Roche Holding Ltd · SIX:RO
Roche — Investor Day (September 2021)
109 slides from Roche's investor day presentation, Sep 14, 2021
Slide 1: Roche Pharma Day 2021
Roche Pharma Day 2021 14 September 2021
Slide 2: Welcome
Roche Pharma Day 2021 Welcome Karl Mahler | Head of Investor Relations
Slide 3: Agenda
Agenda Welcome Karl Mahler, Head of Investor Relations Pharma Strategy: Sustainable growth by delivering more patient benefits at reduced cost to society Bill Anderson, CEO Roche Pharmaceuticals Commercial Opportunities: Up-date on ongoing and up-coming launches Teresa Graham, Head Pharma Global Pro
Slide 4: Strong portfolio rejuvenation and diversification
Strong portfolio rejuvenation and diversification HY 2011 HY 2016 HY 2021 AHR CHFm CHFm CHFm AHR AHR 16,815 19,460 21,671 Metabolism/Bone Oncology Ophthalmology Renal anemia Immunology Infectious diseases Other Neuroscience Hemophila A Source: Pharma HY sales as reported in HY reports; AHR=Avastin,
Slide 5: 38 Breakthrough Therapy Designations received since 2013
38 Breakthrough Therapy Designations received since 2013 Innovation driving portfolio value Year Molecule Indication Making a novel contribution (external view) 2021 Venclexta + azacitidine higher-risk MDS tiragolumab +Tecentriq 1L PD-L1+ NSCLC mosunetuzumab 3L+ FL 2020 Tecentriq unresectable or met
Slide 6: Pharma Strategy: Sustainable growth by delivering more patient benefits at reduced cost to society
Roche Pharma Day 2021 Pharma Strategy: Sustainable growth by delivering more patient benefits at reduced cost to society Bill Anderson | CEO Roche Pharmaceuticals
Slide 7: What has changed since Pharma Day 2020?
What has changed since Pharma Day 2020? 7
Slide 8: Pipeline at all times high: Assets in Ph III & registration
Pipeline at all times high: Assets in Ph III & registration Continued momentum in the second half Outlook H2 2021: 10 new Ph III studies planned 18 Tecentriq + lurbinectedin in 1L maintenance ES-SCLC NMEs 2 Venclexta in adults with AML in first remission after chemo 14 3 13 Gavreto in RET-mutant med
Slide 9: What has changed since our Pharma day a year ago?
What has changed since our Pharma day a year ago? Further increased confidence in delivering growth 2018-2023 consensus view1 2019-2024 consensus view2 2020-2025 consensus view3 +8.1 bn CHF +11.9 bn CHF +6.7 bn CHF 9.6 bn 16.3 bn 9.6 bn 17.7 bn 6.2 bn 18.1 bn Gap to fill New product contribution Gap
Slide 10: Transformation is a key enabler of our Pharma Vision
Transformation is a key enabler of our Pharma Vision Guiding principles & decentralized execution for maximum impact Global Decentralised Pharma Pharma Product Pharma Pharma execution Development Technical US International Strategy Following common VACC Pharma VITAL Outcomes principles Leadership Op
Slide 11: Adjusting to the new environment: HY 2021 vs. HY 2016
Adjusting to the new environment: HY 2021 vs. HY 2016 Making a greater impact: Increasing financial flexibility Pharma Technical Pharma US Pharma International Pharma China Pharma Development NMEs at pivotal stage1 Sales volume growth Sales growth Sales growth Sales growth +44% +68% +23% +18% +117%
Slide 12: Half-Year 2021: Pharma Division performance
Half-Year 2021: Pharma Division performance Continued investments into R&D to drive future growth & medical advances HY 2021 – Pharma Division R&D investment allocation (% of OPEX) CHFm CER growth vs PY Others Sales 21,671 -3% R&OOI 1,372 +34% Cost of sales -3,882 -4% M&D -2,962 -6% R&D R&D -5,883 +
Slide 13: Broad investment in early stage pipeline and new technologies
Broad investment in early stage pipeline and new technologies 13
Slide 14: Many serious conditions lack adequate treatment
Many serious conditions lack adequate treatment Total clinical development spend by therapeutic area vs. global disease burden Circle Area = global prevalence, rate per 100k Note: Disease with higher mortality show lower prevalence Clinical development spend, USDbn 90 Oncology 80 30 Central Nervous
Slide 15: Roche pipeline evolution, increasing leverage of multiple modalities
Roche pipeline evolution, increasing leverage of multiple modalities Diversify the portfolio for future growth Industry: Pipeline by therapeutic modality1 Roche: Pipeline by therapeutic modality2 100% 100% 90% Antibodies 90% Antibodies Conjugated & minimized antibodies 80% 80% Bispecific antibodies
Slide 16: Roche with leading portfolio of multiple modalities
Roche with leading portfolio of multiple modalities Small Large molecules Nucleic acid based medicines Cell therapies Vaccines molecules Antibodies Small Protein RNA based Gene Cell & protein Vaccines molecules conjugates technologies therapy therapies engineering Monoclonal antibodies; antibody Act
Slide 17: Recent deals and partnerships
Recent deals and partnerships1 Accelerate drug discovery and driving personalized healthcare Technology stage at the time of licensing Research technologies Early stage assets Late stage assets Digital & PHC 92 new agreements in 2020 focused on High disease burden / Promising targets / Novel enablin
Slide 18: Diversifying and deepening our portfolio
Diversifying and deepening our portfolio 18
Slide 19: Strong commercial potential throughout late stage portfolio
Strong commercial potential throughout late stage portfolio +24 late-stage assets PDS w/ ranibizumab AT-527 with large sales potential faricimab prasinezumab crovalimab fenebrutinib Xofluza giredestrant SRP-9001 Evrysdi inavolisib anti-tau mAbs Enspryng tiragolumab gantenerumab Phesgo glofitamab etr
Slide 20: Broadening and deepening the ophthalmology portfolio
Broadening and deepening the ophthalmology portfolio Core focus area for Roche Faricimab PDS with ranibizumab PDS with DutaFabs Geographic Atrophy • Anti-VEGF/Ang2 bispecific mAb • First Roche intravitreal implant • DutaMab technology enables • Chronic progressive degeneration creation of a novel bi
Slide 21: Committed to advancing the understanding of CNS diseases
Committed to advancing the understanding of CNS diseases Leveraging digital approaches to improve research & disease management Smarter, more efficient R&D Patient care & access MULTIPLE SCLEROSIS MULTIPLE SCLEROSIS NeuroImmunology Internal decision endpoints Patient care tools Digital, MRI, PET, EE
Slide 22: Investing in early disease in Oncology
Investing in early disease in Oncology Presenting the opportunity for cure Lung / Rare GI / GU Molecule Indication Ph 1 Ph 2 Ph 3 Molecule Indication Ph 1 Ph 2 Ph 3 Adjuvant NSCLC IMpower010 Adjuvant RCC IMmotion010 Tecentriq Neoadjuvant NSCLC IMpower030 Adjuvant HCC IMbrave050 Adjuvant SCCHN IMvoke
Slide 23: Examples of addressing high unmet need in earlier lines
Examples of addressing high unmet need in earlier lines Giredestrant in HR+ BC: Potential best in class profile Polivy in DLBCL: Addressing high unmet need in 1L 1L DLBCL offers the opportunity for cure Ongoing / planned trials: DLBCL Patient coopERA lidERA persevERA acelERA 1L R-CHOP Ph II Ph III P
Slide 24: Making a sustainable impact
Making a sustainable impact 24
Slide 25: Our impact on society
Our impact on society Ranked most sustainable healthcare company by DJSI for the 11th time Environment Access to our products Providing a great workplace Net price increase2 < medical Net price increase2 > medical Women in workforce4 inflation3 inflation3 Women in key leadership roles4 58% 2016 60%
Slide 26: What can you expect from us?
What can you expect from us? 26
Slide 27: Our replace and extend strategy is progressing well
Our replace and extend strategy is progressing well Entering new Replace ongoing franchises franchises Strong news flow ahead (data readout) tiragolumab (SKY-1) Oncology: in PDL1-high NSCLC Gazyva, Tecentriq (mUC, SCLC, tiragolumab (SKY-2) Venclexta, HCC, mM), in 1L ES-SCLC MabThera/Rituxan Polivy,
Slide 28: Positive outlook re-iterated
Positive outlook re-iterated Pharma NME and Dia launches Ocrevus, Perjeta, Hemlibra, Tecentriq, Venclexta, Gazyva, Alecensa, Xofluza, Polivy, Rozlytrek, Evrysdi, Enspryng, PHESGO, Gavreto, PDS, faricimab, etrolizumab, tiragolumab, gantenerumab, giredestrant, etc. cobas 6800/8800, cobas 5800, cobas p
Slide 29: Near-term growth drivers
Roche Late Stage Pipeline Event 2021 Near-term growth drivers Teresa Graham | Head of Global Product Strategy
Slide 30: COVID-19 impact: normalization of healthcare systems ongoing
COVID-19 impact: normalization of healthcare systems ongoing Pandemic continues to impact business dynamics Some normalization, but not yet back to pre COVID-19 levels in certain indications and geographies Multiple Sclerosis: US new-to-brand market1 Oncology US total patient visits2 7'000 99% basel
Slide 31: Significant short term news flow driving near term growth
Significant short term news flow driving near term growth 2021 pivotal trial readouts 2022 pivotal trial readouts Molecule Trial Indication Pts (US/EU5) Molecule Trial Indication Pts (US/EU5) 1 4 Tecentriq IMpower010 Adjuvant NSCLC ~101K Tecentriq IMvoke010 Adjuvant SCCHN ~40K Polivy POLARIX 1L DLBC
Slide 32: Commercial opportunities
Commercial opportunities 1. Oncology / Hematology • Tecentriq • Tiragolumab • HER2-franchise (Kadcyla, Perjeta/Phesgo) • Giredestrant • Polivy • CD20xCD3 bispecifics (mosunetuzumab, glofitamab) • Hemlibra 2. Ophthalmology / Immunology / Infectious Disease • Faricimab • Port Delivery System 3. Neuros
Slide 33: Tecentriq
Tecentriq Annualized sales >3b CHF with significant near term catalysts Neoadjuvant / adjuvant • Positive data in adjuvant NSCLC (IMpower010) • Ph 3 readouts for Adj SCCHN, Adj RCC, Neoadj NSCLC, and Adj HCC all in 2022 CIT combinations • Tecentriq + Tiragolumab has the potential to reset the standa
Slide 34: Tecentriq: adjuvant NSCLC
Tecentriq: adjuvant NSCLC Filed with FDA under RTOR (Priority Review) High unmet need in early NSCLC 5-year OS by disease stage1 100% Adjuvant NSCLC treatment is still evolving 90% 80% 70% Screening: Early detection technologies 60% 50% expected to increase diagnosis at early stage 40% 30% 20% 10% T
Slide 35: Tiragolumab (aTIGIT)
Tiragolumab (aTIGIT) Nine Ph II/III trials initiated, with four readouts in 2022 Lung Cancer: treated patients (US/EU5) Indication Ph 1 Ph 2 Ph 3 150 ~138k Number of treated pts, thousands 1L NSCLC: PD-L1 high SKYSCRAPER-01 2022 US 125 1L ES-SCLC SKYSCRAPER-02 2022 EU5 100 Lung Cancer Stage III unre
Slide 36: HER2 Franchise
HER2 Franchise Continuing to innovate for patients with HER2+ BC Near term growth driven by eBC, Phesgo uptake Continuing to build on existing standard of care KATE-2 (2L+ HER2-positive mBC): PD-L1+ subset 14K 2L mBC Kadcyla + Tecentriq Progression-free survival (%) 19K 1L mBC HER2+ treated patients
Slide 37: Giredestrant (SERD)
Giredestrant (SERD) Large addressable population, with best-in-class potential High unmet need remains in HR+/HER2- BC • Up to 50% of eBC pts stop treatment early due to tolerability1 Endocrine Therapy giredestrant Given until resistance or Replace ET as standard of HR+/HER2- treated • 30% of patien
Slide 38: Polivy + R-CHP
Polivy + R-CHP First positive trial in 1L DLBCL in >20 years 1L DLBCL can be curative, but high unmet need remains Multibillion CHF market opportunity in 1L DLBCL DLBCL Patient ~52k 1L R-CHOP ~16k EU5 ~9k US “Cured” R/R DLBCL 1L 2L 3L+ (~60%) (~40%) • ~40% of patients are not cured with R-CHOP in 1L
Slide 39: Mosunetuzumab and glofitamab (CD20 x CD3 bispecifics)
Mosunetuzumab and glofitamab (CD20 x CD3 bispecifics) Potential to be first-in-class and best in class in FL and DLBCL Mosun and Glofit are differentiated and can be tailored Most advanced clinical development plan with to address diverse patient and customer needs pivotal cohorts reading out in 202
Slide 40: Hemlibra
Hemlibra Transformational advance for Hemophilia A patients Continuing to gain market share in US and globally Additional subgroups supported by further data US total Hemophilia A patient share ~85% 15% 5% Hemlibra target 40% 5% population 30% Inhibitors 20% 20% 60% Severe PwHA 60% Moderate PwHA 10%
Slide 41: Ophthalmology
Ophthalmology Preparing for first launch of PDS in 2021 and faricimab in 2022* Global retina market growing to $15b 16 14 2.4 Global Sales US $B 12 2.0 3.9 Faricimab: First new MOA in nAMD/DME >15 yrs. 10 Strong durability, with approximately half of patients 3.1 8 0.7 able to be maintained on Q16W
Slide 42: Ocrevus
Ocrevus Ocrevus continues to have a strong growth profile Continued opportunity to grow CD20 class share 100% Best in disease efficacy and safety 90% • Robust, consistent, and sustained delay in disability progression New to brand share (US) 80% 70% • Ocrevus is the only therapy approved in PPMS 60%
Slide 43: Evrysdi
Evrysdi Growth supported by global expansion, and further share gains US: fastest uptake for a DMT in SMA1 2000 Number of SMA pts treated in the US Strong global launch with approval now in all major markets 1500 • 20% market share in Germany within 4 months of launch • Ongoing dialogue with EU reim
Slide 44: Gantenerumab
Gantenerumab Pivotal data expected 2H’22; most comprehensive data in AD Large patient population and high unmet need Confidence in GRADUATE I/II to deliver clear & robust dataset AD Continuum Distribution 2 • Well powered: two parallel studies with ~1,000 participants each Severe Moderate • Extended
Slide 45: Late Stage Pipeline Oncology
Roche Pharma Day 2021 Late Stage Pipeline Oncology Levi Garraway | Chief Medical Officer and Head Global Product Development
Slide 46: Late stage pipeline Oncology
Late stage pipeline Oncology 1. Hematology franchise • Polivy in DLBCL • Mosunetuzumab (CD20xCD3) in NHL • Glofitamab (CD20xCD3 2:1 format) in NHL • Venclexta in CLL, AML, MM, MDS • Cevostamab in MM 2. HR+/HEr2- Breast cancer portfolio • Giredestrant in HR+ BC • Inavolisib in HR+ BC (PIK3CAm) 3. Oth
Slide 47: Late stage oncology pipeline (Phase II/III)
Late stage oncology pipeline (Phase II/III) 6 Oncology NMEs with near-term pivotal data rhPTX-2 autogene cevumeran RG6354 RG6180 myelofibrosis 1L melanoma tiragolumab + Tecentriq PD1xTIM3 glofitamab + chemo RG6058 RG7769 RG6026 1L PD-L1+ NSCLC solid tumors 2L DLBCL inavolisib mosunetuzumab + glofita
Slide 48: Broadest set of technology platforms applied in Oncology
Broadest set of technology platforms applied in Oncology * List of pipeline molecules shown below is not complete; Molecules in the orange box are developed in Oncology 48
Slide 49: Hematology: Evolving the standard of care in CLL, DLBCL and FL
Hematology: Evolving the standard of care in CLL, DLBCL and FL chemotherapy Chronic Lymphocytic Leukemia Diffuse Large B cell Lymphoma Follicular Lymphoma (CLL) (DLBCL) (FL) Venclexta chemo free combinations Polivy drives higher CR rates with durable Gazyva established as SOC in 1L iNHL with induce
Slide 50: Hematology: Expanding into AML, MM and MDS
Hematology: Expanding into AML, MM and MDS chemotherapy Acute Myeloid Leukemia Multiple Myeloma Myelodysplastic Syndrome (AML) (MM) (MDS) Setting new SOC in a market Ph III (CANOVA) in Ph I interim data presented at which has been historically t(11;14) R/R MM initiated ASH 2020; Ph III (VERONA) 1997
Slide 51: Hematology: Polivy in DLBCL
Hematology: Polivy in DLBCL First positive Ph III (POLARIX) in a curative setting in the last 20 years Polivy program Ph III (POLARIX) in 1L DLBCL Anti-CD79b ADC • Positive Ph III (POLARIX) results for Polivy + R-CHP in 1L DLBCL to be presented at upcoming conference • Ph III (SUNMO) in 2L+ DLBCL fo
Slide 52: Hematology: Glofitamab in NHL
Hematology: Glofitamab in NHL On track for early 3L+ DLBCL filing in 2022 Glofitamab program Ph I glofitamab step up dosing in heavily pretreated R/R NHL Response rates (2.5/10/16mg or 2.5/10/30mg) • High and durable response rates in patients who have failed multiple lines of treatment • Good safet
Slide 53: Hematology: Mosunetuzumab in NHL
Hematology: Mosunetuzumab in NHL On track for early 3L+ FL filing in 2021 Mosunetuzumab program Ph I mosunetuzumab step up dosing in heavily pretreated R/R FL Response rates in high risk patients DOR in patients who achieved CR • Fixed duration treatment induced strong and durable responses in multi
Slide 54: Hematology: Venclexta in CLL, AML, MM, MDS
Hematology: Venclexta in CLL, AML, MM, MDS 6th BTD for Venclexta in MDS obtained Venclexta progam Ph I dose escalation Venclexta + azacitidine in 1L high-risk MDS Bcl-2 inhibitor Response rate Overall survival (OS) Median time on study 16.4m Historical azacitidine ORR: 38%1 Historical azacitidine mO
Slide 55: Hematology: Cevostamab in R/R MM with unique MOA
Hematology: Cevostamab in R/R MM with unique MOA Promising activity in heavily pretreated patients FcRH5 x CD3 bispecific mAb Ph I dose escalation interim results Response rate in ≥3.6/20mg cohorts • Bispecific T-cell engaging antibody • Preliminary Ph I dose escalation data: Strong response rates i
Slide 56: HR+/HER2- breast cancer: Giredestrant a next generation SERD
HR+/HER2- breast cancer: Giredestrant a next generation SERD Well differentiated with outstanding efficacy/safety profile Selective ER degrader Well differentiated small molecule Trial program accelerated (SERD) In vitro potency comparison Differentiated MOA = interim Editorial by Shao P., J.Med.Che
Slide 57: HR+/HER2- breast cancer: Giredestrant with early promising data
HR+/HER2- breast cancer: Giredestrant with early promising data Strong efficacy/safety data in early and late settings Stage I-III operable HR+/HER2- BC Metastatic HR+/HER2- BC (≤2L) Metastatic HR+/HER2- BC (≤2L) Window-of-opportunity study Ph Ib Ph Ib giredestrant monotherapy (10/30/100mg) giredest
Slide 58: HR+/HER2- breast cancer: Inavolisib in PIK3CA-mutant tumors
HR+/HER2- breast cancer: Inavolisib in PIK3CA-mutant tumors Ph III for potentially best in class PI3Kα inhibitor started PI3Kα inhibitor/mutant PI3Kα degrader Ph I (dose escalation and expansion cohort) Inavolisib + palbociclib + letrozole • Differentiation from previous PI3K inhibitors: • More sele
Slide 59: Adjuvant program: Pivotal read-outs in 2022
Adjuvant program: Pivotal read-outs in 2022 Earlier treatment increases chances for cure Outcomes by cancer type and stage Ph III adjuvant trial program at diagnosis 1 • Early detection technologies and increasing screening will allow for earlier treatment • Early treatment increases cure rates and
Slide 60: Lung franchise: Tecentriq in adjuvant NSCLC
Lung franchise: Tecentriq in adjuvant NSCLC First positive CIT read-out defining a new standard of care Ph III (IMpower010) interim results in adjuvant NSCLC DFS in the PD-L1 TC ≥1%a DFS in the all-randomized Early overall survival stage II-IIIA population stage II-IIIA population PD-L1 TC ≥1% stage
Slide 61: Lung franchise: Tiragolumab + Tecentriq in NSCLC & SCLC
Lung franchise: Tiragolumab + Tecentriq in NSCLC & SCLC Four Ph II/III tiragolumab studies reading out in 2022 Anti-TIGIT mAb Randomized Ph II (CITYSCAPE) results in 1L NSCLC ORR PFS: PD-L1 TPS ≥ 50% • Fully human IgG1/kappa Ab with • Tiragolumab + Tecentriq showed clinically meaningful improvement
Slide 62: Different technologies applied to leverage T cell responses
Different technologies applied to leverage T cell responses PD1 x LAG3 and PD1 x TIM3 bispecific Abs moved into Ph II PD1 x LAG3 bispecific Ab PD1 x TIM3 bispecific Ab Improved in-vivo tumor control in Improved in-vivo tumor control in pancreatic mouse model (BxpC3) human PD1/humanTIM-3 dTg mice No
Slide 63: Non-malignant hematology: SPK-8011 in hemophilia A
Non-malignant hematology: SPK-8011 in hemophilia A Efficacy and safety data up to 4 years Hemophilia A gene therapy Ph I/II results (SPK-8011-101) AAV-Spark200 • Bio-engineered adeno-associated viral • 15 (out of 17) participants maintained expression with stable, durable Factor VIII activity and a
Slide 64: Non-malignant hematology: Crovalimab in PNH, aHUS, SCD
Non-malignant hematology: Crovalimab in PNH, aHUS, SCD Recycling anti-C5 mAb for maximal complement inhibition Atypical Hemolytic Uremic Syndrome Sickle Cell Disease Anti-C5 mAb (aHUS) (SCD) 1. High affinity binding 2. Preferential Ab uptake of antigen-bound Ab (PI engineering) 3. Acid-sensitive ant
Slide 65: Late Stage Pipeline Neuroscience
Roche Late Stage Pipeline Event 2021 Late Stage Pipeline Neuroscience Paulo Fontoura M.D. Ph.D. | Global Head Neuroscience, Immunology, Ophthalmology, Infectious and Rare Diseases, Clinical Development
Slide 66: Late stage pipeline Neuroscience & Immunology
Late stage pipeline Neuroscience & Immunology 1. Multiple sclerosis • Ocrevus high dose • Fenebrutinib • Floodlight App 2. Alzheimer’s disease • Gantenerumab • Gantenerumab brain shuttle • Semorinemab & bepranemab 3. Spinal muscular atrophy • Evrysdi 5. Duchenne muscular dystrophy • SRP-9001 Gene th
Slide 67: Neuroscience and rare diseases portfolio
Neuroscience and rare diseases portfolio Strongly differentiated pipeline Ph I (4 NMEs) Ph II (7 NMEs) Ph III (3 NMEs, 1LE) Launched (3) UBE3A LNA prasinezumab gantenerumab Ocrevus RG6091 Angelman syndrome RG7935 RG1450 RG1594 Parkinson’s Alzheimer’s MS semorinemab SRP microdystrophin RD Enspryng RD
Slide 68: New technology platforms applied in Neuroscience and I2O
New technology platforms applied in Neuroscience and I2O* * List of pipeline molecules shown below is not complete; Molecules in the blue box are developed in Neuroscience and I2O (Immunology, Infectious diseases, Ophthalmology) 68
Slide 69: Digital endpoints to drive scientific progress
Digital endpoints to drive scientific progress Delivering new patient insights and building holistic solutions for patients Continuous product improvement Broad development program in neuroscience • Clinical trials utilizing mobiles, wearables and gaming devices • More sensitive, precise and objecti
Slide 70: Multiple sclerosis: Higher dose Ocrevus
Multiple sclerosis: Higher dose Ocrevus New Ph III program in RMS and PPMS started in 2020 Ph III study design for Ocrevus Higher Dose versus 600 mg in RMS and PPMS • Ocrevus showed a significant benefit on 12/24W-CDP, ARR, MRI measures in Ph III studies in RMS and PPMS and 7 year OLE • Exposure/res
Slide 71: Multiple sclerosis: Floodlight launched in US and EU
Multiple sclerosis: Floodlight launched in US and EU Building ecosystems to serve patients, society and scientific progress Value creation for patients Value creation for society • MS progression, often undetected by • Earlier intervention has the potential to current clinical scales improve health
Slide 72: Multiple sclerosis: Fenebrutinib in MS
Multiple sclerosis: Fenebrutinib in MS Highly differentiated and potentially best-in-class BTKi BTK inhibitor Dual MOA Outstanding selectivity profile Inhibition of myeloid and B cell activation xxx assay Kinase selectivity in whole human blood • Oral, highly selective and only reversible noncovalen
Slide 73: Multiple sclerosis: Fenebrutinib trials in RMS and PPMS started
Multiple sclerosis: Fenebrutinib trials in RMS and PPMS started Well established clinical safety profile in autoimmune diseases Ph III trials in RMS and PPMS run against active comparators Key endpoint on progression Ph III RMS (FENhance) Ph III PPMS (FENtrepid)* *First PPMS study against an active
Slide 74: Alzheimer’s disease: Gantenerumab SC targeting Amyloid β
Alzheimer’s disease: Gantenerumab SC targeting Amyloid β (Aβ) Strong target engagement and downstream biological impact DIAN-TU study shows Anti-Aβ mAb OLE studies shows robust Aβ plaque removal* downstream impact CSF Phospho-Tau levels over 4 years Aβ plaque levels over 3 years CSF NfL levels over
Slide 75: Alzheimer’s disease: Gantenerumab SC in early AD patients
Alzheimer’s disease: Gantenerumab SC in early AD patients Ph III program with optimized design to maximize exposure Global, randomized, double-blind, placebo-controlled Ph III trial design (GRADUATE I/II) Gradual titration to reduce ARIA-E incidences • Two parallel studies with large sample size of
Slide 76: Alzheimer’s disease: Gantenerumab brain shuttle
Alzheimer’s disease: Gantenerumab brain shuttle Vision: Superior target access leading to slowing of AD progression Gantenerumab brain shuttle Preclinical data Ph I PK/PD data in healthy volunteers Immunofluorescence staining1 CSF/plasma ratio2 • Gantenerumab brain shuttle is a fusion protein combin
Slide 77: Alzheimer’s disease: Two anti-TAU mAbs in development
Alzheimer’s disease: Two anti-TAU mAbs in development Ph II (LAURIET) semorinemab results show first hint of clinical activity Anti-Tau mAbs Proposed MOA Ph II (TAURIEL) PD results Semorinemab had pharmacodynamic activity semorinemab suggestive of target engagement Anti-Tau Abs potentially block or
Slide 78: Spinal muscular atrophy: Evrysdi in type 1/2/3 SMA
Spinal muscular atrophy: Evrysdi in type 1/2/3 SMA Excellent preliminary data in presymptomatic babies Ph III (RAINBOWFISH) interim results in presymptomatic babies with SMA Motor milestones within the WHO windows for healthy children CHOP-INTEND • Presymptomatic babies treated with Evrysdi for at l
Slide 79: Duchenne muscular dystrophy: Gene therapy SRP-9001
Duchenne muscular dystrophy: Gene therapy SRP-9001 Positive expression and safety data for commercial drug material Ph Ib (SRP-9001-103, cohort 1) expression results at week 12 Micro-dystrophin gene therapy in 4-7 y.o. ambulatory patients (n=11) Immunofluorescence (IF) staining Expression summary Ve
Slide 80: Parkinson’s disease: Prasinezumab with signals of efficacy
Parkinson’s disease: Prasinezumab with signals of efficacy Ph IIb started to further define patient population and endpoints Anti-α-synuclein mAb Ph II (PASADENA part 1) results at 52 weeks • Humanized mAb designed to target aggregated forms of α-synuclein • Ph II (PASADENA) study did not meet its p
Slide 81: Parkinson’s disease: First Ph II digital biomarker results
Parkinson’s disease: First Ph II digital biomarker results Digital biomarkers support clinical drug development Daily assessment for 6 months Ph II (PASADENA) digital biomarker results Smartphone sensor results correlate with clinical MDS-UPDRS scores (example tremor) • The PASADENA digital biomarke
Slide 82: Enspryng in myasthenia gravis (MG)
Enspryng in myasthenia gravis (MG) Recycling Ab for maximal inhibition of IL-6 signaling Anti-IL-6 receptor mAb MG: Autoantibodies at the Ph III (LUMINESCE) trial design neuromuscular junction • Recycling mAb with high-affinity to • MG is a chronic, autoimmune disease of the neuromuscular junction,
Slide 83: Immunology: Gazyva in LN, MN, SLE
Immunology: Gazyva in LN, MN, SLE Potential benefit in autoimmune diseases through sustained B cell depletion Glycoengineered anti-CD20 mAb Ph II (NOBILITY) results in LN Ph III trial program to increases B-cell depletion Type II anti-CD20 region Sustained depletion leads to increased • Increased di
Slide 84: Immunology: Recombinant human pentraxin-2 in fibrotic diseases
Immunology: Recombinant human pentraxin-2 in fibrotic diseases Ph III in IPF started in 2021 Recombinant human pentraxin-2 Ph II results Ph III (STARSCAPE) trial design in IPF (rhPTX-2) Mean change in FVC (%) from baseline to week 28 • PTX-2 is an immune regulatory protein that binds DAMPs (cell sig
Slide 85: Ophthalmology portfolio
Roche Late Stage Pipeline Event 2021 Ophthalmology portfolio Nilesh Mehta | Lifecycle Leader, faricimab
Slide 86: Ophthalmology
Ophthalmology 1. Ophthalmology landscape 2. Faricimab 3. Port Delivery System 4. Ophthalmology pipeline / PHC
Slide 87: Reduction in treatment burden is a key unmet medical need
Reduction in treatment burden is a key unmet medical need Real world vision outcomes are suboptimal Adherence to IVT therapies is low and infrequent Improved durability will help improve dosing in the real world correlates with vision loss real world outcomes 8'000 7'000 6'000 5'000 4'000 3'000 2'00
Slide 88: Faricimab
Faricimab Filed in US and EU with approvals expected in 2022 Positive results over four studies in nAMD/DME Faricimab improves vascular stability via Indication Ph1 Ph2 Ph3 neutralization of both Ang-2 and VEGF-A DME YOSEMITE/RHINE Anti–Ang-2 Fab Anti–VEGF-A Fab Ang-2 binding leads to VEGF-A promote
Slide 89: Faricimab: positive data in DME and nAMD
Faricimab: positive data in DME and nAMD Demonstrating advantages in durability (up to Q16W) and anatomy 75-80% of patients maintained on ≥Q12W dosing, ~50% of patients maintained on ≥Q16W dosing • BCVA gains with faricimab Q8W or up to Q16W non- BCVA inferior to aflibercept Q8W YOSEMITE/RHINE TENAY
Slide 90: Port Delivery System (PDS)
Port Delivery System (PDS) Filed in US and EU in Q2 2021, with FDA approval expected this year Positive Ph 3 results in nAMD with With PDS, nearly all patients can be maintained on 6m dosing, additional trials ongoing in DME, DR improving patient compliance and real world outcomes Indication Ph1 Ph2
Slide 91: PDS: nearly all patients able to be maintained on 6m dosing
PDS: nearly all patients able to be maintained on 6m dosing Strong patient preference for PDS Equivalent Vision Treatment Durability Patient preference PDS maintained vision through week 72 > 90% of patients did not receive 93% of patients preferred PDS supplemental treatment before each over intrav
Slide 92: Preparing for a global launch in nAMD
Preparing for a global launch in nAMD US launch planned for 2021, ex-US for 2022 Virtual reality training Field-based support Payer discussions ongoing • Virtual reality (VR) technology enables • Surgical Device Specialists (SDS) • Currently engaging with payers preoperative training of surgeons on
Slide 93: Industry leading ophthalmology pipeline
Industry leading ophthalmology pipeline Eight NMEs in early stage development (Ph 1/2) Indication Phase I Phase II Phase III RG7921 faricimab1 Neovascular AMD RG6120 PDS w ranibizumab1 faricimab1 Approved: Diabetic Macular Edema RG6179 PDS w ranibizumab Diabetic Retinopathy RG7774 PDS w ranibizumab
Slide 94: Port Delivery System is a platform technology
Port Delivery System is a platform technology DutaFabs* are next generation bispecifics designed for increased efficacy & durability Positive PDS Ph3 has enabled acceleration of DutaFabs in PDS platform • DutaFabs are a novel bispecific Fab format significantly smaller than bispecific antibodies • D
Slide 95: Ophthalmology Personalized Healthcare
Ophthalmology Personalized Healthcare Remote monitoring & advanced analytics to help treat vision loss early Remote vision monitoring Retinal imaging and algorithms Data portfolio Clinical Imaging Omics Sensors • App-based designed test to detect • Demonstrated PoC utilizing internal • RWD and data
Slide 96: Late Stage Pipeline Infectious Diseases
Roche Pharma Day 2021 Late Stage Pipeline Infectious Diseases Barry Clinch| Global Head of Infectious Diseases, Clinical development
Slide 97: Late stage pipeline Infectious diseases
Late stage pipeline Infectious diseases 1. HBV franchise • CpAM / TLR7 agonist / siRNA HBV / PDL-1 LNA 2. SARS-CoV-2 franchise • Actemra • Ronapreve • AT-527 3. SARS-CoV-2 Pandemic outlook
Slide 98: Hepatitis B virus: CpAM / TLR7 agonist / HBV siRNA / PDL-1 LNA
Hepatitis B virus: CpAM / TLR7 agonist / HBV siRNA / PDL-1 LNA 4 new MOAs in clinical development Core protein allosteric modulator (CpAM) Toll like receptor 7 (TLR7) agonist • TLR7 detects single-stranded • Effective against all major HBV viral RNA and mediates anti- genotypes viral cytokine produc
Slide 99: Hepatitis B virus: Combination platform initiated
Hepatitis B virus: Combination platform initiated Multiple combinations now in Ph II testing Screening drug combinations efficiently HBV development program progresses Highly adaptive HBV combination platform • Adaptive platform for Ph II study with shared control arm • Designed to find the best com
Slide 100: SARS-CoV-2: Our outstanding contribution battling the pandemic
SARS-CoV-2: Our outstanding contribution battling the pandemic > 1 million hospitalized patients received Roche’s treatments = positive Ph III results Overview: not all COVID-19 related developments and health solutions captured; EUA=emergency use authorization; RUO=Research use only; * through GenM
Slide 101: SARS-CoV-2: Broad development program ongoing
SARS-CoV-2: Broad development program ongoing Different scientific approaches serving different pandemic needs EUA=emergency use authorization; nAb=neutralizing antibodies; DAA=direct acting antiviral; * RECOVERY trial conducted by the University of Oxford; REMAP-CAP trial conducted by the Imperial
Slide 102: SARS-CoV-2: Actemra for severe COVID-19 associated pneumonia
1 SARS-CoV-2: Actemra for severe COVID-19 associated pneumonia WHO recommends IL-6 inhibitors for hospitalized patients Anti-IL6 receptor mAb Totality of randomized Ph IIIs demonstrates efficacy in hospitalized patients • Approved in RA, JIA, GCA and for • Ph III (RECOVERY)* results showed that when
Slide 103: SARS-CoV-2: Ronapreve maintains activity against key variants
2 SARS-CoV-2: Ronapreve maintains activity against key variants Positive data in prophylaxis, non-hospitalized & hospitalized patients Neutralizing Ab cocktail Extensive trial program with >25.000 patients REGN10987 • Two potent, virus neutralizing Abs • Ph I-III (Study 2067) results show that Ronap
Slide 104: SARS-CoV-2: AT-527 for the outpatient setting
3 SARS-CoV-2: AT-527 for the outpatient setting Ph II interim viral load results in hospitalized patients Purine nucleotide prodrug Ph II interim results* Ph III results expected end of 2021 Viral load (n=62) through day 8 • Oral, direct acting antiviral (DAA) • Inhibits SARS-CoV-2 viral replication
Slide 105: SARS-CoV-2: Pandemic outlook
SARS-CoV-2: Pandemic outlook Three scenarios how the pandemic might evolve in coming years Less severe Three potential scenarios More severe A B C COVID-19 cases plummet COVID-19 will become a Constant mutations create and disease vanishes soon seasonal endemic disease an unpredictable disease Lower
Slide 106: Doing now what patients need next
Doing now what patients need next
Slide 107: New product growth with strong momentum
New product growth with strong momentum Considerable optionality Biosimilar gap (20-25) Consensus sales growth (20-25) Sensitivity analysis: Post-HY 2021 consensus survey Assuming conservative planning assumptions Ocrevus 2.6 bn CHF Tecentriq 3.8 bn Avastin Hemlibra 2.7 bn 5.0 bn Gap to fill: Gazyva
Slide 108: New product growth with strong momentum (Post-HY 2020 consensus)
New product growth with strong momentum Considerable optionality Biosimilar gap (19-24) Consensus sales growth (19-24) Sensitivity analysis: Post-HY 2020 consensus survey Assuming conservative planning assumptions Ocrevus 3.1 bn CHF Tecentriq 4.1 bn Avastin Hemlibra 3.0 bn 7.0 bn Gap to fill: Gazyva
Slide 109: New product growth with strong momentum (Post-HY 2019 consensus)
New product growth with strong momentum Considerable optionality Biosimilar gap (18-23) Consensus sales growth (18-23) Sensitivity analysis: Post-HY 2019 consensus survey Assuming conservative planning assumptions Ocrevus 3.8 bn Tecentriq 3.5 bn Avastin Hemlibra 3.5 bn 6.8 bn Gazyva 0.8 bn Gap to fi