Novel targets, better treatments
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1 Novel targets, better treatments Investor presentation May 2018
2 Disclaimer This presentation contains forward-looking statements, including (without limitation) statements concerning the progress of our clinical pipeline, the slides captioned GLPG: strong investment case GLPG: data rich 2018 Advancing our innovation to market Strong R&D Establishing commercial footprint Building the filgotinib franchise Inflammation market ~$65 B by 2027 Ambition with filgotinib FINCH Ph3 design for RA DIVERSITY & SELECTION in IBD Filgotinib in psoriatic arthritis Filgotinib in ankylosing spondylitis $1.9B market with large unmet needs IPF: $5B market by 2025 Building an IPF franchise Ph3 program ISABELA 1&2 CF approach to triple combo PELICAN FALCON 1972 for osteoarthritis MOR106 for atopic dermatitis IGUANA Ph2 program 2018 late-stage clinical newsflow, statements regarding the development of the triple combination therapy CF program, statements regarding the expected timing, design and readouts of ongoing and planned clinical trials (i) with filgotinib in RA, IBD, and other potential indications (ii) in the CF program, (iii) with GLPG1690, GLPG1205, and GLPG3499 in IPF, (iv) with GLPG1972 in OA, (v) with MOR106 in atopic dermatitis, and expectations regarding the commercial potential of our product candidates. When used in this presentation, the words anticipate, believe, can, could, estimate, expect, intend, is designed to, may, might, will, plan, potential, possible, predict, objective, should, and similar expressions are intended to identify forward-looking statements. 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. Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, clinical trial and product development activities, regulatory approval requirements (including that data from the company's development programs may not support registration or further development of its compounds due to safety, efficacy or other reasons), reliance on third parties (including Galapagos collaboration partners AbbVie, Gilead, Servier and MorphoSys) and estimating the commercial potential of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in Galapagos Securities and Exchange Commission ( SEC ) filing and reports, including Galapagos most recent Form 20-F filing for the year ended December 31, Given these uncertainties, you are advised not to place any undue reliance on such forward-looking statements. All statements contained herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any statement in this document to reflect any change or future development with respect thereto, any future results, or any change in events, conditions and/or circumstances on which any such statement is based, unless specifically required by law or regulation. Under no circumstances may any copy of this presentation, if obtained, be retained, copied or transmitted. 2
3 GLPG: strong investment case Candidates for $80+B inflammation & fibrosis markets Proven platform for innovation, deep pipeline Late stage data from filgotinib Building commercial infrastructure Strong cash position for growth with ~$1.3 B 3
4 GLPG: data rich 2018 Filgotinib Best-in-class JAK Topline results in 3 indications (RA, PsA, AS) Building commercial organization with Gilead IPF ISABELA Ph3 program with 1690 Franchise of 3 proprietary novel assets CF Individual components validated in patients Topline 1 st triple in patients Q3 18 Expanding pipeline 19 Ph2 trials in 18 Additional novel drugs into clinic 4
5 Advancing our innovation to market Potential for multiple product launches New pipeline opportunities Pivotal trials Expansion of late stage pipeline Commercial preparations GILD partnership 2nd and 3rd PoC on novel targets 5
6 Strong R&D Area Preclinical Ph1 Ph2 Ph3 Filgotinib 10+ indications evaluated in Ph2 and Ph3, pivotal trial completion as of 2018 IPF ISABELA Ph3 to start H2 18, fully proprietary CF FALCON Ph2 to readout Q3 18 Atopic dermatitis IGUANA Ph2 ongoing OA Inflammation Fibrosis Ph2 to start in H1 18 >20 programs 6
7 Unique target discovery engine NOVEL TARGETS disease-modifying multiple disease areas first-in-class candidates SMART DEVELOPMENT rapid, multiple PoCs swift moves to pivotal development 3 PROOFS OF CONCEPT filgotinib (JAK1) 1690 (autotaxin) MOR106 (IL17-C) 7
8 Partnerships Gilead: filgotinib $750M upfront $1.35B in milestone payments profit-split, co-promote in 8 EU countries 20-30% royalties AbbVie: CF $600M milestones profit-split and co-promotion in Benelux China/Korea rights 15-20% royalties Servier: 1972 $290M milestones single digit % royalties US rights MorphoSys: MOR106 50/50 cost/benefit 8
9 Establishing commercial footprint Further pipeline expansion 1690 in IPF global launch Experience in launch and international operations Established global presence Partnerships as opportunity Orphan, shape the market Expand beyond EU Compact medical and patient community Filgotinib EU co-promotion Rheumatology and IBD advanced markets First organizations in EU Leverage Gilead partnership 9
10 Building the filgotinib franchise Area Ph 1 Ph 2 Ph 3 RA Crohn s disease Ulcerative colitis Ankylosing spondylitis Psoriatic arthritis Small bowel CD Fistulizing CD Sjögren s Cutaneous lupus Lupus nephropathy Uveitis Status Jan 18 Expected progress in
11 Inflammation market ~$65B by 2027 Unmet needs Current use of biologics <40% ~2027 market size, $B Oral and monotherapy Rapid response Higher, maintained efficacy Market growth AS ~8 UC ~9 PsA ~10 RA ~30 Differentiation vs. biologics CD ~10 Source: Goldman Sachs 2017, Leerink 2017, Stifel 2017, Global Data, Galapagos estimates 11
12 Readiness to adopt JAKs EULAR guidelines RA Recent trends 2 nd line 3 3d line csdmards (MTX, ) 1 st line Baricitinib in Germany fastest uptake in RA >40% bio-naive 85% high dose Tofacitinib in US fastest growing therapy in RA for the last 2 years >40% bio-naïve UC high-dose AdComm unanimous recommendation Source: EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update; Ely Lilly ; IMS; KOLs interviews; Xeljanz US promotional material 12
13 Ambition with filgotinib TOLERABILITY ACTIVITY CONVENIENCE most selective JAK1 >2,000 PYE strong biomarker & AE profile strong in RA strong in CD in biologic naive rapid onset & sustained response once-daily oral monotherapy Note: potential indicated here is based on Ph2 filgotinib data, no head to head comparison studies, filgotinib is an investigational candidate drug 13
14 Fold selectivity Filgotinib Most JAK1 selective JAK1 vs. JAK2 JAK1 vs. JAK filgotinib tofacitinib baricitinib upadacitinib 00 filgotinib tofacitinib baricitinib upadacitinib Source: Galapagos human whole blood assay Source: Galapagos biochemical assay Independently confirmed at ACR 2017* * Ex Vivo Comparison of Baricitinib, Upadacitinib, Filgotinib, and Tofacitinib for Cytokine Signaling in Human Leukocyte Subpopulations, McInnes et al, ACR
15 Superior activity JAK class in RA ACR50% ACR50% (W12, (W12) active delta) placebo active active delta mg QD + MTX 100 mg Q.D. + MTX (DARWIN-1, 2016, W12) 200 mg QD + MTX 200 mg Q.D. + MTX (DARWIN-1, 2016, W12) 40mg EOW + cdmards Adalimumab 40mg EOW (RA-BEAM, 2017, W12) 2 mg QD + cdmards 2 mg Q.D. + cdmards (RA-BUILD, 2017, W12) 4 mg Q.D. + cdmards (RA-BUILD, 2017, W12) 15 mg Q.D. + cdmards (SELECT NEXT, 2017, + cdmards W12) Filgotinib Baricitinib Upadacitinib Filgotinib DARWIN 1 Adalimumab MTX IR (cdmard IR) Baricitinib 4 mg QD + cdmards 15 mg QD Upadacitinib RA-BEAM RA-BUILD SELECT-NEXT 30 mg QD 30 mg Q.D. + cdmards (SELECT NEXT, 2017, + cdmards W12) Note: data not from head-to-head studies 15
16 Superior activity in CD, TNF naive Clinical remission: induction Active delta to placebo, % responders Filgotinib 200mg W10 FITZROY Humira 160mg W4 CLASSIC-1 Xeljanz 5mg W8 Panes et al 2017 Note: data not from head-to-head studies; PRECISE-1 CIMZIA and Stelara study populations include TNF naives and TNF responders, but TNF-IR are excluded; Humira dose is 160mg at week0 and 80mg at week 2, Xeljanz overall study result including TNF-IR patients did not meet primary endpoint 16 7 Cimzia 400mg W12 PRECISE-1 Stelara 6mg/kg IV UNITI-2, W10 W10 Entyvio 300mg W10 GEMINI-3
17 Beneficial hemoglobin profile Hb mean CFB (g/dl), W pbo 100mg200mg qd qd pbo 2mg qd 4mg qd pbo 5mg bid 10mg bid pbo 6mg bid 12mg bid 18mg bid filgotinib baricitinib tofacitinib upadacitinib Note: data from separate RA studies not conducted by the Company. filgotinib Westhovens et al, and Kavanaugh et al, ARD 2016; baricitinib Dougados et al, Annrheumdis 2016, 17 RA-BUILD; tofacitinib FDA AdComm briefing document May 2012; upadacitinib Genovese et al A&R 2016 BALANCE 2.
18 No reduction of NK cells NK cells, mean CFB (%), W No impact pbo 100mg200mg qd qd pbo 2mg qd 4mg qd pbo 5mg bid 15mg bid pbo 6mg bid 12mg bid 18mg bid filgotinib baricitinib* tofacitinib** upadacitinib Note: data from separate RA studies not conducted by the Company. filgotinib Westhovens et al, and Kavanaugh et al, ARD 2016; baricitinib FDA briefing documents bariciitinib AdComm 23 April 2018; tofacitinib Van Vollenhoven abstract 2013, median CFB at W6; upadacitinib Genovese et al A&R 2016 BALANCE 2. 18
19 Change from baseline (10 9 /L) Reduction of platelets platelets, mean CFB (giga/l), W pbo 100mg qd 200mg qd pbo 2mg qd 4mg qd pbo 5mg bid 10mg bid pbo 6mg bid 12mg bid 18mg bid filgotinib baricitinib tofacitinib upadacitinib Note: filgotinib DARWIN 1 W12 results; baricitinib Dougados et al, Annrheumdis 2016; tofacitinib FDA AdComm briefing document May 2012, upadacitinib Genovese et al ACR
20 Low incidence DVT and infections Event Per 100 PYE filgotinib (50-)200mg daily DARWIN 3 Wk 84 upadacitinib 6 and 12mg BID baricitinib 2 and 4mg QD tofacitinib 5mg bid tocilizumab 4 and 8 mg/kg adalimumab Genovese, ACR2017 Genovese et al., ACR2017 Genovese et al, ACR 2017 Wollenhaupt et al, ACR 2017 Genovese et al, ACR 2012 Burmester et al, 2011 Patient year exposure 1, ,637 5,891 14,994 23,943 Serious infection Herpes Zoster NR NR DVT/PEs N cases/100py 2/1, / /6, /1,849* * DVT/PE data on tofacitinib from Mease et al, ACR2017, 5mg bid 20
21 FINCH Ph3 design for RA 100 and 200 mg FINCH 1: MTX - IR 1, weeks ACR20 at W12 MTX add-on adalimumab control radiographic assessment FINCH 2: biologic - IR weeks ACR20 at W12 cdmard add-on FINCH 3: MTX naive 1, weeks ACR20 at W24 monotherapy, +MTX arms radiographic assessment FINCH 2 topline expected H2 18; FINCH 1 & 3 fully recruited
22 DIVERSITY & SELECTION in IBD 100 and 200 mg DIVERSITY 1 Crohn s Ph3 1,320 pts 58 weeks PRO2, endoscopic response Induction & maintenance DIVERSITY 2 Long term extension study SELECTION 1 UC Ph2/3 1,300 pts 58 weeks Mayo score components Induction & maintenance SELECTION 2 Long term extension study Interim decision SELECTION expected H1 18; recruitment completion DIVERSITY expected H2 19
23 Filgotinib in psoriatic arthritis EQUATOR trial fully recruited 16 weeks Screening filgotinib, 200mg once daily (n=62) placebo (n=62) Follow-up Patients with moderate to severe psoriatic arthritis Recruitment in 8 European countries Primary objective: ACR20 at week 16 Expected completion Q
24 Filgotinib in ankylosing spondylitis TORTUGA trial fully recruited 12 weeks Screening filgotinib, 200mg once daily (n=50) placebo (n=50) Follow-up Patients with moderate to severe ankylosing spondylitis Recruitment in 8 European countries Primary objective: ASDAS at week 12 Expected completion H
25 There is no cure yet for IPF About IPF Progressive lung fibrosis leading to death 200,000 prevalent cases in US & EU ~75,000 new cases annually Median survival 2-5 years > 50% of patients misdiagnosed Source: IPF: a disease with similarities and links to cancer biology. C Vancheri et al, Eur Respir J
26 $1.9B market with large unmet needs 2017 drug sales $1.9B Ofev & Esbriet have limitations only slow FVC decline ~25% annual discontinuations list price in US ~$95,000/yr Ofev Esbriet Sources: Stifel, Global Data, Maher et al. BMC Pulmonary Medicine (2017) 17:124 Note: Ofev is a drug marketed by Boehringer Ingelheim, Esbriet is a drug marketed by Roche 26
27 IPF: $5B market by 2025 Current unmet needs lengthy diagnosis low treatment rate and duration low survival Improve treatment more diagnosed patients treated patients longer on treatment awareness and education Galapagos aspiration Improve outcomes shorten diagnosis time improve efficacy combination therapies long term treatment compliance Sources: Stifel, Global Data, Galapagos assessment 27
28 Building an IPF franchise Drug (MoA) Pre-clinical Ph 1 Ph 2 Ph 3 '1690 (Autotaxin) '1205 (GPR84) '3499 Status Jan 18 Expected progress in 2018 Fully proprietary, oral therapies Three novel modes of action to address unmet need Opportunity to investigate combinations 1690 has orphan drug designation in EU & US GLPG to commercialize IPF assets 28
29 Positive 1690 data in patients Flora Placebo mg QD *= p<0.05 Placebo 1690 BSL N=6 N=17 4 N=3 N=16 8 N=4 N=15 12 N=4 N=13 FU N=4 N=15 FVC stabilization over 12-week period 29
30 FRI indicates disease stabilization Flora Functional respiratory imaging tracks ahead of FVC 30
31 Strong biomarker reduction Flora Reduction of LPA18:2 in blood plasma Placebo mg QD Placebo 1690 BSL N=6 N=17 4 N=5 N=16 12 N=6 N=15 FU N=5 N=15 **= p<0.01 Biomarker reduction = target engagement 31
32 Ph3 program ISABELA 1&2 52 weeks 1690 dose A Screening 1690 dose B Topline Part 1 expected Q3 18 Follow -up OLE Placebo 1500 IPF patients total, remain on standard of care throughout Global study with substantial US and EU component Primary endpoint: forced vital capacity (FVC) at 52 weeks Secondary: hospitalizations, mortality, quality of life, safety/tolerability Robust Ph3 program expected to begin in H
33 5 4 Ashcroft score (median) Score (median) Ashcroft score Volume (ml) Additional novel mechanisms in IPF 3499: target undisclosed BLM signs & symptoms * * 1205: targets GPR84 BLM inspiratory capacity Healthy BLM (30mg/kg bid) BLM - Ofev (60mg/kg qd) BLM - Diseased Healthy *=p>0.05 PBS + vehicle Diseased BLM + vehicle Ofev 60mg/kg qd BLM + Ninte QD, 60mpk mg/kg bid BLM+G Pressure (cm H 2 0) 3499 and 1205 reduce IPF signs & symptoms in BLM model Note: both experiments are 21 day therapeutic bleomycin lung fibrosis model in mice (BLM) 33
34 CF approach to triple combo today Discover novel correctors & potentiators Validate triple combo in patients Validate individual components in patients: Potentiator: SAPHIRA C1: ALBATROSS, FLAMINGO C2: PELICAN Comprehensive clinical network Multiple triples in patient studies Triple studies in US & Europe >130 patients, 10 countries, >60 sites in studies to date Interim results of 1 st triple therapy in patients (FALCON) expected Q nd triple therapy completed dosing in healthy volunteers 34
35 PELICAN up to 4 wks 4 wks up to 3 wks Screening 2737, oral (n=12) placebo (n=6) Follow-up orkambi (400 mg lumacaftor, 250 mg ivacaftor twice daily) Adult CF patients homozygous for F508del mutation Patients remain on stable dose of Orkambi 10 sites in Germany Primary endpoints: safety & tolerability Secondary endpoints: sweat chloride, FEV1, CFQ-R Fully recruited; topline expected Q
36 FALCON 2 weeks 2 weeks Part 1, dose A Screening Dual Triple Follow-up homozygous Part 2, dose B Dual Triple Screening Topline Part 1 expected Q3 18 Dual heterozygous min homozygous Triple Follow-up F508del patients, n=8 in each cohort Recruitment in Europe, incl. UK Primary endpoints: safety, tolerability, PK Secondary endpoints: sweat chloride, ppfev%, CFQ-R 36
37 1972 for osteoarthritis OA: breakdown of joint cartilage 118 M patients in US, Europe & Japan No disease-modifying drugs approved today Targets ADAMTS-5 Inhibits cartilage breakdown biomarker in healthy volunteers Phase 1: clear target engagement, favorable safety & PK GLPG Ph1b 30-patient study in US: positive data Ph2 start in H
38 1972 targets ADAMTS-5 in OA 1972 is a potent and selective chondroprotective ADAMTS-5 inhibitor ADAMTS-5 plays a key role in aggrecan degradation in OA Strong literature evidence for ADAMTS-5: validated in animal models², ³ validated in human samples¹ ARGS levels increased in human knee synovial fluid in OA 4 Source: ¹ Song, 2007; ² Glasson, 2005 & Malfait, 2010; ³ Miller, 2016; 4 Larsson,
39 1972 protects cartilage Histopathology in mouse model cartilage vehicle 1972 low dose 1972 medium dose 1972 high dose 39
40 Strong reduction of ARGS 1972 Ph1b study in OA patients -20 ARGS % reduction vs baseline Blood serum ARGS % reduction vs baseline placebo Placebo 1972 Low dose Med dose High dose Days post-dosing Dose-dependent reduction of ARGS, well-tolerated in OA patients 40
41 MOR106 for atopic dermatitis AtopicD: disease causing very dry skin, severe itching 35M patients in US, Europe & Japan First-in-class human MAb Novel MOA: IL-17C target discovered by Galapagos Ph1 (SAD): favorable safety & PK in healthy volunteers Ph1b (MAD): 83% patients at EASI50 within 4 weeks at highest dose Ph2 IGUANA study started in Q
42 Dual mode of action IL-17C target of MOR106 Dual action described Local amplifier of inflammation First-in-class IL-17A Source: Haines & Cua, Immunity
43 % change from baseline MOR106 Ph1b EASI, % change from baseline, pooled data, median Weeks after start of treatment Infusion Placebo MOR106 Source: Thaci et al, AAD
44 IGUANA Ph2 program 12 weeks MOR106, 1mg/kg Screening MOR106, 3 mg/kg Topline Part 1 MOR106, expected 10mg/kg Q3 18 Placebo 16 wk Follow-up 180 patients with moderate-to-severe AtD IV infusion at 2 or 4 week intervals for 1 & 3 mg/kg IV infusion at 2 week interval for 10 mg/kg Recruitment in Europe Primary endpoint: % change in EASI score at week 12 44
45 2018 late-stage clinical newsflow TRIAL INITIATIONS Ph in IPF Ph in IPF Ѵ Ph2 1 st CF triple (FALCON) Ph2 2 nd CF triple combo Ph in OA in US Ѵ Ph2 MOR106 in AtD POC DATA Filgotinib in PsoA (EQUATOR) Filgotinib in AS (TORTUGA) CF PELICAN CF FALCON PIVOTAL DATA Filgotinib in RA (FINCH 2) Filgotinib interim UC (SELECTION, go/no go) Ѵ Recruitment completed for FINCH 1, FINCH 3 45
46 glpg.com
47 Cash & cash equivalents Cash Burn: 41.3M M 1, ,108.2 Dec-17 Cash proceeds from capital increases Currency translation effects Cash income from milestones Cash expense Mar-18 Q1 18 cash burn of 41M, cash of 1.1B end of March Notes: excluding tax incentive receivable from Belgian & French governments of 80.9 M in March 18 47
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