Roche Diagnostics. Introduction and Business Overview

Transcription

1 Roche Diagnostics Introduction and Business Overview

2 About Roche Diagnostics Diagnostics Strategy and Business Model Financials Organization and Core Technologies Personalized Healthcare and Data Management 2

3 Roche Clear Leader in Growing IVD Market Share of IVD sales 2017 Expected IVD market growth 19% CHF 70bn IVD Market: +4% CAGR 13% CHF 58bn Blood Glucose Monitoring Tissue Diagnostics Blood Glucose Monitoring Tissue Diagnostics Molecular Diagnostics -3% CAGR +6% CAGR +9% CAGR Molecular Diagnostics 9% 8% Centralized and Point of Care Centralized and Point of Care +4% CAGR 4% 4% 3% 3% 3% Roche Abbott Danaher Siemens Sysmex biomeriux OCD Becton Dickinson J&J * includes acquisition of Alere by Abbott 3

4 Diagnostics in a Glance Diagnostics Division as Part of Roche Group Diagnostics Division 23% of 2017 Revenue % of Group Sales growth % of Group Core Operating Profit % of Group R&D spend 22% 10% 13% 4

5 Roche continuously outgrowing the market Increasing market leadership Quarterly growth (% in CER) 10% 9% 8% 7% 6% 5% Strong commercial presence Broadest test menu 4% 3% 2% 1% Roche Diagnostics Division WW IVD market 0% Q1 16 Q2 16 Q3 16 Q4 16 Q1 17 Q2 17 Q3 17 Q4 17 Source: 3 rd party IVD consultancy; Q market growth is an estimate 5

6 About Roche Diagnostics Diagnostics Strategy and Business Model Financials Organization and Core Technologies Personalized Healthcare and Data Management 6

7 Roche Diagnostics Our competitive advantage Total solution offering Breadth of technologies Comprehensive menu IT and workflow connectivity End-to-end workflow 7

8 Servicing Clinical Diagnostics Customers Managing complex product offering and business processes Roche Diagnostics Customers Central lab Pathology Patients (Self Testing) Molecular Lab Point of Care Roche Diagnostics Business Model 8

9 About Roche Diagnostics Diagnostics Strategy and Business Model Financials Organization and Core Technologies Personalized Healthcare and Data Management 9

10 2017: Diagnostics Division sales Growth driven by CPS & Tissue Diagnostics Change in % CHFm CHFm CHF CER Diagnostics Division 12,079 11, Centralised and Point of Care Solutions 7,179 6, Diabetes Care 1,965 2, Molecular Diagnostics 1,920 1, Tissue Diagnostics 1, CER=Constant Exchange Rates Underlying growth of Molecular Diagnostics excluding sequencing business: +4% 10

11 2017: Diagnostics regional sales Strong growth in emerging markets North America +0% 25% of divisional sales EMEA 1 +2% 40% of divisional sales Japan +2% 4% of divisional sales Latin America +10% 7% of divisional sales Asia Pacific +15% 24% of divisional sales +17% growth in E7 countries 2 1 Europe, Middle East and Africa; 2 Brazil, China, India, Mexico, Russia, South Korea, Turkey All growth rates at Constant Exchange Rates 11

12 2017: Diagnostics Division highlights Growth driven by Immunodiagnostics YoY CER growth Centralised and Point of Care Solutions +7% Driven by immunodiagnostics (+13%); clinical chemistry (+3%) Diabetes Care -4% Continued US pricing and reimbursement pressures Molecular Diagnostics 1 +4% Virology (0%), HPV (+15%); MD Sys (+10%) Tissue Diagnostics CHFbn +11% EMEA North America RoW Advanced staining portfolio (+11%); primary staining (+12%) and companion diagnostics (+13%) 1 Underlying growth of Molecular Diagnostics excluding sequencing business: +4% CER=Constant Exchange Rates; EMEA=Europe, Middle East and Africa 12

13 About Roche Diagnostics Diagnostics Strategy and Business Model Financials Organization and Core Technologies Personalized Healthcare and Data Management 13

14 Our Business Area/Unit structure Centralized and POC Solutions Molecular Solutions Serum work area/immuno-assays and clinical chemistry Point-of-care testing Specialty testing (hemostasis, hematology, urinalysis) Lab IT and workflow management Custom Biotech (applications for manufacturing) Molecular Diagnostics Virology Blood screening Genomics/oncology Microbiology Nucleic acid DNA purification and real-time PCR Tissue Diagnostics Primary staining Advanced staining Workflow management Digital pathology Companion Diagnostics Sequencing Unit Sample preparation Sequencing for clinical and life science applications Analytics Harmony prenatal test Diabetes Care Blood glucose monitoring Insulin delivery Continuous glucose monitoring Diabetes Management Solutions 14

15 Integrated Core Lab Expansion with integrated solutions and entering new disciplines IT Solutions Integrating Disciplines Service & Consulting Molecular cobas 6800/8800 Digital Solutions Remote service Coagulation cobas t 511/711 Assays & Analysers Automation & Workflow cobas p 512/612 cobas infinity CCM High Speed cobas 6000 assays cobas e 801 cobas pro 15

16 About Roche Diagnostics Diagnostics Strategy and Business Model Financials Organization and Core Technologies Centralized and Point of Care Solutions Personalized Healthcare and Data Management 16

17 Centralized and Point of Care Solutions #1 in clinical chemistry and immunoassays New launches of Immunoassays GDF-15 Active B-12* HIV Duo IGFBP-3 Androstenedione 17-OH-Progesteron IGF-1* Chagas PIVKA HCV Duo Launched in 2016 Launch planned in 2017 Launch planned in 2018 Launch planned in 2019 Installed base of ~900 cobas e 801 since launch Part of the cobas 8000 family Double throughput on same footprint * Assays will be available on the cobas e 801 by GDF 15 = growth-differentiation factor 15; Active B-12 = Vitamin B12; HIV Duo = HIV-1 and HIV-2 ( HIV Antigen and HIV Antibody); IGF-1 = Insulin like growth factor; Pivka = Protein Induced by Vitamin K Absence or Antagonist II; HCV Duo (HCV Antigen and HCV antibody) IGFBP-3 = Insulin-like growth factor-binding protein 3; B2MG urine = Human β2 Microglobulin; AMH CDx = Anti-Müllerian hormone companion diagnostic; AB-42 = A beta Alzheimer marker; t-tau p-tau = Tau protein Alzheimer marker 17

18 Other lab instruments Portfolio Overview cobas c 513 cobas m 511 cobas t 411 cobas 6500 analyzer Diabetes Testing Hematology Coagulation Monitoring Urine Testing HbA1c (Glycated hemoglobin) analyzer Digital morphology analyzer, cell counter and classifier Blood coagulation management Fully automated urine work area solution 18

19 CPS: POC Solutions Portfolio Overview cobas b123 Accu-Chek Inform II cobas h232 CoaguChek Pro II Reflotron Sprint Urisys 1100 Blood Gas & Electrolytes Metabolic Disease Testing Cardiac Testing Coagulation Monitoring Kidney/ Liver Diseases Urine Testing Critical Care Diabetes Cardiovascular Diseases Acute Cardiovascular Diseases Blood coagulation management Diabetes Cardiovascular Diseases Kidney Injury Diabetes Kidney/Liver Diseases Urinary Tract Infections 19

20 About Roche Diagnostics Diagnostics Strategy and Business Model Financials Organization and Core Technologies Molecular Diagnostics Personalized Healthcare and Data Management 20

21 Roche Molecular Solutions Connecting complementary disciplines H&E Staining IHC/ISH Staining Digital Slide Scanning & Advanced Image Analysis PATHOLOGY WORKFLOW AVENIO Millisect* PCR MOLECULAR WORKFLOW MagNA Pure 24 NGS AVENIO ctdna Analysis Kits* *Research Use Only. Not for diagnostic use. 21

22 Molecular Diagnostic: Centralized and PoC Solutions Blood Screening Virology HPV & CT/NG Microbiology Genomics & Oncology PoC RMD Assays Multiplex HIV, HCV, HBV West Nile Virus B19 and HAV HIV Hepatitis B, C HSV CMV Human Papillomavirus Chlamydia & Gonorrhea MTBMAI MRSA C. Difficile BRAF K-RAS EGFR PIK3CA Influenza A/B Influenza A/B & RSV Strep A C. Diff RMD Platform Strategy cobas 6800/8800 Systems cobas 4800 System cobas Liat Advanced PCR automation Highest throughput (3x above closest competitor) Broadest menu Low to middle volume throughput Broadest menu Point of care lab quality PCR results in ~20 min 22

23 cobas 6800/8800 systems driving growth in molecular Main menu completion in 2018 Installed instrument base: ~500 MPX Multiplex detection of HIV-1, HIV-2, HCV and HBV; WNV - West Nile virus; DPX duplex detection of parvovirus B19 and HAV; HEV - Hepatitis E virus; CHIKVV - chikungunya virus; DENV - Dengue virus; CMV Cytomegalovirus; MTB - Mycobacterium tuberculosis; MAI - Mycobacterium avium-intracellulare infection; RIF rifampicin; INH isoniazid (detection of RIF/INH resistance in MTB positive samples); TV - Trichomonas vaginalis; MG - Mycoplasma genitalium; Babesia detection of babesiosis caused by tick-born parasites; EBV - Epstein-Barr virus; BKV is a common post transplant opportunistic viral infection 23

24 Strong Flu season driving cobas Liat System sales Pediatric and emergency room focus segments Growing number of placements worldwide NAM ~1900 EMEA ~220 cobas Liat Analyzer cobas Liat assay tube APAC ~15 LATAM ~30 Easy to use with less than one minute hands on time Lab quality performance in 20 minutes or less Menu of assays available Suitable for testing in a variety of settings CE US cobas Influenza A/B cobas Strep A cobas Influenza A/B & RSV cobas Cdiff 24

25 About Roche Diagnostics Diagnostics Strategy and Business Model Financials Organization and Core Technologies Tissue Diagnostics Personalized Healthcare and Data Management 25

26 Tissue Diagnostics: Product Portfolio Comprehensive offering across the pathology workflow Pre-Analytical Primary Staining Advanced Staining Imaging/Reporting Tissue Preparation H&E Stain SS IHC ISH Image Analysis Work processes Tracking Grossing Fixation Processing Binary Diagnosis Tissue Morphology Detection of protein targets (IHC) Detection of molecular target (ISH) Predictive/Prognostic Quantitative analyses Report generation Tele-pathology Archiving RTD Platforms Vantage VENTANA HE 600 Benchmark Benchmark iscan HT Special Strainer ULTRA VANTAGE Workflow and Connectivity SS= Special Stains; IHC = immunohistochemistry; ISH= in situ hybridization 26

27 Workflow of future Pathology Lab Superior multiplex IHC* clinical lab workflow enhanced by digital pathology and Navify tumorboard solution Patient specimen arrives for analysis Whole slide scanning (BF**, FL**) Spatial characterisation of tumor micro-environment Navify portfolio and platform of decision support solutions Automated multiplex IHC staining Automatic whole slide image analysis Result interpretation cold vs. hot tumor with TILs** Diagnostic and/or treatment decision * IHC = Immunohistochemistry ** BF = brightfield; FL = fluorescent; TILs = tumor-infiltrating lymphocytes 27

28 About Roche Diagnostics Diagnostics Strategy and Business Model Financials Organization and Core Technologies Sequencing Personalized Healthcare and Data Management 28

29 Roche Sequencing Vision MRD Transplantation Field Testing TILS HCV AUTO IMMUNITY IMMUNOLOGY HEART DISEASE Immunosequencing HUMAN GENETICS INFECTIOUS DISEASE HIV MICROBIOME POSTNATAL SCREENING Early Diagnosis PRENATAL TESTING ONCOLOGY Monitoring Trisomy OTHER Personalization Resistance Recurrence 29

30 Roche Sequencing Solutions Innovating across the workflow SAMPLE PREPARATION SEQUENCING ANALYTICS AND REPORTING MEDICAL & RESEARCH CONTENT AVENIO MilliSect System (Tissue Dissection) Kapa portfolio Nanopore Instruments Software & Informatics NIPT: Harmony Prenatal Test CLIA lab service SeqCap & HEAT-Seq Portfolio CE-IVD & RUO Harmony Kits Automated Extraction for ctdna Library Prep / Target Enrichment AVENIO ctdna Analysis Kits AVENIO Tumor Tissue Analysis Kit 30

31 About Roche Diagnostics Diagnostics Strategy and Business Model Financials Organization and Core Technologies Diabetes Care Personalized Healthcare and Data Management 31

32 Roche Diabetes Care Portfolio Continuous Glucose Monitoring Blood Glucose Monitoring Accu-Chek Insight CGM Accu-Chek Guide Insulin Delivery Systems Accu-Chek Instant Accu-Chek Mobile Accu-Chek Solo Micropump Accu-Chek Insight Accu-Chek Combo Accu-Chek Infusion Sets Accu-Chek DiaPort Digital Diabetes Management Solutions Lancing Devices emminens Accu-Chek Connect Accu-Chek SmartPix Accu-Chek Lancing Systems 32

33 About Roche Diagnostics Diagnostics Strategy and Business Model Financials Organization and Core Technologies Personalized Healthcare and Data Management 33

34 Roche Diagnostics Leader in Personalised Healthcare (PHC) 60% of late stage Pharma development products have an accompanying companion diagnostics test Combined strengths of Pharmaceuticals and Diagnostics: 300 internal collaboration, 50 external collaborations Synergies in research, development and marketing 34

35 Growing a portfolio of decision support solutions NAVIFY Portfolio and Platform Aggregated Data Insights 1 Decision Support Apps (incl. AI): e.g. Literature Search, Clinical Trial Matching, Guidelines, Medical Algorithms Workflow Products: e.g. Tumor Board, Oncologist workflow, Lab Interpretation Support and Tumor Profiler NAVIFY TM Platform Aggregated data sets and Insights as a Service. Feedback loop to Decision Support Apps.. 35

36 Expanding CDx Menu Market leading portfolio Therapy Indication(s) Biomarker Technology Herceptin Perjeta Kadcyla XALKORI ZYKADIA TECENTRIQ IMFINZI KEYTRUDA, OPDIVO Breast, Gastric Breast Breast HER2 IHC/ISH NSCLC ALK IHC Bladder, NSCLC Bladder NSCLC PD-L1 IHC GLEEVEC GIST C-KIT IHC Tarceva TAGRISSO TM NSCLC EGFR PCR (Tissue/Plasma) Zelboraf & COTELLIC Melanoma BRAF PCR ERBITUX Vectibix CRC KRAS PCR 36

37 First liquid biopsy test approved by FDA cobas EGFR v2 CDx for Tarceva and Tagrisso Test can utilize plasma and tissue sample Leverages cobas 4800 platform cobas

38 Doing now what patients need next