Gsk Plc · LSE:GSK
Gsk — Investor Day (November 2021)
25 slides from Gsk's investor day presentation, Nov 7, 2021
Slide 1: Investor Science Event: Getting ahead of anaemia due to chronic kidney disease
Investor Science Event Getting ahead of anaemia due to chronic kidney disease ASN Kidney Week 2021 7 November 2021
Slide 2: Cautionary statement regarding forward-looking statements
Cautionary statement regarding forward-looking statements This presentation may contain forward-looking statements. Forward-looking statements give the Group’s current expectations or forecasts of future events. An investor can identify these statements by the fact that they do not relate strictly t
Slide 3: Speakers
Speakers 1 2 3 1. Dr Hal Barron 2. Dr Ajay Singh 3. Luke Miels 3
Slide 4: Agenda
Agenda Daprodustat: a potential Dr Hal Barron best-in-class treatment ASCEND Phase III programme Dr Ajay Singh Commercial opportunity Luke Miels Dr Hal Barron Dr Ajay Singh Q&A Luke Miels John Lepore Chris Corsico 4
Slide 5: Daprodustat: a potential best-in-class treatment
Daprodustat: a potential best-in-class treatment Dr Hal Barron, Chief Scientific Officer and President, R&D 5
Slide 6: Daprodustat: potential best-in-class treatment for patients with anaemia due to CKD
Daprodustat Potential best-in-class treatment for patients with anaemia due to CKD1 Nobel prize-winning science ASCEND2: Phase III clinical High unmet medical need development programme with large geographical reach • >8,000 patients with anaemia due to CKD3 in five Phase III trials • Consistent cli
Slide 7: ASCEND Phase III programme
ASCEND Phase III programme Dr Ajay K. Singh, Senior Associate Dean for Postgraduate Medical Education from Harvard Medical School, and Principal Investigator 7
Slide 8: ASCEND Clinical Trial Program
ASCEND Clinical Trial Program The Anemia Studies in Chronic Kidney Disease: Erythropoiesis via a Novel prolyl hydroxylase inhibitor Daprodustat (ASCEND) Phase III program investigated the efficacy and safety profile of daprodustat across a spectrum of patients with CKD Dialysis trials Non-dialysis t
Slide 9: ASCEND-D and -ND: Trial Design
ASCEND-D and -ND: Trial Design Event-driven, open-label, randomized, active-controlled, parallel-group, multicenter, Phase 3 trials ASCEND-D and ASCEND-ND accepted for publication Open-abel* 1:1 randomization 4-week placebo run-in 4-week screening Daprodustat, oral, daily Hb treatment target: 10.0-1
Slide 10: Patient Disposition
Patient Disposition ITT Population Few patients withdrew and withdrawal rates were similar across treatment groups Premature discontinuation of randomized treatment was balanced across treatment groups Known vital status was high in both trials across both treatment groups Randomized, n 2964 Randomi
Slide 11: Co-primary Efficacy Endpoint: ASCEND-D
Co-primary Efficacy Endpoint: ASCEND-D Mean Hb change from baseline to the evaluation period (Weeks 28-52) — ITT Population Daprodustat was inferior to ESA for mean change in Hb from baseline to evaluation period (Weeks 28-52) T i in: 2 | aSCeND/D “4 Daprodustat © ESA Prespecified NI margin: ee -0.7
Slide 12: Co-primary Efficacy Endpoint: ASCEND-ND
Co-primary Efficacy Endpoint: ASCEND-ND Mean Hb change from baseline to the evaluation period (Weeks 28-52) — ITT Population stat was noninferior to darbepoetin alfa for mean change in Hb from baseline evaluation period (Weeks 28-52) 125 I i in: 12 ASCeND/VD -# Daprodustat -® Darbepoetin alfa eee eg
Slide 13: First Occurrence of Adjudicated MACE
First Occurrence of Adjudicated MACE During the Time Period for Follow-up of CV Events — ITT Population ASCEND / D — Daprodustat ——~ ESA ASCeND/ND — Daprodustat — Darbepoetin alfa 09 4 HR (95% Cl): 0.93 (0.81, 1.07) 09-4 HR (95% Cl): 1.03 (0.89-1.19) Bor Pte etary Eo ietoan cio 5 07+ 5 0.7- :- First
Slide 14: MACE Supplementary Analyses
MACE Supplementary Analyses MACE analyses were generally consistent with noninferiority conclusions from the primary analysis, except the ASCEND-ND ‘eatment MACE analysis Daprodustat ESA Daprodustat Darbepoetin alfa better better better better > —m— AaSCEND/D No. of | Ni margin = 1.25 asCceND /IND N
Slide 15: Principal Secondary Endpoints
Principal Secondary Endpoints Principal secondary endpoints ultiplicity-adjusted statistical significance for superiority* MACE (superiority) 0.93 (0.81, 1.07) MACE (superiority) 1.03 (0.89, 1.19) mace Spee 0.88 (0.78, 1.00) jee ug Grants 1.08 (0.93, 1.22) oes o iesbtelecien for 0.97 (0.85, 1.11) we
Slide 16: Adverse Events
Adverse Events Safety population reporting treatment-emergent events AE and SAE rates were similar between treatment groups in both studies Rates of AESIs were generally similar between treatment groups in both studies Daprodustat SCEND Daprodustat (N=1482) NON-DIALYSIS (N=1937) Rate of AEs 88% 85%
Slide 17: ASCEND Program-Level Cardiovascular Safety Data
ASCEND Program-Level Cardiovascular Safety Data MACE profile was generally consistent across treatment groups in all trials* Patients with events Rate per 100 PY Favors Favors nN ("h) (95% Cl) . Daprodustat ESA Mace ee <—— —— ASCEND-ND aay ine eae. el (ES, fen oe OZB (GLB 17) kT ASCEND-D O52) O60) o
Slide 18: ASCEND Program-Level Cardiovascular Safety Data
ASCEND Program-Level Cardiovascular Safety Data MACE components were generally consistent across treatment groups in all trials* Patients with events Rate per 100 PY Favors Favors nN (%) (95% Cl) Daprodustat ESA Absolute rate difference per 100 PY (95% Cl) |“ —_____* All-cause mortality 301/1937 298
Slide 19: Summary and Conclusions
Summary and Conclusions — Daprodustat was as effective as conventional ESA therapy in treating anemia of CKD - Daprodustat was noninferior to ESA with respect to CV safety and no new safety signals were observed Daprodustat could represent an oral alternative to ESA for treating anemia of CKD in bot
Slide 20: Commercial opportunity
Commercial opportunity Luke Miels, Chief Commercial Officer 20
Slide 21: Prevalence of anaemia increases as CKD progresses
The prevalence of anaemia increases as CKD progresses; it is associated with an increased risk of hospitalisation, cardiovascular complications and death North America 30 million 19 million Treating patients with anaemia due to CKD CKD prevalence Stages 3-5 Average Diagnosed treatment Stage of Kidne
Slide 22: HIF-PHI class could become the new standard of care
HIF-PHI1 class could become the new standard of care Daprodustat has the potential to deliver patient benefit across populations Non-dialysis dependent Dialysis dependent >1 million >850 thousand Patients treated in the US and Europe Patients treated in the US and Europe c.30% c.12% Patients with Hb
Slide 23: Japan: Duvroq has achieved market-leading share
Japan: Duvroq has achieved market-leading share Encouraging launch despite Leading market share Translating success in Japan to global expansion being second to market Strong momentum across populations JP¥ • 75% of patients switching from ESA to Duvroq 3,000 100% • 25% new to treatment 2,500 80% •
Slide 24: Daprodustat: an innovative, convenient oral treatment for patients with anaemia due to CKD
Daprodustat: an innovative, convenient oral treatment for patients with anaemia due to CKD Strong clinical data supports Significant market opportunity Leveraging experience to deliver competitive commercial profile commercial success • Convenient oral option for non-dialysis and dialysis patients >
Slide 25: Q&A
Q&A 25