Roche Holding Ltd · SIX:RO
Roche — Investor Day (September 2025)
168 slides from Roche's investor day presentation, Sep 22, 2025
Slide 1: Slide 1
Slide 2: Roche Pharma Day 2025
Roche Pharma Day 2025 London, 22 September 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: Welcome
Welcome Bruno Eschli Head of Investor Relations
Slide 5: Agenda: Pharma Day 2025
Agenda: Pharma Day 2025 Introduction 09:30 BST Bruno Eschli, Head of Investor Relations Strategy Pharma Strategy and Commercial Growth Drivers Teresa Graham, CEO Roche Pharmaceuticals R&D Excellence Levi Garraway, CMO and Global Head of Product Development 11:00-11:30 Q&A – Strategy 11:30-12:20 Lunc
Slide 6: Roche delivered consistent growth throughout the last decade
Roche delivered consistent growth throughout the last decade Increased diversification with 17 blockbusters in Pharma CAGR at CER* 70 +5% Sales 60 +8% Core EPS Ronapreve 50 Sales in CHFbn (CER) 40 Pharma 30 20 Avastin, Herceptin, MabThera/Rituxan Dia COVID-19 10 Diagnostics 2015 2016 2017 2018 2019
Slide 7: A solid base to deliver long-lasting future growth
A solid base to deliver long-lasting future growth Emerging pipeline complemented by business development to add significant upside potential illustrative Business development ▪ BD to accelerate pipeline rejuvenation ▪ In-house pipeline with upside potential Pharma pipeline ▪ Today’s on-market Pharm
Slide 8: Pharma Strategy and Commercial Growth Drivers
Pharma Strategy and Commercial Growth Drivers Teresa Graham CEO Roche Pharmaceuticals
Slide 9: Progress since Pharma Day 2024
Progress since Pharma Day 2024 Pharma strategy and on-market portfolio update Obesity strategy Future growth opportunities 9
Slide 10: Our Ten-Year Pharma Ambition
Our 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 in avg. pipeline peak sales of pi
Slide 11: Significant progress made on Ten-Year Pharma Ambition
Significant progress made on Ten-Year Pharma Ambition Pharma Ambition Value Innovation Access Ten-Year Ambition 20 +40% 80% +200% +55% +9%p vs FY ‘23 67% 10 +40% 10 transformative +55% avg. peak sales per 67% late-stage projects +40% more patients medicines1 launched pipeline project2 with BID poten
Slide 12: Significant progress made since Pharma Day 2024
Significant progress made since Pharma Day 2024 Milestones reached for operational efficiency, R&D Excellence and Pharma strategy implementation Financials1 R&D Excellence Strategy TA strategies aligned to overall +10% HY 25 sales growth +26% total portfolio value2 5 Pharma strategy E2E disease area
Slide 13: On-market portfolio with strong growth in the midterm
On-market portfolio with strong growth in the midterm Portfolio increasingly diversified with 17 blockbusters today HY 2025 Pharma sales (CHFbn, YoY CER growth) 1.5 ▪ Establishing a leading position in Ophtha with +17% ▪ Well established HER2+ BC franchise to peak in Vabysmo emerging as new SoC in r
Slide 14: Operational excellence in Pharma since 2023
Operational excellence in Pharma since 2023 Efficiency gains & cost control driving steady COP Pharma margin improvement HY Pharma OPEX development (% of OPEX) HY Pharma sales & profit development +1.7%p Sales CER +15% COP +0.9%p 52.2% volume CER +14% margin growth 50.4% +13% 49.6% +10% +5% CER CHFb
Slide 15: Defining our portfolio focus and implementing the Bar
Defining our portfolio focus and implementing the Bar Purposeful balance between exploration and focus Follow the science Intentional focus with emphasis on breakthrough innovation and patient value + in end-to-end disease areas where we develop depth of experience and operational scale to deliver t
Slide 16: First wave of post Bar NMEs entering Ph III
R&D progress made: First wave of “post Bar NMEs” entering Ph III 55% of clinical pipeline now consists of post Bar assets “Post Bar” assets moved into Ph III development Portfolio composition (# of NMEs)* TA Asset Indication Peak sales potential 36 Oncology/ NXT007 Hem A Hematology cevostamab R/R MM
Slide 17: Pipeline acceleration through partnering and acquisitions
Pipeline acceleration through partnering and acquisitions Stringent R&D budget control in combination with BD to catalyze portfolio rejuvenation * Onc, Immuno & Ophthalmology Onc/Heme Onc/Heme Immunology CVRM CVRM CVRM CVRM Neuro Allogeneic Anti-TL1A siRNA CDKi Dual GLP- Long-acting Wnt agonist HER2
Slide 18: Progress since Pharma Day 2024
Progress since Pharma Day 2024 Pharma strategy and on-market portfolio update Obesity strategy Future growth opportunities 18
Slide 19: Our Pharma Strategy introduced in 2024
Our Pharma Strategy introduced in 2024 Providing clarity and intentional focus to leverage our scientific strengths and impact patients globally Our five Therapeutic Areas Covering 60% of total global burden of disease Global burden of disease ‘23 and ‘35 Growth (m DALYs) p.p% Neurology Oncology/ He
Slide 20: Oncology strategy highlights
Oncology/Hematology Oncology strategy highlights Clear focus on our E2E disease areas to accelerate innovation and strengthen our key franchises End-to-end disease areas Solid tumors: Breast cancer Lung cancer OUR AMBITION Where we play Hematology: Malignant heme1 Hemophilia Strengthen Oncology 1 fr
Slide 21: Breast Cancer: A key focus area for future innovation
Oncology/Hematology Breast Cancer: A key focus area for future innovation Positive Ph III (evERA) results for giredestrant enable expansion into HR+ BC HER2+ BC treatment paradigm to evolve further Breast cancer portfolio Neoadjuvant Adjuvant cont. First line PCR (55%) 65% Surgery Ph I Ph II Ph III
Slide 22: Malignant heme: Established portfolio with strong pipeline
Oncology/Hematology Malignant heme: Established portfolio with strong pipeline Bispecifics expanding into earlier lines; cevostamab to move into Ph III in R/R multiple myeloma Polivy in 1L DLBCL Columvi/Lunsumio in 2L+ NHL Malignant hematology portfolio US Market share (1L DLBCL, IPI 0-5) 40 Patient
Slide 23: Hemophilia A: Building on Hemlibra success with NXT007
Oncology/Hematology Hemophilia A: Building on Hemlibra success with NXT007 Hemlibra with >30,000 patients on treatment globally consolidating it as the SoC Hemlibra in Hemophilia A NXT007: Structure & function Hemophilia A portfolio Global patient count* Further optimized Optimized Lch for 32 Hemlib
Slide 24: Neurology strategy highlights
Neurology Neurology strategy highlights Maintain and grow our leadership through the next wave of transformative medicines and diagnostics End-to-end disease areas Multiple sclerosis Alzheimer’s disease OUR AMBITION Where we play Breakthrough innovation Product leadership (e.g., PD) (e.g., SMA, DMD)
Slide 25: Multiple sclerosis: Ocrevus firmly established as global SoC
Neurology Multiple sclerosis: Ocrevus firmly established as global SoC 420,000 patients treated with Ocrevus globally; broad pipeline in MS, including allogeneic CAR-T Ocrevus in MS Multiple sclerosis portfolio Global patient (thousands) Ocrevus Zunovo (SC) >12,000 pts on treatment Ph I PORTAMENTO P
Slide 26: Immunology strategy highlights
Immunology Immunology strategy highlights Roche is well positioned to capture future innovation End-to-end disease areas IBD COPD OUR AMBITION Where we play Breakthrough innovation Pan-immuno pathways (e.g., Lupus, AtD) (e.g., TL1A, CD20/CD19, OSMR) Maximize the value of our 1 pipeline via multi-ind
Slide 27: Strong Xolair uptake in food allergy, Gazyva filed in LN
Immunology Immunology: Strong Xolair uptake in food allergy, Gazyva filed in LN B-cell-depleting bispecifics and allogeneic CAR-T moving into chronic autoimmune diseases Xolair in food allergy Gazyva in LN Immunology portfolio 60 Patients on treatment (US) LN market1 (USD bn, CAGR in %) * Ph I Ph II
Slide 28: Ophthalmology strategy highlights
Ophthalmology Ophthalmology strategy highlights Amplify leading position in retina through next generation innovation and expand to Glaucoma and Dry eye End-to-end disease areas RVD (nAMD, DME, RVO, DR) GA, iAMD OUR AMBITION Where we play Breakthrough innovation Product leadership (e.g., Dry eye dis
Slide 29: Retinal vascular disorders: Vabysmo with strong global growth
Ophthalmology Retinal vascular disorders: Vabysmo with strong global growth Continued market share gains in the branded IVT market, despite US market contraction* Vabysmo: US branded IVT total patient share (R3M, all indications)* Retinal vascular disorder portfolio 62 60 57 56 67 66 64 Ph I Ph II P
Slide 30: CVRM strategy highlights
Cardiovascular, Renal & Metabolism CVRM strategy highlights Deliver current portfolio in the near term, focus on innovation, transformative solutions for patients End-to-end disease areas Obesity OUR AMBITION Where we play Breakthrough innovation (e.g., MASH, uHTN, CVD, CKD, T1D) Secure a strong ent
Slide 31: Entry into new disease areas
Cardiovascular, Renal & Metabolism Entry into new disease areas Resource prioritization required to excel in diversified portfolio 2015 2025 2035 Over the past 10 years, Roche has successfully entered In the next 10 years, Roche will enter broad-scale Disease Areas like new Disease Areas, primarily
Slide 32: 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 33: Roche with full Pharma and Diagnostics value chains in the US
R&D/Manufacturing Roche with full Pharma and Diagnostics value chains in the US Serving key geographies out of local manufacturing sites 13+1* manufacturing and 15+1* R&D sites in the US Biologics productivity evolution 2000 to 2030 New CVRM research hub* Indianapolis Hillsboro South Philadelphia /
Slide 34: Leveraging AI to supply faster, ensure robust & compliant processes
Data & AI Leveraging AI to supply faster, ensure robust & compliant processes Rethinking the end-to-end process for Pharma Technical Operations Regulatory & Manufacturing Drug development Commercialization reimbursement & distribution Applications: Predictive & agentic AI transforms data into action
Slide 35: Streamlining our drug delivery approach
Devices Streamlining our drug delivery approach Significant investments in device development excellence will be critical to support our future portfolio Therapeutic areas Currently four device platforms Investing for the future Needle safety ▪ Planned device pilot facility in Basel for medical Onco
Slide 36: Leveraging AI to increase productivity along the value chain
Data & AI Leveraging AI to increase overall productivity along the value chain Rethinking the end-to-end process for Pharma commercial & medical content creation Regulatory & Manufacturing Drug development Commercialization reimbursement & distribution Applications: Agentic AI powered content ecosys
Slide 37: Our people: Critical enablers for our Pharma Strategy
Our People Our people: Critical enablers for our Pharma Strategy We commit to creating a culture where our people can thrive across the Pharma Division An attractive employer High performing organization We strive to hire, develop and retain the best people in the We purposefully commit to the five
Slide 38: Progress since Pharma Day 2024
Progress since Pharma Day 2024 Pharma strategy and on-market portfolio update Obesity strategy Future growth opportunities 38
Slide 39: Our capabilities strongly position us to deliver in Obesity
Cardiovascular, Renal & Metabolism Our capabilities strongly position us to deliver in Obesity Best-in-disease Synergies across Manufacturing Global commercial End-to-end potential TAs and supply chain footprint patient journey 39
Slide 40: Obesity is quite different from other disease areas at Roche
Cardiovascular, Renal & Metabolism Obesity is quite different from other disease areas at Roche Scale and complexity, with prominent patients and primary care role, make obesity like no other disease area Patient as key decision driver* Unprecedented size Two-track system: primary and and scale spec
Slide 41: Physical, emotional and social needs driving patient decisions
Cardiovascular, Renal & Metabolism Physical, emotional and social needs driving patient decisions Patients view obesity as a medical condition and take the initiative to seek treatment Patients driving treatment decision1 Key patient needs2 ▪ Preserve health & prevent disease ~55% ▪ Physical well-be
Slide 42: Both primary and specialty care providers are key in Obesity
Cardiovascular, Renal & Metabolism Both primary and specialty care providers are key in Obesity >50% of US GLP-1 prescribers are primary care providers, with different priorities than specialists Distribution of US GLP-1 prescriptions by setting1 Current ranking of comorbidity importance2 Endos & GP
Slide 43: Reimbursement and out-of-pocket market
Cardiovascular, Renal & Metabolism Reimbursement and out-of-pocket market Obesity is not an established disease for reimbursement across countries AOM coverage status in key countries US AOM coverage, % of patients1 Chronic disease Reimbursement ✓ ✓2 Covered through commercial Cover CWM plans or emp
Slide 44: The global Obesity epidemic presents a monumental challenge
Cardiovascular, Renal & Metabolism The global Obesity epidemic presents a monumental challenge Only small population currently served, with expected expansion towards preventative treatment BMI distribution, AOM eligibility and GLP-1 usage1 [ Illustrative ] Prevention Early Tx of Obesity Tx of high-
Slide 45: Significant market fragmentation is expected
Cardiovascular, Renal & Metabolism Significant market fragmentation is expected >70% of PwO have at least one comorbidity which may impact treatment choice Potential future segments Number of comorbidities by BMI cohort (US population), #1 Comorbidity Tolerability management Depth of Quality of weig
Slide 46: Obesity is a major risk factor for a range of diseases
Cardiovascular, Renal & Metabolism Obesity is a major risk factor for a range of diseases >220 complications and comorbidities are associated with Obesity1 Metabolic disease ▪ Metabolic syndrome ▪ Associated diseases (T2D, HF, dyslipidemia, MASH) Cardiovascular disease* ▪ Hypertension Atherosclerosi
Slide 47: A patient-centric approach is key to meet evolving needs of PwO
Cardiovascular, Renal & Metabolism A patient-centric approach is key to meet the evolving needs of PwO Shifting from “one-size-fits-all" to tailored solutions for diverse patient needs Patient profiles based on point in AOM journey, unmet needs & GTM considerations Prevention of Obesity Early Tx of
Slide 48: Incretins have unlocked a new era in Obesity treatment
Cardiovascular, Renal & Metabolism Incretins have unlocked a new era in Obesity treatment Significant unmet need remains, requiring new treatment options, modalities and combinations Age of incretins What’s next? Better understanding of gut-brain axis biology unlocked the development of incretins Sc
Slide 49: Incretins offer many benefits, but come with some limitations
Cardiovascular, Renal & Metabolism Incretins offer many benefits, but come with some limitations Unmet need for next-gen incretins, combination therapies, and novel mechanisms of action Tolerability Ceiling effect on weight loss e.g. nausea/emesis is a main driver for discontinuation e.g., weight lo
Slide 50: Our near-term portfolio offers a strong foundation
Cardiovascular, Renal & Metabolism Our near-term portfolio offers a strong foundation Our differentiation potential relies on the breadth of options to address patient needs Tolerability Ceiling effect on weight loss e.g. nausea/emesis is a main driver for discontinuation e.g., weight loss plateaus
Slide 51: Our capabilities strongly position us to deliver in Obesity
Cardiovascular, Renal & Metabolism Our capabilities strongly position us to deliver in Obesity Best-in-disease Synergies across Manufacturing Global commercial End-to-end potential TAs and supply chain footprint patient journey Multiple pipeline assets with Leverage potential of Robust manufacturing
Slide 52: Progress since Pharma Day 2024
Progress since Pharma Day 2024 Pharma strategy and on-market portfolio update Obesity strategy Future growth opportunities 52
Slide 53: 8 NMEs new to Ph III in 2025 YTD
8 NMEs new to Ph III in 2025 YTD Increased value potential of post Bar NMEs entering Ph III NXT007 in cevostamab in trontinemab in prasinezumab in zosurabalpin in zilebesiran in CT-388 in pegozafermin in hemophilia A R/R MM AD PD MDR bacterial inf. hypertension obesity MASH* Onc/Heme Onc/Heme Neurol
Slide 54: 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 CHF Vabysmo 2.5bn Itovebi 1.1bn Ronapreve 015 bn Lucentis 0.1bn Polivy 1.0bn Assets with low to no coverage in Columvi 0.9bn c
Slide 55: Up to 18 NMEs with launch potential by 2030
Up to 18 NMEs with launch potential by 2030 Including 15 NMEs with blockbuster potential 0.5-1bn peak sales 1-2bn peak sales afimkibart 2-3bn peak sales >3bn peak sales CT-388 IBD, AtD, MASH Obesity +/- T2D sefaxersen CT-868 IgAN T1D with BMI ≥25 zosurabalpin CT-996 Bacterial infections Obesity +/-
Slide 56: R&D Excellence
R&D Excellence Levi Garraway EVP, Global Head of Product Development and Chief Medical Officer
Slide 57: Recap: Our 2030 ambition
Recap: Our 2030 ambition R&D Excellence is accelerating our path to a more productive R&D engine 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 ‘
Slide 58: R&D Excellence: Our solutions
R&D Excellence: Our solutions All seven solutions are now being actively implemented across the enterprise Adopt a unified portfolio Transform our portfolio Access the best external framework management & governance innovation Embrace ambitious R&D Evolve our R&D engine and Align our incentives with
Slide 59: R&D Excellence: Our solutions
R&D Excellence: Our solutions All seven solutions are now being actively implemented across the enterprise Adopt a unified portfolio Transform our portfolio Access the best external framework management & governance innovation Embrace ambitious R&D Evolve our R&D engine and Align our incentives with
Slide 60: Prioritizing transformative assets with the Bar
Adopt a unified portfolio framework Prioritizing transformative assets with the Bar The merits of the Bar are driving alignment and focus Answers a clear & Engages a Possesses worthy Achieves Unlocks a path to addressable ‘foundational pharmacologic & meaningful value (e.g., robust unmet need target
Slide 61: Pipeline prioritization since start of R&D Excellence
Adopt a unified portfolio framework Pipeline prioritization since start of R&D Excellence Focus on high-impact projects and resource allocation to partnerships and fast-track initiatives siRNA targeting AGT in Allogeneic CAR-T in hypertension Onc/Heme, Immuno and Neuro FGF21 analog in MASH* 8 -8 81
Slide 62: Pipeline evolution since YE 2023
Adopt a unified portfolio framework Pipeline evolution since YE 2023 Growing share of potential best in disease assets and increasing peak sales for pipeline projects Share of late-stage projects with BID potential1 Average peak sales per pipeline project, CHFbn2 +55% +9%p 1.3 Total 0.8 portfolio va
Slide 63: Overall portfolio shift - before introduction of the Bar
Adopt a unified portfolio framework Overall portfolio shift - before introduction of the Bar Shifting portfolio to higher value and more balanced risk as a result of these combined solutions Risk-reward profile of assets with Ph III Go decisions pre introduction of the Bar1, NMEs only PTS (Ph III) i
Slide 64: Overall portfolio shift - after introduction of the Bar
Adopt a unified portfolio framework Overall portfolio shift - after introduction of the Bar Shifting portfolio to higher value and more balanced risk as a result of these combined solutions Risk-reward profile of assets with Ph III Go decisions post introduction of the Bar vs pre the Bar1, NMEs only
Slide 65: R&D Excellence: Our solutions
R&D Excellence: Our solutions All seven solutions are now being actively implemented across the enterprise Adopt a unified portfolio Transform our portfolio Access the best external framework management & governance innovation Embrace ambitious R&D Evolve our R&D engine and Align our incentives with
Slide 66: New governance and E2E portfolio management implemented
Transform our portfolio management & governance New governance and E2E portfolio management implemented Development & Business Boards shape our portfolio with broad adoption across R&D Portfolio Governance Disease area specific boards assess E2E alignment Research Phase I Phase II Phase III ▪ Asset
Slide 67: Assessing the health of our overall portfolio
Transform our portfolio management & governance Assessing the health of our overall portfolio Ensure long term portfolio health to reach our ambitions and drive sustainable value creation Portfolio health framework Volume and value Transformative Risk / reward Strategic fit potential Components Cons
Slide 68: Zilebesiran Ph III Go decision based on meeting the Bar criteria
Transform our portfolio management & governance Zilebesiran Ph III Go decision based on meeting the Bar criteria Ph III trial informed by comprehensive KARDIA data set from 3 Ph II studies: KARDIA-1, KARDIA-2 and KARDIA-3 The Bar Zilebesiran Answers a clear & addressable ▪ HTN is the #1 modifiable r
Slide 69: Prasinezumab Ph III Go decision based on meeting the Bar criteria
Transform our portfolio management & governance Prasinezumab Ph III Go decision based on meeting the Bar criteria Multiple endpoints from Ph II studies (PASADENA & PADOVA) and OLE suggest potential to delay motor progression The Bar Prasinezumab Answers a clear & addressable ▪ >10m Parkinson’s disea
Slide 70: Trontinemab Ph III Go decision based on meeting the Bar criteria
Transform our portfolio management & governance Trontinemab Ph III Go decision based on meeting the Bar criteria Ph III in early symptomatic AD initiation planned in 2025 based on totality of data The Bar Trontinemab Answers a clear & addressable ▪ >55m living with dementia, Alzheimer’s disease acco
Slide 71: R&D Excellence: Our solutions
R&D Excellence: Our solutions All seven solutions are now being actively implemented across the enterprise Adopt a unified portfolio Transform our portfolio Access the best external framework management & governance innovation Embrace ambitious R&D Evolve our R&D engine and Align our incentives with
Slide 72: Pipeline acceleration through partnering and acquisitions
Access the best external innovation Pipeline acceleration through partnering and acquisitions Key deals completed to complement our pipeline across our five therapeutic areas Key deals completed since start of R&D Excellence External innovation to catalyze portfolio rejuvenation ▪ Prioritization of
Slide 73: R&D Excellence: Our solutions
R&D Excellence: Our solutions All seven solutions are now being actively implemented across the enterprise Adopt a unified portfolio Transform our portfolio Access the best external framework management & governance innovation Embrace ambitious R&D Evolve our R&D engine and Align our incentives with
Slide 74: Our cumulative impact (2024 - YTD 2025)
Embrace ambitious R&D objectives Our cumulative impact (2024 - YTD 2025) Added 29 assets total from early CHF +0.45bn1 average peak year sales Team-assessed Ph III PTS has increased R&D and high-value partnerships across late-stage portfolio since R&D Excellence roll-out (+12 in 2025) Success Volume
Slide 75: Roche beginning to reduce R&D spend per NME launch
Embrace ambitious R&D objectives Roche beginning to reduce R&D spend per NME launch Increasing share of R&D budget spent on high value programs since start of R&D Excellence R&D spend per NME launch1 (USD bn2) Roche: Share of Ph II/III R&D costs for high value programs (%)4 USD bn R&D Spend per NME
Slide 76: Material progress achieved across all fast-track programs
Embrace ambitious R&D objectives Material progress achieved across all “fast-track” programs R&D Excellence initiatives and “fast-track” jointly enable acceleration of selected assets trontinemab CT-388 afimkibart 21 months 9 months up to 6 months faster to filing faster to filing faster to filing ▪
Slide 77: R&D Excellence: Our solutions
R&D Excellence: Our solutions All seven solutions are now being actively implemented across the enterprise Adopt a unified portfolio Transform our portfolio Access the best external framework management & governance innovation Embrace ambitious R&D Evolve our R&D engine and Align our incentives with
Slide 78: Efficiency: Resource reallocation
Evolve our R&D engine and invest in its excellence Efficiency: Resource reallocation CHF ~1.1bn spend reallocated to transformative programs and productivity initiatives Reallocation of the R&D budget in 2024+20251 (CHFm) Reinvestment into the portfolio 1,050 1,050 ▪ Increased the number of high val
Slide 79: New CRO model delivers on speed, site experience, efficiency & quality
Evolve our R&D engine and invest in its excellence New CRO model delivers on speed, site experience, efficiency & quality Increased efficiency expected to deliver CHF ~300m in annual savings by 2030 Speed Site experience Efficiency Quality On track to deliver 20% Enabling industry-leading site Achie
Slide 80: R&D Excellence: Our solutions
R&D Excellence: Our solutions All seven solutions are now being actively implemented across the enterprise Adopt a unified portfolio Transform our portfolio Access the best external framework management & governance innovation Embrace ambitious R&D Evolve our R&D engine and Align our incentives with
Slide 81: Leveraging AI to increase productivity along the value chain
Build a simplified system landscape & data foundation Leveraging AI to increase overall productivity along the value chain Rethinking the end-to-end process for clinical development AI-driven data and content generation Regulatory & Manufacturing Drug development reimbursement & distribution Commerc
Slide 82: Leveraging AI in drug discovery
Build a simplified system landscape & data foundation Leveraging AI in drug discovery Lab-in-the-Loop: Embedding AI from target discovery to the clinic * Replay and slides available on the IR homepage: https://www.roche.com/investors/events/roche-virtual-ir-digitalization-day; FM: Foundation model 8
Slide 83: By 2030, with our ongoing efforts in R&D excellence, we will…
By 2030, with our ongoing efforts in R&D excellence, we will… Adopt a unified portfolio Implemented and moving into business as usual framework Delivered many of the world’s most Implementation in progress Transform our portfolio management & governance impactful medicines (20 transformative medicin
Slide 84: Oncology/Hematology
Oncology/Hematology Charles Fuchs SVP and Global Head of Oncology and Hematology Product Development
Slide 85: Oncology/Hematology R&D focus areas
Oncology/Hematology Oncology/Hematology R&D focus areas Critical Capabilities Examples Itovebi: BIC PI3Ki being developed in HR+ BC and beyond Precision medicine Right medicines for the right patient Divarasib: BIC KRAS G12Ci with a comprehensive Phase III program across NSCLC lines of treatment Col
Slide 86: A diversified portfolio by drug modalities and targets
Oncology/Hematology A diversified portfolio by drug modalities and targets Strengthening our portfolio through external innovation Oncology/ hematology pipeline Small Bispecifics/ Antibody-drug Neoantigen Allogenic Antibodies Fusion proteins Gene therapy Cyclic peptides molecules trispecifics conjug
Slide 87: Oncology solid tumor pipeline
Oncology/Hematology Oncology solid tumor pipeline Focus on breast and lung as end-to-end investment areas Phase I Phase II Phase III Registration RG6114 inavolisib autogene cevumeran giredestrant Tecentriq RG6180 RG6171 RG7446 RG6171 giredestrant multiple indications multiple HR+ BC indications 1L m
Slide 88: Building a portfolio to address unmet needs in BC
Oncology/Hematology Building a portfolio to address unmet needs in BC Targeting key signaling nodes contributing to etiology and progression of BC Key signaling pathways in BC Remaining unmet needs ▪ Phesgo HER2+ ▪ Perjeta 1 HER2 ▪ Kadcyla ▪ HER2+ mBC five-year survival remains at 40%1 ▪ Herceptin ▪
Slide 89: HR+/HER2- BC treatment paradigm
Oncology/Hematology HR+/HER2- BC treatment paradigm Targeting three critical signaling pathways that drive underlying disease and resistance HR+ BC treatment landscape ET Endocrine Therapy (ET) Low risk (~55%)1 Medium risk (~25%)1 High risk (~20%)1 ET is backbone treatment for ER+ BC; Neoadj however
Slide 90: Giredestrant: A next-gen SERD with BIC potential
Oncology/Hematology Giredestrant: A next-gen SERD with BIC potential Selective ER degrader (SERD)1 Novel two-step MoA2 More potent than competitor SERDs3 Potency (IC50) across Endocrine therapy three ER-positive BC cell lines (nM) giredestrant 4.5–8.7 camizestrant 11.5–27.2 fulvestrant 19.1–34.1 4-h
Slide 91: Giredestrant: Comprehensive clinical program across patient populations
Oncology/Hematology Giredestrant: Comprehensive clinical program across patient populations Potential to become the ET backbone of choice throughout lines of treatment giredestrant 1L ER+/HER2- mBC Giredestrant aims to replace SoC ET across eBC & mBC 1 (persevERA) (ET-sensitive) Readout Q1 ‘26 gired
Slide 92: Giredestrant: Positive Ph III (evERA) in ESR1m and ITT post-CDKi ER+ mBC
Oncology/Hematology Giredestrant: Positive Ph III (evERA) in ESR1m and ITT post-CDKi ER+ mBC First positive H2H Ph III trial investigating an all-oral SERD-containing regimen vs. SoC Ph III (evERA): Gire + everolimus in ER+ mBC post-CDKi Ph III (persevERA): Gire + palbociclib in 1L ER+ mBC Patients
Slide 93: Itovebi in PIK3CAm HR+ BC to define new SoC
Oncology/Hematology Itovebi in PIK3CAm HR+ BC to define new SoC Approved in US, EU and China, additional launches ongoing BIC PI3Kα inhibitor Ph III (INAVO120): First PI3K-targeted therapy to significantly extend OS2 Potency/selectivity (inavolisib vs. alpelisib)1 Median, 96.8 months 100 87.0 Inavol
Slide 94: Itovebi: Potential to expand broadly in PIK3CAm BC
Oncology/Hematology Itovebi: Potential to expand broadly in PIK3CAm BC inavolisib 1L PIK3CAm Potential for inavolisib-based regimen in PIK3CAm HR+ BC 1 (INAVO120) HR+/HER2- mBC (AI resistant) inavolisib Post-CDK4/6i PIK3CAm 2 Readout 2026 (INAVO121) HR+/HER2- BC Low risk (~55%)1 Medium risk (~25%)1
Slide 95: Divarasib: Best-in-class potential in KRAS G12C-mutated tumors
Oncology/Hematology Divarasib: Best-in-class potential in KRAS G12C-mutated tumors Comprehensive Ph III development program in NSCLC Higher potency and selectivity1 Durable clinical activity2 Expanding the program into eNSCLC Divarasib Ph I results in 2L mNSCLC cORR mPFS Progression Free Survival %
Slide 96: Tecentriq: Positive Ph III results in SCLC, colon cancer and MIBC
Oncology/Hematology Tecentriq: Positive Ph III results in SCLC, colon cancer and MIBC Overall Tecentriq sales expected to remain stable in the long term IMforte: 1L maintenance in SCLC1 ATOMIC: dMMR colon cancer2 IMvigor011: MIBC mOS 13.2m vs. 10.6m HR=0.73 P=0.0174 lurbi + atezo atezo ▪ Tecentriq +
Slide 97: Hematology pipeline
Oncology/Hematology Hematology pipeline Cevostamab moving into Phase III in r/r MM Ph I Ph II Ph III Registration englumafusp alfa combos NXT007 Columvi Lunsumio SC RG6076 RG6512 hemophilia A RG6026 1L DLBCL, r/r MCL RG7828 heme tumors 3L FL P-BCMA-ALLO1 SPK-8011QQ Lunsumio RG65381 RG6797 hemophilia
Slide 98: Moving CD20xCD3 bispecifics into earlier lines
Oncology/Hematology Moving CD20xCD3 bispecifics (Lunsumio/Columvi) into earlier lines NHL accounts for almost 50% of Comprehensive development program across NHL subtypes hematological malignancies1 Regimen Indication Ph I Ph II Ph III Polivy + R-GemOx 2L DLBCL POLARGO PEP of OS met Polivy + R-CHP 1
Slide 99: 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 with low CRS potentially suitable for outpatient community care Ph III (SUNMO) results for Lunsumio+Polivy in 2L R/R aggressive LBCL1 Response rates PFS 100 Median, months: 100 Mos
Slide 100: 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 Columvi's combinability with current SoC, with high response rates and low CRS rates Ph Ib: High response rates and durable remissions1 Ph III (SKYGLO): Columvi + Polivy-R-CHP in 1L DLBCL Polivy-R-CHP + Columv
Slide 101: Cevostamab: Potential to become FIC FcRH5xCD3 bispecific
Oncology/Hematology Cevostamab: Potential to become FIC FcRH5xCD3 bispecific Ph III (CEVOLUTION) Go decision in 2L+ r/r MM to create treatment optionality for patients Unique MoA to address unmet need in r/r MM Ph I (CAMMA 1): Cevostamab + Pd in r/r MM1 100 ORR: 88.0% ORR: 86.2% 80 34.5% 36.0% Patie
Slide 102: CAR-Ts to further complement our NHL and MM pipeline
Oncology/Hematology CAR-Ts to further complement our NHL and MM pipeline Rapid, accessible, and “off-the-shelf” investigational allogeneic CAR-T to treat patients without waiting Roche allogeneic CAR-Ts key features P-BCMA-ALLO1 highly clinically active1 Robust healthy donor screening system Respons
Slide 103: NXT007: Next-gen Factor VIIIa mimetic bispecific
Oncology/Hematology NXT007: Next-gen Factor VIIIa mimetic bispecific with BID potential No treated bleeds in cohorts B-3 and B-4 during NXT007 prophylaxis; Ph III program to initiate in 2026 Thrombin generation activity1 Ph I/II (NXTAGE Part B) in Hemophilia A2 Ph III clinical development Mean ABR f
Slide 104: Neurology
Neurology Hideki Garren SVP and Global Head of Product Development Neurology
Slide 105: Neurology R&D focus areas
Neurology Neurology R&D focus areas End-to-end investment in MS and AD Critical Capabilities Examples BrainshuttleTM in AD (trontinemab) and MS (RG6035) Therapeutic modalities Allo-CAR-T (P-CD19 CD20-ALLO1) to enter Ph I in MS TRAVELLER prescreening program in AD uses blood-based biomarkers to reduc
Slide 106: Neurology pipeline
Neurology Neurology pipeline Trontinemab in AD and prasinezumab in PD moving into Ph III development Phase I Phase II Phase III Registration Brainshuttle CD20 Ocrevus SC OBI Enspryng Elevidys1 RG6035 RG1594 MS RG6168 MOG-AD RG6356 DMD2 Multiple Sclerosis RD RD P-CD19 CD20-ALLO1* nivegacetor (GSM) En
Slide 107: Fenebrutinib: Potentially BIC BTKi different by design
Neurology Fenebrutinib: Potentially BIC BTKi different by design The only BTKi that achieves CSF concentrations >IC90 for B-cells and microglia for 24h1 Dual mechanism of action Optimized PK profile1 CNS Penetration1 Free plasma concentration of BTKis CSF: Concentration relative to Periphery unbound
Slide 108: Fenebrutinib: The only non-covalent, reversible BTKi in Ph III MS studies
Neurology Fenebrutinib: The only non-covalent, reversible BTKi in Ph III MS studies Highly selective BTKi, potentially contributing to long-term safety BTKi selectivity1 Fenebrutinib development program F Fenebrutinib E Evobrutinib T Tolebrutinib R Remibrutinib Ind. Vs. Ph I Ph II Ph III RMS placebo
Slide 109: Ph II (FENopta) data add to confidence of fenebrutinib in RMS
Neurology Ph II (FENopta) data add to confidence of fenebrutinib in RMS Participants treated with fenebrutinib had low clinical disease activity through week 96 ARR was low in participants receiving fenebrutinib New T1 Gd+ lesions reduced to near zero DBTP (12 weeks) OLE No. of new T1 Gd+ Lesions pe
Slide 110: Elevidys benefit/risk profile in ambulatory DMD remains positive
Neurology Elevidys benefit/risk profile in ambulatory DMD remains positive Continuing to engage with global health authorities to resume shipping and advance approvals High unmet need in DMD Positive-benefit risk profile in ambulatory DMD Mean trajectory of DMD natural history EMBARK Part 1: Functio
Slide 111: Emugrobart Ph II results in SMA, FSHD expected 2025
Neurology Emugrobart (GYM329) Ph II results in SMA, FSHD expected 2025 Emugrobart has best-in-class potential among anti-myostatin mAbs Anti-latent myostatin mAb SMA/FSHD development program SMA combination rationale Ph I Ph II Ph III GYM329 Evrysdi treats the underlying Emugrobart + MANATEE disease
Slide 112: Parkinson's: Progressive neurodegenerative disease
Neurology Parkinson’s: Progressive neurodegenerative disease Current symptomatic treatments only address motor symptoms, but do not affect PD progression Loss of dopaminergic neurons starts many years before Significant economic burden to people and HC systems onset of symptoms1 with no therapies to
Slide 113: Prasinezumab: Totality of evidence supports Ph III Go decision
Neurology Prasinezumab: Totality of evidence supports Ph III Go decision Multiple endpoints from Ph II PASADENA and PADOVA suggest potential to delay motor progression Prasinezumab Ph II PASADENA/PADOVA results inform Ph III trial design (anti-α-synuclein mAb) Ph II PASADENA OLE: Ph IIb PADOVA: Time
Slide 114: NLRP3 inhibition in Parkinson's disease
Neurology NLRP3 inhibition in Parkinson’s disease Potential to reduce pro-inflammatory responses in Parkinson’s and other diseases NLRP3 inflammasome inhibition Selnoflast development program Parkinson’s Disease Inflammatory TA Indication Ph I Ph II Ph III Status markers blocked Parkinson’s Neurolog
Slide 115: Considerations for successful drug development in AD
Neurology Considerations for successful drug development in AD Limitations of current AD therapies Amyloid removal associated with clinical response Blood–brain barrier penetration Predicted relationship between amyloid Actual relationship between amyloid Ensuring drug is reaching site of removal an
Slide 116: Trontinemab has best-in-disease potential in Alzheimer's disease
Neurology Trontinemab has best-in-disease potential in Alzheimer’s disease Updated interim data continue to support differentiated profile on safety and efficacy Trontinemab Recent interim data confirm rapid and deep amyloid lowering with a (BrainshuttleTM anti-Aβ mAb) favorable safety profile Ph Ib
Slide 117: Trontinemab: First patient in Ph III TRONTIER 1&2 studies
Neurology Trontinemab: First patient in Ph III TRONTIER 1&2 studies in early AD Ph III trial in preclinical AD to be initiated Trontinemab development program TRONTIER 1 & 2 trials in early symptomatic AD supported by TRAVELLER pre-screener study Ph I Ph II Ph III trontinemab Ph Ib/II TRONTIER1 & 2
Slide 118: Identifying amyloid pathology is critical for early AD diagnosis
Neurology Identifying amyloid pathology is critical for early AD diagnosis Blood-based tests drive access to therapies and support disease management Diagnosis plays a crucial role in AD Clinically validated, commercially available blood-based biomarkers are key for differential diagnosis and early
Slide 119: Nivegacetor: Potential first-in-class GSM in Alzheimer's disease
Neurology Nivegacetor: Potential first-in-class GSM in Alzheimer’s disease Targeting amyloid precursor protein processing to prevent Aβ-aggregation GSM to reduce Aβ aggregation1 Ph I dose escalation results2 Ph IIa (GABriella) study design3 Mean change from baseline Mean change from baseline Aβ37 Sc
Slide 120: Immunology
Immunology Larry Tsai SVP and Global Head of Product Development Immunology
Slide 121: Immunology R&D focus areas
Immunology Immunology R&D focus areas Addressing immunology challenges in efficacy, durability, and heterogeneous patient responses Critical Capabilities Examples Multiple approaches for enhanced B-cell depletion, Improve known pathways/targets for Optimize pathways targeting multiple disease areas
Slide 122: Immunology pipeline
Immunology Immunology pipeline Broad development portfolio across several disease areas Phase I Phase II Phase III Registration CD19 x CD3 vixarelimab Gazyva Gazyva RG6382 SLE RG6536 IPF/SSc-ILD RG7159 Membranous nephropathy RG7159 Lupus nephritis selnoflast Lunsumio Gazyva RG6418 Asthma RG7828 SLE
Slide 123: Well positioned for immune-mediated kidney diseases
Immunology Well positioned for a strong future in immune-mediated kidney diseases Chronic kidney disease is predicted to become the 5th Development program leading cause of death globally by 20401 Years of life loss due to CKD predicted to continue to increase5 Molecule Indication Ph I Ph II Ph III
Slide 124: Gazyva: Deeper B-cell depletion key to improved clinical response
Immunology Gazyva: Deeper B-cell depletion key to improved clinical response Ph III (REGENCY) in lupus nephritis US/EU filing completed; US PDUFA set for October 2025 Gazyva (anti-CD20 mAb) Ph III (REGENCY) results in lupus nephritis B cell depletion vs 60 Treatment Difference 1 Rituxan4 Primary End
Slide 125: Multiple B cell depletion approaches for SLE/LN in development
Immunology Multiple B cell depletion approaches for SLE/LN in development Initiated Ph II study for Lunsumio and Ph I study for P-CD19CD20-ALLO1 Bispecifics: Allogeneic CAR-T: Lunsumio (CD20xCD3) & CD19xCD3 P-CD19CD20-ALLO1 CAR-T B-Cell Depletion in pts with SLE treated with Lunsumio1 ▪ Transposon-b
Slide 126: Sefaxersen: First ASO for selective complement suppression in IgAN
Immunology Sefaxersen: First ASO for selective complement suppression in IgAN Convenient monthly dosing with robust Ph II clinical outcomes; Ph III (IMAGINATION) results expected 2026 Sefaxersen (ASO Factor B) Clinical development program in IgAN Alternative complement pathway Early Ph II results3 P
Slide 127: Afimkibart: Broad anti-TL1A development program
Immunology Afimkibart: Broad anti-TL1A development program TL1A is linked to multiple immunological diseases: IBD, AtD, MASH trials ongoing, initiated RA & pediatric IBD TL1A is upstream of multiple immunological cytokine & Development program cellular pathways, presenting pan-immunological potentia
Slide 128: Afimkibart in UC: Significant recruitment acceleration
Immunology Afimkibart in UC: Significant recruitment acceleration Fast-Track designation enabled expedited trial enrollment and execution Ph IIb (TUSCANY-2) in UC1 Ph III (AMETRINE-1&2) study design in UC AMETRINE-1: With treat-through design Efficacy Efficacy assessment assessment Induction W12 Mai
Slide 129: p40xTL1A bispecific: Simultaneously targeting two pathways in IBD
Immunology p40xTL1A bispecific: Simultaneously targeting two pathways in IBD Bispecifics inhibiting TL1A and other validated targets may break the IBD efficacy ceiling p40xTL1A inhibits two key targets central to IBD pathology: Development program IL-12/IL-23 and TL1A p40xTL1A bispecific*9-10 FPI In
Slide 130: Zosurabalpin in antimicrobial resistance
Immunology: Infectious diseases Zosurabalpin in antimicrobial resistance Zosurabalpin represent the first new class of antibiotics against gram negative bacteria in 50 years Antimicrobial resistance (AMR) Zosurabalpin (Abx macrocyclic peptide) Cryo-EM structure of Localization of the LPS transport z
Slide 131: Ophthalmology
Ophthalmology Christopher Brittain SVP and Global Head of Product Development Ophthalmology
Slide 132: Ophthalmology: Aiming to alter the trajectory of vision loss
Ophthalmology Ophthalmology: Aiming to alter the trajectory of vision loss 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 preservation ▪ Supplement cu
Slide 133: Ophthalmology R&D focus areas
Ophthalmology Ophthalmology R&D focus areas Improving patient outcomes and reducing treatment burden Critical Capabilities Examples Novel MoAs & new indications, New MoAs to target a broader range of disease pathways and addressing multiple disease address additional indications pathways Extended du
Slide 134: Ophthalmology pipeline
Ophthalmology Ophthalmology pipeline Further improving the standard of care and expanding in new indications Phase I Phase II Phase III Data to be presented vamikibart Data to be presented VEGF x IL6 DutaFab vamikibart at future medical RG6179 at AAO and to be RG6209 RG6179 UME DME DME congress; Piv
Slide 135: Susvimo in nAMD: Maintained vision over 7 yrs
Ophthalmology Susvimo in nAMD: Maintained vision over 7 yrs with x2 refills/yrs Continuing to innovate on Port Delivery Platform with multiple assets in development Ph III (Ladder) / OLE (Portal): 7 yrs outcomes in nAMD Port Delivery Platform (PDP) All patient received ~ Mean BCVA Over Time 3 inject
Slide 136: Vamikibart: Targeting IL-6 to achieve better visual outcomes
Ophthalmology Vamikibart: Targeting IL-6 to achieve better visual outcomes Ph III (SANDCAT/MEERKAT) results in UME with favorable benefit-risk profile to be shared with regulators Il-6 is a key pro-inflammatory cytokine Development plan in the pathogenesis of uveitis and retinal diseases Vamikibart
Slide 137: VEGFxIL6 DutaFab: A next generation bispecific for DME
Ophthalmology VEGFxIL6 DutaFab: A next generation bispecific for DME Ph II (BARDENAS) establishes role of IL-6 inhibition in DME Ph II (BARDENAS): Anti-IL-6 (vamikibart) + anti-VEGF (ranibizumab) Accelerating development of showed superior efficacy in DMEa VEGFxIL6 DutaFab Primary endpoint: Change f
Slide 138: Vamikibart in UME: Potential FIC non-steroid IVT treatment
Ophthalmology Vamikibart in UME: Potential FIC non-steroid IVT treatment Ph III (SANDCAT/MEERKAT) data in-house demonstrating improvements in vision and anatomy Ph I (DOVETAIL) results for vamikibart in UME1 Ph III (SANDCAT/MEERKAT) in UME Change from baseline in BCVA Patients with absence of retina
Slide 139: Zifibancimig in nAMD: Potential for once-yearly dosing
Ophthalmology Zifibancimig in nAMD: Potential for once-yearly dosing Combing dual VEGF/Ang-2 inhibition & continuous delivery through Port Delivery Platform Zifibancimig (VEGFxAng-2 DutaFab) PhI/II (BURGUNDY) trial design Part 1 Zifibancimig IVT Anti-VEGF-A Anti-Ang2 Reduces vascular leakage Stabili
Slide 140: Satralizumab: Potential to be the first SC therapy in TED
Ophthalmology Satralizumab: Potential to be the first SC therapy in TED Designed to enable maximal IL-6 suppression with a well-established safety profile IL-6 pathway plays a key role in TED1 and clinical evidence Ph III (SatraGo-1/SatraGo-2) trial design supports IL-6R inhibition IL-6 expression c
Slide 141: OpRegen Tx in GA: Replenishing the retinal pigment epithelium
Ophthalmology OpRegen® Tx in GA: Replenishing the retinal pigment epithelium Ph IIa GAlette surgical development study ongoing Potential to treat RPE loss in GA Ph I/IIa results: Visual function and retinal structure improvements sustained through month 361 BCVA RPE – Drusen Complex (RPEDC) Cohort 4
Slide 142: Acquired proprietary surgical devices for OpRegen Tx development
Ophthalmology Acquired proprietary surgical devices for OpRegen® Tx development Potential for broader application in the delivery of other pipeline assets across different modalities Advanced subretinal delivery devices under development in Ph IIa GAlette in GA Transvitreal Subretinal Injector with
Slide 143: Cardiovascular, Renal and Metabolism
Cardiovascular, Renal and Metabolism Manu Chakravarthy SVP and Global Head of Cardiovascular, Renal and Metabolism (CVRM) Product Development
Slide 144: Roche views CVRM diseases as a continuous interdependent spectrum
Cardiovascular, Renal & Metabolism Roche views CVRM diseases as a continuous interdependent spectrum1 1 in 4 US adults have a CVRM condition and 1 in 10 have more than one2 CV Disease ▪ 85% of people with T2D are also living with Overall Patient Population 133.3 M overweight or obesity4 61.5 M† ▪ 75
Slide 145: Roche is well positioned to capture future innovation
Cardiovascular, Renal & Metabolism Roche is well positioned to capture future innovation Drivers of innovation in Cardiovascular, Renal & Metabolism Critical Capabilities Examples CT-388: Obesity ± T2D Incretins Combat obesity as a driver for metabolic CT-996: Obesity ± T2D and beyond diseases Petre
Slide 146: Diverse patient needs will lead to increased market segmentation
Cardiovascular, Renal & Metabolism Diverse patient needs will lead to increased market segmentation Physicians expect new therapies to improve weight-related comorbidities Roche internal KOL survey results Obesity market outlook by segment and drug class Expectation for upcoming treatments by freque
Slide 147: 2024: Starting to build an innovative CVRM portfolio
Cardiovascular, Renal & Metabolism 2024: Starting to build an innovative CVRM portfolio Clinical development Indication Asset Ph I Ph II Ph III Hypertension zilebesiran KARDIA-1,KARDIA-2, KARDIA-3 Obesity +/- T2D* CT-388 103/104 Obesity +/- T2D CT-996 201 T1D w. OW/OB as adjunct CT-868 004 treatment
Slide 148: 2025: On the path to a leading CVRM portfolio
Cardiovascular, Renal & Metabolism 2025: On the path to a leading CVRM portfolio creating optionality Clinical development Indication Asset Ph I Ph II Ph III To be initiated Hypertension zilebesiran KARDIA-1,KARDIA-2, KARDIA-3 (Q4 2025) To be initiated Obesity +/- T2D* CT-388 103/104 (H1 2026) ENLIG
Slide 149: Zilebesiran, a novel therapy targeting AGT for uncontrolled HTN
Cardiovascular, Renal & Metabolism Zilebesiran, a novel therapy targeting AGT for uncontrolled HTN Continuous control of blood pressure aiming to reduce cardiovascular and renal risk Potential for tightest control of BP by Biannual dosing offers a unique value proposition in uHTN leading blocking up
Slide 150: Zilebesiran shows enhanced effect in pts at risk, nocturnal BP control
Cardiovascular, Renal & Metabolism Zilebesiran shows enhanced effect in pts at risk, nocturnal BP control Zilebesiran investigated in three Ph II studies in more than 1,300 patients Ph II (KARDIA-3) results KARDIA-3 Post Hoc Subgroup Analysis: Placebo-Adjusted Hourly Mean (Exploratory) and Placebo-A
Slide 151: Zilebesiran moving into global Ph III cardiovascular outcomes trial
Cardiovascular, Renal & Metabolism Zilebesiran moving into global Ph III cardiovascular outcomes trial Potential new SoC with tighter pathway control, synergistic effect with diuretics and improved Tx adherence Ph III (ZENITH) will evaluate CV outcomes in pts with HTN and high CV risk or established
Slide 152: Expanding CVRM portfolio with differentiated MoAs
Cardiovascular, Renal & Metabolism Expanding CVRM portfolio, creating optionality with differentiated MoAs Leveraging biased GLP-1/GIP and amylin agonism for potentially greater efficacy and tolerability CT-388, CT-868 and CT-996 are biased agonists1 Petrelintide is a long-acting amylin analog Petre
Slide 153: CT-388 showed a competitive profile with robust efficacy in Ph I
Cardiovascular, Renal & Metabolism CT-388 showed a competitive profile with robust efficacy in Ph I CT-388 is a biased, dual GLP-1/GIP receptor agonist for people living with OW/OB with or without T2D Development program Ph I data show glycemic control (OB+T2D) and robust LFC reduction (OW/OB) Ph Ph
Slide 154: CT-388: Ph I completed, Ph II ongoing, Ph III to be initiated
Cardiovascular, Renal & Metabolism CT-388: Ph I completed, Ph II trials ongoing, Ph III to be initiated Clinical data support the potential for development in T2D and chronic weight management Phase 1 Phase 2 Phase 3 CT-388-101 (cohorts 11, 12, and 13) - weight loss at week 12/24 Without T2D1 With T
Slide 155: Pegozafermin: Potential best-in-disease therapy in MASH
Cardiovascular, Renal & Metabolism Pegozafermin: Potential best-in-disease therapy in MASH Further strengthens CVRM portfolio and offers optionality for future combination development Pegozafermin1 Ph II (ENLIVEN) week 24 results in pts with MASH and fibrosis (F2-F4)2* Fibrosis improvement ≥ 1stage
Slide 156: Petrelintide: Potential to be a foundational therapy in obesity
Cardiovascular, Renal & Metabolism Petrelintide: Potential to be a foundational therapy in obesity Strengthening our growing CVRM portfolio with a long-acting amylin analog Development program Ph I results: Change in body weight from baseline and selected GI TEAEs Ph Ph Ph MAD trial – Part 21 MAD tr
Slide 157: CT-996: Ph II trials in people with OW/OB ± T2D ongoing
Cardiovascular, Renal & Metabolism CT-996: Ph II trials of CT-996 in people with OW/OB ± T2D ongoing Oral small molecule with high bioavailability and no food restrictions Development program Once-daily oral dosing of CT-996 over 4 wks shows WL of up to 7.3%; Ph II studies ongoing Ph I Ph II CT-996-
Slide 158: Emugrobart + tirzepatide Ph II (GYMINDA) results expected in 2026
Cardiovascular, Renal & Metabolism Emugrobart + tirzepatide Ph II (GYMINDA) results expected in 2026 Combination has potential to improve weight loss and preserve muscle mass Emugrobart (GYM329, anti-latent myostatin mAb) Ph II GYMINDA (tirzepatide + emugrobart) OB/OW pts Whole-body muscle change (g
Slide 159: CT-868: Ph II results in T1D expected in Q4 2025
Cardiovascular, Renal & Metabolism CT-868: Ph II results in T1D expected in Q4 2025 Flexible and easy integration into standard insulin regimens for patients with T1D through once-daily dosing Development program CT-868 concomitantly reduces plasma glucose and insulin excursion1 Ph I Ph II Mixed Mea
Slide 160: Our near-term portfolio offers a strong foundation
Cardiovascular, Renal & Metabolism Our near-term portfolio offers a strong foundation Our differentiation potential relies on the breadth of options to address patient needs Tolerability Ceiling effect on weight loss e.g. nausea/emesis is a main driver for discontinuation e.g., weight loss plateaus
Slide 161: Doing now what patients need next
Doing now what patients need next Driving performance and strategy implementation Preparing for future growth ▪ 2 key readouts (giredestrant, fenebrutinib) in ‘25/26 ▪ Finalized five TA strategies for implementation ▪ 8 NMEs new to Ph III in ‘25, first readouts from ‘27 ▪ Strengthening capabilities
Slide 162: Appendix
Appendix
Slide 163: 2025: Significant key newsflow ahead
2025: Significant key newsflow ahead* Compound Indication Milestone Itovebi + palbociclib + fulvestrant 1L PIK3CA-mut HR+ BC EU approval Columvi + GemOx 2L+ DLBCL US/EU approval / (US/EU) Lunsumio SC 3L+ FL US approval/EU filing (EU filing) Elevidys DMD EU approval Regulatory Gazyva Lupus nephritis
Slide 164: 2026: Key newsflow outlook
2026: Key newsflow outlook* Compound Indication Milestone Lunsumio + Polivy 2L+ DLBCL US approval giredestrant + everolimus post CDKi ER+/HER2- mBC US/EU filing/ US approval Susvimo nAMD EU approval Regulatory Susvimo DME EU filing vamikibart UME US/EU filing divarasib 2L KRASG12C+ NSCLC Ph III KRAS
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 1 NME: 1 NME: 1 NME: CHU pan-KRAS inhibitor (AUBE00) – solid tumors RG6652 GLP-1 RA (CT-996) - obesity +/- T2D RXXXX* pegozafermin* - MASH (F2-3; F4) RG6102 trontinemab - Alzheim
Slide 166: Roche Group development pipeline
Roche Group development pipeline Phase I (38 NMEs + 7 AIs) Phase II (17 NMEs + 8 AIs) RG6026 Columvi monotherapy + combos heme tumors RG6382 CD19 x CD3 SLE RG6114 Itovebi early-stage, PIK3CA-mut. BC RG6076 englumafusp alfa combos heme tumors RG6377 - IBD RG6171 giredestrant endometrial cancer RG6114
Slide 167: Roche Group development pipeline
Roche Group development pipeline Phase III (9 NMEs + 28 AIs) Registration US & EU (1 NME + 4 AIs) RG3502 Kadcyla + T HER-2+ eBC high-risk RG6149 astegolimab COPD RG7446 Tecentriq + lurbinectedin1 1L maintenance SCLC RG6013 Hemlibra Type 3 VWD RG6299 sefaxersen (ASO factor B) IgA nephropathy RG7828 L
Slide 168: Doing now what patients need next
Doing now what patients need next