Roche Holding Ltd · SIX:RO
Roche — YTD Sep 2023 Earnings Presentation
188 slides from Roche's earnings presentation, Oct 19, 2023
Slide 1: Slide 1
Slide 2: Forward-looking statements
This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, str
Slide 3: Roche YTD September 2023 results
Roche YTD September 2023 results Basel, 19 October 2023
Slide 4: Group
Group Thomas Schinecker Chief Executive Officer
Slide 5: YTD September 2023 performance; Outlook
YTD September 2023 performance Outlook
Slide 6: YTD Sep 2023: Strong base business growth in both divisions
YTD Sep 2023: Strong base business growth in both divisions Group sales +1% at CER driven by strong base business growth in both divisions • Strong Pharma YTD growth (+9% at CER) driven by Vabysmo, Ocrevus, Hemlibra, Polivy, Evrysdi, Phesgo and Tecentriq • Strong Diagnostics base business YTD growth
Slide 7: YTD Sep 2023: Strong base business growth
YTD Sep 2023: Strong base business growth Young Pharma portfolio and industry leading Diagnostics business driving growth 2023 2022 Change in % Excl. CHFbn CHFbn CHF CER C191 Pharmaceuticals Division 33.6 33.2 1 9 9 Diagnostics Division 10.4 13.8 -25 -18 7 Roche Group 44.1 47.0 -6 1 9 CER=Constant E
Slide 8: Strong Q3 driven by the uptake of new medicines and diagnostics
Strong Q3 driven by the uptake of new medicines and diagnostics Base business more than offsets the decline in COVID-19 products and AHR 15% 14%* 13% 12% 11% 10% 9% 9% 7% 7% 7% 6% 6% 6% 6% 8% 8% 4% 5% 3% 7% 6% 4% 5% 3% 4% 3% 1% 0% 0% 1% 0% -5% -4% -3% -6% -10% AHR1 impact -15% COVID-19 impact Q1 Q2
Slide 9: Strong base business growth in both divisions
YTD Sep 2023: Strong base business growth in both divisions COVID-19 impact to reduce significantly by end of Q1 2024 Pharma Diagnostics Quarterly sales evolution 2022-2023 Quarterly sales evolution 2022-2023 % CER % CER +30% +30% +24% +20% +20% +11% +8% +9% +9% +7% +8% +7% +10% +7% +10% +4% +6% +4%
Slide 10: Roche played a significant role in fighting the pandemic
Roche played a significant role in fighting the pandemic Q4 2023 and Q1 2024 are the final quarters impacted by the decline in COVID-19 products CHFbn CER 2.0 1.7 1.5 TIB MOLBIOL LightMix® Modular SARS-CoV-2 1.2 ePlex® Respiratory Pathogen Panel 2 cobas® SARS-CoV-2 on the cobas® Liat® cobas® SARS-Co
Slide 11: Strong base business, sales growth impacted by Fx
YTD Sep 2023: Strong base business, sales growth impacted by Fx Ophthalmology and neuroscience franchises drive portfolio diversification CHFm +1% at CER Diversification of Roche portfolio +665 -856 YTD Sep 2018 YTD Sep 2023 -29 CHF 42.1bn CHF 44.1bn +3,827 -3,152 -3,439 47,037 44,053 Diagnostics Ne
Slide 12: Young portfolio driving Pharma division growth momentum
Young portfolio driving Pharma division growth momentum Keeping historic launch momentum with two NMEs approved in 2023 CHFm % of Pharma Sales** 18,000 50% 16,000 42% 14,000 12,000 34% 10,000 23% 8,000 * 6,000 4,000 2,000 0 YTD Sep 2020 YTD Sep 2021 YTD Sep 2022 YTD Sep 2023 Cotellic Alecensa Tecent
Slide 13: 2023 performance; Outlook
2023 performance Outlook
Slide 14: 2023: Upcoming newsflow
2023: Upcoming newsflow Pharma Diagnostics Tiragolumab + Tecentriq in 1L Columvi + GemOx in 2L+ DLBCL 2024 Modular transportation system, integrated Q1 2024 CCM Vertical PDL1+ NSCLC into existing cobas connection modules Lunsumio + Polivy in 2L+ DLBCL 2024 Tiragolumab + Tecentriq + chemo in Flexible
Slide 15: FY 2023 sales guidance confirmed
FY 2023 sales guidance confirmed Sales drivers1 Pharma: Key products with strong growth and momentum from ongoing launches Diagnostics: Base business with good growth Group sales growth1 Low single digit decline COVID-19 sales for Diagnostics and Pharma expected to decline by roughly CHF -4.5bn AHR2
Slide 16: FY 2023 guidance confirmed
FY 2023 guidance confirmed Group sales growth1 Low single digit decline Core EPS growth1 Broadly in line with sales decline Dividend outlook Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER) 16
Slide 17: Pharmaceuticals Division
Pharmaceuticals Division Teresa Graham CEO Roche Pharmaceuticals
Slide 18: YTD Sep 2023: Pharmaceuticals Division sales
YTD Sep 2023: Pharmaceuticals Division sales All regions delivering strong growth, currency headwinds further intensifying in Q3 2023 2022 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 33,622 33,189 1 9 United States 17,680 17,199 3 8 Europe 6,259 6,100 3 7 Japan 2,937 3,029 -3 10 Internati
Slide 19: Young portfolio delivering strong growth
YTD Sep 2023: Young portfolio delivering strong growth Vabysmo to surpass CHF 2bn in 2023; Polivy with strong launch in 1L DLBCL Vabysmo >500% Ocrevus 14% Hemlibra 19% Polivy 126% Evrysdi 45% Phesgo 66% Tecentriq 11% Perjeta 6% Gazyva 22% Tamiflu 175% Alecensa 9% TNKase / Activase 8% Enspryng 55% Xo
Slide 20: Oncology portfolio growing +5%
YTD Sep 2023: Oncology portfolio growing +5% YoY CER growth Phesgo (+66%) HER2 franchise HER2 franchise Herceptin Perjeta (+6%) +4% • Kadcyla (+2%): growth in International compensating for US/EU Kadcyla (+2%) • Perjeta (+6%): driven by International Tecentriq +11% • Phesgo (+66%): global conversion
Slide 21: Alecensa: Unprecedented Ph III results in adjuvant ALK+ NSCLC
Alecensa: Unprecedented Ph III results in adjuvant ALK+ NSCLC Risk of disease recurrence or death reduced by 76% Ph III (ALINA) Alecensa in adjuvant ALK+ NSCLC trial design Alectinib Resected 600 mg BID Recurrence Further Stage IB (≥4cm)-IIIA* 2 years treatments at ALK+ NSCLC R Inv. choice 1:1 ECOG
Slide 22: Hematology: Successful rejuvenation leading to rebound
Hematology: Successful rejuvenation leading to rebound Ph III results for Columvi (STARGLO) & Lunsumio (SUNMO) in 2L+ DLBCL expected in 2024 Q3 update • Ph III (SKYLGO) Columvi + Polivy + R-CHP in 1L DLBCL initiated CHFm YoY CER growth Gazyva (+22%) 1,000 -26% • Growth driven by Gazyva combinations
Slide 23: Tecentriq: First PD-(L)1 with subcutaneous formulation
Tecentriq: First PD-(L)1 with subcutaneous formulation Improving convenience for patients, saving resources for healthcare systems CHFm YoY CER growth Q3 update 1,100 • Tecentriq SC: Great Britain approval achieved 1,000 +9% +10% +23% • Ph III (IMbrave152/SKYSCRAPER-14) Tecentriq + tiragolumab + Ava
Slide 24: Hemophilia A: Global SoC with ~40% patient share
Hemophilia A: Global SoC with ~40% pts share reached in US/EU5* Expecting continued market share gains for Hemlibra globally CHFm YoY CER growth Q3 update 1,200 • ~22,000 patients treated globally +17% +23% • Continued penetration across all approved patient segments 1,000 • >2/3 of patients on Q4W
Slide 25: Immunology: Overall stable sales
Immunology: Overall stable sales US approval for Xolair autoinjector achieved, option with added convenience CHFm YoY CER growth Q3 update 2,500 Xolair (+3%) +13% • US approval of Xolair autoinjector achieved +1% 2,000 • Growth driven by CSU -25% 0% 1,500 Actemra (+21%) • US/EU: Solid performance in
Slide 26: Multiple Sclerosis: 24% global market share reached
Multiple Sclerosis: 24% global market share reached Positive Ph III (OCARINA II) results of Ocrevus SC Q6M presented at ECTRIMS CHFm YoY CER growth Q3 update 1,750 • Ocrevus with 24% patient share globally (>300k pts treated ) +12% +16% 1,500 • Market leader in US and EU-5 +7% +37% • Higher retentio
Slide 27: Ocrevus: Positive Ph III (OCARINA II) results for SC Q6M dosing
Ocrevus: Positive Ph III (OCARINA II) results for SC Q6M dosing Ocrevus SC Q6M with potential to expand overall CD20 class and gain class share Ph III (OCARINA II) results in RMS/PPMS B-cell depletion over 24 weeks (Ocrevus SC vs IV)a T1 Gd+/- and N/E T2 adjusted lesion ratesb Mean number T1 Gd+/- N
Slide 28: Ocrevus: Strong 10-year results and RWD on family planning
Ocrevus: Strong 10-year results and RWD on family planning Early Tx preserves function in MS; Only CD20 studied for family planning Ocrevus 10-year data in RMS/PPMS RWD with RMS during pregnancy & postpartum2 Ph III (OPERA I/II) Ph III (ORATORIO) in RMS1 in PPMS1 1.25 Annualized relapse rates (95% C
Slide 29: Fenebrutinib: Potential for a best-in-class BTKi in MS
Fenebrutinib: Potential for a best-in-class BTKi in MS Brain penetration and strong efficacy data presented at ECTRIMS Ph II (FENopta) results in RMS Clinical development program Total new T1 Gd+ lesions* CSF concentration Combined (W4, 8 and 12) W4 W8 W12 Fenebrutinib CSF conc. (ng/mL) Fenebrutinib
Slide 30: Spinal muscular atrophy: Evrysdi on track to become global #1
Spinal muscular atrophy: Evrysdi on track to become global #1 Ph II results confirm strong efficacy & safety profile in <2 mos old; EU label expansion achieved CHFm YoY CER growth Q3 update 450 • >11,000 patients treated worldwide; retention rate in first 12 400 +41% months of ~90% globally 350 • US
Slide 31: Ophthalmology: Vabysmo with continued strong momentum
Ophthalmology: Vabysmo with continued strong momentum US/EU filing for third indication in RVO completed Q3 update CHFm YoY CER growth • US market share reaches 19% in nAMD and 12% in DME*; double-digit market share achieved in early launch countries 700 +309% • US: 37% of Vabysmo new patient starts
Slide 32: Zilebesiran: Best-in-disease potential in hypertension
Zilebesiran: Best-in-disease potential in hypertension Positive Ph II (KARDIA-1) results to be presented at AHA Ph I results Ph II (KARDIA-1) topline results Clinical development program Primary endpoint met Ph I Ph II Ph III >90% reduction of serum AGT 24h mean SBP change at month 3 for up to 6 mon
Slide 33: 2023: Key late-stage newsflow
2023: Key late-stage newsflow* Compound Indication Milestone Hemlibra Moderate hemophilia A EU approval Polivy + R-CHP 1L DLBCL US approval Vabysmo RVO US approval/EU filing EU filing Regulatory Tecentriq Subcutaneous administration US approval/EU filing US 2024 / EU filing Columvi (glofitamab) 3L+
Slide 34: Diagnostics Division
Diagnostics Division Matt Sause CEO Roche Diagnostics
Slide 35: YTD Sep 2023: Diagnostics Division sales
YTD Sep 2023: Diagnostics Division sales Strong base business growth, partially offsetting COVID-19 sales decrease 2023 2022 Change in % Excl. CHFm CHFm CHF CER C191 Diagnostics Division 10,431 13,848 -25 -18 7 Core Lab 5,836 5,833 0 9 Molecular Lab 1,647 2,735 -40 -35 Pathology Lab 1,046 975 7 15 D
Slide 36: Diagnostics Division sales growth by quarter
Diagnostics Division sales growth by quarter Strong base business growth in Q3 2023 24% 10% 8% 7% 8% 7% 3% 4% 0% -9% -4% -5% -17% Diagnostics Division sales growth Base business sales growth1 -28% Q1 22 Q2 22 Q3 22 Q4 22 Q1 23 Q2 23 Q3 23 1.9bn 1.2bn 0.6bn 0.5bn 0.3bn 0.1bn 0.1bn COVID-19 sales Grow
Slide 37: YTD Sep 2023: Diagnostics Division highlights
YTD Sep 2023: Diagnostics Division highlights Strong base business growth, partially offsetting COVID-19 sales decrease CHFbn YoY CER growth • Immunodiagnostics (+11%) Core Lab +9% • Clinical Chemistry (+10%) • Custom biotech (-11%) • Cervical Cancer (+25%) Molecular Lab -35% • Blood Screening (+14%
Slide 38: Diagnostics Division regional sales
YTD Sep 2023: Diagnostics Division regional sales Strong base business growth across all regions; significantly lower COVID-19 sales North America -23% EMEA ~28% of divisional sales -17% ~34% of divisional sales Asia Pacific Latin America -19% +6% ~31% of divisional sales ~7% of divisional sales Gro
Slide 39: cobas connection modules (CCM) Vertical
cobas® connection modules (CCM) Vertical Modular and flexible vertical transportation connecting laboratories across floors Fully customizable single-element design • Increase competitiveness: Of the core labs with an to meet customer needs complete automation offering • Optimize laboratory space: C
Slide 40: cobas c 703 and cobas ISE neo analytical units
cobas c 703 and cobas ISE neo analytical units1 Introducing industry leading high-throughput clinical chemistry testing to cobas® pro Increased throughput and New generation analytical units more reagent positions with differentiating innovations Up to 2,000 tests per hour and Self-operating mainten
Slide 41: Core Lab menu expansion driving future growth
Core Lab menu expansion driving future growth >240 assays running on >100k installed cobas® serum work area instruments Launches in 2021, 2022, 2023 and upcoming4 Immuno chemistry assays Clinical chemistry assays EBV EBNA IgG (CE) IGRA SARS-CoV-2 Interferon Gamma Anti-HEV IgG and Fentanyl3 (CE, US)
Slide 42: IL-6 CE claim extension for neonatal sepsis
IL-6 CE claim extension for neonatal sepsis Early diagnosis can prevent ~84% of neonatal deaths1 Neonatal sepsis disease burden1 Addressing unmet need for earlier and improved detection of neonatal sepsis • 3m out of 50m total sepsis cases • Early diagnosis of neonatal sepsis is crucial for timely a
Slide 43: Diagnostics key launches 2023
Diagnostics key launches 2023 Area Product Description Markets Status Modular transportation system, integrated into the existing cobas connection modules, allowing for overhead CCM Vertical Global sample transportation over different work areas or different floors enabling effective use of lab spac
Slide 44: Finance
Finance Alan Hippe Chief Financial Officer
Slide 45: YTD Sep 2023: Highlights
YTD Sep 2023: Highlights Sales • Group sales +1% at CER driven by strong base business growth, overcompensating COVID-19 sales decline and AHR biosimilar impact • Strong Pharma YTD growth (+9% at CER) driven by Vabysmo, Ocrevus, Hemlibra, Polivy, Evrysdi, Phesgo and Tecentriq • Strong Diagnostics ba
Slide 46: YTD Sep 2023: Regional sales development
YTD Sep 2023: Regional sales development CER Group sales increase of +1% driven by Pharma Division +8% +7% +12% +10% -18% +1% -6% Pharma Division -18% +9% +303 +397 +799 -2,487 +1,443 455 -3,439 -2,984 1 United States Europe Intl. Chugai Dia Division Group Fx ¹ Group (Japan) CER CHF Absolute values
Slide 47: YTD Sep 2023 exchange rate impact on sales growth
YTD Sep 2023 exchange rate impact on sales growth Negative impact driven by the USD, CNY (APAC), JPY and EUR -0.5%p +1.0% -1.6%p CER CHF -2.4%p sales growth sales growth YTD Sep 2023 YTD Sep 2023 vs. -6.3% vs. YTD Sep 2022 YTD Sep 2022 -0.7%p -1.0%p -0.5%p -0.6%p CER EUR APAC USD LATAM JPY Other Oth
Slide 48: Expected 2023 currency impact
Expected 2023 currency impact CHF / USD Assumed avg. YTD 2023 0% -3% -5% -5% 0.95 0.95 0.94 0.92 Assuming the 30 September 2023 exchange rates 0.90 0.91 remain stable until end of 2023, 0.93 0.91 2023 impact1 is expected to be (%p): 0.92 0.92 0.93 0.90 0.90 0.90 0.87 0.88 0.90 0.92 0.92 0.92 Q1 HY S
Slide 49: 2023 outlook confirmed
2023 outlook confirmed Group sales growth1 Low single digit decline Core EPS growth1 Broadly in line with sales decline Dividend outlook Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER) 49
Slide 50: Upcoming Roche IR events
Upcoming Roche IR events Updates on Neuroscience, Digitalization, ASH presentations and Diagnostics Neuroscience Update Digitalization Day ASH Update Diagnostics Day Oct 30 Nov 29 TBA May 22, 2024 Virtual event Virtual event Virtual event London & virtual • Covering ECTRIMS & CTAD data: • Presenting
Slide 51: Doing now what patients need next
Doing now what patients need next
Slide 52: Roche Group development pipeline
Roche 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 inform
Slide 53: Changes to the development pipeline
Changes to the development pipeline Q3 2023 update New to phase I New to phase II New to phase III New to registration 3 NMEs: 1 NME: 1 NME: 1 AI (EU): RG6614 USP1 inhibitor – solid tumors RG6615 zilebesiran – hypertension RG6299 ASO factor B – IgA nephropathy RG7716 Vabysmo – BRVO & CRVO RG6596 HER
Slide 54: Roche Group development pipeline
Roche Group development pipeline Phase I (51 NMEs + 10 AIs) Phase II (21 NMEs + 9 AIs) RG6026 Columvi monotherapy + combos heme tumors RG7827 FAP-4-1BBL combos solid tumors tiragolumab + T NSCLC RG6058 tiragolumab combos solid tumors RG7828 Lunsumio monotherapy + combos heme tumors tiragolumab + T +
Slide 55: Roche Group development pipeline
Roche Group development pipeline Phase III (9 NMEs + 40 AIs) Registration US & EU (1 NME + 3 AIs) RG3502 Kadcyla + T HER-2+ eBC high-risk RG3648 Xolair food allergy RG6107* crovalimab PNH Columvi + chemo 2L+ DLBCL RG6149 astegolimab COPD RG7446 Tecentriq SC all approved indications RG6026 Columvi +
Slide 56: NME submissions and their additional indications
NME submissions and their additional indications* Projects in phase II and III tiragolumab + T latent myostatin + giredestrant RG6058 locally adv esophageal RG6171 RG6237 Evrysdi endometrial cancer cancer SMA tiragolumab + T + autogene cevumeran latent myostatin RG6058 chemo RG6180 RG6237 1L melanom
Slide 57: Additional indication submissions for existing products
Additional indication submissions for existing products Projects in phase II and III New Molecular Entity (NME) Cardiovascular & Metabolism ✓ Indicates submission to health authorities has Additional Indication (AI) Neuroscience occurred Oncology / Hematology Ophthalmology Unless stated otherwise su
Slide 58: Major pending approvals 2023
Major pending approvals 2023 US EU China Japan-Chugai Tecentriq SC Tecentriq SC Phesgo Vabysmo RG7446 all approved indications RG7446 all approved indications RG6264 HER-2+ BC RG7716 BRVO/CRVO Filed Nov 2022 Filed Nov 2022 Filed July 2022 Filed April 2023 Vabysmo crovalimab crovalimab crovalimab RG7
Slide 59: Major granted approvals 2023
Major granted approvals 2023 US EU China Japan-Chugai Polivy Xofluza Polivy Phesgo RG7596 1L DLBCL (US) RG6152 influenza pediatric RG7596 1L DLBCL RG6264 HER-2+ BC/CC April 2023 Jan 2023 Jan 2023 Sept 2023 Columvi (glofitamab) Hemlibra Polivy Actemra RG6026 3L+ DLBCL RG6013 moderate hemophilia A RG7
Slide 60: Roche Group development pipeline
Roche 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 inform
Slide 61: Hemophilia: Hemlibra
Hemlibra (emicizumab, RG6013) Factor VIII mimetic for treatment of hemophilia A Hemophilia A patients Hemophilia A patients with and without inhibitors to Factor VIII, dosing Indication without inhibitors to factor VIII every 4 weeks Phase III Phase III Phase/study HAVEN 3 HAVEN 4 # of patients N=13
Slide 62: Hemophilia: Hemlibra
Hemlibra (emicizumab, RG6013) Factor VIII mimetic for treatment of hemophilia A Hemophilia A mild to moderate patients without inhibitors to Indication Hemophilia A patients with and without inhibitors to Factor VIII Factor VIII Phase III Phase III Phase/study HAVEN 5 HAVEN 6 # of patients N=85 N=70
Slide 63: Oncology: Alecensa
Alecensa (alectinib, RG7853) New CNS-active inhibitor of anaplastic lymphoma kinase Treatment-naïve Indication Adjuvant ALK+ NSCLC ALK+ advanced NSCLC Phase III Phase III Phase/study ALEX ALINA # of patients N=286 N=257 ARM A: Alecensa 600mg BID ARM A: Alecensa 600mg BID Design ARM B: Crizotin
Slide 64: Oncology: Kadcyla
Kadcyla (trastuzumab emtansine, RG3502) First ADC for HER2-positive breast cancer HER2-positive early breast cancer (BC) HER2-positive early breast cancer (BC) Indication high-risk patients high-risk patients Phase III Phase III Phase/study KATHERINE ASTEFANIA # of patients N=1,484 N=1,700 ARM A:
Slide 65: Oncology: Phesgo
Phesgo (pertuzumab/trastuzumab, RG6264) FDC of Perjeta and Herceptin for subcutaneous administration Indication HER2-positive early breast cancer (BC) HER2-positive breast cancer (BC) Phase III Phase II Phase/study Pivotal Phase I1 FeDeriCa PHranceSCa # of patients N=500 N=160 N=144 Phesgo in combin
Slide 66: Oncology: Tecentriq lung cancer
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – lung cancer Indication Adjuvant NSCLC Periadjuvant NSCLC Phase III Phase III Phase/study IMpower010 IMpower030 # of patients N=1,280 N=450 Following adjuvant cisplatin-based chemotherapy ARM A: Tecentriq plus platinum-based chemoth
Slide 67: Oncology: Tecentriq lung cancer
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – lung cancer Indication 1L maintenance extensive-stage SCLC Stage IV NSCLC Phase III Phase Ib/III Phase/study IMforte1 IMscin0012 # of patients N=450 N=371 ARM A: Platinum-etoposide + Tecentriq followed by maintenance Phase Ib Tecen
Slide 68: Oncology: Tecentriq SCCHN
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – SCCHN Indication Adjuvant squamous cell carcinoma of the head and neck (SCCHN) Phase III Phase/study IMvoke010 # of patients N=406 ARM A: Tecentriq 1200mg Q3W ARM B: Placebo Oncology Design Event-free survival and overall survi
Slide 69: Oncology: Tecentriq urothelial carcinoma
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – urothelial carcinoma High-risk non-muscle-invasive ctDNA+, high-risk muscle-invasive Indication bladder cancer (NMIBC) bladder cancer (MIBC) Phase III Phase III Phase/study ALBAN IMvigor011 # of patients N=516 N=495 ARM A: BCG indu
Slide 70: Oncology: Tecentriq HCC
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – hepatocellular carcinoma Indication Adjuvant hepatocellular carcinoma (HCC) Phase III Phase/study IMbrave050 # of patients N=668 ARM A: Tecentriq plus Avastin ARM B: Active surveillance Oncology Design Primary endpoint Recurren
Slide 71: Oncology: Tecentriq breast cancer
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – breast cancer Previously untreated metastatic Indication triple negative breast cancer (TNBC) Phase III Phase III Phase/study IMpassion130 IMpassion132 # of patients N=902 N=572 ARM A: Tecentriq plus nab-paclitaxel ARM A: Tecentr
Slide 72: Oncology: Tecentriq breast cancer
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – breast cancer Indication Neoadjuvant triple negative breast cancer (TNBC) Phase III Phase/study IMpassion031 # of patients N=333 ARM A: Tecentriq plus nab-paclitaxel ARM B: Placebo plus nab-paclitaxel Oncology Design Primary endp
Slide 73: Oncology: Venclexta CLL
Venclexta (venetoclax, RG7601) Novel small molecule Bcl-2 selective inhibitor – chronic lymphocytic leukemia Untreated chronic lymphocytic leukemia (CLL) patients with Indication Untreated fit chronic lymphocytic leukemia (CLL) patients coexisting medical conditions Phase III Phase III Phase/study C
Slide 74: Oncology: Venclexta multiple myeloma
Venclexta (venetoclax, RG7601) Novel small molecule Bcl-2 selective inhibitor – multiple myeloma Indication Relapsed or refractory multiple myeloma (MM) Phase III Phase/study Phase I CANOVA # of patients N=117 N=263 Dose escalation cohort: Venclexta dose escalation ARM A: Venclexta plus dexameth
Slide 75: Oncology: Venclexta MDS
Venclexta (venetoclax, RG7601) Novel small molecule Bcl-2 selective inhibitor – myelodysplastic syndromes Relapsed or refractory myelodysplastic Treatment-naive myelodysplastic syndromes Newly diagnosed higher-risk Indication syndromes (MDS) (MDS) myelodysplatic syndrome (MDS) Phase III Phase/study
Slide 76: Oncology: Polivy
Polivy (polatuzumab vedotin, RG7596) ADC targeting CD79b to treat B cell malignancies Indication 1L DLBCL Phase III Phase/study POLARIX # of patients N=879 ARM A: Polivy plus R-CHP ARM B: R-CHOP Design Oncology Primary endpoint Progression-free survival Data presented at ASH 2021 and 2022
Slide 77: Oncology: Gavreto
Gavreto (pralsetinib, RG6396) Highly selective RET inhibitor RET+ NSCLC, thyroid cancer and Indication 1L RET fusion-positive, metastatic NSCLC other advanced solid tumors Phase I/II Phase III Phase/study ARROW AcceleRET Lung # of patients N=647 N=250 Part I: Gavreto 30-600mg dose escalation ARM
Slide 78: Oncology: Lunsumio
Lunsumio (mosunetuzumab, CD20 x CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously 3L+ FL, 3L+ DLBCL & other relapsed or Indication 1L DLBCL Relapsed or refractory DLBCL refractory NHL Phase/study Phase I/II Phase Ib/II Phase Ib/II # of patients N=746 N=160 N=262
Slide 79: Oncology: Lunsumio
Lunsumio (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 Phase I Phase Ib # of patients N=188 N=27 Cohort A: Lunsumio monotherapy (after a res
Slide 80: Oncology: Lunsumio
Lunsumio (mosunetuzumab, CD20 x CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 2L+ FL Relapsed or refractory CLL Phase III Phase/study Phase Ib/II CELESTIMO # of patients N=400 N=56 ARM A: Lunsumio plus lenalidomide Lunsumio monotherapy (3L+ CLL)
Slide 81: Oncology: Lunsumio
Lunsumio (mosunetuzumab, CD20 x CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 2L+ SCT ineligible DLBCL Phase III Phase/study SUNMO # of patients N=222 ARM A: Lunsumio plus Polivy ARM B: R + GemOx Oncology Design Progression-free survival Primar
Slide 82: Oncology: Columvi
Columvi (glofitamab, CD20-TCB, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Relapsed or refractory Non-Hodgkin’s lymphoma (NHL) Phase/study Phase I Phase Ib Phase I # of patients N=700 N=140 N=18-36 Cohort 1: Single-agent dose escalation study Dose escal
Slide 83: Oncology: Columvi
Columvi (glofitamab, CD20-TCB, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Non-Hodgkin’s lymphoma (NHL) 2L+ SCT-ineligible DLBCL 1L ctDNA high risk DLBCL Phase III Phase/study Phase Ib Phase II STARGLO Part I: 15-60 # of patients N=270 N=40 Part II: ~66
Slide 84: Oncology: Columvi
Columvi (glofitamab, CD20-TCB, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 2L+ SCT-eligible DLBCL 2L+ SCT-ineligible DLBCL 1L DLBCL fit (IPI 2-5) Phase III Phase/study Phase Ib Phase Ib SKYGLO # of patients N=40 N=112 N=1130 Columvi plus R-ICE (single
Slide 85: Neuroscience: Ocrevus
Ocrevus (ocrelizumab, RG1594) Humanized monoclonal antibody selectively targeting CD20+ B cells Primary progressive Indication Relapsing multiple sclerosis (RMS) multiple sclerosis (PPMS) Phase III Phase III Phase III Phase/study OPERA I OPERA II ORATORIO # of patients N=821 N=835 N=732 96-week trea
Slide 86: Neuroscience: Ocrevus
Ocrevus (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 IIIb Phase IIIb Phase/study ENSEMBLE PLUS ORATORIO-HAND # of patients N=1,2
Slide 87: Neuroscience: Ocrevus
Ocrevus (ocrelizumab, RG1594) Humanized monoclonal antibody selectively targeting CD20+ B cells Indication Primary progressive multiple sclerosis (PPMS) Relapsing multiple sclerosis (RMS) PPMS & RMS Phase IIIb Phase IIIb Phase III Phase/study GAVOTTE MUSETTE Ocarina II1 # of patients N ~ 699 N ~ 786
Slide 88: Neuroscience: Evrysdi
Evrysdi (risdiplam, RG7916) Oral SMN2 splicing modifier Indication Spinal muscular atrophy (SMA) Phase II/III Phase II/III Phase II Phase/study FIREFISH SUNFISH JEWELFISH # of patients N=21 (Part 1), 41 (Part 2) N=51 (Part 1), 180 (Part 2) N=174 Infants with type 1 SMA Adult & pediatric patients wit
Slide 89: Neuroscience: Evrysdi
Evrysdi (risdiplam, RG7916) Oral SMN2 splicing modifier Indication Spinal muscular atrophy (SMA) Phase II Phase/study RAINBOWFISH # of patients N=25 Infants aged from birth to 6 weeks who have been genetically diagnosed with SMA but are not yet presenting with symptoms Neuroscience Design Propor
Slide 90: Neuroscience: Enspryng
Enspryng (satralizumab, RG6168, SA237) Anti-IL-6 receptor humanized monoclonal antibody Indication Neuromyelitis optica spectrum disorder (NMOSD) Phase III Phase III Phase/study SAkuraStar SAkuraSky # of patients N=95 N=83 Enspryng monotherapy: Add-on therapy of Enspryng: ARM A: Enspryng 120mg SC
Slide 91: Neuroscience: Enspryng
Enspryng (satralizumab, RG6168, SA237) Anti-IL-6 receptor humanized monoclonal antibody Myelin oligodendrocyte glycoprotein antibody Indication Generalised myasthenia gravis (MG) Autoimmune encephalitis (AIE) disease (MOG-AD) Phase III Phase III Phase III Phase/study Luminesce METEOROID CIELO # of p
Slide 92: Immunology: Gazyva
Gazyva (obinutuzumab, RG7159) Immunology development program Indication Lupus nephritis Membranous nephropathy Phase II Phase III Phase III Phase/study NOBILITY REGENCY MAJESTY # of patients N=126 N=252 N=140 ARM A: Gazyva 1000mg IV plus MFF / ARM A: Gazyva 1000mg IV (6 doses through ARM A: Ga
Slide 93: Immunology: Gazyva
Gazyva (obinutuzumab, RG7159) Immunology development program Indication Systemic lupus erythematosus (SLE) Childhood onset idiopathic nephrotic syndrome* Phase III Phase III Phase/study ALLEGORY INShore # of patients N=200 N=80 ARM A: Gazyva 1000mg IV on Day 1 and Weeks 2, 24 and 26. ARM A: Gazy
Slide 94: Immunology: Mosunetuzumab
Mosunetuzumab (CD20 x CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Systemic lupus erythematosus (SLE) Phase/study Phase I # of patients N=50 ARM A: Mosunetuzumab SC on either Day 1 or on Days 1 and 8 ARM B: Fractionated (divided) dose of mosunet
Slide 95: Immunology: Xolair
Xolair (omalizumab, RG3648) Humanized monoclonal antibody that selectively binds to IgE Indication Food allergy Phase III Phase/study OUtMATCH1 # of patients N=225 Xolair by SC injection either Q2W or Q4W for 16 to 20 weeks Immunology Design Primary endpoint Number of participants who successful
Slide 96: Ophthalmology: Susvimo
Susvimo (PDS, RG6321) First eye implant to achieve sustained delivery of a biologic medicine Indication Wet age-related macular degeneration (wAMD) Phase III Phase II+III extension Phase IIIb Phase/study Archway Portal Velodrome # of patients N=418 N=1,000 N=442 ARM A: PDS Q24W Patients from LAD
Slide 97: Ophthalmology: Susvimo
Susvimo (PDS, RG6321) First eye implant to achieve sustained delivery of a biologic medicine Diabetic retinopathy (DR) without Indication Diabetic macular edema (DME) center-involved diabetic macular edema (DME) Phase III Phase III Phase/study Pagoda Pavilion # of patients N=634 N=174 ARM A: PDS Q
Slide 98: Ophthalmology: Vabysmo
Vabysmo (faricimab, RG7716) Bispecific antibody to simultaneously bind Ang-2 and VEGF-A Indication Center-involving diabetic macular edema (CI-DME) Phase III Phase III Phase/study YOSEMITE RHINE # of patients N=940 N=951 ARM A: Faricimab Q8W ARM A: Faricimab Q8W ARM B: Faricimab PTI up to Q16W
Slide 99: Ophthalmology: Vabysmo
Vabysmo (faricimab, RG7716) Bispecific antibody to simultaneously bind Ang-2 and VEGF-A Indication Wet age related macular degeneration (wAMD) Phase III Phase III Phase/study TENAYA LUCERNE # of patients N=671 N=658 ARM A: Faricimab 6.0mg Q16W flexible after 4 IDs ARM A: Faricimab 6.0mg Q16W fle
Slide 100: Ophthalmology: Vabysmo
Vabysmo (faricimab, RG7716) Bispecific antibody to simultaneously bind Ang-2 and VEGF-A Indication Macular edema (ME) secondary to branch retinal vein occlusion (RVO) Macular edema (ME) secondary to central retinal vein occlusion (RVO) Phase III Phase III Phase/study BALATON COMINO # of patients N=5
Slide 101: Ophthalmology: Satralizumab
Satralizumab (RG6168, SA237) Anti-IL-6 receptor humanized monoclonal antibody Indication Thyroid eye disease Phase III Phase III Phase/study SatraGo-1 SatraGo-2 # of patients N=120 N=120 ARM A: Satralizumab at weeks 0, 2, 4 (loading doses) and maintenance ARM A: Satralizumab at weeks 0, 2, 4 (lo
Slide 102: Infectious Diseases: Xofluza
Xofluza (baloxavir marboxil, RG6152, S-033188 ) Small molecule, novel CAP-dependent endonuclease inhibitor Indication Influenza Phase III Phase III Phase IIIb Phase/study miniSTONE 1 (0-1 year old) miniSTONE 2 (1- <12 years old ) CENTERSTONE # of patients N=30 N=176 N=3,160 Healthy pediatric patient
Slide 103: Roche Group development pipeline
Roche 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 inform
Slide 104: Oncology: Tiragolumab
Tiragolumab (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 III Phase III Phase/study SKYSCRAPER-01 SKYSCRAPER-03 # of patients N=500-560 N=800 ARM A: Tiragolumab plus Tecent
Slide 105: Oncology: Tiragolumab
Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT Metastatic and/or recurrent PD-L1+ Indication Neoadjuvant and adjuvant NSCLC 1L non-squamous NSCLC cervical cancer (CC) Phase II Phase II Phase III Phase/study SKYSCRAPER-04 SKYSCRAPER-05
Slide 106: Oncology: Tiragolumab
Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT 1L recurrent/metastatic PD-L1 positive Indication Locally advanced esophageal cancer (EC) 1L esophageal cancer (EC) squamous cell head and neck carcinoma (SCCHN) Phase III Phase III Phase
Slide 107: Oncology: Tiragolumab
Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT Indication Locally advanced, recurrent or metastatic solid tumors 1L HCC Phase II Phase III Phase/study SKYSCRAPER-11 SKYSCRAPER-14 # of patients N=60 N=650 Tiragolumab plus Tecentriq IV
Slide 108: Oncology: Tiragolumab
Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT Indication Solid tumors NSCLC Phase II Phase/study Phase I CITYSCAPE # of patients N=540 N=135 Phase Ia: Dose escalation and expansion of tiragolumab ARM A: Tecentriq plus tiragolumab
Slide 109: Oncology: Inavolisib
Inavolisib (RG6114, GDC-0077) A potent, orally available, and selective PI3Kα inhibitor PIK3CA-mutant HR-positive metastatic breast PIK3CA mutant solid tumors and metastatic Indication post CDKi HR-positive breast cancer cancer (mBC) ER+ HER2-negative breast cancer Phase III Phase III Phase/study Ph
Slide 110: Oncology: Inavolisib
Inavolisib (RG6114, GDC-0077) A potent, orally available, and selective PI3Kα inhibitor Indication 1L HER2-positive PIK3CA mutant metastatic breast cancer (mBC) Phase III Phase/study INAVO122 # of patients N=230 ARM A: Inavolisib plus Phesgo after induction therapy with Phesgo + taxane ARM B: Pl
Slide 111: Oncology: Giredestrant
Giredestrant (SERD (3),RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator ER+ HER2-negative metastatic breast cancer ER+ HER2-negative Stage I-III operable breast Indication Neoadjuvant ER-positive breast cancer (BC) (mBC) cancer (BC) Phase II Phase/study Phase I Phase I coopE
Slide 112: Oncology: Giredestrant
Giredestrant (SERD (3),RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator Indication 1L ER-positive metastatic breast cancer (mBC) Adjuvant ER-positive breast cancer (BC) Phase III Phase III Phase/study persevERA Breast Cancer lidERA Breast Cancer # of patients N=978 N=4,100
Slide 113: Oncology: Giredestrant
Giredestrant (SERD (3),RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator 1L ER-positive/HER2-positive breast cancer ET resistant ER+/HER2-negative breast cancer Indication Grade 1 endometrial cancer (BC) (BC) Phase III Phase II Phase III Phase/study heredERA endomERA pionERA
Slide 114: Oncology: Divarasib
Divarasib (KRAS G12C inhibitor, RG6330, GDC-6036) A potent, orally available, and selective inhibitor of the KRAS G12C mutant protein Advanced or metastatic solid tumors with a Indication 2L NSCLC 2L, 1L metastatic colorectal cancer (mCRC) KRAS G12C mutation Phase II/III Phase Ib Phase/study Phase I
Slide 115: Oncology: Divarasib
Divarasib (KRAS G12C inhibitor, RG6330, GDC-6036) A potent, orally available, and selective inhibitor of the KRAS G12C mutant protein Indication 1L NSCLC Phase Ib Phase/study KRASCENDO 170 # of patients N=60 Combination of divarasib and pembrolizumab in 1L PD-L1+ metastatic NSCLC Design Oncology
Slide 116: Haematology: Crovalimab
Crovalimab (RG6107, SKY59) A humanized monoclonal antibody against complement C5 Paroxysmal nocturnal hemoglobinuria (PNH) patients switching from a Indication Paroxysmal nocturnal hemoglobinuria (PNH) C5 inhibitor Phase I/II Phase III Phase/study COMPOSER COMMODORE 1 # of patients N=59 N=89 (ARMs A
Slide 117: Haematology: Crovalimab
Crovalimab (RG6107, SKY59) A humanized monoclonal antibody against complement C5 Paroxysmal nocturnal hemoglobinuria (PNH) Paroxysmal nocturnal hemoglobinuria (PNH) Indication C5 inhibitor naive patients C5 inhibitor naive patients (China only) Phase III Phase III Phase/study COMMODORE 2 COMMODORE 3
Slide 118: Haematology: Crovalimab
Crovalimab (RG6107, SKY59) A humanized monoclonal antibody against complement C5 Atypical hemolytic uremic syndrome (aHUS) Atypical hemolytic uremic syndrome (aHUS) Indication study 1 - adults study 2 - paediatrics Phase III Phase III Phase/study COMMUTE-a COMMUTE-p # of patients N=90 N=35 Single-ar
Slide 119: Haematology: Crovalimab
Crovalimab (RG6107, SKY59) A humanized monoclonal antibody against complement C5 Sickle cell disease (SCD) Sickle cell disease (SCD) Indication acute treatment chronic VOC prevention Phase Ib Phase IIa Phase/study CROSSWALK-a CROSSWALK-c # of patients N=30 N=90 ARM A: Crovalimab ARM A: Crovalima
Slide 120: Immunology: Crovalimab
Crovalimab (RG6107, SKY59) A humanized monoclonal antibody against complement C5 Indication Lupus nephritis (LN) Phase/study Phase I # of patients N=15 Single-arm study of patients with active class III, IV, or V lupus nephritis and urine protein-to-creatinine ratio >=1.5 g/g All patients to rec
Slide 121: Immunology: Astegolimab
Astegolimab (RG6149, Anti-ST2) A monoclonal antibody that selective binds to ST2 Indication Chronic obstructive pulmonary disease (COPD) Phase II Phase IIb Phase III Phase/study COPD-ST2OP ALIENTO ARNASA # of patients N=81 N=1,290 N=1,290 Astegolimab SC 490mg Q4W for 48 weeks ARM A: SC astegolim
Slide 122: Immunology / Ophthalmology: ASO factor B
ASO factor B (RG6299) Antisense oligonucleotide that targets factor B Indication IgA nephropathy (igAN) Geographic atrophy (GA) Phase III Phase II* Phase/study Phase II* IMAGINATION GOLDEN STUDY # of patients N=25 N=428 N=330 ASO factor B SC at week 1 following Q4W ARM A: ASO factor B SC at week
Slide 123: Ophthalmology: Anti-IL-6
Anti-IL-6 (RG6179) A monoclonal antibody that potently binds interleukin-6 (IL-6) cytokine Diabetic macular edema (DME) and Uveitic Indication Diabetic macular edema (DME) macular edema (UME) Phase I Phase II Phase II Phase/study DOVETAIL BARDENAS ALLUVIUM # of patients N=90 N=210-230 N=360-400 Pa
Slide 124: Ophthalmology: Anti-IL-6
Anti-IL-6 (RG6179) A monoclonal antibody that potently binds interleukin-6 (IL-6) cytokine Indication Uveitic macular edema (UME) Phase III Phase III Phase/study MEERKAT SANDCAT # of patients N=225 N=225 ARM A: Anti-IL-6 low-dose Q4W to week 12, followed by PRN ARM A: Anti-IL-6 low-dose Q4W to w
Slide 125: Neuroscience: Crenezumab
Crenezumab (RG7412) Humanized monoclonal antibody targeting all forms of Aß Indication Alzheimer’s prevention initiative (API) Colombia Phase II Phase/study Cognition study # of patients N=252 ARM A: PSEN1 E280A mutation carriers receive crenezumab SC or IV ARM B: PSEN1 E280A mutation carriers r
Slide 126: Neuroscience: Tominersen
Tominersen (RG6042, HTT ASO) Antisense oligonucleotide (ASO) targeting human HTT mRNA Indication Huntington’s disease Phase II Phase/study GENERATION HD2 # of patients N=360 Patients aged 25 to 50 years with prodromal (very early subtle signs of HD) or early manifest HD ARM A: Tominersen 60mg Q16W
Slide 127: Neuroscience: Fenebrutinib
Fenebrutinib (RG7845, GCD-0853) Highly selective and reversible (noncovalent) bruton tyrosine kinase Primary progressive multiple sclerosis Indication Relapsing multiple sclerosis (RMS) (PPMS) Phase III Phase III Phase III Phase/study FENtrepid FENhance 1 FENhance 2 # of patients N=946 N=736 N=736
Slide 128: Neuroscience: Fenebrutinib
Fenebrutinib (RG7845, GCD-0853) Highly selective and reversible (noncovalent) bruton tyrosine kinase Indication Relapsing multiple sclerosis (RMS) Phase II (Biomarker study) Phase/study FENopta # of patients N=109 ARM A: Fenebrutinib ARM B: Placebo Design Neuroscience Primary endpoint Total nu
Slide 129: Neuroscience: Balovaptan
Balovaptan (RG7314) Small molecule antagonist of the V1A vasopressin receptor Indication Post-traumatic stress disorder (PTSD) Phase/study Phase II # of patients N=30 ARM A: Balovaptan IV once a day for 12 weeks ARM B: Placebo Design Neuroscience Primary endpoint Change from baseline in the Cl
Slide 130: Neuroscience: Latent myostatin
Latent myostatin (RG6237, GYM329) Recycling and antigen-sweeping monoclonal anti-latent myostatin antibody Indication Facioscapulohumeral Muscular Dystrophy (FSHD) Spinal muscular atrophy (SMA) Phase II Phase II/III Phase/study MANOEUVRE MANATEE1 # of patients N=48 N=180 ARM A: 4-week pre-treatmen
Slide 131: Roche Group development pipeline
Roche 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 inform
Slide 132: pRED oncology development programs -1
pRED oncology development programs -1 Molecule Indication Phase # of patients Status CT Identifier Oncology FPI Q3 2021 FAP-4-1BBL (RG7827) 3L+ MSS mCRC Ib 80 NCT04826003 Combination study with cibisatamab FPI Q4 2019 Solid tumors I 320 Data presented at ESMO 2022 NCT04140500 Recruitment completed Q
Slide 133: pRED oncology development programs -2
pRED oncology development programs -2 Molecule Indication Phase # of patients Status CT Identifier Oncology Advanced and metastatic solid FPI Q4 2020 Anti-CD25 (RG6292) I 160 NCT04642365 tumors PK/PD data presented at AACR 2023 forimtamig FPI Q4 2020 Multiple myeloma I 400 NCT04557150 (Anti-GPRC5D,
Slide 134: pRED neuroscience development programs -1
pRED neuroscience development programs -1 Molecule Indication Phase # of patients Status CT Identifier Neuroscience trontinemab Alzheimer's disease IIa ~210 FPI Q1 2021 NCT04639050 (BS-gantenerumab, RG6102) ISRCTN16295 Brain Shuttle-CD20 (BS-CD20, Multiple sclerosis I 30-63 FPI Q3 2021 177 RG6035) N
Slide 135: pRED neuroscience development programs -2
pRED neuroscience development programs -2 Molecule Indication Phase # of patients Status CT Identifier Neuroscience MAGLi (RG6182) Multiple sclerosis I Up to 36 FPI Q3 2023 NME (RG6163) Psychiatric disorders I 84 FPI Q1 2022 selnoflast* Parkinson’s disease Ib 48 FPI Q3 2022 (NLRP3i, RG6418) basmisan
Slide 136: pRED immunology and ophthalmology development programs
pRED immunology and ophthalmology development programs Molecule Indication Phase # of patients Status CT Identifier Immunology selnoflast* Chronic obstructive pulmonary FPI Q2 2022 Ib 102 (NLRP3i, RG6418) disease Study closed Q3 2022 Ophthalmology zifibancimig NCT04567303 nAMD I 251 FPI Q4 2020 (VEG
Slide 137: pRED infectious diseases development programs
pRED infectious diseases development programs Molecule Indication Phase # of patients Status CT Identifier Infectious Diseases ruzotolimod FPI Q4 2016 Chronic hepatitis B I 150 NCT02956850 (TLR7 agonist (3) RG7854) Data presented at APASL 2019 ruzotolimod/ xalnesiran1/ NCT04225715 PDL1 LNA Chronic h
Slide 138: Roche Group development pipeline
Roche 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 inform
Slide 139: gRED oncology development programs -1
gRED oncology development programs -1 Molecule Indication Phase # of patients Status CT Identifier Oncology FPI Q3 2017 R/R multiple myeloma I 300 NCT03275103 Data presented at ASH 2020, 2021 & 2022 cevostamab R/R multiple myeloma I 120 FPI Q2 2021 NCT04910568 (anti-FcRH5 x CD3; RG6160) BCMA-experie
Slide 140: gRED oncology development programs -2
gRED oncology development programs -2 Molecule Indication Phase # of patients Status CT Identifier Oncology SHP2i (RG6433)1 Solid tumors Ib ~125 FPI Q3 2022 NCT05487235 FPI Q4 2021 KRAS-G12C mutant solid tumors Ib ~500 Arm F of a combination study investigating NCT04449874 divarasib monotheraphy and
Slide 141: gRED immunology and ophthalmology development programs
gRED immunology and ophthalmology development programs Molecule Indication Phase # of patients Status CT Identifier Immunology NME (RG6287, GDC-8264) Acute graft versus host disease Ib 40 FPI Q2 2023 NCT05673876 NME (RG6315, MTBT1466A) Systemic sclerosis Ib 100 FPI Q1 2023 NCT05462522 Asthma Ia/Ib 8
Slide 142: gRED neuroscience and infectious diseases development programs
gRED neuroscience and infectious diseases development programs Molecule Indication Phase # of patients Status CT Identifier Neuroscience FPI Q1 2019 Mild-to-moderate Alzheimer’s One of two co-primary endpoints met Q3 2021 NCT03828747 semorinemab (RG6100)1 II 272 disease Data presented at CTAD 2021 (
Slide 143: Roche Group development pipeline
Roche 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 inform
Slide 144: Hemophilia A gene therapy
Hemophilia A Unique gene therapy platform Dirloctogene Samoparvovec (SPK-8011) Molecule (RG6357) Indication Hemophilia A Phase/study Phase I Phase I/II # of patients N=100 N=30 Long term follow up study of patients who have received SPK-8011 in any Gene transfer, dose-finding safety, tolerabilit
Slide 145: Pompe disease gene therapy
Pompe disease Unique gene therapy platform SPK-3006 Molecule (RG6359) Indication Pompe disease Phase I/II Phase/study RESOLUTE # of patients N=20 Gene transfer study for late-onset Pompe disease Cardiovascular and Metabolism Design Safety Primary endpoint FPI Q4 2020 Status Recruitment compl
Slide 146: Roche Group development pipeline
Roche 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 inform
Slide 147: Geographical sales split by Divisions and Group
Geographical sales split by Divisions and Group* CHFm YTD Sep 2022 YTD Sep 2023 % change CER Pharmaceuticals Division 33,189 33,622 +9 United States 17,199 17,680 +8 Europe 6,100 6,259 +7 Japan 3,029 2,937 +10 International 6,861 6,746 +12 Diagnostics Division 13,848 10,431 -18 United States 3,471 2
Slide 148: Pharma Division sales YTD Sep 2023: Top products
Pharma Division sales YTD Sep 2023 Top 20 products Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Ocrevus 4,767 14 3,492 12 877 12 - - 398 35 Hemlibra 3,112 19 1,862 17 637 22 281 15 332 36 Perjeta 2,995 6 1,101 2 615 -4 161 4 1,118 15 Tecentriq 2,791 11
Slide 149: Pharma Division sales: Products launched since 2015
Pharma Division sales YTD Sep 2023 Products launched since 2015 Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Cotellic 39 23 18 81 8 -22 - - 13 15 Alecensa 1,126 9 340 8 220 5 157 6 409 12 Tecentriq 2,791 11 1,476 7 628 14 313 9 374 24 Ocrevus 4,767 14 3
Slide 150: Pharma Division sales: Product sales
Pharma Division sales YTD Sep 2023 Product sales Pharmaceuticals Division Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Ocrevus 4,767 14 3,492 12 877 12 - - 398 35 Hemlibra 3,112 19 1,862 17 637 22 281 15 332 36 Perjeta 2,995 6 1,101 2 615 -4 161 4 1,118
Slide 151: Pharma Division CER sales growth: Global top products
Pharma Division CER sales growth1 in % Global top 20 products Q1/22 Q2/22 Q3/22 Q4/22 Q1/23 Q2/23 Q3/23 Ocrevus 18 17 16 18 14 15 12 Hemlibra 30 31 23 24 24 17 17 Perjeta 1 9 5 4 11 6 0 Tecentriq 8 13 9 24 15 8 10 Actemra / RoActemra 3 -23 -42 -22 -12 2 21 Vabysmo - - - - * * 309 Xolair 9 13 8 6 5 4
Slide 152: Pharma Division CER sales growth: Top products by region
Pharma Division CER sales growth1 in % Top 20 products by region US Europe Japan International Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Ocrevus 15 13 14 10 26 11 16 10 - - - - 29 32 23 50 Hemlibra 21 21 14 15 27 27 18 22 14 24 19 5 45 38 31 39 Perjeta 13 8 6 -6 -15 1 -12 0 3 2 5 6 13 22 18 4
Slide 153: CER sales growth quarterly development
CER sales growth (%) Quarterly development 2022 vs. 2021 2023 vs. 2022 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Pharmaceuticals Division 6 0 -6 9 9 7 11 United States 2 1 -6 1 6 7 11 Europe -1 -6 4 -3 5 5 9 Japan 69 3 -27 69 18 8 1 International 0 4 -3 4 13 6 17 Diagnostics Division 24 0 -4 -9 -28 -17 -5 Roche Group 11
Slide 154: Ocrevus
Ocrevus Global sales CER growth Regional sales CER growth CHFbn +14% 5.0 US +12% 4.0 3.0 Europe +12% 2.0 International +35% 1.0 0.0 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 23 YTD Sep 2023 sales of CHF 4,767m • US: Moving into earlier lines displacing orals; #1 in US for both dynamic and total share
Slide 155: Hemlibra
Hemlibra Global sales CER growth Regional sales CER growth CHFbn 3.6 +19% US +17% 3.2 Europe +22% 2.8 2.4 Japan +15% 2.0 1.6 1.2 International +36% 0.8 0.4 0.0 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 23 YTD Sep 2023 sales of CHF 3,112m • US: Continued share gains in non-inhibitor patients • EU: Con
Slide 156: Perjeta
Perjeta Global sales CER growth Regional sales CER growth CHFbn 3.5 +6% US +2% 3.0 Europe -4% 2.5 Japan +4% 2.0 1.5 1.0 International +15% 0.5 0.0 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 23 YTD Sep 2023 sales of CHF 2,995m • US: Growth driven by eBC; increasing conversion to Phesgo • EU: Conversion
Slide 157: Tecentriq
Tecentriq Global sales CER growth Regional sales CER growth CHFbn 3.2 +11% US +7% 2.8 Europe +14% 2.4 2.0 1.6 Japan +9% 1.2 0.8 International +24% 0.4 0.0 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 23 YTD Sep 2023 sales of CHF 2,791m • US: Growth driven by adj NSCLC; 1L HCC nearing peak penetration •
Slide 158: Actemra / RoActemra
Actemra / RoActemra Global sales CER growth Regional sales CER growth CHFbn 3.2 +2% US +1% 2.8 2.4 Europe +1% 2.0 1.6 1.2 Japan +3% 0.8 0.4 International +6% 0.0 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 23 YTD Sep 2023 sales of CHF 1,943m • US: Ongoing patient shift from Actemra IV to SC in RA; COVI
Slide 159: Vabysmo
Vabysmo CHFbn Global sales CER growth Regional sales CER growth 1.8 >500% US +449% 1.5 1.2 Europe >500% 0.9 Japan +236% 0.6 International >500% 0.3 0.0 YTD Sep 20 YTD Sep 21 YTD Sep 22YTD Sep 23 YTD Sep 2023 sales of CHF 1,613m • US: Strong uptake with 37% naïve patients, 63% switches (mostly from a
Slide 160: Xolair
Xolair Global sales CER growth Regional sales CER growth CHFbn 1.8 +4% 1.5 1.2 US +4% 0.9 0.6 0.3 0.0 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 23 YTD Sep 2023 sales of CHF 1,601m • US: Growth driven by uptake in CSU CER=Constant Exchange Rates 160
Slide 161: Kadcyla
Kadcyla Global sales CER growth Regional sales CER growth CHFbn +2% 1.8 US -3% 1.5 1.2 Europe -9% 0.9 0.6 Japan -14% 0.3 International +29% 0.0 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 23 YTD Sep 2023 sales of CHF 1,486m • US: Share decline in metastatic BC due to competition • EU: Share decline in
Slide 162: Herceptin
Herceptin Global sales CER growth Regional sales CER growth CHFbn 3.5 -17% US -28% Europe -15% 3.0 2.5 Japan -33% 2.0 1.5 1.0 International -13% 0.5 0.0 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 23 YTD Sep 2023 sales of CHF 1,261m • US: Biosimilar erosion slowing; Switching of patients with residual
Slide 163: Rituxan / Mabthera
Rituxan / Mabthera CHFbn Global sales CER growth Regional sales CER growth 3.5 -15% US -20% 3.0 Europe -7% 2.5 2.0 Japan -13% 1.5 International -8% 1.0 0.5 0.0 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 23 YTD Sep 2023 sales of CHF 1,260m • US: Biosimilar erosion slowing; Switching of patients with re
Slide 164: Avastin
Avastin Global sales CER growth Regional sales CER growth CHFbn 4.5 -20% US -22% 4.0 Europe -48% 3.5 3.0 2.5 Japan -25% 2.0 1.5 1.0 International -8% 0.5 0.0 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 23 YTD Sep 2023 sales of CHF 1,210m • US: Biosimilar erosion slowing • EU: Ongoing biosimilar erosion
Slide 165: Alecensa
Alecensa CHFbn Global sales CER growth Regional sales CER growth +9% US +8% 1.2 1.0 Europe +5% 0.8 0.6 Japan +6% 0.4 0.2 International +12% 0.0 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 23 YTD Sep 2023 sales of CHF 1,126m • US: Market leadership in 1L ALK+ NSCLC is maintained • EU: Market leadership
Slide 166: Evrysdi
Evrysdi Global sales CER growth Regional sales CER growth CHFbn 1.2 +45% US +15% 1.0 Europe +54% 0.8 0.6 Japan +29% 0.4 International +115% 0.2 0.0 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 23 YTD Sep 2023 sales of CHF 1,065m • US: Strong uptake across all patient segments; including treatment-naïve
Slide 167: TNKase / Activase
TNKase / Activase Global sales CER growth Regional sales CER growth CHFbn 1.2 +8% US +8% 1.0 0.8 0.6 0.4 International +7% 0.2 0.0 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 23 YTD Sep 2023 sales of CHF 903m • Spontaneous TNKase use in AIS early time window CER=Constant Exchange Rates 167
Slide 168: Phesgo
Phesgo Global sales CER growth Regional sales CER growth CHFbn 0.9 +66% US +56% 0.8 0.7 0.6 Europe +53% 0.5 0.4 0.3 0.2 International +186% 0.1 0.0 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 23 YTD Sep 2023 sales of CHF 817m • US: Strong growth driven by eBC, switching of patients from Perjeta+Hercept
Slide 169: Gazyva
Gazyva Global sales CER growth Regional sales CER growth CHFbn 0.7 +22% US +25% 0.6 Europe +25% 0.5 0.4 0.3 Japan -17% 0.2 International +24% 0.1 0.0 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 23 YTD Sep 2023 sales of CHF 615m • US: Strong growth driven by combination therapies in 1L CLL • EU: Strong
Slide 170: Polivy
Polivy Global sales CER growth Regional sales CER growth CHFbn 0.7 +126% 0.6 US +100% 0.5 +70% Europe 0.4 0.3 Japan +181% 0.2 0.1 International +372% 0.0 YTD Sep 20 YTD Sep 21 YTD Sep 22 YTD Sep 23 YTD Sep 2023 sales of CHF 605m • US: Strong growth following approval in 1L DLBCL and inclusion to the
Slide 171: Roche Group development pipeline
Roche 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 inform
Slide 172: Diagnostics Division CER growth by region and customer area
YTD Sep 2023: Diagnostics Division CER growth By Region and Customer Area (vs. 2022) Global EMEA¹ North America Asia-Pacific Latin America CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Core Lab2 5,836 9 1,999 9 1,017 0 2,356 12 464 18 Molecular Lab 1,647 -35 530 -42 729 -24 326 -45 62 -18 P
Slide 173: Diagnostics Division quarterly sales and CER growth
Diagnostics Division quarterly sales and CER growth1 Q1 22 Q2 22 Q3 22 Q4 22 Q1 23 Q2 23 Q3 23 CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Core Lab 2 1,896 8 1,979 1 1,958 7 1,942 9 1,928 7 2,007 12 1,901 8 Molecular Lab 1,189 21 791 -20 755 -24 715 -35 593 -48 525 -
Slide 174: Diagnostics Division regional sales
YTD Sep 2023: Diagnostics Division regional sales Decline in most regions Sales YTD CHFm & % of total sales Sales growth at CER Total YTD Sales = 10,431 Diagnostics Division -18% GLOBAL 746 / -17% EMEA* 7% -23% NOA 3,569 / -19% APAC 34% 6% LAM 3,263 / 31% 2,853 / 28% EMEA* NOA APAC LAM CER=Constant
Slide 175: Core Lab
Core Lab1 2023 vs. 2022 CHFbn CER growth +9% 7.0 6.0 0% 5.0 +10% 4.0 +11% 3.0 2.0 1.0 0.0 YTD Sep 2021 YTD Sep 2022 YTD Sep 2023 Immunodiagnostics Clinical Chemistry Other CER=Constant Exchange Rates; 1 incl. Roche Information Solutions; underlying growth of Core Lab excluding Roche Information Solu
Slide 176: Molecular Lab
Molecular Lab 2023 vs. 2022 CHFbn CER growth -35% 3.5 3.0 -5% 2.5 -46% 2.0 +25% 0% 1.5 -33% 1.0 +14% 0.5 -57% 0.0 YTD Sep 2021 YTD Sep 2022 YTD Sep 2023 Virology Blood Screening MD Systems Microbiology Cervical Cancer qPCR&NAP Other CER=Constant Exchange Rates 176
Slide 177: Diabetes Care
Diabetes Care 2023 vs. 2022 CHFbn CER growth -6% 1.4 1.2 1.0 -24% 0.8 -4% 0.6 0.4 0.2 0.0 YTD Sep 2021 YTD Sep 2022 YTD Sep 2023 Blood Glucose Monitoring Other CER=Constant Exchange Rates 177
Slide 178: Pathology Lab
Pathology Lab 2023 vs. 2022 CHFbn CER growth +15% 1.2 1.0 +30% 0.8 +19% 0.6 +12% 0.4 0.2 0.0 YTD Sep 2021 YTD Sep 2022 YTD Sep 2023 Advanced Staining Primary Staining Companion Diagnostics CER=Constant Exchange Rates 178
Slide 179: Point of Care
Point of Care 2023 vs. 2022 CHFbn CER growth -70% 3.5 3.0 2.5 2.0 1.5 -42% 1.0 -7% 0.5 +3% -88% 0.0 YTD Sep 2021 YTD Sep 2022 YTD Sep 2023 Clinical Chem. & Immunodiagn. Hospital Glucose Coagulation & Urinalysis POC MDx CER=Constant Exchange Rates 179
Slide 180: Roche Group development pipeline
Roche 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 inform
Slide 181: CHF/USD
CHF/USD Monthly averages 1.00 -7% -8% 0.90 0% 0.80 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2022 2023 Year-To-Date averages 1.00 -3% -5% 0.90 0% 0.80 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2022 2023 181
Slide 182: CHF/USD
CHF/USD 0.99 Sep YTD 2023 -5% 0.97 0.95 0.93 0.91 0.89 0.87 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec avg full year 2022 avg full year 2023 monthly avg 2022 monthly avg 2023 182
Slide 183: CHF/EUR
CHF/EUR Monthly averages 1.10 1.05 -3% -5% 1.00 -1% 0.95 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2022 2023 Year-To-Date averages 1.10 -4% -4% 1.05 -3% 1.00 0.95 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2022 2023 183
Slide 184: CHF/EUR
CHF/EUR Sep YTD 2023 -3% 1.05 1.03 1.01 0.99 0.97 0.95 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec avg full year 2022 avg full year 2023 monthly avg 2022 monthly avg 2023 184
Slide 185: Average CHF Exchange Rates
Average CHF Exchange Rates Sep YTD Sep YTD Sep YTD 2023 vs. Sep YTD 2022 2023 2022 USD 0.90 0.95 -5% EUR 0.98 1.01 -3% JPY 0.65 0.74 -12% -15% -10% -5% 0% 185
Slide 186: Exchange rate impact on sales growth
Exchange rate impact on sales growth Q3 2023: negative impact of USD, CNY, JPY and EUR Development of average exchange rates versus prior year period CHF / USD 0.2% -6.8% -8.6% CHF / EUR -4.3% -4.8% -1.3% CHF / JPY -12.1% -12.0% -12.5% CHF / CNY -7.0% -12.1% -13.7% Difference in CHF / CER -3.7% -8.6
Slide 187: Exchange rate impact on sales growth
Exchange rate impact on sales growth YTD Sep 2023: negative impact of USD, CNY, JPY and EUR Development of average exchange rates versus prior year period CHF / USD 0.2% -3.4% -5.1% CHF / EUR -4.3% -4.5% -3.4% CHF / JPY -12.1% -11.9% -12.0% CHF / CNY -7.0% -9.6% -11.0% Difference in CHF / CER -3.7%
Slide 188: Doing now what patients need next
Doing now what patients need next