Roche Holding Ltd · SIX:RO
Roche — Investor Day (May 2025)
128 slides from Roche's investor day presentation, May 27, 2025
Slide 1: Slide 1
Slide 2: Roche Diagnostics Day 2025
Roche Diagnostics Day 2025 London, 27 May 2025
Slide 3: 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 4: Opening Remarks
Opening Remarks Bruno Eschli Head of Investor Relations
Slide 5: Agenda
Agenda Opening Remarks 13:00 BST Bruno Eschli, Head of Investor Relations Roche Diagnostics: Overview and Strategy Matt Sause, CEO of Roche Diagnostics Portfolio Priorities Palani Kumaresan, Global Head of Roche Diagnostics Solutions Digital Solutions Moritz Hartmann, Global Head of Roche Informatio
Slide 6: The future of healthcare: Our Ten-Year Ambitions 2020-2029
The future of healthcare: Our Ten-Year Ambitions 2020-2029 Updated ambitions outline our aspirational long-term objectives Ten-Year Ambitions Long-term objectives ▪ Combine Diagnostics & Pharma strengths to address Innovate across the patient journey to unmet needs along the entire patient journey G
Slide 7: A solid base to deliver future growth
A solid base to deliver future growth Pipeline and business development to add significant upside potential illustrative Business development ▪ BD to accelerate pipeline portfolio ▪ In-house pipeline with upside Pharma pipeline potential ▪ On-market Pharma portfolio to deliver growth until 2028 Sale
Slide 8: Consensus outlook 2024-29
Consensus outlook 2024-29* Growth driven by our young on-market portfolio; potential pipeline up-side Biosimilar gap (24-29) Consensus sales growth (24-29) Potential up-side 2026+ CHF Vabysmo 3.6bn Itovebi 1.2bn Assets with low to no coverage in Ronapreve 015bn Lucentis 0.1 bn Ocrevus 1.0bn current
Slide 9: Roche Diagnostics: Overview and Strategy
Roche Diagnostics: Overview and Strategy Matt Sause CEO of Roche Diagnostics
Slide 10: The future of healthcare
The future of healthcare Disease burden and system pressures increase, while care delivery becomes more decentralized Increasing disease burden Healthcare system pressures 50% of disease burden will be cardiovascular-metabolic, Average healthcare cost grew above GDP growth the oncological, and neuro
Slide 11: Two divisions working together to address healthcare needs
Two divisions working together to address healthcare needs Three shared priority disease areas between Diagnostics and Pharmaceuticals Diagnostics Pharma Leader in in-vitro diagnostics Leader in key disease areas Our products Diagnostic solutions Digital products Medicines Three shared priority dise
Slide 12: 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 tients & hea Pa o lth et car Valu Outcomes Enable confident healthcare Costs e 2 decisions Improve care
Slide 13: Our Goals as Roche Diagnostics
Our Goals as Roche Diagnostics Delivering impact for patients, society, and our business Maintain and expand Become a leader in Differentiate through Deliver disease our #1 position in the decentralized comprehensive solutions management solutions clinical laboratory testing across highest burden to
Slide 14: Roche Diagnostics product area breadth
Roche Diagnostics product area breadth Customer areas spanning diverse disciplines and settings in the clinical lab and near patient care Customer area Core Lab Molecular Lab Pathology Lab Near Patient Care ▪ Serum Work Area (immuno- ▪ Molecular work area3 ▪ Advanced staining (IHC ▪ Diabetes managem
Slide 15: Delivering strong consistent growth
Delivering strong consistent growth Diagnostics growing sales mid-to-high single digit ahead of IVD market1 22 CAGR at CER2 20 +6% 18 16 Sales in CHFbn (CER) 14 COVID-19 12 10 8 6 4 2 Base Business 2019 2020 2021 2022 2023 2024 1. IVD base business excl. DC; 2. CAGR based on CER growth rates of each
Slide 16: Roche Diagnostics financial ambition
Roche Diagnostics financial ambition Sales and profit drivers ▪ Continued strong on-market portfolio growth ▪ Future product growth opportunities: Roche Diagnostics ambition1 ▪ Menu and share expansion in Core Lab, Molecular Lab, Pathology Lab and Near Patient Care Sales growth Mid- to high-single d
Slide 17: Q1 2025: Diagnostics sales
Q1 2025: Diagnostics sales Diagnostics Division stable due to healthcare pricing reforms in China Q1 2025 Q1 2024 Change in % CHFm CHFm CHF CER Diagnostics Division 3,491 3,478 0 0 Core Lab1 1,904 1,926 -1 -1 Molecular Lab 634 611 4 2 Near Patient Care 536 569 -6 -5 Pathology Lab 417 372 12 11 17
Slide 18: Our Goals as Roche Diagnostics
Our Goals as Roche Diagnostics Delivering impact for patients, society, and our business Maintain and expand Become a leader in Differentiate through Deliver disease our #1 position in the decentralized comprehensive solutions management solutions clinical laboratory testing across highest burden to
Slide 19: Roche Diagnostics industry leading solution pipeline
Roche Diagnostics industry leading solution pipeline Non-exhaustive Continue to deliver Disrupt the market with Become a leader in in areas of strength transformative innovations decentralized testing cobas® cobas® cobas® cobas® vital cobas® click cobas® sense cobas® Mass Spectrometry ISE neo c 703
Slide 20: Diagnostics key launches
Diagnostics key launches Pivotal launches that will chart the future growth for Roche Diagnostics Accu-Chek® SmartGuide CGM cobas® Mass Spectrometry Roche Sequencing solution (2024) (2024) (2026 launch) On market CGM: Continuous glucose monitoring 20
Slide 21: Our Goals as Roche Diagnostics
Our Goals as Roche Diagnostics Delivering impact for patients, society, and our business Maintain and expand Become a leader in Differentiate through Deliver disease our #1 position in the decentralized comprehensive solutions management solutions clinical laboratory testing across highest burden to
Slide 22: Disease area focus
Disease area focus Changing the standard of care across disease areas with the highest burden Global mortality by cause1 Value of Roche Diagnostics solutions (million deaths) +45% 53 9 Oncology 37 Early detection Precise diagnosis 10 Infectious diseases 7 Neurology Neurology 6 15 Oncology 10 Infecti
Slide 23: Assay pipeline
Assay pipeline Strong pipeline of assay launches with ~130 new tests in the next three years1 Highlights (not exhaustive) Elecsys® pTau 1812 Elecsys® NfL2 Elecsys® TnT-hs Gen 6 Core Lab 77 Elecsys® Dengue Ag Elecsys® pTau2172 Elecsys® TB IGRA cobas® MPXE eplex® ME panel cobas® BV/CV Molecular Lab 22
Slide 24: Digital solutions pipeline
Digital solutions pipeline Leading digital portfolio with 34 new launches over the next three years1 On market In development Highlights (not exhaustive) Clinical Workflow 10 1 navify® Clinical hub PDM One Optimization Clinical GastroFlag algorithm Chest pain triage algorithm Fib-4 algorithm Decisio
Slide 25: Our Goals as Roche Diagnostics
Our Goals as Roche Diagnostics Delivering impact for patients, society, and our business Maintain and expand Become a leader in Differentiate through Deliver disease our #1 position in the decentralized comprehensive solutions management solutions clinical laboratory testing across highest burden to
Slide 26: Accu-Chek SmartGuide CGM solution
Accu-Chek® SmartGuide CGM solution Clear roadmap and focus will ensure our long-term success in diabetes management 2025 - 2026 2027 - 2029 2030+ Augment offering and scale Differentiate and expand Grow through innovation ▪ Launch full factory calibration ▪ Expand to new therapy segments ▪ Enable co
Slide 27: Roche is setting new standards for IVD and Healthcare
Roche is setting new standards for IVD and Healthcare We are the IVD1 industry We will accelerate our We are delivering We will enhance the leader with a clear growth trajectory with innovative solutions to impact of our products strategy to grow above our three key pivotal tackle society’s largest
Slide 28: Portfolio Priorities
Portfolio Priorities Palani Kumaresan Global Head of Roche Diagnostics Solutions
Slide 29: Roche is the industry leader in IVD solutions
Roche is the industry leader in IVD solutions Leading portfolio of assays, systems, and automation solutions across all four customer areas Core Lab Molecular Lab Pathology Lab Near Patient Care #1 in market share globally1 #1 in Lab-MDx market1 #1 in market share globally1 Revamped strategy to beco
Slide 30: Instrument placements at the core of our business model
Instrument placements at the core of our business model Continued strong growth of instrument placements in 2024 Non-exhaustive Core Lab Molecular Lab Pathology Lab Near Patient Care +10% +7% BenchMark cobas® liat ULTRA/ULTRAPLUS +60% cobas® pro analytical units +22% cobas® 5800/6800/8800 analytical
Slide 31: Strategy around menu expansion
Strategy around menu expansion Broadest menu and differentiated medical value solutions across priority disease areas Broad menu on our instruments Medical Value/ Smart gap fills innovative solutions Cardiometabolic Oncology Infectious Neurology diseases Focused strategy paying off with a strong pip
Slide 32: Addressing disease areas with highest burden
Addressing disease areas with highest burden A broad menu of diagnostics solutions to change standard of care and improve outcomes Not exhaustive Early Precise Therapy Patient Disease areas detection diagnosis selection monitoring Increasing healthcare & social burden Accu-Chek® Cardiometabolic hs-C
Slide 33: Our Goals as Roche Diagnostics: Core Lab
Core Lab Our Goals as Roche Diagnostics: Core Lab Delivering impact for patients, society, and our business Maintain and expand Become a leader in Differentiate through Deliver disease our #1 position in the decentralized comprehensive solutions management solutions clinical laboratory testing acros
Slide 34: Core Lab strategic priorities
Core Lab Core Lab strategic priorities Maintain leadership by winning in key segments and markets through our differentiated pipeline Core Lab | Market performance and outlook1 Core Lab | 5 year strategic priorities (Worldwide sales in CHFbn) Core Lab Market 2024 Evolve our next-gen systems portfoli
Slide 35: Reimagining laboratory automation
Core Lab Reimagining laboratory automation Modularity, flexibility, space efficiency & ultra-high throughput key tenants of cobas® ultra cobas® ultra: next gen lab automation in development Market needs and opportunity ▪ Until 2030 the number of connected/ Modular components Transport automated anal
Slide 36: The future of cobas ultra starts already in 2026
Core Lab The future of cobas® ultra starts already in 2026 A new future proof version of the current highly successful lab automation systems: p512/p612 cobas® ultra pre-analytical work station in development ▪ The cobas® ultra pre-analytical work station is building on the p512/p612 legacy as one o
Slide 37: Continue menu expansion with a focus on high medical value assays
Core Lab Continue menu expansion with a focus on high medical value assays Rich pipeline with >5 assay launches per year expected in the coming years Highlights 2025-2027 2028- 2030 Cardio metabolic Lp(a) US TnT hs Gen6 4 +4 Oncology proC3 ADAPT 6 +5 pTau181 Neurology ApoE4p pTau217 6 +6 Dengue Ag,
Slide 38: Generative AI in protein engineering
Core Lab Generative AI in protein engineering Lab in the loop approach to identify the most promising antibody candidates across disease areas Learn Design Initial protein sequences (wet lab data) ▪ Learn and design: AI models1 predict desired antibody properties and help select the most promising c
Slide 39: Our Goals as Roche Diagnostics: Molecular Lab
Molecular Lab Our Goals as Roche Diagnostics: Molecular Lab Delivering impact for patients, society, and our business Maintain and expand Become a leader in Differentiate through Deliver disease our #1 position in the decentralized comprehensive solutions management solutions clinical laboratory tes
Slide 40: 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 Molecular Lab | Market performance and outlook1 Molecular Lab | 5-year strategic priorities (Worldwide sales in CHF bn) PCR Market 2024 Sequencing Market 2024 Maximize p
Slide 41: STI as attractive growth driver for molecular diagnostics
Molecular Lab STI as attractive growth driver for molecular diagnostics Menu expansion and self sampling to unlock new opportunities in rapidly growing market Key pillars to capture growth in STI market Menu expansion Market expansion Market opportunity and key differentiation ▪ STI market growing r
Slide 42: The transformative Roche SBX sequencer
Molecular Lab The transformative Roche SBX sequencer Ability to advance research, translational and clinical applications over time Overall advance in sequencing Whole Genome Spatial ▪ Ultra-high throughput, especially for single cell, Sequencing spatial, proteomics applications ▪ Improved speed and
Slide 43: Our Goals as Roche Diagnostics: Pathology Lab
Pathology Lab Our Goals as Roche Diagnostics: Pathology Lab Delivering impact for patients, society, and our business Maintain and expand Become a leader in Differentiate through Deliver disease our #1 position in the decentralized comprehensive solutions management solutions clinical laboratory tes
Slide 44: Pathology Lab strategic priorities
Pathology Lab Pathology Lab strategic priorities Innovate in digital pathology while maintaining market leadership in the core advanced staining segment Pathology Lab | Market performance and outlook1 Pathology Lab | 5 year strategic priorities (Worldwide sales in CHFbn) Pathology Lab Market 2024 St
Slide 45: Leading presence in advanced staining
Pathology Lab Leading presence in advanced staining Largest installed base in advanced staining, with product offerings across the value chain World's largest menu of 250+ ready-to-use IHC/ISH assays Leading CDx (PHCS) portfolio with 60+ Workflow solutions pharma collaborations and automation in his
Slide 46: navify Digital Pathology as the centerpiece of our ecosystem
Pathology Lab navify® Digital Pathology as the centerpiece of our ecosystem Driving towards full digitalization of the Pathology Lab FDA cleared end-to-end digital pathology solution navify® Digital Pathology (nDP) platform navify® Digital Pathology VENTANA® DP 200 VENTANA® DP 600 navify® Digital Pa
Slide 47: Our Goals as Roche Diagnostics: Near Patient Care
Near Patient Care Our Goals as Roche Diagnostics: Near Patient Care Delivering impact for patients, society, and our business Maintain and expand Become a leader in Differentiate through Deliver disease our #1 position in the decentralized comprehensive solutions management solutions clinical labora
Slide 48: Near Patient Care strategic priorities
Near Patient Care Near Patient Care strategic priorities Investing in targeted areas to become a leader in decentralized testing Near Patient Care | Market performance and outlook1 Near Patient Care | 5 year strategic priorities (Worldwide sales in CHF bn) POC and mPOC Market 2024 Diabetes Care Mark
Slide 49: Comprehensive platform strategy in Near Patient Care
Near Patient Care Comprehensive platform strategy in Near Patient Care Platforms specifically tailored to multiple test settings and end user requirements Accu-Chek® cobas® sense cobas® pulse cobas® vital cobas® liat LumiraDx SmartGuide CGM Lab equivalent Highly reliable hospital Reliable and sustai
Slide 50: Our Goals as Roche Diagnostics
Our Goals as Roche Diagnostics Delivering impact for patients, society, and our business Maintain and expand Become a leader in Differentiate through Deliver disease our #1 position in the decentralized comprehensive solutions management solutions clinical laboratory testing across highest burden to
Slide 51: Digital Solutions
Digital Solutions Moritz Hartmann Global Head of Roche Information Solutions
Slide 52: Our focus areas in digital health
Our focus areas in digital health From the central lab towards decentralized care The connected lab The informed clinician The empowered patient Clinical Workflow & Remote Patient Management Diagnostics Insights portfolio Decision Support portfolio portfolio 52
Slide 53: Our Goals as Roche Diagnostics: The connected lab
Our Goals as Roche Diagnostics: The connected lab Delivering impact for patients, society, and our business Maintain and expand Become a leader in Differentiate through Deliver disease our #1 position in the decentralized comprehensive solutions management solutions clinical laboratory testing acros
Slide 54: The connected lab
The connected lab Combining high-performing IVDs with cutting-edge digital solutions to improve lab performance Commercially available portfolio Upcoming highlights Industry-leading middleware Recent launches Actionable performance Advanced quality assurance analytics across lab modalities navify® n
Slide 55: The connected lab
The connected lab Boost laboratory performance and optimize resources Customer Examples Portfolio benefits for lab customers ▪ Improved service levels and turn around times (TAT) through -69% -68% workflow modification ▪ Auto-validated results and standardized processes to ensure Reduction in Pre-an
Slide 56: Our Goals as Roche Diagnostics: The informed clinician
Our Goals as Roche Diagnostics: The informed clinician Delivering impact for patients, society, and our business Maintain and expand Become a leader in Differentiate through Deliver disease our #1 position in the decentralized comprehensive solutions management solutions clinical laboratory testing
Slide 57: The informed clinician: navify Algorithm Suite
The informed clinician: navify® Algorithm Suite Enhancing clinical decision-making across multiple indications with clinical algorithms Panels Available H2 2025 H1 2026 H2 2026 Later CHRONIC KIDNEY CE: Kidney Klinrisk FDA: Kidney Klinrisk CE & FDA: KFRE DISEASE CE: CKD-EPI FDA: CKD-EPI CE: Adapt-Pro
Slide 58: navify Algorithms: Chest Pain Triage & Kidney Klinrisk
navify® Algorithms: Chest Pain Triage & Kidney Klinrisk Early detection/screening Risk stratification Diagnosis Early detection/screening Risk stratification Diagnosis CE mark planned for Q4 2025 A total of 6 standard blood Chest pain Chest Pain Triage Algorithm1,2 and urine Kidney Klinrisk Algorith
Slide 59: Clinical Hub for Oncology
Clinical Hub for Oncology Integrating the Oncology workflow to enable disease management Diagnosis Treatment Decision & Care Management Monitoring 1 2 3 Integration of fragmented diagnostics Integration of clinical insights into Linking patient care plans & and clinical workflows the clinician’s wor
Slide 60: Clinical Hub: recent highlight and upcoming expansions
Clinical Hub: recent highlight and upcoming expansions Recent Highlights Upcoming Expansions Integration with Foundation Extensibility to multi-disease Medicine workflows Quick access to longitudinal Strengthening integration of patient data complex data sources Standardized patient Intelligence lay
Slide 61: Our Goals as Roche Diagnostics: The empowered patient
Our Goals as Roche Diagnostics: The empowered patient Delivering impact for patients, society, and our business Maintain and expand Become a leader in Differentiate through Deliver disease our #1 position in the decentralized comprehensive solutions management solutions clinical laboratory testing a
Slide 62: The empowered patient
The empowered patient Empowering patients to take control and stay connected to their physician, when needed From "empowering people with diabetes with predictive applications"... …toEnhancing diabetes "enhancing management diabetes management" Launched in 2024 Coming in 2026 Future Accu-Chek® Smart
Slide 63: Driving scalable digital growth
Driving scalable digital growth Our go to market approach builds on two main pillars Platform approach Subscription plans ▪ Seamless content access: Once set up, customers can ▪ Always up-to-date: Customers receive the latest content, easily download and activate new and additional feature updates,
Slide 64: Artificial Intelligence and Machine Learning in our portfolio
Artificial Intelligence and Machine Learning in our portfolio Leveraging AI and ML to optimize workflows and improve patient outcomes Clinical Diagnostics Clinical Remote Patient Decision Insights Workflow Management Support Path AI1 LGI flag2 Clinical case Accu-Chek® summarization SmartGuide CGM3 A
Slide 65: Molecular Lab and Sequencing
Molecular Lab and Sequencing Josh Lauer Global Head of Customer Area Molecular Labs
Slide 66: Roche Molecular Lab Portfolio Overview
Molecular Lab Roche Molecular Lab Portfolio Overview Roche owns the most comprehensive portfolio of molecular products PCR Sequencing Molecular Work Area High-plex mPoC1 Sample Prep Routine efficiency, mid to high volume Syndromic and fast Fast and easy to use cobas® PRIME cobas® 5800 cobas® 6800 co
Slide 67: cobas BV/CV test for use on cobas x800 systems
Molecular Lab cobas® BV/CV test for use on cobas® x800 systems BV/CV assay will complete the sexual health menu and unlock growth in this expanding market Expanding sexual health assay menu Market opportunity ▪ Vaginitis is the primary growth driver in sexual health segment, with a yearly growth rat
Slide 68: cobas eplex system expanded menu: GI and ME panel
Molecular Lab cobas® eplex system expanded menu: GI and ME panel Simultaneously test and detect the most common pathogens associated GI and ME cobas® eplex cobas® eplex cobas® eplex gastrointestinal panel (GI) meningitis and encephalitis panel (ME) ▪ Provides management insight on more Simplified &
Slide 69: Global Sequencing Market
Molecular Lab Global Sequencing Market Clinical segment growth driven by oncology; research segment driven by single cell/emerging applications Global NGS market expected grow to CHF 8.4bn in 2028 with an 11% CAGR Market size in CHFbn Clinical represents majority of the market 24-28 CAGR: +11% 8.4 (
Slide 70: Roche Sequencing solution
Molecular Lab Roche Sequencing solution A disruptive end-to-end solution for translational and clinical labs Sample preparation Sequencing Analysis and insights SBX analysis tools Kapa or other library Application analysis preparation solutions navify® Mutation profiler AVENIO Edge or other or other
Slide 71: Sequencing by Expansion (SBX) technology
Molecular Lab Sequencing by Expansion (SBX) technology Combination of two powerful innovations creates a leap forward in sequencing SBX chemistry High-throughput sensor module Unique speed and flexibility + = ▪ Novel chemistry from Stratos1 turns DNA ▪ 8 million microwell array CMOS chip from ▪ Clea
Slide 72: Benefits of SBX technology
Molecular Lab Benefits of SBX technology Designed to deliver flexibility and throughput with potential for future improvement Flexible operation Read length Batch flexibility Simplex: 50 - 1000+ bp Duplex: 150 - 350 bp (insert) Accuracy Urgent samples Q39 average for HG001 (Duplex) Sample to VCF in
Slide 73: Roche's high throughput sequencing solution (in development)
Molecular Lab Roche’s high throughput sequencing solution (in development) Separate Xpandomer synthesis from single molecule measurement for maximum flexibility Library Preparation Synthesis Instrument Sequencing Instrument Multiplexed & indexed libraries Synthesis of Xpandomer Single molecule seque
Slide 74: Xpandomer synthesis
Molecular Lab Xpandomer synthesis Automated instrument has flexibility to synthesize up to 4 separate library pools in <4 hours Flexible operation Resulting Xpandomer molecule ▪ Automated instrument creates Xpandomers from ▪ Highly engineered polymerase translates original DNA sequence into an entir
Slide 75: Xpandomer sequencing
Molecular Lab Xpandomer sequencing High-throughput sequencing carried out on a reusable sensor module Sensor module Pore formation & reuse Controllable signal Setup Initialize run Sequencing System clean Amplitude Signal Translated Xp basecalls ▪ 8 million microwell CMOS array ▪ Xpandomers are threa
Slide 76: SBX library structures and workflows
Molecular Lab SBX library structures and workflows Different approaches for different applications SBX-Duplex SBX-Simplex Library Xpandomer High Accuracy Ultra-High Throughput 200-300 bp <500 bp >500 bp Potential WGS/WES WTS DNA Structural Variants Future Somatic Oncology Proteomics Phasing Applicat
Slide 77: SBX-Duplex variant calling performance
Molecular Lab SBX-Duplex variant calling performance Potential for clinical accuracy using Roche’s modified GATK and Google’s DeepVariant GATK + Roche Machine Learning DeepVariant F1 Score F1 Score Mean Insert Sample SNV Indels SNV Indels Read Length HG001 235 99.77% 99.54% 99.80% 99.56% HG002 233 9
Slide 78: SBX-Fast Time Trial at Broad
Molecular Lab SBX-Fast Time Trial at Broad February 11, 2025 using HG001 Sample SBX-Fast Xpandomer SBX Analysis through Prep Library Prep Synthesis Sequencing Variant Calling 2 μg DNA Blood, Saliva, tissue 20 min 124 min 138 min 20 min 103 min Library prep through VCF in 6 hours, 25 minutes GATK + R
Slide 79: SBX-Fast Time Record
Molecular Lab SBX-Fast Time Record NA22010 sample from Coriell affected with Propionic Acidemia Sample SBX-Fast Xpandomer SBX Analysis through Prep Library Prep Synthesis Sequencing Variant Calling 2 μg DNA Blood, Saliva, tissue 20 min 108 min 99 min 20 min 36 min Library prep through VCF in 4 hours
Slide 80: Broad Clinical Labs collaboration
Molecular Lab Broad Clinical Labs collaboration Continued development of standardized rapid genetic testing for trio samples CONTINUOUS IMPROVEMENT OF TOTAL TESTING TIME FOR THREE GENOMES SBX-D Xpandomer SBX Analysis through Total Time Library Prep Synthesis Sequencing Variant Calling As of January
Slide 81: Roche analysis pipelines and open-source tools development
Molecular Lab Roche analysis pipelines and open-source tools development Solution will include on-premise acceleration to enable concurrent data processing Roche On-Premise Local Accelerated Partner / Primary / Post-Primary Analysis Pipeline Variant Calling Customer Cloud SBX-D BAM / VCF Base Intram
Slide 82: SBX-Simplex applications
Molecular Lab SBX-Simplex applications Combination of high-throughput and read length enable more efficient translational research Short read counting applications Longer reads for novel isoform detection Read count (M) Read length (100 bp bins) ▪ 1m cell PerturbSeq experiment performed ▪ 5’ Gene Ex
Slide 83: Oncology focused applications
Molecular Lab Oncology focused applications Formalin fixed paraffin embedded and minimal residual disease: Utility of SBX technology in oncology Formalin fixed paraffin embedded (FFPE)1 Minimum residual disease (MRD) TMB [mut/Mbps] Tumour fraction Colour Cancer patient ctDNA Healthy donor cfDNA Tiss
Slide 84: Roche is building an open platform for E2E sequencing solutions
Molecular Lab Roche is building an open platform for E2E sequencing solutions Roche has access to unique ecosystem to drive sequencer content development Roche Pharma & Genentech Roche Diagnostics Drug Development product development Open platform Roche tools Third party tools (automation, (library
Slide 85: Roche Sequencing solution: Path to commercialization
Molecular Lab Roche Sequencing solution: Path to commercialization 2025 2026 Beyond 2026 Early access Launch Expansion ▪ Demonstrate workflows and ▪ Launch SBX system in key ▪ Expand to the next wave of applications including: countries across North countries – WGS America, Western Europe, select AP
Slide 86: Make space for
Molecular Lab Make space for 86
Slide 87: Pathology Lab
Pathology Lab Jill German Head of Pathology Customer Lab Area
Slide 88: Roche Pathology Lab global market leader
Pathology Lab Roche Pathology Lab global market leader Unparalleled reach across the world Pathology lab market ▪ 2024 market size of 4.4bn CHF (+7% vs. 2023)2 13,143 ▪ ’23 – ’24 market growth estimated at 7%2 Market leader; growing above market IHC/ISH instruments ▪ 2024 revenues of 1.56bn CHF (+17
Slide 89: Market leading Personalized Healthcare Solutions
Pathology Lab Market leading Personalized Healthcare Solutions Unique driver of medical innovation and Digital Pathology (DP) algorithms 25 65 85+ years’ ongoing IVD pharma experience development partners programs 5.6M 400+ 150+ patients tested with clinical trials unique biomarkers our HER2, ALK, P
Slide 90: The best content from around the world
Pathology Lab The best content from around the world Delivered in an efficient clinical workflow Partners Algorithms Today PD-L1 28-8, MASH H&E / Trichrome Prostate H&E, Breast H&E Scope PD-L1 TPS 22C3 Prostate H&E HER2, ER, PR, Ki-67, PD-L1 SP263 navify® DP 3.0 offers a game-changing user HER2, ER,
Slide 91: Innovating to deliver medical value
Pathology Lab Innovating to deliver medical value Leveraging our strengths in Personalized Healthcare Solutions and Digital Pathology Roche Algorithms Today TROP2 QCS Algorithm Developing the 1st computational pathology RxDx device in partnership with AstraZeneca ER breast HER2 Dual ISH HER2 breast
Slide 92: Deeper understanding of cancer changes diagnostic needs
Pathology Lab Deeper understanding of cancer changes diagnostic needs Increasing biomarker complexity puts pressure on sample availability and testing efficiency FDA approvals for lung cancer treatments1 ▪ Increasing therapy options driven by new biomarkers ▪ Multi-modal testing requires more sample
Slide 93: Multiplex IHC can solve multiple challenges
Pathology Lab Multiplex IHC can solve multiple challenges From conserving tissue to understanding spatial relationships Increasing complexity Increasing predictive value Example use cases Tissue conservation Co-expression Inter-marker spatial context Markers that would otherwise be stained on Multip
Slide 94: Multiplex IHC can effectively predict therapy response
Pathology Lab Multiplex IHC can effectively predict therapy response Example of a PD-1/PD-L1 spatial distribution is a predictive signature that effectively stratifies patients Image analysis of PD-1/PD-L1 IHC multiplex PFS of responders vs. non-responders Responder: High value (responders) High pre
Slide 95: Translucent chromogens enable multiplex IHC
Pathology Lab Translucent chromogens enable multiplex IHC Digital-friendly design to support pathologists detect co-located markers & complex interactions IVD Translucent chromogen configuration Unmixing of colors and image analysis + Multiplex IHC VENTANA® DP200/600 Digital singleplex + = Illustrat
Slide 96: Driving diagnostic certainty for nearly 41 million patients each year
Driving diagnostic certainty for nearly 41 million 2020 2021 2022 2023 patients each year 1 26.7 32.1 33.7 38.4 million million million million 1. Data on file with Roche Diagnostics. Based 96 on 2024 sales.
Slide 97: Near Patient Care
Near Patient Care Ildikó Amann-Zalán Head of Research & Development Roche Diagnostics Solutions
Slide 98: NPC market and portfolio segments
Near Patient Care NPC market and portfolio segments Serving patients and customers across multiple settings, disease areas and technologies Cardiovascular Infectious diseases Diabetes Digital enablement and value drivers Home Pharmacy General practitioners & specialists Emergency room & intensive ca
Slide 99: Comprehensive technology roadmap across NPC
Near Patient Care Comprehensive technology roadmap across NPC Solutions1 to address customer needs across settings Highly decentralized Domestic Hospital Network settings settings Hospital Mini Patient side (ICU, Freestanding Urg. Care Pharmacy ER Specialists2 GP2 Others2 At home Lab Labs Ward, outp
Slide 100: Comprehensive technology roadmap across NPC
Near Patient Care Comprehensive technology roadmap across NPC Solutions1 to address customer needs across settings Highly decentralized Domestic Hospital Network settings settings Hospital Mini Patient side (ICU, Freestanding Urg. Care Pharmacy ER Specialists2 GP2 Others2 At home Lab Labs Ward, outp
Slide 101: cobas liat CT/NG & cobas liat CT/NG/MG
Near Patient Care 1 cobas® liat CT/NG & cobas® liat CT/NG/MG Addressing the unmet need with two high medical value STI solutions at the point of care cobas® liat CT/NG and cobas® liat CT/NG/MG Key assay highlights ▪ Dual target assay design for CT, NG and/or MG ▪ Qualitative, differentiated results
Slide 102: cobas liat Lesion panel (EUA)
Near Patient Care 1 cobas® liat Lesion panel 1 (EUA2) Minimize the risk of misdiagnosis and delayed treatment cobas® liat Lesion panel Key assay highlights ▪ Qualitative, differentiated results from a single test supporting the challenge of overlapping disease presentation ▪ Differentiation of key p
Slide 103: cobas sense - Our NPC Immunochemistry platform
Near Patient Care 2 cobas® sense 1 - Our NPC Immunochemistry platform Lab equivalent immunoassay testing at the Point of care cobas® sense Key instrument attributes ▪ Standardized to core lab solution allowing for comparability of results ▪ Expanding menu with a focus on high value markers for indic
Slide 104: LumiraDx: Our solution for the highly decentralized market
Near Patient Care 3 LumiraDx: Our solution for the highly decentralized market Multi-modality: Immunoassay, clinical chemistry, potentially molecular LumiraDx Key instrument features ▪ Multi-modality: immunoassay, clinical chemistry, potentially molecular1 ▪ Multiplex testing up to 3 immunoassay ana
Slide 105: LumiraDx: Menu differentiation to serve to most urgent needs
Near Patient Care 3 LumiraDx: Menu differentiation to serve to most urgent needs Assays targeting high-prevalence diseases at the point of care CURRENT ASSAYS ASSAYS COMING SOON NT-proBNP assay HbA1c 2.0 D-Dimer assay TC Lipid panel HbA1c TG CRP (non hs) HDL, LDL (calc.) INR SARS-CoV-2 Ag assay SARS
Slide 106: Accu-Chek SmartGuide CGM update
Near Patient Care 3 Accu-Chek® SmartGuide CGM update Rollout progressing as planned Accu-Chek® SmartGuide CGM sterile unit assembling Launch phase progresses according to plan ▪ Early launch activities in 10+ countries in Q2 2025 and 30+ by end of the year ▪ 10x increase in sensor volume manufacturi
Slide 107: Core Lab: Instruments
Core Lab: Instruments Benjamin Lilienfeld Lifecycle Leader Serum Work Area Systems
Slide 108: IVD and SWA market overview 2024
Core Lab IVD1 and SWA market overview 2024 Roche is a leading player in IVD and SWA2 IVD market 2024 SWA market 2024 Roche SWA CHF 7bn CHF 2bn Clinical chemistry 26% CHF 5bn Immunochemistry 43% 40% CHF CHF 65bn 28bn 59% 14% SWA market 5% 9% 11% 8% SWA Other IVD Roche Competitor 1 Competitor 2 Compet
Slide 109: Evolving our next generation systems portfolio
Core Lab Evolving our next generation systems portfolio Multi-year roadmap of systems launches planned in our strategic markets 2024 2025 2026 Increased productivity FDA Clearance of CMDA Clearance of with the new analytical units cobas® ISE neo & c 703 cobas® ISE neo & c 703 cobas® ISE neo & c 703
Slide 110: Core Lab: Instrument placements
Core Lab Core Lab: Instrument placements Large installed base with significant growth potential FY 2024 growth Strong uptake of new generation instruments Units 15’000 cobas pro 12’350 +4,580 (+60%) cobas pure cobas® pro analytical units 10’000 7’770 5’940 5’000 4’500 +2,540 (+77%) 3’400 cobas® pure
Slide 111: The cobas Mass Spec solution
Core Lab The cobas® Mass Spec solution First fully integrated IVD platform for clinical mass spectrometry Seamless integration Full automation into routine testing from sample to result Clinical Chemistry Immunochemistry Mass Spectrometry Broad assay menu of Increased patient access to high medical
Slide 112: Clinical application of Mass Spec
Core Lab Clinical application of Mass Spec Sensitive estradiol (E2) testing to detect early treatment failures in breast cancer patients Limit of quantification - Immunoassays E 2 Limit of quantification - Mass Spec High-sensitivity test Low-sensitivity test Waiting – insufficient E2 ▪ Earlier detec
Slide 113: Ionify assay roll-out plan wave 1
Core Lab Ionify® assay roll-out plan wave 1 Staggered launch of > 40 analytes in countries accepting CE mark in 2025 Europe and CE markets: 2025 2026 cobas® i Steroids 1 Vitamin D ISDs Steroids 2 Antibiotics 1 Antiepileptics 1 Antiepileptics 2 3MV Antibiotics 2 601 i-pack i-pack i-pack i-pack i-pack
Slide 114: Overview local launch and regulatory approval timelines
Core Lab Overview local launch and regulatory approval timelines cobas® Mass Spec solution China 2027 South Korea 2026 USA 2025* USA 2026** Taiwan 2026 Australia 2026 New Zealand 2026 Launched Pursuing regulatory approval UAE 2025 Wave 2 countries *Soft launch in the US of system & class I exempt as
Slide 115: Strong customer feedback from multicenter evaluation
Core Lab Strong customer feedback from multicenter evaluation cobas® Mass Spec solution cobas® Mass Spec solution Multicentre evaluation study insights Prof. Dr. med. Michael Vogeser LMU Munich, Germany Prof. Dr. Pieter Vermeersch UZ Leuven, Belgium 115
Slide 116: cobas smart e
Core Lab cobas® smart e Low volume immunochemistry analyzer Key specifications Market potential and differentiation ▪ Low volume laboratories, addressable market: ~1bn CHF, +5% CAGR ▪ Successor of cobas® e 411: Current installed base >18,000 ▪ Suitable for remote areas: Easy-to use, minimal maintena
Slide 117: Core Lab: Assays
Core Lab: Assays Olivier Gilliéron Lifecycle Leader Cardiometabolic and Neurology
Slide 118: Core Lab assay menu expansion strategy
Core Lab Core Lab assay menu expansion strategy Offer broad menu with differentiated medical value solutions in key focus disease areas Increasing healthcare & social burden Medical value solutions Cardiometabolic that are differentiated, based on clinical evidence and improve the standard of care O
Slide 119: Core Lab assay pipeline by focus disease areas
Core Lab Core Lab assay pipeline by focus disease areas Rich pipeline with >5 assay launches per year expected in the next few years Highlights 2025-2027 2028- 2030 Total & medical value (MV) 4 +4 =8 thereof 6 MV Cardio Lp(a) US metabolic TnT hs Gen6 Oncology proC3 ADAPT 6 +5 =11 thereof 2 MV pTau18
Slide 120: Elecsys high-sensitivity Troponin-T generation 6
Cardiometabolic Elecsys® high-sensitivity Troponin-T generation 6 Setting a new standard in the diagnosis of acute coronary syndrome (ACS) with integrated solutions ACS Ecosystem components Market potential and differentiation ▪ Global TSIX study across 89 sites ▪ Elecsys® high-sensitivity Troponin-
Slide 121: Lipoprotein (a) and cardiovascular risk
Cardiometabolic Lipoprotein (a) and cardiovascular risk Roche’s differentiated Lp(a) assay is expected be leveraged in screening and Pharma partnership In 2022 est. 1 in 5 people globally had elevated Lp(a) levels >100-125 nmol/L.1 Roche’s Tina-quant® Lp(a) Gen.2 6 novel Lp(a) lowering therapies in
Slide 122: Roche's commitment to become a leader in CVM
Cardiometabolic Roche’s commitment to become a leader in CVM Leveraging Diagnostics and Pharma synergies to build a leading CVM strategy Diagnostics Pharma 1 2 3 Leading cardiac/metabolic biomarker portfolio Broad portfolio of differentiated assets in Technologies for solutions across settings obesi
Slide 123: Diagnostics solutions in liver disease and MASLD
Oncology Diagnostics solutions in liver disease and MASLD Elecsys® Pro-C3 ADAPT algorithm for aid in severity assessment of liver fibrosis Screening Diagnose and monitor Treat risk population chronic liver disease liver cancer Diagnosis of Diagnosis of Treatment HCC Surveillance Treatment Hepatitis/
Slide 124: Alzheimer's disease: Timely diagnosis & integrated patient management
Neurology Alzheimer’s disease: Timely diagnosis & integrated patient management Leverage Pharma partnerships across the lifecycle to drive access to novel DMTs Screening & early diagnosis Diagnosis Treatment & monitoring pTau181 ApoE4p & (rule out) APOE (genetic) PET scan Patient monitoring Digital
Slide 125: Elecsys IGRA Tuberculosis (TB)
Infectious Diseases Elecsys® IGRA Tuberculosis (TB) Addressing highly attractive TB IGRA segment and strengthening Roche’s Infectious Disease offering Automation & consolidation of the assay Market potential and differentiation ▪ ~25% of the global population is infected with Latent Tuberculosis.1 U
Slide 126: Dengue and Lyme disease
Infectious Diseases Dengue and Lyme disease Driving menu expansion and consolidation in Infectious Diseases Dengue Lyme disease • Assays: Dengue Ag, IgG and IgM • Assays: Lyme IgG and IgM • Most common mosquito-borne viral disease globally • Most common vector-borne disease in northern hemisphere •
Slide 127: Roche is well positioned to drive adoption of new tests
Core Lab Roche is well positioned to drive adoption of new tests Build on our large installed base and commercial presence around the world ~50 thereof ~20 Addressing important unmet needs in key focus disease areas new assays until 2030 medical value solutions until 2030 Significant opportunity to
Slide 128: Doing now what patients need next
Doing now what patients need next