Innovation and growth

Transcription

1 Innovation and growth Alan Hippe, CFO Roche Group Jefferies Healthcare Conference, June 2014

2 Performance update Industry in context Building pillars of growth / ASCO 2014 Summary 2

3 Q1 2014: Strong sales growth Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division Diagnostics Division Roche Group CER=Constant Exchange Rates 3

4 Q1 2014: Both Divisions growing in all regions 5 +4% 4 +5% +10% % +11% +3% +3% Diagnostics Pharma 1 +17% +7% +1% +5% CHFbn 0 +19% Japan International Europe US All growth rates at constant exchange rates 4

5 Group operating profit and margin 33.2% 34.9% 35.6% 37.7% 38.3% +8% 1 % of sales CHFbn 1 At constant exchange rates

6 2014 Outlook Group sales growth 1 Low- to mid-single digit Core EPS growth 1 Ahead of sales growth Dividend outlook Further increase dividend 1 At constant exchange rates 6

7 Performance update Industry in context Building pillars of growth / ASCO 2014 Summary 7

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

9 Access and pricing Dynamics stratified into 3 geographic clusters Developed world ex-us (37% of world market, 10% of population) Payers determine price Emerging Markets (28% of world market, 85% of population) Spend limited by GDP per capita United States (35% of world market, 5% of pop) Free, stable pricing 9

10 Access Access and pricing Dynamics stratified into 3 geographic clusters High Developed world United States United States (35% of world market, 5% of pop) Free, stable pricing Japan Germany France Developed world ex-us (37% of world market, 10% of population) Payers determine price Italy Emerging Markets (28% of world market, 85% of population) Spend limited by GDP per capita UK Turkey Russia Mexico Brazil Low China India Emerging markets Low Pricing flexibility High 10

11 Innovating business models in developed markets Enabling access through innovative pricing Today Pack based pricing Personalized Reimbursement Models Value based pricing Episode-of-care based Future Undifferentiated $$ by vial + Combinations Indication based Need for data from healthcare systems 11

12 Performance update Industry in context Building pillars of growth / ASCO 2014 Summary 12

13 Roche oncology: continued sales growth A portfolio of differentiated medicines (CHF mn) 25'000 20'000 15'000 10' medicines 14 tumour types 5'000 ' Sales at 2013 exchange rates 13

14 Roche: A leading portfolio Launched Oncology 10 drugs launched 6 Phase III Avastin MabThera Herceptin Xeloda Tarceva Zelboraf Erivedge Perjeta Kadcyla Gazyva Immunology/ Inflammation 4 drugs launched 4 Phase III Mabthera RA Actemra Lucentis Xolair Neuroscience 2 Phase III Phase III Pictilisib 2 Beta s. PI3K 2 MetMab (onartuzumab) anti-pdl1 BCL2i cobimetinib (MEKi) Oral octreotide lebrikizumab etrolizumab 1 lampalizumab 2 ocrelizumab gantenerumab Phase II 8 phase II 1 phase II 4 phase II Strong and growing Strongly emerging Earlier stage 1 FPI expected 1H 2014; 2 Phase III decision pending 14

15 Cancer immunotherapy at Roche Pipeline overview Pre-clinical Phase I Phase II Phase III ImmTAC Neg. Regulator NME 1 IMA 942 Anti-cytokine NME 2 T-cell bispecific Anti-PDL1 Solid tumors Anti-PDL1+Avastin Solid tumors Anti-PDL1+cobimetinib Solid tumors Anti-PDL1+Zelboraf Met. Melanoma Anti-PDL1+Tarceva NSCLC Anti-PDL1 + immune m. Solid tumors Anti-PDL1 + Gazyva Heme tumors Anti-PDL1 NSCLC (Dx+) Anti-PDL1 NSCLC Anti-PDL1+Avastin Renal Anti-PDL1 Bladder Anti-PDL1 NSCLC 2/3 L Anti-PDL1 Bladder CSF1R humab CEA IL-2v Anti-OX40 Anti-PDL1 trials Start planned for 2014 Stimulator Anti-CD40 Inhibitor INO-5150 Note: Anti-PDL1 is listed as MPDL3280A in clinicaltrials.gov 15

16 No. of drugs approved by FDA Urothelial bladder carcinoma (UBC) High unmet need for patients with advanced disease New therapies in RCC, prostate and bladder cancer Prostate cancer RCC US: 74, 690 new cases diagnosed p.a. 1 Metastatic UBC prognosis: 5-year OS ~17% 1L median OS: 9.3 months 2 2L median OS: 6.9 months 3 US: no therapies approved for patients who relapse on Pt-based chemo UBC Year Galsky et. al Sources: 1 Siegel R, CA Cancer J Clin 2014; 64: De Santis et al, JCO, 2012, Vol. 30, No.2, p , 3 Bellmunt J et al, JCO, 2009, Vol. 27, No 27, p

17 MPDL3280A (anti-pdl1) in metastatic UBC Response by PD-L1 IHC status PD-L1 IHC (n) ORR (95% CI) IHC 3 (n=10) 50% (22-78) IHC 2 (n=20) 40% (22-64) IHC 1 (n=23) 13% (4-32) IHC 0 (n=12) 8% (0.4-35) Dx+ vs Dx- ORR (95% CI) 43% (26-63) 11% (4-26) 2 complete responses in the IHC 2 / 3 cohort 16 of 17 responding patients had ongoing responses at the time of data cut-off * Patients with complete responses. Patients with a CR had 100% reduction of the target lesions due to lymph node target lesions. All lymph nodes returned to normal size as per RECIST v1.1.ic; tumor-infiltrating immune cells.best response is not known for 7 patients. IHC 0 < 1% of ICs PD-L1-positive; IHC 1 1% but < 5%; IHC 2 5% but < 10%; IHC 3 10%. Patients dosed by Nov 20, 2013 with a baseline tumor assessment. Clinical data cut-off was Jan 1,

18 Anti-PDL1 in metastatic non-small cell lung cancer (mnsclc) FIR: Phase II Dx-positive advanced mnsclc PDL1-positive NSCLC n = 130 BIRCH: Phase II Dx-positive advanced mnsclc PDL1-positive NSCLC n = 300 POPLAR: Phase II 2/3L mnsclc All comers 2,3L NSCLC n = 287 Anti-PDL mg IV Q3 weeks Anti-PDL mg IV Q3 weeks Docetaxel 75 mg/m2 IV Q3 wk Anti-PDL mg IV Q3 wk Primary end-point: ORR FPI Q Data expected end 14 Primary end-point: ORR FPI Q Primary end-point: OS FPI Q Enrollment complete OAK: Phase III 2/3L mnsclc All comers 2,3L NSCLC n = 850 Docetaxel 75 mg/m2 IV Q3 wk Anti-PDL mg IV Q3 wk Primary end-point: OS FPI Q Phase III trials in first line NSCLC in preparation Note: Anti-PDL1 is listed as MPDL3280A in clinicaltrials.gov 18 18

19 MPDL3280A (anti-pdl1) development Readouts over the next 12 months Study Indication Readout Anti-PDL1 as single agent Phase I New tumor type First readout Lung Renal Bladder Melanoma Follow-up data Follow-up data Follow-up data Follow-up data Phase II (FIR) NSCLC (PD-L1+) First readout Phase II (POPLAR) 2/3L NSCLC First readout Anti-PDL1 in combination Phase Ib Multiple tumor types First readout Outcome studies are event driven, timelines may change 19

20 Medical value Strategies beyond great medicines Hematology Replace and extend Extend BCL-2i Replace BCL-2i ADCs ADCs ADC 79b ADC 22 Gazyva ADC 79b Gazyva Chemo ADC 22 MabThera MabThera CLL11 GOYA GALLIUM GADOLIN Murano (CLL) Romulus (NHL) Phase Ib CLL(G+Bcl-2) Bcl-2 i. in collaboration with AbbVie (ABT 199) 20

21 ROMULUS: Phase II head to head study in NHL Study design R/R FL, n= 40 2/3+L DLBCL, n= 80 Rituximab (375 mg/m 2 ) + ADC (2.4 mg/kg) administered in every 21-day cycles Randomize 1:1 Anti-CD22 ADC + RTX polatuzumab vedotin + RTX PD PD polatuzumab vedotin + RTX Anti-CD22 ADC + RTX FL: follicular lymphoma, DLBCL: diffuse large B-cell lymphoma Morschhauser, F., ASCO 2014, abstract #

22 Max % change tumor decrease from BL ROMULUS: Phase II head to head study in NHL Promising results for polatuzumab polatuzumab ved.+rituximab in FL Regimen R/R DLBCL R/R FL polatuzumab vedotin + rituximab anti-cd22 ADC + rituximab ORR = 56% CR = 15% ORR = 57% CR = 24% ORR = 70% CR = 40% ORR = 59% CR = 9% Polatuzumab ved. selected for late stage development based on high level of anti-tumor activity Morschhauser, F., ASCO 2014, abstract #

23 ABT-199 cohort Cohort Dose dose Bcl-2 inhibitor (GDC-0199) single agent Encouraging duration of response in R/R CLL 200 mg 300 mg 400 mg 500 mg 600 mg 400 mg SE Months on Study Months on study Most patients are still progression-free, even those on lower doses In collaboration with AbbVie (ABT-199). J.F. Seymour, ASCO 2014, abstract # 7015 R/R CLL: relapsed/refractory chronic lymphocytic leukemia. SE: safety expansion 23

24 Bcl-2 inhibitor (GDC-0199)+R in R/R CLL Efficacy in combining with an anti-cd 20 antibody Best % change from baseline in Lymphocyte Count Response Evaluable* n=25 Response rate 21 (84%) Complete response 9 (36%) Partial response 12 (48%) Stable disease 1 (4%) Disease progression 1 (4%) Discontinued prior to assessment 2 (8%) * Evaluable pts have reached the month 7 bone marrow assessment, discontinued, or progressed on therapy High level of complete response and MRD (6/7 CR, 86%) Results supported move into phase III (MURANO) study in R/R CLL In collaboration with AbbVie (ABT 199). Shuo Ma, ASCO 2014, abstract #7013, R: rituximab. MRD: minimal residual disease (PB or BM) 24

25 Bcl-2 inhibitor (GDC-0199) Safety update No further clinical TLS 1 cases since program restart (120 new patients treated) New revised monitoring agreed with FDA: No hospitalization for low/ medium risk patients Hospitalization for high risk patients 2 : at treatment initiation and first escalation one week later In collaboration with AbbVie (ABT-199). 1 TLS: Tumor lysis syndrome. 2 High risk is currently defined at those patients who have large tumors (10+ cm) and those patients who have tumors 5-10 cm and high circulating lymphocyte counts 25

26 Bcl-2 (GDC-0199) development Next steps Study Indication Status Readout (exp.) CLL Phase II 17p del Enrolment complete 2015 Phase III combo with R (MURANO) R/R CLL Enrolling 2016 Phase III combo with Gazyva 1L CLL Start planned in and beyond NHL Phase II combo with R Follicular lymphoma Start planned in Phase II combo with R/G DLBCL Start planned in In collaboration with AbbVie (ABT-199) Outcome studies are event driven, timelines may change. R=rituximab, G=obinutuzumab 26

27 Roche Hematology pipeline Broad range of indications and approaches Phase I Bcl-2 inh (GDC 199) + Gazyva CLL Bcl-2 inh (GDC 199) NHL Bcl-2 inh (GDC 199) AML Bcl-2 inh (GDC 199) Multiple myeloma LSD1 inh (RG6016) AML MDM2 (RG738) AML ADC (RG7598) multiple myeloma ChK1 inh (RG7741) lymphoma RG 7845 heme tumors Phase II Bcl-2 inh (GDC 199) CLL R/R 17p del Erivedge AML polatuzumab ved. (CD 79b) NHL pinatuzumab ved. (CD22) NHL New Molecular Entity Additional Indication Phase III Gazyva DLBCL Gazyva inhl relapsed Gazyva inhl front-line Bcl-2 inh. (GDC 199) CLL R/R Registration Gazyva 1 CLL 1 Approved in US, submitted in EU 27

28 Performance update Industry in context Building pillars of growth / ASCO 2014 Summary 28

29 1H 2014: Upcoming clinical newsflow ASCO Chicago May 30-June 3 Multiple oncology assets ENDO Chicago June Oral octreotide Ph III, Acromegaly AAIC Copenhagen July Crenezumab Ph II, Alzheimer s Disease Oncology Immunology 29 Neuroscience

30 Summary: Focus on innovation and growth 1 Strategic focus on innovation and driving Personalised Healthcare 2 Strong growth in Emerging Markets facilitated by tailored access models 3 Leading product pipeline providing value for the future 30

31 Doing now what patients need next 31

32 2014: 14 new compounds in late stage development Oncology anti-cd79b ADC 1 pictilisib (PI3K) 1 beta-sparing PI3K 1 (mutant selective) alectinib (ALKi) 1 NSCLC Bcl-2i (GDC 0199) hem. cancers anti-pdl1 solid tumours cobimetinib (MEKi) melanoma onartuzumab (MetMAb) Gastric cance Immunology / Ophthalmology lampalizumab geographic atrophy etrolizumab UC and CD oral octreotide acromegaly lebrikizumab asthma Neuroscience gantenerumab Alzheimer s ocrelizumab MS Oncology Ophthalmology 1 Phase III decision pending 32 Neuroscience Immunology

33 M E D I C A L V A L U E Building pillars of growth: Her2 franchise Replace & Extend Extend Perjeta Replace Perjeta Kadcyla Kadcyla Herceptin + chemo Lapatinib + chemo Herceptin + chemo Illustrative EMILIA / MARIANNE study CLEOPATRA study MARIANNE study 33

34 M E D I C A L V A L U E Building pillars of growth: Hematology franchise Replace & Extend Replace Extend BCL2 BCL2 ADC CD22 ADC CD79b ADC CD22 ADC CD79b Other molecules Gazyva combo(s) Other molecules Gazyva MabThera/ Rituxan combos Chemo MabThera/ Rituxan Illustrative CLL11 study, etc. E.g. ROMULUS study Our vision 34

35 Roche hematology: Entering new treatment areas and extending benefit in existing ones MabThera/Rituxan Pre-clinical Phase I Phase II Phase III NHL, CLL approved Approved Gazyva GDC-0199 * BCL-2 inhibitor Polatuzumab vedotin anti-cd79b-adc MDM2 antagonist CLL approved in US; ongoing in NHL NHL, CLL, MM, AML NHL AML and solid tumors Erivedge AML, solid tumors Anti-PDL1 Heme Malignancies & solid tumors ADC (RG7598) MM RG7845 T-Cell Dependent Bispecific (TDB) AB, PIM, CD44, Others Heme malignancies Heme malignancies ADC=Antibody-Drug Conjugate; AML=Acute Myeloid Leukemia; CLL=Chronic Lymphocytic Leukemia; NHL=Non-Hodgkin s Lymphoma; *Co-development molecule with AbbVie 35