©Copyright 2015 Galapagos NV

Week 12 study results

15 April 2015

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• This document may contain certain statements, including forward-looking statements, such as statements concerning the safety and efficacy of filgotinib following the 12-week results from the DARWIN 1 and 2 trials and the expected timing and announcement of topline 24-week results from the DARWIN 1 and 2 trials and expectations regarding the commercial potential of our product candidates, all of which involve certain uncertainties and risks.

• Forward-looking statements are often, but are not always, made through the use of words or phrases such as “believes,” “anticipates,” “expects,” “intends,” “plans,” “seeks,” “estimates,” “may,” “will,” “could,” “stands to,” “continues,” “we believe,” “we intend,” as well as similar expressions. Such forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause the actual results, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, performance or achievements expressed or implied by such forward-looking statements.

• Among the factors that may result in differences between the statements contained herein and the actual future results, performance or achievements, are the inherent uncertainties associated with competitive developments, clinical trial and product development activities, regulatory approval requirements and estimating the commercial potential of our product candidates. Given these uncertainties, you are advised not to place any undue reliance on such 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 or any change in events, conditions or circumstances on which any such statement is based, unless required by law or regulation.

• The 12-week results from the DARWIN 1 trial are based on the interim study database, reflect the then available data and respect the blinded nature of the ongoing clinical trial. The data might be subject to changes in light of the 24-week results from the DARWIN 1 trial.

Disclaimer

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1. Filgotinib: first-in-class oral in RA

2. Transformational CF therapies

4. Platform to fill pipeline

5. Strong financials & partnerships

3. Fully-owned Ph2 programs in IBD/IPF

Galapagos at a glance5 key aspects

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Filgotinib, a new mode of actionJAK1 discovered by us as target for bone & joint disease

Start Phase I trial

development

2005 2006 2007 2008 2009

PCC nomination

lead optimization

compound screening

JAK1 discovered using SilenceSelect®

2010 2011

Start PoC

PoC results

2012 2013 2014

Start Ph2A

Start Ph2B

2015

DARWIN 12w results

Deal with AbbVie

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• Oral administration

• Highly efficacious, measured as ACR50

• Rapid onset of action

• Safe & well tolerated

What are patients looking for in RA treatment?

6

• 4 JAK family members signal for cytokines and growth factors

JAK1 IFNs, IL-6, IL-2, IL-7, IL-15, IL-21, …

JAK2 IL-23, EPO, TPO, GM-CSF, GH, …

JAK3 IL-2, IL-7, IL-15, IL-21

TYK2 IL-12, IL-23

• JAK1 breaks the vicious cycle in autoimmune inflammation

Jakinibs

Multiple

cytokines

Court

esy

D

r. J

ohn J

. O

’Shea, N

IH, Beth

esd

aWhy JAK1 inhibition?

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Selectivity matters…Filgotinib is the selective JAK1 inhibitor

0

5

10

15

20

25

30

baricitinib decernotinib Xeljanz™ filgotinib

Ratio JAK1/JAK2 in human whole blood assay

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Filgotinib is a JAK1 inhibitor

• First selective inhibitor of JAK1

• Novel mode of action for treatment of RA

• Oral treatment, small molecule

• Favorable safety & efficacy profile in 4-week studies in RA

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Competitor dataACR responses at W12

active treatment

placebo

% responders

0

10

20

30

40

50

60

70

80

90

100

ACR20 ACR50 ACR70 ACR20 ACR50 ACR70 ACR20 ACR50 ACR70

adalimumab 40 mg EOWARMADA 2003

tofacitinib 5 mg bidKremer 2012

baricitinib 4 mg qdKeystone 2014

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W12analysis

primary endpoint

W24analysis

W0ScreeningDay -29 to Day -2

Placebo

25 mg bid

50 mg qd

50 mg bid

100 mg qd

100 mg bid

200 mg qd

DesignDouble-blind, MTX background

W12-24 treatment period

ONGOING

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• Primary

ACR20 response of any dose or dose regimen versus placebo at week 12

• Major secondary

ACR50, ACR70, ACR-N, DAS28(CRP), CDAI, and SDAI compared to placebo up to week 12

safety & tolerability

Objectives

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• Inclusion

diagnosis of RA since at least 6 months (2010 ACR/EULAR criteria of RA & ACR functional class I-III)

≥6 SJC (66 joint count) & ≥8 TJC (68 joint count)

screening serum CRP ≥0.7 x ULN*

MTX for ≥6 months on stable dose (15 – 25 mg/week)

• Exclusion

current therapy with any DMARD other than MTX

current or previous RA treatment with a biologic DMARD

Key eligibility criteriaComparable to other studies in moderate to severe RA patients

* ULN = 9 mg/L

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Largest Phase 2B study in RAEqual group sizes, low dropout rates

Screened N=1276

Randomized N=599

Randomized & exposed

N=594

Placebo

N=86

50 mg

N=82

100 mg

N=85

200 mg

N=86

2x25 mg

N=86

2x50 mg

N=85

2x100 mg

N=84

Not exposed N=5

Discontinuations (blinded): 6.4%

• for safety: 1.7%

• for efficacy: 0.2%

• for other: 4.7%

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Baseline characteristicsDemographics & disease

qd groups bid groups

Placebo 50 mg 100 mg 200 mg2 x

25 mg2 x

50 mg2 x

100 mg

Age, mean, years 52 53 52 55 52 55 54

Female 81% 84% 76% 86% 79% 76% 83%

Duration of RA, mean, years 8 7 8 9 9 8 10

DAS28(CRP), mean 6.0 6.1 6.1 6.2 6.1 6.1 6.1

CRP, mean, mg/L 16 28 25 27 26 25 27

TJC68, mean 25 25 25 29 25 27 26

SJC66, mean 16 17 16 17 16 18 16

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Patient distributionGeographically balanced

219

126

152

97

Latin America

West and Asia-Pacific

Central Europe

Eastern Europe

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Primary endpoint: ACR20 at W12ITT-NRI

Primary endpoint achieved

qd groups bid groups

Placebo 50 mg 100 mg 200 mg2 x

25 mg2x

50 mg2x

100 mg

ACR20 45% 56% 62% 69% 57% 59% 80%

p-value vs placebo (multiplicity-corrected)

0.17 0.11 0.01 0.17 0.17 <0.0001

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ACR responses at W12ITT-NRI

% responders

Placebo

50 mg

100 mg

200 mg

2x25 mg

2x50 mg

2x100 mg

45

56

62

69

57 59

80

15

32

3943

28

34

55

8

1620

24

1419

31

*

**

*

*

**

**

***

***

***

0

10

20

30

40

50

60

70

80

90

100

qd bid qd bid qd bid

*: p<0.05; **: p<0.01; ***: p<0.001

ACR20 ACR50 ACR70

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ACR responses at W12ITT-LOCF

% responders

Placebo

50 mg

100 mg

200 mg

2x25 mg

2x50 mg

2x100 mg

44

6064

71

58 59

80

15

32

3944

2934

56

8

16

22 24

1419

30

*

**

*

*

**

**

**

***

***

***

0

10

20

30

40

50

60

70

80

90

100

qd bid qd bid qd bid

*: p<0.05; **: p<0.01; ***: p<0.001

ACR20 ACR50 ACR70

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DAS28(CRP) ITT-LOCF

Mean change from baseline

*: p<0.05; **: p<0.01; ***: p<0.001

-3.0

-2.5

-2.0

-1.5

-1.0

-0.5

0.0

0 2 4 6 8 10 12

Week

bid vs placebo

Placebo 2x25 mg 2x50 mg 2x100 mg

***

***

***

***

***

***

***

**** **

*

-3.0

-2.5

-2.0

-1.5

-1.0

-0.5

0.0

0 2 4 6 8 10 12

Week

qd vs placebo

Placebo 50 mg 100 mg 200 mg

****

***

***

***

******

***

*

***

***

*

1 1

20

DAS28(CRP) at W12ITT-LOCF: remission rate & low disease activity

% responders

712

21 22

1518

36

7

12

1315

13 11

14

0

10

20

30

40

50

60

70

80

90

100

Placebo 50 mg 100 mg 200 mg 2x25 mg 2x50 mg 2x100 mg

Remission (%) Low disease activity (%)

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Subject Global Assessment VASITT-LOCF

Mean change from baseline

*: p<0.05; **: p<0.01; ***: p<0.001

-40.0

-35.0

-30.0

-25.0

-20.0

-15.0

-10.0

-5.0

0.0

0 2 4 6 8 10 12

Week

qd vs placebo

Placebo 50 mg 100 mg 200 mg

-40.0

-35.0

-30.0

-25.0

-20.0

-15.0

-10.0

-5.0

0.0

0 2 4 6 8 10 12

Week

bid vs placebo

Placebo 2x25 mg 2x50 mg 2x100 mg

*

*

*

*

*

*

***

*

**

****

***

***

***

*

11

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Overview of adverse events (AE)

• Low incidence of treatment-emergent AEs and SAEs, no deaths• Even distribution over dose groups, including placebo• Few serious treatment-emergent infections (0.5% - blinded)

50 mg/day 100 mg/day 200 mg/day

Placebo qd bid qd bid qd bid Total

Treatment-emergent AE 37% 41% 37% 31% 42% 44% 43% 39%

Serious treatment-emergent AE 2% 0% 1% 4% 0% 0% 2% 1%

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Hemoglobin & neutrophilsChanges from baseline at W12

0 0 50 mg/day 100 mg/day 200 mg/day

Placebo qd bid qd bid qd bid

Hemoglobin (g/L) -0.4 1.1 3.1 2.4 1.5 4.1 4.4

Neutrophils (giga/L) -0.1 -1.0 -0.6 -0.6 -0.8 -1.1 -1.6

• No discontinuations due to anemia or neutropenia• Hemoglobin increases• Normalization of neutrophils

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ALTWithin first 12 weeks of treatment

* Worst case TE CTCAE grades

Low incidence of grade 2, no grade 3-4

50 mg/day 100 mg/day 200 mg/day

Placebo qd bid qd bid qd bid Total

grade 1: ]1.0,2.5] x ULN * 4 (5%) 4 (5%) 6 (7%) 7 (8%) 6 (7%) 7 (8%) 4 (5%) 38 (6%)

grade 2: ]2.5,5.0] x ULN * blinded blinded blinded blinded blinded blinded blinded 4 (1%)

grade 3-4: > 5.0 x ULN * - - - - - - - -

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LDL vs HDL at W12

% change from baseline

-10

0

10

20

30

40

50

placebo 50 mg 100 mg 200 mg 2x25 mg 2x50 mg 2x100 mg

LDL HDL

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LipidsPercent change from baseline at W12

HDL increases with doseImproved total cholesterol/HDL ratio (atherogenic index) at 200mg/day

#REF!50 mg/day 100 mg/day 200 mg/day

Placebo qd bid qd bid qd bid

LDL -1.0% 5.8% 5.6% 5.7% 2.3% 8.0% 11.9%

HDL -0.1% 6.5% 5.7% 8.5% 9.3% 21.2% 23.1%

Total cholesterol/HDL -0.3% 1.5% 1.5% -0.5% -0.9% -6.9% -4.8%

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• Primary endpoint achieved

• All key efficacy endpoints achieved

• High ACR50 & ACR70 responses

• Fast onset within one week

• Safety profile is consistent with previous filgotinib RA studies

• Confirms rationale for JAK1

Conclusions

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• Patients

• Investigators

• Team

• AbbVie

Thank you

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DARWIN in upcoming months

• 24 week data July

• 12 week data beginning of May• 24 week data August

• 98% rollover rate from DARWIN 1&2

Add-on to MTX594 patients

Monotherapy287 patients

Long term extension

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Filgotinib: multiple Phase 2 readouts

CF program on track to deliver combination therapy

Strong balance sheet to support R&D

Fully owned programs in IBD/IPF

Proprietary target discovery to feed pipeline