Slide 1: Late-stage development
Late-stage development Growth-enabling & accelerating pipeline Briggs W. Morrison, Executive Vice President, Global Medicines Development & Chief Medical Officer
Slide 2: Improve the lives of 200 million patients...one patient at a time
Improve the lives of 200 million patients...one patient at a time.
Slide 3: Summary
Summary Excellent pipeline progress Focusing R&D spend on core therapeutic areas Potential 14-16 submissions & 8-10 approvals 2015-2016 (NME/LE) 3 – Late-stage development
Slide 4: Attracting & retaining strong talent
Attracting & retaining strong talent External hires in all science units External senior scientist hires 21% 26% Hires defined as employees hired or transitioned-in since the beginning of 2013 up to 1 October 2014. Total science units population 8,956. 4 – Late-stage development
Slide 5: Scientific leadership
Scientific leadership Achieve 1 FOCUS on distinctive science in 3 core TAs scientific PRIORITISE & ACCELERATE our pipeline leadership TRANSFORM our innovation culture & model 5 – Late-stage development
Slide 6: Investment focused on core therapeutic areas (TAs)
Investment focused on core therapeutic areas (TAs) R&D across all science units 2015 2015 ~25% ~45% ~20% ~5% ~5% 2013 ~20% ~30% ~30% ~10% ~10% Small Protein Biologics Immuno-therapies Devices molecules engineering 6 – Late-stage development
Slide 7: Targets used to measure progress
2013: Targets used to measure progress Phase III and Registration NME Near-term pipeline volume (#) In 2013–2014 we anticipate ~5–7 NME Phase III starts 10 potential NME submission opportunities between now 9–10 and 2016 8 6 By 2016 we will be at the target volume in Phase III and 2012 2013E 2016E R
Slide 8: Status: NME Phase III/Registration starts well ahead of goal
Status: 9 NME Phase III/Registration starts well ahead of goal MEDI4736 (PD-L1) NSCLC moxetumomab (CD22) tremelimumab (CTLA-4) hairy cell leukaemia mesothelioma selumetinib (MEK) AZD9291 (EGFR) Goal of NSCLC NSCLC 5–7 NME Lynparza (PARP) roxadustat (HIF) Phase III solid tumours CKD / ESRD starts ben
Slide 9: Status: On track to deliver NME submissions
Status: On track to deliver NME submissions MET (cMET) papillary renal cell carcinoma CAZ AVI tremelimumab (CEPH/BLI) (CTLA-4) serious infections mesothelioma Goal of selumetinib (MEK) MEDI4736 (PD-L1) 10 potential uveal melanoma NSCLC NME submissions Movantik (PAMORA) AZD9291 (EGFR) roxadustat (HIF
Slide 10: Status: Late-stage pipeline volume well ahead of plan
Status: Late-stage pipeline volume well ahead of plan Targeted Achieved/On track to achieve Phase III & Registration NME Phase III & Registration NME pipeline volume (#) pipeline volume (#) 14 13-15 11 9–10 8 6 6 2012 2013E 2016E 2012 2013 2014 2016E 10 – Late-stage development
Slide 11: R&D spend has shifted to support late-stage development
R&D spend has shifted to support late-stage development Targeted Pipeline progression driving faster shift R&D investment by stage (%) towards late-stage development 2013 – 2016 Plan* Late-stage 40% 44% development 47% Late-stage 53% 58% development Early development 38% 33% 32% 30% Early 28% develo
Slide 12: 2013: Early pipeline
2013: Early pipeline Phase I (26 New Molecular Entities) Phase II (21 New Molecular Entities) Phase III / Registration (6 New Molecular Entities) Small molecule Large molecule Small molecule Large molecule Small molecule Large molecule ATM AVI MEDI-550 AZD5847 benralizumab* CAZ AVI* brodalumab* BL/B
Slide 13: 2014: Early pipeline stronger with late-stage acceleration
2014: Early pipeline stronger with late-stage acceleration Phase I (39 New Molecular Entities†) Phase II (26 New Molecular Entities†) Phase III / Registration (14 New Molecular Entities†) Small molecule Large molecule Small molecule Large molecule Small molecule Large molecule ATM AVI MEDI-550 AZD58
Slide 14: Late-stage pipeline: Continued momentum
Late-stage pipeline: Continued momentum Compound Indication Milestone RIA lesinurad gout Phase III topline results Bydureon Pen type 2 diabetes US & EU approval Farxiga/Forxiga type 2 diabetes US & Japan approval CVMD Xigduo type 2 diabetes US & EU approval Epanova hypertriglyceridaemia US approval
Slide 15: Late-stage pipeline: Key news flow through 2015
Late-stage pipeline: Key news flow through 2015 Compound Indication Potential milestone brodalumab psoriasis Regulatory submission PT003 (LAMA/LABA) COPD Phase III results & regulatory submission RIA anifrolumab SLE Phase II presentation lesinurad gout Regulatory submission Brilinta prior MI (PEGASU
Slide 16: Targets to measure progress
2015-2016: Targets to measure progress Near-term delivery & Anticipated 2015-2016 delivery longer-term sustainability • Focus shifting from rebuilding 14-16 the late-stage pipeline to 12-16 following through with (50% submissions and approvals NMEs) 8-10 • High quality Phase II starts 6 (50% ensure
Slide 17: 14-16 NME & LE submissions
2015-2016: 14-16 NME & LE submissions MEDI4736 + tremelimumab 2L SCCHN Faslodex MEDI4736 1L metastatic breast 2L SCCHN cancer Lynparza LE submission Brilinta BRCAm metastatic opportunities stroke breast cancer Lynparza saxa/dapa FDC brodalumab* BRCAm PSR type 2 diabetes psoriatic arthritis ovarian c
Slide 18: Summary
Summary Excellent pipeline progress Focusing R&D spend on core therapeutic areas Potential 14-16 submissions & 8-10 approvals 2015-2016 (NME/LE) 18 – Late-stage development
Slide 19: Late-stage development
Late-stage development Growth-enabling & accelerating pipeline Briggs W. Morrison, Executive Vice President, Global Medicines Development & Chief Medical Officer