Roche Holding Ltd · SIX:RO
Roche — H1 2024 Earnings Presentation
193 slides from Roche's earnings presentation, Jul 25, 2024
Slide 1: Roche
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 HY 2024 results
Roche HY 2024 results Basel, 25 July 2024
Slide 4: Group
Group Thomas Schinecker Chief Executive Officer
Slide 5: Performance Outlook
Performance Outlook
Slide 6: HY 2024: Strong business performance in both divisions
HY 2024: Strong business performance in both divisions Sales growth acceleration in the second quarter and double digit core operating profit growth in H1 Group sales +5% at CER driven by strong base business of +8% • Strong Pharma (+8% at CER) and Diagnostics (+9% at CER) base business growth • COV
Slide 7: HY 2024: Group growth at +5% with base business growing +8%
HY 2024: Group growth at +5% with base business growing +8% Both divisions with continued strong momentum HY 2024 HY 2023 Change in % Excl. CHFbn CHFbn CHF CER C191 Pharmaceuticals Division 22.6 22.5 1 5 8 Diagnostics Division 7.2 7.3 -1 5 9 Roche Group 29.8 29.8 0 5 8 1Base business=Pharma excludin
Slide 8: HY 2024: Acceleration of growth momentum in second quarter
HY 2024: Acceleration of growth momentum in second quarter No significant COVID-19 impact going forward Group base business sales growth Group sales growth excluding COVID related sales1 %CER %CER +15% +15% +10% +9% +9% +10% +9% +8% +7% +5% +5% +3% +3% +2% +2% +1% +1% 0% 0% COVID-19 Pandemic -3% COV
Slide 9: HY 2024: High single digit growth in both divisions in Q2
HY 2024: High single digit growth in both divisions in Q2 Second quarter 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% +8% +9% 10% +6% +9% +7% +7% +7% +9% 10% +7% +8% +8%
Slide 10: Key growth drivers of the Roche portfolio in 2024
Key growth drivers of the Roche portfolio in 2024 Establishing new leadership positions while further diversifying our portfolio +5% HY 2024 sales Diagnostics: +9% base business growth (+9%) (YoY CER growth) +2% Adj. ALK+ NSCLC included in NCCN guideline as Significant launches in Q2 and upcoming ca
Slide 11: CE mark approvals for two key Diagnostics products
CE mark approvals for two key Diagnostics products Diagnostics to deliver mid to high single digit growth in coming years cobas ISE neo and Continuous glucose Next generation Mass spectrometry cobas c703 monitoring (CGM) sequencing (NGS) • Up to 100% higher throughput • 14 day real-time glucose sens
Slide 12: Progress on key strategic initiatives
Progress on key strategic initiatives Updated Group and Pharma strategies to be presented at Pharma Day on September 30th 2023 2024 Milestones achieved Q2 Q3 Q4 Q1 Q2 Q3 Q4 • Revised Ten-Year Ambitions and Group Strategy Group Presentation @ • New performance and reward practices rolled out Pharma D
Slide 13: R&D Excellence update
R&D Excellence update Implementation ongoing to strengthen and accelerate our pipeline Transform portfolio management 1 Set ambitious R&D objectives 2 Strengthen portfolio 3 & governance Q4 ’23 Q1 Q4 ‘23 Set clear and ambitious targets for all Introduced ‘the Bar’ Established end-to-end R&D producti
Slide 14: Performance Outlook
Performance Outlook
Slide 15: 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 PiaSky in PNH achieved; inavolisib in HR+ breast cancer with PDUFA 27 Nov CHFm % of Pharma Sales2 14.0 55% 12.0 50% 10.0 41% 8.0 33% 6.0 1 4.0 2.0 0.0 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 HY 2021 H
Slide 16: 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 Final Ph III data H2 2024 Total solution for clinical mass i601 mass spec 2024 spectrometry an
Slide 17: 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 Final Ph III data H2 2024 Total solution for clinical mass i601 mass spec 2024 spectrometry an
Slide 18: 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 LOE2 impact of roughly CHF 1.4bn expected Base business=Pharma excluding Ronapreve and Diagnostics ex
Slide 19: 2024 guidance raised
2024 guidance raised 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 Further in
Slide 20: Finance
Finance Alan Hippe Chief Financial Officer
Slide 21: Upcoming Roche IR events 2024
Upcoming Roche IR events 2024 Additional events driven by readouts CVM/EASD Pharma Day Neurology/CTAD Digitalization Day Sep 13 Sep 30 Oct/Nov Nov/Dec • Key data presented at EASD: • Group & Pharma strategy • Key data presented at CTAD: • Roche digital efforts in Pharma • CT-388 (Ph I cohort 11 & 12
Slide 22: Results, Cash & balance sheet, Currency guidance & outlook
Results Cash & balance sheet Currency guidance & outlook
Slide 23: HY 2024: Group performance
HY 2024: Group performance Sales increase of +5% and Core EPS increase of +9% HY 2024 HY 2023 Change in % CHFm CHFm CHF CER Sales 29,848 29,779 0 5 Core operating profit 11,293 10,911 4 11 as % of sales 37.8 36.6 Core net income 8,651 8,587 1 8 as % of sales 29.0 28.8 Core EPS (CHF) 10.23 10.10 1 9
Slide 24: HY 2024: Base business overcompensating for COVID-19 and LOE
HY 2024: Base business overcompensating for COVID-19 and LOE COVID-19 and LOE impact in line with guidance; currency impact of -5%p in HY CHFm +5% at CER +574 +2,301 -518 -600 -1,446 -242 29,779 29,848 HY 2023 Dia Dia Pharma Ronapreve LOE Fx HY 2024 base COVID-19 (excl. Ronapreve & sales business sa
Slide 25: HY 2024: Group core operating performance
HY 2024: Group core operating performance Core operating profit higher by +11% driven by higher sales and effective cost management HY 2024 HY 2024 vs. HY 2023 CHFm abs. CER CER growth Sales 29,848 +1,515 5% Other revenue 908 +94 11% Cost of sales -7,300 -168 2% R&D -6,268 -21 0% SG&A -6,376 -96 2%
Slide 26: HY 2024: Core operating profit and margin
HY 2024: Core operating profit and margin 49.6% 50.4% % of sales +0.9%p¹ 36.6% 37.8% +1.9%p¹ +11%¹ +7%¹ 22.0% CHFm 20.4% 11,293 11,157 11,409 +3.3%p¹ 10,911 +22%¹ 1,480 1,583 HY 2023 HY 2024 Roche Group Pharma Division Diagnostics Division Note: Group Core operating profit includes -1.7bn from Corpo
Slide 27: HY 2024: Core net financial result
HY 2024: Core net financial result Decrease mainly due to increased interest expenses CHFm • Net financial result decreased by -306m / +54% at CER • Interest expenses1 increased by -225m / +58% at CER -582 -838 +45 -25 -209 -67 HY 2023 Equity Net interest Interest Other HY 2024 securities income exp
Slide 28: HY 2024: Core tax rate
HY 2024: Core tax rate Tax rate up due to Pillar Two top-up tax in 2024, partially offset by favourable profit mix +0.4%p 16.9% 17.3% 1.8% Impact of Pillar Two top-up tax Effective tax rate excl. impact from Pillar Two top-up tax 16.9% -1.4%p 15.5% Effective tax rate Effective tax rate HY 2023 HY 20
Slide 29: HY 2024: Core EPS development
HY 2024: Core EPS development Increase in operations partially offset by lower gains on product disposals and higher interest expense +8.9% - 2.3%p - 2.3%p 10.78 + 13.9%p - 0.4%p 9.90 HY 2023 Operations1 Product disposals Financial Tax rate change HY 2024 Income/Expense All values at CER=Constant Ex
Slide 30: HY 2024: Non-core and IFRS income
HY 2024: Non-core and IFRS income Non-core operating expenses higher vs. PY mainly due to higher impairments of intangible assets HY 2023 HY 2024 Var. Change in % CHFm CHFm at CER CHF CER Core operating profit 10,911 11,293 +1,113 +4 +11 Global restructuring plans -678 -762 -104 Amortisation of inta
Slide 31: Results, Cash & balance sheet, Currency guidance & outlook
Results Cash & balance sheet Currency guidance & outlook
Slide 32: HY 2024: Group operating free cash flow
HY 2024: Group operating free cash flow OFCF +9%; higher cash operating profit, partly offset by NWC movement and higher IA investments CHFm -316 +171 +1,210 -487 -71 -137 -315 7,682 8,368 8,053 OFCF up by +9%/+686m at CER HY OP, net of cash NTWC Other NWC Investments Investments HY Foreign HY start
Slide 33: HY 2024: Group net debt development
HY 2024: Group net debt development Net debt higher by CHF 6.9bn vs. YE 2023 CHFbn Free Cash Flow CHF +5.6 [PY: +6.1] [PY: -15.6] [PY: +8.0] [PY: -1.9] [PY: -8.4] [PY: -17.9] Taxes -2.0 Dividends paid -7.9 -18.7 Treasury -0.5 M&A & All. trans. -2.5 Curr. Transl. & Oth. -1.6 -2.5 Trans. own eq. inst.
Slide 34: Balance sheet 30 June 2024
Balance sheet 30 June 2024 Equity ratio at 34% (31 Dec 2023: 37%, 30 June 2023: 36%) % change in CER % change in CER vs 31 Dec 2023 vs 31 Dec 2023 CHFbn 95.8 +3% 95.8 +3% Cash and 90.5 90.5 8.8 -13% marketable 10.5 9% 26.6 securities 12% +4% +5% Current 24.8 24.8 28% Other 23.0 liabilities 27% 26% c
Slide 35: Results, Cash & balance sheet, Currency guidance & outlook
Results Cash & balance sheet Currency guidance & outlook
Slide 36: Expected 2024 currency impact
Expected 2024 currency impact USD / CHF Assumed avg. YTD 2024 Assuming the 28 June 2024 exchange rates remain stable -6% -3% -1% -1% 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 0.89 0.89 Sales -8 -2 0 0 0.86 0.88 0.89 0.91 0.91 0.89 0.90 0.90 0.9
Slide 37: 2024 guidance raised
2024 guidance raised 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 Further in
Slide 38: Pharmaceuticals Division
Pharmaceuticals Division Teresa Graham CEO Roche Pharmaceuticals
Slide 39: HY 2024: Pharmaceuticals sales
HY 2024: Pharmaceuticals sales All regions ex-Japan delivering strong growth, Japan impacted by Ronapreve sales in Q1 2023 HY 2024 HY 2023 Change in % CER w/o CHFm CHFm CHF CER Ronapreve Pharmaceuticals Division 22,637 22,511 1 5 8 United States 11,882 11,573 3 5 5 Europe 4,425 4,105 8 10 10 Japan 1
Slide 40: HY 2024: Pharmaceuticals core operating profit
HY 2024: Pharmaceuticals core operating profit Core operating profit higher by +7% driven by cost management and higher sales HY 2024 HY 2024 vs. HY 2023 CHFm abs. CER CER growth Sales 22,637 +1,184 5% Other revenue 886 +111 14% Cost of sales -4,031 -213 5% R&D -5,335 -9 0% SG&A -3,197 -31 1% OOI&E
Slide 41: HY 2024: Young portfolio delivering strong growth
HY 2024: Young portfolio delivering strong growth Vabysmo and Phesgo excellent growth momentum continues; Polivy on-track for blockbuster status Vabysmo 93% Phesgo 60% Ocrevus 8% Polivy 54% Evrysdi 25% Hemlibra 7% Xolair 10% Columvi >500% Gazyva 15% Alecensa 7% Xofluza 183% Actemra / RoActemra 3% En
Slide 42: Inavolisib in 1L PIK3CA-mut HR+ breast cancer received FDA BTD
Oncology solid tumors / Hematology Inavolisib in 1L PIK3CA-mut HR+ breast cancer received FDA BTD Tecentriq SC with strong EU launch, reaching 32% conversion rate in UK Others Q2 update Avastin CHFm 331 / -7% • Phesgo: Strong uptake and conversion at 41% (51 countries)* CHFm 654 / -16% Perjeta • Per
Slide 43: Polivy US patient share in 1L DLBCL reaching 26%
Oncology solid tumors / Hematology Polivy US patient share in 1L DLBCL (IPI 0-5) reaching 26% Hemlibra US/EU-5 patient share climbing to 41% Columvi Lunsumio CHFm 37 / +34% Q2 update CHFm 67 / >500% Gazyva PiaSky • Hemlibra: Continued penetration across all approved patient CHFm 2 / N/A segments wit
Slide 44: Columvi + GemOx reduces risk of death by 41% in 2L DLBCL
Oncology solid tumors / Hematology Columvi + GemOx reduces risk of death by 41% in 2L DLBCL1 Ph III ( STARGLO): Columvi is the first CD20xCD3 bispecific to demonstrate an OS benefit in DLBCL Ph III (STARGLO) in 2L DLBCL*: Results Median OS Efficacy results R-GemOx Columvi + GemOx (n=91) (n=183) Medi
Slide 45: EU filing of Elevidys in DMD completed
Neurology EU filing of Elevidys in DMD completed Ocrevus market leader in US/EU5 with 26% global patient share and >350k patients treated Elevidys CHFm 29 / N/A Others Q2 update CHFm 217 / +25% Enspryng • Ocrevus: #1 new to brand in US; higher retention rate than other CHFm 143 / +32% MS medicines;
Slide 46: Xolair in food allergy already with >15k patients on treatment
Immunology Xolair in food allergy already with >15k patients on treatment Gazyva Ph III (REGENCY) in lupus nephritis to readout in Q3 2024 Q2 update Others CHFm 472 / -13% • Xolair: Strong food allergy launch with >15k patients on treatment only four months post-launch MabThera/ • Additional growth
Slide 47: Vabysmo US market share growth in nAMD, DME and RVO continues
Ophthalmology Vabysmo US market share growth in nAMD, DME and RVO continues Vabysmo pre-filled syringe approved in the US Luxturna CHFm 10 / +26% Susvimo Q2 update Lucentis CHFm 1 / -26% • Vabysmo: Continued market share gains across early launch CHFm 87 / -70% countries and ongoing global expansion
Slide 48: Susvimo: US commercial nAMD relaunch commencing, ex-US 2025+
Ophthalmology Susvimo: US commercial nAMD relaunch commencing, ex-US 2025+ Continuous delivery for predictable and immediate 6-month durability preferred by 93 % patients vs IVT1 nAMD: Visual acuity gains Ongoing development for the Port Delivery Platform equivalent to monthly injections Ph III (ARC
Slide 49: CT-388 and CT-996 demonstrating strong weight loss effect
Cardiovascular & Metabolism CT-388 and CT-996 demonstrating strong weight loss effect Ph I CT-388 topline results indicate best-in-class potential; Additional data to be shared at EASD GLP-1/GIP RA (CT-388) Ph I topline results for CT-388 in obesity2 Percent change in body weight by week* Adenylyl c
Slide 50: Pipeline update: Strengthening the Pharma pipeline
Pipeline update: Strengthening the Pharma pipeline Portfolio shaping ongoing: Focus on high-impact projects led to termination of 25% of total NMEs since Q2 23 NME changes in Q2 NME and LE (QoQ change, Q2 24 vs Q1 24) ±0 2 ±0 6 8 -1 Phase Indication RG6377 I IBD ±0 11 +1 9 cMET ADC* I Solid tumors -
Slide 51: 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 EU PiaSky (crovalimab) PNH US/EU approval US Elevidys DMD EU filing Ocrevus 6m S
Slide 52: Diagnostics Division
Diagnostics Division Matt Sause CEO Roche Diagnostics
Slide 53: HY 2024: Diagnostics Division sales
HY 2024: Diagnostics Division sales Strong base business growth more than offsetting decline in COVID-19 sales HY 2024 HY 2023 Change in % Excl. CHFm CHFm CHF CER C191 Diagnostics Division 7,211 7,268 -1 5 9 Core Lab 4,069 3,935 3 10 22 Molecular Lab 1,275 1,288 -1 3 33 Near Patient Care 1,097 1,358
Slide 54: HY 2024: Diagnostics highlights
HY 2024: Diagnostics highlights Strong base business growth more than offsetting decline in COVID-19 sales CHFbn YoY CER growth • Immunodiagnostics (+11%) Core Lab +10% • Clinical Chemistry (+8%) • Custom biotech (+5%) • COVID-19 (-67%) Molecular Lab1 +3% • Blood Screening (+13%) • Virology base bus
Slide 55: HY 2024: Diagnostics regional sales
HY 2024: Diagnostics regional sales Strong base business growth across all regions North America +5% EMEA ~30% of divisional sales +4% ~34% of divisional sales Asia Pacific Latin America +3% +16% ~29% of divisional sales ~7% of divisional sales Base business=excluding COVID-19-related products; Grow
Slide 56: 2024: Diagnostics core operating profit
2024: Diagnostics core operating profit Core operating profit higher by +22% HY 2024 HY 2024 vs. HY 2023 CHFm abs. CER CER growth Sales 7,211 +332 5% Other revenue 22 -17 -44% Cost of sales -3,269 +44 -1% R&D -933 -11 1% SG&A -1,485 -71 5% OOI&E 37 +25 205% Core operating profit 1,583 +302 22% Core
Slide 57: cobas ISE neo and cobas c703
Core Lab cobas® ISE neo and cobas® c703 CE market launch of high-volume clinical chemistry and ISE testing analytical units on cobas pro integrated solutions Increased throughput & more Increased flexibility, Numerous differentiating Simplified serviceability through reagent positions on cobas® pro1
Slide 58: cobas liat SARS-CoV-2, Flu A/B & RSV
Near Patient Care cobas® liat SARS-CoV-2, Flu A/B & RSV Four-in-one molecular POC test for SARS-CoV-2, Influenza A/B viruses and RSV receives FDA EUA1 • Detection and differentiation of four respiratory targets in one test: o SARS-CoV-2, RSV, Influenza A and B • Prompt diagnosis at the Point of Care
Slide 59: Accu-Chek SmartGuide CGM solution
Near Patient Care Accu-Chek SmartGuide CGM solution Authorized for launch in CE mark countries Accu-Chek SmartGuide CGM solution Improving diabetes management and care continuum • 14 days of reliable and accurate real-time glucose sensor data • One-step application with initial calibration • Predict
Slide 60: 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 61: Doing now what patients need next
Doing now what patients need next
Slide 62: 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 63: Changes to the development pipeline
Changes to the development pipeline Q2 2024 update New to phase I New to phase II New to phase III New to registration 3 NMEs: 1 NME: 1 NMEs: RG6540 P-CD19 x CD20 - ALLO1 heme RG6289 gamma-secretase modulator - RG6114 inavolisib + palbociclib + fulv. – tumors Alzheimer’s 1L HR+ PIK3CA-mut. mBC RG664
Slide 64: Roche Group development pipeline
Roche Group development pipeline Phase I (47 NMEs + 8 AIs) Phase II (20 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 65: Roche Group development pipeline
Roche Group development pipeline Phase III (7 NMEs + 34 AIs) Registration US & EU (3 NME + 8 AIs) RG3502 Kadcyla + T HER-2+ eBC high-risk RG6149 astegolimab COPD RG6107 PiaSky (crovalimab) 2 PNH Columvi + chemo 2L+ DLBCL RG6299 ASO factor B IgA nephropathy inavolisib + palbociclib + 1L HR+ PIK3CA-mu
Slide 66: Expected regulatory submissions
Expected regulatory submissions* New Molecular Entities: Lead and additional indications anti-latent myostatin + giredestrant RG6237 Evrysdi New Molecular Entity (NME) Cardiovascular & Metabolism RG6171 endometrial cancer SMA Additional Indication (AI) Neurology Oncology / Hematology Ophthalmology g
Slide 67: Expected regulatory submissions
Expected regulatory submissions* Marketed products: Additional indications New Molecular Entity (NME) Cardiovascular & Metabolism Additional Indication (AI) Neurology Oncology / Hematology Ophthalmology Immunology Other Infectious Diseases Lunsumio + lenalidomide ✓ Indicates submission to health aut
Slide 68: Major pending approvals 2024
Major pending approvals 2024 US EU China Japan-Chugai Inavolisib + palbociclib + fulvestrant Inavolisib + palbociclib + fulvestrant Ocrevus Alecensa RG6114 1L HR+ PIK3CA-mut. mBC RG6114 1L HR+ PIK3CA-mut. mBC RG1594 RMS & PPMS RG7853 ALK+ NSCLC adj Filed March 2024 Filed April 2024 Filed June 2023 F
Slide 69: Major granted approvals 2024
Major granted approvals 2024 US EU China Japan-Chugai Xolair Tecentriq SC PiaSky (crovalimab) PiaSky (crovalimab) 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
Slide 70: 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 71: Oncology/Hematology: Alecensa
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 72: Oncology/Hematology: 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=1150 ARM A: K
Slide 73: Oncology/Hematology: Phesgo
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 74: Oncology/Hematology: 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 75: Oncology/Hematology: Tecentriq SCLC and NSCLC
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 76: Oncology/Hematology: 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 77: Oncology/Hematology: 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/Hematology Design P
Slide 78: Oncology/Hematology: 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 79: Oncology/Hematology: 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 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 com
Slide 80: Oncology/Hematology: 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 81: Oncology/Hematology: Columvi
Columvi (glofitamab, CD20-TCB, 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 +
Slide 82: Oncology/Hematology: 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=713 N=117 N=235
Slide 83: Oncology/Hematology: 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/Hematology Design Progression-free surv
Slide 84: Oncology/Hematology: 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 FL Phase/study Phase I/II Phase Ib/II # of patients N=187 N=183 Cohort A: Lunsumio monotherapy (after a response to prior syste
Slide 85: Oncology/Hematology: 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=412 N=8 ARM A: Lunsumio plus lenalidomide Lunsumio monotherapy (3L+ CLL)
Slide 86: Oncology/Hematology: 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 Oncology/Hematology Design Primary endpoint Progression-free survival Data presented at ASH 2021
Slide 87: Oncology/Hematology: 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 88: Oncology/Hematology: Venclexta MDS
Venclexta (venetoclax, RG7601) Novel small molecule Bcl-2 selective inhibitor – myelodysplastic syndromes Newly diagnosed higher-risk Indication myelodysplastic syndromes (MDS) Phase III Phase/study VERONA # of patients N=500 ARM A: Venclexta plus azacitidine ARM B: Placebo plus azacitidine Onco
Slide 89: Oncology/Hematology: 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 90: Oncology/Hematology: 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 91: Oncology/Hematology: PiaSky
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: Crovalimab ARM B: Eculizumab Oncology/Hemat
Slide 92: Oncology/Hematology: PiaSky
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 CO
Slide 93: Oncology/Hematology: PiaSky aHUS
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
Slide 94: Oncology/Hematology: PiaSky sickle cell disease
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: Crovalimab ARM A:
Slide 95: Neurology: Elevidys
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 96: Neurology: Enspryng
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 97: Neurology: Evrysdi
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 98: Neurology: Evrysdi
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 99: Neurology: Ocrevus
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 100: Neurology: 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 101: 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 MMF / ARM A: Gazyva 1000mg IV (6 doses through ARM A: Ga
Slide 102: 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=300 N=80 ARM A: Gazyva 1000mg IV on Day 1 and Weeks 2, 24 and 26. ARM A: Gazy
Slide 103: Immunology: Lunsumio
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 104: Immunology: Xolair
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 Number of participants who successful
Slide 105: Ophthalmology: Enspryng
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 106: 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 100mg/mL Q24W Ex-LADDE
Slide 107: 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: Intra
Slide 108: Ophthalmology: Vabysmo
Vabysmo (faricimab, RG7716) Bispecific antibody for the eye which targets and inhibits two signalling 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: Faricimab 6.0 mg Q8W ARM A
Slide 109: Ophthalmology: Vabysmo
Vabysmo (faricimab, RG7716) Bispecific antibody for the eye which targets and inhibits two signalling pathways (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 aft
Slide 110: Ophthalmology: Vabysmo
Vabysmo (faricimab, RG7716) Bispecific antibody for the eye which targets and inhibits two signalling 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 III Ph
Slide 111: Ophthalmology: Vabysmo
Vabysmo (faricimab, RG7716) Bispecific antibody for the eye which targets and inhibits two signalling pathways (Ang-2 and VEGF-A) Indication Myopic choroidal neovascularization (CNV) Phase III Phase/study POYANG # of patients n=280 ARM A: Faricimab 6.0 mg Q4W PRN ARM B: Ranibizumab 0.5 mg Q4W PR
Slide 112: 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 patients
Slide 113: 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 114: Oncology/Hematology: 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 KRAS G12C Indication 2L, 1L metastatic colorectal cancer (mCRC) mutation Phase Ib Phase/study Phase I INTRINSIC # of patien
Slide 115: Oncology/Hematology: Divarasib
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 II/III Phase/study KRASCENDO 170 B-FAST* # of patients N=60 Modular design Cohort A: Combination of divarasib plus pembr
Slide 116: Oncology/Hematology: 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 coop
Slide 117: Oncology/Hematology: 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 118: Oncology/Hematology: 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 119: Oncology/Hematology: Inavolisib
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 Phase III
Slide 120: Oncology/Hematology: 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 121: Oncology/Hematology: 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 122: Oncology/Hematology: 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 123: Oncology/Hematology: 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 124: Oncology/Hematology: Tiragolumab
Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT Indication Solid tumors Phase/study Phase I # of patients N=540 Phase Ia: Dose escalation and expansion of tiragolumab Phase Ib: Dose escalation and expansion of tiragolumab in combina
Slide 125: Oncology/Hematology: NXT007
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 126: Neurology: Anti-latent myostatin
Anti-latent myostatin (RG6237, GYM329) 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=30-3
Slide 127: Neurology: 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=985 N=736 N=751
Slide 128: Neurology: 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 Neurology Design Primary endpoint Total numbe
Slide 129: Neurology: 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=300 Patients aged 25 to 50 years with prodromal (very early subtle signs of HD) or early manifest HD Neurology ARM A: Tominersen
Slide 130: 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 131: Immunology: ASO factor B
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 132: Ophthalmology: Vamikibart
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 133: Ophthalmology: Vamikibart
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 134: Cardiovascular & Metabolism: CT-388
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 135: Cardiovascular & Metabolism: CT-996
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 136: Cardiovascular & Metabolism: CT-868
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 & Metabolism Design ARM C: CT-868 high dose ARM D: Placebo Prima
Slide 137: 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 138: pRED oncology development programs -1
pRED oncology development programs -1 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 FPI Q4 2019 Solid tumors I 320 Data presented at ESMO 2022 NCT04140500
Slide 139: pRED oncology development programs -2
pRED oncology development programs -2 Molecule Indication Phase # of patients Status CT Identifier Oncology Part I: FPI Q2 2020; recruitment completed Q4 eciskafusp alfa 2021 Solid tumors Ib 256 NCT04303858 (PD1-IL2v, RG6279) Part II: FPI Q1 2022 Part III: FPI Q1 2023 forimtamig FPI Q4 2020 Multiple
Slide 140: 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 141: 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) *molecule also in gRED development: Phase Ic in coronary
Slide 142: 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 Ophthalmology zifibancimig NCT04567
Slide 143: 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 144: 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 145: 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 146: 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 147: 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 148: gRED infectious diseases development program
gRED infectious diseases development program Molecule Indication Phase # of patients Status CT Identifier Infectious Diseases LepB inhibitor (RG6436) Complicated urinary tract infection I 104 FPI Q2 2024 ISRCTN18049481 148
Slide 149: 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 150: Hemophilia A gene therapy
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 151: 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 152: Pharma TA definitions
Pharma TA definitions TA split as in the TA split as in the Half-Year Report 2024 HY 2024 IR presentation CHFbn 29.8 Polivy, Gazyva, Columvi, Lunsumio, Mabthera/Rituxan oncology sales CHFbn 29.8 moved from Oncology to “Hemophilia A” and renamed to “Hematology” Remaining Oncology renamed to “Oncology
Slide 153: Geographical sales split by Divisions and Group
Geographical sales split by Divisions and Group* CHFm HY 2023 HY 2024 % change CER Pharmaceuticals Division 22,511 22,637 +5 United States 11,573 11,882 +5 Europe 4,105 4,425 +10 Japan 2,210 1,366 -28 International 4,623 4,964 +17 Diagnostics Division 7,268 7,211 +5 United States 1,915 1,917 +3 Euro
Slide 154: Pharma Division sales HY 2024: Top products
Pharma Division sales HY 2024 Top 20 products Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Ocrevus 3,359 8 2,411 5 639 12 - - 309 27 Hemlibra 2,143 7 1,231 1 468 14 171 3 273 32 Perjeta 1,921 -2 694 -7 341 -16 66 -30 820 14 Tecentriq 1,798 2 898 -8 429
Slide 155: Pharma Division sales HY 2024: Products launched since 2015
Pharma Division sales HY 2024 Products launched since 2015 Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Cotellic 20 -27 8 -41 6 3 - - 6 -22 Alecensa 766 7 236 9 145 1 96 4 289 10 Tecentriq 1,798 2 898 -8 429 10 182 -2 289 32 Ocrevus 3,359 8 2,411 5 639
Slide 156: Pharma Division sales HY 2024: Product sales
Pharma Division sales HY 2024 Product sales Pharmaceuticals Division Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Ocrevus 3,359 8 2,411 5 639 12 - - 309 27 Hemlibra 2,143 7 1,231 1 468 14 171 3 273 32 Perjeta 1,921 -2 694 -7 341 -16 66 -30 820 14 Tecent
Slide 157: 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 Ocrevus 14 15 12 9 8 9 Hemlibra 24 17 17 9 8 6 Perjeta 11 6 0 -11 -3 -1 Tecentriq 15 8 10 5 1 2 Vabysmo * * 309 160 108 81 Actemra / RoActemra -12 2 21 13 -2 8 Xolair 5 4 3 7 10 11 Kadcyla 5 -5 5 13 3 9
Slide 158: Pharma Division CER sales growth: Top products by region
Pharma Division CER sales growth1 in % Top 20 products by region US Europe Japan International Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Ocrevus 10 8 5 6 10 11 8 15 - - - - 50 22 28 27 Hemlibra 15 8 -1 3 22 8 17 12 5 5 2 4 39 14 51 16 Perjeta -6 -35 -7 -6 0 -21 -19 -12 6 3 -19 -39 4 21 14 14 T
Slide 159: CER sales growth (%)
CER sales growth (%) Quarterly development 2023 vs. 2022 2024 vs. 2023 Q1 Q2 Q3 Q4 Q1 Q2 Pharmaceuticals Division 9 7 11 -2 2 9 United States 7 8 11 5 5 6 Europe 5 5 9 3 11 10 Japan 18 8 1 -50 -45 -3 International 13 6 17 16 12 23 Diagnostics Division -28 -17 -5 4 2 8 Roche Group -3 0 7 0 2 9 CER=Co
Slide 160: Ocrevus
Ocrevus Global sales CER growth Regional sales CER growth CHFbn 3.6 +8% US +5% 3.0 2.4 1.8 Europe +12% 1.2 International +27% 0.6 0.0 HY 2021 HY 2022 HY 2023 HY 2024 HY 2024 sales of CHF 3,359m • US: Moving into earlier lines displacing orals; #1 in US for both dynamic and total share • EU: Moving i
Slide 161: Hemlibra
Hemlibra Global sales CER growth Regional sales CER growth CHFbn 2.4 +7% US +1% 2.0 Europe +14% 1.6 Japan +3% 1.2 0.8 International +32% 0.4 0.0 HY 2021 HY 2022 HY 2023 HY 2024 HY 2024 sales of CHF 2,143m • US: Continued share gains in non-inhibitor patients • EU: Continued share gains in non-inhibi
Slide 162: Perjeta
Perjeta Global sales CER growth Regional sales CER growth CHFbn 2.4 -2% US -7% 2.0 Europe -16% Japan -30% 1.6 1.2 0.8 International +14% 0.4 0.0 HY 2021 HY 2022 HY 2023 HY 2024 HY 2024 sales of CHF 1,921m • US: Increasing conversion to Phesgo • EU: Conversion to Phesgo • Japan: Conversion to Phesgo
Slide 163: Tecentriq
Tecentriq Global sales CER growth Regional sales CER growth CHFbn 2.0 +2% US -8% 1.6 Europe +10% 1.2 Japan -2% 0.8 International +32% 0.4 0.0 HY 2021 HY 2022 HY 2023 HY 2024 HY 2024 sales of CHF 1,798m • US: 1L HCC nearing peak penetration; adj. NSCLC competitive pressure intensifying • EU: Growth d
Slide 164: Vabysmo
Vabysmo Global sales CER growth Regional sales CER growth CHFbn 2.0 +93% US +78% 1.6 Europe +183% 1.2 Japan +35% 0.8 International +324% 0.4 0.0 HY 2021 HY 2022 HY 2023 HY 2024 HY 2024 sales of CHF 1,794m • US: Increasing penetration in naive patients; expanding market shares in nAMD, DME and RVO •
Slide 165: Actemra / RoActemra
Actemra / HY RoActemra 2021 HY 2022 HY 2023 HY 2024 CHFbn Global sales CER growth Regional sales CER growth 1.8 +3% US +6% 1.5 Europe -3% 1.2 0.9 0.6 Japan +7% 0.3 International +4% 0.0 HY 2021 HY 2022 HY 2023 HY 2024 HY 2024 sales of CHF 1,276m • US: Ongoing patient shift from Actemra IV to SC in R
Slide 166: Xolair
Xolair Global sales CER growth Regional sales CER growth CHFbn 1.2 +10% 1.0 0.8 US +10% 0.6 0.4 0.2 0.0 HY 2021 HY 2022 HY 2023 HY 2024 HY 2024 sales of CHF 1,110m • US: Growth driven by uptake in CSU; Strong food allergy launch with >15k patients on treatment CER=Constant Exchange Rates 166
Slide 167: Kadcyla
Kadcyla Global sales CER growth Regional sales CER growth CHFbn +6% 1.2 US +1% 1.0 0.8 Europe -1% 0.6 Japan +2% 0.4 0.2 International +23% 0.0 HY 2021 HY 2022 HY 2023 HY 2024 HY 2024 sales of CHF 999m • US: Share decline in metastatic BC due to competition • EU: Share decline in metastatic BC due to
Slide 168: Evrysdi
Evrysdi CHFbn Global sales CER growth Regional sales CER growth 1.0 +25% US +14% 0.8 Europe +21% 0.6 Japan +14% 0.4 International +50% 0.2 0.0 HY 2021 HY 2022 HY 2023 HY 2024 HY 2024 sales of CHF 838m • US: Strong uptake across all patient segments; including treatment-naïve patients; leading market
Slide 169: Phesgo
Phesgo Global sales CER growth Regional sales CER growth CHFbn 1.0 +60% US +27% 0.8 Europe +51% 0.6 0.4 Japan n/a 0.2 International +115% 0.0 HY 2021 HY 2022 HY 2023 HY 2024 HY 2024 sales of CHF 799m • US: Strong growth driven by eBC, switching of patients from Perjeta+Herceptin to Phesgo • EU: Stro
Slide 170: Alecensa
Alecensa Global sales CER growth Regional sales CER growth CHFbn 0.8 +7% US +9% 0.6 Europe +1% 0.4 Japan +4% International +10% 0.2 0.0 HY 2021 HY 2022 HY 2023 HY 2024 HY 2024 sales of CHF 766m • US: Market leadership in 1L ALK+ NSCLC is maintained • EU: Market leadership in 1L ALK+ NSCLC is maintai
Slide 171: Herceptin
Herceptin Global sales CER growth Regional sales CER growth CHFbn 1.6 -11% US -19% Europe -14% 1.2 Japan -44% 0.8 0.4 International -5% 0.0 HY 2021 HY 2022 HY 2023 HY 2024 HY 2024 sales of CHF 740m • US: Biosimilar erosion slowing; Switching of patients with residual disease to Kadcyla; Conversion t
Slide 172: Rituxan / Mabthera
Rituxan / Mabthera CHFbn Global sales CER growth Regional sales CER growth 1.5 -17% US -19% 1.2 Europe -17% 0.9 Japan -23% 0.6 International -11% 0.3 0.0 HY 2021 HY 2022 HY 2023 HY 2024 HY 2024 sales of CHF 706m • US: Biosimilar erosion slowing • EU: Biosimilar erosion bottoms out • Japan: Biosimila
Slide 173: Avastin
Avastin CHFbn Global sales CER growth Regional sales CER growth 1.8 -16% US -20% Europe -20% 1.5 1.2 Japan -33% 0.9 0.6 International -4% 0.3 0.0 HY 2021 HY 2022 HY 2023 HY 2024 HY 2024 sales of CHF 654m • US: Biosimilar erosion slowing • EU: Biosimilar erosion slowing • Japan: Ongoing biosimilar er
Slide 174: TNKase / Activase
TNKase / Activase Global sales CER growth Regional sales CER growth CHFbn 0.8 -2% US -3% 0.6 0.4 0.2 International +17% 0.0 HY 2021 HY 2022 HY 2023 HY 2024 HY 2024 sales of CHF 593m • Spontaneous TNKase use in AIS early time window CER=Constant Exchange Rates 174
Slide 175: Polivy
Polivy Global sales CER growth Regional sales CER growth CHFbn 0.6 +54% 0.5 US +112% 0.4 0.3 Europe +9% 0.2 0.1 Japan -1% International +107% 0.0 HY 2021 HY 2022 HY 2023 HY 2024 HY 2024 sales of CHF 513m • US: Strong growth following approval in 1L DLBCL • EU: Strong growth following approval in 1L
Slide 176: Gazyva
Gazyva Global sales CER growth Regional sales CER growth CHFbn 0.5 +15% US +14% Europe +13% 0.4 0.3 Japan -16% 0.2 International +29% 0.1 0.0 HY 2021 HY 2022 HY 2023 HY 2024 HY 2024 sales of CHF 445m • US: Strong growth driven by combination therapies in 1L CLL • EU: Strong growth driven by combinat
Slide 177: 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 178: HY 2024: Diagnostics Division CER growth
HY 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 CHFm
Slide 179: HY 2024: Diagnostics Division quarterly sales and CER growth
HY 2024: Diagnostics Division quarterly sales and CER growth1 Reported Restatement Q1 23 Q2 23 Q3 23 Q4 23 Q1 24 Q2 24 Q1 23 Q2 23 Q3 23 Q4 23 Q1 24 Q2 24 CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Core Lab 1,92
Slide 180: HY 2024: Diagnostics Division regional sales
HY 2024: Diagnostics Division regional sales Growth in all regions Sales YTD CHFm & % of total sales Sales growth at CER Total YTD Sales = 7,211 Diagnostics Division 5% GLOBAL 515 / 4% EMEA* 7% 5% NAM 2,431 / 3% APAC 2,102 / 34% 16% LATAM 29% 2,163 / 30% EMEA* NAM APAC LATAM CER=Constant Exchange Ra
Slide 181: Core Lab
Core Lab 2024 vs. 2023 CHFbn CER growth +10% 5.0 4.0 +4% +8% 3.0 +11% 2.0 1.0 0.0 HY 2022 HY 2023 HY 2024 Immunodiagnostics Clinical Chemistry Other CER=Constant Exchange Rates 181
Slide 182: Molecular Lab
Molecular Lab 2024 vs. 2023 CHFbn CER growth +3% 2.4 2.0 +10% 1.6 -4% -2% 1.2 +13% 0.8 +8% +13% 0.4 -7% 0.0 HY 2022 HY 2023 HY 2024 Virology Blood Screening MD Systems Microbiology Cervical Cancer qPCR&NAP Other CER=Constant Exchange Rates 182
Slide 183: Near Patient Care
Near Patient Care 2024 vs. 2023 CHFbn CER growth -14% 4.0 3.0 2.0 -1% -8% -7% 1.0 -5% -60% 0.0 HY 2022 HY 2023 HY 2024 Clinical Chem. & Immunodiagn. Hospital Glucose Coagulation & Urinalysis Diabetes Care POC MDx CER=Constant Exchange Rates 183
Slide 184: Pathology Lab
Pathology Lab 2024 vs. 2023 CHFbn CER growth +17% 0.8 +46% 0.6 +9% +11% 0.4 0.2 0.0 HY 2022 HY 2023 HY 2024 Advanced Staining Primary Staining Companion Diagnostics CER=Constant Exchange Rates 184
Slide 185: 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 186: CHF/USD
CHF/USD Monthly averages 0.93 0.91 -4% 0.89 -1% 0.87 0.85 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 0.87 0.85 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2023 2024 186
Slide 187: CHF/USD
CHF/USD 0.93 HY 2024 -1% 0.92 0.91 0.90 0.89 0.88 0.87 0.86 0.85 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 187
Slide 188: CHF/EUR
CHF/EUR Monthly averages 1.00 0.98 0.96 -3% -1% 0.94 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% -2% 0.96 0.94 0.92 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2023 2024 188
Slide 189: CHF/EUR
CHF/EUR 1.00 HY 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 189
Slide 190: Average CHF Exchange Rates
Average CHF Exchange Rates HY 2024 HY 2023 HY 2024 vs. HY 2023 USD 0.89 0.91 -3% EUR 0.96 0.99 -2% JPY 0.58 0.68 -14% -15% -10% -5% 0% 190
Slide 191: Exchange rate impact on sales growth
Exchange rate impact on sales growth HY 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% CHF / EUR -4.4% -2.5% CHF / JPY -15.8% -13.6% CHF / CNY -10.2% -6.5% Difference in CHF / CER -7.6% -5.0% 0.0% 0
Slide 192: Exchange rate impact on sales growth
Exchange rate impact on sales growth Q2 2024: negative impact of JPY, CNY and EUR; positive impact of USD Development of average exchange rates versus prior year period Q1 Q2 Q3 Q4 CHF / USD -5.6% 0.6% CHF / EUR -4.4% -0.6% CHF / JPY -15.8% -11.4% CHF / CNY -10.2% -2.7% Difference in CHF / CER -7.6%
Slide 193: Doing now what patients need next
Doing now what patients need next