Performance and pipeline update

Transcription

1 Performance and pipeline update Dr. Bruno Eschli, IR Officer Dr. Sabine Borngräber, IR Officer Kepler Cheuvreux Swiss Conference Zürich, March 22 nd, 2016

2 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 All mentioned trademarks are legally protected. 2

3 2015 group results Pharma update Appendix 3

4 2015: Highlights Growth Sales Profit Group sales +5% 1 driven by HER2 franchise (+19%), Avastin (+9%), Esbriet (n.m.), Actemra (+23%) and Professional Diagnostics (+8%) +7% Core EPS growth 1,2 driven by strong underlying business Innovation Oncology Hematology Neuroscience 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 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 Ocrelizumab: Phase III in RMS (OPERA I/II) and PPMS (ORATORIO) 1 At constant exchange rates (CER); 2 Excluding sale of filgrastim rights in

5 2015: Strong sales growth in both divisions Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division Diagnostics Division Roche Group CER=Constant Exchange Rates 5

6 2015: Strong sales growth in all regions CHFbn 21 +5% 18 +1% % +13% +3% +2% +6% Diagnostics Pharma % 0% +5% +4% +6% Japan International Europe US All growth rates are YoY at Constant Exchange Rates (CER) 6

7 2015: Strong underlying Group Core operating profit & margin CHFbn 35.6% 15.1 % of sales 37.7% 38.3% 37.2% 36.4% (+0.7%*) +5% at CER (+7%*) CER=Constant Exchange Rates; * Excluding sale of filgrastim rights in

8 2015: Operating free cash flow and margin 35.0% 33.2% 30.9% 41.3% 40.4% 38.8% CHFm 16,381 15,778-7% 1 (-6%) -3.8%p 1 (-2.3%p) 14,872 14,976 14,821 14, % Capex driven by expanding manufacturing network 13.2% 8.9% Investments in intangible assets ,962 1,417 Roche Group Pharma Division Diagnostics Division 1 At CER=Constant Exchange Rates 8

9 2015: Dividend and payout ratio further increased CHF payout ratio: 60.0% Dividend payout ratio (%) Payout ratio calculated as dividend per share divided by Core earnings per share (diluted); 2015 dividend as proposed by the Board of Directors; 1 Note: compound For 1995, a annual special dividend growth was rate paid out to mark F. Hoffmann-La Roche s 100th anniversary in

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) 10

11 2015 results Pharma update Appendix 11

12 2015: Pharma Division Core operating profit growth +8%* 2015 CHFm % sales Sales 37, vs CER growth 5% Royalties & other op. inc. 2, Cost of sales -7, M & D -6, R & D -8, G & A -1, % -11% 7% 4% 4% Excl. filgrastim* +10% Capacity increase in manufacturing Core operating profit 16, % in CHF 5% Excl. filgrastim* +8% CER=Constant Exchange Rates; * Excluding sale of filgrastim rights in

13 2015: Strong performance from oncology and immunology franchises Herceptin Avastin Perjeta Esbriet +10% +9% +61% n.m. MabThera/Rituxan Actemra/RoActemra Kadcyla Xolair +5% +23% +51% +25% Xeloda -31% Lucentis Tamiflu Valcyte/Cymevene Pegasys -44% -45% -15% -28% US Europe Japan International -,600 -,400 -,200,0,200,400,600 Absolute amounts and growth rates at Constant Exchange Rates (CER) CHFm 13

14 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 Molecule Ocrelizumab (PPMS) Venetoclax (AML) Venetoclax + Rituxan (R/R CLL) Actemra (Systemic sclerosis) Atezolizumab (NSCLC) Venetoclax (R/R CLL 17p del) Emicizumab/ACE 910 (Hemophilia A) Esbriet (IPF) Lucentis (DR) Atezolizumab (Bladder) Alectinib (2L ALK+ NSCLC) Gazyva (1L CLL) Source: as at 21 January 2016; CLL=Chronic Lymphocytic Leukemia; NSCLC=Non- Small Cell Lung Cancer; IPF=Idiopathic Pulmonary Hypertension; DR=Diabetic Retinopathy 14

15 Positive outlook provided at Investor Day 2015 Strong pipeline mitigates biosimilar impact Sales NME launches Venetoclax, Alectinib, Cotellic, Ocrelizumab, Atezolizumab, Lebrikizumab, Emicizumab (ACE910), Lampalizumab Pipeline Biosimilars MabThera, Herceptin, Avastin Marketed products E 2016E 2017E 2018E 2019E 2020E 2021E 2022E 2023E NME=new molecular entities 15

16 line extensions NMEs Late-stage development program A record 14 NMEs in late-stage development idasanutlin gantenerumab alectinib Cotellic ocrelizumab atezolizumab emicizumab (ACE910) lampalizumab crenezumab taselisib venetoclax lebrikizumab olesoxime etrolizumab Post 2017 Herceptin + Perjeta (APHINITY) atezolizumab + chemo (IMpower studies) Gazyva (GOYA) Gazyva (GALLIUM) Oncology/ hematology Neuroscience Ophthalmology Immunology Data readout/ Filed/ Approved NME=new molecular entity; Timeline indicates year of expected filing or pivotal data readout Major line extension: 2016 (APHINITY; GOYA); 2017 (IMpower 1L lung cancer; GALLIUM) 16

17 Late-stage development program Market opportunities and investments needed Year Molecule Indication Post 2017 Market opportunity Incremental infrastructure alectinib ALK+ NSCLC Low to medium Cotellic+Zelboraf Melanoma Low venetoclax Hematology (CLL 17p del) Low ocrelizumab Multiple Scelerosis Medium atezolizumab NSCLC, bladder (2/3L) Medium lebrikizumab Asthma, AD, IPF, COPD Large APHINITY Adj HER2+ breast cancer Low GOYA NHL (aggressive) Low emicizumab (ACE 910) Hemophilia A Low to medium lampalizumab Geographic atrophy Low to medium GALLIUM NHL (indolent) Low IMpower studies NSCLC (1L) Low taselisib (PI3Ki) HER2-/HR+ breast cancer Low to medium idasanutlin (MDM2) Acute myeloid leukemia Low to medium Oncology Neuroscience Ophthalmology Immunology Small: up to CHF 0.5 bn medium= CHF 0.5 to CHF 1bn large > CHF1bn NSCLC=non-small cell lung cancer; CLL=chronic lymphocytic leukemia; AD=atopic dermatitis; IPF=idiopathic pulmonary fibrosis; COPD=chronic obstructive pulmonary disease; NHL=non-Hodgkin s lymphoma; Venetoclax in collaboration with AbbVie 17

18 line extensions NMEs Venetoclax* (Bcl-2 inhibitor) A potential new hematology cornerstone idasanutlin gantenerumab alectinib Cotellic ocrelizumab atezolizumab emicizumab (ACE910) lampalizumab crenezumab taselisib venetoclax lebrikizumab olesoxime etrolizumab Post 2017 Herceptin + Perjeta (APHINITY) atezolizumab + chemo (IMpower studies) Gazyva (GOYA) Gazyva (GALLIUM) Oncology/ hematology Neuroscience Ophthalmology Immunology Data readout/ Filed/ Approved NME=new molecular entity; Timeline indicates year of expected filing or pivotal data readout Major line extension: 2016 (APHINITY; GOYA); 2017 (IMpower 1L lung cancer; GALLIUM); * venetoclax in collaboration with AbbVie 18

19 Development plan hematology franchise I 8 NMEs in the clinic NHL Compound Combination Study name Indication P Ph1 1 Ph2 P 2 Ph3 P 3 Gazyva +bendamustine GADOLIN inhl (Rituxan refractory) Gazyva +CHOP GOYA anhl ASCO CLL Gazyva +chemo GALLIUM 1L inhl Gazyva +FC/bendamustin/Clb GREEN CLL and R/R CLL NHL venetoclax* +Rituxan/+Rituxan+bendamustine CONTRALTO R/R FL (inhl) venetoclax +Rituxan+CHOP/Gazyva+CHOP CAVALLI 1L anhl venetoclax +Rituxan+bendamustine R/R NHL venetoclax R/R CLL and R/R NHL ASCO ASCO venetoclax +Rituxan R/R CLL and SLL venetoclax +Gazyva CLL14 CLL CLL venetoclax +Rituxan MURANO R/R CLL venetoclax R/R CLL 17p venetoclax R/R CLL after ibru/idel ASCO venetoclax +Rituxan+bendamustine R/R CLL and CLL venetoclax +Gazyva R/R CLL and CLL MM venetoclax R/R MM venetoclax +bortezomib+dexamethasone R/R MM ASCO ASCO AML venetoclax AML venetoclax +decitabine/+azacitidine/+ldarac AML ASCO = approved/filed ASCO = abstracts submitted (to be confirmed) venetoclax (Bcl2 inhibitor); NME=new molecular entity; inhl=indolent non-hodgkin`s lymphoma; anhl=agressive NHL; CLL=chronic lymphoid leukemia; R/R CLL=relapsed/refractory CLL; MM=multiple myeloma; AML=acute myeloid leukemia; CHOP=cyclophosphamide, doxorubicin, vincristine and prednisone; FC=fludarabine, cyclophosphamide; LdAraC=low dose cytarabine; * venetoclax in collaboration with AbbVie 19

20 Development plan hematology franchise II 8 NMEs in the clinic Compound Combination Study name Indication P Ph1 1 Ph2 P 2 Ph3 P 3 NHL NHL NHL MM MDS AML polatuzumab* +Rituxan/Gazyva ROMULUS R/R FL and anhl polatuzumab +Gazyva+benda/Rituxan+benda R/R FL (inhl) and anhl polatuzumab +Gazyva+CHP/Rituxan+CHP 1L anhl polatuzumab +Gazyva+lenalidomide R/R FL and anhl Q4 polatuzumab +Gazyva+venetoclax R/R FL and anhl Q4 undisclosed ADC R/R NHL atezolizumab +Gazyva R/R FL (inhl) and anhl atezolizumab +Gazyva+lenalidomide R/R FL and anhl Q4 atezolizumab +CHOP anhl Q4 atozolizumab +bendamustine R/R FL and anhl Q4 atezolizumab +Gazyva+polatuzumab R/R FL and anhl Q1 atezolizumab +lenalidomide MM atezoliozumab +azacitidine MDS acd20/cd3 bimab Heme tumors LSD1 inhibitor** AML idasanutlin Heme tumors ASCO ASCO = additional trials starting in coming quarters ASCO = abstracts submitted (to be confirmed) polatuzumab vedotin (acd79b ADC); atezolizumab (apd-l1 MAb); acd20/cd3 bimab (RG7828); LSD1 inhibitor (RG6016); idasanutlin (MDM2 antagonist); inhl=indolent non-hodgkin`s lymphoma; R/R FL=relapsed/refractory follicular lymphoma; anhl=agressive NHL (DLBCL); MM=multiple myeloma; MDS=myelodysplastic syndrom; AML=acute myeloid leukemia; *in collaboration with Seattle Genetics; ** in collaboration with Oryzon Genomics 20

21 Multiple approaches to protect MabThera/Rituxan Rapidly and sustainably convert market to SC Gazyva (GALLIUM) (improve > SoC) Gazyva (GADOLIN) in Rituxan-refractory inhl inhl 49% 1L CLL Typical 5% R/R anhl 6% 1L anhl 27% 1L CLL Fit 6% CLL 17p del 1% R/R CLL 5% Gazyva (GREEN) Extend chemo backbone Venetoclax Extend efficacy Rapidly and sustainably convert market to SC GAZYVA (GOYA) in anhl (improve > SoC) Broad development program for venetoclax as add on and in new tumour types SoC=standard of care; SC=subcutaneous; CLL=chronic lymphocytic leukemia; inhl=indolent non-hodgkin s lymphoma; anhl=aggressive NHL; R/R=relapsed/refractory 21

22 line extensions NMEs Atezolizumab (anti-pdl1 MAb) A new key backbone in oncology idasanutlin gantenerumab alectinib Cotellic ocrelizumab atezolizumab emicizumab (ACE910) lampalizumab crenezumab taselisib venetoclax lebrikizumab olesoxime etrolizumab Post 2017 Herceptin + Perjeta (APHINITY) atezolizumab + chemo (IMpower studies) Gazyva (GOYA) Gazyva (GALLIUM) Oncology/ hematology Neuroscience Ophthalmology Immunology Data readout/ Filed/ Approved NME=new molecular entity; Timeline indicates year of expected filing or pivotal data readout Major line extension: 2016 (APHINITY; GOYA); 2017 (IMpower 1L lung cancer; GALLIUM) 22

23 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 anti-cd27* (Celldex) entinostat* (Syndax) T cell infiltration anti-vegf (Avastin) anti-ang2/vegf (vanucizumab) Antigen presentation T-Vec oncolytic virus* (Amgen) INFa anti-cd40 CMB305 vaccine* (Immune Design) Clinical development Preclinical development Established therapies * Partnered or external In-house immunotherapy NMEs Antigen release EGFRi (Tarceva) ALKi (Alectinib) BRAFi (Zelboraf) MEKi (Cotellic) anti-cd20 (Gazyva) anti-her2 (Herceptin; Kadcyla; Perjeta) various chemotherapies lenalidomide* rociletinib* (Clovis) T cell killing anti-pdl1 (atezolizumab) anti-csf-1r (emactuzumab) IDOi (NewLink) IDOi* (Incyte) CPI-444* (Corvus) anti-tigit IDO1/TDOi* (Curadev) Cancer T cell recognition anti-cea/cd3 TCB anti-cd20/cd3 TCB KTE-C19* (Kite Pharma) anti-her2/cd3 TCB ImmTAC* (Immunocore) Chen and Mellman. Immunity 2013 NME=new molecular entity; CIT=cancer immunotherapy; FP=fusion protein; TCB=T-cell bispecific 23

24 Combination trials as of beginning 2015 Launched/ late-stage portfolio chemo acsf-1r acea-il2v FP acd40 Immunotherapy portfolio aox40 atezolizumab IDO acea/cd3 TCB cobimetinib venetoclax polatuzumab alectinib Targeted combinations approved Chemotherapy combinations approved Roche combinations in trials Chemotherapy combinations in trials NMEs late stage NMEs early stage 24

25 and combination trials as of today Launched/ late-stage portfolio chemo acsf-1r acea-il2v FP afap-il2v FP acd40 Immunotherapy portfolio aox40 atezolizumab IDO acea/cd3 TCB acd20/cd3 TCB venetoclax Targeted combinations approved 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 25

26 Cancer immunotherapy read-outs in 2016 Phase I Phase II atezo Solid tumors atezo+chemo Solid tumors atezo+tarceva NSCLC atezo+zelboraf Melanoma acea-il2v FP Solid tumors aox40 Solid tumors acea/cd3 TCB Solid tumors IDO Solid tumors atezo NSCLC (Dx+) atezo 2/3L NSCLC atezo+avastin 1L Renal atezo 1/2L Bladder atezo+cotellic acsf-1r Solid tumors Solid tumors atezo+gazyva acd20/cd3 TCB R/R FL / anhl heme tumors atezo+avastin+/-chemo afap-il2v FP Solid tumors Solid tumors atezo+lenalidomide atezo+ipilimumab MM Solid tumors atezo+zelboraf+cotellic atezo+ifn-alfa Melanoma Solid tumors atezo+alecensa atezo+acd40 ALK+ NSCLC Solid tumors atezo+/-azacitidine atezo+aox40 MDS Solid tumors atezo+gazyva+chemo atezo+acsf-1r R/R FL/aNHL Solid tumors atezo+gazyva+lenalidomide atezo+acea-il2v FP R/R FL/aNHL Solid tumors atezo+kadcyla/herceptin+perjeta atezo+ido HER2+ ebc/mbc Solid tumors atezo+gazyva+polatuzumab atezo+acea/cd3 TCB R/R FL/aNHL Solid tumors Status as of Jan 28, 2016; Outcome studies are event-driven: timelines may change. Phase III atezo 2/3L NSCLC atezo 2/3L Bladder atezo+avastin+chemo 1L non sq NSCLC atezo+chemo 1L non sq NSCLC atezo+chemo 1L sq NSCLC atezo 1L non sq NSCLC (Dx+) atezo 1L sq NSCLC (Dx+) atezo+chemo 1L TNBC atezo+avastin 1L Renal atezo Adjuvant MIBC (Dx+) atezo Adjuvant NSCLC (Dx+) atezolizumab trials NME monotherapy Immune doublets Results in

27 line extensions NMEs Ocrelizumab in multiple sclerosis First drug active in both RMS & PPMS idasanutlin gantenerumab alectinib Cotellic ocrelizumab atezolizumab emicizumab (ACE910) lampalizumab crenezumab taselisib venetoclax lebrikizumab olesoxime etrolizumab Post 2017 Herceptin + Perjeta (APHINITY) atezolizumab + chemo (IMpower studies) Gazyva (GOYA) Gazyva (GALLIUM) Oncology/ hematology Neuroscience Ophthalmology Immunology Data readout/ Filed/ Approved NME=new molecular entity; Timeline indicates year of expected filing or pivotal data readout Major line extension: 2016 (APHINITY; GOYA); 2017 (IMpower 1L lung cancer; GALLIUM) 27

28 MoA Ocrelizumab (humanized anti-cd20 MAb) Results confirm central role of B cells in MS 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 MOA=mechanism of action; 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; IV=intravenous; Adapted from Lublin 1996, Arnold

29 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 H 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 29

30 Multiple Sclerosis: Improvements over SoC driving market growth Global sales (lc) USDm 20,000 19,420 18,999 15,000 13,955 15,855 Orals Tecfidera Aubagio Gilenya* 10,000 8,930 10,084 11,053 12,323 New biologics Lemtrada Tysabri 5,000 4,406 5,036 5,803 6,932 ABCRs Betaseron Rebif Avonex Copaxone, Q Source: Evaluate Pharma Multiple Sclerosis report, October 2015; * Includes Imusera sales; SoC=standard of care 30

31 EFFICACY Range of treatment options in RMS Varying efficacy and safety profiles ILLUSTRATIVE More Alemtuzumab Natalizumab Natalizumab Unmet need (JCV+) (JCV-) Fingolimod Dimethyl fumarate Teriflunomide ABCRs (Interferons and Copaxon) Less Less / Later SAFETY/ USE More / Earlier Orals New biologics ABCRs RMS=relapsing forms of multiple sclerosis; ABCR=Avonex ; Betaseron ; Copaxon ; Rebif ; Source: Adapted from Hauser SL, et al. Ann. Neurol. 2013;74(3):

32 line extensions NMEs Lebrikizumab in asthma First-in-class molecule in expanding markets idasanutlin gantenerumab alectinib Cotellic ocrelizumab atezolizumab emicizumab (ACE910) lampalizumab crenezumab taselisib venetoclax lebrikizumab olesoxime etrolizumab Post 2017 Herceptin + Perjeta (APHINITY) atezolizumab + chemo (IMpower studies) Gazyva (GOYA) Gazyva (GALLIUM) Oncology/ hematology Neuroscience Ophthalmology Immunology Data readout/ Filed/ Approved NME=new molecular entity; Timeline indicates year of expected filing or pivotal data readout Major line extension: 2016 (APHINITY; GOYA); 2017 (IMpower 1L lung cancer; GALLIUM) 32

33 Development plan: Lebrikizumab Programs in asthma, IPF, atopic dermatitis and COPD Severe uncontrolled asthma Adults High dose/low dose Q4W Mild to moderate asthma Adults LAVOLTA I/II STRETTO Severe uncontrolled asthma Adolescents High/low dose Q4W ACOUSTICS Asthma Adults (OCS-sparing) High/low dose Q4W VOCALS Asthma Biomarker CLAVIER IPF Mono and lebrikizumab+esbriet RIFF Moderate to severe atopic dermatitis Moderate to severe atopic dermatitis TREBLE ARBAN Phase I Phase II COPD VALETA Phase III Q4W=monthly dosing; PK=pharmacokinetic study; IPF=idiopathic pulmonary fibrosis; COPD=chronic obstructiv pulmonary disease; OCS=oral corticosteroid 33

34 line extensions NMEs Emicizumab (ACE910) in hemophilia A A game changing molecule with a unique mechanism idasanutlin gantenerumab alectinib Cotellic ocrelizumab atezolizumab emicizumab (ACE910) lampalizumab crenezumab taselisib venetoclax lebrikizumab olesoxime etrolizumab Post 2017 Herceptin + Perjeta (APHINITY) atezolizumab + chemo (IMpower studies) Gazyva (GOYA) Gazyva (GALLIUM) Oncology/ hematology Neuroscience Ophthalmology Immunology Data readout/ Filed/ Approved NME=new molecular entity; Timeline indicates year of expected filing or pivotal data readout Major line extension: 2016 (APHINITY; GOYA); 2017 (IMpower 1L lung cancer; GALLIUM) 34

35 Emicizumab in hemophilia A First-patient-in achieved in inhibitor study First-patient-in in the inhibitor phase III study achieved Inhibitor non-interventional study has recruited >90 patients and will be expanded to non-inhibitors Non-inhibitor and pediatrics studies expected to start in 2016 New data at ASH 2015: Patient underwent surgery without need for any Factor VIII replacement therapy QW=weekly dosing; Q2W= dosing every 2 weeks; Q4W=monthly dosing; PK=pharmacokinetic study; OLE=open label extension 35

36 Emicizumab in hemophilia A Extension study confirms excellent efficacy ABR reduction Extension Median follow up Months [Range] C1 (0.3mg/kg) n= [ ] C2 (1mg/kg) n= [ ] C3 (3mg/kg) n=5 6.6 [ ] Phase I results: 95% to 100% ABR reduction in inhibitor and non-inhibitor patients No thromboembolic AEs when given with rfviii ABR=annual bleeding rate; C1/2/3=cohort 1/2/3; AE=adverse events; Nogami K. et al, presented at ISTH

37 line extensions NMEs Perjeta+Herceptin in adjuvant BC (APHINITY) Keeping the HER2 franchise growing despite biosimilars idasanutlin gantenerumab alectinib Cotellic ocrelizumab atezolizumab emicizumab/ace910 lampalizumab crenezumab taselisib venetoclax lebrikizumab olesoxime etrolizumab Post 2017 Herceptin + Perjeta (APHINITY) atezolizumab + chemo (IMpower studies) Gazyva (GOYA) Gazyva (GALLIUM) Oncology/ hematology Neuroscience Ophthalmology Immunology Data readout/ Filed/ Approved NME=new molecular entity; Timeline indicates year of expected filing or pivotal data readout Major line extension: 2016 (APHINITY; GOYA); 2017 (IMpower 1L lung cancer; GALLIUM) 37

38 Pipeline (Trial starts) Market (Product launches) HER2 franchise Strengthening standard of care Est. Biosimilars launch (EU) 2nd line mbc Xeloda + lapatinib Kadcyla (EMILIA) 1st line mbc Herceptin + chemo Herceptin & Perjeta + chemo (CLEOPATRA) Adjuvant BC Herceptin + chemo Herceptin SC+ chemo (HannaH) Herceptin & Perjeta + chemo (APHINITY) Neoadjuvant BC Herceptin + chemo (NOAH) 1 Herceptin & Perjeta + chemo (Neosphere, Tryphaena) 2 Kadcyla & Perjeta + chemo (KRISTINE) ebc/mbc atezolizumab + Herceptin + Perjeta ebc/mbc atezolizumab + Kadcyla Established SoC Potentially new SoC New trials atezolizumab (apd-l1 MAb); mbc=metastatic breast cancer; ebc=early breast cancer; SC=subcutaneous; SoC=standard of care 38

39 Sales market share (%) Sales market share (%) Strong subcutaneous conversion rates for Herceptin and MabThera SC share of Herceptin sales in launched countries* SC share of MabThera NHL sales in launched countries* 40% 30% 35% 30% 25% 20% 20% 15% 10% 10% 5% 0% Q2 13 Q3 13 Q4 13 Q1 14 Q2 14 Q3 14 Q4 14 Q1 15 Q2 15 Q3 15 Q4 15 0% Q2 14 Q3 14 Q4 14 Q1 15 Q2 15 Q3 15 Q4 15 SC=subcutaneous; * Herceptin SC has been launched in 48 countries; MabThera SC has been launched in 12 countries 39

40 Strengthening Pharma through collaborations Data analysis driving innovation and efficiencies Access meaningful data Create insights Create Realise insights value Diagnostic Data Advanced analytics of integrated data Clinical Trial Data Smarter, more efficient R&D Real World Data Improved access & personalised patient care 40

41 2016: Key late-stage news flow Regulatory Phase III readouts* Phase II readouts* Compound Indication Milestone Gazyva MabThera/Rituxan-refractory inhl US/EU approval venetoclax R/R CLL US approval ocrelizumab RMS/PPMS US/EU filing atezolizumab Bladder cancer US approval atezolizumab 2/3L NSCLC US approval Alecensa 2L ALK+ NSCLC EU approval 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 venetoclax R/R FL (inhl) Ph II CAVALLI venetoclax 1L anhl Ph II CONTRALTO Mixed results * Outcome studies are event driven, timelines may change 41

42 2015 results Pharma update Appendix 42

43 Pipeline & execution Achievements: Productivity Doubled number of projects at same costs Late stage development costs & number of projects +90% Filing Ph3 Ph0-2 Pharma Development Spend Excludes Chugai, pred and gred, Medical Affairs and PTD Source: Roche internal development data 43

44 Pipeline & execution Achievements: Innovation Above-average R&D success rate Likelihood of launch from phase Roche Industry 8% 5% Despite some set-backs, Roche continues to stay ahead of the industry Note: Success rates calculated at the project/indication level for overlapping 5-year periods (9 data points between ) based on KMR data (with 13 Industry peers and Roche). From 2009 all Genentech projects are included; before that only those opted-in by Roche. 44

45 Pipeline & execution Unmet medical need Sales We set a high bar for our R&D pipeline Targeting clear differentiation in areas of unmet need Assessment for late stage entry candidates & line extensions Total sales potential Illustrative high Greater differentiation Threshold low low Clinical differentiation high Time Continued Disqualified 45

46 Pipeline & execution POL (%) and rigorously prioritize our R&D activities Focused investments on the most promising candidates Late stage portfolio overview Go, Wait, Gate Examples Illustrative Cost Focus Go Low Priority Mitigate Risk ,000 10,000 NPV (CHF m) Go Move fast and make broad investments example Immunotherapy Mitigate Risk: Wait Waiting until we get further data to initiate programs example Polatuzumab Mitigate Risk: Gate Gate larger investments on further data, for example interim readouts, safety analyses, or different studies example Alzheimer s 46

47 Pipeline & execution Resources shifted to new & strategic products while overall spend only increases slightly Product Marketing and Medical Costs ( ) 60% 75% Recently launched + NME Strategic In-market Mature E 47

48 2015: Diagnostics sales Strong sales performance Change in % CHFm CHFm CHF CER Diagnostics Division 10,814 10, Professional Diagnostics 6,175 6, Diabetes Care 2,128 2, Molecular Diagnostics 1,719 1, Tissue Diagnostics CER=Constant Exchange Rates; Underlying growth of Molecular Diagnostics excluding Sequencing business: +7% 48

49 Roche outgrowing the market in a challenging environment Quarterly growth (%) 8% FY 2015: 6% 7% 6% 5% 4% 3% Worldwide IVD market leader Strong commercial presence Broadest test menu 2% 1% Market Roche 0% Q1 Q2 Q Q4 Q1 Q Q3 Q4 * Sources: 3rd party IVD consultancy, Analyst reports, Roche Analysis; *Q market growth is an estimate 49

50 2015: Diagnostics regional sales Growth driven by APAC and EMEA North America +3% 26% of divisional sales EMEA 1 +4% 42% of divisional sales Japan 0% 4% of divisional sales Latin America +11% 7% of divisional sales Asia Pacific +15% 21% of divisional sales 14% 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 50

51 2015: Diagnostics highlights Growth driven by Professional Diagnostics YoY CER growth Professional Dia +8% Growth driven by immunodiagnostics (+13%) Diabetes Care -3% Decline in blood glucose monitoring (-4%), insulin delivering systems (+8%) Molecular Dia1 +10% Virology (+14%) incl. HPV (+27%) Tissue Dia +12% EMEA North America Advanced staining portfolio (+11%) RoW CHFbn Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +7% CER=Constant Exchange Rates; EMEA=Europe, Middle East and Africa 51

52 2015: Diagnostics Division Profitability impacted by investments in sequencing* vs CHFm % sales CER growth Sales 10, % Royalties & other op. inc Cost of sales -4, M & D -2, R & D -1, G & A % 5% 7% 9% 18% Core operating profit 1, % -7% in CHF CER=Constant Exchange Rates; * Sequencing investments refer to the acquisitions of Genia, Ariosa, Bina and Signature Diagnostics 52

53 Doing now what patients need next