Diagnostics Solutions Strategic Priorities

Made public by

sourced by PitchSend

52 of 78

Creator

Roche logo
Roche

Category

Healthcare

Published

2010

Slides

Transcriptions

#1Roche Diagnostics Investor Day 2021 23rd March 2021 Roche#2Roche Diagnostics Investor Day 2021 Welcome Karl Mahler | Head of Investor Relations and Roche Group Planning Roche#3Agenda Welcome Karl Mahler, Head of investor Relations and Roche Group Planning Strategy & Organization Thomas Schinecker, CEO Diagnostics Diagnostics Solutions & Customer Areas Ann Costello, Global Head Roche Diagnostics Solutions Research & Development 2.00-2.40pm Palani Kumaresan, Head of Research & Development Q&A 2.40-3.05pm Birgit Masjost, Investor Relations Officer, & speaker panel Break 3.05-3.10pm Systems Benjamin Lilienfield, Life Cycle Leader Systems Infectious Diseases Michael Hombach, Global Clinical Leader Infectious Diseases 3.10-3.35pm Cardiology Andre Ziegler, Global Clinical Leader Cardiology Oncology Jill German, Global Head of Pathology Lab Q&A 3.35-3.55pm Closing 3.55-4.00pm Thomas Schinecker, CEO Diagnostics Roche 3#4IVD Market has seen consolidation Roche staying in the lead CAGR² IVD market size¹ (in bnCHF) 63 - Market Share in % - +4% 42 Other Other 48% Roche 19% Roche Abbott Abbott 12% Siemens J&J Danaher 10% Beckman Coulter 2009 Siemens bioMérieux 2019 7% 4% Insights • Roche staying in the lead with 4% growth (CAGR 2009- 2019) - broadest menu, highest automation • Significant M&A activities / consolidation with Abbott (Alere), Danaher (Radiometer, Leica, Beckman Coulter, Cepheid), bioMérieux (BioFire) etc. • «Other>> category has expanded driven by specialty players like Sysmex or low-cost entrants like Mindray (China based) Source: Divisional MCI, IVD Market Books 2009-2019; CAGR: Compound Annual Growth Rate; 1 Market size accounts for IVD incl. Blood Glucose Monitoring; 2 Growth in constant exchange rate adjusting for currency fluctuations Roche 4#5Roche Diagnostics Investor Day 2021 Strategy & Organization Thomas Schinecker | CEO Diagnostics Roche#6Roche clear leader in growing IVD market 14 billion CHF revenue in 20201 19% share as IVD market leader' 23.4 billion tests¹ #1 in Clinical Chemistry & Immunodiagnostics #1 in Molecular Diagnostics #1 in Tissue Diagnostics #3 in Point-of-Care Diagnostics #1 in Workflow & IT IVD: In-Vitro Diagnostics; 1 Incl. Diabetes Care Roche 6#7Global transformation exercise Develop strategic options and recommendations Strategic topics ... Customers & value pools ... addressed by cross-functional teams of experts 1 15+ Workshops 2 Diagnostics portfolio segments 40+ Customers 3 Digital solutions 200+ Experts and leaders 4 Geographical focus 30+ Coaching sessions 5 People & culture 400+ Internal & external expert interviews 6 7 Customer centricity & customer experience Fuel innovation engine Roche 7#8Healthcare objectives Improve patient outcomes and reduce costs Healthcare systems aim to... Value to Healthcare Patients & Outcomes Costs Improve outcomes Better outcomes and better social and economic benefits for patients, healthcare providers and the healthcare system as a whole Reduce costs Lower total care delivery costs with more effective prevention, diagnosis, treatments and care along patient journey Roche 8#9Patient journey Optimising care along the patient journey Prevention Diagnosis Treatment Monitoring Core Lab: ECL results Physician consultation Pathology Lab: H&E results Roche Therapy 4 A Key unmet needs (e.g. markers, decision support) Diagnostic solutions Healthcare Decision 圃 support Therapy Molecular Lab: PCR or NGS results RDS: NAVIFY Mutation Profiler links findings to therapy Patient journey: sequence of care events (e.g. diagnosis steps, medical procedures, medicines) which a patient has to go through for a specific disease from the point where the patient enters the healthcare systems to the point of exit due to any cause; ECL: Electrochemiluminescence; RDS: Roche Diagnostics Solutions; NGS: Next Generation Sequencing; PCR: Polymerase chain reaction; H&E: Hematoxylin & Eosin 9#10Strategy and financial ambitions e to Patients Value to Healthcare Outcomes Costs Improve care along patient journeys Enable confident healthcare decisions 8 Deliver medical value on integrated testing solutions کہا Improve patients' lives via 'OneRoche Approach' Build the leading, profitable insights business Double patient access to novel, high- medical-value diagnostics solutions Grow talent Invest in strategic priorities Grow market share Roche 10#11Organizational transformation enabling new strategic priorities Simplification and focus through customer & function centricity New diagnostics organization Roche Diagnostics Solutions Roche Information Solutions Global Regions Functions Roche Diabetes Care 3 to 1 Business areas¹ 4 to 1 Digital Roche Roche Diagnostics solutions Information Solutions organizations Solutions 1 Roche Diabetes Care excluded based on previous transformation Roche 11#12Diagnostics reporting 2021 onwards Moving from business to customer areas and adjusting regions Old New Roche Changes in regional reporting Changes in customer areas reporting 2020 2019 Change in % 2020 2019 CHFm CHFM CHF CER CHFM CHFM CHF Change in % CER Diagnostics Division 13,791 12,950 6 14 Diagnostics Division 13,791 12,950 6 14 Centralised and Point of Care Solutions 7,273 7,819 -7 -1 Core Lab¹ 6,194 7.078 -12 -6 Molecular Diagnostics 3,760 2,109 78 90 Molecular Lab 3,760 2,109 78 90 Diabetes Care 1,670 1,918 -13 -5 Point of Care 1,079 741 46 54 Tissue Diagnostics 1,088 1,104 -1 5 Pathology Lab 1,088 1,104 -1 5 Diabetes Care 1,670 1,918 -13 -5 North America +26% -28% of divisional sales EMEA² +19% -40% of divisional sales Latin America +74% -6% of divisional sales Japan +5% -4% of divisional sales Asia Pacific -3% -23% of divisional sales CER: Constant Exchange Rates; 1 Includes Roche Information Solutions sales; 2 Europe, Middle East and Africa North America +26% -28% of divisional sales EMEA² +19% -40% of divisional sales Latin America +14% -6% of divisional sales Asia Pacific -2% -26% of divisional sales 12#13Funding the Strategy Shifting investments into strategic priorities Free resources due to increased efficiencies Fund strategic priorities: Re-invest in strategic focus · Medical value solutions • areas Digital solutions & insight generation Margin improvement · Disease management • Access capabilities Roche 13#14Diagnostics solutions Deliver medical value on integrated testing solutions Value to Patients & Healthcare Outcomes Costs 3 Improve care along patient journeys Enable confident healthcare decisions N Deliver medical value on integrated testing solutions Roche 14#15Diagnostics Solutions strategic priorities Developing comprehensive solutions for our customers Focus on customer solution and experience Core Labs Differentiators Systems & assays Medical value Efficiency Molecular Labs¹ IT Digital & IT Pathology Labs¹ Points of Care Services 1 Sequencing as key technology to address needs of molecular and pathology labs customer segments Digitalisation Access Roche 15#16Healthcare decision support solutions Enable confident healthcare decisions Value to Patients & Outcomes Costs Healthcare 3 N Improve care along patient journeys Enable confident healthcare decisions Deliver medical value on integrated testing solutions Roche 16#17Roche Information Solutions strategic priorities Supporting healthcare decisions Focus on customer solutions and experience Differentiators Lab Insights Platforms, applications, marketplace ΣΣΣΣ Platform Efficiency Lab and clinical workflow Provider Insights Clinical decision support Disease management Patient Insights Medical Value Insight generation Roche 17#18Disease management solutions Improve care along patient journeys Value to Patients & Outcomes Costs Healthcare 3 N Value-based solutions Improve care along patient journeys Enable confident healthcare decisions - Patient journey unmet needs Deliver medical value on integrated testing solutions ලදී Roche 18#19Disease management solutions Unlocking value through orchestration along patient journey Patient journey IVD test GP consultation Sensors Clinical Algorithms Patient self-management Clinical decision support Medicines Care coordination Others Diagnostic solutions Healthcare decision support Medicine Medicines Remote monitoring POC test Orchestration through disease management solutions Disease management solution (e.g. AFib) Disease management solution (e.g. Diabetes) AFib: Atrial Fibrillation; GP: General Practitioners; IVD: In-Vitro Diagnostics; POC: Point Of Care Roche 19#20Improve patients' lives via 'OneRoche Approach' Build the leading, profitable insights business Strategy and financial ambitions e to Patients Value to Healthcare Outcomes Costs Improve care along patient journeys Enable confident healthcare decisions 8 Deliver medical value on integrated testing solutions کہا Double patient access to novel, high- medical-value diagnostics solutions Roche Grow talent Invest in strategic priorities Grow market share 20 20#21Roche Diagnostics Investor Day 2021 Diagnostics Solutions & Customer Areas Ann Costello | Global Head Roche Diagnostics Solutions Roche#22Diagnostics solutions: Strategic priorities Providing comprehensive solutions for our key customer segments Roche Customer Core Lab Molecular Lab¹ Pathology Lab¹ Point of Care area Customer segments Central Labs Molecular Labs Pathology Labs Blood Banks Solution components Systems & assays 1 Sequencing as key technology to address needs of molecular and pathology labs customer segments Satellite Labs ERS/ICUS GPs / Specialists Patients Pharmacies 10 + Digital & IT IT + Services ↑ t 22#23Diagnostics solutions: Strategic priorities Achieving differentiation based on four distinct pillars + Medical value Diagnostics efficiency Digitalization Address top disease areas and unmet clinical needs Drive integration & connectivity from labs to patients Digitalize lab operations and test interpretation Examples of success FDA BDD FDA Molecular Lab & Core Lab, Point of Care: 9 FDA Breakthrough Device Designations since 2018 1 Product to be launched in 2021 Molecular Lab: Point of Care: cobasⓇ prime cobasⓇ pulse¹ Pathology Lab: uPath Software Point of Care: v-TAC Software Market access Ensure access to novel diagnostics Roche Molecular & Pathology Lab: Cervical Cancer Screening Core Lab: Pre-eclampsia in guidelines 23 23#24SARS-CoV-2 diagnostics portfolio¹ Comprehensive portfolio of tests and digital solutions Clinical Labs • cobas® SARS-COV-2 • cobasⓇ SARS-CoV-2 Variant Molecular solutions cobasⓇ SARS-CoV-2 & Influenza A/B Immunology solutions TIB MOLBIOL LightMix® Modular SARS-CoV-2 Near Patient Launched Launched Launched • cobasⓇ SARS-CoV-2 & Influenza A/B Launched • cobas® SARS-CoV-2 Roche Launched In-development . ElecsysⓇ Anti-SARS-CoV-2 ElecsysⓇ Anti-SARS-CoV-2 S² ElecsysⓇ SARS-CoV-2 antigen Launched Launched Launched4 • SARS-CoV-2 rapid antibody • SARS-COV-2 rapid antigen Launched 3,4 Launched 3,4 SARS-CoV-2 rapid antigen nasal • ElecsysⓇ IL-6 Test to diagnose cytokine release syndrome Launched • SARS-CoV-2 rapid antigen nasal self-testing • SARS-COV-2 & Influenza A/B rapid antigen Launched 3,4 Launched 3,4,5 In-development3,4 • NAVIFY Remote Monitor6 Launched Digital solutions Viewics LabOps COVID-19 for efficiency improvements Launched • v-TAC digital algorithm for blood-gas Launched • iThemba Life COVID-19 Launched cobas Infinity POC COVID-19 Launched . NAVIFY Pass Launched CER: Constant Exchange Rates (avg FY 2020); 1 Not all products are available in all countries; 2 Spike protein; 3 External distribution partnership; 4 Not yet approved in the U.S; 5 Germany only; 6 US only; 7 v-TAC: venous to arterial conversion 24#25Investing CHF >600m to increase supply chain capacities Driving to unprecedented volume in record time Consumables • 60 new manufacturing lines • 17 locations with 5 new partners 8 new manufacturing lines • 1 new biotech facility Raw materials Reagents • 20 new manufacturing lines • 4 major facility expansions • CHF >600m investment • >1,200 new employees ⚫ 1 new manufacturing space Rx Only cobas SARS-CoV-2 V IVD G Roche Instruments 25#26Molecular Lab installed base We significantly increased our footprint in the market Installed base for cobas® 6800/8800 ~800 +42% ~1,200 2021 aspiration 2018 2019 2020 2021 Roche 26#27Levering our installed base in the future Enabler to sell high medical value biomarkers Further consolidation of labs & customer preference for fully automated solutions Roche Our aim to bring more menu to installed base focusing on medical value +42% Increase of installed base for cobas® 6800/8800 in 2020 We built a strong position for sustainable performance 27#28Roche molecular solutions portfolio GenMark¹ Diagnostics fills the portfolio gap in molecular multiplexing Throughput Oce cobasⓇ LiatⓇ GenMark BOD-G cobas® 5800² cobas® 6800 2021 cobas® 8800 Molecular point-of-care Molecular multiplexing Molecular Molecular high throughput medium throughput 1 GenMark Diagnostics offering is subject to successful closing of the merger agreement dated March 12, 2021; 2 Currently in development and not commercially available Roche 28#29Roche Diagnostics Investor Day 2021 Research & Development Palani Kumaresan | Head of Research & Development Roche#30Our commitment to innovation We invest more in our IVD portfolio than other companies 125 CHF million per month Roche Roche Abbott DANAHER SIEMENS 0.7 billion CHF 9% of revenue 0.5 billion CHF 1.5 billion CHF 12% of revenue 8% of revenue 0.3 billion CHF 7% of revenue R&D investments as percentage of revenue for 2019 Ref: Roche estimates for IVD portfolio based on annual reports together with independent 3rd parties (including diabetes care); Product names and trademarks are the property of their respective owners. 30#31R&D efficiencies Implementing our new strategy will improve productivity Increase organizational effectiveness Improve project delivery • • Improved standardization and cross-pollination of best practices Greater shift of funds to projects versus non-project activities More rigorous portfolio prioritization Internalize learnings from unprecedented development timelines of COVID solutions Roche 31#32Strategy around menu expansion Broadest menu and most differentiated medical value solutions Medical value solutions² that are differentiated, based on clinical evidence and improve the standard of care Broad menu that allow customers to consolidate various tests on a single platform Cardiometabolic diseases Infectious diseases Oncology Central nervous system Increasing healthcare & social burden With medical value solutions & broad menu we address top healthcare burdens¹ 1 Based on Divisional Medical & Scientific Affairs definitions and disease burden; 2 Including both top disease burden areas and other disease areas 32 Roche#33Approach to medical value solutions Multi-modal, multi-parametric approach along continuum of care Roche Disease areas Cardio- metabolic Infectious Diseases Oncology Women's Health CNS Indications Atrial fibrillation Heart failure Acute coronary syndrome Addressing unmet medical needs along the care continuum Screening Diagnosis Risk stratification Therapy selection monitoring Digital Solution Biomarker Clinical Algorithms 33#34A broad portfolio of solutions across the care continuum Disease area Indication Atrial fibrillation Cardio- metabolic HF (incl. HF in T2D) ACS Infectious Diseases Sepsis Screening Diagnosis Risk stratification о О Tuberculosis О O Vector-borne disease Hepatitis O Respiratory viruses O Oncology Women's Lung Breast GU, GI, Melanoma Liver Endometriosis Health Carrier screening CNS Alzheimer's disease Parkinson's disease ACS: Acute Coronary Syndrome HF: Heart failure; T2D: Type 2 Diabetes; GU: genitourinary; Gl: Gastrointestinal; CNS: Central nervous system о OOO O 0000000 On market Molecular Pathology Core Lab Lab Lab Point of Care In development Under evaluation Roche Therapy selection / monitoring о о О 34#35Recent Breakthrough Device Designations (BDDs) Leading innovation recognized by the FDA FDA BDD Infectious diseases Oncology Women's health CNS Others cobasⓇ EBV: EBV in transplant patients cobasⓇ BKV: BKV in transplant patients FACT CDx (liquid biopsy assay): 70 oncogenes + MSI + bTMB ElecsysⓇ GALAD score: Diagnosis of early stage hepatocellular carcinoma ElecsysⓇ GDF-15: GDF-15 ElecsysⓇ sFlt-1/PIGF: rule- out of Preeclampsia within 1 week ElecsysⓇ B-Amyloid and ElecsysⓇ p-Tau in Cerebro Spinal Fluid assays: PET concordance and progression in Alzheimer's Disease in cachectic patients with solid tumors¹ CoaguCheck® Direct-X: Patients on Factor Xa EBV: Epstein-Barr virus; BKV: BK virus; FDA: Food & Drug Administration; CDx: Companion Diagnostics; CNS: Central nervous system; 1 Treated with Pfizer Inc.'s investigational drug PF-06946860 Roche 35#36Key launches 2021 Area Product cobasⓇ pure integrated solutions Core Lab cobasⓇ pro integrated solutions Point of Care cobas® pulse Instruments cobas® 5800 Molecular Lab AVENIO Edge System Diabetes Care Accu-Chek Instant Core Lab • • Tests Molecular Lab Pathology Lab Ⓡ Elecsys SARS-CoV-2 Antigen ElecsysⓇ NT-proBNP IU extensions in Heart Failure extension for Atrial Fibrillation ElecsysⓇ TnT-hs 3 claim extensions in Coronary Arterial Disease Description Low-to-medium volume SWA New high throughput configurations of the cobas pro instrument Successor of Accu-ChekⓇ Inform II Fully automated low throughput PCR system Automated sequencing library preparation and target enrichment instrument New features for the monitoring system to increase performance and user experience Automated laboratory assay intended as an aid in the diagnosis of SARS-CoV-2 infection A set of 5 intended use extensions in the Coronary Arterial Disease, Atrial Fibrillation and Heart Failure Space Decentralized kit of the Foundation One test AVENIO FoundationOne kit (RUO) New targeted sequencing portfolio using primer extension for small targets KAPA HyperPETE kit uPath 2.0 First IVD release and version of Open API of the clinical pathologist workflow module for NAVIFY Digital Pathology & on-premise uPath Roche Market¹ CE US & CE CE CE WW WW US CE WW WW WW Digital Solutions Insights Core Lab RUO Algorithms NAVIFY Oncology 1.0 NAVIFY Pass 1.0 ElecsysⓇ GAAD Algorithm Whole slide image analysis algorithms (ER (SP1), Ki-67 (30-9), and PR (1E2)) Modular Oncology decision support solution WW WW³ RocheDiabetes RemoteCare Diabetes Care Accu-Chek SugarView Solution for providers to communicate SARS-CoV-2 rapid antigen test results to a mobile app Algorithm for early detection of HCC in patients with chronic liver disease. Module within the RocheDiabetes Care Platform enabling remote interactions between HCPs and patients, including a patient dashboard, check-in and chat functionality Meter-free blood glucose testing using a smartphone app and test strips US & CE³ CE WW³ OUS³ 36 RDCP: Roche Diabetes Care Platform; 1 CE: European Conformity, US: FDA approval, WW: Worldwide, OUS: Outside the US; 2 Research Use Only; 3 Only a few selected countries#37QᎪ Roche 37#38Roche Diagnostics Investor Day 2021 Systems Benjamin Lilienfield | Life Cycle Leader Systems Roche#39Largest installed base worldwide with significant growth in 2020 cobas® infinity lab +23% Lab SW solutions +10% Histopathology systems cobasⓇ 4000/6000/8000 +9% +42% cobas® 6800/8800 +10% cobas® 4800 +12% Preanalytics / connectivity +452% cobasⓇ pro Roche 39 39#40cobas® 6800/8800 menu expansion driving growth in molecular Further growing the installed base in 2021 Roche DPX Blood Borne Disease Donor Screening MPX HIV-1 HPV WNV HBV CT/NG HCV TV/MG HEV HIV-1/2 Qual PivNG Not available in the US CHIKV/DENV HSV-1/2/VZV HBV RNA (IA) Not available in the US Zika Babesia Malaria Global launch in 2023 Sexual Health Transplant CMV EBV HPV Self-sampling CE-IVD in 2022 BKV ADV Quant Not available in the US HSV-1/2/VZV Not available in the US Installed instrument base >1,200 ~400 new placements in 2020 Respiratory Flu A/B & RSV Not available in the US MTB Not available in the US ΜΑΙ Not available in the US SARS-COV-2 EUA & CE-mark SARS-COV-2 & Flu A/B EUA & CE-mark SARS-COV-2 Variant (RUO in 2021) Influenza A/B & RSV (CE-IVD in 2021) AMER (CE-IVD in 2021) Parainfluenza 1-4 (CE-IVD in 2021) MPLX Respiratory (CE-IVD in 2022, US-IVD in 2023) Antimicrobial Stewardship MTB-RIF/INH Not available in the US C.diff Not available in the US MG Resistance CE-IVD in 2022 GC Resistance CE-IVD in 2022 Launched in 2020 In development 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; CHIKV 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 post-transplant monitoring; BKV=BK virus post-transplant monitoring; ADV=Adenovirus post-transplant monitoring; HSV-1/2/VZV-multiplex detection of Herpes simplex virus 1 and 2 and Varicella-zoster virus; MPLX=detect and discriminate multiple (up to 14) pathogens associated with a clinical syndrome, including SARS-CoV-2; Malaria mosquito-borne infectious disease; SARS-CoV-2=2019 novel coronavirus; HSV=Herpes Simplex Virus; VZV=Varicella-zoster virus, the cause of chickenpox and herpes zoster (also called shingles); PivNG=Neisseria Gonorrhoeae Piv Gene Target; CG-Neisseria gonorrhea (NG)--aka Gonococcus (GC); ADV=Adenovirus; AMER=ADV (Adenovirus), hMPV (Human metapneumovirus), EV/RV (Enterovirus/Rhinovirus) 40#41Roche Serum Work Area menu Broadest menu on one integrated platform Breadth of assay menu 250 231 200 IM¹ 150 Launched in 2020 & upcoming launches in 2021 231 Immuno chemistry assays HBsAg II Auto Conf Androstenedione Anti-SARS-CoV-2 Anti-SARS-CoV-2 S SARS-CoV-2 Ag IL6 (EUA) EBV EBNA IgG EBV VCA IgG EBV IgM Anti-p53 HCV Duo GAAD 100 assays² HIV Duo CC 50 0 Roche cobasⓇ SWA solutions NT-proBNP claim extension4 TnT-hs claim extension4 PCT CE claim extension4 Vit D total ||4 Preeclampsia Anti-HBe Clinical chemistry assays Kappa FLC3 ASTP24 Lambda FLC³ ALTP24 sdLDL3 fCal³ CRP4 A1MG3,4 Fentanyl³ Ethyl Glucuronide³ sTfR Gen 24 Benz 24 Sirolimus Alzh CSF biomarkers PIVKA II On market (Launched in 2020) In development (to be launched in 2021) Roche IM: Immunochemistry; CC: Clinical chemistry; 1 Not including confirmatory tests, stat tests and special assays in the allergy panel. Variants of the same assay (e.g. for HIV AG/Ab, different kit sizes) are counted once; 2 Core unit| ISE |c 702 | c 702 | e 801 | e 801; 3 Partner Channel; 4 Product update 41#42New systems launches in 2021 Enabling comparable results in different size laboratories Serum Work Area solutions 2021 cobasⓇ pure¹ cobasⓇ pro Throughput 2021 cobasⓇ pro (high throughput) Improved outcomes Family concept addressing needs of all lab sizes to increase access Roche Molecular solutions cobas® 58001 2021 cobas® 6800 cobas® 8800 1 Currently in development and not commercially available www. Increased profitability Up to 50% lower SMCs per test and 20% lower service cost More sustainable Up to 80% less plastic waste per test 42#43Live Stream Demo Roche 43#44New innovations driving market access Mass Spectrometry First fully integrated mass spectrometry Emerging Market Analyzer Routing testing in remote areas col Integration of mass spec into the Core Lab Sample in result out - Increase patient access to mass spec technology Promising new high medical value biomarkers Designed for the specific needs of emerging markets • Compact, easy-to-operate benchtop analyzer Combines immunochemistry and clinical chemistry into one box CHF 2.1 billion accessible market CHF 2 billion accessible market Roche 44#45Roche Diagnostics Investor Day 2021 Infectious Diseases Michael Hombach | Global Clinical Leader Infectious Diseases Roche#46Infectious Diseases are still causing global harm Cause of death globally (millions per year)1,2 Roche Cardiovascular diseases Infectious diseases Cancer Injuries Neurological disorders. 3 4 10 18 13 +2 COVID-19 2020 >2tn CHF ECONOMIC IMPACT³ Infectious Diseases +100% estimate" from COVID-19 1 GBD 2017 Causes of Death Collaborators. Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1736-1788. doi: 10.1016/S0140-6736(18)32203-7. Epub 2018 Nov 8; 2 Sung S., Ferlay J., Siegel R., et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;0:1-41; 3 Bloom DE et al. National Bureau of Economic Research Working Paper 7757; 4 Prediction United Nations (March 9, 2020) 46#47Pathogen, immunity and host belong together Developing comprehensive disease-based solutions for patients Roche PATHOGEN Bacteria, Viruses, Fungi, Parasites IMMUNITY Antibodies HOST Inflammation Cytokines, Endothelium 47#48What are the medical use cases across the patient journey? PATHOGEN e.g. SARS-CoV-2 IMMUNITY IgG, IgM, IgA e.g. SARS-CoV-2 antibodies Roche PCR and Antigen assays: e.g. cobas® SARS-CoV-2 or ElecsysⓇ SARS-CoV-2 Antigen Antibody assays: e.g. ElecsysⓇ Anti-SARS-CoV-2 Antibody Is someone actively infected? Has someone recovered? 48#49Global emerging and re-emerging infectious diseases NEWLY EMERGING RE-EMERGING/RESURGING DELIBERATELY EMERGING Enterovirus D68 Heartland Powassan virus Lyme disease Drug-resistant malaria Diphtheria Typhoid fever Cryptosporidiosis E. coli 0104:H4 Akmeta virus MERS-CoV Rift Valley fever H3N2v influenza Antimicrobial- resistand thearts CRE, MRSAS, C. difficile, N. gonorrhoeae Listeriosis Cyclosporiasis E. coli O157:H7 Measles Human monkeypox Adenovirus 14 Bourbon Virus 2009 H1H1 influenza Dengue Chikungunys Hanatavirus pulmonary Cholera syndrome Yellow fever Anthrax bioterrorism vCJD West Nile virus Hepatitis C Lassa fever MDR/XDR tuberculosis Plague Zika virus Source: National Institute of Allergy and Infectious Diseases (NAID) 2017 Ebola virus disease Human monkeypox H10N8 influenza STFTSV bunyavirus H7N9 influenza E. coli O157:H7 SARS H5N1 influenza Nipah virus Enterovirus 71 Human Africa trypanosomiasis Hendra virus HIV Marburg hemorrhagic fever Roche 49#50Roche infectious diseases pipeline Holistic portfolio coverage is a key medical value Viral Hepatitis + STDs Pregnancy + Transplant Respiratory Vector Borne Roche Donor Screening Anti-HCV HBsAg Anti-HBc HIV combi PT HIV Duo Syphilis Vaccination Panel Anti-HBs Rubella IgG Anti-HAV >6 more medical value solutions Gastrointestinal cDiff >3 more medical value solutions Antimicrobial Stewardship MTB-RIF/INH >6 more medical value solutions HIV-1 CT/NG CMV Flu A/B/RSV HBV TV/MG HSV-1/2/VZV MTB Zika IgG Zika IgM HCV HPV EBV ΜΑΙ HIV-1/2 Qual HCV DUO BKV MPLX Respiratory Dengue IgG Dengue IgM Anti-HEV IgG CMV IgG >5 more high medical Dengue Ag Anti-HEV IgM CMV IgM value solutions Chik IgG CMV Avidity Chik IgM Toxo IgG Lyme IgG Anti-HAV Anti-HAV IgM HBsAg HBsAg confirmatory HBsAg quant Anti-HBs Anti-HBc Anti-HBc IgM Anti-HBe HBeAg Anti-HCV HIV combi PT HIV DUO HIV confirmatory HTLV I/II Syphilis Genital Ulcer Panel Vaginal Discharge Panel Mycoplasma Panel HBeAg quant Anti-HBc quant >10 more medical value solutions Toxo IgM Toxo Avidity EBV EBNA IgG EBV VCA IgG EBV IgM Adeno Quant HSV-1/2/VZV >3 more medical value solutions Chagas HTLV I/II Lyme IgM CMV IgG >2 more medical MPX value solutions WNV DPX HEV CHIKV/DENV Zika (US-IVD) Babesia Zika (CE-IVD) >2 more medical value solutions RPR HSV-1 IgG HSV-2 IgG IA: Investigational Assay, US-IVD: Exclusive to US Sepsis PCT IL-6 IL-6 US neonatal & adult New Early Sepsis Marker Digital Decision Support On market In development Considered 50#51Roche infectious diseases pipeline Systematically addressing areas of unmet medical needs Roche Tuberculosis DRG death #1 cause of ICU de SIRS time sensitivity, virus severe bacteria infection blood che. DRG 870 organ failu SEPSIS ic response shock reimbursement mmation? alled DRG mortality increased LOS unnecessary 능 death severe parasite dedicated drug tx Sepsis Dengue Fever IPM TZP 19 FEP 19 SXT 6 NA 17 Antimicrobial Resistance 10m new cases p. a. 1.4m death p.a.1 50m new cases p. a. 11m death p.a.2 400m new cases p. a. 4bn people at risk¹ 1m death p.a. 2020 10m death p.a. in 20503 Adressing >CHF 100bn total healthcare costs per year1-4 1 WHO 2020; 2 Rudd KE, et al. Lancet. 2020; 3 Dadgostar P. Infect Drug Resist. 2019; 4 CDC 2020; 5 ECDC 2020. Lyme Disease 1.1m new cases p. a. Rapidly increasing 4,5 51#52Molecular Diagnostics respiratory multiplex panel Breaking the barriers of syndromic testing TAGS¹ Empowered by TAGS 5 channels = 15 targets ** Channel 1 * 渤 ex Channel 2 Channel 3 Channel 4 Channel 5 Respiratory Panels Timeline (launch timing per year is illustrative): • High unmet medical need: differential diagnosis between viruses • Cost-efficient approach • Fully automated high throughput • Roche Utilizes the cobas® 6800/8800 install base 2020 SARS-CoV-2, Influenza A, Influenza B (3-plex) HMPV, Advenovirus, Entero/Rhinovirus Paraflu 1, Paraflu 2, 2021 (3-plex) Paraflu 3, Influenza A, Influenza B, RSV 2023 (3-plex) 1 TAGS: Temperature Activated Generation of Signal; 2 Common cold coronaviruses including HKU1, OC43, NL63, 229E Paraflu 4 (4-plex) Influenza A, Influenza B, RSV, HMPV, Adenovirus, Entero/Rhinovirus, Paraflu 1, Paraflu 2, Paraflu 3, Paraflu 4, SARS-COV-2, Coronavirus2 (12-plex) 52#53"I share Alfred Nobel's conviction that war is the greatest of all human disasters. Infectious disease runs a good second." Peter C. Doherty, 1996 Nobel Prize Laureate in Physiology or Medicine 53 53 Roche#54Roche Diagnostics Investor Day 2021 Cardiology Andre Ziegler | Global Clinical Leader Cardiology Roche#55Cardiovascular disease is #1 killer in the world Cause of 18 million deaths globally per year¹ Disease Burden Index 2010 2030 Cardiac disease area +78% 1tn CHF ECONOMIC IMPACT2 (2020) Roche Cardiovascular disease major cost driver for healthcare systems5 Prevalence (per million) Coronary Artery Disease³ 197 Strokes3 Heart Failure4 AFib³ Disease burden: Impact of a health problem as measured by mortality, prevalence, quality of life and economic costs; 1 Roth GA et al., Lancet. 2018;392:1736-1788; 2 Mendoza-Herrera K et al., Int J Environ Res Public Health. 2019; 16: 4041; 3 Roth GA et al., JACC 2020; 76: 2982. 4 Groenewegen A et al, Eur J Heart Failure 2020;22: 1342; 5 Timmis A et al., Eur Heart J 2020;41:12-85 101 64 60 55#56Roche is an IVD market leader in cardiovascular diseases Highest benefit class and evidence level in major cardiac guidelines Roche Core Lab cardiovascular market share in 2019¹ Clinical practice guidelines⁹ 34% Roche 19% 17% SIEMENS Healthineers Abbott A Promise for Life 9% QUIDEL 6% ① DANAHER 16% Others Elecsys Troponin T Gen 5 STAT Elecsys and A cobas e analyzers IVD "Redefining the gold standard of myocardial infarction using Troponin T" • Diagnosis²,3 • Risk prediction 2,3 cobas . Early invasive strategy² "NT-proBNP: The gold standard biomarker in heart failure"7 • • Diagnosis 5,6 Prognosis6 - 1 Source Roche Diagnostics with BBC; 2 Roff M et al, Eur Heart J 2016; 37: 267; 3 Amsterdam EA et al., Circulation 2014;130:2354; 4 Ohman EM. Clin Chem 2017; 63: 429; 5 Ponikowski P et al., Eur Heart J 2016; 37:2129; 6 Yancy CW et al, Circulation. 2017;136:e137; 7 McKie PM et al, J Am Coll Cardiol 2016;68:2437; 8 American College of Cardiology / American Heart Association 56#57Leading coronary artery disease Setting new standards of care in diagnosing heart attacks Elecsys® Troponin T-high sensitive (TnT-hs) test New data on cardiac risk in non-cardiac surgery 1 hour decision algorithm 1 HOUR RULE-OUT OBSERVE 57% 25% RULE-IN 18% 5 NSTEMI 158 NSTEMI 572 NSTEMI TRIAGE Shortened hospital stay in suspected heart attack leading to reduced clinical costs 1,2 . • Algorithm confirmed in interventional studies and included in treatment guidelines3,4,5,6 • 100 million chest pain patients treated globally All-Cause Mortality 30%- 15% Preop. TnT-hs >14 ng/L e.g. Prediction Preop. TnT-hs <14 ng/L Identify and prevent 0% - 0 1 2 3 2 Survival time in Years TnT-hs test able to predict heart attack risk and mortality in non-cardiac surgeries • > 80% of myocardial injuries after non-cardiac surgery are clinically asymptomatic • 300 million non-cardiac surgeries globally6,7 1 Twerenbold, R et al. J Am Coll Cardiol. 2018, 72: 620; 2 Ambavane A et al., PLoS One. 2017; 12(11): e0187662; 3 Chew D et al, Circulation. 2019,140:1543; 4 Stoyanov KM et al, Eur Heart J Acute Cardiovasc Care. 2020, 9:39; 5 Puelacher C et al. Circulation. 2018, 137:1221; 6 Devereaux PJ et al. JAMA 2017, 317:1642; 7 Nagele P et al, Am Heart J. 2013, 166: 325 57 Roche#58Transforming diagnostics in heart failure Type-2 diabetes: Identifying heart failure early to improve outcome Stages of heart failure¹ New NT-proBNP intended use (IU) to be launched in 2021 NYHA class Progression of remodeling Ils E = Worsening symptoms ACS IV Stage A Stage B Exacerbation (attack) Stage C Structural heart disease Signs & symptoms Stage D Refractory heart failure Stage of HF Hospitalization or death due to cardiac disease 1.0 0.8 PONTIAC-I study" proBNP >125 pg/mL + treatment (N = 150) Controls (N = 150) p = 0.035 0.6 5 10 15 20 24 Months A 65% Tomorrow's focus: 463 million Today's focus: type-2 diabetes patients² 64 million patients³ Identify type-2 diabetes patients with high cardiovascular risk to start effective drug treatment 1 Kato M. The Concept of Heart Failure. 2018 (doi.org/10.1007/978-4-431-56065-4_1); 2 Saeedi P et al., Diabetes Res Clin Pract 2019; 157: 107843; 3 Groenewegen A et al, Eur J Heart Failure 2020; 22: 1342; 4 Huelsmann M. et al. JACC. 2013, 62:1365, confirmatory clinical trials (RCTs) running both in Europe (NCT02817360, PONTIAC-II) and Asia (NCT04286399, ADOPT). Roche 58#59Improving disease management to reduce strokes Innovation on-market and pipeline for atrial fibrillation Screening NT-proBNP1 and handheld ECG Diagnosis ECG & new biomarkers³ Risk stratification ABC risk scores with GDF-15 and clinical information Therapy selection Integrated digital solutions; ABC scores Launch in 20212 Research ongoing³ On-market4 +29% AFib patients identified Identify patients at high risk for Afib and recurrence of AFib³ Best available predictors of stroke and bleeding risk4 Clinical trials (RCT) 5,6 Roche Personalised risk assessment for better outcomes: Reduce stroke risk 5,6 Increase therapy adherence5 AFib: Atrial Fibrillation; ECG: Electrocardiogram; (N)OAC: (Novel) Oral Anticoagulant ; 1 Article: Gudmundsdottir KK et al, EP Europace 2020, 22: 24; 2 Launch new intended use planned for 2021; 3 New biomarker research projects: Chua W et al., Lancet 2021 (1-Feb-2021, http://dx.doi.org/10.2139/ssrn.3777185), Reyat JS et al, JCI Insight 2020,15: e139179 (and 7 new Roche patents in 2020); 4 Hijazi Z et al, Lancet. 2016; 387: 2302; 5 Clinical outcome trial ongoing (NCT03753490, ABC-AF); 6 Clinical outcome trial ongoing (NCT02743416, STROKESTOP-II) 59#60Roche Cardiovascular disease solutions New solutions to impact medical practice Coronary artery disease >>> Launch new intended uses in 2021 TnT-hs in non-cardiac surgeries. Diagnosis of peri-operative myocardial infarction (MI) TnT-hs in asymptomatic population. Long- term risk stratification of cardiovascular events New patient population 300 million surgeries 1.2 457 million at age 70+ Heart failure >>> Heart Failure prevention in diabetes. Identify patients at high CV risk and start protective therapy 463 million with diabetes³ Stroke prevention in atrial fibrillation >>> NT-proBNP + ECG for atrial fibrillation screening in the elderly 457 million at age 70+ 1 Puelacher C et al. Circulation. 2018;137:1221; 2 Devereaux PJ et al. JAMA 2017;317:1642; 3 Saeedi P et al., Diabetes Res Clin Pract 2019: 4 World Data Atlas. https://knoema.com/atlas/topics/Demographics/Age/Population-aged-70-years 60#61Roche Diagnostics Investor Day 2021 Oncology Jill German | Global Head of Pathology Lab Roche#62Global cancer burden projected to increase Significant impact to both human lives and world economy 2010 2030 Disease Burden Index¹ Roche Oncology disease area +88% 1.7tn CHF ECONOMIC IMPACT² Global cancer impact 20203 19.3 million new cancer incidences 10 million cancer mortalities It is estimated that 1 in 10 women and 1 in 8 men will be diagnosed with cancer during their lifetime 1 Disease burden: Impact of a health problem as measured by mortality, prevalence, quality of life and economic costs; 2 Global economic impact of Oncology estimated at more than 2% of GDP (WHO); 3 Sung S., Ferlay J., Siegel R., et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;0:1-41 62#63The field of oncology is evolving and increasing in complexity Driving the need for novel diagnostic solutions Active T cell Oncology market is rapidly evolving New therapies and therapy combinations emerging to prolong patients' lives Step 3 Dendritic cell Step 2 + Active T cell Step 4 Blood vessel Blood vessel Lymph node Step 5 Tumor microenvironment Lymph node Step 6 Step 7 Antigens Step 1 5,000+ clinical trials are now exploring the utility of cancer immunotherapy Growing understanding of the biological complexity of immune oncology XXX New diagnostics and digital tools are required Innovation is needed to identify optimal therapies for individual patients ⚫ Multi-modal diagnostics · . Clinical decision support S18 4341 A1-2 63 83 Roche#64Supporting patient journeys with our oncology portfolio Sales of oncology reagents surpassing CHF 1.8 bn in 2020 Roche Screening Diagnosis & Classification Prognosis¹ Therapy selection² Monitoring/Surveillance 8 250+ 5 2 1 10 7 5 3 13 1 www IA (CA 19-9) A IHC (Ki67) Π PCR (EGFR) Algorithms IA (CA 19-9) IHC (Ki67) PCR (EGFR) Algorithms IA (CA 19-9) IHC (Ki67) NGS Algorithms IA (CA 19-9) IHC (Ki67) PCR (EGFR) NGS Algorithms IA (CA 19-9) PCR (EGFR) NGS Algorithms 3 1 1 1 Predicting the likely or expected development of a disease 2 On-label CDx indications Polymerase Chain Reaction (PCR) Algorithms Decision support: NAVIFY Mutation Profiler, NAVIFY Tumor Board, NAVIFY guidelines Immunoassay (IA) Immunohistochemistry (IHC) Next Gen Sequencing (NGS) XIM 64 64#65Supporting patient journeys with our oncology pipeline Pharma partner of choice, driving personalised healthcare Roche +2 Screening Diagnosis & Classification Prognosis¹ Therapy selection2 +3 +21 250+ +5 +27 +4 380 Monitoring/Surveillance +5 +10 +7 13 LUJUL 3 +2 +1 1 1 +4 8 5 +1 2 +2 1 1 +1 +1 10 7 5 3 1 +1 +1 wwww H IA IHC PCR Algorithms IA IHC PCR Algorithms IA IHC NGS Algorithms IA (CA 19-9) (Ki67) (EGFR) (CA 19-9) (Ki67) (EGFR) (CA 19-9) (Ki67) (CA 19-9) IHC (Ki67) PCR (EGFR) NGS Algorithms IA (CA 19-9) PCR (EGFR) NGS Algorithms Immunoassay (IA) 1 Predicting the likely or expected development of a disease 2 On-label CDx indications Decision support: NAVIFY Mutation Profiler, NAVIFY Tumor Board, NAVIFY guidelines + Patient Journey, Guidelines adherence tracking, quality reporting, therapy matching Immunohistochemistry (IHC) H Next Gen Sequencing (NGS) MIX 65 Polymerase Chain Reaction (PCR) Algorithms#66Example: Our comprehensive solution for lung cancer Innovating clinical decision making and improving patient care Roche IA Diagnosis & Classification IHC PCR IHC XX Therapy selection ProGRP Napsin A, TTF1, CK5/6, p63, p40, ROS1, pan-TRK EGFR, KRAS, BRAF ALK, PD-L1 PD-L1 Algorithm Monitoring/Surveillance NGS IA PCR JVVV Foundation One CDx Decision Support: NAVIFY Tumor Board, NAVIFY Mutation Profiler M CYFRA 21-1, ProGRP, NSE, SCC EGFR 66#67Integrated oncology decision support AI-enabled digital solutions for informed, efficient patient management Roche NAVIFYⓇ Digital Pathology PD-L1 Algorithm Interpretation of biomarker NAVIFYⓇ Mutation Profiler Therapy options & clinical trials NAVIFYⓇ Tumor Board Radiology, pathology & clinical data together Flatiron and Foundation Medicine Access to clinico- genomics database Quick, accurate answers for patients Clinically significant variants and combinations - Tier I & II (2) variant EGFR p.L858R VAF 39% RD 7,478 Therapies approved/guidelines-recommended in: Non-small cell lung carci ° afatinib bevacizumab + erlotinib ⚫dacomitinib erlotinib + ramucirumab gefitinib ⚫osimertinib variant TP53 p.P72R VAF 100% RD 2711 no approved therapies 53 SURGINGATIMENTS Confident decisions & standardized care 67#68QᎪ Roche 68 80#69Roche Diagnostics Investor Day 2021 Closing Thomas Schinecker | CEO Diagnostics Roche#70Setting up Diagnostics for a sustainable and successful future Point of departure Healthcare is shifting to reward improved patient outcomes at reduced cost of care Roche as a market leader is uniquely positioned to address the evolving healthcare needs Roche Strategy Expand the business model from diagnostics solutions to healthcare decision support and disease management to improve patient outcomes Invest in innovation, access and partnering The new Diagnostics strategy will contribute to the Roche strategic ambitions Implications Shift investments and realign the operating model to implement the strategy 70 70#71Diagnostics investor day summary Grow our market share • Larger installed base and new systems launches fueling growth • Differentiation through medical value Broad and innovative testing pipeline portfolio • Invest in strategic priorities Increase productivity by simplifying the organization Reallocate investments to drive innovations Roche 71#72Doing now what patients need next Roche 72

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Fiscal 3Q Investor Presentation image

Fiscal 3Q Investor Presentation

Healthcare

FY23 Full-Year Results Presentation image

FY23 Full-Year Results Presentation

Healthcare

Healthcare Network P&L Statement and Expansion Projects image

Healthcare Network P&L Statement and Expansion Projects

Healthcare

Accreditation and Quality Assurance Overview image

Accreditation and Quality Assurance Overview

Healthcare

Investment Highlights image

Investment Highlights

Healthcare

Investor Presentation image

Investor Presentation

Healthcare

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update image

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update

Healthcare

BioAtla Investor Presentation Deck image

BioAtla Investor Presentation Deck

Healthcare