Slide 1: Slide 1
Slide 2: Forward-looking statements
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, str
Slide 3: Roche Diagnostics Day 2026
Roche Diagnostics Day 2026 London, 12 May 2026
Slide 4: Agenda
Agenda Opening Remarks 13:00 BST Bruno Eschli, Head of Investor Relations Roche Group Strategy Thomas Schinecker, CEO Roche Group Roche Diagnostics: Our Vision Matt Sause, CEO Roche Diagnostics Pipeline overview Palani Kumaresan, Global Head of Roche Diagnostics Solutions Digital Solutions Moritz Ha
Slide 5: Roche Group strategy
Roche Group strategy Thomas Schinecker Chief Executive Officer
Slide 6: Group strategy update: Growth outlook
Group strategy update Growth outlook
Slide 7: Overview of key strategic initiatives
Overview of key strategic initiatives Significant progress made across the entire organization Ten-Year Ambitions Group Strategy Group Strategy AI / Data Digital Health Sustainability People & Culture Pharma Strategy Diagnostics Strategy Divisional Strategies R&D Excellence Launch Excellence Operati
Slide 8: Overview of key strategic initiatives
Overview of key strategic initiatives Significant progress made across the entire organization Ten-Year Ambitions Group Strategy Group Strategy AI / Data Digital Health Sustainability People & Culture Pharma Strategy Diagnostics Strategy Divisional Strategies R&D Excellence Launch Excellence Operati
Slide 9: Significant progress on the way to achieve our Ten-Year Ambitions
Significant progress on the way to achieve our Ten-Year Ambitions Pharma pipeline value at all time high; industry-leading innovation engine in Diagnostics Pharma Diagnostics Deliver 20 transformative medicines addressing Double patient access to novel, high-medical-value diseases with the highest s
Slide 10: Overview of key strategic initiatives
Overview of key strategic initiatives Significant progress made across the entire organization Ten-Year Ambitions Group Strategy Group Strategy AI / Data Digital Health Sustainability People & Culture Pharma Strategy Diagnostics Strategy Divisional Strategies R&D Excellence Launch Excellence Operati
Slide 11: The future of healthcare
The future of healthcare Our strategy is built to address the key trends in healthcare Increasing disease burden Healthcare system pressures Oncology, neurology and Innovate and offer holistic Prioritize disease areas with Healthcare costs grow CVRM to constitute 50% solutions to improve high societ
Slide 12: Group Strategy rolled out in 2024: Prevent, Stop, Cure
Group Strategy rolled out in 2024: Prevent, Stop, Cure Roche is uniquely positioned to address patient and healthcare system needs across the patient journey Value to patients and healthcare systems by improving outcomes and reducing costs Diagnostics Pharma Inf. Diseases CVRM Oncology Neurology Imm
Slide 13: Overview of key strategic initiatives
Overview of key strategic initiatives Significant progress made across the entire organization Ten-Year Ambitions Group Strategy Group Strategy AI / Data Digital Health Sustainability People & Culture Pharma Strategy Diagnostics Strategy Divisional Strategies R&D Excellence Launch Excellence Operati
Slide 14: Significant progress on the AI journey
Significant progress on the AI journey Three levels covering different applications across the value chain Level Objectives Implementation examples Ensure everyone is using and able to deploy ▪ ~75% AI adoption EverydayAI off-the-shelf AI technology to improve all aspects of their day-to-day work Sy
Slide 15: Roche is an industry frontrunner in big data and AI
Roche is an industry frontrunner in big data and AI Strategic investments into AI to accelerate development of new therapeutics and diagnostics Acquisition of Prescient Design for drug discovery AI Backbone Expansion of AI hardware footprint to Introduction of >3,500 Blackwell GPUs Pharma “Lab-in-a-
Slide 16: Overview of key strategic initiatives
Overview of key strategic initiatives Significant progress made across the entire organization Ten-Year Ambitions Group Strategy Group Strategy AI / Data Digital Health Sustainability People & Culture Pharma Strategy Diagnostics Strategy Divisional Strategies R&D Excellence Launch Excellence Operati
Slide 17: Strengthening Digital Pathology with PathAI acquisition
Strengthening Digital Pathology with PathAI acquisition1 Highly complementary to existing Diagnostics offering and strengthening drug development capabilities Environment and unmet need Synergies between Diagnostics and Pharma Number of available pathologists not keeping pace with increasing deman
Slide 18: Overview of key strategic initiatives
Overview of key strategic initiatives Significant progress made across the entire organization Ten-Year Ambitions Group Strategy Group Strategy AI / Data Digital Health Sustainability People & Culture Pharma Strategy Diagnostics Strategy Divisional Strategies R&D Excellence Launch Excellence Operati
Slide 19: 2025 Sustainability achievements
2025 Sustainability achievements Meaningful contributions to society Environment Access and innovation 100% sustainable electricity achieved across all sites #1 Spot in 2025 Global Reputation Survey by patient organisations* 10% YoY reduction in water consumption; 26% since 2020 Worldwide impact: 31
Slide 20: Overview of key strategic initiatives
Overview of key strategic initiatives Significant progress made across the entire organization Ten-Year Ambitions Group Strategy Group Strategy AI / Data Digital Health Sustainability People & Culture Pharma Strategy Diagnostics Strategy Divisional Strategies R&D Excellence Launch Excellence Operati
Slide 21: Transforming Roche into a high performing organisation
Transforming Roche into a high performing organisation Changes to incentive schemes and to the leadership framework implemented over the last three years Incentives Leadership Performance and Reward Practices to incentivize Leadership Framework and tailored trainings high performance ▪ Compensation
Slide 22: Overview of key strategic initiatives
Overview of key strategic initiatives Significant progress made across the entire organization Ten-Year Ambitions Group Strategy Group Strategy AI / Data Digital Health Sustainability People & Culture Pharma Strategy Diagnostics Strategy Divisional Strategies R&D Excellence Launch Excellence Operati
Slide 23: Our Pharma Strategy focuses on five TAs
Our Pharma Strategy focuses on five TAs Our focus therapeutic areas address ~60% of the global burden of disease and millions of patients worldwide Global Burden of Disease in 2023 and 2035 Number of people living with diseases in our committed (million DALYs) therapeutic areas globally3 (million) +
Slide 24: Substantial progress on Pharma pipeline rejuvenation
Substantial progress on Pharma pipeline rejuvenation R&D Excellence efforts and strategic BD have already translated into a material shift of the pipeline value Key milestones achieved Pipeline evolution -20% Introduction of the Bar Volume (project count) Intentional pipeline focus with 5 priority T
Slide 25: Risk-reward profile of the late stage portfolio keeps maturing
Risk-reward profile of the late stage portfolio keeps maturing Portfolio composition more balanced with respect to value and PTS PTS (Ph III) Value (aNPV) Ph III Go pre the Bar Ph III Go post the Bar illustrative Note: Based on all NMEs with Ph III Go decision since 2019, cut-off for pre the Bar at
Slide 26: Overview of key strategic initiatives
Overview of key strategic initiatives Significant progress made across the entire organization Ten-Year Ambitions Group Strategy Group Strategy AI / Data Digital Health Sustainability People & Culture Pharma Strategy Diagnostics Strategy Divisional Strategies R&D Excellence Launch Excellence Operati
Slide 27: Group strategy update: Growth outlook
Group strategy update Growth outlook
Slide 28: Roche delivered consistent growth throughout the last decade
Roche delivered consistent growth throughout the last decade Increased diversification with 16 blockbusters in Pharma CAGR at CER* 65 +5% Sales 60 +8% Core EPS Ronapreve 55 50 Sales in CHFbn (CER) 45 40 35 Pharma 30 25 20 Avastin, Herceptin, MabThera/Rituxan 15 Dia COVID-19 10 5 Diagnostics 2016 201
Slide 29: Up to 19 NMEs with launch potential by 2030
Up to 19 NMEs with launch potential by 2030 Two NMEs with Ph III readouts in 2026 (divarasib in NSCLC and sefaxersen in IgAN) afimkibart 0.5-1bn peak sales 1-2bn peak sales enicepatide** IBD, AtD, RA, MASH >3bn peak sales Obesity +/- T2D 2-3bn peak sales sefaxersen* acmopatide*** IgAN T1D with BMI ≥
Slide 30: Roche Diagnostics: Key technology launches driving future growth
Roche Diagnostics: Key technology launches driving future growth AXELIOS sequencing solution launching in summer 2026 Key platform launches Selected assays cobas® Lp(a) Gen 2 Near Patient Care Core Lab Molecular Lab Cardiovascular risk Elecsys® hs-TnT Gen 6 1,2 Acute coronary syndrome Accu-Chek Smar
Slide 31: A strong base to deliver long-lasting future growth
A strong base to deliver long-lasting future growth Year end 2025 pipeline successes provide a clear path for sustained and strong top-line growth beyond 2030 illustrative Business development BD to further accelerate pipeline growth Late-stage pipeline with major readouts Pharma pipeline from 2
Slide 32: Updated 2025-30 consensus outlook
Updated 2025-30 consensus outlook* Long-term growth outlook improved; significant upside potential remains on the late-stage pipeline Biosimilar gap (25-30) Consensus sales growth (25-30) Potential upside CHF Vabysmo 2.1bn Itovebi 1.1bn Assets with low to no coverage in Columvi 0.8bn current sell si
Slide 33: Roche Diagnostics: Our Vision
Roche Diagnostics: Our Vision Matt Sause CEO Roche Diagnostics
Slide 34: Roche Diagnostics strategy
Roche Diagnostics strategy Driving continued and sustainable success Our vision: Innovating diagnostics, shaping healthcare, changing lives Deliver medical value on 1 integrated testing solutions Outcomes Enable confident healthcare Costs 2 decisions Improve care along patient 3 journeys
Slide 35: Our Goals as Roche Diagnostics
Our goals Our Goals as Roche Diagnostics Delivering impact for patients, society, and our business Expand our #1 Become a leader in Differentiate through Deliver disease position in the clinical decentralized comprehensive solutions management solutions laboratory testing across highest burden to tr
Slide 36: Roche Diagnostics product area focus
Roche Diagnostics product area focus Organized by customer segment Roche Diagnostics 3 Customer Core Molecular Pathology Near segments Lab Lab Lab Patient Care Serum Work Area Advanced staining Diabetes management Molecular work area2 Precision medicine (immunochem., clin.chem.) (IHC diagnostics) (C
Slide 37: Roche is the industry leader in IVD solutions
Roche is the industry leader in IVD solutions Leading portfolio of assays, systems, and automation solutions Core Lab Molecular Lab Pathology Lab Near Patient Care #1 market share globally #1 In Lab-MDx market #1 market share globally Investment to become a leader in decentralized care PCR Sequencin
Slide 38: Healthcare burden and growth drivers across disease areas
Healthcare burden and growth drivers across disease areas Focus disease areas represent ~60% of the global health burden Infectious Oncology Neurology Cardiometabolic Diseases 1 2 5 ~54m ~3bn ~4bn ~6bn 3 CURRENT CASES CURRENT CASES CURRENT CASES CURRENT CASES +50% +67% +40% +29% 1 1 2 2 4 4 5 5 ~10m
Slide 39: Our Goals as Roche Diagnostics
Our goals Our Goals as Roche Diagnostics Delivering impact for patients, society, and our business Expand our #1 Become a leader in Differentiate through Deliver disease position in the clinical decentralized comprehensive solutions management solutions laboratory testing across highest burden to tr
Slide 40: Roche Diagnostics industry leading solution pipeline
Our goals Roche Diagnostics industry leading solution pipeline Continue to deliver in areas of strength Disrupt the market with new innovations Systems Systems cobas® ultra cobas® smart e cobas® i 601 Mass Spec AXELIOS Sequencing solution 1 Future technologies Next gen Next gen Protein to DNA analys
Slide 41: Our Goals as Roche Diagnostics
Our goals Our Goals as Roche Diagnostics Delivering impact for patients, society, and our business Expand our #1 Become a leader in Differentiate through Deliver disease position in the clinical decentralized comprehensive solutions management solutions laboratory testing across highest burden to tr
Slide 42: Near Patient Care: Decentralizing testing
Our goals Near Patient Care Near Patient Care: Decentralizing testing Comprehensive product offerings across the entire decentralized care continuum Decentralized settings Emergency Room & General Practitioners & Pharmacy Consumer/patient Intensive Care Health Clinics Infectious Diseases Cardiometab
Slide 43: Our Goals as Roche Diagnostics
Our goals Our Goals as Roche Diagnostics Delivering impact for patients, society, and our business Expand our #1 Become a leader in Differentiate through Deliver disease position in the clinical decentralized comprehensive solutions management solutions laboratory testing across highest burden to tr
Slide 44: The importance of diagnostics along the patient journey
Our goals The importance of diagnostics along the patient journey Roche integrated solutions deliver critical answers across the care continuum Early Precise Therapy Disease Detection Diagnosis Selection Monitoring Screening and early Highly precise characterization Companion diagnostics to Disease
Slide 45: Oncology: Strategy and portfolio highlights
Our goals Oncology Oncology: Strategy and portfolio highlights Drive growth and share by capitalizing on Roche oncology position, including FMI Early Detection Diagnosis & Therapy selection Disease Monitoring CHF 5.3bn CHF 17.3bn CHF 5.0bn 2030 market 2030 market 2030 market +10% ‘24-’30 CAGR, +35%
Slide 46: Oncology: End-to-end offering along the patient journey
Our goals Oncology Oncology: End-to-end offering along the patient journey Expanding oncology offering and ecosystem; SAGA and PathAI are recent examples1,2 Early Precise Therapy Disease Detection Diagnosis Selection Monitoring 3 2 1 Early detection Ultra sensitive MRD cancer screening technology AI
Slide 47: PathAI acquisition agreement
Our goals Oncology PathAI acquisition agreement1 Expanding our pathology portfolio with the best-in-class digital pathology solution PathAI overview Digital Pathology Market Outlook2 1 +14% AISight Dx AISight Clinical Trials AISight TxR CAGR Precision Diagnostics Services Clinical Development Servic
Slide 48: Neurology: Strategy and portfolio highlights
Our goals Neurology Neurology: Strategy and portfolio highlights Establish market leadership by leveraging global presence, broad portfolio and pharma partnerships Early Detection and Diagnosis Therapy Selection Disease Monitoring CHF 480m CHF 140m CHF 250m 2030 market 2030 market 2030 market +20% ‘
Slide 49: Cardiometabolic: Strategy and portfolio highlights
Our goals Cardiometabolic Cardiometabolic: Strategy and portfolio highlights Expand leading market position by offering holistic and integrated solutions Early Detection Diagnosis - acute Disease Monitoring CHF 6.9bn CHF 4.2bn CHF 24.7bn 2030 market 2030 market 2030 market +5% ‘24-’30 CAGR +3% ‘24-’
Slide 50: Accu-chek SmartGuide CGM: Redefine disease management
Our goals Cardiometabolic Accu-chek SmartGuide CGM: Redefine disease management Enabling people living with diabetes to take control of their illness with AI-powered digital tools Key digital features: Night Low Predict Nutrition Insights AI-powered diabetes to predict blood sugar highs and lows L
Slide 51: Infectious Diseases: Strategy and portfolio highlights
Our goals Infectious Diseases Infectious Diseases: Strategy and portfolio highlights Roche global reach and portfolio enables market leadership as new pathogens arise and epidemiology shifts Early detection, diagnosis, and therapy selection Disease Monitoring CHF 25.0bn CHF 1.6bn 2030 market 2030 ma
Slide 52: Roche Diagnostics financial ambition
Roche Diagnostics financial ambition Key drivers Roche Diagnostics ambition Continued strong performance of on-market portfolio Sales growth Mid- to high-single digit sales growth Key Product launches including AXELIOS, cobas® Mass Spec, and Accu-Chek® SmartGuide CGM Profit contribution from o
Slide 53: Pipeline overview
Pipeline overview Palani Kumaresan Global Head of Roche Diagnostics Solutions
Slide 54: Broad presence across four key IVD customer areas
Broad presence across four key IVD customer areas Leading portfolio of assays, systems, and automation solutions across all four customer areas Core Lab Molecular Lab Pathology Lab Near Patient Care Leading immunoassay, SWA, Broad PCR menu, AXELIOS Leading ISH/IHC portfolio & Broad coverage across C
Slide 55: Instrument placements at the core of our business model
Instrument placements at the core of our business model Continued strong growth of new instrument placements will drive future sales Non-exhaustive +52% +55% +18% +11% +25% cobas® pro cobas® pure cobas® BenchMark DP200/600 analytical units analytical units 5800/6800/8800 ULTRA/ULTRA PLUS analytical
Slide 56: We have a rich pipeline of instruments
We have a rich pipeline of instruments… Great depth in our innovative systems and automation pipeline, with major launches ahead Non-exhaustive Recent Key Launches 2026 2027-2029 2030+ Next Gen AXELIOS Next Gen cobas® cobas® cobas® Mass cobas® ultra px13 cobas® ultra centrifuge Advanced Sequencing M
Slide 57: Complemented with a rich pipeline of tests
…complemented with a rich pipeline of tests Our test pipeline will continue to differentiate us in areas with the highest disease burden Disease Area 2026-2029 pipeline1 Highlights (non-exhaustive) HPV self collection 2.0 HPV indiv. genotyping VENTANA® BAP1 Oncology 36 MPx core Ab duplex 1&2 VENTANA
Slide 58: Core Lab strategic priorities
Core Lab Core Lab strategic priorities Maintain leadership by winning in key segments and markets through our differentiated pipeline 5 years strategic priorities Evolve our next-gen systems portfolio 1 Consolidate our position in key strategic markets through the next wave of our system evolution a
Slide 59: cobas Mass Spectrometry solution
Core Lab cobas® Mass Spectrometry solution Accelerating placements on the back of very positive customer feedback cobas® i 601 Mass Spectrometry Market needs and opportunity The clinical mass spectrometry market is CHF 3bn, currently relying on manual, labour-intensive laboratory developed tests1
Slide 60: cobas Mass Spectrometry growing menu
Core Lab cobas® Mass Spectrometry growing menu Robust rollout out of industry first Mass Spec IVD menu both in Europe and the U.S. Europe and CE markets: 2025 2026 cobas® i 601 Steroids 1 Vitamin D ISDs Steroids 2 Antibiotics 1 & 2 Antiepileptics 1&2 3MV Amikacin1 i-pack i-pack i-pack i-pack i-packs
Slide 61: cobas smart e
Core Lab cobas® smart e Low-throughput standalone immunoanalyser targeting low-volume labs cobas® smart e Market needs and opportunity Low-volume laboratories represent a CHF ~1bn addressable market with a +5% CAGR1 Compact benchtop Random access 36 reagent positions system with ~ 0.9m2 IA system
Slide 62: cobas ultra integrated solutions
Core Lab cobas® ultra integrated solutions Reimagining automation with modular, flexible, space-efficient, and ultra-high throughput solutions cobas® ultra components roadmap, differentiation, and key benefits cobas® ultra cobas® ultra Mobile robots cobas® ultra cobas® ultra ultra controller pre-ana
Slide 63: Neurology portfolio: CE mark for Elecsys pTau217 received
Core Lab Neurology portfolio: CE mark for Elecsys® pTau217 received Broadening our neurology portfolio with clinically robust assays validated across care settings 2025 March 2026 April 2026 Today Elecsys® pTau181 (CE, US): Elecsys® ApoE4 (CE): Elecsys® NfL (CE): IVD Elecsys® pTau217 (CE): First IVD
Slide 64: Molecular Lab strategic priorities
Molecular Lab Molecular Lab strategic priorities Drive menu expansion on PCR platforms and launch a new class of sequencer in 2026 5 years strategic priorities Maximize potential of current PCR systems 1 Expand platform menu (x800, eplex), grow market share in multiplex testing, and strengthen leade
Slide 65: PCR ecosystem: Advancing innovation and fortifying the future
Molecular Lab PCR ecosystem: Advancing innovation and fortifying the future High-volume, fully Open Molecular automated IVD Solutions Point of Care Syndromic panel testing testing Highly automated molecular testing Cover continuum of testing setting Deliver high-quality results 65
Slide 66: Donor Screening: Our commitment to protect the blood supply
Molecular Lab Donor Screening: Our commitment to protect the blood supply Leveraging innovation and demonstrated leadership to advance blood safety Advancing Blood Safety Solution Offering Market needs and opportunity Donor Screening is a CHF 1.8bn market across Systems Menu Expansion serology & N
Slide 67: AXELIOS sequencing solution
Molecular Lab AXELIOS sequencing solution Broadening application space by leveraging pre-launch collaborations Market needs and opportunity Whole Genome Spatial Ultra-high throughput, especially for single cell, Sequencing spatial, proteomics applications Improved speed and flexibility Whole Exo
Slide 68: Pathology Lab strategic priorities
Pathology Lab Pathology Lab strategic priorities Innovate in digital pathology while maintaining our market position in the core advanced staining segment 5 years strategic priorities Strengthen advanced staining core business 1 Continue growth of installed base and drive workflow efficiency via con
Slide 69: Leading ecosystem around advanced staining
Pathology Lab Leading ecosystem around advanced staining Largest installed base in advanced staining and extensive product offerings for the pathology lab Leading solutions across the value chain Future solutions Non-exhaustive Primary Staining Special Staining Advanced Staining Digital Pathology
Slide 70: Best-in-class test menu
Pathology Lab Best-in-class test menu Exploiting synergies between menu growth, placements, and pharma partnerships Pathology menu with Personalised Healthcare Services: 250+ ready-to-use IHC/ISH assays 85+ pharma partnerships with 150+ ongoing IVD programs Accelerating menu growth through partnersh
Slide 71: Near Patient Care strategic priorities
Near Patient Care Near Patient Care strategic priorities Investing in targeted areas to become a leader in decentralized testing 5 years strategic priorities Build a leading portfolio in clinical chemistry and immunoassay 1 Lead and expand market segment with clinical chemistry & immunoanalyser plat
Slide 72: Our roadmap towards leadership in decentralised care
Near Patient Care Our roadmap towards leadership in decentralised care Delivering new launches, menu expansion, and next Gen products to build up our Near Patient Care business Accu-Chek ® cobas® sense cobas® vital cobas® pulse cobas® liat LumiraDx SmartGuide CGM Launch in 2027 with Launch in 2028 w
Slide 73: Digital Solutions
Digital Solutions Moritz Hartmann, Global Head of Roche Information Solutions Guest speaker: Andy Beck, CEO Path AI
Slide 74: Our focus areas in digital health
Our focus areas in digital health Three product segments with clear value proposition for the customers and healthcare system Clinical Workflow & Remote Patient Diagnostics Insights Decision Support Management Support lab professionals to Support providers to manage clinical Collect and analyse pati
Slide 75: Digital solutions accelerate Diagnostics value creation
Digital solutions accelerate Diagnostics value creation Delivering efficiency and opportunity for our customers and Roche Differentiate Roche Diagnostics Increase value streams In and beyond the lab, certified digital products driving Increase commercial win rate and extend differentiated customer e
Slide 76: Building a native AI-first Lab Environment
Building a native AI-first Lab Environment Turning the lab into an industry-first automated, intelligent, and adaptive environment navify Analytics AI Automatic Issue Detection Phase 3 The Cognitive AI Stack Demand Forecasting Holistic Precision Engine Workload Prediction Phase 2 + selected EM
Slide 77: Our broad digital portfolio
Our broad digital portfolio Delivering value for our customers and the healthcare system Laboratory Insights Clinical Workflows & Decision Support Patient Monitoring navify® navify® navify® navify® Accu-Chek® mySugr Sample Transport1 Quality Performance Algorithm Suite 1 Clinical Hub1 Care navify® n
Slide 78: Unlocking the value of digital pathology
Unlocking the value of digital pathology Roche to acquire1 PathAI to strengthen the offering to laboratory and biopharma customers Value to Roche Digital Pathology Value to Roche PHCS Algos/IMS 1 Augment offering in digital Consolidate leadership in PHCS by pathology by complementing enhancing incre
Slide 79: Improve patient outcomes with AI-powered pathology
Improve patient outcomes with AI-powered pathology Technical and Biopharma and Regulatory Market Medical Diagnostics Validation Inflection Leadership Synergy PathAI is building the operating system for precision pathology Powering patient diagnosis and drug development at a global scale 79
Slide 80: Two synergistic customer segments, one AI flywheel
Two synergistic customer segments, one AI flywheel Precision Regulated diagnostics AI tools Single platform Deep learning analysis Specialized Clinical AI enabled workflow Biopharma Precision scoring and tissue-specific platforms endpoint assessment Diagnosis Partners AI tools Pathology network Regu
Slide 81: Unlocking insights from whole-slide images for drug development
TRANSLATIONAL RESEARCH Unlocking insights from whole-slide images for drug development PathExplore IHC Explore Characterize the tumor and immune micro-environment Detect and localize target antigens in tissue to support to inform translational studies into pathological drivers PK studies, biomarker
Slide 82: Building AI-enabled companion diagnostics with Roche Diagnostics
COMPANION DIAGNOSTICS Building AI-enabled companion diagnostics with Roche Diagnostics Drug Development Translational Early Drug Late Drug Life Cycle Commercialization Research Development Development Management CDx/IVD Development: initiate asset/assay specific development under design control Defi
Slide 83: PathAI and Genentech partnership
CASE STUDY PathAI and Genentech partnership Uncovering a novel candidate H&E-based predictive biomarker of immuno-oncology drug response in NSCLC Biomarker discovery and validation Overall Survival Overall Survival, PD-L1 negative Key takeaways 22C3 <1% OS Analysis of H&E WSI using PathAI’s TME HI
Slide 84: Broad menu of algos to advance diagnostics and drug development
AI ALGORITHMS Broad menu of algos to advance diagnostics and drug development Workflow Optimization Primary Diagnosis (Assist)2 Biomarker Quantification2 Research Algorithms2 ArtifactDetect1 PathAssist: Derm (FDA BDD, in Q1-26) AIM-PDL1-Suite PathExplore LiverExplore TumorDetect2 AIM-MASH AI-Assist
Slide 85: AISight Dx: CE-IVDR and FDA-cleared hub for digital pathology workflows
DIGITAL DIAGNOSTICS · AISIGHT DX AISight Dx: CE-IVDR and FDA-cleared hub for digital pathology workflows Intelligent Case Management Purpose-built for pathology First digital pathology IMS PCCP High-Performance Case Review Interoperable and future-fit Value-creation through innovation IMS: I
Slide 86: Driving the future of the pathology lab
Driving the future of the pathology lab 2035 outlook By 2035, AI is woven into every slide and every report PathAI leading the next decade AI runs on every case driving both quality and AI-native AISight becomes Operating system efficiency for pathology AI-powered CDx accompany most new approvals Da
Slide 87: Molecular Labs: Highlights
Molecular Labs: Highlights Josh Lauer Global Head of Customer Area Molecular Labs
Slide 88: Molecular Lab strategic priorities
Molecular Lab Molecular Lab strategic priorities Drive menu expansion on PCR platforms and launch a new class of sequencer in 2026 5 years strategic priorities Maximize potential of current PCR systems 1 Expand platform menu (x800, eplex), grow market share in multiplex testing, and strengthen leade
Slide 89: PCR ecosystem: Advancing innovation and fortifying the future
Molecular Lab PCR ecosystem: Advancing innovation and fortifying the future High-volume, fully Open Molecular automated IVD Solutions Point of Care Syndromic panel testing testing Highly automated molecular testing Cover continuum of testing setting Deliver high-quality results 89
Slide 90: Molecular Lab assay roadmap highlights
Molecular Lab Molecular Lab assay roadmap highlights Expanding our clinical menu across infectious diseases, oncology, and genetics Non-exhaustive 2026 2027 2028 cobas® MPX-E cobas® HPV IGT cobas® Respiratory Bac cobas® HDV cobas® HPV Home-Sampling cobas® Gastro panel cobas® BV/CV (US) cobas® STI Ho
Slide 91: cobas HDV captures a premium market
Molecular Lab cobas® HDV captures a premium market Advanced chronic and acute Hepatitis D detection together with patient management WHO regional value of prevalence1 Market opportunity Hepatitis D affects nearly 12 million people,1 it is a unique Prevalence in general population “satellite virus”
Slide 92: Roche AXELIOS platform: launch summer 2026
Molecular Lab Roche AXELIOS 1 platform: launch summer 2026 Sequencing Synthesis instrument instrument Automated Xpandomer Synthesis Sequencing module Pore-based sequencing Analysis module Flexible, accelerated analysis Note: AXELIOS 1 is for research use only. Not for use in diagnostic procedures 92
Slide 93: Amplification-free workflow in less than 5 hours
Molecular Lab Amplification-free workflow in less than 5 hours Faster than majority of on-market workflow AXELIOS 1 workflow DNA 4 Sequencing and Library prep1 Quant/Pool Xpandomer synthesis on-station analysis3 ~9 hours ~1 hour ~4 hour ~5-20 hours2 Typical workflow can generate 16 whole genomes i
Slide 94: Driving effectiveness: reuse of the sensor module
Molecular Lab Driving effectiveness: reuse of the sensor module Users can queue up to 4 Xpandomers on instrument, and run 20 per sensor module 4 Xpandomers Run Queue Run Setup Run Setup Run Setup Run Setup Initialize run Sequencing Initialize run Sequencing Initialize run Sequencing Initialize run S
Slide 95: Multi-run experiments: Carryover assessment
Molecular Lab Multi-run experiments: Carryover assessment Effectiveness of the reuse protocol No run-to-run carryover from previous runs was detected in Run 1 <0.0015% of read carryover was observed from the previous runs within the queue Run Queue Run 1 Run 2 Run 3 Run 4 System System System Sy
Slide 96: Flexibility through multiple run modes
Molecular Lab Flexibility through multiple run modes Duplex or simplex modes for different methods AXELIOS library Sequencing read SBX-Duplex Parent strands are physically linked Intramolecular consensus used to improve accuracy SBX-Simplex SBX-Simplex Capable of longer read lengths1 and higher thro
Slide 97: Demonstrated fast, flexible throughput capabilities
Molecular Lab Demonstrated fast, flexible throughput capabilities Duplex and simplex read modes in details Parameters SBX-Duplex SBX-Simplex Short ~175bp average read length >40bn total reads 4 hours 1.8 – 2.7 Tb1 Output Concordant duplex bases in 4 hours1 Longer ~500bp average read length >10bn rea
Slide 98: AXELIOS platform pricing
Molecular Lab AXELIOS 1 platform pricing1 WGS with SBX-D scRNA with SBX-S cfDNA panel with SBX-S ~16 genomes per run2 >40bn reads per run ~1.1 Mb panel using UMIs Up to 64 genomes per day ~160bn per day 96 samples/run; 2000x coverage ~USD 150 per genome ~USD 0.06 per million reads ~USD 2
Slide 99: Target enrichment strategies
Molecular Lab Target enrichment strategies Multiple methods under development Simplex Duplex Start with DNA, then ligate adapters PCR-mediated SBX hairpin libraries UMI and non-UMI adapter options Start with any pre-made enriched libraries Proof of concept shown for cfDNA with a representa
Slide 100: High performance across a variety of applications
Molecular Lab High performance across a variety of applications Early access collaborations have shown SBX performance Duplex SBX-D Simplex SBX-S SBX-D SBX-Fast SBX-DM SBX-S SBX-SLR SBX-SLD GIAB benchmarking Long-range phased FFPE - SBS & SBX Flex benchmarking 3’/5’ Benchmarking haplotype detection
Slide 101: Proteomics workflows on AXELIOS
Molecular Lab Proteomics workflows on AXELIOS 1 SBX libraries show1 high concordance with data generated from original libraries Proximity extension assay Proximity network assay NULISA technology Normalized protein expression (NPX) Uniquely positioned single protein molecules per cell NULISA protei
Slide 102: SBX technology key strategic pillars
Molecular Lab SBX technology key strategic pillars Near and mid-term roadmap NGS Ecosystem Multi-Omics Scalable E2E Workflows Collaborate with key industry Easy to use solutions From sample prep to analysis participants More insights from the same Readily adoptable across Amplify AXELIOS
Slide 103: AXELIOS platform: strong foundation, scalable future
Molecular Lab AXELIOS 1 platform: strong foundation, scalable future Designed for flexibility and performance with headroom Chemistry Bioinformatics Xpandomer & X-NTP structure Real time analysis capabilities on Low Multi instrument compute Protein engineering throughput omics New applicatio
Slide 104: MRD research: AXELIOS shows higher sensitivity
Molecular Lab MRD research: AXELIOS 1 shows higher sensitivity Tissue informed co-analysis of WGS data from 46 FFPE and Plasma pairs ctDNA detection using the AXELIOS 1 workflow for samples with low tumour fraction Key takeaway Tumour informed MRD calling is demonstrated on the AXELIOS platform Th
Slide 105: Pipeline acceleration through partnering: Freenome
Molecular Lab Pipeline acceleration through partnering: Freenome Commercialize cancer screening tests outside the U.S. and expand technology collaboration Survival rate by cancer type1 Opportunity Securing global rights for decentralized early cancer detection, making it more accessible for ex-US
Slide 106: Foundation Medicine: Highlights
Foundation Medicine: Highlights Dan Malarek Chief Executive Officer of Foundation Medicine
Slide 107: Oncology: End-to-end offering along the patient journey
Oncology Oncology: End-to-end offering along the patient journey Expanding oncology offering and ecosystem; SAGA and PathAI are recent examples1,2 Early Precise Therapy Disease Detection Diagnosis Selection Monitoring 3 2 1 Early detection Ultra sensitive MRD cancer screening technology AI-powered p
Slide 108: Fundamentally changed the course of precision medicine
Molecular Lab Fundamentally changed the course of precision medicine Innovations since 2010 2010 2013 2017 2020 2024 Founded following the Launched one of the first Received first FDA approved Received FDA-approved Launched RNA sequencing Human Genome Project and commercially available companion dia
Slide 109: Dual business model with patient-centric value loop
Molecular Lab Dual business model with patient-centric value loop Feedback loop where clinical insights fuel research, and research advances new innovations Patient care Drug development Translational research via Risk stratification FlexOMx Lab Germline Biomarker discovery Diagnosis and classificat
Slide 110: The oncology diagnostic testing market
Molecular Lab The oncology diagnostic testing market Sector is growing and evolving rapidly Significant global market expansion CHF 19.9bn Key drivers CHF 5.0bn Increase in number of medicines requiring personalized approaches +32% CHF 9.0bn CHF 9.8bn CHF 1.0bn Rise in multi-time point testing +11%
Slide 111: Our differentiators set the stage for future successes
Molecular Lab Our differentiators set the stage for future successes Executing strategic initiatives to advance global healthcare Differentiators Future Direction Uphold our commitment to provide high- Quality driven quality sequencing that “misses not one” Deliver high quality tests and services ac
Slide 112: Not all cancer diagnostic tests are created equal
Molecular Lab Not all cancer diagnostic tests are created equal High-quality sequencing tests that are intended to “miss not one” actionable mutation or alteration Among 10,936 solid tumour samples tested with In a study1, FoundationOne®CDx reported MTAP loss more FoundationOne®CDx, 9.4% were report
Slide 113: Innovation through a comprehensive monitoring portfolio
Molecular Lab Innovation through a comprehensive monitoring portfolio Advancing strategy to go beyond therapy selection 3 FOUNDATIONONE® MONITOR Tissue naive, blood test to Ultra-sensitive, tumour-informed monitor changes to ctDNA MRD platform: levels in late-stage cancers1,2 WGS tissue baseline
Slide 114: Delivering breakthrough solutions
Molecular Lab Delivering breakthrough solutions Launching new solutions in the FlexOMx Lab Deep insights from broad services Areas of innovation and exploration compatible with AXELIOS Gene expression profiling (RNA sequencing) assay for Single cell sequencing research use only and translational
Slide 115: Centralized and decentralized delivery models
Molecular Lab Centralized and decentralized delivery models Robust global presence NHS Foundation Trust HQ & Lab Manchester University (UK) Lab Boston (US) Penzberg (DE) Sequanta Shanghai (CN) Zurich University Hospital Institute Gustave Roussy Zurich (CH) Paris(FR) Lab SRL, Inc./Chugai Morrisville
Slide 116: Uniquely positioned to leverage Roche's innovative solutions
Molecular Lab Uniquely positioned to leverage Roche’s innovative solutions Group capabilities strongly position us to deliver the best solutions Complementary solutions Clinical Hub ✓ Clinical Trial Matching ✓ Dynamic Guidelines ✓ Publication Search ✓ AI Patient Education Mutation Profiler ✓ Annotat
Slide 117: Pivotal milestones for charting our growth
Molecular Lab Pivotal milestones for charting our growth Strategic inflection points shaping our growth trajectory ‘26 ‘27 ‘28+ Pharmacogenetic testing incl. DPYD Expanded FoundationOne®¨Heme CDx FoundationOne®MRD CDx IHC menu expansion Content RNA sequencing platform expansion CGP sample type expan
Slide 118: Key Takeaways
Molecular Lab Key Takeaways Market growth Portfolio expansion Delivery at scale We are building our portfolio across The oncology testing market is Together with Roche, we have the the patient journey and to win in poised to grow rapidly in the next power to integrate vertically and the monitoring s
Slide 119: Pathology Lab: Highlights
Pathology Lab: Highlights Laura Apitz Global Head of Customer Area pathology Lab
Slide 120: Pathology Lab strategic priorities
Pathology Lab Pathology Lab strategic priorities Innovate in digital pathology while maintaining our market position in the core advanced staining segment 5 years strategic priorities Strengthen advanced staining core business 1 Continue growth of installed base and drive workflow efficiency via con
Slide 121: Roche Pathology Lab momentum
Pathology Lab Roche Pathology Lab momentum Unparalleled reach across the world, consistently growing above market 2025 Revenue of 1.7bn CHF1 +14% growth vs. 2024 +10% +25% >13,000 Advanced Staining growth PHCS revenue growth IHC/ISH instruments installed worldwide Pathology lab market Growing above
Slide 122: Our vision: fully automated Pathology Lab
Pathology Lab Our vision: fully automated Pathology Lab Driving efficiency gains and enabling new AI-driven value for customers Strategic focus Value drivers Partnering with Hitachi to Partnering develop the next generation of advanced staining instruments Optimizing performance and Automation resou
Slide 123: Driving precision medicine with our multiplexing portfolio
Pathology Lab Driving precision medicine with our multiplexing portfolio Enabling broad adoption through translucent chromogens On Market Pipeline Future K/L DISH HER2 Prostate CD3/ CINTEC+ Lung Melanoma CDx CDx+ Digital Non Gyn Triplex DISH Cocktail CD20 p40/TTF1 SOX10/Ki67 Pathology Cytology Capab
Slide 124: Innovating in personalized healthcare solutions
Pathology Lab Innovating in personalized healthcare solutions Rapidly growing our PHCS business, fuelled by digital pathology Uniquely positioned in PHCS Highlight: TROP2, first computational pathology RxDx device >25 years of experience, serving >85 Pharma partners Launched as RUO, CDx launch p
Slide 125: Accelerating clinical excellence with digital pathology
Pathology Lab Accelerating clinical excellence with digital pathology Bridging the gap between labs and AI, driving workflow efficiency Introducing AISight® DX Digital Pathology Platform1,2 DP scanner updates Software updates delivering performance enhancements and 1 Leading customizable cloud-b
Slide 126: Advancing innovation to eliminate cervical cancer
Pathology Lab Advancing innovation to eliminate cervical cancer HPV genotyping differentiating 14 individual genotypes cobas® individual HPV genotyping Market opportunity 660,000 women per year affected with HPV infection, the leading cause of cervical cancer1 70% of women to be screened for HPV
Slide 127: Offering self-collection solution for STIs and HPV
Pathology Lab Offering self-collection solution for STIs and HPV Driving market expansion and patient access through a seamless home-to-lab ecosystem Expanding access through self-collection Market opportunity All over the world, economic, social, and structural barriers prevent women from testing
Slide 128: Driving diagnostic certainty for nearly 44 million patients and counting
Driving diagnostic certainty for nearly 44 million 2021 2022 2023 2024 2025 patients and counting 26.7 32.1 33.7 38.4 44.0 million million million million million 128
Slide 129: Near Patient Care: Highlights
Near Patient Care: Highlights Ildikó Amann-Zalán Head of Research & Development Roche Diagnostics Solutions
Slide 130: Near Patient Care strategic priorities
Near Patient Care Near Patient Care strategic priorities Investing in targeted areas to become a leader in decentralized testing 5 years strategic priorities Build a leading portfolio in clinical chemistry and immunoassay 1 Lead and expand market segment with clinical chemistry & immunoanalysers pla
Slide 131: Near Patient Care: Decentralizing testing
Our goals Near Patient Care Near Patient Care: Decentralizing testing Comprehensive product offerings across the entire decentralized care continuum Decentralized settings Emergency Room & General Practitioners & Pharmacy Consumer/patient Intensive Care Health Clinics Infectious Diseases Cardiometab
Slide 132: Accu-Chek SmartGuide update and upcoming milestones
Near Patient Care Accu-Chek® SmartGuide update and upcoming milestones Ramping up our commercial presence and foundation in the CGM market 11 Mannheim (DE) manufacturing lines running (sensor, sterile unit and assembly lines) H1 2026 Continue to ramp-up production by increasing automation and enab
Slide 133: Optimising the patient experience
Optimising the patient experience Integrating Accu-Chek SmartGuide Predict into the mySugr application Accu-Chek SmartGuide Predict mySugr Glucose Insights Accelerated BGM AI-enabled algorithms to CGM conversion 2-hour glucose forecasting "Night Low" predictive alerts Enhanced clinical mySugr
Slide 134: Expansion of Roche CGM offering
Near Patient Care Expansion of Roche CGM offering Expanding within CGM segments and integrating BGM and CGM use ROCHE OFFERING TODAY FUTURE1 CSII/Pump BGM ▪ Integrate with 3rd party systems and INSULIN USERS devices to expand into CSII/pump users segment Multiple Daily Injections BGM & CGM BGM & CGM
Slide 135: Accu-Chek SmartGuide Product Evolution
Near Patient Care Accu-Chek SmartGuide Product Evolution Significant size and manufacturing cost reduction Accu-Chek SmartGuide Gen 1 vs. Gen 2 Key evolution aspects Leveraging the technology and learnings of the Gen 1 Gen 2 first generation to focus on key improvements Significant size reductio
Slide 136: The impact of LumiraDx today
Near Patient Care The impact of LumiraDx today How we are shaping up to change POC testing Non-exhaustive Unique offering in the PoC market Ongoing collaborations Commercially active CRP testing in Wales (UK) 53 countries Since Roche ■ 2-year national CRP testing pilot across PC and commercializatio
Slide 137: LumiraDx portfolio and platform roadmap
Near Patient Care LumiraDx portfolio and platform roadmap Groundbreaking technology facilitates performing multiple tests on a single instrument Current assays Future assays D-dimer INR HbA1c Further Expansion HbA1c 2.0 NT-proBNP Infectious disease & Inflammation 2026 2027 2028 2029+ Cardiometabolic
Slide 138: Maximizing on the decentralized footprint
Near Patient Care Maximizing on the decentralized footprint Leveraging the cobas® liat installed base for high medical value growth Growing cobas® liat assay menu Market opportunity The 2025 market size for molecular point-of-care diagnostics is cobas® liat Bordetella panel estimated at CHF 2.65 b
Slide 139: Launch of cobas sense with high sensitive cTnT in 2027
Near Patient Care Launch of cobas® sense1 with high sensitive cTnT in 2027 Providing lab-standardised results and the flexibility of crossover use in the emergency department cobas® sense performance evaluation Key preliminary results Demonstrate excellent correlation between cobas® sense and Elec
Slide 140: Core Lab Assays: Highlights
Core Lab Assays: Highlights Olivier Gilliéron Lifecycle Leader Cardiometabolic and Neurology
Slide 141: Core Lab assays by focus disease area
Core Lab Core Lab assays by focus disease area Delivery of rich pipeline in Core Lab on track with key launches ahead of us Disease areas Assay Launch Oncology proC3 ADAPT ✓ CE pTau181 ✓ CE / US ApoE4p ✓ CE Neurology NfL ✓ CE pTau217 ✓ CE Lp(a) US ✓ CE / US Cardiometabolic TnT hs Gen6 ✓ CE Dengue Ag
Slide 142: Roche serology infectious disease
Infectious Diseases Roche serology infectious disease A long-term commitment to provide a high-quality, comprehensive testing menu Year 2006/08 2009/11 2012/15 2016/18 2019/20 2021/22 2023/24 2025 2026 2027 2028 + Parameters 20 26 28 31 35 39 43 44 46 47 55 Rubella IgG HSV-1 IgG Syphilis Chagas Anti
Slide 143: The two faces of the deadliest infectious disease
Infectious Diseases The two faces of the deadliest infectious disease Introduction to Tuberculosis Active Tuberculosis Latent Tuberculosis >10 million new active cases ~25% of global population (~2 globally in 20241 billion)2 may have been infected Symptomatic, contagious Not symptomatic, no
Slide 144: Elecsys IGRA TB assay and platforms
Infectious Diseases Elecsys® IGRA TB assay and platforms Robust assay on a large install base of instruments across testing settings Performance Workflow, platforms, and throughput Automation Multicentre evaluation in both high and low burden settings Aliquoting Centrifug. Validation in >2,000 p
Slide 145: Elecsys installed base and IGRA TB market growth
Infectious Diseases Elecsys® installed base and IGRA TB market growth Drive access to Elecsys® IGRA TB assay through large installed base and strong global presence Global Elecsys® installed base 20251 IGRA TB testing market growth ~5-6% >1bn CHF 0,6bn CHF Elecsys® Countries with >48,000 instruments
Slide 146: Neurology unmet needs and opportunities
Neurology Neurology unmet needs and opportunities Leverage Diagnostics solutions to drive access to disease modifying therapies Alzheimer’s Disease Multiple Sclerosis 75% 45% undiagnosed on low efficacy patients1 treatments3 98% 40% untreated untreated patients2 patients4 Significant opportunity to
Slide 147: Elecsys NfL
Neurology Elecsys® NfL Identifying neuroinflammation in patients with relapsing remitting multiple sclerosis Elecsys® NfL Market opportunity MS is a progressive disease affecting 2.8 million people worldwide1 ~45% of patients are treated with low efficacy treatments and Treatment Disease monitor
Slide 148: Patient journey in Alzheimer's disease
Neurology Patient journey in Alzheimer’s disease Drive access to DMTs through early detection of amyloid pathology and integrated solutions Digital solution Imaging IVD Treatment On market Screening & early diagnosis Diagnosis Treatment & monitoring (CE/ US) (CE) pTau181 ApoE4p (rule out) (carrier s
Slide 149: Elecsys pTau217
Neurology Elecsys® pTau217 Standalone, best in class pTau217 assay with dual cut-offs valid across primary and secondary care Validation strategy Clinical performance and CEOi guidelines Patients with signs and symptoms of Primary care Secondary care cognitive decline aged 55+ years 100% pTau 217
Slide 150: Neurology portfolio and pipeline
Neurology Neurology portfolio and pipeline Broadest on market portfolio and strong pipeline across diseases and pathologies IVD portfolio Research Use Only Portfolio Ab42 CSF (CE/US/CN) Ab40 CSF (CE) tTau CSF (CE/US/CN) pTau181 CSF (CE/US/CN) Research Use Only NeuroToolKit tests Robust prototype pTa
Slide 151: Neurology leadership and Alzheimer's disease market growth
Neurology Neurology leadership and Alzheimer's disease market growth Continue to innovate Neurology and shape clinical care pathways Neurology innovation & leadership Alzheimer’s Disease testing market growth Core Lab IVD assays across #1 market leadership 10 geographies +14,9% CAGR 1.3bn FDA Breakt
Slide 152: Roche is setting new standards for IVD and Healthcare
Roche is setting new standards for IVD and Healthcare 1 We are the IVD1 AXELIOS has a We have an industry We are enhancing the industry leader with a differentiated value leading end to end impact of our products clear strategy to grow proposition and will oncology portfolio with digital and above t
Slide 153: Doing now what patients need next
Doing now what patients need next 153