Roche Pharmaceutical Development and Sales Overview

Made public by

sourced by PitchSend

68 of 199

Creator

Roche logo
Roche

Category

Healthcare

Published

Q1 2019

Slides

Transcriptions

#1Roche#2Roche 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, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others: 1 pricing and product initiatives of competitors; 2 legislative and regulatory developments and economic conditions; 3 delay or inability in obtaining regulatory approvals or bringing products to market; 4 fluctuations in currency exchange rates and general financial market conditions; 5 uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products; 6 increased government pricing pressures; 7 interruptions in production; 8 loss of or inability to obtain adequate protection for intellectual property rights; 9 litigation; 10 loss of key executives or other employees; and 11 adverse publicity and news coverage. Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche's earnings or earnings per share for this year or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. For marketed products discussed in this presentation, please see full prescribing information on our website www.roche.com All mentioned trademarks are legally protected.#3Roche YTD September 2022 sales Basel, 18 October 2022 Roche#4Group Severin Schwan Chief Executive Officer Roche#5YTD Sep 2022 performance Outlook Roche#6YTD Sep 2022: Group sales +2% despite COVID-19 decline in Q3 Group sales +2% driven by Diagnostics division • • Pharma with stable performance, key products compensating for LOEs and declining COVID-19 sales Diagnostics with good growth momentum (+6%) including good base business growth (+6%) Key products growing strongly; new launches with significant sales potential • • • Pharma growth drivers Ocrevus, Hemlibra, Evrysdi, Phesgo, Vabysmo and Tecentriq with strong momentum Promising new launches with Vabysmo in ophthalmology and Polivy & Lunsumio in hematology New launches of next generation of SARS-CoV-2 rapid antigen test 2.0, Prame immunohistochemistry assay for melanoma and Digital LightCyler Upcoming late-stage newsflow in 2022 · Pharma: Gantenerumab in Alzheimer's disease; Venclexta in MM (t11;14); Vabysmo in RVO; Susvimo in DME & DR . Diagnostics: ElecsysⓇ pTau/AB42 ratio Gen2 CSF (FDA), cobas® 5800 (FDA) Growth rates at CER (Constant exchange Rates); LOE-loss-of-exclusivity Roche 6#7YTD Sep 2022: Group sales growth driven by Diagnostics Division 2022 2021 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 33.2 33.4 -1 0 Diagnostics Division 13.8 13.3 4 6 Roche Group 47.0 46.7 1 2 CER=Constant Exchange Rates; totals may include differences due to rounding Roche 7#8Quarterly sales performance: COVID-19 sales coming down 15% 13% 14%* 12% 11% 9% 9% 10% 7% 7% 7% 6% 6% 6% 6% 6% 8% 8% 7% 5% 4% 6% 5% 5% 4% 4% 1% 3% 3% 3% 0% 1% 0% -5% -10% -15% AHR¹ impact -4% COVID-19 impact -6% Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 15 15 15 15 16 16 16 16 17 17 17 17 18 18 18 18 19 19 19 19 20 20 20 20 21 21 21 21 22 22 22 Growth rates at CER (Constant Exchange Rates); * Q2 2020 sales severely impacted by COVID-19 pandemic onset; 1AHR: Avastin, Herceptin, Rituxan/MabThera Roche 8#9YTD Sep 2022: Portfolio rejuvenation ongoing CHFM 46'684 +2% at CER -383 +2'397 -612 +217 -1,460 +621 -427 47'037 YTD Sep 2021 Dia base business Dia Pharma Ronapreve Actemra COVID-19 underlying sales sales sales business AHR erosion1 Fx YTD Sep 2022 YTD Sep 2022 values in reported CHFm, variances in CERm; 1AHR: Avastin, Herceptin, Rituxan/MabThera sales erosion Diversification of Roche business YTD Sep 2017 CHF 39.4bn YTD Sep 2022 CHF 47.0bn AHR AHR Diagnostics Other pharma Ophthalmology Infectious diseases Immunology Oncology AHR Neuroscience Hemophilia A Roche 9#10YTD Sep 2022: Solid underlying sales growth in both divisions Pharma Quarterly sales evolution 2021-2022 Diagnostics Quarterly sales evolution 2021-2022 Roche % CER % CER +55% +55% +48% +55% +45% +45% +35% +35% +31% +24% +25% +25% +17% +18% +14% +15% +15% +9% +4% +5% +6% +6% +7% +5% +2% +5% +11% +3% +10% +7% +8% -5% -9% +2% -0% -5% 0% -1% -3% -6% -4% -13% -15% -15% Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2021 vs. 2020 2022 vs. 2021 2021 vs. 2020 2022 vs. 2021 -Pharma Underlying business -Diagnostics -Diagnostics Base business Growth rates at CER (Constant Exchange Rates); 1 Excl. Ronapreve and Actemra 10 10#11YTD Sep 2022 performance Outlook Roche#12Als NMES Continuous increase in pipeline breadth and depth All-time high for Ph III Als and industry-leading number of NMEs in the clinic Projects in Ph III & registration Record number of NMEs and Als (YTD Sep 2022) 18 Phase I 2 2% 8% Phase II 3% 10% 14 3 11% 13 13 38% 2 1 3% 2 62 29 11 3 11% 31% 1 65% 4 9 5 4 2 4 4 1 1 1 1 1 6% 10% Phase III 9% 1 8 7 5 5 LO 5 21% 3 56 57% HY 2017 HY 2018 HY 2019 HY 2020 HY 2021 YTD Sep 2022 4% 9% 38 40 39 41 43 53 NME=new molecular entity; Al-additional indication Oncology/Hematology Immunology Infectious Diseases Neuroscience Ophthalmology Other 12 Roche#132022/23: Upcoming Pharma newsflow Vabysmo in RVO 2022 Susvimo in DME Susvimo in DR Venclexta in R/R MM (t11;14) Gantenerumab in Alzheimer's disease 2023 Tiragolumab + Tecentriq in 1L PDL 1+ NSCLC Tiragolumab + Tecentriq in 1L Esophageal Tecentriq in adjuvant HCC Tecentriq in adjuvant SCCHN Tecentriq + chemo in adjuvant TNBC Tecentriq neoadjuvant/adjuvant TNBC Tecentriq periadjuvant NSCLC Phesgo OBI in HER2+ BC Alecensa in adjuvant ALK+ NSCLC Venclexta in 1L high risk MDS Crovalimab in PNH Glofitamab in 2L+ DLBCL* Lunsumio in 2L+ DLBCL* Neuroscience Oncology Ophthalmology Immunology Delandistrogene moxeparvovec in DMD Ocrevus SC in RMS / PPMS TNKase in Stroke Xolair in Food allergy DME-diabetic macular edema; DLBCL-diffuse large B-cell lymphoma; NSCLC=non-small cell lung cancer; HCC-hepatocellular carcinoma; MM-multiple myeloma; RVO-retinal vein occlusion; CSF-cerebrospinal fluid; PCR-polymerase chain reaction; SC=subcutaneous; *Results are event-driven, read-outs expected 2023/24 Roche 13#14R&D focus area Alzheimer's disease Clinical results for gantenerumab and blood-based biomarkers to be presented at CTAD Roche CTAD Clinical Trials on Alzheimer's Disease گولا Pharmaceuticals gantenerumab FDA BTD • Nearly two decades of scientific investigation with nearly 7000 patient years on treatment GRADUATE I/II: Patients with early AD (FDA BTD) SKYLINE: Patients at risk of, or at the earliest stages of AD Brain shuttle gantenerumab Improve transport of gantenerumab across the blood brain barrier Promising Ph I PK data Platform technology: Ph I trial in MS with a CD20 Anti-tau mABs Different MoA, targeting tau protein tangles instead of AB plaques • Two assets (semorinemab & bepranemab) in Ph II trials Roche Diagnostics Blood-based biomarker Elecsys Amyloid Plasma Panel (FDA BDD) A minimally invasive test to help pre-select patients for confirmatory testing Runs on serum work area platforms CSF-based biomarker Elecsys Aẞ and pTau CSF Confirmatory test equivalent to PET scan Runs on serum work area platforms Multiple Real World Data (RWD) studies* *Topics include natural history, predictors of progression in early AD, QoL across the AD continuum and more; Latest RWD study: Delphi study CONCORD-AD 2.0, connecting cohorts to diminish AD AD=Alzheimer's disease; PK-pharmacokinetics; MS=multiple sclerosis; AB-amyloid beta; BDD-breakthrough device designation; CSF-Cerebrospinal fluid; QoL-quality of life FDA BDD 14#152022 outlook confirmed Group sales growth1 Core EPS growth¹ • Stable to low-single digit • Dividend outlook • 1 At Constant Exchange Rates (CER) Low- to mid-single digit Further increase dividend in Swiss francs Roche 15#16Pharmaceuticals Division Bill Anderson CEO Roche Pharmaceuticals Roche#17YTD Sep 2022: Pharmaceuticals Division sales New products compensate for loss-of-exclusivity and COVID-19 sales decline Roche CER=Constant Exchange Rates 2022 2021 Change in % CHFM CHFM CHF CER Pharmaceuticals Division 33,189 33,379 -1 0 United States 17,199 16,707 3 -1 Europe 6,100 6,610 -8 -1 Japan 3,029 3,186 -5 7 International 6,861 6,876 0 0 17#18YTD Sep 2022: Portfolio diversification accelerating Ocrevus 17% Hemlibra 28% Evrysdi Phesgo Vabysmo Tecentriq Alecensa 101% 150% n/a 10% 16% Kadcyla 11% Perjeta Xolair Polivy Enspryng Gazyva Tamiflu Gavreto Esbriet Lucentis Herceptin 5% 10% 79% 108% 8% 56% 299% -25% US -25% -18% Europe Ronapreve -36% MabThera -20% Actemra/RoActemra -23% Japan International Avastin -29% -800 -400 0 400 Absolute values and growth rates at Constant Exchange Rates (CER) 800 Roche 18#19YTD Sep 2022: Oncology portfolio rejuvenation on-going YoY CER growth Phesgo (+150%) HER2 franchise Herceptin Perjeta (+5%) +4% • Kadcyla (+11%) Tecentriq +10% Polivy (+79%) Hematology Rituxan franchise -7% Gazyva(+8%) Avastin -29% Alecensa +16% Cotellic + Cotellic (+1%) -3% Zelboraf Rozlytrek +50% Tarceva -33% Gavreto +299% CHFbn 0.0 2.0 4.0 6.0 8.0 HER2 franchise • • Kadcyla (+11%) with growth ex-US due to adjuvant BC Perjeta (+5%) driven by International, especially APAC Phesgo (CHF 526m): 30% conversion in early launch countries Tecentriq • Growth (+10%) driven by adjuvant NSCLC, 1L HCC and 1L SCLC Hematology franchise • Venclexta*: Expanding patient share in 1L AML & R/R CLL . Gazyva (+8%): Growth due to 1L FL and in 1L CLL • Polivy (+79%): Strong 1L DLBCL uptake in early launch countries; PDUFA date for 1L DLBCL (POLARIX) set for Apr 2nd Roche • Lunsumio: Approved in EU with strong early launch in Germany and Austria; PDUFA set for Dec 29th Alecensa • Strong growth (+16%) and 1L ALK+ NSCLC leadership in major markets YTD Sep 2022 Oncology sales: CHF 15.0bn; CER growth -1%; CER-Constant Exchange Rates; * Venclexta sales booked by AbbVie and therefore not included; Polivy in collaboration with Seagen; BC=breast cancer; HCC-hepatocellular carcinoma; NSCLC-non-small cell lung cancer; SCLC-small cell lung cancer; AML-acute myeloid leukemia; R/R CLL=relapsed/refractory chronic lymphocytic leukemia; FL=follicular lymphoma; DLBCL-diffuse large B cell lymphoma; PDUFA-Prescription Drug User Fee Act; ALK-anaplastic lymphoma kinase 19#20HER2+ franchise: Continued growth Multiple Ph III combination trials initiated Phesgo's strong global launch continues 50% Global Phesgo conversion rate* • 40% 30% 30% 20% 10% 0% 720 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 20 21 21 21 21 22 22 22 Phesgo conversion rate at 30% in early launch countries Phesgo significantly cuts healthcare costs and resource use P+H in eBC (APHINITY): 8-year follow up data presented at ESMO Virtual Plenary showing a 28% reduction in the risk of recurrence or death for high risk, lymph-node positive patients • ⚫ Ph III (heredERA) Phesgo + giredestrant in 1L HER2+/HR+ mBC initiated Kadcyla Roche PHESGO® ado-trastuzumab emtansine for injection Kadcyla growth driven by adjuvant setting Neoadjuvant 50% PHESGO® HER2+ eBC pts 50% Surgery Adjuvant cont. PCR (55%) PHESGO® Kadcyla Residual Disease (45%) ado-trastuzumab emtansine for injection Adjuvant only PHESGO® • Continued growth enabled by global expansion in the adjuvant setting • • Kadcyla remains SoC in adjuvant patients with residual disease (KATHERINE) with > 60% of sales in the adjuvant setting ⚫ Ph III (KATE-3) Kadcyla + Tecentriq in 2L+ HER2+/PD-L1+ mBC initiated ⚫ Ph III (ASTEFANIA) Kadcyla + Tecentriq in HER2+/PD-L1+ eBC initiated P=Perjeta; H-Herceptin; HR-Hormone receptor; HER2-Human epidermal growth factor receptor 2; BC-Breast cancer; eBC-Early breast cancer; mBC=Metastatic breast cancer; PCR-pathologic complete response; SoC-standard of care; ESMO-European Society for Medical Oncology; *Phesgo conversion rate is based on volumes (vials) and includes all launch countries after the 2nd quarter after the launch (25 countries); Phesgo in collaboration with Halozyme 20 20#21Roche Giredestrant: Early data support continued development in ER+ BC Ph III (persevERA) interim results in 1L ER+ BC expected for 2024 Ph II (acelERA) results in 2/3L ER+/HER- BC Ph II (coopERA) results in neoadjuvant ER+/HER- BC PFS-INV: ESR1m subgroup 100+ 90- 80- 70- PFS-INV, % 60- 50 40- 30- 20- 10- 0- 0 2 4 6 8 10 12 14 Months No. at risk giredestrant 51 36 26 12 9 4 PCET 39 20 9 1 congress PARIS 2022 ESMO HR (95% CI) p-value (log-rank) mPFS, months giredestrant (n = 51) PCET (n = 39) 0.60 (0.35, 1.03) 0.0610 5.3 3.5 Ki67 response at wk 2 and at surgery Relative reduction in Ki67% from baseline OHNWAG Baseline to week 2 Giredestrant (n=107) -75% Anastrazole (n=94) -67% Baseline to surgery G+P (n = 93) -81% A+P (n=91) -74% 2022 ASCO ANNUAL MEETING 。%% 0.00 -0.25- -0.50- -0.75- -1.00- • • . PFS benefit was more pronounced in patients with ESR1 mutations (HR of 0.81 in all-comers vs HR of 0.60 in patients with ESR1 mutations) In 2L/3L setting patients have received multiple cycles of ET The activity observed in patients whose tumours still depend on estrogen receptor activity for viability is encouraging for earlier lines, where nearly all ER+ tumours are dependent on ER activity . G+P, Giredestrant + Palbociclib; A+P, Anastrozole + Palbociclib First randomized study to show superior activity of an oral SERD (giredestrant) over an aromatase inhibitor (anastrozole) in ER+/HER2- eBC Final analysis confirmed greater suppression of Ki67 and rates of complete cell cycle arrest with giredestrant vs. anastrazole at time of surgery Ki67 is a biomarker of proliferation associated with improved long-term efficacy outcomes in early stage disease Safety data consistent with known safety profile Fasching P et al., ASCO 2022; Martin M et al., ESMO 2022; Clinical cutoff: 18 Feb 2022; median follow-up 7.89 months; SERD-Selective estrogen receptor degrader; BC-Breast cancer; ER=estrogen receptor; ESR1-estrogen receptor 1; ET-estrogen therapy; PFS-INV-progression-free survival by investigator assessment; HR-hazard ratio; PCET=physician's choice of endocrine therapy; HER2-Human epidermal growth factor receptor 2 22 21#22Tecentriq overview: Adjuvant key trials now to read out in 2023 First PD-(L)1 with pivotal SC results to be filed in 2022 Roche CHFM 1,000 YoY CER growth +9% 900 800 +23% +49% 700 600 +154% 500 400 300 200 100 0 Q3 19 Q3 20 Q3 21 Q3 22 US Europe International Japan Tecentriq Q3 update • Positive Ph III (IMscin001) results for SC administration Lung franchise (NSCLC, SCLC) • EU: Strong launch in adj. NSCLC; 1L SCLC with continued growth • US: Continued strong launch in adj. NSCLC Gl franchise (HCC) • US/EU/Japan: Further growth in 1L HCC Outlook 2022 • Further growth due to first-to-market indications CER-Constant Exchange Rates; SC-subcutaneous; NSCLC-non-small cell lung cancer; SCLC-small cell lung cancer; HCC-hepatocellular cancer 22 22#23Hemophilia A franchise: Hemlibra new global standard of care 36% US/EU-5 patient share reached Roche CHFM 1,200 1,000 800 600 >500% 400 200 +57% YoY CER growth +23% . +37% Hemophilia Q3 update • >18,000 patients treated globally • Hemlibra continues to penetrate across all approved patient segments • 2nd generation FIXa x FX bi-specific (NXT007) to be taken into Roche clinical development Outlook 2022 • US/EU: Further patient share gains in non-inhibitors • EU: Label expansion to include mild/moderate patients • (HAVEN 6) expected ⚫ Ph III (HAVEN 7) in infants (0-1 year) submitted for presentation at ASH 2022 0 Q3 19 Q3 20 Q3 21 Q3 22 US Europe International Japan CER=Constant Exchange Rates 23#24Immunology franchise Actemra COVID-19 sales declining and Esbriet generic competition CHFM 2,500 +13% +5% +1% 2,000 1,500 1,000 500 0 Q3 19 Q3 20 Q321 ■Rituxan/MabThera (RA) Actemra SC CellCept Esbriet YoY CER growth Actemra IV Xolair Pulmozyme Other -25% Q3 22 Immunology Q3 updates Actemra (-42%) . COVID-19 demand completely washed out in Q3 • Submitted to EMA for approval in SSC-ILD • Shift from IV to SC ongoing Xolair (+8%) • Market leader in asthma biologics and strong • growth in CSU Autoinjector submitted to FDA for approval Esbriet (-48%) • US: Generic competition CER=Constant Exchange Rates; RA=rheumatoid arthritis; IV-intravenous; SC=subcutaneous; CSU-chronic spontaneous urticaria; SSC-ILD=systemic sclerosis-interstitial lung disease Roche 24#25MS franchise: Ocrevus #1 treatment in US and now also in EU-5 MS development programs well on track Roche Q3 update • >250.000 patients treated globally • #1 treatment in US and EU-5, both in total share and new to brand share Higher persistence than other MS medicines ⚫Ph Ill program (FENhance I/II, FENtrepid) for fenebrutinib in RMS and PPMS on track ⚫ Ph III (OCARINA II) Ocrevus SC with strong recruitment; results expected in 2023 Outlook 2022 • US/EU: Further market share gains expected CHFM YoY CER growth 1,750 1,500 1,250 +16% . +7% +37% 1,000 +48% 750 500 250 0 Q3 19 Q3 20 Q3 21 Q322 . US ■Europe International CER=Constant Exchange Rates; MS-multiple sclerosis; SC=subcutaneous; RMS=relapsing MS; PPMS-primary progressive MS 25#26MS franchise: Subcutaneous dosing and higher dose Ocrevus Q6M SC dosing readout expected in 2023 Ocrevus SC will retain Q6M dosing Administration and observation schedule Total time Regular IV IV pre- medication 30- 60 min Shorter IV =Infusion =Observation Roche OCREVUS ocrelizumab Ocrevus higher dose vs 600 mg in RMS and PPMS Double-blind treatment (min. of ≥120 weeks) Ocrevus higher dose 1,200/1,800 mg Additional 5.5-6h enen Dose 1 3.5-4h Screening 2:1 Dose 2 Dose 3 Dose 4 Ocrevus 600 mg Dose 5 doses of blinded treatment Onon On et Dose 1 Dose 2 Dose 3 Dose 4 Dose 5 Additional doses of blinded treatment Primary analysis ~1h SC injection Oral pre- medication* Dose 1-2 10min+ Dose >2 *1-2 h pre injection =Infusion |=Observation (first two doses only)* ⚫ Ph III (OCARINA II) evaluating subcutaneous Q6M dosing of Ocrevus for non- inferiority vs Ocrevus IV in RMS & PPMS with data expected in 2023 • Increases potential for Ocrevus use in centers with IV capacity constraints . Open label treatment (total of 96 weeks) Ocrevus higher dose 1,200/1,800 mg Safety Follow Up Dose 1 Dose 2 Dose 3 Dose 4 B-Cell Monitoring Two double-blind, randomized Ph III studies were designed to test higher dose Ocrevus (MUSETTE in RMS and GAVOTTE in PPMS)1 Exposure/response analysis of Ph III data suggests a higher dose could lower the risk of disability progression without compromising safety 1 Hauser S.L. et al, ACTRIMS-ECTRIMS 2020; *Expected, but may vary based on clinical results; MS-multiple sclerosis; IV-intra-venous; SC-Subcutaneous; RMS=relapsing multiple sclerosis; PPMS=primary progressive MS; Q6M-dosing every 6 months 26#27SMA franchise: Evrysdi with strong global momentum Well-positioned to become #1 worldwide CHFM 350 300 250 200 >500% 150 100 50 Q3 20 Q3 21 ■US ■Europe International Japan CER-Constant Exchange Rates; SMA-spinal muscular atrophy YoY CER growth +93% Q3 22 Q3 update • >7,000 patients treated worldwide (commercial, clinical trials, compassionate use) Retention rate in first 12 months of ~90% globally US: Growth driven by switch and naive patient starts including patients <2 months old • Ex-US: Continued strong growth and share gains in all major markets Positive Ph II (JEWELFISH) 2 year data presented at WMS; largest SMA study in previously treated patients Outlook 2022 • Continued growth and market share gains across all market segments expected • EU: Label extension (<2 months old) based on Ph II RAINBOWFISH expected Roche 27#28Ophthalmology franchise: Excellent Vabysmo launch More than 165k vials shipped in the US in the first 7 months CHFM 200 150 100 50 Q122 Q2 22 ■ US Europe International ■Japan Q3 22 Q3 update Vabysmo VABYSMO SuSvim o™ ranibizumab injection Form 100mm Roche • US: Strong uptake with switches primarily from aflibercept and first naïve patient starts US: Permanent J-code granted on October 1st • EU: Approval granted in DME and nAMD • Ph III (TENAYA/LUCERNE) 2 year data in nAMD presented at ASRS • Real-world study (TRUCKEE*) update presented at AAO supporting efficacy and safety profile Susvimo • Voluntary recall due to manufacturing issue Outlook 2022 Ph III (BALATON/COMINO) results for Vabysmo in RVO expected ⚫ Ph III (PAGODA/PAVILLION) results for Susvimo in DME/DR expected ⚫ Ph III (MEERKAT/SANDCAT) IL-6 mAb in UME to be initiated *Investigator initiated study; DME=diabetic macular edema; nAMD-neovascular age-related macular degeneration; RVO-retinal vein occlusion; DR-diabetic retinopathy; UME=uveitic macular edema; mAb-monoclonal antibody; Eylea (aflibercept) is a registered trademark/product of Regeneron 28#29Vabysmo: Improved overall disease control in DME Treat & extend study design well-aligned with clinical practice Ph III trial design in DME (YOSEMITE/RHINE) VABYSMO Ph III (YOSEMITE/RHINE) 2 year results YOSEMITE/RHINE Pooled • . YOSEMITE & RHINE Phase 3, randomized, double-masked, active comparator-controlled trials Patients with center-involving DME (CST ≥ 325 μm)a BCVA 25-73 ETDRS letters (Snellen BCVA-20/320-20/40) b Anti-VEGF treatment-naïve or previously treated patients with DMEC (1 eye per patient) YOSEMITE: N=940 RHINE: N 951 Faricimab 6.0 mg Q8W Faricimab 6.0 mg PTI Aflibercept 2.0 mg Q8W Primary Endpointd Study End D1 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100 Time, Weeks Active treatment (faricimab 6.0 mg or aflibercept 2.0 mg) Sham PTI visit (sham or faricimab 6.0 mg) Final study visit Adjusted Mean BCVA Change From Baseline, ETDRS Letters Adjusted Mean CST Change From Baseline, um 12086420 Average of weeks 92-100a Faricimab Q8W: +10.8 ETDRS letters Faricimab PTI: +10.4 ETDRS letters Aflibercept Q8W: +10.3 ETDRS letters 0 8 16 24 32 40 48 56 Time, Weeks 64 72 80 88 96 0 -50 -100 -150 -200 -250 0 8 16 24 32 40 Aflibercept Q8W (n=627) Average of weeks 92-100a Faricimab Q8W: -209.4 μm* Faricimab PTI: -201.0 μm* Aflibercept Q8W:-190.9 μm 48 Time, Weeks Faricimab Q8W (n=632) 56 64 72 80 88 96 Faricimab PTI (n=632) First time treat & extend principals were consistently applied in a randomized Ph III setting aligned with clinical practice Share of patients on ≥Q12W dosing at 78% in year 2, with share of patients on Q16W dosing improving to 62% from 52% in year 1 YOSEMITE (NCT03622580)/RHINE (NCT03622593). Test for superiority: * Nominal P < 0.05 versus aflibercept Q8W. P values are nominal and not adjusted for multiplicity; a CST was measured as the distance from the internal limiting membrane to Bruch's membrane. b BCVA was measured using the ETDRS visual acuity at a starting distance of 4 m. c Previously anti-VEGF-treated eyes (treated>= 3 months before day 1) were limited to 25% of the total enrolment. d Primary efficacy endpoint: adjusted mean BCVA change from baseline at year 1, averaged over weeks 48, 52 and 56. BCVA=best corrected visual acuity; CST=central subfield thickness; DME-diabetic macular edema; ETDRS-early diabetic retinopathy study; PTI=personalized treatment interval; Q8W-every 8 weeks; Eylea (aflibercept) is a registered trademark/product of Regeneron Roche 29 29#30Vabysmo: 2 year nAMD data presented at ASRS Strong BCVA and CST results sustained over 2 years Ph III trial design in nAMD (TENAYA/LUCERNE) VABYSMO Ph III (TENAYA/LUCERNE) 2 year results R 1:1 Disease Activity Assessment Initial dosing Faricimab 6.0 mg up to Q16W Active disease at week 24 Active disease at week 20 Initial dosing Aflibercept 2.0 mg Q8W Primary Endpointa Change in BCVA from baseline averaged over the week 40, 44, and 48 visits 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 Time, Weeks Aflibercept 2.0 mg Faricimab 6.0 mg Sham Final Visit Year 2 ongoing PTI Continue dosing 108 112 ITT Population Adjusted Mean CST Change From Baseline, μm From Adjaseline, ETDRS Letters BCVA Change 0 4 0 -50 -100 -150 -200 0 4 TENAYA/LUCERNE Pooled I Roche ASRS Average of weeks 104-112a 1 1 1 I + 4.4 letters 1 + 4.3 letters 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100 104 108 112 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100 104 108 112 Time, Weeks Aflibercept Q8W (n = 664) Faricimab up to Q16W (n = 665) . • • Disease activity criteria at week 20 and 24 used to allocate patients to treatment intervals (Q8W or Q12W or Q16W) for the remainder of year 1 During year 2, Vabysmo patients could be reallocated to personalized treatment intervals Share of patients on ≥Q12W dosing at 78% in year 2, with share of patients on Q16W dosing improving to 63% from 45% in year 1 Average of weeks 104-112a - 148.4 μm 144.0 μm Khanani A.M. et al., ASRS conference 2022; TENAYA (NCT03823287)/LUCERNE (NCT03823300): a BCVA was measured using the ETDRS visual acuity chart at a starting distance of 4 m; BCVA-best-corrected visual acuity; nAMD=neovascular age-related macular degeneration; CST-central subfield thickness; ETDRS-early diabetic retinopathy study; Q8W-every 8 weeks; ITT-intention to treat; Eylea (aflibercept) is a registered trademark/product of Regeneron 30 30#31Vabysmo: Disease criteria chosen impact patient allocation Vabysmo nAMD trials use disease criteria reflective of clinical practice 1 Different ≥Q12W disease criteria as applied to TENAYA/LUCERNE patients Stringent criteria** Treatment change if ANY criteria are met (based on criteria used in pivotal trials) VABYSMO Share of patients on ≥Q12W dosing Assessment done at week 20 ≥ 5 letters BCVA loss vs avg. BCVA over previous 2 scheduled visits, due to nAMD* ≥ 10 letters BCVA loss vs highest BCVA recorded over OR OR > 50 μm CST increase vs avg. OR previous 2 scheduled visits, due CST over previous 2 ≥ 75 μm CST increase vs lowest CST recorded at either of previous 2 Presence of new OR scheduled visits macular hemorrhage*, due to nAMD activity scheduled visits to nAMD* Less stringent criteria Treatment change if ALL criteria are met >5 letters BCVA loss vs week 16 BCVA AND > 25 μm CST increase vs week 16 CST or new macular hemorrhage 22% 4% Roche 78% >Q12W Q8W 96% • Ph III TENAYA/LUCERNE trial with stringent patient-centric criteria resulted in 22% of patients being allocated to Q8W dosing • Utilizing less stringent criteria only 4% of patients would have resulted in Q8W dosing (post hoc analysis) 1 Heier et al. Lancet. 2022;399(10326):729-40; TENAYA (NCT03823287) & LUCERNE (NCT03823300); *per the investigator; **Additional patients with a missing Week 20 assessment were considered to have met disease activity criteria and were treated Q8W; Q8W-every 8 weeks; BCVA-best-corrected visual acuity; nAMD-neovascular age-related macular degeneration; CST-central subfield thickness 31#322022: Key late-stage news flow* and upcoming IR events Regulatory Phase III/ pivotal readouts Compound Vabysmo Susvimo Lunsumio (mosunetuzumab) Tecentriq Hemlibra Polivy + R-CHP glofitamab Tecentriq + tiragolumab + chemo Tecentriq + chemo Tecentriq + tiragolumab Tecentriq giredestrant Tecentriq + Avastin Venclexta + dexamethasone Tecentriq + chemo Tecentriq + tiragolumab + chemo Alecensa gantenerumab Susvimo Vabysmo Indication nAMD/DME nAMD 3L+ FL Adjuvant NSCLC Mild to moderate hemophilia A 1L DLBCL 3L+ DLBCL 1L ES-SCLC Adjuvant SCCHN 1L PDL 1+ NSCLC Adjuvant RCC 2/3L HR+ MBC Adjuvant HCC t(11;14) R/R MM Periadjuvant NSCLC 1L esophageal cancer Adjuvant ALK+ NSCLC Alzheimer's disease DME / DR RVO Milestone US/EU approval EU approval US/EU approval EU approval EU approval EU/US approval Ph lb NP30179 Ph III SKYSCRAPER-02 Ph III IMvoke010 Ph III SKYSCRAPER-01 Ph III IMmotion010 Ph II acelERA Ph III IMbrave050 Delayed EU EU × 2023 Continues to OS IA Х 2023 Ph III CANOVA Ph III IMpower030 2023 Ph III SKYSCRAPER-08 (China only) 2023 Ph III ALINA 2023 Ph III GRADUATE 1/2 Ph III PAGODA / PAVILION Ph III BALATON/COMINO Virtual event Angiogenesis Monday, 14 Feb 16:30 to 17:45 CEST Virtual event MDA Wednesday, 16 Mar 16:30 to 17:30 CEST Roche ESG Day Access to Healthcare Monday, 16 May 15:00 to 16:30 CEST Virtual event ASCO Monday, 6 Jun 16:00 to 17:30 CEST Roche Pharma Day London Monday, 12 Sep 10:30 to 15:00 BST Virtual event ASH Wednesday, 14 Dec 16:00 to 17:30 CET * Outcome studies are event-driven: timelines may change; OS-overall survival; IA=interim analysis Roche 32#33Diagnostics Division Thomas Schinecker CEO Roche Diagnostics Roche#34YTD Sep 2022: Diagnostics Division sales Sales increase of +6% driven by base business and COVID-19 testing 2022 2021 Change in % CHFM CHFM CHF CER Diagnostics Division 13,848 13,305 4 6 Core Lab¹ 5,833 5,677 3 5 Point of Care 1 3,086 2,415 28 30 Molecular Lab¹ 2,735 3,030 -10 -8 Diabetes Care 1,219 1,294 -6 -3 Pathology Lab 975 889 10 10 Roche CER-Constant Exchange Rates; underlying growth of Core Lab excluding Roche Information Solutions: +5%; 1 Sales in the Point of Care customer area include sales from the Liat business (POC molecular), and sales in the Core Lab customer area include sales from the Life Science Alliances, both previously shown as part of Molecular Lab customer area. The comparative information for 2021 has been updated accordingly. In Q1 21 POC molecular sales = 90mCHF, Q2 21=92mCHF, Q3 21=175mCHF, Q4 21-194mCHF. In Q1 21 LS Alliances = 21mCHF, Q2 21-23mCHF, Q3 21-23m CHF, Q4 21=20mCHF. 34 4#35YTD Sep 2022: Diagnostics Division highlights Growing from a high base in 2021 CHFbn Core Lab 1,3 Point of Care³ Molecular Lab³ Diabetes Care -3% Pathology Lab +30% -8% YoY CER growth +5% • Immunodiagnostics (+6%) • Clinical Chemistry (+8%) • Custom biotech (-8%)³ . ⚫ POC Immunodiagnostics (+39%) • POC Molecular³ (+33%) qPCR&NAP (-28%) · Virology (-7%) . • Blood glucose monitoring (-4%) • ⚫ Insulin delivery systems (+9%) • Advanced staining (+8%) +10% EMEA² Asia-Pacific North America Latin America • Companion diagnostics (+28%) 0.0 1.0 2.0 3.0 4.0 5.0 6.0 Roche CER-Constant Exchange Rates; POC-point of care; 1 Underlying growth of Core Lab excluding Roche Information Solutions: +5%; 2 EMEA-Europe, Middle East and Africa; 3 Sales in Point of Care customer area include sales from the Liat business (POC molecular), and sales in the Core Lab customer area include sales from the Life Science Alliances, both previously shown as part of Molecular Lab customer area. The comparative information for 2021 has been updated accordingly. In Q1 21 POC molecular sales = 90mCHF, Q2 21=92mCHF, Q3 21=175mCHF, Q4 21=194mCHF. In Q1 21 LS Alliances = 21mCHF, Q2 21-23mCHF, Q3 21-23mCHF, Q4 21=20mCHF. 35#36YTD Sep 2022: Diagnostics Division regional sales Strong base business growth across all regions North America +20% ~28% of divisional sales EMEA¹ -13% ~33% of divisional sales Latin America -3% ~6% of divisional sales Asia Pacific +28% ~33% of divisional sales Growth rates at CER (Constant exchange Rates); 1 Europe, Middle East and Africa Roche 36 56#37Diagnostics Division sales growth by quarter Strong base business growth -Diagnostics Division sales growth Base business sales growth ' 55% 48% 31% 28% 18% 17% 24% 18% 9% 10% 7% 5% 2% 3% 11% 1% -2% 8% -5% -4% 0% Q1 20 Q2 20 Q3 20 Q4 20 Q1 21 Q2 21 Q3 21 Q4 21 Q1 22 Q2 22 Q3 22 -17% 0.1bn 0.6bn 0.6bn 1.1bn 1.2bn 1.3bn 1.0bn 1.2bn 1.9bn 1.2bn 0.6bn COVID-19 sales Growth rates at CER (Constant exchange Rates); 1 Quarterly sales growth excluding COVID-19 sales Roche 37#38Our contribution against COVID-19 Roche has enabled access to >1.8 billion tests to fight the COVID-19 pandemic Roche 20+ solutions Broad portfolio of COVID-19 solutions Selected launches and acquisitions Responsible pricing to enable access >1.8 billion COVID-19 tests Conducted with our products since 2020 Costs should not be a barrier to access testing ~2'000 cobas® 6800/8800 instruments placed¹ Increase over two-fold since the pandemic, enabling increased access to testing beyond COVID-19 1st SARS-CoV-2 detection test (RUO) Anti-SARS-CoV-2 test (qual. Ab lab test) SARS-COV-2 rapid Ag (POC) Acquisition of GenMark Diagnostics Launch of cobasⓇ 5800 EUA for SARS-COV-2 rapid Ag home test Elecsys® IGRA SARS-COV-2 2020 2021 2022 Test Instrument Acquisition cobasⓇ SARS-CoV-2 on cobas® 6800/8800 cobasⓇ Liat SARS- CoV-2 & Influenza A/B Anti-SARS-CoV-2 S test (quant. Ab lab test) New Antigen Test 2.02 1 cobas® 6800/8800 instruments installed base per September 2022; 2 ElecsysⓇ IGRA SARS-CoV-2 upcoming launch in end of July, 2022; 2 sensitivity of 99.00% (95% CI: 94.55 - 99.97%) and a relative specificity of 99.75% (95% CI: 98.62 -99.99%); RUO: Research use only; POC: Point of care; EUA: Emergency Use Authorization; Ab: Antibody; Ag: Antigen Acquisition of TIB Molbiol Test to detect Omicron variant SARS-CoV-2 Rapid SARS-COV-2 DUO 38#392 Roche Digital LightCyclerⓇ Filling the gap between standard PCR and sequencing Analyzer Partition engine Nanowell plates options: High sensitivity ~45μL sample, ~20k partitions Benchmark ~30μL sample, ~28k partitions 3 High resolution -15μL sample, -100k partitions PCR: Polymerase chain reaction; IVD: In-vitro diagnostic • Digital PCR system with IVD label & superior performance Key differentiators: - - Powerful analytical software & simpler workflow - no more emulsions Flexibility to tailor assays from high sensitivity to high resolution needs Industry-leading multiplexing capabilities High-medical value applications: Cancer treatment monitoring Transplant rejection monitoring COVID-19/Infectious diseases environmental surveillance 50 39 Roche#40PRAME immunohistochemistry assay Roche Enabling optimal patient prognosis via early & accurate diagnosis and treatment of melanoma Melanoma survival 5 year survival rates 99% Localized rates based on treatment per stage 1,2 68% Regional . >300k new cases and ~60k death per year caused by Melanoma cancer³ • 30% Distant • Key immunohistochemistry assay to: Help differentiate between benign and malignant lesions in skin cancer 4,5 Evaluate tumor margins in known melanoma specimens 4,5 Evaluate sentinel lymph nodes in known melanoma cases 6,7 Localized melanoma is highly curable with a simple surgical excision Roche's broad dermatology portfolio includes >50 biomarkers 1 American Cancer Society. https://www.cancer.org/cancer/melanoma-skin-cancer/detection-diagnosis-staging/survival-rates-for-melanoma-skin-cancer-by-stage.html; 2 Definitions of stages: 'Localized': There is no sign that the cancer has spread beyond the skin where it started. 'Regional': The cancer has spread beyond the skin where it started to nearby structures or lymph nodes. 'Distant': The cancer has spread to distant parts of the body, such as the lungs, liver, or skin on other parts of the body. ³ Cazzato G. et al. Genes. 2022;13: 545; 4 Lezcano, C. et al. Am J Surg Pathol 2018;42(11):1456-1465; 5 Lezcano, C. et al. Surg Pathol Clin 2021 Jun;14(2):165-175; 6 Lezcano, C. et al. Am J Surg Pathol 2020;44(4):503-508; 7 NCCN Guidelines Version 3.2022. PRAME: Preferentially expressed Antigen in Melanoma 40 40#41ElecsysⓇ Amyloid Plasma Panel clinical results Addressing the unmet need of early detection of Alzheimer's disease pathology Roche AD patients Non-AD patients 1 1 Triage Patients undergoing initial evaluation for non-specific cognitive decline¹ Elecsys Amyloid Plasma Panel² pTau 181+APOE4 sensitivity>85% specificity > 65% FDA BDD 吧吧吧 EOE 吧吧吧 ਤਾਤ 2 Confirmation Patients referred for amyloid confirmatory testing³ Elecsys CSF AD assays4 pTau/Abeta 42 Therapy Patients identified for future therapies Anti-amyloid antibodies ° O sensitivity >90% specificity >90% 2 吧吧吧 吧吧吧 EEE EEO 3 H Assumed prevalence of AD 30% in symptomatic patients; 2 Mean of clinical performance data from retrospective cohorts measured with Elecsys Amyloid Plasma Panel; 3 Alternative to PET scan; 4 FDA approval expected in Q4 2022 = 10 patients 41#42Key launches 2022 Area Pathology Lab Core Lab Instruments Molecular Lab POC Product BenchMark ULTRA PLUS DP600 cobasⓇ pure integrated solutions cobas® 5800 Digital LightCycler cobasⓇ pulse HER2 Low Breast* Pathology Lab PRAME** Description Automated immunohistochemistry/in situ hybridization (ISH) advanced staining platform with enhanced software capabilities, workflow and testing efficiency High capacity pathology slide scanner for high volume digitization applications Serum work area analyzer for low-to-medium sized labs Real-time PCR molecular testing for low volume labs Novel digital PCR platform for lab developed tests (LDTs) and in-vitro diagnostics labs Handheld device combining professional Glucose Meter and a digital platform to host Roche owned and 3rd party digital clinical decision support applications Assay for diagnosis of HER2 low expression breast cancer First immunohistochemistry assay for differential diagnosis of benign from malignant melanocytic lesions in skin cancer Roche Market Status US & CE WW US US WW US 66 US US & CE HPV Self Sampling cobasⓇ HCV Duo Tests Self sample collection device for patients at home to collect sample for cervical cancer testing Antigen/antibody combined assay for faster diagnosis of hepatitis C CE CE Core Lab Elecsys pTau/AB42 ratio Gen2 (CSF) Detect amyloid disease and enable a broader availability of testing for patients suspected of Alzheimer's Disease US cobasⓇ SARS-CoV-2 DUO Molecular Lab cobasⓇ 5800 Menu Expansion Automated RT-PCR assay for use on the cobas® 6800/8800 systems Assays to test for SARS-CoV-2, chlamydia trachomatis (CT)/neisseria gonorrhoeae (NG) and cytomegalovirus (CMV) Digital solution providing insights for chronic kidney disease patient management US² & OUS1 > > > > US & CE Navify Kidney Companion Cervical Cancer Screening CE Lab Insights Digital Solutions cobas® infinity edge suite Digital solution improving the management of screening programs for cervical cancer Portfolio of digital products to support decentralization of testing and data, to launch commercially with an open ecosystem CE CE Navify Core Integrator Data integration platform for laboratory customers across disciplines CE Payer Dashboard Population-level insights via dashboard for HCPs, Admins and Payers OUS3 Diabetes Care mySugr Pump V2.0 Extended functionalities (e.g. temporary basal rate import from a connected insulin pump), expanded smartphone compatibility OUS3 CE: European Conformity, US: FDA approval, WW: Worldwide including CE, US and China, OUS: Outside the US; PCR: Polymerase Chain Reaction; RT: Real Time; 1 Research Use Only; 2 EUA: Emergency Use Authorization; 3 Only selected countries; *HER2 Low Breast received FDA approval on 4 Oct 2022; **PRAME launched on 11 Oct 2022 42 42#43Finance Alan Hippe Chief Financial Officer Roche#44YTD Sep 2022: Highlights Sales Group sales growth of +2% • Solid Pharma and Diagnostics underlying growth Currency impact on sales • Negative currency impact especially in Q3, particularly weaker EUR and JPY, only partially offset by stronger USD Growth rates at CER (Constant exchange Rates) Roche 44#45YTD Sep 2022: Portfolio rejuvenation ongoing CHFM 46'684 +2% at CER -383 +2'397 -612 +217 -1,460 +621 -427 47'037 YTD Sep 2021 Dia base business Dia Pharma Ronapreve Actemra COVID-19 underlying sales sales sales business AHR erosion1 Fx YTD Sep 2022 YTD Sep 2022 values in reported CHFm, variances in CERm; 1AHR: Avastin, Herceptin, Rituxan/MabThera sales erosion Diversification of Roche business YTD Sep 2017 CHF 39.4bn YTD Sep 2022 CHF 47.0bn AHR Diagnostics Other pharma Ophthalmology Infectious diseases Immunology AHR Oncology AHR Roche Neuroscience Hemophilia A 45 45#46YTD Sep 2022: Regional sales development -1% -1% 0% +7% +6% +2% +1% Pharma Division 0% -427 +838 780 353 Roche -239 +236 +18 -73 United States Europe Intl. Chugai (Japan) Dia Division Group Fx1 Group CER CHF Absolute values in CHFm at Constant Exchange Rates (avg full year 2021); 1 avg. full year 2021 to avg YTD September 2022 fx impact 46 46#47YTD exchange rate swings Negative impact driven by the EUR, JPY and other Europe, partially offset by USD Roche CER sales growth YTD Sep 2022 VS. YTD Sep 2021 -1.2p +1.7% +0.1p +1.9p -0.1p -1.0p +0.1p -0.7p +0.8% CHF sales growth YTD Sep 2022 VS. YTD Sep 2021 CER EUR APAC USD LATAM JPY Other Other Europe CHF 47 CER = Constant Exchange Rates (avg full year 2021)#48Expected currency impact 2022 CHF / USD Average YTD 2022 +2% +4% +4% +5% 0.94 0.95 0.96 0.92 0.90 Average YTD 2021 0.91 0.91 0.91 Roche Assuming the 30 September 2022 exchange rates remain stable until end of 2022, 2022 impact¹ is expected to be (%p): 0.92 0.92 0.93 0.94 0.98 0.97 0.97 0.96 0.97 0.98 0.98 0.98 T Monthly avg fx rates 2022 Fx rates 30th September Q1 HY Sep FY YTD Sales -1 0 -1 -1 CHF / EUR Core -5% -6% -7% -8% operating profit 0 -2 1.09 1.09 1.09 1.08 Core EPS 0 -2 1.04 1.03 1.01 1.00 1.04 1.05 1.02 1.02 1.04 1.03 0.99 0.97 0.96 0.96 0.96 0.96 Monthly avg fx rates 2022 Fx rates 30th September 1 On group growth rates 48 48#492022 outlook Group sales growth¹ Core EPS growth¹ • Stable to low-single digit • Dividend outlook • 1 At Constant Exchange Rates (CER) Low- to mid-single digit Further increase dividend in Swiss francs Roche 49 49#50Doing now what patients need next#51Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (PRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates information Roche#52Changes to the development pipeline Q3 2022 update 2 NMES: New to phase I RG6536 vixarelimab - immunology RG6538 P-BCMA-ALLO1 - multiple myeloma New to phase II New to phase III 1 NME: 4 Als: RG7314 balovaptan - post-traumatic stress disorder RG6168 Enspryng - MOG-AD T RG6168 Enspryng - autoimmune encephalitis I Removed from phase II Removed from phase I 2 NMES: Status as of October 18, 2022 RG7907 CPAM (2) - HBV RG6147 galegenimab (HtrA1) - geographic atrophy 1 Al (removed by Chugai): CHU Oncolytic Type 5 adenovirus - esophageal cancer I RG6058 tiragolumab - 1L non-squamous NSCLC (SKYSCRAPER-06) RG3625 TNKase - stroke (FPI 2019) Roche New to registration 1 NME (First filed in China*): RG6017 crovalimab - PNH Removed from phase III 1 NME (EU): 1 Al: RG7446 Tecentriq - RCC adj Approvals RG7716 Vabysmo - DME 1 AI (EU): RG7716 Vabysmo - WAMD 1 AI (US): RG6512 Xofluza - influenza pediatric *US/EU filing expected 2023 52 52#53Roche Group development pipeline Phase I (51 NMES + 11 Als) RG6007 RG6026 HLA-A2-WT1 x CD3 AML glofitamab monotherapy + combos RG6058 tiragolumab combos heme tumors heme & solid tumors RG6076 CD19-4-1BBL combos RG7827 RG7828 CHU FAP-4-1BBL monotherapy + combos Lunsumio (mosunetuzumab) monotheraphy + combos solid tumors RG6026 glofitamab + chemo heme tumors tiragolumab + T tiragolumab +T+chemo heme tumors glypican-3 x CD3 solid tumors RG6058 tiragolumab + T RG6129 RG6160 RG6171 HLA-A2-MAGE-A4 x CD3 cevostamab (FcRH5 x CD3) giredestrant (SERD) solid tumors CHU codrituzumab HCC tiragolumab +T r/r multiple myeloma CHU CD137 switch antibody solid tumors solid tumors CHU LUNA18 solid tumors RG6114 RG6156 inavolisib (mPI3K alpha inh) EGFRvIII x CD3 CHU SPYK04 solid tumors solid tumors RG6107 RG6139 RG6180 crovalimab PD1 x LAG3 Phase II (21 NMES + 8 Als) Roche 1L ctDNA high risk DLBCL NSCLC NSCLC neoadj-adj cervical cancer 1L PD-L1+mSCCHN sickle cell disease solid tumors autogene cevumeran + pembrolizumab glioblastoma SQZ PBMC vaccine solid tumors RG6287 IBD RG6180 autogene cevumeran + T solid tumors RG6354 RG6357 zinpentraxin alfa (PRM-151) SPK-8011 1L melanoma myelofibrosis hemophilia A RG6341 asthma RG6185 belvarafenib (pan-RAF inh) + Cotellic + T solid tumors RG6358 SPK-8016 hemophilia A with inhibitors to factor VIII RG6418 RG6189 FAP-CD40 ±T solid tumors selnoflast (NLRP3 inh) inflammation RG6149 RG6194 runimotamab (HER2 x CD3) BC RG6234 GPRC5D x CD3 multiple myeloma RG6315 RG65363 RG7828 immunologic disorders astegolimab (Anti-ST2) COPD RG62995 ASO factor B IgA nephropathy vixarelimab immunology RG7854/ RG6264 Phesgo OBI RG6279 PD1-IL2v + T RG6286 HER2+ BC solid tumors colorectal cancer Lunsumio (mosunetuzumab) RG7880 efmarodocokin alfa SLE aGVHD RG6346/ TLR7 ago(3)/siRNA/PDL1 LNA HBV RG6084* RG6359 SPK-3006 RG6006 Abx MCP bacterial infections RG6319 LepB inhibitor complicated urinary tract infection RG6100 semorinemab RG6290 MAGE-A4 ImmTAC + T solid tumors RG6035 BS-CD20 MAb RG6292 CD25 MAb combos heme & solid tumors RG6091 rugonersen (UBE3A LNA) multiple sclerosis Angelman syndrome RG6102 BS-gantenerumab RG6237 latent myostatin + Evrysdi RG6323 IL15/IL15Ra-Fc ±T solid tumors RG6163 psychiatric disorders RG6416 bepranemab Pompe disease Alzheimer's Alzheimer's SMA Alzheimer's RG6330 KRAS G12C solid tumors RG6182 RG6333 CD19 x CD28+ glofitamab RG6344 BRAF inhibitor (3) r/r NHL solid tumors RG6237 latent myostatin RG6289 RG6392 RG6433 SHP2i combos RG6440 TGFB (SOF 10) RG6512 FIXa x FX RG65261 camonsertib oncology solid tumors solid tumors hemophilia solid tumors RG65382 P-BCMA-ALLO1 multiple myeloma RG7637 RG6120 RG6312 RG6351 RG65014 RG7921 CHU VEGF-Ang2 DutaFab neurodegenerative diseases neuromuscular disorders Alzheimer's psychiatric disorders nAMD RG7314 balovaptan RG7412 crenezumab post-traumatic stress disorder familial Alzheimer's healthy pts RG7816 alogabat (GABA Aa5 PAM) ASD RG7906 ralmitaront OpRegen geographic atrophy retinal disease geographic atrophy RG7935 RG6179 RG7774 AMY 109 endometriosis RG7446 Morpheus platform RG7601 Venclexta + azacitidine RG7802 cibisatamab + T solid tumors r/r MDS solid tumors Status as of October 18, 2022 New Molecular Entity (NME) Additional Indication (AI) Oncology/Hematology Immunology Infectious Diseases Metabolism Neuroscience Ophthalmology Other nAMD prasinezumab anti-IL-6 CB2 receptor agonist RG62995 ASO factor B RG-No-Roche/Genentech CHU Chugai managed SQZ-SQZ Biotechnology managed 1Repare Therapeutics managed 2Poseida Therapeutics managed 3Kiniksa Pharmaceuticals managed 4Lineage Cell Therapeutics managed 5IONIS managed *combination platform T=Tecentriq BS=Brain Shuttle OBI-On-Body Delivery System schizophrenia Parkinson's DME DR geographic atrophy 53#54Roche Group development pipeline Phase III (10 NMES + 46 Als) Kadcyla + T 2L+ HER-2+ PD-L1+ mBC RG3648 Xolair RG3502 Kadcyla + T HER-2+ eBC high-risk RG6354 zinpentraxin alfa (PRM-151) RG6026 glofitamab+chemo 2L+ DLBCL Gazyva tiragolumab + T tiragolumab +T RG6058 tiragolumab + T tiragolumab + T tiragolumab + T 1L PD-L1+ NSCLC 1L esophageal cancer locally advanced esophageal cancer stage III unresectable 1L NSCLC 1L non-squamous NSCLC RG7159 Gazyva Gazyva food allergy lupus nephritis membranous nephropathy systemic lupus erythematosus RG6013 Hemlibra¹ IPF RG6026 glofitamab² RG6396 Gavreto1 RG7596 Polivy³ RG7828 Lunsumio (mosunetuzumab)³ Xofluza RG6152 Xofluza gantenerumab RG1450 crovalimab* RG6107 crovalimab PNH aHUS gantenerumab Ocrevus higher dose RG1594 RG6114 RG6171 inavolisib (mPI3K alpha inh) giredestrant (SERD) giredestrant (SERD) 1L HR+ MBC Ocrevus SC 1L ER+/HER2- MBC RG3625 TNKase influenza, pediatric (0-1 year) influenza direct transmission prodromal to mild Alzheimer's preclinical Alzheimer's RMS & PPMS RMS & PPMS stroke RG6321 Susvimo (PDS)1 RG6152 Xofluza1 RG56413+ Ronapreve² RG6412 RG1569 Actemra³ RG7916 Evrysdi¹ Roche Registration US & EU (3 NMES + 7Als) mild to moderate hemophilia A 3L+ DLBCL RET+ MTC, TC 1L DLBCL 3 L+ FL WAMD influenza, pediatric SARS-CoV-2 hospitalised COVID-19 pneumonia SMA pediatric <2months ER+ BC adj RG6042 tominersen RG7440 RG7446 giredestrant (SERD) + Phesgo ipatasertib + abiraterone Tecentriq+platinum chemo Tecentriq Tecentriq+cabozantinib Tecentriq+cabozantinib T± chemo T + capecitabine or carbo/gem T + paclitaxel RG6168 1L ER+/HER2+ BC Enspryng Huntington's myasthenia gravis RG6168 1L CRPC NSCLC periadj NMIBC, high risk Enspryng MOG-AD 2Filed in EU RG6168 Enspryng autoimmune encephalitis 1Approved in US, filed in EU 3Approved in EU, filed in US RG6356 delandistrogene moxeparvovec (SRP-9001) DMD RG7845 fenebrutinib RMS RCC adv RG7845 fenebrutinib PPMS 2L NSCLC T + Avastin T± chemo SCCHN adj 1L TNBC TNBC adj HCC adj 1L MUC Susvimo (PDS) DME T=Tecentriq PDS-Port Delivery System with ranibizumab *First filed in China RG6321 Susvimo (PDS) DR RG7716 Susvimo (PDS) Vabysmo (faricimab) Vabysmo (faricimab) WAMD, 36-week BRVO CRVO 2L NSCLC RG7601 RG7828 RG7853 Tecentriq SC Tecentriq T+ lurbinectedin Venclexta Venclexta + azacitidine ctDNA+ high-risk MIBC 1L maintenance SCLC r/r MM t(11:14) Lunsumio (mosunetuzumab) + lenalidomide Lunsumio (mosunetuzumab) + Polivy Alecensa New Molecular Entity (NME) Additional Indication (Al) Oncology/Hematology 1L MDS 2L+ FL Immunology Infectious Diseases 2L+ DLBCL ALK+ NSCLC adj Status as of October 18, 2022 Metabolism Neuroscience Ophthalmology Other 54#55NME submissions and their additional indications Projects in phase II and III Roche RG6026 New Molecular Entity (NME) Additional Indication (Al) Oncology/Hematology Immunology Infectious Diseases Metabolism Neuroscience Ophthalmology RG6058 glofitamab+chemo 1L ctDNA+ high risk DLBCL tiragolumab +T 1L PD-L1+ cervical RG6180 autogene cevumeran 1L melanoma bepranemab RG6416 Alzheimer's zinpentraxin alfa RG6354 (PRM-151) RG7314 balovaptan post-traumatic stress Other cancer myelofibrosis tiragolumab +T Lunsumio (mosun) + disorder alogabat RG6058 locally adv esophageal RG7828 lenalidomide RG7816 (GABA Aa5 PAM) ✓ Indicates submission to health authorities has occurred Unless stated otherwise submissions are planned to occur in US and EU PDS-Port Delivery System with ranibizumab Mosun-mosunetuzumab *First filed in China 1IONIS managed cancer 2L FL ASD Lunsumio (mosun) + RG6058 tiragolumab + T 1L non-sq NSCLC RG7828 Polivy 2L+ DLBCL (US) RG7845 fenebrutinib RMS RG6058 tiragolumab + T 1L PD-L1+mSCCHN astegolimab RG6149 (anti-ST2) RG7845 fenebrutinib PPMS COPD RG6107 RG6058 crovalimab* PNH (EU, US) tiragolumab + T 1L PD-L1+ NSCLC glofitamab + chemo tiragolumab+T+/- RG6026 RG6058 chemo RG62991 2L DLBCL NSCLC neoadj/adj ASO factor B IgA nephropathy RG7906 ralmitaront schizophrenia RG6058 tiragolumab +T Stage III unresectable RG7854/ TLR7 ago (3)/ siRNA/ RG6107 crovalimab sickle cell disease RG6346/ PDL1 LNA RG7935 prasinezumab Parkinson's 1L NSCLC RG6084 HBV tiragolumab + T RG6058 1L esophageal cancer (CN) RG6107 crovalimab aHUS RG6139 PD1xLAG3 solid tumors gantenerumab RG1450 RG6321 preclinical Alzheimer's Susvimo inavolisib RG6026 glofitamab 3L+ DLBCL ✓ RG6321 (PDS) DME Susvimo RG6114 (mPI3K alpha inh) RG6171 giredestrant (SERD) semorinemab RG6100 RG6179 Alzheimer's crovalimab* 1L HR+ BC zinpentraxin alfa 1L ER+/HER2-mBC giredestrant brain shuttle RG6107 RG6321 (PDS) RG6354 (PRM-151) RG6171 PNH (CN) ✓ (SERD) RG6102 gantenerumab RG62991 gantenerumab RG1450 prodromal to mild RG7716 Alzheimer's DR (US) Vabysmo (faricimab) BRVO/CRVO IPF ER+ BC adj Susvimo (PDS) WAMD, 36-week refill anti-IL-6 DME ASO factor B geographic atrophy Alzheimer's delandistrogene giredestrant (SERD) + latent myostatin + RG6356 moxeparvovec RG6171 Phesgo RG6237 (SRP-9001) DMD (EU) 1L ER+/HER2+ BC Evrysdi SMA CB2 receptor agonist RG7774 DR 2022 2023 2024 2025 and beyond Status as of October 18, 2022 55#56Al submissions for existing products Projects in phase II and III RG6264 Phesgo OBI HER2+ BC New Molecular Entity (NME) Additional Indication (Al) Oncology/Hematology Immunology Infectious Diseases Metabolism Neuroscience Ophthalmology Other Roche RG6396 Gavreto Tumor agnostic (US) Tecentriq + cabozantinib RG7446 2L NSCLC Kadcyla + Tecentriq RG3502 2L+ HER-2+ PD-L1+ mBC RG3502 Kadcyla + Tecentriq HER-2+ eBC high-risk Tecentriq + cabozantinib RG7446 RG7446 RCC adv Tecentriq + Avastin RG7446 RG7446 HCC adj RG6413+ Ronapreve** RG7446 RG6412 SARS-CoV-2 hospitalized (EU)✓ Tecentriq² NSCLC periadj RG1594 Ocrevus SC RMS & PPMS RG7446 Tecentriq + paclitaxel TNBC adj RG7159 Actemra RG1569 RG7446 COVID-19 pneumonia¹ ✓ Tecentriq SCCHN adj TNKase Tecentriq RG3625 RG7446 RG7159 stroke ctDNA+ high-risk MIBC Tecentriq High risk NMIBC Tecentriq+ lurbinectedin 1l maintenance SCLC Gazyva Gazyva systemic lupus erythematosus membranous nephropathy Tecentriq ± chemo Venclexta RG7446 RG7601 RG3648 1L MUC r/r MM t(11:14) Xolair food allergy RG7601 Venclexta + azacitidine 1L MDS Ocrevus higher dose RG1594 Tecentriq + capecitabine RG7446 Tecentriq SC 2L NSCLC RG7446 or carbo/gem RG6152 Xofluza direct transmission RG7159 Gazyva lupus nephritis RG6168 TNBC Xofluza RG7596 Polivy 1L DLBCL (US)✓ Alecensa RG7853 RG6152 ALK+ NSCLC adj influenza, pediatric (0-1 year) RG6168 Enspryng myasthenia gravis RMS & PPMS Enspryng MOG-AD Enspryng RG6168 autoimmune encephalitis 2022 2023 2024 2025 and beyond Status as of October 18, 2022 Indicates submission to health authorities has occurred Unless stated otherwise submissions are planned to occur in US and EU 1Approved in EU, filed in US 2filing timeline based on data from interim analysis PDS-Port Delivery System with ranibizumab OBI-On-Body Delivery System **Ronapreve (casirivimab+imdevimab also known as REGEN-COV in the US) developed in collaboration with Regeneron Pharmaceuticals 56#57Major pending approvals 2022 US EU Japan-Chugai Gazyva 1L CLL Filed March 2022 Phesgo HER-2+ BC/CC Filed Sept 2022 Lunsumio (mosunetuzumab) RG7828 3L+FL RG6321 Susvimo (PDS) WAMD China Polivy RG7596 Filed Dec 2021 Actemra Filed April 2021 1L DLBCL Filed Nov 2021 RG7159 Hemlibra Polivy RG1569 COVID-19 pneumonia RG6013 mild to moderate hemophilia A RG7596 Filed Jan 2022 Filed Oct 2021 r/r DLBCL Filed Dec 2021 RG6264 Cotellic RG7421 histiocytosis RG6396 Filed April 2022 RG7446 Tecentriq ASPS RG6152 Filed June 2022 Polivy RG7596 1L DLBCL (US) RG7916 Filed Aug 2022 RG6413+ RG6412 RG6026 RG1569 Gavreto RET+ MTC, TC Filed Nov 2021 Xofluza influenza pediatric Filed Nov 2021 Evrysdi SMA presymptomatic pediatric <2mo Filed Nov 2021 Ronapreve* SARS-CoV-2 hospitalized Filed Jan 2022 glofitamab 3L+ DLBCL Filed April 2022 Actemra SS-ILD Filed Aug 2022 RG6107 crovalimab PNH Filed Aug 2022 Status as of October 18, 2022 New Molecular Entity (NME) Additional Indication (Al) Oncology/Hematology Immunology Infectious Diseases Metabolism Neuroscience Ophthalmology Other Roche PDS-Port Delivery System with ranibizumab *Ronapreve (casirivimab+imdevimab also known as REGEN-COV in the US) developed in collaboration with Regeneron Pharmaceuticals 57 57#58Major granted approvals 2022 US EU China Vabysmo (faricimab) RG7716 DME Jan 2022 RG7596 Polivy 1L DLBCL May 2022 RG7446 Tecentriq NSCLC adj March 2022 RG1569 Vabysmo (faricimab) RG7716 WAMD RG7446 Tecentriq NSCLC adj RG1569 Actemra RA SC RG7716 Japan-Chugai Actemra COVID-19 pneumonia Jan 2022 Vabysmo (faricimab) DME Jan 2022 June 2022 April 2022 Actemra Lunsumio (mosunetuzumab) Rozlytrek March 2022 Vabysmo (faricimab) RG1569 GCA IV RG7828 3L+ FL RG6268 NTRK+ solid tumors RG7716 WAMD Feb 2022 June 2022 July 2022 Evrysdi Vabysmo (faricimab) Rozlytrek March 2022 Perjeta + Herceptin RG7916 SMA presymptomatic pediatric <2mo RG7716 May 2022 Xofluza DME Sept 2022 Vabysmo (faricimab) RG6268 ROS1+ NSCLC RG1273 Aug 2022 RG6152 influenza pediatric Aug 2022 RG7716 WAMD Sept 2022 RG7446 RG6013 RG105 RG7596 HER-2+ CRC March 2022 Tecentriq NSCLC adj May 2022 Hemlibra acquired Hemophilia A June 2022 Rituxan NMOSD June 2022 Polivy 1L DLBCL Aug 2022 Status as of October 18, 2022 New Molecular Entity (NME) Additional Indication (Al) Oncology/Hematology Immunology Infectious Diseases Metabolism Neuroscience Ophthalmology Other Roche 58#59Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (PRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates information Roche#60Hemlibra (emicizumab, RG6013) Factor VIII mimetic for treatment of hemophilia A Indication Hemophilia A patients without inhibitors to factor VIII Roche Hemophilia A patients with and without inhibitors to Factor VIII, dosing every 4 weeks Phase/study # of patients Phase III HAVEN 3 N=135 Patients on FVIII episodic treatment prior to study entry: ARM A: Hemlibra prophylaxis qw ☐ ARM B: Hemlibra prophylaxis q2w Phase III HAVEN 4 N=46 Multicenter, open-label, non-randomized study to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of Hemlibra administered every 4 weeks. ☐ Part I: Pharmacokinetic run-in part (N=6) Part II: Expansion part (N=40) Design Primary endpoint Status " ARM C: Episodic FVIII treatment; switch to Hemlibra prophylaxis possible after 24 weeks Patients on FVIII prophylaxis prior to study entry: ARM D: Hemlibra prophylaxis qw Number of bleeds over 24 weeks FPI Q3 2016, recruitment completed Q2 2017 Study met primary and key secondary endpoints Q4 2017 FDA granted Breakthrough Therapy Designation April 2018 Data presented at WFH 2018 Filed in US (priority review) and EU in Q2 2018 Data published in NEJM 2018; 379:811-822 Number of bleeds over 24 weeks FPI Q1 2017, recruitment completed Q2 2017 Pharmacokinetic run-in data at ASH 2017 Positive interim analysis outcome reported Q4 2017 Data presented at WFH 2018 Interim data filed in US and EU in Q2 2018 Data published in Lancet Haematology 2019 Jun;6(6):e295-e305 Approved in US Q4 2018 and EU Q1 2019 CT Identifier In collaboration with Chugai NCT02847637 ASH-American Society of Hematology; WFH-World Federation of Hemophilia; NEJM-New England Journal of Medicine NCT03020160 60 60 Hemophilia#61Hemlibra (emicizumab, RG6013) Factor VIII mimetic for treatment of hemophilia A Indication Hemophilia A patients with and without inhibitors to Factor VIII Hemophilia A mild to moderate patients without inhibitors to Factor VIII Phase/study Phase III HAVEN 5 Phase III HAVEN 6 Roche # of patients Design N=85 Patients with Hemophilia regardless of FVIII inhibitor status on prophylactic or episodic treatment prior to study entry: ☐ ARM A: Hemlibra prophylaxis qw ARM B: Hemlibra prophylaxis q4w ARM C: No prophylaxis (control arm) Number of bleeds over 24 weeks N=70 Multicenter, open-label study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of Hemlibra in patients with mild or moderate Hemophilia A without FVIII inhibitors Hemlibra qw (1.5mg/kg), q2w (3.0mg/kg) or q4w (6.0mg/kg) (patients preference) Safety and efficacy Primary endpoint Status FPI Q2 2018 Recruitment completed Q1 2019 Filed in China Q2 2020 Approved in China Q2 2021 CT Identifier NCT03315455 In collaboration with Chugai ASH-American Society of Hematology; ISTH=International Society on Thrombosis and Haemostasis ☐ FPI Q1 2020 Recruitment completed Q1 2021 Interim data presented at ASH 2021 and primary data presented at ISTH 2022 Filed in EU Q4 2021 NCT04158648 61 Hemophilia#62Alecensa (alectinib, RG7853) New CNS-active inhibitor of anaplastic lymphoma kinase Indication Treatment-naïve ALK+ advanced NSCLC Adjuvant ALK+ NSCLC Phase/study # of patients Phase III ALEX N=286 Design Primary endpoint " " ARM A: Alecensa 600mg BID ARM B: Crizotinib 250mg BID Progression-free survival Recruitment completed Q3 2015 Primary endpoint met Q1 2017 Data presented at ASCO 2017, 2018, ESMO 2017, 2018 " Status " Data published in NEJM 2017; 377:829-838 CT Identifier " CNS data presented at ESMO 2017 Final PFS and updated OS presented at ESMO 2019 Approved in US Q4 2017 (priority review) and in EU Q4 2017 NCT02075840 Phase III ALINA N=255 " ARM A: Alecensa 600mg BID ARM B: Platinum-based chemotherapy Disease-free survival FPI Q3 2018 Recruitment completed Q4 2021 NCT03456076 In collaboration with Chugai ALK-anaplastic lymphoma kinase; CNS= Central nervous system; NSCLC=non-small cell lung cancer; OS-Overall survival, PFS=Progression-free survival; ASCO-American Society of Clinical Oncology; NEJM-New England Journal of Medicine; ESMO-European Society for Medical Oncology Roche 62 62 Oncology#63Kadcyla (trastuzumab emtansine, RG3502) First ADC for HER2-positive breast cancer Indication Phase/study # of patients Design Primary endpoint Status HER2-positive early breast cancer (BC) high-risk patients 2L+ HER-2 positive PD-L1 positive metastatic breast cancer (mBC) Phase III KATHERINE N=1,484 ■ ARM A: Kadcyla 3.6mg/kg q3w ☐ ☐ ARM B: Herceptin Invasive disease-free survival " " ☐ Recruitment completed Q4 2015 Stopped at pre-planned interim data analysis for efficacy Q4 2018 Data presented at SABCS 2018 BTD granted by FDA in Q1 2019 US filling completed under RTOR Q1 2019 and filed in EU Q1 2019 Approved in US Q2 2019 and in EU Q4 2019 Data published in NEJM 2019; 380:617-628 Phase III KATE 3 N=320 ARM A: Kadcyla plus Tecentriq ARM B: Kadcyla plus placebo ☐ HER2-positive early breast cancer (BC) high-risk patients Phase III ASTEFANIA N=1,700 ARM A: Kadcyla plus Tecentriq ARM B: Kadcyla plus placebo Progression-free survival and overall survival Invasive disease-free survival FPI Q1 2021 FPI Q2 2021 CT Identifier In collaboration with ImmunoGen, Inc. NCT01772472 NCT04740918 NCT04873362 ADC=antibody drug conjugate; BTD=Breakthrough therapy designation; HER2=Human Epidermal growth factor Receptor 2; SABCS-San Antonio Breast Cancer Symposium; RTOR=Real time oncology review; NEJM-New England Journal of Medicine Roche 63 Oncology#64Perjeta (pertuzumab, RG1273) First-in-class HER2 dimerization inhibitor Indication Phase/study # of patients Design Adjuvant HER2-positive breast cancer (BC) Phase III APHINITY N=4,803 ARM A: Perjeta (840mg loading dose, 420mg q3w) plus Herceptin for 52 weeks plus chemotherapy (6-8 cycles) ☐ ARM B: Placebo plus Herceptin (52 weeks) plus chemotherapy (6-8 cycles) Invasive disease-free survival (iDFS) Primary endpoint Status Primary endpoint met Q1 2017 Data presented at ASCO 2017 and published in NEJM 2017; 377:122-131 Filed in US and EU Q3 2017 Approved in US Q4 2017 (priority review) and EU Q2 2018 CT Identifier " 6-year IDFS data presented at SABCS 2019 8-year iDFS data presented at ESMO virtual 2022 NCT01358877 HER2-Human Epidermal growth factor Receptor 2, IDFS=Invasive disease-free survival; ASCO-American Society of Clinical Oncology; NEJM-New England Journal of Medcine; SABCS-San Antonio Breast Cancer Symposium 64 Roche Oncology#65Phesgo (pertuzumab/trastuzumab, RG6264) FDC of Perjeta and Herceptin for subcutaneous administration Indication HER2-positive early breast cancer (BC) Phase/study # of patients Design Primary endpoint Status Phase III FeDeriCa N=500 FDC of Perjeta and Herceptin for SC administration (Phesgo) in combination with chemotherapy in neoadjuvant/adjuvant setting ARM A: Perjeta IV plus Herceptin IV plus chemotherapy ◉ ARM B: Phesgo plus chemotherapy Trough Serum Concentration (Ctrough) of Perjeta during cycle 7 Primary endpoint met Q3 2019 Data presented at SABCS 2019 Data published in Lancet Oncology 2021 Jan;22(1):85-97 Phase II PHranceSCa N=160 ARM A: Perjeta and Herceptin IV followed by Phesgo ARM B: Phesgo followed by IV Percentage of patients who preferred Perjeta and Herceptin FDC SC Final analysis completed, 85% patients preferred FDC SC ◉ Data presented at ESMO 2020 Data published in Eur J Cancer 2021 Jul;152:223-232 ☐ Filed in US Dec 2019 & in EU Jan 2020; Approved in US Q2 2020 and EU Q4 2020 ■ HER2-positive breast cancer (BC) Phase I¹ N=144 ARM A: Phesgo administered using a handheld syringe with hypodermic needle (SC) ARM B: Phesgo administered using the on- body delivery system (OBI) AUCO-62*, Cmax** ☐ FPI Q2 2022 CT Identifier NCT03493854 In collaboration with West Pharmaceuticals and Halozyme NCT03674112 NCT05275010 *AUCO-62-comparability of area under the time-concentration curve from the start of dosing to 63 days; **Cmax=maximum serum concentration for pertuzumab and trastuzumab within Phesgo; FDC=Fixed-dose combination; Phesgo-FDC of Perjeta and Herceptin for SC administration; HER2-Human Epidermal growth factor Receptor 2, IV-intravenous; SC-Subcutaneous; ASCO=American Society of Clinical Onclogy; NEJM-New England Journal of Medcine; SABCS-San Antonio Breast Cancer Symposium; Eur J Cancer-European Journal of Cancer; ESMO-European Society for Medical Oncology 65 Roche Oncology#66Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy - lung cancer Indication Adjuvant NSCLC Periadjuvant NSCLC Phase/study # of patients Design Phase III IMpower010 N=1,280 Following adjuvant cisplatin-based chemotherapy ARM A: Tecentriq ARM B: Best supportive care Phase III IMpower030 N=450 ARM A: Tecentriq plus platinum-based chemotherapy ARM B: Platinum-based chemotherapy Primary endpoint ☐ Disease-free survival Status CT Identifier " " Trial amended from PD-L1+ selected patients to all-comers FPI for all-comer population Q4 2016 Recruitment completed Q3 2018 Study met primary endpoint Q1 2021 Data presented at ASCO, WCLC and ESMO 2021 Filed in US (priority review) and EU Q2 2021 Approved in US Q4 2021 and EU Q2 2022 NCT02486718 ◉ Event-free survival FPI Q2 2018 Recruitment completed Q3 2021 NCT03456063 NSCLC-non-small cell lung cancer; PD-L1-Programmed cell death-ligand 1; ASCO-American Society of Clinical Oncology; ESMO-European Society for Medical Oncology; WCLC=World Conference on Lung Cancer 66 Roche Oncology#67Roche Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy - lung cancer Indication 1L maintenance extensive-stage SCLC 2L NSCLC previously treated with an immune checkpoint inhibitor Phase/study # of patients Design Primary endpoint Phase III IMforte1 N=450 ■ ARM A: Platinum-etoposide + Tecentriq followed by maintenance Tecentriq plus lurbinectedin ■ ARM B: Platinum-etoposide + Tecentriq followed by maintenance Tecentriq Progression-free survival and overall survival Status CT Identifier FPI Q4 2021 NCT05091567 ¹In collaboration with Jazz Pharma, 2In collaboration with Exelixis NSCLC=non-small cell lung cancer; PD-L1-Programmed cell death-ligand 1; SCLC-small cell lung cancer ■ Phase III CONTACT-012 N=366 ARM A: Tecentriq plus cabozantinib ARM B: Docetaxel Overall survival ☐ FPI Q3 2020 ■ Recruitment completed Q4 2021 NCT04471428 67 Oncology#68Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy - lung cancer Indication Phase/study # of patients " ■ 1L NSCLC Cohort A: ALK+ (Alecensa) Cohort B: RET+ (Alecensa) Phase II/III B-FAST Modular design Cohort C: bTMB-high (Tecentriq) Stage IV NSCLC Phase Ib/III IMscin0011 N=371 ☐ Design " Cohort D: ROS1+ (Rozlytrek) ◉ Cohort E: BRAF+ (Zelboraf plus Cotellic plus Tecentriq) Cohort F: EGFR Exon 20+ (Tecentriq, Avastin, carboplatin, pemetrexed) Phase lb Dose finding, Tecentriq SC followed by Tecentriq IV Phase III 2L NSCLC non inferiority of Tecentriq SC vs Tecentriq IV " " Cohort G: GDC-6036 or Docetaxel ◉ Cohort A/B/D: Objective response rate " Cohort C/G: Progression-free survival Primary endpoint " Cohort E: Time in response Cohort F: Investigator-assessed objective response rate FPI Q3 2017 " Recruitment completed for cohort A Q3 2018 and cohort C Q3 2019 Cohort A: primary endpoint met Q3 2019; approved in US Q1 2021 " Status ☐ Cohort C: did not show statistical significance for primary endpoint, data presented at ESMO 2021 Cohort F: FPI Q2 2021 Observed concentration of Tecentriq in serum at cycle 1 FPI Q4 2018 ◉ FPI in phase III part Q4 2020 Recruitment completed Q1 2022 Study met its primary end point Q3 2022 CT Identifier ¹SC with Halozyme's rHuPH20/ Halozyme's human hyaluronidase NCT03178552 NCT03735121 ALK-Anaplastic lymphoma kinase; BRAF-V-raf murine sarcoma viral oncogene homolog B; bTMB-Blood-based tumor mutational burden; EGFR-Epidermal growth factor receptor; IV-intravenous; NSCLC-non-small cell lung cancer; PD-L1=Programmed cell death-ligand 1; RET-Rearranged during transfection; ROS1-C-ros oncogene 1; SC-Subcutaneous, IV-Intravenous; ESMO-European Society for Medical Oncology 68 Roche Oncology#69Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy - SCCHN and melanoma Indication Adjuvant squamous cell carcinoma of the head and neck (SCCHN) Phase/study # of patients ARM A: Tecentriq 1200mg q3w Design Primary endpoint Status CT Identifier ☐ ARM B: Placebo Event-free survival and overall survival ◉ FPI Q1 2018 Recruitment completed Q1 2020 SCCHN-squamous cell carcinoma of the head and neck Phase III IMvoke010 N=406 NCT03452137 Roche 69 。 Oncology#70Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy - urothelial carcinoma Indication 1L metastatic urothelial carcinoma (UC) High-risk non-muscle-invasive bladder cancer (MIBC) ctDNA+, high-risk muscle-invasive bladder cancer (MIBC) Phase/study # of patients Design ■ Primary endpoint " " Status ☐ CT Identifier " Phase III IMvigor 130 N=1,200 ARM A: Tecentriq plus gemcitabine and carboplatin or cisplatin ARM B: Tecentriq monotherapy ARM C: Placebo plus gemcitabine and carboplatin or cisplatin Progression-free survival, overall survival and safety FPI Q3 2016 FPI for arm B (amended study) Q1 2017 Recruitment completed Q3 2018 Study met co-primary endpoint of PFS Q3 2019 Data presented at ESMO 2019 and AACR 2021 Data published in Lancet 2020 May 16;395(10236):1547-1557 NCT02807636 Phase III ALBAN N=516 ARM A: BCG induction and maintenance ARM B: Tecentriq plus BCG induction and maintenance " Recurrence-free survival FPI Q4 2018 NCT03799835 Phase III IMvigor011 N=495 ARM A: Tecentriq monotherapy " ARM B: Placebo Recurrence-free survival ◉ FPI Q2 2021 NCT04660344 BCG-Bacille Calmette-Guérin; PD-L1-Programmed cell death-ligand 1; PFS-Progression-free survival; AACR-American Association for Cancer Research; ESMO-European Society for Medical Oncology Roche 70 10 Oncology#71Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy - renal cell cancer Indication Phase/study # of patients Design Primary endpoint Status CT Identifier " Advanced renal cell carcinoma (RCC) after immune checkpoint inhibitor treatment ARM A: Tecentriq plus cabozantinib ARM B: Cabozantinib Progression-free survival and overall survival " FPI Q3 2020 Recruitment completed Q4 2021 1In collaboration with Exelixis PD-L1-Programmed cell death-ligand 1; DFS=Disease-free survival Phase III Contact-031 N=500 NCT04338269 Roche 71 Oncology#72Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy - hepatocellular carcinoma Indication Adjuvant hepatocellular carcinoma (HCC) Phase/study # of patients Design " ARM A: Tecentriq plus Avastin ARM B: Active surveillance ☐ Primary endpoint Recurrence-free survival ☐ FPI Q4 2019 Status CT Identifier Recruitment completed Q4 2021 Phase III IMbrave050 N=668 NCT04102098 PD-L1-Programmed cell death-ligand 1; ESMO-European Society for Medical Oncology; NEJM-New England Journal of Medicine; RTOR=Real time oncology review 72 Roche Oncology#73Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy - breast cancer Indication Previously untreated metastatic triple negative breast cancer (TNBC) Phase/study # of patients Design Primary endpoint Phase III IMpassion 130 N=902 " ARM A: Tecentriq plus nab-paclitaxel ARM B: Placebo plus nab-paclitaxel ☐ Progression-free survival and overall survival (co-primary endpoint) " Study met co-primary endpoint of PFS in both PD-L1+ and ITT populations Q3 2018 " " Primary PFS and interim OS data presented at ESMO 2018 and ASCO 2019 Data published in NEJM 2018; 379:2108-2121 Status " US accelerated approval Q1 2019 - US indication voluntarily withdrawn Q3 2021 CT Identifier ☐ Approved in EU Q3 2019 Final OS presented at ESMO Asia 2020 NCT02425891 ☐ Phase III IMpassion 132 N=572 ARM A: Tecentriq plus capecitabine or carbo/gem ARM B: Placebo plus capecitabine or carbo/gem Overall survival FPI Q1 2018 NCT03371017 Carbo/gem-gemcitabine and carboplatin; ITT-Intention to treat; PD-L1-Programmed cell death-ligand 1; PFS-Progression-free survival; OS-Overall survival; ESMO-European Society for Medical Oncology; ASCO=American Society of Clinical Oncology; NEJM=New England Journal of Medicine Roche 73 Oncology#74Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy - breast cancer Indication Neoadjuvant triple negative breast cancer (TNBC) Adjuvant triple negative breast cancer (TNBC) Phase/study # of patients Design Primary endpoint " Status CT Identifier Phase III IMpassion031 N=333 " ARM A: Tecentriq plus nab-paclitaxel ARM B: Placebo plus nab-paclitaxel " " • Percentage of participants with pathologic complete response FPI Q3 2017 Recruitment completed Q2 2018 Study met primary endpoint Q2 2020 Data presented at ESMO 2020 Data published in Lancet 2020;396 (10257):1090-1100 Filed in EU Q4 2020 - application withdrawn Q3 2021 NCT03197935 PD-L1-Programmed cell death-ligand 1; ESMO-European Society for Medical Oncology " Roche Phase III IMpassion030 N=2,300 ARM A: Tecentriq plus paclitaxel followed by Tecentriq plus AC, followed by Tecentriq maintenance ■ ARM B: Placebo plus paclitaxel followed by AC followed by placebo Invasive disease-free survival FPI Q3 2018 NCT03498716 74 14 Oncology#75Venclexta (venetoclax, RG7601) Novel small molecule Bcl-2 selective inhibitor - chronic lymphocytic leukemia Indication Phase/study # of patients Untreated chronic lymphocytic leukemia (CLL) patients with coexisting medical conditions Phase III CLL14 N=445 " ARM A: Venclexta plus Gazyva Relapsed or refractory chronic lymphocytic leukemia (CLL) Phase III MURANO Roche Untreated fit chronic lymphocytic leukemia (CLL) patients Design Primary endpoint " Status CT Identifier ARM B: Chlorambucil plus Gazyva Progression-free survival Study met primary endpoint at pre-specified interim analysis Q4 2018 BTD granted by FDA Q1 2019 US filing completed under RTOR Q1 2019 Filed in EU Q2 2019 Data presented at ASCO 2019, ASH 2019, ASH 2020 and EHA 2021 and EHA 2022 Data published in NEJM 2019; 380:2225-2236 Approved US Q2 2019 and EU Q1 2020 NCT02242942 " ◉ ■ N=389 ARM A: Venclexta plus Rituxan ARM B: Rituxan plus bendamustine Progression-free survival Study met primary endpoint at interim analysis Data presented at ASH 2017 Filed in US Q4 2017 and EU Q1 2018 Data published in NEJM 2018; 378:1107-20 Updated data presented at ASCO 2018, ASH 2019 and ASH 2020 Approved in US Q2 2018 (priority review) EU approval Q4 2018 NCT02005471 " ☐ Phase III CristaLLo N=165 ARM A: Venclexta plus Gazyva ARM B: Fludarabine plus cyclophosphamide plus Rituxan or bendamustine plus Rituxan MRD negativity rate in peripheral blood at 15 months FPI Q2 2020 NCT04285567 Joint project with AbbVie, in collaboration with The Walter and Eliza Hall Institute Bcl-2-B-cell lymphoma 2; BTD=Breakthrough therapy designation; CLL=chronic lymphocytic leukemia; MRD-Minimal Residual Disease; ASH-American Society of Hematology; ASCO-American Society of Clinical Oncology; EHA-European Hematology Association; RTOR=Real time oncology review; NEJM-New England Journal of Medicine 75 Oncology#76Venclexta (venetoclax, RG7601) Novel small molecule Bcl-2 selective inhibitor - multiple myeloma Indication Phase/study # of patients Design Dose escalation cohort: Venclexta dose escalation Safety expansion cohort (t11;14): Venclexta expansion Combination: Venclexta plus dexamethasone Phase I N=117 Safety and maximum tolerated dose Primary endpoint FPI Q4 2012 Data presented at ASCO 2015 Status CT Identifier Relapsed or refractory multiple myeloma (MM) Updated data presented at ASCO 2016 and ASH 2016 Data published in Blood 2017; 130(22):2401-2409 and Am J Hematol 2021 Apr 1;96(4):418-427 NCT01794520 Joint project with AbbVie, in collaboration with The Walter and Eliza Hall Institute; Phase III CANOVA N=244 Venclexta plus dexamethazone vs pomalidomide plus dexamethasone in t(11;14) positive r/r MM Progression-free survival FPI Q4 2018 Bcl-2-B-cell lymphoma 2; MM-multiple myeloma; r/r-Relapsed or refractory; ASCO-American Society of Clinical Oncology; ASH-American Society of Hematology NCT03539744 Roche 76 Oncology#77Venclexta (venetoclax, RG7601) Novel small molecule Bcl-2 selective inhibitor - myelodysplastic syndromes Indication Relapsed or refractory myelodysplastic syndromes (MDS) Treatment-naive myelodysplastic syndromes (MDS) Newly diagnosed higher-risk myelodysplatic syndrome (MDS) Phase/study # of patients Design Primary endpoint Status CT Identifier Phase lb Phase lb Phase III VERONA Roche Cohort 1: N=70 ARM A: Venclexta 400 mg ARM B: Venclexta 800 mg Cohort 2: ARM A: Venclexta plus azacitidine Study expansion: " Venclexta or Venclexta plus azacitidine Safety, efficacy, Pharmacokinetics and Pharmacodynamics FPI Q1 2017 Recruitment completed Q1 2022 NCT02966782 N=129 Dose escalation cohort: Venclexta plus azacitidine dose escalation Safety expansion cohort Safety, Pharmacokinetics, RPTD FPI Q1 2017 Data presented at ASH 2019, ASH 2020 and ASCO 201 BTD granted by FDA July 2021 Recruitment completed Q1 2022 NCT02942290 " N=500 ARM A: Venclexta plus azacitidine ARM B: Placebo plus azacitidine Complete remission rate and overall survival FPI Q4 2020 NCT04401748 Joint project with AbbVie, in collaboration with The Walter and Eliza Hall Institute Bcl-2-B-cell lymphoma 2; BTD=Breakthrough therapy designation; RPTD=Recommended phase II dose; ASH-American Society of Hematology 77 Oncology#78Polivy (polatuzumab vedotin, RG7596) ADC targeting CD79b to treat B cell malignancies Indication Phase/study # of patients Design ☐ Primary endpoint ■ Status CT Identifier In collaboration with Seagen Inc. " 1L DLBCL Phase III POLARIX N=879 " ARM A: Polivy plus R-CHP ARM B: R-CHOP Progression-free survival FPI Q4 2017 Recruitment completed Q2 2019 Study met primary endpoint Q3 2021 Data presented at ASH 2021 Filed in EU, Japan and China Q4 2021 Published in NEJM 2022 Jan 27;386(4):351-363 " Approved in EU Q2 2022 ☐ Filed in US Q3 2022 NCT03274492 DLBCL-diffuse large B cell lymphoma; R-CHP-Rituxan, cyclophosphamide, hydroxydoxorubicin, prednisone; R-CHOP-Rituxan, cyclophosphamide, doxorubicin, vincristine, and prednisone; ASH-American Society of Hematology, NEJM-New England Journal of Medicine Roche 78 Oncology#79Gavreto (pralsetinib, RG6396) Highly selective RET inhibitor Indication Phase/study # of patients Design " RET+ NSCLC, thyroid cancer and other advanced solid tumors Phase I/II ARROW N=647 Part I: Gavreto 30-600mg dose escalation Part II: Gavreto 400mg dose expansion Primary endpoint ■ Status " ■ Safety and efficacy Data presented at ASCO (NSCLC) and ESMO (MTC) 2020 Filed in US and EU for RET fusion-positive NSCLC and US for RET-mutant MTC and RET fusion-positive thyroid cancer Approved in US Q3 2020 in RET fusion-positive NSCLC, in Q4 2020 in RET- mutant MTC and RET fusion-positive thyroid cancer Updated data presented at ASCO 2021 and 2022 Data published in Lancet Oncol 2021 Jul;22(7):959-969 and Lancet Diabetes & Endocrinology Aug 2021;9(8):491-501 Approved in EU for RET fusion-positive NSCLC Q4 2021 CT Identifier NCT03037385 1L RET fusion-positive, metastatic NSCLC Phase III AcceleRET Lung N=250 " ARM A: Gavreto 400mg ◉ ARM B: Platinum-based chemotherapy +/- pembrolizumab Progression-free survival Study initiated in Q1 2020 NCT04222972 In collaboration with Blueprint Medicines NSCLC-non-small cell lung cancer; MTC-medullary thyroid cancer; RET=Rearranged during transfection; ASCO=American Society of Clinical Oncology; ESMO-European Society for Medical Oncology Roche 79 Oncology#80Lunsumio (mosunetuzumab, CD20 x CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 3L+ FL, 3L+ DLBCL & other relapsed or refractory NHL 1L DLBCL Relapsed or refractory DLBCL Phase/study # of patients Phase I/II Phase Ib/II N=746 " Dose escalation study of Lunsumio as single agent and in combination with Tecentriq " N=160 Design " Primary endpoint Expansion cohorts for r/r FL, r/r DLBCL and SC in r/r NHL Safety, tolerability, dose/schedule, PK and response rates " Lunsumio plus CHOP Lunsumio plus CHP plus Polivy Lunsumio plus CHP-Polivy vs Rituximab plus CHP-Polivy Safety/tolerability and response Phase Ib/II N=262 Lunsumio plus Polivy, randomised cohorts ■ ARM A: Lunsumio SC plus Polivy ☐ ARM B: Rituximab plus Polivy ■ Safety/tolerability and response " Data in r/r NHL presented at ASH 2018 and 2019, and in r/r FL at ASH 2020 and ASH 2021 " FPI Q1 2019 " FPI Q3 2018 " " BTD granted by FDA Q2 2020 Data for Lunsumio plus CHOP presented at ASH 2020 Initial data presented at ASCO and ASH 2021 SC cohort FPI Q2 2021 " Status Filed in EU and rolling submission in US Q4 2021 Approved in EU Q2 2022 " Filed in US (priority review) Q2 2022 ■ Data published in J. Clin. Oncol. 40(5)481-491 and in the Lancet July 2022: doi.org/10.1016/S1470- 2045(22)00335-7 CT Identifier NCT02500407 NCT03677141 NCT03671018 FL-follicular lymphoma; DLBCL-diffuse large B cell lymphoma; r/r-relapsed/refractory; NHL-non-Hodgkin's lymphoma; R=Rituximab; SC=subcutaneous; CHOP-cyclophosphamide, doxorubicin, vincristine, and prednisone; CHP-cyclophosphamide, doxorubicin, and prednisone); PK-Pharmacokinetics; BTD=Breakthrough Therapy Designation; ASH-American Society of Hematology; ASCO-American Society of Clinical Oncology 80 Roche Oncology#81Lunsumio (mosunetuzumab, CD20 x CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 1L DLBCL & 2L DLBCL following 1L induction Relapsed or refractory 2L+ FL Phase/study # of patients Design Primary endpoint Status CT Identifier ◉ " Phase I N=92+80 (cohort C) Cohort A: Lunsumio monotherapy (after a response to prior systemic chemotherapy) Cohort B: Lunsumio monotherapy (1L treatment in elderly/frail) Cohort C: Lunsumio SC plus Polivy in 1L elderly/unfit ▪ Safety/tolerability and response FPI Q2 2019 - Cohort B FPI Q3 2019 - Cohort A Initial data presented at ASH 2020 (Cohort B) Cohort C: FPI Q1 2021 NCT03677154 Phase lb N=27 Lunsumio plus lenalidomide safety run-in for phase III Lunsumio SC plus lenalidomide ■ Safety/tolerability and response FPI Q3 2020 Initial data presented at ASH 2021 FL-follicular lymphoma; DLBCL-diffuse large B cell lymphoma; r/r-relapsed/refractory; SC=subcutaneous; ASH-American Society of Hematology NCT04246086 Roche 81 Oncology#82Lunsumio (mosunetuzumab, CD20 x CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 2L+ FL Relapsed or refractory FL Phase/study # of patients Design Phase III CELESTIMO N=400 ARM A: Lunsumio plus lenalidomide ARM B: Rituxan plus lenalidomide Phase Ib/II N=118 ARM A: Lunsumio plus tiragolumab ARM B: Lunsumio plus tiragolumab plus Tecentriq Dose escalation phase Dose expansion phase Primary endpoint Status CT Identifier Relapsed or refractory CLL Phase Ib/II N=56 ☐ Lunsumio monotherapy (3L+ CLL) Progression-free survival " Phase lb: Dose-limiting toxicity FPI Q4 2021 Phase II: Best complete response FPI Phase lb Q2 2022 Safety, dose-limiting toxicity and RPTD FPI Q1 2022 NCT04712097 NCT05315713 FL=follicular lymphoma; r/r=relapsed/refractory; RPTD=Recommended Phase II Dose; CLL=Chronic lymphocytic leukemia Roche 82 42 Oncology#83Lunsumio (mosunetuzumab, CD20 x CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Phase/study # of patients Design Primary endpoint Status CT Identifier " ARM A: Lunsumio plus Polivy ARM B: R + GemOx Progression-free survival FPI Q2 2022 DLBCL-diffuse large B cell lymphoma; SCT=stem cell transplant; R=Rituxan/MabThera; GemOx-Gemcitabin und Oxaliplatin 2L+ SCT ineligible DLBCL Phase III SUNMO N=222 NCT05171647 Roche 83 83 Oncology#84Ocrevus (ocrelizumab, RG1594) Humanized monoclonal antibody selectively targeting CD20+ B cells Indication Relapsing multiple sclerosis (RMS) Primary progressive multiple sclerosis (PPMS) Phase/study # of patients Design Status Phase III OPERA I N=821 96-week treatment period: ARM A: Ocrevus 2x300mg IV followed by 600mg IV every 24 weeks ARM B: Interferon ẞ-1a (Rebif) Phase III OPERA II N=835 96-week treatment period: ARM A: Ocrevus 2x300mg IV followed by 600mg IV every 24 weeks ARM B: Interferon ẞ-1a (Rebif) Phase III ORATORIO N=732 120-week treatment period: ARM A: Ocrevus 2x300mg IV every 24 weeks ARM B: Placebo Primary endpoint Annualized relapse rate at 96 weeks versus Rebif Annualized relapse rate at 96 weeks versus Rebif " Sustained disability progression versus placebo by EDSS Primary endpoint met Q2 2015, OLE ongoing Primary data presented at ECTRIMS 2015 " Primary endpoint met Q3 2015 CT Identifier Updated data presented at AAN and ECTRIMS 2017, AAN and EAN 2018 Data published in NEJM 2017; 376:221-234 Data published on COVID-19 in Mult Scler Relat Disord on Ocrevus treated people with MS, doi.org/10.1016/j.msard.2020.102725 Primary data presented at ECTRIMS 2015, updated data presented at AAN and ECTRIMS 2017, AAN and EAN 2018 Data published in NEJM 2017; 376:209-220 NCT01247324 Approved in US Q1 2017 and EU Q1 2018 NCT01412333 IV-intravenous; EDSS-Expanded Disability Status Scale; OLE=Open label extension; ECTRIMS-European Committee for Treatment and Research in Multiple Sclerosis; AAN=Annual Meeting of the American Academy of Neurology; EAN-European Academy of Neurology; NEJM-New England Journal of Medicine NCT01194570 00 84 Roche Neuroscience#85Ocrevus (ocrelizumab, RG1594) Humanized monoclonal antibody selectively targeting CD20+ B cells Indication Relapsing and primary progressive multiple sclerosis (RMS & PPMS) Primary progressive multiple sclerosis (PPMS) Phase/study # of patients Design Phase Illb ENSEMBLE PLUS N=1,225 Substudy of ongoing phase IIIb, open-label, single-arm ENSEMBLE study Shorter two-hour infusion time Phase Illb ORATORIO-HAND N~ 1,000 120-week treatment period: ARM A: Ocrevus 600mg IV q24w ARM B: Placebo Roche Primary endpoint Status " Safety, measured by the proportion of patients with IRRs following the first randomised 600 mg infusion (frequency/severity assessed during and 24-hours post infusion) Filed in US and EU Q1 2020 Approved in EU Q2 2020 and US Q4 2020 Data published Neurol, Neuroimmunol and Neuroinflamm Sept 2020; 7(5), e807 Time to upper limb disability progression confirmed for at least 12 weeks FPI Q3 2019 CT Identifier IV-intravenous; IRR=Infusion Related Reaction NCT03085810 NCT04035005 85 Neuroscience#86Ocrevus (ocrelizumab, RG1594) Humanized monoclonal antibody selectively targeting CD20+ B cells Indication Primary progressive multiple sclerosis (PPMS) Relapsing multiple sclerosis (RMS) Phase/study # of patients Design Primary endpoint Status CT Identifier Phase IIIb GAVOTTE N-699 Phase IIIb MUSETTE N-786 PPMS & RMS Phase III Ocarina II1 N-232 120-week treatment period: ARM A: Ocrevus 600mg IV every 24 weeks ARM B: Ocrevus 1200mg if body weight <75kg or 1800mg if body weight > or equal to 75kg every 24 weeks Superiority of Ocrevus higher dose versus approved dose on CCDP FPI Q4 2020 " " 120-week treatment period: ARM A: Ocrevus 600mg IV every 24 weeks ARM B: Ocrevus 1200mg if body weight <75kg or 1800mg if body weight > or equal to 75kg every 24 weeks ARM A: Ocrevus IV ARM B: Ocrevus SC Superiority of Ocrevus higher dose versus approved dose on CCDP FPI Q4 2020 Recruitment completed Q4 2021 Serum Ocrevus area under the concentration- time curve (AUCW1-12) at week 12 FPI Q2 2022 NCT04548999 1SC with Halozyme's rHuPH20/ Halozyme's human hyaluronidase CCDP-composite confirmed disability progression; IV-intravenous; SC-Subcutaneous NCT04544436 NCT05232825 98 86 Roche Neuroscience#87Evrysdi (risdiplam, RG7916) Oral SMN2 splicing modifier Indication Spinal muscular atrophy (SMA) Phase/study # of patients Design Primary endpoint Status Phase II/III FIREFISH N=21 (Part 1), 41 (Part 2) Open-label study in infants with type 1 SMA Part I (dose-finding): At least 4 weeks Part II (confirmatory): 24 months " Safety, tolerability, PK/PD and efficacy 12-month data from Part I presented at AAN, CureSMA and EAN 2019; 16-month data presented at WMS 2019 Study met primary endpoint in Part II Q1 2020 Part II 1-year data presented at AAN 2020, Part I 2- year data at WMS 2020 Part I data published in NEJM 2021;384:915-923 Part II 2-year data presented at AAN 2021 Part II 1-year data published in NEJM 2021;385:427-435 3-year data presented at EPNS 2022 Phase II/III SUNFISH N=51 (Part 1), 180 (Part 2) Randomized, double-blind, placebo-controlled study in adult and pediatric patients with type 2 or type 3 SMA: " Part I (dose-finding): At least 12 weeks Part II (confirmatory): 24 months Safety, tolerability, PK/PD and efficacy Recruitment completed for part 2 Q3 2018 12-month data from Part I presented at AAN, CureSMA and EAN 2019; 16-month data presented at WMS 2019 Study met primary endpoint in Part II Q4 2019 Part II 1-year data presented at SMA Europe 2020, 2-year data at MDA 2021 and 3-year data at MDA 2022 Part II 1-year data published in Lancet Neurology, 2022; 21 (1) 42-52 ☐ Phase II JEWELFISH N=174 Open-label single arm study in adult and pediatric patients with previously treated SMA type 1, 2 and 3 " Safety, tolerability, PK/PD FPI Q1 2017 Data presented at WMS 2017, AAN 2018, WMS 2018, CureSMA 2019, WMS 2019, CureSMA 2020 and 2021 Recruitment completed Q1 2020 Orphan drug designation granted by FDA Q1 2017 and EU Q1 2019, PRIME designation in Q4 2018 Approved in US Q3 2020 and EU Q1 2021 NCT02908685 CT Identifier NCT02913482 In collaboration with PTC Therapeutics and SMA Foundation NCT03032172 SMA=Spinal muscular atrophy; SMN=survival motor neuron; PK/PD=Pharmacokinetics/Pharmacodynamics; PRIME=priority medicines; AAN=American Academy of Neurology; WMS=World Muscle Society; EAN-European Academy of Neurology; NEJM-New England Journal of Medicine; MDA-Muscular Dystrophy Association; CureSMA=Annual SMA Conference; EPNS-European Paediatric Neurology Society 87 Roche Neuroscience#88Evrysdi (risdiplam, RG7916) Oral SMN2 splicing modifier Indication Spinal muscular atrophy (SMA) Phase/study # of patients Design Phase II RAINBOWFISH N=25 Open-label, single-arm, multicenter study in infants aged from birth to 6 weeks who have been genetically diagnosed with Spinal muscular atrophy but are not yet presenting with symptoms Primary endpoint Status CT Identifier ARM A: Phase II/III MANATEE N=180 Roche ☐ ☐ Part I: GYM329 plus Evrysdi for 24 weeks, followed by GYM329 plus Evrysdi for 72 weeks Part II: GYM329 plus Evrysdi for 72 weeks ARM B: Placebo plus Evrysdi comparator Change from baseline in revised hammersmith scale (RHS) score after week 72 of treatment Proportion of participants with two copies of the SMN2 gene (excluding the known SMN2 gene modifier mutation c.859G>C) and baseline CMAP>=1.5 millivolt who are sitting without support FPI Q3 2019 Recruitment completed Q1 2022 Initial data presented at CureSMA, WMS 2021, MDA and WMS 2022 Filed in US and EU Q4 2021 Approved in US Q2 2022 ■ Safety, PK/PD and muscle biomarkers ■ FPI Part I Q2 2022 Orphan Drug Designation granted by FDA in Q4 2021 for GYM329 NCT03779334 NCT05115110 In collaboration with PTC Therapeutics and SMA Foundation SMN=survival motor neuron; CMAP=compound muscle action potential; PK/PD-Pharmacokinetics/Pharmacodynamics; WMS-World Muscle Society; CureSMA=Annual SMA Conference; MDA-Muscular Dystrophy Association 88 Neuroscience#89Enspryng (satralizumab, RG6168, SA237) Anti-IL-6 receptor humanized monoclonal antibody Indication Neuromyelitis optica spectrum disorder (NMOSD) Phase/study # of patients Enspryng monotherapy: Design Primary endpoint Status CT Identifier " Phase III SAkuraStar N=95 ARM A: Enspryng 120mg SC monthly ARM B: Placebo SC monthly Efficacy (time to first relapse), safety and PK/PD " Primary endpoint met Q4 2018 Data presented at ECTRIMS 2019 Published in Lancet Neurology 2020; 19(5): 402-412 NCT02073279 Add-on therapy of Enspryng: Phase III SAkuraSky N=83 ARM A: Enspryng 120mg SC monthly ARM B: Placebo SC monthly Both arms on top of baseline therapies: azathioprine, mycophenolate mofetil or oral corticosteroids Efficacy (time to first relapse), safety and PK/PD " FPI Q3 2017 ■ Primary endpoint met Q3 2018 Data presented at ECTRIMS 2018 and AAN 2019 Published in NEJM 2019; 381:2114-2124 BTD granted by FDA Q4 2018 Filed in EU Q3 2019; US acceptance of filing Q4 2019 Approved in US Q3 2020 and EU Q2 2021 " NCT02028884 *Trials managed by Chugai (Roche opted-in) BTD=Breakthrough therapy designation; PK/PD-Pharmacokinetics/Pharmacodynamics; SC-Subcutaneous; ECTRIMS-European Committee for Treatment and Research in Multiple Sclerosis; AAN-American Academy of Neurology; NEJM New England Journal of Medicine Roche 89 Neuroscience#90Enspryng (satralizumab, RG6168, SA237) Anti-IL-6 receptor humanized monoclonal antibody Indication Phase/study # of patients Design " Generalised myasthenia gravis (MG) Myelin oligodendrocyte glycoprotein antibody disease (MOG-AD) Phase III Luminesce N=240 Phase III METEOROID N=152 Autoimmune encephalitis (AE) Phase III CIELO N=152 ARM A: Enspryng plus standard of care ARM B: Placebo plus standard of care ARM A: Enspryng at weeks 0, 2, 4 (loading doses) and maintenance doses q4w ARM B: Placebo ARM A: Enspryng at weeks 0, 2, 4 (loading doses) and maintenance doses q4w ARM B: Placebo Roche Primary endpoint Status Mean change from baseline in total MG-ADL score at week 24 in AChR+ population Orphan Drug Designation granted in US Q1 2021 FPI Q4 2021 Time from randomization to the first occurrence of a MOG-AD relapse FPI Q3 2022 Orphan Drug Designation granted by FDA in Q4 2021 " Efficacy (proportion of participants with mRS score improvement ≥ 1 from baseline and no use of rescue therapy at week 24) and safety FPI Q3 2022 Orphan Drug Designation granted for NMDAR AIE in US Q3 22 CT Identifier In collaboration with Chugai NCT04963270 NCT05271409 NCT05503264 MG-ADL= Myasthenia Gravis Activities of Daily Living; AChR-Acetylcholine receptor; MOG-AD-Myelin Oligodendrocyte Glycoprotein Antibody Disease; AE=Autoimmune encephalitis, mRS-Modified Rankin Scale; NMDAR AIE= Anti- N-Methyl-D-Aspartic Acid Receptor Autoimmune Encephalitis; PK/PD-Pharmacokinetics/Pharmacodynamics 90 00 Neuroscience#91Gazyva (obinutuzumab, RG7159) Immunology development program Indication Lupus nephritis Membranous nephropathy Roche Phase/study # of patients Design Phase II NOBILITY N=126 ARM A: Gazyva 1000mg IV plus mycophenolate mofetil/mycophenolic acid ARM B: Placebo IV plus mycophenolate mofetil/ mycophenolic acid Phase III REGENCY N=252 ARM A: Gazyva 1000mg IV (6 doses through Week 52) plus mycophenolate mofetil ARM B: Gazyva 1000 mg IV (5 doses through Week 52) plus mycophenolate mofetil ARM C: Placebo IV plus mycophenolate mofetil " Phase III MAJESTY N=140 ARM A: Gazyva 1000mg IV dosed at baseline and weeks 0, 2, 24, and 26 on top of renin- angiotensin inhibitors ARM B: Tacrolimus treatment for 12 months Primary endpoint Percentage of participants who achieve complete renal response (CRR) Recruitment completed Q4 2017 " Primary endpoint met Q2 2019 ☐ BTD granted by the FDA Q3 2019 Status CT Identifier Data presented at ASN and ACR 2019 Published in Ann Rheum Dis 2022 Jan;81(1):100- 107 NCT02550652 Percentage of participants who achieve complete renal response (CRR) ◉ FPI Q3 2020 Percentage of patients who achieve complete remission at week 104 FPI Q2 2021 NCT04221477 In collaboration with Biogen BTD=Breakthrough therapy designation; IV=Intravenous; ASN=American Society of Nephrology; ACR=American College of Rheumatology NCT04629248 97 91 Immunology#92Gazyva (obinutuzumab, RG7159) Immunology development program Indication Phase/study Systemic lupus erythematosus (SLE) Phase III ALLEGORY # of patients N=200 ☐ ■ ARM A: Gazyva 1000mg IV on Day 1 and Weeks 2, 24 and 26. ARM B: Placebo IV Design Primary endpoint Status CT Identifier In collaboration with Biogen IV=Intravenous Percentage of participants who achieve Systemic Lupus Erythematosus Responder Index (SRI) at week 52 ■ FPI Q4 2021 NCT04963296 92 44 Roche Immunology#93Actemra/RoActemra (tocilizumab, RG1569) Interleukin 6 receptor inhibitor Indication Phase/study # of patients Phase III COVACTA¹ N=450 ARM A: Actemra plus standard of care ARM B: Placebo plus standard of care Design Adult hospitalised with severe COVID-19 pneumonia Primary endpoint Status ■ Clinical status assessed using 7-Category Ordinal Scale (Day 28) FPI Q1 2020 Recruitment completed Q2 2020 Primary endpoint not met Q3 2020 Published in NEJM 2021; 384:1503-1516 CT Identifier NCT04320615 ◉ Phase III REMDACTA² N=650 ARM A: Remdesivir plus Actemra ARM B: Remdesivir plus placebo ■ Time to hospital discharge or ready for discharge FPI Q2 2020 Recruitment completed Q1 2021 Primary endpoint not met Q1 2021 Published in Intensive Care Med 2021 doi: 10.1007/s00134-021-06507-x Filed in EU Q3 2021 Approved in EU Q4 2021 Filed in US Q1 2022 1In collaboration with US Biomedical Advanced Research and Development Authority (BARDA); 2In collaboration with Gilead Sciences, Inc. NEJM-New England Journal of Medicine Roche NCT04409262 93 Immunology#94Actemra/RoActemra (tocilizumab, RG1569) Interleukin 6 receptor inhibitor Indication Phase/study # of patients Design Primary endpoint Status CT Identifier " " Adult hospitalised with severe COVID-19 pneumonia Phase II MARIPOSA N=100 ARM A: 8 mg/kg Actemra plus standard of care ARM B: 4mg/kg Actemra plus standard of care Phase III EMPACTA N=379 Conducted in sites known to provide critical care to underserved and minority populations that often do not have access to clinical trials ARM A: Actemra plus standard of care ARM B: Placebo plus standard of care Pharmacodynamics and pharmacokinetics FPI Q2 2020 Recruitment completed Q2 2020 Published in Open Forum Infect Dis 2021 Dec 4;9(1) NEJM-New England Journal of Medicine NCT04363736 Roche Cumulative proportion of participants requiring mechanical ventilation by day 28 " FPI Q2 2020 Primary endpoint met Q3 2020 Published in NEJM 2021 Jan 7;384(1):20-30 Filed in EU Q3 2021 Approved in EU Q4 2021 Filed in US Q1 2022 NCT04372186 94 24 Immunology#95Xolair (omalizumab, RG3648) Humanized monoclonal antibody that selectively binds to IgE Indication Food allergy Phase/study Phase III OUTMATCH1 # of patients N=225 Xolair by SC injection either q2w or q4w for 16 to 20 weeks Design Primary endpoint Number of participants who successfully consume ≥600mg of peanut protein without dose-limiting symptoms Status CT Identifier FPI Q3 2019 In collaboration with Novartis; 1 Sponsor of the study is the National Institute of Allergy and Infectious Diseases (NIAID) IgE-Immunoglobulin E; SC-Subcutaneous NCT03881696 95 Roche Immunology#96Lunsumio (mosunetuzumab, CD20 x CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Phase/study # of patients Design ■ ARM A: Lunsumio SC on either Day 1 or on Days 1 and 8 Systemic lupus erythematosus (SLE) ARM B: Fractionated (divided) dose of Lunsumio SC on Days 1 and 8 Safety Primary endpoint FPI January 2022 Status CT Identifier SC=subcutaneous Phase I N=50 NCT05155345 96 Roche Immunology#97Susvimo (PDS, RG6321) First eye implant to achieve sustained delivery of a biologic medicine Indication Wet age-related macular degeneration (wAMD) Roche Phase/study # of patients Design Phase III Archway N=418 ARM A: Port delivery system with ranibizumab q24w ARM B: Intravitreal ranibizumab q4w Phase II+III extension Portal N=1,000 Patients from LADDER or Archway will receive refills of 100mg/mL ranibizumab q24w (patients without the PDS will receive the PDS and subsequent refills) ☐ Phase Illb Velodrome N=442 ARM A: Port delivery system with ranibizumab 936w ARM B: Port delivery system with ranibizumab q24w Primary endpoint Status CT Identifier Change in BCVA from baseline at the average of week 36 and week 40 ☐ FPI Q3 2018 ■ Recruitment completed Q2 2019 Study met primary endpoint Q2 2020 Primary endpoint data presented at ASRS 2020, 44/48 week data at Angiogenesis 2021 and 2- year data at Angiogenesis 2022 Filed in US (PRIME) and EU Q2 2021 Approved in US Q4 2021 NCT03677934 " 1 Safety and long term efficacy FPI Q3 2018 Change in BCVA from baseline averaged over weeks 68 and 72 FPI Q3 2021 NCT03683251 NCT04657289 BCVA=best corrected visual acuity; wAMD-wet age-related macular degeneration; ASRS-American Society of Retinal Specialists; PDS-Port Delivery System with ranibizumab; PRIME=Priority review 97 97 Ophthalmology#98Susvimo (PDS, RG6321) First eye implant to achieve sustained delivery of a biologic medicine Indication Diabetic macular edema (DME) Diabetic retinopathy (DR) without center-involved diabetic macular edema (DME) Phase/study # of patients Design Primary endpoint Status CT Identifier Phase III Pagoda N=545 " ARM A: Port delivery system with ranibizumab q24w " ARM B: Intravitreal ranibizumab q4w Change in BCVA from baseline at the average of week 48 and week 52 ☐ FPI Q3 2019 Recruitment completed Q2 2021 NCT04108156 Phase III Pavilion N=160 Roche ARM A: Intravitreal ranibizumab (X2) followed by PDS implant (refill 936w) ARM B: Q4w comprehensive clinical monitoring until participants receive PDS (refill q36w) Percentage of participants with a ≥2-step improvement from baseline on the ETDRS-DRSS at Week 52 " FPI Q3 2020 Recruitment completed Q3 2021 BCVA=best corrected visual acuity; ETDRS-Early Treatment Diabetic Retinopathy Study; DRSS-Diabetic Retinopathy Severity Scale; PDS-Port Delivery System with ranibizumab NCT04503551 98 Ophthalmology#99Vabysmo (faricimab, RG7716) Bispecific antibody to simultaneously bind Ang-2 and VEGF-A Indication Center-involving diabetic macular edema (CI-DME) Phase/study # of patients ARM A: Faricimab q8w Design Phase III YOSEMITE N=940 ARM B: Faricimab PTI up to q16w ARM C: Aflibercept, q8w Primary endpoint " Change from baseline in BCVA at 1 year FPI Q3 2018 Recruitment completed Q3 2019 Study met primary endpoint Q4 2020 Data presented at Angiogenesis 2021 Status ◉ ARM A: Faricimab q8w Phase III RHINE N=951 ARM B: Faricimab PTI up to q16w ARM C: Aflibercept, q8w " " " Change from baseline in BCVA at 1 year FPI Q4 2018 Recruitment completed Q3 2019 Study met primary endpoint Q4 2020 Data presented at Angiogenesis 2021 Filed in US and EU Q2 2021 Published in the Lancet 2022 Feb 19;399(10326):741-755. 2-year data presented at Angiogenesis 2022 Approved in US Q1 2022 and EU Q3 2022 " CT Identifier NCT03622580 Ang-2-Angiopoietin-2; VEGF-Vascular endothelial growth factor; PTI-Personalized Treatment Interval; BCVA-best corrected visual acuity Roche NCT03622593 99 99 Ophthalmology#100Vabysmo (faricimab, RG7716) Bispecific antibody to simultaneously bind Ang-2 and VEGF-A Indication Wet age related macular degeneration (wAMD) Phase/study # of patients Design Phase III TENAYA N=671 " ARM A: Faricimab 6.0mg q16w flexible after 4 IDs ARM B: Aflibercept 2.0mg q8w after 3 IDs " ◉ " Change from baseline in BCVA week 40, 44 & 48 " Primary endpoint " Status " Phase III LUCERNE N=658 ARM A: Faricimab 6.0mg q16w flexible after 4 IDs ARM B: Aflibercept 2.0mg q8w after 3 IDs Change from baseline in BCVA week 40, 44 & 48 FPI Q1 2019 Recruitment completed Q4 2019 Study met primary endpoint Q1 2021 Data presented at Angiogenesis 2021 " ◉ FPI Q1 2019 Recruitment completed Q4 2019 Study met primary endpoint Q1 2021 Data presented at Angiogenesis 2021 Filed in US and EU Q2 2021 Published in Lancet 2022 Feb 19;399(10326):729-740 ☐ Approved in US Q1 2022 and EU Q3 2022 Π 2-year data presented at ASRS 2022 CT Identifier NCT03823287 BCVA-best corrected visual acuity; Ang-2-Angiopoietin-2; VEGF-Vascular endothelial growth factor; IDs-initiating doses; ASRS-American Society of Retina Specialists NCT03823300 100 Roche Ophthalmology#101Vabysmo (faricimab, RG7716) Bispecific antibody to simultaneously bind Ang-2 and VEGF-A Indication Macular edema (ME) secondary to branch retinal vein occlusion (RVO) Phase/study # of patients Design " Primary endpoint Status CT Identifier Phase III BALATON N=570 " ARM A: Faricimab, q4w/PTI ARM B: Aflibercept, q4w Change from baseline in BCVA at week 24 FPI Q1 2021 Recruitment completed Q1 2022 NCT04740905 PTI-Personalized Treatment Interval; BCVA-best corrected visual acuity; Ang-2-Angiopoietin-2; VEGF-Vascular endothelial growth factor " ◉ Roche Macular edema (ME) secondary to central retinal vein occlusion (RVO) ARM A: Faricimab, q4w/PTI ARM B: Aflibercept, q4w Phase III COMINO N=750 " Change from baseline in BCVA at week 24 FPI Q1 2021 Recruitment completed Q1 2022 NCT04740931 101 Ophthalmology#102Xofluza (baloxavir marboxil, RG6152, S-033188) Small molecule, novel CAP-dependent endonuclease inhibitor Indication Influenza Roche Phase/study # of patients Design Phase III miniSTONE 1 (0-1 year old) N=30 Xofluza on Day 1 (based on body weight and age) in healthy pediatric patients from birth to <1 year with influenza-like symptoms Phase III miniSTONE 2 (1-<12 years old) N=176 Healthy pediatric patients 1 to <12 years of age with influenza-like symptoms ARM A: Xofluza ARM B: Tamiflu Phase Illb CENTERSTONE N=3,160 Reduction of direct transmission of influenza from otherwise healthy patients to household contacts ARM A: Xofluza ARM B: Placebo Safety Primary endpoint Status CT Identifier FPI Q1 2019 In collaboration with Shionogi & Co., Ltd. CAP=Catabolite Activating Protein NCT03653364 " Safety ■ Primary endpoint met Q2 2019 Data presented at OPTIONS X 2019 Filed in US Q1 2020 Data published in Pediatric Infectious Disease 2020 Aug;39(8):700-705 Filed in EU Q4 2021 Approved in the US (age 5 years and older) Q3 2022 NCT03629184 " Percentage of household contacts who are PCR-positive for influenza by day 5 post randomization of index patients FPI Q4 2019 NCT03969212 102 Infectious Diseases#103Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (PRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates information Roche#104Ipatasertib (RG7440, GDC-0068) Highly selective small molecule inhibitor of Akt Indication Phase/study # of patients Design Primary endpoint ■ Status CT Identifier " " " ARM A: Ipatasertib plus abiraterone ARM B: Placebo plus abiraterone 1L castration-resistant prostate cancer (CRPC) rPFS in patients with PTEN loss tumors and overall population Phase III IPATential150 N=1,100 FPI Q2 2017 Recruitment completed Q1 2019 Study met co-primary endpoint in rPFS in patients with PTEN loss tumors Q2 2020 Data presented at ESMO 2020 and interim OS at ASCO 2022 Published in Lancet 2021; 398:131-142 NCT03072238 Akt-Protein Kinase B; PTEN=Phosphatase and Tensin homolog; rPFS=Radiographic progression-free survival; ESMO-European Society for Medical Oncology, ASCO-American Society of Clinical Oncology Roche 104 Oncology#105Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT Indication 1L NSCLC PD-L1 TPS>50% Stage III unresectable 1L NSCLC Phase/study Phase III SKYSCRAPER-01 # of patients N=500-560 ARM A: Tiragolumab plus Tecentriq ARM B: Placebo plus Tecentriq Design Phase III SKYSCRAPER-03 N=800 ARM A: Tiragolumab plus Tecentriq for up to 12 months ARM B: Durvalumab for up to 12 months Overall survival and progression-free survival ◉ Progression-free survival Primary endpoint FPI Q1 2020 FPI Q3 2020 Status Recruitment completed Q3 2021 Study did not meet one of its primary endpoints, PFS Q2 2022 CT Identifier NCT04294810 NCT04513925 NSCLC=Non-small cell lung cancer; ES-SCLC-Extensive stage small cell lung cancer; PD-L1-Programmed cell death-ligand 1; TPS-Tumor Proportion Score; PFS-Progression-free survival 105 Roche Oncology#106Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT Indication Metastatic and/or recurrent PD-L1+ cervical cancer (CC) Neoadjuvant and adjuvant NSCLC 1L non-squamous NSCLC Phase/study # of patients Design Phase II SKYSCRAPER-04 N=172 " ARM A: Tiragolumab plus Tecentriq ARM B: Tecentriq " Roche Phase II SKYSCRAPER-05 N=82 ARM A: (PD-L1 high) neoadjuvant tiragolumab plus Tecentriq followed by adjuvant tiragolumab plus Tecentriq or adjuvant chemotherapy ARM B: (PD-L1 all-comers) neoadjuvant tiragolumab plus Tecentriq plus chemo followed by adjuvant tiragolumab plus Tecentriq Pathologic complete response, major pathological response and safety ■ FPI Q2 2021 " " Phase III SKYSCRAPER-06 N=540 ARM A: Tiragolumab plus Tecentriq plus pemetrexed plus chemo followed by maintenance tiragolumab plus Tecentriq plus pemetrexed ARM B: Placebo plus pembrolizumab plus pemetrexed plus chemo followed by maintenance placebo plus pembrolizumab plus pemetrexed Objective response rate, progression-free survival and overall survival FPI Q4 2020 Objective response rate " Primary endpoint FPI Q2 2020 Status CT Identifier NCT04300647 NSCLC-Non-small cell lung cancer; PD-L1-Programmed cell death-ligand 1 NCT04832854 NCT04619797 106 Oncology#107Roche Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT Indication Phase/study # of patients Locally advanced esophageal cancer (EC) Phase III SKYSCRAPER-07 1L esophageal cancer (EC) Phase III SKYSCRAPER-08 1L recurrent/metastatic PD-L1 positive squamous cell head and neck carcinoma (SCCHN) Phase II SKYSCRAPER-09 N=120 Design " Primary endpoint Status CT Identifier N=750 N=500 ■ ARM A: Tiragolumab plus Tecentriq ☐ ☐ ARM B: Tecentriq plus placebo ARM A: Tiragolumab plus Tecentriq plus cisplatin and paclitaxel ARM C: Placebo plus placebo Progression-free survival (A vs C) Overall survival (A vs C, hierarchical, B vs C hierarchical) FPI Q3 2020 NCT04543617 NSCLC-Non-small cell lung cancer; PD-L1-Programmed cell death-ligand 1 ■ ARM B: Placebo plus placebo plus cisplatin and paclitaxel " ARM A: Tiragolumab plus Tecentriq ARM B: Tecentriq plus placebo Overall survival and progression-free survival Objective response rate FPI Q4 2020 Recruitment completed Q4 2021 NCT04540211 FPI Q1 2021 Recruitment completed Q2 2022 NCT04665843 107 Oncology#108Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT Indication Solid tumors NSCLC Roche Relapsed or refractory multiple myeloma (MM) or r/r B-cell NHL Phase/study # of patients " Design Primary endpoint Status CT Identifier Phase I Phase II CITYSCAPE Phase I N=540 Phase la: Dose escalation and expansion of tiragolumab Phase lb: Dose escalation and expansion of tiragolumab in combination with Tecentriq and/or other anti-cancer therapies Safety, tolerability, PK variability and preliminary efficacy " FPI Q2 2016 Data presented at AACR 2020 " " N=135 ARM A: Tecentriq plus tiragolumab ARM B: Tecentriq monotherapy Overall response rate and progression-free survival FPI Q3 2018 Recruitment completed Q2 2019 Data presented at ASCO 2020 and WCLC and ESMO IO 2021 BTD granted by FDA Q4 2020 Published in Lancet Oncol 2022 Jun;23(6):781-792 ☐ N=52 Phase la: Tiragolumab monotherapy Phase Ib: Tiragolumab plus daratumumab (r/r MM) or rituximab (r/r NHL) Safety, tolerability, PK/PD and preliminary efficacy FPI Q2 2019 NCT02794571 NCT03563716 NCT04045028 BTD=Breakthrough therapy designation; MM-Multiple myeloma; NSCLC=Non-small cell lung cancer; r/r-Relapsed refractory; NHL-Non-Hodgkin's lymphoma; PK-Pharmacokinetics; PD=Pharmacodynamics; ASCO=American Society of Clinical Oncology; AACR-American Association for Cancer Research; WCLC=World Conference on Lung Cancer; ESMO IO-European Society for Medical Oncology - Immuno-Oncology 108 Oncology#109Glofitamab (CD20-TCB, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Relapsed or refractory Non-Hodgkin's lymphoma (NHL) Roche Phase/study # of patients Design Primary endpoint Status CT Identifier Phase I N=700 Cohort 1: Single-agent dose escalation study Initial dose escalation Expansion cohort in r/r DLBCL Expansion cohort in r/r FL All patients will receive pretreatment with a single dose of Gazyva (1000mg) Cohort 2: Glofitamab plus Gazyva (i.e. continuous treatment with Gazyva) Efficacy, safety, tolerability and pharmacokinetics FPI Q1 2017 Data presented at ASH 2018, ICML and ASH 2019; EHA and ASH 2020; ASCO, EHA, ICML and ASH 2021; ASCO and EHA 2022 Data published online June 2021 J Clin Oncology 39:18:1959-1970 Filed in EU April 2022 NCT03075696 Phase lb N=140 Dose escalation and expansion ARM A: Glofitamab plus Tecentriq ARM B: Glofitamab plus Polivy Phase I N=18-36 Glofitamab SC Part 1 dose escalation Safety " Safety ARM A: FPI Q2 2018 FPI Q3 2021 " Data presented at ASH 2019 and ASH 2021 ARM B: FPI Q4 2020 NCT03533283 ISRCTN17975931 DLBCL=diffuse large B cell lymphoma; FL=Follicular lymphoma; r/r-Relapsed or refractory; SC=subcutenous; ASCO-American Society of Clinical Oncology; ASH-American Society of Hematology; EHA-European Hematology Association; ICML-International Conference on Malignant Lymphoma 109 Oncology#110Glofitamab (CD20-TCB, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Non-Hodgkin's lymphoma (NHL) 2L+ SCT-ineligible DLBCL Phase/study # of patients Phase lb Part I: 15-60 Phase III STARGLO N=270 Roche Part II: ~66-104 ■ Part I: Dose-finding for the combination of glofitamab plus G/R-CHOP in r/r indolent NHL ■ Part II: Dose expansion glofitamab plus G/R-CHOP or R-CHOP in 1L DLBCL Design " Part III: Glofitamab plus R-CHP plus Polivy ARM A: Glofitamab plus gemcitabine and oxaliplatin, followed by up to 4 cycles of glofitamab monotherapy ARM B: Rituxan in combination with gemcitabine and oxaliplatin A single dose of Gazyva will be administered 7 days prior to the first dose of glofitamab Primary endpoint Status CT Identifier Safety " Part I: FPI Q1 2018 Part II: FPI Q1 2021 Data presented at ASH 2021 NCT03467373 " Overall survival " FPI Q1 2021 NCT04408638 DLBCL-diffuse large B cell lymphoma; SCT=stem cell transplant; CHOP-cyclophosphamide, doxorubicin, vincristine and prednisone; R=Rituxan/MabThera; G-Gazyva; NHL-Non-Hodgkin's lymphoma; r/r=Relapsed or refractory ASH-American Society of Hematology 110 Oncology#111Glofitamab (CD20-TCB, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Phase/study # of patients Design 1L ctDNA high risk DLBCL Phase II N=40 ■ Glofitamab plus R-CHOP (glofitamab is introduced as a consolidation to R-CHOP at cycle 3-8 in patients ctDNA+ at cycle 2) " EOT PET-CR Primary endpoint Status CT Identifier FPI Q1 2022 NCT04980222 ctDNA-circulating tumor DNA; DLBCL-diffuse large B cell lymphoma; R-CHOP-Rituxan, cyclophosphamide, doxorubicin, vincristine and prednisone; PET=positron emission tomography; EOT PET-CR-End of treatment PET- complete response rate 111 Roche Oncology#112Inavolisib (RG6114, GDC-0077) A potent, orally available, and selective PI3Ka inhibitor Indication Phase/study # of patients Design PIK3CA-mutant HR+ metastatic breast cancer (mBC) Phase III INAVO120 N=400 ■ ARM A: Inavolisib plus palbociclib plus fulvestrant ARM B: Placebo plus palbociclib plus fulvestrant Progression-free survival Primary endpoint FPI Q1 2020 Status CT Identifier NCT04191499 PIK3CA mutant solid tumors and metastatic ER+ HER2-neg breast cancer Phase I Roche N=256 Monotherapy and in combination with standard of care (letrozole; letrozole plus palbociclib; fulvestrant) Stage 1: Dose escalation Stage 2: Dose expansion ■ Safety, tolerability and pharmacokinetics FPI Q4 2016 Preclinical/molecule discovery data presented at AACR 2017 Data presented at SABCS 2019, 2020 and 2021 NCT03006172 ER-Estrogen receptor; HR-Hormon receptor; HER2-Human Epidermal growth factor Receptor 2; PI3K-Phosphoinositide 3-Kinase; AACR-American Association for Cancer Research; SABCS-San Antonio Breast Cancer Symposium 112 Oncology#113Giredestrant (SERD (3), RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator Indication Phase/study # of patients Design ER+ HER2-neg metastatic breast cancer (mBC) ER+ HER2-neg Stage I-III operable breast cancer (BC) Phase I N=181 Dose escalation and expansion at RPTD ☐ Giredestrant monotherapy and in combination with palbociclib and/or LHRH agonist Neoadjuvant ER+ breast cancer (BC) Phase I N=75 Open-label, pre-operative administration Dose escalation Phase II coopERA Breast Cancer N=221 ARM A: Giredestrant followed by giredestrant plus palbociclib ARM B: Anastrazole followed by anastrazole plus palbociclib Primary endpoint Safety Safety, tolerability and PK/PD ☐ FPI Q4 2017 FPI Q3 2019 Data presented at SABCS 2019, ASCO 2020, ASCO 2021 and SABCS 2021 Π Data presented at ASCO 2021 Status CT Identifier NCT03332797 NCT03916744 Roche Safety, tolerability and PK/PD FPI Q3 2020 Data presented at ESMO and SABCS 2021; ASCO 2022 Data (biomarker subgroup analysis) presented at ESMO 2022 NCT04436744 ER-Estrogen receptor; HER2-Human Epidermal growth factor Receptor; RPTD=Recommended phase II dose; LHRH-Luteinizing hormone-releasing hormone; PK/PD-Pharmacokinetics/Pharmacodynamics; SABCS-San Antonio 113 Breast Cancer Symposium; ASCO-American Society of Clinical Oncology Oncology#114Giredestrant (SERD (3), RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator Indication Phase/study # of patients Design Primary endpoint Status CT Identifier 1L ER+ metastatic breast cancer (mBC) Phase III persevERA Breast Cancer N=978 ARM A: Giredestrant plus palbociclib ☐ ARM B: Letrozole plus palbociclib Progression-free survival FPI Q4 2020 ER-Estrogen receptor; HER2-Human Epidermal growth factor Receptor NCT04546009 Adjuvant ER+ breast cancer (BC) Phase III lidERA Breast Cancer N=4,100 ◉ ARM A: Giredestrant monotherapy ARM B: Tamoxifen or aromatase inhibitor Invasive disease-free survival FPI Q3 2021 NCT04961996 Roche 114 Oncology#115Giredestrant (SERD (3), RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator Indication Phase/study # of patients 1L ER+/HER2-positive breast cancer (BC) Induction Phesgo plus taxane followed by maintenance with either: ARM A: Giredestrant plus Phesgo Design " ARM B: Phesgo Primary endpoint Status CT Identifier Progression-free survival ■ FPI Q2 2022 Phase III heredERA N=812 NCT05296798 ER-Estrogen receptor; HER2-Human Epidermal growth factor Receptor; Phesgo=FDC of Perjeta and Herceptin for SC administration 115 Roche Oncology#116Zinpentraxin alfa (PRM-151, RG6354) Recombinant human innate immunity protein pentraxin-2 Indication Idiopathic pulmonary fibrosis (IPF) Myelofibrosis Phase/study # of patients Design Primary endpoint Status Phase II N=117 Randomized, double-blind, placebo- controlled trial: 4-week screening period, 24-week randomized treatment period, 4- week follow-up visit (week 28) Zinpentraxin alfa at days 1, 3 and 5, then every 4 weeks vs placebo Least-squares mean change in FVC percentage of predicted value from baseline to week 28 Study met primary endpoint Data published in JAMA 2018;319(22):2299- 2307 and Lancet Respir Med 2019 Aug;7(8):657-664 Phase III STARSCAPE N=658 Randomized, double-blind, placebo- controlled trial: 4-week screening period, 52-week randomized treatment period Zinpentraxin alfa at days 1, 3 and 5, then every 4 weeks vs placebo Absolute change from baseline to week 52 in FVC FPI Q1 2021 Phase II N=125 Multiple dose study of zinpentraxin alfa Bone marrow response rate ■ Study completed Q1 2021 CT Identifier NCT02550873 FVC-Forced vital capacity, JAMA=Journal of the American Medical Association NCT04552899 NCT01981850 116 Roche Immunology#117Roche Crovalimab (RG6107, SKY59) A humanized monoclonal antibody against complement C5 Indication Paroxysmal nocturnal hemoglobinuria (PNH) Paroxysmal nocturnal hemoglobinuria (PNH) patients switching from a C5 inhibitor Phase/study # of patients Design Phase I/II COMPOSER N=59 Healthy volunteers and treatment naïve and pretreated patients with PNH: Part I: Single ascending dose study in healthy subjects Part II: Intra-patient single ascending dose study in PNH patients Part III: Multiple-dose study in PNH patients ◉ Part IV: Dose confirmation in PNH patients ☐ Safety, PK, PD Primary endpoint ■ Part I: FPI Q4 2016 Part II/III: FPI Q2 2017 Status CT Identifier Part IV: FPI Q2 2019 Nonclinical data published in Scientific Reports 2017 Apr; 7(1):1080 Data presented for Part 2 and 3 at ASH 2018 and 2019 NCT03157635 " ARM A: Crovalimab ARM B: Eculizumab Phase III COMMODORE 1 N=250 ARM C: Patients switching to crovalimab from ravulizumab, higher than labeled doses of eculizumab & C5 SNP patients (descriptive-arm) Non-inferiority of crovalimab compared to eculizumab - mean % change in LDH level (measure of haemolysis) from baseline to week 25 FPI Q3 2020 In collaboration with Chugai ASH-American Society of Hematology; PNH=Paroxysmal nocturnal hemoglobinuria; PK/PD=Pharmacokinetics/Pharmacodynamics; LDH-Lactate Dehydrogenase NCT04432584 117 Immunology#118Crovalimab (RG6107, SKY59) A humanized monoclonal antibody against complement C5 Indication Paroxysmal nocturnal hemoglobinuria (PNH) C5 inhibitor naive patients Paroxysmal nocturnal hemoglobinuria (PNH) C5 inhibitor naive patients (China only) Phase/study # of patients Design Primary endpoint Status CT Identifier " Phase III COMMODORE 2 N=200 ■ ARM A: Crovalimab ARM B: Eculizumab Roche Phase III COMMODORE 3 N=51 Crovalimab loading dose IV on Day 1, followed by weekly crovalimab SC doses for 4 weeks ◉ Non-inferiority of crovalimab compared to eculizumab: % patients with transfusion avoidance from baseline through week 25 % patients with haemolysis control, as measured by LDH <=1.5ULN from week 5-25 FPI Q4 2020 Percentage of patients with transfusion avoidance from baseline through week 25 Mean percentage of participants with hemolysis control (week 5 through week 25) FPI Q1 2021 Recruitment completed Q3 2021 Study met its co-primary endpoints Q1 2022 Filed in China (priority review) Q3 2022 NCT04434092 In collaboration with Chugai LDH-Lactate Dehydrogenase; ULN=Upper Limit of Normal; IV=Intravenous; SC-Subcutaneous NCT04654468 118 Immunology#119Crovalimab (RG6107, SKY59) A humanized monoclonal antibody against complement C5 Indication Atypical hemolytic uremic syndrome (aHUS) study 1-adults Atypical hemolytic uremic syndrome (aHUS) study 2 - paediatrics Phase/study # of patients Phase III COMMUTE-a N=90 Single-arm study of aHUS patients Cohort 1: not previously treated with C5i " Cohort 2: switching from C5i Design Cohort 3: known C5 polymorphism ■ Cohort 1+3: proportion of patients with complete TMA response anytime between baseline and week 25 " Primary endpoint " Cohort 2: proportion of patients with maintained TMA control from baseline through week 25 " FPI Q4 2021 Status CT Identifier NCT04861259 In collaboration with Chugai aHUS=Atypical Hemolytic Uremic Syndrome; C5i-C5 inhibitor; TMA-thrombotic microangiopathy Phase III COMMUTE-P N=35 Single-arm study of aHUS patients Cohort 1: not previously treated with C5i Cohort 2: switching from C5i ≤18y/o Cohort 1: proportion of patients with complete TMA response anytime between baseline and week 25 Cohort 2: proportion of patients with maintained TMA control from baseline through week 25 FPI Q4 2021 NCT04958265 Roche 119 Immunology#120Crovalimab (RG6107, SKY59) A humanized monoclonal antibody against complement C5 Indication Sickle cell disease (SCD) acute treatment Sickle cell disease (SCD) chronic VOC prevention Phase/study # of patients Design Phase Ib CROSSWALK-a N=30 ■ ARM A: Crovalimab ARM B: Placebo " Primary endpoint Safety FPI Q1 2022 Status CT Identifier SCD-Sickle Cell Disease; VOC-Vaso-occlusive crises NCT04912869 Phase lla CROSSWALK-C N=90 ■ ARM A: Crovalimab ARM B: Placebo ■ VOC rate, up to 48 weeks FPI Q1 2022 NCT05075824 120 Roche Immunology#121Crenezumab (RG7412) Humanized monoclonal antibody targeting all forms of Ab Indication Phase/study # of patients Design Alzheimer's prevention initiative (API) Colombia Phase II Cognition study N=252 ■ ARM A: PSEN1 E280A mutation carriers receive crenezumab SC or IV ARM B: PSEN1 E280A mutation carriers receive placebo ARM C: non-mutation carriers receive placebo Primary endpoint Status " Change on Alzheimer's Prevention Initiative (API) Composite Cognitive Test total score at 260 weeks treatment Annualized rate of change in an Episodic Memory Measure: Free and Cued Selective Reminding Task (FCSRT) FPI Q4 2013 Recruitment completed Q1 2017 Study did not meet its co-primary endpoints Q2 2022 CT Identifier ☐ Data presented at AAIC 2022 In collaboration with AC Immune Ab-amyloid-beta; SC-Subcutaneous; IV=Intravenous NCT01998841 121 Roche Neuroscience#122Gantenerumab (RG1450) Fully human monoclonal antibody binding aggregated forms of AB Indication Phase/study # of patients Design " Primary endpoint Status CT Identifier ■ Phase III GRADUATE 1 N=1,016 Prodromal to mild Alzheimer's disease Phase III GRADUATE 2 N=1,016 104-week SC treatment period: ARM A: Gantenerumab ARM B: Placebo " 104-week SC treatment period: ARM A: Gantenerumab ARM B: Placebo Phase II GRADUATION N=192 104-week SC treatment period: Gantenerumab SC treatment q1w dosing regimen Roche Change in CDR-SOB at 27 months FPI Q2 2018 Recruitment completed Q2 2020 Change in CDR-SOB at 27 months FPI Q3 2018 Recruitment completed Q2 2020 BTD granted by FDA Sep 2021 Change from baseline in deposited amyloid (PET centiloid levels) FPI Q4 2020 Recruitment completed Q3 2021 NCT03443973 NCT03444870 In collaboration with MorphoSys AG AB-amyloid-beta; CDR-SOB-Clinical Dementia Rating Scale Sum of Boxes; SC-Subcutaneous; BTD=Breakthrough Therapy Designation; PET= positron emission tomography NCT04592341 122 Neuroscience#123Gantenerumab (RG1450) Fully human monoclonal antibody binding aggregated forms of AB Indication Prodromal Alzheimer's disease Mild Alzheimer's disease Roche Cognitively unimpaired participants at risk for or at the earliest stages of Alzheimer's disease Phase/study # of patients Design " Primary endpoint Status Phase II/III Scarlet ROAD¹ N=799 104-week SC treatment period: ARM A: Gantenerumab (225 mg) ARM B: Gantenerumab (105 mg) ARM C: Placebo Change in CDR-SOB at 2 years Sub-study: change in brain amyloid by PET at 2 years Phase I PET data: Archives of Neurology, 2012 Feb;69(2):198-207 Recruitment completed Q4 2013 Dosing stopped due to futility Q4 2014 FPI in open label extension study Q4 2015 Published in Alzheimers Res Ther 2017 Dec 8;9(1):95 Phase III Marguerite ROAD¹ N=389 104-week SC treatment period: ARM A: Gantenerumab ARM B: Placebo Change in ADAS-Cog and CDR-SOB at 2 years (co-primary) Phase III SKYLINE² N=1,200 ARM A: Gantenerumab q1w or q2w (patient preference) ARM B: Placebo Cognitive composite (PACC5) • FPI Q1 2014 FPI Q2 2022 Recruitment stopped Q4 2015 " FPI Q1 2016 for open label extension CT Identifier NCT01224106 36 OLE data published in J Prev Alzheimers Dis 2021;8(1):3-6 NCT02051608 NCT05256134 'In collaboration with MorphoSys AG; 2In collaboration with Banner Alzheimer's Institute AB-amyloid-beta; CDR-SOB-Clinical Dementia Rating Scale Sum of Boxes; PET= positron emission tomography; ADAS-cog-Alzheimer's Disease Assessment Scale cognitive subscale; SC=Subcutaneous; OLE=Open Label Extension; PACC5=Preclinical Alzheimer's Cognitive Composite 123 Neuroscience#124Tominersen (RG6042, HTT ASO) Antisense oligonucleotide (ASO) targeting human HTT mRNA Indication Phase/study # of patients Design Huntington's disease Phase I/lla Phase II OLE N=46 N=46 ☐ Multiple ascending doses of tominersen administered intrathecally to adult patients with early manifest Huntington's Disease ■ Patients from phase I are enrolled into OLE Safety, tolerability and PK/PD Primary endpoint " Longer term safety, tolerability and PK/PD FPI Q3 2015 " FPI Q1 2018 Status ■ Data presented at CHDI 2018 and AAN 2018 PRIME designation granted 2018 ☐ PK/PD data presented at AAN 2019 ☐ Update presented at CHDI 2020 Published in NEJM 2019; 380:2307-2316 Study completed, patients moved to GEN-EXTEND OLE CT Identifier In collaboration with lonis Pharmaceuticals NCT02519036 NCT03342053 HTT=Huntingtin; PK/PD-Pharmacokinetics/Pharmacodynamics; PRIME=Priority medicines; OLE=Open Label Extension; AAN-American Academy of Neurology; NEJM-New England Journal of Medicine; CHDI-Huntington's Disease Association of Ireland 124 Roche Neuroscience#125Tominersen (RG6042, HTT ASO) Antisense oligonucleotide (ASO) targeting human HTT mRNA Indication Phase/study # of patients Phase III Generation HD1 N=791 ARM A: Tominersen 120mg q2w ARM B: Tominersen 120mg q4m ARM C: Placebo q2w Design Primary endpoint Status CT Identifier ☐ CUHDRS globally TFC USA only " FPI Jan 2019 Huntington's disease Roche Phase III GEN-EXTEND N=1,050 OLE study in patients participating in prior Roche and Genentech sponsored studies ARM A: Tominersen 120mg q2w ARM B: Tominersen 120mg q4m Long term safety, tolerability FPI Q2 2019 Q1 2019 protocol modified to allow for bi-monthly vs four-monthly dosing, FPI for new protocol July 2019 Recruitment completed Q2 2020 Dosing stopped in Q1 2021 based on IDMC recommendation regarding the potential benefit/risk profile for study participants. No new safety signals identified. Data presented at EHDN and CHDI 2022 Dosing stopped in Q1 2021 NCT03761849 NCT03842969 In collaboration with lonis Pharmaceuticals CUHDRS=composite Unified Huntington's Disease Rating Scale; TFC=total function capacity; HTT=Huntingtin; OLE=Open Label Extension; IDMC-Independent Data Monitoring Committee; CHDI-Huntington's Disease Association of Ireland; EHDN-European Huntington's Disease Network 125 Neuroscience#126Fenebrutinib (RG7845, GCD-0853) Highly selective and reversible (noncovalent) bruton tyrosine kinase Indication Primary progressive multiple sclerosis (PPMS) Relapsing multiple sclerosis (RMS) Phase/study # of patients Design Primary endpoint Status CT Identifier Phase III FENtrepid Phase III FENhance 1 Phase III FENhance 2 N=946 N=736 N=736 ■ ARM A: Fenebrutinib twice daily oral ■ ☐ ARM B: Ocrevus 2x300mg IV q24w ARM A: Fenebrutinib twice daily oral ARM B: Teriflunomide once daily oral ■ ARM A: Fenebrutinib twice daily oral ARM B: Teriflunomide once daily oral " Time to onset of CCDP12 Time to onset of CCDP12 and annualized relapse rate FPI Q4 2020 FPI Q1 2021 NCT04544449 IV-Intravenous; CCDP12-Composite 12-week confirmed disability progression NCT04586023 Time to onset of CCDP12 and annualized relapse rate FPI Q1 2021 NCT04586010 126 Roche Neuroscience#127Balovaptan (RG7314) Small molecule antagonist of the V1A vasopressin receptor Indication Phase/study Post-traumatic stress disorder (PTSD) Phase II # of patients N=252 ARM A: Balovaptan (IV) once a day for 12 weeks ARM B: Placebo matched control Design Primary endpoint Change from baseline in the Clinician-Administered PTSD Total Symptom Severity Score Status CT Identifier FPI Q3 2022 NCT05401565 127 Roche Neuroscience#128TNKaseⓇ (RG3625, tenecteplase) Small molecule tissue plasminogen activator Indication Phase/study # of patients Design Stroke patients between 4.5 and 24 hours Phase III TIMELESS N=456 ■ ☐ ARM A: Tenecteplase (0.25 mg/kg, maximum 25 mg) single bolus injection ARM B: Placebo Primary endpoint Ordinal modified Rankin scale (mRS) score after 90 days FPI Q1 2019 Status CT Identifier NCT03785678 128 Roche Neuroscience#129Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (PRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates information Roche#130PRED oncology development programs -1 Molecule Indication Solid tumors Phase # of patients Status Oncology ~150 FPI Q2 2018 Data presented at ESMO 2020 Recruitment completed Q2 2021 Roche CT Identifier FAP-4-1BBL (RG7827) 3L+ MSS MCRC FPI Q3 2021 lb 80 NCT04826003 Combination study with cibisatamab Part I: FPI Q3 2019 CD19-4-1BBL (RG6076) R/R B cell non-Hodgkin's lymphoma 362 NCT04077723 Part II: FPI Q3 2020 Part I: FPI Q2 2020; recruitment completed Q4 PD1-IL2v (RG6279) Solid tumors 348 2021 NCT04303858 Part II: FPI Q1 2022 FPI Q4 2014 la 149 NCT02324257 Data presented at ASCO 2017 cibisatamab (CEA x CD3, RG7802) CEA-positive solid tumors FPI Q1 2016 lb 228 NCT02650713 Data presented at ASCO 2017 3L+ MSS MCRC Solid tumors 2 lb 46 FPI Q1 2019 NCT03866239 FPI Q4 2019 - 320 NCT04140500 Data presented at ESMO 2022 FPI Q2 2021 NCT04785820 PD1-LAG3 (RG6139) Solid tumors || 210 Untreated unresectable or || 80 FPI Q3 2022 Randomized trial, compared with nivolumab TALIOS NCT05419388 metastatic melanoma 130#131PRED oncology development programs -2 Molecule CD25 (RG6292) Anti-GPRC5D (RG6234) Indication Solid tumors Advanced and metastatic solid tumors Multiple myeloma HLA-A2-WT1 x CD3 (RG6007) AML FAP-CD40 (RG6189) Solid tumors HLA-A2-MAGE-A4 x CD3 (RG6129) Solid tumors BRAFI (3) (RG6344) Solid tumors CD19xCD28 (RG6333) R/R B cell non-Hodgkin's lymphoma EGFRvlllxCD3 (RG6156) Glioblastoma Roche Phase # of patients Status CT Identifier Oncology | 110 FPI Q4 2019 NCT04158583 Part I: FPI Q1 2021 160 NCT04642365 Part II: FPI Q4 2021 FPI Q4 2020 240 NCT04557150 Data presented at EHA 2022 220 FPI Q4 2020 NCT04580121 280 FPI Q2 2021 | 260 FPI Q1 2022 292 FPI Q1 2022 FPI Q1 2022 ~200 Combination study with glofitamab | ~200 FPI Q2 2022 NCT04857138 NCT05129280 ISRCTN13713 551 NCT05219513 NCT05187624 131#132PRED neuroscience development programs -1 Molecule Indication Phase # of patients Status Neuroscience Brain Shuttle-gantenerumab (BS- gantenerumab, RG6102) Alzheimer's disease Ila ~120 FPI Q1 2021 Brain Shuttle-CD20 (BS-CD20, RG6035) Multiple sclerosis || 30 FPI Q3 2021 FPI Q4 2018 36 ralmitaront Schizophrenia (partial TAAR1 agonist, RG7906) Recruitment completed Q3 2019 Roche CT Identifier NCT04639050 ISRCTN16295 177 = || 247 FPI Q4 2019 The study did not meet its primary endpoint, but showed a reduced clinical decline of core motor signs (MDS UPDRS partIII). Data presented at MDS & ADPD 2020-22. The Open Label Extension is ongoing. NCT03669640 (TWAIN I) NCT03100149 (PASADENA) || 316 prasinezumab¹ (anti-aSynuclein, RG7935, PRX002) Parkinson's disease llb 575 FPI Q2 2021 alogabat (GABA-Aa5 PAM, RG7816) NME (RG7637) Autism spectrum disorder 105 FPI Q1 2021 Psychiatric disorders 80 FPI Q3 2020 rugonersen Angelman syndrome | 66 FPI Q3 2020 (UBE3A LNA, RG6091) NME (RG6182) Neurodegenerative disorder 30 FPI Q4 2020 Partner: Prothena BS-Brain Shuttle NCT04777331 (PADOVA) NCT04299464 (Aurora) NCT04475848 NCT04428281 132#133PRED neuroscience development programs -2 Molecule Indication Phase # of patients Status Neuroscience NME (RG6289) NME (RG6163) Alzheimer's disease 138 FPI Q4 2021 Psychiatric disorders 84 FPI Q1 2022 selnoflast Parkinson's disease lb 48 FPI Q3 2022 (NLRP3i, RG6418) Partner: ¹Prothena; BS-Brain Shuttle Roche CT Identifier 133#134PRED immunology and ophthalmology development programs Molecule Indication Status Roche CT Identifier Phase # of patients Immunology selnoflast (NLRP3i, RG6418) Chronic obstructive pulmonary disease lb 102 FPI Q2 2022 Ophthalmology DME, UME | 90 FPI Q3 2019 || ~210 FPI Q4 2021 Anti-IL-6 (RG6179) DME FPI Q4 2020 FPI Q2 2020 DOVETAIL NCT05151744 (BARDENAS) NCT05151731 (ALLUVIUM) NCT04567303 NCT04265261 (CANBERRA) || ~360 FPI Q4 2021 VEGF-Ang2 DutaFab (RG6120) nAMD 200 CB2 receptor agonist (RG7774) DR || = 135 134#135PRED infectious diseases development programs Molecule Indication Phase # of patients Infectious Diseases Roche Status CT Identifier TLR7 agonist (3) (RG7854) Chronic hepatitis B FPI Q4 2016 150 TLR7 agonist (3)/ siRNA/ PDL1 LNA Chronic hepatitis B || 275 FPI Q3 2020 (RG7854/RG6346/RG6084) Data presented at APASL 2019 NCT02956850 NCT04225715 (PIRANGA) FPI Q1 2019 PDL1 LNA (RG6084) Chronic hepatitis B 35 Part la: completed Part lb: initiated Abx MCP (RG6006) A. baumannii infections | 204 FPI Q4 2020 NCT04605718 Abx MCP-antibiotic macrocyclic peptide 135#136Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (PRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates information Roche#137gRED oncology development programs -1 Roche Molecule Indication Phase # of patients Status CT Identifier Oncology KRAS G12C (RG6330) Metastatic solid tumors with KRAS G12C mutation FPI Q3 2020 270 NCT04449874 Data presented at WCLC 2022, ESMO 2022 FPI Q3 2017 cevostamab (anti-FcRH5 x CD3; RG6160) R/R multiple myeloma 300 NCT03275103 Data presented at ASH 2020, ASH 2021 R/R multiple myeloma 120 FPI Q2 2021 NCT04910568 runimotamab Metastatic HER2-expressing cancers 440 FPI Q2 2018 NCT03448042 (HER2 x CD3, RG6194) NME (RG6286) Locally advanced or metastatic colorectal cancer Solid tumors IL15/IL15Ra-Fc (RG6323)¹ R/R multiple myeloma autogene cevumeran (Individualized Neoantigen-Specific Therapy (iNeST); RG6180)² Solid tumors 67 FPI Q3 2020 1/11 250 FPI Q1 2020 | 60 FPI Q2 2022 FPI Q4 2017 la/llb 271 Data presented at AACR 2020 NCT04468607 NCT04250155 NCT05243342 Recruitment completed Q1 2022 NCT03289962 SHP2i (RG6344)3³ Partner: 1Xencor, 2BioNTech, ³Relay, "Hanmi 132 FPI Q1 2019 la ~50 FPI Q1 2020 lb ~125 FPI Q3 2022 1L advanced melanoma || = Solid tumors Solid tumors NCT03815058 (IMcode001) NCT04252339 NCT05487235 137#138gRED oncology development programs -2 Molecule Indication Phase # of patients Status Oncology FPI Q2 2021 belvarafenib (RG6185)4 nRASmt CPI-experienced melanoma lb 83 Data presented at ESMO 2021 NME (RG6392) Oncology 60 60 FPI Q4 2021 Partner: 1Xencor, 2BioNTech, ³Relay, "Hanmi Roche CT Identifier NCT04835805 ISRCTN92655 801 138#139Roche gRED immunology and ophthalmology development programs Molecule Indication Phase # of patients Status Immunology CT Identifier efmarodocokin alfa (IL-22Fc, RG7880) aGVHD lb 18 FPI Q4 2020 NCT04539470 FPI Q1 2020 Inflammatory bowel disease | 68 NME (RG6287, GDC-8264) Recruitment completed Q3 2021 EUDRACT201 9-002613-19 Inflammatory diseases 16 FPI Q4 2021 NME (RG6315, MTBT1466A) Immunologic disorders | ~24 FPI Q3 2020 astegolimab (Anti-ST2, Chronic obstructive pulmonary llb 930 FPI Q4 2021 NCT05037929 (RG6149, AMG 282, MSTT1041A)1 disease NME (RG6341, GDC-6599) Asthma la/lb 84 FPI Q4 2021 Ophthalmology NME (RG6312) Geographic atrophy la NME (RG6351) Retinal disease Partner: 1Amgen 63 FPI Q4 2020 42-78 FPI Q2 2022 NCT04615325 139#140Roche gRED neuroscience and infectious diseases development programs Molecule Indication Phase # of patients Neuroscience Status CT Identifier Prodromal to mild Alzheimer's disease semorinemab (RG6100)1 Mild-to-moderate Alzheimer's disease || 457 || = FPI Q4 2017 Primary endpoint not met Q3 2020 NCT03289143 (TAURIEL) Data presented at CTAD 2020 FPI Q1 2019 One of two co-primary endpoints met Q3 2021 Data presented at CTAD 2021 272 The Open Label Extension is ongoing NCT03828747 (LAURIET) Infectious Diseases LepB inhibitor (RG6319) Complicated urinary tract infection 56 FPI Q1 2022 Partner: 1AC Immune 140#141Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (PRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates information Roche#142Hemophilia A Unique gene therapy platform Molecule Indication Phase/study # of patients Design SPK-8011 (RG6357) Spark THERAPEUTICS TM SPK-8016 (RG6358) Roche Phase I N=100 Hemophilia A Phase I/II N=30 Long term follow up study of patients who have received SPK-8011 in any prior Spark- sponsored SPK-8011 study Gene transfer, dose-finding safety, tolerability, and efficacy study of SPK-8011 Hemophilia A with inhibitors to Factor VIII Phase I/II N=30 Gene transfer, dose-finding safety, tolerability, and efficacy study of SPK-8016 in individuals with FVIII inhibitors Safety Primary endpoint Ongoing Status CT Identifier NCT03432520 ☐ ■ Safety and changes from baseline in FVIII activity levels at week 52 FPI Q1 2017 Updated data presented at ISTH 2020 and 2021 Recruitment completed Q1 2021 Data published in NEJM 2021; 385:1961-1973 NCT03003533 Safety; peak and steady state FVIII activity levels at week 52 FPI Q1 2019 NCT03734588 ISTH=International Society on Thrombosis and Haemostasis; NEJM-New England Journal of Medicine 142 Hemophilia#143Pompe disease Unique gene therapy platform Molecule SPK-3006 (RG6359) Indication Phase/study # of patients Gene transfer study for late-onset Pompe disease Pompe disease Phase I/II RESOLUTE N=20 Design Safety Primary endpoint FPI Q4 2020 Status Recruitment completed Q2 2022 CT Identifier NCT04093349 Spark THERAPEUTICS TM 143 Roche Metabolic Diseases#144Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (PRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates information Roche#145Geographical sales split by Divisions and Group* CHFM YTD Sep 2021 Pharmaceuticals Division 33,379 YTD Sep 2022 33,189 % change CER 0 United States 16,707 17,199 -1 Europe 6,610 6,100 -1 Japan 3,186 3,029 +7 International 6,876 6,861 0 Diagnostics Division 13,305 13,848 +6 United States 2,845 3,471 +17 Europe 4,851 3,774 -17 Japan 505 691 +55 International 5,104 5,912 +17 Group 46,684 47,037 +2 United States 19,552 20,670 +1 Europe 11,461 9,874 -8 Japan 3,691 3,720 +14 International 11,980 12,773 +8 CER-Constant Exchange Rates; * Geographical sales split shown here does not represent operational organization Roche 145#146Pharma Division sales YTD Sep 2022 Top 20 products Roche Global US CHFM % CER CHFM % CER CHFM Europe % CER Japan International CHFM % CER CHFM % CER Ocrevus 4,427 17 3,283 13 808 25 336 37 Perjeta 3,090 5 1,135 1 661 -16 175 -1 1,119 33 Hemlibra 2,778 28 1,684 22 542 32 277 20 275 76 Tecentriq 2,692 10 1,451 9 573 19 326 -5 342 16 Actemra/RoActemra 2,039 -23 914 -33 602 -3 256 1 267 -39 Herceptin 1,672 -18 376 -28 329 -13 40 -28 927 -15 Avastin 1,652 -29 497 -36 158 -51 378 -15 619 -21 Xolair 1,625 10 1,625 10 MabThera 1,596 -20 1,002 -20 Kadcyla 1,590 11 619 -3 Alecensa 1,127 16 331 TNKase/Activase 881 -8 836 Lucentis 800 -25 800 -25 Evrysdi 793 101 348 2922 20 5828 156 -18 24 -10 414 508 8 101 21 218 6 169 5 409 -9 ¥8 -23 362 5520 50 26 45 5 24 253 335 * 60 132 Ronapreve 631 -36 102 -81 452 42 77 ៦៩ 100 -49 Esbriet Gazyva 590 -25 381 -34 186 -1 23 -22 539 8 251 3 144 -7 39 -7 105 89 Phesgo Pulmozyme CellCept Pharma Division 526 150 217 112 263 204 46 99 414 -1 280 2 73 -12 61 -2 386 -12 30 -19 101 -6 43 -6 212 -14 33,189 0 17,199 -1 6,100 -1 3,029 7 6,861 0 CER = Constant Exchange Rates (avg. full year 2021); *over 500% 146#147Pharma Division sales YTD Sep 2022 Product sales Pharmaceuticals Division Roche Global US Europe Japan International CHFM % CER CHFM % CER CHFM % CER CHFM % CER CHFM % CER Ocrevus Perjeta 4,427 17 3,283 13 808 25 336 37 3,090 5 1,135 1 661 -16 175 -1 1,119 33 Hemlibra 2,778 28 1,684 22 542 32 277 20 Tecentriq 2,692 10 1,451 9 573 19 326 -5 Actemra/RoActemra 2,039 -23 914 -33 602 -3 256 1 Herceptin 1,672 -18 376 -28 329 -13 40 -28 927 Avastin 1,652 -29 497 -36 158 -51 378 -15 Xolair 1,625 10 1,625 10 MabThera 1,596 -20 1,002 Kadcyla 1,590 11 619 Alecensa 1,127 16 TNKase / Activase 881 -8 Lucentis 800 -25 Evrysdi 793 101 Ronapreve 631 -36 Esbriet 590 -25 381 Gazyva 539 8 251 Phesgo 526 150 217 Pulmozyme 414 -1 280 CellCept 386 -12 Polivy 290 79 121 Vabysmo 282 Erivedge 200 2 Enspryng 133 108 Rozlytrek 53 50 Cotellic 35 1 Gavreto 20 299 Xofluza 6 Susvimo 3 WNG32ARENGE 822 -25 112 126 232922222232208 156 -18 24 -10 -3 508 101 218 6 169 -9 24 253 335 102 -81 452 52'' 26 21 5 409 60 42 -34 186 -1 144 -7 39 ☑ 263 204 73 -12 -19 101 -6 74 84 41 4 182 43 68 161 24 -6 44 7 * 135 6 86 87 40 9 83 5 22 11 -9 22222222222222622-8451 76 16 -39 -15 -21 -23 100 77 -49 23 -14 17 111 30 456 174 5 12 GON, 26 5 -22 89 -2 35 13 34 Lunsumio 1 1 Other Products 2,318 -15 538 -20 259 -20 506 -10 1,015 -13 Pharma Division 33,189 0 17,199 -1 6,100 -1 3,029 7 6,861 0 CER = Constant Exchange Rates (avg. full year 2021); *over 500% 147#148Pharma Division CER sales growth1 in % Global top 20 products Roche Q1/21 Q2/21 Q3/21 Q4/21 Q1/22 Q2/22 Q3/22 Ocrevus 16 31 7 25 18 17 16 Perjeta 2 7 2 3 1 9 5 Hemlibra 33 58 37 38 30 31 23 Tecentriq 26 31 23 17 8 13 9 Actemra/RoActemra 22 12 57 21 3 -23 -42 Herceptin -35 -35 -26 -6 -19 -11 -23 Avastin -40 -40 -37 -30 -32 -27 -28 Xolair -6 3 8 14 9 13 8 Mab Thera -46 -34 -42 -26 -21 -20 -19 Kadcyla 17 21 11 16 9 18 6 Alecensa 14 25 TNKase/Activase -17 Lucentis -7 23 2 18 15 23 16 11 świ 3 22 -20 1 -5 -10 2 -26 -9 -39 * Evrysdi - 347 189 65 93 Ronapreve - Esbriet -8 1 -5 Gazyva -2 18 Phesgo I Pulmozyme -23 CellCept 24 -5 -13 -3 150* 1 M I 272 -91 -92 -7 -6 -21 -48 10 7 9 9 * 410 168 76 -7 3 52 -3 2 -3 -2 -12 -3 -20 CER = Constant Exchange Rates; * over 500%; 1Q1-Q4/21 vs Q1-Q4/20; Q1-Q3/22 vs Q1-Q3/21 148#149Pharma Division CER sales growth¹ in % Top 20 products by region Roche US Europe Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Japan Q1 Q2 Q3 International Q4 Q1 Q2 Q3 Ocrevus Perjeta Hemlibra الله نه الله 12 10 17 26 34 34 11 51 29 62 26 -2 -1 4 이 -8 -21 -12 -15 -3 -1 -1 -1 24 32 37 30 33 28 24 16 53 31 29 36 30 Tecentriq 2 10 15 3 41 14 24 17 Actemra/RoActemra 67 22 -31 -61 18 -4 -2 -3 5 Herceptin -34 -26 -29 -29 -3 -13 -9 -18 -36 36 -30 Avastin -45 -39 -36 -31 -49 -56 -49 -47 55232 15 24 22 55 63 115 53 34 -5 -9 0 24 0 17 30 12 -2 -4 -55 -30 -44 -44 -27 -28 17 -18 -3 -22 0 -12 -13 -19 -24 -23 -17 -23 Xolair 14 9 13 8 I I - I I MabThera -32 -20 -24 -14 -13 -19 -16 -18 Kadcyla 3 0 -1 -8 16 8 12 3 Alecensa 18 25 14 TNKase/Activase 22 -21 1 26 22 9 5 8 5 25 -17 -15 42 28 7 1789 225 -13 -15 -23 -13 -32 16 38 26 81 4 25 45 29 12 46 9 -6 7 -3 4 12 Lucentis 2 -26 -9 -39 Evrysdi 112 36 28 13 * 227 216 * * -5 231 Ronapreve -61 -99 -54 -100 -68 -99 Esbriet -7 -4 -28 -67 0 -5 1 1 -36 -36 -36 109 Gazyva 11 0 3 7 2 -5 -8 -9 -7 -10 -17 * 87 75 101 91 * Phesgo 236 187 134 62 188 107 I 1 278 20 Pulmozyme 6 0 5 2 -15 -11 -12 -12 CellCept -31 -15 -17 -25 3 -7 -7 -5 29 22 -9 18 11 44 -1 45 -8 -9 13 -4 14 -16 -14 3 -29 CER = Constant Exchange Rates; * over 500%; 1 Q4/21 vs Q4/20; Q1-Q3/22 vs Q1-Q3/21 149#150CER sales growth (%) Quarterly development 2021 vs. 2020 2022 vs. 2021 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Pharmaceuticals Division -9 4 5 14 6 0 -6 United States -14 0 0 8 2 1 -6 Europe -6 15 1 19 -1 -6 4 Japan -7 7 60 46 69 3 -27 International 0 4 2 9 0 4 -3 Diagnostics Division 55 48 18 8 24 0 -4 Roche Group 3 14 8 12 11 0 -6 CER-Constant Exchange Rates Roche 150#151Ocrevus Global sales CHFbn CER growth +17% Regional sales 4.9 4.2 3.5 2.8 2.1 1.4 0.7 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 4,427m • • US: Moving into earlier lines displacing orals; #1 in US for both total share and NTB EU: Moving into earlier lines displacing orals; #1 in EU5 for both total share and NTB CER-Constant Exchange Rates US CER growth +13% Europe +25% International +37% Roche 151#152Perjeta Global sales CHFbn CER growth +5% Regional sales CER growth US +1% 3.5 3.0 Europe -16% 2.5 2.0 Japan -1% 1.5 1.0 International +33% 0.5 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 3,090m • US: Cannibalization from Phesgo • ● EU: Cannibalization from Phesgo International: Accelerated growth in all regions (LATAM, APAC, EEMEA) CER=Constant Exchange Rates Roche 152#153Hemlibra Global sales CHFbn CER growth +28% Regional sales CER growth US +22% 3.2 2.8 Europe +32% 2.4 2.0 Japan +20% 1.6 1.2 International +76% 0.8 0.4 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 2,778m • US: Continued share gains in non-inhibitor patients • EU: Continued share gains in non-inhibitor severe patients with market shares -60% in France, UK and GER, Italy, Spain -30% • Japan: Strong uptake in non-inhibitor patients International: Accelerating momentum with strong growth from China CER-Constant Exchange Rates Roche 153#154Tecentriq Global sales CHFbn CER growth +10% Regional sales CER growth US +9% 3.2 2.8 Europe +19% 2.4 2.0 1.6 1.2 0.8 Japan -5% International +16% 0.4 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 2,692m • • US: Growth driven by first-in-class launches in adjuvant PDL1+ NSCLC, in 1L HCC and 1L SCLC EU: Growth driven by first-in-class launches in adjuvant PDL1+ NSCLC, in 1L HCC and 1L SCLC ● Japan: 11% price cut in Q2 2021 CER-Constant Exchange Rates Roche 154#155Actemra/RoActemra Global sales CHFbn CER growth -23% Regional sales CER growth US -33% 3.0 2.5 Europe -3% 2.0 1.5 1.0 0.5 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 2,039m • US: Actemra SC share in RA keeps increasing; COVID-19 sales washed out as of Q3 • . EU: Market leadership in 1L RA monotherapy maintained; COVID-19 sales washed out as of Q3 International: COVID-19 sales washed out as of Q3 CER=Constant Exchange Rates Japan +1% International -39% Roche 155#156Herceptin Global sales CHFbn CER growth -18% Regional sales CER growth US -28% 5.4 Europe -13% 4.5 Japan -28% 3.6 2.7 1.8 0.9 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 International -15% YTD Sep 2022 sales of CHF 1,672m • • US: Biosimilar erosion slowing; Switching of patients with residual disease to Kadcyla; Cannibalization from Phesgo EU: Biosimilar erosion slowing; Switching of patients with residual disease to Kadcyla; Cannibalization from Phesgo • Japan: Decline due to biosimilars International: Decline due to biosimilars; Cannibalization from Phesgo CER-Constant Exchange Rates Roche 156#157Avastin Global sales CHFbn CER growth -29% Regional sales CER growth US -36% 6.0 Europe -51% 5.0 4.0 3.0 2.0 1.0 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 1,652m • US: Biosimilar erosion slowing • EU: Biosimilar erosion slowing • Japan: Limited decline due to biosimilars with narrow labels International: Biosimilar erosion slowing CER-Constant Exchange Rates Japan -15% International -21% Roche 157#158Xolair Global sales CHFbn CER growth +10% Regional sales CER growth 1.8 1.6 1.4 1.2 US +10% 1.0 0.8 0.6 0.4 0.2 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 1,625m • US: Xolair remains market leader in growing biologics asthma market; Growth driven by chronic spontaneous urticaria (CSU) CER-Constant Exchange Rates Roche 158#159Rituxan / Mabthera Global sales CHFbn CER growth -20% Regional sales 5.4 US 4.5 3.6 2.7 1.8 0.9 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 1,596m • US: Biosimilar erosion slowing • EU: Biosimilar erosion slowing . Japan: Biosimilar erosion slowing International: Biosimilar erosion slowing CER-Constant Exchange Rates CER growth -20% Europe -18% Japan -10% International -23% Roche 159#160Kadcyla CER growth -3% Europe +8% Global sales CHFbn CER growth +11% Regional sales 1.8 US 1.6 1.4 1.2 1.0 0.8 0.6 0.4 0.2 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 1,590m • US: Growth in adjuvant eBC; share decline in metastatic BC due to competition • . EU: Strong uptake in adjuvant eBC in patients with residual disease after neoadjuvant treatment International: Growth driven by all regions (LATAM, EEMEA, APAC) CER=Constant Exchange Rates Japan +21% International +50% Roche 160#161Alecensa Global sales CHFbn CER growth +16% Regional sales CER growth US +20% 1.2 1.0 000 0.4 0.8 0.6 0.2 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 1,127m • US: New patient share in 1L at around 70% • • EU: EU-5 new patient share in 1L at around 70% Japan: New patient share in 1L reaching >70% International: Strong growth driven by all regions CER-Constant Exchange Rates Europe +6% Japan +5% International +26% 161 Roche#162TNKase / Activase Global sales CHFbn CER growth -8% Regional sales CER growth US -9% 1.2 1.0 0.8 0.6 0.4 0.2 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 881m • US: Sales impacted by COVID-19 and purchasing patterns CER-Constant Exchange Rates International +5% Roche 162#163Lucentis Global sales CHFbn CER growth -25% Regional sales CER growth 1.5 1.2 0.9 0.6 0.3 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 800m • Impacted by switching to Vabysmo, entrance of biosimilars and order patterns CER-Constant Exchange Rates US -25% Roche 163#164Evrysdi Global sales CHFbn CER growth Regional sales +101% CER growth 0.9 US +24% 0.8 0.7 Europe +335% 0.6 0.5 0.4 0.3 Japan >500% International +100% 0.2 0.1 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 793m • US: Strong growth driven by switch and treatment-naïve patients; market share increasing >20% • EU: Excellent growth driven by Germany and launches in key markets UK, Italy and France . International: Strong growth in all regions CER=Constant Exchange Rates Roche 164#165Ronapreve Global sales CHFbn CER growth -36% Regional sales 1.2 1.0 0.8 0.6 0.4 0.2 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 631m CER growth International -49% Europe -81% Japan 42% · EU: Limited sales potential left as Ronapreve has low activity against Omicron variants . Japan: Additional sales of CHF 1.1 bn to the government expected in Q4 (overall CHF 1.6 bn for FY 2022) CER-Constant Exchange Rates Roche 165#166Esbriet CER growth -34% Europe -1% Global sales CHFbn CER growth -25% Regional sales US 0.9 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0.0 YTD Sep 19 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 2022 sales of CHF 590m • US: Generics have entered the market in Q2, rapid erosion expected • EU: Generic entry expected in Q4 CER-Constant Exchange Rates International -22% Roche 166#167Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (PRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates information Roche#168YTD Sep 2022: Diagnostics Division CER growth By Region and Customer Area (vs. 2021) Roche Reported Restatement³ Global EMEA¹ NOA CHFM %CER CHFm %CER CHFM %CER APAC LATAM CHFm %CER CHFm %CER Global CHFm %CER CHFm %CER EMEA¹ NOA CHFm %CER APAC LATAM CHFm %CER CHFm %CER Core Lab 2,3 Point of Care³ 5,772 5 1,913 6 2,610 1,072 2 2,354 6 433 11 5,833 5 1,971 5 1,074 2 2,355 6 433 11 29 660 -54 868 421 994 386 88 -45 3,086 30 753 -51 1,135 192 1,106 357 92 -43 Molecular Lab³ 3,272 -3 1,133 -4 1,279 -5 769 4 91 -26 2,735 -8 982 -4 1,010 -10 656 -7 87 -28 Diabetes Care Pathology Lab 1,219 -3 652 -3 181 -21 209 1 177 25 1,219 -3 652 -3 181 -21 209 1 177 25 975 10 237 11 523 9 196 13 110 19 29 975 10 237 11 523 9 196 13 19 29 22 Diagnostics Div. 13,848 11 4,595 -14 3,923 34 4,522 28 28 808 -3 13,848 6 4,595-13|| 3,923 20 4,522 28 808 -3 CER=Constant Exchange Rates; ' Europe, Middle East and Africa; 2 incl. Roche Information Solutions; 3 Sales in the Point of Care customer area include sales from the Liat business (POC molecular), and sales in the Core Lab customer area include sales from the Life Science Alliances, both previously shown as part of Molecular Lab customer area. The comparative information for 2021 has been updated accordingly. In Q1 21 POC molecular sales = 90mCHF, Q2 21=92mCHF, Q3 21=175mCHF, Q4 21-194mCHF. In Q1 21 LS Alliances = 21mCHF, Q2 21-23mCHF, Q3 21-23m CHF, Q4 21=20mCHF. 168#169Diagnostics Division quarterly sales and CER growth¹ Roche Q3 21 Q4 21 Reported Q1 22 Restatement³ Q322 CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER Q2 22 Q3 21 Q4 21 Q122 Q2 22 Q322 CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm % CER Core Lab²,3 1,884 12 1,863 10 1,873 8 1,961 1 1,938 7 Point of Care³ Molecular Lab³ Diabetes Care Pathology Lab 442 143 525 -2 1,302 84 987 10 321 -19 617 222 1,907 12 1,883 9 1,896 8 719 15 1,466 84 1,979 1 1,958 7 1,143 15 477 -16 1,238 21 1,358 15 1,376 26 965 -13 931 -22 1,040 5 1,144 7 1,189 21 791 -20 755 -24 400 -7 396 -2 417 -7 415 -3 387 2 400 -7 396 -2 417 -7 415 -3 387 2 299 4 313 7 318 14 334 7 323 10 299 4 313 7 318 14 334 7 323 10 Diagnostics Div. 4,263 18 4,455 8 5,286 24 4,662 0 3,900 -4 4,263 18 4,455 8 5,286 24 4,662 0 3,900 -4 CER-Constant Exchange Rates; ' versus same period of prior year; 2 incl. Roche Information Solutions; 3 Sales in the Point of Care customer area include sales from the Liat business (POC molecular), and sales in the Core Lab customer area include sales from the Life Science Alliances, both previously shown as part of Molecular Lab customer area. The comparative information for 2021 has been updated accordingly. In Q1 21 POC molecular sales = 90mCHF, Q2 21=92mCHF, Q3 21=175mCHF, Q4 21-194mCHF. In Q1 21 LS Alliances = 21mCHF, Q2 21-23mCHF, Q3 21-23m CHF, Q4 21=20mCHF. 169#170YTD Sep 2022: Diagnostics Division regional sales Growth driven by Asia Pacific and North America Sales YTD CHFm & % of total sales Total YTD Sales = 13,848 Sales growth at CER Diagnostics Division 6% GLOBAL 808 -13% EMEA* 6% 20% NAM 4,595 / 28% APAC 33% -3% LATAM 4,522 / 33% 3,923/ 28% EMEA* ■NAM APAC ■ LATAM CER-Constant Exchange Rates (avg. full year 2021); * Europe, Middle East and Africa Roche 170#171Core Lab CHFbn 7.0 2022 vs. 2021 CER growth +5% 6.0 5.0 4.0 3.0 2.0 1.0 0.0 YTD Sep 2020 YTD Sep 2021 YTD Sep 2022 Immunodiagnostics Clinical Chemistry Other CER=Constant Exchange Rates; underlying growth of Core Lab excluding Roche Information Solutions: +5% -4% +8% +6% Roche 171#172Point of Care CER-Constant Exchange Rates CHFbn 3.5 3.0 2.5 2.0 1.5 1.0 0.5 0.0 2022 vs. 2021 CER growth +30% YTD Sep 2020 YTD Sep 2021 Clinical Chem. & Immunodiagn. Coagulation & Urinalysis YTD Sep 2022 Hospital Glucose POC MDX +33% -8% -7% +39% Roche 172#173Molecular Lab CER-Constant Exchange Rates CHFbn 3.5 3.0 2.5 2.0 1.5 1.0 0.5 0.0 YTD Sep 2020 ■ Virology ■Blood Screening Cervical Cancer qPCR&NAP 2022 vs. 2021 CER growth -8% +12% -28% 0% +19% -20% +5% -7% YTD Sep 2021 YTD Sep 2022 MD Systems ■Microbiology Other Roche 173#174Diabetes Care CER-Constant Exchange Rates CHFbn 1.5 1.2 0.9 0.6 0.3 0.0 2022 vs. 2021 CER growth -3% YTD Sep 2020 YTD Sep 2021 YTD Sep 2022 Blood Glucose Monitoring Other +12% -4% Roche 174#175Pathology Lab CER-Constant Exchange Rates CHFbn 1.2 2022 vs. 2021 CER growth +10% 1.0 0.8 0.6 0.4 0.2 0.0 YTD Sep 2020 YTD Sep 2021 YTD Sep 2022 Advanced Staining Primary Staining +28% +4% +8% Companion Diagnostics Roche 175#176Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (PRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates information Roche#177CHF/USD 1.00 0.90 0% Monthly averages 7% 6% 0.80 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec -2021 -2022 1.00 0.90 2% Year-To-Date averages 4% 4% Roche 0.80 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2021 -2022 177#178CHF/USD 1.00 0.98 0.96 0.94 0.92 0.90 Sep YTD 2022 4% 0.88 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec avg full year 2021 avg full year 2022 monthly avg 2021 monthly avg 2022 Roche 178#179CHF/EUR Monthly averages 1.10 -7% -6% 1.05 1.00 -11% 0.95 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2021 -2022 Year-To-Date averages 1.10 -5% -6% 1.05 1.00 -7% Roche 0.95 T Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2021 -2022 179#180CHF/EUR 1.13 1.11 1.09 1.07 1.05 1.03 1.01 0.99 0.97 Sep YTD 2022-6% 0.95 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec avg full year 2021 avg full year 2022 monthly avg 2021 monthly avg 2022 Roche 180#181Average CHF Exchange Rates Sep YTD Sep YTD Sep YTD 2022 vs. Sep YTD 2021 2022 2021 USD 0.95 0.91 4% EUR 1.01 1.09 -7% JPY 0.74 0.84 -12% Roche -15% -10% -5% 0% 5% 10% 181#182Exchange rate impact on sales growth Q3 2022: negative impact of JPY and EUR, positive impact of USD Development of average exchange rates versus prior year period CHF / USD 2.2% CHF / EUR -4.9% 5.9% -6.4% CHF/JPY -6.9% -10.6% Difference in CHF/CER -1.0% growth Sales growth 2022 vs. 2021 11.2% 10.2% CER growth CHF growth Q1 CER = Constant Exchange Rates (avg full year 2021) 5.2% -10.0% -16.2% 0.4% -2.1% 0.0% 0.4% Q2 22 -5.6% Q3 -7.7% Q4 Roche 182#183Exchange rate impact on sales growth YTD Sep 2022: negative impact of JPY and EUR, positive impact of USD Development of average exchange rates versus prior year period CHF / USD CHF/EUR 2.2% 4.0% -4.9% -5.7% CHF/JPY -6.9% -8.9% Difference in CHF / CER -1.0% growth Sales growth 2022 vs. 2021 4.4% -7.2% -11.5% -0.2% -0.9% 11.2% 10.2% 5.4% 5.2% 1.7% 0.8% CER growth CHF growth Q1 HY YTD Sep FY CER = Constant Exchange Rates (avg full year 2021) Roche 183#184Doing now what patients need next

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Fiscal 3Q Investor Presentation image

Fiscal 3Q Investor Presentation

Healthcare

FY23 Full-Year Results Presentation image

FY23 Full-Year Results Presentation

Healthcare

Healthcare Network P&L Statement and Expansion Projects image

Healthcare Network P&L Statement and Expansion Projects

Healthcare

Accreditation and Quality Assurance Overview image

Accreditation and Quality Assurance Overview

Healthcare

Investment Highlights image

Investment Highlights

Healthcare

Investor Presentation image

Investor Presentation

Healthcare

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update image

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update

Healthcare

BioAtla Investor Presentation Deck image

BioAtla Investor Presentation Deck

Healthcare