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Roche Q1 2013 sales April 11, 2013 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 www.roche.com All mentioned trademarks are legally protected. 3
Group Severin Schwan Chief Executive Officer 4
Q1 2013: Strong start to the year 2013 2012 Change in % CHF bn CHF bn CHF CER Pharmaceuticals Division 9.2 8.6 6 7 Diagnostics Division 2.4 2.4 1 1 Roche Group 11.6 11.0 5 6 CER=Constant Exchange Rates 5
Q1 2013: Highlights Q1 2013 performance Strong Pharma performance, driven by US and Emerging Markets Solid growth in Professional and Tissue Diagnostics, challenging environment in Diabetes Care Innovation HER2 franchise strengthened through Perjeta (EU) and Kadcyla (US) approvals Perjeta to be filed in the US in neo-adjuvant HER+ breast cancer setting Emerging pipeline to secure MabThera/Rituxan hematology franchise GA101 (ASCO) Bcl-2 (ASCO) 6
Continued high sales growth 1 8% 6% 4% 2% 0% 0% 0% 1% 4% 2% 6% 4% 6% 6% -2% -4% -3% -5% -6% Q3 '10 Q4 '10 Q1 '11 Q2 '11 Q3 '11 Q4 '11 Q1 '12 Q2 '12 Q3 '12 Q4 '12 Q1' 13 At CER=Constant Exchange Rates 7
Q1 13: US and Emerging markets driving sales growth Pharma Diagnostics Asia 10% Asia- Pacific 10% Latin America 4% Latin America 7% EEMEA 11% US 13% North America -4% Japan 2% Japan -2% Europe 1% EMEA 1% All growth rates at CER=Constant Exchange Rates; EEMEA=Eastern Europe, Middle East, Africa; EMEA=Europe, Middle East and Africa 8
Q1 2013: Pipeline milestones aleglitazar metabolic diseases lebrikizumab asthma mglur2 antagonist treatment-resistant depression gantenerumab 1 Alzheimer s mglur5 antagonist treatment-resistant depression ocrelizumab MS crenezumab Alzheimer's bitopertin schizophrenia Anti-PD-L1* solid tumours HCV combo HepC MEKi melanoma Anti-EGFL7 solid tumours etrolizumab ulcerative colitis Oncology onartuzumab (MetMAb) NSCLC obinutuzumab (GA101) * CLL Kadcyla HER2+ BC EGFR ADCC MAb (GA201) solid tumours PI3 kinase solid tumours dual PI3 kinase/mtor solid tumours Anti-factor D geographic atrophy Anti-PCSK9 metabolic diseases inclacumab (P selectin)* ACS/CVD Neuroscience Virology Immunology Ophthalmology Metabolism Ph III NMEs Late stage enabling data expected in 2013 *Data presentation planned/presented 1 Phase II/III label enabling 2013 R&D to remain stable 9
2013 Outlook Group sales growth 1 In line with sales growth recorded in 2012 Core EPS growth 1 Ahead of sales growth Dividend outlook Further increase dividend 1 At constant exchange rates 10
Pharmaceuticals Division Daniel O Day COO Roche Pharmaceuticals 11
Q1 2013: Pharma sales US and International major growth contributors 2013 2012 Change in % CHF m CHF m CHF CER Pharmaceuticals Division 9,170 8,624 6 7 United States 3,912 3,442 14 13 Europe 2,314 2,268 2 1 Japan 826 930-11 2 International 2,118 1,984 7 8 CER=Constant Exchange Rates 12
Q1 2013: Pharma sales Tamiflu, Oncology and Actemra main growth drivers Tamiflu +84% Avastin Herceptin +11% +11% MabThera/Rituxan +6% Actemra/RoActemra Perjeta +32% NA Evista -100% Pegasys -15% Boniva/Bonviva-59% US Europe Japan International -100-50 0 50 100 150 200 Absolute amounts in CHF m at Constant Exchange Rates (CER) average 2012; all growth rates at CER 13
Q1 2013 sales: Oncology franchise MabThera/ Rituxan CER growth +6% Continued uptake in 1 st line maintenance in follicular lymphoma Herceptin Avastin +11% +11% Increased HER2 testing and further uptake in HER2+ gastric cancer Continued launch in ovarian cancer (EU), increased use in mcrc due to treatment through multiple lines label Xeloda +1% US supply of IV 5FU normalised Tarceva 0% Good uptake in 1 st line EGFR mut+ segment, pressure in 2 nd line wild type Zelboraf +154% Fully penetrated in US, strong growth in Europe CHF bn 0.0 0.5 1.0 1.5 2.0 CER=Constant Exchange Rates Oncology Q1 2013 sales: CHF 5.6 bn 14
Avastin sales: Back to solid growth 1'800 CHF m -6% -9% -10% -2% 1% 5% 11% 8% 11% YoY CER growth 1'200 600 0 Q1 '11 Q2 '11 Q3 '11 Q4 '11 Q1 '12 Q2 '12 Q3 '12 Q4 '12 Q1 '13 International Japan Europe US Absolute amounts at 2012 exchange rates 15
HER2 franchise: further improving standard of care Launched in US February 2013 Already included in NCCN guidelines Good launch in US; Approved in EU March 2013 Filing NEOSPHERE data in early breast cancer in Q2 2013 (US) Standard of care in HER2-positive breast cancer HER2 franchise expected to grow despite potential biosimilars entry 16
HER2 franchise sales expected to grow further CHF bn 1.8 15% YoY CER growth 1.6 1.4 7% 14% 16% 10% Kadcyla Perjeta Herceptin 1.2 1 Q1 2012 Q2 2012 Q3 2012 Q4 2012 Q1 2013 17
Pathological complete response, pcr HER2-positive early breast cancer Perjeta and Kadcyla aim to improve cure rates Perjeta in neo-adjuvant setting Kadcyla in adjuvant setting 45.8% 14 cycles 29.0% 16.8% 24.0% HER2+ ebc Preoperative chemotherapy + Herceptin S U R G E R Y Residual invasive tumor, pcr (breast or nodes) Herceptin Kadcyla Herceptin + docetaxel Herceptin & Perjeta + docetaxel Herceptin & Perjeta NEOSPHERE trial to be filed in US in Q2 2013 Perjeta + docetaxel First patient in: April 2013 FDA granted a SPA (Special Protocol Assesment) 1 of 3 planned Kadcyla trials in early breast cancer 1 Declaration that an uncompleted Phase III trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval 18
Lucentis: signs of stabilisation supported by continued growth in DME 500 400 300 200 Q1 '10 Q2 '10 Lucentis quarterly sales (USD m) Q3 '10 Q4 '10 Q1 '11 Q2 '11 Eylea wamd Q3 '11 Q4 '11 Q1 '12 Lucentis DME Q2 '12 Q3 '12 Q4 '12 Q1 '13 AMD 0.5 mg less frequent than monthly dosing regimen added to label February 2013 Competitive environment remains challenging RVO Lucentis share stable DME Further increase in patient share AMD=wet age-related macular degeneration; RVO=retinal vein occlusion; DME=diabetic macular edema 19
Q1 2013 sales: Emerging markets remain strong 1,200 1,000,800,600 1H 12 +13% 2H 12 +15% Q1 13 +11% -27% 0% +9% +18% +7% +5% India Russia S. Korea Turkey Mexico,400 Brazil China,200 +20%,0 Q1 2012 Q2 2012 Q3 2012 Q4 2012 Q1 2013 All growth YoY at CER=Constant Exchange Rates 20
Roche at ASCO: Highlights GA101 CLL11 stage I GA101 or MabThera + chlorambucil vs. chlorambucil alone Avastin Metastatic cervical cancer Anti-PD-L1 Phase I efficacy in NSCLC, melanoma, renal cancer Bcl-2 inhibitor* Phase I, CLL and NHL * In collaboration with AbbVie 21
2013: Major clinical and regulatory news flow Compound Indication Milestone Avastin mcrc (TML) US EU approval Avastin Newly diagnosed glioblastoma EU filing Erivedge Advanced BCC EU approval Regulatory Phase III Herceptin subcutaneous HER2-positive BC EU approval Lucentis AMD PRN US approval Perjeta 1 st line HER2-positive mbc EU approval Tarceva EGFR mut+ 1 st line NSCLC US approval Kadcyla 2 nd line HER2-positive mbc US EU approval obinutuzumab (GA101) Front line CLL Ph III Tarceva Adjuvant NSCLC Ph III RADIANT Xolair Chronic idiopathic urticaria Ph III Outcome studies are event driven, timelines may change 22
Diagnostics Division Roland Diggelmann COO Roche Diagnostics Picture 23
Q1 2013: Diagnostics Division sales Continued growth in core IVD lab business 2013 2012 Change in % CHF m CHF m CHF CER Diagnostics Division 2,419 2,403 1 1 Professional Diagnostics 1,282 1,224 5 5 Diabetes Care 539 564-4 -5 Molecular Diagnostics 276 285-3 -2 Applied Science 165 183-10 -10 Tissue Diagnostics 157 147 7 7 CER=Constant Exchange Rates 24
Q1 2013: Diagnostics Division sales Growth driven by emerging markets North America -4% 24% of divisional sales EMEA 1 1% 48% of divisional sales Japan -2% 5% of divisional sales Latin America +7% 7% of divisional sales Asia Pacific +10% 16% of divisional sales 7% growth in E7 countries 2 1 Europe, Middle East and Africa; 2 Brazil, China, India, Mexico, Russia, South Korea, Turkey All growth at CER=Constant Exchange Rates 25
Q1 2013: Diagnostics Division sales Good momentum in Professional Diagnostics, weakness in Diabetes Care CHF bn Q1 2013 vs. Q1 2012 CER growth Q1 Highlights Professional Dia +5% Launch of Calcitonin test* for diagnosis and monitoring of medullary thyroid cancer; Strong immunoassay sales Diabetes Care -5% Launch of Accu-Chek Active with maltose-independent test strips; Continued reimbursement cut-backs Molecular Dia -2% FDA approved next-generation HCV viral load test; High base for blood screening in Q1 12 Applied Science -10% Impact on sales from recent portfolio prioritization; Lower research funding Tissue Dia +7% EMEA North America RoW Continued double digit growth in EMEA and APAC; US impacted by change of guidelines; New PHC partnerships 0 0.5 1 1.5 EMEA = Europe, Middle East and Africa, APAC = Asia Pacific *: Global ex-us CER = Constant Exchange Rates 26
Diabetes Care: Challenging market environment Cost control and targeted investments in new products Reimbursement cuts & pricing pressures Medicare reimbursement cut of bgm* strips announced Increased competition from low cost providers Restructuring R&D structure consolidated Further measures to adapt cost structure Recently launched premium products Q1: Strong sales growth of Accu-Chek Mobile (+65%), Nano in US (+177%) and Combo in US (+34%) * Blood glucose monitoring 27
Molecular Diagnostics: FDA approval for nextgeneration HCV Test, v2.0 Novel dual probe approach and excellent performance Improved sensitivity, specificity and accuracy across all HCV genotypes Strengthens market lead in viral load testing and helps optimize therapy for patients COBAS AmpliPrep / COBAS TaqMan System - real time PCR Innovative test design with dual targeting reduces mismatches due to mutations 28
Professional Diagnostics: Elecsys Calcitonin test Launch completes Roche s leading thyroid portfolio Elecsys Calcitonin Thyroid Function Thyroid Cancer (TC) & Tumor Markers Market share Global endocrinology market 2011*: CHF 2,436 million TSH FT3 & FT4 T3 & T4 T-uptake Anti-TG Anti-TPO Anti-TSHR TSH STAT Calcitonin Tg II CEA CA 15-3 CA 19-9 CA 72-4 NSE S100 Others Diasorin Abbott 34% Roche Siemens Most comprehensive diagnostics menu for thyroid disorders and cancer Continue to strengthen market share and installed base * Source: Independent IVD consultancy 29
Professional Diagnostics: Success led by integrated lab systems offering Post-analytics Integrated cobas lab solutions Modular analyzers France Consolidation of labs Placement of cobas 8000 systems with integrated analytics Increased market share with 6% sales growth Integrated Pre-analytics Comprehensive test portfolio IT solutions UK Won important NHS tenders Increased market share with 20% sales growth
Key launches 2013 Area Product Market BA 1 Labs cobas 8100 Next generation modular pre-analytics EU RPD Instruments / Devices Life Sciences Diabetes Care GS FLX+ long amplicons- Software for long read targeted sequencing Accu-Chek Insight- Next generation insulin pump & bgm 2 system Accu-Chek Active LCM- Next-generation bgm 1 meter with maltose independent test strips WW EU EU RAS RDC RDC Tests/ Assays Oncology Infectious Diseases Calcitonin Medullary thyroid cancer progrp- Small cell lung cancer CINtec PLUS Cytology- Cervical pre-cancer ER- Breast cancer EGFR- Lung cancer MPX 2.0 Next generation blood screening multiplex test for HIV, HCV & HBV CAP/CTM HCV 2.0 Next generation HCV viral load test EU EU EU US US US US RPD RPD RTD RTD RMD RMD RMD Transplant Cyclosporin, Tacrolimus immunosuppressive drug monitoring EU RPD Sequencing SeqCap EZ Reagent Kits - Targeted next gen. sequencing WW RAS 1 Business Areas. RPD: Roche Professional Diagnostics; RDC: Roche Diabetes Care; RMD: Roche Molecular Diagnostics; RAS: Roche Applied Science; RTD: Roche Tissue Diagnostics; 2 blood glucose monitoring 31
Finance Alan Hippe Chief Financial Officer 32
Q1 2013: Finance highlights IAS19 (revised) Employee benefits No impact on operating profit No impact on EPS growth Minimal impact on net income, EPS and balance sheet Major Q1 cash outflows Dividend (CHF 6.3 bn) Bond maturity (EUR 3.3 bn) Bond call (USD 1.75 bn) No major currency impact 33
Implications of IAS 19 Employee Benefit accounting change - effective 2013 Restated Roche Group core results (CHF m) Year ended 31 December 2012 Six months ended 30 June 2012 As originally published Application of IAS 19 (revised) Restated As originally published Application of IAS 19 (revised) Restated Operating profit 17,160-17,160 8,641-8,641 Associates - - - (2) - (2) Financing costs (2,273) 350 (1,923) (1,058) 171 (887) Other financial income (expense) 471 (514) (43) 239 (252) (13) Profit before taxes 15,358 (164) 15,194 7,820 (81) 7,739 Income taxes (3,480) 51 (3,429) (1,785) 25 (1,760) Net income 11,878 (113) 11,765 6,035 (56) 5,979 Attributable to - Roche shareholders 11,643 (112) 11,531 5,922 (56) 5,866 - Non-controlling interests 235 (1) 234 113-113 Core EPS Basic (CHF) 13.73 (0.13) 13.60 6.99 (0.06) 6.93 Diluted (CHF) 13.62 (0.13) 13.49 6.94 (0.06) 6.88 Impact on Core EPS <1% 34
Q1 2013: Debt maturity profile 66% of Genentech related debt repaid CHF bn 5 4 3 2 Maturity EUR 3.31bn Call of USD 1.75bn USD Repayment Q1/2013 EUR Repayment Q1/2013 1 0 2013 2014 2015 2016 2017 2018 2019 2021 2022 2023 2035 2039 USD EUR CHF GBP Of the CHF 48.2bn bonds and notes issued to finance the Genentech transaction, cumulative 31.2bn have been repaid as of March 31, 2013 * Nominal values @ actual FX rates; *Original net proceeds in CHF 35
New Pharma geographical sales split reflects internal organization Q1 2013 Q1 2012 CER growth CHF Western Europe (Previous) 2,037 m 2,006 m 0% Europe (New) 2,314 m 2,268 m 1% Previous Western Europe New members of the region "Europe" Europe: Region with common market principles (mostly countries of the European Union, governed by European Medicines Agency as the main healthcare authority) CER=Constant Exchange Rates 36
Expected currency impact in 2013 CHF / USD Average YTD 2012 Assumed average YTD 2013 0.94 0.94 0.94 0.93 0.92 0.93 0.94 0.94 0.92 0.92 0.95 0.95 0.95 0.95 0.95 0.95 0.95 0.95 0.95 0.95 Monthly avg Fx rate at 29 March fx rates 2013 2013 J F M A M J J A S O N D CHF / EUR +1% 1.23 +2% 1.21 +1% 1.22 1.22 0% +1% 1.22 +1% +1% +1% 1.20 1.20 1.21 Assuming the 29 March 2013 exchange rates remain stable until end of 2013, 2013 impact is expected to be (%p): Q1 HY Sep YTD FY Sales -1-1 -1-1 Core operating profit 0-1 Core EPS -2-1 1.23 1.23 1.23 1.22 1.22 1.22 1.22 1.22 1.22 1.22 1.22 1.22 J F M A M J J A S O N D 37
2013 Outlook Group sales growth 1 In line with sales growth recorded in 2012 Core EPS growth 1 Ahead of sales growth Dividend outlook Further increase dividend 1 At constant exchange rates 38
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Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development Genentech research and early development Roche Group 2013 sales Diagnostics Foreign exchange rate information 40
Changes to the development pipeline Q1 2013 update New to Phase I New to Phase II New to Phase III New to Registration New AI RG1273 Perjeta BC neoadjuvant 1 NME following in-licensing RG3806 octreolin acromegaly 1 AI transitioned from Ph2 following FPI (April 3, 2013) RG3502 Kadcyla Her2pos early BC 1AI following EU submission RG435 Avastin glioblastoma 1st line Removed from Phase I Removed from Phase II Removed from Phase III Removed from Registration 1AI following termination of the trial RG1273 Zelboraf + ipilimumab in m. melanoma 1 NME following EU approval RG1273 Perjeta Her+ mbc 1st line 1 AI following US approval RG3435 Lucentis AMD 0.5mg PRN X Ais/NME following EU approval (to be monitored in March) RG3616 Erivedge advanced BCC RG105 MabThera ANCA vasculitis 41
Roche Group development pipeline Oncology RG7112 MDM2 ant solid & hem tumors RG7116 HER3 MAb solid tumors RG7155 CSF-1R MAb solid tumors RG7167 MEK inh solid tumors RG7212 Tweak MAb oncology RG7221 Ang2-VEGF MAb oncology RG7304 Raf & MEK dual inh solid tumors RG7356 CD44 MAb solid tumors RG7388 MDM2 ant solid & hem tumors RG7420 MEK inh solid tumors RG7440 AKT inhibitor solid tumors RG7446 PD-L1 MAb solid tumors RG7450 Steap 1 ADC prostate ca. RG7458 ADC ovarian ca. ADC RG7598 ADC multiple myeloma ADC RG7599 ADC oncology ADC RG7600 ADC oncology RG7601 Bcl-2 inh CLL and NHL RG7602 ChK1 inh solid tum & lymphoma RG7604 PI3K inh solid tumors RG7636 ADC metastatic melanoma RG7666 PI3k inh glioblastoma 2L RG7741 ChK1 inh(2) solid tumors RG7853 ALK inhibitor NSCLC CHU PI3K inh solid tumors CHU WT-1 peptide cancer vaccine Phase I (36 NMEs+1 AI) RG7624 CHU CHU RG7795 Other disease areas IL-17 MAb IL-6 MAb CIM331 TLR7 agonist autoimmune diseases RA atopic dermatitis HBV RG7697 GIP/GLP-1 dual ago type 2 diabetes RG1662 GABRA5 NAM cogn. disorders RG7314 V1 receptor antag autism RG7129 BACE1 inh Alzheimer s RG7203 PDE10A inh schizophrenia RG3645 Lucentis sust. deliv. AMD/RVO/DME FIXa CHU /FX FIXa /FX bispecific MAb hemophilia A New Molecular Entity (NME) Additional Indication (AI) Oncology Immunology Virology CardioMetabolism Neuroscience Ophthalmology Others RG-No Roche Genentech managed CHU Chugai managed Status as of March 31, 2013 42
Roche Group development pipeline Phase II (23 NMEs + 14 Als) RG1273 Perjeta BC neoadjuvant RG1273 Perjeta HER2+ mbc 2 nd line RG1273 Perjeta HER2+ gastric cancer RG3502 Kadcyla (T-DM1) HER2+ gastric cancer RG3616 Erivedge operable BCC RG3638 onartuzumab triple-neg mbc, 1 st /2 nd line RG3638 onartuzumab mcrc 1 st line RG3638 onartuzumab NSCLC non squamous 1 st l RG3638 onartuzumab NSCLC squamous 1 st line RG3638 onartuzumab glioblastoma 2 nd line I RG7160 imgatuzumab (GA201) solid tumors RG7204 Zelboraf papillary thyroid cancer pictilisib RG7321 pictilisib (PI3K inh) solid tumors RG7422 PI3K/mTOR inh solid & hem tumors Pa RG7414 parsatuzumab (EGFL7 Mab) solid tumors RG7593 CD22 ADC hem tumors RG7596 CD79b ADC hem tumors RG7597 HER3/EGFR m. epithelial tumors RG7686 glypican-3 MAb liver cancer RG1569 Actemra systemic sclerosis RG7413 etrolizumab ulcerative colitis RG7415 rontalizumab systemic lupus erythem RG7449 quilizumab asthma RG7128 mericitabine HCV RG7227 danoprevir HCV RG7667 - CMV RG7790 setrobuvir HCV RG1512 inclacumab ACS/CVD RG7652 PCSK9 MAb metabolic diseases RG1450 gantenerumab Alzheimer s RG1577 MAO-B inh Alzheimer s RG1578 mglur2 NAM depression RG1678 bitopertin obsessive compulsive dis. RG7090 mglur5 NAM tx.resistant depression RG7412 crenezumab Alzheimer s SST* arbaclofen autism (ASD) RG7417 lampalizumab (factor D ) geo. atrophy Status as of March 31, 2013 RG435 RG435 RG435 RG435 RG435 1 RG435 1 RG435 1 RG1273 RG1415 RG3502 RG3502 RG3502 RG3638 RG3638 RG7159 RG7159 RG7159 RG7159 RG7204 RG7421 RG1569 RG3637 RG3648 RG3806 CHU RG1439 RG1439 RG1439 CHU RG1594 RG1594 RG1678 RG1678 SST* Phase III (10 NMEs + 24 Als) Avastin HER2+ BC adj Avastin HER2-neg. BC adj Avastin NSCLC adj Avastin high risk carcinoid Avastin ovarian cancer 1 st line Avastin rel. ovarian ca. Pt-resistant Avastin rel. ovarian ca. Pt-sensitive Perjeta HER2+ early BC Tarceva NSCLC adj Kadcyla (T-DM1) HER2+ mbc 3 rd line Kadcyla (T-DM1) HER2+ mbc 1 st line Kadcyla (T-DM1) HER2+ early BC onartuzumab NSCLC 2 nd /3 rd line onartuzumab gastric cancer obinutuzumab CLL obinutuzumab inhl relapsed obinutuzumab DLBCL obinutuzumab inhl front-line Zelboraf m. melanoma adj cobimetinib (MEKinh) m. melanoma Actemra early RA lebrikizumab severe asthma Xolair chronic idiopathic urticaria octreolin acromegaly Suvenyl enthesopathy aleglitazar CV risk red post ACS in T2D aleglitazar CV risk red CVD in T2D/ pre-t2d aleglitazar type 2 diabetes tofogliflozin (SGLT2) type 2 diabetes ocrelizumab RMS ocrelizumab PPMS bitopertin schiz neg symptoms bitopertin schiz subopt control arbaclofen fragile X syndrome Registration (2 NMEs + 7 Als RG105 2 MabThera NHL sc formulation RG435 2 Avastin glioblastoma 1 st line RG597 2 Herceptin HER2+ BC sc form RG1415 4 Tarceva NSCLC EGFR mut 1 st line RG3502 3 Kadcyla (T-DM1) HER2+ pretreated mbc RG3616 3 Erivedge advanced BCC RG105 3 MabThera ANCA assoc vascul RG1569 Actemra RA sc formulation RG1569 Actemra polyarticular JIA 1 US only: ongoing evaluation for FDA submission 2 Submitted in EU 3 Approved in US, submitted in EU 4 Approved in EU, submitted in US * Opt-in opportunity from SeaSide Therapeutics New Molecular Entity (NME) Additional Indication (AI) Oncology Immunology Virology CardioMetabolism Neuroscience Ophthalmology RG-No Roche Genentech managed CHU Chugai managed SST Seaside Therapeutics (opt-in) RG105 MabThera is branded as Rituxan in US and Japan RG1569 Actemra is branded as RoActemra in EU 43
NME submissions and their additional indications Projects currently in phase 2 and 3 obinutuzumab (GA101) Frontline DLBCL NHL obinutuzumab (GA101) Frontline NHL onartuzumab (MetMAb) gastric cancer & other AIs etrolizumab (RG7413) ulcerative colitis quilizumab (RG7449) asthma lebrikizumab (RG3637) asthma obinutuzumab (GA101) CLL onartuzumab (MetMAb) mnsclc, 2 nd /3 rd line cobimetinib (MEK inh) (RG7421) combo Zelboraf met melanoma octreolin (RG3806) acromegaly obinutuzumab (GA101) inhl relapsed aleglitazar type-2 diabetes (US/China) aleglitazar (RG1439) CV risk red post ACS in T2D bitopertin (RG1678) schizophrenia# ocrelizumab (RG1594) PPMS and RMS imgatuzumab EGFR (RG7160) solid tumors pictilisib PI3 kin inh (RG7321) solid tumors PI3K/mTOR inh (RG7422) solid & hem tumors parsatuzumab EGFL7 MAb (RG7414) solid tumors CD22 ADC (RG7593) CD79b ADC (RG7596 heme tumors HER3/EGFR (RG7597) m. epithelial tumors glypican-3 MAb (RG7686) liver cancer RG7667 CMV mericitabine (RG7128) HCV danoprevir (RG7227) HCV setrobuvir (RG7790 ) HCV aleglitazar (RG1439) CV risk red CVD in T2D/pre-T2D inclacumab (RG1512) ACS/CVD PCSK9 MAb (RG7652) metabolic diseases 2013 2014 2015 2016 and beyond bitopertin (RG1678) obsessive compulsive dis. gantenerumab (RG1450) Alzheimer s MAO-B inh (RG1577) Alzheimer s mglur2 antag (RG1578) depression mglur5 (RG7090) depression crenezumab (RG7412) Alzheimer s lampalizumab anti-factor D Fab (RG7417) geographic atrophy Unless stated otherwise, submissions are planned to occur in US and EU. indicates a submission which has occurred with regulatory action pending # negative symptoms and sub-optimal control Status as of March 31, 2013 Oncology Immunology Virology CardioMetabolism Neuroscience Ophthalmology NME 44
Submissions of additional indications for existing products Projects currently in phase 2 and 3 Perjeta HER2-pos BC neoadjuvant Avastin rel. ovarian ca. Pt-resist Kadcyla (T-DM1) HER2-pos. early BC Avastin rel. ovarian ca. Pt-sens.(US) Zelboraf met melanoma adj. Avastin ovarian cancer 1 st line (US) Zelboraf papillary thyroid cancer Avastin glioblastoma 1 st line (EU) Perjeta HER2-pos. EBC Avastin glioblastoma 1 st line (US) Perjeta HER2-pos. mbc 2 nd line Tarceva NSCLC adj (EU) Avastin HER2-pos. BC adj Perjeta HER2-pos. gastric cancer Xolair (US) chronic idiopathic urticaria Kadcyla (T-DM1) HER2-pos. mbc 1st line Avastin HER2-neg BC adj Avastin NSCLC adj Actemra early RA Tarceva NSCLC adj (US) Kadcyla (T-DM1) HER2-pos. gastric cancer Actemra systemic sclerosis 2013 2014 2015 2016 and beyond indicates submission to Health Authorities has occurred. Unless stated otherwise, submissions are planned to occur in US and EU. Oncology Immunology Virology CardioMetabolism Neuroscience Ophthalmology 45 Status as of March 31, 2013
Major granted and pending approvals 2013 Approved Pending approvals Avastin mcrc TML Kadcyla T-DM1 HER2-pos pretreated mbc Feb.22, 2013 Actemra sc formulation Filed Dec 2012 US Lucentis AMD 0.5 mg PRN Feb.6, 2013 Tarceva NSCLC EGFR mut. 1 st line Filed Nov 2012 Actemra polyarticular JIA Filed June 2012 EU Perjeta HER2-pos. mbc 1 st line March 4, 2013 Erivedge adv. basal cell carcinoma Filed Nov 2011 Actemra polyarticularjia Filed June 2012 Kadcyla T-DM1) HER2+ advanced mbc Filed Aug 2012 Actemra sc formulation Filed Dec 2012 MabThera NHL sc formulation Filed Dec 2012 MabThera ANCA associated vasculitis Filed Apr 2012 * Herceptin Her2+ BC sc formulation Filed Mar 2012 *positive CHMP opinion granted Oncology Immunology Virology CardioMetabolism Status as of March 31, 2013 Neuroscience Ophthalmology NME Avastin glioblastoma 1 st line Filed Mar 2013 46
Major Chugai granted and pending approvals 2013 Approved Actemra sc formulation Approved March 25, 2013 Pending approvals Avastin recurrent glioblastoma Filed September 2012 Avastin ovarian cancer Filed October 2012 Kadcyla HER2+ pretreated mbc Filed Jan 2013 Perjeta HER2-pos. mbc Filed May 2012 Tarceva NSCLC EGFR mut 1 st line Filed June 2012 Boniva/Bonviva osteoporosis Filed July 2012 Status as of March 31, 2013 Oncology Immunology Virology CardioMetabolism Neuroscience Ophthalmology NME 47
Doing now what patients need next