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Novel targets, better treatments Jefferies Healthcare Conference London| November 2019

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Page 1: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

Novel targets, better treatments

Jefferies Healthcare Conference London| November 2019

Page 2: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

Disclaimer

This presentation contains forward-looking statements, including (without limitation) statements concerning the progress of our clinical pipeline, the statements regardingthe global R&D collaboration with Gilead, the amount and timing of potential future milestone, opt-in and/or royalty payments by Gilead, the slides captioned “’4059 indiabetic monkeys” “Dual activity confirmed in colon tissue” “Efficacy in arthritis models with ‘3970” “Activity across generations & indications” “Broad indication explorationwith ‘3970” “Expand our target & drug workplace” “Novel targets: next step” “Drug modalities – current and future” “Additional targets to be explored” “Filgotinib program”“Global inflammation market $65B by 2027” “ISABELA timeline” “In full launch mode with filgotinib” two slides titled “Growing geographic footprint” “Bringing ourinnovation to patients” “Looking forward to a newsflow rich 2020” “Pioneering for patients,” all slides pertaining to the collaboration with Gilead announced on 14 July2019, 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)with GLPG1690 and GLPG1205 in IPF and Ssc, (iii) with the Toledo program, (iv) with GLPG1972 in OA, and expectations regarding the commercial potential of ourproduct 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 orachievements of Galapagos, or industry results, to be materially different from any future results, financial conditions, performance or achievements expressed or impliedby such forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, clinical trialand product development activities, regulatory approval requirements (including that data from the company's development programs may not support registration orfurther development of its compounds due to safety, efficacy or other reasons), reliance on third parties (including Galapagos’ collaboration partners Gilead, Servier,MorphoSys, and Novartis) and estimating the commercial potential of its product candidates. A further list and description of these risks, uncertainties and other risks canbe found in Galapagos’ Securities and Exchange Commission (“SEC”) filing and reports, including Galapagos’ most recent Form 20-F and subsequent filings with the SEC.Given these uncertainties, you are advised not to place any undue reliance on such forward-looking statements.

All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any statement in this document to reflectany change in future development with respect thereto, any future results, or any change in events, conditions and/or circumstances, on which any 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.

Page 3: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

Galapagos in a nutshell

Note: All values as per 30-06-2019

Foundedin 1999

HeadquartersMechelen, Belgium

Galapagos R&DBelgium, The Netherlands,France, Switzerland, USA

Service Operation FideltaZagreb, Croatia

SITESFAST FACTS DIVERSITY

EMPLOYEES910

R&D

75041% 59%

Page 4: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

Historic strategic alliance deal

Page 5: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

Gilead-Galapagos collaborationUnique deal in life sciences, with independence anchored

10 YearCollaboration& standstill

$3.95 Bupfront

plus opt-in fees& milestones

$1.5 Bequity investment

20+%Royalties

Galapagos retains full European rights

Page 6: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

Ready for the future

• Independence anchored

• ~6 billion cash in the bank

• Full European rights*

• Ex-Europe royalties 20+%

* Except for GLPG1972

Page 7: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

We discover novel targets

balanced unbalanced

Page 8: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

Prolific late stage pipeline

>40 clinical trials planned in 2019

Area Preclinical Phase 1 Phase 2 Phase 3

Filgotinib

IPF/Fibrosis

OA

Inflammation Fibrosis

In Ph2b

In Ph3 and Ph2

Programs in filing, Ph3 and Ph2

>20 programs

Page 9: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

FilgotinibPipeline in a product opportunity

Page 10: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

Filgotinib program

Phase 3

Phase 2

MAA filed NDA H2 ‘19

RA UC CD PsA AS Other

Ph3toplineQ2 ‘20 Ph3

recruiting

Ph3 initiating

Ph3preparing

Page 11: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

Global inflammation market $65B by 2027

Source: Galapagos estimates, Decision Resources Group

estimated market size, $B

Indications beyond RA 60% of future market

AS~6

PsA~9

RA~26

CD~16

UC~8

Page 12: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

Ph3 in RA: FINCH summary up to W24

Dose-dependent efficacy data on clinically meaningful endpoints

• ACR50/70

• DAS remission

• radiographic progression

Safety data

• very low rates of serious infection, DVT/PE, MACE, death

• normalizing of abnormalities associated with RA (Hb, platelets)

• higher % change in HDL vs LDL

No dose-dependent difference on safety data

Note: Filgotinib is a compound in development by Gilead and Galapagos. The summary above was derived from the filgotinib FINCH trial data up to week 24 (Gilead and Galapagos press releases dated 29 March 2019). Data from the FINCH 1 and FINCH 3 trials will be presented at EULAR 2019.

Supports best-in-class potential in RA

Page 13: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

Filgotinib’s JAK1 inhibition is sufficient to address inflammation

Active in MTX-naïve to bDMARD-IR patients

Treatment effect of 200mg maintained (156 wks)

Clinical benefits seen early

Page 14: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

…without liabilities of off-target effects

No. (%)PBO/MTX

adalimumab40mg EOW

filgotinibtotal

N=1039 N=325 N=2088

serious infection

10 (1.0) 8 (2.5) 29 (1.4)

herpes zoster

4 (0.4) 2 (0.6) 12 (0.6)

DVT/PE 3 (0.3) 0 (0) 1 (<0.1)^

deaths 2 (0.2) 0 (0) 4 (0.2)

^ = excludes 1 case of retinal vein occlusionSource: Winthrop et al., ACR 2019; Kavanaugh et al., ACR 2019

FINCH programup to wk24

Page 15: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

EU5: JAKi’s growing in RA

Source: Gilead and Galapagos analysis on IPSOS data, share of prescriptions

97% 84%

16%

JAKi’s

biologics

Q3 ‘17 Q1 ‘19

3%

EU5

Page 16: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

EU5: JAK patients from biologic naïve

Source: Therapy watch Q1’19

EU5

Q1 ’19

Q1 ’18

Bio-naïve Bio-IR

57%

44% 56%

43%

Page 17: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

Progressive lung fibrosis leading to death

• 200k cases in US & EU

• 75k new cases every year

• Median survival 2-5 years

GLPG1690 For idiopathic pulmonary fibrosis (IPF)

Page 18: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

program discovery preclinical Ph1 Ph2 Ph3

‘1690 (autotaxin) ISABELA IPF

‘1205 (GPR84) PINTA IPF

New IPF programs

We are building a fibrosis portfolio

• Opportunity to combine• Several fibrosis programs in discovery

Status end ‘18

Status end ’19 (projected)

Page 19: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

Positive ‘1690 data in patients

Flora

FVC stabilization over 12-week period

‘1690 600mg QDPlacebo

Placebo‘1690

BSLN=6N=17

*= p<0.05

4N=3N=16

8N=4N=15

12N=4N=13

FUN=4N=15

Page 20: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

ISABELA participating countries

* As on Nov 8, 2019

Page 21: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

ISABELATimeline

2019 2020 2021 2022

Nov 2019

500 patients randomized

2023

Q1 2021

futilityoutcome

toplinedata

Page 22: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

ISABELA, innovative program in IPF

Largest IPFprogram thus far

Assesses efficacy & safety in real world setting

Controlled data on medically-relevant, hard endpoints like changes in FVC, mortality rates, respiratory-related hospitalizations and PROs

Large safety dataset in 1500 patients over 52 weeks or longer

Page 23: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

• novel, undisclosed target

• dual action on inflammation

• IBD models show strong activity

• Ph1 started with ‘3312 & ‘3970

Toledoin inflammation

Page 24: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

Promising preclinical results with ‘3312

Impressive activity of Toledo in 3 IBD models with different mechanisms

DSS model MDR1 model

healthy

diseased

int. control

*p < 0.05; ***p < 0.001

***

***

***

Toledo

disease activity index (AUC)

T-cell transfer model

***

***

*** ***

*

***

healthy

diseased

IL-12p40 Ab

Toledo

healthy

diseased

abatacept

Toledo

Page 25: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

Efficacy in arthritis models with ‘3970

Source: internal data on file

clin

icalsc

ore

AU

C (

D32-D

47)

***p < 0.001

diseased ‘3970

clin

icalsc

ore

AU

C (

D7-D

44)

diseased ‘3970

*** ***

Robust efficacy demonstrated across preclinical models of arthritis with 2nd gen Toledo

***p < 0.001

CIA model PsA model IL-23-induced

Page 26: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

TOLEDO’s expanding family

TOL1

TOL2

TOL3

Different selectivity profiles

• ‘3312 pan-TOL

• ‘3970 TOL2 & TOL3 selective

‘3312

‘3970

Third candidate nominated

• ‘4399 TOL3 selective

‘4399

Page 27: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

Activity across generations & indications

Green: activity; Salmon: insufficient activity

2020 2020

2020

‘3312PanTOL

TOL2/3

TOL3

‘3970

‘4399

2020

LO

2020

5th gen

4th gen

LO

2020

• On track to develop multiple candidates across different selectivity profiles

• Robust activity in broad panel of in vivo disease models

• Plan multiple PoC’s with ‘3970 in patients in 2020

IBD RA Pso PsA SLE OA OP Fib

Page 28: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

Outlook

Page 29: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

Going forward

Build commercial infrastructure EU

• Big5 + Benelux for filgotinib• Whole of Europe for others

Progress pipeline

Expand organization

• Double R&D• Grow support departments• Expand facilities

Page 30: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

Growing geographic footprintBuilding out a European commercial presence

2020-2021

• Benelux

• France, Italy, Spain

• UK, Germany Germany

UK

Page 31: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

Growing geographic footprintBuilding out a European commercial presence

2020-2021

• Benelux

• France, Italy, Spain

• UK, Germany

Europe

2022-2023

• Roll out in rest of Europe

• Future products

Page 32: Novel targets, better treatments - Jefferies · All statements herein speak only as of the release date of this document. Galapagos expressly disclaims any obligation to update any

We are pioneering for patients.

Exploring new frontiersto improve people’s lives.

We discover. We dare.We care.

Pioneeringfor patients