Roche Holding Ltd · SIX:RO
Roche — 43rd Annual J.P. Morgan Healthcare Conference 2025
29 slides from Roche's conference presentation, Jan 13, 2025
Slide 1: Doing now what patients need next
Doing now what patients need next
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: Unlocking the next era of innovation
Unlocking the next era of innovation Teresa Graham CEO Roche Pharmaceuticals
Slide 4: Delivering on the Pharma Ambition / Accelerating R&D Excellence / Looking ahead
Delivering on the Pharma Ambition Accelerating R&D Excellence Looking ahead 4
Slide 5: Sales momentum expected to continue into 2025
Sales momentum expected to continue into 2025 Strong growth by both divisions: Pharma and Diagnostics 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% 2
Slide 6: 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: Achieved approval for Itovebi (inavolisib) in HR+ breast cancer and PiaSky in PNH 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 2024
Slide 7: Our new Pharma Strategy focusing on five TAs
Our new Pharma Strategy focusing on five TAs Ambition to deliver 20 transformative medicines in areas of highest societal burden Where we play: Priority Therapeutic Areas Global Burden of Disease (‘23 & ’35, mn DALYs) +9% Neurology Oncology/ 2,408 Growth (p.p %) Hematology 2,208 33 25 225 33% 184 28
Slide 8: One asset team approach allows us to maximize MoAs across TAs
One asset team approach allows us to maximize MoAs across TAs For example, incretins have the potential to become a foundational target within several TAs Drug target Oncology/Heme Neurology Immunology Ophthalmology CVRM CD20 VEGF IL6 CD19 C5 GLP-1/GIP NLRP3 Latent myostatin VEGF=vascular endothelia
Slide 9: Breast Cancer: Sustained growth in HER2+ and expanding into HR+
Oncology/Hematology Breast Cancer: Sustained growth in HER2+ and expanding into HR+ One of our most advanced E2E DAs, with robust pipeline aiming to address remaining unmet need Breast cancer portfolio Giredestrant aims to replace standard of care ET across eBC & mBC Low risk (~55%)1 Medium risk (~2
Slide 10: Hematology: Portfolio further strengthened by allogeneic CAR-Ts
Oncology/Hematology Hematology: Portfolio further strengthened by allogeneic CAR-Ts Potential to move into autoimmune diseases including MS and SLE Roche/Poseida allogeneic CAR-Ts key features Allogeneic CAR-T pipeline Robust healthy donor screening system Development Molecule TA Indication status N
Slide 11: Hemophilia A: Continuing to elevate the SoC
Oncology/Hematology Hemophilia A: Continuing to elevate the SoC NXT007, a next-gen Factor VIIIa mimetic bispecific mAb, is 30 times more potent than Hemlibra Hemophilia A portfolio NXT007 Structure and function1 NXT007, Hemlibra and FVIII thrombin generation2 Further optimized Optimized Lch for Heml
Slide 12: Alzheimer's disease: Trontinemab expected to enter Ph III in 2025
Neurology Alzheimer’s disease: Trontinemab expected to enter Ph III in 2025 Best-in-class potential: Fast and deep plaque removal with an improved safety profile Trontinemab clears amyloid more rapidly than conventional mAbs Standard IgG1 BrainshuttleTM IgG1 • Trontinemab crosses the BBB using Roche
Slide 13: Fenebrutinib: MS
Neurology MS: Continued pursue of innovation in a key E2E Disease Area Fenebrutinib with best-in-class potential, highly differentiated vs. covalent BTKis Development program Fenebrutinib PK profile vs other BTKis 1 Molecule Ind. Vs. Ph I Ph II Ph III Fenebrutinib Tolebrutinib Evobrutinib Remibrutin
Slide 14: Expanding TL1A development program beyond IBD
Immunology Expanding TL1A development program beyond IBD RG6631 with best-in-disease potential in IBD; Additional trials in atopic dermatitis and MASH to initiate in Q1 2025 TL1A implicated in inflammatory and fibrotic processes1,2 RG6631 (anti-TL1A) development program DR3 Receptor DR3 DR3 Receptor
Slide 15: Astegolimab is a potential FIC anti-ST2 addressing all COPD patients
Immunology Astegolimab is a potential FIC anti-ST2 addressing all COPD patients Phase IIb and Phase III pivotal results expected in 2025 COPD patient population1 PIIb (ALIENTO) / Ph III (ARNASA) trial design Eosinophil (EOS)* Smoking status Astegolimab SC Q2W Screening Follow-up (n=1290) 20% 30% Pat
Slide 16: UME/DME: Vamikibart, first IL-6 in ophthalmology with data in 2025
Ophthalmology UME/DME: Vamikibart, first IL-6 in ophthalmology with data in 2025 Addressing the inflammatory component (IL-6) in macular edema Retinal vascular disorders portfolio Vamikibart Ph I (DOVETAIL) in UME: Improved vision and retinal thickness in all dosing cohorts1 Change from baseline in
Slide 17: Obesity: Potential to differentiate through unique combinations
Cardiovascular, Renal & Metabolism Obesity: Potential to differentiate through unique combinations Accelerating our broad portfolio of assets to address significant unmet need Obesity portfolio Roche’s obesity pipeline Unmet need Differentiation strategy Ph I Ph II Efficacy / safety by NME CT-388 10
Slide 18: Hypertension: Zilebesiran has best-in-disease potential
Cardiovascular, Renal & Metabolism Hypertension: Zilebesiran has best-in-disease potential Ph III CVOT to be initiated in 2025, gated on results of KARDIA-3 Ph II (KARDIA-3): Combination Study in High CV Risk1 Development program Zilebesiran 600 mg SC Q6M Cohort A Ph I Ph II Ph III (N~270, Primary E
Slide 19: Delivering on the Pharma Ambition / Accelerating R&D Excellence / Looking ahead
Delivering on the Pharma Ambition Accelerating R&D Excellence Looking ahead 19
Slide 20: Accelerating R&D Excellence
Accelerating R&D Excellence We are implementing six solutions to achieve top quartile performance Adopt a unified portfolio Transform our portfolio Access the best external framework management & governance innovation Introduce the ‘Bar’ to recognize assets Reconfigure end-to-end governance to Ident
Slide 21: The Bar is applied to each asset entering and progressing in the portfolio
The Bar is applied to each asset entering and progressing in the portfolio Applying rigor to our R&D resource allocation Follow the science Intentional focus in end-to-end disease areas where we develop depth of with emphasis on breakthrough innovation and patient value + experience and operational
Slide 22: 'Fast-track' of selected programs with exceptional potential
‘Fast-track’ of selected programs with exceptional potential Material progress achieved across all three programs since Pharma Day Asset Acceleration Progress since Pharma Day (Sep. 2024) anti-TL1A • Accelerated Ph III recruitment Inflammatory Bowel Disease1 Ph III • Go decisions for additional indi
Slide 23: We have materially reshaped our pipeline through Partnering and M&A
We have materially reshaped our pipeline through Partnering and M&A Key deals completed to complement our pipeline across the Pharma focus therapeutic areas Dual GLP- Molecular Allogeneic 1/GIP RA & siRNA Anti-TL1A in Wnt agonist glue ADCs in CDKi CAR-Ts in PYY targeting inflammatory in degraders in
Slide 24: Delivering on the Pharma Ambition / Accelerating R&D Excellence / Looking ahead
Delivering on the Pharma Ambition Accelerating R&D Excellence Looking ahead 24
Slide 25: 2024: Key newsflow
2024: Key newsflow* Ph II prasinezumab missed primary endpoint, but suggests possible benefit in early-stage Parkinson’s disease Compound Indication Milestone Alecensa Adjuvant ALK+ NSCLC US/EU approval inavolisib + palbociclib + fulvestrant 1L PIK3CA-mut HR+ BC US/EU filing Tecentriq Subcutaneous a
Slide 26: 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 27: A solid base to deliver future growth
A solid base to deliver future growth Pipeline and business development to add significant upside potential illustrative Business development • BD to accelerate pipeline portfolio • In-house pipeline with upside Pharma pipeline potential • On-market Pharma portfolio to deliver growth until 2027 Sale
Slide 28: Unlocking the next era of innovation
Unlocking the next era of innovation ● Young portfolio continues to drive growth in the near- to mid- Delivering on our Pharma 1 Ambition ● term Strengthening our pipeline of transformative medicines ● Allocating significant resources to our focus therapeutic areas ● Applying “The Bar” to each asset
Slide 29: Doing now what patients need next
Doing now what patients need next
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