Roche
2015 results
London, 28 January 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 2015 performance
Outlook
5 2015: Targets fully achieved
Targets for 2015 FY 2015
Group sales growth1 Mid-single digit +5%
Core EPS growth1 Ahead of sales growth2 +7%
Further increase dividend in Swiss francs3 Dividend outlook CHF 8.10 (Payout ratio increased to 60% from 56%)
1 At constant exchange rates (CER); 2 Excluding sale of filgrastim rights in 2014; 3 2015 dividend as proposed by the Board of Directors 6
2015: Highlights
Growth
Sales • Group sales +5%1 driven by HER2 franchise (+19%), Avastin (+9%), Esbriet (n.m.), Actemra (+23%) and Professional Diagnostics (+8%)
Profit • +7% Core EPS growth1,2 driven by strong underlying business
Innovation
Oncology • Cancer immunotherapy: Phase II lung (POPLAR, BIRCH), rolling filing initiated; Phase II bladder (IMvigor 210), filed in US; 9 NMEs in clinical development • Alecensa (alectinib): Approved in US, filed in EU • Cotellic (cobimetinib): Approved in US and EU
Hematology • Venetoclax: Filing acceptance in R/R CLL including 17p del in US • Gazyva: Phase III (GADOLIN) in R/R iNHL, filed in US and EU • Emicizumab (ACE 910): Updated phase Ib, start of Phase III in inhibitors
Neuroscience • Ocrelizumab: Phase III in RMS (OPERA I/II) and PPMS (ORATORIO)
1 At constant exchange rates (CER); 2 Excluding sale of filgrastim rights in 2014 7 2015: Strong sales growth in both divisions
2015 2014 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 37.3 36.7 2 5
Diagnostics Division 10.8 10.8 0 6
Roche Group 48.1 47.5 1 5
CER=Constant Exchange Rates 8 2015: Sales growth for fifth consecutive year
10%
8% 8% 7% 7% 6% 6% 6% 6% 6% 5% 5% 6% 4% 5% 4% 4% 4% 4% 4%
2% 2% 0% 0% 1% 0% Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 11 11 11 11 12 12 12 12 13 13 13 13 14 14 14 14 15 15 15 15
All growth rates at Constant Exchange Rates (CER) 9 2015: Strong sales growth in all regions
CHFbn 21 +5% +1% 18
15 +3% +7% 12 +2% Diagnostics +13% 9 +6% Pharma
6 +5% 0% +5% +4% 3 +6% 0 Japan International Europe US
All growth rates are YoY at Constant Exchange Rates (CER) 10 Roche: Significantly advancing patient care Recognition for innovation 2013-present
Breakthrough Therapy Year Molecule Venetoclax (AML) 11 Designations 2016 Venetoclax + Rituxan (R/R CLL) Actemra (Systemic sclerosis) Rank Company # Atezolizumab (NSCLC) 2015 1 Roche 11 Venetoclax (R/R CLL 17p del) 2 BMS 8 Emicizumab/ACE 910 (Hemophilia A) 3 Novartis 6 Esbriet (IPF) 2014 Lucentis (DR) 3 Merck 6 Atezolizumab (Bladder) 3 Pfizer 6 Alectinib (2L ALK+ NSCLC) 2013 4 GSK 5 Gazyva (1L CLL)
Source: http://www.focr.org/breakthrough-therapies as at 21 January 2016; CLL=Chronic Lymphocytic Leukemia; NSCLC=Non- 11 Small Cell Lung Cancer; IPF=Idiopathic Pulmonary Hypertension; DR=Diabetic Retinopathy 2015: Strong underlying Group Core operating profit & margin
% of sales 37.7% 38.3% 37.2% 36.4% (+0.7%*) 35.6% +5% at CER (+7%*) CHFbn 17.5 17.9 17.2 17.6 15.1
2011 2012 2013 2014 2015
CER=Constant Exchange Rates; * Excluding sale of filgrastim rights in 2014 12 2015: Strong underlying Core EPS growth
+4% at CER (+7%*)
13.49 14.27 14.29 13.49 CHF 12.30
2011 2012 2013 2014 2015
All growth rates at Constant Exchange Rates (CER); * Excluding sale of filgrastim rights in 2014 13 2015: Dividend and payout ratio further increased
CHF Dividend payout ratio (%) 60.0 10 55.3 56.0 9 2015 payout ratio: 60.0% 54.5 54.7 8.10 8 51.6 48.6 7 44.8
6 38.8 34.5 5 31.9 4
3
2
1
0 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014
Payout ratio calculated as dividend per share divided by Core earnings per share (diluted); 2015 dividend as proposed by the Board of Directors; 14 Note:1 compound For 1995, a annualspecial dividend growth was rate paid out to mark F. Hoffmann-La Roche’s 100th anniversary in 1996 2015: Core EPS growth bridge
+2.9% +6.6%
one-time +5.3% filgrastim* +3.7%
Core EPS Core EPS Sales Full Year 2015 Full Year 2015 figures as reported excl. filgrastim*
All growth rates at Constant Exchange Rates (CER); * Excluding sale of filgrastim rights in 2014 15 2015 performance
Outlook
16 2016 onwards: Significant launch activities
Venetoclax R/R CLL including 17p del
Cotellic + Zelboraf Emicizumab (ACE910) BRAFmut melanoma Hemophilia A Alecensa Lebrikizumab NMEs 2L ALK+ lung cancer Severe Asthma Atezolizumab Ocrelizumab Lampalizumab 2L+ lung and bladder cancer RMS/ PPMS Geographic atrophy 2016 2017 2018
Gazyva Perjeta + Herceptin Atezolizumab + abraxane
Refractory iNHL (GADOLIN) eBC HER2+ (APHINITY) TNBC
Gazyva Atezolizumab+Avastin+chemo
ine ine 1L aNHL (GOYA) 1L NSCLC l Actemra Atezolizumab + Avastin extensions Giant cell arteritis 1L RCC Gazyva 1L iNHL (GALLIUM) Alecensa 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. 17 2016 outlook
Group sales growth1 Low to mid-single digit
Core EPS growth1 Ahead of sales growth
Dividend outlook Further increase dividend in Swiss francs
1 At Constant Exchange Rates (CER) 18 Pharmaceuticals Division Daniel O’Day COO Roche Pharmaceuticals
19 2015 results
Innovation
Outlook
20 2015: Pharma sales Strong growth driven by all regions
2015 2014 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 37,331 36,696 2 5 United States 17,616 15,822 11 6 Europe 8,734 9,422 -7 4 Japan 3,224 3,301 -2 6 International 7,757 8,151 -5 5
CER=Constant Exchange Rates 21 2015: Pharma Division Core operating profit growth +8%*
2015 2015 vs. 2014 CHFm % sales CER growth Sales 37,331 100.0 5%
Excl. filgrastim* Royalties & other op. inc. 2,119 5.7 -11% +10% Cost of sales -7,900 -21.2 7% Capacity increase in manufacturing M & D -6,066 -16.2 4% R & D -8,134 -21.8 4% G & A -1,295 -3.5 -17%
Excl. filgrastim* Core operating profit 16,055 43.0 5% +8% 0% in CHF
CER=Constant Exchange Rates; * Excluding sale of filgrastim rights in 2014 22 2015: Strong performance from oncology and immunology franchises
Herceptin +10% Avastin +9%
Perjeta +61%
Esbriet n.m. MabThera/Rituxan +5% Actemra/RoActemra +23% Kadcyla +51% Xolair +25%
Xeloda -31%
Lucentis -15% US Tamiflu -28% Europe Japan Valcyte/Cymevene -45% International Pegasys -44% CHFm -600 -400 -200 0 200 400 600
Absolute amounts and growth rates at Constant Exchange Rates (CER) 23 2015: Oncology with +8% growth
YoY CER growth Perjeta
HER2 Herceptin +19% • Strong uptake of Perjeta and Kadcyla • Growth of Herceptin due to longer treatment Kadcyla • Growth driven mainly by cervical and ovarian Avastin +9% • International: Strong growth in all regions
MabThera/ Rituxan +4% • US: Growth in iNHL maintenance (Oncology)
• In-class competition Tarceva -7% • EU: Avastin + Tarceva filed in 1L EGFR+ NSCLC
Xeloda -31% • Loss of exclusivity
• Competitive pressure in US and EU Zelboraf -21% • Cotellic + Zelboraf approved in Q4
CHFbn 0 2 4 6 8 10
CER=Constant Exchange Rates; 2015 Oncology sales: CHF 23.7bn; CER growth +8% 24
HER2 franchise: Continued strong growth
CHFm YoY CER growth HER2 franchise Q4 2015 2,500 +18% • Herceptin (+10%): Longer treatment +19% duration in combo with Perjeta 2,000 • Perjeta (+50%): Strong demand in 1L mBC +20% +10% • Kadcyla (+36%): Growth driven by EU 1,500
1,000 Outlook 2016 • Perjeta: Further increasing penetration and 500 neoadjuvant uptake • Kadcyla: Increasing penetration and new 0 countries Q4 12 Q4 13 Q4 14 Q4 15 • Ph III APHINITY data (adj. HER2+) expected Herceptin Perjeta Kadcyla
CER=Constant Exchange Rates 25 Strong subcutaneous conversion rates for Herceptin and MabThera
Check SC share of Herceptin sales in SC share of MabThera NHL launched countries* sales in launched countries* NHL sales
40% 35%
30% 30% 25% 20% 20% 15% 10%
10% Sales market share(%) market Sales Sales market share(%) market Sales 5%
0% 0% Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q2 Q3 Q4 Q1 Q2 Q3 Q4 13 13 13 14 14 14 14 15 15 15 15 14 14 14 15 15 15 15
SC=subcutaneous; * Herceptin SC has been launched in 48 countries; MabThera SC has been launched in 12 countries 26 Avastin: Growth in various indications and across all regions
CHFm YoY CER growth Avastin Q4 2015 2,000 +9% • US (+11%) & EU (+5%): Growth in +8% +12% ovarian and cervical cancer 1,600 +8%+8% • International (+7%): Driven by Asia, mainly China (lung cancer launch) 1,200
800 Outlook 2016 • Continued uptake in ovarian and cervical 400 • EU: Avastin + Tarceva approval in EGFR+ NSCLC expected in H2 0 Q4 12 Q4 13 Q4 14 Q4 15 US Europe International Japan
CER=Constant Exchange Rates 27 Immunology: Continued strong performance
CHFm YoY CER growth Immunology Q4 2015 1,800 +26% Xolair (+22%) 1,500 +16% • Growth driven by allergic asthma and +12% 1,200 +8% chronic idiopathic urticaria Actemra (+25%) 900 • SC formulation driving growth 600 • Increasing 1L monotherapy leadership 300 focusing on MTX intolerant patients 0 MabThera/Rituxan (+14%) Q4 Q4 Q4 Q4 12 13 14 15 • Continues to grow in rheumatoid MabThera/Rituxan (RA) Actemra IV arthritis and vasculitis (GPA and MPA) Actemra SC Xolair CellCept Pulmozyme Esbriet Other
CER=Constant Exchange Rates; MTX=methotrexate; GPA=granulomatosis with polyangiitis; MPA=microscopic polyangiitis 28 Lucentis: Ongoing competitive pressure
Lucentis sales (USDm) Lucentis Q4 2015 500 • Competitive pressure in wAMD and DME • Launch in DR ongoing after first-in-class FDA approval in Q1 2015 400 • Protocol S results provide evidence of safe alternative to laser therapy against proliferative DR
300 Outlook 2016 • Moderate decline expected 200 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 12 12 13 13 13 13 14 14 14 14 15 15 15 15
wAMD=wet age-related macular degeneration; DME=diabetic macular edema; DR=diabetic retinopathy (in patients with DME) 29 Esbriet: Market leadership in IPF established
177 Esbriet sales (CHFm) 157 US • Strong underlying growth 141 • Around 100,000 IPF patients in the US with high unmet need
88 EU • Increasing differentiation due to strengthened label including the pooled 1 Yr mortality data 44 36 32 27 Outlook 2016 • Continued growth due to increased penetration and longer treatment Q1 14 Q2 14 Q3 14 Q4 14 Q1 15 Q2 15 Q3 15 Q4 15
30 2015 results
Innovation
Outlook
31 2015: Key late-stage news flow
Compound Indication Milestone Avastin Cervical cancer EU approval Lucentis Diabetic retinopathy US approval Regulatory Alecensa 2L ALK+ NSCLC US/EU approval/filing Cotellic + Zelboraf 1L Melanoma US/EU approval Gazyva MabThera/Rituxan-refractory iNHL Ph III GADOLIN Gazyva Front-line aNHL Ph III GOYA (interim) 2016 ocrelizumab Relapsing forms of MS (RMS) Ph III OPERA I/II Phase III readouts* ocrelizumab Primary progressive MS (PPMS) Ph III ORATORIO Perjeta 2L HER2+ mBC Ph III PHEREXA Data in-house Kadcyla 2L HER2+ gastric cancer Ph II/III GATSBY atezolizumab** 2/3L Bladder cancer Ph III atezolizumab** 1L TNBC Ph III atezolizumab** 1L RCC Ph III Phase III starts atezolizumab** Adjuvant bladder Ph III etrolizumab Crohn`s disease Ph III emicizumab (ACE910) Hemophilia A (inhibitors) Ph III taselisib (PI3K inhib) HR+/PI3Kmut BC Ph III SANDPIPER atezolizumab 2/3L NSCLC Ph II FIR, POPLAR, BIRCH Phase II readouts* atezolizumab Bladder cancer Ph II ipatasertib (AKT inhib) Gastric/prostate cancers Ph II MARTIN, JAGUAR Data in-house
* Outcome studies are event driven, timelines may change; ** For atezolizumab (aPDL1) only P3 trials in new indications are 32 listed (1L and sdjuvant NSCLC starts not shown) Unlocking the full value of cancer immunotherapy Nine in-house immunotherapy NMEs in the clinic
T cell Trafficking
Priming & activation anti-CEA-IL2v FP anti-FAP-IL2v FP anti-OX40 T cell infiltration anti-CD27* (Celldex) anti-VEGF (Avastin) entinostat* (Syndax) anti-Ang2/VEGF (vanucizumab)
Antigen presentation T-Vec oncolytic virus* (Amgen) Cancer T cell recognition INFa anti-CEA/CD3 TCB anti-CD40 anti-CD20/CD3 TCB CMB305 vaccine* (Immune Design) anti-HER2/CD3 TCB ImmTAC* (Immunocore)
Antigen release EGFRi (Tarceva) T cell killing ALKi (Alectinib) anti-PDL1 (atezolizumab) Clinical development BRAFi (Zelboraf) anti-CSF-1R (emactuzumab) Preclinical development MEKi (Cotellic) IDOi (NewLink) anti-CD20 (Gazyva) IDOi* (Incyte) Established therapies anti-HER2 (Herceptin; CPI-444* (Corvus) * Partnered or external Kadcyla; Perjeta) anti-TIGIT In-house immunotherapy NMEs various chemotherapies IDO1/TDOi* (Curadev) lenalidomide* rociletinib* (Clovis)
Chen and Mellman. Immunity 2013 33 NME=new molecular entity; CIT=cancer immunotherapy; FP=fusion protein; TCB=T-cell bispecific Combination trials as of beginning 2015…
aCEA-IL2v FP Immunotherapy portfolio aCSF-1R chemo Launched/ aCD40 late-stage portfolio aOX40 IDO atezolizumab aCEA/CD3 TCB
cobimetinib
venetoclax Targeted combinations approved
alectinib Chemotherapy combinations approved Roche combinations in trials
polatuzumab Chemotherapy combinations in trials NMEs late stage
NMEs early stage
34 …and combination trials as of today
aCEA-IL2v FP Immunotherapy portfolio aCSF-1R aFAP-IL2v FP chemo Launched/ aCD40 late-stage portfolio aOX40 IDO atezolizumab aCEA/CD3 TCB
aCD20/CD3 TCB
Targeted combinations approved venetoclax Chemotherapy combinations approved Roche combinations in trials
Chemotherapy combinations in trials polatuzumab Roche NMEs approval expected in 2016
azacitidine Roche NMEs early stage
lenalidomide Approved non-Roche drugs 35 Cancer immunotherapy read-outs in 2016 Phase I Phase II Phase III Additional 2016 results (according atezo aCEA-IL2v FP atezo atezo to Eka`s publication list): Solid tumors Solid tumors NSCLC (Dx+) 2/3L NSCLC • Ph1: Atezo+Avastin+FOLFOX in atezo+chemo aOX40 atezo atezo 1L CRC Solid tumors Solid tumors 2/3L NSCLC 2/3L Bladder • Ph3 interim: Atezo+abraxane in atezo+Tarceva aCEA/CD3 TCB atezo+Avastin atezo+Avastin+chemo TNBC NSCLC Solid tumors 1L Renal 1L non sq NSCLC atezo+Zelboraf IDO atezo atezo+chemo • Ph1: aCD20/CD3 TCB Melanoma Solid tumors 1/2L Bladder 1L non sq NSCLC • Ph1: Atezo+lena SAFETY atezo+Cotellic aCSF-1R atezo+chemo • Ph1: Atezo+azacitidine SAFETY Solid tumors Solid tumors 1L sq NSCLC atezo+Gazyva aCD20/CD3 TCB atezo R/R FL / aNHL heme tumors 1L non sq NSCLC (Dx+) atezo+Avastin+/-chemo aFAP-IL2v FP atezo Should we Solid tumors Solid tumors 1L sq NSCLC (Dx+) indicate atezo+lenalidomide atezo+ipilimumab atezo+chemo MM Solid tumors 1L TNBC what could atezo+Zelboraf+Cotellic atezo+IFN-alfa atezo+Avastin be at Melanoma Solid tumors 1L Renal atezo+Alecensa atezo+aCD40 atezo ASCO? ALK+ NSCLC Solid tumors Adjuvant MIBC (Dx+) atezo+/-azacitidine atezo+aOX40 atezo MDS Solid tumors Adjuvant NSCLC (Dx+) atezo+Gazyva+chemo atezo+aCSF-1R R/R FL/aNHL Solid tumors atezolizumab trials atezo+Gazyva+lenalidomide atezo+aCEA-IL2v FP NME monotherapy R/R FL/aNHL Solid tumors Immune doublets atezo+Kadcyla/Herceptin+Perjeta atezo+IDO HER2+ eBC/mBC Solid tumors Results in 2016 atezo+Gazyva+polatuzumab atezo+aCEA/CD3 TCB R/R FL/aNHL Solid tumors 36 Status as of Jan 28, 2016; Outcome studies are event-driven: timelines may change. Mention sales in Alecensa in 2L ALK+ lung cancer Japan ? First ALK inhibitor with proven activity in the brain
Phase II US and Global Studies
80 75%
70 59% 60 51% 52% ORR 50 CR
40 All • Accelerated approval in US; Filed in 30 (n=69) the EU in Q3
20 21% • High systemic and CNS disease 10 25%
Overall and CNS Response Rates CNS OverallResponse and control in crizotinib-failed lung cancer 0 All (n=67) Measurable All (n=122) Measurable CNS disease CNS disease • Phase III results (ALEX) in 1L ALK+ (n=16) (n=34) NSCLC expected in 2017 • Median PFS: 8.1m (US) , 8.9m (global) US Study Global Study • Median DOR: 13.5m (US),14.1m (global)
Alecensa (alectinib); ORR=overall response rate; CR=complete responses; CNS=central nervous system; PFS=progression free survival; DOR=duration of response; Shaw A. et al, WCLC 2015; Barlesi F. et al, ESMO/ECC 2015 37 Cotellic + Zelboraf in 1L BRAFmut melanoma Triple combination with atezolizumab started
Phase III coBRIM Study
Zelboraf + Zelboraf + Cotellic Placebo • Approved in the US/EU (n = 247) (n = 248) • Ph I data (at SMR) show that atezolizumab Median OS 22.3 17.4 can be combined with Zelboraf Median PFS 12.3 7.2 • Ph I triplet combination of atezolizumab + % ORR 69.6 50.0 Zelboraf + Cotellic on-going
% CR 15.8 10.5
Cotellic (cobimetinib); OS=overall survival; PFS=progression free survival; ORR=overall response rate; CR=complete responses; Atkinson V. et al, SMR 2015; Shaw A. et al, WCLC 2015; Barlesi F. et al, ESMO/ECC 2015 38 Ocrelizumab in multiple sclerosis First drug active in both RMS and PPMS
Phase III OPERA I/II Studies (RMS) Phase III ORATORIO Study (PPMS)
• First and only investigational medicine to suppress disease progression in both RMS and PPMS • Results confirm B cells play a central role in MS • US/EU filing for RMS and PPMS on track for H1 2016
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 39 Emicizumab (ACE910) in hemophilia A First-patient-in achieved in inhibitor study
2015 2016 2017 2018
Japanese studies OLE Chugai
Inhibitor Non-interventional
Inhibitor (≥12 yrs) Weight based QW dosing • First-patient-in in the inhibitor phase III study achieved Non-inhibitor (≥12 yrs) • Inhibitor non-interventional study has recruited >90 patients and will be expanded to non-inhibitors QW and Q2W dosing • Non-inhibitor and pediatrics studies expected to start in 2016 Pediatrics Inhibitor • New data at ASH 2015: Patient underwent surgery without need for any Factor VIII replacement therapy
(Q4W dosing study planned)
QW=weekly dosing; Q2W= dosing every 2 weeks; Q4W=monthly dosing; PK=pharmacokinetic study; OLE=open label extension 40 Phase I Phase II Phase III Patient transfer Strengthening Pharma through collaborations Data analysis driving innovation and efficiencies
Access meaningful data Create insights CreateRealise insights value
Diagnostic Data Advanced analytics
of integrated data
Smarter, more efficient R&D Clinical Trial Data
Real World Data
Improved access & personalised patient care
41 2015 results
Innovation
Outlook
42 2016 onwards: Significant launch activities
Venetoclax R/R CLL including 17p del
Cotellic + Zelboraf Emicizumab (ACE910) BRAFmut melanoma Hemophilia A Alecensa Lebrikizumab NMEs 2L ALK+ lung cancer Severe Asthma Atezolizumab Ocrelizumab Lampalizumab 2L+ lung and bladder cancer RMS/ PPMS Geographic atrophy 2016 2017 2018
Gazyva Perjeta + Herceptin Atezolizumab + abraxane
Refractory iNHL (GADOLIN) eBC HER2+ (APHINITY) TNBC
Gazyva Atezolizumab+Avastin+chemo
ine ine 1L aNHL (GOYA) 1L NSCLC l Actemra Atezolizumab + Avastin extensions Giant cell arteritis 1L RCC Gazyva 1L iNHL (GALLIUM) Alecensa 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. 43 Compound Indication Milestone US 28 Feb; EU Gazyva MabThera/Rituxan-refractory iNHL US/EU approval May 2016: Key late-stage news flow venetoclax R/R CLL US approval March ocrelizumab RMS/PPMS US/EU filing Q2 Regulatory atezolizumab Bladder US approval Sep launch atezolizumab 2/3L NSCLC US approval Oct launch Compound Indication Milestone Gazyva MabThera/Rituxan-refractory iNHL US/EU approval Alecensa 2L ALK+ NSCLC EU approval Q4 venetoclax R/R CLL US approval Avastin Relapsed Platinum-sensitive OC US/EU filing ocrelizumab RMS/PPMS US/EU filing lebrikizumab Moderate to severe asthma Ph III LAVOLTA I/II Feb ATS Regulatory atezolizumab Bladder cancer US approval atezolizumab 2/3L NSCLC Ph III OAK Q3 WCLC atezolizumab 2/3L NSCLC US approval Gazyva Front-line aNHL Ph III GOYA (interim) Mid July ASH Alecensa 2L ALK+ NSCLC EU approval Perjeta Adjuvant HER2+ BC Ph III APHINITY Q1 17 SABCS lebrikizumab Severe asthma Ph III LAVOLTA I/II Perjeta 2L HER2+ mBC Ph III PHEREXA ASCO atezolizumab 2/3L NSCLC Ph III OAK Phase III Kadcyla Neoadjuvant HER2+ BC Ph III KRISTINE (5% sucess) Feb ASCO readouts* Gazyva Front-line aNHL Ph III GOYA Gazyva Front-line iNHL Ph III GALLIUM (interim) Late May ASH Phase III readouts* Perjeta + Herceptin Adjuvant HER2+ BC Ph III APHINITY Perjeta 1L mGC Ph III JACOB (interim OS) June/July Actemra Giant cell arthritis Ph III GiACTA Actemra Giant cell arthritis Ph III GIACTA Q3 ACR Alecensa 1L ALK+ NSCLC Ph III ALEX Alecensa 1L ALK+ NSCLC Ph III ALEX (PFS) Sep lebrikizumab Atopic dermatitis Ph II TREBLE, ARBAN venetoclax R/R CLL Ph III MURANO Q4 atezolizumab Bladder cancer Ph II IMvigor 210 (1L cohort) Zelboraf Adjuvant melanoma Ph III BRIM8 Q4 Phase II readouts* atezolizumab + Avastin 1L Renal cancer Ph II IMmotion 150 atezolizumab + Avastin 1L RCC Ph II IMmotion ASCO venetoclax R/R FL (iNHL) Ph II CAVALLI lebrikizumab Atopic dermatitis Ph II venetoclax 1L aNHL Ph II CONTRALTO venetoclax R/R FL (iNHL) Ph I/II CAVALLI ASCO ipatasertib Gastric/prostate cancers Ph II MARTIN, JAGUAR ESMO?/ASCO polatuzumab + R/G-CHP 1L aNHL Ph I/II (Ph2 expansion?) ASCO/ASH polatuzumab + R/G-CHP NHL Ph II ROMULUS ASCO/ASH * Outcome studies are event driven, timelines may change 44 Phase II readouts* vanucizumab CRC Ph II McCAVE taselisib Neoadjuvant (1L) TNBC Ph II LORELEI SABCS atezolizumab Bladder Ph II Imvigor 210 (1L cohort) ASCO SERD ER+/HER2- mBC Ph II SABCS lifastuzumab vediotin Platinum-sensitive OC Ph II venetoclax 1L aNHL Ph II CONTRALTO ASH Diagnostics Division Roland Diggelmann COO Roche Diagnostics
45 2015: Diagnostics sales Strong sales performance
2015 2014 Change in % CHFm CHFm CHF CER Diagnostics Division 10,814 10,766 0 6 Professional Diagnostics 6,175 6,045 2 8 Diabetes Care 2,128 2,392 -11 -3 Molecular Diagnostics 1,719 1,613 7 10 Tissue Diagnostics 792 716 11 12
CER=Constant Exchange Rates; Underlying growth of Molecular Diagnostics excluding Sequencing business: +7% 46
Roche outgrowing the market in a challenging environment
Quarterly growth (%)
8% FY 2015: 6%
7%
6% • Worldwide IVD market leader
5% • Strong commercial presence 4% • Broadest test menu 3%
2% Market 1% Roche 0% Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 * 2014 2015
47 Sources: 3rd party IVD consultancy, Analyst reports, Roche Analysis; *Q4 2015 market growth is an estimate 2015: Diagnostics regional sales Growth driven by APAC and EMEA
Japan North America 0% +3% EMEA1 4% of divisional sales 26% of divisional sales +4% 42% of divisional sales
Asia Pacific Latin America +15% +11% 21% of divisional sales 7% of divisional sales
14% growth in E7 countries2
1Europe, Middle East and Africa; 2Brazil, China, India, Mexico, Russia, South Korea, Turkey 48 All growth rates at Constant Exchange Rates 2015: Diagnostics highlights Growth driven by Professional Diagnostics
YoY CER growth
Professional +8% Dia • Growth driven by immunodiagnostics (+13%)
Diabetes • Decline in blood glucose monitoring (-4%), -3% Care insulin delivering systems (+8%)
Molecular +10% • Virology (+14%) incl. HPV (+27%) Dia1
Tissue EMEA Dia +12% North America • Advanced staining portfolio (+11%) RoW
CHFbn 0 2 4 6 8
1 Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +7% 49 CER=Constant Exchange Rates; EMEA=Europe, Middle East and Africa 2015: Diagnostics Division Profitability impacted by investments in sequencing*
2015 2015 vs. 2014 CHFm % sales CER growth Sales 10,814 100.0 6%
Royalties & other op. inc. 139 1.3 5% Cost of sales -4,806 -44.5 7% M & D -2,544 -23.5 9% R & D -1,198 -11.1 18% G & A -458 -4.2 -9%
Core operating profit 1,947 18.0 -2% -7% in CHF
CER=Constant Exchange Rates; * Sequencing investments refer to the acquisitions of Genia, Ariosa, Bina and Signature Diagnostics 50 Immunodiagnostics: 15 years of consecutive double digit growth
CHFbn 3.5 +13% Continuous extension 3.0 • 100+ assays 2.5 • Largest installed instrument base • Mfc capacity expansion in 2015 2.0 1.5 Outlook • Launch of cobas e801 instrument: 1.0 Double throughput with same footprint 0.5 • New reagent plant in China
0.0 2000 2015
51 All growth at CER=Constant Exchange Rates Elecsys Troponin T high sensitive (TnT-hs) Safe and effective AMI* rule-in and rule-out in 1 hour**
Rule-in ? TRAPID -AMI Rule-out Observation
Reduces diagnosis time to 1h in 76-78% of acute chest pain patients
Conventional assays 6 hours
High sensitive assays 3 hours
TnT-hs One-hour algorithm 1 hour
Enables faster treatment decisions and reduced ER waiting times
* AMI: acute myocardial infarction; ** 1 hour refers to time for analysis between two samples 52 References: 1. Mueller, C. et al (2015) : Ann Emerg Med. 10.1016/j.annemergmed.2015.11.013 http://www.annemergmed.com/article/S0196-0644(15)01501-2/fulltext.. 2.Reichlin et al (2012). Arch Intern Med 172:1211-1218. Molecular Diagnostics: cobas 6800/8800 US launch of instruments and viral load tests*
Blood Screening Virology Menu Expansion
• MPX (HIV, HCV, HBV) • HIV-1 • HPV • West Nile Virus • Hepatitis B • CT/NG • DPX (B19 & HAV) • Hepatitis C • HIV 1/2 Qualitative • Hepatitis E • CMV • MTB/MAI & RIF/INH
• Fully automated PCR systems • Highest throughput (3x above closest competitor) • Highest walk-away time to cobas 8800 cobas 6800 increase lab efficiency
* US approved tests for cobas 6800/8800: HBV, HCV and HIV-1 53 Tissue Diagnostics: Launch of VENTANA HE 600 Potential to change standard of care in H&E* staining
• Latest platform with individual slide staining technology, avoids sample cross contamination • Platform features: – Highest result quality and reproducibility – Highest test capacity and most efficient workflow – Easy and safe to operate
* hematoxylin and eosin tissue staining 54 Diabetes Care: Challenging US market Launch of innovative products in 2016
Challenges in 2015: • US: Spillover effect of Medicare prices to private sector
Opportunities in 2016: • Product launches – Accu-Chek Guide: New blood glucose monitoring device with universal test strip for improved accuracy Accu-Chek Guide – Accu-Chek Insight CGM*: New sensor technology • Growth prospect – Insulin Delivery Systems: Sustaining current growth momentum Accu-Chek Insight CGM
55 * CGM: Continuous glucose monitoring Key launches 2015
Area Product Market BA1 cobas c 513 – dedicated HbA1C analyzer EU RPD cobas t 411– core lab coagulation analyzer EU RPD Laboratory cobas 8100 V2 – Integrated pre- and post-analytical solution WW RPD cobas 6800/8800 – Medium to High volume automated real-time PCR US RMD Instruments / VENTANA HE 600 – automated H&E staining platform WW RTD Devices Accu-Chek Active no-code– next-gen. bG meter, no coding of test strips Diabetes WW RDC – bG meter with connectivity to smartphones, mobile Care Accu-Chek Connect US RDC applications and cloud Point of Care CoaguChek Pro II - professional system for PT and aPTT testing EU RPD Blood cobas 6800/8800 MPX – Multiplex Bloodscreening test US RMD Screening * Infectious cobas Liat Influenza A/B + RSV – POC detection US * RMD Diseases HTLV– human T-lymphotropic virus diagnostics test EU RPD cobas 6800/8800 HBV – Quantitative HBV viral load test Tests / EU RMD cobas 4800 HIV-1 - Quantitative HIV viral load test EU RMD Assays Virology cobas 4800 HCV – Quantitative HCV viral load test EU RMD cobas 4800 HBV – Quantitative HBV viral load test EU RMD Genomics & cobas EGFR Test v2 - detection of EGFR in plasma EU RMD Oncology 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; 56 RTD: Roche Tissue Diagnostics; * Submitted to FDA Key launches 2016
Area Product Market
Central cobas 8000
Virology cobas 6800/8800 HIV Qual – early Infant Diagnosis and Confirmatory HIV Test EU HPV / cobas 6800/8800 CT/NG – fully automated solution for screening and diagnosis of Chlamydia EU Microbiology trachomatis and Neisseria gonorrhoeae in symptomatic & asymptomatic patients cobas Liat Influenza A/B plus RSV (CLIA) – automated multiplex real time RT-PCR Tests / Point of Care assay for qualitative detection and discrimination of Influenza A virus, Influenza B virus and respiratory US Assays syncytial virus (RSV) Sequencing ctDNA oncology panels – liquid biopsy for circulating tumor DNA for cancer therapy selection US Companion PD-L1 (SP142) for Bladder Cancer* – companion diagnostic for atezolizumab US Diagnostics PD-L1 (SP142) for NSCLC* – companion diagnostic for atezolizumab US
* achieve commercial readiness, dependent on Pharma label and approval 57 Finance Alan Hippe Chief Financial Officer
58 2015: Highlights
Business
• Strong sales growth of +5%1 and Core EPS growth +7%1 excluding filgrastim2 • Core operating profit up +5%1, excluding filgrastim2 +7%1 • Dividend in Swiss franc and payout ratio further increased
Cash flow
• Cash generation remains strong (Op. FCF of CHF 14.9bn) despite expanding manufacturing network and investments in intangible assets • Accounts receivable in Southern Europe further decreased
Debt restructuring
• Attractive financing conditions in capital markets used for major debt restructuring – Total major restructuring of USD 0.9bn and EUR 0.4bn in 2015 • Lower interest expenses of CHF 61m despite average gross debt of CHF 24bn in 2015 vs. CHF 21bn in 2014
1 At Constant Exchange Rates (CER); 2 Excluding sale of filgrastim rights in 2014 59 2015: Group performance Core EPS growth +4%, +7% excluding filgrastim*
2015 2014 Change in % Excl. CHFm CHFm CHF CER filgrastim* Sales 48,145 47,462 1 5 Core operating profit 17,542 17,636 -1 5 7 as % of sales 36.4 37.2 Core net income 11,837 12,533 -6 1 4 as % of sales 24.6 26.4 Core EPS (CHF) 13.49 14.29 -6 4 7 IFRS net income 9,056 9,535 -5 4
Operating free cash flow 14,872 15,778 -6 -7 as % of sales 30.9 33.2 Free cash flow 3,352 5,322 -37 -41 as % of sales 7.0 11.2
CER=Constant Exchange Rates; * Excluding sale of filgrastim rights in 2014 60 2015: Group operating performance Core OP growth +5%, +7% excluding filgrastim
2015 2015 vs. 2014 CHFm % sales CER growth Sales 48,145 100.0 5%
Royalties & other op. inc. 2,258 4.7 -10% Cost of sales -12,706 -26.4 7% M & D -8,610 -17.9 5% R & D -9,332 -19.4 5% G & A -2,213 -4.6 -12%
Excl. filgrastim* Core operating profit 17,542 36.4 5% +7% -1% in CHF
CER=Constant Exchange Rates; * Excluding sale of filgrastim rights in 2014 61
2015: Strong Core operating profit and margin
CHFm 44.4% 43.6% 43.0% +0.7 %p2 +1.4 %p2 % of sales 38.3% 37.2% 36.4% +0.2%p1 -0.2%p1 (-0.6%p) (-0.8%p) +5%1 (-1%) +5%1 20.8% (0%) 19.5% 18.0% 17,904 17,636 17,542 16,108 16,001 16,055 -1.4%p1 (-1.5%p)
-2%1 (-7%) 2013 2014 2015 2,177 2,096 1,947 Roche Group Pharma Division Diagnostics Division
1 At CER=Constant Exchange Rates; 2 Excluding sale of filgrastim rights in 2014 62 2015: Core net financial result Net financial expense up vs. prior year due to higher FX losses and lower income from equities CHFm
2015 with 27% CHF / 26% CER higher net financial expense -1,116 -1,416 +61 -281 +136 -212 -4
2014 Net losses Interest FX G/L Net income All other, 2015 on debt expense from equity net redemption securities CER=Constant Exchange Rates 63 2015: Group Core tax rate Relative higher Core profits in US
Figures in % +2.5
Relative higher Core profits in US and other
26.6 24.1
2014 Profit mix and other 2015
64 Balance sheet 31 December 2015
CHFbn % change in CER % change in CER vs 31/12/14 vs 31/12/14 75.5 75.8 +4% 75.5 75.8 +4% Cash and 11.7 9.2 marketable 15% 12% -15% Current 23.1 23.8 +6% securities liabilities 30% 31% 19.0 Other 19.4 +4% 25% current 26% assets 30.8 28.7 -4% Non-current 41% 38% Net debt/ liabilities total assets: Non-current 44.4 47.6 +10% 19% assets 59% 63% Equity 21.6 23.3 (Net assets) 29% 31% +14%
31/12/14Assets31/12/15 31/12/14Equity & liabilities31/12/15
CER=Constant Exchange Rates 65 2015: Operating free cash flow and margin
41.3% 40.4% 38.8% 35.0% 33.2% 30.9% -3.8%p1 (-2.3%p) 18.7% CHFm 1 13.2% -7% 8.9% (-6%) 16,381 15,778 • Capex driven by expanding 14,872 14,976 14,821manufacturing14,482 network
• Investments in intangible assets
963 2013 2014 2015 1,962 1,417 Roche Group Pharma Division Diagnostics Division
1 At CER=Constant Exchange Rates 66 2015: Accounts receivable in Southern Europe further decreased
176 Dec 2015 161 CCC- Greece 185 Dec 2014 251 236 Dec 2013 103 Dec 2012 97 Dec 2011 BB Portugal 114 163 209 390 433 BBB- Italy 733 819 980 322 480 BBB Spain 613 604 1,036
Southern 991 1,171 -60% European 1,645 1,836 Countries 2,462
0 500 1,000 1,500 2,000 2,500 CHFm
Sovereign country ratings from Standard & Poor’s, as of 6 Jan 2016 67 2015: Group net debt development Net debt stable vs. 2014
CHFbn Free Cash Flow CHF 3.4bn vs. 5.3bn in 2014
0
-11.5 -14.0 +14.9 -14.1
Dividends -7.0 Taxes -3.7 -3.5 Treasury -0.8 Business combinations -2.1 Currency translation, other -1.4
Net debt Operating Free Non-op. Business combinations, Net debt 31 Dec 2014 Cash Flow FCF Currency translation 31 Dec 2015 & other 68 Exchange rate impact on sales growth Negative impact from EUR, LATAM and Europe more than offsetting positive impact of USD
+2.3p -0.1p -0.3p -0.7p -1.0p
-1.4p
-2.7p
CER +5.3% CHF sales sales growth growth 2015 2015 vs. +1.4% vs. 2014 2014 CER USD As-Pac Other JPY Other LATAM EUR CHF Europe
CER = Constant Exchange Rates (avg full year 2014) 69 Currency impact in 2015/2016
CHF / USD Average In 2015 impact1 is (%p): YTD 2015 0.96 Average 0.95 0.95 Q1 HY Sep FY YTD 0.95 2014 YTD 5% 7% +1% 6% 0.91 Sales -2 -3 -4 -4 +1% 6% 0.89 0.90 0.89 Core 0.95 0.93 0.98 0.96 0.93 0.93 0.95 0.97 0.97 0.97 1.01 0.99 operating -4 -6 Monthly avg fx rates 2015 Fx rates at 31 Dec 2015 J F M A M J J A S O N D profit Core EPS -7 -10 CHF / EUR 1.22 1.22 1.22 1.21
-12% -13% -13% -12% In 2016 currency impact1 expected is 1.06 +2%1.08 +2% 1.07 (based on 31 Dec 2015 FX rates): 1.06 • No FX impact on sales 1.10 1.06 1.06 1.04 1.04 1.05 1.05 1.08 1.09 1.09 1.08 1.08 • -2%p on Core OP and up to -5%p on J F M A M J J A S O N D Core EPS
1 On Group growth rates 70 2016 outlook
Group sales growth1 Low to mid-single digit
Core EPS growth1 Ahead of sales growth
Dividend outlook Further increase dividend in Swiss francs
1 At Constant Exchange Rates (CER) 71
Changes to the development pipeline Q4 2015 update New to Phase I New to Phase II New to Phase III New to Registration 7 NMEs transitioned from Ph0 1 AI 1 NME transitioned from Ph1 2 NMEs transitioned from Ph2 RG4929 NME – glaucoma RG7159 obinutuzumab – lupus RG7388 idasanutlin – AML RG7446 atezolizumab – bladder RG7834 NME – HBV nephritis 1 NME transitioned from Ph2 cancer 2L RG7461 FAP IL2v FP – solid tumors 1 opt-in deal signed RG6013 emicizumab (FIXa/FX RG7601 venetoclax – CLL rel/ref RG7916 SMN2 (2) splicer – SMA PRO VAP-1 inh – inflammatory bispecific MAb) – hemophilia A RG7845 BTK ihn - autoimmune diseases diseases RG7861 NME – infectious diseases 1 AI transitioned from Ph2 RG7992 NME – metabolic diseases RG1569 Actemra – systemic 1 NME following Adheron acquisition sclerosis RG6125 Cadherin-11 MAb - RA 4 AIs RG7159 obinutuzumab – hypersensitized renal transplant RG7159 Gazyva multiple combos - heme indications RG3616 Erivedge + Esbriet – IPF RG7446 atezolizumab combo Kadcyla/ Herceptin+Perjeta – HER2+ breast cancer
Removed from Phase I Removed from Phase II Removed from Phase III Removed from Registration 2 NMEs 1 NME 1 AI 1 NME following approval in RG7450 anti-Steap 1 ADC – prostate ca. RG7599 lifastuzumab vedotin – Pt- RG3502 Kadcyla – HER2+ EU/US RG7689 NME – infectious diseases resistant ovarian cancer gastric cancer 2L RG7421 Cotellic+Zelboraf – metastatic melanoma 73 Status as of January 28, 2016 Roche Group development pipeline Phase I (40 NMEs + 17 AIs) Phase II (18 NMEs + 13 Als) RG6016 LSD1 inh AML RG3616* Erivedge+Esbriet IPF RG3502 Kadcyla HER2+ NSCLC RG6047 SERD (2) ER+(HER2-neg) mBC RG6069 - fibrosis RG6046 SERD ER+(HER2-neg) mBC RG6061 HIF1 alpha LNA solid tumors RG6125 Cadherin-11 MAb RA RG7155 emactuzumab PVNS/solid tumors RG6078 IDO inh solid tumors RG7159 obinutuzumab renal transplant RG7221 vanucizumab mCRC RG6078 IDO inh + atezolizumab solid tumors RG7625 Cat-S antag autoimmune diseases RG7421 Cotellic+paclitaxel TNBC RG7116 lumretuzumab mBC RG7880 IL-22Fc inflammatory diseases RG7440 ipatasertib solid tumors RG7155 emactuzumab + atezolizumab s. tumors RG7845 BTK inh autoimmune diseases RG7446 atezolizumab NSCLC 2/3L RG7159 Gazyva multiple combos heme indications RG6024 Flu B MAb influenza B RG7596 polatuzumab vedotin heme tumors RG7304 Raf & MEK dual inh solid tumors RG6080 DBO β-lactamase inh bact. infections RG7601 venetoclax DLBCL RG7386 FAP-DR5 biMAb solid tumors RG7834 - HBV RG7601 venetoclax+Rituxan FL rel/ref RG7446 atezolizumab solid tumors RG7861 - infectious diseases RG7604 taselisib NSCLC sq 2L RG7446 atezo+Zelboraf+/-Cotellic melanoma RG7944 therapeutic vaccine HBV RG7604 taselisib ER+(HER2-neg) BC neoadj RG7446 atezo+Avastin+chemo solid tumors RG7992 - metabolic diseases RG7686 codrituzumab liver cancer RG7446 atezolizumab+Cotellic solid tumors RG6029 Nav1.7 inh (2) pain RG3637 lebrikizumab +/- Esbriet IPF RG7446 atezolizumab+ipi/IFN solid tumors RG7893 Nav1.7 inh pain RG3637 lebrikizumab atopic dermatitis RG7446 atezo+Tarceva /Alecensa NSCLC RG7800 SMN2 splicer spinal muscular atrophy RG3637 lebrikizumab COPD RG7446 atezolizumab+Gazyva lymphoma RG7916 SMN2 splicer(2) spinal muscular atrophy RG7159 obinutuzumab lupus nephritis RG7446 atezo+lenalidomide multiple myeloma RG7935 a-synuclein MAb Parkinson's Disease CHU nemolizumab (IL-31R) atopic dermatitis RG7446 atezolizumab + K/HP HER2+ BC IONIS ASO Huntington’s Disease CHU nemolizumab (IL-31R) pruritus dialysis pts RG7461 FAP IL2v FP solid tumors CHU PTH1 recep. ago hypoparathyroidism PRO VAP-1 inh inflammatory diseases RG7597 duligotuzumab + Cotellic solid tumors PT CHU - hyperphosphatemia RG7227 danoprevir HCV RG7601 venetoclax heme indications RG4929 - glaucoma RG7745 Flu A MAb influenza A RG7601 venetoclax+Gazyva CLL RG7795 TLR7 agonist HBV RG7741 ChK1 inh solid tum & lymphoma CHU URAT1 inh gout RG7775 MDM2 (4) IV prodrug AML RG1662 basmisanil Down syndrome RG7802 CEA CD3 TCB+atezolizumab s. tumors New Molecular Entity (NME) RG6083 olesoxime spinal muscular atrophy
RG7813 CEA IL2v FP+atezolizumab solid tumors Additional Indication (AI) RG7090 basimglurant TRD RG7828 CD20/CD3 biMAb heme tumors Oncology RG7314 V1 receptor antag autism RG7841 anti-Ly6E ADC solid tumors Immunology RG7412 crenezumab Alzheimer’s RG7842 ERK inh + Cotellic solid tumors Infectious Diseases RG3645 ranibizumab PDS wAMD RG7876 CD40 MAb+atezolizumab solid tumors CardioMetabolism RG7716 VEGF-ANG2 biMAb wAMD Neuroscience RG7882 ADC ovarian ca Ophthalmology RG7888 OX40 MAb solid tumors Other RG7888RG7986 OX40 MAb + atezolizumab solid tumors RGCLL- No Roche/Genentech managed RG7986 ADC r/r NHL CHU Chugai managed IONIS IONIS managed 74 Status as of January 28, 2016 PRO Proximagen managed
Roche Group development pipeline
Phase III Registration (9 NMEs + 30 Als) (3 NMEs + 3 Als) RG435 Avastin glioblastoma 1L RG105 MabThera pemphigus vulgaris RG105 MabThera SC CLL RG435 1 Avastin rel. ovarian ca. Pt-sensitive RG1569 Actemra giant cell arteritis RG435 2 Avastin+Tarceva EGFR mut+ NSCLC RG1273 Perjeta+Herceptin HER2+ mBC 2L RG1569 Actemra systemic sclerosis RG7159 Gazyva iNHL rituximab-refractory RG1273 Perjeta+Herceptin HER2+ BC adj RG3637 lebrikizumab severe asthma RG7446 3 atezolizumab bladder cancer 2L RG1273 Perjeta+Herceptin HER2+gastric ca 1L RG7413 etrolizumab ulcerative colitis RG7601 venetoclax CLL rel/ref RG3502 Kadcyla HER2+ BC adj RG7413 etrolizumab Crohn’s disease RG7853 4 Alecensa (alectinib) ALK+ NSCLC 2L RG3502 Kadcyla + Perjeta HER2+ BC adj CHU Actemra large-vessel vasculitis RG3502 Kadcyla + Perjeta HER2+ BC neoadj CHU IL-6R MAb neuromyelitis optica 1 Global filing RG7159 Gazyva DLBCL1L RG1450 gantenerumab Alzheimer’s 2 EU only RG7159 Gazyva follicular lymphoma 1L RG1594 ocrelizumab RMS 3 Phase 3 ongoing RG7204 Zelboraf melanoma adj RG1594 ocrelizumab PPMS 4 Approved in the US and Japan
RG7446 atezolizumab NSCLC 2L RG7417 lampalizumab geographic atrophy RG7446 atezolizumab+chemo NSCLC non-sq. 1L 1L NSC RG7446 atezo+chemo+Avastin NSCLC non-sq. 1L RG7446 atezolizumab+chemo NSCLC sq. 1L New Molecular Entity (NME) RG7446 atezolizumab Dx+ NSCLC sq. 1L Additional Indication (AI) RG7446 atezolizumab Dx+ NSCLC non-sq. 1L Oncology RG7446 atezolizumab Dx+ NSCLC adj Immunology RG7446 atezolizumab+abraxane TNBC Infectious Diseases RG7446 atezolizumab+Avastin RCC CardioMetabolism RG7446 atezolizumab muscle inv. bladder ca adj Neuroscience RG7601 venetoclax+Rituxan CLL rel/ref Ophthalmology RG7601 venetoclax+Gazyva CLL 1L Other RG7604 taselisib ER+(HER2-neg) mBC RG6013 emicizumab (FIXa/FX biMAb)hemophilia A RG-No Roche/Genentech managed CHU Chugai managed RG7388 idasanutlin AML ISIS ISIS managed RG7853 Alecensa (alectinib) ALK+ NSCLC 1L PRO Proxymagen 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 75 Status as of January 28, 2016 NME submissions and their additional indications
basmisanil GABRA5 NAM Projects currently in phase II and III Down syndrome atezolizumab (RG7446) V1 receptor antag (RG7314) + abraxane TNBC autism
idasanutlin atezolizumab (RG7446) crenezumab (RG7412) AML NSCLC adj (Dx+) Alzheimer‘s
New Molecular Entity taselisib ( RG7604) atezolizumab (RG7446) gantenerumab (RG1450) ER+(HER2NSCLC-neg) sq BC 2L neoadj MIBC adj Alzheimer‘s Oncology Immunology taselisibSERD (RG6046) ( RG7604) atezolizumab(RG7446) lebrikizumab (RG3637) Infectious Diseases ER+(HER2ER+(HER2-neg)-neg) BC mBC neoadj NSCLC sq 1L (Dx+) COPD CardioMetabolism Neuroscience emactuzumabSERD (RG6046) (RG7155) atezolizumab(RG7446) lebrikizumab (RG3637) Ophthalmology PVNSER+(HER2 and solid-neg) tumors mBC NSCLC non-sq 1L (Dx+) atopic dermatitis Other emactuzumabvanucizumab (RG7221)(RG7155) atezolizumab(RG7446)+ lebrikizumab+/-Esbriet PVNScolorectal and solid cancer tumors chemo NSCLC sq 1L (RG3637) IPF
vanucizumabipatasertib (RG7221) atezolizumab(RG7446)+ etrolizumab (RG7413) (RG7440)colorectal solid cancer tumors chemo NSCLC non-sq 1L Crohn’s disease
ocrelizumab (RG1594) polatuzumabipatasertib vedotin (RG7596) atezolizumab(RG7446)+chemo etrolizumab (RG7413) PPMS (RG7440)heme solid tumors tumors + Avastin NSCLC non-sq 1L ulcerative colitis
ocrelizumab (RG1594) olesoxime (RG6083) polatuzumab vedotin (RG7596) Cotellic+paclitaxel TLR7 ago (RG7795) RMS SMA heme tumors TNBC HBV
lebrikizumab (RG3637) venetoclax+Rituxan taselisib (RG7604) venetoclax (RG7601) danoprevir (RG7227) severe asthma (RG7601) CLL rel/refractory HER2 neg ER+ mBC + Rituxan FL rel/ref CLL HCV venetoclax (RG7601) ✓ atezolizumab(RG7446) atezolizumab(RG7446) codrituzumab venetoclax (RG7601) Flu A MAb (RG7745) CLL rel/ref NSCLC 2/3L combo Avastin RCC MAb (RG7686) liver cancer + Gazyva CLL 1L influenza
Alecensa (alectinib) ✓ atezolizumab US* ✓ emicizumab FIXa /FX biMAb lampalizumab (RG7417) venetoclax (RG7601) VEGF/ANG2 biMAb(RG7716) Alk+ NSCLC 2L bladder cancer 2L (RG6013) hemophilia A geographic atrophy DLBCL wAMD 2015 2016 2017 2018 and beyond Unless stated otherwise, submissions are planned to occur in US and EU 76 ✓Indicates a submission which has occurred with regulatory action pending * EU submission pending Status as of January 28, 2016 Submissions of additional indications for existing products Projects currently in phase II and III
Avastin (US) Kadcyla GBM HER2-pos. NSCLC
Kadcyla+Perjeta Kadcyla+Perjeta HER2-pos. BC neoadj. HER2-pos. BC adj.
Avastin Kadcyla rel. ovarian ca. Pt-sens.* HER2-pos. BC adj.
Gazyva Alecensa (alectinib)1L obinutuzumab DLBCL 1L Alk+ NSCLC lupus nephritis
Perjeta + Herceptin Zelboraf MabThera HER2-pos. mBC 2L melanoma adj. pemphigus vulgaris
Gazyva Perjeta + Heceptin Gazyva Actemra iNHL rituximab-ref. ✓ HER2-pos. BC adj. follicular lymphoma 1L systemic sclerosis
Avastin +Tarceva (EU) ✓ Actemra Perjeta+Herceptin ranibizumab PDS (US) EGFR mut+ NSCLC giant cell arteritis HER2-pos. gastric cancer 1L wAMD 2015 2016 2017 2018 and beyond
✓ Indicates submission to health authorities has occurred * Approved in EU Oncology Neuroscience Unless stated otherwise, submissions are planned to occur in US and EU. Immunology Ophthalmology Infectious Diseases Other CardioMetabolism NME 77 Status as of January 28, 2016 Major granted and pending approvals 2015
Approved Pending approvals
Cotellic + Zelboraf m. melanoma November 2015
Alecensa (alectinib) venetoclax ALK+ NSCLC 2L CLL rel/ref December 2015 Filed October 2015 US Lucentis atezolizumab Gazyva diabetic retinopathy bladder cancer 2L iNHL rituximab-ref. February 2015 Filed January 2016 Filed August 2015
Avastin Alecensa (alectinib) Avastin + Tarceva cervical cancer ALK+ NSCLC 2L EGFR mut+ NSCLC EU April 2015 Filed September 2015 Filed July 2015
Perjeta MabThera SC HER2+ BC neoadj. CLL July 2015 Filed November 2014
Cotellic + Zelboraf Gazyva m. melanoma iNHL rituximab-ref. November 2015 Filed September 2015
Japan-Chugai Xeloda Avastin gastric cancer adj. cervical cancer November 2015 Filed September 2015
Bonviva osteoporosis (oral) January 2016 Oncology Neuroscience Immunology Ophthalmology Infectious Diseases Other CardioMetabolism NME 78 Status as of January 28, 2016 Roche Group Development pipeline Combinations
Phase I Phase II Registration (5 NMEs + 14 AIs) (3 Als) (1 AI)
RG6078 IDO inh + atezolizumab solid tumors RG7421 Cotellic+paclitaxel TNBC RG435 1 Avastin+Tarceva EGFR mut+ NSCLC RG7155 emactuzumab + atezolizumab s.tumors RG7601 venetoclax + Rituxan FL rel/ref TNBC RG7159 Gazyva multiple combos heme indications RG3637 lebrikizumab +/- Esbriet IPF 1 EU only RG7446 atezo+Zelboraf+/-Cotellic melanoma RG7446 atezo+Avastin+chemo solid tumors RG7446 atezolizumab +Cotellic solid tumors Phase III RG7446 atezolizumab +ipi/IFN solid tumors (12 AIs) RG7446 atezo+Tarceva/ Alecensa NSCLC
RG7446 atezolizumab+Gazyva lymphoma RG1273 Perjeta+Herceptin HER2+ mBC 2L RG7446 atezo+lenalidomide multiple myeloma RG1273 Perjeta+Herceptin HER2+ BC adj RG7446 atezolizumab + K/ H+P HER2+BC RG1273 Perjeta+Herceptin HER2+gastric ca 1L RG7597 duligotuzumab+Cotellic solid tumors RG3502 Kadcyla + Perjeta HER2+ BC adj RG7601 venetoclax+Gazyva CLL RG3502 Kadcyla + Perjeta HER2+ BC neoadj RG7802 CEA CD3 TCB+atezolizumab s. tumors RG7446 atezo+chemo NSCLC non-sq. 1L RG7813 CEA IL2v FP+atezolizumab s. tumors NSC RG7446 atezo+chemo+Avastin NSCLC non-sq. 1L RG7842 ERK inh + Cotellic solid tumors RG7446 atezolizumab+chemo NSCLC sq. 1L RG7876 CD40 MAb+atezolizumab s. tumors RG7446 atezolizumab+abraxane TNBC RG7888 OX40 MAb + atezolizumab s. tumors RG7446 atezolizumab+Avastin RCC RG3616* Erivedge+Esbriet IPF RG7601 venetoclax+Rituxan CLL rel/ref New Molecular Entity (NME) Additional Indication (AI) RG7601 venetoclax+Gazyva CLL 1L Oncology Immunology RG-No Roche Genentech managed
79 Status as of January 28, 2016 Cancer immunotherapy pipeline overview
Phase I Phase II Registration (7 NMEs+16 AIs) (1 NME + 1 Al) (1 NME)
RG6078 IDO inh solid tumors RG7155 emactuzumab PVNS/solid tumors RG7446 atezolizumab bladder cancer 2L RG6078 IDO inh + atezolizumab solid tumors RG7446 atezolizumab NSCLC 2/3L RG7155 emactuzumab + atezolizumab s.tumors RG7446 atezolizumab solid tumors RG7446 atezo+Zelboraf+/-Cotellic m. melanoma RG7446 atezo+Avastin+chemo solid tumors RG7446 atezolizumab +Cotellic solid tumors RG7446 atezolizumab +ipi/IFN solid tumors RG7446 atezo+Tarceva NSCLC EGFR+ RG7446 atezolizumab+Gazyva lymphoma RG7446 atezo+lenalidomide multiple myeloma Phase III RG7446 atezolizumab + K/HP HER2+ BC (10 AIs) RG7461 FAP IL2v FP solid tumors RG7802 CEA CD3 TCB + atezolizumab s. tumors RG7446 atezo+chemo NSCLC non-sq. 1L RG7813 CEA IL2v FP+atezolizumab solid tumors NSC RG7446 atezo+chemo+Avastin NSCLC non-sq. 1L RG7828 CD20/CD3 biMAb hem tumors RG7446 atezolizumab+chemo NSCLC sq. 1L RG7876 CD40 MAb+atezolizumab solid tumors RG7446 atezolizumab Dx+ NSCLC sq. 1L RG7888 OX40 MAb solid tumors RG7446 atezolizumab Dx+ NSCLC non-sq. 1L RG7888 OX40 MAb + atezolizumab solid tumors RG7446 atezolizumab NSCLC 2L New Molecular Entity (NME) Additional Indication (AI) *INCB atezolizumab + IDO inh solid tumors RG7446 atezolizumab Dx+ NSCLC adj *CDX atezolizumab +varlilumab solid tumors RG7446 atezolizumab+abraxane TNBC Oncology *CO atezo+rociletinib EGFRmut+ NSCLC RG7446 atezolizumab+Avastin RCC *CPI atezo+A2Ai solid tumors RG7446 atezolizumab muscle inv. bladder ca adj RG-No Roche Genentech managed
* External collaborations: INCB- Incyte INCB024360, CDX-1127- Celldex CD27 MAb; CO – Clovis CO-1686 CPI – Corvus CPI-444 80 Status as of January 28, 2016 Doing now what patients need next