflammatory Inflammatory / Degenerative Relapse No Relapse Relapse-Remitting (RRMS) (60-65%) Clearly defined relapses (attacks) with remissions initially returning to baseline but gradually result in sustained disability Secondary Progressive (SPMS) (20-25%) Initial RRMS followed by disability accumulation. Still experience relapses which eventually stop High unmet need: high efficacy therapies have major safety issues diagnosis and classification is difficult, often retrospective and can take 2-5 years Treatment decisions concentrated mainly in MS centers/hospitals Mainly degenerative Primary Progressive (PPMS) (10-15%) Slow but nearly continuous worsening of disease from outset (no relapses) Advocacy groups powerful in access Time Adapted from Lublin 1996, Arnold

18 Ocrelizumab: Positive phase 3 results confirm central role of B cells in MS Complement dependent cytotoxicity (CDC) OCRELIZUMAB Antibody-dependent cellular cytotoxicity (ADCC) Study Endpoint Reduction versus Rebif Apoptosis Primary Secondary Annualized Relapse Rate Confirmed Disability Progression MRI endpoints Antibody-dependent cellular phagocytosis (ADCP) Targeted product profile Humanized antibody targeting CD20+ B cells Selective depletion of a subset of B cells leaving the ability to generate new B cells intact Administered by IV twice yearly SOC=standard of care; MS=multiple sclerosis; RMS=relapsing forms of MS; PPMS= primary progressive MS; Rebif (Interferon beta-1a) Phase 3 OPERA I/II results in RMS Superiority vs. Rebif on primary and major secondary endpoints achieved Adverse events (including serious infections) similar to Rebif Phase 3 ORATORIO in PPMS First investigational medicines to show efficary in PPMS 18

19 Multiple major pivotal trials reading out near term Significant filing and launch activities ahead Year 2015 Molecule Market opportunity Incremental infrastructure Market characteristics Alectinib Medium Low Speciality Cotellic/ Braf Small Low Speciality Venetoclax Potentially large Low Speciality Ocrelizumab Large Medium- high Speciality Atezolizumab Large Medium Speciality 2016 Lebrikizumab Large Medium-high Specialty APHINITY Large Low Specialty GOYA Large Low Specialty ACE 910 Large Medium Speciality Lampalizumab Large Medium Speciality GALLIUM Large Low Specialty Taselisib (PI3Ki) Large Low Speciality Idasanutlin (MDM2) Medium Low Speciality Oncology Neuroscience Ophthalmology Immunology Small: up to CHF 0.5 bn; medium= CHF 0.5 to CHF 1bn; large > CHF1bn 19

20 Performance update Improving the standard of care Outlook 20

21 Planned key data presentations in H Vienna, Sep Barcelona, 7-10 Oct San Francisco, Nov San Antonio, 8-12 Dec Atezolizumab UBC: IMvigor 210 Ph II 1 NSCLC: POPLAR Ph II 1,2 NSCLC: BIRCH Ph II 1 NSCLC: Chemo combos update 2 Alectinib ALK+NSCLC: Ph II update 2 Ocrelizumab RMS: OPERA I / II Ph III PPMS: ORATORIO Ph III Atezolizumab Melanoma: Combo with Zelboraf Ph Ib (abstracts submitted) Cobimetinib + Zelboraf BRAF+Melanoma: cobrim efficacy update (abstracts submitted) Atezolizumab TNBC: Combo with abraxane Ph Ib (abstracts submitted) 1 Data not yet in-house; planned to be submitted to an up-coming congress ; 2 Potentially at World Conference on Lung Cancer (WCLC) 2015 UBC=Urinary Bladder Cancer; NSCLC=Non-Small Cell Lung Cancer; RMS=Relapsing forms of Multiple Sclerosis; TNBC=Triple Negative Breast Cancer 21

22 2015 outlook Group sales growth 1 Low to mid-single digit Core EPS growth 1 Ahead of sales growth 2 Dividend outlook Further increase dividend in Swiss francs 1 At constant exchange rates 2 Excluding sale of filgrastim rights in

23 Doing now what patients need next