Dr. Karl Mahler, Head of Investor Relations Dr. Stefan Frings, Life Cycle Leader Avastin
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1 Roche Positioning AVASTIN-based therapy as essential to treat cancer Dr. Karl Mahler, Head of Investor Relations Dr. Stefan Frings, Life Cycle Leader 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 1
2 Introduction Update on Summary 3 Differentiated and rejuvenated product portfolio From 1 to 9 products with sales around or above CHF 1 billion Pharmaceuticals key products (CHF billion) By year of market introduction 0 '97 '98 '99 '00 '01 '02 '03 '04 '05 '06 '07 Boniva Tarceva Pegasys Herceptin Xeloda NeoRecormon/ Epogin MabThera/ Rituxan CellCept Rocephin Roaccutane 4 2
3 Our oncology strategy: Move the standards of care New tumor types, new combinations, new lines of intervention Clinically differentiated product Example target all tumor types target all important combinations target earlier (adjuvant) intervention Superior outcome for patients 3 rd line 3 rd line 2 nd line 3 rd line 2 nd line 1 st line 2 nd line 1 st line Adjuvant 1 st line Adjuvant Adjuvant NSCLC CRC NHL Ovarian Gastric Prostate RCC BC Completed Ongoing In preparation 5 Introduction Update on Summary 6 3
4 Roche Oncology: Strongest growing franchise : Best growing oncology brand ever CHF billion vs local growth +20 % 6 % +11 % 44 % +14 % Sales launch compared to other cancer therapies (US plus top-5 EU markets 1 ) 5 50 % +28 % Europe/RoW US Japan Quarters since launch 1 Source: IMS. Products included are, Alimta, Arimidex, Camptosar, Eloxatine, Erbitux, Femara, Gemzar, Herceptin, MabThera, Nexavar, Sutent, Tarceva, Taxol, Taxotere, Xeloda 7 Backbone of cancer therapy Number of incident cases per year* 450' ' ' ' ' ' ' '000 50'000 0 *in USA plus top 5 EU countries Breast Prostate Lung Colon and rectum Bladder Non-Hodgkin lymphoma s features remain unique Major cancers tested with VEGF inhibition is broadly applicable in cancer therapy Exclusively targeting VEGF (in contrast to non-specific anti-vegf-r TKIs) Overall good tolerability Preferred partner for combinations Melanoma Stomach Uterus Kidney Leukaemia Pancreas Oral cavity Ovary Liver Brain, nervous system Oesophagus Multiple myeloma Larynx Thyroid Cervix Other pharynx Testis Hodgkin lymphoma Nasopharynx 8 4
5 still early in its journey Realising full potential across tumour types Tumour Colon/ rectal Lung (NSCLC) Breast (HER2-) Breast (HER2+) Kidney (RCC) Early/adjuvant (Potential for cure) (AVANT, NSABP C-08, E5202, E5204) (E1505) (BEATRICE, E5103) (BETH w/herceptin) also trialed in gastric, ovarian, prostate, anhl, and brain (GBM) (Trial names) [Approval status]. More trials are ongoing than listed above. Advanced/metastatic (Extending life) 1 st -line of treatment 2 nd -line of treatment Launched [EU, US, JP; broad label in 1st and subsequent lines] Launched [EU majority of chemos, US carboplatin/paclitaxel] Launched [EU paclitaxel] (AVADO, RIBBON-1) (AVEREL w/herceptin) Launched [EU; with interferon] (BETA Lung w/tarceva) (RIBBON-2, incl. w/xeloda) 9 Major growth opportunities outside the US Herceptin leading the way 100 Herceptin Xeloda Tarceva MabThera/ Rituxan 80 % of Total 2007 Sales % 62 % 53 % 48 % % 0 EU / ROW (incl. Japan) US 10 5
6 in 1 st line mcrc Largest improvement in overall survival in phase III Median survival (months) IFL + placebo: 15.6 vs IFL + : 20.3 HR = 0.66 (95% CI: ) p< OS estimate IFL + IFL + placebo Months CI = confidence interval; IFL irinotecan, bolus 5-FU/FA H. Hurwitz, et al. NEJM 2004;350: in 1 st -line mcrc Consistently delivers the best PFS outcome Hurwitz Hurwitz Douillard BEAT BRiTE AVIRI CRYSTAL NO16966 NO16966 PACCE OPUS IFL n=411 IFL+ n=402 FOLFIRI n=109 FOLFIRI + n=503 FOLFIRI + n=280 FOLFIRI + n=209 FOLFIRI + Cetuximab n=608 FOLFOX/XELOX n=701 FOLFOX/XELOX + n=699 FOLFOX + n=400 FOLFOX + Cetuximab n= months : The only biologic agent with OS benefit in 1 st -line mcrc Adds benefit to all chemotherapies 12 6
7 BRiTE: post 1st progression therapy beyond progression: potential to increase survival No post PD treatment n=253 No post PD n=531 post PD n= Months Superior survival in patients continuing beyond progression demonstrated in a multivariate analysis (HR=0.53, p < 0.001) A. Grothey et al. ASCO Expanding the market for and Xeloda in mcrc to be combined with any chemo in any line of treatment Current EU label: 5-FU or 5-FU + Irinotecan Xeloda 14% 5-FU 8% Oxaliplatin 53% Irinotecan 25% Xeloda Xeloda 14% 5-FU 8% Oxaliplatin 53% Irinotecan 25% New EU label: Any fluoropyrimidine combination Full label any combo 100% Full label any combo 100% New EU label: Any combo, including with Source: Synovate Healthcare
8 in mcrc Conclusions Four randomized trials show compelling efficacy AVF2107g E3200 AVF2192 NO16966 Aiming for cure High rates of surgeries with curative intent shown in BEAT and NO16966 Resection rates for liver mets only patients in NO16966: 19.2% in arm (vs 12.9%) Secondary resection as a concept is promising, but requires further investigation Incidence: 155,000 cases 1, 2) 1) US and top 5 EU, 2) stage IV 15 in adjuvant colon cancer Key phase III trials fully recruited Treatment regimen Number of patients Recruitment duration Efficacy analysis 2,700 NSABP C-08 FOLFOX-6 ± Q until Q First interim look: Q Subsequently every 6 months Next interim look: Q AVANT FOLFOX-4 ± XELOX + 3,450 Q until Q Event-driven analysis Filing 2010 (or earlier) 2010 (or earlier) 1) US and top 5 EU; 2) stage II high risk, and stage III Incidence: 150,000 cases 1,2) 16 8
9 in 1 st line NSCLC (E4599) First drug in a decade to show an overall survival benefit PC + PC 12 mo. 24 mo. 51% 23% 44% 15% HR=0.79 (0.67, 0.92); p = OS estimate Months A. Sandler, et al. NEJM 2006 PC= paclitaxel/carboplatin 17 launching with best-possible label in 1 st -line NSCLC market in Europe 1 Monotherapy / Others 33% Platinum + Vinorelbine 15% Platinum + Gemcitabine 36% Platinum + Taxane 16% Monotherapy / Others 33% label: Platinumbased chemo 67% in combo with all current standards (platinum) Source: Synovate Healthcare, MAT Q3 2007; 1 in non squamous NSCLC 18 9
10 in 1st line NSCLC Conclusions First front-line treatment to demonstrate extended survival in over a decade Efficacy demonstrated in two randomized phase III trials (E4599 and AVAiL) Generally well tolerated Approved in US and approved in EU with a broad label in combination with any platinum-based chemotherapy regimens at least 50% of NSCLC population covered Incidence: 275,000 cases 1, 2) 1) US and top 5 EU, 2) stage IIIb and IV 19 in adjuvant lung cancer High unmet medical need E1505 Stage IB to IIIA adjuvant squamous and non-squamous NSCLC 1500 patients Started Q Chemotherapy +/- (15 mg/kg q3 weeks) Limited therapeutic options currently available Incidence: 135,000 cases 1) 1) US and top 5 EU 20 10
11 Establishing in metastatic breast cancer Strong commitment Current EU label: with paclitaxel Future broad target label Xeloda 17% other 19% Taxane 23% other 19% (e.g. monotherapy Vinorelbine) Anthracycline 25% Anthracyc./ Taxane 16% target label 81% US submission for 1 st line mbc ODAC split vote Dec 5, 2007 FDA action date Feb 23, 2008 Further phase III studies im mbc to report in 2008 AVADO (docetaxel +/- ): primary objective met Feb 2008 RIBBON-1 (var. chemos +/- ): data expected in H Incidence: 100,000 cases 1, 2) Source: Genactis MBC study Q ) US and top 5 EU, 2) stage IV, HER2-pos. and neg. 21 in adjuvant breast cancer Large opportunity major phase III trials started Phase II E2104 E 5103 BEATRICE BETH Patient population HER2-negative HER2-negative HER2-, ER-, PRnegative HER2-positive Number of patients ~3600 Design Primary endpoint Anthracylines + followed by paclitaxel + ( 2 arms) safety AC +/- followed by paclitaxel +/- (3 arms) Disease-free survival Antracycline or taxane-based chemos +/- Disease-free survival Chemo + Herceptin +/- Disease-free survival Status Initial safety results presented at SABCS 2007 FPI Q FPI Q Expect FPI H ) US and top 5 EU Incidence: 320,000 cases 1) 22 11
12 Introduction Update on Summary 23 Roche key therapeutic areas Entering new therapeutic areas beyond oncology Oncology Xeloda MabThera Herceptin Tarceva Pertuzumab R1507 (IGF-1R mab) Apomab Apo2L/TRAIL 14 phase I compounds On Hand RA/Autoimmune MabThera Actemra R1594 ocrelizumab PNP inhibitor 7 phase I compounds Metabolic R1583 GLP-1 R1658 CETP Inh. R1439 dual PPAR R1579 DPP-IV 6 phase I compounds Promising Late Stage Virology Tamiflu Pegasys R3484 HPV16 R1626 HCV pol. Inh. R7128 HCV pol. Inh. R7227 HCV prot. inh. Emerging Mid-Term CNS 4 phase I compounds Early Stage 24 12
13 Roche: A unique investment case Clear and focused strategy Medically-differentiated products; poised to become leader in Personalized Healthcare Attractive risk profile Low generic risk; lowest among European large-cap players 42 phase III projects; many additional indications Assets in place for sustained success World market leader in Oncology Emerging Rheumatology & Autoimmune franchises Promising phase II pipeline in Diabetes, Metabolism; early-stage compounds in CNS and Virology Industry-leading organic growth & value creation 2007: Sales +10 %, Core EPS +20% Unique high-tech healthcare investment 25 Our objectives for 2008 Sales High single-digit local currency sales increase for Roche Group (excl. Tamiflu pandemic 1 ) Above-market sales growth 1 in both divisions Core EPS Core earnings per share target 2 at least at record 2007 level despite significant increase in R&D investment and considerably lower Tamiflu pandemic sales Shareholder return Continuous increase in dividend pay-out ratio over the next 3 years 1 Excluding government and corporate stockpiling orders of Tamiflu for pandemic use 2 At constant exchange rates Barring unforeseen events 26 13
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