Roche Lazard Capital Markets 7 th Annual Healthcare Conference. Thomas Kudsk Larsen, 17 November 2010
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1 Roche Lazard Capital Markets 7 th Annual Healthcare Conference Thomas Kudsk Larsen, 17 November 2010
2 This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as believes, expects, anticipates, projects, intends, should, seeks, estimates, future or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others: 1 pricing and product initiatives of competitors; 2 legislative and regulatory developments and economic conditions; 3 delay or inability in obtaining regulatory approvals or bringing products to market; 4 fluctuations in currency exchange rates and general financial market conditions; 5 uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products; 6 increased government pricing pressures; 7 interruptions in production; 8 loss of or inability to obtain adequate protection for intellectual property rights; 9 litigation; 10 loss of key executives or other employees; and 11 adverse publicity and news coverage. Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. For marketed products discussed in this presentation, please see full prescribing information on our website All mentioned trademarks are legally protected 2
3 Business update Pipeline highlights 3
4 Group: Sales YTD September 2010 Solid sales growth in first nine months YTD Sept YTD Sept change in % Excluding CHF bn CHF local Tamiflu* Pharmaceuticals Division Diagnostics Division Roche Group *in local currency 4
5 Diagnostics: Growth driven by Professional Diagnostics and Diabetes Care CHF bn YTD Sept 10 vs. YTD Sept 09 local growth Professional Dia +10% Nth America growing 10%; Sept US launch of Clinical chemistry modules for cobas 8000 modular analyzer series Diabetes Care +5% Strong above-market growth in EMEA 1 and LATAM 2 ; Driven by Accu-Chek Performa and Accu-Chek Aviva Molecular Dia +4% Strong placements of cobas 4800 systems ex-us; TaqScreen DPX Test (parvo B19 & HAV) received CE mark Applied Science +8% Robust up-take GS Junior DNA sequencer EU & APAC 3 ; Low H1N1 testing dampening reagent sales Tissue Dia +18% EMEA North America RoW Launched 4 new Abs in US as aid diagnosis various cancers; Acquired BioImagene Inc. to strengthen Digital Pathology Europe, Middle East, Africa 2 Latin America 3 Asia Pacific 5
6 Pharma: Sales YTD September change in % Excluding CHF m CHF m CHF local Tamiflu* Pharmaceuticals Division 29,034 28, United States 11,157 10, Western Europe 8,026 7, Japan 3,490 3, International 6,361 7, Quarterly growth rates Q1 Q2 Q3 Q4 Q1 Q2 Q3 Pharmaceuticals Division excl. Tamiflu % in LC vs. prior year *in local currency 6
7 Pharma: Major growth contributors* Oncology products driving growth AVASTIN 528 MABTHERA / RITUXAN HERCEPTIN LUCENTIS ACTEMRA XELODA TARCEVA MIRCERA NEORECORMON / EPOGIN CELLCEPT TAMIFLU *Absolute amounts in CHF m at 2009 exchange rates; products with contribution above CHF 50 m 7
8 Pharma: Late-stage pipeline progressing well Extensive clinical data by year-end Number of NMEs Virology CNS Metabolic Inflammation 10 RG1678 GRI up to 14 HCV pol inh 1 ocrelizumab MS 1 RG1678 GRI SGLT2 inh 2 aleglitazar AASLD ECTRIMS ACNP 5-9 Dec. Phase II in house Recruitment on track Oncology aleglitazar taspoglutide taspoglutide dalcetrapib Recruitment finalized 2 ocrelizumab Actemra 4 taspoglutide dalcetrapib ocrelizumab pertuzumab dalcetrapib ocrelizumab Hedgehog inh BRAF inhibitor T-DM1 RG7159 (CLL) pertuzumab lebrikizumab 2 MetMAb 1 Hedgehog inh BRAF inhibitor T-DM1 RG7159 (CLL, NHL) pertuzumab Phase II data expected in 2010 ESMO SMR/Intl. Melanoma Congress 4-9 Nov. ESMO Data in 2011 ASH 4-7 Dec. SABCS 8-12 Dec E 1 LIP decision made, phase III pending; 2 LIP and phase III decision pending 8
9 Group: 0utlook for on track to achieve goals Sales growth (in LC) Group & Pharma (excl. Tamiflu): mid single-digit Diagnostics: significantly above market Synergies 2010: CHF 800 m 2011: CHF 1,000 m R&D investment Core EPS growth (in LC) Slightly below 2009 level Double-digit Debt 2010: 33% reduction (revised from 25%) 2015: Aim to return to net cash position 3 yr Dividend outlook Maintained (as announced in 2008)* Barring unforeseen events; Total Tamiflu sales of up to CHF 1 bn assumed for 2010; LC=Local Currency * Continuous increase in dividend pay-out ratio over the period
10 Business update Pipeline highlights 10
11 Phase II MetMab Study: Met High NSCLC patients benefit from MetMAb + Tarceva Analysis of Met High Patients PFS, HR=0.56 OS, HR= /23 patients from the Tarceva+placebo arm who crossed over to MetMAb were Met High. Spigel et al, ESMO
12 T-DM1 vs. Herceptin + docetaxel in Breast Cancer Potential for lower rate of chemo-related side effects T-DM1 (n=67) Trastuzumab + Docetaxel (n=70) Patients with an Objective Response 32 (47.8%) 29 (41.4%) Safety Evaluable Patients (n=67) (n=68) Any AE, n (%) 63 (94.0) 68 (100.0) Grade 3 AE 25 (37.3) 51 (75.0) Three most common AEs (any grade) in trastuzumab + docetaxel arm: Alopecia (hair loss) Neutropenia (reduction white blood cells) Diarrhea 1 (1.5) 5 (7.5) 7 (10.4) 45 (66.2) 39 (57.4) 31 (45.6) ESMO
13 Phase II BRAF Inhibitor (RG7204)* in Mutation Positive Metastatic Melanoma Tumor Regression (Target Lesions) Occurred in Majority of Patients (IRC) RECIST 30% Decrease *** 7 patients had 100% tumor shrinkage, 3 of which had confirmed Complete Response (CR); 1 patient had unconfirmed CR and 3 patients had non-target lesions present 122 patients had baseline and 1post-baseline scan with measurable disease *** * Developed in collaboration with Plexxikon Inc. 13
14 BRAF Mutation Analysis for Patient Selection FFPE Tumor Block Tissue Preparation Genomic DNA Extraction cobas 4800 BRAF V600 Mutation Test (in development as companion diagnostic) Designed to detect V600E (1799 T>A) mutation Samples analyzed at central labs Average turnaround from sample receipt to test result < 5 days BRAF V600E 5 TaqMan Real-time PCR 5 BRAF WT 324 samples screened; 183 mutationpositive (56%) Normalized Fluorescence Normalized Fluorescence Cycles -1 Cycles 14
15 Ocrelizumab phase II RRMS 24-week data results Gd-enhancing T1 lesions ARR* at week 24 Lesions on MRI by week (ITT): average imputation P= p< for both ocrelizumab doses vs placebo P= % 73% Primary endpoint Placebo (n=54) IFN beta-1a (n=52) Weeks Ocrelizumab 600 mg (n=51) Ocrelizumab 2000 mg (n=52) 0-24 weeks n=54 n=55 n=55 n=54 Li et al, ECTRIMS 2010 * Annualized Relapse Rate 15
16 Short-term newsflow Progress of New Molecular Entities Ocrelizumab in Multiple Sclerosis randomised phase II in RRMS ECTRIMS (15 October, Gothenburg) GA101 in Non-Hodgkin s Lymphoma phase II data in anhl ASH (December 4-7, Orlando) Nucleoside Polymerase inh. in HCV phase IIb PROPEL interim data AASLD (October 28-Nov 2, Boston) BRAF inh. in 2 nd /3 rd line melanoma single arm phase II (BRIM-2) Intl. Melanoma Congress (November 4-9, Sydney) GRI in Schizophrenia randomised phase II ACNP (December 5-9, Miami) Pertuzumab in neoadj. HER2+Breast Cancer randomised phase II NEOSPHERE SABCS (December 8-12, San Antonio) Roche's Late Stage Pipeline Update Focus on data presented at ESMO, ECTRIMS, ASH, International Melanoma Congress and ACNP London, December 9th,
17 Roche in brief Unique high-tech healthcare investment Clear strategy Biotech-based; medically-differentiated products; poised to become leader in Personalized Healthcare Attractive risk profile Limited patent risk; lowest among large-cap biotech & pharma Late stage pipeline progressing well with up to 14 new molecular entities Assets in place for sustained success New Rheumatology & Autoimmune franchise Emerging franchise in Metabolism & Diabetes; earlier-stage compounds in CNS (FPI expected to GlyT-I Phase III by year-end) Unique high-tech healthcare investment 17
18 We Innovate Healthcare 18
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