Slide 1: Slide 1
Slide 2: ASH Annual Meeting 2023 Virtual IR event
ASH Annual Meeting 2023 Virtual IR event 12 December 2023
Slide 3: Forward-looking statements disclaimer
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 4: Welcome
Welcome Bruno Eschli | Head of Investor Relations
Slide 5: Agenda
Agenda Welcome Bruno Eschli, Head of Investor Relations Roche hematology strategy Peter Ahnesorg, Franchise Head Hematology, Global Product Strategy Key data presented at ASH Charles Fuchs, Global Head of Oncology and Hematology, Product Development Q&A
Slide 6: Building blocks for future growth through 2030
Building blocks for future growth through 2030 Recent acquisitions adding significant upside potential Carmot Alnylam Therapeutics partnership Oncology / Hematology acquisition Neuroscience Ophthalmology Emerging assets from early Immunology pipeline and BD† CVM CT-388 / Telavant anti-IL6 mAb ASO Fa
Slide 7: Building blocks for future growth through 2030: ASH 2023 hematology update
Building blocks for future growth through 2030 ASH 2023: Update on our expanding hematology portfolio ASH 2023 Oncology / Hematology Neuroscience Ophthalmology Emerging assets from early Immunology pipeline and BD† CVM CT-388 / anti-IL6 mAb ASO Factor B zilebesiran CT-996 / CT-868 anti-latent SPK-80
Slide 8: Roche hematology strategy
Roche hematology strategy Peter Ahnesorg | Franchise Head Hematology, Global Product Strategy
Slide 9: Roche has one of the broadest portfolios in hematology
Roche has one of the broadest portfolios in hematology Continuously improving the SoC in various diseases Exploring novel drug modalities Leading in bi-specific antibodies, developing a broad spectrum of novel drug modalities Securing world class access Broadening disease area coverage Established n
Slide 10: One of the broadest and most diverse portfolios in the industry
One of the broadest and most diverse portfolios in the industry 7 drugs on the market and 9 NMEs in development cevostamab (FcRH5 x CD3) P-BCMA-ALLO1 forimtamig (GPRC5D x CD3) Antibody Drug Allogeneic Bispecifics Conjugate CD19 x CD28 CAR-T cells FIXa x FX crovalimab dirloctogene samoparvovec (SPK-8
Slide 11: Hematology portfolio rejuvenation leads to growth rebound
Hematology portfolio rejuvenation leads to growth rebound Driven by a diverse portfolio and a broad pipeline Roche hematology franchise sales § Approved indications CHFm YoY CER growth ** DLBCL & CLL CAGR: +14% MabThera/Rituxan 12,000 Gazyva/Gazyvaro FL & CLL 10,000 Hemlibra Hemophilia A -10% Polivy
Slide 12: Polivy: New standard of care in 1L DLBCL after 20 years of R-CHOP
Polivy: New standard of care in 1L DLBCL after 20 years of R-CHOP On track for blockbuster status in 2024 DLBCL – aggressive and heterogeneous disease1 >15,000 patients in 1L DLBCL with Polivy+R-CHP to date • Polivy approved in >80 countries, reimbursed in 16 countries 60% • Very strong market uptak
Slide 13: Lunsumio and Columvi: Strong launches in late-line settings
Lunsumio and Columvi: Strong launches in late-line settings Off-the-shelf, fixed duration treatments with simple dosing schedule Establishing as new SoC in 3L+ FL Successful launch in 3L+ DLBCL • Approved in 46 countries, reimbursed in 8 countries including US, • Approved in 38 countries including C
Slide 14: Hemlibra: Expecting continued market share gains globally
Hemlibra: Expecting continued market share gains globally The global standard of care with ~40% patient share reached in US/EU5* Steady patient share gains in US and globally Hemlibra Key success factors is well positioned for future growth • Strong uptake in non-inhibitor indication (shares >70% in
Slide 15: Hemlibra: Early prophylaxis enables superior outcomes
Hemlibra: Early prophylaxis enables superior outcomes Ph III (HAVEN 7) data demonstrate Hemlibra to be safe and effective in infants Importance of early prophylaxis in infants Ph III (HAVEN 7) results7 Complications potentially mitigated by early Hemlibra prophylaxis Model-based* ABRs across Partici
Slide 16: Crovalimab: Global filing in PNH, first approval expected H1 2024
Crovalimab: Global filing in PNH, first approval expected H1 2024 PRO and pooled safety data reinforce positive Ph III (COMMODORE) results Broad development program Treatment benefit in PNH supported by PRO and safety data FACIT-Fatigue scores from baseline to Week 25 PNH C5i-naïve patients (COMMODO
Slide 17: Moving CAR-Ts to the next level
Moving CAR-Ts to the next level Highly differentiated new generation of fully allogeneic CAR-Ts The collaboration with Poseida Therapeutics fits Advantages of allogeneic vs autologous CAR-T well into Roche‘s cell therapy strategy Autologous Allogeneic Healthy donor Dual targeting Allogeneic donor- C
Slide 18: Key data presented at ASH 2023
Key data presented at ASH 2023 Charles Fuchs | Global Head of Oncology and Hematology, Product Development
Slide 19: ASH 2023: Roche with >45 abstracts in 10 hematology indications
ASH 2023: Roche with > 45 abstracts in 10 hematology indications Key presentations in focus today Follicular lymphoma (FL) Diffuse large B-cell lymphoma (DLBCL) • Lunsumio in 3L+ FL: 3-year follow-up from pivotal Ph II (GO29781) • Columvi in 3L+ DLBCL: Extended follow-up from a pivotal Ph II (NP3017
Slide 20: Lunsumio in 3L+ FL: 3-year follow-up
Lunsumio in 3L+ FL: 3-year follow-up Fixed duration & outpatient administration: Well-tolerated with long-lasting remissions Ph II (GO29781): Durable responses maintained at 36 months Pharmacodynamic data support fixed-duration treatment DOR in CR (May 2023 cut-off) Overall Survival (OS) B-cell depl
Slide 21: Lunsumio in 1L FL: Promising efficacy in mono tx and in combinations
Lunsumio in 1L FL: Promising efficacy in mono tx and in combinations Future studies may support tailored treatment options for patients Ph II (MorningSun): Lunsumio SC monotherapy in Ph Ib/II (GO41942): Lunsumio SC + lenalidomide in low-tumor burden patients1 high-tumor burden patients2 Response ove
Slide 22: Lunsumio + Polivy in R/R LBCL: Data supportive of Ph III (SUNMO)
Lunsumio + Polivy in R/R LBCL: Data supportive of Ph III (SUNMO) Outpatient therapy with promising efficacy and manageable safety Ph Ib/II (GO40516) Ph Ib/II (GO40516): Fixed-duration Lunsumio + Polivy induces durable primary analysis responses DoCR Baseline characteristics N=98 N= 98 (IRC) DLBCL 70
Slide 23: Columvi in 3L+ DLBCL: Subgroup analyses and extended follow-up
Columvi in 3L+ DLBCL: Subgroup analyses and extended follow-up Fixed-duration Columvi provides long-lasting remissions for patients with r/r DLBCL Fixed duration and simple dosing Ph II (NP30179): Columvi showed high response rates and durable remissions across subgroups OS landmark analysis for pat
Slide 24: Columvi + Polivy + R-CHP in 1L DLBCL: Early data encouraging
Columvi + Polivy + R-CHP in 1L DLBCL: Early data encouraging Building upon POLARIX to address remaining unmet need Ph Ib (NP40126): High response rates and promising PFS with Ph III (SKYGLO) in 1L DLBCL Columvi in combination with Pola-R-CHP and R-CHOP Response rates Progression-free survival (PFS)
Slide 25: Columvi in R/R MCL post BTKi therapy
Columvi in R/R MCL post BTKi therapy Ph III (GLOBRYTE) initiated with FPI achieved in Q4 2023 Ph I/II (NP30179) early results Ph III (GLOBRYTE) monotherapy in r/r MCL Most responses were achieved early and Study design and endpoints were durable Glofitamab monotherapy† D1: Gpt D8: D15: D1: 2000mg 2.
Slide 26: The benefit of Pola-R-CHP transcends COO subtypes in 1L DLBCL
The benefit of Pola-R-CHP transcends COO subtypes in 1L DLBCL Molecular subtyping in Ph III (POLARIX) confirms broad benefit over R-CHOP Molecular subtyping improves precision of Cell of Origin (COO) in DLBCL Distribution of DZsig status across COO subgroups* Plasma- blast Distribution of LymphGen s
Slide 27: Higher 2-year PFS trend with Pola-R-CHP vs R-CHOP in DZsigPos, EZB and undetermined DLBCL
In DZsigPos, EZB and undetermined DLBCL, a trend of higher 2-year PFS was observed with Pola-R-CHP vs R-CHOP 2-yr PFS in DZsigPos DLBCL 2-yr PFS in EZB DLBCL 2-yr PFS in undetermined DLBCL • Pola-R-CHP appears to provide favorable outcomes vs R-CHOP to distinct molecular subsets within both ABC- and
Slide 28: Off-the-shelf CAR-Ts for hematologic malignancies
Off-the-shelf CAR-Ts for hematologic malignancies Early safety and efficacy results of P-BCMA-ALLO1 in r/r MM presented at ASH 2023 P-BCMA-ALLO1 was well tolerated in r/r MM patients P-BCMA-ALLO1 is a promising “off-the-shelf” TSCM-rich allogeneic CAR-T therapy All TEAEs Grades ≥ 3 Deep responses an