ROCHE 9 Months Results 2011 Irp3q11e


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ROCHE 9 Months Results 2011 Irp3q11e

  1. 1. 1
  2. 2. RocheNine months YTD 2011 salesCommitted to innovation and profitable growthOctober 13, 2011Basel 2
  3. 3. This presentation contains certain forward-looking statements. These forward-lookingstatements 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 actualresults to differ materially in the future from those reflected in forward-looking statementscontained 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; and11 adverse publicity and news coverage.Any statements regarding earnings per share growth is not a profit forecast and should not be interpretedto mean that Roche‟s earnings or earnings per share for this year or any subsequent period willnecessarily 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 ourwebsite – 3All mentioned trademarks are legally protected
  4. 4. Group Severin Schwan Chief Executive Officer 4
  5. 5. YTD Sept 2011: Highlights Sales on track for full year guidance • Group and Pharma: low-single digit sales growth 1,2 (+2% & +1%) • Diagnostics: above market sales growth (+6%) Currency impact • Reported sales significantly impacted by strong Swiss franc (-13%p) Outlook confirmed • Core EPS growth target „around 10%‟ 1 Newsflow • US launch of Zelboraf for metastatic melanoma • US filing of vismodegib (hedgehog inh.) for advanced and metastatic BCC • Avastin: CHMP positive recommendation in 1L met. ovarian cancer and mBC approval in Japan 51 at Constant Exchange Rates, 2 excluding Tamiflu
  6. 6. YTD Sept 2011: Group salesSupporting full-year guidance, strong currency impact change in % ExcludingCHF bn 2010 2011 CHF CER Tamiflu1 Pharmaceuticals Division 28.4 24.4 -14 -1 +1 Diagnostics Division 7.7 7.1 -8 +6Roche Group 35.3 31.5 -13 0 +2 61 at Constant Exchange Rates, CER (average full year 2010)
  7. 7. YTD Sept 2011: Group sales+2%2 sales growth excl. Tamiflu +1% +6% +2% -57% 0% -13% +423 -453 +202 +625 +172 -4,807 -4,635 Pharma Diagnostics Group Tamiflu Group Fx 1 Group Division Division incl. CHF Tamiflu1 avg December 2010 to avg YTD September 11 fx local absolute values at avg 2010 fx 72 CER = Constant Exchange Rates (average full year 2010)
  8. 8. Regional performance: Emerging marketsstrongly contribute to sales growth Latin LatinAmerica 16% America 15% All countries in up-swing Asia- Asia 13% Pacific 17% All countries in up-swing North US 1% America 4% Returning to growth Japan -2% Japan 6% Still affected by the earthquake WE -4% Continuing impact of 2010 austerity measures Pharma: Political situation in North Africa CEMAI-6% EMEA 2% and price pressure in Eastern Europe -10% 0% 10% 20% 0% 10% 20% Pharma Diagnostics 8 CER growth rates, excluding Tamiflu
  9. 9. Portfolio outlook An update on key compoundsMarketpotentialLarger> CHF 1bnSmaller< CHF 1bn Zelboraf GA101 Vismodegib T-DM1 MetMAb Lebrikizumab Glyt-1 Dalcetrapib Ocrelizumab Pertuzumab Mericitabine Aleglitazar gRED pREDPotentialLaunch 2011 2012 2013 2014 2015 2016Year 9
  10. 10. Healthcare reforms and austerity measures1. Policy on receivables strengthened in southern European countries; current exposure to Greece government bond below CHF 50 m2. US – continue to monitor the proposals on budget deficit reduction3. Other countries – as of now, no major negative impact expected Limited impact in 2011 expected / outlook confirmed 10
  11. 11. Roche: Supersector leader in Dow JonesSustainability Index – third year in a row Reinforces commitment to creating long-term value for all stakeholders 11
  12. 12. Reconfirming increased outlook for 2011Continued strong business performance Sales growth (CER) Group & Pharma (excl. Tamiflu): low single-digit Diagnostics: significantly above market Genentech synergies 2011+ : CHF 1.0 bn* Operational Excellence 2011 : CHF 1.8 bn savings 2012+ : CHF 2.4 bn Core EPS growth target Around 10% (CER) Grow in-line with Core EPS; maintain at least Dividend outlook last year‟s dividend in CHF 12Barring unforeseen events; CER=Constant Exchange Rates; * vs. 2010: CHF 0.8 bn
  13. 13. Pharmaceuticals Division Pascal Soriot COO Roche Pharmaceuticals 13
  14. 14. YTD Sept 2011: Pharma sales on track to meetguidance 2010 2011 change in % Excluding CHF m CHF m CHF CER Tamiflu1 Pharmaceuticals Division 28,395 24,397 -14 -1 +1 United States 10,878 9,104 -16 +1 +1 Western Europe 7,295 6,210 -15 -4 -4 Japan 3,137 2,712 -14 -6 -2 International 7,085 6,371 -10 +1 +6 Quarterly growth rates 2010 2011 % at CER vs. prior year, excl. Tamiflu Q1 Q2 Q3 Q4 Q1 Q2 Q3 Pharmaceuticals Division +8 +3 +4 +4 +1 +1 0 Roche Pharma (excl. Chugai) +9 +3 +5 +3 +1 +1 +1 Chugai +2 +1 +2 +7 +1 -2 -5 141 at Constant Exchange Rates, CER (average full year 2010)
  15. 15. YTD Sept 2011: Pharma sales +1%1 Western Europe Japan United States 26% Pharma sales, -4%1 11% Pharma sales, -2%1 37% Pharma sales, +1%1 • Austerity measures • Disruption of sales activities in Q2/3 • Lucentis, Rituxan, Actemra • Avastin in mBC bottoming out • Biennial price cuts effective April 2010 growing • Actemra: continued uptake • Avastin in mBC bottoming out • Pegasys Q3 +15% Emerging markets/ International 26% Pharma sales, +6%1 • Growth driven by Lat. America and Asia-Pacific 15All growth at Constant Exchange Rates; 1 Excluding Tamiflu
  16. 16. Pharma in E7: continuous growth in keyemerging markets CHF m 3000 +11% 2500 +13% Korea +6% +5% 2000 Russia Mexico 1500 Turkey 1000 India 500 China 0 Brazil YTD Sep YTD Sep YTD Sep YTD Sep YTD Sep 2007 2008 2009 2010 2011 16All at FY average 2010 exchange rates; growth at CER, excluding Tamiflu
  17. 17. YTD Sept 2011: Pharma Division growth contributorsOncology, Lucentis and Actemra driving growth Herceptin +8% MabThera/Rituxan +7% Lucentis +26%Actemra/RoActemra +86% Pegasys -5% CellCept -12% Boniva/Bonviva -19% US Mircera +45% Western Europe JapanNeorecormon/Epogin -22% International Avastin -8% -600 -400 -200 0 200 400 Tamiflu: -453; -57% 17Absolute amounts in CHF m at 2010 exchange rates
  18. 18. Western EuropeImpact of 2010 special effects levelling out 8.8% 2010 2011 Quarterly growth rates EU austerity CER, excl Tamiflu measures Avastin mBC 2.0% impact -0.8% -2.2% -3.6% -4.5% -4.4% Q1 Q2 Q3 Q4 18
  19. 19. Solid growth of the oncology franchiseMajor brands local growthCHF bn USA: 1L maintenance in NHL included in new NCCNMabThera/ +7% guidelines; emerging markets driven by uptake in NHL Rituxan indications US & EU: Impact from mBC indication and austerity Avastin -8% measures; good growth in Emerging markets and Japan Improvement in quality and penetration of HER2 testing; Herceptin +8% access initiatives in Emerging markets drive volumes increase Xeloda +6% Strong growth in US and Emerging markets Tarceva +6% Growth in US, Emerging markets and Japan YTD Sept 11 0 1 2 3 4 5 19 Oncology Sept YTD 2011 sales: 14.233 bn
  20. 20. Avastin updateOvarian cancer• EU: CHMP positive opinion for 1st line ovarian cancer• US: low likelihood of 1st line ovarian filing (update once OS data available) Breast cancer • mBC approval in Japan • Pending FDA decision on mBC; US mBC patient share bottoming out • AVEREL: in combo with Herceptin, unlikely to meet regulatory requirementsLung cancer• AVAPERL: positive data in combination with pemetrexed in NSCLC Peak sales reconfirmed at CHF 7bn 201 local growth
  21. 21. LucentisDriven by growing wet AMD market and new indication US salesCHF m1200 +26%1 • Diabetic Macular Edema (DME): Filed in the US in October 900 • Market share in RVO: 25% in Q3 vs. 24% in Q2 „11 600 • HARBOR study recently unblinded, efficacy data not supporting initiation of further high-dose studies; 0.5 mg PRN 300 dosing to be discussed with FDA 0 YTD 9 YTD 9 YTD 9 YTD 9 08 09 10 111 CER;AMD=wet age-related macular degeneration; DME=diabetic macular edema; RVO=retinal vein occlusion 21Genentech, a member of the Roche Group, retains commercial rights in the US and Novartis has exclusive commercial rights for rest of the world
  22. 22. Pegasys Back to growth in US Pegasys US HCV Market trend YTD Sept sales CHF 1.1 bn 7000 6000 • Renewed sales growth in the US in Q3 peginterferon Rx (+15%) after launch of new 5000 direct-acting hepatitis C drugs, with Pegasys as foundation of combinationWeekly Rx 4000 therapies 3000 • Positive momentum for EU expected as Pegasys Rx well 2000 • FDA approval of Pegasys ProClick 1000 DAA disposable auto injector (September) – Launch new dosage form to increase patient 0 convenience Jan Apr Jul Oct Jan Apr Jul „10 „10 „10 „10 „11 „11 „11 Source: IMS NPA Weekly Rx reports 22
  23. 23. Actemra/RoActemra in Rheumatoid ArthritisGrowing in all regions Actemra/RoActemra salesCHF m • 24-week ACT RAY X-ray monotherapy500 +86%1 data to be presented at ACR400 • DMARD IR (first-line biologic) filing 2012 in US300 • H2H trial vs Humira (ADACTA): readout H1 2012200 • Subcutaneous formulation: filing 2012 EU, 2013 US; Japanese study positive100 • Did not meet primary end-point in pivotal ankylosing spondylitis trial 0 YTD 9 YTD 9 YTD 9 YTD 9 • sJIA approved in US & EU 08 09 10 11 231 CER
  24. 24. 2011: Major clinical news for late-stage NMEsSupporting future growth Compound Indication Study Zelboraf (BRAFi) 1st line met melanoma BRIM3  Lucentis Diabetic macular edema RIDE  RISE Phase III Avastin Relapsed ovarian cancer OCEANS  pertuzumab + Herceptin 1st line HER2+ mBC CLEOPATRA  Herceptin Early HER2+BC sc HANNAH vismodegib (Hedgehog i) Advanced BCC Pivotal study, ERIVANCE  T-DM1 1st line HER2+ mBC PFS data  GA101 Relapsed indolent NHL GAUSS H2H against MabThera/RituxanPhase II MetMAb NSCLC 2nd / 3rd line Final data  lebrikizumab Severe uncontrolled asthma MILLY MOLLY mericitabine Hepatitis C PROPEL final data; JUMP-C dalcetrapib CV risk reduction dal-VESSEL  dal-PLAQUE  24
  25. 25. Significant news-flow in Q3 2011Approvals / • Zelboraf in US, metastatic melanomaPositive opinions • Tarceva in EU, 1L EGFR mutated NSCLC • Avastin in front-line ovarian cancer; positive CHMP opinionFilings • Lucentis in US (October), Diabetic Macular Edema (DME) • Avastin in EU, recurrent ovarian cancer • vismodegib (hedgehog inh) in US, advanced/met BCCData presented • T-DM1 vs. Herceptin 1st line HER2+ mBC ph II • Zelboraf updated OS from BRIM3 and ph I • lebrikizumab MILLY ph II proof of concept • dalcetrapib dal-PLAQUE and dal-VESSEL ph II 25
  26. 26. ZelborafUS approval and launch in record time 2006 2007 2008 2009 2010 2011 IND Phase I results + BRIM2 results BRIM3 results US launch Less than 5 years from IND to first launch • Fastest development program • Fastest approval in Roche portfolio (<5 years from IND to FDA approval) (3.5 months after submission) • Fastest initiation of a global Expanded • Five days from approval to launch Access Program • 5 weeks after launch: sales of CHF 11 m 26
  27. 27. T-DM1 vs. Herceptin + docetaxel in breast cancer Potential for efficacy with lower rate of chemo-related side effects PFS, 1st line HER2+ breast cancer 1.0 Median Hazard Log-rank PFS, mos ratio P value Phase II 0.8 T+D 9.2 0.594 0.0353 EMCC/ESMO 2011 Proportion progression-free T-DM1 14.2 0.6 • significant improvement in PFS 0.4 Trastuzumab • markedly lower rate of 0.2 + docetaxel (n=70) grade ≥3 AEs T-DM1 (n=67) (46.4% vs 89.4%) 0.0 0 2 4 6 8 10 12 14 16 18 20Number of patients at risk Time (months)T+D 70 66 63 53 43 27 12 4 2 2 0T-DM1 67 60 51 46 42 35 22 15 6 3 0 Filing of T-DM1 in 2nd line HER2+ breast cancer (EMILIA study) in 2012 Hurvitz SA, et al. Abstract 5.001. ESMO 2011 27
  28. 28. Short-term newsflowPipeline progress Pertuzumab in 1L HER2+ breast cancer pivotal phase III CLEOPATRA SABCS (December 6-10, San Antonio) Subcutaneous Herceptin in early HER2+ BC pivotal phase III HANNAH top-line data in Q4 2011 GA101 vs. MabThera/Rituxan in indolent non-Hodgkin’s lymphoma phase II GAUSS ASH (December 10-13, San Diego) Roche Late-Stage Pipeline Update Focus on data presented at ESMO and ERS London, November 7th, 2011 28
  29. 29. Diagnostics Division Daniel O’Day COO Roche Diagnostics 29
  30. 30. YTD Sept 2011: Diagnostics Division salesContinued solid growth above the market 2010 2011 CHF CER CHF m CHF m growth growth Professional Diagnostics 3,602 3,430 -5% 9% Diabetes Care 2,191 1,938 -12% 1% Molecular Diagnostics 900 801 -11% 3% Applied Science 646 544 -16% -2% Tissue Diagnostics 393 382 -3% 15% Diagnostics Division 7,732 7,095 -8% 6%CER = Constant Exchange Rates (average full year 2010) 30
  31. 31. YTD Sept 2011: Sales driven by Asia-Pacific,EMEA and North-America Europe, Middle East, Africa North America 50% Dia sales, +2% Japan 25% Dia sales, +4% • Immunoassays and Coagulation 5% Dia sales, +6% monitoring driving growth • Immunoassays +17% • 12% growth in Professional • Impacted by reduced blood screening • Molecular diagnostics +8% Diagnostics • Molecular Diagnostics flat Asia Pacific Latin America 13% Dia sales, +17% 7% Dia sales, +15% • Professional Diagnostics +21% • Growing strongly in all Business Areas • Molecular Diagnostics up +16% (primarily blood screening) • Professional Diagnostics +17% • China +25% growthAll growth in Constant Exchange Rates (average full year 2010) 31
  32. 32. Growth driven by Professional Diagnostics andTissue DiagnosticsCHF bn YTD Sept ‘11 vs. YTD Sept ‘10 CER growthProfessional Strong growth in Nth America (9%), Latin America +9% Dia (17%) and Asia Pacific (21%); Driven by Immunoassays Diabetes Maltose independent Accu-Chek Aviva Plus strips +1% Care approved in US Molecular +3% cobas BRAF test launched US & EU; Won Swedish tender Dia for pilot primary screening cervical cancer with HPV test Applied Continued impact from deceased H1N1 testing; -2% Science Flat global research funding EMEA North America Launched 11 new Abs incl. H. pylori, BCL-2 and MLH-1; Tissue Dia +15% RoW Completed acquisition of mtm labs (cervical cancer) 0 1 2 3 4CER = Constant Exchange Rates (average full year 2010) 32EMEA = Europe, Middle East, Africa
  33. 33. YTD Sept 2011: Professional DiagnosticsStrong growth driven by immunoassays CHF 3.4 bn, +9% CER growth • Solid instrument placements other Immunoassays • Continuous growth in Immunoassays (+13%) and Clinical Chemistry POCproducts • Continued roll-out of Vitamin D Total (+7%) test in EU and ROW • POC Coagulation monitoring (+14%) – proven medical value of testing – superior product in CoaguChek Clinical – strong growth in EMEA and Nth Chemistry America (+6%)CER = Constant Exchange Rates (average full year 2010) 33EMEA = Europe, Middle East, Africa
  34. 34. Roche awarded first public tender for primaryscreening for cervical cancer with cobas HPV test • Karolinska University Hospital in Sweden to screen women for cervical cancer with cobas HPV test • Represents first primary screening pilot program to be implemented in Europe Fully automated throughput up to 388/12hr • Results and publications to aid in evaluation for country wide implementation • First significant step towards replacing pap smear in a stringent program Hi Risk GT 16 GT 18 Control 1 2 3 4 • In EU, 109 million women in target age group for Genotypes 16/18 & 12 high-risk HPV in one test cervical cancer screening** Second edition of the European Guidelines for Quality Assurance of Cervical Cancer Screening, 2008 34
  35. 35. Personalised healthcare becoming realityCommercialisation of cobas BRAF test in US and EU • Joint US launch of Zelboraf and cobas BRAF test Approved in US for people with BRAF • Roche Pharma sales force direct V600E mutated metastatic melanoma oncologists to labs offering cobas BRAF cobas BRAF test • Only FDA approved companion diagnostic for Zelboraf • Good initial market uptake with key cobas BRAF test labs• Identifies patients with BRAF V600E mutations• Detects patients missed by sequencing• Provides consistent and reliable results 35BRAF gene mutations detected in ~8% of all cancers, over 50% of malignant melanomas
  36. 36. Key launches for 2011* • Vitamin D total and HE4 immunoassays (EU) Professional Diagnostics • cobas 8000 modular analyzer series, cobas c 702 module (EU US ) • cobas b 123 POC system for bloodgas & electrolytes (US) • Accu-Chek Mobile LCM (EU) • Accu-Chek Combo (US)Diabetes Care • Accu-Chek Nano (US) • Accu-Chek Aviva Plus MI strip (US)  • cobas 4800 HPV Test (US)  • cobas 4800 EGFR Mutation Test (EU)Molecular Diagnostics • cobas 4800 KRAS Mutation Test (EU)  • cobas 4800 BRAF V600 Mutation Test (EU, US)  • HLA genotyping on GS Junior & FLX sequencing systems (global)  • GS FLX Titanum-XL system (global) Applied Science • Ultra-high resolution CGH arrays (global) • LightCycler Nano for real time PCR analysis (global)  • ER/PR antibody for IHC (US)Tissue Diagnostics • HER2 dual colour ISH probe (US)  • OptiView detection system (US, EU)  Diagnostics Division Outlook: sales growth significantly above the market 36* Subject to appropriate regulatory approvals barring unforeseen events
  37. 37. Group Alan Hippe Chief Financial Officer 37
  38. 38. Highlights• Further balance sheet deleverage: tender offer for the March 2012 CHF bond, P&L impact up to CHF -10 m• Credit rating: Moody‟s upgrade of Roche from A2 to A1- stable outlook• Carefully monitor receivables, particularly in Mediterranean countries• On track to deliver Operational Excellence savings and profit targets 38
  39. 39. Exchange rate impact on sales growth Negative impact, in particular from USD and EUR Oth Local USD EUR Europe As-Pac Lat-Am JPY Other CHF CER sales 0.4% growthYTD 9 2011 vs.YTD 9 2010 -6.4% CHF sales growth YTD 9 2011 -12.8% vs. -2.9% YTD 9 2010 -1.1% -0.9% -0.9% -0.8% -0.2% CER = Constant Exchange Rates (average full year 2010) 39
  40. 40. Currency impact on Swiss Franc results CHF/USD average YTD 2010 1.07 1.04 -18% Average YTD 2011 0.88 Assuming the 30 September 2011 exchange 0.96 0.95 rates remain stable until year-end, FY 2011 0.92 0.90 0.87 0.84 0.82 0.87 0.90 0.90 Fx Rate at 0.90 impact is expected to be (%) Monthly average fx rate 2011 0.78 30 Sep 2011 J F M A M J J A S O N D FY Sales -12 CHF/EUR Core operating -15 average YTD 2010 1.40 profit 1.38 Average YTD 2011 -12% Core EPS -14 1.241.28 1.30 1.29 1.30 1.25 1.21 1.22 1.22 1.22 1.18 1.20 1.12 J F M A M J J A S O N D 40
  41. 41. Roche with relatively strong credit rating despite high debt levelS&P rating AAA J&J Moody’s upgrade of Roche AA+ Merck Pfizer Abbott from A2 to A1- stable outlook AA Takeda BD Roche AA- AZ Sanofi Novartis • “reflects Roches solid Amgen Lilly deleveraging after its A+ GSK A BMS acquisition of Genentech in A- March 2009” Gilead Bayer BBB+ Biogen • “benign exposure to patent BBB expiries” BBB- BB+ • “relatively high visibility of future cash flows” -35 -30 -25 -20 -15 -10 -5 0 5 10 15 20 25 30 35 2010 Leverage1 (%) 1Net Debt / Total Assets (%) 41 Source: Thompson Datastream; Bloomberg (May 23; 2011); BCG analysis
  42. 42. Reconfirming increased outlook for 2011Continued strong business performance Sales growth (CER) Group & Pharma (excl. Tamiflu): low single-digit Diagnostics: significantly above market Genentech synergies 2011+ : CHF 1.0 bn* Operational Excellence 2011 : CHF 1.8 bn savings 2012+ : CHF 2.4 bn Core EPS growth target Around 10% (CER) Grow in-line with Core EPS; maintain at least Dividend outlook last year‟s dividend in CHF 42Barring unforeseen events; CER=Constant Exchange Rates; * vs. 2010: CHF 0.8 bn
  43. 43. 43
  44. 44. Roche Group development pipelineMarketed products development programmesRoche Pharma global development programmesRoche Pharma research and early developmentGenentech research and early developmentRoche Group YTD Sept 2011 resultsDiagnosticsForeign exchange rate information 44
  45. 45. Roche Development PipelineProjects in Phase 1 phase I (44 NMEs) Phase I Projects - oncology Phase I Projects – other DTAs RG7112 MDM2 ant (2) solid & hem tumors RG4934 anti-IL-17 MAb RA RG7167 CIF/MEK inh solid tumors RG7185 CRTH2 antag asthma RG7212 Tweak MAb oncology CHU Anti-IL 6 MAb RA RG7256 BRaf inh(2) BRAF mut. melanoma RG7432 nucleoside pol inh HCV RG7304 Raf & MEK dual inh solid tumors RG7236 Cat S antag CV risk in CKD RG7321 PI3 kinase inh solid tumors RG7273 ABCA1 inducer dyslipidemia RG7334 anti-PLGF MAb solid tumors RG7652 - metabolic RG7356 anti-CD44-MAb solid tumors RG7685 GIP/GLP-1 dual ago type 2 diabetes RG7420 MEK inh solid tumors RG7421 MEK inh solid tumors RG1578 mGluR2 antag (2) depression RG7422 PI3 K/mTOR inh solid & hem tumors RG1662 GABRA5 cogn. disorders RG7440 AKT inhibitor solid tumors RG7314 V1 receptor antag (2) autism RG7444 anti-FGFR3 MAb oncology RG7129 BACE inh Alzheimer‟s RG7446 tumor immunotherapy oncology RG7166 triple reuptake inh depression RG7450 - ADC prostate ca. RG7458 - ADC ovarian ca. RG7459 IAP ant (2) solid tum & lymphoma RG7593 anti-D22 ADC hem. malignancies RG7594 anti-angiogenic solid tumors NME Additional Indication RG7596 - ADC hematologic tumors RG7597 anti-Her3/EGFR m. epithelial tumors Oncology RG7598 - ADC multiple myeloma Inflammation/Immunology RG7599 - ADC oncology Virology RG7601 Bcl-2 inh CLL Metabolic/Cardiovascular RG7602 Chk-1 inh tumors or lymphoma CNS Ophthalmology RG7603 - solid tumors or NHL Others RG7604 PI3K inh oncology RG7686 anti-glypican-3 MAb liver cancer RG-No Roche Genentech managed CHU Chugai managed CHU ALK inhibitor NSCLC CHU - solid tumors CHU WT-1 vaccine oncology 45Status as of September 30, 2011
  46. 46. Roche Development PipelineProjects in Ph 2, 3 and Registration phase II phase III Registration (19 NMEs + 7 Als) (8 NMEs + 28 Als) (2 NMEs + 6 Als) RG1273 pertuzumab HER2+ EBC RG105 Rituxan NHL fast infusion RG4351 Avastin ovarian cancer 1st line RG1273 pertuzumab HER2+ mBC 2nd line RG105 MabThera NHL s.c. formulation RG4352 Avastin relapsed ovarian ca RG3502 T-DM1 HER2+ EBC RG435 Avastin HER2+ BC adj RG14153 Tarceva NSCLC EGFR mut 1st line RG3616 vismodegib operable BCC RG435 Avastin BC combo Herceptin 1st line RG36164 vismodegib advanced BCC RG3638 MetMAb mNSCLC RG435 Avastin NSCLC adj RG36264 Activase extended time window AIS RG3638 MetMAb mBC RG435 Avastin HER2-neg. BC adj RG36454 Lucentis diabetic macular edema RG3638 MetMAb mCRC 1L RG435 Avastin triple-neg. BC adj RG72045 Zelboraf metastatic melanoma RG7160 EGFR Mab solid tumors RG435 Avastin high risk carcinoid CHU EPOCH chemo induced anemia RG7204 Zelboraf papillary thyroid cancer RG435 Avastin glioblastoma 1st line RG7433 navitoclax (ABT-263) sol & hem tum RG435 Avastin mCRC TML 1 CHMP positive opinion EU RG7414 anti-EGFL7 MAb solid tumors RG435 Avastin mBC 2nd line 2 submitted in the EU RG597 Herceptin HER2+ BC s.c. form. 3 approved in the EU RG3637 lebrikizumab severe asthma 4 submitted in the US RG597 Herceptin HER2+ adj BC (2yrs) RG7413 rhu Mab Beta7 ulcerative colitis 5 approved in the US RG1273 pertuzumab HER2+ mBC 1st line RG7415 rontalizumab SLE RG1415 Tarceva NSCLC adj RG7416 anti-LT alpha MAb RA RG1415 Tarceva NSCLC EGFR mut 1st line RG7449 anti-M1 prime MAb asthma RG3502 T-DM1 HER2+ adv. mBC RG7128 mericitabine HCV NME RG3502 T-DM1 HER2+ mBC 3rd l. RG7227 danoprevir HCV Additional Indication RG3502 T-DM1 HER2+ mBC 1st l. RG4929 11 beta HSD inh metabolic diseases RG7159 GA101 CLL RG1512 P selectin MAb ACS/CVD Oncology RG7159 GA101 iNHL relapsed RG7418 anti-oxLDL MAb sec prev CV events Inflammation/Immunology RG7159 GA101 DLBCL Virology RG1450 gantenerumab Alzheimer‘s RG7159 GA101 iNHL front-line Metabolic/Cardiovascular RG1577 MAO-B inh AD CNS RG105 MabThera ANCA assoc vascul RG7090 mGluR5 antag (2) TRD Ophthalmology RG1569 Actemra sc formulation RA RG7412 anti-Abeta MAb Alzheimer‘s Others RG1569 Actemra early RA RG7417 anti-factor D Fab geographic atrophy RG1569 Actemra RA DMARD IR H2H RG-No Roche Genentech managed RG3648 Xolair chronic idiopathic urticaria CHU Chugai managed RG105 MabThera is branded as RG1439 aleglitazar CV risk reduction in T2D Rituxan in US and Japan RG1658 dalcetrapib atherosc. CV risk red. RG1569 Actemra is branded as CHU tofogliflozin (SGLT2) type 2 diabetes RoActemra in EU RG1594 ocrelizumab RMS RG1594 ocrelizumab PPMS RG1678 GRI schizophrenia negative sympt. RG1678 GRI schizophrenia subopt control 46 Status as of September 30, 2011 RG3645 Lucentis AMD high dose
  47. 47. Changes to the development pipeline Since H1 2011 update New to Phase I New to Phase II New to Phase III New to RegistrationNew NMEs transitioned from Ph0 New NME in Ph2 following FPI New in Ph3 following FPI New NME Filed(5NMEs) RG7413 MAb Beta7 ulcerative colitis RG1594 ocrelizumab RMS RG3616 vismodegib advanced BCCRG7212 Tweak MAb oncology (US)RG7314 V1 receptor antag (2) New NME in Ph2 following in- New AI in Ph3 folllowing FPIautism licensing from Evotec RG3502 T-DM1 HER2+ mBC 3rd New AIs FiledRG7129 BACE inh Alzheimer‟s RG1577 MAO-B inh in AD line RG435 Avastin relapsed ovarianRG7598 oncology cancer (EU)RG7652 metabolic New AI in Ph2 following FPI RG3626 Activase extended time RG3638 MetMAb mCRC 1L window (US)New NMEs managed by Chugai RG3645 Lucentis diabetic macularCHU WT-1 cancer vaccine edema (US)CHU anti-IL6 MAb in RA Removed from Phase I Removed from Phase II Removed from Phase III Removed from Registration NME from Chugai Discontinuation (1AI) Approved in EU CHU Topoisomerase inh in gastric RG1569 Actemra ankylosing RG105 Actemra sJIA cancer spondylitis 47 NME = new molecular entity; AI = additional indication; FPI = first patient in
  48. 48. Projected NME Submissions and their rontalizumab (RG7415) SLE anti-LT alpha Mab (RG7416) rheumatoid arthritisAdditional Indications Mab Beta7 (RG7413) ulcerative colitis lebrikizumab (RG3637) asthmaProjects Currently in Phase 2 and 3 anti-EGFL7 Mab (RG7414) solid tumors anti-M1 prime Mab (RG7449) asthma EGFR Mab (RG7160) aleglitazar (RG1439) solid tumors CV risk reduction in T2D GA101 (RG7159) P selectin huMab (RG1512) DLBCL CVD GA101 (RG7159) Anti-oxLDL (RG7418) NHL indolent frontline prevent secondary CV GA101 (RG7159) 11 beta HSD (RG4929) NHL refractory metabolic diseases MetMAb (RG3638) gantenerumab (RG1450) mNSCLC, mBC, mCRC Alzheimer’s disease T-DM1 (RG3502) navitoclax MAOB inh (RG1577) ABT-263 (RG7433) HER2+ mBC 1st line solid & hem tumors Alzheimer’s disease Zelboraf (RG7204) met. melanoma  GA101 (RG7159) CLL mericitabine (RG7128) HCV pertuzumab (RG1273) HER2+ EBC mGluR5 antag (2) (RG7090) Txt resistant depression pertuzumab (RG1273) dalcetrapib (RG1658) * danoprevir RG7227) vismodegib (RG3616) anti-abeta Mab (RG7412) HER2+ mBC1st line atherosclerosis CV risk red. (HCV protease inh) operable basal cell ca Alzheimer’s disease vismodegib (RG3616) adv basal cell ca (US)§  T-DM1 (RG3502) HER 2+ advanced mBC glycine reuptake inhib. (RG1678) schizophrenia# ocrelizumab (RG1594) PPMS and RMS Zelboraf (RG7204) Papillary thyroid ca anti-factor D Fab (RG7417) geographic atrophy 2011 2012 2013 2014 Post 2014Unless stated otherwise, submissions are planned to occur in US and EU. indicates a submission which has occurred with regulatory action pending Oncology CNS Inflammation/Immunology Ophthalmology* NDA timeline is driven by the event rate in dal-OUTCOMES; updated timeline estimate will Virology NMEbe provided in Q3 2012 after 2nd year event rate is known Metabolic/Cardiovascular# negative symptoms and sub-optimal control§ Filing timelines in EU subject to discussion with EMA 48 Status as of September 30, 2011
  49. 49. Projected additional indications submissions of existing products Projects currently in Phase 2 and 3 Avastin relapsed ovarian cancer (US) Avastin mBC 2nd line (EU) Avastin mCRC TML Herceptin Avastin sc formulation HER2+ HER2+ BC adj Avastin + Herceptin Avastin HER2+ mBC 1st line triple negative BC adj MabThera Avastin sc formulation (EU) glioblastoma 1st line Rituxan Tarceva (US) Herceptin NHL faster infusion (US) NSCLC EGFR mutation 1st line HER2+ BC adj 2 year Avastin Actemra Tarceva ovarian cancer 1st line (US) DMARD IR (US) NSCLC adj (EU) Avastin  relapsed ovarian cancer (EU) Actemra RA DMARD H2H (EU) Xolair (US) chronic idiopathic urticaria Activase extended time window AIS (US) Actemra sc formulation (EU) Actemra early RA Avastin HER2- BC adj Lucentis  diabetic macular edema (US) Lucentis AMD 0.5 mg PRN (US) Actemra sc formulation (US) Tarceva NSCLC adj (US) Avastin NSCLC adj 2011 2012 2013 2014 Post 2014Unless stated otherwise, submissions are planned to occur in US and EU. Oncology CNS Inflammation/Immunology Ophthalmology Virology Metabolic/Cardiovascular 49Status as of September 30, 2011
  50. 50. Roche Group development pipelineMarketed products development programmesRoche Pharma global development programmesRoche Pharma research and early developmentGenentech research and early developmentRoche Group Q3 2011 salesDiagnosticsForeign exchange rate information 50
  51. 51. AvastinOvarian cancer clinical development programmePatient Front-line metastatic Relapsed platinum-sensitivepopulation ovarian cancer ovarian cancer Phase III Phase III Phase IIIPhase/study GOG-0218 ICON7 OCEANS# of patients N=1,873 N=1,528 N=484Design • ARM A: Paclitaxel and carboplatin for 6 cycles plus • ARM A: Paclitaxel and carboplatin for • ARM A: Carboplatin, gemcitabine, and 5 cycles of concurrent placebo followed by placebo 6 cycles concurrent placebo for 6 cycles, followed by alone for up to 22 cycles (15 months) • ARM B: Paclitaxel and carboplatin placebo alone until disease progression • ARM B: Paclitaxel and carboplatin for 6 cycles plus plus concurrent Avastin for 6 cycles • ARM B: Carboplatin, gemcitabine, and 5 cycles of concurrent Avastin followed by placebo followed by Avastin alone for up to 18 concurrent Avastin for 6 cycles, followed by alone for up to 22 cycles (15 months) cycles (12 months) Avastin alone until disease progression. • ARM C: Paclitaxel and carboplatin for 6 cycles plus 5 cycles of concurrent Avastin followed by Avastin alone for up to 22 cycles (15 months)Avastin dose • 15 mg/kg q3 weeks • 7.5 mg/kg q3 weeks • 15 mg/kg q3 weeksPrimary • Progression-free survival • Progression-free survival • Progression-free survivalendpointStatus • Study met its primary endpoint in Q1 2010 • Study met its primary endpoint Q3 • Study met its primary endpoint Q1 2011 • Data presented at ASCO 2010 and 2011 2010 • Data presented at ASCO 2011 • Data presented at ESMO 2010 and ASCO 2011 • EMA submission Q4 2010, positive CHMP opinion Q3’11 • EMA submission Q3 2011 • FDA submission in Q4 2011 only if clear benefit is seen on overall • FDA submission in Q1’12 (with more mature survival endpoint overall survival data) 51ASCO = American Society of Clinical Oncology; ESMO = European Society for Medical Oncology.
  52. 52. AvastinBreast cancer development programmePatient First-line HER2-negative Second-line HER2-negative First-line HER2-positivepopulation Phase III Phase III Phase III Phase IIIPhase/study RIBBON-1 AVADO RIBBON-2 AVEREL# of patients N=1,238 N=736 N=684 N=424Design • ARM A: Anthracycline or • ARM A: Placebo plus • ARM A: Chemotherapy • ARM A: Docetaxel plus taxane plus Avastin OR docetaxel (taxane, Xeloda, gemcitabine, Herceptin Xeloda plus Avastin • ARM B: 7.5 mg/kg dose of or vinorelbine) plus Avastin • ARM B: Docetaxel plus • ARM B: Anthracycline or Avastin plus docetaxel • ARM B: Chemotherapy plus Herceptin plus Avastin taxane plus placebo OR • ARM C: 15 mg/kg dose of placebo Xeloda plus placebo Avastin plus docetaxelAvastin dose • 10 mg/kg q2 weeks or 15 • 15 mg/kg or 7.5 mg/kg q3 • 15 mg/kg q3 weeks • 15 mg/kg q3 weeks mg/kg q3 wks weeksPrimary • Progression-free survival • Progression-free survival • Progression-free survival • Progression-free survivalendpoint (PFS)Status • EU label extended to include • EU: Docetaxel removed from • EU – Consider filing with • Study did not meet protocol Xeloda (June 2) label after EC decision mature OS data in 2012 specified primary endpoint • US: FDA - Received Complete • US: Received Complete • FDA - Received Complete • Improvement in PFS Response Letter Q4 2010 Response Letter Q4 2010 Response Letter Q4 2010 (Investigator assessed) did not • ROW: Approved in 20+ reach significance countries incl. CH • Improvement in PFS (IRC assessed) was statistically significant but is unlikely to meet regulatory approval requirements • No new safety signals 52
  53. 53. AvastinClinical development programmes in other tumor types Patient Metastatic colorectal cancer High risk carcinoid Newly diagnosed glioblastoma population Phase III Phase III Phase III Phase/study ML18147 SWOG SO518 AVAglio TML # of patients N=810 N=424 N=920 Design • 1st-line treatment with • ARM A: Depot octreotide plus • ARM A: Concurrent radiation and chemotherapy* plus Avastin interferon alpha temozolomide plus placebo; • Once patients progress, they are • ARM B: Depot octreotide plus followed by maintenance TMZ randomised to: Avastin plus placebo for 6 cycles; then • ARM A: Chemotherapy* alone placebo until disease progression • ARM B: Chemotherapy* + • ARM B: Concurrent radiation and Avastin TMZ plus Avastin; followed by maintenance TMZ plus Avastin for * Physician‟s choice 6 cycles; then Avastin (15mg/kg q3 weeks) monotherapy until disease progression Avastin • 5 mg/kg q2 weeks or • 15 mg/kg q3 weeks • 10 mg/kg q2 weeks or 15 mg/kg dose 7.5 mg/kg q3 weeks q3 weeks Primary • Overall survival • Progression-free survival • Progression-free survival endpoint • Overall survival Status • Enrolment completed Q2 2010 • FPI Q1 2008 • FPI Q2 2009 • Expect data Q1 2012 • Expect data 2013 • Enrolment completed Q1 2011 • Expect data 2012 53
  54. 54. AvastinAdjuvant clinical development programmePatient Adjuvant Adjuvantpopulation lung cancer breast cancer Phase III Phase III Phase III Phase IIIPhase/study ECOG 5103 BEATRICE BETH ECOG 1505 HER2-negative Triple-negative HER2-positive# of patients N=1,500 N=4,950 N=2,530 N=3,600Design • ARM A: Cisplatin plus • ARM A: Anthracycline plus • ARM A: Anthracycline ± • COHORT 1: Docetaxel/ vinorelbine, docetaxel, cyclophosphamide (AC) taxane or taxane-based carboplatin plus Herceptin ± gemcitabine or pemetrexed followed by paclitaxel chemo alone Avastin • ARM B: Cisplatin plus • ARM B: AC plus Avastin • ARM B: Anthracycline ± • COHORT 2: Docetaxel plus vinorelbine, docetaxel, followed by paclitaxel plus taxane or taxane-based Herceptin ± Avastin, followed gemcitabine or pemetrexed Avastin chemo plus Avastin for 1 year by 5-Fluorouracil, Epirubicin, plus Avastin up to 12 months • ARM C: AC plus Avastin Cyclophosphamide followed by paclitaxel plus Avastin, followed by Avastin For both cohorts, patients up to 12 months receive Herceptin ± Avastin to complete one year of targeted therapyAvastin dose • 15 mg/kg q3 weeks • 15 mg/kg q3 weeks • Dosing equivalent to 5 • 15 mg/kg q3 weeks mg/kg/wPrimary • Overall survival • Disease-free survival • Disease-free survival • Disease-free survivalendpointStatus • FPI Q3 2007 • FPI Q4 2007 • FPI Q4 2007 • FPI Q2 2008 • Recruitment ongoing • Enrolment completed Q2‟11 • Enrolment completed Q4 2009 • Enrolment completed Q4 2010 • Expect data 2014 • Expect data 2012 • Expect data 2013 54
  55. 55. HerceptinThe standard of care for HER2+ early breast cancer Patient Adjuvant HER2-positive Early-stage HER2-positive population breast cancer breast cancer Phase III Phase III Phase/study HERA HANNAH # of patients N=5,102 N=595 Design • ARM A: Herceptin for 12 months • ARM A: Chemotherapy* concurrent with • ARM B: Herceptin for 24 months Herceptin subcutaneous for every three • ARM C: Observation weeks for the first 8 cycles • ARM B: Chemotherapy* concurrent with Herceptin intravenous for every three weeks for the first 8 cycles *Chemotherapy = docetaxel then 5-FU, epirubicin, and cyclophosphamide Primary • Disease-free survival • Serum concentration endpoint • Pathologic complete response Status • Final 2-year versus 1-year analysis • FPI Q4 2009 expected in 2012; event-driven • Enrolment completed Q4 2010 • Expect data October of 2011Subcutaneous Herceptin : applies Enhanze technology, partnered with Halozyme 55
  56. 56. MabThera/RituxanDevelopment programmes Oncology Immunology Front-line diffuse large B-cell or Patient Front-line follicular non- follicular non-Hodgkin’s ANCA-associated vasculitis population Hodgkin’s lymphoma lymphoma Phase III Phase IIIb Phase II/III Phase/study Subcutaneous study RATE* RAVE* Study being conducted ex-US Faster infusion study # of patients N=405 N=450 N=197 Design • ARM A: Intravenous MabThera • Prospective, open-label, single arm • Non-inferiority efficacy and safety plus chemotherapy (CHOP or study study of MabThera/Rituxan and CVP) glucocorticoids versus • ARM B: Subcutaneous MabThera conventional therapy plus chemotherapy (CHOP or (cyclophosphamide) CVP) • Responders will continue on maintenance every 8 weeks over 24 months Primary • Pharmacokinetics, safety and • To determine the incidence of • Induction of complete remission at endpoint efficacy Grade 3 or 4 infusion-related 6 months, defined as a BVAS/WG toxicities resulting from faster of 0 and off glucocorticoid therapy infusion of MabThera/Rituxan Status • FPI Q1 2011 • FPI Q3 2008 • Data presented at ACR 2009 • Expect data 2012 • Enrolment completed Q4 2010 • FDA approved use of Rituxan in • Expect data H2 2011 WG and MPA in Q2 2011*In collaboration with Biogen Idec; subcutaneous MabThera: applies Enhanze technology, partnered with HalozymeCHOP = Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone; CVP = Cyclophosphamide, Vincristine and Prednisolone. 56WG - Wegeners Granulomatosis, MPA - Microscopic Polyangiitis
  57. 57. TarcevaNew approaches to treating lung cancer First-line metastatic Patient Adjuvant non-small non-small cell lung cancer population cell lung cancer EGFR mutation-positive* Phase III Phase III Phase/study RADIANT EURTAC N=974 # of patients N=174 (2:1 randomisation) Design • Following surgical resection ± adjuvant • ARM A: Tarceva chemotherapy: • ARM B: Chemotherapy (platinum-based • ARM A: Tarceva up to 2 years doublet) • ARM B: Placebo up to 2 years Primary • Disease-free survival • Progression-free survival endpoint • EGFR IHC and/or FISH-positive Status • Enrolment completed Q3 2010 • Study met its primary endpoint Q1 2011 • Expect final results in 2012 • Data presented at ASCO 2011 • Expect FDA sNDA submission in 2012 • EU granted approval in Q3 2011In collaboration with OSI Pharmaceuticals, now part of Astellas group;Tarceva is a trademark of OSI Pharmaceuticals, LLC 57
  58. 58. Actemra/RoActemraInterleukin 6 receptor inhibitor• Rheumatoid arthritis programme Rheumatoid arthritisPatient Early moderate-to-severe Moderate-to-severe Moderate-to-severe DMARD inadequatepopulation rheumatoid arthritis rheumatoid arthritis rheumatoid arthritis responders Phase III Phase III Phase III Phase IIIPhase/study ADACTA SUMMACTA BREVACTA FUNCTION Head-to-head study Subcutaneous study Subcutaneous study# of patients N=1,128 N=300 N=1,200 N=600Design • ARM A: Actemra 8 mg/kg • ARM A: Actemra • Add-on to DMARD therapy • Add-on to DMARD therapy • ARM B: Actemra 8 mg/kg • ARM B: Humira • Weekly dosing • Dosing every two weeks plus MTX • ARM A: Subcutaneous • ARM A: Subcutaneous • ARM C: Actemra 4 mg/kg Actemra plus intravenous Actemra plus MTX placebo • ARM B: Subcutaneous • ARM D: MTX alone • ARM B: Intravenous Actemra placebo plus subcutaneous placeboPrimary • DAS28 remission at 24 weeks, • DAS28 at 24 weeks • ACR 20 at week 24 • ACR 20 at week 24endpoint 1 year and 2 yearsStatus • FPI Q4 2009 • FPI Q2 2010 • FPI Q3 2010 • FPI Q1 2011 • Recruitment completed Q2 • Expect data H1 2012 • Recruitment completed Q3 2011 2011 • Expect data 2012 • Expect data 2012In collaboration with ChugaiMTX = Methotrexate; DMARD = Disease-Modifying Anti-Rheumatic Drugs. 58Humira® (adalimumab) is a registered trademark of Abbott Laboratories.