Roche Holding Ltd · SIX:RO
Roche — Investor Presentation (June 2025)
52 slides from Roche's investor presentation, Jun 23, 2025
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 Hematology Virtual IR event 23 June 2025
Roche Hematology Virtual IR event 23 June 2025
Slide 4: Introduction
Introduction Bruno Eschli Head of Investor Relations
Slide 5: Agenda
Agenda Welcome Bruno Eschli, Head of Investor Relations Malignant Hematology Franchise Update Charles Fuchs, SVP Global Head of Oncology and Hematology, Product Development NHL: FL update; DLBCL: Lunsumio + Polivy - Ph III (SUNMO) Primary Analysis; Columvi - Ph III (STARGLO) 2y data Charles Fuchs, S
Slide 6: Roche's marketed portfolio in Hematology
Oncology/Hematology Roche's marketed portfolio in Hematology Hemlibra: ▪ Global SoC in Hemophilia A with extensive real world data CHF 1.2bn (+11%) ▪ Updated administration options in development Q1 2025 sales (YoY CER growth) Polivy: ▪ Strong 1L DLBCL uptake with >50k pts treated globally CHF 0.4bn
Slide 7: 2025 Pharma pipeline
2025 Pharma pipeline Four Ph III Go-decisions so far, including NXT007 in Hemophilia A and prasinezumab in PD New Molecular Entities (NME) giredestrant fenebrutinib vamikibart HR+ BC RMS, PPMS DME, UME Itovebi (inavolisib) Elevidys1 CT-388 Pi3Km BC DMD Obesity +/- T2D divarasib GYM 329 CT-868 KRAS+
Slide 8: 2025: Significant key newsflow ahead
2025: Significant key newsflow ahead* Compound Indication Milestone Itovebi + palbociclib + fulvestrant 1L PIK3CA-mut HR+ BC EU approval Columvi + GemOx 2L+ DLBCL US/EU approval (EU approval) Lunsumio SC 3L+ FL US approval/EU filing (EU filing) Elevidys DMD EU approval Regulatory Gazyva Lupus nephri
Slide 9: IR events currently planned for 2025
IR events currently planned for 2025 Additional events driven by readouts Update on NGS Neurology Update Diagnostics Day Hematology Update Pharma Day 20 Feb 4 Apr 27 May 23 Jun 22 Sep ▪ Update on Sequencing ▪ Neurology franchise ▪ Deep-dive into the ▪ Hematology franchise ▪ Update on Pharma by Expan
Slide 10: Late stage pipeline - Hematology
Late stage pipeline - Hematology Charles Fuchs SVP Global Head of Oncology and Hematology, Product Development
Slide 11: Strategic pillars of oncology and hematology
Oncology/Hematology Strategic pillars of oncology and hematology Precision medicine Novel modalities Rational combinations Improving SoC Investing in key Leverage breadth of Prioritize therapies with Right medicines for the technologies to engage oncology portfolio to potential for significant right
Slide 12: Broad Hematology pipeline enabling novel combinations
Oncology/Hematology Broad Hematology pipeline enabling novel combinations Ph I Ph II Ph III Registration englumafusp alfa RG6107 PiaSky Columvi Columvi RG6076 SCD RG6026 RG6026 Heme tumors 1L DLBCL, r/r MCL 2L+ DLBCL cevostamab SPK-8011QQ Lunsumio Lunsumio SC RG6160 RG6797 RG7828 RG7828 r/r MM Hemop
Slide 13: CAR-Ts are complementary to Hematology pipeline
Oncology/Hematology CAR-Ts are complementary to Hematology pipeline Rapid, accessible, and “off-the-shelf” investigational allogeneic CAR-T to treat patients without waiting Roche allogeneic CAR-Ts key features P-BCMA-ALLO1 highly clinically active in BCMA-naïve, BCMA-exposed and EMD pts1 Robust hea
Slide 14: Key Roche NHL data at ASCO, EHA and ICML
Key Roche NHL data at ASCO, EHA and ICML Charles Fuchs SVP Global Head of Oncology and Hematology, Product Development
Slide 15: Roche: Defining the SoC in NHL treatment for over 25 years
Oncology/Hematology Roche: Defining the SoC in NHL treatment for over 25 years NHL accounts for almost 50% of Roche in NHL: Past, present and future hematological malignancies1 FL FL DL DL DL 1997- 2013- 2019- 2022/23- 2025+ Today Today Today Today FL Combinations in 1L and 2L under investigation FL
Slide 16: Comprehensive clinical program across NHL subtypes
Oncology/Hematology Comprehensive clinical program across NHL subtypes Focus on bringing Lunsumio and Columvi to earlier line patients Comprehensive clinical program across NHL subtypes and Tx lines Recent launch successes ▪ Strong 1L DLBCL uptake with >50k patients treated ▪ Polivy approved in over
Slide 17: Lunsumio SC: Durable, high response rates similar to Lunsumio IV
Oncology/Hematology Lunsumio SC: Durable, high response rates similar to Lunsumio IV Fixed-duration Lunsumio SC shows promising efficacy 1L FL patients with HTB Ph II (GO29781): Lunsumio IV vs SC in 3L+ FL1 Ph II (MorningSun): Lunsumio SC in 1L HTB FL2 Progression-Free Survival 1.0 Progression-Free
Slide 18: Lunsumio + len in 1L high tumor burden FL
Oncology/Hematology Lunsumio + len in 1L high tumor burden FL An attractive outpatient regimen for the future management of untreated FL Ph I/II (CO41942): Lunsumio SC + len in 1L HTB FL1 Progression-Free Survival Overall Survival 12-month event-free OS rate: 12-month event-free PFS rate: 97.4% (95%
Slide 19: Lunsumio + len: A promising chemo-free option for 1L and 2L+ FL
Oncology/Hematology Lunsumio + len: A promising chemo-free option for 1L and 2L+ FL Ph III (MorningLyte): Lunsumio SC+ len in 1L FL1 Ph III (CELESTIMO): Lunsumio IV + len in 2L+ FL2 Age ≥18 years Lunsumio SC + ● Age ≥18 years Lunsumio IV + lenalidomide ● lenalidomide Primary endpoint: Previously unt
Slide 20: SUNMO: Lunsumio + Polivy for R/R DLBCL
SUNMO: Lunsumio + Polivy for R/R DLBCL Primary results of the Phase III trial Charles Fuchs SVP Global Head of Oncology and Hematology, Product Development
Slide 21: Study design
Study design Outpatient Mosun SC (8 cycles) + Pola IV (6 cycles) (21-day cycles) Key eligibility Mosun Mosun Mosun R/R LBCL with 5mg 45mg 45mg ≥1 prior therapy and ASCT-ineligible: C1 Follow up after Screen C2 C3 C4 C5 C6 C7 C8 • DLBCL NOS 2:1 D1 D8 D15 drug completion • Transformed FL Screening 8 1
Slide 22: Mosun-Pola significantly prolonged progression-free survival versus R-GemOx
Mosun-Pola significantly prolonged progression-free survival versus R-GemOx Primary endpoint: Progression-free survival by IRC 100 Median, months (95% CI): Mosun-Pola (n=138) R-GemOx (n=70) Mosun-Pola: 11.5 (5.6–17.6) Censored 80 R-GemOx: 3.8 (2.9–4.1) HR (95% CI): 0.41 (0.28–0.61) P value: <0.0001
Slide 23: Mosun-Pola significantly prolonged progression-free survival versus R-GemOx
Mosun-Pola significantly prolonged progression-free survival versus R-GemOx Primary endpoint: Progression-free survival by IRC 100 Mosun-Pola (n=138) R-GemOx (n=70) 12-month PFS, % (95% CI): Censored 80 Mosun-Pola: 48.5 (39.6–57.4) R-GemOx: 17.8 (5.4–30.3) Mosun-Pola 60 demonstrates a 59% PFS (%) ri
Slide 24: Mosun-Pola significantly increased overall response rate versus R-GemOx
Mosun-Pola significantly increased overall response rate versus R-GemOx Primary Endpoint: Response rates at the primary analysis Improvement in ORR: Mosun-Pola versus R-GemOx 100 90 ORR by ΔORR IRC, % Mosun-Pola R-GemOx P value 80 (95% CI) (95% CI) 70 ORR: 70.3% Patients (%) (n=119) (n=59) 60 PR: 18
Slide 25: Safety summary
Safety summary Mosun-Pola R-GemOx % (n), unless otherwise stated n=135 n=64 Number of cycles, median (range) 8.0 (1–8) 5.0 (1–8) Any AE 97.0% (131) 95.3% (61) Treatment-related AE 93.3% (126) 89.1% (57) SAEs 33.3% (45) 25.0% (16) Treatment-related SAE 24.4% (33) 20.3% (13) Grade 3–4 AE 58.5% (79) 57
Slide 26: Conclusions
Conclusions SUNMO is the first positive Phase III trial without conventional chemotherapy – Mosun-Pola reduced the risk of death or progression by 59% • Tripled the median PFS • Doubled the CR rate Mosun-Pola has the lowest CRS incidence and severity among T-cell directed therapies to date – With 96
Slide 27: STARGLO: Columvi-GemOx for R/R DLBCL - Ph III 2-year update
STARGLO: Columvi-GemOx for R/R DLBCL- Ph III 2-year update Charles Fuchs SVP Global Head of Oncology and Hematology, Product Development
Slide 28: Ph III (STARGLO): Columvi+GemOx reduces risk of death by 41% in 2L DLBCL
Oncology/Hematology Ph III (STARGLO): Columvi+GemOx reduces risk of death by 41% in 2L DLBCL1 The STARGLO ITT population closely reflects the real-world clinical profile of US DLBCL patients Columvi + GemOx significantly improved OS, PFS and CR rates vs R-GemOx alone1 Overall Survival 100 Progressio
Slide 29: ODAC raised question of regional applicability based on subgroup analyses
Oncology/Hematology ODAC raised question of regional applicability based on subgroup analyses1 STARGLO was not powered to draw conclusions from subgroups Exploratory subgroup analysis in STARGLO1 Columvi-GemOx arm by region - Consistent OS outcome across regions2 Overall Survival by Region ▪ The ODA
Slide 30: Ph III (STARGLO): Columvi-GemOx delivers consistent outcomes across regions
Oncology/Hematology Ph III (STARGLO): Coluvmi-GemOx delivers consistent outcomes across regions Exploratory subgroup analysis supportive, however conclusions should be made from the ITT data Columvi-GemOx also shows consistent benefit in NA/EUR/AUS for EFS and CR rates1 Event-Free Survival in NA/EUR
Slide 31: STARGLO: a randomized, global, Phase III trial
STARGLO: a randomized, global, Phase III trial Glofit-GemOx (n=183) Glofitamab 30 mg administered on Patients R/R DLBCL (N=274) Glofitamab plus gemcitabine and oxaliplatin* Day 1 of each cycle Glofitamab step-up dosing in Cycle 1, • R/R DLBCL NOS after ≥1 prior 30 mg administered on Day 1 from Cycle
Slide 32: Sustained OS benefit with Glofit-GemOx
Sustained OS benefit with Glofit-GemOx Overall survival with ~2 years of follow up 100 R-GemOx (n=91) R-GemOx Glofit-GemOx Glofit-GemOx (n=183) Outcome (n=91) (n=183) Censored 80 2-year follow up analysis (median follow up: 24.7 months) 60 OS (%) OS, median (95% CI); months 13.5 (7.9, 18.5) NE (19.2
Slide 33: Sustained PFS benefit with Glofit-GemOx
Sustained PFS benefit with Glofit-GemOx Progression-free survival with extended follow up 100 Median PFS follow up: 17.2 months R-GemOx (n=91) R-GemOx Glofit-GemOx Glofit-GemOx (n=183) Outcome (n=91) (n=183) Censored 80 PFS, median (95% CI); months 3.6 (2.5, 7.1) 13.8 (8.8, 30.0) 13.8 months median
Slide 34: OS benefit with Glofit-GemOx in 2L patients
OS benefit with Glofit-GemOx in 2L patients R-GemOx (n=57) 100 Glofit-GemOx (n=115) Censored R-GemOx Glofit-GemOx Outcome 80 (n=57) (n=115) 24-month OS: 59.9% (95% CI: 50.7, 69.2) 60 2L subgroup (median follow up: 24.3 months) OS (%) 40 15.7 NE 24-month OS: 38.9% OS, median (95% CI); months (10.3, N
Slide 35: Safety profile summary
Safety profile summary R-GemOx Glofit-GemOx (Glofit-exposed) n (%), unless otherwise stated n=88 n=172 Number of infusions, median (range) 4 (1–8) 12 (1–14) Serious AEs 15 (17.0) 90 (52.3) Grade ≥3 AEs 36 (40.9) 132 (76.7) Grade 5 AEs 4 (4.5) 12 (7.0) AE leading to any treatment discontinuation 11 (
Slide 36: Conclusion
Conclusion • Glofit-GemOx showed sustained benefit in survival and response outcomes versus R-GemOx after 2 years of follow up, with 82.4% of patients with a CR at EOT in remission 12 months after EOT • A more pronounced efficacy benefit was observed for Glofit-GemOx versus R-GemOx in 2L DLBCL • Dee
Slide 37: Roche is bringing bispecific Tx options to DLBCL patients worldwide
Oncology/Hematology Roche is bringing bispecific Tx options to DLBCL patients worldwide Summary of Key Efficacy Endpoints STARGLO: Roche Ph Columvi-GemOx III 2L DLBCL trials: Efficacy 1 SUNMO: Lunsumio-Polivy2 Objective Registrational Study Registrational Study Primary Endpoint (s) Overall Survival
Slide 38: Ph III (POLARGO): Polivy + R-GemOx improves 2L+ DLBCL outcomes
Oncology/Hematology Ph III (POLARGO): Polivy + R-GemOx improves 2L+ DLBCL outcomes 40% relative risk reduction for death vs R-GemOx in transplant-ineligible R/R DLBCL1 Polivy-R-GemOx improves OS vs R-GemOx in Polivy-R-GemOx in 2L+ R/R DLBCL transplant ineligible R/R DLBCL1 Polivy + R- R-GemOx GemOx
Slide 39: Ph III (POLARIX): 5-year data confirm Polivy-R-CHP as SoC for 1L DLBCL
Oncology/Hematology Ph III (POLARIX): 5-year data confirm Polivy-R-CHP as SoC for 1L DLBCL Over 50k patients treated with Polivy + R-CHP to date Polivy + R-CHP PFS HR of 0.77 at 5-years1 Polivy + R-CHP needed 23% fewer subsequent therapies vs R-CHOP1 ▪ Sustained and significant PFS and DFS benefits
Slide 40: Columvi + Polivy-R-CHP in 1L DLBCL
Oncology/Hematology Columvi + Polivy-R-CHP in 1L DLBCL Early data support the potential for Columvi in combination with current SoC Ph Ib (NP40126): High response rates and promising Ph III (SKYGLO): Columvi + Polivy-R-CHP in 1L DLBCL PFS with Columvi in combination with Pola-R-CHP1 Progression-free
Slide 41: Non-Malignant Hematology Franchise Update
Non-Malignant Hematology Franchise Update Daud Chaudry Lifecycle Leader Hemophilia Bispecifics, Global Product Strategy
Slide 42: Non-malignant Heme portfolio: Leader in Hemophilia A
Oncology/Hematology Non-malignant Heme portfolio: Leader in Hemophilia A Hemlibra the global SoC in Hem A, achieving ~80% zero treated bleeds with a convenient administration Non-malignant Heme pipeline Hemlibra: Global SoC in Hemophilia A Global patient count* 30 Ph I Ph II Ph III Ph IV 28 Total pa
Slide 43: Hemlibra: Global SoC in Hem A with extensive real-world data
Oncology/Hematology Hemlibra: Global SoC in Hem A with extensive real-world data Strong and proven efficacy & safety profile with expanding convenience options Hemlibra’s extensive clinical and real-world evidence base Sustained bleed protection ~80% of patients with Efficacy in RWD Vabysmo at ARVO
Slide 44: SPK-8011QQ: Next generation gene therapy in Hemophilia A
Oncology/Hematology SPK-8011QQ: Next generation gene therapy in Hemophilia A Enhanced function FVIII variant combined with a well-described AAV capsid and vector platform SPK-8011QQ (Enhanced function FVIII gene therapy) Mode of action1 Preclinical data overview1 FVIII-WT FVIII-QQ FVIII-WT FVIII-QQ
Slide 45: NXT007: Next gen Factor VIIIa mimetic bispecific mAb
Oncology/Hematology NXT007: Next gen Factor VIIIa mimetic bispecific mAb Ph III program, including H2H vs. Hemlibra, to initiate in 2026 NXT007 (FVIIIa mimetic bispecific mAb) Clinical development Structure and function1 NXT007, Hemlibra and FVIII thrombin generation2 Ph I Ph II Ph III Status Furthe
Slide 46: Hemophilia: NXT007 - Ph I/II (NXTAGE Part B) Primary Analysis
Hemophilia: NXT007 - Ph I/II (NXTAGE Part B) Primary Analysis Daud Chaudry Lifecycle Leader Hemophilia Bispecifics, Global Product Strategy
Slide 47: NXT007: Ph I/II MAD trial evaluated four different doses
Oncology/Hematology NXT007: Ph I/II MAD trial evaluated four different doses Based on population PK simulations, cohort B-2 onwards predicted to reach non-hemophilic FVIII-equivalent activity Ph I/II (NXTAGE Part B): Trial design Cohort Loading dose Maintenance dose (including extension) B-1 (n=10)
Slide 48: NXT007: Achieving normal levels of predicted FVIII-equivalent activity
Oncology/Hematology NXT007: Achieving normal levels of predicted FVIII-equivalent activity Dose-dependent increase of NXT007 plasma concentration was observed Ph I/II (NXTAGE Part B): Pharmacokinetics and predicted FVIII-equivalent activity Predicted FVIII-equivalent activity 100 IU/dL Threshold for
Slide 49: NXT007: Ph II results indicate potential for best-in-disease efficacy
Oncology/Hematology NXT007: Ph II results indicate potential for best-in-disease efficacy No treated bleeds in B-3 and B-4 cohort; ABR decreased during NXT007 prophylaxis compared to baseline1 Ph I/II (NXTAGE Part B): Efficacy Mean ABR for treated bleeds2 14 12.83 Before enrollment 12 NXT007 (mainte
Slide 50: NXT007: Well tolerated across all doses
Oncology/Hematology NXT007: Well tolerated across all doses No dose-dependent increases in AEs and no thromboembolic events were observed Ph I/II (NXTAGE Part B): Safety and immunogenicity B-1 B-2 B-3 B-4 Total (N=10) (N=6) (N=6) (N=8) (N=30) Total No. of participants 7 5 3 6 21 with at least one AE
Slide 51: NXT007: Potential for BID in Hemophilia A; Ph III to start in 2026
Oncology/Hematology NXT007: Potential for BID in Hemophilia A; Ph III to start in 2026 Potential to provide coagulative normalization in PwHA with acceptable safety profile Conclusion and next steps NXTAGE Part B examined NXT007, the emicizumab-based next generation bispecific antibody, in PwHA with
Slide 52: Doing now what patients need next
Doing now what patients need next