Transcript Investors Deck February 2016
Novel targets, better treatments
Investor presentation
February 2016 © Copyright 2016 Galapagos NV
Disclaimer
This presentation has been prepared by Galapagos and is furnished to you by Galapagos solely for your information.
This presentation contains forward-looking statements, including (without limitation) statements concerning the progress of our clinical pipeline, the slides captioned “Clinical news flow” and “Outlook”, statements regarding the development of the triple combination therapy CF program, statements regarding the expected timing, design and readouts of ongoing and planned clinical trials (i) with filgotinib in RA and IBD, (ii) with GLPG1690 in IPF, 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, financial condition, performance or achievements of Galapagos, or industry results, 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 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 partner for cystic fibrosis, AbbVie, and its collaboration partner for filgotinib, Gilead) 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 the company’s Securities and Exchange Commission filing and reports, including in the company’s prospectus filed with the SEC on May 14, 2015 and subsequent filings and reports by the company. Given these uncertainties, you are advised not to place any undue reliance on such forward-looking statements.
All statements contained 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 or future development with respect thereto, any future results, or any change in events, conditions and/or circumstances on which any such statement is based, unless specifically required by law or regulation.
Neither Galapagos nor any of its officers, employees, advisers, or agents makes any representation or warranty, express or implied, as to any matter or as to the truth, accuracy, or completeness of any statement made in this presentation, made in conjunction therewith or in any accompanying materials or made at any time, orally or otherwise, in connection with the matters referred to herein and all liability in respect of any such matter or statements is expressly excluded.
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Galapagos at a glance 6 key factors
Filgotinib: safe and effective oral for autoimmune diseases in Ph2 studies Transformational deal with Gilead CF triple combo on track Fully-owned programs Platform to fill pipeline Solid balance sheet
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Clinical pipeline
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Filgotinib
Rheumatoid arthritis Inflammatory bowel disease JAK1 selective inhibitor 900 years patient experience in large Ph2 studies Ph2B RA: 877 patients Ph2 Crohn’s disease: 177 patients Once daily, oral dosing Best-in-class efficacy and safety in RA & Crohn’s studies Low risk for drug-drug interaction Crohn’s 20 week primary endpoint read out: April ’16 Start of Phase 3 in RA, Crohn’s & UC in 2016 5
Selectivity matters
Filgotinib is the selective JAK1 inhibitor
Hb recovery¹ 30
Ratio JAK1/JAK2 in human whole blood assay
20 10 anemia 0
baricitinib
¹A Pardanani, et al, Leukemia (2013) 27, 1322–1327
Xeljanz™
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ABT-494 filgotinib
Competitor data MTX add-on
ACR responses at week 24
% responders 100 90 80 70 60 50 40 30 20 10 0 ACR20 ACR50 ACR70 adalimumab 40 mg EOW ARMADA 2003 ACR20 ACR50 ACR70 tofacitinib 5 mg bid Kremer 2012 active treatment placebo ACR20 ACR50 ACR70 baricitinib 4 mg qd Keystone 2014 Note: data not from head-to-head studies 7
Filgotinib ACR responses
DARWIN 1 study, ITT-NRI, W24
% responders 100 90 80 70 60 50 40 30
42 55
*
61
***
73 56
*
60
***
80
**
35
***
47
20 10
16
0 ACR20 +: p<0.10; *: p<0.05; **: p<0.01; ***: p<0.001
***
50
** **
35 35
ACR50 ***
55 9
*
22
**
33
**
29
*
21
*
24
***
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ACR70 Subjects who switched treatment at Week 12 were handled as if they discontinued at Week 12 This slide contains scores based on the final data set 8 Placebo 50 mg 100 mg 200 mg 2x25 mg 2x50 mg 2x100 mg
Safety – DARWIN 1 & 2
Week 0-24, change versus baseline Parameter Hemoglobin Platelets Lymphocytes Neutrophils Creatinine ALT Lipids Male hormones Measure
increase up to 4% decrease towards mid normal value no drop decrease towards mid normal value increase up to 13% no CTCAE gr 3-4 on treatment increase of HDL (up to 24%) & LDL (up to 17%) no clinically meaningful changes 9
FITZROY: unique study in Crohn’s
• Filgotinib 1st oral drug with Phase 2 data up to 20 weeks: TNF naïve & non-responder population data endoscopy at baseline dose-range, induction & maintenance in same study Placebo (n=44) 100 mg QD Placebo 0 Filgotinib 200 mg QD (n=130) 10 Placebo 100 mg QD 200 mg QD 20 weeks 10
CDAI responses TNF naïves
FITZROY study, ITT-NRI, W10
% responders 80 70 30 20 10 0 60 50 40
13 61 44 68
Clinical remission 100-points clinical response 11 Placebo 200 mg
Competition TNF naïves
Clinical remission: induction
% responders 80 70 60 50 40 30 20 10 0
3 21
Xeljanz 5mg W4
7 20
Cimzia 400mg W12 PRECISE-1
17 18
Active Delta Stelara 6mg/kg IV W8
19 16
Entyvio 300mg W10 GEMINI-3 12 Placebo
24 12
Humira 160mg W4 CLASSIC-1 Note: data not from head-to-head studies
18 23 48 13
Eldelumab 20mg/kg W11 Phase 2A Filgotinib 200mg W10 FITZROY
CDAI responses TNF-failures
FITZROY study, ITT-NRI, W10
% responders 60
54
50 40 30 20 10 0
29 37 39
Clinical remission 100-points clinical response 13 Placebo 200 mg
Competition TNF-failures
Clinical remission: induction
% responders 60 Active Delta Placebo 50 40 30 20 10
7 11
0 Stelara 6mg/kg IV W8 CERTIFI
14 7
Humira 160mg W4 GAIN
1 23 15 12
Eldelumab 20mg/kg W11 Phase 2A 14 Entyvio 300mg W10 GEMINI-3 Note: data not from head-to-head studies
6 23
PF-00547659 225mg W12 OPERA
8 29
Filgotinib 200mg W10 FITZROY
Primary endpoint achieved
FITZROY study CDAI responses, ITT-NRI, W10
% responders 100 90 80 70 20 10 0 60 50 40 30
23
**
48 41
*
60
Clinical remission 100-points clinical response 15 *: p<0.05; **: p<0.01
Placebo 200 mg
LDL & HDL
FITZROY study, data up to W10
mean % CFB 25
LDL
25 20 20 15 15 10 10 5 5 0 0 -5 0 2 4
Week
Placebo 6 200 mg 8 10 -5 0 16
HDL
2 4
Week
6 Placebo 8 200 mg 10
Safety
FITZROY study, W10 Change from baseline
Hemoglobin (g/L)* Neutrophils (Giga/L) Lymphocytes (Giga/L) Creatinine (μmol/L) ALT
Placebo
+2.2
+0.1
No change +4 No change
200 mg
+2.2
-0.2
No change +6 No change *hemoglobin in g/L (European unit) 17
Conclusions
FITZROY study at W10
• First JAK inhibitor to show efficacy in Crohn’s disease • Statistically significant improvement of patient’s quality of life • Efficacy in both TNF-naives and TNF-failures • Safe & well-tolerated, in line with previous studies • Results support progression of filgotinib in IBD A safe & efficacious new oral treatment option for Crohn’s 18
Transformational partnership
• • • • • Co-develop filgotinib in inflammatory diseases GLPG contributes 20% to R&D costs Upfront $725 M, incl. $425 M equity stake @ €58 per share Success-based milestones totalling $1.35 B 50/50 profit split in co-promotion territories Tiered royalties 20%+ Clinical trials Ph III, regulatory & mfg Further Ph I & II trials 19 Marketing and sales Global Big 5 European markets & Benelux
Financial aspects & position
• Deal closed in Jan 2016: cash position ~$1 billion GILD 15% shareholder • Belgian Patent Income Deduction (PID) ruling will be requested income from partnership taxed at 6.8% 20
Cystic fibrosis
Use of potentiators and correctors CLASS II NORMAL
Cl Cl Cell Nucleus Cell Nucleus CF mutation Allele frequency Approved/filed drugs
Galapagos/AbbVie
F508del ~90% Orkambi ®
Potentiator +C1 +C2
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CLASS III
Cell Nucleus G551D 4% Kalydeco ®
Potentiator
CF portfolio
Preclinical Ph 1 Potentiator ‘1837 BU Pot. ‘2451 Ph 2 C1 ‘2222 BU C1 ‘2851 C2 ‘2665 BU C2 ‘2737 Status Ph 2 filed: Q4 ’15 Ph 1 start: Q2 ’16 Ph 1 results: H1 ’16 Ph 1 start: Q4 ’16 Ph 1 start: Q3 ’16 Ph 1 start: Q4 ’16 22
‘1837: superior potentiator
G551D/F508del primary cells
CFTR function, μA/cm² = 10.5% FEV1 in Ph3 studies Kalydeco ® ‘1837 23
‘1690: fully owned Autotaxin
inhibitor
Idiopathic pulmonary fibrosis: scarring and stiffening of lung tissue ~75,000 patients in US & Europe Target plays role in arthritic pain, oncology, metabolic & lung disease Phase 1: target engagement, favorable safety and PK Novel mode of action Once or twice daily oral Start exploratory Ph2a in Q1 ‘16 24
Proprietary platform feeds pipeline
Delivered 23 drug candidates
Adenovirus with shRNA Arrayed collection targeting 6,000 genes Targets • • • Disease models primary human cells, transduced with virus siRNA silences specific gene in a well – depletes 1 specific protein functional readout links disease to target 25
Clinical news flow
Disease area RA CD CF IPF OA Inflammation H1 ‘16
filgotinib Ph 3 start filgotinib W20 topline ‘1837 Ph 2 start ‘2222 Ph 1 topline ‘2457 Ph 1 start ‘1690 Ph 2 start ‘1972 Ph 1 topline MOR106 Ph 1 start 26
H2 ‘16
Ph 3 start ‘2851 Ph 1 start ‘2737 Ph 1 start ‘2665 Ph 1 start ‘2457 Ph 1 topline
Filgotinib: preparing next phase in RA, Crohn’s & UC CF program on track to triple combo therapy Proprietary target discovery to feed pipeline Fully owned programs Strong balance sheet to support innovation
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