JAK1 and beyond. Investor Presentation January Copyright 2014 Galapagos NV

Transcription

1 JAK1 and beyond Investor Presentation January 2014 Copyright 2014 Galapagos NV

2 Disclaimer This presentation has been prepared by Galapagos and is furnished to you by Galapagos solely for your information. This presentation may contain forward-looking statements, including, without limitation, statements containing the words believes, anticipates, expects, intends, plans, seeks, estimates, may, will and continues as well as similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition, performance or achievements of Galapagos, or industry results, to be materially different from any future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, the audience is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as at the date of this presentation. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this presentation to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless required by law or regulation. Neither Galapagos nor any of its officers, employees, advisers, or agents makes any representation or warranty, express or implied, as to any matter or as to the truth, accuracy, or completeness of any statement made in this presentation, made in conjunction therewith or in any accompanying materials or made at any time, orally or otherwise, in connection with the matters referred to herein and all liability in respect of any such matter or statements is expressly excluded. 2

3 Galapagos at a glance Pipeline of novel mode of action medicines five Phase 2 studies with JAK1 in five disease areas (3 GSK-led) two new modes of action in Phase 1 and 2, six candidates, 20 in discovery Major alliances with AbbVie, JnJ, GSK, Servier Leading fee-for-service provider with BioFocus & Argenta 800 staff, research sites in 5 countries, HQ in Belgium Market cap ~ 515 M, 29.7 M shares Ticker symbol 3

4 Growth strategy Execute development of JAK1 Phase 2 programs in RA & Crohn s Build mature clinical portfolio partnered and proprietary Continue productive pharma alliances Sign new alliances and partnerships to leverage our technology Grow Service division revenues 4

5 Revenue generating business model New mode-of-action medicine platform Fee-for-service Alliance business Licensing 5

6 Service division strong in top segment $600 M premium services market Target identification & validation Assay development Screening Lead optimization Preclinical testing Ph I, II, III clinical trials Galapagos service division AMRI WuXi Evotec Galapagos services competitive strengths: scientific excellence discovery of novel targets in human primary cells large, integrated deals with high renewal & expansion rate firewalled sites allow for different clients on same target 6

7 Pharma alliances Indication Partner Deal value Year Inflammation 219 M + royalties 2006 Inflammation 1 B + royalties 2007 Osteoarthritis 300 M + US rights + royalties 2010 Oncology 260 M + US rights + royalties 2011 Autoimmune $1.4 B + double-digit royalties 2012 Cystic fibrosis $405 M + double-digit royalties, cofunding 2013 Alliances have brought in > 390 M in cash since 2006 Source of promising molecules and targets for GLPG 7

8 Deal structure on GLPG0634 Upfront payment $150 M, $20 M expansion payment Galapagos performs & funds Phase 2 in RA & Crohn s License fee $200 million after RA Phase 2B, $50 M Crohn s success fee AbbVie performs & funds Phase 3, registration & commercialization GLPG to receive up to $1 B in milestones + double digit royalties Tax benefits from Belgian Patent Income Deduction law Phase 2 Phase 3 Marketing and sales handover after RA Phase 2B Benelux 8

9 Deal structure on CF Both companies contribute funding & science AbbVie commercializes, GLPG retains China/South-Korea, co-promotion rights in Benelux Upfront payment $45 M GLPG to receive up to an additional $360 M in future milestones + double digit royalties Tax benefits from Belgian Patent Income Deduction Law Discovery Preclinical Phase 2 Phase 3 Marketing & sales Pending achievement of pre-determined criteria 9

10 Broad and deep (pre)clinical pipeline Licensing Indications Partner Target Lead program Stage RA/Crohn s AbbVie JAK1 634 Phase 2B Lupus/Psoriasis/UC Licensed to GSK JAK1 GSK Phase 2 Ulcerative colitis FFA2 974 Phase 2 Inflammatory bowel disease JnJ novel 1205 Phase 1 MRSA DNA pol IIIα 1492 Inflammation JnJ novel Inflammation GSK novel 6 candidates Oncology novel 1790 Cystic Fibrosis AbbVie/GLPG novel 1837 In addition, >20 programs in discovery phase 10

11 JAKs in inflammation, Phase 2+ Company Drug JAK profile Indications Phase Pfizer Xeljanz JAK3>JAK1>JAK2 Incyte/Lilly baricitinib JAK1=JAK2 RA, JIA, PA, psoriasis, UC, AS RA, diabetic kidney disease Approved in US Phase 3 Vertex VX-509 JAK3 RA Phase 2 GLPG/AbbVie 634 JAK1 RA, Crohn s Phase 2B GSK GSK JAK1 SLE, psoriasis, UC Phase 2 Astellas/JnJ ASP015K JAK3/JAK1 RA Phase 2 AbbVie ABT-494 JAK1 RA Phase 2 GLPG has most advanced JAK1 selective compound 11

12 GLPG0634 The first selective JAK1 inhibitor JAK1 inhibition is an accepted new MOA for autoimmune 634 is most advanced JAK1 compound for RA and IBD expected launch in 2017/2018 timeframe high level of efficacy in two independent 4-week RA studies no efficacy gain observed beyond 200 mg 634 is only JAK inhibitor to show: efficacy in RA without impact to LDL, ALT/AST, hemoglobin 24/7 target inhibition after QD dosing 634 profile unmatched by other JAKs in autoimmune 12

13 Pooled results PoC and Phase 2A Moderate to severe RA patients CRP (mg/l) - change from baseline DAS28 - % change from baseline 30 Pbo1 Pbo2 30mg 75mg 150mg 200mg 300mg 0 Pbo1 Pbo2 30mg 75mg 150mg 200mg 300mg ** * ** ** ** ** Full dose range including 200 mg QD from Proof of Concept study Dose trend in efficacy with similar effect for doses >75mg No safety findings 13

14 634 Phase 2B program in RA Moderate to severe RA patients with inadequate MTX response Add-on to MTX 595 patients Monotherapy 280 patients Long term extension 14

15 634 in Crohn s Disease Crohn s market by : $4.5 billion Galapagos funds and runs Ph 2, AbbVie pays $50 M success fee 1 st selective JAK1 inhibitor in Ph 2 in Crohn s 20-week Phase 2A/B study in 180 patients, measuring: induction of disease remission early maintenance of its beneficial effects Timeline: start early 2014, read out topline results in Q enables direct move into Ph 3, gains 2 years in Crohn s ¹ Source: Decision Resources

16 Expected timelines st patient in Crohn s Last RA patient at 12 wk analysis Topline 24 wk RA studies AbbVie licensing decision Last RA patient in Topline 12 wk RA studies Topline Crohn s study Presentations at major conferences 16

17 GSK Ph2 studies with GSK GSK (previously GLPG0778) is an investigational selective JAK1 inhibitor inlicensed by GSK from GLPG in Feb 2012 GSK runs and funds further research, no cost to Galapagos In Phase 2 in three indications, expected completion: psoriasis: March 2014 ulcerative colitis: November 2014 lupus: November 2015 Galapagos milestone payment upon successful POC 17

18 974 Inhibits novel target in inflammatory disease 974 is a potent & selective antagonist of FFA2 reduces migration of neutrophils, major issue in ulcerative colitis first inhibitor of FFA2 to be evaluated clinically no animal models available 974 is fully proprietary to Galapagos 18

19 974 Results Ph1 multiple ascending dose study Pharmacodynamics (Day 13) Acetate-induced CD11b up regulation 100 % inhibition vs predose D Time after last dosing (h) 32 healthy volunteers, 4 cohorts, per cohort 6 active & 2 placebo 24 h inhibition at 200 mg BID Source: Company internal data 19

20 974 Ph2 PoC ulcerative colitis Disease of the colon characterized by ulcers Phase 2: 45 patients, 4 week dosing, 200 mg BID vs placebo 16 centers in 4 European countries evaluate safety & tolerability, characterize PK explore efficacy & effects on selected biomarkers Phase 2 PoC results expected H

21 Anti-bacterial platform Target: DnaE, a subunit of DNApolIII key enzyme involved in bacterial DNA replication (Gram + and Gram -) bactericidal one bug one drug paradigm, in combination with fast diagnosis Unique, scalable discovery platform to target different bacteria tripartite crystal structure: key asset for rational drug design unique natural product family drugs selected for S. aureus and C. difficile discovery programs targeting ESKAPE species 21

22 1492, our MRSA program Methicillin-Resistant Staphylococcus Aureus: resistant to most antibiotics spreading outside hospitals urgent medical need and high demand from clinicians 1492 offers new approach to treat MRSA active against all S. aureus strains excellent in vivo activity p.o., s.c., i.v. no cross resistance with existing antibiotics inhibits 280/280 S. aureus strains tested, of which 163 MRSA 22

23 Tripartite mode of action X-ray structure DNA primer DNA template 1492 DnaE 1492 binds at interface between polymerase, DNA template and primer 23 Resolution: 2.8Å

24 S. aureus infection mouse model 1492 dose response Thigh infection S. aureus CFU/thigh 1.00E E E E E+02 *** T1h T24h 50 mg/kg Cipro SC 50 mg/kg SC 50 mg/kg Line SC 50 mg/kg SC 5 GLPG1492 mg/kg SC 5 mg/kg SC 15 GLPG1492 mg/kg SC 15 mg/kg SC 50 GLPG1492 mg/kg SC 50 mg/kg SC 120 GLPG1492 mg/kg SC 120 mg/kg Administration s.c. BID, PI = Post infection SC Treatment T1-T7 PI, Sacrifice T24 PI *:p<0,05 **:p<0,01 ***:p<0.001 *** *** placebo Cipro Line 1492 *** Efficacy demonstrated in dose-dependent manner from 15 mg/kg 24

25 Timelines CF Delivery PCC potentiator GLPG1837 GLPG starts Phase 1 potentiator GLPG1837 GLPG starts Phase 2 potentiator GLPG Deal with AbbVie in CF Delivery PCC corrector GLPG starts Phase 1 corrector 70,000 patients worldwide; 1,000 new CF cases diagnosed each year Median age of survival is in the late 30 s Combination therapy needed for largest mutation F508del, 70% of patients 25

26 Clinical planning 2014 H1 H RA Phase 2B fully recruited RA Start Darwin Crohn s Start Phase UC Phase 2 topline results JnJ Start Phase anti-bacterial Start Phase RA Phase 2B 12-w topline results Crohn s Phase 2 fully recruited GSK psoriasis Phase 2 results IBD - JnJ Start Phase CF Start Phase 1 26

27 Bright outlook for Galapagos Leadership in JAK1 space: two compounds (one licensed to GSK) in Phase 2 in five indications AbbVie deals & out-licensing to GSK highlight success of our approach Broad pipeline provides further opportunities for clinical success both in internal and alliance programs Business model supports investment in promising proprietary programs Galapagos in excellent position to build on its R&D strengths 27