Eli Lilly And Company · NYSE:LLY
Eli Lilly And — EASD 2018 Diabetes Update Call
15 slides from Eli Lilly And's conference presentation, 2018
Slide 1: Diabetes Update Call
DIABETES UPDATE CALL Sus,
Slide 2: Agenda
AGENDA OPENING REMARKS Enrique Conterno, Senior Vice President, President Lilly Diabetes and Lilly USA INTRODUCTION OF LY3298176 Ruth Gimeno, Vice President Diabetes and Metabolic Research LY3298176 PHASE 2 DATA AND PHASE 3 DEVELOPMENT PLAN Brad Woodward, Incretins Platform Team Leader QUESTION AND
Slide 3: Safe Harbor Provision
SAFE HARBOR PROVISION This presentation contains forward-looking statements that are based on management's current expectations, but actual results may differ materially due to various factors. The company’s results may be affected by factors including, but not limited to, the risks and uncertaintie
Slide 4: U.S. GLP-1 Market Growth Expected to Continue
U.S. GLP-1 MARKET GROWTH EXPECTED TO CONTINUE U.S. GLP-1 Market Growth (4 week TRx YoY % Growth} U.S. New Therapy Starts SOM 9 40% 50% —Adlyxin™ 530% 40% —bydureon® fo Trulicity® —Bydureon BCISE™ rulicil Launch 30% —pyetta® 20% J yen 0 t -@ 20% ——Ozempic zempic 10% Launch —tTanzeum® 10% —Trulicity 0
Slide 5: The Molecule
THE MOLECULE = LY3298176 39 amino acid linear peptide conjugated toa C20 fatty diacid moiety via a linker connected to the lysine residue at position 20 Native GIP peptide sequence; modified to bind and activate both the GIP and GLP-1 receptors Equipotent to native GIP and less potent than native GL
Slide 6: Combining GIP & GLP-1: New Pharmacology
COMBINING GIP & GLP-1 > NEW PHARMACOLOGY x ~ Proposed Direct Effects Proposed Indirect Effects T Insulin Secretion IL Food Intake Qa Delayed Gastric J Glucagon Secretion Emptying Q CV Protection? ee Q Improved Renal Function? Q Improved NASH? T Insulin Secretion T Energy Expenditure? T Glucose Uptak
Slide 7: Publications
PUBLICATIONS Not for promotional use THE LANCET Efficacy and safety of LY3298176, a novel dual GIP and GLP-1 receptor agonist, in patients with type 2 diabetes: a randomised, placebo-controlled and active comparator-controlled phase 2 trial Juan Pablo Frias, Michael A Nauck, Joanna Van, Mark E Kutne
Slide 8: LY3298176 Phase 2b 6-Month Study Design
LY3298176 PHASE 2B 6-MONTH STUDY DESIGN Randomization ¥ 3 weeks Treatment period (26 weeks) 4 weeks Study objectives: * Change in HbA1c At 26 weeks * Safety and tolerability LY 5 mg Inclusion criteria: *T2DM * HbA1c >7% to <10.5% or ona stable dose of metformin Screening Lead-in Follow-up - *K Dulag
Slide 9: HbA1c and Weight Change from Baseline Over Time
0 .5 2 .5 W e ig h t C h a n g e fr o m B a s e lin e 0 .1 o v e r tim e (k g , L S M e a n S E ) 0 .0 0 - 0 .4 H B A 1 c c h a n g e fr o m b a s e lin e - 0 .9 - 0 .5 * - 2 .7 (% , L S M e a n SE) * - 0 .7 -5 - 4 .8 - 1 .0 * * - 1 .1 - 1 .5 * # - 1 .6 # - 8 .7 * P lac ebo - 2 .0 - 2 .0 -10 P l
Slide 10: HbA1c and Weight Change by Dose
0 .5 b a s e l in e ( m m o l/ m o l) p o s t e r i o r m e a n ( S D ) m IT T w ith o u t p o s tr e s c u e 4 0 M e a n H b A 1 c c h a n g e f r o m b a s e l in e ( % ) m I T T w it h o u t p o s t re s c u e m IT T o n tr e a tm e n t m IT T o n tre a tm e n t c h a n g e fr o m b a s e lin e (
Slide 11: Proportion of Participants Reaching HbA1c Targets
100 # 100 * 90 # P lac ebo * P ro p o r tio n o f p a r tic ip a n ts (% ) LY 1 m g P ro p o r tio n o f p a r tic ip a n ts (% ) # * 82 80 LY 5 m g 80 # 77 # * * LY 10 m g # 71 69 * # LY 15 m g # *62 64 * D u la g lu tid e 1 .5 m g 60 * 59 60 # 52 * 47 * # # * *38 * 39 39 40 # 40 * 33 30 # # # *25
Slide 12: Safety and Tolerability Summary
SAFETY AND TOLERABILITY SUMMARY LY LY LY Dula 5mg 10mg 15mg | 1.5mg Adverse Events (AE} (%] 72.7 78.4 84.9 74.1 Serious AEs (%] 1.8 5.9 3.8 5.6 deat men | 9 59 | 245 | 14 Nausea (%J 20.0 21.6 39.6 29.6 Diarrhea (%] 23.6 23.5 32.1 16.7 Vomiting (%} 7.3 15.7 26.4 9.3 Hypoglycemia* (%] 7.3/1.8] 9.8/5.9
Slide 13: LY3298176 Phase 3 T2DM Clinical Program (SURPASS)
LY3298176 PHASE 3 T2DM CLINICAL PROGRAM 223 tate 2018 / early 2019 2022 G08 SURPASS PROGRAM INITIATION POTENTIAL GLOBAL SUBMISSIONS SURPASS 1: monotherapy | SURPASS 3: vs degludec SURPASS 4: vs glargine (established CVD) SURPASS 5: basal insulin add-on SURPASS 2: vs semaglutide SURPASS Japan monothe
Slide 14: Summary
SUMMARY LY3 2 9 8 1 7 6 Next generation once-weekly dual incretin designed to strengthen Lilly’s leadership Dual GIP/GLP-1 Receptor Agonist in the first injectable space. . 2 Exceed expectations Replicate Trulicity’s What We Aim to Do: for glycemic control and injection experience weight reduction L
Slide 15: Slide 15
Eli Lilly and Company — EASD 2018 Diabetes Update Call on 6ix