Roche Holding Ltd · SIX:RO
Roche — Angiogenesis Meeting 2023
47 slides from Roche's conference presentation, Feb 13, 2023
Slide 1: Roche logo
Slide 2: Angiogenesis Meeting 2023
Angiogenesis Meeting 2023 Virtual IR event 13 February 2023
Slide 3: 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 4: Welcome
Welcome Bruno Eschli | Head of Investor Relations
Slide 5: Agenda
Agenda Welcome Bruno Eschli, Head of Investor Relations Roche ophthalmology strategy Nilesh Mehta, Franchise Head Ophthalmology, Global Product Strategy Roche ophthalmology pipeline Christopher Brittain, Global Head of Ophthalmology, Product Development Key data presented at Angiogenesis Veeral Shet
Slide 6: Vabysmo launch among strongest in ophthalmology
Vabysmo launch among strongest in ophthalmology Global Product Revenues Diversification of Roche business 550 500 2017 2022 450 CHF 53.3bn CHF 63.3bn 400 350 AHR CER USD Mn 300 250 AHR 200 150 100 50 Diagnostics Oncology 0 Other pharma Immunology 1 2 3 4 5 6 7 8 Ophthalmology Neuroscience Quarters p
Slide 7: Ophthalmology franchise strategy
Ophthalmology franchise strategy Nilesh Mehta | Global Franchise Head, Ophthalmology 7
Slide 8: Ophthalmology franchise: significant progress made in 2022
Ophthalmology franchise: significant progress made in 2022 Strong global launch of Vabysmo • More than 450k vials shipped globally in first 11 months of launch • Two year follow-up data for Vabysmo presented for nAMD and DME Pipeline development: four positive Ph 3 trials in past 12m • Positive Ph I
Slide 9: Retinal diseases are the fastest growing segment of the ophthalmology market
Retinal diseases are the fastest growing segment of the ophthalmology market Ophthalmology market1 Global retina market ~15 bn USD and growing1 Total Market (2022) ~$21 Billion 20 2% Global Sales USD bn 6% nAMD, DME, RVO 15 12% Glaucoma 10 11% Dry Eye 5 Ocular inflammation/infections 70% Others 0 20
Slide 10: Significant unmet need remains in retinal disease
Significant unmet need remains in retinal disease Discontinuation, undertreatment and suboptimal vision with aVEGF monotherapy DME treatment discontinuation/switch: nAMD: Infrequent dosing correlates with poor vision gains in 6yr follow-up data from the IRIS ophthalmology registry1 real-world2 40% P
Slide 11: Vabysmo 2-year data continue to support excellent launch
Vabysmo 2-year data continue to support excellent launch Q16W dosing increases to ≥ 60% in nAMD and DME Dual pathway: Inhibition of Ang-2 and VEGF-A • First bispecific antibody inhibiting two distinct disease pathways by simultaneously binding Faricimab bispecific Ang-2/VEGF-A antibody to Ang-2 and
Slide 12: Vabysmo real world outcomes consistent with Ph III trials
Vabysmo real world outcomes consistent with Ph III trials* Case reports of anatomic benefits in patients switching from other VEGF therapies TRUCKEE (real-world data) results Case example: SRF response to Vabysmo 8% Patient characteristics: last prior therapy 26% aflibercept Other anti-VEGF treatmen
Slide 13: Vabysmo global growth drivers
Vabysmo global growth drivers Healthcare systems recognize importance of durability to overall outcomes and costs US: Uptake accelerating with establishment of permanent J-code (Oct 1) CHFm • Increasing use among earlier line patients and DME patients (2 year DME data added to US label) 350 • Patien
Slide 14: Susvimo
Susvimo Fully committed to Port Delivery System platform Global launch expected to resume in ~1 year Susvimo will be targeted to patients who wish to • Roche voluntarily recalled Susvimo for nAMD in the US in 2022 achieve optimal vision with the fewest treatments • New implantation including ongoing
Slide 15: Roche ophthalmology pipeline
Roche ophthalmology pipeline Christopher Brittain | Vice President and Global Head of Ophthalmology Product Development 15
Slide 16: Ophthalmology pipeline: altering the trajectory of vision loss
Ophthalmology pipeline Aiming to alter the trajectory of vision loss as experienced today Vision preservation and restoration – technologies Earlier stage disease Later stage disease and approaches for all disease stages iAMD, early nAMD, GA, Retinitis glaucoma glaucoma pigmentosa Prevention Earlier
Slide 17: Ophthalmology R&D focus areas
Ophthalmology R&D focus areas Improving patient outcomes and reducing treatment burden Novel MOAs, Extended durability, Biomarkers enabling PHC New Indications Future technologies Biomarker identification Novel MOAs Long acting delivery • Integration of omics, clinical and imaging • Vabysmo first du
Slide 18: Ophthalmology pipeline gaining momentum
Ophthalmology pipeline gaining momentum Further improving the standard of care and expanding in new indications Ph I (5 NME) Ph II (3 NMEs, 1 AI) Ph III (1 NME, 4 AIs) Launched (2 NMEs, 1AI) NME Anti-IL-6 Vabysmo Vabysmo RG6351 RG6179 RG7716 RG7716 Retinal disease DME BRVO nAMD NME Vicasinabin (CB2
Slide 19: Novel anti-IL-6 mAb: addressing the inflammation cascade
Novel anti-IL-6 mAb: Addressing the inflammation cascade in retinal diseases IL-6: Involved in many pathways, including IL-6: Upregulated in retinal diseases inflammation Concentration of IL-6 in the vitreous cavity of patients; mean (range) in pg/ml1 IL-6 concentration pg/ml Control 12.1 (<30-206.8
Slide 20: Novel anti-IL-6 mAb in DME and UME
Novel anti-IL-6 mAb in DME and UME Ph III study in UME first patient in achieved in January Macular edema is a common end stage complication in retinal diseases MoA High unmet need in patients with DME and UME Diabetic retinopathy (DME) Uveitis (UME) IL-6 IL-6 Caused by long-term hyperglycaemia Caus
Slide 21: DutaFabs have potential for long duration of action
DutaFabs have the potential for long duration of action and enhanced efficacy DutaFabs: next generation Designed for increased durability bispecifics Future development opportunities with the port delivery system Target 1 Monospecific Higher dose: Better affinity: Sustained IVT drug concentration (l
Slide 22: Geographic atrophy (GA): multifactorial and irreversible disease
Geographic atrophy (GA): A multifactorial and irreversible disease Extensive development program covering different MoAs and platform technologies Pathogenesis of GA remains unclear, key risk factors identified >5 mn people globally affected by GA Environmental risks (e.g. smoking, diet) Genetic ris
Slide 23: ASO factor B in GA
ASO factor B in GA: Targeting hyperactive alternative complement pathway via SC delivery MoA Preclinical and Ph1 results Preclinical results in monkeys1 Ph1: Significant dose-dependent reductions in plasma FB levels2 A CV B Systemic (A) and ocular (B) ASO FB protein • Complement Factor B (CFB): key
Slide 24: OpRegen in GA: replenishing the retinal pigment epithelium
OpRegen in GA: Replenishing the retinal pigment epithelium Encouraging early clinical data presented at ARVO 2022 Ph I/IIa data: Outer retinal structure and visual function improvements in patients with Potential to counteract RPE cell loss in GA impaired vision1 Before OpRegen After single Cohort 4
Slide 25: PHC solutions support the Roche ophthalmology vision
PHC solutions support the Roche ophthalmology vision while delivering patient benefits and value for Roche Remote Vision Monitoring Apps AI-powered Retinal Imaging Algorithms Accessible, effective and low cost tracking Segmentation and disease or treatment prediction of disease activity to provide c
Slide 26: Key clinical data presented at Angiogenesis
Key clinical data presented at Angiogenesis Veeral Sheth, MD | Retina Specialist and Clinical Investigator 26
Slide 27: Disclosures
Disclosures Speaker: Genentech, Alimera, Apellis Consultant: Genentech, Novartis, Alimera, EyePoint, IvericBio, Graybug, Apellis, Regeneron, Vial Contracted research: Allergan, Opthea, Oxurion, Recens Medical, Roche, Regenxbio, Eyepoint, Genentech, Ionis, Novartis, Regeneron, Santen, SamChungDang, I
Slide 28: Overview of key clinical data presentations
Overview of key clinical data presentations at Angiogenesis Vabysmo in RVO Results from the Phase III BALATON and COMINO trials Susvimo in Diabetic Macular Edema Results from the Phase III Pagoda Trial Diabetic Retinopathy Results from the Phase III Pavilion Trial
Slide 29: Faricimab in RVO: BALATON and COMINO Phase 3 Studies
Faricimab in RVO: Results From the BALATON and COMINO Phase 3 Studies Ramin Tadayoni, MD, PhD1 Liliana P. Paris, MD, PhD2; Francis Abreu, PhD2; Pablo Arrisi, PhD3; Karen Basu, PhD4; Zdenka Haskova, MD, PhD2; Ying Liu, PhD2; Anne-Cecile Retiere, PharmD3; Jeffrey R. Willis, MD, PhD2; Aachal Kotecha, P
Slide 30: BALATON and COMINO trial design
BALATON and COMINO Phase 3, Randomized, Double-Masked, Multicenter Trials Designed to Evaluate the Efficacy and Safety of Faricimab vs Aflibercept Key Inclusion criteria • Age ≥18 years • Treatment-naive Primary endpoint: Change from baseline in BCVAb at week 24 (faricimab vs aflibercept) macular ed
Slide 31: Faricimab achieved robust vision gains and CST reductions
Faricimab Achieved Robust Vision Gains and Reductions in CST Across Studies: Results Were Comparable Between Treatment Arms in Both Trials ITT Population From Baseline, ETDRS Letters A flib e r c e p t 2 .0 m g (n = 2 7 7 ) F a r ic im a b 6 .0 m g (n = 2 7 6 ) Adjusted Mean BCVA Change A flib e r c
Slide 32: More patients achieved absence of macular leakage with faricimab
More Patients Achieved Absence of Macular Leakagea With Faricimab vs Aflibercept at Week 24 ITT Population (BRVO) (H/CRVO) 100% Aflibercept 2.0 mg (n = 277) Faricimab 6.0 mg (n = 276) Aflibercept 2.0 mg (n = 363) Faricimab 6.0 mg (n = 366) 100% 80% Proportion of Patients Proportion of Patients 80% 6
Slide 33: Faricimab well tolerated, safety similar to aflibercept
Faricimab Was Well Tolerated, With a Safety Profile Similar to That of Aflibercept BALATON (BRVO) COMINO (H/CRVO) Aflibercept Faricimab Aflibercept Faricimab 2.0 mg 6.0 mg 2.0 mg 6.0 mg AEs Through Week 24, Patients With ≥ 1 AE, n (%) n = 274 n = 276 n = 361 n = 365 Ocular AEs 56 (20.4%) 45 (16.3%)
Slide 34: PDS in Diabetic Macular Edema: Pagoda Phase 3 Results
Port Delivery System With Ranibizumab in Patients With Diabetic Macular Edema: Primary Analysis Results of the Phase 3 Pagoda Trial Arshad M. Khanani, MD, MA, FASRS1 Varun Malhotra, MD, MBA2; Paul Latkany, MD2; Shamika Gune, MD2; Stephanie DeGraaf, PhD2; Ashwini Bobbala, MS2; Mel Rabena, BA2; Carlos
Slide 35: Pagoda Phase 3 trial design
Pagoda Phase 3 Trial: Designed to Evaluate Efficacy, Safety, and Pharmacokinetics of PDS Q24W for DME PDS implantation and initial filla,b Primary endpoint WEEK D1 4 8 12 16 20 24 28 32 36 40c 44 48 52 56 60 64c 68 72 76 80 84 88c 92 96 100 104 112 ●●● Final Patients with center- PDS Q24W, n = 381 i
Slide 36: PDS Q24W vision gains and CST reduction comparable to ranibizumab
Proprietary & Confidential Information of Roche/Genentech; For Internal Purposes Only PDS Q24W Resulted Vision Gains and CST Reduction Comparable to Monthly Ranibizumab Through Week 64 Adjusted Mean BCVA Change From Baseline, Adjusted Mean CST Change From Baseline, Efficacy Population mITT Populatio
Slide 37: PDS Q24W clinically meaningful DRSS improvements
PDS Q24W Resulted in Clinically Meaningful DRSS Improvements Over Time Proportion of Patients with a ≥ 2-Step Improvement from Baseline on ETDRS-DRSS in Study Eye Over Time Through Week 64, Efficacy Population 100 PDS 100 mg/mL Q24W (n = 381) (CMH weighted estimatea), n (%) 90 Intravitreal ranibizum
Slide 38: >95% of PDS Q24W patients did not receive supplemental treatment
>95% of PDS Q24W Patients Did Not Receive Supplemental Treatment Through Each Refill-Exchange Interval Patients Who Did Not Receive Supplemental Treatment Through Week 64 100 Supplemental Treatment Criteria, Assessed at 2 Visits Proportion of Patients, % Before Refill-Exchange 75 Decrease of ≥ 15 le
Slide 39: Ocular AESIs were well understood and manageable
Ocular AESIs Were Well Understood and Manageable No Cases of Endophthalmitis or Retinal Detachment Were Reported in the PDS Q24W Arm After Implantation Through Week 64 Ocular AESIs in the Study Eye Through Week 64, Safety Population PDS 100 mg/mL Q24W Intravitreal Ranibizumab 0.5 mg Q4W (n = 320) (n
Slide 40: PDS in Diabetic Retinopathy: Pavilion Phase 3 Results
Port Delivery System With Ranibizumab in Patients With Diabetic Retinopathy: Primary Analysis Results of the Phase 3 Pavilion Trial Dante Pieramici, MD1 Paul Latkany, MD2; Varun Malhotra, MD, MBA2; Christopher Brittain, MD2; Dena Howard, PhD3; Anjana Santhanakrishnan, BPharm (Hons.), RPh2; Monica We
Slide 41: Risk of vision-threatening DR increases with disease severity
Risk of Developing Vision-Threatening Forms of DR Increases With Disease Severity DR affects over one-third of all people with diabetes, and is a leading cause of vision loss in adults worldwide1–3 Patients with moderately severe to severe Progression of DR to PDR4 NPDR are at high risk of progr
Slide 42: Pavilion Phase 3 trial design
Pavilion Phase 3 Trial: Designed to Evaluate Efficacy, Safety, and Pharmacokinetics of PDS Q36W for DR PDS implantation and initial filla Primary Endpoint WEEK D1 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 100 112 ●●● Final Patients PDS 100 mg/mL Q36W arm, with DR Refill-exchang
Slide 43: Greater proportion achieved ≥2-step improvement on ETDRS-DRSS
Proprietary & Confidential Information of Roche/Genentech; For Internal Purposes Only A Greater Proportion of Patients Achieved ≥ 2-step Improvement on ETDRS-DRSS; Retinal Anatomy Maintained Through Week 52 Adjusted Proportion of Patients With ≥ 2-step Improvement Adjusted Mean CST Change From Basel
Slide 44: PDS Q36W: fewer patients developing vision-threatening complications
Proprietary & Confidential Information of Roche/Genentech; For Internal Purposes Only PDS Q36W Resulted in Fewer Patients Developing Vision-Threatening Complications or CI-DME Rate of Patients Developing a Vision-Threatening Complication (PDR or ASNV) or CI-DMEb Through Week 52, ITT Population VTC (
Slide 45: 100% of PDS Q36W patients did not receive supplemental treatment
100% of Patients Treated With PDS Q36W Did Not Receive Supplemental Treatment Through Week 52 Patients Who Did Not Receive Supplemental Treatment Through Week 52 n = 99/99a 100 Proportion of patients, % 75 Supplemental Treatment Criteria n = 41/68a Presence of CI-DME, defined as CST ≥325 µm on SD-OC
Slide 46: Majority of ocular AESIs through Week 52 were non-serious
Majority of Ocular AESIs Through Week 52 Were Non-Serious No Cases of Endophthalmitis or Implant Dislocation Were Reported Through Week 52 Ocular AESIs in the Study Eye Through Week 52 PDS 100 mg/mL Q36W (n = 105) Overall* All Serious Overall total number of AEs, n 22 2 Total number of patients with
Slide 47: Doing now what patients need next
Doing now what patients need next