Upload
others
View
1
Download
0
Embed Size (px)
Citation preview
We discover, we dare, we care
Investor Relations slides | May 2020
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, statements relating to interactionswith regulatory authorities, the potential approval process for filgotinib and statements relating to the build-up of our commercial organization, the impact of COVID-19,and our strategy, business plans and focus, the slides captioned “GLPG: success story with strong fundamentals” “Looking forward to a newsflow rich 2020” “Pipeline withsignificant newsflow in 2020” “Deep, early pipeline” “Filgotinib: potential for 5 launches in 4 years” “Global inflammation market $65B by 2027” “Filgotinib’s JAK1 inhibitionaddresses inflammation…” “…without liabilities of off-target effects” “Filgotinib: GLPG’s commercial footprint” “Building an IPF & fibrosis portfolio” “ziritaxestat pathwayclinically validated” “ISABELA timeline” “PINTA Phase 2 in IPF” “NOVESA Phase 2 in SSc” “ROCCELLA Phase 2b trial” “Toledo robust activity in in vivo models” “Strongfinancials” “A newsflow rich 2020” “Pioneering for patients,” all slides pertaining to the collaboration with Gilead announced on 14 July 2019, statements regarding theexpected timing, design and readouts of ongoing and planned clinical trials (i) with filgotinib in RA, IBD, and other potential indications (ii) with ziritaxestat and GLPG1205in IPF and Ssc, (iii) with the Toledo program, (iv) with GLPG1972 in OA, and expectations regarding the commercial potential of our product candidates. When used in thispresentation, 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, and the uncertainties relating to the impact of the COVID-19 pandemic), reliance on thirdparties (including Galapagos’ collaboration partners Gilead and Servier) and estimating the commercial potential of its product candidates. A further list and description ofthese risks, uncertainties and other risks can be found in Galapagos’ Securities and Exchange Commission (“SEC”) filing and reports, including Galapagos’ most recentForm 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.
GLPG: success story with strong fundamentals
Novel MoA drugs close to market
Strong financials,
incl. €5.7B cash
Gilead collaboration
Filgotinib: Potential
approvals/launches in RA
Topline Ph2+ data from 4
trials in 2020
Solid fundamentals
Long termopportunities
>30 early programs
such as Toledo
Novel target discovery
engine
Topline data:filgotinib Ph3 UC
‘1205 Ph2 IPF
ziritaxestat Ph2 SSc
‘1972 Ph2b OA
Anticipated approvals: filgotinib in RA in US, Europe, Japan
Looking forward toa newsflow rich 2020
Galapagos overview
Note: All values as per 31-03-2020
Foundedin 1999
HeadquartersMechelen, Belgium
ListingsEuronext & Nasdaq: GLPG
SITESFAST FACTS DRUG DEVELOPMENT
We discover novel targets
balanced unbalanced
area preclinical phase 1 phase 2 phase 3
multiple indications, submitted for RA
in Ph3 and Ph2
Ph2b underway
>30 programs
filgotinib
IPF/fibrosis
osteoarthritis
inflammation,
fibrosis, other
Ph1 programsToledo
approval
Pipeline with significant newsflow in 2020
Deep, early pipeline
30validated targets
15 programs in LO
5PCCs
4Ph1 programs
‘4471 – inflammation
‘4399 – inflammation‘4259 – inflammation‘4124 – fibrosis‘4059 – metabolic
‘3970 – inflammation‘3667 – inflammation
‘555 – inflammation‘2737 – kidney disease
FilgotinibPipeline in a product opportunity
Filgotinib: potential for 5 launches in next 4 years
dis
ea
se
are
aphase 2 phase 3 status
RA
UC
CD
PsA
AS
Other
submitted in US, Europe, Japan
Ph3 topline Q2´20
RA: rheumatoid arthritis CD: Crohn’s disease UC: ulcerative colitis AS: ankylosing spondylitis PsA: psoriatic arthritis
trials ongoing, recruitment
on hold (COVID-19)
Global inflammation market $65B by 2027
AS~6
PsA~9
RA~26
CD~16
UC~8
Estimated market size, $B
Source: Galapagos estimates, Decision Resources Group
RA: rheumatoid arthritis CD: Crohn’s disease UC: ulcerative colitis AS: ankylosing spondylitis PsA: psoriatic arthritis
Phase 3 FINCH program in RA100 and 200 mg
FINCH 1: MTX - IR ACR20 at W12MTX add-onadalimumab controlradiographic assessment
1,759 52 weeks
449 24 weeks ACR20 at W12cDMARD add-on
FINCH 3: MTX naïve 1,252 52 weeks ACR20 at W24monotherapy, +MTX armsradiographic assessment
FINCH 2: biologic - IR
ACR20: primary endpoint
FIL: filgotinib; ADA: adalimumab; MTX: methotrexate; PBO: placeboNote: MTX-IR population (inadequate response to MTX); all arms were on a stable dose of MTX
W12
76.6
69.8 70.8
49.9
0
20
40
60
80
100
FIL 200 mg + MTX FIL 100 mg + MTX ADA 40 mg + MTX PBO + MTX
ACR20 r
esp
onders
(%
subje
cts)
Δ 26.7%; p < 0.001
Δ 19.9%; p < 0.001
76.6
47.2
26.3
69.8
36.3
18.5
70.8
35.1
14.2
49.9
19.8
6.7
0
20
40
60
80
100
ACR20 responders (% subjects) ACR50 responders (% subjects) ACR70 responders (% subjects)
FIL 200 mg + MTX FIL 100 mg + MTX ADA 40 mg + MTX PBO + MTX
ACR20/50/70
FIL: filgotinib; ADA: adalimumab; MTX: methotrexate; PBO: placeboNote: MTX-IR population (inadequate response to MTX); all arms were on a stable dose of MTXPress release. Gilead Sciences, Inc. and Galapagos NV. March 28, 2019
W12Δ 26.7%p < 0.001
Δ 19.9%p < 0.001
Δ 27.4%p < 0.001
Δ 16.5%p < 0.001
Δ 19.6%p < 0.001
Δ 11.8%p < 0.001
LDA & clinical remission
*p<0.001, **p<0.01, non-inferiority to ADA; # p<0.01, superiority to ADA; † Comparison not adjusted for multiplicityFIL: filgotinib; ADA: adalimumab; MTX: methotrexate; PBO: placebo; CRP: C-reactive protein; DAS: disease activity scoreNote: MTX-IR population (inadequate response to MTX); all arms were on a stable dose of MTXPress release. Gilead Sciences, Inc. and Galapagos NV. March 28, 2019
W12
49.7*
33.9#†38.8
23.8**†
43.4
23.723.4
9.3
0
20
40
60
80
100
LDA - DAS28(CRP) ≤3.2 (% subjects) Remission - DAS28(CRP) ≤2.6 (% subjects)
FIL 200 mg + MTX FIL 100 mg + MTX ADA 40 mg + MTX PBO + MTX
Δ 26.3%p < 0.001
Δ 15.4%p < 0.001 Δ 24.6%
p < 0.001
Δ 14.5%p < 0.001
Radiographic progression
FIL: filgotinib; ADA: adalimumab; MTX: methotrexate; PBO: placebo; mTSS: modified total Sharp scoresNote: MTX-IR population (inadequate response to MTX); all arms were on a stable dose of MTX
W24
0.13
0.17 0.16
0.38
0
0.1
0.2
0.3
0.4
0.5
FIL 200 mg + MTX FIL 100 mg + MTX ADA 40 mg + MTX PBO + MTX
Mean m
TSS c
hange f
rom
base
line
Δ -0.28; p < 0.001
Δ -0.26; p < 0.001
ACR20: primary endpoint
FIL: filgotinib; MTX: methotrexate; PBO: placebo; csDMARD: conventional synthetic disease-modifying antirheumatic drugNote: MTX-IR population (inadequate response to MTX); all arms were on a stable dose of MTXData derived from Genovese MC, et al. ACR Annual Meeting 2018; abstract L06; poster presentation
W12
66
57.5
31.1
0
20
40
60
80
100
FIL 200 mg + csDMARD FIL 100 mg + csDMARD PBO + csDMARD
ACR20 r
esp
onders
(%
subje
cts)
Δ 26.4%; p < 0.001
Δ 34.9%; p < 0.001
66
42.9
21.8
57.5
32
14.4
31.1
14.9
6.8
0
20
40
60
80
100
ACR20 responders (% subjects) ACR50 responders (% subjects) ACR70 responders (% subjects)
ACR20/5
0/7
0 r
esp
onders
(%
subje
cts)
FIL 200 mg + csDMARD FIL 100 mg + csDMARD PBO + csDMARD
ACR20/50/70
FIL: filgotinib; MTX: methotrexate; PBO: placebo; csDMARD: conventional synthetic disease-modifying antirheumatic drugNote: MTX-IR population (inadequate response to MTX); all arms were on a stable dose of MTXData derived from Genovese MC, et al. ACR Annual Meeting 2018; abstract L06; poster presentation
W12
Δ 34.9%p < 0.001
Δ 26.4%p < 0.001
Δ 28.0%p < 0.001
Δ 17.1%p < 0.001
Δ 15.0%p < 0.001
Δ 7.6%
LDA & clinical remission
FIL: filgotinib; MTX: methotrexate; PBO: placebo; csDMARD: conventional synthetic disease-modifying antirheumatic drug; CRP: C-reactive protein; DAS: disease activity scoreNote: MTX-IR population (inadequate response to MTX); all arms were on a stable dose of MTXData derived from Genovese MC, et al. ACR Annual Meeting 2018; abstract L06; poster presentation
W12
40.8
22.4
37.3
25.5
15.5
8.1
0
20
40
60
80
100
LDA - DAS28(CRP) ≤3.2 (% subjects) Remission - DAS28(CRP) ≤2.6 (% subjects)
FIL 200 mg + csDMARD FIL 100 mg + csDMARD PBO + csDMARD
Δ 25.3%p < 0.001
Δ 21.8%p < 0.001
Δ 14.3%p < 0.001
Δ 17.4%p < 0.001
81 80.2 78.1
71.4
0
20
40
60
80
100
FIL 200 mg + MTX FIL 100 mg + MTX FIL 200 mgmonotherapy
MTX
ACR20 r
esp
onders
(%
subje
cts)
ACR20: primary endpoint
FIL: filgotinib; MTX: methotrexate; PBO: placeboNote: MTX-naïve population
W24Δ 9.6%; p < 0.001
Δ 8.8%; p < 0.05
ACR20/50/70
*Comparison not adjusted for multiplicityFIL: filgotinib; MTX: methotrexate; PBO: placeboNote: MTX-naïve populationPress release. Gilead Sciences, Inc. and Galapagos NV. March 28, 2019
W24
81
61.5
43.8
80.2
57
40.1
78.1
58.1
40
71.4
45.7
26
0
20
40
60
80
100
ACR20 responders (% subjects) ACR50 responders (% subjects) ACR70 responders (% subjects)
FIL 200 mg + MTX FIL 100 mg + MTX FIL 200 mg monotherapy MTX
p < 0.05
p < 0.001
p < 0.01*
p < 0.01
p < 0.001
p < 0.001*
p < 0.01
p < 0.001
Clinical remission
*Comparison not adjusted for multiplicityFIL: filgotinib; MTX: methotrexate; PBO: placeboNote: MTX-naïve populationPress release. Gilead Sciences, Inc. and Galapagos NV. March 28, 2019
W24
54.1
42.5 42.4
29.1
0
20
40
60
80
100
FIL 200 mg + MTX FIL 100 mg + MTX FIL 200 mgmonotherapy
MTX
DAS28(C
RP)
≤2.6
(%
subje
cts)
Δ 13.4%; p < 0.001
Δ 25%; p < 0.001
Δ 13.3%; p < 0.001*
FINCH safety data up to week 24
N (%)
PBO/MTXADA
40 mg EOWFIL 100 mg +
MTX/cDMARDsFIL 200 mg +
MTX/cDMARDsFIL 200 mg
monotherapyFILtotal
N=1039 N=325 N=840 N=1038 N=210 N=2088
serious infection 10 (1.0) 8 (2.5) 13 (1.5) 13 (1.3) 3 (1.4) 29 (1.4)
herpes zoster 4 (0.4) 2 (0.6) 5 (0.6) 6 (0.6) 1 (0.5) 12 (0.6)
DVT/PE 3 (0.3) 0 (0) 0 (0) 1 (0.2)* 0 (0) 1 (<0.1)
deaths 2 (0.2) 0 (0) 1 (0.1) 3 (0.3) 0 (0) 4 (0.2)
malignancy excl. NMSC
4 (0.4) 1 (0.3) 1 (0.1) 0 (0) 0 (0) 1 (<0.1)
MACE 5 (0.5) 1 (0.3) 2 (0.2) 2 (0.2) 1 (0.5) 5 (0.2)
Note: FINCH 1, 2, and 3 events up to week 24*Excludes retinal vein occlusion observed in FINCH 2FIL: filgotinib; ADA: adalimumab; MTX: methotrexate; PBO: placebo; csDMARD: conventional synthetic disease-modifying antirheumatic drug; DVT: deep vein thrombosis; PE: pulmonary embolism; NMSC: nonmelanoma skin carcinoma; MACE: major cardiovascular event
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
Filgotinib’s JAK1 inhibition addresses inflammation…
Active in MTX-naïve to bDMARD-IR patients
Treatment effect maintained (156 wks)
Clinical benefits seen early
Note: DARWIN 3 dose is 200mg
…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
Long term safety data
event per
100 PYE
filgotinib
50-200 mg
DARWIN 3 week 156
patient year exp. 2,203
serious infection 1.0
herpes zoster 1.5
DVT/PE2/2,203*
0.1
deaths 0.2
Data on file; DVT/PE = deep venous thrombosis/pulmonary embolism* one single patient experiencing DVT and PE
FilgotinibJAK1 selectivity
From: “Ex Vivo Comparison of Baricitinib, Upadacitinib, Filgotinib, and Tofacitinib for Cytokine Signaling in Human Leukocyte Subpopulations,” McInnes et al, ACR 2017
JAK1 vs JAK2
JAK1 vs JAK3
0
5
10
15
20
25
30
filgotinib filgotinib
Normalizing RA lab abnormalities
Note: Filgotinib is a compound in development by Gilead and Galapagos. Data above derived from Westhovens et al, and Kavanaugh et al
-0.6
-0.4
-0.2
0
0.2
0.4
0.6
pbo 100mgqd
200mgqd
pbo 2mg qd 4mg qd pbo 5mg bid 10mgbid
pbo 6mg bid 12mgbid
18mgbid
filgotinib baricitinib tofacitinib upadacitinibbaricitinib tofacitinib upadacitinib
-40
-30
-20
-10
0
10
20
30
pbo 100mgqd
200mgqd
pbo 2mg qd 4mg qd pbo 5mgbid
10mgbid
pbo
filgotinib baricitinib tofacitinib
Mean c
hange fro
m b
ase
line
platelets, (giga/L), W12
filgotinib
Hb, (g/dL), W12
Filgotinib: GLPG’s commercial footprint
Rheuma & IBD – Benelux
IBD – UK/Germany
Rheuma – France/Italy/Spain
Ramping up for competitive launch of filgotinib in RA in H2 ‘20
Phase 3 SELECTION program in UC
200 mg
100 mg
placebo
Inductionendpointsweek 10
Biologicnaive
baseline
200 mg
100 mg
placebo
Biologicexp.
resp
onders
re-r
andom
ized
week 11
Maintenanceendpointsweek 58
200 mg
placebo
100 mg
placebo
placebo responders remain on placebo
long t
erm
exte
nsi
on s
tudy
non-responders/worsening of disease: go to LTE
Progressive lung fibrosis leading to death
• 250k cases in US & EU
• 75k new cases every year
• Median survival 2-5 years
ziritaxestatFor idiopathic pulmonary fibrosis (IPF)
IPF $2.8B market with large unmet needs
Sources: Global Data, Maher et al. BMC Pulmonary Medicine (2017) 17:124, sales figures from Roche (pirfenidone; Esbriet®) and Boehringer Ingelheim (nintedanib; Ofev®)Note: FVC = Forced vital capacity
2019 drug sales: $2.8B
nintedanib & pirfenidonehave limitations
• slow FVC decline
• poor tolerability for patients
• ~25% annual discontinuations
pirfenidone nintedanib
Building an IPF & fibrosis portfolio
Status end ‘19
Status end ‘20 (projected)
futility H1 ‘21
topline H2 ‘20
topline H2 ‘20
PCC 2020
pro
gra
ms
next stepspreclinical Ph1
ziritaxestat (autotaxin) ISABELA IPF
‘1205 (GPR84) PINTA IPF
ziritaxestat NOVESA SSc
New programs
Ph2 Ph3
Two toplines in H2 ’20, ISABELA futility in H1 ‘21
FLORA in The Lancet Respir Med
Positive ziritexestat data in patients
Flora
FVC stabilization over 12-week period
ziritaxestat 600mg QDPlacebo
Placeboziritaxestat
BSLN=6N=17
*= p<0.05
4N=3N=16
8N=4N=15
12N=4N=13
FUN=4N=15
Functional respiratory imaging tracks ahead of FVC
FRI indicates disease stabilization
Flora
Strong biomarker reduction
Flora
Reduction of LPA18:2 in blood plasma
Biomarker reduction = target engagement
ziritaxestat 600mg QDPlacebo
Placeboziritaxestat
BSLN=6N=17
**= p<0.01
4N=5N=16
12N=6N=15
FUN=5N=15
ziritaxestat pathway clinically validatedLPA1 inhibition has impact
• BMS-986020 reduced FVC decline
• Study stopped due to off-target cholecystitis
• BMS-986020 inhibits LPA1
• ‘1690, an autotaxin inhibitor, markedly reduces LPA1 levels
-160
-140
-120
-100
-80
-60
-40
-20
0Placebo
BMS-986020 (600mg QD)
BMS-986020 (600mg BID)
* p<0.05
N=47
N=48
N=48
placebo BMS-986020600mg QD
BMS-986020600mg BID
Slope estimate over 26 weeks (ml)
Source: Chest. 2018 Sep 7. pii: S0012-3692(18)32411-5
Phase 3 program ISABELA 1&2
• 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 decline at 52 weeks
• Secondary: hospitalizations, mortality, quality of life, safety/tolerability
Topline Part 1 expected Q3 ‘18ziritaxestat 600mg
placebo
At least 52 weeks
screening follow-up
ziritaxestat 200mg
ziritaxestat has orphan status in IPF in US and EC
ISABELA participating countries
* As of Nov 8, 2019
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
ISABELATimeline
2019 2020 2021 2022 2023
H1 2021
Futilityoutcome
Toplinedata
March 2020
>800 patients randomized
PINTA Phase 2 in IPF
• 60 IPF patients on local standard of care
• Primary endpoint: forced vital capacity (FVC) at 26 weeks
• Secondary: safety, tolerability, broad range of measurements, incl. FRI
• Recruitment in 9 countries in Europe, North Africa, & Middle East
FRI = Functional respiratory imaging
GLPG1205, 100mg once daily (n=40)screening
26 weeks
follow-upplacebo (n=20)
Topline data expected in H2
Systemic sclerosis (SSc)
• Multi-organ (“systemic”) fibrosis
• Rare disease: ~95k patients1
• Among the highest mortality of all autoimmune/rheumatic diseases2
• No approved anti-fibrotic drugs3
1 Global Data 2014; 2 Nikpour et al Curr Opin Rheumatol. 2014; 3 Denton et al Lancet 2017
NOVESA Phase 2 in SSc
• 30 patients with progressive diffuse (multi-organ) SSc
• 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)
24 weeks
ziritaxestat, 600mg oral once daily (n=20)
4 weeks
screening
24 weeks 12 weeks
follow-up
placebo (n=10)
NOVESA topline data expected in H2,orphan status in SSc in US and EC
Breakdown of joint cartilage
• 118 M patients in US, Europe& Japan
• No disease-modifying drugs approved today
GLPG1972For osteoarthritis (OA)
‘1972 low dose
‘1972 medium dose
‘1972 high dose
vehicle
‘1972 protects cartilageHistopathology in mouse model
Source: Amantini et al OARSI 2018
cartilage
-20
0
20
40
60
1 8 15 22 29 36 43 50
AR
GS
% r
ed
ucti
on
vs b
aseli
ne
days post-dosing
placebo
‘1972 dose 1
‘1972 dose 2
‘1972 dose 3
Reduction of ARGS‘1972 Phase 1b study in OA patients
Dose-dependent reduction of ARGS, well-tolerated in OA patients
se
rum
AR
GS
% r
ed
ucti
on
vs b
ase
lin
e
high dose
med dose
low dose
placebo
days post dosing
ROCCELLA Phase 2b trial
• 900+ patients with knee osteoarthritis, recruited globally
• Primary endpoint: reduction in cartilage loss at 52 weeks
• Secondary: structural & clinical parameters (incl. pain & function), safety/tolerability
FDA granted fast track statusTopline data expected H2 ‘20
Topline Part 1 expected Q3 ‘18‘1972 dose C
placebo
52 weeks
screening follow-up
‘1972 dose B
‘1972 dose A
• novel, undisclosed target
• dual action on inflammation
• IBD models show strong activity
• ‘3970 prioritized after Ph1
Toledoin inflammation
disease
autoimmune
immune imbalance
disease resolution
immune balance restored
Toledo
immune balance
healthy
Restoring the immune imbalance
current therapies
autoimmune
immune suppression
immunoregulatory immunoregulatory
immunoregulatory
immunoregulatory
pro-inflammatory pro-inflammatory
pro-inflammatory
pro-inflammatory
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
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
Toledo: robust activity in in vivo models
2020
‘3312PanTOL
TOL2/3
TOL3
‘3970
‘4399
2020
LO
5th gen
4th gen
LO
2020
IBD RA Pso PsA SLE OP Fib
2020 2020
green: preclinical activity; orange: insufficient preclinical activity
Servier: ‘1972 ex-US
$260M milestonessingle digit % royalties
AbbVie: CF
$45M upfront, $200M milestonessingle to double digit % royalties
Partnerships beyondGilead
Gilead-Galapagos collaborationUnique deal in life sciences, with independence anchored
10 YearCollaboration& standstill
$3.95 Bupfront
plus opt-in fees& milestones
$1.5 Bequity investment¹
20+%royalties
Galapagos retains full European rights
¹Includes $1.1B equity investment at deal closing plus exercise of Initial Warrant A
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
Growing geographic footprintBuilding out a European commercial presence
2020 – 2021 filgotinib
• Benelux
• France, Italy, Spain
• UK, Germany
2022 – 2023
• Roll out in rest of Europe
• Future products
Strong financials
€2.9Bdeferred revenues
€5.7B cash FY20 cash burn
€400-430M
Topline data:
SELECTION filgotinib Ph3 UC
PINTA ‘1205 Ph2 IPF
NOVESA ziritaxestat Ph2 SSc
ROCCELLA ‘1972 Ph2b OA
Anticipated approvals:
filgotinib in RA in US, Europe, Japan
A newsflow rich 2020
We discover.
We dare.
We care.
Pioneeringfor patients