Roche Holding Ltd · SIX:RO
Roche — YTD Sep 2024 Earnings Presentation
171 slides from Roche's earnings presentation, Oct 23, 2024
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 2024 sales
Roche YTD September 2024 sales Basel, 23 October 2024
Slide 4: Group
Group Thomas Schinecker Chief Executive Officer
Slide 5: Performance Outlook
Performance Outlook
Slide 6: YTD Sep 2024: Strong business performance in both divisions
YTD Sep 2024: Strong business performance in both divisions Good Pharma pipeline progress in Q3: Five regulatory approvals, three positive Ph III readouts and two deals YTD Group sales +6% at CER driven by strong base business of +8% at CER • Strong Pharma (+9% at CER) and Diagnostics (+8% at CER) b
Slide 7: YTD Sep 2024: Group sales growth at +6% with base business at +8%
YTD Sep 2024: Group sales growth at +6% with base business at +8% Both divisions with continued strong momentum YTD Sep YTD Sep 2024 2023 Change in % Excl. CHFbn CHFbn CHF CER C191 Pharmaceuticals Division 34.3 33.4 3 7 9 Diagnostics Division 10.7 10.7 0 5 8 Roche Group 45.0 44.1 2 6 8 1Base busines
Slide 8: YTD Sep 2024: Continued strong growth momentum
YTD Sep 2024: Continued strong growth momentum COVID-19 sales in Diagnostics of CHF 0.3bn in Q4 2023 Group sales growth Group base business sales growth1 %CER %CER +15% +15% +10% +9% +9% +9% +10% +9% +9% +8% +7% +5% +5% +3% +3% +2% +1% +2% +1% 0% 0% COVID-19 Pandemic -3% COVID-19 Pandemic -5% -5% 20
Slide 9: YTD Sep 2024: Strong growth in both divisions
YTD Sep 2024: Strong growth in both divisions Q3 without significant COVID-19 impact Pharma* Diagnostics* Quarterly sales evolution 2022-2024 Quarterly sales evolution 2022-2024 % CER % CER 30% 30% +24% 20% 20% +12% +9% +10% +10% +9% +9% +7% +7% +7% +7% +8% +8% +7% +8% +8% +9% +7% 10% +6% +4% 10% +4
Slide 10: Key growth drivers of the Roche portfolio
Key growth drivers of the Roche portfolio Significant milestones achieved in Q3 to enable future growth +5% YTD Sep 2024 sales Diagnostics: +8% base business growth (CHFbn, YoY CER growth) (+8%)* Significant launches upcoming Itovebi: US approval in 1L PIK3CA-mut HR+ BC 10.7 Tecentriq Hybreza: US ap
Slide 11: Performance Outlook
Performance Outlook
Slide 12: Young portfolio to drive growth in the near- to mid-term
Young portfolio to drive growth in the near- to mid-term 2024 NME update: US approval for Itovebi (inavolisib) in HR+ breast cancer and PiaSky in PNH achieved CHFm % of Pharma Sales2 20.0 56% 18.0 50% 16.0 42% 14.0 12.0 34% 10.0 8.0 1 6.0 4.0 2.0 0.0 YTD Sep 2021 YTD Sep 2022 YTD Sep 2023 YTD Sep 20
Slide 13: Key growth drivers beyond 2025
Key growth drivers beyond 2025 Many opportunities with significant market potential in both divisions Pharmaceuticals Diagnostics NME Indication Newsflow Timing Product Description Launch tiragolumab NSCLC/other Ph III data 2024/25 Total solution for clinical mass i601 mass spec 2024 spectrometry an
Slide 14: Key growth drivers beyond 2025
Key growth drivers beyond 2025 Many opportunities with significant market potential in both divisions Pharmaceuticals Diagnostics NME Indication Newsflow Timing Product Description Launch tiragolumab NSCLC/other Ph III data 2024/25 Total solution for clinical mass i601 mass spec 2024 spectrometry an
Slide 15: Positive 2024 outlook
Positive 2024 outlook Sales drivers1 Continued strong base business growth in both divisions Group sales growth1 Mid single digit sales growth COVID-19 sales expected to decline by roughly CHF 1.1bn LOE impact of roughly CHF 1.4bn expected Base business=Pharma excluding Ronapreve and Diagnostics exc
Slide 16: 2024 guidance raised at HY
2024 guidance raised at HY Core EPS guidance raised from “broadly in line with sales” to “high single digit Core EPS growth” Group sales growth1 Mid single digit sales growth High single digit Core EPS growth Core EPS growth1 excl. impact from resolution of tax disputes in 2023 Dividend outlook Furt
Slide 17: Finance
Finance Alan Hippe Chief Financial Officer
Slide 18: Upcoming Roche IR events 2024
Upcoming Roche IR events 2024 Additional events driven by readouts Neurology/CTAD Digitalization Day 31 Oct 25 Nov • Overview of the Roche • Roche digital efforts in Pharma Alzheimer's Disease pipeline early R&D • Focus on Ph I/II trontinemab • Highlighting use cases “lab-in- data presented at CTAD
Slide 19: YTD Sep 2024: Base business growth exceeds COVID-19 and LOE impact
YTD Sep 2024: Base business growth exceeds COVID-19 and LOE impact COVID-19 sales decrease and LOE impact in line with guidance CHFm +6% at CER -517 +3,603 -819 -1,887 +815 -264 44,053 44,984 YTD Sep 2023 Dia Dia Pharma Ronapreve LOE Fx YTD Sep 2024 base COVID-19 (excl. Ronapreve, sales business sal
Slide 20: Exchange rate impact on sales growth
Exchange rate impact on sales growth Negative impact driven by the USD, JPY, CNY (APAC) and EUR -0.3%p -0.7%p -1.2%p CER CHF sales growth -0.7%p sales growth Sep YTD 2024 Sep YTD 2024 +6% vs. -0.7%p vs. Sep YTD 2023 Sep YTD 2023 -0.4%p +2% CER EUR APAC USD LATAM JPY Other CHF CER=Constant Exchange R
Slide 21: Expected 2024 currency impact
Expected 2024 currency impact USD / CHF Assumed avg. YTD 2024 Assuming the 30 September 2024 exchange rates remain -6% -3% -2% -3% stable until end of 2024, 0.93 0.91 2024 impact1 is expected to be (%p): 0.90 0.90 0.87 Q1 Q2 Q3 Q4 0.89 0.88 0.87 Sales -8 -2 -3 -5 0.86 0.88 0.89 0.91 0.91 0.89 0.89 0
Slide 22: 2024 guidance raised at HY
2024 guidance raised at HY Core EPS guidance raised from “broadly in line with sales” to “high single digit Core EPS growth” Group sales growth1 Mid single digit sales growth High single digit Core EPS growth Core EPS growth1 excl. impact from resolution of tax disputes in 2023 Dividend outlook Furt
Slide 23: Pharmaceuticals Division
Pharmaceuticals Division Teresa Graham CEO Roche Pharmaceuticals
Slide 24: YTD Sep 2024: Pharmaceuticals sales
YTD Sep 2024: Pharmaceuticals sales All regions ex-Japan delivering strong growth, Japan impacted by Ronapreve sales in Q1 2023 YTD Sep YTD Sep 2024 2023 Change in % CER w/o CHFm CHFm CHF CER Ronapreve Pharmaceuticals Division 34,257 33,372 3 7 9 United States 18,166 17,430 4 7 7 Europe 6,613 6,259
Slide 25: YTD Sep 2024: Young portfolio delivering strong growth
YTD Sep 2024: Young portfolio delivering strong growth Vabysmo and Phesgo excellent growth momentum continues; strong ex-US uptake for Elevidys Vabysmo 79% Phesgo 58% Ocrevus 9% Hemlibra 10% Polivy 41% Evrysdi 21% Xolair 11% Elevidys n/a Columvi >500% Actemra / RoActemra 5% Alecensa 7% Gazyva 13% Xo
Slide 26: Itovebi (inavolisib) US approval in 1L PIK3CA-mut HR+ BC achieved
Oncology/Hematology Itovebi (inavolisib) US approval in 1L PIK3CA-mut HR+ BC achieved Complementing pipeline via Regor deal, adding CDK4/2 (Ph I) and CDK4 (Ph I-ready) in HR+ breast cancer* Others Q3 update Avastin CHFm 489 / -15% • Phesgo: Strong uptake and conversion at 43% (55 countries)** CHFm 9
Slide 27: Breast Cancer: Itovebi in PIK3CA-mut HR+ BC to define new SoC
Oncology/Hematology Breast Cancer: Itovebi in PIK3CA-mut HR+ BC to define new SoC Itovebi first PI3Ki approved in 1L ET resistant setting, with BIC potential in breast cancer and beyond Breast cancer portfolio Potential for Itovebi based regimen in PIK3CA-mut HR+ BC Low risk (~55%)1 Medium risk (~25
Slide 28: Next generation CDKi portfolio acquired from Regor Therapeutics
Oncology/Hematology Next generation CDKi portfolio acquired from Regor Therapeutics* RGT-419B (CDK4/2i) in Ph I with best-in-class potential in HR+ BC, and Ph I ready RGT-587 (CDK4i) Next generation CDKi portfolio RGT-419B development program Potent CDK4 inhibition with activity on CDK21 Completed O
Slide 29: Polivy US patient share in 1L DLBCL reaching 28%
Oncology/Hematology Polivy US patient share in 1L DLBCL (IPI 0-5) reaching 28% NXT007 Ph III-enabling data in Hemophilia A expected in 2025 Lunsumio Q3 update Columvi CHFm 54 / +28% CHFm 116 / >500% • Hemlibra: Continued penetration across all approved patient PiaSky Gazyva CHFm 8 / N/A segments wit
Slide 30: Ocrevus Zunovo (SC) US approval in MS achieved
Neurology Ocrevus Zunovo (SC) US approval in MS achieved Positive fenebrutinib Ph II (FENopta) 48 weeks data in RMS presented at ECTRIMS Elevidys Q3 update CHFm 137 / N/A Others CHFm 300 / +5% • Ocrevus: #1 new to brand in US; higher retention rate than other Enspryng MS medicines; 1,000,000 patient
Slide 31: Positive Ph III (REGENCY) for Gazyva in lupus nephritis
Immunology Positive Ph III (REGENCY) for Gazyva in lupus nephritis Ph III (AMETRINE-1&2) for anti-TL1A in UC initiated Q3 update Others • Xolair: Strong food allergy launch with ~30k pts on treatment CHFm 687 / -12% • Additional growth driven by strong CSU performance MabThera/ • No biosimilar launc
Slide 32: Vabysmo US market share growth in nAMD, DME and RVO continues
Ophthalmology Vabysmo US market share growth in nAMD, DME and RVO continues Vabysmo EU RVO approval achieved; rapid conversion to pre-filled syringe in US Luxturna Q3 update CHFm 15 / -65% Susvimo Lucentis CHFm 3 / +18% • Vabysmo: Continued market share gains across early launch CHFm 119 / -69% coun
Slide 33: Obesity: Pipeline with potentially unique combination opportunities
Cardiovascular, Renal & Metabolism Obesity: Pipeline with potentially unique combination opportunities Despite numerous approved treatments, unmet need remains; Roche set up to leverage obesity opportunity Obesity portfolio Roche’s obesity pipeline Unmet need Differentiation strategy Ph I Ph II Effi
Slide 34: Pipeline update: Strengthening the Pharma pipeline
Pipeline update: Strengthening the Pharma pipeline NME changes in Q3 NME and LE (QoQ change, Q3 24 vs Q2 24) Phase Indication RG6434 I Neurology ±0 -4 2 2 2 ±0 LTBR agonist I Solid tumors ±0 6 6 -2 CDK4/2i (RGT-419B)* I HR+ breast cancer ±0 11 8 -1 PiaSky** Reg. PNH ±0 4 1 ±0 71 (-6) 6 ±0 tobemstomi
Slide 35: 2024: Key newsflow
2024: Key newsflow* Compound Indication Milestone Alecensa Adjuvant ALK+ NSCLC US/EU approval inavolisib + palbociclib + fulvestrant 1L PIK3CA-mut HR+ BC US/EU filing Tecentriq Subcutaneous administration US/EU approval PiaSky (crovalimab) PNH US/EU approval Elevidys DMD EU filing Ocrevus 6m SC RMS/
Slide 36: 2025: Significant key newsflow ahead
2025: Significant key newsflow ahead* Compound Indication Milestone inavolisib + palbociclib + fulvestrant 1L PIK3CA-mut HR+ BC EU approval Columvi + GemOx 2L+ DLBCL US/EU approval Lunsumio SC 3L+ FL US/EU approval Elevidys DMD EU approval Regulatory Gazyva Lupus nephritis US/EU filing; US approval
Slide 37: Diagnostics Division
Diagnostics Division Matt Sause CEO Roche Diagnostics
Slide 38: YTD Sep 2024: Diagnostics Division sales
YTD Sep 2024: Diagnostics Division sales Strong base business growth more than offsetting decline in COVID-19 sales YTD Sep YTD Sep Change in % 2024 2023 Excl. CHFm CHFm CHF CER C191 Diagnostics Division 10,727 10,681 0 5 8 Core Lab 6,052 5,836 4 9 Molecular Lab 1,903 1,897 0 4 Near Patient Care 1,6
Slide 39: YTD Sep 2024: Diagnostics highlights
YTD Sep 2024: Diagnostics highlights Strong base business growth more than offsetting decline in COVID-19 sales CHFbn YoY CER growth • Immunodiagnostics (+10%) Core Lab +9% • Clinical Chemistry (+8%) • Custom biotech (+5%) • COVID-19 (-62%) Molecular Lab +4% • Virology base business (+12%) • Blood S
Slide 40: YTD Sep 2024: Diagnostics regional sales
YTD Sep 2024: Diagnostics regional sales Strong base business growth across all regions North America +6% EMEA ~30% of divisional sales +5% ~34% of divisional sales Asia Pacific Latin America +2% +18% ~29% of divisional sales ~7% of divisional sales Base business=excluding COVID-19-related products;
Slide 41: cobas pro serology solution
Core Lab cobas® pro serology solution FDA approval enables entry into the largest donor screening market in the world cobas® pro serology solution1 Market opportunity • The U.S. Serology blood screening market is ~40% of the Instrument Assays global CHF 900m market • Safety of plasma-derived product
Slide 42: FDA self-collection approval for cobas HPV test
Molecular Lab FDA self-collection approval for cobas HPV test Increases access and options for women in the US HPV self-collection process Market needs and opportunity • >13,000 new cervical cancer patients are diagnosed and ~4,000 die in the US every year1 Analysis on Roche cobas® • ~30% of eligibl
Slide 43: cobas Respiratory flex for use on cobas x800 Systems
Molecular Lab cobas® Respiratory flex for use on cobas® x800 Systems Flexible syndromic testing empowered by Roche’s novel and proprietary TAGS technology Empowered by TAGS 5 channels = up to 15 targets Market opportunity • Address multiplex panel market utilizing large installed high base • Innovat
Slide 44: LumiraDx deal closed
Near Patient Care LumiraDx deal closed Potentially disruptive solution for the Point of Care setting LumiraDx key attributes Value to healthcare systems and Roche • Multi-modal technology that can • Consolidate Point of Care testing on a single perform clinical chemistry, immunoassay, platform (such
Slide 45: Diagnostics key launches 2024
Diagnostics key launches 2024 Area Product Description Markets Status i601 mass spectrometry Launch of an unique total solution for clinical mass spectrometry testing: fully automated, integrated and CE system IVD-compliant Core Lab cobas c703 Introducing high-throughput clinical chemistry testing t
Slide 46: 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 47: Changes to the development pipeline
Changes to the development pipeline Q3 2024 update New to phase I New to phase II New to phase III New to registration 3 NMEs: 2 NME: 2 NME: 1 AI: RG6221 LTBR agonist – solid tumors RG6512 FIXa x FX (NXT007) - hemophilia RG6631 anti-TL1A - ulcerative colitis RG6026 Columvi + chemo - 2L+ DLBCL RG6434
Slide 48: Roche Group development pipeline
Roche Group development pipeline Phase I (46 NMEs + 8 AIs) Phase II (15 NMEs + 8 AIs) RG6026 Columvi monotherapy + combos heme tumors CHU glypican-3 x CD3 solid tumors tiragolumab + T NSCLC RG6058 RG6058 tiragolumab combos solid tumors CHU codrituzumab HCC tiragolumab + T 1L PD-L1+ mSCCHN RG6076 eng
Slide 49: Roche Group development pipeline
Roche Group development pipeline Phase III (8 NMEs + 33 AIs) Registration US & EU (2 NME + 5 AIs) RG3502 Kadcyla + T HER-2+ eBC high-risk RG6149 astegolimab COPD RG6026 Columvi + chemo** 2L+ DLBCL Columvi + Polivy + R-CHP 1L DLBCL RG6299 ASO factor B IgA nephropathy Itovebi (inavolisib) + RG6026 RG6
Slide 50: Expected regulatory submissions
Expected regulatory submissions* New Molecular Entities: Lead and additional indications anti-latent myostatin RG6237 (GYM 329) + Evrysdi SMA New Molecular Entity (NME) Cardiovascular, Renal & Metabolism anti-latent myostatin Additional Indication (AI) Neurology giredestrant RG6237 (GYM 329) RG6171
Slide 51: Expected regulatory submissions
Expected regulatory submissions* Marketed products: Additional indications New Molecular Entity (NME) Cardiovascular, Renal & Metabolism Additional Indication (AI) Neurology Oncology / Hematology Ophthalmology Immunology Other ✓ Indicates submission to health authorities has occurred Unless stated o
Slide 52: Major pending approvals 2024
Major pending approvals 2024 US EU China Japan-Chugai TNKase Itovebi (inavolisib) + palbociclib + Ocrevus Tecentriq fulvestrant RG1594 RMS & PPMS RG7446 Alveolar Soft Part Sarcoma RG3625 stroke RG6114 1L HR+ PIK3CA-mut. mBC Filed March 2024 Filed Jan 2024 Filed June 2023 Filed April 2024 Itovebi (in
Slide 53: Major granted approvals 2024
Major granted approvals 2024 US EU China Japan-Chugai Xolair Tecentriq SC PiaSky PiaSky RG3648 Food allergy RG7446 all approved indications RG6107 PNH RG6107 PNH Feb 2024 Jan 2024 Feb 2024 March 2024 Alecensa Alecensa Vabysmo Vabysmo RG7853 ALK+ NSCLC adj RG7853 ALK+ NSCLC adj RG7716 BRVO/CRVO RG771
Slide 54: 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 55: Alecensa (alectinib, RG7853)
Alecensa (alectinib, RG7853) CNS-active inhibitor of anaplastic lymphoma kinase Indication Adjuvant ALK+ NSCLC Phase III Phase/study ALINA # of patients N=257 Oncology/Hematology ARM A: Alecensa 600mg BID Design ARM B: Platinum-based chemotherapy Primary endpoint Disease-free survival FPI Q3
Slide 56: Itovebi (inavolisib, RG6114, GDC-0077)
Itovebi (inavolisib, RG6114, GDC-0077) A potent, orally available, and selective PI3Kα inhibitor PIK3CA-mutant HR-positive metastatic breast post CDKi HR-positive PIK3CA-mutant breast PIK3CA mutant solid tumors and metastatic Indication cancer (mBC) cancer ER+ HER2-negative breast cancer Phase III P
Slide 57: Itovebi (inavolisib, RG6114, GDC-0077)
Itovebi (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
Slide 58: Kadcyla (trastuzumab emtansine, RG3502)
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=1,150 ARM A:
Slide 59: Phesgo (pertuzumab/trastuzumab, RG6264)
Phesgo (pertuzumab/trastuzumab, RG6264) FDC of Perjeta and Herceptin for subcutaneous administration Indication HER2-positive early breast cancer (BC) Phase III Phase II Phase/study FeDeriCa PHranceSCa # of patients N=500 N=160 Phesgo in combination with chemotherapy in neoadjuvant/adjuvant setting
Slide 60: Tecentriq (atezolizumab, RG7446)
Tecentriq (atezolizumab, RG7446) Anti-PD-L1 cancer immunotherapy – lung cancer Indication Periadjuvant NSCLC Phase III Phase/study IMpower030 # of patients N=450 Oncology/Hematology ARM A: Tecentriq plus platinum-based chemotherapy ARM B: Platinum-based chemotherapy Design Primary endpoint Eve
Slide 61: Tecentriq (atezolizumab, RG7446)
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 62: Tecentriq (atezolizumab, RG7446)
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 63: Tecentriq (atezolizumab, RG7446)
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/Hematology Design P
Slide 64: Columvi (glofitamab, RG6026)
Columvi (glofitamab, 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 escalation and
Slide 65: Columvi (glofitamab, RG6026)
Columvi (glofitamab, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Non-Hodgkin’s lymphoma (NHL) 2L+ SCT-ineligible DLBCL Phase III Phase/study Phase Ib STARGLO Part I: 15-60 # of patients N=270 Part II: ~66-104 Part I: Dose-finding for the combination o
Slide 66: Columvi (glofitamab, RG6026)
Columvi (glofitamab, 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-arm study
Slide 67: Columvi (glofitamab, RG6026)
Columvi (glofitamab, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Relapsed or refractory mantle cell lymphoma (MCL) Phase III Phase/study GLOBRYTE # of patients N=182 ARM A: Columvi monotherapy ARM B: Bendamustine + rituximab or rituximab + lenalidom
Slide 68: Lunsumio (mosunetuzumab, RG7828)
Lunsumio (mosunetuzumab, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 3L+ FL, 3L+ DLBCL & other relapsed or refractory NHL Relapsed or refractory LBCL & MCL Phase/study Phase I/II Phase Ib/II # of patients N=713 N=235 Dose escalation of Lunsumio monoth
Slide 69: Lunsumio (mosunetuzumab, RG7828)
Lunsumio (mosunetuzumab, 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/Hematology Design Progression-free survival Primary
Slide 70: Lunsumio (mosunetuzumab, RG7828)
Lunsumio (mosunetuzumab, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 1L DLBCL & 2L DLBCL following 1L induction FL Phase/study Phase I/II Phase Ib/II # of patients N=187 N=183 Cohort A: Lunsumio monotherapy (after a response to prior systemic Non-Rand
Slide 71: Lunsumio (mosunetuzumab, RG7828)
Lunsumio (mosunetuzumab, 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=412 N=8 ARM A: Lunsumio plus lenalidomide Lunsumio monotherapy (3L+ CLL) ARM B: Ritu
Slide 72: Polivy (polatuzumab vedotin, RG7596)
Polivy (polatuzumab vedotin, RG7596) ADC targeting CD79b to treat B cell malignancies Indication 1L DLBCL Phase III Phase/study POLARIX # of patients N=879 Oncology/Hematology ARM A: Polivy plus R-CHP ARM B: R-CHOP Design Progression-free survival Primary endpoint Data presented at ASH 2021
Slide 73: Venclexta (venetoclax, RG7601)
Venclexta (venetoclax, RG7601) Novel small molecule Bcl-2 selective inhibitor – chronic lymphocytic leukemia Newly diagnosed higher-risk Indication Untreated fit chronic lymphocytic leukemia (CLL) patients myelodysplastic syndromes (MDS) Phase III Phase III Phase/study CristaLLo VERONA # of patients
Slide 74: Hemlibra (emicizumab, RG6013)
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 75: Hemlibra (emicizumab, RG6013)
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 76: PiaSky (crovalimab, RG6107, SKY59)
PiaSky (crovalimab, RG6107, SKY59) A humanized monoclonal antibody against complement C5 Indication Paroxysmal nocturnal hemoglobinuria (PNH) patients switching from a C5 inhibitor Phase III Phase/study COMMODORE 1 # of patients N=89 (ARMs A/B) ARM A: PiaSky ARM B: Eculizumab Oncology/Hematology
Slide 77: PiaSky (crovalimab, RG6107, SKY59)
PiaSky (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 COM
Slide 78: PiaSky (crovalimab, RG6107, SKY59)
PiaSky (crovalimab, RG6107, SKY59) A humanized monoclonal antibody against complement C5 Atypical hemolytic uremic syndrome (aHUS) Atypical hemolytic uremic syndrome (aHUS) Indication - adults - paediatric Phase III Phase III Phase/study COMMUTE-a COMMUTE-p # of patients N=90 N=35 Single-arm study o
Slide 79: PiaSky (crovalimab, RG6107, SKY59)
PiaSky (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: PiaSky ARM A: PiaSk
Slide 80: Elevidys (delandistrogene moxeparvovec, RG6356)
Elevidys (delandistrogene moxeparvovec, SRP-9001, RG6356) rAAVrh74.MHCK7.Micro-dystrophin gene therapy Indication Duchenne muscular dystrophy (DMD) Phase II Phase/study ENVOL # of patients N=21 Open label single arm study in 0 to <4 year old DMD boys who will receive a single intravenous (IV) infusi
Slide 81: Enspryng (satralizumab, RG6168, SA237)
Enspryng (satralizumab, RG6168, SA237) Anti-IL-6 receptor humanized monoclonal antibody Myelin oligodendrocyte glycoprotein antibody disease (MOG- Indication Autoimmune encephalitis (AIE) AD) Phase III Phase III Phase/study METEOROID CIELO # of patients N=152 N=152 ARM A: Enspryng at weeks 0, 2, 4
Slide 82: Evrysdi (risdiplam, RG7916)
Evrysdi (risdiplam, RG7916) Oral SMN2 splicing modifier Indication Spinal muscular atrophy (SMA) Phase II/III Phase II/III Phase/study FIREFISH SUNFISH # of patients N=21 (Part 1), 41 (Part 2) N=51 (Part 1), 180 (Part 2) Infants with type 1 SMA Adult & pediatric patients with type 2 or 3 SMA: Design
Slide 83: Evrysdi (risdiplam, RG7916)
Evrysdi (risdiplam, RG7916) Oral SMN2 splicing modifier Indication Spinal muscular atrophy (SMA) Phase II Phase II Phase/study RAINBOWFISH JEWELFISH # of patients N=25 N=174 Infants aged from birth to 6 weeks who have been genetically Adult and pediatric patients with previously treated SMA type
Slide 84: Ocrevus (ocrelizumab, RG1594)
Ocrevus (ocrelizumab, RG1594) Humanized monoclonal antibody selectively targeting CD20+ B cells Indication Primary progressive multiple sclerosis (PPMS) Phase IIIb Phase/study ORATORIO-HAND # of patients N ~ 1,000 120-week treatment period: ARM A: Ocrevus 600mg IV Q24W Neurology Design ARM B: Pl
Slide 85: Ocrevus (ocrelizumab, RG1594)
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 86: Gazyva (obinutuzumab, RG7159)
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 MMF / ARM A: Gazyva 1000mg IV (6 doses through ARM A: Ga
Slide 87: Gazyva (obinutuzumab, RG7159)
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=300 N=80 ARM A: Gazyva 1000mg IV on Day 1 and Weeks 2, 24 and 26. ARM A: Gazy
Slide 88: Lunsumio (mosunetuzumab, CD20 x CD3, RG7828)
Lunsumio (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
Slide 89: Xolair (omalizumab, RG3648)
Xolair (omalizumab, RG3648) Humanized monoclonal antibody that selectively binds to IgE Indication Food allergy Phase III Phase/study OUtMATCH1 # of patients N=180 Xolair by SC injection either Q2W or Q4W for 16 to 20 weeks Immunology Design Primary endpoint Proportion of participants that succe
Slide 90: Enspryng (satralizumab, RG6168, SA237)
Enspryng (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
Slide 91: Susvimo (PDS, RG6321)
Susvimo (PDS, RG6321) First eye implant to achieve sustained delivery of a biologic medicine Indication neovascular age-related macular degeneration (nAMD) 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 100mg/mL Q24W
Slide 92: Susvimo (PDS, RG6321)
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: Intra
Slide 93: Vabysmo (faricimab, RG7716)
Vabysmo (faricimab, RG7716) First bispecific antibody for the eye which targets and inhibits two signaling pathways (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: Vabysmo 6.0 mg Q8W AR
Slide 94: Vabysmo (faricimab, RG7716)
Vabysmo (faricimab, RG7716) First bispecific antibody for the eye which targets and inhibits two signaling pathways (Ang-2 and VEGF-A) Indication neovascular age related macular degeneration (nAMD) Phase III Phase III Phase/study TENAYA LUCERNE # of patients N=671 N=658 ARM A: Vabysmo 6.0mg Q16W f
Slide 95: Vabysmo (faricimab, RG7716)
Vabysmo (faricimab, RG7716) First bispecific antibody for the eye which targets and inhibits two signaling pathways (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 I
Slide 96: Vabysmo (faricimab, RG7716)
Vabysmo (faricimab, RG7716) First bispecific antibody for the eye which targets and inhibits two signaling pathways (Ang-2 and VEGF-A) Indication Myopic choroidal neovascularization (CNV) Phase III Phase/study POYANG # of patients n=280 ARM A: Vabysmo 6.0 mg Q4W PRN ARM B: Ranibizumab 0.5 mg Q4W
Slide 97: Xofluza (baloxavir marboxil, RG6152, S-033188)
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 patients
Slide 98: 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 99: Divarasib (KRAS G12C inhibitor, RG6330, GDC-6036)
Divarasib (KRAS G12C inhibitor, RG6330, GDC-6036) A potent, orally available, and selective inhibitor of the KRAS G12C mutant protein Indication 1L NSCLC 2L NSCLC Phase Ib Phase III Phase/study KRASCENDO 170 KRASCENDO 1 # of patients N=60 N=320 Cohort A: Combination of divarasib plus pembrolizumab
Slide 100: Divarasib (KRAS G12C inhibitor, RG6330, GDC-6036)
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 KRAS G12C Indication 2L, 1L metastatic colorectal cancer (mCRC) mutation Phase Ib Phase/study Phase I INTRINSIC # of patien
Slide 101: Giredestrant (SERD (3), RG6171, GDC-9545)
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 coop
Slide 102: Giredestrant (SERD (3), RG6171, GDC-9545)
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 103: Giredestrant (SERD (3), RG6171, GDC-9545)
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 104: Tiragolumab (anti-TIGIT, RG6058, MTIG7192A)
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: Tiragolumab (anti-TIGIT, RG6058, MTIG7192A)
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 106: Tiragolumab (anti-TIGIT, RG6058, MTIG7192A)
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 107: NXT007 (RG6512, FIXa x FX)
NXT007 (RG6512, FIXa x FX) Bispecific antibody which targets Factor IXa and Factor X Indication Severe or Moderate Hemophilia A Phase I/II Phase/study (multiple-ascending dose) # of patients N=40 Two loading doses of NXT007 SC (Q2W) followed by Q4W maintenance dosing Design Oncology/Hematology Pri
Slide 108: Anti-latent myostatin (RG6237, GYM 329)
Anti-latent myostatin (RG6237, GYM 329) Recycling and antigen-sweeping monoclonal anti-latent myostatin antibody Facioscapulohumeral Muscular Indication Spinal muscular atrophy (SMA) Obesity Dystrophy (FSHD) Phase II Phase II/III Phase/study Phase Ib MANOEUVRE MANATEE1 # of patients N=48 N=180 N=30-
Slide 109: Fenebrutinib (RG7845, GCD-0853)
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=985 N=736 N=751
Slide 110: Fenebrutinib (RG7845, GCD-0853)
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 Neurology ARM A: Fenebrutinib ARM B: Placebo Design Total number of new gadolini
Slide 111: Tominersen (RG6042, HTT ASO)
Tominersen (RG6042, HTT ASO) Antisense oligonucleotide (ASO) targeting human HTT mRNA Indication Huntington’s disease Phase II Phase/study GENERATION HD2 # of patients N=300 Patients aged 25 to 50 years with prodromal (very early subtle signs of HD) or early manifest HD Neurology ARM A: Tominersen
Slide 112: Astegolimab (RG6149, Anti-ST2)
Astegolimab (RG6149, Anti-ST2) A monoclonal antibody that selective binds to ST2 Indication Chronic obstructive pulmonary disease (COPD) Phase IIb Phase III Phase/study ALIENTO ARNASA # of patients N=1,290 N=1,290 ARM A: SC astegolimab Q2W ARM A: SC astegolimab Q2W ARM B: SC astegolimab Q4W
Slide 113: ASO factor B (RG6299)
ASO factor B (RG6299) Antisense oligonucleotide that targets factor B Indication IgA nephropathy (IgAN) Phase III Phase/study Phase II* IMAGINATION # of patients N=25 N=428 ASO factor B SC at week 1 following Q4W dosing through week 25 ARM A: ASO factor B SC at week 1, 3, 5 following Q4W dosing
Slide 114: Anti-TL1A (RG6631)
Anti-TL1A (RG6631) A monoclonal antibody targeting TL1A, blocking TH1 and TH17 pathways Indication Moderate to severe ulcerative colitis Phase III Phase/study AMETRINE-1 # of patients N=400 (treat through design with no re-randomization after induction) ARM A: Anti-TL1A IV induction followed by
Slide 115: Vamikibart (anti-IL-6; RG6179)
Vamikibart (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=
Slide 116: Vamikibart (anti-IL-6; RG6179)
Vamikibart (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-d
Slide 117: CT-388 (RG6640)
CT-388 (RG6640) Once-weekly subcutaneous injectable dual GLP-1/GIP receptor agonist Indication Overweight/obesity with or without type 2 diabetes Overweight/obesity without type 2 diabetes Phase/study Phase I Phase II # of patients N=129 N=450 Single ascending dose, multiple ascending dose, multip
Slide 118: CT-996 (RG6652)
CT-996 (RG6652) Once-daily oral small molecule GLP-1 receptor agonist Indication Overweight/obesity with or without type 2 diabetes Phase/study Phase I # of patients N=118 Single ascending dose, multiple ascending dose, multiple part study, with low to high doses of CT-996 vs placebo up to 4 weeks
Slide 119: CT-868 (RG6641)
CT-868 (RG6641) Once-daily subcutaneous injectable dual GLP-1/GIP receptor agonist Indication Type 1 diabetes with BMI ≥ 27 Phase/study Phase II # of patients N=96 ARM A: CT-868 low dose ARM B: CT-868 medium dose Cardiovascular, Renal & Metabolism Design ARM C: CT-868 high dose ARM D: Placeb
Slide 120: 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 121: pRED oncology development programs
pRED oncology development programs Molecule Indication Phase # of patients Status CT Identifier Oncology 3L+ MSS metastatic colorectal FPI Q3 2021 FAP-4-1BBL (RG7827) Ib 80 NCT04826003 cancer Combination study with cibisatamab Part I: FPI Q3 2019 Part II: FPI Q3 2020 englumafusp alfa R/R B cell non-
Slide 122: pRED neurology development programs -1
pRED neurology development programs -1 Molecule Indication Phase # of patients Status CT Identifier Neurology trontinemab FPI Q1 2021 Alzheimer's disease IIa ~210 NCT04639050 (BS-anti-Aβ mAb, RG6102) Data presented at ADPD 2024 ISRCTN16295 BrainshuttleTM-CD20 (RG6035) Multiple sclerosis I 30-63 FPI
Slide 123: pRED neurology development programs -2
pRED neurology development programs -2 Molecule Indication Phase # of patients Status CT Identifier Neurology MAGL inhibitor (RG6182) Multiple sclerosis I Up to 36 FPI Q3 2023 selnoflast* Parkinson’s disease Ib 48 FPI Q3 2022 (NLRP3i, RG6418) NME (RG6434) Neurodegenerative disorders I FPI Q4 2023 *M
Slide 124: pRED immunology and ophthalmology development programs
pRED immunology and ophthalmology development programs Molecule Indication Phase # of patients Status CT Identifier Immunology selnoflast* Asthma Ib 60 FPI Q1 2024 (NLRP3i, RG6418) CD19 x CD3 (RG6382) SLE I 70 FPI Q4 2023 NCT05835986 NME (RG6377) IBD I FPI Q2 2024 ISRCTN15555964 Ophthalmology zifiba
Slide 125: 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 126: 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 355 LPI Q2 2023 NCT03275103 Data presented at ASH 2020, 2021 & 2022 R/R multiple myeloma I 120 FPI Q2 2021 NCT04910568 cevostamab BCMA-experienced R/R MM I/I
Slide 127: gRED oncology development programs -2
gRED oncology development programs -2 Molecule Indication Phase # of patients Status CT Identifier Oncology runimotamab FPI Q2 2018 Metastatic HER2-expressing cancers I 440 NCT03448042 (HER2 x CD3, RG6194) Study closed Q1 2024 anti-CCR8 (RG6411) Solid tumors I 110 FPI Q4 2022 NCT05581004 AR degrader
Slide 128: gRED immunology and ophthalmology development programs
gRED immunology and ophthalmology development programs Molecule Indication Phase # of patients Status CT Identifier Immunology FPI Q2 2023 NME (RG6287, GDC-8264) Acute graft versus host disease Ib 40 NCT05673876 Study closed Q4 2023 FPI Q1 2023 NME (RG6315, MTBT1466A) Systemic sclerosis Ib 100 NCT05
Slide 129: 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 130: Hemophilia A
Hemophilia A Unique gene therapy platform Dirloctocogene Samoparvovec (SPK-8011) Molecule (RG6357) Indication Hemophilia A Phase/study Phase I Phase I/II # of patients N=100 N=30 Hemophilia Long term follow up study of patients who have received SPK-8011 in any Gene transfer, dose-finding safety
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: YTD Sep 2024: Pharma Division sales - Top products
YTD Sep 2024: Pharma Division sales Top 20 products Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Ocrevus 5,056 9 3,640 7 961 11 - - 455 26 Hemlibra 3,280 10 1,906 5 690 10 259 4 425 42 Vabysmo 2,816 79 2,146 67 454 148 86 37 130 256 Perjeta 2,809 -1 1,0
Slide 133: YTD Sep 2024: Pharma Division sales - Products launched since 2015
YTD Sep 2024: Pharma Division sales Products launched since 2015 Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Cotellic 30 -21 12 -29 8 -1 - - 10 -23 Alecensa 1,151 7 372 12 217 1 144 3 418 8 Tecentriq 2,703 1 1,325 -8 649 5 277 -1 452 32 Ocrevus 5,056 9
Slide 134: YTD Sep 2024: Pharma Division sales - Product sales
YTD Sep 2024: Pharma Division sales Product sales Pharmaceuticals Division Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Ocrevus 5,056 9 3,640 7 961 11 - - 455 26 Hemlibra 3,280 10 1,906 5 690 10 259 4 425 42 Vabysmo 2,816 79 2,146 67 454 148 86 37 130 2
Slide 135: Pharma Division CER sales growth in %
Pharma Division CER sales growth1 in % Global top 20 products Q1/23 Q2/23 Q3/23 Q4/23 Q1/24 Q2/24 Q3/24 Ocrevus 14 15 12 9 8 9 11 Hemlibra 24 17 17 9 8 6 14 Vabysmo * * 309 160 108 81 59 Perjeta 11 6 0 -11 -3 -1 2 Tecentriq 15 8 10 5 1 2 0 Actemra / RoActemra -12 2 21 13 -2 8 7 Xolair 5 4 3 7 10 11
Slide 136: Pharma Division CER sales growth in %
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 8 5 6 9 11 8 15 11 - - - - 22 28 27 23 Hemlibra 8 -1 3 12 8 17 12 3 5 2 4 4 14 51 16 64 Vabysmo 142 91 68 49 406 224 153 104 42 33 38 40 * 397 281 18
Slide 137: CER sales growth (%)
CER sales growth (%) Quarterly development 2023 vs. 2022 2024 vs. 2023 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Pharmaceuticals Division 9 7 11 -2 2 9 10 United States 7 8 11 5 5 6 9 Europe 5 5 9 3 11 10 2 Japan 18 8 1 -50 -45 -3 1 International 13 6 17 16 12 23 22 Diagnostics Division -28 -17 -5 4 2 8 6 Roche Group -3
Slide 138: Ocrevus
Ocrevus Global sales CER growth Regional sales CER growth CHFbn 6.0 +9% US +7% 5.0 4.0 3.0 Europe +11% 2.0 International +26% 1.0 0.0 YTD Sep YTD Sep YTD Sep YTD Sep 2021 2022 2023 2024 YTD Sep 2024 sales of CHF 5,056m • US: Moving into earlier lines displacing orals; #1 in US for both dynamic and t
Slide 139: Hemlibra
Hemlibra CHFbn Global sales CER growth Regional sales CER growth 3.6 +10% US +5% 3.0 Europe +10% 2.4 Japan +4% 1.8 1.2 International +42% 0.6 0.0 YTD Sep YTD Sep YTD Sep YTD Sep 2021 2022 2023 2024 YTD Sep 2024 sales of CHF 3,280m • US: Continued share gains in non-inhibitor patients • EU: Continued
Slide 140: Vabysmo
Vabysmo Global sales CER growth Regional sales CER growth CHFbn 3.0 +79% 2.5 US +67% 2.0 1.5 Europe +148% 1.0 Japan +37% International +256% 0.5 0.0 YTD Sep YTD Sep YTD Sep YTD Sep 2021 2022 2023 2024 YTD Sep 2024 sales of CHF 2,816m • US: Increasing penetration in naive patients; expanding market s
Slide 141: Perjeta
Perjeta Global sales CER growth Regional sales CER growth CHFbn 3.6 -1% US -4% 3.0 Europe -17% Japan -36% 2.4 1.8 1.2 International +17% 0.6 0.0 YTD Sep YTD Sep YTD Sep YTD Sep 2021 2022 2023 2024 YTD Sep 2024 sales of CHF 2,809m • US: Increasing conversion to Phesgo • EU: Conversion to Phesgo • Jap
Slide 142: Tecentriq
Tecentriq CHFbn Global sales CER growth Regional sales CER growth 3.0 +1% US -8% 2.4 Europe +5% 1.8 Japan -1% 1.2 International +32% 0.6 0.0 YTD Sep YTD Sep YTD Sep YTD Sep 2021 2022 2023 2024 YTD Sep 2024 sales of CHF 2,703m • US: 1L HCC nearing peak penetration; adj. NSCLC competitive pressure int
Slide 143: Actemra/RoActemra
Actemra/RoActemra Global sales CER growth Regional sales CER growth CHFbn 3.0 +5% US +11% 2.5 Europe -11% 2.0 1.5 1.0 Japan +9% 0.5 International +17% 0.0 YTD Sep YTD Sep YTD Sep YTD Sep 2021 2022 2023 2024 YTD Sep 2024 sales of CHF 1,948m • US: Ongoing patient shift from Actemra IV to SC in RA; Bio
Slide 144: Xolair
Xolair Global sales CER growth Regional sales CER growth CHFbn 2.0 +11% 1.6 1.2 US +11% 0.8 0.4 0.0 YTD Sep YTD Sep YTD Sep YTD Sep 2021 2022 2023 2024 YTD Sep 2024 sales of CHF 1,737m • Global US: Growth driven by uptake sales in CSU; Regional Strong food allergy launch with sales >30k patients on
Slide 145: Kadcyla
Kadcyla CHFbn Global sales CER growth Regional sales CER growth +6% 1.8 US +4% 1.5 1.2 Europe -2% 0.9 Japan +4% 0.6 International +22% 0.3 0.0 YTD Sep YTD Sep YTD Sep YTD Sep 2021 2022 2023 2024 YTD Sep 2024 sales of CHF 1,494m • US: Share decline in metastatic BC due to competition, partially compe
Slide 146: Evrysdi
Evrysdi Global sales CER growth Regional sales CER growth CHFbn 1.4 +21% US +15% 1.2 1.0 Europe +18% 0.8 0.6 Japan +10% 0.4 International +35% 0.2 0.0 YTD Sep YTD Sep YTD Sep YTD Sep 2021 2022 2023 2024 YTD Sep 2024 sales of CHF 1,246m • US: Strong uptake across all patient segments; including treat
Slide 147: Phesgo
Phesgo Global sales CER growth Regional sales CER growth CHFbn 1.5 +58% US +29% 1.2 Europe +44% 0.9 0.6 Japan n/a 0.3 International +104% 0.0 YTD Sep YTD Sep YTD Sep YTD Sep 2021 2022 2023 2024 YTD Sep 2024 sales of CHF 1,244m • US: Strong growth driven by eBC, switching of patients from Perjeta+Her
Slide 148: Alecensa
Alecensa Global sales CER growth Regional sales CER growth CHFbn 1.2 +7% US +12% 1.0 Europe +1% 0.8 0.6 Japan +3% 0.4 International +8% 0.2 0.0 YTD Sep YTD Sep YTD Sep YTD Sep 2021 2022 2023 2024 YTD Sep 2024 sales of CHF 1,151m • US: Market leadership in 1L ALK+ NSCLC is maintained • EU: Market lea
Slide 149: Herceptin
Herceptin Global sales CER growth Regional sales CER growth CHFbn 2.4 -11% US -20% Europe -15% 2.0 Japan -48% 1.6 1.2 0.8 International -5% 0.4 0.0 YTD Sep YTD Sep YTD Sep YTD Sep 2021 2022 2023 2024 YTD Sep 2024 sales of CHF 1,063m • US: Biosimilar erosion slowing; Switching of patients with residu
Slide 150: Rituxan/MabThera
Rituxan/MabThera CHFbn Global sales CER growth Regional sales CER growth 2.0 -16% US -17% 1.6 Europe -21% 1.2 Japan -26% 0.8 International -10% 0.4 0.0 YTD Sep YTD Sep YTD Sep YTD Sep 2021 2022 2023 2024 YTD Sep 2024 sales of CHF 1,023m • US: Biosimilar erosion slowing • EU: Biosimilar erosion botto
Slide 151: Avastin
Avastin CHFbn Global sales CER growth Regional sales CER growth 2.8 -17% US -20% Europe -17% 2.4 2.0 Japan -33% 1.6 1.2 0.8 International -8% 0.4 0.0 YTD Sep YTD Sep YTD Sep YTD Sep 2021 2022 2023 2024 YTD Sep 2024 sales of CHF 943m • US: Biosimilar erosion slowing • EU: Biosimilar erosion slowing •
Slide 152: TNKase/Activase
TNKase/Activase Global sales CER growth Regional sales CER growth CHFbn 1.0 +2% US +1% 0.8 0.6 0.4 International +5% 0.2 0.0 YTD Sep YTD Sep YTD Sep YTD Sep 2021 2022 2023 2024 YTD Sep 2024 sales of CHF 895m • Spontaneous TNKase use in AIS early time window CER=Constant Exchange Rates 152
Slide 153: Polivy
Polivy Global sales CER growth Regional sales CER growth CHFbn 1.2 +41% 1.0 US +83% 0.8 0.6 Europe +6% 0.4 0.2 Japan -4% 0.0 International +79% YTD Sep YTD Sep YTD Sep YTD Sep 2021 2022 2023 2024 YTD Sep 2024 sales of CHF 817m • US: Strong growth following approval in 1L DLBCL • EU: Strong growth fo
Slide 154: Gazyva
Gazyva Global sales CER growth Regional sales CER growth CHFbn 0.8 +13% US +15% Europe +8% 0.6 0.4 Japan -16% 0.2 International +21% 0.0 YTD Sep YTD Sep YTD Sep YTD Sep 2021 2022 2023 2024 YTD Sep 2024 sales of CHF 670m • US: Strong growth driven by combination therapies in 1L CLL • EU: Strong growt
Slide 155: 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 156: YTD Sep 2024: Diagnostics Division CER growth
YTD Sep 2024: Diagnostics Division CER growth By Region and Customer Area (vs. 2023) Reported Restatement Global EMEA North America Asia-Pacific Latin America Global EMEA North America Asia-Pacific Latin America CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER
Slide 157: YTD Sep 2024: Diagnostics Division quarterly sales and CER growth
YTD Sep 2024: Diagnostics Division quarterly sales and CER growth1 Reported Restatement Q1 23 Q2 23 Q3 23 Q4 23 Q1 24 Q2 24 Q3 24 Q1 23 Q2 23 Q3 23 Q4 23 Q1 24 Q2 24 Q3 24 CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm %
Slide 158: YTD Sep 2024: Diagnostics Division regional sales
YTD Sep 2024: Diagnostics Division regional sales Growth in all regions Sales YTD CHFm & % of total sales Sales growth at CER Total YTD Sales = 10,727 Diagnostics Division 5% GLOBAL 770 / 5% EMEA* 7% 6% North America 3,589 / 2% Asia-Pacific 3,146 / 34% 18% Latin America 29% 3,222 / 30% EMEA* North A
Slide 159: Core Lab
Core Lab 2024 vs. 2023 CHFbn CER growth +9% 7.0 6.0 +5% 5.0 +8% 4.0 +10% 3.0 2.0 1.0 0.0 YTD Sep 2022 YTD Sep 2023 YTD Sep 2024 Immunodiagnostics Clinical Chemistry Other CER=Constant Exchange Rates 159
Slide 160: Molecular Lab
Molecular Lab 2024 vs. 2023 CER growth CHFbn +4% 3.0 2.4 +10% -2% 1.8 -3% +11% 1.2 -2% 0.6 +15% -3% 0.0 YTD Sep 2022 YTD Sep 2023 YTD Sep 2024 Virology Blood Screening MD Systems Microbiology Cervical Cancer qPCR&NAP Other CER=Constant Exchange Rates 160
Slide 161: Near Patient Care
Near Patient Care 2024 vs. 2023 CER growth CHFbn -10% 5.0 4.0 3.0 -1% 2.0 -6% -6% 1.0 -3% -51% 0.0 YTD Sep 2022 YTD Sep 2023 YTD Sep 2024 Clinical Chem. & Immunodiagn. Hospital Glucose Coagulation & Urinalysis Diabetes Care POC MDx CER=Constant Exchange Rates 161
Slide 162: Pathology Lab
Pathology Lab 2024 vs. 2023 CHFbn CER growth +15% 1.2 1.0 +35% +7% 0.8 +11% 0.6 0.4 0.2 0.0 YTD Sep 2022 YTD Sep 2023 YTD Sep 2024 Advanced Staining Primary Staining Companion Diagnostics CER=Constant Exchange Rates 162
Slide 163: 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 164: CHF/USD
CHF/USD Monthly averages 0.94 0.92 0.90 -4% 0.88 -1% 0.86 -6% 0.84 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2023 2024 Year-To-Date averages 0.93 0.91 -6% -3% 0.89 -2% 0.87 0.85 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2023 2024 164
Slide 165: CHF/USD
CHF/USD 0.93 Sep YTD 2024 -2% 0.92 0.91 0.90 0.89 0.88 0.87 0.86 0.85 0.84 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec avg full year 2023 avg full year 2024 monthly avg 2023 monthly avg 2024 165
Slide 166: CHF/EUR
CHF/EUR Monthly averages 1.00 0.98 0.96 0.94 -3% -1% -2% 0.92 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2023 2024 Year-To-Date averages 1.00 0.98 -4% 0.96 -2% -2% 0.94 0.92 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2023 2024 166
Slide 167: CHF/EUR
CHF/EUR 1.00 Sep YTD 2024 -1% 0.99 0.98 0.97 0.96 0.95 0.94 0.93 0.92 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec avg full year 2023 avg full year 2024 monthly avg 2023 monthly avg 2024 167
Slide 168: Average CHF Exchange Rates
Average CHF Exchange Rates Sep YTD Sep YTD Sep YTD 2024 vs. Sep YTD 2023 2024 2023 USD 0.88 0.90 -2% EUR 0.96 0.98 -2% JPY 0.58 0.65 -11% -15% -10% -5% 0% 168
Slide 169: Exchange rate impact on sales growth
Exchange rate impact on sales growth Sep YTD 2024: negative impact of JPY, CNY, USD and EUR Development of average exchange rates versus prior year period Q1 HY YTD Sep FY CHF / USD -5.6% -2.5% -2.3% CHF / EUR -4.4% -2.5% -2.0% CHF / JPY -15.8% -13.6% -10.8% CHF / CNY -10.2% -6.5% -4.7% Difference i
Slide 170: Exchange rate impact on sales growth
Exchange rate impact on sales growth Q3 2024: negative impact of JPY, USD, EUR and CNY Development of average exchange rates versus prior year period Q1 Q2 Q3 Q4 CHF / USD -5.6% 0.6% -2.0% CHF / EUR -4.4% -0.6% -1.0% CHF / JPY -15.8% -11.4% -5.0% CHF / CNY -10.2% -2.7% -0.9% Difference in CHF / CER
Slide 171: Doing now what patients need next
Doing now what patients need next