Roche Holding Ltd · SIX:RO
Roche — Investor Day (May 2024)
35 slides from Roche's investor day presentation, May 31, 2024
Slide 1: Slide 1
Slide 2: Roche Late Stage Oncology Pipeline Update
Roche Late Stage Oncology Pipeline Update Virtual IR event 31 May 2024
Slide 3: Opening remarks
Opening remarks Bruno Eschli Head of Investor Relations
Slide 4: Agenda
Agenda Opening remarks 15:00 – 15:05 CET Bruno Eschli, Head of Investor Relations Late-stage pipeline Oncology 15:05 – 15:40 CET Charles Fuchs, SVP Global Head of Oncology and Hematology, Product Development Q&A 15:40 – 16:00 CET
Slide 5: Young portfolio to drive growth in the near- to mid-term
Young portfolio to drive growth in the near- to mid-term Two NME approvals expected for 2024: PiaSky (crovalimab) in PNH1 and inavolisib in HR+ breast cancer CHFm % of Pharma Sales3 7,000 50% 55% 6,000 5,000 42% 4,000 32% 3,000 2 2,000 1,000 0 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 Q1 202
Slide 6: Roche's key oncology products
Oncology solid tumors & Hematology Roche’s key oncology products 0.9 bn (+1%) • Growth driven ex-US by adjuvant NSCLC and 1L HCC • EU launch of SC formulation ongoing Q1 2024 sales (YoY CER growth) • Strong launch uptake and ongoing geographic expansion 0.4 bn (+70%) • Global conversion rate reachin
Slide 7: HER2+ franchise outlook
7 Oncology solid tumors HER2+ franchise outlook Phesgo HER2+ BC treatment landscape • Strong launch uptake and ongoing geographic expansion with conversion rate reaching 41%* • Phesgo leading to increased market penetration Neoadj • Phesgo conversion to exceed 50% by 2026 Adjuvant only (50%) SURGERY
Slide 8: 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 9: Upcoming Roche IR events 2024
Upcoming Roche IR events 2024 Additional events driven by readouts Diagnostics Day Oncology/ASCO Hematology/EHA Ophthalmology/ASRS Pharma Day May 22 May 31 June 16 Jul 23 Sep 30 • Deep-dive into the • Oncology solid tumors • Ph III (STARGLO) results • Ophthalmology • Update on Group & current produc
Slide 10: Late stage pipeline Oncology
Late stage pipeline Oncology Charles Fuchs SVP Global Head of Oncology and Hematology, Product Development
Slide 11: Strategic pillars of oncology and hematology
Oncology solid tumors & Hematology Strategic pillars of oncology and hematology Precision medicine Early disease Novel immunotherapy Rational combinations Right medicines for the right Early diagnosis and treatment Need more options for Leverage breadth of oncology patient increases the chance for c
Slide 12: Advancing new modalities across key oncology pathways
Oncology solid tumors & Hematology Advancing new modalities across key oncology pathways A pioneer in bispecific antibodies and antibody drug conjugates (ADC) Oncogenic pathways/drivers Bispecifics / Cyclic peptides trispecifics Synthetic lethality/DNA damage response T-cell redirection Synthetic im
Slide 13: Oncology solid tumor pipeline
Oncology solid tumors Oncology solid tumor pipeline A broad portfolio differentiated on targets and modalities Ph I (22 NMEs) Ph II Ph III Launched RG6194 runimotamab (HER2 x CD3) RG6279 eciskafusp alfa (PD1-IL2v) tiragolumab tiragolumab Alecensa RG6058 RG6058 RG6058 Multiple indications Multiple in
Slide 14: Hematology pipeline
Hematology Hematology pipeline A broad portfolio enabling novel combinations Ph I (7 NMEs) Ph II Ph III Registration englumafusp alfa RG6107 PiaSky (crovalimab) Columvi PiaSky (crovalimab)2 RG6076 RG6026 RG6107 PNH Heme tumors SCD 1L & 2L+ DLBCL, r/r MCL dirloctogene cevostamab RG6357 samoparvovec L
Slide 15: HR+/HER2- Breast cancer landscape
Oncology solid tumors HR+/HER2- Breast cancer landscape Breast cancer cases by subtype1 Unknown 6% TNBC PIK3CAm prevalence Despite a variety of treatment options, high unmet medical need remains • HR+/HER2- 40% 11% • HER2+ 30% HR-/HER2+ 4% 1929 1938 1958 1977 1995-99 2002 2016-present HR+/HER2+ 10%
Slide 16: HR+/HER2- BC treatment pathway
Oncology solid tumors HR+/HER2- BC treatment pathway HR+ BC treatment landscape Low risk (~55%)1 Medium risk (~25%)1 High risk (~20%)1 ET Endocrine Therapy (ET) Neoadj Endocrine therapy is backbone treatment for ER+ breast cancer; however, there are SURGERY limitations with current ET options ET ET+
Slide 17: Giredestrant has the potential to overcome limitations of current ET options
Oncology solid tumors Giredestrant has the potential to overcome the limitations of current ET options and improve patient outcomes Extracellular space Androgen Pituitary gland Current standard Fulvestrant (SERD) of care* – Remaining unmet needs1-15 • Tolerability and AEs leading to low adherence Ad
Slide 18: Giredestrant data support potential in 1L and adjuvant HR+ BC
Oncology solid tumors Giredestrant data support potential in 1L and adjuvant HR+ BC Ki67 suppression in the neoadjuvant setting can Giredestrant drives benefit where ER dependency persists predict benefit of ET in adjuvant trials Ph II (coopERA) results in neoadj setting Tumor ER pathway activity by
Slide 19: Giredestrant: Potential new best-in-class endocrine backbone
Oncology solid tumors Giredestrant: Potential new best-in-class endocrine backbone Giredestrant aims to replace standard of care ET across eBC and mBC Low risk (~55%)1 Medium risk (~25%)1 High risk (~20%)1 gire giredestrant Neoadj • First results from Ph III persevERA (1L mBC) expected 2025 • Initia
Slide 20: Inavolisib in PiK3CAm HR+ BC
Oncology solid tumors Inavolisib in PiK3CAm HR+ BC Best-in-class PI3Kα inhibitor PIK3CA is one of the most frequently mutated oncogenes in cancers Potency/selectivity (inavolisib vs. alpelisib) Tumor type PIK3CAmut prevalence HR+ BC 40% 58x Pi3Kα potency HER2+ BC 30% 1 6x Ovarian Clear Cell ~33% PI3
Slide 21: Inavolisib has potential to expand broadly in PiK3CAm BC
Oncology solid tumors Inavolisib has potential to expand broadly in PiK3CAm BC Potential for inavolisib based regimen in PIK3CA mutated HR+ BC Low risk (~55%)1 High risk (~20%)1 inavo inavolisib Medium risk (~25%)1 • Ph III (INAVO123) to be initiated in 1L ET sensitive Neoadj patients • Ph III (INAV
Slide 22: INAVO120: Strong PFS supported by TTNT analysis, interim OS
Oncology solid tumors INAVO120: Strong PFS supported by TTNT analysis, interim OS Data submitted to FDA, EMA and granted FDA BTD and Priority Review (PDUFA date Nov 2024) Inavolisib more than doubles PFS in 1L PIK3CAm HR+ BC Time to Next Treatment (TTNT) Analysis PFS (investigator assessed) Time fro
Slide 23: Tiragolumab with a comprehensive development program
Oncology solid tumors Tiragolumab with a comprehensive development program Mode of action indicates potentially improved and durable tumor control1 Key insights from Guan et al.1 Clinical development program Indication Ph I Ph II Ph III 1L NSCLC: PD-L1 high SKYSCRAPER-01 Stage III unres. NSCLC SKYSC
Slide 24: Divarasib in KRAS G12C-mutant tumors
Oncology solid tumors Divarasib in KRAS G12C-mutant tumors Building on best-in-class potential and strong previous clinical results KRAS G12C inhibitor Ph I results in 2L+ mNSCLC2 Proliferation potency/selectivity1 PFS and cORR of divarasib monotherapy (all doses) Divarasib mPFS 13.1 mos cORR 53% •
Slide 25: Ph III H2H vs. sotorasib/adagrasib in 2L NSCLC to initiate in H2 2024
Oncology solid tumors Ph III H2H vs. sotarasib/adagrasib in 2L NSCLC to initiate in H2 2024 Potential to establish divarasib as the superior KRAS G12C inhibitor Clinical development program Ph III (Krascendo 1) divarasib in 2L mNSCLC Indication Regimen Ph I Ph II Ph III Key inclusion criteria divara
Slide 26: Roche keeps shifting the standard of care in NHL
Hematology Roche keeps shifting the standard of care in NHL chemotherapy Diffuse Large B cell Lymphoma Follicular Lymphoma NHL: accounting for ~ 50% of hematological malignancies1 (DLBCL) (FL) 1997 chemotherapy 4% 1L R/R 3L+ 1L 2L+ 3L+ 7% 26% CHOP benda chemo benda 10% 1997 2013 R-CHOP R+benda R+che
Slide 27: NHL development program progressing
Hematology NHL development program progressing Fixed duration, off the shelf, high CR rates with durable responses & manageable safety Comprehensive clinical trial program • 20% US patient share in 3L+ FL, ~1200 patients treated to date • No required hospitalization (low grade, infrequent CRS), best
Slide 28: Ph III STARGLO: Primary endpoint of OS in 2L DLBCL met
Hematology Ph III STARGLO: Primary endpoint of OS in 2L DLBCL met Late Breaking Abstract accepted at EHA 2024 Progressing patients Ph III (STARGLO) Columvi + GemOx in 2L R/R DLBCL Patients (N=274) Columvi + GemOx Age ≥18 years (N=183) Primary endpoint: ● Overall Survival ● R/R DLBCL ● ECOG PS 0–2 2:
Slide 29: Ph III SUNMO: Chemo-free combo of two unique MoAs in 2L DLBCL
Hematology Ph III SUNMO: Chemo-free combo of two unique MoAs in 2L DLBCL High activity and durable responses for patients unable to tolerate chemo Ph Ib/II (GO40516): Lunsumio + Polivy with Ph III (SUNMO) Lunsumio + Polivy in 2L+ R/R aggressive LBCL3 durable ORR and CR rates in R/R LBCL2 Efficacy Re
Slide 30: Polivy+R-CHP: New SoC with >23k pts treated to date in 1L DLBCL
Hematology Polivy+R-CHP: New SoC with >23k pts treated to date in 1L DLBCL Ph III (POLARIX): Polivy+R-CHP with a Reducing DLBCL progression results in PFS HR of 0.76 at 36 months1 cost savings2 HR 0.761 mFU 39.7 months (CI: 0.60-0.97) Figure adapted from Burke et al. Clin Lymphoma Myeloma Leuk. 2023
Slide 31: Ph III SKYGLO: Adding Columvi to Polivy + R-CHP in 1L DLBCL
Hematology Ph III SKYGLO: Adding Columvi to Polivy + R-CHP in 1L DLBCL Early data support the potential for Columvi in combination with current SoC Ph Ib (NP40126): Columvi + R-CHOP or Pola-R-CHP Ph III (SKYGLO) Columvi + Polivy-R-CHP in 1L DLBCL with high ORR and promising PFS Progression-free surv
Slide 32: Ph III GLOBRYTE: Columvi monotherapy in R/R MCL
Hematology Ph III GLOBRYTE: Columvi monotherapy in R/R MCL Updated Ph Ib/II data for Columvi in R/R MCL presented at ASCO 2024 Ph Ib/II (NP30179): Columvi in R/R MCL, incl. post- Ph III (GLOBRYTE) Columvi monotherapy in R/R MCL2 BTKi, with compelling and durable response rates1 Overall Pop post-BTKi
Slide 33: Lunsumio adds to Roche's strong presence in FL
Hematology Lunsumio adds to Roche’s strong presence in FL Fixed duration treatment that can be given as outpatient regimen Follicular lymphoma treatment landscape1, 2 Asymptomatic Low Tumor High Tumor Lunsumio is approved for use in 3L+ FL Burden Burden • Lunsumio delivers high rates of durable CRs
Slide 34: Lunsumio + lenalidomide as a chemo-free option in 1/2L FL
Hematology Lunsumio + lenalidomide as a chemo-free options in 1/2L FL Ph III program building on encouraging early results Ph Ib/II (CO41942): High ORR and CMR rates with durable Ph III (CELESTIMO) Lunsumio IV + Len in R/R FL2 responses using Lunsumio IV + Len in R/R FL1 Duration of response ~ Lunsu
Slide 35: Doing now what patients need next
Doing now what patients need next