Roche. YTD September 2014 sales. Basel, 16 October 2014
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2 Roche YTD September 2014 sales Basel, 16 October 2014
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 Q3 2014: Highlights Growth Group sales +5% 1 as of YTD Sept 2014 driven by HER2 franchise (+21% 1 ), Avastin (+6% 1 ), Actemra (+24% 1 ) and Professional Diagnostics (+8% 1 ) Group International growth accelerated to +8% 1 in Q (up from +6% 1 in Q2 & +3% 1 in Q1) Innovation ESMO 2014 highlights: new data on Perjeta, Avastin in TML and cobimetinib/zelboraf in melanoma as well as encouraging updates on cancer immunotherapy Approvals: Avastin in ovarian cancer (EU), cervical cancer (US); Actemra in early RA (EU); Gazyvaro in CLL (EU) Filings: Lucentis in diabetic retinopathy (US), Perjeta in neo-adjuvant (EU) Acquisition of InterMune Tender offer: Successfully completed, closing September 29, 2014 Financing: Bond issuance successfully completed with USD 5.75bn raised Esbriet: Approved in the US 1 CER=Constant Exchange Rates 5
6 YTD Sept 2014: Strong sales growth continues Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division Diagnostics Division Roche Group CER=Constant Exchange Rates 6
7 Roche Group sales: Continued growth for 3yrs 10% 8% 6% 4% 2% 0% 0% 0% 1% 4% 2% 6% 4% 6% 6% 4% 8% 7% 5% 4% 5% -2% -3% -4% -6% Q3 10 Q4 10-5% 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 All growth rates at Constant Exchange Rates (CER) 7
8 YTD Sept 2014: Both Divisions growing in all regions CHFbn 14 +5% % +12% +2% +2% +6% +5% Diagnostics Pharma % +3% +3% +3% +7% Japan International Europe US All growth rates at Constant Exchange Rates (CER) 8
9 Roche: A pipeline of distinct products Oncology Immunology/ Ophthalmology Neuroscience Avastin Rituxan/MabThera Herceptin Launched Xeloda Tarceva Zelboraf Erivedge Perjeta Kadcyla Gazyva/Gazyvaro Esbriet Pulmozyme Xolair Actemra/RoActemra Lucentis Rituxan/MabThera RA pictilisib 1 Phase III taselisib 1 anti-pdl1 BCL2i cobimetinib alectinib lebrikizumab etrolizumab 2 lampalizumab 3 ocrelizumab gantenerumab Phase II 8 phase II 1 phase II 7 phase II 1 Phase III decision pending; 2 FPI in 1H 2014; 3 FPI in 2H 2014 = Respiratory portfolio highlighted 9
10 Planned data presentations in H ASH Berlin, Oct mglu5 MARIGOLD study (Phase 2 in depression) Chicago, 30 Oct -1 Nov Alecensa (alectinib) 1 Japan Phase 1/2 update Avastin Lung BEYOND study (planned) San Francisco, 6-9 Dec Gazyva GREEN study G + various backbones ACE910 1 Hemophilia 1 In collaboration with Chugai 10
11 2014 Outlook Group sales growth 1 Low- to mid-single digit Core EPS growth 1 Ahead of sales growth Dividend outlook Further increase dividend 1 At constant exchange rates 11
12 Pharmaceuticals Division Daniel O Day COO Roche Pharmaceuticals 12
13 YTD Sept 2014 sales Innovation Outlook 13
14 YTD Sept 2014: Pharma sales US and EU remain major growth contributors Change in % CHFm CHFm CHF CER Pharmaceuticals Division 26,965 27, United States 11,528 11, Europe 7,070 6, Japan 2,406 2, International 5,961 6, CER=Constant Exchange Rates 14
15 YTD Sept 2014: Pharma sales HER2, Avastin & Actemra main growth drivers CER growth Perjeta +255% Herceptin Avastin Kadcyla Actemra/RoActemra MabThera/Rituxan Xolair +7% +6% +148% +24% +3% +24% Activase/TNKase Lucentis Pegasys Xeloda -43% -17% +14% +5% US Europe Japan International CHFm Absolute amounts in CHFm at Constant Exchange Rates (CER) average 2013; all growth rates at CER 15
16 YTD Sept 2014: Oncology sales up 5% Perjeta CER growth HER2 MabThera/ Rituxan Herceptin +21% Kadcyla +3% Strong uptake of Perjeta & Kadcyla Increased usage across a variety of indications Comparison distorted by 340B baseline effect Avastin +6% Treatment through multiple lines in CRC Continued uptake in breast cancer (EU) Tarceva 0% In-class competition Xeloda -43% Loss of exclusivity in EU (Dec 13) & US (March 14) Zelboraf CHFbn -8% Competitive pressure in US & EU Strong growth in International regions CER=Constant Exchange Rates 16
17 Avastin: Future growth supported by ovarian, cervical, breast and colorectal cancer CHFm CER growth % +14% +6% Platinum-resistant ovarian cancer Priority review (FDA, PDUFA Nov 19) and EU approved Cervical cancer US approved and filed in EU HER2 negative breast cancer 500 Positive Phase 3 data in treatment through multiple lines (TML) and 1L 0 Q3 12 Q3 13 Q3 14 US Europe International Japan Colorectal cancer CALGB H2H data support standard of care in 1L CER=Constant Exchange Rates 17
18 HER2 franchise: Strong growth driven by Perjeta and Kadcyla CHFm CER growth % +15% +23% Perjeta 1L ESMO: Unprecedented overall survival benefit in combo with Herceptin of 56.5 months US: OS label update expected in Q Kadcyla 2L 500 Now approved in 63 countries, UK funding through Cancer Drug Fund 0 Q3 12 Q3 13 Q3 14 Herceptin Perjeta Kadcyla Clinical trials MARIANNE results in Q4 14 CER=Constant Exchange Rates 18
19 Actemra: Continued uptake SC formulation driving further growth CHFm CER growth % % +32% +27% +30% +32% +33% +33% +23% +23% +21% 19% SC % IV 50 0 Q1 12 Q2 12 Q3 12 Q4 12 Q1 13 Q2 13 Q3 13 Q4 13 Q1 14 Q2 14 Q3 14 CER=Constant Exchange Rates 19
20 YTD Sept 2014 sales Innovation Outlook 20
21 ESMO 2014: Highlights Strong data across the major oncology franchises Metastatic breast cancer Perjeta: Unprecedented overall survival benefit in 1L HER2+ mbc Avastin: Positive phase 3 data in HER2- mbc in 1L and treatment through multiple lines Cancer immunotherapy anti-pdl1 Bladder cancer: Strong follow-on data in monotherapy Renal cancer: Promising early efficacy data in mono & in combo with Avastin Colorectal cancer : Good safety profile in combo with Avastin & chemo Melanoma cobimetinib + Zelboraf: Strong profile in a market with rapidly changing treatment options Colorectal cancer Avastin: Confirmed standard of care - proven survival benefit in 1L & 2L, irrespective of biomarker status 21
22 CLEOPATRA: Perjeta + Herceptin in 1L mbc Unprecedented overall survival benefit 1.0 OS analysis: Feb Proportion event-free HR % CI = 0.56, 0.84 p = Δ Unprecedented overall survival benefit of ~5 years despite crossover MARIANNE still expected by year end (Perjeta + Kadcyla 1L mbc) Time (months) Perjeta + Herceptin + chemo Placebo + herceptin + chemo Source: Published online in Lancet Oncology Presented at ESMO
23 TANIA: Avastin in 2/3L HER2- mbc Continued use improves outcomes 2L PFS 100 Progression-free survival (%) Δ HR % CI = 0.61, 0.93 p = Statistically significant improvement in 2L PFS No new safety signals Final OS in 2015 Time (months) Avastin + chemo chemo Source: Published online in Lancet Oncology Presented at ESMO
24 cobrim: cobimetinib + Zelboraf in melanoma A competitive MEK/BRAF inhibitor combination PFS Progression-free Survival (%) HR % CI = 0.39, 0.68 p < Δ Time (months) cobimetinib + Zelboraf (n = 247) Placebo + Zelboraf (n = 248) Statistically & clinically significant Benefits of combination therapy across all relevant subgroups Regulatory status: EU filed, US fast track designation with filing in 2014 Source: NEJM 2014 Presented at ESMO
25 Roche in cancer immunotherapy: A comprehensive program in monotherapy and combination Compound Combination Indication Ph 1 Ph 2 Ph 3 PDL1 Mono +Tarceva Lung PDL1 Mono Bladder PDL1 Mono +Avastin Renal PDL1 +Zelboraf Melanoma PDL1 Mono +Avastin +cobimetinib +ipilimumab +IFN alfa-2b Solid tumors PDL1 +Avastin+FOLFOX Colorectal PDL1 Mono +Gazyva Hematology CSF1R Mono +PDL1 Solid tumors +CD40 CEA IL-2v Mono Solid tumors OX-40 Mono Solid tumors CD-40 Mono Solid tumors DNA vaccine Mono Prostate Study ongoing Study planned/imminent 25
26 Anti-PDL1 in bladder: Confirming strength in cancer immunotherapy PD-L1 IHC (n) ORR (95% CI) Dx+ vs Dx- ORR (95% CI) Median PFS (range), weeks IHC 3 (n=10) 60% (27-85) Not reached (5 to 48+) 52% (34-69) IHC 2 (n=23) 48% (27-68) 24 (5 to 50+) IHC 1 (n=24) 17% (6-37) 11 (0.1+ to 30+) 14% (6-28) IHC 0 (n=12) 8% (0-35) 7 (5 to 24+) PD-L1 IHC Durability of response 3 complete responses in PD-L1+ Sustained durability: 19/22 responders continuing to respond Benign side effect profile Phase 3 trials planned Anti-PDL1 is listed as MPDL3280A in clinicaltrials.gov. Diagnostic PD-L1-positive: IHC 2 ( 5% but < 10% ICs); IHC 3 ( 10%. ), PD-L1 negative: IHC 0 (< 1% of ICs) and IHC 1 ( 1% but < 5%). 26
27 Lampalizumab: Pivotal phase 3 started Early AMD Intermediate AMD Advanced AMD Wet AMD Increased drusen & early pigmentary changes CHROMA & SPECTRI: 2 identical, randomized studies (c.940 pts each) Primary endpoint: Reduction in the rate of GA 1 disease progression Geographic Atrophy GA is a progressive, irreversible & blinding disorder Phase 2 (MAHALO): Showed high efficacy in subpopulation with exploratory biomarker 1 Geographic Atrophy 27
28 Esbriet in the US IPF: Rate of disease progression Actions taken Respiratory function / symptoms Adapted from Raghu, 1987 Rapid decline Median survival following diagnosis (years) Progressive fibrotic disease (slow decline) Episodes of acute respiratory worsening US: Change the market from watch and wait to early diagnosis and treatment Field force trained and in place, logistics ready Engagement with pulmonologists from existing Xolair franchise Highlight efficacy and safety profile from day one Ex-US: initiatives to reflect latest clinical data in label Roche to support ongoing efforts 1 Roman et al 2013; 2 Raghu et al 2011; 3 Nalysnyk et al
29 YTD Sept 2014 sales Innovation Outlook 29
30 Q Pipeline update on Phase 3 activity Phase 3 readouts Key Phase 3 starts Compound Kadcyla/Perjeta cobimetinib Indication 1L met. HER2+ BC (MARIANNE) BRAF+ mm (co-brim) Compound Kadcyla Kadcyla Bcl-2 inh anti-pdl1 alectinib etrolizumab gantenerumab lampalizumab Indication adjuvant BC (KAITLIN) neo-adjuvant (KRISTINE) Rel/Ref CLL (MURANO) 2/3L NSCLC (OAK) ALK+ NSCLC inflammatory bowel disease mild AD (Marguerite RoAD) geographic atrophy Outcome studies are event driven, timelines may change 30
31 2014: Key regulatory milestones Compound Indication Milestone Actemra subcutaneous Rheumatoid arthritis EU approval Avastin Glioblastoma EU approval Avastin Cervical cancer US, EU filing Avastin Pt-resistant ovarian cancer EU approval MabThera subcutaneous NHL EU approval Gazyvaro Front line CLL EU approval Xolair Chronic idiopathic urticaria US approval Outcome studies are event driven, timelines may change 31
32 Planned data presentations in H ASH Berlin, Oct mglu5 MARIGOLD study (Phase 2 in depression) Chicago, 30 Oct -1 Nov Alecensa (alectinib) 1 Japan Phase 1/2 update Avastin Lung BEYOND study (planned) San Francisco, 6-9 Dec Gazyva GREEN study G + various backbones ACE910 1 Hemophilia 1 In collaboration with Chugai 32
33 Diagnostics Division Roland Diggelmann COO Roche Diagnostics Picture 33
34 YTD Sept 2014: Diagnostics sales Growth driven by Professional Diagnostics Change in % CHFm CHFm CHF CER Diagnostics Division 7,792 7, Professional Diagnostics 4,397 4, Diabetes Care 1,721 1, Molecular Diagnostics 1,165 1, Tissue Diagnostics Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +7% CER=Constant Exchange Rates 34
35 YTD Sept 2014: Diagnostics regional sales Growth across all geographies North America +6% 25% of divisional sales EMEA 1 +3% 46% of divisional sales Japan +3% 4% of divisional sales Latin America +12% 7% of divisional sales Asia Pacific +15% 18% of divisional sales 15% growth in E7 countries 1 1 Europe, Middle East and Africa; 2 Brazil, China, India, Mexico, Russia, South Korea, Turkey All growth rates at constant exchange rates 35
36 YTD Sept 2014: Growth driven by Professional Diagnostics CER growth Professional Dia +8% Continued double digit growth in immunodiagnostics (+12%) Launch of Anti-Müllerian Hormone test Diabetes Care +1% Sales driven by Accu-Chek Aviva/Performa (+6%), Accu-Chek Mobile (+22%) and Insulin Delivery Systems (+5%) Molecular Dia1 +5% CE launch of cobas 6800/8800, HPV (+57%), virology (+7%) and blood screening (+5%) Tissue Dia Sales CHFbn +10% EMEA North America RoW Double digit growth driven by advanced staining portfolio (+8%) and companion diagnostics (+33%) 1 Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +7% CER=Constant Exchange Rates; EMEA=Europe, Middle East and Africa 36
37 First fully-automated Anti-Müllerian hormone test for fertility Expands leading immunoassay portfolio Target market (IVF): ~ 25 mchf ; +10% AMH test superior to FSH, estradiol and ultrasound measurements Competitive advantages vs manual AMH testing: High sensitivity Improved accuracy At any day of the menstrual cycle Short time to result Test is currently also in development as CDx assay Elecsys AMH cobas e411 FSH = follicle-stimulating hormone; rfsh = recombinant follicle-stimulating hormone; IVF = in vitro fertilization; AMH = Anti-Müllerian hormone 37
38 RMD: Meet the new family - launches of cobas 6800/8800 High Throughput Reference Labs cobas 8800 Advanced PCR automation Highest throughput (3x above closest competitor) CE launch of blood screening assays; virology assays in Q4 Large Hospitals cobas 6800 Medium Hospitals cobas 4800 Low to middle volume throughput Broadest menu incl HPV testing Low Throughput 38
39 Personalised diabetes management New product launches in 2014 Blood glucose monitoring Wireless transfer of blood glucose results Connect: App with proven bolus advisor Data synchronization with healthcare professional portal via cloud Diabetes therapy system Two-way bluetooth communication between pump and remote control Remote control with proven bolus advisor Discrete and easy handling; intuitive display Accu-Chek Aviva / Performa Connect Accu-Chek Insight 39
40 Global access program Landmark partnership in HIV with United Nations The program Special access pricing partnership 40% savings on viral load tests The goals UNAIDS target by 2020: 90% diagnosed 90% treated 90% virally suppressed cobas AmpliPrep/cobas TaqMan HIV-1 Test 40
41 The Ebola outbreak: Roche distributes Ebola PCR Test for research applications LightCycler 480 II Exclusively distributed by Roche 1 on the Lightcycler and cobas platforms For the presence of the Ebola Zaire virus RNA in biological sample material cobas z 480 Technical evaluation currently underway to prepare for Emergency Use Authorization submission to the US FDA and WHO prequalification 1 Developed and produced by TIB MOLBIOL GmbH 41
42 Key launches 2014 Instruments / Devices Area Product Market BA 1 Labs Diabetes Care cobas 6800/8800 Next generation molecular (PCR) system cobas m 511 Fully integrated and automated hematology system cobas 6500 Automated urinalysis work area platform Connect-V Middleware providing connectivity to LIS 2 Accu-Chek Insight- Next generation insulin pump & bgm 3 system Accu-Chek Connect bg meter with connectivity to smart phones, mobile App and cloud WW* EU EU WW EU EU RMD RPD RPD RTD RDC RDC Tests / Assays Infectious Diseases / Blood Screening Microbiology MPX 2.0 Next generation blood screening multiplex test MPX (HIV, HCV, HBV), HEV, DPX 4, WNV 5 Full NAT blood screening menu for cobas 6800/8800 HIV, HCV, HBV Virology tests for cobas 6800/8800 HSV- Detection of Herpes Simplex Virus on cobas 4800 Syphilis Immunoassay for the detection of Treponema pallidum MRSA/SA Next generation assay on cobas 4800 C-difficile Diagnosis of infections and associated diarrhea US WW* WW* EU EU EU EU RMD RMD RMD RMD RPD RMD RMD Women s Health PE Prognosis- Claim extension for short-term prediction of Preeclampsia in pregnancy AMH- Assessment of ovarion reserve for fertility EU EU RPD RPD * Excluding US; 1 Business Areas: RPD: Roche Professional Diagnostics; RDC: Roche Diabetes Care; RMD: Roche Molecular Diagnostics, RTD: Roche Tissue Diagnostics; 2 hospital information systems; 3 blood glucose monitoring; 4 parvovirus B19 and hepatitis A virus; 5 west nile virus 42
43 Finance Alan Hippe Chief Financial Officer 43
44 Q3 2014: Highlights Sales and major currency impact Moderated mainly due to strengthening of US dollar Acquisition of InterMune Transaction completed Financing: Bond issuance successfully completed with USD 5.75bn raised 44
45 Group sales YTD September 2014: Driven by US and Diagnostics +5% +3% +3% +7% +8% +1% +5% 0% Pharma Division +4% Dia Division +6% +1,601-1, 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 2013); 1 avg December 2013 to avg September 2014 fx 45
46 Q3 2014: Acquisition of InterMune Update Tender offer and second step merger Tender offer expired on September 26, 2014 and was not extended Approx. 79% of InterMune s outstanding shares were validly tendered on a fully diluted basis Roche completed acquisition all remaining shares through a second step merger on September 29, 2014 Bond issuance Bond offering successfully completed on September 22, 2014 Total of USD 5.75bn raised Impact on outlook Financial impact expected to be neutral to Core EPS in 2015 and accretive from 2016 No material impact expected from the transaction in 2014 to sales and core earnings outlook 46
47 InterMune financing Roche issues USD 5.75 bn of bonds Nominal (USD bn) Treasury yield or Libor (%) Spread bp Roche yield (%) Coupon 3yr fixed yr floating yr fixed yr floating yr fixed yr fixed TOTAL
48 Q3 2014: Debt maturity profile 72% of Genentech related debt repaid CHFbn September 2014 bond issuance (InterMune financing - USD) GBP CHF EUR USD Of the CHF 48bn bonds and notes issued to finance the Genentech transaction, cumulative CHF 35bn have been repaid as of September 30, 2014* Nominal actual FX rates; *Original net proceeds in CHF 48
49 Currency impact on Swiss franc results 2014 Negative currency impact expected CHF / USD Assumed average YTD 2014 Average YTD % -4% -4% -2% % % Monthly avg fx rates 2014 Fx rates at 30 September 2014 J F M A M J J A S O N D CHF / EUR % -1% % +2% 0% +2% Assuming the 30 Sep 2014 exchange rates remain stable until end of 2014, 2014 impact is expected to be (%p): Q1 HY Sep FY YTD Sales Core operating -8-5 profit Core EPS J F M A M J J A S O N D 49
50 2014 Outlook Group sales growth 1 Low- to mid-single digit Core EPS growth 1 Ahead of sales growth Dividend outlook Further increase dividend 1 At constant exchange rates 50
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52 Changes to the development pipeline Q update New to Phase I New to Phase II New to Phase III New to Registration 3 NMEs added by gred RG6046 SERD ER-pos. HER2- neg. mbc (origin Seragon) RG7888 anti-ox40 MAb - solid tumors RG7893 Nav1.7 inhibitor - pain 1NME added by pred RG6061 HIF1 alpha locked nucleic acid (LNA) - solid tumors (origin Santaris) 1AI RG7446 PD-L1 MAb + ipilimumab or IFN solid tumors 1AI added following filing go decision RG105 MabThera SC - CLL 1 NME moved from Phase 1 RG7697 GIP/GLP-1 dual agonist - T2D 2 NMEs moved from Phase 2 RG7853 alectinib - NSCLC RG7417 lampalizumab - geographic atrophy 1 AI added to reflect the pending FDA submission RG435 Avastin glioblastoma 1st line 1NME following EU submission RG7421 cobimetinib + Zelboraf - metastatic melanoma 1 AI following EU submission RG1273 Perjeta - HER2-pos. BC neoadjuvant 1AI following US submission RG3645 Lucentis diabetic retinopathy Removed from Phase I Removed from Phase II Removed from Phase III Removed from Registration 3 NMEs terminated by gred RG7600 mesothelin ADC - pancreatic cancer RG7636 ETBR ADC - metastatic melanoma RG7845 NME - heme tumors 1 NME terminated by gred RG7667 CMV MAb CMV 1AI RG3616 Erivedge AML 1 AI following EU CHMP neg. opinion RG435 Avastin - glioblastoma 1st line 1NME following approval in the EU RG7159 Gazyvaro - CLL 1 AI following approval in the EU RG1569 Actemra - early RA Status as of October 16,
53 Roche Group development pipeline Phase I (28 NMEs + 10 AIs) Oncology Other disease areas RG105 RG6016 RG6046 RG6061 RG7116 RG7304 RG7388 RG7446 RG7446 RG7446 RG7446 RG7446 RG7446 RG7450 RG7458 RG7601 RG7601 RG7666 RG7741 RG7775 RG7813 RG7841 RG7842 RG7882 RG7888 CHU MabThera SC CLL LSD1 inh AML SERD ER+(HEr2-) mbc HIF1 alpha LNA solid tumors HER3 MAb solid tumors Raf & MEK dual inh solid tumors MDM2 ant solid & hem tumors PD-L1 MAb+Tarceva NSCLC EGFR+ PD-L1 MAb+Zelboraf m. melanoma PD-L1 MAb+Avastin+chemo solid tumors PD-L1 MAb+cobimetinib solid tumors PD-L1 MAb+ipilimum./IFN solid tumors PD-L1 MAb solid tumors Steap 1 ADC prostate ca. MUC16 ADC ovarian & pancreatic ca. Bcl-2 inh + Gazyva CLL Bcl-2 inh heme indications PI3k inh glioblastoma 2L ChK1 inh solid tum & lymphoma MDM2 (4) IV prodrug AML CEA IL2v solid tumors ADC solid tumors ERK inh solid tumors ADC ovarian ca OX40 solid tumors PI3K inh solid tumors RG7624 RG7795 RG7641 CHU RG7203 RG7342 RG7410 RG7893 RG7800 RG7935 RG3645 RG7716 IL-17 MAb autoimmune diseases TLR7 agonist HBV aldosterone synth inh kidney disease URAT 1 inh gout PDE10A inh schizophrenia mglu5 PAM schizophrenia TAAR1 ago schizophrenia Nav1.7 inh pain SMN2 splicer spinal muscular atrophy a-synuclein MAb Parkinson's Disease Lucentis sust. deliv. AMD/RVO/DME VEGF-ANG2 MAb wamd New Molecular Entity (NME) Additional Indication (AI) Oncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other RG-No Roche Genentech managed CHU Chugai managed Status as of October 16,
54 Roche Group development pipeline Phase II (27 NMEs + 7 Als) RG7155 CSF-1R MAb solid tumors & PVNS RG7221 Ang2-VEGF MAb colorectal cancer pictilisib RG7321 pictilisib (PI3K inh) solid tumors RG7440 ipatasertib (AKT inh) solid tumors RG7446 PD-L1 MAb NSCLC 2 nd /3 rd line RG7446 PD-L1 MAb + Avastin RCC RG7446 PD-L1 MAb bladder cancer RG7593 pinatuzumab vedotin (CD22 ADC) hem tumors RG7596 polatuzumab vedotin (CD79bADC) hem tumors RG7597 HER3/EGFR MAb m. epithelial tumors ADC RG7599 lifastuzumab vedotin (NaPi2bADC)Pt-resist. OC RG7601 Bcl-2 inh CLL rel/refract 17pdel RG7601 Bcl-2 inh DLBCL RG7604 taselisib (PI3K inh beta sparing) solid tumors RG7686 glypican-3 MAb liver cancer RG1569 Actemra systemic sclerosis RG3637 lebrikizumab idiopathic pulmonary fibrosis RG7449 quilizumab asthma CHU IL-31R MAb atopic dermatitis RG7128 mericitabine HCV RG7227 danoprevir HCV RG7745 Flu A MAb influenza RG7790 setrobuvir HCV RG7929 LptD antibiotic antibacterial RG7697 GIP/GLP-1 dual ago type 2 diabetes RG1512 inclacumab ACS/CVD RG1577 MAO-B inh Alzheimer s RG1578 decoglurant (mglu2 NAM ) depression RG1662 GABRA5 NAM Down Syndrome RG1678 bitopertin obsessive compulsive dis. RG7090 basimglurant (mglu5 NAM) TRD RG7314 V1 receptor antag autism RG7412 crenezumab Alzheimer s RG6013 FIXa /FX bispecific MAb Status as of October 16, 2014 hemophilia A Phase III (9 NMEs + 19 Als) RG435 1 Avastin glioblastoma 1 st line RG435 Avastin NSCLC adj RG435 1 Avastin ovarian cancer 1 st line RG435 1 Avastin rel. ovarian ca. Pt-sensitive RG1273 Perjeta HER2+ mbc 2 nd line RG1273 Perjeta HER2+ BC adj RG1273 Perjeta HER2+ gastric cancer RG3502 Kadcyla HER2+ gastric cancer RG3502 Kadcyla +/- Perjeta HER2+ mbc 1 st l RG3502 Kadcyla HER2+ BC adj RG3502 Kadcyla + Perjeta HER2+ BC adj RG3502 Kadcyla + Perjeta HER2+ BC neoadj RG7159 Gazyva (obinutuzumab) DLBCL RG7159 Gazyva (obinutuzumab) inhl relapsed RG7159 Gazyva (obinutuzumab) inhl front-line RG7204 Zelboraf melanoma adj RG7446 PD-L1 MAb NSCLC 2 nd line RG7601 Bcl-2 inh CLL rel/refract RG7853 RG1569 RG3637 RG7413 CHU CHU RG1450 RG1594 RG1594 RG7417 alectinib (ALK inhibitor) NSCLC Actemra giant cell arteritis lebrikizumab severe asthma etrolizumab ulcerative colitis Suvenyl enthesopathy IL-6R MAb neuromyelitis optica gantenerumab Alzheimer s ocrelizumab RMS ocrelizumab PPMS lampalizumab (factor D) geo. atrophy Registration (1 NMEs + 4 Als) 2 RG435 2 Avastin recurrent cervical cancer RG435 3 Avastin rel. ovarian ca. Pt-resistant RG1273 Perjeta HER2+ BC neoadj RG7421 cobimetinib + Zelboraf m. melanoma RG Lucentis diabetic retinopathy 1 US only: FDA submission pending 2 Approved in US, submitted in EU 3 Approved in EU, submitted in US 4 Submitted in US New Molecular Entity (NME) Additional Indication (AI) Oncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other 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 54
55 NME submissions and their additional indications Projects currently in phase 2 and 3 CSF-1R MAb (RG7155) PVNS FIXa /FX bispecific MAb (RG6013) hemophilia A Ang2-VEGF MAb (RG7221) colorectal cancer CRC gantenerumab (RG1450) Alzheimer s pictilisib PI3K inh (RG7321) solid tumors MAO-B inh (RG1577) Alzheimer s ipatasertib AKT inh (RG7440) solid tumors decoglurant (RG1578) depression lebrikizumab (RG3637) idiopathic pulmonary fibrosis pinatuzumab vedotin, RG7593 CD22 ADC heme tumors GABRA5 NAM (RG1662) Down syndrome etrolizumab (RG7413) ulcerative colitis polatuzumab vedotin, RG7596 CD79b ADC heme tumors bitopertin (RG1678) obsessive compulsive dis. quilizumab (RG7449) asthma HER3/EGFR MAb (RG7597) m. epithelial tumors basimglurant (RG7090) depression lampalizumab anti-factor D (RG7417) geo atrophy lebrikizumab (RG3637) severe asthma lifastuzumab RG7599 NaPi2b ADC Pt resistant OC V1 receptor antag (RG7314) autism mericitabine (RG7128) HCV PDL-1 MAb (RG7446) bladder cancer taselisib PI3K inh β-sparing (RG7604) solid tumors crenezumab (RG7412) Alzheimer s danoprevir* (RG7227) HCV cobimetinib (MEK inh) combo Zelboraf met melanoma ocrelizumab (RG1594) PPMS and RMS Unless stated otherwise, submissions are planned to occur in US and EU * lead market China PD-L1 MAb (RG7446) NSCLC 2 nd /3 rd line Bcl-2 inh (RG7601) CLL rel/refract glypican-3 MAb(RG7686) liver cancer alectinib ALK inh (RG7853) NSCLC and beyond Status as of October 16, 2014 Oncology Immunology Infectious Diseases CardioMetabolism PDL-1 MAb (RG7446) combo Avastin RCC Bcl-2 inh (RG7601) DLBCL LptD antibiotic (RG7929) antibacterial Neuroscience Ophthalmology Other NME Flu A MAb (RG7745) influenza 55
56 Submissions of additional indications for existing products Projects currently in phase 2 and 3 Lucentis (US) diabetic retinopathy Gazyva inhl relapsed MabThera SC (EU) CLL **Perjeta (EU) EBC neoadjuvant Gazyva frontline NHL Zelboraf met. melanoma adj. *Avastin (US) ovarian cancer 1 st line Gazyva DLBCL Perjeta HER2-pos. gastric cancer *Avastin (US) rel. ovarian ca. Pt-sens *Avastin (US) rel. ovarian ca. Pt-resist **Avastin (EU) cervical cancer recurrent Avastin (US) glioblastoma 1 st line Kadcyla +/- Perjeta HER2-pos mbc 1st line Kadcyla HER2-pos gastric cancer Perjeta HER2-pos. mbc 2 nd line Perjeta HER2-pos. BC adj Actemra giant cell arteritis Kadcyla HER2-pos. early BC Avastin NSCLC adj Actemra systemic sclerosis and beyond Indicates submission to health authorities has occurred. * approved in EU; ** approved in US Unless stated otherwise, submissions are planned to occur in US and EU. Status as of October 16, 2014 Oncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other NME 56
57 Major granted and pending approvals 2014 Approved Pending approvals Esbriet* idiopathic pulmonary fibrosis October 2014 US Avastin cervical cancer August 2014 Xolair chronic idiopathic urticaria March 2014 Avastin rel. ovarian ca. Pt-resist Filed May 2014 Lucentis diabetic retinopathy Filed August 2014 EU MabThera NHL sc formulation March 2014 Actemra RA sc formulation April 2014 Avastin cervical cancer Filed April 2014 Gazyvaro CLL July 2014 Actemra early RA September 2014 Perjeta BC neoadjuvant Filed September 2014 Avastin rel. ovarian ca. Pt-resist August 2014 Esbriet* idiopathic pulmonary fibrosis March 2011 cobimetinib + Zelboraf m. melanoma Filed September 2014 Japan-Chugai alectinib ALECENSA ALK-pos rec/adv NSCLC July 2014 Zelboraf m. melanoma Filed April 2014 Status as of October 16, 2014; * Newly acquired asset (InterMune) Oncology Immunology Infectious Diseases CardioMetabolism Neuroscience Ophthalmology Other NME 57
58 Doing now what patients need next
Innovation and value creation. Severin Schwan, CEO Roche Group. Zurich, January 2015
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