Roche Holding Ltd · SIX:RO
Roche — Investor Day (September 2024)
169 slides from Roche's investor day presentation, Sep 30, 2024
Slide 1: Doing now what patients need next
Doing now what patients need next
Slide 2: Roche Pharma Day 2024
Roche Pharma Day 2024 London, 30 September 2024 17 September 2024 | for internal use only
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: Welcome
Welcome Bruno Eschli Head of Investor Relations
Slide 5: Agenda: Pharma Day 2024
Agenda: Pharma Day 2024 Introduction 09:30 BST Bruno Eschli, Head of Investor Relations Group Thomas Schinecker, CEO Roche Group Strategy Pharma Teresa Graham, CEO Roche Pharmaceuticals R&D Excellence Levi Garraway, CMO and Global Head of Product Development 11:10-11:40 Q&A – Strategy 11:40-12:30 Lu
Slide 6: Group
Group Thomas Schinecker CEO Roche Group
Slide 7: Performance and growth outlook
Performance and growth outlook Strategy update 7
Slide 8: Progress made since Pharma Day 2023
Progress made since Pharma Day 2023 Significant progress for operational efficiency, deals and pipeline achieved Internal innovation External innovation Operational efficiency • R&D Excellence: Application of the • Telavant (anti-TL1A) Bar and portfolio prioritization 2 NMEs launched • Carmot (CT-38
Slide 9: Sales momentum expected to continue into 2025
Sales momentum expected to continue into 2025 Strong growth by both divisions: Pharma and Diagnostics Group base business sales growth Group sales growth excluding COVID related sales1 %CER %CER +15% +15% +10% +9% +9% +10% +9% +8% +7% +5% +5% +3% +3% +2% +2% +1% +1% 0% 0% COVID-19 Pandemic -3% COVID
Slide 10: Positive Core Operating Profit momentum
Positive Core Operating Profit momentum Higher sales and effective cost management resulting in strong performance HY 2024 HY 2024 vs. HY 2023 CHFm abs. CER CER growth Sales 29,848 +1,515 5% Other revenue 908 +94 11% Cost of sales -7,300 -168 2% R&D -6,268 -21 0% SG&A -6,376 -96 2% OOI&E 481 -212 -3
Slide 11: Roche delivered consistent growth through biosimilar erosion
Roche delivered consistent growth through biosimilar erosion Successful diversification driven by young portfolio with 16 blockbusters in Pharma CAGR at CER 70 37 years of continuous Ronapreve dividend increases +5% Sales 60 +7% Core EPS 50 Sales in CHFbn (CER) 40 Pharma 30 20 Avastin, Herceptin, Ma
Slide 12: 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 2027 Sale
Slide 13: Consensus outlook 2023-28
Consensus outlook 2023-28* Growth driven by our young on-market portfolio; potential pipeline up-side Biosimilar gap (23-28) Consensus sales growth (23-28) Potential up-side 2025+ Vabysmo 4.6 bn Ocrevus 1.5 bn Ronapreve 0.5 bn Polivy 1.3 bn Assets with low to no coverage in Lucentis 0.5 bn Columvi 1
Slide 14: Strategy update
Performance and growth outlook Strategy update 14
Slide 15: Overview of key strategic initiatives
Overview of key strategic initiatives Significant progress made across the entire organization Ten-Year Ambitions Group Strategy Group Strategy Digital Health Sustainability People & Culture Pharma Strategy Diagnostics Strategy Divisional Strategies R&D Excellence Formation of Near Patient Care Oper
Slide 16: 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 17: Overview of key strategic initiatives
Overview of key strategic initiatives Significant progress made across the entire organization Ten-Year Ambitions Group Strategy Group Strategy Digital Health Sustainability People & Culture Pharma Strategy Diagnostics Strategy Divisional Strategies R&D Excellence Formation of Near Patient Care Oper
Slide 18: 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 in cardiovascular-metabolism, Average healthcare cost grew above GDP growth the oncological, and neurologi
Slide 19: Disease burden increase and decentralization trend
Disease burden increase and decentralization trend Shared priority areas to account for ~50% of disease burden; care delivery growing faster in outpatient setting ~50% of disease burden in shared priority areas by 2035 Outpatient setting to grow 3x faster vs. hospital setting Increase of Disability-
Slide 20: The future of healthcare: Business implications
The future of healthcare: Business implications How we address these trends through our strategy Increasing disease burden Healthcare system pressures Innovate and offer holistic solutions to improve outcomes Prioritize disease areas with high societal burden and reduce cost Decentralized care deliv
Slide 21: Two divisions working together to address healthcare needs
Two divisions working together to address healthcare needs Three shared priority areas between Diagnostics and Pharma Diagnostics Pharma Leader in in-vitro diagnostics Leader in key therapeutic areas Our products Diagnostic solutions Digital products Medicines Three shared priority areas Infectious
Slide 22: Two divisions with synergy potential across the value chain
Two divisions with synergy potential across the value chain Key enabler of our strategy is the collaboration across our two divisions Launch & post- Research Development Manufacturing Commercialization market Share proprietary data and Share technologies, Jointly engage policy makers & disease speci
Slide 23: Creating a healthier future, together
Creating a healthier future, together Roche is uniquely positioned to address patient and healthcare system needs across the patient journey Value to Diagnostics Pharma Value to health- patients Inf. Diseases CVM Oncology Neurology Immunology Ophthalmology care systems by identifying high-risk … to
Slide 24: Overview of key strategic initiatives
Overview of key strategic initiatives Significant progress made across the entire organization Ten-Year Ambitions Group Strategy Group Strategy Digital Health Sustainability People & Culture Pharma Strategy Diagnostics Strategy Divisional Strategies R&D Excellence Formation of Near Patient Care Oper
Slide 25: Updated Digital Health Strategy
Updated Digital Health Strategy Focus on four product segments enabled by one technology stack and one operating model Where to play How to win How to win Four Product Segments One Technology Stack One Operating Model Products / applications Diagnostics Pharma Lab Insights Application Sales and mark
Slide 26: Strategy implementation: Prioritization and consolidation
Strategy implementation: Prioritization and consolidation Recent example of significant synergies realized 8 products consolidated and 6 discontinued in 13 products discontinued in Pharma Diagnostics Application layer • Generated CHF ~170m in annual savings • Provided >50 reusable components • Integ
Slide 27: Overview of key strategic initiatives
Overview of key strategic initiatives Significant progress made across the entire organization Ten-Year Ambitions Group Strategy Group Strategy Digital Health Sustainability People & Culture Pharma Strategy Diagnostics Strategy Divisional Strategies R&D Excellence Formation of Near Patient Care Oper
Slide 28: Roche's strengthened sustainability commitment
Roche’s strengthened sustainability commitment Our strategy contributes to the long-term success of Roche and society, focusing on six priorities Creating value for all stakeholders On track to meet our new Net Zero target Maximize access to our innovative medicines innovation Access to and diagnost
Slide 29: Roche's exceptional commitment to Global Health Security
Roche’s exceptional commitment to Global Health Security Diagnostics and Pharma taking a leading role to address antimicrobial resistance (AMR) crisis Diagnostics: Rapid identification of pathogens Pharma: First novel classes of antibiotics in 50 years 2 novel MoAs discovered by Roche/Genentech scie
Slide 30: Overview of key strategic initiatives
Overview of key strategic initiatives Significant progress made across the entire organization Ten-Year Ambitions Group Strategy Group Strategy Digital Health Sustainability People & Culture Pharma Strategy Diagnostics Strategy Divisional Strategies R&D Excellence Formation of Near Patient Care Oper
Slide 31: Our people and culture
Our people and culture Fostering and rewarding high performance Roche Framework (selection) Focus areas Our Purpose • Talent: Strengthened talent management and Doing now what patients need next succession planning (internal/external), building critical capabilities Our Ways of Working Our Leadershi
Slide 32: Overview of key strategic initiatives
Overview of key strategic initiatives Significant progress made across the entire organization Ten-Year Ambitions Group Strategy Group Strategy Digital Health Sustainability People & Culture Pharma Strategy Diagnostics Strategy Divisional Strategies R&D Excellence Formation of Near Patient Care Oper
Slide 33: Transformation of Roche Diagnostics 2020-2021
Transformation of Roche Diagnostics 2020-2021 Simplified operating model and shift of investments; increased employee engagement Innovation & financial success Operating model Culture Engagement & diversity • Increased R&D investments by 500m CHF • Simplified processes and • Updated operating princi
Slide 34: Accelerated momentum driven by key launches
Accelerated momentum driven by key launches Diagnostics to deliver mid to high single digit growth in coming years Continuous glucose Next generation LumiraDx Mass spectrometry monitoring (CGM) sequencing (NGS) • Consolidate PoC testing on a • 14 day real-time glucose sensor • First fully integrated
Slide 35: Overview of key strategic initiatives
Overview of key strategic initiatives Significant progress made across the entire organization Ten-Year Ambitions Group Strategy Group Strategy Digital Health Sustainability People & Culture Pharma Strategy Diagnostics Strategy Divisional Strategies R&D Excellence Formation of Near Patient Care Oper
Slide 36: Balancing centralization and decentralization
Balancing centralization and decentralization Improving operational performance and realizing synergies across the Group Maximize benefit of two divisions with streamlined structures Pharma Decentralized • Independent early research units aligned to drive innovation Diagnostics Pharma with focus on
Slide 37: Overview of key strategic initiatives
Overview of key strategic initiatives Significant progress made across the entire organization Ten-Year Ambitions Group Strategy Group Strategy Digital Health Sustainability People & Culture Pharma Strategy Diagnostics Strategy Divisional Strategies R&D Excellence Formation of Near Patient Care Oper
Slide 38: Pharma
Pharma Teresa Graham CEO Roche Pharmaceuticals
Slide 39: Pharma Strategy
Pharma Strategy Therapeutic Areas & focus diseases Our core capabilities Significant future growth opportunities
Slide 40: Today, Roche Pharma leads in multiple Therapeutic Areas
Today, Roche Pharma leads in multiple Therapeutic Areas Diversified portfolio of innovative medicines Number 1 in key Therapeutic Areas Pipeline #1 in Neurology, a leader in 72 NMEs in clinical development Ophthalmology and Oncology/Hematology Portfolio Innovation Roche Sales per therapeutic area CH
Slide 41: Our updated Ten-Year Pharma Ambition
Our updated Ten-Year Pharma Ambition Focus on delivering transformative medicines, enabled by R&D and business objectives Pharma Ambition 2020-2029 Deliver 20 transformative medicines1 addressing diseases with the highest societal burden2 Value Innovation Access +40% 80% 3x of pipeline has best-in-
Slide 42: Defining our portfolio focus
Defining our portfolio focus Purposeful balance between exploration and focus Follow the science Intentional focus in end-to-end disease areas where we develop depth of with emphasis on breakthrough innovation and patient value + experience and operational scale to deliver transformative medicines T
Slide 43: Our new Pharma Strategy
Our new Pharma Strategy Providing clarity and intentional focus to leverage our scientific strengths and impact patients globally Where we play: Priority Therapeutic Areas How we succeed: Core capabilities Neurology Oncology/ Hematology Modalities & Devices Manufacturing Technologies Ophthalmology I
Slide 44: Therapeutic Areas & focus diseases
Pharma Strategy Therapeutic Areas & focus diseases Our core capabilities Significant future growth opportunities
Slide 45: Selecting our therapeutic areas and focus disease areas
Selecting our therapeutic areas and focus disease areas Our focus considers societal burden and transformational potential, as well as Roche’s current capabilities External drivers Internal drivers Burden of disease and Potential to yield Roche’s strengths societal costs transformative medicines ● D
Slide 46: Global burden of disease by Therapeutic Area
Global burden of disease by Therapeutic Area 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 Growth, Number of people living with diseases in our (million DALYs) p.p % committed therapeutic areas gl
Slide 47: Significant future growth potential in focus Therapeutic Areas
Significant future growth potential in focus Therapeutic Areas Our focus TAs account for ~80% of future growth Global market size and forecast growth for top Therapeutic Areas 26 Obesity Oncology/ Hematology 14 Size of bubble: Forecast 5-YR CAGR 2024–2028 (%) Market size in 2028 12 Mental Health 10
Slide 48: E2E disease areas: Focus on delivering transformative medicines
E2E disease areas: Focus on delivering transformative medicines Discovery, R&D and commercialization resources concentrated on our end-to-end disease areas Selection Implications 5 priority Therapeutic Areas Dedicated research teams to drive novel scientific innovation Discovery Burden of Significan
Slide 49: Disease areas where we invest end-to-end
Currently, 11 disease areas where we ‘invest end-to-end’ We focus at scale, end-to-end, in these disease areas to bring transformative medicines to patients Oncology/ Neurology Immunology Ophthalmology CVRM Hematology Breast cancer Multiple sclerosis IBD Retinal vascular disorders1 Obesity Lung canc
Slide 50: Building blocks for future growth
Building blocks for future growth Pipeline and business development to add significant upside potential Business development Oncology/Hematology Emerging assets from early pipeline Neurology Immunology CT-388 / gamma-secretase Ophthalmology zilebesiran CT-996 / CT-868 NXT007 modulator CVRM vamikibar
Slide 51: Pipeline acceleration through partnering and acquisitions
Pipeline acceleration through partnering and acquisitions Key deals completed to complement our pipeline across the Pharma focus therapeutic areas * Dual GLP- Molecular 1/GIP RA & siRNA Anti-TL1A in Wnt agonist Zinc finger glue CDKi ADCs in PYY targeting inflammatory in molecules in degraders in por
Slide 52: Breast Cancer: Sustained growth in HER2+ and expanding into HR+
Oncology/Hematology Breast Cancer: Sustained growth in HER2+ and expanding into HR+ Inavolisib in 1L PIK3CA-mut HR+ HER2- mBC (Nov 27th PDUFA); additional indications in development Breast cancer portfolio Expanding beyond HER2+ breast cancer (new cases by subtype1) On market Pipeline Ph I Ph II Ph
Slide 53: Breast Cancer: Inavolisib filed in 1L PIK3CA-mut HR+ BC
Oncology/Hematology Breast Cancer: Inavolisib filed in 1L PIK3CA-mut HR+ BC Inavolisib with BIC potential in breast cancer and beyond Breast cancer portfolio Inavolisib Ph III (INAVO120) in 1L PIK3CA-mut HR+ BC - PFS results1 PIK3CA mutation frequency Ph I Ph II Ph III Tumor type PIK3CAmut 100 preva
Slide 54: Malignant hematology: Diverse portfolio and a broad pipeline
Oncology/Hematology Malignant hematology: Diverse portfolio and a broad pipeline Columvi Ph III (STARGLO) in 2L+ DLBCL: positive results have been filed with global health authorities Malignant hematology portfolio Polivy Columvi/Lunsumio Market share trend (1L DLBCL, IPI 0-5) Patient share (%) Pati
Slide 55: Hemophilia A: Hemlibra the global SoC
Oncology/Hematology Hemophilia A: Hemlibra the global SoC with extensive real-world data Achieving ~80% zero treated bleeds with a convenient administration Hemophilia A portfolio Hemlibra US&EU5 patient share 50% Patient share (US MMS/EU5 Severe) 40% New vial options Ph I Ph II Ph III Ph IV 30% Mor
Slide 56: Multiple sclerosis: Ocrevus Zunovo (SC) US approval achieved
Neurology Multiple sclerosis: Ocrevus Zunovo™ (SC) US approval achieved Ocrevus Zunovo™ with strong US label; Positive fenebrutinib Ph II (FENopta) relapse data presented at ECTRIMS Multiple sclerosis portfolio Ocrevus Ph IV (MINORE/SOPRANO) results MS total patient share (global)* for family planni
Slide 57: Immunology kidney: Positive Ph III for Gazyva in lupus nephritis
Immunology Immunology kidney: Positive Ph III for Gazyva in lupus nephritis New Immunology strategy, including bispecifics moving into autoimmune diseases Immunology kidney portfolio Gazyva Glycoengineered anti-CD20 mAb LN market1 (USD$ bn, CAGR in %) * Type II anti-CD20 region 5.2 • Increased direc
Slide 58: Retinal vascular disorders: Vabysmo US market shares continuing to grow
Ophthalmology Retinal vascular disorders: Vabysmo US market shares continuing to grow Vabysmo pre-filled syringe launched in the US; Susvimo US commercial relaunch in nAMD commencing Retinal vascular disorders portfolio Vabysmo US patient share since launch* Pre-filled syringe launch 60% nAMD 60% DM
Slide 59: Anti-obesity market is expanding significantly
Cardiovascular, Renal & Metabolism Anti-obesity market is expanding significantly > 50% of global population expected to be obese/overweight by 2035 Global obese/overweight population1 Obesity market could grow beyond 100bn US$ by 20302 Global anti-obesity pharmacotherapy market Bn people (Share of
Slide 60: Obesity: Pipeline with potentially unique combination opportunities
Cardiovascular, Renal & Metabolism Obesity: Pipeline with potentially unique combination opportunities Despite numerous approved treatments, unmet need remains; Roche set up to leverage Obesity opportunity Obesity portfolio Roche’s obesity pipeline Unmet need Differentiation strategy Ph I Ph II Effi
Slide 61: Our core capabilities
Pharma Strategy Therapeutic Areas & focus diseases Our core capabilities Significant future growth opportunities
Slide 62: How we succeed: Our Core Capabilities
How we succeed: Our Core Capabilities Modalities & Technologies Devices Manufacturing Focus on approaches with breakthrough Making devices an integral part of our Optimizing and future-proofing our potential in focus TAs & diseases assets, from R&D to commercialization manufacturing network Customer
Slide 63: Diversified portfolio of technologies and modalities
Modalities & Technologies Diversified portfolio of technologies and modalities Newest platform technologies brain shuttle and cyclic peptides have entered the pipeline Brain Shuttle Peptides Cyclic peptides RNA molecules • trontinemab • CT-388 • LUNA18 • ASO factor B Small Monoclonal Bispecifics / F
Slide 64: Increased focus on drug delivery devices
Devices Increased focus on drug delivery devices Significant investments in device development excellence will be critical to support our future portfolio Intravitreal delivery Subcutaneous delivery Oral delivery Pulmonary delivery Pre-filled syringe for ophthalmic use Intravenous delivery Pre-fille
Slide 65: Establishing our resilient manufacturing network of the future
Manufacturing Establishing our resilient manufacturing network of the future Global network investments to enable portfolio evolution Network of the future Milestones achieved Single-use technology, modular filling & Biologics Modular technology & optimized capacity process intensification; Vacavill
Slide 66: Leeway to invest in new drug modalities, including peptides
Manufacturing Leeway to invest in new drug modalities, including peptides Enabled by manufacturing network optimization and ongoing productivity improvement Biologics portfolio evolution with 5-fold productivity Incretin manufacturing strategy increase from 2000 to 2030 CT-388 / CT-868: Injectable p
Slide 67: Roche has a track record in reaching leadership in new markets
Customer experience & Access Roche has a track record in reaching leadership in new markets Leveraging learnings from successful launches for upcoming expansion into IBD and CVRM Market at time of launch Commercialization approach Result ● Highly competitive market with >10 ● Pre-launch market shapi
Slide 68: Leveraging AI to increase overall Pharma productivity
Data & AI Leveraging AI to increase overall Pharma productivity Selected AI use cases along the value chain Regulatory & Manufacturing Drug development Commercialization reimbursement & distribution gRED’s ‘Lab-in-a-loop’ Document writing Digital twin Predictive alerts • AI/ML: Computational • Gen A
Slide 69: Our people: Critical enablers for our new Pharma Strategy
Our People Our people: Critical enablers for our new Pharma Strategy We commit to creating a culture where our people can thrive across the Pharma Division An attractive employer High performing organisation We strive to hire, develop and retain the best people in We purposefully commit to the five
Slide 70: Significant future growth opportunities
Pharma Strategy Therapeutic Areas & focus diseases Our core capabilities Significant future growth opportunities
Slide 71: Peak sales potential of key pipeline assets
Peak sales potential of key pipeline assets (NMEs and LEs) New Molecular Entities (NME) giredestrant prasinezumab astegolimab HR+ BC Parkinson's disease COPD inavolisib fenebrutinib ASO Factor B • 7+ NMEs with CHF >3bn peak Pi3Km BC RMS, PPMS IgAN sales potential per asset divarasib Elevidys1 vamiki
Slide 72: 2025: Significant key newsflow ahead
2025: Significant key newsflow ahead* Compound Indication Milestone inavolisib + palbociclib + fulvestrant 1L PIK3CA-mut HR+ BC EU approval Columvi + GemOx 2L+ DLBCL US/EU approval Elevidys DMD EU approval Gazyva Lupus nephritis US/EU filing; US approval Regulatory Susvimo DME/DR US approval Susvimo
Slide 73: R&D Excellence
R&D Excellence Levi Garraway EVP, Global Head of Product Development and Chief Medical Officer
Slide 74: By 2030, we aspire to
By 2030, we aspire to Consistently deliver many of the world’s most impactful medicines (20 transformative medicines1 by end 2029) Reach top-quartile performance in R&D productivity across the biopharma industry 1. Reaching ‘Bar’ criteria: Future medicines that can have high impact for patients, hig
Slide 75: R&D Excellence: Our solutions
R&D Excellence: Our solutions We identified six solutions to achieve top quartile performance - with implementation ongoing Adopt a unified portfolio Transform our portfolio Access the best external framework management & governance innovation Introduce the ‘Bar’ to recognize assets Reconfigure end-
Slide 76: R&D Excellence: Our solutions
R&D Excellence: Our solutions We identified six solutions to achieve top quartile performance - with implementation ongoing Adopt a unified portfolio Transform our portfolio Access the best external framework management & governance innovation Introduce the ‘Bar’ to recognize assets Reconfigure end-
Slide 77: The world's most valuable medicines
The world’s most valuable medicines NME peak sales expectations at launch Number of blockbusters (FY 2023 sales in USD) for top 10 Pharma 90 90 15 80 Category Count 71 Number of NMEs Launched 70 16 23 ‘Unicorn’ (>10bn) 8 60 NME peak sales 50 expected Uber-blockbuster (5-10bn) 19 16 >3bn 40 24 1-3bn
Slide 78: Adopt a unified portfolio framework
Adopt a unified portfolio framework Using the ‘Bar’ to identify and invest sufficiently in medicines with transformative potential The Bar Answers a clear & Engages a Possesses worthy Achieves meaningful Unlocks a path to addressable unmet ‘foundational pharmacologic therapeutic value need target’ c
Slide 79: 'Fast-track' of selected programs
‘Fast-track’ of selected programs Initial set of assets designated for acceleration based on exceptional potential Asset Acceleration Examples of potential acceleration levers: anti-TL1A Expediting enrollment with additional clinical trial Ph III Inflammatory Bowel Disease1 sites Trontinemab Ph III
Slide 80: Pharma pipeline evolution since Pharma Day 2023
Pharma pipeline evolution since Pharma Day 2023 Since Pharma Day 2023, 17 NMEs were added and 26 NMEs removed, resulting in a higher impact portfolio Pipeline changes since Q2’23 siRNA targeting AGT in hypertension 8 -8 17 Additions 81 4 -3 1 • 8 Ph I/Ph II NMEs acquired as -5 3 -4 2 part of high va
Slide 81: R&D Excellence: Our solutions
R&D Excellence: Our solutions We identified six solutions to achieve top quartile performance - with implementation ongoing Adopt a unified portfolio Transform our portfolio Access the best external framework management & governance innovation Introduce the ‘Bar’ to recognize assets Reconfigure end-
Slide 82: Reconfiguring governance and strategic portfolio management
Reconfiguring governance and strategic portfolio management Transforming our portfolio oversight and end-to-end governance to execute the ‘Bar’ and increase our PTS STRATEGY 4 Pharma Portfolio Team Delivers end-to-end development plans to 1 minimize whitespace 3 Development and Business Boards GOVER
Slide 83: R&D Excellence: Our solutions
R&D Excellence: Our solutions We identified six solutions to achieve top quartile performance - with implementation ongoing Adopt a unified portfolio Transform our portfolio Access the best external framework management & governance innovation Introduce the ‘Bar’ to recognize assets Reconfigure end-
Slide 84: Access the best external innovation
Access the best external innovation Partnering and acquisitions over the past year clearly met the ‘Bar’ criteria Recent acquisitions Portfolio impact Entered high-impact partnerships since • Business Development deals exemplify commencing R&D Excellence, e.g., characteristics of the ‘Bar’ • Assets
Slide 85: R&D Excellence: Our solutions
R&D Excellence: Our solutions We identified six solutions to achieve top quartile performance - with implementation ongoing Adopt a unified portfolio Transform our portfolio Access the best external framework management & governance innovation Introduce the ‘Bar’ to recognize assets Reconfigure end-
Slide 86: R&D productivity: Comparison of leading Pharma players
R&D productivity: Comparison of leading Pharma players We aim to be in the top quartile of all players R&D productivity as annual peak sales vs. average annual R&D spend Our ambition 10 Top quartile Average annual peak 6 sales, 2014-23 (USD bn) 5 Median 4 Roche Bottom quartile 3 2 Peers 1 Average an
Slide 87: Embracing bold objectives: Our 2030 R&D ambitions
Embracing bold objectives: Our 2030 R&D ambitions Toward top quartile industry performance Increase average peak year sales of Increase Ph 0 initiations/yr1: Increase Ph III success rate: pipeline assets: +50% +22%p +50% Success Volume Value rate Effectiveness R&D Excellence Costs Cycle time Efficie
Slide 88: Meaningful improvements achieved in 2024
Meaningful improvements achieved in 2024 R&D Excellence enables us to reallocate resources to new projects, new deals & accelerate priority assets Added 8 assets through high- CHF +0.24bn average peak year sales per Recent team-assessed PTS for value partnerships and 9 assets project through termina
Slide 89: R&D Excellence: Our solutions
R&D Excellence: Our solutions We identified six solutions to achieve top quartile performance - with implementation ongoing Adopt a unified portfolio Transform our portfolio Access the best external framework management & governance innovation Introduce the ‘Bar’ to recognize assets Reconfigure end-
Slide 90: Simplifying and harmonizing our systems
Simplifying and harmonizing our systems Further streamlining our processes to elevate performance with AI Progress in complexity reduction in several Generative AI as Clinical Study Report co-author to key R&D areas enable faster regulatory submissions Starting point: From Moving towards Generation
Slide 91: Streamlining our processes: CRO partnerships
Streamlining our processes: CRO partnerships Leveraging our scale to build long-lasting, end-to-end strategic relationships with vendors Consolidation of vendors Cycle time reduction Cost reduction Collaborative partnerships with three Eliminate switching and recontracting Leverage economies of scal
Slide 92: R&D Excellence: Our solutions
R&D Excellence: Our solutions We identified six solutions to achieve top quartile performance - with implementation ongoing Adopt a unified portfolio Transform our portfolio Access the best external framework management & governance innovation Introduce the ‘Bar’ to recognize assets Reconfigure end-
Slide 93: By 2030, with our ongoing efforts in R&D excellence, we will have…
By 2030, with our ongoing efforts in R&D excellence, we will have… Adopt a unified portfolio Implementation in progress framework Implemented and moving Delivered many of the world’s most into business as usual Transform our portfolio impactful medicines (20 management & governance transformative me
Slide 94: Our new product development leadership team
Our new product development leadership team Aligned to our 5 focus therapeutic areas Levi Garraway Chief Medical Officer / Head of PD Charles Fuchs Christopher Brittain Head of Oncology/Hematology PD Head of Ophthalmology PD Larry Tsai Manu Chakravarthy Head of Immunology PD Head of Cardiovascular,
Slide 95: Oncology/Hematology
Oncology/Hematology Charles Fuchs SVP and Global Head of Oncology and Hematology Product Development
Slide 96: Strategic pillars of oncology and hematology
Oncology/Hematology Strategic pillars of oncology and hematology Precision medicine Novel modalities Rational combinations Early disease Investing in key Leverage breadth of Early diagnosis and Right medicines for the technologies to engage oncology portfolio to treatment increases the right patient
Slide 97: Oncology solid tumor pipeline
Oncology/Hematology Oncology solid tumor pipeline A broad portfolio differentiated by targets and modalities Ph I Ph II Ph III Registration RG6194 runimotamab (HER2 x CD3) RG6279 eciskafusp alfa (PD1-IL2v) autogene cevumeran tiragolumab inavolisib RG6180 RG6058 RG6114 efbalropendekin alfa multiple i
Slide 98: HR+/HER2- BC treatment paradigm
Oncology/Hematology HR+/HER2- BC treatment paradigm Roche has potential to establish new standards of care across major treatment modalities HR+ BC treatment landscape Low risk (~55%)1 Medium risk (~25%)1 High risk (~20%)1 ET Endocrine Therapy (ET) Neoadj ET is backbone treatment for ER+ BC; however
Slide 99: Giredestrant has the potential to overcome limitations of current ET options
Oncology/Hematology Giredestrant has the potential to overcome limitations of current ET options in 1L and eBC Giredestrant with best-in-class ET potential Giredestrant data support development in 1L and adj HR+ BC Tumor ER pathway activity by time of sample collection1 2 ER Activity Zone 1 0 (gired
Slide 100: Giredestrant a new, potentially best-in-class endocrine backbone
Oncology/Hematology Giredestrant a new, potentially best-in-class endocrine backbone Ph III (persevERA) 1L ER+ mBC and Ph III (evERA) 2L ER+ mBC results expected in 2025 Giredestrant aims to replace standard of care ET across eBC & mBC gire giredestrant Low risk (~55%)1 Medium risk (~25%)1 High risk
Slide 101: Inavolisib in PIK3CAm HR+ BC to define new SoC
Oncology/Hematology Inavolisib in PIK3CAm HR+ BC to define new SoC Ph III (INAVO120) data submitted with Priority Review ongoing (PDUFA 27 Nov 2024) Inavolisib a BIC PI3Kα inhibitor Inavolisib more than doubles PFS in 1L PIK3CAm HR+ BC Potency/selectivity (inavolisib vs. alpelisib)1 100 PFS (investi
Slide 102: Inavolisib has potential to expand broadly in PIK3CAm BC
Oncology/Hematology Inavolisib has potential to expand broadly in PIK3CAm BC Potential for inavolisib based regimen in PIK3CAm HR+ BC inavo inavolisib Low risk (~55%)1 Medium risk (~25%)1 High risk (~20%)1 • Ph III (INAVO123) to be initiated in 1L ET sensitive pts Neoadj • Potential to initiate addi
Slide 103: Next generation CDKi portfolio acquired from Regor
Oncology/Hematology Next generation CDKi portfolio acquired from Regor RGT-419B is the most advanced CDK4/2 inhibitor in the clinic CDKi are critical regulators of cell cycle progression Next generation CDKi portfolio Potent CDK4 inhibition with activity on CDK22 CDK4/ CDK2/ Biochemical Ki (nM) Cycl
Slide 104: RGT-419B has best-in-class potential as next-gen CDKi in HR+ BC
Oncology/Hematology RGT-419B has best-in-class potential as next-gen CDKi in HR+ BC Targeting expansion into 1L and eBC Durable single agent activity in pts who have progressed on CDK4/6i Ph I: US dose escalation trial in post-CDKi HR+/HER2- BC (n=12) Completed Ongoing Future development Ph I mono d
Slide 105: Multiple upcoming readouts for tiragolumab
Oncology/Hematology Multiple upcoming readouts for tiragolumab Final OS results for Ph III (SKYSCRAPER-01) in 1L PD-L1 high NSCLC expected in Q4 2024 Tiragolumab development program Indication Ph I Ph II Ph III 1L NSCLC: PD-L1 high SKYSCRAPER-01 2024 Lung cancer Stage III unres. NSCLC SKYSCRAPER-03
Slide 106: Divarasib with best-in-class potential in KRAS G12C-mutated tumors
Oncology/Hematology Divarasib with best-in-class potential in KRAS G12C-mutated tumors Ph I data in 2L+ mNSCLC show improved mPFS with longer follow-up KRAS G12C inhibitor Updated data at WCLC 2024 Development program Proliferation potency/selectivity1 Ph I results in 2L+ mNSCLC2 Indication Regimen
Slide 107: Hematology pipeline
Oncology/Hematology Hematology pipeline A broad portfolio enabling unique combinations Ph I Ph II Ph III Registration englumafusp alfa RG6107 PiaSky Columvi Columvi RG6076 RG6026 RG6026 Heme tumors SCD 1L DLBCL, r/r MCL 2L+ DLBCL cevostamab NXT007 Lunsumio RG6160 RG6512 RG7828 r/r MM Hemophilia A 1L
Slide 108: Comprehensive development program across B-cell malignancies
Oncology/Hematology Comprehensive development program across B-cell malignancies Ph III trials for Lunsumio and Columvi in 1L FL and DLBCL initiated Regimen Indication Ph I Ph II Ph III Polivy + R-CHP 1L DLBCL POLARIX US/EU approved • Strong 1L DLBCL uptake with >33k pts treated globally; treatment
Slide 109: Ph III (STARGLO) Columvi + GemOx reduces risk of death by 41%
Oncology/Hematology Ph III (STARGLO) Columvi + GemOx reduces risk of death by 41% in 2L DLBCL1,2 Columvi is the first CD20xCD3 bispecific to demonstrate an OS benefit in DLBCL Columvi + GemOx significantly improved PFS Median OS for Columvi + GemOx was nearly and CR rates1,3,4 double that of R-GemOx
Slide 110: Ph III (SUNMO) chemo-free combo in 2L DLBCL
Oncology/Hematology Ph III (SUNMO) chemo-free combo of two unique MoAs in 2L DLBCL High activity and durable responses for patients unable to tolerate chemo Ph Ib/II (GO40516): Lunsumio + Polivy with Ph III (SUNMO): Lunsumio SC + Polivy in durable ORR and CR rates in R/R LBCL2 2L+ R/R aggressive LBC
Slide 111: Ph III (SKYGLO) Columvi + Polivy-R-CHP in 1L DLBCL
Oncology/Hematology Ph III (SKYGLO) Columvi + Polivy-R-CHP in 1L DLBCL Early data support potential for Columvi in combination with current SoC Ph Ib (NP40126): Columvi in + Pola-R-CHP and Columvi + Ph III (SKYGLO): Columvi + Polivy-R-CHP in 1L DLBCL R-CHOP with high response rates & promising PFS1
Slide 112: Allogeneic CAR-Ts for hematologic malignancies
Oncology/Hematology Allogeneic CAR-Ts for hematologic malignancies Partnership with Poseida Therapeutics Proprietary technologies set Poseida apart CAR Insert • Can stably integrate DNA into the genome piggyBac • High efficiency transposase carries large DNA cargo Non-viral, transposon- • Preferenti
Slide 113: CAR-Ts are complementary to Roche's pipeline
Oncology/Hematology CAR-Ts are complementary to Roche’s pipeline Roche/Poseida allogeneic CAR-Ts key features High rate of deep responses in R/R MM1 Robust healthy donor screening system Non-viral gene insertion and gene “On-demand” delivery from inventory editing customized for TSCM cells Proprieta
Slide 114: NXT007: A next-generation Factor VIIIa mimetic bispecific mAb
Oncology/Hematology NXT007: A next-generation Factor VIIIa mimetic bispecific mAb Brings together FIXa and FX to normalise the hemostatic potential of the clotting cascade Optimized structure and function based NXT007 promotes thrombin generation Dose dependent protection from bleeding on Hemlibra1
Slide 115: Neurology
Neurology Azad Bonni SVP and Global Head of Neuroscience & Rare Diseases, Roche Pharma Research & Early Development
Slide 116: Neurology R&D focus areas
Neurology Neurology R&D focus areas Preserving what makes people who they are Multiple sclerosis Neuromuscular disorders Neurodegenerative diseases Stop, reverse and prevent MS and Create a future of strength and Slow progression of Parkinson’s and preserve quality of life independence in NMD Alzhei
Slide 117: Neurology pipeline
Neurology Neurology pipeline Industry leading portfolio differentiated on targets and platform technologies Ph I Ph II Ph III Registration Brainshuttle™ CD20 prasinezumab Enspryng Evrysdi 5mg tablets RG6035 RG7935 RG6168 RG7916 Multiple Sclerosis Parkinson’s MOG-AD RD SMA RD MAGLi trontinemab Enspry
Slide 118: Fenebrutinib is a highly selective, non-covalent, brain-penetrant BTKi
Neurology Fenebrutinib is a highly selective, non-covalent, brain-penetrant BTKi Fenebrutinib with best-in-class potential, highly differentiated vs. covalent BTKis Development program Fenebrutinib PK profile vs other BTKis 1 Fenebrutinib selectivity vs. other BTKis3 Fenebrutinib Tolebrutinib Evobru
Slide 119: Ph II (FENopta) with compelling RMS data at weeks 12 and 48
Neurology Ph II (FENopta) with compelling RMS data at weeks 12 and 48 Rapid and sustained suppression of disease activity Ph II (FENopta) double-blind period at weeks 4, 8, 121 Ph II (FENopta) open label extension at week 482 Total new T1 Gd+ lesions* DBTP OLE W4 W8 W12 Combined (W4, 8 and 12) 0.4 0
Slide 120: GYM 329 to promote muscle growth in SMA
Neurology GYM 329 (anti-latent myostatin mAb) to promote muscle growth in SMA Ph II (MANATEE) Part 1 results expected in 2025 GYM 329 (Anti-latent myostatin mAb) Pre-clinical data in a mouse models of muscle disease2 Combination rationale GYM 329 Change in muscle mass (g) • Evrysdi treats the underl
Slide 121: Elevidys providing clinically meaningful benefits in DMD
Neurology Elevidys providing clinically meaningful benefits in DMD EU filing completed in DMD patients aged 3-7 years; final decision expected in H2 2025 Ph III (EMBARK) results in DMD Key development projects Favors Elevidys LSMean difference (95% CI) p-value Ph I Ph II Ph III 301 EMBARK Filed in E
Slide 122: Prasinezumab is a mAb selectively binding aggregated α-synuclein
Neurology Prasinezumab is a mAb selectively binding aggregated α-synuclein Current symptomatic treatments only address motor symptoms, but do not affect PD progression Prasinezumab: First potential disease Ph II (PASADENA): Prasinezumab-treated individuals progress less modifying therapy in PD1, 2 t
Slide 123: Ph II (PADOVA) based on Ph II (PASADENA) learnings
Neurology Ph II (PADOVA) is based on Ph II (PASADENA) learnings to evaluate prasinezumab in patients on symptomatic therapy Ph II (PASADENA) subpopulation analysis1 Ph IIb (PADOVA) results expected in Q4 20242 Primary endpoint: Time to confirmed motor progression event defined as ≥5 points on Figure
Slide 124: Trontinemab in AD clears Aβ more rapidly than conventional mAbs
Neurology Trontinemab in AD clears Aβ more rapidly than conventional mAbs Brainshuttle™ technology efficiently transports anti-Aβ mAb across the blood-brain-barrier (BBB) Trontinemab Trontinemab reduces plaques rapidly and robustly with low ARIA rates (Brainshuttle™ anti-Aβ mAb) Ph Ib/IIa trontinema
Slide 125: RG6289, a FIC oral γ-secretase modulator in Alzheimer's disease
Neurology RG6289, a FIC oral γ-secretase modulator in Alzheimer’s disease Targeting amyloid precursor protein processing to prevent Aβ-aggregation GSMs reduce Aβ aggregation1 Ph I dose escalation results for RG62892 Ph II (GABriella) study design3 Mean change from baseline Mean change from baseline
Slide 126: Transforming the AD journey across the breadth of AD
Neurology Roche is committed to transforming the AD journey by developing solutions across the breadth of AD Preclinical Early AD Moderate AD (primary and secondary prevention) (MCI-AD to mild AD dementia) Approved CSF biomarkers [pTau181/Aβ 42; tTau/Aβ 42] Therapy In development Plasma biomarkers [
Slide 127: Immunology
Immunology Larry Tsai SVP and Global Head of Product Development Immunology
Slide 128: Drivers of innovation in Immunology
Immunology Drivers of innovation in Immunology Roche is well positioned to capture future innovation Optimize pathways Combinations Endotypes Cure Improve known Target multiple pathways to Identify patients subsets to Aim for curative treatment pathways/targets for achieve improved efficacy improve
Slide 129: Immunology pipeline
Immunology Immunology pipeline Phase I Phase II Phase III undisclosed undisclosed Gazyva RG6341 Asthma RG6341 RG7159 Chronic cough Lupus nephritis undisclosed RG6287 immunology vixarelimab Gazyva RG6536 RG7159 CD19 x CD3 IPF/SSc-ILD Membranous nephropathy RG6382 SLE vixarelimab Gazyva Lunsumio RG653
Slide 130: Xolair in food allergy is the first FDA-approved medicine
Immunology Xolair in food allergy is the first and only FDA-approved medicine to reduce allergic reactions to multiple foods Xolair (anti-IgE mAb) Ph III (OUtMATCH) in food allergy1,* Primary endpoint Key secondary endpoints % of patients who consumed threshold dose Difference, 60 Difference, 56 Dif
Slide 131: Well positioned in immunological kidney diseases
Immunology Well positioned for a strong future in immunological kidney diseases Development programs Lupus nephritis (LN) B cells are central to LN pathogenesis Risk of ESKD in patients with LN over lifetime Molecule Indication Ph1 Ph2 Ph3 LN REGENCY SLE ALLEGORY Gazyva MN MAJESTY INS INShore COMMUT
Slide 132: Gazyva Ph III (REGENCY) in lupus nephritis met primary endpoint
Immunology Gazyva Ph III (REGENCY) in lupus nephritis met primary endpoint Gazyva shows superiority in CRR over SoC with clinically meaningful treatment benefits Gazyva (anti-CD20 mAb) Ph III (REGENCY) in LN trial design Treatment Primary endpoint B cell depletion vs Rituxan Group 1: Gazyva + MMF R
Slide 133: TL1A is implicated in multiple immunological diseases
Immunology TL1A is implicated in multiple immunological diseases Continuing to explore additional indications TL1A implicated in inflammatory and fibrotic processes1,2 RG6631 (anti-TL1A) development program DR3 Receptor DR3 DR3 Receptor Receptor Indication Development stage Status Gastroenterology I
Slide 134: Anti-TL1A in ulcerative colitis
Immunology Anti-TL1A in ulcerative colitis Ph III (AMETRINE-1&2) trials in UC initiated; Ph III (AMETRINE-1) achieved FPI Ph IIb (TUSCANY-2) in UC1 Ph III (AMETRINE-1&2) in UC study design Clinical remission (mMS)† Endoscopic improvement‡ AMETRINE-1: With treat-through design Efficacy Efficacy asses
Slide 135: Astegolimab a first-in-class anti-ST2 mAb in COPD
Immunology Astegolimab a first-in-class anti-ST2 mAb in COPD Early results show benefit in key endpoints throughout broad patient populations Anti-ST2 mAb Ph IIa (COPD-ST2OP) results at 48 weeks1 Exacerbation rate SGRQ FEV1 Adjusted mean change from baseline in post-bronchodilator FEV1 (95% CI) Adju
Slide 136: Ph IIb/III results for astegolimab in COPD expected 2025
Immunology Ph IIb/III results for astegolimab in COPD expected 2025 Aiming to address all COPD patients COPD patient population1 PIIb (ALIENTO) / Ph III (ARNASA) trial design Eosinophil (EOS)* Smoking status Astegolimab SC Q2W Screening Follow-up (n=1290) 20% 30% Patients with R Astegolimab SC Q4W H
Slide 137: Selnoflast is a potent inhibitor of the NLRP3 inflammasome
Immunology Selnoflast (NLRP3i) is a potent inhibitor of the NLRP3 inflammasome Potential to be the first new oral asthma therapy in 25 years where high unmet need remains Selnoflast Development program (NLRP3 inflammasome inhibitor) Indication Ph I Ph II Ph III Status Immunology Asthma FPI achieved
Slide 138: Our contribution to Global Health Security
Immunology: Infectious diseases Our contribution to Global Health Security Delivering curative therapies in areas of high unmet need Influenza Antimicrobial resistance (AMR) The global burden of AMR is a present and growing danger3 1bn cases of influenza annually, including 3-5mn cases of severe ill
Slide 139: Zosurabalpin and RG6436 first new antibiotic classes in 50 years
Immunology: Infectious diseases Zosurabalpin and RG6436 (LepBi) represent the first new classes of antibiotics against gram negative bacteria in 50 years Zosurabalpin (Abx macrocyclic peptide) LepB inhibitor (macrocyclic lipopeptides) Localization of the LPS transport Cryo-EM structure of system in
Slide 140: Ophthalmology
Ophthalmology Christopher Brittain SVP and Global Head of Product Development Ophthalmology
Slide 141: Ophthalmology pipeline
Ophthalmology Ophthalmology pipeline Aiming to alter the trajectory of vision loss as experienced today Earlier stage disease Later stage disease Improve outcome across all stages of ocular diseases iAMD, nAMD, GA, Retinitis early glaucoma glaucoma pigmentosa Prevention Earlier stage disease: Vision
Slide 142: Ophthalmology R&D focus areas
Ophthalmology Ophthalmology R&D focus areas Improving patient outcomes and reducing treatment burden Extended durability & future Novel MoAs and new indications, Digital Capabilities technologies addressing multiple disease pathways Novel MoAs Biomarker and data analytics Long acting delivery • Vaby
Slide 143: Ophthalmology pipeline gaining momentum
Ophthalmology Ophthalmology pipeline gaining momentum Further improving the standard of care and expanding in new indications Phase I Phase II Phase III Registration NME vamikibart vamikibart Susvimo RG6351 RG6179 RG6179 RG6321 Retinal disease DME UME DME NME OpRegen1 Enspryng Susvimo RG6209 RG6501
Slide 144: Vamikibart in UME and DME
Ophthalmology Vamikibart in UME and DME Addressing the inflammatory component (IL-6) in macular edema IL-6 is involved in many pathways, including Ph I (DOVETAIL) data in UME: Improved vision and retinal inflammation thickness in all dosing cohort 1 Change from baseline in BCVA Patients with absence
Slide 145: Enspryng in thyroid eye disease
Ophthalmology Enspryng in thyroid eye disease Potential to be the first SC therapy in TED with strong efficacy and a well-established safety profile IL-6 and IL-6R play a key role in the pathogenesis of TED1 and Ph III (SatraGo-1/SatraGo-2) trial design clinical evidence supports IL-6 signaling inhi
Slide 146: OpRegen in GA: Replenishing the retinal pigment epithelium
Ophthalmology OpRegen in GA: Replenishing the retinal pigment epithelium FDA RMAT Designation granted based on preliminary clinical evidence Ph I/IIa data: Visual function and retinal structure Potential to counteract RPE loss in GA improvements sustained through month 241-2 Cohort 4 (n=12) Patients
Slide 147: Continuing to innovate on Port Delivery Platform beyond Susvimo
Ophthalmology Continuing to innovate on Port Delivery Platform beyond Susvimo Zifibancimig in nAMD: Combining the benefits of dual VEGF/Ang-2 inhibition and continuous drug delivery Port Delivery Platform (PDP) Zifibancimig PhI/II (BURGUNDY) trial design VEGF/ Ang-2 DutaFab Part 1 Zifibancimig IVT A
Slide 148: Investigating Wnt agonism with ANT-Pharm
Ophthalmology Investigating Wnt agonism with ANT-Pharm Acquisition of AntlerA, a leader in Wnt signaling, added a library of anti-FZD/LRP drug candidates Wnt pathway ANT-Pharm: A combinatorial Wnt-mimetic library platform Anti-FZD Anti-LRP • Extensive scientific expertise on the Wnt pathway in Roche
Slide 149: Cardiovascular, Renal and Metabolism
Cardiovascular, Renal and Metabolism Manu Chakravarthy M.D. Ph. D. SVP and Global Head of Cardiovascular, Renal and Metabolism (CVRM) Product Development
Slide 150: Cardiovascular, renal and metabolic diseases are interdependent
Cardiovascular, Renal & Metabolism Cardiovascular, renal and metabolic diseases are interdependent, and obesity is a key driver Individuals with a BMI ≥30 kg/m2 carry more than a 40% elevated risk for overall mortality Despite numerous approved treatments in cardiometabolic diseases, unmet needs rem
Slide 151: Strategic pillars of Cardiovascular, Renal & Metabolism at Roche
Cardiovascular, Renal & Metabolism Strategic pillars of Cardiovascular, Renal & Metabolism at Roche Incretins Comorbidities Combinations E2E patient solutions Roche portfolio set up to Establish a portfolio of Synergies with Roche Incretins to combat obesity address further causal combination therap
Slide 152: Roche Clinical Development in Cardiovascular, Renal & Metabolism
Cardiovascular, Renal & Metabolism Roche Clinical Development in Cardiovascular, Renal & Metabolism Broad portfolio of differentiated assets Development program Phase I Phase II Phase III Zilebesiran Uncontrolled CVOT trial (Q6M) KARDIA 1, KARDIA 2, KARDIA 3 Exp. FPI H2 2025 (siRNA) hypertension CT-
Slide 153: Obesity: Addressing remaining unmet needs for weight loss
Cardiovascular, Renal & Metabolism Obesity: Addressing remaining unmet needs for weight loss and weight maintenance Weight loss unmet needs Roche portfolio Current weight loss curve 1 Improved tolerability and/or 1 simple up-titration CT-388 (low dose) Better quality weight loss 4 2 (muscle preserva
Slide 154: CT-388, 868 and 996 are designed with biased-signaling
Cardiovascular, Renal & Metabolism CT-388, 868 and 996 are purposefully designed with biased-signaling Novel incretin agonists with unique signaling have potential to improve weight loss and glycemic control Minimal to no ß-arrestin recruitment results in prolonged CT-388, CT-996 and CT-868 are bias
Slide 155: CT-388 being developed for overweight/obese patients +/- T2D
Cardiovascular, Renal & Metabolism CT-388 being developed for overweight/obese patients +/- T2D Robust Ph I weight loss results indicate best-in-class potential CT-388 led to clinically meaningful weight loss over 12 and 24 weeks of Development program treatment1, Ph2 study initiated Ph Ph Ph PhI CT
Slide 156: CT-996 being developed for overweight/obese patients +/- T2D
Cardiovascular, Renal & Metabolism CT-996 being developed for overweight/obese patients +/- T2D Potentially best-in-class oral small molecule with high bioavailability and no food restrictions Development program Once-daily oral dosing of CT-996 over 4 wks with weight loss of up to 7.3% Ph I Ph II 0
Slide 157: CT-868 being developed for overweight/obese patients with T1D
Cardiovascular, Renal & Metabolism CT-868 being developed for overweight/obese patients with T1D First-in-class and best-in-class potential as adjunctive therapy in patients with type 1 diabetes Development program Clinically meaningful reduction in HbA1c demonstrated in T2D Ph II trial4 Change in H
Slide 158: CT-173 + CT-388 further induced weight loss in DIO mice
Cardiovascular, Renal & Metabolism CT-173 + CT-388 further induced weight loss in DIO mice In vivo data support CT-173+388 combination to overcome weight loss plateau, Ph I expected to start in 2025 Weight loss in DIO mice by combining CT-173 (PYY analogue) and CT-388 (QD dosing) CT-173 + CT-388 ini
Slide 159: Despite available therapies hypertension often remains uncontrolled
Cardiovascular, Renal & Metabolism Despite available therapies hypertension often remains uncontrolled Zilebesiran has an innovative MoA with first-in-class and best-in-disease potential in hypertension Zilebesiran (siRNA targeting AGT) Half of adults in US with uncontrolled hypertension unaware of
Slide 160: Zilebesiran with best-in-disease potential in hypertension
Cardiovascular, Renal & Metabolism Zilebesiran with best-in-disease potential in hypertension Robust Ph II results with zilebesiran alone and as add-on to SoC Ph II (KARDIA-2): Zilebesiran add-on to 1 SoC in mild-to-mod HTN • Single dose reduced 24h Primary endpoint: Change in baseline to Secondary
Slide 161: Zilebesiran: Comprehensive development program ongoing
Cardiovascular, Renal & Metabolism Zilebesiran: Comprehensive development program ongoing Ph II (KARDIA-3) with zilebesiran as add-on to 2-4 SoC for uncontrolled hypertension with high CV risk initiated Ph II (KARDIA-3): Combination Study in High CV Risk1 Clinical development program Zilebesiran 600
Slide 162: Roche committed to rapidly expand footprint in CVRM
Cardiovascular, Renal & Metabolism Roche committed to rapidly expand footprint in CVRM CVRM diseases continue to be the leading causes of Roche is well-positioned to tackle one of the most death and have high patient overlap important public health challenges of our modern times US Data Sources only
Slide 163: Setting up Roche for the next innovation cycle and long-term growth
Setting up Roche for the next innovation cycle and long-term growth Significant progress over past 12 months Our young portfolio, people and scientific capabilities serve as a strong foundation for future growth We have made significant progress over the last year: • Strengthening our portfolio and
Slide 164: Appendix
Appendix
Slide 165: Changes to the development pipeline
Changes to the development pipeline Pharma Day update New to phase I New to phase II New to phase III New to registration 2 NMEs: 1 NME: 1 NME: RG6221 LTBR agonist RG6512 FIXa x FX (NXT007) - hemophilia RG6631 anti-TL1A - ulcerative colitis RGXXXX* CDK4/2i (RGT-419B) - (HR+) breast cancer 1 AI: RG66
Slide 166: Roche Group development pipeline
Roche Group development pipeline Phase I (46 NMEs + 8 AIs) Phase II (16 NMEs + 9 AIs) RG6026 Columvi monotherapy + combos heme tumors CHU glypican-3 x CD3 solid tumors tiragolumab + T NSCLC RG6058 RG6058 tiragolumab combos solid tumors CHU codrituzumab HCC tiragolumab + T 1L PD-L1+ mSCCHN RG6076 eng
Slide 167: Roche Group development pipeline
Roche Group development pipeline Phase III (8 NMEs + 34 AIs) Registration US & EU (2 NME + 4 AIs) RG3502 Kadcyla + T HER-2+ eBC high-risk RG6149 astegolimab COPD inavolisib + palbociclib + 1L HR+ PIK3CA-mut. RG6114 Columvi + chemo 2L+ DLBCL IgA fulv. mBC RG6299 ASO factor B influenza, pediatric (0-1
Slide 168: Expected 2024 currency impact
Expected 2024 currency impact Assuming the 26 September 2024 exchange rates remain stable until end of 2024, 2024 impact1 is expected to be (%p): Q1 Q2 Q3 Q4 Sales -8 -2 -3 -4 Q1 HY Sep FY YTD Sales -8 -5 -4 -4 Core operating -7 -6 profit Core EPS -8 -7 1On group growth rates 170
Slide 169: Doing now what patients need next
Doing now what patients need next