investor relations slides | sept 2021

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Investor Relations slides | Sept 2021

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Page 1: Investor Relations slides | Sept 2021

Investor Relations slides | Sept 2021

Page 2: Investor Relations slides | Sept 2021

2

Disclaimer

This presentation contains forward-looking statements, including (without limitation) statements concerning the rate and timing of our cash burn, the progress of our refocused R&D and clinical pipeline, theexecution of our savings program, the global R&D collaboration with Gilead, Galapagos' strategic R&D ambitions, including progress on our fibrosis portfolio, oral therapeutics and SIK platform, ourexpectations regarding commercial sales of Jyseleca and rollout in Europe, the amendment of our arrangement with Gilead for the commercialization and development of Jyseleca, the timing and/or outcomeof the strategic re-evaluation and of the cash burn guidance 2021, the amount and timing of potential future opt-in and/or royalty payments by Gilead, interactions with regulatory authorities, the timing orlikelihood of additional regulatory authorities’ approval of marketing authorization for filgotinib for RA, UC or any other indication, including UC and IBD indications for Jyseleca in Europe, Great Britain, Japan,and the US, such additional regulatory authorities requiring additional studies, the timing or likelihood of pricing and reimbursement interactions for filgotinib, the build-up of our commercial organization forfilgotinib, changes in our management board and key personnel, our ability to effectively transfer knowledge during this period of transition, the search and recruitment of a suitable successor to lead ourorganization and for the CSO role, the risk that Galapagos will be unable to successfully achieve the anticipated benefits from its leadership transition plan, the timing and likelihood of potential futurebusiness development opportunities, the impact of COVID-19, our beliefs regarding the inflammation market, and our strategy, business plans and focus, the slides captioned ”Current valuation anopportunity,” “Delivering on strategic review,” “Cash burn peak expected this year,” “Outlook 2022 & 2023,” “Jyseleca franchise in Europe,” "Jyseleca market performance on target," "Filgotinib in Europe,"“Differentiated pipeline,” including list of compounds, “TYK2 unlocking new class of oral therapeutics,” “SIKi: potential novel MOA in inflammation,” "Potential broad application in inflammaiton," and “Outlook2021,” statements regarding the expected timing, design and readouts of ongoing and planned clinical trials, including (without limitation) (i) with filgotinib in RA, UC, CD, and other potential indications, (ii)with GLPG4716 in IPF, (iii) with the SIK2/3 program, including with GLPG3970 in systemic lupus erythematosus and primary Sjögren's syndrome (iv) with GLPG3667 in Pso and UC, (v) with GLPG555 in OA,(vi) MANTA/MANTA-Ray trials with filgotinib,(vii) with GLPG2737 in APCKD, (viii) with GLPG4586 and GLPG4605 in fibrosis, (ix) with GLPG3121 in IBD, and expectations regarding the commercial potential ofour 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 industryresults, 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 indifferences are the inherent uncertainties associated with competitive developments, clinical trial and product development activities, regulatory approval requirements (including the risk that data fromGalapagos’ ongoing and planned clinical research programs in RA, Crohn’s disease, UC, IPF, OA, other inflammatory indications, and kidney disease may not support registration or further development of itsproduct candidates due to safety, efficacy or other reasons and the uncertainties relating to the impact of the COVID-19 pandemic), the possibility that Galapagos will encounter challenges retaining orattracting talent, the risk that Galapagos will not be able to continue to execute on its business plan, reliance on third parties (including Galapagos’ collaboration partner Gilead), the timing of and the risksrelated to implementing the amendment of our arrangement with Gilead for the commercialization and development of filgotinib, estimating the commercial potential of our product candidates, andGalapagos’ expectations regarding the costs and revenues associated with the transfer of European commercialization rights to filgotinib may be incorrect. 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 and subsequent filings with the SEC.Given these uncertainties, you are advised not to place any undue reliance on such forward-looking statements.

Except for filgotinib's approval for the treatment of RA by the European Commission, Great Britain's Medicines and Healthcare Products Regulatory Agency and Japanese Ministry of Health, Labour andWelfare, our drug candidates are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority.

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 reflect any change in future developmentwith 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: Investor Relations slides | Sept 2021

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Current valuation and opportunity

Note: based on cash position last reported for 30 June 2021

MarketCapCash €5.0B

Inve

stm

en

t ca

se

BD opportunities

€5.0B cash & long term GILD collaboration

Deep pipeline in inflammation & fibrosis

Jyseleca franchise in Europe

Page 4: Investor Relations slides | Sept 2021

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Gilead-Galapagos R&D collaboration 201910 years, independence anchored

¹ Includes $1.1B equity investment at deal closing plus exercise of Initial Warrant A

• Access to compounds, assays, libraries & expertise

• Gilead option opportunity after Ph2b

• $3.95B upfront plus opt-in fees & milestones

• $1.5B equity investment¹, 25.5% share

• 20+% royalties US/RoW, Galapagos full European rights

Page 5: Investor Relations slides | Sept 2021

5

R&D

Progress refocused pipeline

Commercial

Roll out Jyseleca in Europe

BD

Scout for opportunities

Financial

Execute on savings program

Delivering on strategic review

Recruiting new CEO and CSO

Page 6: Investor Relations slides | Sept 2021

6

Cash burn peak expected this year

Note: these are management projections and analysis excludes prepaid R&D for Jyseleca and any impact from potential BD

6

2021

Jyselecaburn

R&D burn

Jyselecacontribution

~€600M

2024 2027-2028

~€350M~30%

~70%

pipeline

2022 2023

topline3x

Ph2-Ph3 break-even peak sales

Page 7: Investor Relations slides | Sept 2021

7

Outlook 2022 & 2023

7

2022

Jyseleca franchise growth, rebuild pipeline

2023

Emerging late stage pipeline

• Topline MANTA/RAy 52w

• Potential launches Jyseleca UC in EU/JP

• Topline ‘555 OA Ph1b

• Topline SIK2/3i Ph1

• Start TYK2 ‘3667 Pso/UC Ph2

• Start chitinase ‘4716 IPF Ph2

• Topline filgotinib CD Ph3

• Topline ‘2737 PCKD Ph2

• Topline TYK2 ‘3667 Pso Ph2

• Start SIK2/3i Ph2

Page 8: Investor Relations slides | Sept 2021

8

Jyseleca franchise in Europe

Preferential JAK1 inhibitor

Reimbursed for RA in 12 EU countries

Filed for UC in EU & JP

Global Ph3 for CD nearly recruited

Target €500m peak sales, break-even by 2024

Launch progressing according to plan

Note: launch since Q4 2020

Page 9: Investor Relations slides | Sept 2021

9

JAKi RA market shareincreasing in EU5

64% 61% 58% 58%

5% 10% 15% 16%

31% 28% 26% 26%

Jun'18 Jun'19 Jun'20 Jun'21

Anti-TNF JAKi Other biologics

Source: IQVIA LRX June 2021, Jyseleca approved for patients who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs)

0%

1%

2%

3%

4%

5%

Oct'20

Nov Dec Jan'21

Feb Mar Apr May

Jyseleca

Jyseleca market performance on target

Source: Therapy Watch, Q2 2021

Germany RA dynamic market(switch & naïve)

Page 10: Investor Relations slides | Sept 2021

10

EU5 RA/IBD market today

RA: rheumatoid arthritis; CD: Crohn’s disease; UC: ulcerative colitis; AS: ankylosing spondylitis; PsA: psoriatic arthritis Source: IQVIA Analytic Link (MAT to Q2 2020) – est value by disease at ex mfr list prices. All biologics and tsDMARDs.

EU5 inflammation market accounts for approximately 68% of total EU market

EU5€5.7B

CD~1.7

UC~0.8

RA~3.2

Ambition: ≈€0.5B peak sales

8-12% market share for filgotinib

Page 11: Investor Relations slides | Sept 2021

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UC market still underserved

Source: UC Therapy Watch (Research Partnership) Q2 2020. Share of prescriptions

UC market in EU5

36%

44%

3%7%

Anti-TNF branded Anti-TNF biosimilars

tofacitinib vedolizumab

Remission still challenging

• Induction: ~20% in bio-naive, ~10% in bio-IR

• Maintenance 1yr: 35-45%

Page 12: Investor Relations slides | Sept 2021

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Filgotinib in EuropeA profitable business case

Peak sales (RA, and potentially UC, CD – 2nd half of 2020’s)

Contribution margin at peak (incl COGS, royalties, commercial expenses)

Full commercial structure in place

Break-even product contribution

Patent exclusivity

€500M

50%

2022

2024

2035

ESTIMATES

Page 13: Investor Relations slides | Sept 2021

13

GermanyLaunched Q4 20

“Additional benefit” status granted

FranceLaunched Q2 21

Female only (MANTA data to be submitted)

UKLaunched Q2 21

First advanced therapy recommended by NICE for moderate & severe RA

Spain & Italy Reimbursement Italy, Spain expected Q3

Rest of EuropeProgressing reimbursement as per label & in line with class

Launched in BeNeLux, Norway, Finland, Sweden, Austria, Ireland

On target 9 months after EMA approval

Jyseleca reimbursed in 12 EU countries for RA

Page 14: Investor Relations slides | Sept 2021

14

Placebo

Placebo

Ph3 DIVERSITY in CD

Filgotinib is not approved in CD by any regulatory authority

200mg

100mg

Induction endpoints W10

Biologic-naïve and experienced

Baseline

Biologic-experienced

Resp

onders

re-r

andom

ized

Week 11

Maintenance endpoints W58

200mg

100mg

Placebo responders remain on placebo

Long term extension study

Non-responders/worsening of disease: go to LTE

Ph3 DIVERSITY nearly recruited, topline in 2023

• Clinical remission (CDAI <150)• Endoscopic response (SES-CD score, reduction ≥50% from BSL)

Placebo

200mg

100mg

Placebo

Page 15: Investor Relations slides | Sept 2021

Deep pipeline

Inflammation & fibrosis assets based on novel targets

• Target discovery engine

• Large pipeline of diverse early-stage assets

Page 16: Investor Relations slides | Sept 2021

16

Target discovery approach

Adenoviral knock-down library

High throughput screening

Hits

Rescreen

To identify novel targetsHigh throughput

screening platformUsing core GLPG technology

Validation

Adenoviral KD library

Phenotypic screening assay

Page 17: Investor Relations slides | Sept 2021

17

Differentiated pipeline

PCKD

CD

Class Phase 1 Phase 2 Phase 3

filgotinib

Ph2a in SLE; Sjö‘3970

Approval

‘4399

2 PCC

Asset

JAK1

SIK2/3

‘2737CFTR

‘3667TYK2

‘4716

‘4586

IPFChitinase

Undisclosed

‘555 OA

JAK1/TYK2 ‘3121 IBD

SIK2/3 ‘4605

UC RA

Filing

SIK3

SIK2/3

Inflammation

Fibrosis

Kidney disease

Page 18: Investor Relations slides | Sept 2021

TYK2in inflammation

Portfolio aimed at TYK2 pathways

• ‘3667: selective TYK2 inhibitor ready for Ph2

• ‘3121: JAK1/TYK2 inhibitor in Ph1

Page 19: Investor Relations slides | Sept 2021

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TYK2 unlocking new class of oral therapeutics

• Mediator of IFN, IL-12, IL-23 signaling

• Potential in several autoimmune indications

• Promising tolerability profile

‘3667 is a proprietary, selective TYK2 inhibitor

TYK2 inhibition

IFNα/β IL-12 IL-23

TYK2

Pro-inflammatory mediators

p-STAT

Page 20: Investor Relations slides | Sept 2021

20

Positive topline with ‘3667 in Pso Ph1b

• Generally well tolerated

• Positive signal in Pso at W4

➢ 4/10 PASI 50 response with high dose vs 1/10 on placebo

➢ consistent activity across efficacy endpoints

➢ plateau not reached at 4 weeks

Note: DRF: dose range finder, PASI 50: a 50% reduction in the Psoriasis Area and Severity Index, Pso: psoriasis, UC: ulcerative colitis

Exploring higher doses in Ph1;

intend to launch Ph2b DRF in Pso, Ph2 in UC in 2022

Page 21: Investor Relations slides | Sept 2021

21

Clinical activity in Pso with ‘3667 at W4

Note: CFB: change from baseline

PASI 50PASI 75

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

-100% -75% -50% -25% 0% 25%

% o

f su

bje

cts

ach

ievin

g %

CFB o

r le

ss

PASI %CFB

3667 (high dose) (N=10) 3667 (low dose) (N=11) Placebo (N=10)‘ ‘

Page 22: Investor Relations slides | Sept 2021

SIKin inflammation

Dual action in inflammation

• Novel, SIK target

• Preclinical models show strong activity

• Confirmed SIK activity in patient studies

• Additional SIK2/3 molecule in Ph1 in 2022

Page 23: Investor Relations slides | Sept 2021

23

SIKi: potential novel MOA in inflammation

• GLPG elucidating role of SIKi in inflammation

• Compounds with multiple selectivity profiles

• Potential broad applicationAdaptor proteins

SIKs

HDACs CRTCs

SIK inhibition

CREB

CRTCs

HDACs

NFκB

Pro-inflammatory mediators

Regulatory mediators

Page 24: Investor Relations slides | Sept 2021

24

TNFIL-12IL-1

IL-10

TNFIL-12IL-23

IL-10IL-2IFN TNF IL-10

MCs/M

Potential broad application in inflammation

DCs T cells B cells

InnateAdaptive

Innate

Broad cellular activity with Toledo on both innate and adaptive immune cells

Page 25: Investor Relations slides | Sept 2021

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Biologic activity of SIKi in 6W patient studies

Note: ER: Endoscopic Response, MCS: Mayo Clinic Score

• ‘3970 generally well tolerated

• CALOSOMA in Pso: improvement in PASI score

➢ 4/13 PASI 50 response at W6 vs 0/10 on placebo, activity across efficacy endpoints

• SEA TURTLE in UC: signs of biologic activity on objective endpoints

➢ no signal on MCS

➢ 7/18 ER vs 1/9 on placebo

• LADYBUG in RA: no signal

Page 26: Investor Relations slides | Sept 2021

26

Clinical activity in Pso with ‘3970 at W6

Note: CFB: change from baseline

PASI 50PASI 75

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

-100% -75% -50% -25% 0% 25%

% o

f su

bje

cts

ach

ievi

ng

%C

FB o

r le

ss

PASI %CFB

3970 (N=13) Placebo (N=10)

Page 27: Investor Relations slides | Sept 2021

27

4

5

6

7

8

9

Placebo 3970

Total MCS with ‘3970 at W6 in UC

Note: BSL: Baseline, MCS: Mayo Clinic Score

No differentiation from placebo on total MCS at W6

% C

FB t

ota

l M

CS

BSL W6

No difference from placebo on composite Mayo Clinic Score

Page 28: Investor Relations slides | Sept 2021

28

Signal on objective endpoints with ‘3970 in UC

Note: ER: Endoscopic Response, histology as measured by the Robart’s Histology Score (RHI)

BSL W6

His

tolo

gy s

core

(re

ctum

)

% p

atients

with E

ndosc

opic

Im

pro

vem

ent

(0 o

r 1 o

n E

R s

core

)

• Endoscopic Improvement supported by histology results

0

10

20

30

40

Placebo (N=1)

0

20

40

60

80

100

1

Placebo (N=9) 3970 (N=18) ‘3970 (N=7)

Page 29: Investor Relations slides | Sept 2021

29

Biologic activity of SIKi in 6W patient studies

• Encouraging topline results of first SIK2/3 patient studies with ‘3970

➢ additional efficacy and biomarker analysis ongoing

• Data package points to role of SIK2/3 in inflammation

• Design SIKi compounds with higher target engagement

Data support further development of SIK portfolio; aim to start Ph1 HV with SIK2/3 follow-up in 2022

Page 30: Investor Relations slides | Sept 2021

Kidney disease

Autosomal dominant kidney disease (ADPKD)

• Cyst growth leading to kidney failure

• ‘2737 (CFTR inhibitor) in Ph2

• No cure (tolvaptan, dialysis, transplant)

• Tolvaptan (Jynarque® marketed by Otsuka) 2020 global sales $750M

Page 31: Investor Relations slides | Sept 2021

31

MANGROVE Ph2 in polycystic kidney disease

Note: eGFR: Estimated Glomerular Filtration Rate (eGFR)

• Adults with rapidly progressing ADPKD

• Primary endpoint: kidney volume, safety/tolerability

• Secondary: kidney function (eGFR), PK

52 weeks

Screening

‘2737 oral (n=40)

Placebo (n=20)Follow-up

4 weeks

Topline expected 2023

Page 32: Investor Relations slides | Sept 2021

ABBV guides for Ph2 CF patient data with triple combo

• GLPG sold CF portfolio to ABBV in 2018

• Tiered single to low double-digit royalties in global sales of CF products

• Up to $175M in additional milestones

Cystic fibrosis

Page 33: Investor Relations slides | Sept 2021

33

Outlook 2021

33

• DIVERSITY recruited CD

• ‘2737 PCKD recruited by YE21

Outcomes Trial progress

• ‘3667 (TYK2) Ph1b Pso

• SIK2/3 ‘3970 Pso/UC/RA

• EU positive CHMP opinion

• EU approval decision UC

Page 34: Investor Relations slides | Sept 2021

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