novel targets, better treatments - jefferies · all statements herein speak only as of the release...
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Novel targets, better treatments
Jefferies Healthcare Conference London| November 2019
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, the slides captioned “’4059 indiabetic monkeys” “Dual activity confirmed in colon tissue” “Efficacy in arthritis models with ‘3970” “Activity across generations & indications” “Broad indication explorationwith ‘3970” “Expand our target & drug workplace” “Novel targets: next step” “Drug modalities – current and future” “Additional targets to be explored” “Filgotinib program”“Global inflammation market $65B by 2027” “ISABELA timeline” “In full launch mode with filgotinib” two slides titled “Growing geographic footprint” “Bringing ourinnovation to patients” “Looking forward to a newsflow rich 2020” “Pioneering for patients,” all slides pertaining to the collaboration with Gilead announced on 14 July2019, 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, and expectations regarding the commercial potential of ourproduct 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 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), 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 canbe 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 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.
Galapagos in a nutshell
Note: All values as per 30-06-2019
Foundedin 1999
HeadquartersMechelen, Belgium
Galapagos R&DBelgium, The Netherlands,France, Switzerland, USA
Service Operation FideltaZagreb, Croatia
SITESFAST FACTS DIVERSITY
EMPLOYEES910
R&D
75041% 59%
Historic strategic alliance deal
Gilead-Galapagos collaborationUnique deal in life sciences, with independence anchored
10 YearCollaboration& standstill
$3.95 Bupfront
plus opt-in fees& milestones
$1.5 Bequity investment
20+%Royalties
Galapagos retains full European rights
Ready for the future
• Independence anchored
• ~6 billion cash in the bank
• Full European rights*
• Ex-Europe royalties 20+%
* Except for GLPG1972
We discover novel targets
balanced unbalanced
Prolific late stage pipeline
>40 clinical trials planned in 2019
Area Preclinical Phase 1 Phase 2 Phase 3
Filgotinib
IPF/Fibrosis
OA
Inflammation Fibrosis
In Ph2b
In Ph3 and Ph2
Programs in filing, Ph3 and Ph2
>20 programs
FilgotinibPipeline in a product opportunity
Filgotinib program
Phase 3
Phase 2
MAA filed NDA H2 ‘19
RA UC CD PsA AS Other
Ph3toplineQ2 ‘20 Ph3
recruiting
Ph3 initiating
Ph3preparing
Global inflammation market $65B by 2027
Source: Galapagos estimates, Decision Resources Group
estimated market size, $B
Indications beyond RA 60% of future market
AS~6
PsA~9
RA~26
CD~16
UC~8
Ph3 in RA: 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 is sufficient to address inflammation
Active in MTX-naïve to bDMARD-IR patients
Treatment effect of 200mg maintained (156 wks)
Clinical benefits seen early
…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
EU5: JAKi’s growing in RA
Source: Gilead and Galapagos analysis on IPSOS data, share of prescriptions
97% 84%
16%
JAKi’s
biologics
Q3 ‘17 Q1 ‘19
3%
EU5
EU5: JAK patients from biologic naïve
Source: Therapy watch Q1’19
EU5
Q1 ’19
Q1 ’18
Bio-naïve Bio-IR
57%
44% 56%
43%
Progressive lung fibrosis leading to death
• 200k cases in US & EU
• 75k new cases every year
• Median survival 2-5 years
GLPG1690 For idiopathic pulmonary fibrosis (IPF)
program discovery preclinical Ph1 Ph2 Ph3
‘1690 (autotaxin) ISABELA IPF
‘1205 (GPR84) PINTA IPF
New IPF programs
We are building a fibrosis portfolio
• Opportunity to combine• Several fibrosis programs in discovery
Status end ‘18
Status end ’19 (projected)
Positive ‘1690 data in patients
Flora
FVC stabilization over 12-week period
‘1690 600mg QDPlacebo
Placebo‘1690
BSLN=6N=17
*= p<0.05
4N=3N=16
8N=4N=15
12N=4N=13
FUN=4N=15
ISABELA participating countries
* As on Nov 8, 2019
ISABELATimeline
2019 2020 2021 2022
Nov 2019
500 patients randomized
2023
Q1 2021
futilityoutcome
toplinedata
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
• novel, undisclosed target
• dual action on inflammation
• IBD models show strong activity
• Ph1 started with ‘3312 & ‘3970
Toledoin inflammation
Promising preclinical results with ‘3312
Impressive activity of Toledo in 3 IBD models with different mechanisms
DSS model MDR1 model
healthy
diseased
int. control
*p < 0.05; ***p < 0.001
***
***
***
Toledo
disease activity index (AUC)
T-cell transfer model
***
***
*** ***
*
***
healthy
diseased
IL-12p40 Ab
Toledo
healthy
diseased
abatacept
Toledo
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
Activity across generations & indications
Green: activity; Salmon: insufficient activity
2020 2020
2020
‘3312PanTOL
TOL2/3
TOL3
‘3970
‘4399
2020
LO
2020
5th gen
4th gen
LO
2020
• On track to develop multiple candidates across different selectivity profiles
• Robust activity in broad panel of in vivo disease models
• Plan multiple PoC’s with ‘3970 in patients in 2020
IBD RA Pso PsA SLE OA OP Fib
Outlook
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
• Benelux
• France, Italy, Spain
• UK, Germany Germany
UK
Growing geographic footprintBuilding out a European commercial presence
2020-2021
• Benelux
• France, Italy, Spain
• UK, Germany
Europe
2022-2023
• Roll out in rest of Europe
• Future products
We are pioneering for patients.
Exploring new frontiersto improve people’s lives.
We discover. We dare.We care.
Pioneeringfor patients