Roche. Pascal Soriot COO Roche Pharmaceuticals

Transcription

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2 Roche Pascal Soriot COO Roche Pharmaceuticals 2

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 Solid Fundamentals Operational Excellence adapting to a changing environment 4

5 YTD Sept 2010: Pharma Division sales 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 5

6 Pharma Division major growth contributors* Oncology products driving growth AVASTIN MABTHERA HERCEPTIN LUCENTIS ACTEMRA XELODA TARCEVA MIRCERA NEORECORMON / EPOGIN CELLCEPT US Western Europe Japan International *Absolute amounts in CHF m at 2009 exchange rates; products with contribution above CHF 50 m 6

7 Oncology* sales up 8% YTD Major brands CHF bn Avastin MabThera Rituxan Herceptin local growth +11% +8% +8% China: Avastin launched in mcrc Japan: Good uptake in mcrc and mnsclc Continued uptake in CLL and strong use in NHL WE: Benefit from uptake in gastric cancer Japan: negative impact of price cuts in April Xeloda +18% Japan benefiting from mcrc indication approval China: increasing use in gastric cancer Tarceva +8% YTD 9 '10 YTD 9 '09 Strong growth in International, US and Japan Pricing pressure in WE region * YTD Sept 2010 sales: 16.1 bn

8 Actemra/RoActemra in Rheumatoid Arthritis Successful launch Actemra/RoActemra quarterly sales CHF m Uptake remains very encouraging In US, Actemra prescribed by nearly 60% of rheumatologists, patient share currently 4-7% following anti-tnfs In Japan, launch restrictions lifted, improving patients access to Actemra Filed for sjia in US and EU 20 0 Q1 08 Q2 08 Q3 08 Q4 08 Q1 09 Q2 09 Q3 09 Q4 09 Q1 10 Q2 10 Q3 10 8

9 Lucentis New indications fueling growth, mitigating risk CHF m Quarterly US sales AMD: Increase in new patients (~2% per year) and # of injections per patient (currently average of 8 injections in 1 st year and 5 in 2 nd year) Target US population ~188,000 patients RVO: FDA approval in Q2 2010; initial uptake encouraging Growth opportunities Target US population ~100,000 patients DME: Phase III data H Target US population ~245,000 patients Risk CATT Study Data expected early Q1 08 Q2 08 Q3 08 Q4 08 Q1 09 Q2 09 Q3 09 Q4 09 Q1 10 Q2 10 Q3 10 AMD = wet age-related macular degeneration; RVO = retinal vein occlusion; DME = diabetic macular edema. Genentech, a member of the Roche Group, retains commercial rights in the US and Novartis has exclusive commercial rights for the rest of the world. 9

10 Late-stage pipeline progressing well Extensive clinical data by year-end Number of NMEs up to 14 Virology HCV pol inh 1 AASLD CNS ocrelizumab MS 1 ECTRIMS Metabolic Inflammation 10 GlyT-1 inh GlyT-1 inh SGLT2 inh 2 aleglitazar ACNP Phase II in house Recruitment on track Oncology aleglitazar taspoglutide taspoglutide dalcetrapib Recruitment completed dalcetrapib lebrikizumab 2 Phase II data expected in ocrelizumab Hedgehog inh MetMAb 1 Hedgehog inh ESMO Data in ocrelizumab Actemra taspoglutide dalcetrapib ocrelizumab pertuzumab BRAF inhibitor T-DM1 GA101 (CLL) pertuzumab BRAF inhibitor T-DM1 GA101 (CLL, NHL) pertuzumab SMR / Intl. Melanoma Congress ESMO ASH SABCS E 1 LIP decision made, phase III pending; 2 LIP and phase III decision pending 10

11 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) 11

12 MetMAb + Tarceva in lung cancer New example of Personalised Healthcare approach PFS HR=0.56 Early analysis of Met High Patients 2nd/3rd line mnsclc OS HR=0.55 Met receptor: amplified, mutated, over-expressed or uniquely activated in many tumors associated with worse prognosis in many cancers including Non Small Cell Lung Cancer ~50% of NSCLC are Met High IHC diagnostics tool developed by Roche Tissue Diagnostics (Ventana) 12

13 BRAF inhibitor (RG7204) in melanoma Early results have shown unprecedented clinical benefit Early studies of RG7204 in patients with BRAF V600 mutated, refractory metastatic melanoma, Phase II 80% of patients benefited 7 patients with 100% tumor shrinkage, 3 confirmed CR Response onset is often rapid Common toxicities: arthralgias, rash, photosensitivity, fatigue SCC of skin (Kerathoacanthoma type) observed in ~25% of patients, treated by excision Baseline Day 15 PET Scan Melanoma Congress, Sydney,

14 Results from 10 key trials in Q4 Short-term newsflow Breast Cancer: T-DM1 in 1st line HER2-positive breast cancer randomised Phase II data - first cut; RR but not yet PFS or OS ESMO (October 8-12, Milano) Non-Small Cell Lung Cancer: MetMab in 2nd/ 3rd line NSCLC randomised Phase II - ESMO Ovarian Cancer: ICON7 Avastin in front line ovarian cancer Phase III pivotal trial- ESMO Multiple Sclerosis: Ocrelizumab in RRMS randomised Phase II - ECTRIMS (15 October, Gothenburg) Hepatitis C: Nucleoside Polymerase inh (RG7128) randomised Phase IIb PROPEL interim data AASLD (October 28-Nov 2, Boston) Metastatic Melanoma: BRAF inh Phase II; Intl. Melanoma Research Congress (November 4-9, Sydney) Non-Hodgkin's Lymphoma: GA101 in anhl randomised Phase II data ASH (December 4-7, 2010, Orlando) Schizophrenia: GLYT1 inh randomised Phase II - ACNP (December 5-9, Miami) Breast Cancer: Pertuzumab neoadjuvant randomised Phase II - NEOSPHERE- SABCS (December 8-12, San Antonio) Asthma: Lebrikizumab randomised Phase II data will be in house 14

15 Biosimilar draft guidelines in Europe Phase III clinical trials (double blind, equivalence) as normal route for showing similarity, in particular where no pharmacodynamic (PD) pathway In Oncology usually no PD established End points: Response Rate, PFS where most sensitive. OS data to be collected Clinical trials required for diseases with different mode of action Rheumatoid Arthritis, Oncology Metastatic, adjuvant Extrapolation only to indications with same mode of action Not for different diseases, different mode of action, different dosing, different safety requirements The requirements for clinical evaluation of biosimilar mabs are open to broad interpretation in the current draft guideline. Roche believes that a number of aspects needs to be clarified prior to final implementation 15

16 Biosimilar draft guidelines in Europe Similarity on safety is of utmost importance Reassurance on clinical safety prior to approval Also for MAbs specific toxicities (i.e. cardiotoxicity) Large post-approval safety studies For all claimed indications and to detect rare and serious events (PML) Biosimilars to have their own brand names no automatic substitution 16

17 HER2-positive breast cancer Improving the standard of care 2nd line mbc Xeloda + lapatinib T-DM1 (EMILIA) 1st line mbc Herceptin + chemotherapy Herceptin & pertuzumab + chemotherapy (CLEOPATRA) Herceptin + Avastin + chemotherapy (AVEREL) T-DM1& pertuzumab (MARIANNE) Early (adjuvant) BC Herceptin + chemotherapy Herceptin Subcutaneous Herceptin + Avastin+ chemotherapy (BETH) Herceptin & pertuzumab + chemotherapy Timelines refer to the expected dates of first filing 17

18 A position of strength Operational Excellence adapting to a changing environment 18

19 Industry environment and Roche Responding decisively to recent challenges Industry Innovation remains core of industry Huge unmet medical need Dramatic progress in science & technology Roche Solid Fundamentals Clear strategic focus on Rx and Dx Leadership in innovation and markets High cash-flow and profitability Changing environment Pricing pressure in US and Europe Increasing regulatory hurdles Operational Excellence Recent product setbacks Focus on investments that will drive innovation 19

20 Approach Comprehensive scope, differentiated measures Pharma Medicines gred pred Pharma Partnering Group Functions 1 Research & Early Dev. Development Tech Ops / Sites Commercial US/EU Commercial - ROW G&A/Procurement 1 Finance, IT, HR, Communication, Legal Strong impact Moderate impact 20

21 Pharma Medicines Overview Implementing comprehensive initiatives commercial technical operations Downsize primary care sales force in response to taspoglutide setback Adapt related infrastructure, support functions and product promotion spend Focus resources to high growth products and markets Streamline manufacturing network Consolidate technical development and clinical production network Drive productivity through procurement savings development Strategic roles: co-locate at strategic sites Basel and South San Francisco Transactional roles: outsource to India Operational roles: move to more cost effective Roche sites like Welwyn or Shanghai Nutley becomes a pred center of excellence Shanghai buildup as a result of strategic focus on China 21

22 Pharma Medicines Development Global future footprint SSF - Oncology - Inflammation - Ophthalmology - Virology Nutley Welwyn Basel - Metabolism - CNS India Shanghai Strategic centers Operational centers Outsourcing site pred support 22

23 Strong product pipeline Personalized Healthcare becoming a reality T-DM1 Metastatic breast cancer (HER-2 expression level) MetMAb Non-small cell lung cancer (MET status) Pertuzumab Metastatic breast cancer (HER-2/3 expression level) Lebrikizumab 1 Asthma (periostin level) RG 7128 Hepatitis C (HCV viral load, genotype) RG7204 Metastatic melanoma (BRAF V600E mutation) 1 LIP and phase III decision pending 23

24 Conclusions Roche well positioned for the future Unchanged innovation-driven strategy Optimized operational setup driving current business and increasing profitability Continued significant investments in industry-leading product pipeline Financial Outlook to be updated with Year-End 2010 results 24

25 We Innovate Healthcare 25