Roche Analyst Event Monday, 5 December 2016 This Presentation Contains Certain Forward-Looking Statements
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58th ASH Annual Meeting, San Diego Roche Analyst Event Monday, 5 December 2016 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. 3 Introduction Karl Mahler Head Investor Relations Agenda Welcome Karl Mahler, Head of Investor Relations New paths in hematology Nancy Valente, M.D., Vice President, Product Development Hematology/Oncology Gazyva - New standard of care in FL (iNHL) David Traub, M.D., Lifecycle Leader anti-CD20 Franchise Venclexta – New data in CLL, NHL, AML and MM Reema Mewar, Ph.D., Lifecycle Leader Venclexta/Venclyxto Polatuzumab vedotin – A potent ADC in NHL Michael Wenger, M.D., Senior Group Medical Director Q&A 5 2016 onwards: Significant launch activities Venclexta R/R CLL with 17p del Cotellic + Zelboraf BRAFmut melanoma Alecensa 2L ALK+ NSCLC NMEs Tecentriq OCREVUS 2L+ bladder cancer RMS/ PPMS Tecentriq Emicizumab (ACE910) Lampalizumab 2L+ all-comers NSCLC Hemophilia A Geographic atrophy 2016 2017 2018 Gazyva Perjeta + Herceptin Tecentriq+Avastin+chemo Refractory iNHL (GADOLIN) eBC HER2+ (APHINITY) 1L NSCLC Gazyva Tecentriq + Avastin 1L iNHL (GALLIUM) 1L RCC line line Actemra Alecensa extensions Giant cell arteritis (GiACTA) 1L ALK+ NSCLC Oncology/ FDA Breakthrough Neuroscience Ophthalmology Immunology hematology Therapy Designation Outcome studies are event-driven: timelines may change. Standard approval timelines of 1 year assumed. 6 Roche significantly advancing patient care Five BTD designations in hematology Year Molecule Actemra (Giant cell arteritis) Breakthrough Therapy Alecensa (1L ALK+ NSCLC) 14 Designations 2016 Ocrevus (PPMS) Venclexta (AML) Venclexta + Rituxan (R/R CLL) Rank Company # Actemra (Systemic sclerosis) 1 Roche 14 Tecentriq (NSCLC) 2015 2 Novartis 11 Venclexta (R/R CLL 17p del) 3 BMS 10 Emicizumab/ACE 910 (Hemophilia A) 4 Merck 9 Esbriet (IPF) 2014 Lucentis (Diabetic retinopathy) 5 AbbVie 7 Tecentriq (Bladder) 6 Pfizer 7 Alecensa (2L ALK+ NSCLC) 2013 Gazyva (1L CLL) Source: http://www.focr.org/breakthrough-therapies as at Oct 2016; PPMS=Primary Progressive Multiple Sclerosis; CLL=Chronic 7 Lymphocytic Leukemia; AML=acute myeloid leukemia; NSCLC=Non-Small Cell Lung Cancer; IPF=Idiopathic Pulmonary Fibrosis ASH 2016: Improving upon on standard of care Key presentations DLBCL FL CLL Polatuzumab shows Establishing Gazyva as SOC Venclexta unfolding promiseDLBCL (Ph2 ROMULUS in (Ph3 GALLIUMFL in 1L and Ph3 (run-in dataCLL for Ph3 CLL14) R/R and Ph1/2 in 1L) GADOLIN in Rituxan- ref FL) Rituxan-CHOP remains MabThera SC comparable to standard of care IV (Ph3 SABRINA) AML MM Hemophilia Venclexta + LDAC with strong Strong efficacy of Venclexta Real world data of patients efficacyAML/MDS in 1L unfit AML (Ph2) in R/R MMMM (Ph1 monotherapy withHemophilia hemophilia A to support and combination data) further development of emicizumab 8 New paths in hematology Nancy Valente, M.D. Vice President, Product Development Hematology/Oncology Unmet need in hematology Hematology portfolio & strategy Cancer immunotherapy Emicizumab update 10 Today: Hematology indications still represent large unmet need DLBCL FL CLL 40% of DLBCL Still no cure, many patients Still no cure, many patientsDLBCL relapse and experience multipleFL patients achieveCLL succumb to their relapses before succumbing incomplete responses and disease to their disease require chronic treatment AML/MDS MM Hemophilia SOC in AML has made little Foundation of therapy based High unmet need for patients progressAML/MDS in decades, on two drugMM classes associated withHemophilia inhibitors to Factor VIII; combinations will significantly with significant side effects; Existing therapies are hampered improve outcomes for patients targeted therapy combinations by burden on therapy and to advance SOC compliance Blood cancer: Still high unmet medical need Incidence cases reach 330,000 pts1 aCD20/CD3 TCB 1 aCD20/CD3 TCB 2 polatuzumab vedotin idasanutlin LSD1 inhibitor BET inhibitor ChK1 inhibitor = Roche marketed = Roche in development undisclosed ADC ¹ Datamonitor; incidence rates includes the 7 major markets (US, Japan, France, Germany, Italy, Spain, UK); NHL=non-hodgkin`s lymphoma; DLBCL (aNHL)=diffuse large B-cell lymphoma; FL (iNHL)=follicular lymphoma; ALL=acute lymphoblastic leukemia; AML=acute myeloid leukemia; CLL=chronic lymphoid leukemia; MM= multiple myeloma; MDS=myelodysplastic syndrome; Venclexta in collaboration with AbbVie; Cotellic in collaboration with Exelixis; Gazyva in collaboration with Biogen; polatuzumab vedotin in collaboration with Seattle Genetics; LSD1inhibitor in collaboration with Oryzon Genomics; ChK1i in collaboration with Array BioPharma 12 Unmet need in hematology Hematology portfolio & strategy Cancer immunotherapy Emicizumab update 13 Gazyva initial trial program completed New standard of care in iNHL and CLL Primary end-point: CLL11: Ph III 1L Chronic Lymphocytic Leukemia (CLL) Gazyva + chlorambucil 1L CLL PFS Rituxan + chlorambucil n=781 Approved in Q4 2013 chlorambucil GADOLIN: Ph III Rituxan-refractory Follicular Lymphoma (FL) Induction Maintenance PFS CR, PR, Rituxan-refractory FL Gazyva + bendamustine Gazyva SD Approved in Q1 2016 (indolent NHL) q2mo x 2 years n=411 bendamustine GALLIUM: Ph III 1L Follicular Lymphoma (FL) Induction Maintenance Gazyva + CHOP or Gazyva Gazyva + CVP or 1L FL q2mo x 2 years PFS Gazyva + bendamustine (indolent NHL) CR, PR Stopped at interim analysis n=1401 Rituxan + CHOP or Rituxan Rituxan + CVP or q2mo x 2 years Rituxan + bendamustine GOYA: Ph III 1L Diffuse Large B-cell Lymphoma (DLBCL) Gazyva + CHOP Front-line DLBCL PFS (aggressive NHL) Endpoint not met n=1418 Rituxan + CHOP Gazyva in collaboration with Biogen; CHOP=Cyclophosphamide, Doxorubicin, Vincristine and Prednisone; CVP=Cyclophosphamide, 14 Vincristine and Prednisolone Establishing Gazyva as new CD20 backbone Improving the standard of care in iNHL and CLL Rituxan sales split by indication 1L CLL Gazyva in 1L CLL 5% 1L CLL Fit (CLL 11) 6% R/R CLL 6% Gazyva in 1L FL (iNHL) (GALLIUM) iNHL 49% Gazyva in Rituxan-refractory 1L aNHL FL (iNHL) (GADOLIN) 27% R/R aNHL 6% CLL=chronic lymphocytic leukemia; iNHL=indolent non-hodgkin’s lymphoma; FL=follicular lymphoma; aNHL=aggressive NHL; DLBCL=diffuse large B cell lymphoma; Gazyva in collaboration with Biogen 15 Evolving landscape in NHL Increasing segmentation and new surrogate endpoints Present Future 2014 2014 2024 Competition No competition for 17 years Increased competition Combination therapies for diagnostic subsegments Segmentation All comers studies ABC Unclassified GCB DLBCL (aNHL) Traditional Potential Traditional Endpoints Surrogate Endpoints New PFS OS MRD CR30 PFS OS Endpoints CLL NHL 5 yrs 7 yrs 15mo 30mo 5 yrs 7 yrs Induction Induction Early Filing ABC=activated B-cell, GCB=germinal center B-cell 16 Increasing segmentation in 1L DLBCL (aNHL) New combinations based on Rituxan backbone Elevated BCL-2 % of Median OS Segment incidence [months] ~50% All Comers 100% >60 Double Positive Double Hit BCL-2 and myc* BCL-2 and myc GCB 55% >60 ABC** 30% 30-40 18-33% Double Positive 24 ~50% (46% of ABC) Double-Hit 5-10% 12 Un- ABC classified GCB ** worse outcomes in ABC may be driven by higher proportion of double positive patients ~30% ~15% ~55% Rituxan backbone Lenalidomide (ROBUST) Ibrutinib (PHOENIX) *46% of ABC patients are double positive (Hu S et l. Blood, 2013); Source: Roche internal data presented during REFORCE F2F Feb- 2015; Johnson N et al, JCO 2012; Hu S et al, Blood 2013; Iqbal J et al. Clin Can Res 2011; Iqbal J et al. JCO, 2006; Davis et al. Nature 2010; Haberman T et al, JCO 2006; Thieblemont C et al. JCO 2011 17 ABC=activated B-cell, GCB=germinal center B-cell Surrogate endpoints to accelerate development MRD level Predict long-term outcome early on <10-4 ≥10-4 to <10-2 ≥10-2 Novel endpoints: • MRD in CLL • CR30 months in FL • PET-CT negative CR in DLBCL MRD=minimal