Galapagos PowerPoint Template (Confidential)2
Disclaimer
This presentation contains forward-looking statements, including (without limitation) statements concerning the progress of our clinical pipeline, the slides captioned “We go step by step on commercial” “Prolific late stage pipeline” “R&D ambit ion” “FINCH Phase 3 design for RA” “We build a filgotinib franchise” “Differentiated profile of filgotinib” “Inflammation market ~$65B by 2027” “Our ambition with filgotinib” “$1.9B market with large unmet needs” “We are building a fibrosis portfolio” “Phase 3 program ISABELA 1&2” “PINTA Phase 2 trial in IPF” “’1972 for osteoarthritis (OA)” “ROCCELLA Phase 2 trial” “MOR106 in atopic dermatit is” ”IGUANA Phase 2 trial” “MOR106 Ph1b bridging trial” “Toledo in inflammation” “Promising preclinical results” “Our Toledo development strategy” “Partnerships” “Expected news in
2019” “Invest in GLPG,” 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, (v) with MOR106 in atopic dermatit is and other potential indications, 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, financ ial condition, performance or achievements of Galapagos, or industry results, to be materially different from any future results, financ ial conditions, performance or achievements expressed or implied by such forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, clinical trial and product development activities, regulatory approval requirements (including that data from the company's development programs may not support registration or further 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 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.
All statements herein speak only as of the release date of this document. Galapagos expressly disc laims any obligation to update any statement in this document to reflect any 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.
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Application for 1st commercial product planned in 20th anniversary year
2000 2005 2010 2015
2012 1st clinical PoC
Headquarters Mechelen, Belgium
employees
702
1690 IPF global scale, independent launch
collaborations as opportunity
filgotinib top EU markets
Filgotinib
IPF/fibrosis
OA
AtD
10+ indications, more pivotal readouts in ‘19
Ph2 underway
>20 programs
Ph2b underway
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Area Phase 1 Phase 2 Phase 3 Status
rheumatoid arthritis recruited
Phase 3 FINCH program in RA 100 and 200 mg
FINCH 1: MTX - IR ACR20 at W12 MTX add-on adalimumab control radiographic assessment
1,759 52 weeks
448 24 weeks ACR20 at W12 cDMARD add-on
FINCH 3: MTX naive 1,252 52 weeks ACR20 at W24 monotherapy, +MTX arms radiographic assessment
FINCH 1 and FINCH 3 topline expected in Q1 ‘19
FINCH 2: biologic - IR
BEYOND, 2017, W12)
BEYOND, 2017, W12)
W12
% responders
2mg QD 4mg QD 5mg BID 10mg BID 15mg QD 30mg QD100mg QD 200mg QD
filgotinib FINCH 2 cDMARDs
Note: Data not from head-to-head studies, comparisons may be inaccurate.
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filgotinib, 24-week period # of events
upadacitinib, 24-week period # of events
100 mg QD 200 mg QD 15 mg QD 30 mg QD
Event type N=153 N=148 N=236 N=240
SAEs 8 6 18 22
opportunistic infections - - 1 3
DVT/PE - - 3 1
deaths - - 1 1
Note: Data not from head-to-head studies; comparisons may be inaccurate. Note: Upadacitinib patient numbers refer to the patients initially randomized to drug, 15mg: 164, 30mg: 165, plus the number of placebo patients switched to drug in the second part of the study, 15mg: 72, 30mg: 75, and does not include dropouts, based on the SELECT-BEYOND publication (Genovese et al, The Lancet, 2018.)
FINCH 2 SELECT-BEYOND
pbo 2mg qd 4mg qd pbo 5mg bid 10mg bid
pbo 6mg bid 12mg bid
18mg bid
filgotinib baricitinib tofacitinib upadacitinib
Note: data from separate RA studies not conducted by the Company, comparisons may be inaccurate 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.
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Note: data from separate RA studies not conducted by the Company, comparisons may be inaccurate filgotinib – Westhovens et al, and Kavanaugh et al, ARD 2016; baricitinib – FDA briefing documents bariciitinib AdComm 23 April 2018; tofacitinib – Van Vollenhoven abstract 2014, median CFB at W6; upadacitinib – Genovese et al A&R 2016 BALANCE 2.
No reduction of natural killer cells
NK cells, mean CFB (%), W12
-50
-40
-30
-20
-10
0
10
pbo 2mg qd 4mg qd pbo 5mg bid 15mg bid
pbo 6mg bid 12mg bid
18mg bid
10mg bid
m b
a se
lin e (
1 0
9 /L
)
Note: data from separate RA studies not conducted by the Company, comparisons may not be accurate 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
event per
100 PYE
filgotinib baricitinib tofacitinib upadacitinib tocilizumab adalimumab
50-200 mg 2 and 4 mg QD 5 mg BID 6 and 12 mg BID 4 and 8 mg/kg
DARWIN3 wk132
serious infection
herpes zoster 1.5 3.2 3.8 3.7 ND ND
DVT/PE 2/2,042*
0.1 31/6,754
0.5 3/1,849
deaths 0.2 0.3 0.6 0.3 0.6 0.8
*: one single patient experiencing DVT and PE DVT/PE = deep venous thrombosis/pulmonary embolism Note: data not from head-to-head studies, comparisons may not be accurate Tofacitinib DVT/PE data from Mease, ACR2017 (5mg bd), and death data from 2012 FDA Medical review Baricitinib: DVT/PE Weinblatt ACR 2017
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• Reduction of platelets & low incidence of thromboembolic events
JAK1 selectivity makes the difference
Note: Profile indicated here is based on Ph2 filgotinib data, no head-to-head comparison studies, filgotinib is an investigational drug candidate.
Phase 3 program in IBD 100 and 200 mg
DIVERSITY 1 PRO2, endoscopic response Induction & maintenance
Crohn’s Ph3 1,320 pts
58 weeks
UC Ph3 1,300 pts
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• oral and monotherapy
• differentiation vs. biologics
Source: Goldman Sachs 2017, Leerink 2017, Stifel 2017, Global Data, Galapagos estimates
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MS change Q3 2018 vs Q3 2016
-2.2%
-2.9%
-1.0%
3.4%
Humira
Enbrel
Xeljanz
Olumiant
Remicade
97% 86%
3%
Source: Gilead and Galapagos analysis on IPSOS data, share of prescriptions
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Germany – RA market
monotherapy
Note: Potential indicated here is based on Ph2 filgotinib data, no head-to-head comparison studies, filgotinib is an investigational drug candidate.
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Progressive lung fibrosis
leading to death
• Median survival 2-5 years
2017 drug sales: $1.9B
nintedanib & pirfenidone have limitations
pirfenidone nintedanib
Sources: Global Data, Maher et al. BMC Pulmonary Medicine (2017) 17:124, sales figures from Roche and Boehringer Ingelheim
Note: FVC = Forced vital capacity
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‘1690 (autotaxin) ISABELA IPF
‘1205 (GPR84) PINTA IPF
• Opportunity to combine • Several fibrosis programs in discovery
Status end ‘18
FVC stabilization over 12-week period, ‘1690 well-tolerated
Flora
‘1690
N=4
FVC (Δ baseline, mL) +116 -87 +15 -140 +8 -87 -55 -205
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• BMS-986020 reduced FVC decline
• BMS-986020 inhibits LPA1
-160
-140
-120
-100
-80
-60
-40
-20
Source: Chest. 2018 Sep 7. pii: S0012-3692(18)32411-5.
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Topline Part 1 expected Q3 ‘18 ‘1690 600mg
placebo
• 1500 IPF patients total in two identical Phase 3 studies
• Patients remain on standard of care throughout
• Global program with US & EU component
• Primary endpoint: FVC at 52 weeks
• Secondary: hospitalizations, mortality, quality of life, safety/tolerability
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GLPG1205, 100mg once daily (n=40) screening
26 weeks
follow- up
• Primary endpoint: forced vital capacity (FVC) at 26 weeks
• Secondary: safety, tolerability, broad range of measurements, incl. FRI
• Recruitment in 10 countries in Europe, North Africa, & Middle East
placebo (n=20)
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• Multi-organ (“systemic”) fibrosis
• No approved anti-fibrotic drugs3
1Global Data 2014; 2 Nikpour et al Curr Opin Rheumatol. 2014; 3Denton et al Lancet 2017
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24 weeks
screening follow-up
• Recruitment in US & 5 EU countries
• Primary endpoint: modified Rodnan Skin Score at 24 weeks
• Secondary & exploratory endpoints: safety, tolerability, broad range of measures (FVC, QoL, CRISS)
‘1690, 600mg oral once daily (n=20)
4 weeks
• No disease-modifying drugs
cartilage
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-20
0
20
40
60
A R
G S
Reduction of ARGS ‘1972 Phase 1b study in OA patients
Dose-dependent reduction of ARGS, well-tolerated in OA patients
s e
ru m
A R
G S
placebo
• Primary endpoint: reduction in cartilage loss at 52 weeks
• Secondary: change in structural and clinical parameters, safety/tolerability
FDA granted fast track status Recruitment completion targeted Q4 ‘19
‘1972 dose A
MOR106 in atopic dermatitis
Chronic inflammatory skin disorder
• Affects up to 20% of children and 1 to 3% of adults
• 35M patients in US, Europe & Japan
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MOR106 Phase 1b trial EASI, % change from baseline, pooled data, median
-100
-80
-60
-40
-20
0
% c
placebo
MOR106
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MOR106, 3mg/kg
• ~240 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 from baseline in EASI score at week 12
MOR106, 10mg/kg
• Recruitment in EU
Screening 16 week follow-up
s.c. 320mg, n=30
s.c. placebo, n=15
12 weeks, bi-weekly dosing, loading dose D1
Part 1, healthy volunteers
• ‘3312 Ph1 started
• start Ph1 with ‘3970 (2nd gen Toledo) planned in H2
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Promising preclinical results
Impressive activity of Toledo in 3 IBD models with different mechanisms
DSS model MDR1 model
• Test in broad panel of in vivo disease models
• Plan multiple PoC’s in patients in parallel to maximize potential
2019 2019 2019
2019 2019 2019
LO
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Partnerships Gilead: filgotinib
$725M upfront $1.35B milestones 20-30% royalties profit-split, co-promote in 8 EU countries
Servier: ‘1972
Novartis: MOR106
$111M upfront, $1B milestones low-teens – low twenties royalties all development paid MorphoSys: 50/50 cost/benefit
AbbVie: CF
Note: all milestones are potential
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• FY19 cash burn guidance €320 – 340M
increase in spending in filgotinib, ‘1690, and other proprietary programs
expansion of the team to deliver on our deep clinical pipeline
setting up commercial organization to support potential launch as of 2020
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H1 H2
filgotinib SELECTION Ph3 recruited Sjögren’s Ph2 recruited CLE Ph2 recruited lupus nephropathy Ph2 recruited FINCH 1 topline wk 24 FINCH 3 topline wk 24 FINCH 2 manuscript publication
Sjögren’s PoC topline CLE PoC topline Ph3 PsA start applications for approval in RA
fibrosis 1st dosing NOVESA Ph2 ‘1690 PINTA Ph2 recruited ERS ACS (structure ‘1205)
‘1972 OARSI symposium ROCCELLA Ph2b recruited
MOR106 GECKO Ph2 start/IND opening Japan study start
IGUANA Ph2 primary analysis SQ bridging topline
earlier programs
start Ph1 ‘3312 (1st gen Toledo) start Ph1 ‘2534, ‘3121
topline ‘3312, ‘2534, ‘3121 start ‘3970 Ph1 (2nd gen Toledo) start PoC ‘3312 in IBD
Boldface = new data
Proven platform, deep pipeline
Moving toward commercial stage
Substantial newsflow expected