Roche Holding Ltd · SIX:RO
Roche — Investor Day (September 2023)
133 slides from Roche's investor day presentation, Sep 11, 2023
Slide 1: Slide 1
Slide 2: Roche Pharma Day 2023
Roche Pharma Day 2023 London, 11 September 2023
Slide 3: Forward-looking statements
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’,
Slide 4: Welcome
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Welcome Bruno Eschli | Head of Investor Relations Previous Page Next Page
Slide 5: Agenda
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Agenda Welcome 10:30 – 10:35 BST Bruno Eschli, Head of Investor Relations Group Update 10:35 – 11:05 BST Thomas Schinecker, CEO Roche Group Pharma Update and On-Market Portfolio 11:
Slide 6: Group Update
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Roche Pharma Day 2023 Group Update Thomas Schinecker | CEO Roche Group Previous Page Next Page
Slide 7: Group update topics
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing New Leadership Team Performance and Outlook Pharma R&D Excellence Upcoming IR Events Previous Page Next Page
Slide 8: Corporate Executive Committee since April 2023
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Corporate Executive Committee since April 2023 Pharma R&D functions from early to late stage and partnering represented Dr. Thomas Schinecker Teresa Graham Matt Sause Dr. Alan Hippe
Slide 9: Corporate Executive Committee: New members
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Corporate Executive Committee: New members Experienced leaders with breadth of scientific, commercial and strategic experience Dr. Thomas Schinecker Teresa Graham Matt Sause Dr. Lev
Slide 10: Sustainability now represented on CEC level
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Sustainability now represented on CEC level ESG is part of everything we do • Develop new medicines, diagnostics and integrated health solutions that address the needs of diverse pa
Slide 11: Group update topics
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing New Leadership Team Performance and Outlook Pharma R&D Excellence Upcoming IR Events Previous Page Next Page
Slide 12: Global Roche network delivering patient benefits worldwide
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Global Roche network delivering patient benefits worldwide Pharmaceuticals + Diagnostics Switzerland (Basel, Kaiseraugst, Rotkreuz) Penzberg, Mannheim Hillsboro Barcelona Indianapol
Slide 13: Our achievements
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Our achievements Roche is continuously shifting the standard of care A legacy of patient and business …with a track record of establishing standard of care impact… across new therap
Slide 14: Roche delivered consistent growth through biosimilar erosion
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Roche delivered consistent growth through biosimilar erosion Successful diversification of our portfolio From three oncology assets driving ~50% of … to a diversified portfolio with
Slide 15: Young portfolio: 20 NMEs launched since 2015 driving growth
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Young portfolio: 20 NMEs launched since 2015 driving growth Keeping launch momentum with two NMEs approved in 2023 CHFm % of Pharma Sales** 12,000 50% 10,000 41% 8,000 33% 6,000 22%
Slide 16: Consensus outlook 2022-26
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Consensus outlook 2022-26* Growth driven by our young on-market portfolio; potential pipeline up-side Biosimilar gap (22-26) Consensus sales growth (22-26) Potential up-side3 Post-H
Slide 17: Important launches ahead in Diagnostics
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Important launches ahead in Diagnostics Diagnostics to deliver mid to high single digit growth in coming years Continuous glucose Next generation Core & Molecular Lab Mass spectrome
Slide 18: FY guidance confirmed - strong half year performance
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing FY guidance confirmed - strong half year performance Base business with continued strong momentum; COVID sales washed-out by Q1 24 Guidance1 HY Results Pharma: Key products with str
Slide 19: Group update topics
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing New Leadership Team Performance and Outlook Pharma R&D Excellence Upcoming IR Events Previous Page Next Page
Slide 20: Roche R&D has multiple proven strengths
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Roche R&D has multiple proven strengths Strategy and • Commitment to scientific excellence and discovery of novel modalities (e.g. ADCs, bispecifics) portfolio • Ability to expand s
Slide 21: Commitment to innovation
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Commitment to innovation After reallocating resources to R&D, focus is now on ‘R&D Excellence’ HY Roche Pharma R&D investment allocation R&D investment and profitability1 (2018-2023
Slide 22: Holistic, end-to-end analysis of our R&D productivity
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Holistic, end-to-end analysis of our R&D productivity Commitment to delivering the worlds most impactful medicines Success rate Volume Value Effectiveness R&D productivity Costs Cyc
Slide 23: Roche with leading success rate by molecule
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Success rate Roche with leading success rate by molecule… …but higher Phase III failure rate recently Molecule success (PoL Preclinical - Approval) Molecule Success Rate in Phase II
Slide 24: Number of pipeline assets in Phase I to III
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Volume Number of pipeline assets in Phase I to III Roche ranks #2 in total pipeline volume Total number of pipeline assets by phase*, # Phase III Phase II Phase I Peer1 12 39 50 101
Slide 25: Pipeline assets segmented by innovation potential
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Value Pipeline assets segmented by innovation potential Roche ranks #2 in number of NMEs with first-in-class potential Total number of pipeline assets by innovation potential*, # Fi
Slide 26: R&D spend per NME launch
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Costs R&D spend per NME launch Roche spend is above industry average R&D spend per NME launch2, bn USD, 2018-20221 6.2 6.1 5.8 5.7 5.1 5.1 4.4 Ø 4.7 4.3 4.2 3.9 3.3 2.8 Peer 1 Peer
Slide 27: Development timelines compared to industry
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Cycle time Development timelines compared to industry Roche with faster than average Phase III cycle time, but lagging in Phase II Composite cycle time at a project level, years Pre
Slide 28: Levers to drive R&D excellence were identified
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Levers to drive R&D excellence were identified E.g., go/no go decisions based on E.g., leverage RWD and AI to increase E.g., focus on assets with best-in- critical review of scienti
Slide 29: Prioritization of our R&D investments
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Prioritization of our R&D investments Pharma portfolio management with an end-to-end perspective 100% Low risk Low Risk Go Cost focus Low reward High reward Move fast and make broad
Slide 30: Portfolio committee established
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Portfolio committee established Taking a holistic view and managing R&D productivity end-to-end CEO Group Pharma CEO Thomas Schinecker Teresa Graham Head of pRED Head of gRED Hans C
Slide 31: Pipeline acceleration via partnering
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Pipeline acceleration via partnering Deals of the past two years increasingly focused on clinical stage NMEs* TA NME Indication Partner Development stage P-CD19CD20-ALLO1 B-cell mal
Slide 32: Evolution of our R&D engines
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Evolution of our R&D engines, with impact on the full value chain Leveraging the newest technologies to bring unprecedented changes Computational Biology, AI/ML and advanced Organoi
Slide 33: Our Operating Principles: How we shape our culture
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Our Operating Principles: How we shape our culture Putting patients first is at our core; additional key areas to focus on going forward Put patients first I always act as if patien
Slide 34: R&D focus areas to speed up delivery of our medicines
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing R&D focus areas to speed up delivery of our medicines 1 2 3 Set ambitious Strengthen portfolio Transform portfolio R&D objectives framework management & governance 4 5 6 Access the
Slide 35: Group update topics
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing New Leadership Team Performance and Outlook Pharma R&D Excellence Upcoming IR Events Previous Page Next Page
Slide 36: Upcoming IR events on Neuroscience, Digitalization and Diagnostics
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Upcoming IR events on Neuroscience, Digitalization and Diagnostics Neuroscience Update on Oct 30 Roche Digitalization Day on Nov 29 Roche Diagnostics Day in H1 2024 Virtual event Vi
Slide 37: Pharma Update & On-Market Portfolio
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Pharma Update & On-Market Portfolio Teresa Graham | CEO Roche Pharmaceuticals Previous Page Next Page
Slide 38: Pharma Update
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Pharma Update On-Market Portfolio With Further Growth Potential Significant Growth Opportunities Ahead Previous Page Next Page
Slide 39: HY 2023: Pharmaceuticals Division sales
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing HY 2023: Pharmaceuticals Division sales All regions delivering strong growth, intensifying currency headwinds in Q2 2023 2022 Change in % CHFm CHFm CHF CER Pharmaceuticals Division
Slide 40: Why we changed our customer engagement model
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Why we changed our customer engagement model Why we changed In-person, product-specific field approach not meeting customer needs Industry representative’s access to physicians (US)
Slide 41: New customer engagement model driving future growth
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing New customer engagement model driving future growth Integrated customer experience and greater agility How we are changing Impact we see today 1 Successful uptake of new products (e
Slide 42: Pharma Corporate Access Goal
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Pharma Corporate Access Goal Opportunities to remove barriers and substantially increase access Inclusive clinical trials Regulatory filing & Affordability Capacity Partnerships Acc
Slide 43: Responsible pricing as we advance the standard of care
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Responsible pricing as we advance the standard of care Savings for healthcare systems and lower out-of-pocket costs for patients Key products priced below competitors in the US Hist
Slide 44: Pharma Update
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Pharma Update On-Market Portfolio With Further Growth Potential Significant Growth Opportunities Ahead Previous Page Next Page
Slide 45: Building blocks for future growth through 2030
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Building blocks for future growth through 2030 Currently 16 blockbusters on the market Oncology / Hematology Neuroscience Ophthalmology Emerging assets from early pipeline and BD Im
Slide 46: Building blocks for future growth through 2030
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Building blocks for future growth through 2030 Young on-market portfolio with strong momentum and potential for line extensions Oncology / Hematology Neuroscience Ophthalmology Emer
Slide 47: HY 2023: Strong momentum for key growth drivers
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing HY 2023: Strong momentum for key growth drivers Vabysmo >500% Ocrevus 15% Hemlibra 20% Evrysdi 48% Phesgo 69% Tecentriq 12% Polivy 114% Perjeta 9% Tamiflu 298% TNKase / Activase 15%
Slide 48: Vabysmo: Expecting more than CHF 2bn sales in 2023
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Vabysmo: Expecting more than CHF 2bn sales in 2023 Highly successful first launch under new commercial model US patient share since launch* Vabysmo performance update nAMD DME • US
Slide 49: Vabysmo: Disease activity criteria affect durability outcomes
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Vabysmo: Disease activity criteria chosen affect durability outcomes Vabysmo nAMD trials use vision or anatomical disease activity criteria, reflecting clinical practice1 Different
Slide 50: Susvimo: Continuous 6m delivery preferred by patients
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Susvimo: Continuous 6m delivery preferred by 93 % patients vs IVT Commercial US relaunch expected in 2024 and ex-US 2025+ Stronger vision outcomes Ongoing development for the Port D
Slide 51: Ocrevus: Continued growth in all markets
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Ocrevus: Continued growth in all markets around the world Opportunity to expand overall CD20 class and gain class share MS total patient share (global)* Ocrevus performance update •
Slide 52: Ocrevus: Positive Ph III OCARINA II results
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Ocrevus: Positive Ph III (OCARINA II) results for Q6M SC dosing Further improving treatment experience and expand usage Cutting administration time from 3.5-6hrs to 10 min US: Estim
Slide 53: Evrysdi: Becoming a global SMA market leader
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Evrysdi: Becoming a global SMA market leader >11,000 patients treated worldwide Worldwide SMA sales* Evrysdi performance update • Significant population of untreated adults remain i
Slide 54: Tecentriq: First PD-1/L1 with subcutaneous formulation
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Tecentriq: First PD-1/L1 with subcutaneous formulation Improving convenience for patients, saving resources for healthcare systems SC administration time (in minutes) Tecentriq perf
Slide 55: Growing portfolio in breast cancer
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Growing portfolio in breast cancer: Expanding beyond HER2+ BC Breast cancer cases by subtype1 Ph III clinical development overview Novel mechanisms and technologies Ph I Ph II Ph II
Slide 56: Phesgo: Rapid conversion in early launch countries
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Phesgo: Rapid conversion in early launch countries Significantly reducing healthcare costs and resource use Phesgo reduces administration time & costs Strong global launch Global Ph
Slide 57: Growing portfolio in malignant hematology
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Growing portfolio in malignant hematology Hematologic tumor cases by subtype1 Ph III clinical development overview On-market portfolio 3% Pipeline molecules Ph I Ph II Ph III 12% 9%
Slide 58: Polivy: Accelerated growth following 1L DLBCL approval
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Polivy: Accelerated growth following 1L DLBCL approval Transforming the standard of care in 1L DLBCL again after 20 years Global Polivy sales Polivy performance update • Currently a
Slide 59: Hematology: Shifting the standard of care in CLL, DLBCL, FL
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Hematology: Shifting the standard of care in CLL, DLBCL, and FL Chronic Lymphocytic Leukemia Diffuse Large B cell Lymphoma Follicular Lymphoma chemotherapy (CLL) (DLBCL) (FL) 1997 E
Slide 60: Hemlibra: Expecting continued market share gains
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Hemlibra: Expecting continued market share gains globally The global standard of care with ~40% patient share reached in US/EU5* Steady patient share gains in US and globally Hemlib
Slide 61: Alecensa: Unprecedented Ph III results in adjuvant ALK+ NSCLC
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Alecensa: Unprecedented Ph III results in adjuvant ALK+ NSCLC Continued >70 market share with further growth potential Global Alecensa sales Alecensa performance update CHFm YoY CER
Slide 62: 2023: Key late-stage newsflow
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing 2023: Key late-stage newsflow* Compound Indication Milestone Hemlibra Moderate hemophilia A EU approval Polivy + R-CHP 1L DLBCL US approval Vabysmo RVO US approval/EU filing EU fili
Slide 63: Pharma Update
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Pharma Update On-Market Portfolio With Further Growth Potential Significant Growth Opportunities Ahead Previous Page Next Page
Slide 64: Building blocks for future growth through 2030
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Building blocks for future growth through 2030 Several mid-term in-house late-stage projects that can deliver upside Oncology / Hematology Neuroscience Ophthalmology Emerging assets
Slide 65: Adding to in-house opportunities through BD
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Adding to in-house opportunities through BD Successful track record of disrupting the SoC and building new franchises Zilebesiran (siRNA targeting AGT) Our proven strengths Strong t
Slide 66: Key late-stage pipeline assets with 1bn+ sales potential
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Key late-stage pipeline assets with 1bn+ sales potential* Oncology, Neuroscience, Immunology, Hematology Cardiometabolic Ophthalmology tiragolumab Elevidys astegolimab NSCLC, HCC, E
Slide 67: Late Stage Pipeline Oncology (Solid Tumors)
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Late Stage Pipeline Oncology (Solid Tumors) Levi Garraway | EVP, Head of Global Product Development and Chief Medical Officer Previous Page Next Page
Slide 68: Product Development
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Product Development Continued commitment to delivering the worlds most impactful medicines Selected Product Development Leaders R&D Excellence Head of PD/CMO Levi Garraway Clinical
Slide 69: Strategic pillars of oncology
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Strategic pillars of oncology Precision medicine Early disease Novel immunotherapy Rational combinations New modalities Right medicines at the Early diagnosis and Need more options
Slide 70: Oncology – solid tumor pipeline
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Oncology – solid tumor pipeline A leading portfolio differentiated on targets and modalities Ph I (26 NMEs) Ph II Ph III Launched RG6156 EGFRvIII x CD3 RG6185 belvarafenib (pan-RAF
Slide 71: Building blocks for future growth through 2030
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Building blocks for future growth through 2030 4 NMEs in oncology with FIC/BIC potential in late stage development Oncology / Hematology Neuroscience Ophthalmology Emerging assets f
Slide 72: Tiragolumab development program continues to expand
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Tiragolumab development program continues to expand Continued confidence in anti-TIGIT biological activity based on numerous evidence to date First-in-class anti-TIGIT mAb Clinical
Slide 73: Tiragolumab in 1L NSCLC and 1L HCC
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Tiragolumab in 1L NSCLC and 1L HCC SKYSCRAPER-01 continues to final OS analysis; Ph III in HCC initiated Ph III (SKY-01) trial design in 1L PDL1+ NSCLC Ph I/II (MORPHEUS) results in
Slide 74: Giredestrant in HR+ breast cancer
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Giredestrant in HR+ breast cancer Potential new endocrine backbone potential across eBC and mBC Selective ER degrader (SERD) Broad development program in eBC and mBC Ph III (lidERA)
Slide 75: Giredestrant data support potential in 1L and adj HR+ BC
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Giredestrant data support potential in 1L and adj HR+ BC Tumor response is correlated with higher tumor ER activity In eBC , 1L, and ESR1m patients, the tumor is ER pathway dependen
Slide 76: Inavolisib in PI3K-mutant breast cancer
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Inavolisib in PI3K-mutant breast cancer H2H trial vs alpelisib initiated; Ph III (INAVO120) results in 1L expected Q4 2023 Potential best-in-class PI3Kα inh Potential for differenti
Slide 77: ZN-1041 in HER2+ BC with brain metastases
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing ZN-1041 in HER2+ BC with brain metastases Building on HER2+ breast cancer franchise, exploring novel combinations Potential best-in-class HER2 TKI Encouraging preliminary activity a
Slide 78: Divarasib in KRAS G12C-mutant tumors
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Divarasib in KRAS G12C-mutant tumors Potential best-in-class molecule; Ph II/III in 2L NSCLC ongoing KRAS G12C inhibitor Best-in-class potential supported by early clinical data Pro
Slide 79: DNA Damage Response (DDR)
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing DNA Damage Response (DDR) Building a diversified and differentiated portfolio in DDR Camonsertib (ATR inhibitor) KSQ-4279 (first-in-class USP1 inhibitor) • ATR is a key mediator of
Slide 80: Neoantigen vaccine: Autogene cevumeran
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Neoantigen vaccine: Autogene cevumeran Substantially and durably expanded T-cells, correlating with delayed recurrence Phase I results in surgically resectable PDAC (target n=20) Va
Slide 81: Advancing new modalities across key oncology pathways
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Advancing new modalities across key oncology pathways Oncogenic pathways/drivers Synthetic lethality/DNA damage response T-cell redirection Bispecifics / Neoantigen Degraders trispe
Slide 82: Late Stage Pipeline Hematology
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Late Stage Pipeline Hematology Charles Fuchs | SVP – Global Head of Hematology and Oncology Product Development Previous Page Next Page
Slide 83: Roche: A leader in malignant and non-malignant hematology
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Roche: A leader in malignant and non-malignant hematology Launching new Investing in growing & Broad portfolio enables Exploring different Improving patient / standards of care new
Slide 84: Broad hematology pipeline enabling novel combinations
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Broad hematology pipeline enabling novel combinations A pioneer in bispecific antibodies and antibody drug conjugates Ph I Ph II Ph III Registration englumafusp alfa Columvi Columvi
Slide 85: Update late-stage hematology pipeline
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Update late-stage hematology pipeline Malignant hematology: B-cell malignancies Non-malignant hematology: PNH, Hemophilia A Previous Page Next Page
Slide 86: Building blocks for future growth through 2030
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Building blocks for future growth through 2030 Oncology / Hematology Neuroscience Ophthalmology Emerging assets from early pipeline and BD Immunology CVM anti-IL6 mAb ASO Factor B z
Slide 87: Update late-stage hematology pipeline
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Update late-stage hematology pipeline Malignant hematology: B-cell malignancies Non-malignant hematology: PNH, Hemophilia A Previous Page Next Page
Slide 88: Polivy + R-CHP to become a new SOC in 1L DLBCL
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Polivy + R-CHP to become a new SOC in 1L DLBCL POLARIX subgroup data confirm benefit in elderly patients Polivy + R-CHP first new treatment Ph III (POLARIX) subgroup of ~280 patient
Slide 89: Lunsumio and Columvi: Tailored to patient and system needs
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Lunsumio and Columvi: Tailored to address diverse patient and healthcare system needs in off-the-shelf approach Approved in 3L+ follicular lymphoma CD20 x CD3 development program mo
Slide 90: Lunsumio: Durable efficacy in 3L+ FL
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Lunsumio: Durable efficacy with a manageable safety profile in patients with 3L+ FL after > 2 years of follow-up Pivotal Ph II (GO29781) in 3L+ FL Exploratory analysis of pivotal Ph
Slide 91: Columvi: Durable remissions in 3L+ DLBCL
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Columvi: Durable remissions achieved in 3L+ DLBCL with fixed- duration therapy Pivotal Ph II (NP30179) in 3L+ DLBCL Columvi: Fixed duration and simple dosing schedule Efficacy summa
Slide 92: Columvi + Polivy + R-CHP in 1L DLBCL early data
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Columvi + Polivy + R-CHP in 1L DLBCL early data encouraging Building upon POLARIX to address remaining unmet need Ph I study design Patient Endpoint assessment Cycle 1 Cycle 2 Cycle
Slide 93: Englumafusp alfa (CD19-4-1BBL) in r/r NHL
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Englumafusp alfa (CD19-4-1BBL) in r/r NHL First-in-class B cell-targeted costimulatory T cell agonist Englumafusp alfa + Columvi Pharmacodynamic biomarker data support novel MoA • S
Slide 94: Off-the-shelf CAR-Ts for hematologic malignancies
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Off-the-shelf CAR-Ts for hematologic malignancies Highly differentiated new generation of fully allogeneic CAR-Ts Long-lived self-renewing stem High-fidelity, proprietary gene Cost,
Slide 95: Update late-stage hematology pipeline
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Update late-stage hematology pipeline Malignant hematology: B-cell malignancies Non-malignant hematology: PNH, Hemophilia A Previous Page Next Page
Slide 96: Crovalimab: Expanding program in complement-mediated diseases
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Crovalimab: Expanding program in complement-mediated diseases Positive Ph III data in PNH filed globally; US filing accepted on 1 Sep Crovalimab (anti-C5 recycling Ab) Broad develop
Slide 97: SPK-8011 in hem A: Durable FVIII activity up to 5 years
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing SPK-8011 in hem A: Durable FVIII activity observed up to 5 years FVIII activity accompanied by durable clinical benefit in ABR, joint health and quality of life Study design Stable
Slide 98: Late Stage Pipeline Neuroscience, Immunology and Cardiovascular-Metabolism
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Late Stage Pipeline Neuroscience, Immunology and Cardiovascular-Metabolism Paulo Fontoura M.D. Ph. D. | SVP and Global Head of Neuroscience and Immunology Previous Page Next Page
Slide 99: Building blocks for future growth through 2030
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Building blocks for future growth through 2030 9 NMEs in Neuroscience, Immunology and CVM with FIC/BIC potential in late stage development Oncology / Hematology Neuroscience Ophthal
Slide 100: Neuroscience pipeline
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Neuroscience pipeline Industry leading portfolio differentiated on targets and platform technologies Ph I (5 NMEs) Ph II (10 NMEs) Ph III (1 NME, 5AI) Launched (4) prasinezumab Ensp
Slide 101: Elevidys, first FDA approved DMD gene therapy
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Elevidys, first FDA approved DMD gene therapy by partner Sarepta Ph III (EMBARK) results expected in Q4 Pooled analysis of studies 101/102/103* Development program Change from basel
Slide 102: Elevidys development program
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Elevidys development program Largest development plans in the broadest patient population Ph III EMBARK study design1 Additional Ph II/III studies ENVOL ENVISION Study 302 Study 303
Slide 103: Fenebrutinib, potential for a best-in-class BTKi in MS
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Fenebrutinib, potential for a best-in-class BTKi in MS Additional Ph II (FENopta) data to be presented at ECTRIMS Fenebrutinib (BTK inhibitor) Ph II (FENopta) results in RMS Periphe
Slide 104: Fenebrutinib, pivotal trials in RMS and PPMS ongoing
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Fenebrutinib, pivotal trials in RMS and PPMS ongoing The only BTKi in H2H Ph III trial in PPMS vs Ocrevus BTKi competitive landscape1 Ph III program overview Fenebrutinib Tolebrutin
Slide 105: Enspryng in neurological disorders gMG, AIE, and MOG-AD
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Enspryng in neurological disorders gMG, AIE, and MOG-AD First-in-class anti-IL-6R mAb with best-in-disease potential in AcHR+ gMG Enspryng (Anti-IL-6 receptor mAb) gMG: Autoantibodi
Slide 106: Anti-latent myostatin mAb to promote muscle growth in SMA
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Anti-latent myostatin mAb to promote muscle growth in SMA Ph II/III combination trial with Evrysdi ongoing GYM329 (Anti-latent myostatin mAb) Pre-clinical data in a mouse models of
Slide 107: Anti-latent myostatin mAb in FSHD
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Anti-latent myostatin mAb in the neuromuscular disorder FSHD Ph II (MANOEUVRE) in FSHD, a disorder with high unmet need, ongoing FSHD: Rare genetic disease with Ph II (MANOEUVRE) tr
Slide 108: Alzheimer's disease: Continuing to invest in high unmet need area
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Alzheimer’s disease: Continuing to invest in high unmet need area Leveraging key learnings to develop next generation therapies AD program strategy Clinical development program in A
Slide 109: Trontinemab: First Aβ-targeting Ab brain shuttle technology
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Trontinemab: First Aβ-targeting Ab brain shuttle technology Best-in-disease potential: Fast and highly efficient plaque removal after 3-6 months Trontinemab Ongoing Ph I/II dose fin
Slide 110: Immunology, Infectious Disease and CVM pipeline
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Immunology, Infectious Disease and CVM pipeline Gazyva Ph III data in lupus nephritis expected in 2024; zilebesiran in hypertension added Ph I (8 NMEs) Ph II (8 NMEs) Ph III (1 NMEs
Slide 111: Astegolimab: First-in-class anti-ST2 mAb in COPD
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Astegolimab: First-in-class anti-ST2 mAb in COPD Early results show benefit in key endpoints throughout broad patient population Astegolimab (anti-ST2 mAb) Ph IIa (COPD-ST2OP) resul
Slide 112: Astegolimab: Pivotal program results expected in 2025
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Astegolimab: Pivotal program results expected in 2025 Two pivotal trials ARNASA and ALIENTO with similar design currently ongoing PIIb (ALIENTO) / Ph III (ARNASA) trial design Popul
Slide 113: Astegolimab: Potential for biologic addressing broadest population
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Astegolimab: Potential for biologic addressing broadest population Aiming to address all COPD patients COPD patient population overview1 Astegolimab target patient population: Low 8
Slide 114: Gazyva with best-in-disease potential in lupus nephritis
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Gazyva with best-in-disease potential in lupus nephritis Potential benefit in autoimmune diseases through sustained B cell depletion Gazyva Ph II (NOBILITY) results in LN1 Clinical
Slide 115: Antisense oligonucleotide Factor B in IgAN
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Antisense oligonucleotide Factor B in IgAN Positive Ph II UPCR results at 6 months; Ph III (IMAGINATION) initiated in Q2 2023 Antisense oligonucleotide Factor B Clinical development
Slide 116: Zilebesiran with best-in-disease potential in hypertension
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Zilebesiran with best-in-disease potential in hypertension New MoA with tight upstream blockade of AGT pathway and strong early results Zilebesiran (siRNA targeting AGT) Ph I result
Slide 117: Zilebesiran: Comprehensive development program ongoing
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Zilebesiran: Comprehensive development program ongoing Positive Ph II (KARDIA-1) results to be presented at upcoming conference Ph II (KARDIA-2) trial design1 Ph II (KARDIA-1) topli
Slide 118: Late Stage Pipeline Ophthalmology
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Late Stage Pipeline Ophthalmology Christopher Brittain | Vice President and Global Head of Ophthalmology Product Development Previous Page Next Page
Slide 119: Building blocks for future growth through 2030
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Building blocks for future growth through 2030 5 novel targets in Ophthalmology with differentiated potential in late stage development Oncology / Hematology Neuroscience Ophthalmol
Slide 120: Roche poised for a leading role in Ophthalmology
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Roche poised for a leading role in Ophthalmology Opportunities Products and data Capabilities Leadership ambition • aVEGF therapies: • Vabysmo: • Leading in-house • Near-term: trans
Slide 121: Ophthalmology strategy
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Ophthalmology strategy Further improving the standard of care and expanding in new indications Update on key clinical data & outlook Improve outcome across all stages of ocular dise
Slide 122: R&D focus area ophthalmology
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing R&D focus area ophthalmology Better visual outcomes in the future via diagnostics and combination therapies Future SoC Current SoC Biomarker analyses Personalized treatment options
Slide 123: Ophthalmology pipeline gaining momentum
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Ophthalmology pipeline gaining momentum Expanding into new disease areas with satralizumab initiating Ph III in TED Phase I Phase II Phase III Launched NME anti-IL-6 Vabysmo Vabysmo
Slide 124: Susvimo: Adding new indications
Welcome Ph III in DME Group Update (PAGODA) Pharma Business Update 1 Oncology Hematology Ph III in DR (PAVILION) 2 Ophthalmology Neuroscience, Immunology and CVM Closing Susvimo: Adding new indications Positive Ph III results in DME and DR with filing in 2024 Ph III in DME (PAGODA)1 Ph III in DR (PA
Slide 125: RG6179: Novel anti-IL-6 mAb for intraocular use
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing RG6179: Novel anti-IL-6 mAb for intraocular use New data investigating anti-IL-6 in uveitic macular edema shared at ARVO 2023 Anti-IL-6 mAb Uveitic macular edema Ph I data (DOVETAIL
Slide 126: RG6179: Novel anti-IL-6 mAb in UME and DME
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing RG6179: Novel anti-IL-6 mAb in UME and DME Two identical Ph III studies in UME initiated Q1 2023 Ph III (Sandcat/Meerkat) trials in UME D1 W4 W8 W12 W16 W20 W48 Anti-IL6 0.25mg Q4W
Slide 127: Satralizumab in thyroid eye disease
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Satralizumab in thyroid eye disease Potential disease-modifying treatment option with a well-established safety profile Thyroid eye disease IL-6 as a potential target for treating T
Slide 128: ASO factor B in GA
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing ASO factor B in GA: Targeting hyperactive alternative complement pathway via SC delivery ASO factor B Preclinical and Ph I data Preclinical results in monkeys1 Ph I: Significant dos
Slide 129: OpRegen in GA: Replenishing the retinal pigment epithelium
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing OpRegen in GA: Replenishing the retinal pigment epithelium Encouraging early clinical data presented at ARVO 2022 and 2023 Potential to counteract RPE cell loss in Ph I/IIa data: Ou
Slide 130: Roche application of deep learning in ophthalmology
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Roche application of deep learning in ophthalmology Vabysmo reduces HRF volumes more vs. aflibercept, indicating better disease control The application of deep learning to segment V
Slide 131: Closing remarks
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Closing remarks Thomas Schinecker | CEO Roche Group Previous Page Next Page
Slide 132: Consensus outlook 2022-26
Welcome Group Update Pharma Business Update Oncology Hematology Neuroscience, Immunology and CVM Ophthalmology Closing Consensus outlook 2022-26* Growth driven by our young on-market portfolio; potential pipeline up-side Biosimilar gap (22-26) Consensus sales growth (22-26) Potential up-side3 Post-H
Slide 133: Doing now what patients need next
Doing now what patients need next