Gsk Plc · LSE:GSK
Gsk — Investor Day (September 2016)
61 slides from Gsk's investor day presentation, Sep 2, 2016
Slide 1: Meet the Respiratory management
Meet the Respiratory management 2 September 2016
Slide 2: Contents
Contents Agenda Presenter biographies Presentations Investor Relations contacts: UK +44 (0)20 8047 5557 US +1 215 751 4611 1
Slide 3: Agenda
Agenda Eric Dube Neil Barnes Dave Allen Q&A Respiratory Respiratory clinical Respiratory R&D commercial perspectives perspectives 2
Slide 4: Presenters biographies
Presenters biographies Eric Dube, Senior Vice President and Head, Global Respiratory Franchise Eric started his career at GSK in 2000 as a Medical Science Liaison and has worked in a variety of marketing, sales, operations and strategy roles in the USA, Japan and UK. During his time within US Pharma
Slide 5: Presenters biographies
Presenters biographies Neil Barnes, Respiratory Global Franchise Medical Head Professor Neil Barnes is Medical Head of the Global Respiratory Franchise at GSK. Until October 2013 he was Consultant Respiratory Physician at London Chest Hospital, Barts Health NHS Trust and Professor of Respiratory Med
Slide 6: Presenters biographies
Presenters biographies Dave Allen, Senior Vice President and Head, Respiratory R&D Dave Allen is the head of the Respiratory Therapy Area at GSK and is responsible for the identification of novel differentiated medicines and their progression to registration and launch. He leads a group of over 200
Slide 7: Respiratory commercial perspectives
Respiratory commercial perspectives Eric Dube
Slide 8: Respiratory commercial landscape
Respiratory commercial landscape Market trends highlight the need for truly innovative medicines Key market trends • Deliver the right medicine for the right patient • Intense competition in inhaled medication driving pricing and access pressure • Technological / digital convergence to improve outco
Slide 9: Respiratory portfolio in transition – new portfolio
Respiratory portfolio in transition – new portfolio provides platform for continued market leadership £24bn global respiratory market (MAT Mar’16) with 8% growth over MAT Mar’15 Biologicals Others Rescue ICS/LABA Relvar/Breo Ellipta™ inhaler approved & launched Anoro Ellipta™ inhaler approved & laun
Slide 10: GSK offers a broad portfolio across COPD and asthma treatment
GSK offers a broad portfolio across the spectrum of COPD and asthma treatment GSK Respiratory COPD Asthma Symptomatic patients / Mild- Moderate- Patients at higher risk of Paediatric Severe patients at lower risk of moderate severe exacerbation patients patients patients exacerbation patients Relvar
Slide 11: GSK well positioned to address key unmet needs in asthma
GSK well positioned to address the key unmet needs in asthma Mild asthma patients Moderate asthma patients Severe asthma patients Low-dose ICS/LABA Consider low-dose ICS Med/high-dose ICS Refer for add-on treatment Leukotriene receptor antagonist Low-dose ICS+LTRA e.g. tiotropium, omalizumab, Low-do
Slide 12: GSK expects to maintain leadership in COPD segments
GSK expects to maintain leadership in COPD segments Our belief Current Future priority opportunity opportunity Patients at higher risk Exacerbation risk Exacerbation risk Exacerbation risk are best treated with ICS + Closed Triple* bronchodilation Symptomatic patients / patients at lower risk are be
Slide 13: Respiratory portfolio performance
Respiratory portfolio performance Return to growth driven by the performance of new medicines New Respiratory product growth offsetting Increasing proportion of sales from launches Seretide/Advair decline 16% Q1’15 Q2’15 Q3’15 Q4’15 Q1’16 Q2’16 £172m 14% 15% New product growth^ £123m Offsetting 12%
Slide 14: Significant momentum in the US respiratory portfolio
Significant momentum in the US respiratory portfolio Upward trajectory in US market share supporting respiratory growth Breo Anoro + Incruse 18% US ICS/LABA market share 40% US LAMA containing market share 16% Anoro+Incruse 35% 14% NBRx 30.1% Breo NBRx 30% 12% share 17.1% 25% 10% 20% Anoro+Incruse 8
Slide 15: Relvar performance exceeds recent launch analogues, Anoro European launches
Relvar performance continues to exceed recent launch analogues, Anoro European launches underway Europe Relvar performance vs. analogues Japan Relvar performance vs. analogues 7% 25% Relvar Relvar 6% 20% 5% 15% 4% 3% Competitor 1 Ryotan lifted 10% 2% Competitor 1 5% Competitor 2 1% 0% 0% M1 M3 M5 M7
Slide 16: Nucala performance - US
Nucala performance - US Strong patient demand and favourable access position driving volume growth 9,000,000 Sales value ($) by Market access 1% launch month 8,000,000 Covered no more restrictive than label 7,000,000 Nucala 36% Covered by exception 6,000,000 pending review 63% Covered more 5,000,000
Slide 17: Expect 2020 total respiratory sales at or above 2015
Expect 2020 total respiratory sales to be at or above sales in 2015, whether or not there is US generic competition to Advair 90% of 2015 sales 90% of 2020 sales 4 9 products products Seretide/Advair Avamys Seretide/Advair Avamys Incruse Ventolin Flixotide Ventolin Relvar/Breo Nucala Flixotide Anoro
Slide 18: Respiratory clinical perspectives
Respiratory clinical perspectives Professor Neil Barnes
Slide 19: Asthma management – GINA guidelines
Asthma management – GINA guidelines Mild / moderate patients – focus on delivery of care Step 5 Step 4 Refer for add- on treatment Med/high e.g. tio* ICS/LABA omalizumab, Step 3 mepolizumab* Step 1 Step 2 Preferred Low dose controller Low dose ICS ICS/LABA** choice Med/high dose Other Consider low
Slide 20: Asthma management – GINA guidelines
Asthma management – GINA guidelines Mild / moderate patients – focus on delivery of care Step 5 Major unmet need: Better delivery of care Step 4 reduces unscheduled care Refer for add- on treatment Med/high e.g. tio* ICS/LABA omalizumab, Step 3 mepolizumab* Step 1 Step 2 Preferred Low dose controll
Slide 21: Making asthma treatment effective
Making asthma treatment effective Address adherence and Get the diagnosis right compliance Get inhaler technique Get the treatment right right 20
Slide 22: Get inhaler technique right
Get inhaler technique right Critical error rates lower with Ellipta inhaler Patients making at least one critical error after reading patient information leaflet 35 p<0.001 Proportion of patients with Critical error rates were 30 a critical error (%) consistently low with Ellipta inhaler; this findi
Slide 23: Connected inhaler system: integrated sensor model
Connected inhaler system: integrated sensor model 3. Product with sensor/program given to patients via pharmacy; patient 4. Patient uses sensors and enrols and is required to enter HCP information from the prescription. app/ecosystem, which provides information via app, SMS, on- device signals, etc.
Slide 24: Asthma management – severe patients
Asthma management Severe patients – focus on drug discovery Step 5 Major unmet need: Better delivery of care Step 4 Refer for add- reduces unscheduled care on treatment e.g. tio* Med/high omalizumab, ICS/LABA mepolizumab* Step 3 Step 1 Step 2 Preferred Low dose controller Low dose ICS ICS/LABA** ch
Slide 25: Asthma management – severe patients
Asthma management Severe patients – focus on drug discovery Step 5 Major unmet need: Better delivery of care Step 4 Refer for add- reduces unscheduled care on treatment e.g. tio* Med/high omalizumab, ICS/LABA mepolizumab* Step 3 Delivery + Step 1 Step 2 Preferred Low dose new controller Low dose IC
Slide 26: Nucala pivotal studies
Nucala pivotal studies MENSA and SIRIUS studies MENSA: asthma exacerbations at 32 weeks SIRIUS: at 24 weeks, mepolizumab 50% placebo 0% p=0.007 Maintenance phase Median OCS change from baseline (%) placebo (n=66) mepolizumab 100mg SC (n=69) Optimised dose 0 4 8 12 16 20 24 Weeks Rate of exacerbation
Slide 27: MENSA study: Nucala improves QoL
MENSA study: Nucala improves QoL Changes from baseline in the St George’s Respiratory Questionnaire at week 32 Ortega HG et al. N Engl J Med 2014;371:1198-1207. 26
Slide 28: COPD management – GOLD guidelines
COPD management – GOLD guidelines A complex treatment picture Recommended first Patient Alternative choice Other possible treatments choice SAMA prn LAMA or LABA A or or theophylline SABA prn SABA and SAMA SABA and/or SAMA B LAMA or LABA LAMA and LABA theophylline LAMA and LABA or ICS + LABA SABA an
Slide 29: Potential COPD treatment paradigm: reducing complexity
Potential COPD treatment paradigm: reducing complexity Reduce symptoms, reduce risk Short-acting bronchodilators Exacerbation LABA or LAMA risk Use eosinophil count to guide Add ICS Use LABA & LAMA
Slide 30: Most COPD patients remain breathless on one bronchodilator
Real world studies have shown that most COPD patients remain breathless when using only one long acting bronchodilator Post bronchodilator FEV1 % predicted 45 ≥50% <50% 40 • Patients treated with a single 35 bronchodilator remain breathless 30 % of subjects 25 • Percent who are breathless has little
Slide 31: Comparative studies of Anoro versus tiotropium
Comparative studies of Anoro versus tiotropium ∆ Trough FEV1 • 24-week, PhIII, multicentre, ZEP1171151 DB21133602 DB21133742 randomised, blinded, double-dummy, parallel-group study of UMEC/VI (62.5/25 mcg) versus tio (18 mcg) in patients with moderate-to-very severe COPD • Primary endpoint: Trough F
Slide 32: Trough FEV1 at day 85 – PP population
Trough FEV1 at day 85 – PP population Umeclidinium was significantly superior to tiotropium (p<0.001) in the PP population LS mean change from baseline in trough FEV1 at day 85 59 mL 160 154 LS Mean change from baseline There were no significant differences in safety findings. in trough FEV1 (mL) 12
Slide 33: Blood eosinophil count and exacerbation frequency
Blood eosinophil count is associated with exacerbation frequency and predicts ICS response: post-hoc analysis • In an exacerbating COPD patient population a higher blood eosinophil count is a predictor of exacerbation risk • Blood eosinophils are a predictor of response to inhaled steroids Source: S
Slide 34: Potential COPD treatment paradigm: reducing complexity
Potential COPD treatment paradigm: reducing complexity Reduce symptoms, reduce risk Short-acting bronchodilators Exacerbation LABA or LAMA risk Use eosinophil count to guide Add ICS Use LABA & LAMA
Slide 35: COPD Salford Lung Study with Relvar/Breo
COPD Salford Lung Study with Relvar/Breo RCT in real world setting Constant real-time data collection of all 2,802 interventions/safety monitoring COPD patients FF/VI open label 1 • Patients in primary care electronic medical • Aged 40+ years 12 months record system • GP diagnosis of COPD Randomisat
Slide 36: What has the healthcare community asked for?
What has the healthcare community asked for? Data that provides understanding about effectiveness and value of medicines Traditional randomised Salford Lung Study control trial Focus on EFFICACY Focus on EFFECTIVENESS by measuring a medicine’s by measuring a medicine’s impact under impact under clos
Slide 37: COPD Salford Lung Study with Relvar/Breo
COPD Salford Lung Study with Relvar/Breo Primary endpoint: rate of moderate and severe on-treatment exacerbations Primary Efficacy Analysis (PEA) Population Usual Care Relvar/Breo Conclusion: (n=1134) (n=1135) LS Mean Annual Rate 1.90 1.74 Initiating treatment with Relvar/Breo 100/25mcg FF/VI vs Usu
Slide 38: Late phase inhaled COPD portfolio
Late phase inhaled COPD portfolio Understanding the role of triple therapy in COPD Consistent improvement in lung function with UMEC plus ICS/LABA vs. ICS/LABA UMEC add on vs. ICS/LABA (Study 201314, ITT pop n=236) • Triple therapy already part of clinical practice1 • Open triple with Incruse launch
Slide 39: FULFIL study design
FULFIL study design Lung FUnction and quality of LiFe assessment in COPD with closed trIpLe therapy* FF/UMEC/VI (100/62.5/25mcg) od (n=911) Run-in on current Follow-up COPD meds budesonide/formoterol bid 400mcg/12mcg (n=899) 2 weeks 24 weeks 1 week Population (COPD GOLD D) - FEV1 <50% + CAT ≥10; OR
Slide 40: FULFIL efficacy data
FULFIL efficacy data Co-primary efficacy endpoints: trough FEV1 and SGRQ week 24 – ITT population FF/UMEC/VI 100/62.5/25 vs BUD/FOR 400/12 Difference Standard error p-value FEV1 171mL 12 <0.001 SGRQ -2.2 0.64 <0.001 Up to 24 weeks Up to 52 weeks Annual rate of COPD exacerbations FF/UMEC/VI BUD/FOR F
Slide 41: FULFIL safety data
FULFIL safety data Overview of on-treatment adverse event up to week 24 – ITT population FF/UMEC/VI BUD/FOR Number (%) of subjects with: (100/62.5/25 mcg) (400/12 mcg) (n=911 ) (n=899 ) Any on treatment AE 354 (39%) 339 (38%) Any on treatment SAE 49 (5.4%) 51 (5.7%) Any on treatment non-fatal SAE 45
Slide 42: Journey to personalised medicine
Journey to personalised medicine Yesterday: Today: Tomorrow: Traditional Medicine Stratified Medicine Personalised Medicine All patients with a given disease Groups of relatively Single individuals with a disease homogenous patients or risk of a disease (biomarkers; phenotypes) • Emerging scientific
Slide 43: Respiratory R&D
Respiratory R&D Dave Allen
Slide 44: COPD R&D strategy
COPD R&D strategy Targeting the fundamental drivers of disease Once Daily Inhaled Infection Driven • Anoro Ellipta inhaler Exacerbations • Relvar/Breo Ellipta inhaler • PI3Kδ (interim PhIIa data) (Japan file) • danirixin (interim PhIIa data) GSK Pipeline • Incruse Ellipta inhaler • Closed Triple (EU
Slide 45: GSK2269557: Inhaled PI3Kδ inhibitor
GSK2269557: Inhaled PI3Kδ inhibitor Two PhIIa studies in COPD patients, completed August 2016* Directionality of neutrophil migration is aberrant in COPD • PI3Kδ over-activation causes human rare disease (APDS) with patients and corrected by PI3Kδ inhibition - in vitro severe, recurrent COPD-like ba
Slide 46: Danirixin (GSK1325756): oral CXCR2 antagonist
Danirixin (GSK1325756): oral CXCR2 antagonist Interim PhIIa data in symptomatic COPD, completed August 2016 Real-time data demonstrate improvement of symptoms with Trend for reduction in COPD exacerbations requiring danirixin in symptomatic COPD (frequent exacerbators) health care resource utilisati
Slide 47: Asthma R&D strategy
Asthma R&D strategy From secondary prevention to primary disease modification Once Daily Inhaled Extended Duration • Relvar/Breo Ellipta inhaler Biologicals (paediatrics) • long-acting anti-IL-5 • Arnuity Ellipta inhaler (Japan file) • anti-IL-5/13 GSK Pipeline • Closed Triple (PhIIb data) Targeted
Slide 48: Asthma population
Asthma population Opportunity for biologics and improved symptom control Total asthma population GINA step 4/5 >80% of GINA step 4/5 patients do 20-28% of total asthma not exacerbate At least 50% are uncontrolled >1 exacerbation per year Exacerbations / severe asthma 13-17% >2 exacerbations per year
Slide 49: Closed Triple for asthma
Closed Triple for asthma PhIIb data support progression, completed May 2016 • Assessing all the data, it is likely FF/UMEC/VI will UMEC add-on: study of asthma-COPD overlap syndrome have significant benefit compared to FF/VI (approx 120mL trough FEV1) in asthma uncontrolled by Change from baseline i
Slide 50: Diverse asthma biologic pipeline continues to develop
Diverse asthma biologic pipeline continues to develop Nucala sirukumab GSK3772847 long acting anti-TSLP dAb anti-IL-5/13 anti-IL-5 anti-IL-6 anti-IL-33r anti-IL-5 (NBE) Bispecific dAb-mAb Extended Modality mAb mAb mAb pharmacology mAb Inhaled dAb in Ellipta extended pharmacology Expected file 2014 2
Slide 51: Anti-IL33r mAb for severe asthma
Anti-IL33r mAb for severe asthma In-licensed from Janssen, July 2016 IL33 engages with a wide range of immune cells amplifying a • Biological therapy that prevents IL33 binding mixed inflammatory response to the ST2 receptor (IL33r) Viral infection / cell necrosis / • Strong human genetic evidence a
Slide 52: Beyond asthma and COPD
Beyond asthma and COPD Other disease areas of interest Eosinophilic disorders Acute lung injury Idiopathic pulmonary fibrosis • mepolizumab EGPA (PhIII • TNFR1 dAb (PhIIa underway) • inhaled αvβ6 antagonist (PET results this year) data) • mepolizumab nasal polyposis (PhIIa data) • mepolizumab HES (P
Slide 53: Mepolizumab, severe nasal polyposis
Mepolizumab, severe nasal polyposis Reduction in polyp size/symptoms and in the need for surgery in PhIIb study Improvement in the % subjects in need of surgery at 6 months • Mepolizumab (n=54) vs placebo (n=51): 6 doses 750mg i.v. patients with severe refractory nasal placebo polyposis, all had pre
Slide 54: GSK3008348 inhaled αvβ6 inhibitor
GSK3008348 inhaled vβ6 inhibitor FTIH commenced, December 2015 • Inhibits αvβ6 integrin-mediated activation TGFβ PET/CT clinical enabling, [18F]-A20FMDV2 binds to vβ6 in on myofibroblasts, so may slow progression of fibrotic regions of IPF lungs fibrosis • FTIH outcome: GSK3008348 was well tolerat
Slide 55: Digital ecosystem: real-time full patient experience
Digital ecosystem: real-time full patient experience Potential for acceleration and de-risking clinical development Adherence monitor Did the patient take the Ellipta clip-on or other e-sensor medicine? Rescue medicine use Did the markers of the Clip-on monitor patient’s disease improve? Biosensors
Slide 56: Q&A
Q&A 55
Slide 57: Appendix – additional safety information
Appendix – additional safety information 56
Slide 58: Important Safety Information (ISI) for FF/VI (Breo Ellipta) in the US
Important Safety Information (ISI) for FF/VI (Breo Ellipta) in the US The following ISI is based on the Highlights section of the US Prescribing Information for Breo Ellipta. Please consult the full Prescribing Information for all the labelled safety information for Breo Ellipta. Long-acting beta2-a
Slide 59: Anoro v tiotropium head to head safety results
Anoro v tiotropium head to head safety results (study 117115) The most commonly reported side effects for both UMEC/VI and tiotropium included headache (9% UMEC/VI; 7% tiotropium), nasopharyngitis (6% UMEC/VI; 7% tiotropium), cough (3% UMEC/VI; 3% tiotropium) and back pain (2% UMEC/VI; 3% tiotropium
Slide 60: Important Safety Information for Umeclidinium (Incruse Ellipta)
Important Safety Information for Umeclidinium (Incruse Ellipta) The following Important Safety Information is based on the Highlights section of the Prescribing Information for Incruse Ellipta. Please consult the full Prescribing Information for all the labeled safety information for Incruse Ellipta
Slide 61: Mepolizumab safety information
Mepolizumab safety information MENSA Adverse events reported in the study were similar across all treatment groups, including placebo. The most common reported adverse events across all treatment groups were nasopharyngitis, headache, upper respiratory tract infection and asthma. The frequency of ad