Diagnostics Division Daniel O Day COO Roche Diagnostics

Transcription

1 Diagnostics Division Daniel O Day COO Roche Diagnostics 1

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 Q1 2010: High growth for both divisions Well above world markets CHF bn % change in Q1 09 Q1 10 CHF local harmaceuticals Diagnostics Roche Group

4 Diagnostics Division Continues to grow significantly above the IVD market Q1 09 Q1 10 CHF local CHF m CHF m growth growth rofessional Diagnostics 1,086 1,170 8% 9% Diabetes Care % 6% Molecular Diagnostics % 2% Applied Science % 19% Tissue Diagnostics % 21% Diagnostics Division 2,361 2,518 7% 9% IVD = in vitro diagnostics 4

5 Roche Diagnostics strategy firmly on track Accessing novel content is a key driver of differentiation Improving Medical Value Expanding menu Novel markers Companion Dx Increasing Testing Efficiency Automation Workflow IT

6 Innovative product launches - on both fronts Expand leadership, develop new markets, drive growth cobas 8000 Consolidated clinical chemistry & immunoassays Accu-Chek Mobile Integrated blood glucose meter Testing efficiency cobas 4800 Automated CR Benchmark Ultra Automated IHC & ISH LightCycler 1536 High throughput CR Medical value Trop I, hstrop T, IL-6, anti-cc, lgf/ SFlt1, tsa, fsa Strip-free meter (Mobile) Combined pump & meter (Combo) HV, CT/NG KRAS Mutations HER2 SISH & Gastric, MET, EGFR 17 Oncology Antibodies Influenza A/H1N1 Sequencing reagents 6

7 Increasing testing efficiency Strong launch cobas 8000 modular analyzer series H Q2 Q3 Q4 hase 1a: Very high volume laboratories c 701 c 502 EMEA AAC (AUS, NZ, HK) US hase 1b: Very high volume laboratories e 602 EMEA AAC (AUS, NZ, HK) US c 702 e 602 hase 2: High vol laboratories EMEA All AAC LATAM c = clinical chemistry modules e = Immunoassay modules 7

8 Accu-Chek meters and pumps Continued roll-out of innovative products driving growth 2008 Accu-Chek Aviva Nano 2009 Accu-Chek Mobile Accu-Chek erforma Nano Small, sleek design developed for young, high-frequency testers Successful competitor conversions Accu-chek Aviva Nano US launch H2 Only strip-free system enabling less steps for greater ease of use Available in 12 countries in EU & AAC Accu-Chek Combo First interactive insulin pump in EU allowing patients to operate pump by meter Now launched in 16 markets 8

9 The unique Medingo patch-pump technology Lower hurdles for patients to switch to pump therapy Insulin delivery market ~CHF 1.6 bn, growing at +11% Insulin patch pump segment estimated to grow over-proportionally atients new to pumps in the U.S. increasingly favor patch-pump systems Current durable pumps hurdles: weight, size, infusion set high initial up-front costs Source: Boston Medical Consultants, Company Reports, Roche Analysis Bolus buttons Adhesive Cannula Micro patch-pump: light weight, tubing-free Competitive advantages: semi-disposable product solution - easy disconnect & reconnect function direct bolus release on pump Significantly lower up-front costs for patient Launch planned for

10 Creating medical value Through new diagnostics tests Medical Value Diagnostics Screening Diagnosis rognosis rediction Monitoring Companion Diagnostics + Treatment selection Response prediction Treatment monitoring 10

11 Cervical Cancer: HV screening algorithms Growth and market size driven by adoption of screening Clinical Applications Number of HV tests in the US ASCUS Triage Adjunct screening + + ap HV Colposcopy ap/ HV - 1 year year 3 years Colposcopy ~1 m U.S. Market: $250 m, 20% growth per year ~28 m rimary screening HV + + ap - 3 years Colposcopy ~50 m Company reports, Roche analysis 11

12 ATHENA trial demonstrates medical value of HV testing and Genotyping in Cervical Cancer screening Enrolment Completed 2009 ~47,000 women The ATHENA Trial Women with colposcopy (~8,000) Follow-Up Year 1 Follow-Up Year 2 Cytology vs. HV Testing* Follow-Up Year 3 Targets ASCUS triage, adjunct screening and HV 16/18 claims Study results confirm variability of cytology and support improved consistency of HV DNA based cervical cancer screening programs Site Cytology Abnormal CIN 2+ overall A 3.7% 6.5% B 5.2% 6.1% C 8.1% 5.7% D 9.8% 4.5% Data support HV 16/18 genotyping as actionable information for intervention HR HV ositive Deferred follow up ASCUS/ HV- 13.8% Yearly follow up * Wright, TC., EUROGIN % 15.6% Immediate follow up ASCUS/ HV+ 15.5% Immediate follow up for HV 16/18 ap-/ HV - ap-/ HV + ap-/ 16/18+ ASCUS/ 16/18+ 2 % 10 % Increasing risk of CIN2+ FDA submission mid 2010; data to be presented at IV, Montreal 07/2010 ATHENA establishes the value of genotyping in cervical cancer screening programs 12

13 rostate Cancer: Rearrangements between TMRSS2 and ERG genes found in ~50% of prostate cancer patients Survival from rostate Cancer % Overall survival from rostate cancer* 5 Deletion/ 3 Duplication Normal 70%, n=311 5 Deletion Rearrangement status may determine clinical outcome How aggressive is my cancer? What should the course of my primary therapy be? What is my risk of metastasis? * Oncogene (2008) 27, TMRSS2= transmembrane protease, serine 2 (androgen responsive gene) ERG=Ets Related Gene 13

14 Assay in development for ERG gene rearrangements Identifying prostate cancer aggressiveness for appropriate treatment Oncologist Surgeon atient tumor needle biopsy Imaged Slide Review for athologist Normal Likely Indolent 3 Insertion Likely Aggressive Ventana SYMHONY rostate cancer diagnosis via H&E 5 Deletion Likely Aggressive Ventana BenchMark ULTRA 5 Deletion and 3 Duplication Highly Aggressive 14

15 Creating medical value Through Companion Diagnostics Medical Value Diagnostics Screening Diagnosis rognosis rediction Monitoring Companion Diagnostics + Treatment selection Response prediction Treatment monitoring 15

16 Strong pipeline of companion diagnostics Joint harma and Diagnostics programs - Oncology Roche harma targeting multiple pathways Molecular Tests for assessing presence of mutations offers opportunities to tailor treatment RTK ipeline Drug Biomarker ipeline Assay Ras Ras p110a I I 22 p85 p85 I I 33 TEN RG7204 BRAF Inh/LX4032 RG7167 MEK Inh/CIF RG7112 MDM2 Antagonist RG7112 MDM2 Antagonist BRAF p53 MDM2 cobas 4800 BRAF V600E test AmpliChip p53 array cobas MDM2 expression assay Raf MEK ERK Cyclin D1 D1 Cell Cell cycle cycle progression and and proliferation I3K Forkhead p2 p2 77 Fas Fas LL AKT Bad Bad Survival AKT AKT Bcl-2 TSC TSC 1 TSC TSC 2 mtor mtor mtor rotein synthesis and and growth Tarceva RG7167 MEK Inh/CIF RG1273 ertuzumab RG3502 T-DM1 RG7321 I3K Inh RG7422 I3K Inh EGFR KRAS Her1, 2, 3 AREG, BTC IK3CA TheraScreen EGFR mutation test TheraScreen KRAS mutation test cobas 4800 HER Family expression assay CR IK3CA mutations FISH IK3CA copy number assay List not exhaustive 16

17 Key launches in 2010* Roche Investor event, AACC, July 26th rofessional Diagnostics Diabetes Care Molecular Diagnostics Applied Science Tissue Diagnostics cobas 8000 e 602 & c 702 modules (EU, AAC, LATAM) cobas 8000 c 701, c 502 and e 602 modules (US) cobas b 123 for bloodgas & electrolytes (EU) New immunoassays: 8 (US) 6 (EU) Accu-Chek Aviva Nano (US) Accu-Chek Mobile (AAC) Accu-Chek Combo (AAC) cobas TaqScreen DX blood screening test for B19 virus & HAV (EU) MRSA Test (US) CA/CTM CMV test (EU) GS Junior sequencing system (global) Next-generation ultra-high density NimbleGen microarrays (global) xcelligence RTCA HT instrument (global) Benchmark GX (EU, AAC) Molecular probes for Top2a and IGF-1R (EU) Discovery Ultra for IHC & ISH research (US EU) Diagnostics Division Outlook: Sales growth significantly above the market * Subject to appropriate regulatory approvals barring unforeseen events 17

18 We Innovate Healthcare 18

19 Q1 2010: Diagnostics Division sales Growth driven by EMEA and Asia acific CHF 2,518 m local sales growth North America 25% Diagnostics Division 9% Latin America 6% North America 5% 270 Asia acific 11% EMEA* 8% 118 Japan 4% Latin America 11% 1'352 EMEA 1 54% Asia acific 21% Japan 7% 1 Europe, Middle East and Africa 19

20 Q1 2010: Diagnostics Division local sales By Region and Business Area (vs. Q1 2009) Sales CHF m Global North Am. EMEA RoW % loc growth % loc growth % loc growth % loc growth rofessional Diag. 1, Diabetes Care Molecular Diagnostics Applied Science Tissue Diagnostics Diagnostics Division 2, ,

21 Diagnostics Division quarterly sales and local growth 1 Sales CHF m Q4 08 Q1 09 Q2 09 Q3 09 Q4 09 Q1 10 % loc % loc % loc % loc % loc % loc rofessional 1,139 9% 1,086 8% 1,152 9% 1,125 11% 1,190 8% 1,170 9% Diagnostics Diabetes 764-7% 679 4% 759 2% 720 7% % 708 6% Care Molecular 303 6% 294 7% 300 4% 288 3% 301 4% 294 2% Diagnostics Applied % 196 6% % % % % Science Tissue 115 n.a % % % % % Diagnostics DIA Division 2,544 9% 2,361 8% 2,541 7% 2,463 10% 2,690 10% 2,518 9% 1 versus same period of prior year 21

22 2010: Key planned product launches rofessional Diagnostics roduct Description Region Time cobas e 602 immunoassay module Module for the cobas 8000 modular analyser series for highvolume laboratories. Throughput: up to 170 tests/hour EU US Q2 Q3 cobas c 701 and cobas c 502 clinical chemistry modules Modules for the cobas 8000 modular analyser series. Throughput: up to 2,000 and 600 tests/hour, respectively US Q2 cobas c 702 advanced clinical chemistry module Module for the cobas 8000 modular analyser series. Features automated reagent loading, enabling consolidation of a broader test menu. Throughput: up to 1,900 tests/hour EU Q4 Immunochemistry menu Eight Elecsys immunoassays in the US; six in the EU Global Q1-Q4 HIV combi 27 min Improved combination assay for HIV 1 antigen (p24) and HIV antibodies, enabling more reliable early detection of infection with the human immunodeficiency virus EU Q4 cobas p 501 and cobas p 701 Automated post analytical sample storage and retrieval modules for bar-coded primary and secondary sample tubes US Q2 cobas b 123 OC system Benchtop multiparameter analyser for blood gas, electrolytes, COoximetry and metabolites. For use in critical care settings at the point of care lanned launches may be delayed or not occur as a result of adverse regulatory decisions or other factors. EU = European Union; EMEA = Europe, Middle East and Africa; AAC = Asia acific; LATAM = Latin America; US = United States. EU Q4 22

23 2010: Key planned product launches Diabetes Care roduct Description Region Time Accu-Chek Aviva Nano Sleeker versions of the Accu-Chek Aviva meter offering an enhanced feature set US H2 Accu-Chek Mobile Integrated lancing and blood glucose monitoring device employing a unique no strip technology that replaces single-use test strips with a continuous tape of 50 tests Additional EU markets Q1-Q4 AAC Q1 Accu-Chek Combo Interactive insulin delivery system combining an insulin pump (Accu-Chek Spirit Combo) and a blood glucose meter (Accu-Chek Aviva Combo) with broad data management capabilities; the meter also functions as a pump remote control Additional EU markets AAC Q1-Q4 Q1 lanned launches may be delayed or not occur as a result of adverse regulatory decisions or other factors. EU = European Union; EMEA = Europe, Middle East and Africa; AAC = Asia acific; LATAM = Latin America; US = United States. 23

24 2010: Key planned product launches Molecular Diagnostics roduct Description Region Time LightCycler MRSA Advanced Test Automated real-time CR-based test for methicillin-resistant Stapholococcus aureus US Q2 Cobas Amplirep/ Cobas TaqMan CMV Viral load monitoring test that will enable physicians to improve the management of cytomegalovirus (CMV) disease in solid organ transplant patients EU Q3 cobas TaqScreen DX Test Blood Screening test designed to simultaneously provide a quantitative result for parvovirus B19 virus and a qualitative result for hepatitis A virus EU Q3 Cobas Amplirep/ Cobas TaqMan HIV-1 v2 Second-generation test with a unique dual-target design enabling detection of two separate regions of the HIV-1 genome US Q4 Cobas Amplirep/ Cobas TaqMan HBV v2 Second generation fully automated HBV test with improved dynamic range requiring minimal serum and plasma sample volume US Q4 lanned launches may be delayed or not occur as a result of adverse regulatory decisions or other factors. EU = European Union; EMEA = Europe, Middle East and Africa; AAC = Asia acific; LATAM = Latin America; US = United States. 24

25 2010: Key planned product launches Applied Science roduct Description Region Time GS Junior System Economical benchtop next-generation DNA sequencing system for smaller laboratories Global Q2 NimbleGen CGX-6 multiplex arrays Microarrays for high-resolution analysis of chromosomal abnormalities; capable of analysing six samples simultaneously Global Q1 xcelligence RTCA HT instrument Automated high-throughput real-time cell analyses and screening Global Q1 SeqCap EZ Exome v.2 In-solution enrichment capture technology for targeted nextgeneration sequencing Global Q2 Arrays Next-generation ultra-high density NimbleGen microarrays Global H2 lanned launches may be delayed or not occur as a result of adverse regulatory decisions or other factors. EU = European Union; EMEA = Europe, Middle East and Africa; AAC = Asia acific; LATAM = Latin America; US = United States. 25

26 2010: Key planned product launches Tissue Diagnostics roduct Dual colour / dual hapten in situ hybridisation (ISH) kit anti-her2 neu (4B5) primary antibody and HER2 DNA probe BenchMark GX Molecular probes targeting the enzyme Top2a & the cell surface receptor IGF1R Discovery Ultra Description Enabling target gene detection and control on a single slide. For use with all molecular markers; specifically to support HER2 testing. For assessing likelihood of response to Herceptin treatment in both breast and gastric cancer patients Economical, low-volume advanced tissue staining platform that automates all slide processing steps from baking to staining For use as an aid in diagnosing and managing breast and lung cancer latform for immunohistochemistry and in situ hybridisation research, offering significant improvements in ease of use, workflow and flexibility Region EU EU EU, AAC EU US, EU AAC, Japan, LATAM lanned launches may be delayed or not occur as a result of adverse regulatory decisions or other factors. EU = European Union; EMEA = Europe, Middle East and Africa; AAC = Asia acific; LATAM = Latin America; US = United States. Time Q2 Q2 Q2 Q2-Q4 Q1, Q2 Q4 26