Investor Relations slides | March 2021 - Galapagos
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Investor Relations slides | March 2021
Disclaimer This presentation c ontains forward-looking statements, inc luding (without limitation) statements conc erning the progress of our R&D and c linic al pipeline, our expec tatio ns regarding commerc ial sales of Jy selec a, the global R&D collaboration with Gilead, the amendment of our arrangement with Gilead for the commerc ialization and dev elopment o f Jyselec a, the timing and/or outco me o f the strategic re-evaluation and o f the c ash burn guidanc e 2021 , the amount and timing o f potential future opt-in and/or roy alty payments by Gilead, interactions with regulatory autho rities, the timing or likelihood of additional regulatory authorities’ approv al of marketing authorizatio n fo r filgotinib for RA, UC or any o ther indic ation, inc luding UC and IBD indic ation for Jy selec a in Europe, Japan, and the US, suc h additional regulatory authorities requiring additional studies, the timing or likelihood o f reimbursement dec isio ns, the build-up o f our commerc ial organization fo r filgotinib, the impact o f COVID -19, our beliefs regarding the inflammation market, and our strategy , business plans and foc us, the slides c aptioned ”Ready for an exc iting future,” “GLPG: strong fundamentals,” “Strong R&D engine,” “Our appro ac h to innov atio n,” “D eep R&D pipeline,” “Innov ativ e pipeline,” “ Inflammation franc hise,” inc luding list of compounds, “Jy selec a,” “New agreement fo r Jyselec a,” “EU5 inflammation market today,” "Jy selec a in RA," “Filgotinib’s expected newsflow ’21,” “Phase 3 FINC H program in RA,” “Filgotinib’s preferential JAK1 inhibitio n addresses inflammation…,” “Phase 3 SELEC TION program in UC ,” “D IVERGENC E in SBCD ,” “TYK 2,” “Toledo,” "Resto ring the Immune Balanc e," “Potential broad applic ation in inflammation,” “Toledo po rtfo lio today ,” inc luding list o f c ompounds, “Promising and broad in v iv o activ ity,” “Ambitio us informed dev elopment strategy,” “C linic al path,” “Paralle l POC studies,” “Fast trac king PsA with ‘3970,” “Toledo data pac kage conv inc es,” “Promising assets,” “Key newsflow Toledo,” “Fibrosis franc hise,” inc luding list o f compounds, “C asting a wide net in IPF,” “IPF,” “PINTA Ph2 in IPF,” “PINTA Ph2 with ‘1205 in IPF,” “Gilead-Galapagos R&D c ollaboration,” “Jyselec a in Europe,” “2020 in rev iew” and “2021 outloo k,” statements regarding the expected timing, design and readouts o f ongoing and planned c linic al trials, inc luding (without limitatio n) (i) w ith filgo tinib in RA, UC , IBD , and other potential indic ations, (ii) w ith GLPG1205 and GLPG4716 in IPF, ( iii) w ith the Toledo program, (iv ) with GLPG3667 in Pso, (v ) with GLPG555 in OA, (v i) MANTA/MANTA-Ray trials with filgotinib, and expectations regarding the c ommerc ial potential of our product c andidates. When used in this presentation, the words “antic ipate,” “believ e,” “c an,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “might,” “will,” “plan,” “potential,” “possible,” “predic t,” “objectiv e,” “should,” and similar ex pressions are intended to identify forward-lo o king statements. Fo rward-looking statements inv olv e known and unknown risks, unc ertainties and other factors whic h might c ause the actual results, financ ial c ondition, performanc e or ac hiev ements of Galapagos, or industry results, to be materially different from any future results, financ ial c onditio ns, performanc e o r ac hiev ements ex pressed or implied by such forward-looking statements. Amo ng the fac to rs that may result in differenc es are the inherent unc ertainties assoc iated with competitiv e dev elopments, c linic al trial and product dev elopment ac tiv ities, regulatory approval requirements (inc luding that data from the c ompany's dev elopment programs may not support registration or further development of its compounds due to safety , effic acy or other reasons, inc luding ziritax estat fo r IPF, SSc o r any other indic ation, and the unc ertainties relating to the impac t of the C OVID -19 pandemic ), relianc e on third parties (inc luding Galapago s’ collaboration partner Gilead) and estimating the c ommerc ial potential o f its product c andidates, inc luding Galapagos’ estimates regarding the commerc ial potential o f ziritax estat, and the possibility that Galapagos and Gilead may make a strategic dec ision to discontinue development of ziritax estat and that ziritax estat may as a result nev er be succ essfully c ommerc ialized. A further list and description of these risks, unc ertainties and other risks c an be found in Galapagos’ Sec urities and Exchange Co mmissio n (“SEC”) filing and repo rts, inc luding Galapagos’ most rec ent Form 20-F and subsequent filings with the SEC . Giv en these unc ertainties, y ou are adv ised not to plac e any undue relianc e o n suc h forward-looking statements. Exc ept for filgotinib's approv al for the treatment of RA by the European Commission and Japanese Ministry of Health, Labour and Welfare, our drug c andidates are inv estigational; their effic ac y and safety hav e not been fully ev aluated by any regulatory authority and they are not y et approv ed fo r any use o utside of c linic al trials. All statements herein speak only as of the release date o f this document. Galapagos ex pressly disc laims any obligation to update any statement in this doc ument to reflec t any change in future dev elopment with respect thereto, any future results, or any change in ev ents, c onditions and/or c irc umstanc es, on which any statement is based, unless spec ific ally required by law or regulation. 2 Under no c irc umstances may any c opy o f this presentation, if obtained, be retained, c opied or transmitted.
Business case for growth
Value creation Build out Capital for
through European growth
science commercial
footprint
3
Strong R&D engine Value creation through science • Target discovery engine • Large pipeline of early-stage assets
Target discovery approach
High throughput
Using core GLPG technology To identify novel targets
screening platform
Adenoviral knock-down
library
Adenoviral KD
High throughput
library
screening
Rescreen
Phenotypic
screening assay
Validation
Hits
5
Our approach to innovation • Novel targets • Chemistry reinforced by biology • Smart path to early clinical data 6
Deep R&D pipeline
• Novel targets
• Chemistry reinforced by biology
• Smart path to early clinical data 10
3
clinical stage programs
preclinical candidate
13 programs
27 programs in LO
validated targets
* LO: Lead optimization
7
Broad pipeline
Asset Target Preclinical Phase 1 Phase 2 Phase 3 Approval
Filgotinib JAK1 CD Ph3 ongoing, submitted UC in EU, approved for RA in EU & Japan
‘3970 SIK2/3 Toledo, PoCs in 5 indications
‘3667 TYK2 Ph1b Pso
‘555 JAK1 Ph1b OA
‘4399 SIK3 Toledo
‘3121 JAK1/TYK2
‘4876 SIK2/3 Toledo
Other >10 novel
‘1205 GPR84 Preparing for Ph2b in IPF
‘4716 Chitinase Preparing for Ph2 in IPF
‘4586 Undisclosed
Inflammation
'4605 SIK2/3 Toledo
Fibrosis
Other 7 novel Kidney diseases
GLPG2737 CFTR PCKD Other
GLPG4059 Novel Metabolic
8Inflammation franchise 1st marketed product & maturing pipeline • Jyseleca • Toledo • Other mechanisms
Inflammation franchise Asset Target Preclinical Phase 1 Phase 2 Phase 3 Approval Filgotinib JAK1 CD Ph3 ongoing, submitted UC in EU, approved for RA in EU & Japan ‘3970 SIK2/3 Toledo, PoCs in 5 indications ‘3667 TYK2 Ph1b Pso ‘555 JAK1 Ph1b OA ‘4399 SIK3 Toledo ‘3121 JAK1/TYK2 ‘4876 SIK2/3 Toledo Other >10 novel 10
Jyseleca 1st marketed product • GLPG launching commercially in RA in Europe • Potential expansion to UC and CD, if approved
New agreement for Jyseleca
• Europe P&L share till YE '21
• Full European rights • From '24: royalty 8-15% to • GILD retains ex-Europe
GILD
• Transition YE '21 • Milestones & 20-30%
• No EU milestones to GLPG royalties outside Europe
• GILD to pay €160M
Broader R&D collaboration unchanged
12Transition path
Market size
≈10% No change to Belgium & NL
≈70% EU5: Transfer of full business
asap in ‘21
≈15% Alpine, Nordics & Ireland: transfer
by YE ‘21
≈5% Rest of Europe: rights to GLPG
Transition to full European coverage by end 2021
13EU5 inflammation market today*
UC
UC AS
≈0.8
~0.8 ~0.9
Ambition:
≈€0.5B peak
CD EU5 RA sales
≈1.7 ≈3.2
€5.7B
8-12% market
share for
Jyseleca
RA
~3.2
RA: rheumatoid arthritis; CD: Crohn’s disease; UC: ulcerative colitis
Source: IQVIA Analytic Link (MAT to Q2 2020) – est value by disease at ex mfr list prices. All biologics and tsDMARDs.
* U5 inflammation market accounts for approximately 68% of total EU market
14Jyseleca in Europe
A profitable business case
ESTIMATES
Peak sales (RA, UC, CD – 2nd half of 2020’s) €500M
Contribution margin at peak 50%
(incl COGS, royalties, commercial expenses)
Full commercial structure in place 2022
Break-even product contribution 2024
Patent exclusivity 2035
15Jyseleca in RA
Lasting activity
Differentiated Fast onset
safety profile
Two doses approved in Convenience
Europe and Japan of oral
Robust responses Monotherapy
Filgotinib is approved for RA in the EU and Japan and not approved for use in any other indication nor any other region.
See the European Summary of Product Characteristics (SmPC) for Jyseleca, which includes contraindications and special warnings and precautions, available at www.ema.europa.eu.
16Regulatory status Jyseleca® (filgotinib) in RA
Approved in EU & Japan
Received CRL in US
• MANTA & MANTA-RAy results
• filgotinib 200 mg risk/benefit
Filed in EU for UC
First shipments made in Germany & Netherlands
17Filgotinib expected newsflow ‘21
H1 H2
MANTA/RA-y W26 DIVERSITY recruited CD
outcome
UC approval decision EC
UC submission Japan
European commercial transition
CHMP opinion UC complete
Commercial transition
18Ulcerative colitis (UC) Chronic inflammation of the large intestine Common symptoms: • Loose and urgent bowel movements • Bloody stool • Persistent diarrhea and abdominal pain Filgotinib is not approved in UC by any regulatory authority
UC disease burden is high
Feel the condition is controlling Psychological impact of UC
their lives
100 100
84* 82
80 80
70
62
Patients (%)
60 53* 60
44
40 37 40
19
20 20
0 0
UC Asthma Migraine RA Worry about Making life Feel Sometimes or
(n=451) (n=305) (n=305) (n=309) long-term more embarrassed always feel
effects stressful depressed
* pPhase 3 SELECTION program in UC
Induction Maintenance
endpoints endpoints
Baseline week 10 Week 11 week 58
200 mg 200 mg
Responders re-randomized
Long term extension study
Biologic- Placebo
100 mg
naïve
Placebo 100 mg
Placebo
200 mg
Biologic-
100 mg
experienced
Placebo responders
Placebo remain on placebo
UEGW 2020 presentation
Filgotinib is not approved in UC by any regulatory authority
Non-responders/worsening of disease: go to LTE
21SELECTION population
Selected baseline Biologic-naïve cohort Biologic-
characteristics n=659 experienced cohort
n=689
Mayo Clinic Score ≥9 52% 74%
Previous exposure to
TNFα & integrin N/A 51%
receptor antagonist
UEGW 2020 presentation
Filgotinib is not approved in UC by any regulatory authority
22SELECTION
Primary endpoint
Assessed at week 10 (induction) and week 58 (maintenance)
EBS remission
(derived from
Mayo Clinical
Endoscopic subscore Score) Rectal bleeding
0 or 1 subscore 0
≥1 point
decrease in stool frequency from
baseline to achieve a subscore of
0 or 1
UEGW 2020 presentation
Filgotinib is not approved in UC by any regulatory authority
23SELECTION
Induction primary endpoint achieved
EBS remission at week 10
100
achieving Clinical
80
Filgotinib 200 mg
patientsAchieving
Placebo
EBS remission
60 Δ 10.8%
Remission
p=0.0157
Patients
Δ 7.3%
40
p=0.0103
26.1
% of
Percent of
20 15.3
11.5
4.2
0
BIOLOGIC-NAÏVE
Biologic-naïve BIOLOGIC-EXPERIENCED
Biologic-experienced
Filgotinib 100 mg did not meet primary endpoint in any cohort at week 10
UEGW 2020 presentation
Filgotinib is not approved in UC by any regulatory authority
24SELECTION
Maintenance primary endpoint achieved
EBS remission at week 58
100
achievingClinical
80
Achieving
Δ 26%
EBS remission
pSELECTION
Sustained remission
Patients achieving remission at week 10 and week 58
100
Percent of Patients Achieving Clinical
80
% of patients
60
Remission
Δ 13.0
p=0.0024
40 Δ 0.9
p=0.7951
20
18.1
8.7 7.9
5.1
0
Filgotinib Placebo Filgotinib Placebo
200 mg 100 mg
UEGW 2020 presentation
Filgotinib is not approved in UC by any regulatory authority
26SELECTION
Remission at week 58
MCS remission = score ≤2 and no single subscore >1
100
Percent of Patients Achieving Clinical
80
Δ 25.5
% of patients
60 pSELECTION
Endoscopic remission at week 58
Mayo endoscopic subscore of 0
100
Percent of Patients Achieving Clinical
80
% of patients
60
Remission
Δ 9.5
p=0.0157 Δ 5.5
40 p=0.1808
20 15.6 13.4
6.1 7.9
0
Filgotinib Placebo Filgotinib Placebo
200 mg 100 mg
UEGW 2020 presentation
Filgotinib is not approved in UC by any regulatory authority
28SELECTION
Histologic remission at week 58
100
Percent of Patients Achieving Clinical
80
Δ 24.9
% of patients
pSELECTION Safety data Induction trial safety results Events Filgotinib 200 mg Filgotinib 100 mg Placebo SAE in biologic-naïve patients 1.2% 4.7% 2.9% SAE in biologic-experienced patients 7.3% 5.3% 6.3% Maintenance trial safety results Events Filgotinib 200 mg Placebo¹ Filgotinib 100 mg Placebo² SAE 4.5% - 4.5% 7.7% Deaths* 2 - - - *Two deaths were observed in the filgotinib 200 mg treatment group in the maintenance trial; one patient with pre-existing asthma died due to asthma exacerbation, and the second patient with pre-existing atherosclerosis died due to left ventricular heart failure per autopsy report. Neither death was assessed as related to study drug by the investigator. “Rates of serious infections, herpes zoster, venous thrombosis, pulmonary embolism and gastrointestinal perforation were low and comparable across treatment groups in both the induction and maintenance phases of the trial” FILGO: filgotinib; PBO: placebo; SAE: serious adverse event ¹Placebo for filgotinib 200 mg group; ²Placebo for filgotinib 100 mg group UEGW 2020 presentation Filgotinib is not approved in UC by any regulatory authority. 30
DIVERGENCE 1 in small bowel CD
Baseline Week 10 Week 24
100mg filgotinib (n=40)*
200mg filgotinib (n=40)
Placebo (n=20)
Disease worsening
Non-responders
Long term extension
Small bowel CD (SBCD) is defined as disease located anywhere in the duodenum, jejunum or ileum
Non-responder: Subject who never achieves a ≥ 70 point CDAI reduction from baseline or CDAI < 150 at any point up to and including week 10
Disease worsening: A ≥ 100 point increase in CDAI score from the Week 10 value and CDAI score ≥ 220 points at 2 consecutive visits
*Recruitment for DIVERGENCE 1 was stopped prior to achievement of these targeted patient numbers
31DIVERGENCE 1
Exploratory study of filgotinib in small bowel CD
60
40
% patients achieving
CDAI remission at
week 10
20
4/18 11/28 8/28 26/71 10/44 60/128
0
DIVERGENCE 1 FITZROY TNF- FITZROY overall
75% bio-experienced experienced cohort
Placebo 200mg Placebo 200mg
Notes: data on file, CDAI remission = CDAITYK2 in inflammation
TYK2 inhibitor GLPG3667
• Reversible kinase domain inhibitor
• PK profile favorable for once daily dosing
• Good PD activity in Ph 1
• First indications: PsA & others
Aim to start DRF studies in 2021
34Strong ex vivo PD activity in Ph1
INFa/pSTAT1 ↓ IL-6/pSTAT1 ↓
Change from baseline at D1
Change from baseline at D1
0 0.5 1 3 6 12 24 0 0.5 1 3 6 12 24 hours 0 0.5 1 3 6 12 24 0 0.5 1 3 6 12 24 hours
Day 1 Day 10 Day 1 Day 10
Aim to start DRF studies in 2021
35Toledo in inflammation • Novel, SIK target • Dual action on inflammation • Preclinical models show strong activity • GLPG3970 in multiple PoC studies 1Globa l Da t a ; 2 Nikpour e t a l C urr O pin R he uma tol. 2014; 3 De nt on e t a l La ncet 2017
Can we make a difference?
% of responders
%
100
Psoriasis
90
PASI 90
80 Δ
70
Unmet
need Other
60
inflammatory
50 diseases
40
30
20
10
0
2000 2002 2003
2004 2006 2008 2010 2012 2014 2016 2018 2020
Reference: Data on file Years
37Restoring the immune balance 38
Dual activity confirmed
In both macrophages & dendritic cells
TNF IL-10
Fold increase
% Inhibition
[Toledo] M
39Potential broad application in inflammation
TNF TNF
IL-12 IL-10 IL-12 IL-10 IL-2
IFN TNF IL-10
IL-1 IL-23
MCs/M DCs T cells B cells
Adaptive
Innate
Innate
Broad cellular activity with Toledo
on both innate and adaptive immune cells
40Innovative chemistry
>3,000 molecules
synthesized >200 dedicated FTE years
since 2014 SIK1 Optimization
10 chemical series
FTEs
investigated 50
Optimization SIK2
40
30
GLPG3970
SIK3 GLPG4399
Multiple selectivity profiles 20
10 GLPG4605
0
2014 2015 2016 2017 2018 2019 2020 GLPG4876
4 patents filed, exemplifying CHEM BIO
GLPG4605
GLPG4605
~ 1,000 compounds
41Robust activity in vivo in 3 IBD models
DSS model T-cell transfer model MDR1 model
*
Disease activity index
***
*** ***
(AUC)
***
***
### ###
###
###p < 0.001
*p < 0.05; ***p < 0.001 (vs diseased)
AUC: area under the curve
42Impacting both sides of the balance in vivo
Macrophage phenotypes in IBD colon tissue
(T-cell transfer model)
M1 marker M2 marker
***
***
Pro-inflammatory Immunoregulatory
macrophage reduced macrophage induced
***pToledo portfolio
Asset Target Preclinical Phase 1 Phase 2 Phase 3 Approval
‘3970 SIK2/3
‘4399 SIK3
‘4876 SIK2/3
Next
compounds Inflammation
Fibrosis
'4605 SIK2/3
Next compounds
44Promising and broad in vivo activity
Immune-mediated inflammation models Fibrosis models
IBD Pso PsA RA SLE OA SSc IPF
SIK2/3 GLPG3970 2020
SIK3 GLPG4399 2021
SIK2/3 GLPG4605 2021 2021
SIK2/3 GLPG4876 2021
Next SIK 2021 - 2022
compounds
Activity demonstrated
No activity
45Dual activity confirmed ex vivo
GLPG3970
Phase 1
Ex vivo analysis in whole blood, mean per treatment
TNF levels ↓ IL-10 levels ↑
Change from baseline at D1
Change from baseline at D1
46GLPG3970 activity in psoriasis model
Pso model Ear thickness model
(IL-23-induced)
Day 5
Healthy
Diseased
Ear thickness on day 5
Pos Control
Ear thickness
GLPG3970
*** ***
###
Days
###p< 0.0 01
*pRobust activity across arthritis models
PsA model
CIA model IL-23-induced
***
Disease activity index
***
Disease activity index
(AUC)score
(AUC) score
***
AUC clinical
AUC clinical
***
***p < 0.001 (vs. diseased)
CIA: collagen induced arthritis; PsA: psoriatic arthritis
AUC: area under the curve
48Robust fibrosis activity in vivo
Therapeutic BLM model Chronic GvHD model
lung fibrosis skin fibrosis
Fold change alpha-SMA staining
*
Ashcroft histological score
*
***
***
# ###
###p< 0.001
*pAmbitious, informed development strategy
Psoriasis study generates rapid clinical data
Accelerated path taken in PsA based on biology
Rapid progression into Ph2 dose rangers, based on Ph1 PD fingerprints
& cross-learnings
Robust program in line with novel pharmacology, investment size, and
development stage
Programmatic approach for acceleration to patients
50Clinical path
PsA Phase 3
inflammatory
RA diseases
UC Fibrosis
Pso CD
UC AS
RA
SLE
Phase 3 + fibrosis
pSS
Dose-range finding,
indication expansion
Validating Phase 2b dose-range finding
Phase 2 PoC new indication
51Parallel Proof of Concept studies
GLPG3970
2020 2021
Disease area
Psoriasis Cohort 6 weeks CALOSOMA
Ulcerative colitis PoC 6 weeks SEA TURTLE
Rheumatoid arthritis PoC 6 weeks LADYBUG
Systemic lupus erythematosus PoC TAPINOMA
Primary Sjögren’s syndrome PoC GLIDER
5 PoCs to investigate mode of action
Toplines as of mid 2021*
* Timelines subject to delays due to global COVID-19 pandemic
52Fast tracking psoriatic arthritis GLPG3970
with ‘3970
2021 2022 2023 2024+
Disease area
Psoriasis Phase 1b
Psoriatic arthritis Phase 2 DRF Phase 3
Shortens timelines by 18-24 months
DRF = Dose-range finding
53CALOSOMA Phase 1b in psoriasis
Up to 21 days 6 weeks Up to 2 weeks
GLPG3970, target active dose, oral (n=15)
Screening Follow-up
placebo (n=10)
• Adults with moderate/severe psoriasis
(baseline PASI≥12, BSA ≥10%)
• Evaluate safety/tolerability & efficacy GLPG3970 in psoriasis
54SEA TURTLE Phase 2 in ulcerative colitis
Up to 21 days 6 weeks Up to 2 weeks
GLPG3970, target active dose, oral (n=20)
Screening Follow-up
placebo (n=10)
• Adults with moderate/severe active UC
(treatment experienced)
• Key outcomes: Mayo clinical score, safety/tolerability,
PK & PD efficacy markers
55LADYBUG Phase 2 in rheumatoid arthritis
Up to 21 days 6 weeks Up to 2 weeks
GLPG3970, target active dose, oral (n=15)
Screening Follow-up
placebo (n=10)
• Patients with moderately/severely active RA &
inadequate response to MTX
• Evaluate effect on signs & symptoms of RA,
safety & tolerability, PK & PD efficacy markers
56Toledo data package convinces
Target identification data
Literature evidence Confirmed dual mode of action
Safety package for clinical
Preclinical data development
Phase 1 data
57Promising assets
Potential master switch for inflammation
Strong, broad IP protection
Phase 1 confirms mode of action
Safety package supports clinical plans
Smart path in clinical development
Head start on competition
58Key newsflow Toledo
2021 2022
Readout Ph1 GLPG4399 Readout last 2 PoCs GLPG3970
Readout first 3 PoCs GLPG3970 Readout first Ph2b
Additional Ph1 readouts
Aim to bring our innovation to patients as fast as possible
59Fibrosis franchise Aiming for leadership in this underserved space • Broad approach to pipeline in fibrosis • GLPG1205 in preparation for Phase 2b
ISABELA discontinued
• Dose dependent mortality
• Efficacy below expectations
• All activities with ziritaxestat discontinued
• IPF pipeline: 4 development programs aimed at fibrosis
Cash burn €517M; cash position ~€5.2B end of 2020
We remain committed to IPF and fibrosis
61Fibrosis franchise
Asset Target Preclinical Phase 1 Phase 2
‘1205 GPR84 Preparing for Ph2b in IPF
‘4716 Chitinase Preparing for Ph2 in IPF
‘4586 Undisclosed
'4605 SIK2/3 Toledo
Other 7 novel
62Casting a wide net in IPF
Aim to cover wide spectrum of fibrosis biology
Epithelium Immune response: Fibroblast Extracellular matrix
injury macrophages activation accumulation
GLPG1205 GLPG4586 GLPG target
GLPG4716 2 GLPG targets Ryvu program
2 Toledo moleculesIdiopathic pulmonary fibrosis (IPF) Progressive lung fibrosis leading to death • 250k cases in US & EU • 75k new cases every year • Median survival 2-5 years pain
IPF market with large unmet needs
2019 drug sales: $2.8B
Nintedanib & pirfenidone
have limitations
• Slow FVC decline
Pirfenidone Nintedanib
• Poor tolerability for patients
• ~25% annual discontinuations
Sources: Global Data, Maher et al. BMC Pulmonary Medicine (2017) 17:124, sales figures from Roche (pirfenidone; Esbriet®) and Boehringer Ingelheim (nintedanib; Ofev®)
FVC: Forced vital capacity
65PINTA Phase 2 in IPF
26 weeks
GLPG1205, 100 mg once daily (n=40)
Screening Follow-up
Placebo (n=20)
• 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. functional respiratory imaging (FRI)
• Recruitment in 9 countries in Europe, North Africa, &
Middle East
Positive topline data, continuing into dose-ranger Ph2b
66PINTA Ph2 with GLPG1205 in IPF
• FVC effect
consistent
across strata
• Ph2b dose
range finder
to start in ‘21
67Capital for growth Solid financials • Gilead R&D collaboration • Balance sheet for R&D investment
Gilead-Galapagos R&D collaboration
10 years, independence anchored
Access to compounds, $3.95B upfront plus opt-in fees
assays, libraries & expertise & milestones
Gilead option opportunity after Ph2b $1.5B equity investment¹,
25.5% share
20+% royalties US/RoW,
Galapagos full European rights
¹ Includes $1.1B equity investment at deal closing plus exercise of Initial Warrant A
69Cash & current financial investments
5,780.8
28.3 -122.4 €M
-517.4
5,169.3
Dec-19 Cash proceeds Fair value & Cash burn Dec-20
from capital Currency
increases translation effects
(warrant
exercises)
Cash burn €517M; cash position ~€5.2B end of 2020
70Key financials FY ’20
Revenues: €530.3M (*)
• €228.1M revenue recognition for filgotinib + €16.2M royalties,
• €229.6M revenue recognition for the platform
Operating costs: - €708.9M (*)
• Increase driven by filgotinib, Toledo and S,G&A
Net loss: - €305.4M
• €134.2M net other financial expense
(*) Continuing operations (excluding Fidelta)
71Outlook
Filgotinib Readouts
• Filing UC Japan • Toledo POCs Pso/RA/UC
• Outcome MANTA/RA-y • ‘3667 (TYK2) Ph1b Pso
• EU approval decision UC • ‘555 (JAK1) Ph1b OA
• DIVERSITY recruited CD
Cash burn guidance 2021 under review
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