Roche. Q sales. Basel, 22 April 2015

Transcription

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2 Roche Q sales Basel, 22 April 2015

3 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. 3

4 Group Severin Schwan Chief Executive Officer 4

5 Q1 2015: Highlights Growth Group sales +5% 1 driven by HER2 franchise (+23% 1 ), Avastin (+6% 1 ), Actemra (+27% 1 ) and Professional Diagnostics (+6% 1 ) Esbriet: Off to a strong start Innovation Second Breakthrough Therapy Designation for anti-pdl1 Phase 3 starts: Seven in immuno-oncology, etrolizumab in Crohn s disease and taselisib in HR+ breast cancer M&A Foundation Medicine: Transaction closed 1 CER=Constant Exchange Rates 5

6 Q1 2015: Strong sales growth Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division Diagnostics Division Roche Group CER=Constant Exchange Rates 6

7 Q1 2015: Continued strong growth in all regions CHFbn % -10% * +6% +3% +10% +1% +14% +3% +6% +9% +1% -2% Japan International Europe US * Japanese sales impacted by consumption tax base effect Diagnostics Pharma CER=Constant Exchange Rates 7

8 Q1 2015: Sales growth for 5 th consecutive year 10% 8% 6% 6% 6% 6% 8% 7% 5% 5% 6% 4% 4% 4% 4% 4% 5% 2% 2% 0% 0% 0% 1% Q1 11 Q2 11 Q3 11 Q4 11 Q1 12 Q2 12 Q3 12 Q4 12 Q1 13 Q2 13 Q3 13 Q4 13 Q1 14 Q2 14 Q3 14 Q4 14 Q1 15 All growth rates at Constant Exchange Rates (CER) 8

9 Progressing in Personalised Healthcare 60% of phase 2 & 3 products have PHC component Phase 2 Phase 3/Registration Marketed FIXa/FX bispecific MAb MAO-B inh PD-L1 MAb Tarceva SERD GABRA5 NAM venetoclax (Bcl-2 inh) Zelboraf CSF-1R MAb bitopertin alectinib (ALK inh) Erivedge Ang2-VEGF MAb basimglurant taselisib Rituxan ipatasertib V1 receptor antag cobimetinib Gazyva polatuzumab vedotin crenezumab lebrikizumab Herceptin lifastuzumab vedotin olesoxime etrolizumab Perjeta glypican-3 MAb danoprevir gantenerumab Kadcyla Flu A MAb ocrelizumab Avastin LptD antibiotic lampalizumab Xeloda Esbriet Pulmozyme Oncology Immunology Infectious Diseases Neuroscience Ophthalmology Molecular Diagnostics Tissue Diagnostics Professional Diagnostics Xolair Actemra Lucentis 9

10 Roche: Making progress in advancing patient care Recognising innovation Breakthrough Therapy Designations Rank Company # 1 Roche 6 1 GSK 6 3 Novartis 5 4 Merck 4 5 JNJ 4 Q Anti-PDL1 (NSCLC) Esbriet Lucentis Diabetic Retinopathy Anti-PDL1 (bladder) Alectinib Gazyva Source: FDA 10

11 2015 outlook Group sales growth 1 Low to mid-single digit Core EPS growth 1 Ahead of sales growth 2 Dividend outlook Further increase dividend in Swiss francs 1 At constant exchange rates 2 Excluding sale of filgrastim rights in

12 Pharmaceuticals Division Daniel O Day COO Roche Pharmaceuticals 12

13 Q sales Innovation Outlook 13

14 Q1 2015: Strong sales growth driven by US and International Change in % CHFm CHFm CHF CER Pharmaceuticals Division 9,322 9, United States 4,392 3, Europe 2,178 2, Japan International 1,989 1, CER=Constant Exchange Rates 14

15 Q1 2015: Strong performance from oncology and immunology franchises; Esbriet off to a good start Herceptin +12% Perjeta +82% Esbriet n.a. MabThera/Rituxan +5% Avastin +6% Kadcyla +80% Actemra/RoActemra +27% Xolair +28% Lucentis Valcyte/Cymevene Pegasys Xeloda -53% -39% -41% -9% US Europe Japan International CHFm Absolute amounts and growth rates at Constant Exchange Rates (CER) 15

16 Q1 2015: Oncology products with +6% growth YoY CER growth HER2 Avastin Perjeta Herceptin +23% Kadcyla +6% +23% Strong uptake of Perjeta & Kadcyla Accelerated growth of Herceptin US: Continued uptake in ovarian, cervical and lung EU: Growth in ovarian and breast MabThera/ Rituxan +4% Increased usage across a variety of indications Tarceva -3% In-class competition Xeloda -53% Loss of exclusivity Zelboraf CHFbn -25% Competitive pressure in US & EU Approval of cobrim expected in 2015 CER=Constant Exchange Rates; Q Oncology sales: CHF 5.8bn 16

17 HER2 franchise: Growth of Perjeta also driving Herceptin sales CHFm 2'400 1'800 15% 7% 15% 20% 17% 23% 23% 19% YoY CER growth 23% 1' Q1 13 Q2 13 Q3 13 Q4 13 Q1 14 Q2 14 Q3 14 Q4 14 Q1 15 Kadcyla Perjeta Herceptin CER=Constant Exchange Rates 17

18 Total number of countries Sales market share (%) Herceptin SC launched in 44 countries Conversion rate already exceeds 30% Number of countries where Herceptin SC has been launched SC share of Herceptin sales in launched countries % 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 0% Q2 13 Q3 13 Q4 13 Q1 14 Q2 14 Q3 14 Q4 14 Q

19 Avastin: Strong growth across various indications and in all regions CHFm 1'800 1'500 1' YoY CER growth +11% +9% +6% +1% Q1 12 Q1 13 Q1 14 Q1 15 US Europe International Japan Avastin Q Main growth drivers are ovarian (US; EU), lung (US) and cervical cancer (US) EU: Positive momentum in breast cancer due to IMELDA International (+11%) in all regions Outlook EU launch in cervical cancer CER=Constant Exchange Rates 19

20 Immunology franchise remains driven by Actemra, Xolair and MabThera/Rituxan CHFm 1'500 1' % +11% +11% YoY CER growth +20% Actemra (+27%): SC launch and 1L monotherapy setting Xolair (+28%): Allergic asthma and strong growth in Chronic Idiopathic Urticaria (CIU) post FDA approval in Q Q1 12 Q1 13 Q1 14 Q1 15 Other (incl Esbriet) Pulmozyme CellCept Xolair Actemra SC Actemra IV MabThera/Rituxan MabThera/Rituxan (+11%): Continues to grow in rheumatoid arthritis and vasculitis (GPA and MPA) GPA=Granulomatosis with polyangiitis; MPA=Microscopic polyangiitis CER=Constant Exchange Rates 20

21 Ophthalmology franchise: Competitive pressure on Lucentis; Fast Track status for lampalizumab USDm Lucentis sales Lucentis Q Continued competitive pressure in wamd First-in-class FDA approval to treat diabetic retinopathy (DR) in patients with DME 300 Lucentis DME AMD Less-frequent than monthly dosing Lucentis outlook Ongoing competition in AMD & DME First sales in DR Lampalizumab update 200 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 FDA granted Fast Track status for geographic atrophy (GA) Ph3 global enrollment well on track wamd=wet age-related macular degeneration; DME=diabetic macular edema 21

22 Esbriet: Off to a strong start Esbriet sales (CHFm) 88 US launch off to strong start Patients still in transition to full reimbursement post approval Establishing market leadership in IPF European sales with continued growth Label was strengthened by including ASCEND and pooled 1Y mortality data Q1 14 Q2 14 Q3 14 Q4 14 Q

23 Q sales Innovation Outlook 23

24 Gazyva: First positive readout in inhl CLL11: Ph III front-line chronic lymphocytic leukemia (CLL) Front-line CLL n=781 Gazyva 1000mg IV + chlorambucil MabThera/Rituxan + chlorambucil chlorambucil Primary end-point: PFS Approved in Q GADOLIN: Ph III MabThera/Rituxan refractory indolent non-hodgkin`s lymphoma (inhl) MabThera-refractory inhl n=411 Induction Gazyva + bendamustine x 6 cycles bendamustine x 6 cycles CR, PR, SD Maintenance Gazyva q2mo x 2 years Primary end-point: PFS Data at ASCO 2015 GOYA: Ph III diffuse large B-cell lymphoma (DLBCL) Front-line DLBCL (aggressive NHL) n=1,418 Gazyva x 8 cycles + CHOP x 6 or 8 MabThera x 8 cycles + CHOP x 6 or 8 Primary end-point: PFS Trial to continue until 2016 GALLIUM: Ph III front-line indolent non-hodgkin`s lymphoma (inhl) Front-line inhl n=1,401 Induction Gazyva x 8 cycles + CHOP x 6 or Gazyva x 8 cycles + CVP x 8 or Gazyva x 6 cycles + benda. x 6 MabThera x 8 cycles + CHOP x 6 or MabThera x 8 cycles + CVP x 8 or MabThera x 6 cycles + benda. x 6 CR, PR Maintenance Gazyva q2mo x 2 years MabThera q2mo x 2 years Primary end-point: PFS Enrolment complete Q Data expected 2017 In collaboration with Biogen Idec CHOP=Cyclophosphamide, Doxorubicin, Vincristine and Prednisone; CVP=Cyclophosphamide, Vincristine and Prednisolone 24

25 Roche cancer immunotherapy Extensive phase III program to start in 2015 PDL1+Tarceva NSCLC PDL1+Zelboraf Melanoma PDL1 Solid tumors PDL1+Avastin Solid tumors PDL1+cobimetinib Solid tumors PDL1+ipilimumab Solid tumors PDL1+IFN-alfa Solid tumors PDL1+CD40 Solid tumors PDL1+Avastin+FOLFOX CRC PDL1 + Gazyva Blood cancer PDL1 TNBC CSF-1R Solid tumors CEA IL2v Solid tumors Status as at April 22, 2015 Phase I OX40 Solid tumors CEA CD3 Solid tumors IDO Solid tumors PDL1+OX40** Solid tumors PDL1+CSF-1R** Solid tumors PDL1+CEA IL2v** Solid tumors PDL1+Zelboraf+cobi** Solid tumors PDL1** tba PDL1** tba PDL1** tba ** Phase II PDL1 NSCLC (Dx+) PDL1 2/3L NSCLC PDL1+Avastin 1L Renal PDL1 1/2L Bladder Anti-PDL1 trials NMEs monotherapy Immune doublets 2015 readout expected Study start in 2015 Phase III PDL1 2/3L NSCLC PDL1** 2/3L Bladder PDL1+Avastin+chemo** 1L non sq NSCLC PDL1+chemo** 1L non sq NSCLC PDL1+chemo** 1L sq NSCLC PDL1** 1L non sq NSCLC (Dx+) PDL1** 1L sq NSCLC (Dx+) PDL1+chemo** 1L TNBC PDL1+Avastin** 1L RCC PDL1** tba PDL1** tba 25

26 Breakthrough Therapy Designation granted for anti-pdl1 in 2/3L NSCLC in Q1 FIR: Ph II Dx-selected advanced metastatic Non-Small Cell Lung Cancer (mnsclc) PDL1-selected NSCLC n = 138 anti-pdl mg IV Q3 weeks Primary end-point: ORR Data at ASCO POPLAR: Ph II 2/3L mnsclc All comers 2/3L NSCLC (stratified by PDL1 expression) n = 287 docetaxel 75 mg/m2 IV Q3 wk anti-pdl mg IV Q3 wk Primary end-point: OS Interim data at ASCO Final data in H BIRCH: Ph II Dx-positive advanced mnsclc PDL1-selected NSCLC n = 667 anti-pdl mg IV Q3 weeks Primary end-point: ORR Data in Q OAK: Ph III 2/3L mnsclc All comers 2/3L NSCLC (stratified by PDL1 expression) n = 1100 docetaxel 75 mg/m2 IV Q3 wk anti-pdl mg IV Q3 wk Primary end-point: OS FPI Q Data expected 2016 Note: Anti-PDL1 is listed as MPDL3280A in clinicaltrials.gov 26

27 Five anti-pdl1 phase III studies started addressing the entire 1L metastatic lung cancer market Study Indication Patient population Treatment arms n Primary completion* Combination studies GO L Non-squamous NSCLC All comers (PD-L1 subgroup analysis) carbo/pac/anti-pdl1 carbo/pac/avastin/anti-pdl1 carbo/pac/avastin 1, (PFS) GO L Non-squamous NSCLC All comers (PD-L1 subgroup analyis) carbo/nab-p/anti-pdl1 carbo/nab-p (PFS) GO L Squamous NSCLC All comers (PD-L1 subgroup analysis) carbo/pac/anti-pdl1 carbo/nab-p/anti-pdl1 carbo/nab-p 1, (PFS) Monotherapy studies GO L Non-squamous NSCLC PD-L1 selected anti-pdl1 cis or carbo/pem (PFS) GO L Squamous NSCLC PD-L1 selected anti-pdl1 cis or carbo/gem (PFS) * Outcome studies are event driven, timelines may change, OS endpoint included for all studies Carbo = Carboplatin; Pac = Paclitaxel; Nab-p = Nab-paclitaxel; Cis = Cisplatin; Pem = Pemetrexed; Gem = Gemcitabine Note: Anti-PDL1 is listed as MPDL3280A in clinicaltrials.gov 27

28 Anti-PDL1 phase III study announced in TNBC Updated phase I data presented at AACR IC2/3 patients a, n b 21 ORR (95% CI) 19% (5-42) 24-Week PFS (95% CI) 27% (7-47) Anti-PDL1 was generally well tolerated (n=54) Responses included 2 CRs (1 IC3 and 1 IC2) and 2 PRs (IC2) 3 of 4 responses ongoing In addition, three patients recorded as PD appeared to experience pseudoprogression, with durable shrinkage of target and new lesions Phase III study to start in H a PD-L1 expression was centrally evaluated on tumor-infiltrating immune cells (ICs) based on an immunohistochemistry (IHC) assay; b IC0/1 patients not yet evaluable for efficacy Emens LA, et al. AACR

29 Foundation Medicine (FMI) Molecular Information supporting drug development Roche/FMI R&D Collaboration 1. Comprehensive tumor analysis in Roche` Clinical Trials DNA & RNA sequencing 2. We will innovate together Immunotherapy Panel Blood based continuous monitoring Our phase III anti-pdl1 program is a primary focus of the collaboration We will use FMI's FoundationOne next generation DNA sequencing to look at a spectrum of DNA mutations We will also be working with Foundation Medicine to develop RNA signatures that may be predictive of patient benefit Transaction closed in April

30 Alzheimer s disease: Renewed confidence in Aß hypothesis Amyloid pathway and targets Amyloid Precursor Protein (APP) soluble Aβ fibrillar Aβ oligomeric Aβ Aducanumab (BIIB): Similar to gantenerumab by measure of target engagement Cell membrane Gantenerumab and crenezumab: Assessment ongoing to inform next steps solanezumab crenezumab bapineuzumab gantenerumab aducanumab BAN2401 Aß mab's 30

31 Q sales Innovation Outlook 31

32 ASCO 2015: Highlights in various cancer types Skin cobimetinib + Zelboraf: Ph III (cobrim) in 1L BRAF+ mm; PFS & biomarker update cobimetinib + Zelboraf: Ph Ib (BRIM7) in BRAF+ mm; OS update Lung alectinib: Two Ph II in 2L ALK+ NSCLC anti-pdl1: Ph II interim (POPLAR) in 2/3L NSCLC anti-pdl1: Ph II (FIR) in PDL1-selected advanced NSCLC anti-pdl1: Ph I update in NSCLC anti-pdl1: Ph I data from chemo combinations in NSCLC anti-pdl1: Biomarker analysis in NSCLC Bladder anti-pdl1: Ph I update in bladder Breast Kadcyla + Perjeta: Ph III (MARIANNE) in 1L HER2+ mbc; primary data Avastin + Letrozole: Ph III (CALGB40503) in 1L HR+ mbc Herceptin + Perjeta: Ph II (NEOPSPHERE) in neoadjuvant HER2+ BC Hematology Gazyva: Ph III (GADOLIN) in R/R inhl Polatuzumab vedotin: Ph II (ROMULUS) interim data in R/R inhl Zelboraf in collaboration with Plexxikon; Cobimetinib in collaboration with Exelixis; Alectinib in collaboration with Chugai, Gazyva in collaboration with Biogen Idec; Kadcyla in collaboration with ImmunoGen 32

33 2015: Key late-stage news flow Regulatory Phase III readouts* Phase III starts Phase II readouts* Compound Indication Milestone Avastin Cervical cancer EU approval Lucentis Diabetic retinopathy US approval alectinib 2L ALK+ NSCLC US filing cobimetinib + Zelboraf 1L Melanoma US, EU approval Gazyva MabThera/Rituxan-refractory inhl Ph III GADOLIN Gazyva Front-line anhl Ph III GOYA (interim) ocrelizumab Relapsing MS (RMS) Ph III OPERA I/II ocrelizumab Primary progressive MS (PPMS) Ph III ORATORIO Perjeta 2L HER2+ mbc Ph III PHEREXA Kadcyla HER2+ gastric cancer Ph II/III GATSBY anti-pdl1 ** 2/3L Bladder Ph III anti-pdl1 ** 1L TNBC Ph III anti-pdl1 ** 1L RCC Ph III anti-pdl1 ** Tumor type 1 Ph III etrolizumab Crohn`s disease Ph III ACE910 Hemophilia A Ph III taselisib (PI3K inhib) HR+/PI3Kmut BC Ph III SANDPIPER anti-pdl1 2/3L NSCLC Ph II FIR, POPLAR, BIRCH anti-pdl1 Bladder Ph II ipatasertib (AKT inhib) Gastric/prostate cancers Ph II A.MARTIN, JAGUAR 2016 * Outcome studies are event driven, timelines may change; ** For anti-pdl1 only P3 trials in new indications are listed (1L NSCLC starts not shown) 33

34 Diagnostics Division Roland Diggelmann COO Roche Diagnostics Picture 34

35 Q1 2015: Diagnostics Division sales Good growth in all units Change in % CHFm CHFm CHF CER Diagnostics Division 2,511 2, Professional Diagnostics 1,425 1, Diabetes Care Molecular Diagnostics Tissue Diagnostics Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +8% CER=Constant Exchange Rates 35

36 Q1 2015: Diagnostics regional sales Strong performance in APAC North America +5% 27% of divisional sales EMEA 1 +4% 44% of divisional sales Japan -10% 4% of divisional sales Latin America +11% 6% of divisional sales Asia Pacific +16% 19% of divisional sales 16% growth in E7 countries 2 1 Europe, Middle East and Africa; 2 Brazil, China, India, Mexico, Russia, South Korea, Turkey All growth rates at Constant Exchange Rates 36

37 Q1 2015: Diagnostics Growth driven by Professional Diagnostics YoY CER growth Professional Dia +6% Growth driven by immunodiagnostics (+11%) and coagulation self testing (+14%) Diabetes Care +1% Accu-Chek Aviva/Performa (+2%) and insulin delivering systems (+10%) Molecular Dia 1 +10% Virology (+10%) incl. HPV (+39%) Ariosa: Entry into NIPT Tissue Dia Sales CHFbn +14% EMEA North America RoW Advanced staining portfolio (+13%) 1 Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +8% CER=Constant Exchange Rates; EMEA=Europe, Middle East and Africa; NIPT=Non-invasive prenatal testing 37

38 Professional Diagnostics: Global launch of cobas 8100 version 2 Bidirectional sample flow between pre-analytical, analytical and post-analytical steps optimizes laboratory workflow Automated sample check reduces work load and enhances patient safety Integrated cobas 8100 lab solutions Elecsys assay menu Post-analytics Integrated Pre-analytics Modular analyzers 38

39 Immunoassays: 26% of Diagnostic sales growing double digit (+11%) 12% YoY CER growth Sales 6% 10% 7% 14% 23% 30% 4% 9% Cardiac Thyroid Tumor marker Women's Health Infectious Diseases Other Critical Care Anemia Hormones CER=Constant Exchange Rates; Other include Needed Common Products, Allergy, Rheumatoid Arthritis, Immunosuppressants 39

40 Molecular Diagnostics: Launch of HBV Test for cobas 6800/8800 systems Complements the viral load monitoring portfolio of cobas 6800/8800 Lower sample requirement, higher sensitivity and faster test results across all genotypes Strengthens market lead in viral load testing and helps optimize therapy for patients Integrated cobas 8800 Modular analyzers Pre-analytics cobas

41 Roche sequencing: Delivering on acquisitions NEXT* study results demonstrate superiority of Harmony test vs conventional testing Study results Significant superiority of the Harmony TM Prenatal Test over first trimester combined screening for assessing risk of Trisomy 21 Lowers number of false positives which may reduce the need for invasive testing Single largest trial > than 18,500 pregnant women Supports the use of NIPT as a first line screening option * NEXT: Non-invasive examination of trisomy; NIPT=Non-invasive prenatal testing 41

42 Key launches 2015 Instruments / Devices Tests / Assays Area Product Market BA 1 Laboratory Diabetes Care cobas c 513 dedicated HbA1C analyzer cobas t 411 core lab coagulation analyzer cobas 8100 V2 Integrated pre- and post-analytical solution cobas 6800/8800 Medium to High volume automated real-time PCR VENTANA HE 600 automated H&E staining platform Accu-Chek Active no-code next-gen. bg meter, no coding of test strips Accu-Chek Connect bg meter with connectivity to smartphones, mobile applications and cloud EU EU WW US WW Point of Care CoaguChek Pro II - professional system for PT and aptt testing EU RPD Blood Screening Infectious Diseases Virology Genomics & Oncology WW US RPD RPD RPD RMD RTD RDC RDC cobas 6800/8800 MPX Multiplex Bloodscreening test US RMD cobas Liat Influenza A/B + RSV POC detection HTLV human T-lymphotropic virus diagnostics test cobas 6800/8800 HBV Quantitative HBV viral load test cobas 4800 HIV-1 - Quantitative HIV viral load test cobas 4800 HCV Quantitative HCV viral load test cobas 4800 HBV Quantitative HBV viral load test US EU EU EU EU EU RMD RPD RMD RMD RMD RMD cobas EGFR Test v2 - detection of EGFR in plasma EU RMD Cardiac Cobas h 232 Troponin T Point of Care test version of Elecsys ctnt-hs EU RPD 1 Business Areas. RPD: Roche Professional Diagnostics; RDC: Roche Diabetes Care; RMD: Roche Molecular Diagnostics; RTD: Roche Tissue Diagnostics; 42

43 Finance Alan Hippe Chief Financial Officer 43

44 Q1 2015: Highlights Currency impact EUR and JPY currencies major negative contributors Negative 2%p impact on Q sales growth Q1 debt refinancing and major cash outflows Two bond redemptions USD: 0.6 bn maturity in coupon 6.00% s.a. GBP: 0.5 bn maturity in coupon 5.50% Two bond issuances USD: 0.6 bn maturity in coupon 2.00% EUR: 1.0 bn maturity in coupon 0.875% FMI transaction Tender offer completed Roche owns ~57% of the outstanding shares of FMI s common stock on a fully diluted basis s.a. = Semi-annual coupon 44

45 Q1 2015: Strong sales across the board * +6% +1% +9% -2% +7% +1% +5% +3% Pharma Division +4% Dia Division +6% United States Europe Intl. Chugai (Japan) Dia Diabetes Care Group Fx Group CHF 1 Absolute values in CHFm at CER = Constant Exchange Rates (avg full year 2014) 1 avg December 2014 to avg March 2015 fx * Japanese sales impacted by consumption tax base effect 45

46 Exchange rate impact on sales growth USD and EUR impacts balance out +2.8%p +0.2%p -0.1%p -0.6%p -0.6%p -0.9%p -2.7%p CER sales growth Q vs. Q % +2.9% CHF sales growth Q vs. Q CER USD Asia- Pac Other Lat-Am JPY Other Europe EUR CHF CER=Constant Exchange Rates 46

47 Negative currency impact in 2015 expected CHF / USD Assumed average YTD % Average 7% 7% 8% 0.91 YTD +1% % Monthly avg fx rates 2015 Fx rates at 31 March 2015 J F M A M J J A S O N D CHF / EUR % -13% -13% -13% +2% % Assuming the 31 Mar 2015 exchange rates remain stable until end of 2015, 2015 impact is expected to be (%p): Q1 HY Sep YTD FY Sales Core operating profit -3-4 Core EPS J F M A M J J A S O N D 47

48 Roche: Net trade working capital Continuous improvements over the years Group NTWC / sales Accounts payable 31.6% 31.1% 29.7% Renegotiated existing supply payment terms Simplified downstream processes Established standard payment terms Accounts receivable Southern Europe: Reduced accounts receivables Eastern Europe: Adopted EU payment terms Pro-active collection strategy Dec-2012 Dec-2013 Dec-2014 Note: NTWC calculated as Q4 average for all years; NTWC 2014 excl. Esbriet inventory step-up 48

49 2015 outlook Group sales growth 1 Low to mid-single digit Core EPS growth 1 Ahead of sales growth 2 Dividend outlook Further increase dividend in Swiss francs 1 At constant exchange rates 2 Excluding sale of filgrastim rights in

50 Pipeline summary Marketed products additional indications Global Development late-stage trials pred (Roche Pharma Research & Early Development) gred (Genentech Research & Early Development) Roche Group Q results Diagnostics Foreign exchange rate information 50

51 Changes to the development pipeline Q update New to Phase I New to Phase II New to Phase III New to Registration 1AI RG7813 CEA IL2v + PD-L1MAb - solid tumors 1 NME (Trophos acquisition) RG6083 olesoxime - SMA 1 NME (shown to reflect upcoming submission) RG7853 alectinib - ALK-mut. pos. NSCLC 2L 1 AI (previous P2 in solid tumors split out) RG7604 taselisib - NSCLC sq. 2L 1 NME RG7604 taselisib - ER+/HER2- neg mbc 7 AIs RG7413 etrolizumab - Crohn s disease RG7446 PD-L1 MAb Dx-pos. patients - NSCLC sq. 1L RG7446 PD-L1 MAb Dx-pos. patients - NSCLC non-sq. 1L RG7446 PD-L1 MAb + chemo - NSCLC sq. 1L RG7446 PD-L1 MAb + chemo - NSCLC non sq. 1L RG7446 PD-L1 MAb + chemo +/- Avastin - NSCLC non sq. 1L RG7853 alectinib Alk-mut.pos. - NSCLC 1L Removed from Phase I Removed from Phase II Removed from Phase III 2 NMEs RG7410 TAAR1 ago - schizophrenia RG7342 mglu5 PAM - schizophrenia 2 NMEs RG7790 setrobuvir HCV RG7321 pictilisib solid tumors 1 AI RG435 Avastin - NSCLC adj. Removed from Registration 1 AI following US approval RG3645 Lucentis - diabetic retinopathy 1 AI following EU approval RG435 Avastin cervical cancer Status as of April 22,

52 Roche Group development pipeline Oncology Phase I (31 NMEs + 12 AIs) Other disease areas RG6016 LSD1 inh AML RG autoimmune diseases RG6047 SERD (2) ER+(HER2-neg) mbc RG inflammatory diseases RG6061 HIF1 alpha LNA solid tumors RG6080 DBO β-lactamase inh bact. infections RG6078 IDO inh solid tumors RG infectious diseases RG7116 lumretuzumab (HER3 MAb) solid tumors RG7795 TLR7 agonist HBV RG7155 emactuzumab (CSF-1R) + PDL1 s.tumors RG7641 aldosterone synth inh met. diseases RG7304 Raf & MEK dual inh solid tumors RG7203 PDE10A inh schizophrenia RG7388 idasanutlin (MDM2 ant) s. & hem tumors RG7345 TAU MAb Alzheimer s RG7446 PD-L1 MAb solid tumors RG7893 Nav1.7 inh pain RG7446 PD-L1+Zelboraf+/-cobimetinib melanoma RG7800 SMN2 splicer spinal muscular atrophy RG7446 PD-L1+Avastin+chemo solid tumors RG7935 a-synuclein MAb Parkinson's Disease RG7446 PD-L1 MAb+cobimetinib solid tumors RG3645 Lucentis sust. deliv. AMD/RVO/DME RG7446 PD-L1 MAb+ipi/IFN solid tumors RG7716 VEGF-ANG2 MAb wamd RG7446 RG7446 PD-L1 MAb+Tarceva PD-L1 MAb+Gazyva NSCLC EGFR+ lymphoma New Molecular Entity (NME) Additional Indication (AI) RG7450 RG7597 RG7601 RG7601 RG7741 RG7775 RG7787 RG7802 RG7813 Steap 1 ADC prostate ca. duligotuzumab (HER3/EGFR)+ cobi s. tum. venetoclax heme indications venetoclax+gazyva CLL CLL ChK1 inh solid tum & lymphoma MDM2 (4) IV prodrug AML MSLN PE cfp solid tumors CEA CD3 TCB solid tumors CEA IL2v solid tumors Oncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other RG-No Roche Genentech managed CHU Chugai managed RG7813 CEA IL2v + PD-L1 MAb solid tumors RG7841 ADC solid tumors RG7842 ERK inh solid tumors RG7876 CD40 imab+pd-l1 MAb solid tumors RG7882 ADC ovarian ca RG7888 OX40 MAb solid tumors 52 Status as of April 22, 2015

53 Roche Group development pipeline Phase II (22 NMEs + 14 Als) Phase III (9 NMEs + 27 Als) Registration (1 NME + 2 Als) RG435 RG3502 RG6013 RG6046 RG7155 RG7221 RG7421 RG7440 RG7446 RG7446 RG7446 RG7596 RG7601 RG1569 RG3637 RG6062 CHU RG7227 RG7745 RG1577 RG1678 danoprevir bitopertin HCV obsessive compulsive dis. RG7929 RG6083 olesoxime spinal muscular atrophy RG7090 basimglurant TRD RG7314 FIXa/FX bispecific MAb ipatasertib PD-L1 MAb +Avastin polatuzumab vedotin venetoclax Actemra sembragiline (MAO-B inh) V1 receptor antag solid tumors hem tumors systemic sclerosis lebrikizumab Esbriet SSc interstitial idiopathic pulmonary lung disease fibrosis IL-31R MAb Flu A MAb LptD antibiotic hemophilia A PD-L1 MAb NSCLC 2/3L RCC ADC RG7599 lifastuzumab vedotin Pt-resist. OC RG7601 RG7601 RG7604 RG7604 RG7686 RG7853 RG3637 RG7929 RG7697 CHU RG1662 Avastin+Tarceva Kadcyla SERD emactuzumab (CSF-1R) PVNS/s. tumors vanucizumab (Ang2-VEGF MAb) cobimetinib+paclitaxel PD-L1 MAb bladder cancer 1/2L RCC venetoclax venetoclax+rituxan taselisib taselisib glypican-3 MAb alectinib lebrikizumab GIP/GLP-1 dual ago URAT 1 inh GABRA5 NAM EGFR mut+ NSCLC HER2+ NSCLC ER+(HER2-neg) mbc mcrc TNBC 17p del CLL rel/ref DLBCL FL rel/ref NSCLC sq 2L ER+(HER2-neg) BC neoadj liver cancer ALK+ NSCLC 2L IPF atopic dermatitis influenza antibacterial type 2 diabetes gout Alzheimer s Down Syndrome autism RG435 RG1273 RG1273 RG1273 RG3502 RG3502 RG3502 RG3502 RG3502 RG7159 RG7159 RG7159 RG7204 RG7446 RG7601 RG7601 RG7853 RG1569 RG3637 RG7413 RG1450 RG1594 RG1594 Avastin Kadcyla +/- Perjeta Gazyva Actemra gantenerumab ocrelizumab ocrelizumab glioblastoma 1L RG435 1 Avastin ovarian cancer 1L RG435 1 Avastin rel. ovarian ca. Pt-sensitive RG7446 NSC RG7446 RG7446* RG7446* RG7446* RG7446 RG7604 RG7413 HER2+ mbc 1L DLBCL1L large-vessel vasculitis Alzheimer s RMS RG7412 crenezumab Alzheimer s RG7417 lampalizumab geographic atrophy CHU CHU Perjeta+Herceptin Perjeta+Herceptin Perjeta+Herceptin HER2+gastric ca 1L Kadcyla Kadcyla Kadcyla + Perjeta Kadcyla + Perjeta Gazyva Gazyva Zelboraf PD-L1 MAb PD-L1+chemo PD-L1 MAb venetoclax+rituxan venetoclax+gazyva alectinib Actemra lebrikizumab etrolizumab IL-6R MAb HER2+ mbc 2L HER2+ BC adj HER2+ gastric cancer 2L HER2+ BC adj HER2+ BC adj HER2+ BC neoadj inhl rituximab-ref follicular lymphoma 1L melanoma adj NSCLC 2L NSCLC non-sq 1L PD-L1+chemo+Avastin NSCLC non-sq 1L PD-L1+chemo PD-L1 MAb Dx+ PD-L1 MAb Dx+ taselisib etrolizumab NSCLC sq 1L NSCLC sq 1L NSCLC non-sq 1L bladder cancer 2L CLL rel/ref CLL 1L ER+(HER2-neg) mbc ALK+ NSCLC 1L giant cell arteritis severe asthma ulcerative colitis Crohn s disease neuromyelitis optica PPMS RG105 MabThera SC RG Perjeta HER2+ BC neoadj RG7421 cobimetinib + Zelboraf m. melanoma 1 US only : FDA submission decision pending 2 Approved in US, submitted in EU * FPI imminent New Molecular Entity (NME) Additional Indication (AI) Oncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other CLL RG-No Roche Genentech managed CHU Chugai 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 Status as of April 22,

54 NME submissions and their additional indications Projects currently in phase 2 and 3 GABRA5 NAM (RG1662) Down syndrome bitopertin (RG1678) obsessive compulsive dis. taselisib ( RG7604) ER+(HER2-neg) BC neoadj basimglurant (RG7090) depression New Molecular Entity Oncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other SERD (RG6046) ER+(HER2-neg) mbc FIXa/FX bispecific MAb (RG6013) hemophilia A emactuzumab (RG7155) PVNS and solid tumors vanucizumab (RG7221) colorectal cancer taselisib ( RG7604) NSCLC sq 2L PDL1 MAb (RG7446) NSCLC sq 1L (Dx+) PDL1 MAb (RG7446) NSCLC non-sq 1L (Dx+) PDL1 MAb (RG7446)+ chemo NSCLC sq 1L V1 receptor antag (RG7314) autism crenezumab (RG7412) Alzheimer s sembragiline (RG1577) Alzheimer s gantenerumab (RG1450) Alzheimer s ipatasertib (RG7440) solid tumors PDL1 MAb (RG7446)+ chemo NSCLC non-sq 1L lebrikizumab (RG3637) idiopathic pulmonary fibrosis ocrelizumab (RG1594) PPMS polatuzumab vedotin (RG7596) heme tumors PDL1 MAb (RG7446)+chemo + Avastin NSCLC non-sq 1L etrolizumab (RG7413) Crohn s disease lebrikizumab (RG3637) severe asthma lifastuzumab (RG7599) Pt resistant OC cobimetinib+paclitaxel TNBC etrolizumab (RG7413) ulcerative colitis PDL-1 MAb (RG7446) bladder cancer olesoxime (RG6083) SMA taselisib (RG7604) HER2 neg ER+ mbc venetoclax (RG7601) + Rituxan FL rel/ref danoprevir* (RG7227) HCV ocrelizumab (RG1594) RMS PD-L1 MAb (RG7446) NSCLC 2/3L PDL-1 MAb (RG7446) combo Avastin RCC glypican-3 MAb (RG7686) liver cancer venetoclax (RG7601) + Gazyva CLL 1L Flu A MAb (RG7745) influenza alectinib (RG7853) Alk+ NSCLC 2L venetoclax (RG7601) CLL rel/ref alectinib (RG7853) Alk+ NSCLC 1L lampalizumab (RG7417) geographic atrophy venetoclax (RG7601) DLBCL LptD antibiotic (RG7929) antibacterial and beyond * lead market China Unless stated otherwise, submissions are planned to occur in US and EU Status as of April 22,

55 Submissions of additional indications for existing products Projects currently in phase 2 and 3 Gazyva inhl rituximab refractory *Avastin (US) ovarian cancer 1 st L *Avastin (US) rel. ovarian ca. Pt-sens Zelboraf melanoma adj. Kadcyla HER2+ NSCLC Avastin +Tarceva(EU) EGFR mut+ NSCLC Gazyva DLBCL 1L Kadcyla+Perjeta HER2+ BC neoadj Avastin (US) GBM Perjeta + Herceptin HER2+ mbc 2L Kadcyla+Perjeta HER2+ BC adj Kadcyla +/- Perjeta HER2+ mbc 1L Perjeta + Heceptin HER2+ BC adj Gazyva follicular lymphoma 1L Kadcyla HER2+ BC adj Kadcyla HER2+ gastric cancer 2L Actemra giant cell arteritis Perjeta+Herceptin HER2+ gastric cancer 1L Actemra systemic sclerosis and beyond * approved in EU Unless stated otherwise, submissions are planned to occur in US and EU Status as of April 22, 2015 Oncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other NME 55

56 Major granted and pending approvals 2015 Approved Pending approvals US Lucentis diabetic retinopathy February 2015 cobimetinib + Zelboraf m. melanoma Filed December 2014 Avastin cervical cancer April 2015 Perjeta HER2+ BC neoadj Filed September 2014 EU cobimetinib + Zelboraf m. melanoma Filed September 2014 MabThera SC CLL Filed November 2014 Japan-Chugai Xeloda gastric cancer adj Filed December 2014 Bonviva osteoporosis (oral) Filed February 2015 Status as of April 22, 2015 Oncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other NME 56

57 Cancer immunotherapy pipeline overview Phase I (7 NMEs + 9 AIs) Phase II (1NME + 3 Als) Phase III (1NME + 6AIs) RG6078 IDO inh solid tumors RG7155 emactuzumab (CSF-1R) PVNS/s. tumors RG7446 PD-L1 MAb NSCLC 2L RG7155 emactuzumab (CSF-1R) + PDL1 s.tumors RG7446 PD-L1 MAb NSCLC 2/3L RG7446 PD-L1+chemo NSCLC non-sq 1L RG7446 RG7446 RG7446 PD-L1 MAb solid tumors PD-L1+Zelboraf+/-cobimetinib melanoma PD-L1+Avastin+chemo solid tumors RG7446 RG7446 PD-L1 MAb bladder cancer 1/2L RCC NSC RG7446 PD-L1 MAb +Avastin RCC RG7446 RG7446 PD-L1+chemo+Avastin NSCLC non-sq 1L PD-L1+chemo NSCLC sq 1L PD-L1 MAb Dx+ NSCLC sq 1L RG7446 PD-L1 MAb+cobimetinib solid tumors RG7446 PD-L1 MAb Dx+ NSCLC non-sq 1L RG7446 PD-L1 MAb+ipi/IFN solid tumors RG7446 PD-L1 MAb bladder cancer 2L RG7446 PD-L1 MAb+Tarceva NSCLC EGFR+ RG7446 PD-L1 MAb+Gazyva lymphoma RG7802 RG7813 CEA CD3 TCB CEA IL2v solid tumors solid tumors RG7813 CEA IL2v + PD-L1 MAb solid tumors RG7876 CD40 imab+pd-l1 MAb solid tumors RG7888 OX40 MAb solid tumors *INCB *CDX PD-L1 MAb + IDO inh solid tumors PD-L1 MAb + varlilumab solid tumors *external collaborations: INCB- Incyte INCB024360; CDX Celldex CD27 MAb Status as of April 22,

58 Pipeline summary Marketed products additional indications Global Development late-stage trials pred (Roche Pharma Research & Early Development) gred (Genentech Research & Early Development) Roche Group Q results Diagnostics Foreign exchange rate information 58

59 Avastin Ovarian cancer clinical development programme Indication Phase/study Phase III GOG-0218 Front-line metastatic ovarian cancer Phase III ICON7 # of patients N=1,873 N=1,528 Design ARM A: Paclitaxel and carboplatin for 6 cycles plus 5 cycles of concurrent placebo followed by placebo alone for up to 22 cycles (15 months) ARM B: Paclitaxel and carboplatin for 6 cycles plus 5 cycles of concurrent Avastin followed by placebo alone for up to 22 cycles (15 months) ARM C: Paclitaxel and carboplatin for 6 cycles plus 5 cycles of concurrent Avastin followed by Avastin alone for up to 22 cycles (15 months) Avastin dose 15 mg/kg q3 weeks 7.5 mg/kg q3 weeks ARM A: Paclitaxel and carboplatin for 6 cycles ARM B: Paclitaxel and carboplatin plus concurrent Avastin for 6 cycles followed by Avastin alone for up to 18 cycles (12 months) Primary endpoint Progression-free survival Progression-free survival Status Study met its primary endpoint in Q Data presented at ASCO 2010 and 2011 Results: NEJM 2011 Dec 29;365(26): Study met its primary endpoint Q Data presented at ESMO 2010 and ASCO 2011 Results: NEJM 2011 Dec 29;365(26): OS data presented at ECC 2013 EMA approval granted Q Re-evaluate FDA submission in 2015 ASCO=American Society of Clinical Oncology; ESMO=European Society for Medical Oncology 59

60 Avastin Cervical and brain cancer clinical development programmes Indication Stage IVB, recurrent or persistent cervical cancer Newly diagnosed glioblastoma Phase/study Phase III GOG-240 Phase III AVAglio # of patients N=452 N=920 Design Avastin dose Primary endpoint ARM A: Paclitaxel, cisplatin ARM B: Paclitaxel, cisplatin plus Avastin ARM C: Paclitaxel, topotecan ARM D: Paclitaxel, topotecan plus Avastin 15 mg/kg q3 weeks Overall survival Status Study met its primary endpoint Q Results published in NEJM Feb. 2014; 370(8): Filed globally Q FDA approval granted Q Approved in EU Q ARM A: Concurrent radiation and temozolomide plus placebo; followed by maintenance TMZ plus placebo for 6 cycles; then placebo until disease progression ARM B: Concurrent radiation and TMZ plus Avastin; followed by maintenance TMZ plus Avastin for 6 cycles; then Avastin (15mg/kg q3 weeks) monotherapy until disease progression 10 mg/kg q2 weeks or 15 mg/kg q3 weeks Progression-free survival Overall survival Co-primary endpoint of PFS met Q Overall survival data presented at ASCO 2013 Filed in EU Q Negative CHMP opinion Q US filing pending TMZ=temozolomide ASCO=American Society of Clinical Oncology 60

61 Avastin Lung, breast and ovarian cancer development programmes Indication Adjuvant lung cancer First-line HER2-negative metastatic breast cancer Relapsed platinum-sensitive ovarian cancer Phase/study Phase III ECOG 1505 Phase III MERiDiAN Phase III OCEANS # of patients N=1,500 N=480 N=484 Design Avastin dose Primary endpoint ARM A: Cisplatin plus vinorelbine, docetaxel, gemcitabine or pemetrexed ARM B: Cisplatin plus vinorelbine, docetaxel, gemcitabine or pemetrexed plus Avastin up to 12 months ARM A: Paclitaxel + Avastin ARM B: Paclitaxel + Placebo ARM A: Carboplatin, gemcitabine, and concurrent placebo for 6-10 cycles, followed by placebo alone until disease progression ARM B: Carboplatin, gemcitabine, and concurrent Avastin for 6-10 cycles, followed by Avastin alone until disease progression. 15 mg/kg q3 weeks 10 mg/kg q2 weeks 15 mg/kg q3 weeks Overall survival Status Recruitment completed Q Trial stopped for futility Q SGO=Society of Gynecologic Oncology PFS in ITT PFS in patients with high plasma VEGF-A Co-primary endpoints met Q Data to be presented in 2015 Progression-free survival Study met its primary endpoint Q EMA approval granted Q Final data presented at SGO 2014 Re-evaluate FDA submission in

62 Erivedge A novel small molecule inhibitor of the hedgehog signaling pathway Indication Locally advanced or metastatic basal cell carcinoma Idiopathic pulmonary fibrosis Phase/study Phase II STEVIE Phase II # of patients N=1,200 N=129 Design Single ARM: 150 mg Erivedge orally once daily ARM A: Erivedge 150mg daily ARM B: placebo Primary endpoint Safety: Incidence of adverse events Change in forced vital capacity (FVC) Status FPI Q FPI pending in anticipation of trial design amendment to incorporate new standard of care Esbriet In collaboration with Curis 62

63 Esbriet Small molecule with activity in fibrotic diseases Indication Systemic sclerosis-related interstitial lung disease (SSc-ILD) Phase/study Phase II LOTUSS # of patients N=63 Design Open-label, randomized, parallel-group, safety and tolerability study 2 week vs. 4 week dose titration regimens Primary endpoint Safety Status LPI Q Data to be presented at ATS 2015 ATS=Annual Meeting of American Thoracic Society 63

64 Gazyva/Gazyvaro Type II, glycoengineered anti-cd20 monoclonal antibody Indication Previously untreated or relapsed/refractory chronic lymphocytic leukemia Diffuse large B-cell lymphoma (DLBCL) Phase/study Phase III GREEN Phase III GOYA # of patients N=800 N=1,418 Design Single-arm cohort study: Gazyva alone or in combination with different chemotherapy regimens (FC, Bendamustin or Clb), investigation of different strategies to reduce IRRs ARM A: Gazyva 1000mg IV plus CHOP ARM B: MabThera/Rituxan plus CHOP Primary endpoint Safety in combination with different chemotherapy regimens Progression-free survival Status FPI Q Initial safety data presented at ASH 2014 Recruitment completed Q Trial continues after interim analysis in 2015 Final data expected in 2016 In collaboration with Biogen Idec ASH=American Society of Hematology 64

65 Gazyva/Gazyvaro Type II, glycoengineered anti-cd20 monoclonal antibody Indication Indolent non-hodgkin s lymphoma MabThera/Rituxan refractory Front-line indolent non-hodgkin s lymphoma Phase/study Phase III GADOLIN Induction and maintenance study Phase III GALLIUM Induction and maintenance study # of patients N=411 N=1,401 Design ARM A: Gazyva 1000mg IV plus bendamustine followed by Gazyva mainteinance ARM B: bendamustine ARM A: Gazyva 1000mg IV plus chemotherapy followed by Gazyva maintenance ARM B: MabThera/Rituxan plus chemotherapy followed by MabThera/Rituxan maintenance Chemotherapy: For follicular lymphoma: CHOP, CVP or bendamustine For non-follicular lymphoma: physician s choice Primary endpoint Progression-free survival Progression-free survival Status Trial stopped at interim for efficacy Q Data to be presented at ASCO 2015 Expect global filing in 2015 Recruitment completed Expect data in 2017 In collaboration with Biogen Idec CHOP=Cyclophosphamide, Doxorubicin, Vincristine and Prednisone; CVP=Cyclophosphamide, Vincristine and Prednisolone 65

66 Kadcyla Evaluating new treatment options in HER2-positive early breast cancer Indication Phase/study HER2-positive neoadjuvant breast cancer Phase III KRISTINE HER2-positive early breast cancer high-risk patients Phase III KATHERINE Operable HER2-positive early breast cancer Phase III KAITLIN # of patients N=432 N=1,484 N=2,500 Design Before surgery patients will receive 6 cycles of: ARM A: Herceptin plus Perjeta plus docetaxel plus carboplatin ARM B: Kadcyla plus Perjeta After surgery patients will receive: ARM A: Herceptin plus Perjeta ARM B: Kadcyla plus Perjeta ARM A: Kadcyla 3.6mg/kg q3w ARM B: Herceptin Following surgery and antracycline-based therapy: ARM A: Herceptin 6mg/kg q3w plus Perjeta 420 mg/kg q3w plus chemo ARM B: Kadcyla 3.6mg/kg q3w plus Perjeta 420mg/kg q3w plus chemo Primary endpoint Pathologic Complete Response (pcr) Invasive disease-free survival (IDFS) Invasive disease-free survival (IDFS) Status FPI Q FPI Q FPI Q In collaboration with ImmunoGen, Inc. 66

67 Kadcyla Evaluating new treatment options in HER2-positive breast and gastric cancer Indication Phase/study Previously untreated HER2 pos. metastatic breast cancer Phase III MARIANNE Previously treated locally advanced or metastatic HER2-positive gastric cancer Phase II/III GATSBY HER2-positive advanced (2L+) NSCLC Phase II # of patients N=1,092 N=412 N=40 Design ARM A: Herceptin plus taxane ARM B: Kadcyla 3.6mg/kg q3w plus Perjeta ARM C: Kadcyla 3.6 mg/kg q3w plus placebo ARM A: Kadcyla 3.6mg/kg q3w ARM B: Kadcyla 2.4mg/kg weekly ARM C: docetaxel or paclitaxel Single-agent Kadcyla 3.6 mg/kg Primary endpoint Progression-free survival assessed by IRF Phase II: Dose-finding Phase III: Overall survival Overall response rate and safety Status Study met non-inferiority endpoint, showing similar progression-free survival (PFS) among the three arms Q Study did not meet PFS superiority endpoint for Kadcyla-containing regimens Q Data to be presented at ASCO 2015 Recruitment completed Q Data expected in 2015 FPI Q In collaboration with ImmunoGen, Inc. ASCO=American Society of Clinical Oncology 67

68 MabThera/Rituxan Oncology development programme Indication Phase/study Previously untreated chronic lymphocytic leukemia Phase Ib SAWYER Subcutaneous study Study being conducted ex-us # of patients N=225 Design Two-stage design: - Stage 1 (dose-finding, N=55) - Stage 2 (N=170): CLL dose confirmation: ARM A: MabThera IV plus chemotherapy (fludarabine and cyclophosphamide) ARM B: MabThera 1600mg SC plus chemotherapy (fludarabine and cyclophosphamide) Primary endpoint Status Part 1: PK (dose selection) Part 2: PK of MabThera IV versus MabThera SC (arm A vs. arm B) Stage 2 data confirmed non-inferior PK and comparable safety/efficacy of MabThera 1600mg SC vs. MabThera IV Presented at ASH 2014 Filed in EU Q Subcutaneous MabThera : applies Enhanze technology, partnered with Halozyme ASH=American Society of Hematology 68

69 Perjeta First in a new class of HER dimerization inhibitors Indication Phase/ study Neoadjuvant HER2-positive breast cancer Phase II NEOSPHERE Phase II TRYPHAENA Adjuvant HER2-positive breast cancer Phase III APHINITY # of patients N=417 N=225 N=4,803 Design Primary endpoint Status ARM A: Herceptin plus docetaxel ARM B: Perjeta (840mg loading, 420mg q3w) plus Herceptin and docetaxel ARM C: Perjeta plus Herceptin ARM D: Perjeta plus docetaxel Pathologic complete response (pcr) Positive data presented at SABCS 2010 Biomarker data presented SABCS 2011 Survival data to be presented at ASCO 2015 ARM A: FEC followed by Taxane with Herceptin and pertuzumab (H+P given concurrently) ARM B: FEC followed by Taxane with Herceptin + pertuzumab (H+P given sequentially) ARM C: TCH + pertuzumab (H+P given concurrently) Safety Positive safety and efficacy data presented at SABCS 2011 FDA approval granted Q Filed in EU Q ARM A: Perjeta (840mg loading, 420 q3w) plus Herceptin for 52 weeks plus chemotherapy (6-8 cycles) ARM B: placebo plus Herceptin (52 weeks) plus chemotherapy (6-8 cycles) Invasive disease-free survival (IDFS) Recruitment completed Q Expect data in 2016 FEC = Fluorouracil, Epirubicin, and Cyclophosphamide; TCH = Docetaxel, Carboplatin, Herceptin; SABCS=San Antonio Breast Cancer Symposium; ASCO=American Society of Clinical Oncology 69

70 Perjeta First in a new class of HER dimerization inhibitors Indication Second-line HER2- positive metastatic breast cancer Advanced HER2-positive gastric cancer Neoadjuvant/adjuvant HER2-positive breast cancer Phase/ study Phase III PHEREXA Phase III JACOB Phase II BERENICE # of patients N=450 N=780 N=400 Design ARM A: Herceptin plus Xeloda ARM B: Perjeta plus Herceptin and Xeloda ARM A: Perjeta (840mg loading, 420mg q3w) plus Herceptin and chemotherapy ARM B: placebo plus Herceptin and chemotherapy Neoadjuvant treatment: ARM A: ddac q2w x4 cycles followed by weekly paclitaxel for 12 weeks, with P+H x4 cycles ARM B: FEC+P+H x4 cycles followed by docetaxel+p+h x4 cycles Adjuvant treatment: P+H q3w to complete 1 year of HER2 therapy Hormonal and radiation therapy as indicated Primary endpoint Progression-free survival Overall survival Safety Status Recruitment completed Q Expect data in 2015 FPI Q FPI Q ddac=dose-dense doxorubicin plus cyclophosphamide; FEC = Fluorouracil, Epirubicin, and Cyclophosphamide 70

71 Zelboraf A selective novel small molecule that inhibits mutant BRAF Indication Adjuvant therapy in patients with resected cutaneous BRAF mutation positive melanoma Phase/study Phase III BRIM8 # of patients N=725 Design 52-week treatment ARM A: Zelboraf 960mg bid ARM B: Placebo Primary endpoint Disease-free survival Status FPI Q In collaboration with Plexxikon, a member of Daiichi Sankyo Group See also combinations with: cobimetinib (RG7421) and anti-pdl1 (RG7446) 71

72 Actemra/RoActemra Interleukin 6 receptor inhibitor Indication Systemic sclerosis Giant Cell Arteritis Phase/study Phase II fasscinate Proof-of-concept study Phase III GiACTA # of patients N=86 N=250 Design Primary endpoint Blinded 48-week treatment with weekly dosing: ARM A: Actemra SC 162mg ARM B: Placebo SC Open-label weekly dosing at weeks 49 to 96: Actemra SC 162mg Change in modified Rodnan skin score (mrss) at week 24 Safety Part 1: 52-week blinded period ARM A: Actemra SC 162mg qw + 26 weeks prednisone taper ARM B: Actemra SC 162mg q2w + 26 weeks prednisone taper ARM C: Placebo+ 26 weeks prednisone taper ARM D: Placebo+ 52 weeks prednisone taper Part II: 104-week open label extension patients in remission followed off of the study drug; Patients with active disease receive open label Actemra SC 162mg qw Proportion of patients in sustained remission at week 52 Status 48 week data presented at ACR 2014 Primary and all key secondary endpoints showed trend for improved efficacy FPI Q In collaboration with Chugai ACR=American College of Rheumatology 72

73 Pipeline summary Marketed products additional indications Global Development late-stage trials pred (Roche Pharma Research & Early Development) gred (Genentech Research & Early Development) Roche Group Q results Diagnostics Foreign exchange rate information 73

74 Alectinib (ALK inhibitor, RG7853, AF802) New CNS-active inhibitor of anaplastic lymphoma kinase Indication Phase/study Treatment naïve ALK-positive advanced NSCLC Phase III ALEX ALK-positive crizotinib-naïve advanced NSCLC Phase I/II AF-001JP Japanese study # of patients N=286 N=70 Design ARM A: alectinib 600mg BID ARM A: crizotinib 250mg BID Part 1: Dose escalation monotherapy Part 2: Monotherapy, dose selected based on the results of Part 1 Primary endpoint Progression-free survival Phase I: Determination of recommended dose Phase II: Safety and efficacy Status FPI Q Results published in Lancet Oncology 2013 Jun;14(7):590-8 Approved in Japan with brand name ALECENSA July 2014 In collaboration with Chugai 74

75 Alectinib (ALK inhibitor, RG7853, AF802) New CNS-active inhibitor of anaplastic lymphoma kinase Indication Phase/study ALK-positive advanced NSCLC after progression on crizotinib treatment Phase I/II AF-002JG/NP28761 US study ALK-positive advanced NSCLC after progression on crizotinib treatment Phase I/II ACCALIA/NP28673 # of patients Design Phase I: N=36 Phase II: N=85 Part 1: Dose escalation monotherapy Part 2: Monotherapy, dose selected based on the results of Part 1 N=130 Part 1: Dose escalation monotherapy Part 2: Monotherapy, dose selected based on the results of Part 1 Primary endpoint Phase I: Determination of recommended dose Phase II: Safety and efficacy Phase I: Determination of recommended dose Phase II: Safety and efficacy Status Phase I data presented at ECC 2013 Phase I full cohort including CNS data published in Lancet Oncology 2014, Sept.15(10): Phase II FPI Q Primary analysis positive Q Data to be presented at ASCO 2015 Phase II FPI Q Primary analysis positive Q Updated analysis in Q Data to be presented at ASCO 2015 Expect global filing in 2015 Breakthrough therapy designation granted by the FDA June 2013 In collaboration with Chugai ECC=European Cancer Congress; ASCO=American Society of Clinical Oncology 75