Galapagos PowerPoint Template (Confidential)

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Novel targets, better treatments Investor presentation | May 2018

Transcript of Galapagos PowerPoint Template (Confidential)

Novel targets, better treatments

Investor presentation | May 2018

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Disclaimer

This presentation contains forward-looking statements, including (without limitation) statements concerning the progress of our clinicalpipeline, 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” “$1.9Bmarket with large unmet needs” “IPF: $5B market by 2025” “Building an IPF franchise” “Ph3 program ISABELA 1&2” “CF approach totriple combo” “PELICAN” “FALCON” “’1972 for osteoarthritis” “MOR106 for atopic dermatitis” ”IGUANA Ph2 program” “2018 late-stageclinical newsflow,” statements regarding the development of the triple combination therapy CF program, statements regarding theexpected 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 mayresult in differences are the inherent uncertainties associated with competitive developments, clinical trial and product developmentactivities, regulatory approval requirements (including that data from the company's development programs may not support registrationor 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. Afurther 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, 2017. Given theseuncertainties, 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 updateany statement in this document to reflect any change or future development with respect thereto, any future results, or any change inevents, 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.

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GLPG: strong investment case

Late stage data from filgotinib

2018-2019

Building commercial infrastructure

Proven platform for innovation, deep pipeline

Candidates for $80+B inflammation & fibrosis

markets

Strong cash positionfor growth with

~$1.3 B

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GLPG: data rich 2018

• Best-in-class JAK

• Topline results in 3 indications (RA, PsA, AS)

• Building commercial organization with Gilead

• ISABELA Ph3 program with ‘1690

• Franchise of 3 proprietary novel assets

• Individual components validated in patients

• Topline 1st triple in patients Q3 ‘18

• 19 Ph2 trials in ‘18

• Additional novel drugs into clinic

Filgotinib

IPF

CF

Expanding pipeline

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Advancing our innovation to market

2020-2022

• Potential for multiple product launches

• New pipeline opportunities

2018-2019

• Pivotal trials

• Expansion of late stage pipeline

• Commercial preparations

2016-2017

• GILD partnership

• 2nd and 3rd PoC on novel targets

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Strong R&DArea Preclinical Ph1 Ph2 Ph3

Filgotinib

IPF

CF

Atopic dermatitis

OA

Inflammation Fibrosis

FALCON Ph2 to readout Q3 ‘18

ISABELA Ph3 to start H2 ‘18,fully proprietary

10+ indications evaluated in Ph2 and Ph3,pivotal trial completion as of 2018

IGUANA Ph2 ongoing

>20 programs

Ph2 to start in H1 ‘18

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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)

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PartnershipsGilead: filgotinib

$750M upfront$1.35B in milestone paymentsprofit-split, co-promote in 8 EU countries20-30% royalties

AbbVie: CF

$600M milestonesprofit-split and co-promotion in BeneluxChina/Korea rights15-20% royalties

Servier: ‘1972

$290M milestonessingle digit % royaltiesUS rights

MorphoSys: MOR106

50/50 cost/benefit

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Establishing commercial footprint

Further pipeline

expansion

‘1690 in IPF

global launch

Filgotinib

EU co-promotion

• Experience in launch and international operations

• Established global presence

• Partnerships as opportunity

• Orphan, shape the market

• Expand beyond EU

• Compact medical and patient community

• Rheumatology and IBD advanced markets

• First organizations in EU

• Leverage Gilead partnership

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Building the filgotinib franchise

Status Jan ‘18 Expected progress in 2018

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

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Inflammation market ~$65B by 2027

Source: Goldman Sachs 2017, Leerink 2017, Stifel 2017, Global Data, Galapagos estimates

• Current use of biologics <40%

• Oral and monotherapy

• Rapid response

• Higher, maintained efficacy

Unmet needs

RA~30

CD~10

UC~9

AS~8

PsA~10

~2027 market size, $B

• Market growth

• Differentiation vs. biologics

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Readiness to adopt JAKs

• 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 AdCommunanimous recommendation

2nd line

33d line

1st line

csDMARDs (MTX, …)

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

EULAR guidelines RA Recent trends

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Ambition with filgotinib

most selective JAK1

>2,000 PYE

strong biomarker & AE profile

TOLERABILITY ACTIVITY CONVENIENCE

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

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FilgotinibMost JAK1 selective

Independently confirmed at ACR 2017*

Source: Galapagos human whole blood assay

Fold

sele

ctiv

ity

0

5

10

15

20

25

30

filgotinib tofacitinib baricitinib upadacitinib

JAK1 vs. JAK2

00

05

10

15

20

25

30

filgotinib tofacitinib baricitinib upadacitinib

JAK1 vs. JAK3

Source: Galapagos biochemical assay

* “Ex Vivo Comparison of Baricitinib, Upadacitinib, Filgotinib, and Tofacitinibfor Cytokine Signaling in Human Leukocyte Subpopulations,” McInnes et al, ACR 2017

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Superior activity JAK class in RA

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28

17

21 2023

28

0

10

20

30

40

50

100 mg Q.D. + MTX(DARWIN-1, 2016, W12)

200 mg Q.D. + MTX(DARWIN-1, 2016, W12)

Adalimumab 40mg EOW(RA-BEAM, 2017, W12)

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,

W12)

30 mg Q.D. + cDMARDs(SELECT NEXT, 2017,

W12)

Filgotinib Baricitinib Upadacitinib

MTX IR (cDMARD IR)

ACR50% (W12)placebo active active delta

100 mg QD+ MTX

200 mg QD+ MTX

40mg EOW + cDMARDs

2 mg QD+ cDMARDs

4 mg QD+ cDMARDs

15 mg QD+ cDMARDs

30 mg QD+ cDMARDs

Filgotinib

DARWIN 1

Baricitinib

RA-BUILD

Upadacitinib

SELECT-NEXT

Adalimumab

RA-BEAM

ACR50% (W12, active delta)

Note: data not from head-to-head studies

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Superior activity in CD, TNF naiveClinical remission: induction

Active delta to placebo, % responders

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

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27

47

2427

7

1719

0

10

20

30

40

50

Filgotinib 200mgW10 FITZROY

Humira 160mg W4CLASSIC-1

Xeljanz 5mg W8Panes et al 2017

Cimzia 400mg W12PRECISE-1

Stelara 6mg/kg IVW10

Entyvio 300mgW10 GEMINI-3UNITI-2, W10

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Beneficial hemoglobin profile

-0.6

-0.4

-0.2

0

0.2

0.4

0.6

pbo 100mgqd

200mgqd

pbo 2mgqd

4mgqd

pbo 5mgbid

10mgbid

pbo 6mgbid

12mgbid

18mgbid

filgotinib baricitinib tofacitinib upadacitinib

Hb mean CFB (g/dL), W12

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, RA-BUILD; tofacitinib – FDA AdComm briefing document May 2012; upadacitinib – Genovese et al A&R 2016 BALANCE 2.

filgotinib baricitinib tofacitinib upadacitinib

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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.

No reduction of NK cells

NK cells, mean CFB (%), W12

-50

-40

-30

-20

-10

0

10

pbo 100mgqd

200mgqd

pbo 2mgqd

4mgqd

pbo 5mgbid

15mgbid

pbo 6mgbid

12mgbid

18mgbid

filgotinib baricitinib* tofacitinib** upadacitinib

No impact

filgotinib baricitinib tofacitinib upadacitinib

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Reduction of platelets

-40

-30

-20

-10

0

10

20

30

pbo 100mgqd

200mgqd

pbo 2mg qd 4mg qd pbo 5mgbid

10mgbid

pbo 6mgbid

12mgbid

18mgbid

filgotinib baricitinib tofacitinib upadacitinib

Change fro

m b

ase

line (

10

9/L

)

Note: filgotinib – DARWIN 1 W12 results; baricitinib – Dougados et al, Annrheumdis 2016;tofacitinib – FDA AdComm briefing document May 2012, upadacitinib – Genovese et al ACR 2017

platelets, mean CFB (giga/L), W12

filgotinib baricitinib tofacitinib upadacitinib

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Low incidence DVT and infections

EventPer 100 PYE

filgotinib

(50-)200mg dailyDARWIN 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

1,708 725 6,637 5,891 14,994 23,943

Serious infection

1.5 2.3 2.9 2.2 4.5 4.6

Herpes Zoster

1.2 3.7 3.2 3.6 NR NR

DVT/PEs

N cases/100PY

2/1,708

0.1

5/725

0.7

31/6,754

0.5

3/1,849*

0.2- -

* DVT/PE data on tofacitinib from Mease et al, ACR2017, 5mg bid

FINCH Ph3 design for RA100 and 200 mg

FINCH 1: MTX - IR ACR20 at W12MTX add-onadalimumab controlradiographic assessment

1,650 52 weeks

FINCH 2: biologic - IR 423 24 weeks ACR20 at W12cDMARD add-on

FINCH 3: MTX naive 1,200 52 weeks ACR20 at W24monotherapy, +MTX armsradiographic assessment

FINCH 2 topline expected H2 ’18; FINCH 1 & 3 fully recruited

DIVERSITY & SELECTION in IBD100 and 200 mg

DIVERSITY 1 PRO2, endoscopic response Induction & maintenance

Crohn’s Ph31,320 pts

58 weeks

DIVERSITY 2 Long term extension study

SELECTION 1 Mayo score components Induction & maintenance

UC Ph2/31,300 pts

58 weeks

SELECTION 2 Long term extension study

Interim decision SELECTION expected H1 ’18; recruitment completion DIVERSITY expected H2 ’19

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Filgotinib in psoriatic arthritisEQUATOR trial fully recruited

filgotinib, 200mg once daily (n=62)Screening

16 weeks

Follow-up

• Patients with moderate to severe psoriatic arthritis

• Recruitment in 8 European countries

• Primary objective: ACR20 at week 16

• Expected completion Q2 ‘18

placebo (n=62)

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Filgotinib in ankylosing spondylitisTORTUGA trial fully recruited

filgotinib, 200mg once daily (n=50)Screening

12 weeks

Follow-up

• Patients with moderate to severe ankylosing spondylitis

• Recruitment in 8 European countries

• Primary objective: ASDAS at week 12

• Expected completion H2 ’18

placebo (n=50)

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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 2010

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$1.9B market with large unmet needs

Sources: Stifel, Global Data, Maher et al. BMC Pulmonary Medicine (2017) 17:124Note: Ofev is a drug marketed by Boehringer Ingelheim, Esbriet is a drug marketed by Roche

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

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IPF: $5B market by 2025

Sources: Stifel, Global Data, Galapagos assessment

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

Improve outcomes

• shorten diagnosis time

• improve efficacy

• combination therapies

• long term treatment compliance

Galapagos aspiration

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Building an IPF franchise

• 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

Status Jan ‘18 Expected progress in 2018

Other Pipeline Assets

Area Drug (MoA) Pre-clinical Ph 1 Ph 2 Ph 3

'1690 (Autotaxin)

'1205 (GPR84)

'3499

IPF

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Positive ‘1690 data in patients

FVC stabilization over 12-week period

Flora

‘1690 600mg QDPlacebo

Placebo‘1690

BSLN=6N=17

*= p<0.05

4N=3N=16

8N=4N=15

12N=4N=13

FUN=4N=15

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Functional respiratory imaging tracks ahead of FVC

FRI indicates disease stabilization

Flora

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Strong biomarker reduction

Flora

Reduction of LPA18:2 in blood plasma

Biomarker reduction = target engagement

‘1690 600mg QDPlacebo

Placebo‘1690

BSLN=6N=17

**= p<0.01

4N=5N=16

12N=6N=15

FUN=5N=15

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Ph3 program ISABELA 1&2

Topline Part 1 expected Q3 ‘18‘1690 dose B

Placebo

52 weeks

ScreeningFollow

-up

‘1690 dose A

OLE

• 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 H2 ‘18

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Ashcroft score (median)

PBS + veh

icle

BLM +

veh

icle

BLM +

Ninte Q

D, 60m

pk

BLM+G12

3999

9-5

1

2

3

4

5

Sco

re (

media

n)

DiseasedHealthyOfev

60mg/kgqd

‘349910mg/kg

bid

Additional novel mechanisms in IPF

‘3499 and ‘1205 reduce IPF signs & symptoms in BLM model

‘3499: target undisclosedBLM – signs & symptoms

‘1205: targets GPR84BLM – inspiratory capacity

Pressure (cm H20)

HealthyBLM - ‘1205 (30mg/kg bid)

BLM - Ofev (60mg/kg qd)

BLM - Diseased

Note: both experiments are 21 day therapeutic bleomycin lung fibrosis model in mice (BLM)

Volu

me (

mL)

Ash

croft

sc

ore

* *

*=p>0.05

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• >130 patients, 10 countries, >60 sites in studies to date

• Interim results of 1st triple therapy in patients (FALCON) expected Q3 ‘18

• 2nd triple therapy completed dosing in healthy volunteers

2005 - today 2018 -

Validate triple combo in patients

Discover novel correctors & potentiators

Validate individual components in patients:

Potentiator: SAPHIRA

C1: ALBATROSS, FLAMINGO

C2: PELICAN

CF approach to triple combo

Comprehensive clinical network

Multiple triples in patient studies

Triple studies in US & Europe

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PELICAN

• 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

Screening

4 wks up to 3 wks

Follow-up

‘2737, oral (n=12)

placebo (n=6)

up to 4 wks

orkambi (400 mg lumacaftor, 250 mg ivacaftor twice daily)

Fully recruited; topline expected Q2 ‘18

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FALCON

• F508del patients, n=8 in each cohort

• Recruitment in Europe, incl. UK

• Primary endpoints: safety, tolerability, PK

• Secondary endpoints: sweat chloride, ppFEV%, CFQ-R

Screening

2 weeks

Follow-upDual

Topline Part 1 expected Q3 ‘18

Triple

2 weeks

Part 1, dose A

homozygous

Dual Triple

Part 2, dose B

Dual Triple

heterozygous min

homozygous

Screening Follow-up

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‘1972 for osteoarthritis

Targets ADAMTS-5Inhibits cartilage breakdown biomarker in healthy volunteers

Phase 1: clear target engagement, favorable safety & PK

GLPG Ph1b 30-patient study in US: positive dataPh2 start in H1 ‘18

OA: breakdown of joint cartilage118 M patients in US, Europe & JapanNo disease-modifying drugs approved today

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‘1972 targets ADAMTS-5 in OA

• ‘1972 is a potent and selective chondroprotective ADAMTS-5 inhibitor

• ADAMTS-5 plays a key role in aggrecandegradation 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, 2009

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‘1972 low dose

‘1972 medium dose

‘1972 high dose

vehicle

‘1972 protects cartilageHistopathology in mouse model

cartilage

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Strong reduction of ARGS‘1972 Ph1b study in OA patients

Dose-dependent reduction of ARGS, well-tolerated in OA patients

-20

0

20

40

60

1 8 15 22 29 36 43 50

AR

GS

% r

ed

ucti

on

vs b

aseli

ne

Days post-dosing

placebo

‘1972 dose 1

‘1972 dose 2

‘1972 dose 3

Blo

od

se

rum

AR

GS

% r

ed

ucti

on

vs b

ase

lin

e

Low dose

Med dose

High dose

Placebo

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MOR106 for atopic dermatitis

AtopicD: disease causing very dry skin, severe itching 35M patients in US, Europe & Japan

First-in-class human MAbNovel 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 Q2 ‘18

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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 2011

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MOR106 Ph1bEASI, % change from baseline, pooled data, median

-100

-90

-80

-70

-60

-50

-40

-30

-20

-10

0

0 2 4 6 8 10 12 14

% c

hange f

rom

base

line

Weeks after start of treatment

Placebo

MOR106

Infusion

Source: Thaci et al, AAD 2018

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IGUANA Ph2 program

Topline Part 1 expected Q3 ‘18

MOR106, 3 mg/kg

Placebo

12 weeks

Screening16 wk

Follow-up

MOR106, 1mg/kg

• 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

MOR106, 10mg/kg

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2018 late-stage clinical newsflow

TRIAL INITIATIONS

Ph3 ‘1690 in IPF

Ph2 ‘1205 in IPF

Ѵ Ph2 1st CF triple (FALCON)

Ph2 2nd CF triple combo

Ph2 ‘1972 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

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glpg.com

47

Cash & cash equivalents

17.03.91,151.2

Dec-17 Cash proceeds

from capital increases

-5.6

Currency translation

effects

Cash income from

milestones

-58.3

Cash expense Mar-18

1,108.2

€M

Notes:• excluding tax incentive receivable from Belgian & French governments of €80.9 M in March ‘18

Cash Burn: €41.3M

Q1 ‘18 cash burn of €41M, cash of ≈€1.1B end of March