©Copyright 2015 Galapagos NV

DARWIN 1 Final filgotinib study results

30 July 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 topline 24-week results from the DARWIN 1 and/or DARWIN 2 trials and expectations regarding the commercial potential of our product candidates, 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 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 and reflect the then available data, whichmight be subject to changes in light of future results, events, conditions and/or circumstances. Galapagos expressly disclaims any obligation to update any statement in this document to reflect any change or future development with respect thereto, anyfuture results, or any change in events, conditions and/or circumstances on which any such statement is based, unless required by law or regulation.

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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• Oral administration

• Highly efficacious on patient relevant parameters (ACR50, ACR70, DAS28 remission)

• Rapid onset of action

• Safe & well tolerated

What are patients looking for in RA treatment?

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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 final Ph2B results

Deal with AbbVie

6

Selectivity mattersFilgotinib is the selective JAK1 inhibitor

0

10

20

30

baricitinib tofacitinib filgotinib

Ratio JAK1/JAK2 in human whole blood assay

(GLPG0634)

Hbrecovery¹

anemia

¹A Pardanani, et al, Leukemia (2013) 27, 1322–1327

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• High response rates

clear dose response, consistent across read-outs

fast onset of action (ACR response & subscores)

high ACR50 & ACR70 responses

• Safety (AEs): no dose effect, low AE/SAE rate

increased hemoglobin of particular interest in population

lipids: higher percentage increase in HDL than LDL

DARWIN 1 week 12 conclusions

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Competitor dataACR responses at week 24

% 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

Note: data reported in listed publications, not resulting from head-to-head studies.

active treatment

placebo

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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) and ≥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 criteria

* ULN = 9 mg/L

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Patient dispositionScreenedN=1276

RandomizedN=599

PlaceboN=86

Randomized & exposed

N=594

Not exposedN=5

Not eligible at screeningN=677

50 mgN=82

100 mgN=85

200 mgN=86

2x25 mgN=86

2x50 mgN=85

2x100 mgN=84

PlaceboN=53

100 mgN=15

2x50 mgN=15

50 mgN=57

100 mgN=19

100 mgN=78

200 mgN=80

2x25 mgN=60

2x50 mgN=17

2x50 mgN=80

2x100 mgN=83

W13-24

W0-12

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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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Early discontinuationsWeek 0-24

Categories are not mutually exclusive

Low discontinuation rate, equally distributed across groups

placebo only(N=56)

filgotinib exposed (N=538)

Safety 3.6% 3.9%

Efficacy 0.0% 0.6%

Other 7.1% 6.1%

Total 10.7% 10.2%

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ACR20ITT-NRI

Placebo

50 mg

100 mg

200 mg

2x25 mg

2x50 mg

2x100 mg

Subjects who switch treatment at week 12 are handled as if they discontinued at week 12.

45

56

62

70

57 59

80

42

5560

73

5660

80**

***

***

***

0

10

20

30

40

50

60

70

80

90

100

W12 W24

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

% responders

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ACR50ITT-NRI

% responders

Subjects who switch treatment at week 12 are handled as if they discontinued at week 12.

Placebo

50 mg

100 mg

200 mg

2x25 mg

2x50 mg

2x100 mg15

32

39

43

28

34

55

17

35

46

50

35 35

55

*

*

* * * *

**

***

***

***

***

***

0

10

20

30

40

50

60

70

W12 W24

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

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ACR70ITT-NRI

% responders

Subjects who switch treatment at week 12 are handled as if they discontinued at week 12.

Placebo

50 mg

100 mg

200 mg

2x25 mg

2x50 mg

2x100 mg

8

16

20

24

14

19

31

9

22

33

29

21

24

39

** *

*

****

**

***

0

5

10

15

20

25

30

35

40

45

50

W12 W24

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

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ACR70 at week 24

% responders

Note: data reported in listed publications, not resulting from head-to-head studies.Ph3/marketed dose (competitors) vs best Ph2 dose (filgotinib)

0

5

10

15

20

25

30

35

40

45

50

tofacitinib 5 mg bid(n= 71)

Kremer 2012

sarilumab 200mg E2W(n=399)

Genovese 2015

adalimumab 40 mg EOW(n=67)

Weinblatt 2003

baricitinib 4 mg qd(n=52)

Keystone 2014

filgotinib 100 mg bid(n=84)

DARWIN1 2015

active treatment

placebo

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ACR responsesITT-NRI, at week 24

% responders

Placebo

50 mg

100 mg

200 mg

2x25 mg

2x50 mg

2x100 mg

Subjects who switch treatment at week 12 are handled as if they discontinued at week 12.

42

55

60

73

5660

80

17

35

4650

35 35

55

9

22

3329

2124

39* * *

* **

****

***

***

******

***

***

0

10

20

30

40

50

60

70

80

90

100

ACR20 ACR50 ACR70*: p<0.05; **: p<0.01; ***: p<0.001

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-3.5

-3.0

-2.5

-2.0

-1.5

-1.0

-0.5

0.0

0 4 8 12 16 20 24Week

bid vs placebo

Placebo 2x25 mg 2x50 mg 2x100 mg

DAS28(CRP)ITT-LOCF

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

Subjects who switch treatment at week 12 are handled as if they discontinued at week 12.

mean CFB

**

***

***

***

***

***

***

***

*

**

***

**

***

***

**

***

*** ***

***

***

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DAS28(CRP) Non-responders at week 12 switching to 100 mg/day

-3

-2.5

-2

-1.5

-1

-0.5

0

0.5

0 4 8 12 16 20 24

Week

Placebo to 100 mg Placebo to 2x50 mg 50 mg to 100 mg 2x25 mg to 2x50 mg

switch

mean CFB

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DAS28(CRP)ITT-LOCF, at week 24: remission rate & low disease activity

Subjects who switch treatment at week 12 are handled as if they discontinued at week 12.

9

21

36

2623 24

40

9

12

1426

16 14

24

*

***

******

***

0

10

20

30

40

50

60

70

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

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

Remission <2.6 (%) Low disease activity [2.6,3.2] (%)% responders

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DAS28(CRP)ITT-LOCF, at week 24: remission rate & low disease activity

% responders

Note: data reported in listed publications, not resulting from head-to-head studies.Ph3 dose (competitors) vs best Ph2 dose (filgotinib)

0

10

20

30

40

50

60

70

baricitinib 4 mg qd (n=52)Keystone 2014

sarilumab 200mg E2W (n=399)Genovese 2015

filgotinib 100 mg bid (n=84)DARWIN1 2015

Remission <2.6 (%) Low disease activity [2.6,3.2] (%)

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Overview safety endpointsWeek 0-24

Subjects with:placebo only

(N=56)filgotinib exposed

(N=538)

TE AE 57.1% 52.6%

Serious TE AE 7.1% 2.0%

Serious TE infection 1.8% 0.9%

SAE leading to death 0.0% 0.2%

TE AE leading to stop 3.6% 3.3%

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TEAEs of special interestWeek 0-24

* non fatal and not considered drug related

Subjects with:placebo only

(N=56)filgotinib exposed

(N=538)

All infections 17.9% 25.5%

All serious infections 1.8% 0.9%

Herpes zoster 1.8% 0.7%

Urinary tract infections 1.8% 3.7%

Upper RTI 1.8% 3.7%

Pneumonia 0.0% 0.4%

MACE* 0.0% 0.4%

No cases of opportunistic infections, tuberculosis, malignancies or lymphoma

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SafetyWeek 0-24, change versus baseline

Parameter Measure

Hemoglobin increase up to 4%

Platelets decrease towards mid normal value

Lymphocytes no effect

Neutrophils decrease towards mid normal value

Creatinine increase up to 11%

ALT no CTCAE gr 3-4

Lipids increase of HDL (up to 23%) > LDL (up to 13%)

Male reproductive hormonesno clinically meaningful changes; no discontinuations

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Hemoglobin Data up to W24

Responder: at least 20% drop in TJC68 and SJC66 versus baseline

-6

-4

-2

0

2

4

6

8

0 4 8 12 16 20 24

Week

Continued groups (qd vs placebo)

Placebo in resp. 50 mg in resp. 100 mg 200 mg

mean % CFB

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• Fast onset of action

• Clear dose response

• No difference between bid and qd regimens

• Sustained high level of ACR20 and ACR50 response

• Further increase in efficacy over 24 weeks

ACR70 response

DAS28 CRP remission

DAS28 CRP low disease activity

Conclusions – efficacyWeek 0-24

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• Low drop out rate

• Similar incidence in TEAEs, SAEs and serious infections between filgotiniband placebo

• No dose dependent increase of infections

• Stabilization of decrease in neutrophils, increase in creatinine

• Safety profile consistent with data at week 12

• Confirmation of differentiated safety profile versus other JAKs in RA:

increase in Hb, HDL>LDL, no effect on lymphocytes

Conclusions – safetyWeek 0-24

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• Patients

• Investigators

• Team

• AbbVie

Thank you

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Filgotinib: DARWIN 2, license decision, FITZROY

Triple combo CF program on track to deliver

Strong balance sheet to support R&D

Fully owned programs in IBD/IPF

Proprietary target discovery to feed pipeline