Roche YTD September 2015 sales Basel, 22 October 2015
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Group Severin Schwan Chief Executive Officer 4
Q3 2015: Guidance upgraded to mid-single digit sales growth 1, Core EPS ahead of sales growth 2 Growth YTD Sept Sales Group sales +6% 1 driven by HER2 franchise (+19%), Avastin (+9%), Actemra (+22%) and Professional Diagnostics (+7%) Outperformance in all major regions: US (+6% 1 ), Europe (+3% 1 ), Japan (+6% 1 ) and International (+8% 1 ) Innovation Oncology Neuroscience Diagnostics Atezolizumab: Phase II lung (POPLAR, BIRCH); Phase II bladder (IMvigor 210) Alectinib: Phase II in 2L ALK+ NSCLC (update) Cotellic + Zelboraf: Phase III 1L melanoma (cobrim), overall survival Ocrelizumab: Phase III RMS (OPERA I/II) met primary and key secondary endpoints Phase III PPMS (ORATORIO) met primary and key secondary endpoints Launch of cobas EGFR Mutation Test v2 - first Roche liquid biopsy PCR test 1 At constant exchange rates (CER) 2 Excluding sale of filgrastim rights in 2014 5
YTD Sept 2015: Strong sales growth continues 2015 2014 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 27.7 27.0 3 6 Diagnostics Division 7.8 7.8 1 6 Roche Group 35.5 34.8 2 6 CER=constant exchange rates 6
Q3 2015: Sales growth for fifth consecutive year 10% 8% 6% 6% 6% 6% 8% 7% 5% 5% 6% 7% 6% 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 Q3 15 All growth rates at constant exchange rates (CER) 7
YTD Sept 2015: Strong sales growth in all regions CHFbn 18 15 12 9 6 3 0 +6% +1% +8% +3% +14% +2% +7% +6% -5% +6% +3% +8% Japan International Europe US Diagnostics Pharma All growth rates at constant exchange rates (CER) 8
Roche: Significantly advancing patient care Recognising innovation 2013-15 9 Breakthrough Therapy Designations Rank Company # 1 Roche 9 2 BMS 8 3 Novartis 6 4 GSK 5 4 Merck 5 5 JNJ 4 YTD 2015 2014 2013 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: http://www.focr.org/breakthrough-therapies as at 9 September 2015; CLL=Chronic Lymphocytic Leukemia; NSCLC=Non- Small Cell Lung Cancer; IPF=Idiopathic Pulmonary Hypertension; DR=Diabetic Retinopathy 9
Pharma: Making a difference for patients Significant opportunities ahead Year Molecule Indication Trial name Event 2015 2016 2017 Alectinib ALK+ NSCLC AF-002JG, ACCALIA NME filed Cotellic+Zelboraf BRAF V600 melanoma cobrim NME filed Venetoclax 17p del R/R CLL NME filing Atezolizumab 2/3L NSCLC, bladder BIRCH, POPLAR, Imvigor 210 NME filing Ocrelizumab RMS, PPMS OPERA I/II, ORATORIO NME filing Lebrikizumab Asthma LAVOLTA I/II, ACOUSTICS Pivotal data Perjeta+Herceptin Adjuvant HER2+ breast APHINITY Pivotal data Gazyva Front-line anhl GOYA Pivotal data ACE 910 Hemophila A Pivotal data Lampalizumab Geographic atrophy CHROMA, SPECTRI Pivotal data Gazyva 1L inhl GALLIUM Pivotal data Atezolizumab+chemo 1L NSCLC IMpower 110/150/130/111/131 Pivotal data Oncology Neuroscience Ophthalmology Immunology Timelines may change as trials can be event-driven NME=new molecular entity; NSCLC=non-small cell lung cancer; CLL=chronic lymphoid leukemia; RMS=relapsing multiple sclerosis (MS); PPMS=primary progressive MS; anhl=aggressive non-hodgkin`s lymphoma; inhl=indolent non-hodgkin`s lymphoma 10
2015 outlook: Guidance upgraded Group sales growth 1 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 (CER) 2 Excluding sale of filgrastim rights in 2014 11
Pharmaceuticals Division Daniel O Day COO Roche Pharmaceuticals 12
YTD Sept 2015 sales Innovation Outlook 13
YTD Sept 2015: Pharma sales Strong growth driven by all regions 2015 2014 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 27,690 26,965 3 6 United States 13,047 11,528 13 7 Europe 6,476 7,070-8 3 Japan 2,341 2,406-3 8 International 5,826 5,961-2 6 CER=constant exchange rates 14
YTD Sept 2015: Strong performance from oncology and immunology franchises Herceptin Avastin Perjeta Esbriet +10% +9% +66% n.a. MabThera/Rituxan +5% Kadcyla +57% Actemra/RoActemra +22% Xolair +25% Lucentis Xeloda Valcyte/Cymevene Pegasys -48% -36% -47% -15% US Europe Japan International -500-250 0 250 500 Absolute amounts and growth rates at constant exchange rates (CER) CHFm 15
YTD Sept 2015: Oncology with +8% growth HER2 Avastin MabThera/ Rituxan (Oncology) YoY CER growth Perjeta Herceptin +19% Kadcyla +9% +4% Strong uptake of Perjeta and Kadcyla Growth of Herceptin due to longer treatment Growth driven by ovarian and cervical International: Growth in all regions US: Growth in inhl maintenance Tarceva -7% In-class competition Xeloda -36% Loss of exclusivity Zelboraf CHFbn -25% 0 1 2 3 4 5 6 7 Competitive pressure in US and EU Cotellic + Zelboraf approval expected in 2015 CER=constant exchange rates YTD September 2015 Oncology sales: CHF 17.6bn; CER growth +8% 16
HER2 franchise: Growth driven by Herceptin, Perjeta and Kadcyla CHFm 2,500 2,000 1,500 +16% +15% +23% YoY CER growth +16% HER2 franchise Q3 2015 Herceptin (+7%): Longer treatment duration in combination with Perjeta Perjeta (+57%): Strong demand in 1L mbc (US & EU) and neoadjuvant (US) Kadcyla (+44%): Growth driven by EU 1,000 500 0 Q3 12 Q3 13 Q3 14 Q3 15 Herceptin Perjeta Kadcyla Outlook Perjeta: Neoadjuvant approval in the EU achieved in Q3 15 Kadcyla: Continued growth to be driven by EU and International CER=constant exchange rates 17
Avastin: Growth in various indications and across all regions CHFm 1,600 1,200 800 400 0 YoY CER growth +14% +6% +8% +11% Q3 12 Q3 13 Q3 14 Q3 15 US Europe International Japan Avastin Q3 2015 US (+6%): Continued uptake in lung, ovarian and cervical cancer EU (+5%): Growth in ovarian and cervical International (+16%): Driven by LATAM and China Outlook Potential filing in mesothelioma China: Lung cancer indication launched EU: Avastin + Tarceva filed in lung cancer CER=constant exchange rates 18
Immunology: Strong performance by Xolair, Actemra and MabThera/Rituxan CHFm 1,600 1,200 800 400 0 YoY CER growth +23% +15% +15% +6% Q3 12 Q3 13 Q3 14 Q3 15 MabThera/Rituxan (RA) Actemra IV Actemra SC Xolair CellCept Pulmozyme Esbriet Other Xolair (+21%) Allergic asthma and strong growth in chronic idiopathic urticaria due to longer treatment duration Actemra (+18%) SC formulation driving growth Increasing 1L monotherapy leadership focusing on MTX intolerant patients MabThera/Rituxan (+10%) Continues to grow in rheumatoid arthritis and vasculitis (GPA and MPA) CER=constant exchange rates; MTX=methotrexate; GPA=granulomatosis with polyangiitis; MPA=microscopic polyangiitis 19
Actemra: Continued uptake in 1L monotherapy SC formulation driving growth in the EU and US CHFm YoY CER growth 400 350 300 250 200 +46% +32% +27% +30% +32% +33% +33% +23% +23% +21% +28% +20% +27% +23% +18% 32% 150 100 68% 50 0 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 Q3 15 IV SC CER=constant exchange rates; IV=intravenous formulation; SC=subcutaneous formulation 20
Lucentis: Competitive pressure continues; ophthalmology pipeline progresses 500 400 Lucentis sales (USDm) Lucentis Q3 2015 Competitive pressure Outlook Ongoing competition in AMD & DME Launch in DR ongoing after first-inclass FDA approval in Q1 2015 Pipeline update ophthalmology 300 Phase II Port Delivery System study for Lucentis started (expect data 2017) 200 Q3 12 Q4 12 Q1 13 Q2 13 Q3 13 Q4 13 Q1 14 Q2 14 Q3 14 Q4 14 Q1 15 Q2 15 Q3 15 Anti-VEGF/Ang2 bimab moved into phase II in wamd Lampalizumab phase III studies in GA well on track (expect data 2017) wamd=wet age-related macular degeneration; DME=diabetic macular edema; DR=diabetic retinopathy; GA=geographic atrophy 21
Esbriet: Market leadership in IPF established Esbriet sales (CHFm) 141 157 US New patient numbers on track with shift to office based pulmonologists EU 88 Increasing differentiation due to strengthened label including the pooled 1 yr mortality data 44 36 32 27 Q1 14 Q2 14 Q3 14 Q4 14 Q1 15 Q2 15 Q3 15 Newsflow / Pipeline update ERS: Pooled data analysis presented showing a strong trend towards 2 yr mortality benefit Start of enrolment in IPF (phase II in combination with lebrikizumab) IPF=idiopathic pulmonary fibrosis 22
YTD Sept 2015 sales Innovation Outlook 23
2015 Roche cancer immunotherapy: Eight NMEs in the clinic T cell Trafficking Priming & activation anti-cea-il2v FP anti-ox40 anti-ctla4 anti-cd27* (Celldex) entinostat* (Syndax) anti-fap-il2v FP NME (anti-ctyokine) T cell infiltration anti-vegf (Avastin) anti-ang2/vegf (vanucizumab) Antigen presentation anti-cd40 CMB305 vaccine* (Immune Design) T-Vec oncolytic viruses* (Amgen) neo-epitope vaccine Clinical development Preclinical development Established therapies * Partnered projects (external) New in 2015 Chen and Mellman. Immunity 2013 Antigen release EGFRi (Tarceva) ALKi (Alectinib) BRAFi (Zelboraf) MEKi (Cotellic) anti-cd20 (Gazyva) various chemotherapies lenalidomide rociletinib* (Clovis) T cell killing Cancer T cell recognition anti-pdl1 (atezolizumab) anti-csf-1r anti-cea-il2v FP anti-ox40 IDOi IDOi* (Incyte) anti-fap-il2v FP anti-tigit IDO1/TDOi* (Curadev) anti-cea/cd3 TCB anti-cd20/cd3 bimab anti-her2/cd3 bimab ImmTAC* (Immunocore) 24
Roche cancer immunotherapy beginning 2015 Phase I Phase II Phase III apdl1 apdl1+chemo apdl1+tarceva NSCLC apdl1+zelboraf Melanoma apdl1+cotellic apdl1+avastin apdl1+gazyva R/R FL / anhl apdl1+avastin+chemo acsf-1r acea-il2v FP aox40 acea/cd3 TCB IDO apdl1+ipilimumab Status as at December 31, 2014 apdl1+ifn-alfa apdl1+acd40 apdl1 NSCLC (Dx+) apdl1 2/3L NSCLC apdl1+avastin 1L Renal apdl1 1/2L Bladder apdl1 2/3L NSCLC apdl1 trials NMEs monotherapy Immune doublets 25
Roche cancer immunotherapy at Q3 2015 apdl1 apdl1+chemo apdl1+tarceva NSCLC apdl1+zelboraf Melanoma apdl1+cotellic apdl1+avastin apdl1+gazyva R/R FL / anhl apdl1+avastin+chemo apdl1+lenalidomide MM apdl1+zelboraf+cotellic Melanoma apdl1+alectinib ALK+ NSCLC apdl1+/-azacitidine MDS acea-il2v FP aox40 acea/cd3 TCB Status as of Oct 22, 2015 Phase I IDO acsf-1r acd20/cd3 bimab apdl1+ipilimumab apdl1+ifn-alfa apdl1+acd40 apdl1+aox40 apdl1+acsf-1r apdl1+acea-il2v FP apdl1+ido Phase II apdl1 NSCLC (Dx+) apdl1 2/3L NSCLC apdl1+avastin 1L Renal apdl1 1/2L Bladder Phase III apdl1 2/3L NSCLC apdl1 2/3L Bladder apdl1+avastin+chemo 1L non sq NSCLC apdl1+chemo 1L non sq NSCLC apdl1+chemo 1L sq NSCLC apdl1 1L non sq NSCLC (Dx+) apdl1 1L sq NSCLC (Dx+) apdl1+chemo 1L TNBC apdl1+avastin 1L RCC apdl1 Adjuvant MIBC (Dx+) apdl1 Adjuvant NSCLC (Dx+) apdl1 trials NME monotherapy Immune doublets Additions in 2015 Data at ECC 2015 26
POPLAR/BIRCH: OS benefit in 2/3L NSCLC Filing in early 2016 on track POPLAR Improved OS correlates with PD-L1 expression Likelihood of survival doubled in PD-L1 high Majority of responses still ongoing: 57% BIRCH ORR met for all subgroups (1L/2L/3L+) ORR similar to POPLAR 6-month OS rate consistent with POPLAR OS=overall survival; NE=not estimable; a=unstratified HR for subgroups and stratified HR for ITT; Data cut-off POPLAR May 8, 2015. Data cutoff BIRCH May 28, 2015 27
IMvigor 210: New standard of care in bladder Filing in early 2016 on track IC2/3 n = 100 IC0/1 n = 211 All n = 311 6 mo-os, % 70% 56% 60% Median OS, mo NR 6.7 7.9 Median PFS, mo 2.1 2.1 2.1 ORR, % 27% 10% 15% CR, % 8% 2% 4% IMvigor 210 Response rates and 6-month OS correlate with PD-L1 status OS data immature: Median OS in IC2/3 patients not yet reached Durable responses with median DOR not reached in any subgroup Well tolerated with superior safety profile over chemotherapy OS=overall survival; IC=immune cells; PFS=progression free survival; ORR=overall response rate; CR=complete response; NR=not reached; Data cutoff May 5, 2015. Follow up 24 weeks. 28
Ocrelizumab: First drug active in both RMS & PPMS Results confirm central role of B cells in MS Targeted product profile Humanised anti-cd20 antibody Selective depletion of a B cell subset leaving the ability to generate new B cells intact Administered IV twice yearly RMS=relapsing forms of multiple sclerosis (MS) which includes patients with RRMS and SPMS with superimposed relapses; RRMS=relapsing-remitting MS; SPMS=secondary progressive MS; PPMS=primary progressive MS; Adapted from Lublin 1996, Arnold 2004 29
OPERA I/II: Positive results in RMS Superior efficacy, similar safety to Rebif Study Endpoint Relative Risk Reduction versus Rebif OPERA I OPERA II POOLED 1 EP ARR -46% -47% NA Key 2 EP CDP (12 wks) -43% -37% -40% CDP (24 wks) -43% -37% -40% T1 Gd-enhancing lesions New and/or enlarging T2 lesions -94% -95% NA -77% -83% NA OPERA I/II Ocrelizumab superior to Rebif (interferon beta-1a) in substantially reducing the three major markers of disease activity: Annualized relapse rate Confirmed Disability Progression for both 12 and 24 weeks MRI outcomes of brain inflammation and damage Similar safety to interferon beta-1a over the two-year controlled treatment period RMS=relapsing forms of multiple sclerosis; ARR=annualized relapse rate; CDP=confirmed disability progression; MRI=magnetic resonance imaging; IFN=interferon; *Adjusted ARR calculated by negative binomial regression and adjusted for baseline EDSS score (<4.0 vs 4.0), and geographic region (US vs ROW); EDSS=expanded disability status scale 30
EFFICACY Range of treatment options in RMS Varying efficacy and safety profiles ILLUSTRATIVE More Alemtuzumab Natalizumab Natalizumab Unmet Need (JCV+) (JCV-) Daclizumab Fingolimod Dimethyl fumarate Less Injectable Oral Teriflunomide ABCRs (Interferons and Copaxon) Less / Later SAFETY/ USE More / Earlier Source: Adapted from Hauser SL, et al. Ann. Neurol. 2013;74(3):317-327 RMS=relapsing forms of multiple sclerosis; ABCR=Avonex ; Betaseron ; Copaxon ; Rebif 31
ORATORIO: Positive results in PPMS First positive efficacy outcome Study Endpoint Relative Risk Reduction versus placebo ORATORIO 1 EP CDP (12 wks) 24% Key 2 EP CDP (24 wks) 25% Timed 25-foot walk (baseline to wk 120) T2 lesion volume (baseline to wk 120) Whole brain volume (wk 24 to wk 120) 29% 3.4% 17.5% ORATORIO Data establishes role of B cells in PPMS Significant risk reductions on primary and key secondary endpoints Favourable safety profile: Serious infections similar to placebo during a mean treatment duration of 3 years PPMS=primary progressive multiple sclerosis; CDP=confirmed disability progression 32
YTD Sept 2015 sales Innovation Outlook 33
2015: Key late-stage news flow Regulatory Phase III readouts* Phase III starts Phase II readouts* Compound Indication Milestone Avastin Cervical cancer EU approval Lucentis Diabetic retinopathy US approval alectinib 2L ALK+ NSCLC US/EU filing cobimetinib + Zelboraf 1L Melanoma US/EU approval Gazyva MabThera/Rituxan-refractory inhl Ph III GADOLIN Gazyva Front-line anhl Ph III GOYA (interim) ocrelizumab Relapsing forms of MS (RMS) Ph III OPERA I/II ocrelizumab Primary progressive MS (PPMS) Ph III ORATORIO Perjeta 2L HER2+ mbc Ph III PHEREXA Kadcyla 2L HER2+ gastric cancer Ph II/III GATSBY atezolizumab** 2/3L Bladder Ph III atezolizumab** 1L TNBC Ph III atezolizumab** 1L RCC Ph III atezolizumab** Adjuvant bladder Ph III etrolizumab Crohn`s disease Ph III ACE910 Hemophilia A Ph III taselisib (PI3K inhib) HR+/PI3Kmut BC Ph III SANDPIPER atezolizumab 2/3L NSCLC Ph II FIR, POPLAR, BIRCH atezolizumab Bladder Ph II ipatasertib (AKT inhib) Gastric/prostate cancers Ph II A.MARTIN, JAGUAR * Outcome studies are event driven, timelines may change; ** For atezolizumab (apdl1) only P3 trials in new indications are listed (1L NSCLC starts not shown) 2016 34
Pharma: Making a difference for patients Significant opportunities ahead Year Molecule Indication Trial name Event 2015 2016 2017 Alectinib ALK+ NSCLC AF-002JG, ACCALIA NME filed Cotellic+Zelboraf BRAF V600 melanoma cobrim NME filed Venetoclax 17p del R/R CLL NME filing Atezolizumab 2/3L NSCLC, bladder BIRCH, POPLAR, Imvigor 210 NME filing Ocrelizumab RMS, PPMS OPERA I/II, ORATORIO NME filing Lebrikizumab Asthma LAVOLTA I/II, ACOUSTICS Pivotal data Perjeta+Herceptin Adjuvant HER2+ breast APHINITY Pivotal data Gazyva Front-line anhl GOYA Pivotal data ACE 910 Hemophila A Pivotal data Lampalizumab Geographic atrophy CHROMA, SPECTRI Pivotal data Gazyva 1L inhl GALLIUM Pivotal data Atezolizumab+chemo 1L NSCLC IMpower 110/150/130/111/131 Pivotal data Oncology Neuroscience Ophthalmology Immunology Timelines may change as trials can be event-driven NME=new molecular entity; NSCLC=non-small cell lung cancer; CLL=chronic lymphoid leukemia; RMS=relapsing multiple sclerosis (MS); PPMS=primary progressive MS; anhl=aggressive non-hodgkin`s lymphoma; inhl=indolent non-hodgkin`s lymphoma 35
Newsflow in H2 2015 Vienna, 25-29 Sep Barcelona, 7-10 Oct San Francisco, 18-21 Nov atezolizumab (+chemo) - NSCLC: POPLAR, BIRCH, P1b chemo combo update - Bladder: P2 (2L cohort) alectinib - ALK+ NSCLC: P2 update ocrelizumab - RMS: P3 OPERA I/II - PPMS: P3 ORATORIO atezolizumab + Zelboraf - mm: P1 Cotellic + Zelboraf - BRAF+mM: cobrim OS data CEA-IL2v FP; IDOi - solid tumors: P1 updates San Antonio, 19-22 Nov Orlando, 5-8 Dec San Antonio, 8-12 Dec atezolizumab - GBM: P1 Presentations planned venetoclax - R/R CLL: P2 venetoclax combinations - AML: P1 + chemo - CLL: P1 + Rituxan+benda - CLL: P1 + Gazyva Gazyva + chemo - NHL: P3 GADOLIN update - CLL: P3 GREEN update Atezolizumab + chemo - TNBC: P1b abraxane combo 36
Diagnostics Division Roland Diggelmann COO Roche Diagnostics 37
YTD September 2015: Diagnostics sales Strong sales performance 2015 2014 Change in % CHFm CHFm CHF CER Diagnostics Division 7,835 7,792 1 6 Professional Diagnostics 4,487 4,397 2 7 Diabetes Care 1,533 1,721-11 -3 Molecular Diagnostics 1,248 1,165 7 10 Tissue Diagnostics 567 509 11 12 Underlying growth of Molecular Diagnostics excluding Sequencing business: +7% CER=constant exchange rates 38
YTD September 2015: Diagnostics regional sales Growth driven by APAC and EMEA North America +2% 26% of divisional sales EMEA 1 +4% 43% of divisional sales Japan -5% 4% of divisional sales Latin America +13% 7% of divisional sales Asia Pacific +15% 20% of divisional sales 16% growth in E7 countries 2 1 Europe, Middle East and Africa; 2 Brazil, China, India, Mexico, Russia, South Korea, Turkey All growth rates at constant exchange rates 39
YTD September 2015: Diagnostics Division Growth driven by Professional Diagnostics YoY CER growth Professional Dia +7% Growth driven by immunodiagnostics (+12%) and coagulation monitoring (+10%) Diabetes Care -3% Accu-Chek Aviva/Performa (-1%) and insulin delivering systems (+8%) Molecular 1 Dia +10% Virology (+13%) incl. HPV (+24%) Tissue Dia +12% EMEA North America Advanced staining portfolio (+12%) RoW CHFbn 0 1 2 3 4 5 1 Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +7% CER=constant exchange rates; EMEA=Europe, Middle East and Africa 40
Immunoassays: 28% of Diagnostics sales Growing double digit (+12%) Sales +13% +8% +10% +12% YoY CER growth +13% +21% +30% +9% +11% Tumormarker Endo - Thyroid Cardiac Women's Health Infectious Diseases Other Critical Care Anemia Hormones CER=constant exchange rates; Other include Needed Common Products, Allergy, Rheumatoid Arthritis, Immunosuppressants 41
Launch of cobas c 513 for diabetes testing* Double throughput with the same footprint cobas c 513 High throughput HbA1c** testing: Risk identification, diagnosis and monitoring 5 times faster than closest competitor Highest result reliability Highest test capacity allows for most efficient workflow and hands-off time Target market: ~CHF 520m (+5%)*** * Available for countries accepting CE mark approval; **HbA1c: glycated hemoglobin is a marker used for diabetes testing *** market growth for 2014 and CAGR for 2014-19 42
Point of Care Molecular Diagnostics CLIA waiver for cobas Liat Flu A/B test Liat tube Fast readout and easy-to-use Plans to extend menu in: RSV tests MRSA and C-difficile Target market: ~CHF 350m (+20%) Liat Analyzer Point of Care: e.g. physician s office, emergency rooms, health clinics, pharmacies; MRSA=methicillin resistant staphylococcus aureus; RSV=respiratory cyntical virus 43
Launch of EGFR liquid biopsy and tissue test Potential to detect tumor progression in NSCLC Patient example SQI* Treatment initiation Re-appearance of tumor mutations Clinical Progression Detection of tumor mutations may aid in the management of NSCLC patients *SQI (semi-quantitative index) reflects a trend in the cell free tumor DNA quantity. Upon TKI treatment, we see a decline in tumor mutations (L858R and T790M), in a background of non-tumor DNA (cfdna_wt); Sorenson et al Cancer 2014;120:3896-901 44
Key launches 2015 Instruments / Devices Tests / Assays Area Product Market BA 1 Laboratory Diabetes Care cobas c 513 dedicated HbA1C analyzer cobas t 411 core lab coagulation analyzer cobas 8100 V2 Integrated pre- and post-analytical solution cobas 6800/8800 Medium to High volume automated real-time PCR VENTANA HE 600 automated H&E staining platform Accu-Chek Active no-code next-gen. bg meter, no coding of test strips Accu-Chek Connect bg meter with connectivity to smartphones, mobile applications and cloud Point of Care CoaguChek Pro II - professional system for PT and aptt testing EU RPD Blood Screening Infectious Diseases Virology Genomics & Oncology EU EU WW US WW WW US RPD RPD RPD RMD RTD RDC RDC cobas 6800/8800 MPX Multiplex Bloodscreening test US RMD cobas Liat Influenza A/B + RSV POC detection HTLV human T-lymphotropic virus diagnostics test cobas 6800/8800 HBV Quantitative HBV viral load test cobas 4800 HIV-1 - Quantitative HIV viral load test cobas 4800 HCV Quantitative HCV viral load test cobas 4800 HBV Quantitative HBV viral load test US EU EU EU EU EU RMD RPD RMD RMD RMD RMD cobas EGFR Test v2 - detection of EGFR in plasma EU RMD Cardiac cobas h 232 Troponin T Point of Care test version of Elecsys ctnt-hs EU RPD 1 Business Areas. RPD: Roche Professional Diagnostics; RDC: Roche Diabetes Care; RMD: Roche Molecular Diagnostics; RTD: Roche Tissue Diagnostics 45
Finance Alan Hippe Chief Financial Officer 46
Q3 2015: Highlights Sales Strong underlying sales growth in all regions and both divisions Guidance for FY 2015 Upgraded Q3 debt restructuring Bond maturity USD: 1.0bn maturity on 15 July 2015 - coupon 4.75% s.a. Bond tender offer results USD: 337m of 1.6bn outstanding coupon 7.00% s.a. Notes due 2039 (RHI) USD: 543m of 2.0bn outstanding coupon 6.00% s.a. Notes due 2019 (RHI) USD: 25m of 350m outstanding coupon 5.25% s.a. Senior Notes due 2035 (Genentech) s.a.=semi-annual coupon; RHI = Roche Holdings, Inc. (USA) 47
Exchange rate impact on sales growth Negative impact from EUR, LATAM and Europe more than offsetting positive impact of USD +2.6p +0.1p -0.2p -0.8p -1.0p -1.3p -2.9p CER sales growth YTD Sep 15 vs. YTD Sep 14 5.7% CER=constant exchange rates CER USD As-Pac Other JPY Other Europe 2.2% LATAM EUR CHF CHF sales growth YTD Sep 15 vs. YTD Sep 14 48
Negative currency impact in 2015 expected CHF / USD 0.95 Assumed average YTD 2015 0.95 0.95 0.96 Average YTD 2014 CHF / EUR 7% 6% +1% +1% 0.89 0.89 0.95 0.93 0.98 0.96 0.93 0.93 0.95 0.97 0.97 0.97 0.97 0.97 +2% 1.08 +2% 1.06 0.90 J F M A M J J A S O N D 1.22 6% Monthly avg fx rates 2015 Fx rates at 30 Sep 2015-12% -13% 0.91 1.22 1.22 1.21 1.06 5% -13% -12% 1.07 Assuming the 30 Sept 2015 exchange rates remain stable until end of 2015, 2015 impact is expected to be (%p): Q1 HY Sept YTD FY Sales -2-3 -4-4 Core operating profit -4-6 Core EPS -7-9 1.10 1.06 1.06 1.04 1.04 1.05 1.05 1.08 1.09 1.09 1.09 1.09 J F M A M J J A S O N D 49
2015 outlook: Guidance upgraded Group sales growth 1 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 (CER) 2 Excluding sale of filgrastim rights in 2014 50
Changes to the development pipeline Q3 2015 update New to Phase I New to Phase II New to Phase III New to Registration 5 NMEs transitioned from Ph0 RG6024 anti-flub MAb influenza B RG6029 Nav1.7 inh (2) pain RG7386 FAP-DR5 bimab solid tumors RG7828 CD20/CD3 bimab hem tumors RG7986 ADC r/r NHL 1 NME in collaboration with ISIS ISIS antisense oligonucleotide (ASO) Huntington s Disease 1 NME added by Chugai CHU - hyperphosphatemia 1 NME transitioned from Ph1 RG7716 VEGF/ANG2 MAb - wamd 1 AI transitioned from Ph1 RG3645 ranibizumab port delivery system (PDS) - wamd 1 AI RG3637 lebrikizumab COPD 1 AI added by Chugai nemolizumab (IL-31) MAb - pruritus in dialysis patients 1 NME transitioned from Ph2 following EU & US submissions RG7853 alectinib ALK+ NSCLC 2L 1 AI transitioned from Ph3 following EU & US submissions RG7159 Gazyva inhl rituximabrefractory Removed from Phase I Removed from Phase II Removed from Phase III Removed from Registration 1 NME RG7345 Tau MAb Alzheimer s disease 1 NME RG1678 bitopertin obsessive compulsive disorders 1 NME returned to partner RG1577 sembragiline - Alzheimer s disease 1 AI (filing no go decision) RG435 Avastin ovarian ca. 1L 1 AI following EU approval RG1273 Perjeta HER2+ BC neoadj Status as of October 22, 2015 52
Roche Group development pipeline Phase I (35 NMEs + 13 AIs) Phase II (20 NMEs + 14 Als) RG6016 LSD1 inh AML RG6047 SERD (2) ER+(HER2-neg) mbc RG6061 HIF1 alpha LNA solid tumors RG6078 IDO inh solid tumors RG6078 IDO inh + atezolizumab solid tumors RG7116 lumretuzumab mbc RG7155 emactuzumab + atezolizumab s. tumors RG7304 Raf & MEK dual inh solid tumors RG7386 FAP-DR5 bimab solid tumors RG7388 idasanutlin solid & heme tumors atezolizumab solid tumors atezo+zelboraf+/-cobi m. melanoma atezo+avastin+chemo solid tumors atezolizumab+cobimetinib solid tumors atezolizumab+ipi/ifn solid tumors atezo+tarceva /alectinib NSCLC atezolizumab+gazyva lymphoma atezo+lenalidomide multiple myeloma RG7450 anti-steap 1 ADC prostate ca. RG7597 duligotuzumab + cobi solid tumors RG7601 venetoclax heme indications RG7601 venetoclax+gazyva CLL RG7741 ChK1 inh solid tum & lymphoma RG7775 MDM2 (4) IV prodrug AML RG7802 CEA CD3 TCB solid tumors RG7813 CEA IL2v FP+atezolizumab solid tumors RG7828 CD20/CD3 bimab heme tumors RG7841 anti-ly6e ADC solid tumors RG7842 ERK inh + cobimetinib solid tumors RG7876 CD40 imab+atezolizumab solid tumors RG7882 ADC ovarian ca RG7888 OX40 MAb solid tumors RG7888 OX40 MAb + atezolizumab solid tumors RG7986 ADC r/r NHL Status as of October 22, 2015 RG6069 RG7625 RG7880 RG6024 RG6080 RG7689 RG7944 RG6029 RG7893 RG7800 RG7935 ISIS CHU CLL - fibrosis Cat-S antag - inflammatory diseases Flu B MAb DBO β-lactamase inh Nav1.7 inh autoimmune diseases bact. infections - infectious diseases therapeutic vaccine Nav1.7 inh (2) HBV pain SMN2 splicer spinal muscular atrophy a-synuclein MAb Parkinson's Disease ASO PTH1 recep. ago influenza B pain Huntington s Disease hypoparathyroidism PT CHU - hyperphosphatemia New Molecular Entity (NME) Additional Indication (AI) Oncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other RG-No Roche Genentech managed CHU Chugai managed ISIS ISIS managed RG3502 RG6013 RG6046 RG7155 RG7221 RG7421 RG7440 RG7596 RG7601 RG1569 CHU RG7745 RG1662 RG7929 RG6083 olesoxime spinal muscular atrophy RG7090 basimglurant TRD RG7314 RG7412 RG3645 RG7716 FIXa/FX bimab emactuzumab vanucizumab ipatasertib polatuzumab vedotin venetoclax Actemra nemolizumab (IL-31) Flu A MAb V1 receptor antag crenezumab ranibizumab PDS VEGF-ANG2 bimab hemophilia A solid tumors atezolizumab NSCLC 2/3L atezolizumab bladder cancer 1/2L RCC basmisanil PVNS/solid tumors mcrc heme tumors ADC RG7599 lifastuzumab vedotin Pt-resist. OC RG7601 RG7601 RG7604 RG7604 RG7686 RG3637 RG3637 RG3637 CHU RG7227 RG7795 CHU Kadcyla SERD cobimetinib+paclitaxel venetoclax venetoclax+rituxan taselisib taselisib codrituzumab (glypican-3) lebrikizumab +/- Esbriet lebrikizumab lebrikizumab TLR7 agonist URAT1 inh HER2+ NSCLC ER+(HER2-neg) mbc TNBC 17p del CLL rel/ref DLBCL FL rel/ref NSCLC sq 2L ER+(HER2-neg) BC neoadj liver cancer systemic sclerosis IPF atopic dermatitis COPD atopic dermatitis nemolizumab (IL-31) pruritus dialysis pts danoprevir HCV influenza A HBV gout Down Syndrome autism Alzheimer s wamd wamd 53
Roche Group development pipeline RG435 RG435 1 RG1273 RG1273 RG1273 RG3502 RG3502 RG3502 RG3502 Avastin Phase III (8 NMEs + 30 Als) glioblastoma 1L RG3637 CHU CHU RG1594 RG7417 lebrikizumab Actemra IL-6R MAb ocrelizumab RG7159 Gazyva DLBCL1L RG1594 ocrelizumab PPMS RG7159 RG7204 NSC RG7601 RG7601 RG7604 RG7853 Avastin Perjeta+Herceptin Perjeta+Herceptin Perjeta+Herceptin HER2+gastric ca 1L Kadcyla Kadcyla Kadcyla + Perjeta Kadcyla + Perjeta Gazyva Zelboraf atezolizumab venetoclax+rituxan venetoclax+gazyva alectinib rel. ovarian ca. Pt-sensitive HER2+ mbc 2L HER2+ BC adj HER2+ gastric cancer 2L HER2+ BC adj HER2+ BC adj HER2+ BC neoadj follicular lymphoma 1L melanoma adj NSCLC 2L atezolizumab+chemo NSCLC non-sq. 1L 1L atezo+chemo+avastin NSCLC non-sq. 1L atezolizumab+chemo atezolizumab Dx+ atezolizumab Dx+ atezolizumab Dx+ atezolizumab+abraxane atezolizumab+avastin atezolizumab taselisib NSCLC sq. 1L NSCLC sq. 1L NSCLC non-sq. 1L NSCLC adj TNBC RCC bladder cancer 2L atezolizumab muscle inv. bladder ca adj Status as of October 22, 2015 CLL rel/ref CLL 1L ER+(HER2-neg) mbc ALK+ NSCLC 1L RG105 RG1569 RG7413 RG7413 RG1450 MabThera Actemra etrolizumab etrolizumab gantenerumab lampalizumab pemphigus vulgaris giant cell arteritis severe asthma ulcerative colitis Crohn s disease large-vessel vasculitis neuromyelitis optica Alzheimer s RMS geographic atrophy RG105 RG435 2 RG7159 RG7421 3 RG7853 Registration (2 NMEs + 3 Als) MabThera SC Avastin+Tarceva Gazyva inhl rituximab-refractory cobimetinib+zelboraf m. melanoma alectinib ALK+ NSCLC 2L 1 US only: FDA submission pending 2 EU only 3 Positive CHMP opinion EU Sept 2015 CLL EGFR mut+ NSCLC New Molecular Entity (NME) Additional Indication (AI) Oncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other RG-No Roche Genentech managed CHU Chugai managed ISIS ISIS managed RG105 MabThera is branded as Rituxan in US and Japan RG1569 Actemra is branded as RoActemra in EU RG7159 Gazyva is branded as Gazyvaro in EU 54
NME submissions and their additional indications Projects currently in phase 2 and 3 basmisanil GABRA5 NAM Down syndrome atezolizumab () + abraxane TNBC V1 receptor antag (RG7314) autism taselisib ( RG7604) NSCLC sq 2L atezolizumab () NSCLC adj (Dx+) crenezumab (RG7412) Alzheimer s New Molecular Entity Oncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other taselisib ( RG7604) ER+(HER2-neg) BC neoadj SERD (RG6046) ER+(HER2-neg) mbc emactuzumab (RG7155) PVNS and solid tumors vanucizumab (RG7221) colorectal cancer atezolizumab () MIBC adj atezolizumab() NSCLC sq 1L (Dx+) atezolizumab() NSCLC non-sq 1L (Dx+) atezolizumab()+ chemo NSCLC sq 1L gantenerumab (RG1450) Alzheimer s lebrikizumab (RG3637) COPD lebrikizumab (RG3637) atopic dermatitis lebrikizumab+/-esbriet (RG3637) IPF ipatasertib (RG7440) solid tumors atezolizumab()+ chemo NSCLC non-sq 1L etrolizumab (RG7413) Crohn s disease ocrelizumab (RG1594) PPMS olesoxime (RG6083) SMA polatuzumab vedotin (RG7596) heme tumors atezolizumab()+chemo + Avastin NSCLC non-sq 1L etrolizumab (RG7413) ulcerative colitis ocrelizumab (RG1594) RMS venetoclax+rituxan (RG7601) CLL rel/refractory lifastuzumab (RG7599) Pt resistant OC cobimetinib+paclitaxel TNBC TLR7 ago (RG7795) HBV lebrikizumab (RG3637) severe asthma alectinib (RG7853) Alk+ NSCLC 1L taselisib (RG7604) HER2 neg ER+ mbc venetoclax (RG7601) + Rituxan FL rel/ref danoprevir* (RG7227) HCV venetoclax (RG7601) 17p del CLL rel/ref atezolizumab () bladder cancer atezolizumab() combo Avastin RCC codrituzumab (RG7686) liver cancer venetoclax (RG7601) + Gazyva CLL 1L Flu A MAb (RG7745) influenza alectinib (RG7853)(US) Alk+ NSCLC 2L atezolizumab() NSCLC 2/3L FIXa /FX bimab (RG6013) hemophilia A Unless stated otherwise, submissions are planned to occur in US and EU * lead market China Status as of October 22, 2015 lampalizumab (RG7417) geographic atrophy venetoclax (RG7601) 2015 2016 2017 2018 and beyond DLBCL VEGF/ANG2 bimab(rg7716) wamd 55
Submissions of additional indications for existing products Projects currently in phase 2 and 3 Kadcyla HER2-pos. NSCLC *Avastin (US) rel. ovarian ca. Pt-sens. Kadcyla HER2-pos. gastric cancer 2L Gazyva DLBCL 1L Kadcyla+Perjeta HER2-pos. BC neoadj. Kadcyla+Perjeta HER2-pos. BC adj. Kadcyla HER2-pos. BC adj. Gazyva inhl rituximab-ref. Avastin (US) GBM Avastin +Tarceva (EU) EGFR mut+ NSCLC Perjeta + Herceptin HER2-pos. mbc 2L Perjeta + Heceptin HER2-pos. BC adj. Actemra giant cell arteritis Zelboraf melanoma adj. Gazyva follicular lymphoma 1L Perjeta+Herceptin HER2-pos. gastric cancer 1L MabThera pemphigus vulgaris Actemra systemic sclerosis ranibizumab PDS (US) wamd 2015 2016 2017 2018 and beyond *approved in EU Unless stated otherwise, submissions are planned to occur in US and EU. Status as of October 22, 2015 Oncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other NME 56
Major granted and pending approvals 2015 Approved Pending approvals alectinib ALK+ NSCLC 2L Filed July 2015 US Lucentis diabetic retinopathy February 2015 cobimetinib + Zelboraf m. melanoma Filed December 2014 Gazyva inhl rituximab-ref. Filed August 2015 EU Avastin cervical cancer April 2015 alectinib ALK+ NSCLC 2L Filed September 2015 Avastin + Tarceva EGFR mut+ NSCLC Filed July 2015 Perjeta HER2+ BC neoadj. July 2015 *cobimetinib + Zelboraf m. melanoma Filed September 2014 MabThera SC CLL Filed November 2014 Gazyva inhl rituximab-ref. Filed September 2015 Japan-Chugai Xeloda gastric cancer adj. Filed December 2014 Bonviva osteoporosis (oral) Filed February 2015 Avastin cervical cancer Filed September 2015 Status as of October 22, 2015 * Positive CHMP opinion EU Sep 2015 Oncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other NME 57
Cancer immunotherapy pipeline overview Phase I (6 NMEs + 13 AIs) Phase II (1 NME + 2 Als) Phase III (1 NME + 10 AIs) RG6078 RG6078 RG7155 RG7802 RG7813 RG7828 RG7876 RG7888 RG7888 *INCB *CDX IDO inh solid tumors IDO inh+atezolizumab solid tumors emactuzumab+atezolizumab s.tumors atezolizumab atezo+zelboraf+/-cobimetinib atezo+avastin+chemo solid tumors m. melanoma solid tumors atezolizumab+cobimetinib solid tum atezolizumab+ipi/ifn solid tumors atezo+tarceva NSCLC EGFR+ atezolizumab+gazyva lymphoma atezo+lenalidomide multiple myeloma CEA CD3 TCB solid tumors CEA IL2v FP+atezolizumab solid tumors CD20/CD3 bimab hem tumors CD40 imab+atezolizumab solid tumors OX40 MAb solid tumors OX40 MAb + atezolizumab solid tumors atezolizumab + IDO inh solid tumors atezolizumab +varlilumab solid tumors RG7155 emactuzumab PVNS/solid tumors atezolizumab NSCLC 2L atezolizumab NSCLC 2/3L atezolizumab bladder cancer 1/2L RCC NSC atezo+chemo atezolizumab atezolizumab+avastin NSCLC non-sq. 1L atezo+chemo+avastin NSCLC non-sq. 1L atezolizumab+chemo atezolizumab Dx+ NSCLC sq. 1L NSCLC sq. 1L atezolizumab Dx+ NSCLC non-sq. 1L atezolizumab Dx+ atezolizumab+abraxane bladder cancer 2L NSCLC adj TNBC RCC atezolizumab muscle inv. bladder ca adj New Molecular Entity (NME) Additional Indication (AI) *external collaborations: INCB- Incyte INCB024360, CDX-1127- Celldex CD27 MAb Oncology RG-No Roche Genentech managed CHU Chugai managed Status as of October 22, 2015 58
Roche Group development pipeline Combinations Phase I (4 NMEs + 11 AIs) Phase II (1 NME + 2 Als) Phase III (1 NME + 1 AI) RG6078 RG7155 IDO inh+atezolizumab solid tumors emactuzumab+atezolizumab s.tum atezo+zelboraf+/-cobimetinib m. melanoma RG7421 RG7601 RG3637 cobimetinib+paclitaxel venetoclax+rituxan lebrikizumab +/- Esbriet TNBC FL rel/ref IPF RG435 1 Avastin+Tarceva EGFR mut+ NSCLC RG7421 2 cobimetinib+zelboraf m. melanoma atezo+avastin+chemo solid tumors atezolizumab+cobimetinib solid tum atezolizumab+ipi/ifn solid tumors atezo+tarceva/alectinib NSCLC atezolizumab+gazyva lymphoma atezo+lenalidomide multiple myeloma Phase III (12 AIs) 1 EU only 2 Positive CHMP opinion EU Sept 2015 RG7597 duligotuzumab+cobi solid tumors RG7601 RG7813 RG7842 RG7876 RG7888 venetoclax+gazyva CLL CLL RG1273 CEA IL2v FP+atezolizumab solid tum RG1273 ERK inh+cobimetinib solid tumors RG1273 CD40 imab+atezolizumab solid tum RG3502 OX40 MAb+atezolizumab solid tum RG3502 Perjeta+Herceptin Perjeta+Herceptin Perjeta+Herceptin HER2+gastric ca 1L Kadcyla + Perjeta Kadcyla + Perjeta HER2+ mbc 2L HER2+ BC adj HER2+ BC adj HER2+ BC neoadj atezo+chemo NSCLC non-sq. 1L NSC atezo+chemo+avastin NSCLC non-sq. 1L atezolizumab+chemo atezolizumab+abraxane NSCLC sq. 1L TNBC New Molecular Entity (NME) Additional Indication (AI) RG7601 atezolizumab+avastin venetoclax+rituxan RCC CLL rel/ref Oncology Immunology RG7601 venetoclax+gazyva CLL 1L RG-No Roche Genentech managed CHU Chugai managed Status as of October 22, 2015 59
Doing now what patients need next