Roche Q1 2016 sales Basel, 19 April 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
Group Severin Schwan Chief Executive Officer 4
Q1 2016: Good start to the year Growth Sales Group sales +4% 1 driven by HER2 franchise (+9%), Immunology franchise (+16%), Avastin (+4%), and Professional Diagnostics (+7%) Good growth 1 in all regions: US (+3%), Europe (+3%), Japan (+3%) and International (+7%) Innovation Oncology Neuroscience Diagnostics Atezolizumab: Acceptance of filing for advanced bladder and lung cancer in the US Successful US launches of Alecensa and Cotellic US approval of Gazyva in R/R NHL (GADOLIN) US approval of Venclexta (venetoclax) in R/R CLL 17p deletion Ocrevus (ocrelizumab): Updated NEDA and MRI data at AAN (April, 15 th 21 st ) IND approval to initiate Zika blood screening 1 At constant exchange rates (CER); NEDA=no evidence of disease activity; MRI=magnetic resonance imaging; IND: Investigational New Drug Application 5
Q1 2016: Solid sales growth continues 2016 2015 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 9.8 9.3 5 4 Diagnostics Division 2.6 2.5 4 5 Roche Group 12.4 11.8 5 4 CER=Constant Exchange Rates 6
Q1 2016: Sales growth for fifth consecutive year 10% 8% 6% 6% 6% 6% 8% 7% 5% 5% 6% 7% 6% 4% 4% 4% 4% 5% 4% 4% 2% 2% 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 Q4 15 Q1 16 All growth rates at Constant Exchange Rates (CER) 7
Q1 2016: Solid sales growth in all regions CHFbn 6 5 +3% 0% 4 3 2 1 0 +3% +7% -1% +16% +3% +3% -3% +4% +5% +4% Japan International Europe US Diagnostics Pharma All growth rates at Constant Exchange Rates (CER) 8
Roche significantly advancing patient care Recognition for innovation 2013-present 12 Breakthrough Therapy Designations Rank Company # 1 Roche 12 2 BMS 8 3 Novartis 7 3 Merck 6 3 Pfizer 6 4 GSK 5 Year 2016 2015 2014 2013 Molecule Ocrelizumab (PPMS) Venclexta (AML) Venclexta + Rituxan (R/R CLL) Actemra (Systemic sclerosis) Atezolizumab (NSCLC) Venclexta (R/R CLL 17p del) Emicizumab/ACE 910 (Hemophilia A) Esbriet (IPF) Lucentis (DR) Atezolizumab (Bladder) Alectinib (2L ALK+ NSCLC) Gazyva (1L CLL) Source: http://www.focr.org/breakthrough-therapies as at 22 March 2016; PPMS=Primary Progressive Multiple Sclerosis; CLL=Chronic Lymphocytic Leukemia; NSCLC=Non-Small Cell Lung Cancer; IPF=Idiopathic Pulmonary Hypertension; DR=Diabetic Retinopathy 9
Significant launch activities ahead 2016 2017 2018 Venclexta R/R CLL with 17p del Emicizumab (ACE910) Hemophilia A Lampalizumab Geographic atrophy Cotellic + Zelboraf BRAFmut melanoma Lebrikizumab Severe Asthma Atezolizumab+Avastin+chemo 1L NSCLC Pharma Alecensa 2L ALK+ NSCLC Atezolizumab 2L+ lung and bladder cancer Ocrelizumab RMS/ PPMS Perjeta + Herceptin ebc HER2+ (APHINITY) Atezolizumab + Avastin 1L RCC Gazyva 1L inhl (GALLIUM) Gazyva Refractory inhl (GADOLIN) Gazyva 1L anhl (GOYA) Alecensa 1L ALK+ NSCLC Actemra Giant cell arteritis Diagnostics cobas e 801 launch in immunodiagnostics cobas t 511 cobas t 711 cobas 6000 (new) Oncology/ hematology Neuroscience Ophthalmology Immunology FDA Breakthrough Therapy Designation Outcome studies are event-driven: timelines may change. Standard approval timelines of 1 year assumed. 10
2016 outlook Group sales growth 1 Low to mid-single digit Core EPS growth 1 Ahead of sales growth Dividend outlook Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER) 11
Pharmaceuticals Division Daniel O Day COO Roche Pharmaceuticals 12
Q1 2016 sales Innovation Outlook 13
Q1 2016: Pharma sales Good growth driven by all regions 2016 2015 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 9,800 9,322 5 4 United States 4,716 4,392 7 3 Europe 2,319 2,178 6 5 Japan 853 763 12 4 International 1,912 1,989-4 4 CER=Constant Exchange Rates 14
Q1 2016: Oncology and immunology driving growth Perjeta +33% Esbriet +96% Herceptin +4% Avastin +4% Xolair +22% MabThera/Rituxan +3% Actemra/RoActemra +14% Activase/TNKase +21% Tamiflu -6% Tarceva Lucentis Pegasys -50% -13% -14% US Europe Japan International -120-60 0 60 120 CHFm Absolute values and growth rates at Constant Exchange Rates (CER) 15
Q1 2016: Oncology launches off to a good start HER2 Avastin Perjeta Herceptin +9% +4% YoY CER growth Kadcyla Strong uptake of Perjeta and Kadcyla Growth of Herceptin due to longer treatment Growth driven mainly by cervical and ovarian CD20 MabThera/Rituxan (Oncology) +3% Gazyva approved in R/R inhl (GADOLIN) Tarceva -14% Gazyva/Gazyvaro Increased competition EU: Avastin + Tarceva filed in 1L EGFR+ NSCLC Xeloda -17% Loss of exclusivity Zelboraf + Cotellic Cotellic +18% Back to growth post launch of Cotellic Alecensa +161% US: launch off to a strong start Japan: Continued strong growth (J-ALEX study) CHFbn 0 1 2 3 CER=Constant Exchange Rates Q1 2016 Oncology sales: CHF 6.1bn; CER growth +4% 16
HER2 franchise: Growth mainly driven by Perjeta CHFm 2,500 2,000 1,500 +15% +17% +23% YoY CER growth +9% HER2 franchise Q1 2016 Herceptin (+4%): Longer treatment duration in combo with Perjeta Perjeta (+33%): Strong demand in 1L mbc and neoadjuvant in the US and EU Kadcyla (+11%): Growth driven by EU, International and Japan 1,000 500 0 Q1 13 Q1 14 Q1 15 Q1 16 Herceptin Perjeta Kadcyla Outlook 2016 Herceptin: Further SC conversion Perjeta: Further increasing penetration Kadcyla: New launch countries Ph III APHINITY data (adj. HER2+) expected CER=Constant Exchange Rates 17
Avastin: Strong underlying growth CHFm 2,000 YoY CER growth Avastin Q1 2016 1,600 1,200 +11% +9% +6% +4% Growth impacted by Health Insurance Plan impact in Japan International (+27%): Driven by Asia, mainly China (lung cancer launch) 800 Outlook 2016 400 0 Q1 13 Q1 14 Q1 15 Q1 16 US Europe International Japan Continued uptake in ovarian and cervical EU: Avastin + Tarceva approval in EGFR+ NSCLC expected in H2 CER=Constant Exchange Rates 18
Immunology: Continued strong growth, now >CHF 7bn on an annualised basis CHFm 1,800 1,500 1,200 +11% +11% +20% YoY CER growth +16% Immunology Q1 2016 Xolair (+22%) Continued strong uptake in allergic asthma, chronic idiopathic urticaria Actemra (+14%) 900 SC formulation driving growth 600 Increasing 1L monotherapy leadership focusing on MTX intolerant patients 300 MabThera/Rituxan (+11%) 0 Q1 Q1 13 14 MabThera/Rituxan (RA) Actemra SC CellCept Esbriet Q1 15 Actemra IV Xolair Pulmozyme Other CER=Constant Exchange Rates; GPA=granulomatosis with polyangiitis; MPA=microscopic polyangiitis Q1 16 Continues to grow in rheumatoid arthritis and vasculitis (GPA and MPA) 19
Esbriet: Expanding beyond severe patients CHFm 200 150 YoY CER growth +96% 178 US (+145%) Strong underlying growth with patient starts and treatment rate on track Around 100,000 IPF patients in the US with high unmet need 100 50 0 10 Q1 13 27 Q1 14 88 Q1 15 US Europe International Q1 16 EU (+36%) Increasing differentiation due to strengthened label including the pooled 1 Yr mortality data Outlook 2016 Increasing patient pool and new launch countries 20
Q1 2016 sales Innovation Outlook 21
Venclexta* in R/R CLL with 17p deletion First Bcl-2 inhibitor with significant upside potential Phase II (M13-982) Response, n (%) Venclexta (n = 106) ORR 85 (80.2) CR/CRi 8 (7.5) Median DOR not reached Accelerated approval in the US following breakthrough therapy designation in R/R CLL 17p del Additional breakthrough therapy designations: Venclexta+Rituxan in R/R CLL and Venclexta in AML Several read-outs at ASCO in NHL, CLL, MM and AML NHL=non-hodgkin`s lymphoma; CLL=chronic lymphoid leukemia; MM=multiple myeloma; AML=acute myeloid leukemia; * Venclexta (venetoclax) in collaboration with AbbVie 22
Ocrelizumab: Additional efficacy data at AAN Breakthrough therapy designation in PPMS NEDA, disability progression and MRI data to be presented at AAN (April, 15 th 21 st ) Breakthrough therapy designation granted in PPMS US/EU filings in RMS/PPMS on track for H1 2016 NEDA=no evidence of disease activity; MRI=magnetic resonance imaging 23
Emicizumab (ACE 910) development plan Non-interventional study expanded to all patients Inhibitor study: Enrollment progressing well Inhibitor non-interventional study fully recruited (>90 patients) and expanded to non-inhibitors Non-inhibitor, pediatric and Q4W dosing studies expected to start in 2016 QW=weekly dosing; Q2W=dosing every 2 weeks; Q4W=dosing every 4 weeks; OLE=open label extension 24
Unlocking the full value of cancer immunotherapy New deals signed in Q1 Priming & activation anti-cea-il2v FP (cergutuzumab amunaleukin) anti-fap-il2v FP anti-ox40 anti-cd27* (Celldex) entinostat* (Syndax) T cell Trafficking T cell infiltration anti-vegf (Avastin) anti-ang2/vegf (vanucizumab) Antigen presentation T-Vec oncolytic virus* (Amgen) INFa anti-cd40 CMB305 vaccine* (Immune Design) Cancer T cell recognition anti-cea/cd3 TCB anti-cd20/cd3 TCB KTE-C19* (Kite Pharma) ImmTAC* (Immunocore) Clinical development Preclinical development Established therapies In-house CIT NMEs in the clinic * Partnered or external Antigen release EGFRi (Tarceva) ALKi (Alecensa) BRAFi (Zelboraf) MEKi (Cotellic) anti-cd20 (Gazyva) anti-her2 (Herceptin; Kadcyla; Perjeta) various chemotherapies lenalidomide* (Celgene) rociletinib* (Clovis) daratumumab* (Janssen) T cell killing anti-pdl1 (atezolizumab) anti-csf-1r (emactuzumab) IDOi (NewLink) IDOi* (Incyte) CPI-444* (Corvus) anti-tigit IDO1/TDOi* (Curadev) Chen and Mellman. Immunity 2013 NME=new molecular entity; CIT=cancer immunotherapy; FP=fusion protein; TCB=T-cell bispecific 25
Cancer immunotherapy read-outs in 2016 Priority review granted for bladder and lung cancer atezo+chemo Solid tumors atezo+cotellic Solid tumors atezo+avastin+/-chemo Solid tumors acea-il2v FP Solid tumors aox40 Solid tumors acea/cd3 TCB Solid tumors atezo+ido Solid tumors atezo+aox40 Solid tumors atezo Solid tumors atezo+acd40 Solid tumors atezo+ifn-alfa Solid tumors afap-il2v FP Solid tumors atezo+ipilimumab Solid tumors Phase I IDO Solid tumors atezo+acea/cd3 TCB Solid tumors atezo+acsf-1r Solid tumors atezo+acea-il2v FP Solid tumors acsf-1r Solid tumors atezo+zelboraf+cotellic Melanoma atezo+zelboraf Melanoma atezo+tarceva NSCLC atezo+alecensa ALK+ NSCLC atezo+kadcyla/herceptin+perjeta HER2+ ebc/mbc atezo+gazyva R/R FL / anhl atezo+gazyva+lenalidomide R/R FL/aNHL acd40+vanucizumab R/R FL/aNHL Status as of April 19, 2016; Outcome studies are event-driven: timelines may change. atezo+daratumumab+len R/R MM atezo+lenalidomide MM atezo+gazyva+polatuzumab R/R FL/aNHL atezo+gazyva+chemo R/R FL/aNHL acd20/cd3 TCB heme tumors atezo+/-azacitidine MDS Phase II atezo NSCLC (Dx+) (BIRCH) atezo 2/3L NSCLC (POPLAR) atezo 1/2L Bladder (IMvigor 210) atezo+avastin 1L Renal (IMmotion 150) = Read-outs expected in 2016 Phase III atezo 2/3L NSCLC (OAK) atezo+avastin+chemo 1L nsq NSCLC (IMpower 150) atezo+chemo 1L nsq NSCLC (IMpower 130) atezo+chemo 1L nsq NSCLC (IMpower 132) atezo 1L nsq NSCLC (Dx+) (IMpower 110) atezo 1L sq NSCLC (Dx+) (IMpower 111) atezo+chemo 1L sq NSCLC (IMpower 131) atezo Adj NSCLC (Dx+) (IMpower 010) atezo 2/3L Bladder (IMvigor 211) atezo Adj MIBC (Dx+) (IMvigor 010) atezo+chemo 1L TNBC (IMpassion 130) atezo+avastin 1L Renal (IMmotion 151) 26
Q1 2016 sales Innovation Outlook 27
2016: Focus on ongoing and upcoming launches Approvals & launch preparation Ocrevus (ocrelizumab) in MS Atezolizumab in bladder and lung cancer Gazyva (GOYA) and Perjeta (APHINITY) Maximise recent launches Venclexta (venetoclax) in R/R CLL with 17p deletion Alecensa in ALK positive NSCLC Cotellic + Zelboraf in 1L BRAF positive metastatic melanoma Gazyva in Rituxan-refractory inhl (GADOLIN) * Outcome studies are event driven, timelines may change 28
line extensions NMEs 2016 onwards: Significant launch activities Venclexta R/R CLL with 17p del Cotellic + Zelboraf BRAFmut melanoma Emicizumab (ACE910) Hemophilia A Alecensa 2L ALK+ NSCLC Atezolizumab 2L+ lung and bladder cancer Lebrikizumab Severe Asthma Ocrelizumab RMS/ PPMS Lampalizumab Geographic atrophy 2016 2017 2018 Gazyva Refractory inhl (GADOLIN) Perjeta + Herceptin ebc HER2+ (APHINITY) Atezolizumab+Avastin+chemo 1L NSCLC Gazyva 1L anhl (GOYA) Actemra Giant cell arteritis Atezolizumab + Avastin 1L RCC Gazyva 1L inhl (GALLIUM) Alecensa 1L ALK+ NSCLC Oncology/ hematology Neuroscience Ophthalmology Immunology Outcome studies are event-driven: timelines may change. Standard approval timelines of 1 year assumed. FDA Breakthrough Therapy Designation 29
ASCO 2016: Highlights in various cancer types Solid tumors atezolizumab + aox40: Ph I atezolizumab + Cotellic: Ph I in CRC Lung Alecensa: Ph III (J-ALEX) in 1L ALK+ NSCLC atezolizumab: Ph II OS update (POPLAR) in 2/3L NSCLC Bladder atezolizumab: Ph II (IMvigor210) 1L cohort and 2L cohort update in bladder Breast Herceptin + Perjeta: Ph III (PHEREXA) in 2L HER2+ mbc atezolizumab + abraxane: Ph I update in TNBC Hematology Venclexta: Ph II (CAVALLI) in 1L anhl Venclexta: Ph I in R/R CLL and R/R NHL Venclexta +/- chemo: Ph I in R/R MM Venclexta + chemo: Ph I in AML Cotellic in collaboration with Exelixis; Alecensa in collaboration with Chugai; Gazyva in collaboration with Biogen Idec 30
Additional key oncology presentations in 2016* New Orleans, 16-20 Apr EHA Copenhagen, 9-12 Jun aox40: Ph I dose escalation in atezoliztumab + Avastin + FOLFOX: Ph I in CRC atezolizumab + Gazyva: Ph I in R/R anhl/inhl idasanutlin + AraC: Ph I in R/R AML Copenhagen, 7-11 Oct atezolizumab + abraxane: Ph I in TNBC atezolizumab + IDOi: Ph I atezolizumab + Zelboraf + Cotellic: Ph1 in 1L BRAF+ mm atezolizumab: Ph II (IMvigor 210) in bladder atezolizumab: Ph I in SCLC atezolizumab: Ph III (OAK) in 2L NSCLC [or IASLC Vienna] San Diego, 3-6 Dec atezolizumab + lenalidomide: Ph I in MM (safety) atezoliztumab + azacytidine: Ph I in MDS (safety) acd20/cd3 TCB: Ph I dose escalation in Gazyva: Ph III (GOYA) in front-line anhl polatuzumab + Gazyva/Rituxan: Ph II (ROMULUS) in R/R FL / anhl polatuzumab + Gazyva/Rituxan + CHP: Ph I/II in 1L anhl polatuzumab + Gazyva: Ph I/II in 1L anhl and R/R FL Venclexta + Rituxan +/- bedamustin: Ph II (CONTRALTO) in R/R FL Venclexta + Gazyva or +Rituxan +/- benda: Ph I in R/R CLL Venclexta: Ph II in ibrutinib/idelalisib ref R/R CLL atezolizumab: Ph III (OAK) in 2L NSCLC atezoliztumab + Tarceva: Ph I in NSCLC Vienna, 4-7 Dec San Antonio, 6-10 Dec atezolizumab + abraxane: Ph I update in TNBC taselisib: Ph II (LORELEI) in neoadjuvant HER2-/ER+ BC SERD: Ph II * Planned submissions (to be confirmed); Outcome studies are event driven, timelines may change 31
2016: Key late-stage news flow Regulatory Phase III readouts* Phase II readouts* Compound Indication Milestone Gazyva Rituxan-refractory inhl US/EU approval Venclexta R/R CLL with 17p deletion US approval ocrelizumab RMS/PPMS US/EU filing atezolizumab Bladder cancer US approval atezolizumab 2/3L NSCLC US approval Alecensa 2L ALK+ NSCLC EU CHMP opinion lebrikizumab Severe asthma Ph III LAVOLTA I/II atezolizumab 2/3L NSCLC Ph III OAK Gazyva Front-line anhl Ph III GOYA Perjeta + Herceptin Adjuvant HER2+ BC Ph III APHINITY Actemra Giant cell arthritis Ph III GiACTA Alecensa 1L ALK+ NSCLC Ph III ALEX lebrikizumab Atopic dermatitis Ph II TREBLE, ARBAN atezolizumab Bladder cancer Ph II IMvigor 210 (1L cohort) atezolizumab + Avastin 1L Renal cancer Ph II IMmotion 150 Venclexta + Rituxan R/R FL (inhl) Ph II CONTRALTO Venclexta + Rituxan/Gazyva 1L anhl Ph II CAVALLI mixed * Outcome studies are event driven, timelines may change 32
Diagnostics Division Roland Diggelmann COO Roche Diagnostics 33
Q1 2016: Diagnostics Division sales Strong sales growth in laboratory businesses 2016 2015 Change in % CHFm CHFm CHF CER Diagnostics Division 2,614 2,511 4 5 Professional Diagnostics 1,519 1,425 7 7 Molecular Diagnostics 446 401 11 11 Diabetes Care 443 507-13 -11 Tissue Diagnostics 206 178 16 13 CER=Constant Exchange Rates; Underlying growth of Molecular Diagnostics excluding Sequencing business: +4% 34
Q1 2016: Diagnostics regional sales Growth driven by Asia Pacific and Latin America North America 0% 27% of divisional sales EMEA 1 +1% 43% of divisional sales Japan -3% 4% of divisional sales Latin America +21% 6% of divisional sales Asia Pacific +16% 20% of divisional sales 23% 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 35
Q1 2016: Diagnostics highlights Growth driven by Professional Diagnostics YoY CER growth Professional Dia +7% Driven by immunodiagnostics (+12%) Molecular 1 Dia +11% Virology (+16%) incl. HPV (+16%) Diabetes Care -11% Spillover of US reimbursement cuts to private sector Tissue Dia +13% EMEA North America RoW Advanced staining portfolio (+10%); primary staining (+24%) CHFbn 0.0 0.5 1.0 1.5 2.0 1 Underlying growth of Molecular Diagnostics excluding sequencing business: +4% CER=Constant Exchange Rates; EMEA=Europe, Middle East and Africa 36
Providing the full solution in hepatitis testing Comprehensive menu in serology & molecular Complete platform and test portfolio Hepatitis contributes ~60% of Roche s Infectious Disease/Virology portfolio Serology hepatitis: (+5% 1 ) Molecular/NAT* hepatitis: (+11% 1 ) Leader in a CHF 4.3bn market 5yr CAGR: ~6% projected Strong growth potential in serology Roche 25% Others 75% 1 Q1 2016 growth; *NAT: nucleic acid amplification technology 37
FDA approves IND for cobas Zika assay Screening initiated at Puerto Rico blood centres Currently testing in Puerto Rico, expect to expand into southern US centres Operating under an IND* cost-recovery model, no commercial sales * IND: Investigational New Drug Application 38
Key launches 2016 Instruments / Devices Tests / Assays Area Product Market Central Laboratory Point of Care Sequencing Diabetes Care cobas 8000 <e 801> high throughput immunochemistry analyzer cobas c 513 high throughput dedicated HbA1c analyzer CoaguChek INRange (Zenith) modified analyzer for intuitive self testing with full blue tooth connectivity Roche SMRT Sequencer single molecule sequencer for clinical research (in collaboration with Pacific Biosciences) Accu-Chek Guide next-generation blood glucose monitoring system Accu-Chek Insight CGM new high-performance continuous glucose monitoring system Virology cobas 6800/8800 HIV Qual early Infant Diagnosis and Confirmatory HIV Test EU HPV / Microbiology Point of Care Sequencing Companion Diagnostics cobas 6800/8800 CT/NG fully automated solution for screening and diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae in symptomatic & asymptomatic patients cobas Liat Influenza A/B plus RSV (CLIA) automated multiplex real time RT-PCR assay for qualitative detection and discrimination of Influenza A virus, Influenza B virus and respiratory syncytial virus (RSV) ctdna oncology panels liquid biopsy for circulating tumor DNA for cancer therapy selection PD-L1 (SP142) for Bladder Cancer* companion diagnostic for atezolizumab PD-L1 (SP142) for NSCLC* companion diagnostic for atezolizumab EU US EU WW EU EU EU US US US US * achieve commercial readiness, dependent on Pharma label and approval 39
Finance Alan Hippe Chief Financial Officer 40
Q1 2016: Highlights Sales Good sales growth in all regions and both divisions Guidance for FY 2016 2015 core EPS base for CER calculation: CHF 13.85 Currency impact Positive impact from USD, JPY and EUR currencies partly offset by Latin America Capital markets update Bond maturity EUR: 2.1bn maturity on 4 March 2016 - coupon 5.625% Bond tender USD: 0.6bn (0.86bn outstanding, maturity in 2019) coupon 6.0% s.a. Bond issuance EUR: 0.65bn maturity in 2023 - coupon 0.5% USD: 1.0bn maturity in 2026 - coupon 2.625% s.a. s.a.=semi-annual coupon 41
Q1 2016: Group sales Increase driven by US & EU Pharma and Diagnostics +3% +5% +4% +4% +5% +4% +5% Pharma Division +4% +115 +124 +133 +107 +72 +30 +457 +581 United States Europe Intl. Japan Diagnostics Division Group Fx Group CHF 1 Absolute values and growth rates at Constant Exchange Rates (CER) 1 average Full Year 2015 to average Q1 2016 Fx 42
Exchange rate impact on sales growth Positive impact from USD, JPY and EUR +1.9p +0.6p +0.4p -0.2p -0.2p -0.2p -1.3p CER sales growth Q1 2016 vs. Q1 2015 +3.9% +4.9% CHF sales growth Q1 2016 vs. Q1 2015 CER USD JPY EUR Other Europe As-Pac Other Lat-Am CHF CER=Constant Exchange Rates 43
Currency impact on Swiss Franc results 2016 Low currency impact expected CHF / USD Average YTD 2015 CHF / EUR 0.99 0.98 Assumed average YTD 2016 4% 3% 2% 1% 0.97 +1% 0.95 +1% 0.95 0.95 0.97 1.01 0.99 0.98 0.97 0.97 0.97 0.97 0.97 0.97 0.97 0.97 0.97 Monthly avg fx rates 2016 Fx rates at 31 March 2016 J F M A M J J A S O N D 0.96 2% 3% 3% 2% 1.10 1.10 1.09 1.09 1.08 +2% +2% 1.06 1.06 1.07 Assuming the 31 Mar 2016 exchange rates remain stable until end of 2016, 2016 impact is expected to be (%p): Q1 HY Sep YTD FY Sales 1 1 1 0 Core operating profit 0-1 Core EPS -1 0 1.09 1.10 1.09 1.09 1.09 1.09 1.09 1.09 1.09 1.09 1.09 1.09 J F M A M J J A S O N D 44
2015: Core EPS base for FY 2016 guidance +0.36 13.85 13.49 excl. Venezuela & Argentina FX losses Core EPS Full Year 2015 as reported Core EPS Full Year 2015 @ CER 45
2016 outlook Group sales growth 1 Low to mid-single digit Core EPS growth 1 Ahead of sales growth Dividend outlook Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER) 46
2016: Upcoming IR events 5 June 21 July 2 August 20 October Analyst Event at ASCO Half Year Results Analyst Event on Diagnostics Division at AACC Third Quarter Results Further details available online: http://www.roche.com/investors/agenda.htm 47
Pipeline summary Marketed products additional indications Global Development late-stage trials pred (Roche Pharma Research & Early Development) gred (Genentech Research & Early Development) Roche Group Q1 2016 sales Diagnostics Foreign exchange rate information 48
Changes to the development pipeline Q1 2016 update New to Phase I New to Phase II New to Phase III New to Registration 1 NME transitioned from Ph0 RG7906 psychiatric disorders 1 NME re-opened in Ph1 RG7203 PDE10A inh schizophrenia 1 NME in-licensed from Amgen RG6149 ST2 MAb - asthma 1 NME acquired from Tensha RG6146 BET inh oncology (CIT) 3 new AIs RG7876 CD40+vanucizumab RG7601 Venclexta+Cotellic/idasanutlin AML RG3616 Erivedge+ruxolitinib myelofibrosis 1 NME in-licensed from Shionogi RG6152 CAP endonuclease inh - influenza 1 NME transitioned from Ph2 RG7412 crenezumab Alzheimer s 1 AI atezolizumab + chemotherapy + pemetrexed NSCLC non-sq. 1L 1 AI transitioned from Ph2 atezolizumab NSCLC 2L+ Removed from Phase I Removed from Phase II Removed from Phase III Removed from Registration 2 NMEs RG7116 lumretuzumab mbc RG7597 duligotuzumab 1 NME RG7090 basimglurant TRD (out-licensing activities ongoing) 1 NME (status assigned to Ph1) RG7155 emactuzumab PVNS tumors 1NME following FDA approval RG7601 Venclexta (venetoclax) 17pdel CLL rel/ref Status as of April 19, 2016 49
Roche Group development pipeline RG6016 RG6047 RG6061 RG6078 RG6078 RG6146 RG7155 RG7159 RG7304 RG7386 RG7461 RG7601 RG7601 RG7601 RG7741 RG7775 RG7802 RG7813 RG7828 RG7841 RG7842 RG7876 RG7876 RG7882 RG7888 RG7888 RG7986 LSD1 inh SERD (2) HIF1 alpha LNA IDO inh IDO inh + atezolizumab BET inh Raf & MEK dual inh atezolizumab atezo+zelboraf+/-cotellic atezo+avastin+chemo atezolizumab+cotellic atezolizumab+ipi/ifn atezo+tarceva /Alecensa atezolizumab+gazyva Venclexta (venetoclax)+gazyva Phase I (43 NMEs+19 AIs) melanoma NSCLC CLL Venclexta+Cotellic/idasanutlin AML CL ChK1 inh solid tum & lymphoma MDM2 (4) IV prodrug Ly6E ADC ERK inh + Cotellic ADC OX40 MAb AML ER+(HER2-neg) mbc emactuzumab + atezolizumab s. tumors FAP-DR5 bimab atezo+lenalidomide/daratumumab FAP IL2v FP lymphoma Venclexta (venetoclax) heme indications AML CEACD3 TCB ± atezolizumab s. tumors *CEA IL2v FP+atezolizumab CD20/CD3 bimab Gazyva multiple combos heme indications atezolizumab + K/HP MM s. tumors heme tumors CD40 MAb+atezolizumab CD40 MAb+vanucizumab ovarian ca OX40 MAb + atezolizumab ADC * INN: cergutuzumab amunaleukin oncology HER2+ BC r/r NHL RG3616 RG3616 RG6069 RG6125 RG6149 RG7159 RG7625 RG7845 RG7880 RG6024 RG6080 RG7834 RG7861 RG7944 RG7992 RG6029 RG7203 RG7800 RG7893 RG7906 RG7916 RG7935 IONIS CHU RG4929 CLL Erivedge+Esbriet Erivedge+ruxolitinib - fibrosis Cadherin-11 MAb ST2 MAb obinutuzumab Cat-S antag BTK inh IL-22Fc Flu B MAb SMN2 splicer Nav1.7 inh a-synuclein MAb autoimmune diseases autoimmune diseases inflammatory diseases DBO β-lactamase inh bact. infections - HBV StaphA vcrifalog TAC therapeutic vaccine FGFR1/KLB MAb Nav1.7 inh (2) PDE10A inh ASO PTH1 recep. ago IPF RA renal transplant influenza B infect. diseases HBV metabolic diseases pain spinal muscular atrophy pain SMN2 splicer(2) spinal muscular atrophy Parkinson's Disease Huntington s Disease hypoparathyroidism PT CHU - hyperphosphatemia - glaucoma New Molecular Entity (NME) Additional Indication (AI) Oncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other myelofibrosis asthma schizophrenia - psychiatric disorders RG-No CHU IONIS PRO Phase II (16 NMEs+12 Als) RG3502 Kadcyla HER2+ NSCLC RG6046 SERD ER+(HER2-neg) mbc RG7221 vanucizumab mcrc RG7421 Cotellic+paclitaxel TNBC RG7440 ipatasertib RG7596 polatuzumab vedotin heme tumors RG7601 Venclexta (venetoclax) DLBCL RG7601 Venclexta (venetoclax)+rituxan FLrel/ref RG7604 taselisib NSCLC sq 2L RG7604 taselisib ER+(HER2-neg) BC neoadj RG7686 codrituzumab hepatocell. carcinoma RG3637 lebrikizumab +/- Esbriet IPF RG3637 lebrikizumab atopic dermatitis RG3637 lebrikizumab COPD RG7159 obinutuzumab lupus nephritis CHU nemolizumab (IL-31R) atopic dermatitis CHU nemolizumab (IL-31R) pruritus dialysis pts PRO VAP-1 inh inflammatory diseases RG6152 CAP endonuclease inh influenza RG7227 danoprevir HCV RG7745 Flu A MAb influenza A RG7795 TLR7 agonist HBV CHU URAT1 inh gout RG1662 basmisanil Down s syndrome RG6083 olesoxime spinal muscular atrophy RG7314 V1 receptor antag autism RG3645 ranibizumab PDS wamd RG7716 VEGF-ANG2 bimab wamd Roche/Genentech managed Chugai managed IONIS managed Proximagen managed Status as of April 19, 2016 50
Roche Group development pipeline RG435 RG435 1 RG1273 RG1273 RG1273 RG3502 RG3502 RG7159 RG7159 RG7204 RG7601 RG7853 Avastin Perjeta+Herceptin Gazyva Zelboraf glioblastoma 1L HER2+ mbc 2L Perjeta+Herceptin HER2+ BC adj Perjeta+Herceptin HER2+gastric ca 1L Kadcyla Kadcyla + Perjeta Gazyva Alecensa (alectinib) HER2+ BC adj HER2+ BC adj DLBCL1L follicular lymphoma 1L melanoma adj Venclexta (venetoclax)+rituxancll rel/ref ALK+ NSCLC 1L Phase III (10 NMEs + 30 Als) RG1569 RG3637 RG7413 RG7413 CHU RG1450 RG1594 RG1594 RG7417 Actemra lebrikizumab etrolizumab etrolizumab Actemra gantenerumab ocrelizumab ocrelizumab lampalizumab giant cell arteritis severe asthma ulcerative colitis Crohn s disease large-vessel vasculitis RG3502 Kadcyla + Perjeta HER2+ BC neoadj CHU IL-6R MAb neuromyelitis optica RG7601 Avastin atezolizumab+avastin rel. ovarian ca. Pt-sensitive atezolizumab+chemo NSCLC non-sq. 1L 1L NSC atezo+chemo+avastin NSCLC non-sq. 1L RG7604 RG6013 RG7388 atezo+chemo+pemetrexed NSCLC non-sq. 1L atezolizumab+chemo atezolizumab Dx+ atezolizumab Dx+ atezolizumab Dx+ atezolizumab+abraxane Venclexta (venetoclax)+gazyva taselisib NSCLC sq. 1L NSCLC non-sq. 1L NSCLC adj TNBC RCC atezolizumab muscle inv. bladder ca adj emicizumab idasanutllin Status as of April 19, 2016 NSCLC sq. 1L CLL 1L ER+(HER2-neg) mbc hemophilia A AML RG105 RG1569 RG7412 MabThera Actemra crenezumab pemphigus vulgaris systemic sclerosis Alzheimer s RMS PPMS Alzheimer s geographic atrophy RG105 2 MabThera SC CLL RG435 3 Avastin+Tarceva EGFR mut+ NSCLC RG7159 4 5 5 RG7853 6 Registration (2 NMEs + 4 Als) Gazyva inhl rituximab-refractory atezolizumab bladder cancer 2L atezolizumab NSCLC 2L+ Alecensa (alectinib) ALK+ NSCLC 2L 1 Global filing 2 CHMP positive opinion Q1 16 3 EU only 4 Approved in the US 5 Phase 3 ongoing 6 Approved in the US and Japan New Molecular Entity (NME) Additional Indication (AI) Oncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other RG-No Roche/Genentech managed CHU Chugai managed IONIS IONIS Managed PRO Proximagen 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 51
NME submissions and their additional indications Projects currently in phase 2 and 3 New Molecular Entity Oncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other lampalizumab (RG7417) geographic atrophy atezolizumab()+chemo +pemetrexed NSCLC non-sq 1L crenezumab (RG7412) Alzheimer s V1 receptor antag (RG7314) autism VEGF/ANG2 bimab (RG7716) wamd taselisib ( RG7604) ER+(HER2-neg) BC neoadj basmisanil (RG1662) Down syndrome gantenerumab (RG1450) Alzheimer s idasanutlin (RG7388) AML atezolizumab() NSCLC sq 1L (Dx+) olesoxime (RG6083) SMA lebrikizumab (RG3637) COPD lebrikizumab (RG3637) atopic dermatitis lebrikizumab+/-esbriet (RG3637) IPF atezolizumab()+chemo + Avastin NSCLC non-sq 1L taselisib ( RG7604) NSCLC sq 2L atezolizumab() NSCLC non-sq 1L (Dx+) etrolizumab (RG7413) Crohn s disease ocrelizumab (RG1594) PPMS atezolizumab()+ chemo NSCLC sq 1L SERD (RG6046) ER+(HER2-neg) mbc atezolizumab () NSCLC adj (Dx+) etrolizumab (RG7413) ulcerative colitis ocrelizumab (RG1594) RMS atezolizumab()+ chemo NSCLC non-sq 1L ipatasertib (RG7440) atezolizumab () MIBC adj TLR7 ago (RG7795) HBV lebrikizumab (RG3637) severe asthma atezolizumab() combo Avastin RCC vanucizumab (RG7221) colorectal cancer Venclexta (venetoclax) + Rituxan FL rel/ref danoprevir (RG7227) HCV atezolizumab () US* NSCLC 2L+ Venclexta (venetoclax) + Rituxan CLL rel/refractory atezolizumab () + abraxane TNBC polatuzumab vedotin (RG7596) heme tumors Venclexta (venetoclax) + Gazyva CLL 1L Flu A MAb (RG7745) influenza atezolizumab () US* bladder cancer 2L emicizumab (RG6013) hemophilia A taselisib (RG7604) HER2 neg ER+ mbc codrituzumab (RG7686) liver cancer Venclexta (venetoclax) DLBCL CAP endonuclease inh (RG6152) influenza 2016 2017 2018 2019 and beyond Unless stated otherwise, submissions are planned to occur in US and EU indicates a submission which has occurred with regulatory action pending Status as of April 19, 2016 * EU submission pending 52
Submissions of additional indications for existing products Projects currently in phase 2 and 3 Avastin (US) GBM *Avastin rel. ovarian ca. Pt-sens. Kadcyla+Perjeta HER2-pos. BC neoadj Gazyva DLBCL 1L Perjeta + Herceptin HER2-pos. mbc 2L Gazyva follicular lymphoma 1L Alecensa (alectinib) Alk+ NSCLC 1L Cotellic+paclitaxel TNBC Kadcyla HER2-pos. NSCLC Kadcyla+Perjeta HER2-pos. BC adj. Kadcyla HER2-pos. BC adj. Perjeta + Heceptin HER2-pos. BC adj. Actemra giant cell arteritis Zelboraf melanoma adj. Perjeta+Herceptin HER2-pos. gastric cancer 1L MabThera pemphigus vulgaris Actemra systemic sclerosis obinutuzumab lupus nephritis ranibizumab PDS (US) wamd 2016 2017 2018 2019 and beyond indicates submission to health authorities has occurred *approved in EU Unless stated otherwise, submissions are planned to occur in US and EU. Status as of April 19, 2016 Oncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other NME 53
Major granted and pending approvals 2016 Approved Pending approval US EU Japan-Chugai Venclexta (venetoclax) 17pdel CLL rel/ref April 2016 Gazyva inhl rituximab-ref. February 2016 Bonviva osteoporosis (oral) January 2016 atezolizumab NSCLC 2L+ Filed February 2016 atezolizumab bladder cancer 2L Filed January 2016 Alecensa (alectinib) ALK+ NSCLC 2L Filed September 2015 Avastin + Tarceva EGFR mut+ NSCLC Filed July 2015 Gazyva inhl rituximab-ref. Filed September 2015 MabThera SC* CLL Filed November 2014 *CHMP pos. opinion Avastin cervical cancer Filed September 2015 Status as of April 19, 2016 Oncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other NME 54
Roche Group Development pipeline Combinations Phase I (5 NMEs + 16 AIs) Phase II (3 Als) Registration (1 AI) RG6078 RG7155 RG7159 RG7601 RG7601 RG7802 RG7813 RG7842 RG7876 RG7876 RG7888 RG3616 RG3616 IDO inh + atezolizumab emactuzumab + atezolizumab atezo+zelboraf+/-cotellic atezo+avastin+chemo atezolizumab +Cotellic atezolizumab +ipi/ifn atezo+tarceva/ Alecensa atezolizumab+gazyva atezo+lenalidomide CEA IL2v FP+atezolizumab s.tumors melanoma NSCLC lymphoma CD40 MAb+atezolizumab OX40 MAb + atezolizumab Gazyva multiple combos heme indications atezolizumab + K/ H+P multiple myeloma Venclexta+Gazyva CLL Venclexta+Cotellic/idasanutlin AML CLL CEA CD3 TCB+atezolizumab ERK inh + Cotellic HER2+BC s. tumors s. tumors CD40 MAb+vanucizumab Erivedge+Esbriet Erivedge+ruxolitinib s. tumors IPF myelofibrosis RG7421 RG7601 RG3637 RG1273 RG1273 RG1273 RG3502 RG3502 Venclexta (venetoclax) +Rituxan FL rel/ref TNBC Phase III (13 AIs) atezo+chemo atezolizumab+avastin NSCLC non-sq. 1L NSC atezo+chemo+avastin NSCLC non-sq. 1L RG7601 RG7601 Cotellic+paclitaxel lebrikizumab +/- Esbriet Perjeta+Herceptin Perjeta+Herceptin atezolizumab+chemo atezolizumab+abraxane TNBC IPF HER2+ mbc 2L Perjeta+Herceptin HER2+gastric ca 1L Kadcyla + Perjeta Kadcyla + Perjeta HER2+ BC adj HER2+ BC adj HER2+ BC neoadj atezo+chemo+pemetrexed NSCLC non-sq. 1L NSCLC sq. 1L TNBC RCC Venclexta(venetoclax)+RituxanCLL rel/ref Venclexta (venetoclax)+gazyva CLL 1L RG435 1 Avastin+Tarceva 1 EU only New Molecular Entity (NME) Additional Indication (AI) Oncology Immunology EGFR mut+ NSCLC RG-No Roche Genentech managed Status as of April 19, 2016 55
Cancer immunotherapy pipeline overview Phase I (8 NMEs + 19 AIs) Phase II (2 AIs) Registration (1 NME + 1 AI) RG6078 IDO inh IMDZ atezo+ny-eso-1 soft tissue sarcoma 1 atezolizumab bladder cancer 2L RG6078 RG7155 RG7461 RG7802 RG7813 RG7828 RG7876 RG7876 RG7888 RG7888 *INCY *CLDX *CLVS *CRVS *KITE *AMGN *JNJ IDO inh + atezolizumab emactuzumab + atezolizumab s.tumors atezolizumab atezo+zelboraf+/-cotellic atezo+avastin+chemo atezolizumab +Cotellic atezolizumab +ipi/ifn atezo+tarceva atezolizumab+gazyva atezo+lenalidomide/daratumumab atezolizumab + K/HP FAP IL2v FP OX40 MAb NSCLC EGFR+ lymphoma CEA CD3 TCB + atezolizumab s. tumors CD40 MAb+atezolizumab atezolizumab + IDO inh atezolizumab+varlilumab MM CEA IL2v FP+atezolizumab CD20/CD3 bimab m. melanoma HER2+ BC hem tumors CD40 MAb+vanucizumab OX40 MAb + atezolizumab atezo+rociletinib atezo+a2ai atezo+cd19 CAR-T atezo+talimogene laherp. atezo+daratumumab EGFRmut+ NSCLC TNBC, CRC solid tumor NHL NSC SNDX atezo+entinostat TNBC NSC Phase III (10 AIs) atezo+chemo atezolizumab+avastin NSCLC non-sq. 1L atezo+chemo+avastin NSCLC non-sq. 1L atezo+chemo+pemetrexed NSCLC non-sq. 1L atezolizumab+chemo atezolizumab Dx+ NSCLC sq. 1L NSCLC sq. 1L atezolizumab Dx+ NSCLC non-sq. 1L atezolizumab Dx+ atezolizumab+abraxane NSCLC adj TNBC RCC atezolizumab muscle inv. bladder ca adj 1 atezolizumab 1 Phase 3 ongoing New Molecular Entity (NME) Additional Indication (AI) Oncology RG-No Roche Genentech managed NSCLC 2L *external collaborations: INCY- Incyte INCB024360, CLDX - Celldex CD27 MAb; CLVS Clovis EGFRi, CRVS Corvus CPI-444, KITE Kite KTE-C19, AMGN Amgen oncolytic virus, JNJ Janssen CD38 MAb., IMDZ Immune Design CMB305, SNDX Syndax HDACi Status as of April 19, 2016 56
Doing now what patients need next