Think
big
Annual Report 2018
CONTENTS
Contents
The Galapagos group
CSR report
Letter from the management ........................... 4
Our commitment .............................................. 68
At a glance ........................................................... 8
Improving people’s lives .................................. 69
Strategy ............................................................. 10
Diversity and Human Capital Management .. 71
Think big ............................................................ 13
Business ethics ................................................. 74
Going concern statement ............................... 21
Environment, Health, and Safety .................... 77
Risk management and internal control ......... 21
The Galapagos share ....................................... 23
Corporate governance
Overview of Galapagos NV ............................. 25
Disclaimer and other information ................. 27
R&D
Policies ............................................................... 80
Board of directors ............................................ 80
Committees ....................................................... 84
Share capital and shares ................................. 87
The Galapagos pipeline ................................... 30
Shareholders ..................................................... 91
Target discovery platform ............................... 31
Remuneration report ....................................... 92
Filgotinib ............................................................ 33
Conflict of interests and related parties ........ 97
Fibrosis .............................................................. 44
Code of Business Conduct and Ethics ........... 98
Osteoarthritis ................................................... 49
Statement by the board of directors ............. 98
Atopic dermatitis .............................................. 51
Toledo ................................................................ 54
Financial statements
Cystic fibrosis .................................................... 56
Risk factors
Product development, regulatory approval and
commercialization ........................................... 58
Consolidated financial statements ............... 100
Notes to the consolidated financial
statements ...................................................... 106
Non-consolidated financial statements ....... 165
Financial position and need for additional
capital ................................................................ 60
Auditor's report
Reliance on third parties ................................. 60
Competitive position ....................................... 61
Intellectual property ........................................ 62
Report of the statutory auditor .................... 168
Other information
Organization, structure and operation ......... 63
Glossary of terms ........................................... 173
Galapagos shares ............................................. 66
Financial calendar .......................................... 185
General statement ........................................... 66
Colophon ......................................................... 185
Contact ............................................................ 185
2
Galapagos NV • Annual Report 2018
The Galapagos
group
An overview of Galapagos, its strategy
and portfolio in 2018
we raise the bar.
THE GALAPAGOS GROUP
Letter from the management
Dear shareholder,
2018 was a truly pivotal year in the history of our company, with the publication of our first ever Phase 3 results,
FINCH 2, for filgotinib in rheumatoid arthritis. We again find the results very promising. Moreover, we and our
collaboration partner Gilead also announced promising Phase 2 results in ankylosing spondylitis (TORTUGA) and
psoriatic arthritis (EQUATOR), highlighting once more filgotinib’s potential as a veritable ‘pipeline in a product’.
We are proud that both the TORTUGA and EQUATOR results were published in The Lancet.
We also expanded our fully proprietary fibrosis portfolio, most notably
with the start of the Phase 3 program with autotaxin inhibitor GLPG1690
(ISABELA) and the Phase 2 trial in IPF with our GPR84 inhibitor, GLPG1205
(PINTA). Early 2019, we announced that we broadened the potential reach
of our GLPG1690 program with the Phase 2 trial in systemic sclerosis
(NOVESA). Beyond fibrosis, our MOR106 program entered a Phase 2 trial
(IGUANA) in atopic dermatitis as well as a subcutaneous Phase 1b bridging
trial. Together with our collaboration partner Servier, we started a global
Phase 2b trial in osteoarthritis (ROCCELLA).
With these proofs of platform now in mid-to-late-stage trials, we continue
to leverage our
innovative target discovery platform to develop
breakthrough drugs and ultimately deliver these to patients with large unmet needs. The best example of our
continued efforts to raise the bar in science may be Toledo, our newly revealed preclinical program focused on a
fully proprietary, as of yet undisclosed, novel target class. True to our DNA of ‘following the data’ with agility,
scientific rigor, and purpose, we plan to roll out a comprehensive program in a number of indications with
multiple candidates exhibiting various selectivity profiles.
All this contributes to our purpose of striving to keep at the forefront of innovation in our core disease areas,
inflammation and fibrosis.
In 2019, we look forward to substantial news flow: first and foremost, we just reported that the Phase 3 FINCH 1
& 3 trials with filgotinib in rheumatoid arthritis met their primary and key secondary endpoints. The excellent
safety data shown in FINCH 1 & 3 fully confirmed the differentiated safety profile observed in FINCH 2 and
other previous studies with filgotinib. Our collaboration partner Gilead will now share these positive data with
regulatory agencies and discuss next steps for filings. Also for filgotinib, we expect Gilead to announce the proof-
of-concept results in Sjögren’s and cutaneous lupus and initiate the Phase 3 in psoriatic arthritis. For MOR106,
together with collaboration partners MorphoSys and Novartis, we look forward to the topline results from the
IGUANA trial and the subcutaneous bridging study. For Toledo, we expect results of the first Phase 1 in the second
half of the year, and plan to initiate a Phase 1 study with a second generation Toledo compound.
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Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
From a financial perspective, we ended 2018 with a strong balance sheet, helped by a successful capital
transaction, bringing in gross proceeds of EUR 296 million. We also announced two important business
development deals: together with collaboration partner MorphoSys, we closed a license agreement with Novartis
for MOR106, and we outlicensed our cystic fibrosis portfolio to AbbVie. Looking ahead, we guide for an operational
cash burn1 between EUR 320 and EUR 340 million for full year 2019, mainly driven by our growing and maturing
clinical pipeline. In 2019, we expect to run over 40 trials, with a significant number of late-stage and
proprietary programs, and we are expanding the team in order to deliver on our pipeline. Further, we continue to
build out our commercial organization, as we gear up for the expected market launch of filgotinib.
R&D
In the field of inflammation:
▪ We and Gilead announced positive results in FINCH 2, the first of three Phase 3 trials in RA patients with our
selective JAK1 inhibitor filgotinib
▪ We and Gilead announced positive results in EQUATOR, a Phase 2 trial with filgotinib in psoriatic arthritis
patients. These results were presented in a plenary session at ACR 2018 and published in The Lancet
▪ We and Gilead announced positive results in TORTUGA, a Phase 2 trial with filgotinib in ankylosing
spondylitis patients. These results were published in The Lancet
▪ We and Gilead announced that SELECTION, a Phase 2/3 trial with filgotinib in UC patients moved into Phase
3, following a planned futility analysis
▪ We initiated the IGUANA Phase 2 trial and a Phase 1b bridging trial with MOR106 in atopic dermatitis
patients, together with collaboration partners MorphoSys and Novartis
In fibrosis:
▪ We initiated the Phase 3 ISABELA 1 & 2 trials with fully proprietary autotaxin inhibitor GLPG1690 in IPF
patients
▪ We initiated the PINTA Phase 2 trial with our fully proprietary GPR84 inhibitor GLPG1205 in IPF patients
▪ We presented the FLORA Phase 2a results with GLPG1690 at ATS 2018 and published them in The Lancet
Respiratory
In osteoarthritis:
▪ We and Servier reported that ADAMTS-5 inhibitor GLPG1972 was well tolerated and showed a dose dependent
decrease in ARGS neoepitope, a cartilage breakdown biomarker, in serum of osteoarthritis patients
▪ We and our collaboration partner Servier initiated the global ROCCELLA Phase 2 trial with GLPG1972 in
osteoarthritis patients
▪ We obtained Fast Track review status with GLPG1972 from the FDA
Corporate:
▪ We raised €296.2 million in gross proceeds in a U.S. public offering of ADS and €7.7 million from warrant
exercises
▪ We restructured our CF collaboration agreement with partner AbbVie
▪ We and collaboration partner MorphoSys outlicensed MOR106 in atopic dermatitis to Novartis
Post-period events:
▪ We initiated a Phase 2 trial with fully proprietary autotaxin inhibitor GLPG1690 in systemic sclerosis (SSc;
NOVESA), and recruited the first patient
▪ We initiated a Phase 1 trial with our first Toledo target class inhibitor GLPG3312
1 The operational cash burn (or operational cash flow if this performance measure is positive) is equal to the sum of the net cash flows generated/used (–) in
operating activities and the net cash flows generated/used (–) in investing activities minus (i) the proceeds or cash used, if any, in acquisitions or disposals of
businesses; and (ii) the movement in restricted cash, if any. This alternative performance measure is in our view an important metric for a biotech company
in the development stage. For 2017, the operational cash burn represented €154.1 million
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Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
▪ We announced partnerships with both Fibrocor and Evotec, inlicensing preclinical targets in the field of
fibrosis
▪ We initiated the GECKO study for MOR106, a Phase 2 study testing a subcutaneous formulation of MOR106 in
combination with topical corticosteroids in patients with atopic dermatitis
▪ We and Gilead reported that the Phase 3 FINCH 1 & 3 trials met their primary and most key secondary
endpoints, confirming the encouraging safety profile observed in FINCH 2 and other previous studies
2018: Details of the financial results
Revenues
Galapagos’ revenues and other income for 2018 amounted to €317.8 million, compared to €155.9 million in 2017.
Increased revenues and other income were mainly driven by an upfront payment of €47.5 million from Novartis
related to the MOR106 program, increased recognition in revenue of the upfront payment and milestones
related to the filgotinib program with Gilead, revenue recognition related to the additional upfront payment
of $45.0 million from AbbVie and previous upfront payment and milestones, and the change in accounting
treatment from the adoption of IFRS 15 – Revenue from contract with customers on 1 January 2018.
Operating result
The group realized a net operating loss in 2018 of €44.8 million, compared to a net operating loss of €89.8 million
in 2017.
R&D expenses for the group in 2018 were €322.8 million compared to €218.5 million in 2017. This planned increase
was due mainly to increased efforts on our clinical and preclinical programs, primarily filgotinib, our IPF
program, and the proprietary preclinical programs in inflammation and fibrosis.
G&A and S&M expenses of the group were €39.8 million in 2018, compared to €27.2 million in 2017. This increase
was due primarily to a planned headcount increase and higher costs for warrant plans (non-cash), mainly as a
result of the increase of the Galapagos share price.
Net result
The group realized a net loss in 2018 of €29.3 million, compared to a net loss of €115.7 million in 2017.
Cash position
Cash and cash equivalents totaled €1,290.8 million on 31 December 2018.
A net increase of €139.6 million in cash and cash equivalents was recorded in 2018, compared to an increase
of €178.0 million in 2017. Net cash flows from financing activities generated €287.9 million of cash, consisting
of €280.2 million net proceeds from the U.S. public offering, and €7.7 million proceeds from warrant exercises.
Furthermore, a net cash outflow from operating activities was
realized for €142.5 million in 2018.
Finally, €15.9 million was used in investing activities and €10.1 million positive exchange rate differences were
generated on cash and cash equivalents. The operational cash burn amounted to €158.4 million.
Furthermore, Galapagos’ balance sheet holds a receivable from the French government (Crédit d’Impôt
Recherche2), payable in 4 yearly tranches, and a receivable from the Belgian Government for R&D incentives, for
a total of both receivables of €84.6 million.
Outlook 2019
For filgotinib, in the second half of the year, we expect Gilead to report topline results for the proof-of-concept
studies in Sjögren’s and cutaneous lupus, and to launch a Phase 3 trial in PsA.
2 Crédit d’Impôt Recherche refers to an innovation incentive system underwritten by the French government
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Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
We also plan to fully recruit our Phase 2 PINTA study for our fully proprietary IPF compound GLPG1205, as well
as our ROCCELLA study in OA, together with collaboration partner Servier. For GLPG1690, we plan to continue our
ISABELA trials as well as the NOVESA Phase 2 trial in systemic sclerosis (SSc), for which a first patient was dosed
in early 2019.
For MOR106, together with our collaboration partners MorphoSys and Novartis, we plan to continue our recently
started Phase 2 trial in AtD with MOR106 in combination with topical corticosteroids (the GECKO Phase 2 trial)
as well as a Japanese ethno-bridging study. In the second half of the year, we expect the primary analysis of the
IGUANA Phase 2 trial in AtD and topline results of the subcutaneous Phase 1 bridging study. Pending positive
results, these four studies combined should offer a solid data package for our collaboration partner Novartis to
move into Phase 3.
With regard to our earlier and fully proprietary programs, we expect Phase 1 readouts of a number of earlier stage
studies, including for GLPG3312, the first Toledo compound that entered the clinic in early 2019. This molecule
is scheduled to be dosed in patients in a first proof-of-concept study before the end of the year. We also plan to
initiate a Phase 1 trial with our second generation Toledo compound, GLPG3970, in the second half of the year.
Given the large number of maturing proprietary clinical programs and the expansion of our R&D and commercial
team, we expect an operational cash burn between €320 and €340 million in 2019.
I wish to thank our shareholders for their support last year. We took substantial steps towards becoming an
integrated biopharmaceutical company in 2018. Please stay with us as we continue to "Think Big" and break
innovative ground in inflammation and fibrosis.
Regards,
Onno van de Stolpe
CEO
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Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
At a glance
Consolidated Key Figures
(thousands of €, if not stated otherwise)
Year ended 31
December 2018
Year ended 31
December 2017
Year ended 31
December 2016
INCOME STATEMENT
Revenues(1)
Other income
R&D expenditure
S, G&A expenses
Operating expenses
Operating loss
Net financial results
Taxes
Net income / loss (-)
BALANCE SHEET
Cash and cash equivalents
R&D incentives receivables
Assets
Shareholders’ equity(1)
Deferred income(1)
Other liabilities
CASH FLOW
288,836
29,009
(322,875)
(39,776)
(362,652)
(44,807)
15,598
(50)
127,087
28,830
(218,502)
(27,218)
(245,720)
(89,802)
(25,705)
(198)
(29,259)
(115,704)
1,290,796
1,151,211
84,646
1,439,496
1,214,249
149,801
75,446
75,783
1,286,274
1,011,983
219,892
54,399
Operational cash burn (-) / operational cash flow(2)
(158,379)
(154,089)
Cash flow from financing activities
Increase in cash and cash equivalents
287,876
129,497
353,357
205,778
Effect of currency exchange rate fluctuation on cash and cash
equivalents
10,089
(27,808)
Cash and cash equivalents on 31 December
1,290,796
1,151,211
129,519
22,093
(139,573)
(23,530)
(163,103)
(11,491)
65,737
(235)
54,012
973,241
64,342
1,083,338
758,701
285,612
39,025
231,881
395,996
628,111
4,816
973,241
FINANCIAL RATIOS
Number of shares issued on 31 December
54,465,421
50,936,778
46,256,078
Basic income / loss (-) per share (in €)
Diluted income / loss (-) per share (in €)
Share price on 31 December (in €)
Total group employees on 31 December (number)
(0.56)
(0.56)
80.56
725
(2.34)
(2.34)
78.98
600
1.18
1.14
60.94
508
(1) Our revenues, shareholders’ equity and deferred income for the year ended 31 December 2018 were influenced by the adoption of the new
standard IFRS 15 – Revenue from contracts with customers, on 1 January 2018. We refer to the notes of this consolidated financial report for
additional information.
(2) The operational cash burn (or operational cash flow if this performance measure is positive) is equal to the sum of the net cash flows generated /
used (-) in operating activities and the net cash flows generated / used (-) in investing activities minus (i) the proceeds or cash used, if any, in
acquisitions or disposals of businesses; and (ii) the movement in restricted cash, if any. This alternative performance measure is in our view an
important metric for a biotech company in the development stage.
8
Galapagos NV • Annual Report 2018
Employees per site
6 staff
United Kingdom
8 staff
United States
THE GALAPAGOS GROUP
81 staff
The Netherlands
163 staff
France
303 staff
Belgium
10 staff
Switzerland
154 staff
Croatia
Number of employees Galapagos group
725
285
Men
gender:
education:
440
Women
102
Other
237
PhD
112
Bachelor
274
Master
Average age:
41
Number of
employees older
than 45:
269
Nationalities:
Average years
of service:
Employee
turnover:
38
7
10.7%
9
Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
Strategy
Our mission is to develop first-in-class medicines based on the discovery of novel targets. Using human primary cells,
we discover which proteins (‘targets’) play a key role in causing diseases. We then identify and develop small molecules
that inhibit these targets, restore the balance, and thereby positively influence the course of the disease. This approach
addresses the root cause of the disease rather than just treating symptoms.
Our ambition is to become a fully integrated biopharmaceutical company focused on the development and
commercialization of novel medicines which will improve people’s lives.
Key elements of our strategy include:
▪ Rapidly advance the development of filgotinib with our collaboration partner Gilead in RA, CD, UC,
PsA, AS, and other inflammatory diseases
Based on the results from our Phase 2 and Phase 3 clinical trials, we believe that filgotinib is a promising
candidate for the treatment of RA, CD, UC, PsA, AS, and other inflammatory diseases. Our collaboration
partner Gilead is conducting Phase 3 clinical programs in RA (FINCH), CD (DIVERSITY) and UC (SELECTION)
and multiple Phase 2 clinical programs in additional inflammatory diseases. In 2018, we disclosed promising
results in a Phase 3 clinical program in RA (FINCH 2) and in Phase 2 clinical programs in PsA (EQUATOR) and
AS (TORTUGA).
▪ Build a commercial organization
We exercised an option to co-promote filgotinib with Gilead in the UK, Germany, France, Italy, Spain, the
Netherlands, Belgium, and Luxembourg. We take a step-wise approach: if approved, we aim to co-promote
filgotinib in a number of European territories with our collaboration partner, Gilead, keeping full commercial
responsibility for RA in our home markets of Belgium, the Netherlands, and Luxembourg. In a next step, we intend
to commercialize successful candidates from our fully proprietary fibrosis pipeline, with a focus on IPF. In order to
support our commercial ambitions, we are expanding the team, starting with a number of key hires with extensive
expertise in our franchises of inflammation and fibrosis. This enables us to set up a commercial organization and
make progress in our ambition to grow towards a fully integrated biopharmaceutical company.
We go step by step on commercial
Mission:
established global biopharma
1690 IPF
global scale, independent launch
collaborations as opportunity
2022+
U.S. & prioritized ROW
filgotinib
top EU markets
Gilead co-promotion
2021
EU - IBD
filgotinib
home territory
booking sales
2020
Benelux –
RA
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Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
▪ Build a fibrosis franchise
In 2017, we reported positive results with the FLORA Phase 2a trial evaluating GLPG1690 targeting ATX in IPF
patients and initiated the ISABELA global Phase 3 program with GLPG1690 in 2018. We expanded indications
with GLPG1690 by initiating the NOVESA Phase 2a trial in SSc in early 2019. We directed an additional
candidate program with a distinct mechanism of action toward IPF: we started the PINTA Phase 2a trial with
GLPG1205 in IPF patients in 2018. We have worldwide development and commercialization rights for GLPG1690
and GLPG1205. In early 2019, we also inlicensed two early stage compounds with novel modes of action in the
field of fibrosis from Fibrocor and Evotec.
▪ Rapidly advance our Toledo class franchise
We reported remarkable activity with the first of many compounds targeting the Toledo target class
during our R&D Update in 2018. Molecules inhibiting this target family effectuate a dual mode of action on
inflammation by stimulating anti-inflammatory cytokines and inhibiting pro-inflammatory cytokines. We
have observed unprecedented activity in various inflammatory preclinical models with compounds targeting
the class. We are executing on a broad program to discover and develop multiple series of compounds acting
on Toledo, aimed at activity across several conditions, with a key focus on inflammation. We started the
first Phase 1 trial with GLPG3312 in early 2019, and plan to initiate a Phase 1 trial with the second Toledo
compound, GLPG3970, later this year.
▪ Advance GLPG1972 in OA patient clinical trials with our collaboration partner Servier
In 2016, we announced that a Phase 1 first-in-human trial of GLPG1972, targeting ADAMTS-5 for the
treatment of OA, showed the product candidate reduced ARGS neoepitope in healthy volunteers up to
60% within two weeks. In early 2018, we disclosed that GLPG1972 showed a similar, dose-dependent ARGS
neoepitope reduction in OA patients within four weeks. We initiated the ROCCELLA global Phase 2 program
with GLPG1972 together with collaboration partner Servier in 2018 and intend to complete recruitment in
2019. Servier licensed the compound for further development in OA patient trials outside the United States.
We retain all development and commercialization rights to this compound in the United States, where we
also lead all clinical development of GLPG1972.
▪ Advance MOR106 in AtD patient clinical trials with our collaboration partners MorphoSys and Novartis
We announced that 83% of AtD patients treated in Phase 1b with the highest dose of MOR106 achieved
EASI-50, with the effect being sustained for months after stop of treatment. MOR106 targets IL17‑C, a novel
antibody target discovered by us. We initiated a number of Phase 1 and Phase 2 trials with MOR106 in AtD
patients in 2018, with the aim of preparing for Novartis to run the Phase 3 program.
▪ Maximize and capture the value of our target discovery platform by becoming a fully integrated
biotechnology company
Our platform has yielded many new mode-of-action investigational therapies across multiple therapeutic
areas. Our most mature preclinical programs are GLPG2534, GLPG3121, and GLPG3667 and our second
generation Toledo compound GLPG3970 for inflammation, which we plan to take into Phase 1 trials in 2019.
Additionally, we are exploring the potential of preclinical product candidates in AS, Pso, IBD, AtD, lupus, IPF,
SSc, nonalcoholic steatohepatitis, type 2 diabetes, and hepatitis B. We aim to initiate a Phase 3 trial every
other year, while conducting three proof-of-concept trials, delivering three preclinical product candidates
and six new validated targets every year. We aim to select promising programs for internal development and
commercialization and establish ourselves as a fully integrated biopharmaceutical company.
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Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
R&D ambition
PHASE 3
START
every 2 years
PROOFS-
OF-CONCEPT
every year
PRECLINICAL
CANDIDATES
every year
NEW
TARGETS
every year
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Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
THINK BIG.
‘We are on a mission'
In 2018, our team has grown immensely.
Diversity and the complementarity of talents is key:
it enables us to develop the company in a way that
is sustainable long-term.
we raise the bar.
+21%
Annelies Missotten has been VP Human Resources at Galapagos since March 2018. In the same year, the
company’s workforce increased from 600 to 725 employees, and this growth is showing no signs of slowing.
“Creating a challenging and secure environment where people can perform at their best, without being
afraid to make mistakes along the way, is crucial for realizing our ambitions.”
Annelies Missotten
VP Human Resources
“As a company, it’s important to be able to offer people a meaningful job with room for
personal development. In our case, that’s not so difficult: we are all united around a terrific
common goal, which is to use our scientific expertise to improve the health of patients. At
the same time, we are constantly expanding, which offers a wealth of opportunities that we
combine with an attractive work environment. Our transition to a fully integrated, global
biopharmaceutical company with a human face offers prospects for plenty of talent.”
We have to help each other to remain responsive and to
remain able to make decisions quickly and flexibly
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Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
Vision and audacity
“‘Think big’ is an inspiring vision that has brought Galapagos to where we are today and it
will take us much further still; it sets a challenge and generates a lot of energy. Such an
ambitious vision means that you have to dare to step out of your comfort zone on a regular
basis, stay alert, be capable of self-reflection, and keep up with what’s going on in the wider
environment. Furthermore, a very important part of the dynamics of our growth is helping
each other to avoid getting bogged down in cumbersome processes, and to remain responsive
and able to make decisions quickly and flexibly.”
Cultivating talent
“For an emerging biopharmaceutical company, the human capital makes all the difference.
How can we best mobilize our knowledge for innovation? Quite a lot depends on the mindset
and attitude of our people. It is the role of HR, together with the Galapagos leadership, to
ensure that every employee feels engaged and challenged, and that people are supported and
guided from the moment they are hired to the start of their career and further development
within the organization. It is essential to develop talent management, professionalize the
way that newcomers are welcomed, and to maintain a human approach in an ever larger
and more geographically widespread organization. Providing a buddy for new employees is
one of the many little examples that support this.”
Mix & match
“We are deliberately developing this company with people from different industries, with
a wide spectrum of backgrounds and experience. Diversity and the complementarity of
talents in our teams is a key part of this. This is a well-considered choice: it enables us
to develop the company in a way that is sustainable long-term. Recruiting people on the
employment market ourselves, wherever possible without intermediaries, is very important
for the success of this strategy. A match stands or falls with the cultural fit and we are best
positioned to make that call.”
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Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
Receiving and taking responsibility
“We expect our people to take responsibility and take ownership of their work. Our basic
principle is: you have skills and experience, you can do your job in whatever way you think
will allow you to make the greatest contribution. It’s all about entrepreneurship: you give the
best of yourself, take initiative and follow-through. Of course, you may make mistakes along
the way. As an employer, we do our best to create the conditions in which you can excel. ‘I
have the feeling that what I do has impact, that it really matters’, is something I hear a lot
from employees. Taking care of people and creating an environment that is stimulating and
secure, where you can succeed through trial and error, is crucial for realizing our ambition
to bring our medicines to patients as rapidly as possible.”
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Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
THINK BIG.
Charlotte, Karin and Yves share their story
“I really feel part of this company”
Charlotte Op de Beeck
Development Operations
Officer
Charlotte Op de Beeck is Development Operations Officer and works at Galapagos for
about six months. Although the job is pretty demanding, there are no bumps in the
road. And you can take that literally.
Are the order numbers correct? Are the invoices under budget? Does everyone have access
to the right computer programs? Charlotte will run your administration smoothly. “I’ve
already learnt such an enormous amount here,” says Charlotte. “Not just about my job, but
also about the company.”
I am a wheelchair user and I’ve been pleasantly
surprised by what they do for me at Galapagos
For Charlotte, it’s enormously important that she feels comfortable in an organization. “I am a
wheelchair user and I’ve been pleasantly surprised by what they do for me at Galapagos. Before
I started here, a future colleague took me for a quick tour to check whether everything was
wheelchair friendly. At my interview, there was a little sill difficult for me to get over with my
wheelchair. On my first day of work, that threshold was gone and I could smoothly come and
go.”
Charlotte works on the eighth floor. Especially for her, Galapagos has purchased an
evacuation chair that will safely bring her downstairs in the event of a fire. “I have already
worked in a number of companies, but this is the first time that I’ve come across something
like this. There are times I feel a bit shy about it all. But of course, it sets me at ease that
everybody is looking after me so well. It means I can take part in everything. I feel I am truly
part of the company. That helps me to grow and go through life more independently.”
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Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
“Team building combined with a good cause hits the
bullseye”
Karin Geerts
Management Assistant
For the first time, the Galapagos Company Day in 2018 was dedicated to a good cause.
The annual team-building event focused not just on the employees, but also benefited
organizations where help is always welcome.
Every Galapagos site supported a local organization of its own choosing. In Mechelen,
Galapagos worked with Sjarabang, a creative atelier where people with intellectual or
multiple disabilities work with art, theatre and music. An artist designed a polyester mould
in the form of a fish that Galapagos employees decorated to create a beautiful piece of
artwork. Team building in the form of art!
“This assignment took our scientists outside their comfort zone,” says Management Assistant
Karin Geerts, who was responsible for organizing the day in Mechelen. “Luckily, the members
of Sjarabang were there to teach us artistic techniques and guide us.”
The enthusiasm and the warmth during the Company
Day were unforgettable. It made me realize once again
that I had come to the right company
Karin was as impressed by how focused everybody was on the job, as well as the variety of
creations. The artworks were finally auctioned during the De Warmste Week, a Belgian event
that raises funds for charity, with the proceeds going to Sjarabang. “For me, it’s important
that as a company, we leave our ivory towers and meet people who might not have things
quite so easy. The enthusiasm and the warmth during the Company Day were unforgettable.
It made me realize once again that I had come to the right company.”
17
Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
“Making a difference, one day at a time”
Yves Galimidi
Purchasing Category Buyer
Yves Galimidi is responsible for procuring a range of corporate services and products,
ranging from electricity to company cars. In every aspect of his work, he thinks about
a bright, clean and green future.
Green energy
“I’ll give you an example of how we have gone green. Our electricity provider offered two
options: normal electricity and sustainably sourced electricity. It’s my job to screen options
and analyze figures so we can make the right decision. In this case, despite the slightly higher
cost, management agreed to opt for an environmentally friendly option. In Mechelen, we are
now powered entirely by electricity from renewable sources.”
Driven to lower CO2
“We are working on a project for our fleet of company cars, and are including hybrids and
electric cars. The average CO2 emissions for every car in our fleet will drop from 118 g/km to
99 g/km between 2018 and 2020.”
Virtual meetings
“Of course, there’s no point in travelling when it isn’t necessary. We are in the age of video
conferencing and Skype calls are a click away. Working this way is very efficient. It slashes
our ecological footprint.”
Proud to be green
“Galapagos is very much aware of environmentally friendly solutions that are better for the
environment. Thanks to the choices we make, we are making a difference. One day at a
time.”
18
Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
THINK BIG.
We deliver
20 years ago Onno van de Stolpe
founded Galapagos together with two
scientists …
… Galapagos R&D doubled in staff from 298
in December 2014 to 571 employees
in December 2018 …
… In 2015 we conducted 8 clinical studies,
in 2019 we plan to conduct more than 40,
an increase of 400% …
… Our cash balance increased from 198.4
million euro at years’ end 2014 to 1.291
billion euro in December 2018 …
… From 68,751 average daily trading volume of
ordinary shares on Euronext in 2014 to
approximately 481,000 ordinary shares and ADS
average daily trading volume on Euronext and
Nasdaq year to date in 2019 …
… Our ambition is to deliver
6 new targets,
3 preclinical candidates and
3 proof-of-concepts a year, and
1 Phase 3 start every other year …
… To date, 12 Galapagos compounds with
novel modes of action discovered by us
have entered studies in patients …
19
Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
… We went from 8 investment banks
covering Galapagos in 2008
to 19 in 2019 …
… To date, we have 3 novel mechanisms
showing promising patient results:
filgotinib in multiple inflammatory diseases
GLGP1690 in IPF and
MOR106 in atopic dermatitis …
… In our senior management levels,
33% of our staff is female …
… On 20 June 2019 we will celebrate our
20th birthday as a company …
… In 2018, we nominated 4 new
preclinical candidates, all with a
novel mechanism of action …
… Our global presence extended
from 4 sites in 2014 to 7 in 2018 …
… In 2019, we plan to file our first
medicine for registration …
… We went from 21 nationalities in 2015
to 38 in 2018 …
… The stock price on Euronext has increased
>1,000% and the market capitalization has
increased from ~€62 million to ~€4.8 billion
(>7,000%) from 10 May 2005 to 13 March 2019 …
… We keep delivering.
20
Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
Going concern statement
To date, we have incurred significant operating losses, which are reflected in the balance sheet showing
€297.8 million accumulated losses as at 31 December 2018. We realized a consolidated net loss of €29.3 million
for the year ended 31 December 2018. The board of directors has examined the financial statements and
accounting policies. Based on conservative assumptions, we believe that our existing cash and cash equivalents
of €1,290.8 million at 31 December 2018 will enable us to fund our operating expenses and capital expenditure
requirements at least through the next three years. The board of directors is also of the opinion that additional
financing could be obtained,
if required. Taking this into account, as well as the favorable outlook of
developments of our drug discovery and development activities, the board of directors is of the opinion that it can
submit the financial statements on a going concern basis. Whilst our cash position is sufficient for our immediate
and mid-term needs, the board of directors points out that if the R&D activities continue to go well, we may seek
additional funding to support the continuing development of our products or to be able to execute other business
opportunities.
Risk management and internal control
Risk management is embedded in our strategy and is considered important for achieving our operational targets.
To safeguard the proper implementation and execution of the group’s strategy, our executive committee has set
up internal risk management and control systems within Galapagos. The board of directors has delegated an
active role to the audit committee members to monitor the design, implementation and effectiveness of these
internal risk management and control systems. The purpose of these systems is to manage in an effective and
efficient manner the significant risks to which Galapagos is exposed.
The internal risk management and control system is designed to ensure:
▪ the careful monitoring of the effectiveness of our strategy
▪ Galapagos’ continuity and sustainability, through, for instance, consistent accounting, reliable financial
reporting and compliance with laws and regulations
▪ our focus on the most efficient and effective way to conduct our business
We have defined our risk tolerance on a number of internal and external factors including:
▪ financial strength in the long run, represented by revenue growth and a solid balance sheet
▪ liquidity in the short run; cash
▪ business performance measures; operational and net profitability
▪ scientific risks and opportunities
▪ dependence on our alliance partners
▪ compliance with relevant rules and regulations
▪ reputation
The identification and analysis of risks is an ongoing process that is naturally a critical component of internal
control. On the basis of these factors and Galapagos’ risk tolerance, the key controls within Galapagos will be
registered and the effectiveness will be monitored. If the assessment shows the necessity to modify the controls
we will do so. This could be the situation if the external environment changes, or the laws or regulations or the
strategy of Galapagos change.
21
Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
The financial risks of Galapagos are managed centrally. The finance department of Galapagos coordinates the
access to national and international financial markets and considers and manages continuously the financial
risks concerning the activities of the group. These relate to the financial markets risk, credit risk, liquidity
risk and currency risk. There are no other important risks, such as interest rate risk, because the group has
nearly no financial debt and has a strong cash position. The group does not buy or trade financial instruments
for speculative purposes. For further reference on financial risk management, see note 31 of the notes to the
consolidated financial statements. We also refer to the “Risk factors” section of the annual report for additional
details on general risk factors.
The company’s internal controls over financial reporting are a subset of internal controls and include those
policies and procedures that:
▪ pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions
and dispositions of the assets of the company
▪ provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial
statements in accordance with IFRS as adopted by the EU, and that receipts and expenditures of the company
are being made only by authorized persons; and
▪ provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or
disposition of the company’s assets that could have a material effect on the financial statements
Since the company has securities registered with the SEC and is a large accelerated filer within the meaning of
Rule 12b-2 of the U.S Securities Exchange Act of 1934, the company needs to assess the effectiveness of the internal
controls over financial reporting and provide a report on the results of this assessment.
In 2018 management has reviewed its internal controls over financial reporting based on criteria established in
the Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the
Treadway Commission (COSO) and engaged an external advisor to help assess the effectiveness of those controls.
As described in Section 404 of the U.S. Sarbanes-Oxley Act of 2002 and the rules implementing such act, we will
include the management and the statutory auditor’s assessment of the effectiveness of internal control over
financial reporting in our annual report on Form 20-F, which is expected to be filed with the SEC on or around
the publication date of the present annual report.
Management as well as the statutory auditor concluded that the group maintained, in all material respects,
effective internal control over financial reporting as of 31 December 2018.
22
Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
The Galapagos share
Galapagos NV (ticker: GLPG) has been listed on Euronext Amsterdam and Brussels since 6 May 2005 and on
the Nasdaq Global Select Market since 14 May 2015. Galapagos NV forms part of the Bel20 index (top 20 listed
companies) on Euronext Brussels, the AEX Index (top 25 listed companies) on Euronext Amsterdam, and the
Nasdaq Biotechnology Index on Nasdaq in New York.
The Galapagos share in 2018
130
120
110
100
90
80
70
01.01.2018
01.04.2018
01.07.2018
01.10.2018
31.12.2018
GLPG.AM (in EUR)
GLPG.US (in USD)
In 2018, the average daily trading volume on Euronext was 440,551 shares and €38.7 million turnover. The daily
trading volume on Nasdaq in 2018 was 113,218 ADSs and $11.7 million turnover.
Galapagos vs Next Biotech Index in 2018
1.4
1.3
1.2
1.1
1
0.9
01.01.2018
01.04.2018
01.07.2018
01.10.2018
31.12.2018
GLPG (Euronext)
Next Biotech Index
23
Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
Galapagos vs Nasdaq Biotechnology Index
1.3
1.2
1.1
1
0.9
0.8
01.01.2018
01.04.2018
01.07.2018
01.10.2018
31.12.2018
GLPG (Nasdaq)
Nasdaq Biotechnology Index
Investor relations activities
We attracted additional sell-side analyst coverage by U.S. and European banks in 2018. Our IR team presented at a
number of conferences in 2018 and did several of broker-organized and self-organized roadshows throughout the
U.S. and Europe. We presented 2017 Full Year, and Q1, Half Year, and Q3 2018 results, and our Annual R&D Update
via webcasts.
The main topics of discussion with investors included the filgotinib development programs with collaboration
partner Gilead, our Phase 3 plans with GLPG1690 in IPF patients, our ROCCELLA global Phase 2b trial with
collaboration partner Servier in osteoarthritis, and our Toledo program for inflammation.
24
Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
Overview statutory results of Galapagos NV
This overview only concerns the non-consolidated statutory results of Galapagos NV. These results are part
of the consolidated results as discussed in the letter from the management.
Galapagos NV’s operating income in 2018 amounted to €513.1 million compared to €350.6 million in 2017. This
increase is due to internally generated intangible assets – being capitalized R&D expenses – which contributed
by €86.6 million more to operating income than previous year, and due to €87.4 million higher turnover due
to increased milestone revenues and upfront payments. Other operating income amounted to €9.2 million,
including €2.0 million of grants recognized for R&D projects, €1.4 million of recharges to subsidiaries and
€5.4 million recuperation of withholding taxes for scientists. The income recognized for tax incentives for
investments in intangible fixed assets of €11.3 million (2017: €11.2 million, classified as other operating income), is
in 2018 considered as tax income.
The operating costs of 2018 amounted to €654.6 million compared to €490.4 million in 2017. Services and other
goods increased substantially to €299.8 million compared to €201.2 million in 2017, primarily due to increased
internal and external subcontracting for our preclinical studies and clinical trials as well as increased fees for
insourced personnel.
Material purchases increased slightly from €4.8 million in 2017 to €6.2 million in 2018.
Personnel costs in 2018 amounted to €33.4 million compared to €24.8 million in 2017. The number of employees
at Galapagos NV at the end of 2018 amounted to 262 as compared to 214 at the end of 2017, excluding insourced
personnel.
Depreciation increased to €305.7 million in 2018, compared to €251.4 million in 2017, and related primarily to
amortization of R&D expenses.
Galapagos NV’s 2018 financial income increased to €35.7 million compared to €8.4 million in 2017, while financial
costs decreased to €21.3 million compared to €34.4 million in 2017. This can mainly be explained by non-cash
currency exchange gains on U.S. dollar in 2018, as compared to non-cash currency exchange losses on U.S. dollar
in 2017.
Taxes recorded in 2018 consist of €11.3 million tax income, as compared to €34 thousand tax expenses in 2017. This
is due to the reclassification in 2018 of the income recognized for tax incentives for investments in intangible
fixed assets.
Galapagos NV capitalizes its incurred R&D expenses to the extent that the costs capitalized do not exceed a
prudent estimate of their value in use or their future economic benefits for the entity. The ability to recover the
capitalized amounts takes into account assumptions (e.g. future peak sales, market share, sale prices, attrition
rates regarding the successful completion of the different R&D phases) which have a highly judgmental nature
and depend on the outcome of uncertain factors which are beyond the control of the entity (e.g. test results). The
achievement of these assumptions is critical and may impact the recoverability of the amounts capitalized. The
net book value of capitalized R&D expenditure is zero in 2018 compared to €18.7 million in 2017. The driver for this
decrease was the amortization of internally generated intangible assets prior to 2016. R&D expenses capitalized
as from 2016 onwards are fully amortized in the year in which they’re capitalized. R&D expenses capitalized in
previous years are all amortized at 31 December 2018.
Investments in fixed assets in 2018 amounted to €10.0 million, excluding the internally generated assets. They
consisted mainly of costs for the new building, new laboratory and IT equipment, as well as investments in
intangible assets, being software and licenses.
25
Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
Accrued income in 2017 included receivables for tax incentives of €39.7 million; in 2018 the receivable for tax
incentives amounted to €48.2 million and was included in other receivables.
Galapagos NV’s cash position at the end of 2018 amounted to €1,274.0 million.
The non-consolidated annual accounts of Galapagos NV which we submit for your approval were prepared in
accordance with Belgian accounting rules as well as with the legal and regulatory requirements. They show a
negative result. The financial year 2018 closed with a loss of €115.7 million compared to a loss of €165.9 million
in 2017. Overall, the result of Galapagos NV is affected by the fact that, as from financial year 2010, Galapagos
NV capitalized some of its R&D expenses and revenues that were eligible for such capitalization under Belgian
GAAP and amortized these costs over a 3-year period until 2015. R&D expenses capitalized as from 2016 onwards
are fully amortized in the year itself. This amortization negatively impacted the net result of Galapagos NV by
€1.1 million in 2018, compared to a negative impact of €17.4 million in 2017. The non-consolidated annual accounts
of Galapagos NV show accumulated losses of €459.5 million as at 31 December 2018; we refer to the Going Concern
Statement for justification for the application of the valuation rules under the going concern assumption.
In 2018, neither Galapagos NV nor its affiliates made direct or active use of financial instruments such as hedging
instruments.
26
Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
Disclaimer and other information
This report contains all information required by Belgian law.
Galapagos NV is a limited liability company organized under the laws of Belgium and has its registered office at
Generaal De Wittelaan L11 A3, 2800 Mechelen, Belgium. Throughout this report, the term “Galapagos NV” refers
solely to the non-consolidated Belgian company and references to “we,” “our,” “the group” or “Galapagos” include
Galapagos NV together with its subsidiaries.
This report is published in Dutch and in English. Galapagos is responsible for the translation and conformity
between the Dutch and English versions. In case of inconsistency between the Dutch and the English versions,
the Dutch version shall prevail.
This report, including the statutory financial statements of Galapagos NV, is available free of charge and upon
request to be addressed to:
Galapagos NV
Investor Relations
Generaal De Wittelaan L11 A3 2800 Mechelen
Belgium
Tel: +32 15 34 29 00
E-mail: ir@glpg.com
A digital version of this report, including the statutory financial statements of Galapagos NV, is available on our
website, www.glpg.com.
We will use reasonable efforts to ensure the accuracy of the digital version, but do not assume responsibility
if inaccuracies or inconsistencies with the printed document arise as a result of any electronic transmission.
Therefore, we consider only the printed version of this report to be legally valid. Other information on our website
or on other websites does not form a part of this report.
As a U.S. listed company, we are also subject to the reporting requirements of the U.S. Securities and Exchange
Commission, or SEC. An annual report will be filed with the SEC on Form 20‑F. The Form 20‑F will be available in
the SEC’s EDGAR database (https://www.sec.gov/edgar.shtml) and a link thereto will be posted on our website.
Forward-looking statements
This report contains forward-looking statements, all of which involve certain risks and uncertainties. These
statements are often, but are not always, made through the use of words or phrases such as “believe,” “anticipate,”
“expect,” “intend,” “plan,” “seek,” “estimate,” “may,” “will,” “could,” “stand to,” “continue,” as well as similar
expressions. Forward-looking statements contained in this report include, but are not limited to, statements
made in the “Letter from the management”, the information provided in the section captioned “Outlook 2019”,
guidance from management regarding the expected operational use of cash during financial year 2019, and
statements regarding the expected timing, design and readouts of ongoing and planned clinical trials (i) with
filgotinib in rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and other indications (ii) with GLPG1690
and GLPG1205 in IPF, (iii) with MOR106 in atopic dermatitis, (iv) with GLPG1972 in osteoarthritis, and (v) with
GLPG3312 in inflammation. We caution the reader that forward-looking statements are not guarantees of future
performance. Forward-looking statements may involve known and unknown risks, uncertainties and other
factors which might cause our actual results, financial condition and liquidity, performance or achievements,
or the development of the industry in which we operate, to be materially different from any historic or
27
Galapagos NV • Annual Report 2018
THE GALAPAGOS GROUP
future results, financial conditions, performance or achievements expressed or implied by such forward-looking
statements. In addition, even if our results of operations, financial condition and liquidity, and the development
of the industry in which we operate are consistent with such forward-looking statements, they may not be
predictive of results or developments in future periods. Among the factors that may result in differences are
that our expectations regarding our 2019 revenues and financial results and our 2019 operating expenses may be
incorrect (including because one or more of our assumptions underlying our revenue or expense expectations
may not be realized), the inherent uncertainties associated with competitive developments, clinical trial and
product development activities and regulatory approval requirements (including that data from our clinical
research programs in rheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, ankylosing
spondylitis, idiopathic pulmonary fibrosis, osteoarthritis, and other inflammatory indications may not support
registration or further development of our product candidates due to safety, efficacy, or other reasons), our
reliance on collaborations with third parties (including our collaboration partner for filgotinib, Gilead, our
collaboration partner for GLPG1972, Servier, and our collaboration partners for MOR106, MorphoSys and Novartis),
and estimating the commercial potential of our product candidates. A further list and description of these
risks, uncertainties and other risks can be found in our Securities and Exchange Commission filing and reports,
including in our most recent annual report on Form 20‑F filed with the SEC and our subsequent filings and
reports filed with the SEC. We also refer to the “Risk Factors” section of this report. Given these uncertainties,
the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking
statements speak only as of the date of publication of this document. We expressly disclaim any obligation to
update any such forward-looking statements in this document to reflect any change in our expectations with
regard thereto or any change in events, conditions or circumstances on which any such statement is based
or that may affect the likelihood that actual results will differ from those set forth in the forward-looking
statements, unless specifically required by law or regulation.
28
Galapagos NV • Annual Report 2018
R&D
Research & Development
we raise the bar.
R&D
The Galapagos pipeline
We are an integrated biopharmaceutical company active in the discovery, development, and preparation for
future commercialization of medicines with novel modes of action, addressing disease areas of high unmet
medical need. Our pipeline comprises programs ranging from discovery to Phase 3 clinical trials in inflammation,
fibrosis, osteoarthritis (OA), and other indications. Our highly flexible platform is applicable across many
therapeutic areas. Our clinical stage programs include: filgotinib, which is currently in Phase 3 trials in
rheumatoid arthritis (RA), Crohn’s disease (CD), and ulcerative colitis (UC) and in Phase 2 trials in multiple
additional indications; GLPG1690, our fully proprietary autotaxin (ATX) inhibitor, which is currently in the
ISABELA 1 & 2 pivotal trials for idiopathic pulmonary fibrosis (IPF) and the NOVESA Phase 2 proof-of-concept trial
in systemic sclerosis (SSc); GLPG1205, our fully proprietary GPR84 inhibitor which is currently in the PINTA Phase
2 proof-of-concept trial in IPF; GLPG1972, which is in the ROCCELLA global Phase 2 trial in OA patients; MOR106,
which is being evaluated in Phase 1 and 2 trials in atopic dermatitis (AtD) patients; and the Toledo molecule
GLPG3312, aimed at a novel class of targets discovered by us and currently in Phase 1 clinical development. Almost
exclusively these programs are based on inhibiting targets which were identified using our proprietary target
discovery platform.
We have collaborations with Gilead for filgotinib, with Servier for GLPG1972, and with MorphoSys and Novartis
for MOR106. In 2018 we outlicensed our CF programs to AbbVie. The following table highlights key aspects of our
development program indication areas at the beginning of 2019:
Prolific late stage pipeline
area
filgotinib
IPF/fibrosis
OA
AtD
inflammation/fibrosis
preclinical
phase 1
phase 2
phase 3
10+ indications, more pivotal readouts in ‘19
in ph3 and ph2, proprietary
ph2b underway
ph2 underway
>20 programs
30
Galapagos NV • Annual Report 2018
R&D
Proprietary target discovery platform
Our target discovery platform provides a significant and substantial competitive advantage as it:
▪ closely mimics the invivo situation through the use of primary human cell with relevant trigger and readout
for a specific disease phenotype
▪ identifies possible points to intervene in a disease pathway by knocking down an individual protein in these
assays; and
▪ enables us to rapidly analyze all of the drugable genome and select pharmaceutically tractable protein targets
directly by their ability to regulate key disease biology
Our product candidate filgotinib acts on a target whose role in the specific disease was discovered by us using
our discovery platform and we believe is a proof of success of this approach. Further proof of this approach was
shown in 2017 with autotaxin inhibitor GLPG1690 in IPF patients, and with MOR106 directed toward IL-17C in AtD
patients. Autotaxin and IL-17C are targets we discovered for these diseases.
The human genome is made up of tens of thousands of genes which code for the proteins that make up the
human body. Nearly all chronic diseases and disorders are caused by a disruption in the normal function of
certain proteins. The main goal of the industry is to discover and develop molecules that alter the activity of
these proteins so that normal function returns and the cause of the disease is minimized or eliminated. One of
the main obstacles in discovering new drugs is to understand exactly which of the body’s thousands of proteins
play a key role in a particular disease. Once these proteins are discovered, they become targets for drug design.
Finding these targets is one of the critical steps in the drug discovery process. Our approach to target discovery
is unique as our discovery platform focuses on target identification using primary human cells, which we believe
provides a good system to study the effect that a protein might have on the disease in the human body.
In order to study proteins in human cells, we take advantage of the distinctive properties of adenoviruses.
Adenovirus is the virus that causes the common cold and has the capability to infect almost every type of human
cell. The adenoviruses we work with have been engineered to act as a shuttle vehicle, allowing the delivery of
specific pieces of DNA into human cells. Additionally, these viruses have been made replication incompetent,
meaning they do not replicate in the human cell they infect, and so do not interfere with the processes in the
cell. We engineered the viruses to carry small pieces of DNA, specific for individual human genes. When the
virus enters the cell, this DNA piece leads to the production of a short sequence of RNA that is processed in the
cell to become “short interfering RNA,” or siRNA, which specifically interferes with the mRNA of the protein it
was designed for. By using these viruses, we can cause the cells to block, or “knock-down,” the production of a
certain protein, mimicking what a small molecule drug does in the human body. We built a collection with these
adenoviruses, now in excess of 20,000 viruses, that addresses around 6,000 drugable genes.
Our drug discovery research is based on the targets discovered using this technology. Once a target is validated,
it is tested against large collections of chemical small molecules to identify chemical structures that interact
with the target and block or activate protein production. These chemical structures are then optimized to obtain
“drug-like” characteristics followed by testing of the product candidate in the clinic.
This discovery approach provides starting points for the discovery and development of new mode of action drugs.
Since 2009, we have generated 41 preclinical candidates of which 23 have novel modes of action. Of these, 19 have
entered the clinic, 12 with novel modes of action.
31
Galapagos NV • Annual Report 2018
R&D
19
14
12
41
preclinical candidates
entered clinic
novel modes of action
novel modes of action in patient studies
In addition to our pipeline of molecules in the clinic, we have multiple discovery programs which are advancing
toward clinical development. Further to targets and molecules in RA, IBD, and fibrosis, we are exploring new
modes of action in AS, PsA, IBD, AtD, lupus, IPF, SSc, nonalcoholic steatohepatitis, type 2 diabetes, and hepatitis.
32
Galapagos NV • Annual Report 2018
R&D
Filgotinib: selective JAK1 inhibitor with a potential
best-in-class product profile
Based on results from our Phase 2 trials and the FINCH Phase 3 trials, we believe that filgotinib is a promising
candidate for the treatment of RA, CD and potentially other inflammatory diseases. We are party to a
collaboration agreement with Gilead to develop and commercialize filgotinib in multiple diseases. Under the
terms of the collaboration, Gilead is primarily responsible for development and seeking regulatory approval of
the licensed product. We are required to use commercially reasonable efforts as requested by Gilead to assist
Gilead with certain development activities. Gilead initiated Phase 3 clinical programs in RA, CD, and UC in 2016,
and we and Gilead initiated Phase 2 trials with filgotinib in additional indications in 2017, with the first readouts
from these trials reported in 2018. The following table highlights our filgotinib program and status at the time of
publication of this report:
We build a filgotinib franchise
area
phase 1
phase 2
phase 3
status
rheumatoid arthritis
Crohn’s disease
ulcerative colitis
ankylosing spondylitis
psoriatic arthritis
small bowel CD
fistulizing CD
Sjögren’s
cutaneous lupus
lupus nephropathy
uveitis
recruited
recruiting
recruited
study
completed
study
completed
recruiting
recruiting
recruited
recruited
recruited
recruiting
Markets for inflammation drugs are considerable and growing. We estimate that the inflammation market
could grow to approximately $65 billion by 2027, driven by new drugs filling the current unmet need for oral,
monotherapy treatments with a rapid response, and higher efficacy maintained over time. RA remains the
largest single market indication, which we estimate to be approximately $30 billion, with the other main markets
combined representing a slightly larger opportunity than in RA:
33
Galapagos NV • Annual Report 2018
R&D
Inflammation market in ~2027, $B
~10
psoriatic arthritis
~8
ankylosing spondylitis
~9
ulcerative colitis
~30
rheumatoid arthritis
~10
Crohn’s
Based on the Phase 2 and 3 data observed with filgotinib in RA and Phase 2 data in CD, AS, and psoriatic arthritis
(PsA) thus far, we believe that filgotinib has the potential to improve treatment standards substantially in RA,
inflammatory bowel diseases (IBD), AS, and PsA. Compared with biologic agents, filgotinib is orally administered,
with a rapid onset, sustained response, and potential for monotherapy. American College of Rheumatology (ACR)
scores with filgotinib in Phase 2 and 3 trials in RA patients are encouraging, and CDAI remission and SES-50 scores
are similarly promising with filgotinib in a Phase 2 trial in CD patients who are naïve to TNF therapy. ACR and
enthesitis scores were encouraging with filgotinib in PsA in the EQUATOR Phase 2 trial, while spine mobility and
function were significantly improved with filgotinib in AS patients in the TORTUGA Phase 2 trial. Filgotinib is
highly selective for JAK1, resulting in favorable tolerability so far, including low rates of infection reported in all
trials.
Our filgotinib program in RA
RA is a chronic autoimmune disease that affects approximately more than three million patients in the United
States and Europe. RA is characterized by inflammation and degeneration of the joints. Patients suffer from
pain, stiffness, and restricted mobility due to a persistent inflammation of multiple joints, ultimately resulting
in irreversible damage of the joint cartilage and bone. According to GlobalData, sales of RA therapeutics across
the 10 main healthcare markets was $21.7 billion in 2017, with the current market being dominated by injectable,
biological therapies. Biologics, mostly TNF therapies, often lose their effect over time, so there continues to be a
considerable unmet need with regard to efficacy, safety, and convenience of use with existing treatments.
New oral therapies that target the Janus kinase (JAK) signaling pathway are emerging to treat inflammatory
diseases; some JAK inhibitors, however, are associated with a range of side effects, including aberrations in low-
density lipoprotein(LDL cholesterol) and red blood and NK cell counts. We discovered JAK1 in an inflammation
target discovery assay in 2003 and subsequently discovered filgotinib as a JAK1 specific small molecule inhibitor.
In a human whole blood assay we demonstrated that filgotinib has a nearly 30-fold selectivity for JAK1 over JAK2
and for JAK1 over JAK3. These findings were independently corroborated by Dr. Iain McInnes at the 2017 Annual
Meeting of the ACR.
We believe the high selectivity of filgotinib for JAK1 may allow for a positive efficacy profile, with an improved
safety profile for filgotinib due to the improved selectivity over JAK2 and JAK3.
34
Galapagos NV • Annual Report 2018
R&D
Filgotinib
High selectivity for JAK1
JAK1 vs. JAK2
JAK1 vs. JAK3
30
25
20
15
10
5
0
y
t
i
v
i
t
c
e
e
s
d
o
f
l
l
i
b
n
i
t
o
g
fi
l
i
b
n
i
t
i
c
i
r
a
b
i
b
n
i
t
i
c
a
f
o
t
i
b
n
i
t
i
c
a
d
a
p
u
i
b
n
i
t
o
g
fi
l
i
b
n
i
t
i
c
i
r
a
b
i
b
n
i
t
i
c
a
f
o
t
i
b
n
i
t
i
c
a
d
a
p
u
Source: Galapagos human whole blood assay
Source: Galapagos biochemical assay
“ExVivo Comparison of Baricitinib, Upadacitinib, Filgotinib, and Tofacitinib for Cytokine Signaling in Human Leukocyte Subpopulations,” McInnes et al, ACR 2017
DARWIN Phase 2 program with filgotinib in RA
Clinical trials to date have shown that filgotinib is well-tolerated, with atherogenic index improvement, absence
of anemia, low infection rates and low incidence of deep venous thrombosis and pulmonary embolisms. We
believe its once-a-day oral dosage and its low risk for drug-drug interactions make it convenient for patient use.
We reported positive results from the DARWIN 1 & 2 Phase 2b dose-range finding clinical trials in 2015; these findings
were published in the Annals of Rheumatological Diseases (Westhovens et al 2016 and Kavanaugh et al 2016).
DARWIN 3 is a multi-center, open-label, long-term follow-up safety and efficacy trial of subjects who have
completed either DARWIN 1 or DARWIN 2. All subjects started the trial at the same dose level, either at 200 mg
filgotinib once per day or at 100 mg filgotinib twice per day (except for males in the U.S. sites of these trials who
receive a maximum daily dose of 100 mg), depending on the regimen administered during the preceding trial,
with DARWIN 1 subjects continuing to use filgotinib in combination with MTX.
We and our collaboration partner Gilead reported findings from DARWIN 3 at 132 weeks of treatment at ACR
2018. Promising activity levels were maintained and a favorable tolerability profile was reported. Data in DARWIN
3 were consistent with the risk/benefit profiles reported in DARWIN 1 and 2. These data were presented by Dr.
Arthur Kavanaugh at the 2018 Annual Meeting of the ACR.
35
Galapagos NV • Annual Report 2018
R&D
Based on our review of published studies, filgotinib has shown the lowest rates of infection, deep venous
thrombosis (DVT) and pulmonary embolisms per 100 patient year experience (PYE) versus other JAKs and other
therapy types thus far in RA:
Low incidence of DVT and infections
filgotinib
baricitinib
tofacitinib
upadacitinib
tocilizumab
adalimumab
event per
100 PYE
50-200 mg
2 and 4 mg QD
5 mg BID
6 and 12 mg BID 4 and 8 mg/kg
DARWIN3
wk132
Genovese et al
ACR 2017
Wollenhaupt
ACR 2017
Genovese
ACR 2017
Genovese
ACR 2012
Burmester
2011
patient year exp.
2,042
6,637
5,278
serious infection
herpes zoster
1.0
1.5
2.9
3.2
DVT/ PE
deaths
2/2,042*
0.1
31/6,754
0.5
0.2
0.3
2.4
3.8
3/1,849
0.2
0.6
725
2.3
3.7
5/725
0.7
0.3
14,994
23,943
4.5
ND
ND
0.6
4.6
ND
ND
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, ACR 2017 (5 mg bd), and death data from 2012 FDA Medical review
Baricitinib: DVT/PE Weinblatt ACR 2017
FINCH Phase 3 program with filgotinib in RA
In August 2016, Gilead initiated the FINCH global Phase 3 program investigating the efficacy and safety of 100
mg and 200 mg filgotinib once daily, in RA patient populations, ranging from early stage to biologic-experienced
patients:
FINCH 1 is an ongoing 52 week, randomized, placebo- and adalimumab-controlled trial in combination with
methotrexate (MTX) enrolling 1,759 adult patients with moderately to severely active RA who have had inadequate
response to MTX. The primary endpoint is ACR20 at week 12. The trial includes radiographic assessment at weeks
24 and 52. We and Gilead reported on 28 March 2019 that FINCH 1 met primary and key secondary endpoints.
FINCH 2 was a 24 week, randomized, placebo-controlled trial in 449 patients who were on conventional disease-
modifying anti-rheumatic drugs (cDMARD), and had an inadequate response to biological treatment. In this
study, 23.7 percent of patients had received three or more bDMARDs. The primary endpoint was ACR20 at week 12.
We and Gilead reported in September 2018 that FINCH 2 met all primary and key secondary endpoints.
FINCH 3 is an ongoing 52 week, randomized trial in 1,252 MTX-naïve patients to study filgotinib in combination
with MTX, as well as monotherapy. The primary endpoint is ACR20 at week 24. Radiographic progression will also
be assessed. We and Gilead reported on 28 March 2019 that FINCH 3 met the primary endpoint.
In addition, Gilead is performing a dedicated male patient testicular safety trial in UC patients, called MANTA,
concurrent to all Phase 3 programs. This randomized, double-blind, placebo-controlled trial is intended to enroll
adult male UC patients with a treatment phase of up to 26 weeks.
36
Galapagos NV • Annual Report 2018
R&D
FINCH 1 results
The study achieved its primary endpoint for both doses of filgotinib in the proportion of patients achieving an
American College of Rheumatology 20 percent response (ACR20) compared to placebo at Week 12.
The proportion of patients achieving ACR50 and ACR70 response was also significantly greater for filgotinib
compared with placebo at Week 12, for both doses. Patients receiving filgotinib 100 mg or 200 mg had a
statistically significant reduction in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
compared with those receiving placebo. The proportions of patients achieving clinical remission (DAS28(CRP) <
2.6) and low disease activity (DAS28(CRP) ≤ 3.2) at Week 12 were significantly higher for patients in both filgotinib
arms compared with placebo. When comparing low disease activity rates at Week 12, filgotinib 200 mg was non-
inferior to adalimumab. Filgotinib 100 mg and 200 mg also significantly inhibited the progression of structural
damage at Week 24 as assessed by change from baseline in modified total Sharp score (mTSS) compared with
placebo.
Top-line FINCH 1 efficacy^ data are summarized in the table below.
filgotinib
adalimumab
placebo
filgotinib
200 mg
+MTX
(n=475)&
76.6***
47.2***
26.3***
49.7***$
100 mg
+MTX
(n=480)&
69.8***
36.3***
18.5***
38.8***
33.9***¥#
23.8***£#
-0.69***
0.13***
-0.56***
0.17***
40 mg
+MTX
(n=325)&
70.8
35.1
14.2
43.4
23.7
-0.61
0.16
+MTX
(n=475)&
49.9
19.8
6.7
23.4
9.3
-0.42
0.38
ACR20 (%)
ACR50 (%)
ACR70 (%)
DAS28(CRP) ≤ 3.2
(low disease activity) (%)
DAS28(CRP) < 2.6
(clinical remission) (%)
HAQ-DI change
mTSS change
& Number of patients randomized to each treatment group and who received at least one dose of study drug
ACR20/50/70 represents American College of Rheumatology 20%/50%/70% improvements.
*** p <0.001, compared with placebo
$ p <0.001, non-inferiority to adalimumab
£ p <0.01, non-inferiority to adalimumab
¥ p <0.01, superiority to adalimumab
# Comparison not adjusted for multiplicity
^ All efficacy time points assessed at Week 12 except mTSS which was assessed at Week 24
The safety profile of filgotinib in FINCH 1 is consistent with prior studies up to Week 24. Serious adverse events
occurred in 4.4 percent, 5.0 percent, 4.3 percent and 4.2 percent of the patients in the filgotinib 200 mg, filgotinib
100 mg, adalimumab and placebo groups, respectively. There were five deaths, two patients were assigned to
the placebo group, two to the filgotinib 200 mg group and one to the filgotinib 100 mg group. Five patients
with a malignancy were also reported -- three receiving placebo, one receiving adalimumab and one receiving
filgotinib 100 mg, respectively. Three venous thrombotic events were observed (two in the placebo group, one
in the filgotinib 200 mg group), and there were four adjudicated major adverse cardiovascular events, two in
the placebo, one in the adalimumab and one in the filgotinib 100 mg groups. The proportion of patients with
herpes zoster was similar across treatment groups (filgotinib 200 mg = 0.4 percent, filgotinib 100 mg = 0.4 percent,
adalimumab = 0.6 percent, placebo = 0.4 percent), as was the rate of serious infections (filgotinib 200 mg = 1.7
percent, filgotinib 100 mg = 1.7 percent, adalimumab = 2.5 percent, placebo = 0.8 percent).
37
Galapagos NV • Annual Report 2018
R&D
FINCH 2 results
Filgotinib achieved its primary endpoint in the FINCH 2 trial in the proportion of patients achieving an ACR20
at week 12. Also at weeks 12 and 24, the proportion of patients achieving ACR50 and ACR70 response, low disease
activity, and clinical remission were significantly higher for patients receiving once-daily filgotinib 100mg or
200mg compared to patients receiving placebo. Topline efficacy data are summarized in the table below:
non-responder
imputation
ACR20 (%)
ACR50 (%)
ACR70 (%)
DAS28(CRP) < 2.6
(clinical remission)
(%)
DAS28(CRP) ≤ 3.2
(low disease
activity) (%)
week 12
week 24
placebo
filgotinib
filgotinib
placebo
filgotinib
filgotinib
(n=148)
31.1
14.9
6.8
8.1
100 mg
(n=153)
57.5***
32.0***
14.4*
200 mg
(n=147)
66.0***
42.9***
21.8***
25.5***
22.4***
(n=148)
34.5
18.9
8.1
12.2
100 mg
(n=153)
54.9***
35.3**
20.3**
200 mg
(n=147)
69.4***
45.6***
32.0***
26.1**
30.6***
15.5
37.3***
40.8***
20.9
37.9**
48.3***
ACR20/50/70 represents American College of Rheumatology 20%/50%/70% improvements.
* p <0.05, compared to placebo
** p <0.01, compared to placebo
*** p <0.001, compared to placebo
Filgotinib was generally well-tolerated in the FINCH 2 trial, with no new safety signals compared to those reported
in previous trials of filgotinib. Treatment-emergent adverse events and serious adverse events were mostly mild
or moderate in severity. Serious adverse events occurred in 3.4, 5.2 and 4.1 percent of the patients in the placebo,
100mg and 200mg groups, respectively. The proportion of patients who discontinued study drug due to treatment-
emergent adverse events was also similar across groups. Two cases of uncomplicated herpes zoster were reported
in each filgotinib group. Two MACE were identified, one subarachnoid hemorrhage in the placebo group and one
myocardial ischemia in the filgotinib 100mg group. There was one case of non-serious retinal vein occlusion in
the filgotinib 200mg group and no reports of VTE or pulmonary embolism. There were no deaths, malignancies,
gastrointestinal perforations, or opportunistic infections, including active tuberculosis.
FINCH 3 results
The study achieved its primary endpoint in the proportion of patients achieving an American College of
Rheumatology 20 percent response (ACR20) at Week 24. The proportion of patients achieving the primary
endpoint of ACR20 response at Week 24 was significantly higher for filgotinib 200 mg plus MTX and filgotinib 100
mg plus MTX compared with MTX alone.
The proportion of patients achieving ACR50, ACR70, and clinical remission (DAS28(CRP) < 2.6) at Week 24 was
also significantly higher for patients receiving once-daily filgotinib 100 mg or 200 mg plus MTX compared with
patients receiving MTX alone. Additionally, those who received filgotinib experienced greater reduction in the
Health Assessment Questionnaire Disability Index (HAQ-DI) compared with those receiving MTX alone at Week
24. Filgotinib 200 mg monotherapy inhibited the progression of structural damage at Week 24 compared with
MTX alone as assessed by modified total Sharp score (mTSS).
38
Galapagos NV • Annual Report 2018
R&D
Top-line FINCH 3 efficacy^ data are summarized in the table below:
filgotinib
200 mg
+MTX
(n=416)&
81.0***
61.5***
43.8***
54.1***
-0.94***
0.20
filgotinib
100 mg
+MTX
(n=207)&
80.2*
57.0**
40.1***
42.5***
-0.90**
0.22
filgotinib
200 mg
monotherapy
(n=210)&
78.1
58.1**#
40.0***#
42.4***#
-0.89*#
-0.04**#
MTX
(n=416)&
71.4
45.7
26.0
29.1
-0.79
0.52
ACR20 (%)
ACR50 (%)
ACR70 (%)
DAS28(CRP) < 2.6 (clinical
remission) (%)
HAQ-DI change
mTSS change
& Number of patients randomized to each treatment group and who received at least one dose of study drug
ACR20/50/70 represents American College of Rheumatology 20%/50%/70% improvements.
* p < 0.05 compared with MTX
** p <0.01, compared with MTX
*** p <0.001, compared with MTX
# Comparison not adjusted for multiplicity
^ Efficacy assessed at Week 24 for all endpoints
The safety profile of filgotinib in FINCH 3 is consistent with prior studies up to Week 24. Serious adverse events
occurred in 4.1 percent, 2.4 percent, 4.8 percent, and 2.9 percent of patients receiving filgotinib 200 mg plus MTX,
filgotinib 100 mg plus MTX, filgotinib 200 mg monotherapy and MTX alone, respectively. There was one venous
thrombotic event (in the MTX group), five cases of adjudicated major adverse cardiovascular events (two in the
filgotinib 200 mg plus MTX group, one in the filgotinib 200 mg group and two in the MTX group) and one
malignancy (in the MTX group). There was one death, reported in the filgotinib 200 mg plus MTX group. Serious
infections occurred in 1.0 percent, 1.0 percent, 1.4 percent and 1.0 percent of the patients in the filgotinib 200
mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg monotherapy and MTX groups, respectively. The
proportion of patients reporting herpes zoster was 0.5 percent in each of the treatment groups.
FINCH and DARWIN 3 safety
We and Gilead also announced interim safety information from four studies of the investigational compound
filgotinib for the treatment of rheumatoid arthritis (RA). The data include 24 week results of the ongoing Phase 3
FINCH 1, 2, and 3 trials, and updated Week 156 safety data from the Phase 2b DARWIN 3 long term extension study
in patients with RA.
Week 24 safety data from the FINCH 1, 2, and 3 studies are aggregated and summarized in the table below. Data
from 3,452 patients are reported, including 2,088 patients who received filgotinib.
39
Galapagos NV • Annual Report 2018
R&D
placebo/
MTX
(n=1039)
no. (%)
10 (1.0)
4 (0.4)
3 (0.3)
2 (0.2)
4 (0.4)
5 (0.5)
adalimumab
filgotinib
filgotinib
filgotinib
filgotinib
100 mg
200 mg
200 mg
total
+MTX
40 mg EOW
+MTX/
csDMARD
(n=325)
no. (%)
8 (2.5)
2 (0.6)
0 (0)
0 (0)
1 (0.3)
1 (0.3)
(n=840)
no. (%)
13 (1.5)
5 (0.6)
0 (0)
1 (0.1)
1 (0.1)
2 (0.2)
+MTX/
csDMARD
(n=1038)
no. (%)
13 (1.3)
6 (0.6)
1 (0.1)μ
3 (0.3)
0 (0)
(n=210)
no. (%)
3 (1.4)
1 (0.5)
0 (0)
0 (0)
0 (0)
(n=2088)
no. (%)
29 (1.4)
12 (0.6)
1 (<0.1)
4 (0.2)
1 (<0.1)
2 (0.2)
1 (0.5)
5 (0.2)
serious infections&
herpes zoster&
DVT/PE&
death@
malignancy excluding
NMSC&
MACE&
MTX, methotrexate; EOW, every other week; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DVT, deep venous thrombosis;
PE, pulmonary embolism; NMSC, non-melanoma skin cancer; MACE, major adverse cardiac events
& Treatment-emergent events
μ Excludes one retinal vein occlusion
@ All events
The Phase 2b DARWIN 3 long term extension trial initially enrolled 739 patients, who received filgotinib 100
mg twice daily, 100 mg or 200 mg once daily. Safety data are summarized in the table below. Results represent
treatment through 156 weeks or longer, and comprise 2,203 patient-years of exposure (PYE) to filgotinib.
serious infections
herpes zoster
DVT/PE
death
malignancy excluding NMSC
MACE
number of events
(events per 100 patient-years)
PYE=2,203
27 (1.2)
34 (1.5)
2 (0.1)
5 (0.2)
11 (0.5)
3 (0.1)
DVT, deep venous thrombosis; PE, pulmonary embolism; NMSC, non-melanoma skin cancer; MACE, major adverse cardiac events
40
Galapagos NV • Annual Report 2018
R&D
Our filgotinib program in inflammatory bowel disease (IBD)
IBD includes CD and UC. We observed high activity and a favorable safety profile in a Phase 2 trial with filgotinib
in CD, as reported in The Lancet (Vermeire et al 2016). The profile we saw with filgotinib in this CD patient trial
leads us to believe the product candidate may show activity and tolerability in UC patient trials as well. IBD
affects approximately two million patients (of which approximately 0.5 million are being treated with biologics)
in the United States and Europe, and the market for IBD therapies is approximately $9 billion today, according
to GlobalData. Current treatments are dominated by anti-TNF agents, with new biologic products gaining some
ground in second line treatment.
CD is an IBD of unknown cause, resulting in chronic inflammation of the gastrointestinal (GI) tract with a
relapsing and remitting course. Today, only 10% of CD patients achieve prolonged clinical remission. There are
currently no highly effective oral therapies approved for CD and, similar to RA, treatment is dominated by
injectable, biologic treatments including anti-TNF therapies. Anti-TNF agents have improved the management
of CD; however, not all patients respond to these drugs, and secondary loss of response is reported in up to 50%
of patients per year in placebo-controlled trials. There continues to be a considerable unmet need with these
existing treatments. Dysregulation of the JAK signaling pathway has also been associated with CD, and we believe
that filgotinib, with its high selectivity for JAK1, is a highly attractive candidate for the treatment of CD. By
inhibiting JAK1 but not JAK2, unwanted effects such as anemia may be prevented. This absence of anemia is of
particular importance to IBD patients, who frequently experience fecal blood loss.
Our clinical program with filgotinib in CD
Our FITZROY Phase 2 trial (174 patients) evaluated filgotinib once-daily versus placebo in patients with moderate
to severely active CD and mucosal ulceration. Patients recruited were either anti-TNF naïve or anti-TNF failures.
FITZROY was the first trial in CD to require endoscopic confirmation of lesions at entry, and also to include a
placebo control on endoscopy. The trial comprised two parts, each of 10 weeks duration: the first part investigated
the safety and efficacy of filgotinib 200 mg once daily versus placebo, while the second part of the trial
investigated continued treatment through 20 weeks in an observational exploratory design. As reported in The
Lancet (Vermeire et al ), the FITZROY trial achieved the primary endpoint of clinical remission at 10 weeks:
the percentage of patients overall achieving a Crohn’s Disease Activity Index (CDAI) score lower than 150 was
statistically significantly higher in patients treated with filgotinib (47%) versus patients receiving placebo (23%).
The share of patients achieving 100-points clinical response (60%) also was significant versus those receiving
placebo (41%). We believe that the activity observed with filgotinib in TNF naïve patients in FITZROY compared
favorably to that seen with other treatments in other, separate trials.
Overall, in the FITZROY trial at 20 weeks of treatment, filgotinib demonstrated a favorable safety profile
consistent with the DARWIN trials in RA. An increase in hemoglobin was also observed in FITZROY, without
difference between filgotinib and placebo. No clinically significant changes from baseline in neutrophils or liver
function tests were observed.
Gilead initiated a Phase 3 trial (DIVERSITY) with filgotinib in CD in November 2016. The DIVERSITY Phase 3 trial
investigates efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in patients
with moderately to severely active disease including those with prior antibody therapy failure. Gilead will recruit
approximately 1,300 patients from the United States, Europe, Latin America, Canada, and Asia/Pacific regions.
Men and women in the DIVERSITY trial will be randomized to receive placebo, 100 mg or 200 mg filgotinib. In the
United States, males may receive 200 mg if they failed at least one anti-TNF and vedolizumab, a monoclonal anti-
integrin antibody marketed by Takeda. We expect Gilead to complete recruitment for DIVERSITY in the third
quarter of 2020.
In March 2017, Gilead initiated a Phase 2 trial in small bowel CD and a Phase 2 trial in fistulizing CD.
41
Galapagos NV • Annual Report 2018
R&D
Our clinical program with filgotinib in UC
UC is an inflammatory bowel disease resulting in ulcerations and inflammation of the colon and rectum. Unlike
CD, UC involves damaging inflammation of only the colon and rectum. According to GlobalData, there were
1.2 million patients being treated for ulcerative colitis in the 7 major markets, for combined total sales of just over
$5 billion in 2017. Although the introduction of anti-TNF biologics has improved the treatment of some patients,
only 33% of patients will achieve long-term remission, and many patients lose their response to treatment over
time. The medical need for improved efficacy is high and could likely be achieved by a new mechanism of action.
Gilead initiated the SELECTION Phase 2b/3 trial in UC with filgotinib in December 2016. SELECTION investigates
efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in patients with moderately
to severely active disease including those with prior antibody therapy failure. Gilead will recruit approximately
1,300 patients from the United States, Europe, Latin America, Canada, and Asia/Pacific regions. Men and women
in SELECTION were randomized to receive placebo, 100 mg or 200 mg filgotinib. In the United States, males may
receive 200 mg if they failed at least one anti-TNF and vedolizumab.
In May 2018, Gilead and we announced that an independent Data Monitoring Committee (DMC) conducted a
planned interim futility analysis of SELECTION after 350 patients completed the induction period in the Phase 2b
portion of the trial. The DMC recommended that the study proceed into Phase 3 as planned at both the 100 mg
and 200 mg once daily dose level in biologic-experienced and biologic-naïve patients. Gilead completed screening
for SELECTION in 2019.
Other clinical programs with filgotinib
In the course of 2017, Gilead initiated clinical trials with filgotinib in Sjögren’s disease, cutaneous lupus
erythematosus, lupus membranous nephropathy, and uveitis. We initiated patient trials with filgotinib in PsA
and AS, for which we reported topline results in 2018. In 2019, Gilead reported completion of recruitment
for Sjögrens disease and cutaneous lupus erythematosus, and that they are no longer recruiting for lupus
membranous nephropathy.
Psoriatic arthritis
PsA is an inflammatory form of arthritis, affecting up to 30% of psoriasis patients. There are approximately
1 million patients in the U.S. and European Union today, with men and women being affected equally. PsA can
cause swelling, stiffness and pain in and around the joints and cause nail changes and overall fatigue. Studies
show that delaying treatment for PsA as little as six months can result in permanent joint damage. Early
recognition, diagnosis and treatment of PsA are critical to relieve pain and inflammation and help prevent joint
damage. Despite the availability of a number of treatment options, few current treatments effectively relieve the
enthesitis (inflammation of the tendons or ligaments) and symptoms in the joints and the skin.
The EQUATOR Phase 2 trial was a multi-center, randomized, double-blind, placebo-controlled trial to assess
the safety and efficacy of filgotinib in adult patients with moderately to severely active PsA. 131 patients were
randomized in the trial in a 1:1 ratio to receive 200 mg filgotinib or placebo once-daily administered for 16 weeks.
EQUATOR was recruited in eight European countries.
In May 2018, Gilead and we announced that the EQUATOR trial achieved its primary endpoint of improvement
in the signs and symptoms of PsA at week 16, as assessed by ACR20 score. There was an ACR20 response of 80%
for filgotinib versus 33% for placebo (p<0.001). The ACR50 and ACR70 responses at week 16 were also significantly
higher for filgotinib versus placebo (ACR50: 48% for filgotinib versus 15%, p<0.001; ACR70: 23% versus 6%, p<0.01).
Filgotinib was generally well-tolerated in the EQUATOR trial, with no new safety signals observed and similar
laboratory changes compared to those reported in previous trials with filgotinib in RA patients. The adverse
event rate was similar in both groups with mostly mild or moderate events reported. There was one serious
42
Galapagos NV • Annual Report 2018
R&D
infection in the filgotinib group, a patient who experienced pneumonia with a fatal outcome. One other
patient receiving filgotinib developed herpes zoster. There were no cases of opportunistic infection, tuberculosis,
thromboembolism, or malignancy. The full results of EQUATOR were published in TheLancet and presented in a
plenary session at ACR 2018 (Mease et al 2018).
Ankylosing spondylitis (AS)
AS, a systemic, chronic, and progressive inflammatory arthritis, is one of the most common rheumatic diseases
across the globe, affecting approximately 2 million patients in the U.S., Europe, and Japan today. AS primarily
affects the spine and sacroiliac joints and progresses into severe inflammation that fuses the spine, leading to
permanent painful stiffness of the back. Currently, there is no known cure for AS, but there are treatments
and medications available to reduce symptoms and manage pain. Recent studies show that the newer biologic
medications can potentially slow disease progression in some patients; however, patients respond to different
medications with varying levels of effectiveness. Thus, it takes time to find the most effective course of treatment.
TORTUGA was a multi-center, randomized, double-blind, placebo-controlled, Phase 2 trial to assess the safety and
efficacy of filgotinib in adult patients with moderately to severely active AS. The trial was conducted in Belgium,
Bulgaria, Czech Republic, Estonia, Poland, Spain and Ukraine. In total, 116 patients were randomized in a 1:1 ratio
to receive filgotinib 200 mg or placebo once daily for 12 weeks.
In September 2018, Gilead and we announced that the TORTUGA trial achieved its primary efficacy endpoint in
adults with moderately to severely active AS. In the trial, patients treated with filgotinib achieved significantly
greater improvements in AS Disease Activity Score, the primary endpoint, at week 12, with a mean change from
baseline of -1.5 versus -0.6 for those treated with placebo (p<0.0001). More patients receiving filgotinib also achieved
an Assessment in AS Response of at least 20% improvement compared to those treated with placebo (76% versus
40%, p<0.0001).
Adverse events were generally mild or moderate in severity and were reported in an equal proportion of patients
in the filgotinib and placebo groups. Laboratory changes were consistent with those previously reported for
filgotinib, and no new safety signals were observed in the trial. There was one treatment-emergent serious
adverse event reported for a patient receiving filgotinib who experienced pneumonia and recovered after
hospital-based antibiotic treatment. One patient randomized to filgotinib, with an inherited risk for thrombosis,
experienced a non-serious deep venous thrombosis after completing the course of study drug. No deaths,
malignancies, hepatic events, opportunistic infections or cases of herpes zoster were observed in the study. The
full results of the TORTUGA trial were reported in The Lancet (Van der Heijde et al 2018).
43
Galapagos NV • Annual Report 2018
R&D
Our fibrosis programs
We are building a fibrosis portfolio with different modes of action, with an initial focus on IPF and aim to expand
to other forms of organ and skin fibrosis. To this end, we are currently working on a number of drug candidates
with distinct novel mechanisms of action, which are fully proprietary to us. In IPF, we believe that having
multiple mechanisms of action within our own portfolio of candidates allows the exploration of combinations of
therapies. We also recently expanded clinical research into SSc, and plan to explore additional fibrotic indications
with our earlier stage compounds in 2019.
Moreover, we actively pursue business development opportunities in the space. In January 2019, we announced a
global collaboration with Fibrocor, focused on a novel target for IPF and other fibrotic indications, followed by a
collaboration with Evotec for an undisclosed target in fibrosis, announced in February.
The following is an overview of our IPF portfolio and expected clinical development in 2019:
program
discovery
preclinical
phase 1
phase 2
phase 3
‘1690 (autotaxin) ISABELA IPF
‘1205 (GPR84) PINTA IPF
new IPF programs
‘1690 NOVESA SSc
status end ‘18
status end ’19 (projected)
About IPF
IPF is a chronic, relentlessly progressive fibrotic disorder of the lungs that typically affects adults over the age
of 40. According to GlobalData, IPF affects approximately 200,000 patients in the United States and Europe, and
this population is expected to grow, in part thanks to improved diagnosis. Furthermore, prevalence is expected to
increase with the aging population3. The clinical prognosis of patients with IPF is poor, as the median survival at
diagnosis is two to four years. Currently, no medical therapies have been found to cure or stop the progression
of IPF. The medical treatment strategy aims to slow disease progression and improve quality of life. Lung
transplantation may be an option for appropriate patients with progressive disease and minimal comorbidities.
Regulatory agencies have approved Esbriet4 and Ofev5 for the treatment of mild to moderate IPF. Both Esbriet
and Ofev have been shown to slow the rate of functional decline in IPF and are gaining ground as the standard
of care worldwide. Combined sales of both drugs reached $1.9 billion in 2017, with 74% of global revenues being in
the United States. These regulatory approvals represent a major breakthrough for IPF patients; yet neither drug
stops the decline in lung function, and the disease in most patients on these therapies continues to progress.
Moreover, the adverse effects associated with these therapies are considerable (e.g., diarrhea, liver function test
abnormalities with Ofev; nausea and rash with Esbriet). Therefore, there is still a large unmet medical need as
IPF remains a major cause of morbidity and mortality. We estimate that the market of approved IPF drugs will
grow to $5 billion by 2025.
3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3848422/
4 Esbriet® (pirfenidone) is an approved drug for IPF, marketed by Roche/Genentech
5 Ofev® (nintedanib) is an approved drug for IPF, marketed by Boehringer Ingelheim
44
Galapagos NV • Annual Report 2018
R&D
Our IPF trials
GLPG1690
Our most advanced IPF asset is our product candidate GLPG1690, a potent and selective inhibitor of ATX, which
is fully proprietary to us. We identified ATX as a potential target for IPF, after finding the target using an
inflammation assay in our target discovery platform. Pharmacology and translational studies published by other
parties since then suggest that ATX may also play a role in metabolic disease, arthritic pain, oncology, and lung
disease. Palmer et al published in Chest in 2018 on Bristol Meyers Squibb’s LPA1 inhibitor tested in Phase 2,
showing activity in reducing loss of Forced Vital Capacity in mL (FVC) in IPF patients. LPA1 is downstream of
ATX, supporting further evaluation of ATX inhibition. We evaluated GLPG1690 in a preclinical lung fibrosis model
(bleomycin-treated mice) and observed effects on reducing the fibrotic score, numerically favoring GLPG1690 over
Esbriet.
In August 2017, we announced positive topline results for our Phase 2a FLORA trial in IPF patients. This
randomized, double-blind, placebo-controlled trial investigated a once-daily 600 mg oral dose of GLPG1690,
administered for 12 weeks in 23 IPF patients, 17 of whom received GLPG1690 and six placebo. Primary objectives
of the trial were to assess safety, tolerability, pharmacokinetics and pharmacodynamics of GLPG1690 in an IPF
patient population. Secondary objectives included the evaluation of lung function, changes in disease biomarkers,
functional respiratory imaging (FRI), and quality of life. The IPF diagnosis was confirmed by central reading.
Over the 12-week period, patients receiving GLPG1690 showed an FVC increase of 8 mL, while patients on placebo
showed an FVC reduction of 87 mL (mean from baseline):
FVC: stabilization by ‘1690
FVC (∆ baseline, mL)
300
200
100
0
-100
-200
-300
*
BSL
N=6
N=17
week 4
N=3
N=16
week 8
N=4
N=15
week 12
N=4
N=13
placebo
‛1690 600 mg
FU
N=4
N=15
* p<0.05
In addition to the demonstrated absence of lung function decline over the 12 week period, sensitive FRI confirmed
disease stabilization in the GLPG1690 arm, versus the expected disease progression in the placebo arm, reaching
statistical significance on two specific parameters, despite the trial not being powered for significance:
45
Galapagos NV • Annual Report 2018
R&D
FRI: airway volume & resistance
Significant difference between ‘1690 & placebo
specific airway volume (Δ baseline, mL/L)
specific airway resistance (Δ baseline, kPa/sec)
p=0.0137
3.5
3
2.5
2
1.5
1
0.5
0
p=0.0255
0.01
0
-0.01
-0.02
-0.03
-0.04
placebo
‛1690
Source: Mignot et al. ATS 2018
Patients on GLPG1690 treatment showed a clear reduction of serum LPA18:2, a biomarker for autotaxin inhibition,
as expected based on the mechanism of action of GLPG1690. Thus, the level of target engagement observed in
Phase 1 with healthy volunteers was confirmed in IPF patients in FLORA.
GLPG1690 was found to be generally well-tolerated in this Phase 2 trial. Rates of discontinuation due to adverse
events, as well as serious adverse event rates, were similar between patients on GLPG1690 and placebo.
Following these encouraging results, in 2018 we announced the design of our worldwide Phase 3 program, ISABELA,
based on feedback from the FDA and EMA. The ISABELA Phase 3 program consists of two identically designed
trials, ISABELA 1 & 2, and plan to enroll a total of 1,500 IPF patients combined. Recruitment will be worldwide, with
a significant proportion of patients in the U.S. and Europe. The program is intended to support application for
a broad label in IPF in both the NDA and Market Authorization Application (MAA) submissions in, respectively,
the U.S. and EU. Patients will continue on their standard of care and will be randomized to one of two doses of
GLPG1690 or placebo. The primary endpoint will be the rate of decline of FVC (in mL) until week 52. Secondary
assessments will include respiratory-related hospitalizations, mortality, quality of life, safety and tolerability.
All patients will continue on their treatment until the last patient in their respective trial has completed 52
weeks of treatment. Therefore, some patients will remain in the study for substantially longer than 52 weeks.
This approach will allow assessment of less frequent clinical events that are otherwise difficult to assess in
conventional clinical studies of one-year duration.
46
Galapagos NV • Annual Report 2018
R&D
The following is an overview of the ISABELA trial design:
Phase 3 program ISABELA 1&2
screening
at least 52 weeks
‘1690 200mg
‘1690 600mg
placebo
follow-up
▪ 1500 IPF patients total in two identical Phase 3 studies
▪ Patients remain on standard of care throughout
▪ Global program with U.S. & EU component
▪ Primary endpoint: FVC at 52 weeks
▪ Secondary: hospitalizations, mortality, quality of life, safety/tolerability
First patient dosing in ISABELA was announced in December 2018, and new centers are currently being opened, as
recruitment efforts will continue throughout 2019.
We have received orphan drug designation for GLPG1690 in IPF from the FDA as well as from the European Commission.
GLPG1205
The second product candidate for IPF in our pipeline is GLPG1205, currently in a Phase 2 trial called PINTA.
GLPG1205 is a fully proprietary small molecule selectively inhibiting GPR84, a target discovered by us. GLPG1205 showed a
reduction in signs and symptoms in IPF animal models and has shown favorable tolerability in healthy volunteers and UC
patients in previous trials.
PINTA is a randomized, double-blind, placebo-controlled trial investigating a 100 mg once-daily oral dose of GLPG1205.
The drug candidate or placebo will be administered for 26 weeks in up to 60 IPF patients. Patients may remain on their
local standard of care as background therapy. The primary objective of the trial is to assess the change from baseline (FVC
in mL over 26 weeks compared to placebo. Secondary measures include FRI, safety, tolerability, pharmacokinetics and
pharmacodynamics, time to major events, changes in functional exercise capacity, and quality of life. IPF diagnosis will be
confirmed by central reading. Recruitment for PINTA is planned in 10 countries in Europe, North Africa, and the Middle
East. The first patient dosing was announced in October 2018, and we expect to complete recruitment of this trial in the
course of 2019.
PINTA Phase 2 in IPF
26 weeks
GLPG1205, 100mg 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. FRI
▪ Recruitment in 10 countries in Europe, North Africa, & Middle East
Note: FRI = Functional respiratory imaging
Recruitment completion targeted Q4 ‘19
47
Galapagos NV • Annual Report 2018
R&D
Our fibrosis trials
Systemic sclerosis (SSc)
SSc is a severe autoimmune disease. One of the most visible manifestations is hardening of the skin. SSc affects
approximately 95,000-155,000 patients in the U.S. and Europe, with a predominance of female patients (over 75%).
Broadly speaking, there are two types of SSc: limited cutaneous SSc, where the skin involvement is restricted, and
diffuse cutaneous SSc. In diffuse cutaneous SSc, which represents about 35% of the SSc patient population, skin
thickening affects several body areas, and patients have a higher risk of developing fibrosis of various internal
organs, such as the lung.
Currently, there are no approved drugs for this disease, which has one of the highest mortality rates among
rheumatic diseases. Hence, SSc represents a significant unmet medical need. Current treatment mainly consists
of
immunosuppressive drugs
and other
symptom-alleviating
therapies
such as methotrexate or
cyclophosphamide. These aim to avoid cutaneous fibrosis, interstitial lung disease and renal crisis.
NOVESA is a double-blind, placebo-controlled Phase 2a trial evaluating the efficacy, safety and PK/PD of GLPG1690
in patients with SSc. NOVESA is planned to recruit 30 patients with diffuse cutaneous SSc.
NOVESA Phase 2 in SSc
4 weeks
screening
24 weeks
‘1690, 600mg oral once daily (n=20)
placebo (n=10)
12 weeks
follow-up
▪ 30 patients with progressive diffuse (multi-organ) SSc
▪ Recruitment in U.S. & 5 EU countries
▪ Primary endpoint: modified Rodnan Skin Score at 24 weeks
▪ Secondary & exploratory endpoints: safety, tolerability, broad range of measures (FVC, QoL, CRISS)
The primary endpoint of NOVESA is the modified Rodnan skin score (mRSS) at 24 weeks. The mRRS measures the
skin thickness as a surrogate measure of disease severity and mortality, with an increase in thickness associated
with involvement of internal organs and increased mortality. Secondary objectives and exploratory endpoints
include FVC, quality of life, and other scores.
Early in 2019 we recruited our first patient for NOVESA.
48
Galapagos NV • Annual Report 2018
R&D
Our OA program
Sometimes called degenerative joint disease or degenerative arthritis, OA is the most common chronic condition of the
joints. OA can affect any joint, but it occurs most often in the knees, hips, lower back and neck, the small joints of the
fingers, and the bases of the thumb and big toe. According to GlobalData, OA will be the fourth leading cause of disability
by the year 2020. GlobalData estimates that diagnosed cases will grow to approximately 131 million cases by 2024.
In normal joints, a firm, rubbery material called cartilage covers the end of each bone. Cartilage provides a smooth,
gliding surface for joint motion and acts as a cushion between the bones. In OA, the cartilage breaks down, causing
pain, swelling and problems moving the joint. As OA worsens over time, bones may break down and develop growths
called spurs. Bits of bone or cartilage may chip off and float around in the joint. In the body, an inflammatory process
occurs and cytokines (proteins) and enzymes develop that further damage the cartilage. In the final stages of OA, the
cartilage wears away and bone rubs against bone leading to joint damage and more pain.
Although OA occurs in people of all ages, it is most common in people older than 65. Common risk factors include
obesity, previous joint injury, over-use of the joint, and weak thigh muscles. One in two adults will develop symptoms
of knee OA during their lives. One in four adults will develop symptoms of hip OA by age 85. Current treatments for OA
include weight loss, physical therapy, pain and anti-inflammatory medicines, and surgery, all of which address only
the symptoms of the disease. There are currently no disease-modifying therapies available for OA.
GLPG1972/S201086, also referred to as GLPG1972, is a drug candidate developed by us under our collaboration agreement
with Servier. GLPG1972 acts on ADAMTS-5, a key aggrecanase involved in the breakdown of aggrecan in joint cartilage.
ADAMTS-5 has been validated in the literature in both animal models and human explants, and ARGS, a byproduct of
the cartilage breakdown action of ADAMTS-5, has been shown to be elevated in the joints of human OA patients.
In a Phase 1b trial in OA patients in the U.S., GLPG1972 reduced the ARGS neoepitope, a cartilage breakdown biomarker
measured in the serum, by over 50% over a four-week period:
Strong reduction of ARGS
‘1972 Ph1b study in OA patients
e
n
i
l
e
s
a
b
s
v
n
o
i
t
c
u
d
e
r
%
S
G
R
A
m
u
r
e
s
-20
0
20
40
60
1
8
15
22
29
36
43
50
placebo
low dose
med dose
high dose
days post-dosing
Given these results, we and our collaboration partner Servier advanced GLPG1972 to a Phase 2b trial, ROCCELLA,
the start of which was announced in June 2018.
49
Galapagos NV • Annual Report 2018
ROCCELLA Phase 2b trial
screening
R&D
52 weeks
‘1972 dose A
‘1972 dose B
‘1972 dose C
placebo
follow-up
▪ 850 patients with knee osteoarthritis, recruited globally
▪ Primary endpoint: reduction in cartilage loss at 52 weeks
▪ Secondary: change in structural and clinical parameters, safety/tolerability
ROCCELLA is a multiregional, randomized, double-blind, placebo-controlled, dose ranging trial evaluating the
efficacy and safety of three different once-daily oral doses of GLPG1972 in patients with knee osteoarthritis. The
trial is planned to recruit approximately 850 patients in up to 15 countries. We are responsible for ROCCELLA in
the U.S., where we retain full commercial rights, and Servier will run the trial in all other countries.
The primary objective of ROCCELLA is to evaluate the efficacy of at least one dose of GLPG1972 compared
to placebo in reducing cartilage loss after 52 weeks of treatment. Cartilage thickness will be measured using
quantitative magnetic resonance imaging of the central medial tibiofemoral compartment of the target knee.
Secondary objectives include safety and tolerability, several additional measures of structural progression,
changes in bone area, pain, function, stiffness, and patient global assessment.
We intend to finalize recruitment of ROCCELLA in the second half of 2019.
We work with Servier to develop GLPG1972. We are eligible to receive milestones and single-digit royalties on
potential commercial sales for GLPG1972, while we retain full commercial rights in the United States.
50
Galapagos NV • Annual Report 2018
R&D
Our AtD program
AtD, the most severe and common type of eczema, is a chronic relapsing inflammatory skin disease that causes
severe itch, dry skin and rashes, predominantly on the face, inner side of the elbows and knees, and on hands
and feet. Scratching of the afflicted skin leads to a vicious cycle causing redness, swelling, cracking, scaling of
the skin and an increased risk of bacterial infections. Lichenification, thickening of the skin, is characteristic in
older children and adults. The National Eczema Association estimates that AtD affects over 30 million Americans
or up to 25% of children and 2-3% of adults. Sixty percent of AtD patients are diagnosed in the first year of life,
and 90% of patients have a disease onset before age five. Symptoms commonly fade during childhood, however,
approximately 10-30% of the patients will suffer from AtD for life. A smaller percentage first develop symptoms
as adults.
Generic drugs are the approved standard of care, including immunomodulators cyclosporine and mycophenolate
mofetil and topical treatments. There are disease-modifying biologics and small molecules currently in
development, with dupilimab (targeting IL-4Rα) most recently approved.
MOR106 is a human monoclonal antibody designed to selectively target IL‑17C in clinical development worldwide.
IL-17C as a target for AtD was discovered by us and has been shown to be distinct from other members of the
IL-17 cytokine family, playing an important and pro-inflammatory role in certain skin disorders. MOR106 potently
inhibits the binding of IL-17C to its receptor and thus inhibits its biological activity.
MOR106 arises from an alliance between us and MorphoSys, in which both companies contributed their core
technologies and expertise and equally shared costs and benefits. In July 2018, we and MorphoSys announced that
we entered into a collaboration regarding MOR106 with Novartis.
We evaluated MOR106 in a randomized, double-blind, placebo-controlled Phase 1 trial, with the first part
evaluating single ascending doses (SAD) followed by multiple ascending doses (MAD) compared to placebo in
approximately 25 patients with moderate to severe AtD in several European centers. Topline results of the
complete trial were reported in September 2017. In the MAD portion with MOR106 in patients, all adverse drug
reactions observed were mild-to-moderate and transient in nature and did not lead to clinically relevant safety
signals. No serious adverse events and no infusion-related reactions were recorded.
Even though the trial was not statistically powered to show differences in efficacy between treatment groups,
at the highest dose level of MOR106, in 83% of patients (five out of six) an improvement of at least 50% in signs
and symptoms of AtD measured by the Eczema Area and Severity Index (EASI-50) was recorded at week four. The
onset of activity was rapid and occurred within a few weeks and was maintained for over two months after the
last treatment. Among patients receiving placebo, in 17% of patients (one out of six) an EASI-50 improvement was
seen at week four.
As reported at AAD 2018, the pooled, mean EASI scores over time versus placebo show a sustained effect for weeks
after completion of dosing:
51
Galapagos NV • Annual Report 2018
R&D
MOR106 Ph1b
EASI, % change from baseline, pooled data, median
0
-10
-20
-30
-40
-50
-60
-70
-80
-90
-100
e
n
i
l
e
s
a
b
m
o
r
f
e
g
n
a
h
c
%
0
2
4
6
8
10
12
14
weeks after start of treatment
infusion
placebo
MOR106
Following the results of MOR106, together with Morphosys and then Novartis, we established a Phase 2
development program to enable a Phase 3 program that will be conducted by Novartis. We conduct all of the
Phase 2 clinical research, with funding from Novartis.
We initiated the Phase 2 IGUANA trial with MOR106 in May 2018. This trial is aimed at evaluating various dosages
and administration frequency. In the IGUANA Phase 2-trial, approximately 240 patients with moderate-to-severe
AtD are treated over a 12-week period with one of three different intravenous doses of MOR106 (1, 3 or 10 mg/
kg) or placebo using two different dosing regimens, in multiple centers across Europe. The placebo controlled,
double-blind study will evaluate the efficacy, safety and pharmacokinetics of MOR106. Dosing at two or four-
week intervals will be evaluated over the 12-week treatment period, followed by a 16-week observation period. The
primary objective will be assessed by the percentage change from baseline in EASI score at week 12.
IGUANA Phase 2 trial
screening
12 weeks
MOR106, 1mg/kg
MOR106, 3mg/kg
MOR106, 10mg/kg
placebo
16 week
follow-up
▪ ~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
We expect to report the primary analysis from IGUANA in 2019.
52
Galapagos NV • Annual Report 2018
R&D
In September 2018 we initiated a Phase 1b bridging trial testing a subcutaneous formulation of MOR106. This
bridging trial is a parallel-design Phase 1 clinical trial conducted in two parts. Part 1 is a single center, randomized,
open-label trial in healthy volunteers who are treated with different single dose levels of MOR106 administered
subcutaneously or intravenously. Part 2 is a multiple center, randomized, placebo-controlled, multiple dose trial
in patients with moderate to severe AtD who will be treated subcutaneously for 12 weeks. Safety and tolerability,
pharmacokinetics and occurrence of anti-drug-antibodies after administration of MOR106 will be assessed as
endpoints. In addition, the efficacy of MOR106 will be explored in subjects with moderate to severe AtD.
MOR106 Phase 1b bridging trial
screening
part 1, healthy volunteers
part 2, atopic dermatitis patients
s.c. 320mg, n=30
s.c. placebo, n=15
12 weeks, bi-weekly dosing, loading dose D1
16 week
follow-up
▪ Primary endpoints: safety, tolerability, PK
▪ Recruitment in EU
▪ Secondary endpoints Part 2: EASI/other efficacy scores, patient reported outcomes
We expect to report the topline results of this trial in 2019.
We initated a Phase 2 trial testing a subcutaneous formulation of MOR106 in combination with topical
corticosteroids in patients with moderate to severe AtD. This trial, called GECKO, aims to randomize 60 patients
who receive either a dose of MOR106 or placebo subcutaneously for 8 weeks, together with topical steroids, with
a 16 week follow-up period foreseen. The primary endpoint of GECKO is the incidence of treatment emergent
adverse events and severe adverse events through day 169.
Pharmacokinetics and occurrence of anti-drug-antibodies after administration of MOR106 will be assessed as
secondary endpoints. In addition, the efficacy of MOR106 will be explored.
Recruitment for GECKO will take place in the U.S. and Canada and will serve as a first trial under an IND to be
submitted to the FDA.
GECKO Phase 2 trial
screening
8 weeks, s.c. dosing every other week
MOR106, n=40
placebo, n=20
16 week
follow-up
▪ Patients with moderate-to-severe AtD, remain on topical steroid
▪ Double (loading) dose on day 1 only
▪ Primary endpoint: incidence of TEAEs and SAEs through day 169
▪ Secondary measures: PK & immunogenicity
▪ Exploratory measures: EASI and other efficacy scores
▪ Recruitment in Canada & U.S.
53
Galapagos NV • Annual Report 2018
R&D
Our Toledo program
‘Toledo’ is a code name for a novel target class discovered by us. Molecules inhibiting this target family effectuate
a dual mode of action on inflammation by stimulating anti-inflammatory cytokines and inhibiting pro-
inflammatory cytokines. We have observed unprecedented activity in various inflammatory preclinical models
with compounds targeting the class.
Below are the results for the first Toledo compound, GLPG3312, in three preclinical models, each demonstrating
a different mechanism of IBD. These results were first reported at our R&D Update in October 2018. Prior to
discovering Toledo, no single compound showed activity in all three of these preclinical models in our research:
DSS model
T-cell transfer model
MDR1 model
x
e
d
n
i
y
t
i
v
i
t
c
a
e
s
a
e
s
i
d
)
C
U
A
(
***
***
***
***
*
***
***
***
***
healthy diseased
int.
control
Toledo
healthy diseased
IL-12p40
Ab
Toledo
healthy diseased
abatacept Toledo
*p < 0.05; ***p < 0.001
We are now executing on a broad program to discover and develop multiple series of compounds acting on
the Toledo class of targets, aimed at activity across numerous conditions, with a key focus on inflammation.
We initiated our first Phase 1 trial with GLPG3312 in early 2019 to evaluate the efficacy, safety, tolerability, and
pharmacokinetics and pharmacodynamics of GLPG3312 in up to 76 adult healthy male volunteers.
In the second half of 2019, we aim to report topline results for GLPG3312 as well as initiate a Phase 1 trial with the
second Toledo compound, GLPG3970.
The development strategy for Toledo is to advance multiple Toledo candidates across different selectivity profiles,
and to test these in a broad panel of in vivo disease models targeting a number of indications.
The graph below shows the current status of our Toledo program. The different disease areas that we are
currently investigating are IBD, RA, psoriasis (Pso), systemic lupus erythematosus (SLE), OA, osteoporosis (OP), and
fibrosis (Fib). The first generation Toledo, GLPG3312, has delivered promising preclinical results in IBD, RA, Pso, PsA
and Fib, and we expect to generate preclinical data in SLE, OA and OP in 2019. The second generation, GLPG3970,
has shown results in IBD, RA, Pso, SLE and fibrosis, with preclinical read-outs for PsA, SLE, OA and OP planned for
2019. The third, fourth and fifth generation are currently in the lead optimization (LO) stage.
As a next step, we plan on setting up multiple parallel-running proof-of-concept (PoC) trials in patients to
investigate swiftly and efficiently the potential across the different Toledo compounds. A PoC trial for the 1st
generation Toledo compound, GLPG3312, is planned for late 2019, pending satisfactory results of the Phase 1 trial
currently ongoing.
54
Galapagos NV • Annual Report 2018
R&D
Our Toledo development strategy
▪ Develop multiple candidates across different profiles
▪ Test in broad panel of in vivo disease models
▪ Plan multiple PoC’s in patients in parallel to maximize potential
IBD
RA
Pso
PsA
SLE
OA
OP
Fib
1st gen
‘3312
2nd gen
‘3970
3rd gen
4th gen
5th gen
LO
LO
LO
2019
2019
2019
2019
2019
2019
2019
2019
2019
2019
55
Galapagos NV • Annual Report 2018
R&D
CF program
Cystic fibrosis (CF) is a rare, life-threatening, genetic disease affecting the lungs and the digestive system,
impacting approximately 80,000 patients worldwide.
Despite the approval of several drugs, there is need for better therapies to improve pulmonary function for a large
majority of the patient population. Though many pediatric patients have normal lung function at the time of
diagnosis, physicians generally believe that earlier treatments can have downstream benefits for the patient by
slowing the deterioration in lung function.
In October 2018, we and AbbVie announced a restructuring of our CF alliance. AbbVie took over all programs in
CF and will continue the development of a combination therapy for CF.
AbbVie obtained exclusive worldwide rights to the current CF drug candidate portfolio developed by the two
companies in the course of the collaboration. The portfolio includes all potentiator and corrector candidates
for CF, with the exception of GLPG1837 and a specific arrangement for GLPG2737. We retain rights to these two
compounds for use outside the field of CF.
AbbVie will be responsible for all future activities and will bear all costs associated with the portfolio in CF going
forward.
We are eligible to receive up to $200 million in additional milestone payments from AbbVie pending completion
of certain development, regulatory, and commercial achievements in CF by AbbVie, as well as royalties ranging
from the single digits to the low teens. AbbVie is eligible for future milestone payments and tiered single digit
royalties on future global commercial sales of GLPG2737, if approved, in indications outside CF.
56
Galapagos NV • Annual Report 2018
Risk factors
Description of the risks of which
investors should be aware
we raise the bar.
RISK FACTORS
Risks related to product development, regulatory
approval and commercialization
We operate adequate standard operating procedures to secure the integrity and protection of our research and
development activities and results, and the optimum allocation of our R&D budgets. The progress of the most
important research and development programs is continuously monitored by our executive committee; they are
discussed with the board of directors at least once per quarter, and board members with expertise in clinical
and scientific matters occasionally attend meetings with our scientific staff to discuss and assess such programs.
Nevertheless, due to our limited resources and access to capital, we must and have in the past decided to prioritize
development of certain product candidates; these decisions may prove to have been wrong and may adversely
affect our business.
We are heavily dependent on the success of our product candidate filgotinib. We are also dependent on the
success of our other product candidates, such as GLPG1690, GLPG1205, GLPG1972, MOR106, and GLPG3312. We cannot
give any assurance that any product candidate will successfully complete clinical trials or receive regulatory
approval, which is necessary before it can be commercialized.
Our business and future success is substantially dependent on our ability to develop successfully, obtain
regulatory approval for, and then successfully commercialize our product candidate filgotinib and our other
product candidates. We are not permitted to market or promote any of our product candidates before we receive
regulatory approval from the FDA, the EMA or any other comparable regulatory authority, and we may never
receive such regulatory approval for any of our product candidates. We cannot give any assurances that our
clinical trials for filgotinib or our other product candidates will be completed in a timely manner, or at all. We
have never submitted an NDA. If filgotinib or any other product candidate is not approved and commercialized,
we will not be able to generate any product revenues for that product candidate.
The regulatory approval processes of the FDA, the EMA and other comparable regulatory authorities are lengthy,
time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for
our product candidates, our business will be substantially harmed.
Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain.
Results of earlier studies and trials as well as data from any interim analysis of ongoing clinical trials may not be
predictive of future trial results and failure can occur at any time during the clinical trial process. If we experience
delays in the completion of, or termination of, any clinical trial of our product candidates, the commercial
prospects of our product candidates will be harmed, and our ability to generate product revenues from any of
these product candidates will be delayed. If filgotinib or any other product candidate is found to be unsafe or lack
efficacy, we will not be able to obtain regulatory approval for it and our business would be materially harmed.
The rates at which we complete our scientific studies and clinical trials depend on many factors, including,
but not limited to, patient enrolment. Patient enrolment is a significant factor in the timing of clinical trials
and is affected by many factors including competing clinical trials, clinicians’ and patients’ perceptions as to
the potential advantages of the drug being studied in relation to other available therapies and the relatively
limited number of patients. Any of these occurrences may harm our clinical trials and by extension, our business,
financial condition and prospects.
Our product candidates may cause undesirable side effects or have other properties that could delay or prevent
their regulatory approval, limit the commercial profile of an approved label, or result in significant negative
consequences following marketing approval, if any.
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RISK FACTORS
Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt,
delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval
by the FDA, the EMA or other comparable regulatory authorities. The drug-related side effects could affect patient
recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims.
Any of these occurrences may harm our business, financial condition and prospects significantly.
Based on preclinical findings, we expect that filgotinib, if approved, may have a labeling statement warning
female patients of child-bearing age to take precautionary measures of birth control to protect against pregnancy,
similar to warnings included with other frequently used medications in RA, such as methotrexate.
In addition, there may be dose limitations imposed for male patients that are prescribed filgotinib, if approved. In
connection with the DARWIN clinical program, we agreed with the FDA to exclude the 200 mg filgotinib daily dose
for male subjects in the United States; males received a maximum daily dose of 100 mg in the U.S. sites in these
trials. This limitation was not imposed by any other regulatory agency in any other jurisdiction in which the
DARWIN clinical program is being conducted. We agreed to this limitation because in both rat and dog toxicology
studies, filgotinib induced adverse effects on the male reproductive system and the FDA determined there was
not a sufficient safety margin between the filgotinib exposure at the no-observed-adverse-effect-level, or NOAEL,
observed in these studies and the anticipated human exposure at the 200 mg daily filgotinib dose. Accordingly,
in connection with the DARWIN 3 clinical trial, in the United States, male subjects are dosed at a daily dose of
100 mg only. Male participants in this study and their partners are required to use highly effective contraceptive
measures for the duration of the study and during a washout period thereafter. As an additional safety measure,
we monitor clinical laboratory changes in hormone levels for subjects in the DARWIN 3 clinical trial.
More recently generated non-clinical data showed filgotinib did not induce any macroscopic or microscopic
findings in the male reproductive system in animals with higher filgotinib exposure versus previous studies.
The Phase 3 FINCH program, led by our collaboration partner Gilead, is evaluating 100 mg and 200 mg filgotinib
in both males and females in major RA patient populations world-wide. Men and women in both the Phase 2b/
3 SELECTION and Phase 3 DIVERSITY trials in UC and CD, respectively, will be randomized to receive placebo, 100
mg or 200 mg filgotinib. In these SELECTION and DIVERSITY trials in the United States, males may receive 200 mg
only if they failed conventional therapy, anti-TNF and vedolizumab. The filgotinib Phase 3 program also contains
dedicated male patient testicular safety study called MANTA.
Even if filgotinib does receive regulatory approval or marketing authorization, the FDA or other regulatory
authorities may impose dosing restrictions that differ from the approved dosing regimen in other jurisdictions.
Box warnings, labeling restrictions, dose limitations and similar restrictions on use could have a material adverse
effect on our ability to commercialize filgotinib in those jurisdictions where such restrictions apply.
If we are not able to maintain orphan product exclusivity for GLPG1690, or obtain such status for other or for
future product candidates for which we seek this status, or if our competitors are able to obtain orphan product
exclusivity before we do, we may not be able to obtain approval for our competing products for a significant
period of time.
Our commercial success depends upon attaining significant market acceptance of our product candidates, if
approved, among physicians, healthcare payers, patients and the medical community.
Coverage and reimbursement decisions by third-party payers may have an adverse effect on pricing and
market acceptance. Legislative and regulatory activity may exert downward pressure on potential pricing and
reimbursement for any of our product candidates, if approved, that could materially affect the opportunity to
commercialize.
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Galapagos NV • Annual Report 2018
RISK FACTORS
As a result of the 2016 election in the United States, there is great political uncertainty concerning the fate of
the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act,
or, collectively, the ACA, which became law in the United States in 2010, and other healthcare laws. The United
States Congress is expected to draft legislation to repeal parts of the ACA, but it is uncertain when such legislation
would be passed and whether Congress would replace the law and what any replacement law would encompass.
We cannot predict any initiatives that may be adopted in the future.
Risks related to our financial position and need for
additional capital
We are a clinical-stage biotechnology company and have not yet generated significant income. Our operations to
date have been limited to developing our technology and undertaking preclinical studies and clinical trials of our
product candidates.
Since our inception, we have incurred significant operating losses. We expect to continue incurring significant
research, development and other expenses related to our ongoing operations, and to continue incurring operating
losses for the foreseeable future. We do not anticipate generating revenues from sales of products for the
foreseeable future, if ever. Because of the numerous risks and uncertainties associated with pharmaceutical
product development, we are unable to predict the timing or amount of expenses and when we will be able to
achieve or maintain profitability, if ever.
We will require substantial additional future capital which may not be available to us on acceptable terms, or
at all, in order to complete clinical development and, if we are successful, to commercialize any of our current
product candidates. In addition, raising additional capital may cause dilution to our existing shareholders, restrict
our operations or require us to relinquish rights to our product candidates or technologies. The incurrence of
additional indebtedness could result in increased fixed payment obligations and could also result in certain
additional restrictive covenants that could adversely impact our ability to conduct our business. In the event
that we enter into collaborations and/or licensing arrangements in order to raise capital, we may be required to
accept unfavorable terms, including relinquishing or licensing to a third party on unfavorable terms our rights
to technologies or product candidates.
For further reference on financial risks in particular, see note 31 of the notes to the consolidated financial
statements.
Risks related to our reliance on third parties
We may not be successful
in maintaining development and commercialization collaborations, and a
collaboration partner may not devote sufficient resources to the development or commercialization of our
product candidates. In particular, we are heavily dependent on Gilead for its further development of our product
candidate filgotinib. Gilead may not devote sufficient resources or give sufficient priority to the filgotinib
program. Our collaborators may not elect to advance the product candidates on which we collaborate. Gilead
may not be successful in the further development and commercialization of filgotinib, even when they do devote
resources and prioritize their efforts for filgotinib.
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RISK FACTORS
The collaboration arrangements that we have established, and any collaboration arrangements that we may
enter into in the future, may ultimately not be successful, which could have a negative impact on our business,
results of operations, financial condition and growth prospects. It is possible that a collaboration partner may not
devote sufficient resources to the development or commercialization of our product candidate or may otherwise
fail in development or commercialization efforts, in which event the development and commercialization of such
product candidate could be delayed or terminated and our business could be substantially harmed.
We rely on third party suppliers for which a reliable supply of materials is required in order to avoid delays in
the drug discovery and development process. Most goods and services are provided by several different suppliers,
which mitigates the risk of loss of key suppliers.
Expanding the suppliers’ network can be time consuming as all source suppliers are subject to rigorous ethical
and quality control standards. Our suppliers are required to adhere to contractual terms that include anti-bribery
and anti-corruption provisions. Our general terms and conditions of purchase also contain a specific clause on
anti-bribery and anti-corruption. They can be found on our website.
We have relied on and plan to continue to rely on contract research organizations, or CROs, to monitor
and manage data for our preclinical and clinical programs. We and our CROs also rely on clinical sites and
investigators for the performance of our clinical trials in accordance with the applicable protocols and applicable
legal, regulatory and scientific standards. If CROs do not successfully carry out their contractual duties or
obligations or meet quality standards, regulatory requirements or expectations, our clinical trials may be
extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully
commercialize our product candidates. We do retain responsibility for all our studies and are required to and have
put in place measures to manage, oversee, and control our studies, including the CRO selection process, audits,
strong focus on deliverables, timelines, roles & responsibilities, and oversight of conduct of the studies.
We rely on clinical data and results obtained by third parties that could ultimately prove to be inaccurate or
unreliable.
As part of our strategy to mitigate development risk, we seek to develop product candidates with validated
mechanisms of action and we utilize biomarkers to assess potential clinical efficacy early in the development
process. This strategy necessarily relies on clinical data and other results obtained by third parties. If the third-
party data and the results that we rely on prove to be inaccurate, unreliable or not applicable to our product
candidates, we could make inaccurate assumptions and conclusions about our product candidates and our
research and development efforts could be materially adversely affected.
Risks related to our competitive position
We face significant competition for our drug discovery and development efforts, and if we do not compete
effectively, our commercial opportunities will be reduced or eliminated.
The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant
technological change. Our competitors may develop drug products that render our products obsolete or non-
competitive by developing more effective drugs or by developing their products more efficiently. In addition, our
ability to develop competitive products would be limited if our competitors succeeded in obtaining regulatory
approvals for drug candidates more rapidly than we were able to or in obtaining patent protection or other
intellectual property rights that limited our drug development efforts.
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RISK FACTORS
Risks related to our intellectual property
Our ability to compete may decline if we do not adequately protect our proprietary rights.
We endeavor to protect our proprietary technologies and know-how by entering into confidentiality and
proprietary information agreements with our employees and partners, and by setting up special procedures (e.g.
with respect to the handling of the laboratory books).
Our commercial success depends on obtaining and maintaining proprietary rights to our product candidates,
as well as successfully defending these rights against third party challenges. We will only be able to protect
our product candidates, and their uses from unauthorized use by third parties to the extent that valid and
enforceable patents, or effectively protected trade secrets, cover them. If we fail to maintain to protect or to
enforce our intellectual property rights successfully, our competitive position could suffer, which could harm our
results of operations.
Pharmaceutical patents and patent applications involve highly complex legal and factual questions, which, if
determined adversely to us, could negatively impact our patent position. Our success will depend in part on our
ability to operate without infringing the intellectual property and proprietary rights of third parties. We cannot
guarantee that our business, products and methods do not or will not infringe the patents or other intellectual
property rights of third parties. There is significant litigation activity in the pharmaceutical industry regarding
patent and other intellectual property rights. Such litigation could result in substantial costs and be a distraction
to management and other employees.
The patent positions of biotechnology and pharmaceutical companies can be highly uncertain and involve
complex legal and factual questions. The interpretation and breadth of claims allowed in some patents covering
pharmaceutical compositions may be uncertain and difficult to determine, and are often affected materially
by the facts and circumstances that pertain to the patented compositions and the related patent claims. The
standards of the United States Patent and Trademark Office, the European Patent Office, and other foreign
counterparts are sometimes uncertain and could change in the future. If we fail to obtain and maintain patent
protection and trade secret protection of our product candidates, we could lose our competitive advantage and
the competition we face would increase, reducing any potential revenues and adversely affecting our ability to
attain or maintain profitability.
We will not seek to protect our intellectual property rights in all jurisdictions throughout the world and we
may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek
protection.
Filing, prosecuting and defending patents on our product candidates in all countries and jurisdictions throughout
the world would be prohibitively expensive, and our intellectual property rights in some countries could be less
extensive than those in the United States and Europe. Consequently, we may not be able to prevent third parties
from practicing our inventions in all countries, or from selling or importing products made using our inventions.
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RISK FACTORS
Risks related to our organization, structure and
operation
Our future success depends on our ability to retain the members of our executive committee and to attract,
retain and motivate qualified personnel. If we are not successful in attracting and retaining highly qualified
personnel, we may not be able to successfully implement our business strategy. Attractive development and
training programs, adequate remuneration and incentive schemes and a safe and healthy work environment
mitigate this risk.
We expect that if we continue to build our development, medical and commercial organizations, we will require
significant additional investment in personnel, management and resources. Our ability to achieve our research,
development and commercialization objectives depends on our ability to respond effectively to these demands
and expand our internal organization, systems, controls and facilities to accommodate additional anticipated
growth. If we are unable to manage our growth effectively, our business could be harmed and our ability to
execute our business strategy could suffer.
We currently have a limited marketing and sales organization. To the extent any of our product candidates for
which we maintain commercial rights is approved for marketing, if we are unable to establish marketing and
sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may
not be able to effectively market and sell any product candidates, or generate product revenues.
Our information technology systems could face serious disruptions that could adversely affect our business.
Continuing an uninterrupted performance of our IT system is critical to the success of our business strategy
and operations. A recovery plan for data has been implemented, as well as a system for interception of power
failures. Fire walls and virus scanners provide an additional and adequate protection. Our personnel should
adhere to continuity plans and procedures regarding access rights and installation of different programs. Business
interruptions could delay us in the process of developing our product candidates. This risk has a high potential
impact, but is mitigated by policies and procedures such as surveillance of the buildings, annual appraisals and
bonuses, and monthly management meetings.
We have to comply with applicable data privacy laws, including the European General Data Protection Regulation,
or GDPR, which imposes strict obligations and restrictions on the collection and use of personal data. In the
ordinary course of our business, we collect and store sensitive data. Many third party vendors that support our
business processes also have access to and process sensitive information. Although we have taken preventative
measures and set up procedures regarding data processing, data breaches, loss of data and unauthorized access
could still occur. These could result in legal claims or proceedings, liability under laws that protect the privacy
of personal information, including the GDPR, and significant regulatory penalties, disrupt our operations and
damage our reputation.
Despite our efforts to monitor social media and comply with applicable rules, there is a risk that the use of
social media by us or our employees to communicate about our drug candidates or business may cause us to
be found in violation of applicable requirements. In addition, our employees may knowingly or inadvertently
make use of social media in ways that may not comply with our social media policy or other legal or contractual
requirements, which may give rise to liability, lead to the loss of trade secrets, or result in public exposure of
sensitive information. Furthermore, negative posts or comments in social media could seriously damage our
reputation, brand image, and goodwill.
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RISK FACTORS
Our collaboration arrangements with our strategic partners may make us an attractive target for potential
acquisitions under certain circumstances. Under certain circumstances, due to the structure of our collaboration
arrangements with our strategic partners, our strategic partners may prefer to acquire us rather than paying
the milestone payments or royalties under the collaboration arrangements, which may bring additional
uncertainties to our business development and prospects.
We may undertake strategic acquisitions in the future and any difficulties from integrating such acquisitions
could adversely affect our share price, operating results and results of operations. We may acquire companies,
businesses and products that complement or augment our existing business. We may not be able to integrate
any acquired business successfully or operate any acquired business profitably. Integrating any newly acquired
business could be expensive and time-consuming. Integration efforts often take a significant amount of time,
place a significant strain on managerial, operational and financial resources, result in loss of key personnel and
could prove to be more difficult or expensive than we predict. As part of our efforts to acquire companies, business
or product candidates or to enter into other significant transactions, we conduct business, legal and financial
due diligence with the goal of identifying and evaluating material risks involved in the transaction. Despite our
efforts, we ultimately may be unsuccessful in ascertaining or evaluating all such risks and, as a result, might not
realize the intended advantages of the transaction.
The United Kingdom held a referendum on 23 June 2016 in which a majority voted for the United Kingdom’s
withdrawal from the European Union (referred to as “Brexit”). While the United Kingdom’s withdrawal from
the European Union is expected to take effect shortly after the date of publication of this report, significant
uncertainty remains regarding the future relationship between the United Kingdom and the European Union,
in particular if the United Kingdom and the European Union fail to reach agreement on the terms of such
withdrawal (referred to as a “No-Deal Brexit”). The effects of Brexit have been and are expected to continue to
be far-reaching. Brexit and the perceptions as to its impact may adversely affect business activity and economic
conditions in Europe and globally and could continue to contribute to instability in global financial and foreign
exchange markets. Brexit could also have the effect of disrupting the free movement of goods, services and people
between the United Kingdom and the European Union. In the event of a No-Deal Brexit, we anticipate incurring
additional costs for customs duties and declarations, and handling and storage of supplies. In addition, we expect
that Brexit could lead to legal uncertainty and potentially divergent national laws and regulations. If the United
Kingdom significantly alters its regulations affecting the pharmaceutical industry, we could face significant new
costs and altered regulations could also add time and expense to the process by which our product candidates
receive regulatory approval in the United Kingdom and European Union. Given these possibilities and others we
may not anticipate, as well as the lack of comparable precedent, the full extent to which our business, results of
operations and financial condition could be adversely affected by Brexit is uncertain.
If we are unable to use tax loss carryforwards to reduce future taxable income or benefit from favorable tax
legislation, our business, results of operations and financial condition may be adversely affected. We may incur
unexpected tax charges, including penalties, due to the failure of tax planning or due to the challenge by tax
authorities on the basis of transfer pricing. Any changes to Belgian and international taxation legislation or the
interpretation of such legislation by tax authorities may influence our activities, financial situation and results.
Such potential changes and their impact are monitored carefully by management and its advisors.
Being active in research and development in Belgium and France, we have benefited from certain research and
development incentives. If the Belgian and/or the French government decide to eliminate, or reduce the scope or
the rate of, the research and development incentive benefit, either of which it could decide to do at any time, our
results of operations could be adversely affected.
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Galapagos NV • Annual Report 2018
RISK FACTORS
As a company active in research and development in Belgium, we also expect to benefit from the “innovation
income deduction” in Belgium. The innovation income deduction regime allows net profits attributable to
revenue from among others patented products (or products for which the patent application is pending) to be
taxed at a lower rate than other revenues, i.e., 4.4%, and 3.75% as of 1 January 2020.
When taken in combination with tax losses carried forward and research and development incentives mentioned
above, we expect that this will result in a long-term low rate of corporation tax for us. It should be noted however
that the Belgian corporate income tax reform introduced as of assessment year 2019 a defacto minimum taxable
base, whereby the existing tax attributes have to be allocated into 2 so-called “baskets”: a first basket which
contains the tax deductions that can be applied without any restrictions and a second basket which contains
the tax deductions that are subject to restrictions. The first basket contains (in order of deduction) the non-
taxable items (such as deductible gifts), current year dividends received deduction (DRD), grandfathered patent
income deduction (PID), current year innovation income deduction (IID) and investment deduction. The second
basket contains (in order of deduction and subject to the restrictions as mentioned hereunder) the current year
notional income deduction (NID), DRD carry-forward, IID carry-forward, tax loss carry-forward, unlimited NID
carry-forward and NID carry-forward subject to the 7-year limitation. The taxable base can be reduced without
any limitation with the deductions contained in the first basket. Any remaining taxable basis below €1 million
can be fully compensated with deductions contained in the second basket. If the remaining taxable basis exceeds
€1 million, the excess above €1 million can only be compensated with deductions of the second basket up to
70%. Such minimum taxable basis may have an impact on our future cash flows. At the end of 2018 we had
€195.4 million of carryforward innovation income deduction in Belgium.
Our inability to qualify for the abovementioned advantageous tax regimes, as well as the introduction of the
minimum taxable base and any other future adverse changes of Belgian tax legislation, may adversely affect our
business, results of operations and financial condition.
We have received several technological innovation grants to date, to support various research programs from an
agency of the Flemish government to support technological innovation in Flanders. If we fail to comply with our
contractual obligations under the applicable technological innovation grant agreements, we could be forced to
repay all or part of the grants received. Such repayment could adversely affect our ability to finance our research
and development projects.
We annually establish a detailed budget that is submitted to the board of directors for review and approval. Our
performance compared to the budget is continuously monitored by our executive committee and is discussed
with the board of directors at least once per quarter. For the establishment of our financial information, we have
processes and methods in place that enable the preparation of consolidated financial statements for our annual
and quarterly reporting. Our management reporting systems – which include an advanced integrated ERP system
– secure the generation of consistent financial and operational information, allowing management to follow-up
our performance on a daily basis.
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Galapagos NV • Annual Report 2018
RISK FACTORS
Market risks relating to the Galapagos shares
We have identified the following major market risks:
▪ Possible volatility of share price
The market price of the shares might be affected by a variety of factors outside management control, such
as the global economic situation, the business development of competitors, sector mergers and acquisitions;
it is difficult to mitigate this risk.
▪ Economic risk due to failure in confidence
General public confidence about future economic conditions or performance of us or our suppliers or
customers may impact the ability or willingness of others to trade with us.
▪ Dilution through capital increases
Raising additional capital may cause dilution to our existing shareholders. By raising additional capital
through capital
increases with cancellation of the preferential subscription rights of our existing
shareholders, these shareholders will be diluted.
▪ Dilution through exercise of warrant plans
The exercise of existing warrants can significantly increase the number of outstanding Galapagos shares.
▪ Inability to distribute dividends
We have a limited operating history and future profitability cannot be guaranteed. Galapagos NV has
significant losses carried-forward and will thus not be able to distribute dividends in the near future. This
can cause people to refrain from investing in Galapagos shares.
▪ Reputational damage
High ethical standards are maintained throughout the entire organization at all levels. Laws and guidelines
are complied with. Our suppliers are required to adhere to contractual terms which include anti-bribery and
anti-corruption provisions. In addition, our external consultants are required to comply with our Code of
Business Conduct and Ethics and U.S. Foreign Corrupt Practices Act Policy.
▪ Belgian law provisions
There are several provisions of Belgian company law and certain other provisions of Belgian law, such as the
obligation to disclose important shareholdings and merger control, that may apply to us and which may
make an unfriendly tender offer, merger, change in management or other change in control, more difficult.
These provisions could discourage potential takeover attempts that third parties may consider and thus
deprive the shareholders of the opportunity to sell their shares at a premium (which is typically offered in
the framework of a takeover bid).
General statement about Galapagos' risks
According to our current assessment we consider the risks to be manageable and our going concern not to be
endangered at the time of the current report. Assuming no further deterioration of the global business, financial
and regulatory environment, we consider ourselves well prepared to meet all future challenges.
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Galapagos NV • Annual Report 2018
CSR report
Improving lives
we raise the bar.
CSR REPORT
Our commitment
Our commitment to Corporate Social Responsibility (CSR) is to find new ways to improve healthcare and quality
of life for patients and their families with our novel mode of action investigational medicines. Our core business
is discovery of breakthrough therapies for diseases with large unmet medical needs in primarily inflammation
and fibrosis. On a daily basis, we aim to make a lasting contribution to society with our discovery and clinical
development efforts. Filgotinib, GLPG1690, and MOR106 are the first clinical examples of how our approach to
finding novel medicines may be able to make a difference for patients in many disease areas. We have a
substantial pipeline of novel candidate medicines in inflammation and fibrosis. This approach addresses the
disease itself rather than just treating the symptoms. In this way, we aim to make a lasting positive contribution
to society through discovery of breakthrough therapies. We aim to bring impactful medicines to patients
ourselves.
Implementing our CSR initiatives
In our business operations we strive to comply with all relevant laws, standards, and guidelines, prioritize the
well-being of our employees, and minimize our impact on the environment. We have high ethical standards
and aim to conduct business with companies that share our ethics and respect the protection of internationally
proclaimed human rights. We aim to support and respect the protection of human rights through policies that
address responsible supplier management, ethical procedures, and health and safety procedures.
Starting in 2019, the audit committee of the board of directors will regularly review CSR initiatives, ensuring
that we implement our planned initiatives and communicate them effectively and accurately to our employees
and shareholders. Our CSR report discloses the main highlights of our CSR initiatives but does not reflect all of
our ongoing initiatives and procedures. As part of our commitment to CSR, we monitor new developments and
practices and will consider implementing new initiatives that could further enhance our CSR activities in the
future.
Our CSR report focuses on:
▪ Improving people’s lives
▪ Diversity and human capital management
▪ Business ethics
▪ Environment, health, and safety
This CSR report provides the non-financial information required by article 96, §4 and article 119, §2 of the Belgian
Companies Code. We have further considered reporting frameworks, such as the Global Reporting Initiative (GRI)
Sustainability Reporting Standards (SRS) and the ‘European Federation of Financial Analysts Societies Guideline
for the Integration of ESG into Financial Analysis and Corporate Valuation’ and used different elements as an
inspiration to build this report.
For a discussion of risks, please see the section called “Risk Factors” in this Annual Report.
The KPIs for our new drug development, handled in the section Improving People’s Lives, are the most material
non-financial KPIs in our report.
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Galapagos NV • Annual Report 2018
CSR REPORT
Improving people’s lives
We seek to discover, develop, and eventually commercialize medicines with novel modes of action, addressing
disease areas of high unmet medical need. Our main mission is to improve lives with medicines which offer new
treatment options to patients. Our pipeline comprises programs ranging from discovery to Phase 3 clinical trials
in inflammation, fibrosis, osteoarthritis (OA), and other indications.
There is a real need for medicines with novel mechanisms of action. There are many diseases for which there is
no approved therapy today and many more diseases for which current therapies leave room for improvement in
clinical outcomes. New mechanism of action medicines offer opportunity for new clinical options for caregivers
and patients, and could possibly decrease the burden for society, including lowered healthcare costs.
Our highly flexible target and drug discovery platform has been applied across many therapeutic areas, and our
pipeline today ranges from inflammation to fibrosis candidate drugs.
Almost all of these programs are based on inhibiting targets which were identified using our proprietary target
discovery platform. Using human primary cells, we discover which proteins (‘targets’) play a key role in causing
diseases. We then discover and develop small molecules that inhibit these targets, restore the balance, and
thereby positively influence the course of the disease. This approach addresses the disease itself rather than just
treating the symptoms. In this way, we aim to make a lasting positive contribution to society through discovery
of breakthrough therapies.
Our target discovery platform provides a significant and substantial competitive advantage as it:
▪ closely mimics the in vivo situation through the use of primary human cells with relevant trigger and
readout for a specific disease phenotype
▪ identifies possible points to intervene in a disease pathway by knocking down an individual protein in these
assays; and
▪ enables us to analyze rapidly all of the drugable genome and select pharmaceutically tractable protein targets
directly by their ability to regulate key disease biology
R&D goal
PHASE 3
START
every 2 years
PROOFS-
OF-CONCEPT
every year
PRECLINICAL
CANDIDATES
every year
NEW
TARGETS
every year
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Galapagos NV • Annual Report 2018
CSR REPORT
We aim to initiate a Phase 3 trial every other year, while conducting three proof-of-concept trials, delivering
three preclinical product candidates and six new validated targets every year following the determination of
more stringent, general target validation criteria in 2018. We aim to select promising programs for internal
development and commercialization and establish ourselves as a fully integrated biopharmaceutical company.
Improving people’s lives - 2018 actions
▪ We delivered 2 new validated targets, compared to our goal of 6
▪ We nominated 4 new preclinical candidates, all with a novel mechanism of action, compared to our
goal of 3
▪ We started 4 proof-of-concept trials, compared to our goal of 3
▪ We initiated the ISABELA 1 & 2 Phase 3 program, meeting our goal of 1
▪ These successes brought us to 41 preclinical candidates since 2009, most of which have novel modes
of action. Of these 19 have entered the clinic, 12 with novel modes of action
19
14
12
41
preclinical candidates
entered clinic
novel modes of action
novel modes of action in patient studies
▪ We dedicated 50 FTEs to discovery efforts exploring the Toledo class of targets in inflammation
Future ambitions
▪ Expand capabilities to support more than 40 planned clinical trials in 2019
▪ Continue to deliver on our annual research & development ambition targets
▪ Invest in our target discovery capabilities to maintain our competitive edge in novel targets
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Galapagos NV • Annual Report 2018
CSR REPORT
Diversity and Human Capital Management
We believe that attracting, developing, and retaining human capital is key to our success in developing novel
mechanism of action drugs which can make a difference for patients. We are dedicated to ensuring diversity of
our workforce, while continuously striving to offer our employees a nurturing and rewarding work environment
which facilitates their professional success. With the goal to execute more than 40 clinical trials in 2019, our
organization continues to expand and build capability.
Approximately 125 new employees joined us in 2018, an increase of 21% versus 2017. Most new employees
started in our Drug Development departments such as Clinical Operations, Biometrics, Medical Science, Clinical
Pharmacology, and Project Management, but we also filled key positions in the new Commercial team. The
recruitment of new colleagues will enable us to bring our novel product candidates further through development,
with the ultimate goal to obtain approval for these therapies for patients as quickly as possible.
We expect that our Drug Development departments will continue to grow rapidly and, in 2019, our Commercial
team will expand substantially as well. We continue to invest in Drug Discovery and our Shared Services
departments. Expansion of staff is foreseen at all sites, including Basel, Switzerland and Boston, Massachusetts,
U.S. We seek approximately 130 additional colleagues in 2019 across the business in order to meet our business
goals.
Diversity
We aim to develop a balanced workforce across a number of criteria such as gender, nationality, ethnicity,
experience level, and disability. Our Executive Committee reviews the diversity of the workforce annually and is
committed to creating equal opportunities for inclusion of diverse talent.
Diversity - actions 2018
In 2018 we report a healthy balance in diversity, which continues to improve.
Number of employees Galapagos group
725
285
Men
gender:
education:
440
Women
102
Other
237
PhD
112
Bachelor
274
Master
Average age:
41
Number of
employees older
than 45:
269
Nationalities:
Average years
of service:
Employee
turnover:
38
7
10.7%
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CSR REPORT
▪ Our board of directors currently comprises seven members of whom three are female (we refer to the
section Board of directors of our Annual Report 2018 for further information on each board member)
▪ We attracted 125 new employees in 2018, an increase of 21% versus 2017
▪ We report stability in gender mix evolution, with 61% of staff overall being female in 2018, 53% of mid-
level staff and 33% of senior management level
▪ Across all functions, over 10% of internal staff at Galapagos R&D experienced a personal growth step
through promotion, extended responsibilities, or new project assignments in 2018
▪ We became more international with staff from 38 nationalities (compared to 25 in 2017)
▪ An additional ombudsperson (“vertrouwenspersoon”) was hired at our Mechelen site
Diversity future goals
▪ Continue the commitment to build a diverse workforce
Human capital management
We invest in the development of employee knowledge, skills, and competencies to continue to deliver innovative
science at our company. Furthermore, we aim to ensure that training of employees takes place on all handling of
hazardous materials, laboratory and other safety aspects, and other relevant policies for conducting our business.
We have policies in place to ensure the well-being of our employees, for example, addressing different forms
of leave and allowing flexible working. We aim to ensure an inclusive, open, and supportive professional work
environment across our international locations. We organize regular engagement meetings for research and
development staff to inspire and align the fast growing teams behind our vision and ambition. We hold regular
informal lunch meetings with executive committee members for new and other employees at different sites. We
organize an all-staff day to reflect upon our core values and last year’s day was reserved for charitable activities.
We use a variety of indicators to measure employee satisfaction, including the rates of absenteeism and turnover
among our employees. These and other indicators allow us to consider actions to optimize our work environment
or working practices.
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CSR REPORT
Human capital management - actions 2018
▪ Strengthened our human resources team to build and implement an innovative workplace strategy
▪ Streamlined the onboarding process across sites, designation of mentor for each new employee
▪ Identified four core values which we wish to maintain and develop within our company, and which
are designed to foster employee engagement and work satisfaction: Act as a pioneer, Raise the bar,
Embrace change, and Make it happen
▪ Incorporated a focus on our core values in our recruiting, onboarding, and development programs for
employees
▪ Across all functions, over 10% of internal staff experienced a personal growth step through promotion,
extended responsibilities, or new project assignments in 2018
▪ Raised EUR 27,578 for Sjarabang (a charity) in Mechelen, planted city gardens and created dolls for a
Unicef project in Romainville, sported with kids, refurbished elderly homes and taught asylum seekers
in the Netherlands the Dutch language during corporate sponsored charity activities
▪ Implemented a new travel policy to streamline policy with travel needs
▪ 1.4% annual absenteeism reported by Mechelen, Leiden, Romainville sites
▪ 10.7% turnover of employees for the Galapagos group
▪ 93% of employees are trained in our codes of conduct, including insider trading, and other policies &
procedures required by Sarbanes Oxley
Human capital management future goals
▪ Deploy a senior leader-led program to foster culture and build leadership capability across the group
▪ Continue to incorporate our core values into how we attract, onboard, and develop employees
▪ Revisit our performance management approach to deliver a meaningful and impactful way to drive
performance, support personal growth, build a strong company culture, and have a competitive
reward & recognition
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Galapagos NV • Annual Report 2018
CSR REPORT
Business ethics
At Galapagos, our primary business is the discovery and development of drugs with novel modes of action, and
we prioritize ethical behavior in all facets of our business.
We believe that ethical behavior when discovering and developing drugs touches particularly on these key areas
for us in this point in our corporate development: preclinical and clinical testing, expanded access to drugs
currently in development, and our codes of ethical conduct while doing business.
Preclinical testing
We are required by law to carry out preclinical testing of our product candidates. For preclinical development
studies including those that help assess safety, pharmacology, toxicology, and absorption, distribution,
metabolism and excretion of our product candidates, we strive to follow the “Three Rs” (3Rs) of Refinement,
Reduction, and Replacement in our preclinical testing involving use of animals. For example, we plan to
use more in silico (computer modelling) and in vitro (cellular testing) designs and approaches for assessing
pharmacodynamics, for example, DEREK software and in vitro micronucleus assay for evaluating genotoxicity,
in vitro hERG assay for evaluating cardiotoxicity. These examples show how we reduce and replace preclinical
testing involving use of animals.
In addition, we follow Directive 2010/63/EU6 in Europe with regards to preclinical testing. The requirement to
be compliant with Directive 2010/63/EU forms part of the pre-assessment and selection process of the European
laboratories that we use for preclinical testing, and we monitor animal welfare in the European laboratories that
we have engaged on a regular basis. We require compliance with local animal welfare regulations in laboratories
outside of the European Union. In the United States, for example, we work only with laboratories that are
accredited by the Association for Assessment and Accreditation of Laboratory Animal Care.
Our clinical trials ethics
Galapagos sponsors and conducts clinical trials in accordance with the applicable international standards.
The fundamental guidelines are the Declaration of Helsinki (and its amendments) and the Good Clinical
Practice (including amendments) and Good Pharmacovigilance Practice guidelines of the International Council
for Harmonisation. Our adherence to these internationally recognized guidelines ensure the rights, safety and
well-being of participants in our clinical trials. Other international guidelines like The Belmont Report, Council
for Coordination of
International Medical Congresses guidelines, The Nuremberg Code, United National
Educational, Scientific and Cultural Organization’s (Declaration on Bioethics and Human Rights) also form the
ethical foundation for our trial activities. We comply with laws and regulation in the countries/regions in which
we are conducting our trials, including the U.S. Code of Federal Regulations, the EU Directive on Clinical Trials7,
etc.
We uphold our own internal procedures and standards for clinical trials, irrespective of the country in which the
trial is conducted, and we only conduct clinical trials in countries where we intend to market our drugs.
Overall, it is our policy that the interest, safety, and well-being of the trial subject will always supersede the
interests of science, commerce, as well as those of society.
6 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals uses for scientific purposes, OJ L 276,
20 October 2010
7 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions
of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, OJ L 121,
1 May 2001
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Our trials are only initiated if they are scientifically and medically justified and when they have external
validation by clinical experts, and will always be reviewed by local health authorities and ethical committees
before they are initiated. Trial participants (or the legally authorized representative) must give written consent
after being properly informed of the trial, including the risks and potential benefits. Participants are duly
informed that they are able to withdraw from the trial at any time without any explanation and then will receive
appropriate standard care.
We or our representatives conduct regular site monitoring visits to ensure that clinical trials are conducted in
accordance with the applicable approved study protocol.
Any adverse events are monitored and reported to authorities and ethical committees as needed, and appropriate
actions taken.
Our trials ensure proper indemnification of participants in case a product candidate or trial procedure causes
bodily harm.
We favor transparency and make results from our clinical trials conducted in patients available, independent
of outcome to patients, physicians, and researchers, with full consideration for protection of patient data
privacy and commercial confidentiality. We report the outcome in accordance with the CONSORT Statement, or
Consolidated Standards of Reporting Trials, designed to improve transparency around clinical trials.
We publish our trials on the appropriate clinical trial registries (clinicaltrials.gov and the EudraCT Trial Registry)
in a timely manner. We attempt to publish results in peer reviewed journals in accordance with Good Publication
Practice and the International Committee of Medical Journal Editor’s Uniform Requirements for Manuscripts
Submitted to Biomedical Journals or at relevant scientific meetings and congresses. As a publicly listed company
we may also have obligations to communicate trial results by other means, such as via press releases.
Expanded access policy
In our pursuit of the development and commercialization of novel medicines that will improve people’s lives,
we encourage patients to participate in clinical trials whenever possible. These clinical trials are critical to
developing the information (or data) needed to evaluate investigational products and seek their approval by
health authorities, such as the FDA and the EMA. In rare cases, patients are unable to participate in clinical
trials and have exhausted all available treatment options. In these cases, Galapagos may consider providing an
investigational product outside of a clinical trial, through a program called “expanded access.” Expanded access
is also often referred to as “compassionate use.” A full copy of our Expanded Access Policy can be found on our
website.
Our code of business conduct and ethics
We have established a code of business conduct and ethics (the code) to ensure that our directors, officers and
employees are making ethical and legal decisions when conducting Galapagos’ business and performing their
day-to-day duties. We expect our directors, officers and employees to conduct business with integrity, ethics and
respect for human rights. We expect them to turn away from conflicts of interest, corruption and fraud. To this
end, we give trainings on this code to our employees. The code is available at www.glpg.com/charters-and-codes.
Our suppliers are required to adhere to contractual terms that include anti-bribery and anti-corruption
provisions. Our general terms and conditions of purchase also contain a specific clause on anti-bribery and anti-
corruption.
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Galapagos NV • Annual Report 2018
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Business ethics - actions 2018
▪ We completed an Animal Welfare Agency audit in Romainville. There were no citations recorded
▪ We formalized our clinical trials ethics policy
▪ We established a compassionate use policy, in compliance with the 21st Century Cures Act in the U.S.
▪ We trained 93% of all employees in our codes of conduct, including insider trading, and other policies
required by Sarbanes-Oxley
▪ We were not informed of any breaches of our code of business conduct and ethics in 2018
Future goals
▪ Promote the 3R’s further in preclinical testing
▪ Monitor and adjust training to ensure full compliance with our business ethics guidelines
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Environment, health, and safety
We are committed to acting in a sustainable and responsible manner by keeping our environmental impact to
a minimum, reducing waste, and handling it in a safe and responsible way. We operate in a highly regulated
sector and are subject to numerous laws and regulations pertaining to impact on the environment, well-being
of employees, safety, and management of laboratory waste, which also is audited. The effectiveness of our
Environmental, Health, and Safety (EHS) efforts is anchored in the shared responsibility of our staff in ensuring
a safe, healthy and environmentally friendly work environment: every employee is responsible for protecting
people and environment, in and around his or her workplace.
We currently have a limited impact on the environment, as at present, we have no production sites, we own
no buildings, and our administrative facilities have only minor environmental liabilities such as waste handling
and emissions from fume hoods. Nonetheless, we aim to reduce our environmental impact further by recycling
and replacing paper for digital means altogether. We maintain safety monitoring records, in compliance with
applicable legislation. We treat our dangerous waste in accordance with local laws, and we ensure that training
of employees takes place on all handling of hazardous materials, laboratory and other safety aspects, and other
relevant policies for conducting our business.
We also take reasonable and practical initiatives to eliminate accidents and ill health and to provide a safe work
environment and processes. Our goal is to have work form part of a satisfying life, which is to the benefit of both
the individual and the organization.
Environmental, health, and safety - actions 2018
▪ We hired a full time EHS Manager for the group with the mandate to assess current EHS efforts and
establish an improvement roadmap
▪ We established a company-wide EHS framework based on ISO 45001 (HS)+ISO 14001 (E)
▪ There were no safety incidents reported, no recordable injury counts, no fatalities, and no days away
from work reported due to safety issues in 2018
▪ We completed an environmental audit in Leiden and a Federal Agency for nuclear control audit in
Mechelen. There were no major citations recorded in these audits, and all sites were compliant with
applicable EHS laws & regulations in 2018
▪ We completed compliance reviews for health and safety and environment in each of the Leiden,
Mechelen, and Romainville sites, with a number of improvement items identified. Following the
findings, we set priorities and prepared action plans for each site, completing most actions
▪ At our Mechelen site we decommissioned one of our two radio-isotope laboratories. Fluorescence and
luminescence-based technologies were used instead and we did not use radioisotopes in 2018. This
further reduced our toxic and dangerous waste flows
▪ We rolled out a company-wide implementation of Skype video meetings in an effort to reduce
business travel by employees
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Future goals
▪ We organized exclusive use of green energy at our Mechelen site starting in 2019
▪ We plan to establish green car options in our company car fleet to start in 2019
▪ Investigate the possibilities to expand green energy use to other sites
▪ Make employees more aware of the need to limit the environmental impact in their workplaces
▪ We aim to use fewer radio-isotopes
▪ Establish further EHS key performance indicators for internal monitoring and external reporting
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Galapagos NV • Annual Report 2018
Corporate
governance
Corporate governance at
Galapagos in 2018
we raise the bar.
CORPORATE GOVERNANCE
Galapagos’ corporate governance policies
We have
adopted the Belgian Corporate Governance Code
2009
(which can be
consulted on
www.corporategovernancecommittee.be) as our reference code. Galapagos NV’s board of directors approved a
corporate governance charter (which is available on our website, www.glpg.com). The corporate governance
charter applies in addition to the law, Galapagos NV’s articles of association and the corporate governance
provisions included in the Belgian Companies Code and the Belgian Corporate Governance Code 2009.
The board of directors strives to comply with the rules of the Belgian Corporate Governance Code 2009 as much
as possible. At the same time, the board of directors is of the opinion that certain deviations from the provisions
of the Belgian Corporate Governance Code 2009 are justified, in view of our activities, our size and the specific
circumstances in which we operate. In such cases, which are mentioned in this corporate governance statement,
we apply the “comply or explain” principle. Reference is made to the “Remuneration of non-executive directors of
Galapagos NV” section below.
In addition to the information set out below, we refer to the “Risk management” and “Risk factors” sections of
this report for a description of the most important characteristics of our internal control and risk management
systems. The “Risk management” and “Risk factors” sections are incorporated by reference in this corporate
governance statement.
Board of directors of Galapagos NV
Composition of Galapagos NV’s board of directors
Onno van de Stolpe – Please refer to the “Composition of Galapagos NV’s executive committee” for a biography.
Rajesh Parekh, MA, DPhil has served as the Chairman of our board of directors since 2004. Dr. Parekh is a
General Partner at Advent Life Sciences LLP, which he joined in 2006. During an academic career at Oxford
University, he co-founded Oxford GlycoSciences PLC, where he served as Chief Scientific Officer and Chief
Executive Officer from 1988 until its sale to Celltech Group PLC (now UCB SA) in 2003. He has founded or served
on the boards of several life sciences companies in the United States and Europe including Celldex Therapeutics,
Inc.; Avila Therapeutics, Inc.; EUSA Pharma (Europe) Limited; Thiakis Limited; Biocartis NV; Amsterdam Molecular
Therapeutics (AMT) Holding NV (now uniQure); Aura, Inc.; Itara Ltd.; and Cellnovo SA. Dr. Parekh currently serves
as a member of the board of directors of Advent Venture Partners; Advent Life Sciences LLP; Aleta, Inc.; Amphista
Therapeutics Ltd.; Arrakis, Inc.; Artax, Inc.; Capella BioSciences Ltd.; Levicept Limited; PE Limited; Alpha Anomeric
SA; Macrolide, Inc.; Project Paradise Limited; and Tridek-One Therapeutics SAS. He is also a member of the
supervisory board of the Novartis Venture Fund. He received his MA in Biochemistry and DPhil in Molecular
Medicine from the University of Oxford, where he has also been a Senior Research Fellow and Professor.
Werner Cautreels, Ph.D. has served as a member of our board of directors since 2009. Dr. Cautreels was the
President and Chief Executive Officer and member of the board of Selecta Biosciences, Inc. from 2010 until
December 2018. He is a co-founder and board member of Accoy Pharmaceuticals since 2016. Previously, Dr.
Cautreels joined Solvay Pharmaceuticals SA in 1998 where he was Global Head of R&D and later Global Chief
Executive Officer from 2005 onwards, until it was acquired by Abbott Laboratories Inc. in February 2010. Prior to
joining Solvay he was employed by Sanofi SA, Sterling Winthrop, Inc. and Nycomed Amersham PLC in a variety
of R&D management positions in Europe and in the United States from 1979 to 1998. Dr. Cautreels was a director
of Innogenetics NV and ArQule, Inc. from 1999 until 2006, and of Seres Therapeutics Inc. from 2012 until 2016. He
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Galapagos NV • Annual Report 2018
CORPORATE GOVERNANCE
was the President of the Belgian-Luxemburg Chamber of Commerce for Russia and Belarus until June 2010. He
graduated from the University of Antwerp, with a Doctorate in Chemistry, specializing in mass spectrometry. He
received his management and financial education from the Harvard Business School.
Howard Rowe, JD has served as a member of our board of directors since 2010. Mr. Rowe is Managing Director at
Hayfin Capital Management LLP. Prior to joining Hayfin Capital Management, he was a Managing Director with
The Goldman Sachs Group, Inc. where he had multiple healthcare responsibilities over his 12 years at the firm.
His most recent roles at Goldman Sachs were as part of the European Special Situations and Principal Strategies
teams where he established and led the private healthcare investing effort. During that time he served on the
boards of EUSA Pharma (Europe) Limited, Healthcare Brands International Limited, SmallBone Innovations, Inc.,
MedAvante, Inc. and Ikonisys, Inc. Prior to his investing activities, Mr. Rowe was a senior member of the European
Healthcare Investment Banking team, where he advised numerous corporate clients on M&A and corporate
finance activities. Before joining Goldman Sachs, he was a corporate lawyer with the law firm Sullivan & Cromwell
LLP. Mr. Rowe received his Bachelor of Science in Psychobiology from the University of Southern California and
his JD from Harvard Law School. He currently serves as a member of the Board of Managers of Paradigm Spine
LLC.
Katrine Bosley has served as a member of our board of directors since 2013. Ms. Bosley served as the President,
Chief Executive Officer and member of the board of directors of Editas Medicine, Inc. from June 2014 to March 2019.
Prior to joining Editas, she was the Entrepreneur-in-Residence at The Broad Institute from 2013 to 2014. From 2009
to 2012, she was President, Chief Executive Officer and member of the board of directors of Avila Therapeutics,
Inc., which was acquired by Celgene Corporation in 2012. She served as President, Celgene Avilomics Research at
Celgene in 2012. Prior to her time at Avila Therapeutics she was Vice President, Strategic Operations at Adnexus,
a Bristol-Myers Squibb R&D Company, and was Vice President, Business Development at Adnexus Therapeutics,
Inc. before that. Ms. Bosley joined Adnexus Therapeutics from Biogen Idec, Inc. where she had roles in business
development, commercial operations and portfolio strategy in the United States and Europe. Ms. Bosley graduated
from Cornell University with a B.A. in Biology. She currently serves on the boards of Genocea Biosciences, Inc., the
Biotechnology Innovation Organization and of the Massachusetts Eye and Ear Institute.
Christine Mummery, Ph.D. has served as a member of our board of directors since 30 September 2015. Dr.
Mummery has served as a Professor of Developmental Biology and Chair of the Department of Anatomy and
Embryology at the Leiden University Medical Centre (LUMC) since 2008 and a Professor of Vascular Modelling at
the Technical University of Twente in the Netherlands since September 2015. In 2007, she was a Radcliffe fellow at
the Harvard Stem Cell Institute and Massachusetts General Hospital when human-induced pluripotent stem cells
were being developed, and she was the first to derive these from patients in the Netherlands. In 2002, she became
a Professor at the Utrecht University Medical Centre in the Netherlands. She was a postdoctoral fellow from 1981
to 1984 at the Hubrecht Institute in Utrecht, where she later also served as a staff scientist and group leader until
2008. Dr. Mummery obtained her B.S. in Physics, Electronics, and Mathematics at the University of Nottingham
and her Ph.D. in BioPhysics at London University in the United Kingdom. Her primary research focus is currently
the development and use of stem cells in cardiovascular development and disease. She served on the Ethical
Councils of the Dutch Ministry of Health, is member of the Royal Netherlands Academy of Arts and Sciences
(KNAW), the KHMW, editor of the Cell Press journal Stem Cell Reports, (vice) president of the International Society
for Stem Cell Research and past-president of the International Society of Differentiation. She was co-founder of
Pluriomics BV (now Ncardia BV). In addition, she chairs the executive board of the Institute for human Organ and
Disease Model Technologies (hDMT), a non-profit R&D institute of which the LUMC is a founding partner. She is
a review committee member of the European Research Council, the Leducq Foundation, the Wellcome Trust (ad
hoc) and the Heineken Jury Prize (KNAW). She is further on the scientific advisory boards of the Gurdon Institute
(Cambridge, UK), Stem Cell Australia and the Allen Institute, Seattle.
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Mary Kerr, Ph.D., has served as a member of our board of directors since 26 July 2016. Dr. Kerr, a UK national,
is Chief Executive Officer and director at NeRRe Therapeutics and Chief Executive Officer and director at KaNDy
Therapeutics. Prior to her appointment at NeRRe, Dr. Kerr held a range of senior leadership roles at GSK over more
than 20 years, most recently as Senior Vice President and Global Franchise leader for the Immuno-inflammation
and Infectious Diseases franchise. Dr. Kerr was a founding member and on the Corporate Executive team of
ViiV Healthcare where she led a turnaround in the performance of the HIV business in Europe. She has spent
the majority of her career on the R&D commercial interface in global strategy and regional operational roles,
predominantly in the specialty and orphan space. Dr. Kerr gained a Ph.D. in Pharmacology at the University of
Bradford, did post-doctoral research at the Michigan Cancer Foundation in Detroit and has an MBA from the
University of Kingston.
About Galapagos NV’s board of directors
Galapagos NV’s board of directors consists of minimum five and maximum nine members, including the
Chairman and the CEO. The Chairman is a non-executive director and does not hold the office of CEO. At least
three directors are independent.
The directors are appointed by the shareholders’ meeting upon the proposal of the board, for a renewable term
of up to four years. When a position on the board becomes vacant, the other directors may temporarily fill the
mandate until the shareholders’ meeting appoints a new director. The nomination and remuneration committee
nominates, for the approval of the board, candidates to fill vacancies and advises on proposals for appointment
originating from shareholders, in each case taking into account Galapagos’ needs and the selection criteria
determined by the board.
Except for Mr. Van de Stolpe, all board members are non-executive directors.
In 2018, the following persons were members of the board: Dr. Parekh (Chairman), Mr. Van de Stolpe (CEO), Dr.
Van Barlingen (until 24 April 2018), Dr. Cautreels, Mr. Rowe, Ms. Bosley, Dr. Mummery and Dr. Kerr; the latter four
directors were appointed as independent directors within the meaning of article 526ter of the Belgian Companies
Code. Dr. Cautreels, who had previously served as an independent director, no longer met the independence
criteria upon his reappointment for a fourth consecutive term on 24 April 2018 because article 526ter, 2° of the
Belgian Companies Code only allows for a maximum of three consecutive terms for independent directors.
In 2018, the board thus consisted of three women and five men (as from 24 April 2018: four men), representing
four different nationalities and different age categories.
Name
Onno van de Stolpe
Rajesh Parekh
Harrold van Barlingen(1)
Werner Cautreels
Howard Rowe
Katrine Bosley
Christine Mummery
Mary Kerr
(1) Until 24 April 2018
Nationality
Dutch
British
Dutch
Belgian
British and U.S.
U.S.
British and Dutch
British
Year of birth
1959
1960
1965
1952
1969
1968
1953
1961
Furthermore, our board members have different educational backgrounds, as can be read in each of their profiles
(above).
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During 2018, Galapagos NV complied with the Law of 28 July 2011 with respect to gender diversification in the
board of directors, and the board will continue to monitor future compliance. In proposing candidates, particular
consideration is given to diversity in gender, age, nationality, educational and professional background, as well as
complementary skills, knowledge and experience.
The board’s role is to pursue the long-term success of Galapagos. The board does so by assuming the authority
and responsibilities assigned to it by Belgian corporate law and by combining entrepreneurial leadership with
appropriate risk assessment and management. Each of the directors’ expertise and experience is exemplified by
the varied professional activities they carry out and offices they hold. During its meetings in 2018, the board dealt
with matters pertaining to, among other things, our strategy and growth, the evaluation of business development
opportunities, convening of the shareholders' meeting and preparation of resolutions to be submitted for
approval to the shareholders, review and approval of our financial reporting and assessment of the board and its
committees.
In 2018, the board of directors held four regular meetings, eight meetings by telephone conference to discuss
specific matters and two meetings in the presence of a notary (relating to the issuance of Warrant Plan 2018
and Warrant Plan 2018 RMV, and the issuance of shares with cancellation of the shareholders’ preferential
subscription rights). One meeting in the presence of a notary was attended by Dr. Cautreels and Dr. Van Barlingen
via telephone conference; all other directors were represented by proxy. The other meeting in the presence of a
notary was attended by Mr. Van de Stolpe and Dr. Cautreels; all other directors were represented by proxy.
The attendance rate for the other meetings was as follows: Dr. Parekh: 67%; Mr. Van de Stolpe: 92%; Dr. Cautreels:
100%; Dr. Van Barlingen: 100%; Mr. Rowe: 83%; Ms. Bosley: 75%; Dr. Mummery: 92% and Dr. Kerr: 92%. The overall
attendance rate was 88%. In addition, certain board members also attended a number of review meetings with
scientific staff of the group.
The board of directors acts as a collegial body. A formal evaluation of the board and its committees was initiated
in December 2017 and was completed in March 2018. Each board member provided feedback through individual
assessment forms. The results were presented on an aggregate basis by the secretary of the board and served as
a basis for discussion by the full board. This evaluation specifically addressed the functioning of the board, the
size and composition of the board, the interaction between the board and the executive management, and the
functioning of the audit committee and the nomination and remuneration committee.
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Galapagos NV • Annual Report 2018
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Committees
Executive committee
Composition of Galapagos NV’s executive committee
Onno van de Stolpe founded our company in 1999 and has served as our
Chief Executive Officer and a member of our board of directors from 1999
to the present. From 1998 to 1999, he was the Managing Director of
Genomics at IntroGene BV (later Crucell NV, which was acquired by
Johnson & Johnson Services, Inc. in 2011). Prior to joining IntroGene in 1998,
he was Managing Director of Molecular Probes Europe BV. He established
the European headquarters after joining Molecular Probes, Inc. in the
United States. Previously, he worked for The Netherlands Foreign
Investment Agency in California, where he was responsible for recruiting
biotechnology and medical device companies to locate in the Netherlands.
Mr. Van de Stolpe started his career as Manager of Business Development
at MOGEN International NV in Leiden. He received an MSc degree from
Wageningen University. Mr. Van de Stolpe has previously served as a member of the board of directors of DCPrime
BV and as a member of the supervisory board of the Stichting Institute for Human Organ and Disease Model
Technologies.
Bart Filius, MBA has served as our Chief Financial Officer since December
2014 and as our Chief Operating Officer since September 2017. Prior to that,
Mr. Filius worked over 13 years at Sanofi SA, where he was the Chief
Financial Officer of Sanofi Europe during the last three years. Earlier at
Sanofi, he was the Country Manager and Chief Financial Officer of Sanofi
in the Netherlands. Before that, he was Vice President for Mergers &
Acquisitions, during which time he led and completed the divestiture of
various franchises. Prior to joining Sanofi, he was a strategy consultant at
Arthur D. Little. Mr. Filius has an MBA degree from INSEAD and a
bachelor’s degree in business from Nyenrode Business University.
Piet Wigerinck, Ph.D. joined us in April 2008 as SVP Development and was
appointed Chief Scientific Officer in 2012. Under his leadership, we have
developed a large pipeline of novel mechanism of action drug candidates.
He has supervised multiple successful proof-of-concept patient studies,
including filgotinib, GLPG1690, and MOR106. Prior to his tenure at
Galapagos, Dr. Wigerinck was Vice President, Drug Discovery, Early
Development and CM&C at Tibotec-Virco Comm VA (a subsidiary of
Johnson & Johnson Services, Inc.). Under his leadership at Tibotec, TMC114
(Prezista™) and TMC435 (Olysio™) were selected and moved forward into
clinical trials. Dr. Wigerinck played a key role in Tibotec’s expansion into
novel diseases such as Hepatitis C and advanced several compounds into
Phase 1 and Phase 2 clinical trials. Dr. Wigerinck has over 30 years of R&D
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experience in the pharmaceutical industry and biotechnology. He holds a Ph.D. from the KU Leuven and is
inventor on more than 25 patent applications. In May 2018, Dr. Wigerinck was elected as an independent board
member of Ipsen SA in France.
Andre Hoekema, Ph.D. is responsible for M&A, licensing and Intellectual
Property at Galapagos as our Chief Business Officer. He joined Galapagos in
March 2005 from Invitrogen Corporation, where he was Managing Director
of Corporate Development Europe. He brings 20 years of biotech experience
from positions at Molecular Probes Europe BV (Managing Director), Crucell
NV (Director of Business Development), DSM Life Sciences NV and
Syngenta MOGEN BV (Research and Project Management) and Genentech,
Inc. (R&D). Dr. Hoekema has a Ph.D. degree from Leiden University and is
the inventor of over 20 series of patent applications, resulting in 15 patents
issued in the United States. Dr. Hoekema currently also serves as a member
of the supervisory board of Mimetas BV and has previously served as a
member of the supervisory board of VitalNext BV.
Walid Abi-Saab, MD started his job as Chief Medical Officer at Galapagos
in March 2017. Dr. Abi-Saab drives Galapagos’ overall medical strategy and
is responsible for late stage clinical development and operations, medical
and regulatory affairs, and safety. Before, Dr. Abi-Saab worked at Shire AG
where he held various clinical development leadership roles, most recently
as Group Vice President, Global Clinical Development – Therapeutic Area
Head, Gastro-intestinal, Endocrinology and Metabolism. Prior to that, he
led clinical development activities at Novartis Pharma AG, Abbott
Laboratories Inc. and Pfizer Inc., addressing a wide range of therapeutic
areas and leading teams throughout the clinical development process.
Under his leadership, more than 30 molecules have advanced through
clinical development leading to several approvals in the United States, EU
and Canada. Prior to his pharma roles, Dr. Abi-Saab was Assistant Professor of Psychiatry and Neurosurgery at
Yale University Medical School, where he headed their Schizophrenia Research at the Clinical Neuroscience
Research Unit and the Neurosurgery Epilepsy Microdialysis Research Program. Dr. Abi-Saab holds an MD degree
from Université Saint Joseph in Beirut, Lebanon.
About the executive committee of Galapagos NV
The tasks of the executive committee include the following matters: the research, identification and development
of strategic possibilities and proposals which may contribute to our development in general, management of
the group, the supervision of the actual performance of the business compared to its strategic goals, plans and
budgets, and the support of the CEO with the day-to-day management of Galapagos.
The executive committee meets regularly, and in principle once per month.
On 31 December 2018, the executive committee consisted of five people: Mr. Van de Stolpe (CEO, also executive
director), Mr. Filius (CFO and COO), Dr. Wigerinck (CSO), Dr. Hoekema (CBO), and Dr. Abi-Saab (CMO), representing
four different nationalities and different age categories.
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Nationality
Dutch
Dutch
Belgian
Dutch
U.S. and Lebanese
Name
Onno van de Stolpe
Bart Filius
Piet Wigerinck
Andre Hoekema
Walid Abi-Saab
Year of birth
1959
1970
1964
1957
1965
Furthermore, the members of our executive committee have different educational backgrounds, as can be read
in each of their profiles (above).
In proposing candidates for the executive committee, particular consideration is given to educational and
professional background, complementary skills, knowledge and experience, as well as to diversity in age, gender
and nationality.
Audit committee
The role of the audit committee is to follow up on financial reporting and verification of financial data, safeguard
the integrity of our financial reporting, verify and follow up on the internal control mechanisms, evaluate and
verify the effectiveness of the risk assessment systems, follow up on the internal and external audit activities,
review, monitor and evaluate the independence and performance of the external auditor and inform the board
on the results of the statutory audit. The audit committee also reviews corporate social responsibility initiatives.
At the end of 2018, the audit committee consisted of the following three directors: Mr. Rowe (chairman), Dr. Kerr
and Dr. Cautreels . Dr. Kerr replaced Dr. Van Barlingen on the audit committee as from 20 March 2018. Mr. Rowe
took over from Dr. Cautreels as audit committee chairman on 23 April 2018. Dr. Cautreels did remain in office
as audit committee member. All members of the audit committee are non-executive directors, the majority of
whom are independent within the meaning of article 526ter of the Belgian Companies Code. The chairman is
an independent non-executive director. All members of the audit committee have extensive experience in the
life sciences industry. Dr. Cautreels has relevant expertise in financial matters (including general accounting and
financial reporting) and in matters of audit, internal control and risk control. The other members have extensive
experience in these matters as well.
In 2018, the audit committee held seven meetings, in which it dealt with matters pertaining to, among other
things, audit review, risk management, monitoring financial reporting, the monitoring of Sarbanes-Oxley
compliant internal and external audit systems and corporate social responsibility initiatives. The audit
committee acts as a collegial body. The overall attendance at the audit committee meetings in 2018 was 100%.
Some of the meetings were attended by the statutory auditor.
Nomination and remuneration committee
The nomination and remuneration committee’s role is twofold: providing recommendations to the board of
directors regarding the remuneration policy of Galapagos and the remuneration of directors and members of the
executive committee, and selecting the appropriate candidates and making recommendations to the board of
directors in relation to the appointment of directors and members of the executive committee.
At the end of 2018, the nomination and remuneration committee consisted of the following three non-executive
directors: Dr. Parekh (chairman), Ms. Bosley and Mr. Rowe, the majority of whom are independent directors.
Mr. Rowe replaced Dr. Cautreels on the nomination and remuneration committee as from 20 March 2018. The
committee has the necessary expertise in the area of remuneration policy.
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The nomination and remuneration committee meets at least twice per year. In 2018, the nomination and
remuneration committee held three meetings, dealing with, among other things, matters pertaining to grants
of warrants and bonuses, the nomination and remuneration of directors and salary increases. The nomination
and remuneration committee acts as a collegial body. The overall attendance rate at the nomination and
remuneration committee meetings in 2018 was 88%. Mr. Rowe’s attendance rate was 50% whereas the other
committee members’ attendance rates were all 100%. The CEO attended the meetings of this committee when
the remuneration of the other members of the executive committee was discussed.
Composition of board committees (excluding the executive
committee)
Audit committee
Nomination and remuneration
committee
Onno van de Stolpe
Raj Parekh
Werner Cautreels
Howard Rowe(1)
Katrine Bosley(1)
Christine Mummery(1)
Mary Kerr(1)
• denotes committee membership
* denotes committee chairmanship
•
*
•
*
•
•
(1) denotes qualification as an independent director within the meaning of article 526ter of the Belgian Companies Code
Galapagos NV’s share capital and shares
Share capital increases and issue of shares by Galapagos NV in 2018
On 1 January 2018, the share capital of Galapagos NV amounted to €275,509,753.48 represented by 50,936,778 shares.
In the course of 2018 there were four capital increases resulting from the exercise of warrants, resulting in the
issuance of 567,270 new shares, an increase of the share capital by €3,068,930.70 and an increase of the issuance
premium account by €4,587,747.80. In addition, on 17 September 2018, Galapagos NV completed the offering in the
U.S. of 2,961,373 new shares in the form of American Depositary Shares at a price of $116.50 per share. This resulted
in a share capital increase of €16,021,027.93 and an increase of the issuance premium account by €280,167,119.82.
At the end of 2018, the share capital of Galapagos NV amounted to €294,599,712.11 represented by 54,465,421 shares.
On 19 April 2018, the board of directors issued 1,235,245 warrants (after acceptance by the beneficiaries) within the
framework of the authorized capital, for the benefit of the directors and an independent consultant of Galapagos
NV, and of employees of the group under new warrant plans (“Warrant Plan 2018” and “Warrant Plan 2018 RMV”).
The offer of warrants to the directors and to the members of the executive committee under Warrant Plan 2018
was approved by the annual shareholders’ meeting of 24 April 2018. The warrants issued under Warrant Plan 2018
and Warrant Plan 2018 RMV have a term of eight years and an exercise price of €79.88.
Number and form of Galapagos shares
Of the 54,465,421 shares of Galapagos NV outstanding at the end of 2018, 6,762,666 were registered shares and
47,702,755 shares were dematerialized shares. All shares are issued and fully paid up and are of the same class.
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Rights attached to Galapagos shares
Each share (i) entitles its holder to one vote at the shareholders’ meetings; (ii) represents an identical fraction of
the share capital and has the same rights and obligations and shares equally in the profit of Galapagos NV; and
(iii) gives its holder a preferential subscription right to subscribe to new shares, convertible bonds or warrants in
proportion to the part of the share capital represented by the shares already held. The preferential subscription
right can be restricted or cancelled by a resolution approved by the shareholders’ meeting, or by the board
of directors subject to an authorization of the shareholders’ meeting, in accordance with the provisions of the
Belgian Companies Code and Galapagos NV’s articles of association.
Galapagos NV’s authorized capital
In accordance with the articles of association, the extraordinary shareholders’ meeting of Galapagos NV
authorized the board of directors to increase the share capital of Galapagos NV, in one or several times, and
under certain conditions set forth in extenso in the articles of association of Galapagos NV. This authorization
was renewed and is valid for a period of five years from the date of publication of this renewal in the Annexes
to the Belgian State Gazette, i.e. 31 May 2017. The board of directors may increase the share capital of Galapagos
NV within the framework of the authorized capital for an amount of up to €82,561,764.93. In 2018, Galapagos NV’s
board of directors made use of the right to increase the capital in the framework of the authorized capital on
two occasions: (1) on 19 April 2018, in connection with the issuance of Warrant Plan 2018 and Warrant Plan 2018
RMV, under which a maximum of 1,235,245 new shares can be issued for a total maximum capital increase of
€6,682,675.45 (plus issuance premium); and (2) on 17 September 2018, in connection with the public offering in
the U.S. of 2,961,373 new shares in the form of American Depositary Shares, resulting in an increase of the share
capital by €16,021,027.93 (plus issuance premium). On 31 December 2018, an amount of €59,858,061.55 still remained
available under the authorized capital.
When increasing the share capital within the limits of the authorized capital, the board of directors may,
in Galapagos NV’s interest, restrict or cancel the shareholders’ preferential subscription rights, even if such
restriction or cancellation is made for the benefit of one or more specific persons other than the employees of
the group.
Procedure for changes in Galapagos NV’s share capital
In accordance with the Belgian Companies Code, Galapagos NV may increase or decrease its share capital by
decision of the extraordinary shareholders’ meeting approved by a majority of 75% of the votes cast, at a meeting
where at least 50% of the share capital of Galapagos NV is present or represented. If the attendance quorum of 50%
is not met, a new extraordinary shareholders’ meeting must be convened at which the shareholders may decide
on the agenda items, irrespective of the percentage of share capital present or represented at such meeting. In
this respect, there are no conditions imposed by Galapagos NV’s articles of association that are more stringent
than those required by law.
Within the framework of the powers granted to it under the authorized capital, the board of directors may also
increase Galapagos NV’s capital as specified in its articles of association.
Purchase and sale of Galapagos treasury shares
In accordance with the Belgian Companies Code, Galapagos NV may purchase, subject to the provisions of
the Belgian Companies Code, Galapagos NV’s own shares and dispose thereof by decision of the extraordinary
shareholders’ meeting approved by a majority of 80% of the votes cast, at a meeting where at least 50% of the
share capital of Galapagos NV is present or represented. If the attendance quorum of 50% is not met, a new
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extraordinary shareholders’ meeting must be convened at which the shareholders may decide on the agenda
items, irrespective of the percentage of share capital present or represented at such meeting. The aforementioned
rules are also applicable to the acquisition of shares of Galapagos NV by its subsidiaries.
The board of directors has currently not been authorized by an extraordinary shareholders’ meeting to purchase
or sell its own shares.
On 31 December 2018, neither Galapagos NV nor any subsidiary of Galapagos NV held any shares in Galapagos NV,
nor did any third party hold any shares in Galapagos NV on behalf of Galapagos NV or any of its subsidiaries
either.
Anti-takeover provisions in Galapagos NV’s articles of association
Galapagos NV’s articles of association currently do not contain any anti-takeover provisions.
Anti-takeover provisions under Belgian law
Under Belgian law, public takeover bids for all outstanding voting securities of the issuer are subject to the
supervision of the FSMA. If the latter determines that a takeover violates Belgian law, it may lead to suspension
of the exercise of the rights attached to any shares that were acquired in connection with the envisaged takeover.
Pursuant to the Belgian Law of 1 April 2007 on public takeovers, a mandatory takeover bid must be made when,
as a result of its own acquisition or the acquisition by persons acting in concert with it, a person owns, directly
or indirectly, more than 30% of the securities with voting rights in a company with registered office in Belgium
whose securities are admitted to trading on a regulated or recognized market. The acquirer must offer to all other
shareholders the opportunity to sell their shares at the higher of (i) the highest price offered by the acquirer for
shares of the issuer during the 12 months preceding the announcement of the bid or (ii) the weighted average
price of the shares on the most liquid market of the last 30 calendar days prior to the date on which it became
mandatory for the acquirer to launch a mandatory takeover bid for the shares of all other shareholders.
Material contracts containing change of control clauses
The license and collaboration agreement between Galapagos NV and Gilead Biopharmaceutics Ireland Unlimited
Company ("Gilead") dated 16 December 2015 contains provisions granting certain rights to Gilead upon the
occurrence of a public takeover bid on our shares or a change of control in respect of Galapagos NV, including
clause 15.6 (Assignment;IndustryTransaction;AcquiredPrograms), entitling Gilead (i) in the event of an industry
transaction involving Galapagos, as a result of which a drug company of a certain minimum size acquires control
over Galapagos, to terminate our co-promotion rights, to disband all joint committees and undertake exclusive
control of their activities; and (ii) in the event of a change of control as a result of which we acquire rights to
an alternative product that would violate certain of our exclusivity obligations under the agreement, to require
us to either divest or terminate this acquired program. Gilead Biopharmaceutics Ireland Unlimited Company’s
rights and obligations under the license and collaboration agreement were assigned to another affiliate of Gilead
on 7 December 2017.
The product development, license and commercialization agreement between Galapagos NV, Les Laboratoires
Servier and Institut de Recherches Servier (“Servier”) as amended and restated on 8 May 2018 contains provisions
granting certain rights to Servier upon the occurrence of a public takeover bid on our shares or a change of
control in respect of Galapagos NV including, but not limited to, clause 13.4 (Termination by Servier Without
Cause or Due to Galapagos Change of Control), clause 13.5 (Rights on Termination) and clause 13.7 (Change of
Control), entitling Servier, in the event of a change of control of Galapagos NV, to elect to terminate the agreement
subject to an option for Galapagos NV to choose from two contractual termination regimes, both including the
termination of the licenses granted by Galapagos NV to Servier and the freedom for Galapagos NV to conduct
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research and development activities on terminated licensed products, or to have the licenses granted to Servier
continue, with all payment obligations remaining in place, but with Servier having full control over the further
development and patent strategies for the licensed product in Servier’s territory.
The exclusive license agreement among Galapagos NV, MorphoSys AG and Novartis Pharma AG ("Novartis") dated
19 July 2018 contains provisions granting certain rights to Novartis upon the occurrence of a public takeover
bid on our shares or a change of control in respect of Galapagos NV including, but not limited to, clause 3.7
(Change of Control), entitling Novartis, in the event of a change of control of Galapagos NV, to have Galapagos
NV’s representatives removed from the joint committees.
The second amended and restated collaboration agreement between Galapagos NV and AbbVie S.à r.l. ("AbbVie")
dated 24 October 2018 contains provisions granting certain rights to AbbVie upon the occurrence of a public
takeover bid on our shares or a change of control in respect of Galapagos NV, including, but not limited to clause
11.2 (Change in Control of Galapagos), entitling AbbVie, to oblige Galapagos NV to take appropriate measures
to avoid the disclosure of confidential information, to limit AbbVie's reporting obligations to Galapagos NV, or,
depending on the stage in which the change of control occurs, to terminate the agreement.
Procedure for amendments to Galapagos NV’s articles of association
Pursuant to the Belgian Companies Code, any amendment to the articles of association, such as an increase or
decrease in the share capital of Galapagos NV, and certain other matters, such as the approval of the dissolution,
merger or de-merger of Galapagos NV may only be authorized with the approval of at least 75% of the votes validly
cast at an extraordinary shareholders’ meeting where at least 50% of Galapagos NV’s share capital is present or
represented. If the attendance quorum of 50% is not met, a new extraordinary shareholders’ meeting must be
convened at which the shareholders may decide on the agenda items, irrespective of the percentage of share
capital present or represented at such meeting.
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Shareholders
Major shareholders of Galapagos NV
Based on the transparency notifications received by Galapagos NV under Belgian law and the statements of acquisition
of beneficial ownership filed on Schedule 13G with the U.S. Securities and Exchange Commission under U.S. securities
law, the shareholders owning 5% or more of Galapagos NV’s shares on 31 December 2018 were Gilead Therapeutics
A1 Unlimited Company (6,760,701 shares or 12.41%), Van Herk Investments B.V. (5,379,305 shares or 9.88%), Wellington
Management Group LLP (3,427,128 shares or 6,29%) and Sands Capital Management LLC (2,894,535 shares or 5.31%).
Major shareholders on 31 December 2018
12.41%
Gilead
65.07%
Other shareholders
9.88%
Van Herk Investments
5.31%
Sands Capital Management
6.29%
Wellington Management
Group
1.04%
Insiders
At the end of 2018, our CEO owned 478,289 shares of Galapagos NV and 786,874 warrants. The other members of our
executive committee held an aggregate of 67,502 shares and 1,352,500 warrants. The other members of our board held an
aggregate of 17,974 shares and 216,780 warrants. Each warrant entitles its holder to subscribe to one share of Galapagos NV.
Agreements between Galapagos NV shareholders
On the date of this report, Galapagos NV had no knowledge of the existence of any shareholders’ agreements
between its shareholders.
Agreements with major Galapagos NV shareholders
On 16 December 2015, we signed an exclusive license and collaboration agreement to develop and commercialize filgotinib
in multiple indications with Gilead Biopharmaceutics Ireland Unlimited Company. This agreement was assigned to
another affiliate of Gilead on 7 December 2017. Under the terms of the collaboration, Gilead is primarily responsible for
development and for seeking regulatory approval of the licensed product. We are required to use commercially reasonable
efforts as requested by Gilead to assist Gilead with certain development activities. In addition, we agreed on a 20‑80 cost
split for development costs of the licensed product, i.e. we will bear 20% of all development costs. We have retained certain
mechanisms to give us cost protection as filgotinib advances in clinical development. We can defer our portion of the
global co-development study costs if they exceed a predetermined level, which we expect to reach at the end of 2019, and
this deferment would be credited against future milestones, royalties or profit sharing at our option. If there are no future
amounts to be paid by Gilead, we will not be obligated to make any payments to Gilead for such deferment.
In the framework of the closing of the transaction on 19 January 2016, Gilead paid a license fee of $300 million (or
€275.6 million) and made a $425 million (or €392 million) equity investment in Galapagos NV by subscribing to new
shares at a price of €58 per share, including issuance premium. This resulted in Gilead owning 6,760,701 ordinary shares
of Galapagos NV, representing 14.75% of the then outstanding share capital of Galapagos. In the framework of this
transaction, the parties agreed to a lock-up arrangement and a standstill arrangement, both of which expired on
31 December 2017.
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Remuneration report
Determination of remuneration of directors and executive
committee members of Galapagos NV
The procedure for establishing the remuneration policy and setting remuneration for members of the board of
directors and of the executive committee is determined by the board of directors on the basis of proposals from
the nomination and remuneration committee, taking into account relevant benchmarks with appropriate peer
companies and, for the members of the executive committee, also the group’s performance rating system.
The remuneration of the members of the board and the grant of warrants to members of the board are
submitted by the board for approval to the shareholders’ meeting, and are only implemented after such approval.
The fixed and variable remuneration of the CEO (who is a member of the board) is established by the board of
directors based upon an authorization from the shareholders’ meeting. The fixed and variable remuneration of,
and grant of warrants to, the other members of the executive committee is established by the board of directors,
upon recommendation of the nomination and remuneration committee.
Our remuneration policy
Principles
The objective of our remuneration policy is to attract, motivate and retain the qualified and expert individuals
that we need in order to achieve our strategic and operational objectives. In light of the remuneration policy, the
structure of the remuneration package for the executive committee is designed to balance short-term operational
performance with the long-term objective of creating sustainable value, while taking into account the interests
of all stakeholders.
The remuneration of the non-executive directors consists of a fixed annual amount, irrespective of the number of
board meetings that are held during the year. The remuneration of the non-executive directors does not contain
a variable part. The board fees are paid in quarterly installments at the end of each calendar quarter.
The remuneration of the CEO and of the other members of the executive committee consists of a fixed part and
a variable part (bonus). Remuneration increases and bonuses are merit-driven and based on our performance
rating system that is based on individual performance (including exceptional deliverables) in combination
with our overall performance, compared to individual and corporate objectives that are established annually.
The corporate objectives and the CEO’s objectives are established annually by the board of directors upon
recommendation of the nomination and remuneration committee, and the objectives of the other members
of the executive committee are established annually by the CEO and are in relation to the corporate objectives
set by the board. For 2018, the corporate objectives included elements of clinical trial progression, cash position,
corporate development and business development; all of these objectives were considered to be of equal
importance. The level of achievement of the objectives for the CEO is reviewed at the end of each year by the
nomination and remuneration committee and discussed and finally established by the board, and the level of
achievement of the objectives of the other members of the executive committee is assessed by the CEO at the end
of the year in connection with appraisal discussions, discussed by the nomination and remuneration committee
and finally established by the board of directors.
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Pursuant to the rules of the Senior Management Bonus Scheme, 50% of the bonus is paid immediately around
year-end and the payment of the other 50% is deferred for three years. The deferred 50% component is dependent
on the change in the price of Galapagos NV’s share relative to the Next Biotech Index (which tracks Euronext-
listed biotech companies). The share price and the Next Biotech Index at the start and end of the 3‑year period is
calculated by the average price over the preceding and last month of the 3‑year period, respectively.
▪ If the share price change is better than or equal to the change in the Next Biotech Index, the deferred bonus
will be adjusted by the share price increase/decrease and paid out
▪ If the share price change is up to 10% worse than the change in the Next Biotech Index, 50% of the deferred
bonus will be adjusted by the share price increase/decrease and paid out, and the remainder will be forfeited
▪ If the share price change is more than 10% worse than the change in the Next Biotech Index, the deferred
bonus will be forfeited
To be entitled to any deferred payment under the bonus scheme, the beneficiary must still be in our employ,
except in case of retirement with Galapagos’ consent or in case of redundancy. If employment within the
Galapagos group ends because of either retirement with Galapagos’ consent or redundancy, then the deferred
bonus will become payable on the last day of employment of the beneficiary with the Galapagos group. In
this case, the increase or decrease in the deferred bonus will be calculated in a similar manner to that quoted
above with the exception that the final reference share price will be the price at the close of business on
the Amsterdam/Brussels Euronext Exchange on the last working day immediately preceding the last day of
employment and the final reference value of Next Biotech Index will be the value quoted at the close of trading
on the day preceding the last day of employment.
In addition, exceptional special bonuses, outside the scope of the regular bonus schemes, can be considered
by the board upon recommendation of the nomination and remuneration committee in the event of and for
exceptional achievements.
Relative importance of the various components
The CEO’s bonus under the Senior Management Bonus Scheme can be maximum 100% of the fixed part of his
annual remuneration of the year for which the bonus is awarded. The aggregate bonuses of the other members
of the executive committee under the Senior Management Bonus Scheme can be maximum 75% of the total
amount of the fixed part of their aggregate annual remuneration of the year for which the bonus is awarded.
In addition, the CEO and/or the other members of the executive committee enjoy a number of benefits such as
pension payments, insurances and other fringe benefits, the monetary value of which is, however, limited.
Performance-related premiums in shares, options or other rights to acquire shares
Galapagos does not provide for any performance-related premiums in shares, options or other rights to acquire
shares. The warrants granted to members of the board of directors (including the CEO) are not considered as a
(performance-related or otherwise) variable remuneration as defined by the Belgian Companies Code.
Information on the remuneration policy for the next two years
Upon recommendation of the nomination and remuneration committee, the board of directors of 18 February
2019 resolved to update the compensation package of the members of the executive committee, based on a
benchmarking exercise performed by an independent advisor. This update aims to (i) bring the short-term
compensation in line with the median of the benchmark (cash and bonus), (ii) bring the total compensation
in line with the median of the benchmark, and (iii) increase the share-based portion of long-term incentives,
reflecting practices within relevant peer companies.
Under the updated compensation structure, a part of the variable remuneration will consist of restricted share
units (“RSUs”). Each RSU reflects the value of one Galapagos share and will be payable, at the company’s discretion,
in cash or in shares after a vesting period of three years, subject to continued employment. If employment within
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the Galapagos group ends because of either retirement with Galapagos’ consent or redundancy, then the RSUs
will become payable on the last day of employment of the beneficiary with the Galapagos group. The allocation
of RSUs will be partly performance-based against the previous year’s objectives, and partly upon the discretion of
the board of directors.
The updated compensation package is being implemented per 1 January 2019 for salary increases, April 2019 for
discretionary grant of RSUs and as from 2020 for objective-related RSUs and cash bonus.
Remuneration of non-executive directors of Galapagos NV
Upon recommendation of the nomination and remuneration committee, the annual shareholders’ meeting
of 24 April 2018 resolved that the compensation (excluding expenses) of the non-executive directors for the
exercise of their mandate during the financial year ending 31 December 2018 was established as follows: (i)
chairman of the board (Dr. Parekh): €80,000; (ii) other non-executive board members (Dr. Cautreels, Mr. Rowe,
Ms. Bosley, Dr. Mummery and Dr. Kerr): €40,000 each; (iii) annual additional compensation for membership of
a board committee (audit committee: Mr. Rowe and Dr. Van Barlingen, replaced by Dr. Kerr as from 20 March
2018; nomination and remuneration committee: Dr. Cautreels, replaced by Mr. Rowe as from 20 March 2018,
and Ms. Bosley): €5,000; (iv) annual additional compensation for the chairmanship of a board committee (audit
committee: Dr. Cautreels, replaced by Mr. Rowe as from 23 April 2018; nomination and remuneration committee:
Dr. Parekh): €10,000.
The remuneration of the non-executive directors does not contain a variable part; hence no performance criteria
apply to the remuneration of the non-executive directors.
In 2018, we issued two warrant plans for the benefit of employees of the group and of the directors and one
independent consultant of Galapagos NV: Warrant Plan 2018 and Warrant Plan 2018 RMV. In accordance with the
resolution of the annual shareholders’ meeting of 24 April 2018, the following number of warrants were offered
under Warrant Plan 2018 to the non-executive directors: Dr. Parekh: 15,000 warrants; and Dr. Cautreels, Ms. Bosley,
Mr. Rowe, Dr. Mummery and Dr. Kerr: each 7,500 warrants. All directors accepted the warrants offered. These
warrants have a term of eight years. The exercise price of the warrants is €79.88. As regards the directors, the
warrants vest over a period of 36 months at a rate of 1/36th per month. The warrants cannot be transferred and
cannot be exercised prior to the end of the third calendar year following the year of the grant. No warrants were
offered to directors under Warrant Plan 2018 RMV. The board of directors does not consider the above warrants
as variable remuneration as defined by the Belgian Companies Code as they are not subject to any performance-
related criteria.
The board of directors points out that provision 7.7 of the Belgian Corporate Governance Code 2009 stipulates
that non-executive directors should not be entitled to stock-related long-term incentive schemes. In deviation
from this provision, the board of directors has decided to grant warrants to non-executive directors. This
way, Galapagos has additional possibilities to attract competent non-executive directors and to offer them
an attractive additional remuneration that does not affect Galapagos’ cash position. Furthermore, the grant
of warrants is a commonly used method in the sector in which Galapagos operates. Without this possibility,
Galapagos would be confronted with a considerable disadvantage compared to competitors and peer companies
that do offer stock-related incentive schemes to their non-executive directors. The board of directors is of the
opinion that the granting of warrants has no negative impact on the functioning of the non-executive directors.
In addition to the benefits set forth above, the non-executive directors also received benefits consisting of tax
advisory services in 2018 for an aggregate amount of €3,700.
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Galapagos NV • Annual Report 2018
CORPORATE GOVERNANCE
Remuneration of executive directors of Galapagos NV
Mr. Van de Stolpe is an executive member of the board of directors. As managing director and CEO, he acts as
chairman of the executive committee. Mr. Van de Stolpe does not receive any specific or additional remuneration
for his work on the board of directors, as this is part of his total remuneration package as member of the
executive committee.
Criteria and methods to evaluate the performance of Galapagos NV’s
CEO and other executive committee members in connection with
their performance-based remuneration
The executive director (CEO) and the members of the executive committee are eligible for performance-based
remuneration (bonus). The level of the achieved bonus is established annually by the board of directors upon
recommendation of the nomination and remuneration committee (with respect to the other members of the
executive committee, such recommendation is based on proposals from the CEO). The award of a bonus is merit-
driven and based on the group’s performance rating system that is based on annual individual performance
(including exceptional deliverables) in combination with our overall performance, compared to the level of
achievement of individual and corporate objectives that are established annually. The corporate objectives and
the CEO’s objectives are established annually by the board of directors, and the objectives of the other members
of the executive committee are established annually by the CEO. For 2018, the corporate objectives included
elements of clinical trial progression, cash position, corporate development and business development. Each of
the corporate objectives is clear and measurable so that it is easy to determine whether or not a specific objective
has been achieved or not.
Gross remuneration of our CEO for financial year 2018
i. Base salary (fixed): €500,193.18 (including €18,859.44 in the form of pension contributions).
ii. Variable remuneration (bonus): given the level of achievement of the criteria from the Senior Management
Bonus Scheme to be entitled to a bonus (i.e. the corporate objectives for 2018), a bonus equal to 100% of the
2018 base salary was awarded over 2018, of which 50% was paid early January 2019, and the other 50% was
deferred for 3 years. The value of the 50% deferred part of the bonus awarded over 2015 was established at the
end of 2018 and resulted in a payment in early January 2019 of an amount of €381,909.00 (a multiple of 1.7 of
the deferred bonus, as a result of the share price performance over the period 2015‑2018 as per the provisions
of the Senior Management Bonus Scheme). In addition, an amount of €266,836.00 was paid in June 2018, being
a multiple of 1.9 of the deferred 50% of the exceptional special bonus awarded for the successful Nasdaq listing
in 2015.
iii. Pension: €62,292.17 (of which €18,859.44 is part of the base salary).
iv. Other components of the remuneration: company car, tax advisory services, and payments for invalidity and
healthcare cover, totaling €38,958.28.
During its meeting of 18 February 2019, the board of directors decided, upon recommendation of the nomination
and remuneration committee, to update the structure of the remuneration of the CEO as set forth above under
"information on the remuneration policy for the next two years". This includes salary increases as from 1 January
2019 and the grant of RSUs as from April 2019.
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Galapagos NV • Annual Report 2018
CORPORATE GOVERNANCE
Aggregate gross remuneration of the other executive committee
members for financial year 2018
i. Base salaries (fixed): €1,474,111.39 (including €35,000.00 in the form of pension contributions).
ii. Variable remunerations (bonuses): given the level of achievement of the criteria from the Senior
Management Bonus Scheme to be entitled to a bonus (i.e. the corporate objectives for 2018), an aggregate
bonus of €1,015,000.00 (i.e. 100% of the aggregate bonus pool) was awarded over 2018 of which 50% was paid
early January 2019, and the other 50% was deferred for 3 years. The value of the 50% deferred part of the bonus
awarded over 2015 was established at the end of 2018 and resulted in a payment in early January 2019 of an
amount of €435,922.00 (a multiple of 1.7 of the deferred bonus, as a result of the share price performance over
the period 2015‑2018 as per the provisions of the Senior Management Bonus Scheme). In addition, an amount
of €727,735.00 was paid in June 2018, being a multiple of 1.9 of the deferred 50% of the exceptional special bonus
awarded for the successful Nasdaq listing in 2015.
iii. Pensions: €243,345.59 (of which €35,000.00 are part of the fixed base salary).
iv. Other components of the remunerations: company cars, tax advisory services, and payments for invalidity
and healthcare cover, totaling €68,073.03.
During its meeting of 18 February 2019, the board of directors decided, upon recommendation of the nomination
and remuneration committee, to update the structure of the remuneration of the members of the executive
committee as set forth above under "Information on the remuneration policy for the next two years". This
includes salary increases as from 1 January 2019 and the grant of RSUs as from April 2019.
Shares, warrants or other rights to acquire shares awarded to,
exercised by or expired for the executive committee members
during financial year 2018
In 2018, only warrants were offered to the members of the executive committee, and no shares or other rights
to acquire shares were awarded. No warrants expired for members of the executive committee in 2018 and, in
aggregate, 250,000 warrants were exercised by members of the executive committee in 2018 (60,000 warrants were
exercised by Onno van de Stolpe, 90,000 warrants by Bart Filius and 50,000 warrants by each of Piet Wigerinck and
Andre Hoekema). The board of directors does not consider the granted warrants as a variable remuneration, as
they are not subject to any performance criteria. The following number of warrants were offered to and accepted
by members of the executive committee in 2018 under Warrant Plan 2018, issued by the board of directors under
the authorized capital on 19 April 2018: to Mr. Van de Stolpe: 100,000 warrants, to Mr. Filius: 80,000 warrants, to
each of Dr. Wigerinck and Dr. Abi-Saab: 60,000 warrants and to Dr. Hoekema: 50,000 warrants.
The warrants issued under Warrant Plan 2018 have an exercise price of €79.88, a life time of 8 years, and vest only
and fully at the end of the third calendar year after the year of the grant, except for Mr. Van de Stolpe, whose
warrants vest over a period of 36 months at a rate of 1/36th per month. The warrants cannot be exercised prior to
the end of the third calendar year after the year of the grant; they are not transferable, and each warrant gives
the right to subscribe to one share of Galapagos NV.
At the end of 2018, Mr. Van de Stolpe owned 478,289 shares of Galapagos NV and 786,874 warrants. The other
members of the executive committee held an aggregate of 67,502 shares and 1,352,500 warrants. The other
members of the board held an aggregate of 17,974 shares and 216,780 warrants. Each warrant entitles its holder to
subscribe to one share of Galapagos NV.
96
Galapagos NV • Annual Report 2018
CORPORATE GOVERNANCE
Contractual provisions regarding compensation for severance for the
Galapagos NV executive committee members
The contracts between Galapagos NV (or its relevant affiliates) and the CEO and other members of the executive
committee do not provide for severance compensation. They do not contain notice periods that exceed six
months. However, Galapagos NV entered into undertakings with the CEO and the other members of the executive
committee, providing that in case their contract with the group is terminated as a result of a change of control
of Galapagos, they would be entitled to a severance compensation of 12 months’ base salary for the CEO and 9
months’ base salary for the other members of the executive committee.
Severance payments for departing executive committee members
during financial year 2018
Not applicable; in 2018 no members of the executive committee (including the CEO) left Galapagos.
Claw-back right of Galapagos relating to variable remuneration
There are no contractual provisions in place between Galapagos and the CEO or the other members of the
executive committee that give Galapagos a contractual right to reclaim from said executives the variable
remuneration that would be awarded based on erroneous financial information.
Conflict of interests and related parties
In the event of a transaction where a director’s interest conflicts with the interest of Galapagos NV, the director
shall notify the board of directors in advance of the conflict and will act in accordance with the relevant rules
of the Belgian Companies Code (i.e. article 523 of the Belgian Companies Code). In addition, Galapagos’ Corporate
Governance Charter and Galapagos’ Related Person Transaction Policy contain procedures for transactions
between Galapagos and its directors, members of its executive committee, major shareholders or any of their
immediate family members and affiliates. Without prejudice to the procedure defined in article 523 of the Belgian
Companies Code, these policies provide that all transactions between Galapagos and its directors, its members
of the executive committee or its representatives need the approval of the audit committee and the board of
directors, which approval can only be provided for transactions at normal market conditions. Moreover, conflicts
of interest, even in the event they are not a conflict of interest within the meaning of article 523 of the Belgian
Companies Code, are enacted in the meeting minutes, and the director or member of the executive committee
cannot participate in the voting.
In 2018, one conflict of interests between Galapagos NV and a director within the meaning of article 523 of the
Belgian Companies Code was noted: in a meeting of the board of directors held on 18 December 2018, the following
was reported in accordance with article 523 of the Belgian Companies Code in connection with the bonus for the
CEO: the chairman declared that Mr. Onno van de Stolpe had informed the board of directors of a conflict of
interest, concerning the proposed award to him of a bonus. Given the actual level of achievement of the criteria
from the Senior Management Bonus Scheme to be entitled to a bonus (i.e. the corporate objectives for 2018) a
bonus equal to 100% of his 2018 salary was awarded to Mr. Van de Stolpe for 2018. The board considered that said
bonus is a justified reward for the results achieved by Mr. Van de Stolpe in 2018. The bonus will have no material
impact on the financial position of the company. The board shared the opinion of the remuneration committee
that the proposed bonus is justified and reasonable. Mr. Van de Stolpe did not take part in the deliberation
and the vote concerning this decision. However, during its meeting of 18 February 2019, the board of directors
decided, upon recommendation of the nomination and remuneration committee, to update the structure of the
remuneration of the CEO as set forth above under Information on the remuneration policy for the next two years.
97
Galapagos NV • Annual Report 2018
CORPORATE GOVERNANCE
Code of Business Conduct and Ethics
We have established a Code of Business Conduct and Ethics to ensure that our directors, officers and employees
are making ethical and legal decisions when conducting Galapagos’ business and performing their day-to-day
duties. We expect our directors, officers and employees to conduct business with integrity, ethics and respect for
human rights. We expect them to turn away from conflicts of interest, corruption and fraud. To this end, we give
trainings on this Code to our employees. So far, 93% of our employees from Galapagos R&D have completed the
training.
The Code of Business Conduct and Ethics is available at www.glpg.com/charters-and-codes.
We were not informed of any breaches of our Code of Business Conduct and Ethics in 2018.
Statement by the board of directors
The board of directors of Galapagos NV, represented by all its members, declares that, as far as it is aware, the
statutory accounts and consolidated financial statements, prepared according to the applicable standards for
financial statements, give a true and fair view of the equity, financial position and the results of Galapagos as of
31 December 2018.
The board of directors of Galapagos NV, represented by all its members, further declares that, as far as it is aware,
this report to the shareholders for the financial year ending on 31 December 2018, gives a true and fair view on the
development, results and position of Galapagos and on the most important risks and uncertainties with which
Galapagos is confronted.
The board of directors will submit proposed resolutions to the shareholders’ meeting to approve the annual
accounts for the financial year 2018, and to release the directors and the statutory auditor from liability for the
performance of their mandate during the financial year ended 31 December 2018.
Mechelen, 26 March 2019
On behalf of the board of directors
Onno van de Stolpe
CEO
Raj Parekh
Chairman
98
Galapagos NV • Annual Report 2018
Financial
statements
Consolidated and non-consolidated
financial statements for 2018
we raise the bar.
FINANCIAL STATEMENTS
Consolidated financial statements
Consolidated statements of income and comprehensive income /
loss (–)
Consolidated income statement
(thousands of €, except share and per share data)
Revenues
Other income
Total revenues and other income
Research and development expenditure
General and administrative expenses
Sales and marketing expenses
Total operating expenses
Operating loss
Financial income
Financial expenses
Loss before tax
Income taxes
Net loss
Net loss attributable to:
Owners of the parent
Basic & diluted loss per share
Year ended 31 December
2018
288,836
29,009
317,845
127,087
28,830
155,918
2017
Notes
(322,875)
(218,502)
(35,631)
(4,146)
(24,415)
(2,803)
(362,652)
(245,720)
(44,807)
(89,802)
18,335
(2,737)
4,877
(30,582)
(29,209)
(115,507)
(50)
(198)
(29,259)
(115,704)
10
(29,259)
(0.56)
(115,704)
(2.34)
10
5
5
6
6
6
8
8
9
100
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
Consolidated statement of comprehensive income / loss (-)
(thousands of €)
Net loss
Items that will not be reclassified subsequently to profit or loss:
Re-measurement of defined benefit obligation
Items that may be reclassified subsequently to profit or loss:
Fair value adjustment of available-for-sale financial assets
Translation differences, arisen from translating foreign activities
Other comprehensive income / loss (-), net of income tax
Year ended 31 December
2018
(29,259)
2017
Notes
(115,704)
(94)
–
197
103
(40)
(220)
(664)
(924)
27
13
19
Total comprehensive loss attributable to:
Owners of the parent
(29,155)
(116,629)
101
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
Consolidated statements of financial position
(thousands of €)
Intangible assets
Property, plant and equipment
Deferred tax assets
Non-current R&D incentives receivables
Other non-current assets
Non-current assets
Trade and other receivables
Current R&D incentives receivables
Cash and cash equivalents
Other current assets
Current assets
Total assets
Equity and liabilities
Share capital
Share premium account
Other reserves
Translation differences
Accumulated losses
Total equity
Retirement benefit liabilities
Other non-current liabilities
Non-current deferred income
Non-current liabilities
Finance lease liabilities
Trade and other liabilities
Current tax payable
Current deferred income
Current liabilities
Total liabilities
Total equity and liabilities
31 December
2018
2017
Notes
11
12
20
14
13
15
14
16
15
17
17
18
19
27
21
22
21
9
22
3,632
23,137
2,514
73,443
7,919
110,645
18,609
11,203
2,495
16,692
1,978
64,001
3,461
88,627
27,966
11,782
1,290,796
1,151,211
8,244
1,328,851
1,439,496
6,688
1,197,647
1,286,274
236,540
1,277,780
(735)
(1,557)
(297,779)
1,214,249
3,764
1,578
–
5,342
–
68,928
1,175
149,801
219,905
225,247
233,414
993,025
(1,260)
(1,754)
(211,441)
1,011,983
3,582
1,662
97,348
102,592
9
48,281
865
122,544
171,699
274,291
1,439,496
1,286,274
102
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
Consolidated cash flow statements
(thousands of €)
2018
2017
Notes
Net loss of the period
(29,259)
(115,704)
Adjustment for non-cash transactions
Adjustment for items to disclose separately under operating cash flow
Adjustment for items to disclose under investing and financing cash
flows
Change in working capital other than deferred income
Decrease in deferred income
21,753
(4,389)
(668)
19,922
(153,312)
48,301
(1,912)
–
(12,862)
(65,722)
Cash used in operations
(145,953)
(147,899)
Interest paid
Interest received
Corporate taxes paid
(1,063)
4,558
(8)
(273)
1,341
(199)
Net cash flows used in operating activities
(142,466)
(147,030)
Purchase of property, plant and equipment
Purchase of and expenditure in intangible fixed assets
Proceeds from disposal of property, plant and equipment
Decrease in restricted cash
Acquisition of financial assets held at fair value through P&L
Proceeds from sale of financial assets held at fair value through P&L
(10,392)
(3,325)
1
–
(4,559)
2,361
(5,312)
(2,125)
7
6,510
–
372
Net cash flows used in investing activities
(15,914)
(549)
23
23
23
23
22
12
11
12
15
15
15
103
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
(thousands of €)
Repayment of obligations under finance leases and other debts
Proceeds from capital and share premium increases, gross amount
Issue costs paid related to capital and share premium increases
2018
(5)
296,188
(15,964)
Proceeds from capital and share premium increases from exercise of
warrants
7,657
5,288
Net cash flows generated in financing activities
287,876
353,357
Increase in cash and cash equivalents
129,497
205,778
2017
Notes
(65)
363,924
(15,790)
17
17
17
Cash and cash equivalents at beginning of year
1,151,211
973,241
16
Increase in cash and cash equivalents
129,497
205,778
Effect of exchange rate differences on cash and cash equivalents
10,089
(27,808)
Cash and cash equivalents at end of the year
1,290,796
1,151,211
16
104
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
Consolidated statements of changes in equity
(thousands of €)
Share capital
Share
premium
account
Translation
differences
Other
reserves
Accumul.
losses
Total
On 1 January 2017
223,928
649,135
(1,090)
(1,000)
(112,272)
758,701
Net loss
Other comprehensive loss
Total comprehensive loss
Share-based compensation
Issue of new shares
23,331
340,593
Share issue costs
(15,837)
Exercise of warrants
1,992
3,296
(664)
(664)
(260)
(260)
(115,704)
(115,704)
(924)
(115,704)
(116,629)
16,536
16,536
363,924
(15,837)
5,288
On 31 December 2017
233,414
993,025
(1,754)
(1,260)
(211,441)
1,011,983
On 1 January 2018
233,414
993,025
(1,754)
(1,260)
(211,441)
1,011,983
Change in accounting policy
(modified retrospective application
IFRS 15)
Change in accounting policy
(modified retrospective application
IFRS 9)
Restated total equity at 1 January
2018
Net loss
Other comprehensive income
Total comprehensive loss
Share-based compensation
(83,220)
(83,220)
619
(619)
–
233,414
993,025
(1,754)
(641)
(295,279)
928,766
197
197
(94)
(94)
(29,259)
(29,259)
103
(29,259)
(29,155)
26,757
26,757
296,188
(15,964)
7,657
Issue of new shares
16,021
280,167
Share issue costs
(15,964)
Exercise of warrants
3,069
4,588
On 31 December 2018
236,540
1,277,780
(1,557)
(735)
(297,779)
1,214,249
105
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
Notes to the consolidated financial statements
1. General information
Galapagos NV is a limited liability company incorporated in Belgium and has its registered office at Generaal De
Wittelaan L11 A3, 2800 Mechelen, Belgium. In the notes to the consolidated financial statements, references to
“we”, “us,” “the group” or “Galapagos” include Galapagos NV together with its subsidiaries.
R&D
The R&D operations are specialized in the discovery and development of small molecules. Our ambition is to
become a leading global biotechnology company focused on the development and commercialization of novel
medicines. Our strategy is to leverage our unique and proprietary target discovery platform, which facilitates our
discovery and development of therapies with novel modes of action.
The components of the operating result presented in the financial statements include the following companies:
Galapagos NV, Galapagos Real Estate 1 BVBA and Galapagos Real Estate 2 BVBA (Mechelen, Belgium); Galapagos
SASU (Romainville, France); Galapagos B.V. (Leiden, the Netherlands); Fidelta d.o.o. (Zagreb, Croatia); Galapagos, Inc.
and its subsidiary Xenometrix, Inc. (United States); BioFocus DPI AG and Galapagos GmbH (Basel, Switzerland); and
Galapagos Biotech Ltd. (Cambridge, UK).
Our operations had 725 employees as at 31 December 2018 working in the operating facilities in Mechelen (the
Belgian headquarters), the Netherlands, France, Croatia, the United States, United Kingdom and Switzerland.
2. Significant accounting policies
Our principal accounting policies are summarized below.
Basis of preparation and going concern assumption
The consolidated financial statements are prepared in accordance with the International Financing Reporting
Standards (IFRS), as adopted by the EU. The consolidated financial statements provide a general overview of
our activities and the results achieved. They give a true and fair view of our financial position, our financial
performance and cash flows, on a going concern basis.
New standards and interpretations applicable for the annual period beginning on
1 January 2018
▪ IFRS 9 Financial Instruments and subsequent amendments (applicable for annual periods beginning on or
after 1 January 2018)
▪ IFRS 15 Revenue from Contracts with Customers, and clarifications on this IFRS (applicable for annual periods
beginning on or after 1 January 2018)
▪ IFRIC 22 Foreign Currency Transactions and Advance Consideration (applicable for annual periods beginning
on or after 1 January 2018)
▪ Amendments to IFRS 2 Classification and Measurement of Share-based Payment Transactions (applicable for
annual periods beginning on or after 1 January 2018)
▪ Amendments to IAS 40 Transfers of Investment Property (applicable for annual periods beginning on or after
1 January 2018)
▪ Annual improvements to IFRS Standards (2014‑2016) Cycle (applicable for annual periods beginning on or after
1 January 2018)
The above new applicable standards affected the consolidated financial statements as follows:
106
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
IFRS 15 Revenue from Contracts with Customers
We adopted IFRS 15 on 1 January 2018, using the modified retrospective transition method. The adoption of the
new standard resulted in a timing difference of revenue recognition between prior accounting standards and IFRS
15. The cumulative effect of initially applying the new revenue standard was recognized as an adjustment to the
opening balance of accumulated deficit and deferred income.
To determine revenue recognition for arrangements that we determine are within the scope of IFRS 15, we
perform the following five steps: (i) identify the contract; (ii) identify the performance obligations in the contract;
(iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the
contract; (v) recognize revenue when (or as) the entity satisfies a performance obligation.
As a consequence of the adoption of the new IFRS standard on 1 January 2018, our consolidated accumulated
losses and deferred income were both increased by €83.2 million, reflecting the impact of the new standard on the
revenue recognition of the considerations received related to our ongoing license and collaboration agreements.
Differences in accounting treatment compared to the former standard were identified for (i) the milestones
payments previously received in the scope of our license and collaboration agreement for filgotinib with Gilead,
and (ii) the upfront and milestone payments received related to the license and collaboration agreement with
AbbVie for cystic fibrosis, which were fully recognized in revenue in the previous years under the former
applicable IFRS standard. The collaboration agreement with AbbVie for cystic fibrosis was modified in 2016. Under
IAS 18 this modification was accounted for as a separate contract. However, based on the contract modification
guidance under IFRS 15 we determined that the upfront payment should be recognized over the term of the
modified contract. Finally, the deferred income balance related to the license fee received from Servier in the
scope of our license and collaboration agreement in the field of osteoarthritis was fully reclassified to equity as a
consequence of the adoption of the new standard. We refer to note 5 Total revenues and other income for further
detail.
The impact of the adoption of IFRS 15 on the consolidated financial statements for the year ended 31 December
2018 is detailed in the table below and is due to changes in the accounting policy for revenue recognition
compared to prior accounting standards.
Income statement
Revenues
(thousands of €, except per share data)
Year ended 31 December 2018
Balances in
accordance with IAS
18
As reported
Effect of change
higher / lower (-)
288,836
232,800
56,036
Loss before tax
(29,209)
(85,245)
56,036
Income taxes
Net loss
Basic & diluted loss per share
Balance sheet
Deferred income
Accumulated losses
(50)
(50)
–
(29,259)
(0.56)
(85,295)
(1.64)
56,036
1.08
31 December 2018
149,801
(297,779)
122,617
(270,595)
27,184
(27,184)
107
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IFRS 9 Financial Instruments and subsequent amendments
The only financial instrument held by the group subject to change in accounting treatment following the
adoption of IFRS 9 – Financial Instruments, was the equity investment in a listed company classified as an
available-for-sale financial asset. At 31 December 2017, our balance sheet held shares of this company which were
acquired in 2016. The closing price of the share on Euronext as at the end of the year 2017 led to cumulative
fair value loss amounting to €0.6 million recognized in other comprehensive income following the accounting
treatment applied under IAS 39. Following the adoption of IFRS 9 on 1 January 2018, and considering that the
financial asset should be classified and measured at fair value, with changes in fair value recognized in profit
or loss, the cumulative fair value loss of €0.6 million previously recognized in other comprehensive income was
reclassified to accumulated losses.
Other new standards and interpretations applicable for the annual period beginning on 1 January 2018 did not
have any impact on our consolidated financial statements.
Standards and interpretations published, but not yet applicable for the annual period
beginning on 1 January 2018
▪ IFRS 16 Leases (applicable for annual periods beginning on or after 1 January 2019)
▪ IFRS 17 Insurance contracts (applicable for annual periods beginning on or after 1 January 2021, but not yet
endorsed in the EU)
▪ IFRIC 23 Uncertainty over Income Tax Treatments (applicable for annual periods beginning on or after
1 January 2019)
▪ Amendments to IFRS 9 Prepayment Features with Negative Compensation (applicable for annual periods
beginning on or after 1 January 2019)
▪ Amendments to IAS 28 Long-term Interests in Associates and Joint Ventures (applicable for annual periods
beginning on or after 1 January 2019, but not yet endorsed in the EU)
▪ Annual improvements to IFRS Standards (2015‑2017) Cycle (applicable for annual periods beginning on or after
1 January 2019, but not yet endorsed in the EU)
▪ Amendments to IAS 19 Plan Amendment, Curtailment or Settlement (applicable for annual periods
beginning on or after 1 January 2019, but not yet endorsed in the EU)
▪ Amendments to References to the Conceptual Framework in IFRS Standards (applicable for annual periods
beginning on or after 1 January 2020, but not yet endorsed in the EU)
▪ Definition of a Business (Amendments to IFRS 3) (applicable for Business Combinations for which the
acquisition date is on or after the beginning of the first annual reporting period beginning on or after
1 January 2020, but not yet endorsed in the EU)
▪ Definition of Material (Amendments to IAS 1 and IAS 8) (applicable for annual periods beginning on or after
1 January 2020, but not yet endorsed in the EU)
Standards issued but not yet effective
A number of new standards are effective for annual periods beginning on or after 1 January 2019 with earlier
adoption permitted. However we have not early adopted new or amended standards in preparing our consolidated
financial statements. Of the standards that are not yet effective, we expect IFRS 16 to have a material impact on
our financial statements in the period of initial application.
IFRS 16 Leases (applicable for annual periods beginning on or after 1 January 2019)
We are required to adopt IFRS 16 as of 1 January 2019. We will apply IFRS 16 using the modified retrospective
approach. Consequently, the cumulative effect of adopting IFRS 16 will be recognized as an adjustment to the
opening balance of retained earnings as at 1 January 2019, with no restatement of comparative figures.
We have assessed the estimated impact that the initial application of IFRS 16 will have on our consolidated
financial statements, as further described below.
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IFRS 16 introduces a single, on-balance sheet lease accounting model for lessees. A lessee recognizes a right-of-use
asset representing its right to use the underlying asset and a lease liability representing its obligation to make
lease payments.
We will use the following practical expedients permitted by the standard:
▪ Leases of low-value items
▪ Short-term leases
We will recognize new assets and liabilities for our leases of mainly buildings and cars. The nature of the expenses
related to those leases will change as we will recognize a depreciation charge for the right-of-use assets and an
interest expense on the lease liabilities. Previously we recognized operating lease expenses on a straight-line basis
over the term of the lease.
We will apply the practical expedient to grandfather the definition of a lease on transition, applying IFRS 16 to
all contracts entered into before 1 January 2019 and identified as leases in accordance with IAS 17 and IFRIC 4.
These liabilities are measured at the present value of the remaining lease payments and discounted using our
incremental borrowing rate.
In addition, we will no longer recognize provisions for onerous lease contracts, nor any provisions for termination
payments or liabilities to spread the lease expenses on a straight-line basis over the term of the contract in case
of variable or staggered lease payments.
Based on the information currently available, we estimate that we will recognize right-of-use assets and
corresponding lease liabilities of €26.3 million as of 1 January 2019.
In the statement of profit and loss for accounting year 2019, we expect a shift from lease expenses to depreciation
charges and interest cost of about €5.3 million. Operating result is expected to increase with approximately
€0.2 million offset by a higher finance cost of €0.4 million. The impact on net result is expected to be immaterial.
In the statement of cash flows for accounting year 2019, we expect a shift from cash flow from operating activities
to cash flow from financing activities of approximately €4.9 million with no impact on the net increase/(decrease)
in cash and cash equivalents.
IFRIC 23 Uncertainty over Income Tax Treatments (applicable for annual periods beginning
on or after 1 January 2019)
IFRIC 23 ‘Uncertainty over income tax treatments’ was issued in June 2017 and will be implemented by the group
as from 1 January 2019. The Interpretation clarifies that if it is considered probable that a tax Authority will accept
an uncertain tax treatment, the tax charge should be calculated on that basis. If it is not considered probable, the
effect of the uncertainty should be estimated and reflected in the tax charge. In assessing the uncertainty, it is
assumed that the tax authority will have full knowledge of all information related to the matter. We performed
an assessment of the potential impact of the new interpretation and concluded that it would not have a material
impact on our financial statements.
Consolidated reporting
The consolidated financial statements comprise the financial statements of Galapagos NV and entities controlled
by Galapagos NV. Control is achieved where Galapagos NV has the power to direct the relevant activities of
another entity so as to obtain benefits from its activities. The results of subsidiaries are included in the income
statement and statement of comprehensive income from the effective date of acquisition up to the date when
control ceases to exist. Where necessary, adjustments are made to the financial statements of subsidiaries to
ensure consistency with our accounting policies. All intra-group transactions, balances, income and expenses are
eliminated when preparing the consolidated financial statements.
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Intangible assets
Expenditure on research activities is recognized as an expense in the period in which it is incurred.
An internally generated intangible asset arising from our development activities is recognized only if all of the
following conditions are met:
▪ Technically feasible to complete the intangible asset so that it will be available for use or sale
▪ We have the intention to complete the intangible assets and use or sell it
▪ We have the ability to use or sell the intangible assets
▪ The intangible asset will generate probable future economic benefits, or indicate the existence of a market
▪ Adequate technical, financial and other resources to complete the development are available
▪ We are able to measure reliably the expenditure attributable to the intangible asset during its development
The amount capitalized as internally generated intangible assets is the sum of the development costs incurred as
of the date that the asset meets the conditions described above.
Internally generated intangible assets are amortized on a straight-line basis over their estimated useful lifes. If
the recognition criteria for accounting as an intangible asset are not met, development costs are recognized as an
expense in the period in which they are incurred.
Intellectual property, which comprises patents, licenses and rights, is measured internally at purchase cost and
is amortized on a straight-line basis over the estimated useful life as from the time they are available for use
generally on the following bases:
▪ Customer relationships: 1 – 10 years
▪ In process technology: 3 – 5 years
▪ Software & databases: 3 – 5 years
▪ Brands, licenses, patents & know-how: 5 – 15 years
In the event an asset has an indefinite life, this fact is disclosed along with the reasons for being deemed to have
an indefinite life. Intangible assets with an indefinite useful life and intangible assets which are not yet available
for use are tested for impairment annually, and whenever there is an indication that the asset might be impaired.
Property, plant and equipment
Property, plant and equipment are recognized at cost less accumulated depreciation and any impairment loss.
Depreciation is recognized so as to write off the cost of assets over their useful lives, using the straight-line
method, on the following bases:
▪ Installation & machinery: 4 – 15 years
▪ Furniture, fixtures & vehicles: 4 – 10 years
Any gain or loss incurred at the disposal of an asset is determined as the difference between the sale proceeds
and the carrying amount of the asset, and is recognized in profit or loss.
Leasehold improvements
Leasehold improvements are depreciated over the term of the lease, unless a shorter useful life is expected.
Assets held under finance lease
Assets held under finance leases are depreciated over their useful lives on the same bases as owned assets or,
where shorter, over the term of the related lease agreement.
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Financial instruments
Financial assets and financial liabilities are recognized on our balance sheet when we become a party to the
contractual provisions of the instrument. Hedging and derivatives have never been used: we do not actively
use currency derivatives to hedge planned future cash flows, nor do we make use of forward foreign exchange
contracts. Additionally, we don’t have financial debts at 31 December 2018.
(i) Financial assets
Financial assets are initially recognized either at fair value or at their transaction price. All recognized financial
assets are subsequently measured at either amortized cost or fair value under IFRS 9 on the basis of both
Galapagos' business model for managing the financial assets and the contractual cash flow characteristics of the
financial asset.
▪ a financial asset that (i) is held within a business model whose objective is to collect the contractual cash
flows and (ii) has contractual cash flows that are solely payments of principal and interest on the principal
amount outstanding is measured at amortized cost (net of any write down for impairment), unless the asset
is designated at fair value through profit or loss (FVTPL) under the fair value option;
▪ a financial asset that (i) is held within a business model whose objective is achieved both by collecting
contractual cash flows and selling financial assets and (ii) has contractual terms that give rise on specified
dates to cash flows that are solely payments of principal and interest on the principal amount outstanding,
is measured at fair value through other comprehensive income (FVTOCI), unless the asset is designated at
FVTPL under the fair value option;
▪ all other financial assets are measured at FVTPL;
A financial asset is classified as current when the cash flows expected to flow from the instrument mature within
one year.
We derecognize a financial asset when the contractual rights to the cash flows from the asset expire, or we
transfer the rights to receive the contractual cash flows on the financial asset in a transaction in which
substantially all the risks and rewards of ownership of the financial asset are transferred.
We classify non-derivative financial assets into the following categories:
▪ financial assets at fair value through profit or loss (equity instruments)
▪ financial assets at amortized cost (receivables and cash and cash equivalents).
Financial assets at fair value through profit or loss
Financial assets are designated at fair value through profit or loss if we manage such investments and make
purchase and sale decisions based on their fair value in accordance with our investment strategy. Attributable
transaction costs are recognized in profit or loss as incurred. Financial assets at fair value through profit or loss
are measured at fair value, and changes therein, which take into account any dividend income, are recognized in
profit or loss.
Equity instruments
We hold investments in equity instruments, which based on IFRS 9, are designated as financial assets at fair
value through profit or loss, which qualify for level 1 fair value measurement based upon the closing price of such
securities on Euronext at each reporting date.
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Financial assets at amortized cost
Receivables
Receivables are designated as financial assets measured at amortized costs. They are initially measured either at
fair value or at transaction price, if they do not contain a significant financing component, which is the case for
substantially all trade receivables.
All receivables are subsequently measured in the balance sheet at amortized cost, which generally corresponds to
nominal value less expected credit loss provision.
Receivables mainly comprise trade and other receivables and research and development (R&D) incentives
receivables.
The R&D incentives receivables relate to refunds resulting from R&D incentives on research and development
expenses in France and Belgium. Research and development incentives receivables are discounted over the period
until maturity date according to the appropriate discount rates.
Cash and cash equivalents
Cash and cash equivalents are financial assets measured at amortized costs and comprise cash balances and
short-term deposits with maturities of three months or less from the acquisition date that are subject to an
insignificant risk of changes in their fair value and are used by us in the management of our short-term
commitments.
Cash and cash equivalents exclude restricted cash which is presented separately in the statement of financial
position.
(ii) Financial liabilities
Financial liabilities are initially measured either at fair value or at their transaction price. Subsequent to initial
recognition, financial liabilities are measured at amortized cost.
Financial liabilities mainly comprise trade and other liabilities.
Trade and other liabilities are comprised of liabilities that are due less than one year from the balance sheet
date and are in general not interest bearing and settled on an ongoing basis during the financial year. They also
include accrued expense related to our research and development project costs.
We derecognize a financial liability when our contractual obligations are discharged, cancelled or expire.
Taxation
Income tax in the profit or loss accounts represents the sum of the current tax and deferred tax.
Current tax is the expected tax payable on the taxable profit of the year. The taxable profit of the year differs
from the profit as reported in the financial statements as it excludes items of income or expense that are taxable
or deductible in other years and it further excludes items that are never taxable or deductible. Our liability for
current tax is calculated using tax rates that have been enacted or substantively enacted by the balance sheet
date.
Deferred income tax is provided in full, using the liability-method, on temporary differences arising between the
tax bases of assets and liabilities and their carrying amounts in the financial statements. However, the deferred
income tax is not accounted for if it arises from the initial recognition of an asset or liability in a transaction
other than a business combination that at the time of the transaction affects neither accounting nor taxable
profit nor loss.
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Deferred income tax is determined using tax rates (and laws) that have been enacted or substantively enacted by
the balance sheet date and are expected to apply when the related deferred income tax asset is realized or the
deferred income tax liability is settled. Deferred tax assets are recognized to the extent that it is probable that
future taxable profit will be available against which the temporary differences can be utilized. As such, a deferred
tax asset for the carry forward of unused tax losses will be recognized to the extent that is probable that future
taxable profits will be available.
Foreign currencies
▪ Functional and presentation currency
Items included in the financial statements of each of our entities are valued using the currency of the
primary economic environment in which the entity operates. The consolidated financial statements are
presented in Euros, which is our presentation currency.
▪ Transactions and balances in foreign currency
Foreign currency transactions are translated into the functional currency using the exchange rates prevailing
at the dates of transaction. We use monthly transaction rates based on the closing exchange rates of the
foreign currencies on the last business day of the month preceding the date of the transaction. Foreign
currency gains and losses resulting from the settlement of such transactions and from the translation at
closing rates of monetary assets and liabilities denominated in foreign currencies are recognized in the
income statement.
Non-monetary assets and liabilities measured at historical cost that are denominated in foreign currencies
are translated using the exchange rate at the date of the transaction.
▪ Financial statements of foreign group companies
The results and financial position of all our entities that have a functional currency different from Euro are
translated as follows:
▪ Assets and liabilities for each balance sheet presented are translated at the closing rate at the date of
that balance sheet
▪ Income and expenses for each income statement are translated at average exchange rates
▪ All resulting cumulative exchange differences are recognized as a separate component of equity
▪ Such cumulative exchange differences are recognized in profit or loss in the period in which the foreign
operation is disposed of.
Recognition of expenses linked to clinical trial milestones
We recognize expenses specifically linked to clinical trial milestones with regard to patient recruitment and
patient treatment (i.e. completion), incurred in carrying out clinical trials, in line with actual patient recruitment
or treatment at each period end, in reference to the milestone targets for patient recruitment or treatment.
This involves the calculation of clinical trial accruals at each period end, for which an estimation of the expected
full clinical trial milestone cost is required, as well as the current stage of patient recruitment or treatment.
Clinical trials usually take place over extended time periods and typically involve a set-up phase, a recruitment
phase and a completion phase which ends upon the receipt of a final report containing full statistical analysis
of trial results. Accruals for patient recruitment and patient completion are prepared separately for each clinical
trial in progress and take into consideration the stage of completion of each trial including the number of
patients that have entered the trial and the number of patients that have been treated in the trial. In all cases,
the full cost of each trial is expensed by the time the final report is received.
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Revenue recognition
Revenues to date have consisted principally of milestones, license fees and upfront payments received in
connection with collaboration and license agreements. We also generate revenue from our fee-for-service
activities.
The revenue recognition policies can be summarized as follows:
We recognize revenue when our customer obtains control of promised goods or services, in an amount that
reflects the consideration that we expect to receive in exchange for those goods or services. To determine revenue
recognition for agreements that we determine are within the scope of IFRS 15, we perform the following five steps:
(i) identify the contract; (ii) identify the performance obligations in the contract; (iii) determine the transaction
price; (iv) allocate the transaction price to the performance obligations in the contract; (v) recognize revenue
when (or as) the entity satisfies a performance obligation.
Collaboration and license agreements with our commercial partners for research and development activities
generally include non-refundable upfront fees; costs reimbursements; milestone payments, the receipt of which
is dependent upon the achievement of certain clinical, regulatory or commercial milestones; license fees, royalties
on sales and sometimes profits sharing arrangements.
At contract inception, we assess whether the contract is in scope of IFRS 15. Then, we identify the goods and
services promised in the contract, and assess whether they should be seen as distinct performance obligations
or not. We then recognize as revenue the amount of the transaction price that is allocated to the respective
performance obligation when (or as) the performance obligation is satisfied.
License fees or upfront payments
If the license to our intellectual property is determined to be distinct from the other performance obligations
identified in the arrangement, we recognize revenues from non-refundable upfront fees allocated to the license
at the point in time the license is transferred to the customer and the customer has the right to use the license.
For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined
performance obligation to determine whether the combined performance obligation is satisfied over time or at a
point in time. If over time, revenue is then recognized based on a pattern that best reflects the transfer of control
of the service to the customer.
Milestone Payments
A milestone payment is only included in the transaction price when the achievement of the related milestone
event is highly probable (usually at the time of achievement of the milestone event). We estimate the amount
to be included in the transaction price using the most likely amount method. The transaction price is then
allocated to each performance obligation on a relative stand-alone selling price basis, for which we recognize
revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent
reporting period, we re-evaluate the probability of achievement of such milestones and any related constraint,
and, if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a
cumulative catch-up basis, which would affect revenue and earnings in the period of adjustment.
Reimbursement Income for R&D Services
Collaboration and license agreements may include reimbursement or cost sharing for research and development
services: such as outsourcing costs and payment for full-time equivalents at contractual rates. R&D services are
performed and satisfied over time given that the customer simultaneously receives and consumes the benefits
provided by us.
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Such costs reimbursements received are recognized in revenues when costs are incurred and agreed by the parties
when we are acting as a principal in the scope of our stake of the R&D activities. If the later condition is not
fulfilled, costs reimbursements are accounted for as a decrease of the related expenses.
Royalties
License and collaboration agreements include sales-based royalties, including commercial milestone payments
based on the level of sales, and the license has been deemed to be the predominant item to which the royalties
relate. Related revenue is recognized as the subsequent underlying sales occur.
Revenue recognition policies applicable to period ended 31 December 2017
The revenue recognition policies applicable to period ended 31 December 2017 can be summarized as follows:
Upfront payments
Non-refundable, upfront payments received in connection with research and development collaboration
agreements are deferred and recognized over the relevant, required periods of our involvement. The payments
and our involvement relate to a contractually defined phase of the project. At inception, management estimates
the period of our involvement as well as the cost involved in the project. Upfront payments are recognized over
the estimated period of involvement, either on a straight line basis or based on the cost incurred under the
project if such cost can be reliably estimated. Periodically we reassess the estimated time and our cost to complete
the project phase and adjust the time period over which the revenue is deferred accordingly.
Milestone payments
Research milestone payments are recognized as revenues when achieved. In addition, the payments have to be
acquired irrevocably and the milestone payment amount needs to be substantive and commensurate with the
magnitude of the related achievement. Milestone payments that are not substantive, not commensurate or that
are not irrevocable are recorded as deferred revenue. Revenue from these activities can vary significantly from
period to period due to the timing of milestones.
Reimbursement income
Cost reimbursements resulting from license and collaboration agreements with our commercial partners are
recognized as reimbursement income in revenue as the related costs are incurred and upon agreement by the
parties involved. The corresponding expenses are included in research and development expenditure.
Cost reimbursements from collaboration in which we share equally in the risks and benefits associated with
development of a specific drug with a collaboration partner are recognized as decrease of the related incurred
research and development expenditure.
Licenses
Revenues from term licenses are spread over the period to which the licenses relate, reflecting the obligation over
the term, to update content and provide ongoing maintenance. Revenues from perpetual licenses are recognized
immediately upon sale to the extent that there are no further obligations.
Royalties
Royalty revenues are recognized when we can reliably estimate such amounts and collectability is reasonably
assured. As such, we generally recognize royalty revenues in the period in which the licensees are reporting the
royalties to us through royalty reports, that is, royalty revenues are generally recognized in arrears, i.e. after the
period in which sales by the licensees occurred. Under this accounting policy, the royalty revenues we report are
not based upon our estimates and such royalty revenues are typically reported in the same period in which we
receive payment from our licensees.
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Other income
Grants and R&D incentives
As we carry out extensive research and development activities, we benefit from various grants and R&D incentives
from certain governmental agencies. These grants and R&D incentives generally aim to partly reimburse
approved expenditures incurred in our research and development efforts and are credited to the income
statement, under other income, when the relevant expenditure has been incurred and there is reasonable
assurance that the grants or R&D incentives are receivable.
Interests in joint operations
A joint operation is a joint arrangement whereby the parties that have joint control of the arrangement
have rights to the assets and obligations for the liabilities, relating to the arrangement. Joint control is the
contractually agreed sharing of control of an arrangement, which exists only when decisions about the relevant
activities require unanimous consent of the parties sharing control.
When we undertake our activities under joint operations, we as a joint operator recognize in relation to our
interest in a joint operation:
▪ Our assets, including our share of any assets held jointly
▪ Our liabilities, including our share of any liabilities incurred jointly
▪ Our revenue from the sale of our share of the output arising from the joint operation
▪ Our share of the revenue from the sale of the output by the joint operation
▪ Our expenses, including our share of any expenses incurred jointly
We account for the assets, liabilities, revenues and expenses relating to our interest in a joint operation in
accordance with IFRSs applicable to the particular assets, liabilities, revenues and expenses.
When we transact with a joint operation in which we are a joint operator (such as sale or contribution of assets),
we are considered to be concluding the transaction with the other parties to the joint operation, and gains and
losses resulting from the transactions are recognized in our consolidated financial statements only to the extent
of other parties’ interests in the joint operation.
When we transact with a joint operation in which we are a joint operator (such as purchase of assets), we do not
recognize our share of the gains and losses until we resell those assets to a third party.
Equity instruments
Equity instruments issued by us are measured by the fair value of the proceeds received, net of direct issue costs.
Employee benefits
a/ Defined contribution plans
Contributions to defined contribution pension plans are recognized as an expense in the income statement as
incurred.
b/ Defined benefit plans
For defined retirement benefit plans, the cost of providing benefits is determined using the projected unit credit
method, with actuarial valuations being carried out at the end of each annual reporting period. Re-measurement,
comprising actuarial gains and losses, the effect of the changes to the asset ceiling (if applicable) and the return
on plan assets (excluding interest), is reflected immediately in the statement of financial position with a charge or
credit recognized in other comprehensive income in the period in which they occur. Re-measurement recognized
in other comprehensive income is reflected immediately in retained earnings and will not be reclassified to profit
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or loss. Past service cost is recognized in profit or loss in the period of a plan amendment. Net interest is calculated
by applying the discount rate at the beginning of the period to the net defined benefit liability or asset. Defined
benefit costs are categorized as follows:
▪ Service cost (including current service cost, past service cost, as well as gains and losses on curtailments and
settlements)
▪ Net interest expenses or income
▪ Re-measurement
The retirement benefit obligation recognized in the consolidated statement of financial position represents the
actual deficit or surplus in our defined benefit plans. Any surplus resulting from this calculation is limited to the
present value of any economic benefits available in the form of refunds from the plans or a reduction in future
contributions to the plans. A liability for a termination benefit is recognized at the earlier of when we can no
longer withdraw the offer of the termination benefit and when we recognize any related restructuring costs.
c/ Staff bonus plan
We recognize an expense in the income statement for staff bonus plans.
d/ Management bonus plan
The executive committee members, together with other senior managers, are eligible to receive bonuses under
the Senior Management Bonus Scheme established in 2006. Pursuant to the rules of the Senior Management
Bonus Scheme, 50% of the bonus is paid immediately around year-end and the payment of the remaining 50% is
deferred for three years. The deferred 50% component is dependent on the Galapagos share price change relative
to the Next Biotech Index (which tracks Euronext-listed biotech companies). The Galapagos share price and the
Next Biotech Index at the start and end of the 3‑year period is calculated by the average price over the preceding
and last month of the 3‑year period, respectively.
▪ If the Galapagos share price change is better than or equal to the change in the Next Biotech Index, the
deferred bonus will be adjusted by the share price increase/decrease percentage and paid out
▪ If the Galapagos share price change is up to 10% worse than the change in the Next Biotech Index, 50% of
the deferred bonus will be adjusted by the share price increase/decrease percentage and paid out, and the
remainder will be forfeited
▪ If the Galapagos share price change is more than 10% worse than the change in the Next Biotech Index the
deferred bonus will be forfeited
We recognize the possible payment of the deferred component of the Senior Management Bonus Scheme within
three years at the moment that the bonus amount is determined, based on the fair value of the liability at each
reporting period. The fair value of the liability is measured by use of the Monte Carlo valuation model taking into
consideration (a) the average reference price of the Galapagos share and Next Biotech Index, (b) the average price
of the reporting period of the Galapagos share and the Next Biotech Index, (c) the simulation of the evolution
of the Galapagos share price and the Next Biotech Index based on their volatility and correlation until maturity
of the bonus, (d) the applicable discount rates at the end of the reporting period and (e) the probability of the
number of beneficiaries assumed to stay with us until maturity of the bonus. The changes in fair value are
recognized in profit or loss for the period.
Share-based payments
We grant equity-settled incentives to certain employees, directors and consultants in the form of warrants.
Equity-settled warrants are measured at fair value at the date of acceptance. The fair value determined at the
acceptance date of the warrants is expensed over time until the end of the vesting period, based on our estimate
of warrants that are expected to be exercised. Fair value is measured by use of the Black & Scholes model. The
expected life used in the model has been adjusted, based on management’s best estimate, for the effects of non-
transferability, exercise restrictions, and behavioral considerations.
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Provisions
Provisions are recognized on the balance sheet when we have a present obligation as a result of a past event; when
it is probable that an outflow of resources embodying economic benefits will be required to settle the obligations
and a reliable estimate can be made of the amount of the obligations. The amount recognized as a provision is
the best estimate of the expenditure required to settle the present obligation at the balance sheet date. If the
effect is material, provisions are determined by discounting the expected future cash flows at a pre-tax rate that
reflects current market assessments of the time value of the money and, when appropriate, the risk specific to
the liability.
Finance and operating leases
Leases are classified as finance leases whenever the terms of the lease substantially transfer all the risks and
rewards of ownership to the lessee. All other leases are classified as operating leases.
Assets held under finance leases are recognized as our assets at their fair value or, if lower, at the present value
of the minimum lease payments, each determined at the inception of the lease. The corresponding liability to
the lessor is included in the balance sheet as a finance lease obligation. The payments are divided proportionally
between the financial costs and a diminution of the outstanding balance of the obligation, so that the periodic
interest rate on the outstanding balance of the obligation would be constant. Interest is recognized in the income
statement, unless it is directly attributable to the corresponding asset, in which case it is capitalized.
Rents paid on operating leases are charged to income on a straight-line basis over the term of the relevant lease.
Benefits received and receivable as an incentive to enter into an operating lease are also spread on a straight-line
basis over the lease term.
Impairment
(i) Financial assets
The impairment loss of a financial asset measured at amortized cost is calculated based on the expected loss
model.
For trade receivables that do not contain a significant financing component (i.e. substantially all trade
receivables), the loss allowance is measured at an amount equal to lifetime expected credit losses. Those are the
expected credit losses that result from all possible default events over the expected life of those trade receivables.
Impairment losses are recognized in the consolidated income statement.
(ii) Tangible and intangible assets
At each balance sheet date, we review the carrying amount of our tangible and intangible assets to determine
whether there is any indication that those assets have suffered an impairment loss. If any such indication exists,
the recoverable amount of the asset is estimated in order to determine the extent of the impairment loss (if any).
Where the asset does not generate cash flows that are independent from other assets, we estimate the recoverable
amount of the cash-generating unit to which the asset belongs.
If the recoverable amount of an asset or cash generating unit is estimated to be less than the carrying amount,
the carrying amount of the asset is reduced to its recoverable amount. An impairment loss is recognized as an
expense immediately.
When an impairment loss subsequently reverses, the carrying amount of the asset is increased to the revised
estimate of its recoverable amount, but so that the increased carrying amount does not exceed the carrying
amount that would have been determined, had no impairment loss been recognized for the asset in prior years.
A reversal of an impairment loss resulting from a sale of a subsidiary is recognized as income. In other cases
impairment losses of goodwill are never reversed.
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FINANCIAL STATEMENTS
Net income/loss per share
Basic net income/loss per share is computed based on the weighted average number of shares outstanding
during the period. Diluted net income per share is computed based on the weighted average number of shares
outstanding including the dilutive effect of warrants, if any.
Segment reporting
Segment results include revenue and expenses directly attributable to a segment and the relevant portion of
revenue and expenses that can be allocated on a reasonable basis to a segment. Segment assets and liabilities
comprise those operating assets and liabilities that are directly attributable to the segment or can be allocated to
the segment on a reasonable basis; and do not include income tax items. We have only two segments (see note 4).
3. Critical accounting estimates and judgments
In the application of the accounting policies, we are required to make judgments, estimates and assumptions
about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The
estimates and associated assumptions are based on historical experience and other factors that are considered to
be relevant. Actual results may differ from these estimates.
Our estimates and assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are
recognized in the period in which the estimate is revised if the revision affects only that period or in the period
of the revisions and future periods if the revision affects both current and future periods.
Drafting financial statements in accordance with IFRS requires management to make judgments and estimates
and to use assumptions that influence the reported amounts of assets and liabilities, the notes on contingent
assets and liabilities on the date of the financial statements and the reported amounts of income and expenses
during the reporting period. Actual results may differ from these estimates.
The following are the critical judgments and estimates that we have made in the process of applying the
accounting policies and that have the most significant effect on the amounts recognized in the consolidated
financial statements presented elsewhere in this annual report.
Critical judgments in applying accounting policies
Revenue recognition
Evaluating the criteria for revenue recognition under license and collaboration agreements requires
management’s judgment to assess and determine the following:
▪ The nature of the contractual performance obligations and whether they are distinct or should be combined
with other performance obligations.
▪ The pattern of transfer of each promised license and/or R&D activities identified in the contract, sometimes
using input or output methods which are based on key assumptions such as forecasted costs and
development timelines of our license and collaboration agreements for the assessment of satisfaction of the
performance obligation.
The above may significantly influence our financial statements.
We applied the five step model detailed in IFRS 15 to determine when, how and at what amount revenue is to
be recognized depending on whether certain criteria are met. The positions taken in applying this standard are
detailed below.
The substance of our current arrangements is that we are licensing certain of our intellectual property to
collaboration partners and conduct research and development (“R&D”) activities. Such activities result in a service
that is the output of our ordinary activities. We generate revenue through a number of these arrangements which
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FINANCIAL STATEMENTS
include license fees, milestone payments, reimbursement income and future sales based milestones and sales
based royalties. We assessed that the revenues from our current material licensing and collaboration agreements
are in the scope of IFRS 15.
Collaboration with Gilead
We concluded as follows:
▪ There is one single performance obligation under IFRS 15: the transfer of a license combined with
performance of R&D activities. This is because we considered that the license is not distinct in the context of
the contract.
▪ The transaction price of our agreement with Gilead is currently composed of a fixed part, being an upfront
license fee and a variable part, being milestone payments and cost reimbursements for R&D activities
delivered. Milestone payments are included in the transaction price of the arrangement only when achieved.
Sales based milestones and sales based royalties are a part of our arrangement but are not yet included in
our revenues as our program is still in Phase 3 of development.
▪ The transaction price has been allocated to the single performance obligation and revenues have been
recognized over the estimated service period based on a pattern that reflects the transfer of the license
and progress to complete satisfaction of the R&D activities. This is because we considered that there is a
transformational relationship between the license and the R&D activities to be delivered.
▪ We have chosen an input model to measure the satisfaction of the single performance obligation that
considers percentage of costs incurred for this program that are completed each period (percentage of
completion method).
▪ Costs reimbursements received from Gilead are recognized in revenues when costs are incurred and agreed
by the parties as we are acting as a principal in the scope of our stake of the R&D activities of our ongoing
license and collaboration agreements.
Collaboration with AbbVie
We concluded as follows:
▪ There is one single performance obligation under IFRS 15: the transfer of a license combined with
performance of R&D activities. This is because we considered that the license is not capable of being distinct
and is not distinct in the context of the contract.
▪ The transaction price of our agreement with AbbVie is currently composed of a fixed part, being upfront
license fees, and a variable part, being milestone payments and cost reimbursements for R&D activities
delivered. Milestone payments are included in the transaction price of the arrangement only when achieved.
Sales based milestones and sales based royalties are a part of our arrangement but are not yet included in
our revenues as the program is still in Phase 1 & 2 of development.
▪ The transaction price has been allocated to the single performance obligation and revenues have been
recognized over the estimated service period based on a pattern that reflects the transfer of the license
and progress to complete satisfaction of the R&D activities. This is because we considered that there is a
transformational relationship between the license and the R&D activities to be delivered.
▪ We have chosen an input model to measure the satisfaction of the single performance obligation that
considers a percentage of costs incurred for this program that are completed each period (percentage of
completion method).
▪ Costs reimbursements received from AbbVie are recognized in revenues when costs are incurred and agreed
by the parties as we are acting as a principal in the scope of our stake of the R&D activities of our ongoing
license and collaboration agreements.
The second amended and restated collaboration agreement signed on 24 October 2018 was assessed to be a
contract modification including a change in scope and in pricing as the remaining goods or services are not
distinct and form part of the single performance obligation that was partially satisfied at the date of the
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FINANCIAL STATEMENTS
contract modification. We concluded that we must account for this second amended and restated collaboration
agreement as if it was part of the existing contract and recognized as adjustment to revenue the effect of
the contract modification on the transaction price and on the measure of progress towards satisfaction of the
performance obligation.
Collaboration with Servier
The deferred income balance as of 31 December 2017 related to the license fee received from Servier in the scope
of our license and collaboration agreement in the field of osteoarthritis (€5.4 million) was fully reclassified to
equity as a consequence of the adoption of IFRS 15. Any increase in the transaction price from future potential
development and regulatory milestones, sales based milestones and royalties, will be allocated to the license and
will be fully recognized as revenue at a point in time when achieved, as our performance obligation towards
Servier has been fully satisfied.
The contract signed with Servier on 8 May 2018 takes over the terms of the previous agreement but additionally
includes the framework of a joint Phase 2 clinical trial program in which both parties collaborate, share costs and
mutually exchange services. We concluded that this contract modification was not in the scope of IFRS 15 because
there is a mutual exchange of services between Servier and Galapago, Servier is not assessed as a customer but
as a collaboration partner. Any cost reimbursement from our collaboration partner is not recognized as revenue
but accounted as a decrease of the related expenses.
Collaboration with Novartis
We concluded as follows:
▪ There are two distinct performance obligations under IFRS 15: the transfer of a license and the performance
of R&D activities. This is because we considered that the license is capable of being distinct and is distinct in
the context of the contract.
▪ The transaction price of our agreement with Novartis is currently composed of a fixed part, being an upfront
license fee, and a variable part, being milestone payments and cost reimbursements for R&D activities
delivered. Milestone payments are included in the transaction price of the arrangement only when achieved.
Sales based milestones and sales based royalties are a part of our arrangement but are not yet included in our
revenues as our program is still in Phase 2 of development. In addition, the agreed consideration for the R&D
activities that we will still perform up until the end of the Phase 2 of clinical development was also included
in the transaction price.
▪ The transaction price has been allocated to each of the two distinct performance obligations based on our
assessment of their relative stand-alone selling price, this for the R&D activities and using the residual
approach to allocate the remainder of the transaction price to the license. Revenues are recognized at a
point in time for the transaction price allocated to the transfer of the license as we assessed that the license
confers a right to use the intellectual property to Novartis. For the transaction price allocated to the second
performance obligation, the R&D activities, revenues are recognized over the estimated service period based
on a pattern that reflects the transfer of our services to complete satisfaction of this performance obligation.
▪ We have chosen an input model to measure the satisfaction of the performance obligation of the R&D
activities that considers a percentage of costs incurred for this program that are completed each period
(percentage of completion method).
▪ Costs reimbursements received from Novartis will be recognized in revenues when costs are incurred and
agreed by the parties as we are acting as a principal in the scope of the performance of the R&D activities.
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FINANCIAL STATEMENTS
Critical accounting estimates
Share-based payments plans
We determine the costs of the share-based payments plans (our warrant plans) on the basis of the fair value of
the equity instrument at grant date. Determining the fair value assumes choosing the most suitable valuation
model for these equity instruments, for which the characteristics of the grant have a decisive influence. This
assumes also the input into the valuation model of some relevant judgments, like the estimated expected life of
the warrant and the volatility. The judgments made and the model used are further specified in note 28.
We determine the costs of the deferred component of the Senior Management Bonus Schemes on the basis of the
fair value of the liability at each reporting period. Determining the fair value assumes choosing the most suitable
valuation model for this liability, in which the characteristics of the Senior Management Bonus plans and the
Galapagos share price change relative to the Next Biotech Index have a major influence. This assumes also the
input into the valuation model of some relevant judgments, like the simulation of the evolution of the Galapagos
share price and the Next Biotech Index based on their volatility and correlation until maturity of the bonus, the
applicable discount rates at the end of the reporting period and the probability of the number of beneficiaries
assumed to stay with us until maturity of the bonus.
Corporate income taxes
Significant judgment is required in determining the use of tax loss carry forwards. Deferred tax assets arising
from unused tax losses or tax credits are only recognized to the extent that there are sufficient taxable temporary
differences or there is convincing evidence that sufficient taxable profit will be available against which the
unused tax losses or unused tax credits can be utilized. Management’s judgment is that such convincing evidence
is currently not sufficiently available except for one subsidiary operating intercompany on a cost plus basis and
our fee-for-service business and as such a deferred tax asset is therefore recognized.
At 31 December 2018, we had a total of €374.2 million of statutory tax losses carried forward which can be
compensated with future taxable statutory profits for an indefinite period except for an amount of €10.8 million
in Switzerland, Croatia and the United States with expiry date between 2019 and 2030. At 31 December 2018, the
available tax losses carried forward in Belgium amounted to €305.6 million.
As a company active in research and development in Belgium, we also expect to benefit from the “innovation
income deduction (IID)” in Belgium. The innovation income deduction regime allows net profits attributable to
revenue from among others patented products (or products for which the patent application is pending) to be
taxed at a lower rate than other revenues, i.e., 4.4% (3.75% as of 1 January 2020). The available IID carried forward
amounted to €195.4 million at 31 December 2018. It should be noted however that the Belgian corporate income
tax reform introduced as of assessment year 2019 a de facto minimum taxable base, whereby the existing tax
attributes have to be allocated into 2 so-called “baskets”: a first basket which contains the tax deductions that
can be applied without any restrictions and a second basket which contains the tax deductions that are subject
to restrictions. The first basket contains (in order of deduction) the non-taxable items (such as deductible gifts),
current year dividends received deduction (DRD), grandfathered patent income deduction (PID), current year
innovation income deduction (IID) and investment deduction. The second basket contains (in order of deduction
and subject to the restrictions as mentioned hereunder) the current year notional income deduction (NID), DRD
carry-forward, IID carry-forward, tax loss carry-forward, unlimited NID carry-forward and NID carry-forward
subject to the 7-year limitation. The taxable base can be reduced without any limitation with the deductions
contained in the first basket. Any remaining taxable basis below € 1 million can be fully compensated with
deductions contained in the second basket. If the remaining taxable basis exceeds € 1 million, the excess above
€ 1 million can only be compensated with deductions of the second basket up to 70%.
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
4. Segment information
The group holds two reportable segments, R&D and fee-for-service business.
Segment information for the year 2018
R&D Fee-for-services
Inter-segment
elimination
278,666
29,000
307,666
10,170
8,508
9
(8,508)
18,687
(8,508)
(19,734)
1,751
(thousands of €)
External revenue
Internal revenue
Other income
Revenues & other income
Segment result
Unallocated expenses(1)
Operating loss
Financial (expenses)/income
Result before tax
Income taxes
Net loss
(1) The unallocated expenses of €26,824 thousand principally comprise of €26,757 thousand of warrant costs
Segment information for the year 2017
R&D Fee-for-services
Inter-segment
elimination
118,262
28,815
147,077
8,825
5,104
15
(5,104)
13,945
(5,104)
(73,610)
86
(thousands of €)
External revenue
Internal revenue
Other income
Revenues & other income
Segment result
Unallocated expenses(1)
Operating loss
Financial (expenses)/income
Result before tax
Income taxes
Net loss
Group
288,836
–
29,009
317,845
(17,983)
(26,824)
(44,807)
15,598
(29,209)
(50)
(29,259)
Group
127,087
–
28,830
155,918
(73,524)
(16,278)
(89,802)
(25,705)
(115,507)
(198)
(115,704)
(1) The unallocated expenses of €16,278 thousand principally comprise of €16,536 thousand of warrant costs.
Segment assets and liabilities are not information being provided to management on a recurring basis. This
information is therefore not disclosed in our segment information.
Geographical information
In 2018 our operations were mainly located in Belgium, Croatia, France and the Netherlands.
In 2018 our top 10 customers represented 98.6% of the revenues. Our client base in 2018 and 2017 included nine of
the largest pharmaceutical companies in the world.
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
Following table summarizes our revenues by destination of customer:
(thousands of €)
North America
Europe
Asia Pacific
Total revenues
Year ended 31 December
2018
117.609
171.113
114
288.836
2017
82.050
45.037
–
127.087
Following table summarizes our revenues by major customers:
Gilead
North America
Europe
AbbVie
Europe
Novartis
Europe
Servier
Europe
Total revenues from major customers
Year ended 31 December
2018
2017
(thousands of €)
% (thousands of €)
%
116,640
7,793
40%
3%
80,687
63%
89,936
31%
34,049
27%
55,218
9,000
278,587
19%
3%
96%
114,736
90%
Following table summarizes our revenues by destination of our entity:
(thousands of €)
Galapagos NV (Belgium)
Galapagos SASU (France)
Fidelta d.o.o. (Croatia)
Total revenues
Year ended 31 December
2018
278.649
16
10.170
288.836
2017
118.244
18
8.825
127.087
In 2018, we held €110 million of non-current assets (€89 million in 2017) distributed as follows:
▪ Belgium: €64 million (€47 million in 2017)
▪ France: €36 million (€34 million in 2017)
▪ Croatia: €5 million (€4 million in 2017)
▪ The Netherlands: €4 million (€4 million in 2017)
The increase in non-current assets was mainly explained by the increase in non-current R&D incentives
receivables (see note 14).
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
5. Total revenues and other income
Revenues
The following table summarizes the revenues for the years ended 31 December 2018 and 2017.
(thousands of €)
Recognition of non-refundable upfront payments and license fees
Milestone payments
Reimbursement income
Other revenues
Total revenues
Year ended 31 December
2018
196,487
73,394
8,722
10,233
2017
71,971
42,950
3,273
8,893
288,836
127,087
Galapagos’ revenues for 2018 amounted to €288.8 million, compared to €127.1 million in 2017. Increased revenues
were mainly driven by (i) an upfront payment of €47.5 million from Novartis related to the MOR106 program, (ii)
increased recognition in revenue of the upfront payment and milestones related to the filgotinib program with
Gilead, (iii) revenue recognition related to the additional upfront payment of $45.0 million from AbbVie in the
scope of the restructuring of the collaboration and previous upfront payment and milestones, and (iv) the change
in accounting treatment from the adoption of IFRS 15 on 1 January 2018.
The following table summarizes the revenue recognition of upfront payments, license fees and milestone
payments for the years ended 31 December 2018 and 2017, as well as the impact of the adoption of IFRS 15. The
revenues recognized for the years ended 31 December 2018 are presented under the IFRS 15 standard as well as
under the former applicable IAS 18 standard, with a comparison to the year ended 31 December 2017 under the
former applicable IAS 18 standard.
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
IAS 18
IFRS 15
IFRS 15
IAS 18
IAS 18
IFRS 15
Deferred
income
reclassified
from
equity
following
adoption
of IFRS 15
Outstanding
balance in
deferred
income as at
1 January
2018
Outstanding
balance in
deferred
income as at
31 December
2017
Collabo-
ration
start date
Revenue
recognized,
year ended
31 December
2018
Revenue
recognized,
year ended
31 December
2018
Revenue
recognized,
year ended
31 December
2017
Outstanding
balance in
deferred
income as at
31 December
2018
(thousand of €)
Consideration Consideration
Agreement
(thousand of $) (thousand of €)
Revenue recognition of considerations received prior to 31 December 2017
Gilead
collaboration
agreement
for filgotinib
– Upfront
payment
Gilead
collaboration
agreement
for filgotinib
–
Subscription
agreement(1)
Servier
collaboration
agreement
for
osteoarthritis
– License fee
AbbVie
collaboration
agreement
for CF –
Upfront
payment
Total
upfront
payments
and license
fees:
Gilead
collaboration
agreement
for filgotinib
– Milestone
payments
AbbVie
collaboration
agreement
for CF –
Milestone
payments
Total
milestones:
Total:
300,000
275,558
January
2016
187,449
–
187,449
84,806
84,806
62,488
102,643
N.A.
39,003
January
2016
26,532
–
26,532
12,004
12,004
8,845
14,528
N.A.
6,000 June 2010
5,362
(5,362)
–
–
1,532
638
–
45,000
34,001
September
2013
–
14,872
14,872
14,140
–
–
732
219,343
9,510
228,853
110,950
98,342
71,971
117,903
70,000
64,435
January
2016
–
43,832
43,832
19,831
77,500
68,310
September
2013
–
–
219,343
29,878
29,878
28,406
73,710
83,220
73,710
302,563
48,237
159,187
–
–
–
98,342
9,354
24,001
33,596
1,471
42,950
114,921
25,472
143,375
(1) Deferred income of €39 million booked upon signing of the share subscription agreement with Gilead as required under IAS 39 Financial instruments: recognition and measurement
126
Galapagos NV • Annual Report 2018
Novartis
collaboration
agreement
for MOR106
– Upfront
payment
AbbVie
collaboration
agreement
for CF –
Upfront
payment
Total
upfront
payments
and license
fees:
Gilead
collaboration
agreement
for filgotinib
– Milestone
payments
AbbVie
collaboration
agreement
for CF –
Milestone
payments
Servier
collaboration
agreement
for
osteoarthritis
– Milestone
payment
Total
milestones:
Total:
FINANCIAL STATEMENTS
IAS 18
IFRS 15
IFRS 15
IAS 18
IAS 18
IFRS 15
Deferred
income
reclassified
from
equity
following
adoption
of IFRS 15
Outstanding
balance in
deferred
income as at
1 January
2018
Outstanding
balance in
deferred
income as at
31 December
2017
Collabo-
ration
start date
Revenue
recognized,
year ended
31 December
2018
Revenue
recognized,
year ended
31 December
2018
Revenue
recognized,
year ended
31 December
2017
Outstanding
balance in
deferred
income as at
31 December
2018
(thousand of €)
Consideration Consideration
Agreement
(thousand of $) (thousand of €)
Revenue recognition of considerations received in the year ended 31 December 2018
N.A.
47,500
September
2018
47,500
47,500
45,000
38,874
September
2013
38,037
38,037
85,537
85,537
–
837
837
15,000
12,418
January
2016
7,793
12,418
4,625
10,000
September
2013
8,548
8,364
8,548
184
N.A.
9,000 June 2010
9,000
9,000
25,157
110,694
269,881
29,966
115,503
213,845
–
4,809
5,646
149,021
–
Grand total: upfront payments and license fees and milestones
(1) Deferred income of €39 million booked upon signing of the share subscription agreement with Gilead as required under IAS 39 Financial instruments: recognition and measurement
The adoption of IFRS 15 resulted in a timing difference of revenue recognition between IAS 18 and IFRS 15
which negatively impacted the accumulated losses and increased the amount of deferred income (contract
liabilities) by an amount of €83.2 million, as shown in the table above (column “Deferred income reclassified from
equity following adoption of IFRS 15”). We elected the modified retrospective method for the transition which
foresees that prior period figures remain as reported under the previous standard and the cumulative effect
of applying IFRS 15 is recognized as an adjustment to the opening balance of equity as at the date of initial
application (1 January 2018). The IFRS 15 adoption resulted in the recognition for the year ended 31 December
2018 of €60.8 million of deferred revenues related to previously recognized upfront payments (€12.6 million) and
milestones (€48.2 million) under the former applicable standards of IAS 18.
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FINANCIAL STATEMENTS
The following table details revenue recognition approach and amounts for the years ended 31 December 2018
and 2017 by collaboration and license contract by type of revenue: upfront payments, milestone payment,
reimbursement income, and other revenues.
Disaggregation of revenues
(thousands of €)
Over time
Point in time
2018
2017 Over time
Point in time
IFRS 15
IAS 18
Recognition of non-refundable upfront
payments and license fees
Gilead collaboration agreement
for filgotinib
AbbVie collaboration agreement for CF
Novartis collaboration agreement
for MOR106
Servier collaboration agreement
for osteoarthritis
Milestone payments
Gilead collaboration agreement
for filgotinib
AbbVie collaboration agreement for CF
Servier collaboration agreement
for osteoarthritis
Reimbursement income
Novartis collaboration agreement
for MOR106
AbbVie collaboration agreement for CF
Servier collaboration agreement
for osteoarthritis
Other reimbursement income
Other revenues
Fee-for-services revenues
Other revenues
Total revenues
196,486
71,971
96,809
71,333
52,176
47,500
–
–
–
638
73,394
42,950
27,623
9,354
36,771
33,596
9,000
–
8,722
3,273
7,718
989
–
16
–
453
2,816
4
10,233
8,893
10,170
8,825
63
68
288,836
127,087
For the year ended 31 December 2018, €124.4 million related to the Gilead collaboration agreement were recognized
in revenue under IFRS 15 in function of costs incurred, applying the percentage of completion method. This
revenue recognition consisted of (i) €84.8 million related to the upfront license fee, (ii) €12.0 million related to
the deferred income triggered by the accounting treatment of the share subscription agreement under IAS
39 Financial Instruments: recognition and measurement, at the time of signing of the agreement in 2015, (iii)
€19.8 million related to milestone payments received prior to 31 December 2017, and (iv) €7.8 million related to
milestone payments received in the year 2018. The outstanding balance of deferred income from the Gilead
collaboration agreement at 31 December 2018 amounted to €145.8 million which was all reported as current
deferred income, as we expect to reach cost cap, as specified below, end of 2019.
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FINANCIAL STATEMENTS
In December 2015, we entered into a license and collaboration agreement to co-develop filgotinib with Gilead in
rheumatoid arthritis, Crohn’s disease, ulcerative colitis and other indications. We are responsible for funding 20%
of the associated global development costs of the program. We have retained certain mechanisms to give us cost
protection as filgotinib advances in clinical development. We can defer our portion of the global co-development
study costs if they exceed a predetermined level, which we expect to reach at the end of 2019, and this deferment
would be credited against future milestones, royalties or profit sharing at our option. If there are no future
amounts to be paid by Gilead, we will not be obligated to make any payments to Gilead for such deferment.
For the year ended 31 December 2018, €88.9 million income related to the AbbVie collaboration agreement were
recognized in revenue under IFRS 15 in function of costs incurred, applying the percentage of completion method.
This revenue recognition consisted of (i) €14.1 million related to the initial upfront license fee received in 2013,
(ii) €28.4 million related to milestone payments received in previous years, (iii) €8.4 million related to milestones
achieved in the year 2018 and finally (iv) €38.0 million related to the $45.0 million (€38.9 million) related to
the additional upfront payment received upon execution of the second amended and restated collaboration
agreement in October 2018.. The outstanding balance of deferred income from the AbbVie collaboration
agreement at 31 December 2018 amounted to €3.3 million, all reported as current deferred income.
On 19 July 2018, MorphoSys and Galapagos announced signing of a global exclusive license agreement with
Novartis covering the development and commercialization of the joint program MOR106, a monoclonal antibody
directed against IL-17C, which will be developed further in atopic dermatitis (AtD) and potentially other
indications. MorphoSys and Galapagos received an equal share of an upfront payment of €95 million and are
entitled to potential future milestone payments of up to approximately €850 million plus royalties up to low-
teens to low-twenties. Novartis will bear all future research, development, manufacturing and commercialization
costs related to MOR106. For the year ended 31 December 2018 the upfront payment received from Novartis of
€47.5 million related to the MOR106 program was recognized as revenue.
Finally, for the year ended December 31, 2018, a milestone payment of €9.0 million related to the collaboration
agreement for osteoarthritis with Servier, was additionally recognized in revenue.
Reimbursement income increased by €5.4 million, to €8.7 million for the year ended 31 December 2018 compared
to €3.3 million for the year ended 31 December 2017, due to higher reimbursements in relation with the MOR106
program with MorphoSys. The reimbursement of certain research and development costs for the year ended
31 December 2017 were related to our collaboration agreements with AbbVie and Servier.
Other revenues increased by €1.3 million, or 15%, to €10.2 million for the year ended 31 December 2018 compared to
€8.9 million for the year ended 31 December 2017, principally due to higher revenues from fee-for-service activities.
Other income
The following table summarizes other income for the years ended 31 December 2018 and 2017.
(thousands of €)
Grant income
Other income
Total other income
Year ended 31 December
2018
1,609
27,400
29,009
2017
1,045
27,785
28,830
Total other income was composed of grant income and other income and increased by €0.2 million, or 1%,
from €28.8 million for the year ended 31 December 2017 to €29.0 million for the year ended 31 December 2018.
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FINANCIAL STATEMENTS
Grant income increased by €0.6 million, or 54%, from €1.0 million for the year ended 31 December 2017
to €1.6 million for the year ended 31 December 2018. The majority of this grant income was related to grants from
a Flemish agency, representing approximately 95% of all reported grant income in 2018 (2017: 93%). In many cases
these carry clauses which require us to maintain a presence in the same region for a number of years and invest
according to pre-agreed budgets.
The increase in grant income was partly compensated by a decrease in other income of €0.4 million, or 1%,
from €27.8 million for the year ended 31 December 2017 to €27.4 million for the year ended 31 December 2018. Other
income was primarily composed of:
▪ Income from an innovation incentive system of the French government, which represented €9.3 million of other
income for the year ended 31 December 2018 compared to €10.3 million for the year ended 31 December 2017
▪ Income from Belgian R&D incentives with regard to incurred R&D expenses, which represented €11.3 million of
other income for the year ended 31 December 2018 compared to €11.2 million for the year ended 31 December 2017
▪ Tax rebates on payroll withholding taxes of R&D personnel in Belgium and the Netherlands, representing
€6.3 million of other income for the year ended 31 December 2018 compared to €5.3 million for the year ended
31 December 2017
6. Operating costs
Operating result has been calculated after charging (–)/crediting:
Research and development expenditure
The following table summarizes research and development expenditure for the years ended 31 December 2018 and
2017.
(thousands of €)
Personnel costs
Subcontracting
Disposables and lab fees and premises costs
Other operating expenses
Year ended 31 December
2018
(81,352)
(197,644)
(25,525)
(18,355)
2017
(59,950)
(123,054)
(22,277)
(13,221)
Total research and development expenditure
(322,875)
(218,502)
R&D expenditure increased by €104.4 million, or 48%, to €322.9 million for the year ended 31 December 2018,
from €218.5 million for the year ended 31 December 2017, reflecting the increase of our investments to advance
our partnered and proprietary R&D programs. This increase was principally due to:
▪ Increased R&D personnel costs of €21.4 million, or 36%, from €59.9 million for the year ended 31 December
2017 to €81.4 million for the year ended 31 December 2018, which was explained by an enlarged workforce and
higher warrant costs, mainly as a result of the increase of our share price
▪ Increase in subcontracting costs by €74.6 million, or 61%, from €123.1 million for the year ended 31 December
2017 to €197.6 million for the year ended 31 December 2018 mainly due to increased spending in our IPF
program and in our RA, IBD and other indications program on filgotinib
▪ Intensified spending of lab consumables was the main driver of the increase in disposables, lab fees and
premises costs of €3.2 million, or 15%, from €22.3 million for the year ended 31 December 2017 to €25.5 million
for the year ended 31 December 2018
▪ Other operating expenses increased by €5.2 million, or 39%, from €13.2 million for the year ended 31 December
2017 to €18.4 million for the year ended 31 December 2018, due to an increased headcount.
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
The table below summarizes our research and development expenditure for the years ended 31 December 2018 and 2017,
broken down by research and development expenses under alliance and own funded research and development expenses.
(thousands of €)
R&D under alliance
Galapagos funded R&D
Total R&D expenditure
Year ended 31 December
2018
(134,046)
(188,829)
(322,875)
2017
(122,663)
(95,839)
(218,502)
We track all research and development expenditures against detailed budgets and allocate them by individual
project. The table below summarizes our research and development expenditure for the years ended 31 December
2018 and 2017, broken down by program:
(thousands of €)
Filgotinib program (partnered)
CF program (partnered)
IPF program on GLPG1690 (proprietary)
OA program on GLPG1972 (partnered)
AtD program on MOR106 (partnered)
Other
Total R&D expenditure
Year ended 31 December
2018
(66,138)
(30,137)
(72,718)
(15,751)
(14,999)
(123,132)
(322,875)
2017
(53,212)
(46,192)
(16,190)
(7,317)
(8,404)
(87,187)
(218,502)
R&D expenditure under alliance increased by €11.4 million, or 9%, to €134.0 million for the year ended 31 December
2018, from €122.7 million for the year ended 31 December 2017, mainly due to increased R&D spending in our
RA, IBD and other indications program on filgotinib (partnered with Gilead). We increased our investments in
our own funded portfolio by €93.0 million, or 97%, to €188.8 million for the year ended 31 December 2018, from
€95.8 million for the year ended 31 December 2017, because of intensified research investments in our proprietary
programs primarily on our proprietary IPF program GLPG1690, and also due to increased spending on our
inflammation and fibrosis programs.
General and administrative expenses
The following table summarizes the general and administrative expenses for the years ended 31 December 2018
and 2017.
(thousands of €)
Personnel costs and directors fees
Other operating expenses
Total general and administrative expenses
Year ended 31 December
2018
(25,495)
(10,136)
(35,631)
2017
(17,756)
(6,659)
(24,415)
General and administrative expenses amounted to €24.4 million for the year ended 31 December 2017 and increased by
€11.2 million, or 46%, to €35.6 million for the year ended 31 December 2018. This increase was principally due to higher
personnel expenses, which increased by €7.7 million, or 44%, from €17.8 million for the year ended 31 December 2017
to €25.5 million for the year ended 31 December 2018, resulting from various effects, such as increased headcount and
increased costs of share-based payments plans (our warrant plans), mainly as a result of the increase of our share price.
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
Sales and marketing expenses
The following table summarizes the sales and marketing expenses for the years ended 31 December 2018 and 2017.
(thousands of €)
Personnel costs
Other operating expenses
Total sales and marketing expenses
Year ended 31 December
2018
(2,282)
(1,864)
(4,146)
2017
(2,156)
(646)
(2,803)
Sales and marketing expenses increased by €1.3 million, or 48%, from €2.8 million for the year ended 31 December 2017 to
€4.1 million for the year ended 31 December 2018. This increase was mainly due to the fact that we started to build our
commercial organization in preparation for the co-promotion activities with Gilead for filgotinib in the co-promotion
territories.
7. Staff costs
The table below summarizes the number of our employees on 31 December 2018 and 2017:
Number of employees on 31 December
Total
The average number of employees during the years 2018 and 2017 was:
Executive officers
Research and development
Corporate and support
Total
Their aggregate remuneration comprised:
(thousands of €)
Wages and salaries
Social security costs
Retirement benefit costs
Other personnel costs
Total personnel costs
2018
725
725
Year ended 31 December
2018
5
553
119
677
Year ended 31 December
2018
(61,619)
(11,003)
(2,994)
(27,375)
(102,991)
2017
600
600
2017
5
461
90
556
2017
(46,677)
(9,081)
(2,175)
(16,465)
(74,398)
The other personnel costs mainly related to costs for warrants granted of €21.3 million (2017: €11.8 million). For the
costs of warrants granted, see note 28.
132
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
8. Financial income/expenses
The following table summarizes financial income and expense for the years ended 31 December 2018 and 2017.
(thousands of €)
Financial income:
Interest on bank deposit
Effect of discounting long term R&D incentives receivables
Currency exchange gain
Fair value gain on financial assets held at fair value through profit or loss
Gain upon sale of financial assets held at fair value through profit or loss
Other finance income
Total financial income
Financial expenses:
Interest expenses
Currency exchange loss
Other finance charges
Total financial expense
Year ended 31 December
2018
2017
5,219
199
11,027
1,203
668
19
3,045
–
1,797
–
–
34
18,335
4,877
(780)
(1,174)
(782)
(2,737)
(936)
(29,176)
(469)
(30,582)
Total net financial expense (-)/income
15,598
(25,705)
Financial expenses decreased significantly by €27.8 million, from €30.6 million for the year ended 31 December
2017 to €2.7 million for the year ended 31 December 2018. The currency exchange loss in 2017 primarily related to
a currency exchange loss of €27.8 million on deposits held in U.S. dollars. Our cash and cash equivalents include
cash held in U.S. dollars, which could generate foreign currency exchange gain or loss in our financial results in
accordance with the fluctuation of the EUR/U.S. dollar exchange rate as our functional currency is EUR.
Interest expenses were related to interests on term deposits and on lease of cars.
Financial
income increased by €13.4 million,
from €4.9 million for the year ended 31 December 2017 to
€18.3 million for the year ended 31 December 2018. This increase was due to a currency exchange gain of
€10.1 million on our cash and cash equivalents held in U.S. dollar. Interest income was related to interests on term
deposits. Net exchange gain amounted to €9.9 million for the year ended 31 December 2018, compared to a net
exchange loss of €27.4 million for the year ended 31 December 2017.
For the year ended 31 December 2018, fair value gain on financial assets held at fair value through profit or
loss consisted of positive effects from the fair value re-measurement of financial assets classified as equity
investments which qualify for level 1 fair value measurement based upon the closing price of such securities at
each reporting date. The gain realized upon sale of some of those equity investments was reported in financial
income.
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FINANCIAL STATEMENTS
9. Taxes
The following table summarizes the income tax recognized in profit or loss for the years ended 31 December 2018
and 2017.
(thousands of €)
Current tax
Deferred tax
Income taxes
Year ended 31 December
2018
(584)
535
(50)
2017
(218)
20
(198)
Current tax amounted to €0.6 million for the year ended 31 December 2018 and €0.2 million for the year ended
31 December 2017, and was related to corporate income taxes for subsidiaries operating on a cost plus basis.
Deferred tax income of €0.5 million for the year ended 31 December 2018 and of €0.02 million for the year ended
31 December 2017 related to subsidiaries working on a cost plus basis and to our fee-for-service business.
Tax liabilities
The below table illustrates the tax liabilities related captions in the balance sheet as at 31 December 2018 and 2017.
(thousands of €)
Current tax payable
Total tax liabilities
31 December
2018
1,175
1,175
2017
865
865
On 31 December 2018, €1.2 million of tax liabilities were primarily related to our subsidiaries operating on a cost
plus basis.
Taxes recognized in profit or loss
For the purpose of the disclosure below corporation tax was calculated at 29.58% (2017: 34%) – which is the tax
rate applied in Belgium – on the estimated assessable profit for the year. The applied tax rate for other territorial
jurisdictions was the tax rate that is applicable in these respective territorial jurisdictions on the estimated
taxable result of the accounting year.
134
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
(thousands of €)
Loss before tax
Income tax debit / credit (-), calculated using the Belgian statutory tax rate (29.58%
in 2018, 34% in 2017) on the accounting income / loss (-) before tax (theoretical)
Tax expenses in income statement (effective)
Difference in tax expenses / income to explain
Effect of tax rates in other jurisdictions
Effect of non-taxable revenues
Effect of share-based payment expenses without tax impact
Effect of consolidation elimination without tax impact
Effect of non-tax-deductible expenses
Effect of recognition of previously non recognized deferred tax assets
Effect of tax losses (utilized) reversed
Effect of non-recognition of deferred tax assets
Effect of change in tax rates
Total explanations
Year ended 31 December
2018
(29,209)
(8,640)
50
8,690
411
(11,558)
7,530
382
945
(1,977)
(150)
13,108
–
8,690
2017
(115,507)
(39,261)
198
39,458
14
(11,277)
5,317
102
404
(414)
(763)
45,895
181
39,458
Non-taxable revenues for the years ended 31 December 2018 and 2017 were related to non-taxable subsidies and
tax credits.
135
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
10. Income/loss (–) per share
Basic income/loss (–) per share is calculated by dividing the net income/loss (–) attributable to owners of the
parent by the weighted average number of ordinary shares issued during the year. Diluted income/loss (–)
per share is calculated based on the weighted average number of shares (diluted) also considering outstanding
warrants, for which our average share price of the year was higher than the exercise price.
Loss per share
Net loss attributable to owners of the parent (thousands of €)
Year ended 31 December
2018
(29,259)
2017
(115,704)
Number of shares (thousands)
Weighted average number of shares for the purpose of basic income /
loss (-) per share
52,113
49,479
Basic loss per share (€)
(0.56)
(2.34)
Net loss attributable to owners of the parent (thousands of €)
(29,259)
(115,704)
Number of shares (thousands)
Weighted average number of shares for the purpose of diluted income /
loss (-) per share
Number of dilutive potential ordinary shares
52,113
–
49,479
–
Diluted loss per share (€)
(0.56)
(2.34)
As we reported a net loss in 2018 and 2017, the outstanding warrants (specified in note 28) have an anti-dilutive
effect rather than a dilutive effect. Consequently, basic and diluted loss per share is the same for 2018 and 2017.
136
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
In process
technology
Software &
databases
Brands, licenses,
patents & know-
how
5,561
1,500
7,061
(7,061)
–
5,561
5,561
417
1,083
(7,061)
–
1,500
–
7,185
623
(100)
(212)
7,496
1,561
(20)
74
9,111
6,182
644
(99)
(212)
6,514
681
(20)
74
7,250
982
1,862
1,523
2
1,525
1,763
(569)
2,719
1,501
8
1,509
9
(569)
949
16
1,771
Total
14,269
2,125
(100)
(212)
16,082
3,325
(7,650)
74
11,832
13,246
652
(99)
(212)
13,587
1,107
1,083
(7,650)
74
8,200
2,495
3,632
11. Intangible assets
(thousands of €)
Acquisition value
On 1 January 2017
Additions
Sales and disposals
Translation differences
On 31 December 2017
Additions
Sales and disposals
Translation differences
On 31 December 2018
Amortization and impairment
On 1 January 2017
Amortization
Sales and disposals
Translation differences
On 31 December 2017
Amortization
Impairment
Sales and disposals
Translation differences
On 31 December 2018
Carrying amount
On 31 December 2017
On 31 December 2018
The intangible assets increased by €1.1 million from €2.5 million at 31 December 2017, to €3.6 million at
31 December 2018. The amortization of €1.1 million and the impairment of €1.1 million were fully compensated by
new additions for €3.3 million.
On 31 December 2018, our balance sheet did not hold any internally generated assets capitalized as intangible
asset.
137
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
12. Property, plant and equipment
Land &
building
improvements
Installation &
machinery
Furniture,
fixtures &
vehicles
Other
tangible assets
(thousands of €)
Acquisition value
On 1 January 2017
Additions
Sales and disposals
Reclassifications
Translation differences
On 31 December 2017
Additions
Sales and disposals
Reclassifications
Translation differences
On 31 December 2018
Depreciations and impairment
On 1 January 2017
Amortization
Sales and disposals
Translation differences
On 31 December 2017
Amortization
Sales and disposals
Translation differences
On 31 December 2018
Carrying amount
On 31 December 2017
On 31 December 2018
Total
37,624
5,312
(861)
–
120
42,195
10,392
(1,311)
–
46
51,321
22,663
3,633
(855)
61
25,502
3,974
(1,310)
18
4,412
324
4,736
275
29,733
2,973
3,178
(844)
881
112
33,060
4,674
(486)
753
29
246
(17)
7
3,209
1,039
(826)
13
16
5,011
38,031
3,452
2,025
316
1
2,342
344
18,252
2,184
3,027
(838)
53
20,495
3,377
(485)
16
234
(17)
7
2,407
236
(826)
2
1,819
505
1,564
(881)
1
1,189
4,404
(766)
0
4,827
203
55
258
17
2,686
23,403
275
28,184
2,394
2,325
12,565
14,628
802
1,632
930
4,552
16,692
23,137
The property, plant and equipment increased from €16.7 million as at 31 December 2017 to €23.1 million as at
31 December 2018. This increase was mainly the result of new additions of €10.4 million, partly compensated by a
depreciation charge of €4.0 million.
There are no pledged items of property, plant and equipment. There are also no restrictions in use on any items
of property, plant and equipment.
138
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
13. Other non-current assets
Other non-current assets consisted of non-current restricted cash, financial assets held at fair value through
profit or loss, and other non-current assets.
(thousands of €)
Non-current restricted cash
Financial assets held at fair value through profit or loss
Other non-current assets
Total other non-current assets
31 December
2018
1,276
6,000
643
7,919
2017
1,158
1,754
549
3,461
Restricted cash amounted to €1.2 million on 31 December 2017, and increased to €1.3 million on 31 December
2018, due to additional bank guarantees with regard to the rental of supplementary office space for the Belgian
premises. Restricted cash on 31 December 2018 was composed of bank guarantees on real estate lease obligations
in Belgium and in the Netherlands for €0.7 million and €0.6 million respectively.
Financial assets held at fair value through profit or loss consisted of equity instruments of listed companies.
Galapagos has no restrictions on the sale of these equity instruments and the assets are not pledged under any
Galapagos’ liabilities. These instruments are designated as financial assets held at fair value through profit or loss
which qualify for level 1 fair value measurement based upon the closing price of such securities on Euronext at
each reporting date.
Fair value changes on financial assets with fair value through profit or loss are recognized directly in profit or
loss.
The table below illustrates these financial assets held at fair value through profit or loss as at 31 December 2018
and 2017.
(thousands of €)
Cost at 1 January
Acquisitions of the year
Disposals of the year
Cost at 31 December
Fair value adjustment at 1 January
Cancellation of fair value adjustment following disposal
Fair value adjustment of the year
Fair value adjustment at 31 December
Net book value at 31 December
31 December
2018
2,373
4,736
(2,291)
4,818
(619)
598
1,203
1,182
6,000
2017
2,750
–
(377)
2,373
(399)
55
(275)
(619)
1,754
139
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
14. Research and development incentives receivables
The table below illustrates the R&D incentives receivables related captions in the balance sheet as at 31 December
2018 and 2017.
(thousands of €)
Non-current R&D incentives receivables
Current R&D incentives receivables
Total R&D incentives receivables
31 December
2018
73,443
11,203
84,646
2017
64,001
11,782
75,783
Total R&D incentives receivables increased by €8.9 million compared to 31 December 2017. This increase is
explained by new R&D incentives reported in 2018 for €20.5 million (€9.2 million related to French R&D incentives
and €11.3 million related to Belgian R&D incentives), by the release of discounting profit of €0.2 million, and
less the payments received related to French R&D incentives amounting to €8.4 million and to Belgian R&D
incentives amounting to €3.4 million. The R&D incentives receivables are future expected refunds resulting from
R&D incentives on research and development expenses in France and Belgium. Non-current R&D incentives
receivables are reported at their net present value and are therefore discounted over the period until maturity
date.
The table below provides detailed information on the maturity of the non-current R&D incentives receivables
reported in our balance sheet at 31 December 2018.
Non-current R&D incentives receivables
31 December 2018
Maturity date
(thousands of €)
2020
2021
2022
2023
2024 – 2028
Total
French non-current R&D
incentives receivables – nominal
value
French non-current R&D
incentives receivables –
discounted value
Belgian non-current R&D
incentives receivables – nominal
value
Belgian non-current R&D
incentives receivables –
discounted value
Total non-current R&D incentives
receivables – nominal value
Total non-current R&D incentives
receivables – discounted value
8,959
9,674
10,226
8,959
9,674
10,226
28,859
28,859
3,398
4,009
4,863
6,663
26,355
45,288
3,398
4,009
4,863
6,663
25,650
44,583
12,358
13,683
15,089
6,663
26,355
74,148
12,358
13,683
15,089
6,663
25,650
73,443
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
15. Trade and other receivables and other current assets
(thousands of €)
Trade receivables
Prepayments
Other receivables
Trade and other receivables
Inventories
Accrued income
Deferred charges
Other current assets
31 December
2018
9,206
142
9,261
18,609
276
3,863
4,104
8,244
2017
22,133
543
5,289
27,966
279
2,584
3,825
6,688
Total trade and other receivables & other current assets
26,852
34,653
Trade and other receivables decreased by €9.4 million to €18.6 million as at 31 December 2018 compared to
€28.0 million as at 31 December 2017. This was mainly due to two milestones achieved before year end 2017 in
our CF collaboration with AbbVie which were accounted for $20 million (€ 17.0 million): respectively $10 million
(€8.6 million) for the Phase 1 trial initiation with GLPG3221 and $10 million (€8.4 million) for the Phase 1 trial
initiation with GLPG2851.
We consider that the carrying amount of trade and other receivables approximates their fair value.
The other current assets mainly included accrued income from subsidy projects and deferred charges.
On 31 December 2018, we did not have any provision for expected credit losses.
141
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
16. Cash and cash equivalents
(thousands of €)
Cash at banks
Term deposits
Money market funds
Cash on hand
31 December
2018
358,016
733,537
199,243
–
2017
288,052
713,446
149,711
3
Total cash and cash equivalents
1,290,796
1,151,211
We reported a cash position of €1,290.8 million at the end of December 2018 compared to €1,151.2 million at year-
end 2017. Net cash used in operating activities amounted to €142.5 million for the year ended 31 December 2018.
The net cash used in investing activities amounted to €15.9 million for the year ended 31 December 2018. The net
cash generated from financing activities amounted to €287.9 million for the year ended 31 December 2018, which
can mainly be attributed to the public offering in the U.S. of Galapagos shares for which the cash proceeds from
capital and share premium increases amounted to €280.2 million, net of issue costs. In addition, proceeds received
on exercise of warrants contributed to cash generated in financing activities in 2018 for an amount of €7.7 million.
Finally, €10.1 million of foreign currency exchange rate differences on our cash held in foreign currency positively
impacted the ending balance of our cash and cash equivalents.
Cash and cash equivalents comprise cash at banks, short term bank deposits and money market funds that are
readily convertible to cash and are subject to an insignificant risk of changes in value. Our cash management
strategy monitors and optimizes our liquidity position. Our cash management strategy may allow short term
deposits with an original maturity exceeding 3 months while monitoring all liquidity aspects. Cash and cash
equivalents comprised €733.5 million of term deposits which all had an original maturity longer than 3 months.
All cash and cash equivalents are available upon maximum one month notice period and without significant
penalty. Cash at banks were mainly composed of savings accounts and current accounts. We maintain our bank
deposits in highly rated financial institutions to reduce credit risk. Cash invested in highly liquid money market
funds represented €199.2 million and was aimed at meeting short-term cash commitments, while reducing the
counterparty risk of investment.
On 31 December 2018, our cash and cash equivalents included $320.5 million held in USD, which could generate a
foreign currency exchange gain or loss in our financial results in accordance with the fluctuation of the EUR/USD
exchange rate as our functional currency is EUR.
142
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
17. Share capital
The share capital of Galapagos NV, as set forth in the articles of association, reconciles to ‘share capital’ on the
balance sheet as follows:
(thousands of €)
On 1 January
Share capital increase
Costs of capital increase
Share capital on 31 December
Aggregate share capital
Costs of capital increase (accumulated)
Share capital on 31 December
31 December
2018
233,414
19,090
(15,964)
236,540
294,600
(58,060)
236,540
2017
223,928
25,323
(15,837)
233,414
275,510
(42,096)
233,414
Costs of capital increases are netted against the proceeds of capital increases, in accordance with IAS 32 Financial
instruments: disclosure and presentation.
History of share capital
The history of the share capital of Galapagos NV between 1 January 2017 and 31 December 2018 is as follows:
Date
1 January 2017
6 April 2017
21 April 2017
20 June 2017
21 September 2017
23 November 2017
31 December 2017
1 January 2018
20 March 2018
20 June 2018
Share capital
increase new
shares
(thousands of €)
Share capital
increase warrants
(thousands of €)
Number of shares
issued
(thousands
of shares)
Aggregate number
of shares after
transaction
(thousands
of shares)
Aggregate share
capital after
transaction
(thousands of €)
46,256
250,187
23,331
1,337
281
152
222
1,613
556
733
167
247
4,313
52
28
41
298
103
2,961
135
31
50,937
275,510
50,937
275,510
54,466
294,600
17 September 2018
16,021
3 October 2018
23 November 2018
31 December 2018
On 31 December 2018, Galapagos NV’s share capital amounted to €294,600 thousand, represented by 54,465,421
shares. All shares were issued, fully paid up and of the same class.
All of the share issuances listed above were for cash consideration.
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FINANCIAL STATEMENTS
The below table summarizes our capital increases for the years 2018 and 2017.
(thousands of €, except share
data)
Number of
shares Share capital
Share
premium
Share capital
and
share
premium
Average
exercise price
warrants
(in €/ warrant)
Closing share
price on date
of capital
increase
(in €/ share)
On 1 January 2018
50,936,778
233,414
993,025
1,226,439
20 March 2018:
exercise of warrants
20 June 2018:
exercise of warrants
17 September 2018:
U.S. public offering
298,184
1,613
2,311
3,924
13.16
83.72
102,801
556
781
1,337
13.01
85.00
ADSs (fully paid)
2,961,373
16,021
280,167
296,188
Underwriter discounts and
offering expenses (paid)
(15,964)
(15,964)
Total U.S. public offering
2,961,373
57
280,167
280,224
99.68
3 October 2018:
exercise of warrants
23 November 2018:
exercise of warrants
135,485
733
1,281
2,014
14.86
94.32
30,800
167
215
382
12.40
88.90
On 31 December 2018
54,465,421
236,540
1,277,780
1,514,320
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
(thousands of €, except share
data)
Number of
shares Share capital Share premium
Share capital and
share premium
On 1 January 2017
46,256,078
223,928
649,135
873,063
Average
exercise price
warrants
(in €/ warrant)
Closing
share price
on date of
capital
increase
(in €/ share)
6 April 2017:
exercise of warrants
21 April 2017:
U.S. public offering
247,070
1,337
2,697
4,034
16.33
84.60
ADSs (fully paid)
4,312,500
23,331
340,593
363,924
81.34
Underwriter discounts and
offering expenses (paid)
Offering expenses still to be
paid at 31 December 2017
Total U.S. public offering
4,312,500
(15,790)
(47)
7,494
(15,790)
(47)
340,593
348,087
20 June 2017:
exercise of warrants
21 September 2017:
exercise of warrants
23 November 2017:
exercise of warrants
52,030
281
350
632
12.14
70.66
28,100
152
116
268
9.55
84.62
41,000
222
132
354
8.63
77.53
On 31 December 2017
50,936,778
233,414
993,025
1,226,439
The board of directors is authorized for a period of five years starting from the date of publication in the Annexes
to the Belgian State Gazette of the shareholders’ resolution that granted the renewed authorization, being 31 May
2017, to increase the share capital of Galapagos NV within the framework of the authorized capital through
contributions in kind or in cash, with limitation or cancellation of the shareholders’ preferential subscription
rights. Said authorization can be renewed. The board of directors is currently not authorized to increase the share
capital after notification by the FSMA (Financial Services and Markets Authority) of a public takeover bid on
Galapagos NV’s shares.
The authorized capital as approved by the extraordinary shareholders’ meeting of 25 April 2017 amounted to
€82,561.8 thousand. As of 31 December 2018, €22,703.7 thousand of the authorized capital was used, so that an
amount of €59,858.1 thousand still remained available.
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
18. Other reserves
Actuarial and other gains or losses recognized through other comprehensive income
(thousands of €)
On 1 January
Change in accounting policy (modified retrospective application IFRS 9)
Restated other reserves at 1 January 2018
Loss on defined benefit obligation recognized through OCI
Reclassification of loss on financial asset available for sale to income statement
(after disposal)
Loss on financial asset available for sale recognized through OCI
31 December
2018
(1,260)
619
(641)
(94)
2017
(1,000)
(40)
55
(275)
Other reserves on 31 December
(735)
(1,260)
Other reserves consisted of a negative of €0.7 million, compared to a negative of €0.6 million in 2017, which
was related to the re-measurement of defined benefit obligations recognized through OCI in line with IAS19R
Employee Benefits. The negative of €0.6 million at 31 December 2017, related to the fair value adjustment on the
available-for-sale equity investment, was transferred to retained earnings following the first adoption of IFRS 9
(see note 13).
There were no tax effects applicable to the amounts included in other reserves.
Derivative financial instruments: currency derivatives
We do not actively use currency derivatives to hedge planned future cash flows. On the balance sheet date, total
notional amount of outstanding forward foreign exchange contracts that we have committed are nil (2017: nil).
On 31 December 2018 the fair value of our currency derivatives was nil (2017: nil).
See note 31 for further information on how we manage financial risks.
19. Translation differences
(thousands of €)
On 1 January
Translation differences, arisen from translating foreign activities
Translation differences on 31 December
31 December
2018
(1,754)
197
(1,557)
2017
(1,090)
(664)
(1,754)
Translation differences decreased from a negative €1.8 million at the end of December 2017 to a negative
of €1.6 million at the end of December 2018 mainly due to fluctuations of the GB pounds and the U.S. dollar
exchange rates.
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
20. Deferred tax
(thousands of €)
Recognized deferred tax assets and liabilities
Assets
Liabilities
31 December
2018
2017
2,514
1,978
Deferred tax assets unrecognized
223,377
164,079
Deferred taxes in the consolidated income statement
Tax benefit arising from previously unrecognized tax assets used to
reduce deferred tax expense (+)
Deferred tax expenses relating to change in tax rates
535
1,973
Deferred tax expenses relating to use of previously recognized deferred tax assets
(1,438)
20
414
(181)
(213)
The investment deduction of €1 million (2017: €1 million) could give rise to deferred tax assets. There is no limit
in time for the investment deduction. The amount of notional interest deduction that has been accumulated in
the past (2017: €2.6 million) could not be carried forward to 2018, the notional interest deduction of the year itself
can also not be carried forward.
The consolidated unused tax losses carried forward at 31 December 2018 amounted to €688.7 million
(2017: €567 million), €5.7 million were related to unrecognized tax losses with expiry date between 2019 and 2030.
The available statutory tax losses carried forward that can be offset against future statutory taxable profits
amounted to €374.2 million on 31 December 2018. These statutory tax losses can be compensated with future
statutory profits for an indefinite period except for an amount of €10.8 million in Switzerland, Croatia and the
United States with expiry date between 2019 and 2030. On 31 December 2018, the available tax losses carried
forward in Galapagos NV (Belgium) amounted to €305.6 million. In addition to the latter, Galapagos NV (Belgium)
also benefits from the new Belgian innovation income deduction regime which led to report, on 31 December 2018,
a supplementary carried forward tax deduction amounting to €195.4 million that can also be offset against future
statutory taxable results. It should be noted however that the Belgian corporate income tax reform introduced
as of assessment year 2019 a de facto minimum taxable base, whereby the existing tax attributes have to be
allocated into 2 so-called “baskets”: a first basket which contains the tax deductions that can be applied without
any restrictions and a second basket which contains the tax deductions that are subject to restrictions. We refer
to note 3 for more information.
We have a history of losses. Excluding the impact of possible upfront or milestone payments to be received from
collaborations, we forecast to continue incurring taxable losses in the foreseeable future as we continue to invest
in clinical and preclinical development programs and discovery platforms. Consequently, no deferred tax asset
was set up as at 31 December 2018, except for one subsidiary operating on a cost plus basis and for our fee-for-
service business, for which deferred tax assets were recognized for €2.5 million (2017: €2.0 million).
147
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
21. Trade and other liabilities
(thousands of €)
Trade and other liabilities
Other current liabilities
Other non-current liabilities
Accrued charges
Total trade and other liabilities
31 December
2018
68,038
–
1,578
890
70,506
2017
47,122
–
1,662
1,159
49,942
Our total trade and other liabilities, amounting to €70.5 million as of 31 December 2018, increased by €20.6 million
compared to the €49.9 million reported as of 31 December 2017.
The trade and other liabilities, amounting to €68.0 million as of 31 December 2018, increased by €20.9 million
compared to the €47.1 million reported as of 31 December 2017. This increase is mainly due to higher accrued trade
liabilities on 31 December 2018, reflecting the intensification of our investments in our R&D programs.
22. Deferred income
(thousands of €)
Deferred income related to contracts
Gilead collaboration agreement for filgotinib
Gilead collaboration agreement for filgotinib(1)
AbbVie collaboration for CF
Servier collaboration agreement for osteoarthritis
Deferred income related to contracts in our fee-for-service segment
Other deferred income (grants)
31 December
2018
2017
131,270
14,528
3,223
–
471
309
187,449
26,532
–
5,362
248
301
Total deferred income (long term & current)
149,801
219,892
(1) deferred income of €39 million recognized upon signing of the share subscription agreement with Gilead as required under IAS 39 Financial
instruments: recognition and measurement
Deferred income (long term and short term) amounted to €149.8 million at 31 December 2018 and decreased
by €70.1 million compared to €219.9 million as at 31 December 2017. The adoption of IFRS 15 resulted in a timing
difference of revenue recognition between IAS 18 and IFRS 15 which negatively impacted the accumulated losses
and increased the amount of deferred income (contract liabilities) by an amount of €83.2 million, as shown in the
table in note 5 ‘Total revenues and other income’ (column “Deferred income reclassified from equity following
adoption of IFRS 15”).
The outstanding deferred income balance at 31 December 2018 is all short term and included €145.8 million
deferred income related to the collaboration agreement with Gilead for filgotinib, €3.2 million deferred income
related to the collaboration agreement with AbbVie for CF, €0.5 million related to our fee-for-service segment and
€0.3 million of deferred grant income.
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
23. Note to the cash flow statement
(thousands of €)
Adjustment for non-cash transactions
Depreciation and amortization
Impairment loss
Share-based compensation expenses
Increase in retirement benefit obligations and provisions
Unrealised exchange gains /losses and non-cash other financial expenses
Fair value adjustment financial assets held at fair value through profit or loss
Total adjustment for non-cash transactions
Adjustment for items to disclose separately under operating cash flow
Interest expense
Interest income
Tax expense
Total adjustment for items to disclose separately under operating cash flow
Adjustment for items to disclose under investing and financing cash flows
Gain on sale of financial assets held at fair value through profit or loss
Total adjustment for items to disclose separately under investing and financing
cash flow
Change in working capital other than deferred income
Decrease in inventories
Increase in receivables
Increase in liabilities
Total change in working capital other than deferred income
24. Operating lease obligations
31 December
2018
2017
5,081
1,083
26,757
99
(10,063)
(1,203)
21,753
780
(5,219)
50
(4,389)
(668)
(668)
3
(76)
19,996
19,922
4,285
–
16,536
23
27,457
–
48,301
936
(3,045)
198
(1,912)
–
–
22
(27,656)
14,772
(12,862)
We entered into lease agreements primarily for offices and laboratories which qualify as operating leases.
Minimum lease payments under operating leases recognized in the income statement for the year
(thousands of €)
Total minimum lease payments under operating leases
Year ended 31 December
2018
5,340
2017
4,799
Our outstanding commitments for future minimum lease payments under operating leases are disclosed in the
note 25. Off-balance sheet arrangements.
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
25. Off-balance sheet arrangements
Contractual obligations and commitments
We entered into lease agreements for our offices and laboratories which qualify as operating leases. We also have
certain purchase commitments with CRO subcontractors and with collaboration partners principally.
On 31 December 2018, we had outstanding obligations for future minimum rent payments and purchase
commitments, which become due as follows:
(thousands of €)
Operating lease obligations
Purchase commitments
Total
27,704
Less than
1 year
4,722
199,492
106,516
Total contractual obligations & commitments
227,197
111,238
1 – 3 years
3 – 5 years
More than
5 years
10,024
52,632
62,656
6,234
40,344
46,578
6,724
–
6,724
On 31 December 2017, we had outstanding obligations for future minimum rent payments and purchase
commitments, which become due as follows:
(thousands of €)
Operating lease obligations
Purchase commitments
Total contractual obligations & commitments
Total
26,346
65,246
91,592
Less than
1 year
4,150
53,010
57,160
1 – 3 years
3 – 5 years
More than
5 years
7,820
11,233
19,053
6,010
1,002
7,012
8,366
–
8,366
In addition to the tables above, we have a contractual cost sharing obligation related to our collaboration
agreement with Gilead for filgotinib. This is disclosed in the Corporate Governance chapter of this report, under
“Agreements with major Galapagos NV shareholders”. The contractual cost sharing commitment amounted
to €74.0 million at 31 December 2018 (€129.0 million at 31 December 2017), for which we have direct purchase
commitments of €20.3 million at 31 December 2018 (€10.1 million at 31 December 2017) reflected in the tables
above.
26. Contingent assets and liabilities
On 13 March 2014, we announced the signing of a definitive agreement to sell the service division operations
to Charles River Laboratories International, Inc., or CRL, for a total consideration of up to €134 million. CRL
agreed to pay us an immediate cash consideration of €129 million. The potential earn-out of €5 million due
upon achievement of a revenue target 12 months after transaction closing was not achieved. Approximately
5% of the total consideration, including price adjustments, was being held on an escrow account. Four claims
were introduced by CRL, which have all been settled for a total amount of €1.3 million. The remaining balance
of €6.6 million was released in full, as final agreement between the parties was reached in the first quarter of 2017.
Following the divestment, we remained guarantor until early February 2017 in respect of the lease obligations
for certain U.K. premises. Finally, following common practice, we gave representations and warranties which are
capped and limited in time (since 1 April 2016, CRL can only introduce a claim covered by the Tax Deed (during a
period of 5 years), other claims related to the sale cannot be submitted anymore).
In the course of 2008, a former director of one of our subsidiaries sued for wrongful termination and seeks
damages of €1.5 million. We believe that the amount of damages claimed is unrealistically high. On 29 January
2016, the court made a 1st degree judgment, dismissing all claims in full. In appeal, the 2nd degree court instructed
the 1st degree court to conduct a new trial. On 14 December 2018, the 1st degree court again dismissed all claims
150
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
of the plaintiff. On 14 January 2019, the plaintiff lodged an appeal, which is currently pending. The timing of this
appeal procedure can however not be predicted with any degree of certainty. Considering the defense elements
provided to date, as well as the judgment of the 1st degree court of 14 December 2018, our board and management
evaluated the risk to be possible, but not likely. Accordingly, it was decided not to record any provision as the
exposure was not considered to be probable.
In December 2015, we entered into a license and collaboration agreement to co-develop filgotinib with Gilead in
rheumatoid arthritis, Crohn’s disease, ulcerative colitis and other indications. We are responsible for funding 20%
of the associated global development costs of the program. We have retained certain mechanisms to give us cost
protection as filgotinib advances in clinical development. We can defer our portion of the global co-development
study costs if they exceed a predetermined level, which we expect to reach at the end of 2019, and this deferment
would be credited against future milestones, royalties or profit sharing at our option. If there are no future
amounts to be paid by Gilead, we will not be obligated to make any payments to Gilead for such deferment.
27. Retirement benefit plans
Defined contribution plans
We operate defined contribution systems for our qualifying employees (except for Belgium and France). The assets
of the schemes are held separately from ours in designated pension plans. For defined contribution systems, we
pay contributions to publicly or privately administered pension or insurance funds. Once the contribution is paid,
we do not have any remaining obligation.
Defined benefit plans in Belgium
In view of the minimum returns guarantees, the Belgian plans are classified as defined benefit plans. As at
31 December 2017 a net defined benefit obligation of €169.4 thousand was recorded, which increased to a net
defined benefit obligation of €332.4 thousand on 31 December 2018.
Actuarial gains and losses are recognized immediately in equity, with a charge or credit to other comprehensive
income (OCI), in accordance with IAS 19R Employee Benefits. They are not recycled subsequently. Actuarial losses
of €151.9 thousand were recognized through other comprehensive income (OCI) at the end of 2018 (2017: €53.9
thousand of actuarial gains). The contributions to those plans that were due by the employer for the year ended
31 December 2018 and the year ended 31 December 2017, amounted respectively to €993.0 thousand and €964.0
thousand, of which €49.5 thousand was paid after 31 December 2018 (2017: €64.0 thousand). No contributions were
made by the employees.
The plan assets as on 31 December 2018 consisted of €3,357.5 thousand (2017: €2,554.7 thousand) individual insurance
reserves, which benefit from a weighted average guaranteed interest rate of 2.65% (2017: 2.41%).
Defined benefit plans in France
We use two defined benefit plans for the employees of our French entity. The defined benefit plans are not
supported by funds.
The chemical and pharmaceutical industry’s collective bargaining agreements require that our French entity
pays a retirement allowance depending on the seniority of the employees at the moment they retire. The benefit
obligations for these retirement allowances amounted to €2,110.1 thousand for 2018 (2017: €2,046.8 thousand). This
increase was mainly due to an increased number of participants.
Additionally, there are also seniority premiums obligations in France. The provisions for these premiums
amounted to €1,321.7 thousand on 31 December 2018 (on 31 December 2017: €1,365.7 thousand).
Total obligation included in the balance sheet related to the defined benefit plans amounted to €3,431.8 thousand
on 31 December 2018 (2017: €3,412.5 thousand).
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
Actuarial gains and losses are recognized in equity, with a charge or credit to other comprehensive income
(OCI), in accordance with IAS 19R Employee Benefits. They are not recycled subsequently. Actuarial gains of €58.5
thousand were recognized through other comprehensive income (OCI) at the end of 2018 (2017: €93.9 thousand of
actuarial losses).
Total amounts due by the group to the pension plans in 2018 were €3.0 million (2017: €2.2 million).
Obligations included in the balance sheet
(thousands of €)
Present value of funded defined benefit obligation
Plan assets
Deficit/ surplus
Present value of unfunded defined benefit obligation
Liability included in the balance sheet
The present value of the gross obligation developed as follows
(thousands of €)
Opening balance
Current service cost
Actual taxes on contributions paid
Interest cost
Benefits paid
Actuarial gains (-) or losses due to experience adjustments
Actuarial gains (-) or losses due to experience adjustments related to new financial
assumptions
Actuarial gains (-) or losses due to experience adjustments related to
new demographic assumptions
Closing balance
The fair value of the plan assets developed as follows
(thousands of €)
Opening balance
Interest income on plan assets
Actual administration costs
Contributions from employer
Actual taxes on contributions paid
Plan assets gain during the period
Closing balance
31 December
2018
3,690
(3,358)
332
3,432
3,764
2018
6,136
1,156
(99)
89
(193)
483
(420)
(30)
7,122
2018
(2,555)
(50)
4
(849)
99
(7)
2017
2,724
(2,555)
169
3,412
3,582
2017
5,308
863
(87)
87
(157)
(100)
222
–
6,136
2017
(1,788)
(41)
3
(748)
87
(68)
(3,358)
(2,555)
The fair value of the plan assets is the fair market value of the plan assets. The fair value of the plan assets was
calculated as the reduced lump sums (received from the plan administrators) actualized with the assumptions set
(discount rate and mortality tables). The total plan assets are equal to the fair value of the plan assets increased
with the financing fund.
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
Amounts recognized in profit or loss for defined benefit plans are as follows
Year ended 31 December
(thousands of €)
Current service cost
Interest cost
Interest income
Administration expenses
Revaluations of net liability / net asset
Total expense
Obligation included in the balance sheet reconciles as follows
(thousands of €)
Opening balance
Real employer contributions
Total expense recognized in the income statement
Re-measurement on the net defined benefit liability
Benefits paid
Closing balance
The most important actuarial assumptions are
(%)
Weighted average discount rate
Expected salary increase
Inflation rate
2018
1,156
89
(50)
4
(69)
1,130
2018
3,582
(849)
1,130
94
(193)
3,764
31 December
2018
1.76%
2.50%
1.90%
2017
863
87
(41)
3
14
926
2017
3,520
(748)
926
40
(157)
3,582
2017
1.48%
2.50%
1.86%
The discount rate was based on the Merrill Lynch yields for AA rated Eurozone corporate bonds (bonds with
maturity dates which correspond with the commitments). In addition to the above table, we used mortality
tables issued by Belgian and French national institutions for statistics applicable respectively for the Belgian and
the French population.
Breakdown of defined benefit obligation by type of plan participants:
(number of participants)
Active plan participants
Breakdown of defined benefit obligation by type of benefits:
(thousands of €)
Retirement and death benefits
Other post-employment benefits
31 December
2018
402
31 December
2018
5,800
1,322
2017
324
2017
4,770
1,366
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
Major categories of plan assets: fair value plan of assets:
(thousands of €)
Equity
Debt
Cash
Sensitivity analysis on weighted average discount rate: effect on gross obligation
31 December
2018
134
3,123
101
2017
153
2,402
Obligation (thousands of €)
Discount rate
Discount rate
Discount rate
Discount rate
Discount rate
Sensitivity analysis on weighted average discount rate: effect on gross obligation
Obligation (thousands of €)
Discount rate
Discount rate
Discount rate
Discount rate
Discount rate
31 December
2018
7,635
7,371
7,122
6,886
6,661
31 December
2017
6,663
6,393
6,136
5,895
5,666
1.26%
1.51%
1.76%
2.01%
2.26%
0.98%
1.23%
1.48%
1.73%
1.98%
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
28. Warrant plans
Presented below is a summary of warrant activities for the reported periods. Various warrant plans were approved
for the benefit of our employees, and for directors and independent consultants of Galapagos NV. For warrant
plans issued prior to 2011, the warrants offered to the employees and independent consultants vest according
to the following schedule: 10% of the warrants vest on the date of the grant; an additional 10% vest at the first
anniversary of the grant; an additional 20% vest at the second anniversary of the grant; an additional 20% vest at
the third anniversary of the grant; and an additional 40% vest at the end of the third calendar year following the
grant.
The warrants granted under warrant plans created from 2011 onwards vest at the end of the third calendar year
following the year of the grant, with no intermediate vesting, with the exception of the warrants granted under
Warrant Plan 2015 (B), Warrant Plan 2015 RMV, and Warrant Plan 2016 (B), which vest on the third anniversary of
the notary deed enacting the acceptance and issuance of the warrants.
The warrants offered to directors vest over a period of 36 months at a rate of 1/36th per month.
Warrants cannot be exercised before the end of the third calendar year following the year of the grant, except for
warrants granted under Warrant Plan 2015 (B), Warrant Plan 2015 RMV, and Warrant Plan 2016 (B), which become
exercisable on the third anniversary of the notary deed enacting the acceptance and issuance of the warrants.
In the event of a change of control over Galapagos NV, all outstanding warrants vest immediately and will be
immediately exercisable.
The table below sets forth a summary of warrants outstanding and exercisable at 31 December 2018, per warrant
plan:
Warrant
plan
Allocation
date
Expiry
date
Exercise
price (€)
Outstanding
per
1 January
2018
Granted
during
the year
Exercised
during
the year
Forfeited
during
the year
Expired
during
the
year
Outstanding
per
31 December
2018
Exercisable
per
31 December
2018
2005
2005
04.07.2005 03.07.2018
15.12.2005 14.12.2018
2006 BNL 28.06.2007 27.06.2020
2006 BNL 21.12.2007 20.12.2020
2007
28.06.2007 27.06.2020
2007 RMV 25.10.2007 24.10.2020
2008
2010
2011
2012
2013
2014
26.06.2008 25.06.2021
27.04.2010 26.04.2018
11.55
23.05.2011 22.05.2019
03.09.2012 02.09.2020
16.05.2013 15.05.2021
25.07.2014 24.07.2022
2014 (B)
14.10.2014 13.10.2022
2015
30.04.2015 29.04.2023
2015 (B)
22.12.2015 21.12.2023
2015 RMV 22.12.2015 21.12.2023
2016
01.06.2016 31.05.2024
2016 RMV 01.06.2016 31.05.2024
2016 (B)
20.01.2017 19.01.2025
2017
17.05.2017 16.05.2025
2017 RMV 17.05.2017 16.05.2025
2018
19.04.2018 18.04.2026
2018 RMV 19.04.2018 18.04.2026
6.91
8.60
8.65
7.12
8.65
8.65
5.60
9.95
14.19
19.38
14.54
11.93
28.75
49.00
49.00
46.10
46.10
62.50
80.57
80.57
79.88
79.88
(30,000)
(7,500)
(735)
(19,535)
(8,050)
(42,500)
(15,000)
(99,850)
(65,000)
(189,100)
(90,000)
(2,000)
(10,000)
30,000
7,500
735
1,050
48,909
32,600
77,100
42,500
52,500
209,890
260,560
536,660
150,000
517,053
399,000
97,500
514,250
120,000
150,000
595,500
127,500
1,097,745
137,500
–
–
–
1,050
29,374
24,550
77,100
–
37,500
110,040
195,560
347,560
60,000
–
–
–
1,050
29,374
24,550
77,100
–
37,500
110,040
195,560
347,560
60,000
515,053
399,000
97,500
504,250
120,000
150,000
595,500
127,500
1,097,745
137,500
Total
3,970,807 1,235,245 (567,270)
(12,000)
–
4,626,782
882,734
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
Weighted average
exercise price (€)
27.06
39.32
53.30
Warrants
3,466,407
669,704
873,000
–
(368,200)
(400)
3,970,807
763,344
1,235,245
(12,000)
(567,270)
–
4,626,782
882,734
Outstanding on 31 December, 2016
Exercisable on 31 December, 2016
Granted during the period
Forfeited during the year
Exercised during the period
Expired during the year
Outstanding on 31 December, 2017
Exercisable on 31 December, 2017
Granted during the period
Forfeited during the year
Exercised during the period
Expired during the year
Outstanding on 31 December, 2018
Exercisable on 31 December, 2018
The table below sets forth the inputs into the valuation of the warrants.
Warrant plans
Exercise Price (€)
Share price at acceptance date (€)
Fair value on the acceptance date (€)
Estimated volatility (%)
Time to expiration (years)
Risk free rate (%)
Expected dividends
2018
2018 RMV
2017
2017 RMV
19 April 2018
19 April 2018
17 May 2017
17 May 2017
79.88
84.88
38.39
39.44
8
0.51
None
79.88
84.88
38.39
39.44
8
0.51
None
80.57
68.67
26.85
40.06
8
0.33
None
80.57
68.67
26.80
40.08
8
0.29
None
The exercise price of the warrants is determined pursuant to the applicable provisions of the Belgian Companies
Code.
The estimated volatility is calculated on the basis of the historical volatility of the share price over the expected
life of the warrants, validated by reference to the volatility of a representative biotech index.
The time to expiration of the warrant is calculated as the estimated duration until exercise, taking into account
the specific features of the plans.
The warrants were accounted for in accordance with IFRS 2 Share Based Payments.
Our warrants expense in 2018 amounted to €26,757 thousand (2017: €16,536 thousand).
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FINANCIAL STATEMENTS
The following table provides an overview of the outstanding warrants per category of warrant holders at
31 December 2018 and 31 December 2017.
Category (in number of warrants)
Non-executive directors
Executive team
Other
Total warrants outstanding
31 December
2018
216,780
2,139,374
2,270,628
4,626,782
2017
216,060
2,039,374
1,715,373
3,970,807
The outstanding warrants at the end of the accounting period have an average exercise price of €53.30 (2017: €39.32)
and a weighted average remaining expected life of 1,500 days (2017: 1,441 days).
29. Related parties
Relationship and transactions with entities with (joint) control of, or significant
influence over, Galapagos
There are no shareholders or other entities who, solely or jointly, control Galapagos or exercise significant
influence over Galapagos.
Relationship and transactions with subsidiaries
Please see Note 30 for an overview of the consolidated companies of the group, which are all wholly-owned
subsidiaries of Galapagos NV.
Intercompany transactions between Galapagos NV and its subsidiaries, and amongst the subsidiaries, have been
eliminated in the consolidation and are not disclosed in this note.
Relationship and transactions with key management personnel
Our key management personnel consists of the members of our executive committee and the members of our
board of directors. All amounts mentioned in this section are based on expenses recognized in the financial
statements for the relevant financial year.
Remuneration of key management personnel
On 31 December 2018, our executive committee had five members: Mr. Onno van de Stolpe, Mr. Bart Filius, Dr. Piet
Wigerinck, Dr. Andre Hoekema and Dr. Walid Abi-Saab. On 31 December 2018, our board of directors consisted
of seven members: Mr. Onno van de Stolpe, Dr. Raj Parekh, Dr. Werner Cautreels, Mr. Howard Rowe, Ms. Katrine
Bosley, Dr. Christine Mummery and Dr. Mary Kerr. Dr. Harrold van Barlingen’s mandate as director expired
immediately after the annual shareholders’ meeting of 24 April 2018.
Only the CEO is a member of both the executive committee and the board of directors. Our CEO does not receive
any special remuneration for his board membership, as this is part of his total remuneration package in his
capacity as member of the executive committee.
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FINANCIAL STATEMENTS
The remuneration package of the members of key management personnel comprises:
Remuneration of key management personnel:
Thousands of € (except for the number of warrants)
Short-term benefits(1)
Executive committee members as a group
4,702
3,694
Year ended 31 December
2018
2017
Raj Parekh
Harrold van Barlingen(2)
Howard Rowe
Werner Cautreels
Katrine Bosley
Christine Mummery
Mary Kerr
Post-employment benefits(3)
Total benefits excluding warrants
Number of warrants granted in the year
Executive committee members as a group
Raj Parekh
Harrold van Barlingen(2)
Howard Rowe
Werner Cautreels
Katrine Bosley
Christine Mummery
Mary Kerr
Total number of warrants granted in the year
Total cost of warrants granted in the year
92
15
53
48
45
40
46
305
5,346
350,000
15,000
7,500
7,500
7,500
7,500
7,500
402,500
15,507
91
45
45
55
45
41
41
248
4,305
475,000
15,000
7,500
7,500
7,500
7,500
7,500
7,500
535,000
15,699
(1) Includes for executive committee members: salaries, employer social security contributions, other short-term benefits; includes for board
members: board fees, other short-term benefits.
(2) Dr. Van Barlingen’s director’s mandate expired on 24 April 2018.
(3) Only executive committee members are granted post-employment benefits.
Short-term employee benefits and board fees
The members of the executive committee provide their services to us on a full-time basis.
The five members of the executive committee (including the CEO) who were in function in the course of 2018 were
paid an aggregate amount of €1,920.45 thousand in remuneration and received an aggregate amount of €2,569.20
thousand in bonuses (2017: €1,638.71 thousand in remuneration and €1,908.81 thousand in bonuses). The higher
amounts in 2018 can be explained by the fact that (a) Dr. Abi-Saab was in function during the entire year in 2018,
whereas in 2017 he was in function for only 9 months, (b) the aggregate bonus amount for 2018 also includes the
deferred part of an exceptional bonus granted upon the successful Nasdaq listing in 2015, and (c) Dr. Abi-Saab’s
remuneration of 2018 includes a corrective payment relating to Swiss social security contributions. The aggregate
bonus amount for 2018 was composed of three parts: (i) an aggregate bonus of €756.80 thousand, being 50% of
the bonus for performance over 2018 (paid in January 2019), with the other 50% being deferred for 3 years, (ii)
an aggregate amount of €817.83 thousand as deferred part of the bonus for the performance over 2015 (paid in
January 2019), and (iii) an aggregate amount of €994.57 thousand as deferred part of the exceptional special bonus
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
awarded in 2015 for the successful Nasdaq listing in 2015 (paid in January 2019). The aggregate bonus amount for
2017 was composed of 2 parts: (i) an aggregate bonus of €692.06 thousand, being 50% of the bonus for performance
over 2017 (paid in January 2018), with the other 50% being deferred for 3 years, and (ii) an aggregate amount of
€1,216.75 thousand as deferred part of the bonus for performance over 2014 (paid in January 2018).
Other components of the remuneration of the executive committee members included contributions to health
insurance schemes, company cars, tax advisory services and certain fringe benefits of non-material value.
Pursuant to the decision of the annual shareholders’ meeting of 24 April 2018, Dr. Parekh received €90 thousand
(€80 thousand as chair of the board, and €10 thousand as chair of the nomination and remuneration committee),
Dr. Cautreels received €47.5 thousand (€40 thousand as non-executive director, €2.5 thousand as chair of the audit
committee until 23 April 2018, €3.75 thousand as member of the audit committee as from 23 April 2018, and €1.25
thousand as member of the nomination and remuneration committee until 20 March 2018), Mr. Rowe received
€52.5 thousand (€40 thousand as non-executive director, €1.25 thousand as member of the audit committee until
23 April 2018, €7.5 thousand as chair of the audit committee as from 23 April 2018, and €3.75 thousand as member
of the nomination and remuneration committee as from 20 March 2018), Ms. Bosley received €45 thousand
(€40 thousand as non-executive director, and €5 thousand as member of the nomination and remuneration
committee), Dr. Kerr received €43.75 thousand (€40 thousand as non-executive director, and €3.75 thousand as
member of the audit committee as from 20 March 2018), Dr. Mummery received €40 thousand as non-executive
director, and Dr. Van Barlingen received €15 thousand (€13.3 thousand as non-executive director until 24 April
2018 and €1.7 thousand as member of the audit committee until 20 March 2018). Pursuant to the decision of the
annual shareholders’ meeting of 25 April 2017, Dr. Parekh received €90 thousand (€80 thousand as chair of the
board, and €10 thousand as chair of the nomination and remuneration committee), Dr. Cautreels received €55
thousand (€40 thousand as non-executive director, €10 thousand as chair of the audit committee and €5 thousand
as member of the nomination and remuneration committee), Ms. Bosley, Mr. Rowe and Dr. Van Barlingen each
received €45 thousand (€40 thousand as non-executive director and €5 thousand as member of the nomination
and remuneration committee or audit committee) and Dr. Mummery and Dr. Kerr each received €40 thousand
as non-executive director.
Finally, in 2018, a total amount of €3.7 thousand was paid as other short-term benefit for non-executive directors
(2017: €2.7 thousand). These benefits related to the payment of tax advisory services.
Post-Employment Benefits
The post-employment benefits to the members of the executive committee are granted under separate
retirement benefit schemes,
including pension schemes, post-employment life insurance and additional
individual pension contributions.
Severance payments
The employment and management agreements of the members of the executive committee do not provide for
severance compensation. They do not contain notice periods that exceed six months. However, Galapagos entered
into undertakings with the members of the executive committee providing that, in case their contract with the
group is terminated as a result of a change of control of Galapagos NV, they would be entitled to a severance
compensation of 12 months’ base salary for the Chief Executive Officer and nine months’ base salary for the other
executive committee members.
Warrants granted in 2018
In 2018, 30,000 warrants were granted to independent directors (2017: 37,500) and 22,500 warrants were granted to
the other non-executive directors (2017: 22,500). The higher number of warrants granted in 2017 can be explained
by the fact that there was one additional independent director in 2017.
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
Other
No loans, quasi-loans or other guarantees were given by Galapagos NV or any of its subsidiaries to members of
the board and of the executive committee. We have not entered into transactions with our key management
personnel, other than as described above with respect to remuneration arrangements relating to the exercise of
their mandates as members of the executive committee and the board of directors.
30. Consolidated companies as of 31 December 2018
Name of the subsidiary
Biofocus DPI AG in liquidation
Fidelta d.o.o.
Galapagos Biotech Ltd.
Galapagos BV
Galapagos GmbH
Galapagos NV
Galapagos Real Estate 1 BVBA
Galapagos Real Estate 2 BVBA
Galapagos SASU
Galapagos, Inc.
Xenometrix, Inc.
Country
Switzerland
Croatia
United Kingdom
The Netherlands
Switzerland
Belgium
Belgium
Belgium
France
United States
United States
% voting right
Galapagos NV (directly
or indirectly through
subsidiaries)
Change in % voting
right previous period
(2018 vs 2017)
100%
100%
100%
100%
100%
Parent company
100%
100%
100%
100%
100%
100%
100%
In the fourth quarter of 2018 we incorporated two new legal entities in Mechelen, Belgium: Galapagos Real Estate
1 BVBA and Galapagos Real Estate 2 BVBA.
There are no significant restrictions on the group’s ability to access or use assets, or settle liabilities, of one of the
group’s subsidiaries.
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
31. Financial risk management
See “Risk factors” for additional details on general risk factors.
Financial risk factors
Our financial risks are managed centrally. Our finance department coordinates the access to national and
international financial markets and considers and manages continuously the financial risks concerning our
activities. These relate to the financial markets risk, credit risk, liquidity risk and currency risk. There are no
other important risks, such as interest rate risk on borrowings, because we have no financial debt and have a
strong cash position. We do not buy or trade financial instruments for speculative purposes.
Categories of financial assets and liabilities:
(thousands of €)
Financial assets held at fair value through profit or loss
Equity instruments
Financial assets at amortized cost
Cash and cash equivalents
Restricted cash (current and non-current)
Trade & other receivables ( excl prepayments)
R&D incentives receivables (current and non-current)
31 December
2018
2017
6,000
1,754
1,290,796
1,151,211
1,276
18,467
84,646
1,158
27,423
75,783
Total financial assets
1,401,184
1,257,329
Financial liabilities at amortized cost
Trade and other liabilities
Other non-current liabilities
Financial lease liabilities
Tax payable
Total financial liabilities
68,038
1,502
–
1,175
70,715
47,122
1,597
9
865
49,592
Financial assets held at fair value through profit or loss
Financial assets held at fair value through profit or loss consisted of equity instruments of listed companies.
Galapagos has no restrictions on the sale of these equity instruments and the assets are not pledged under any
Galapagos’ liabilities. These instruments are classified as financial assets held at fair value through profit or loss
which qualify for level 1 fair value measurement based upon the closing price of such securities on Euronext at
each reporting date.
The market price of those shares might face fluctuations and might be affected by a variety of factors, such as
the global economic situation, the business development of competitors, sector mergers and acquisitions; it is
difficult to mitigate this risk.
Liquidity risk
Our cash and cash equivalents amounted to €1,290.8 million on 31 December 2018. Cash used in operating
activities amounted to €142.5 million for the year ended 31 December 2018. Management forecasts our liquidity
requirements to ensure that we have sufficient cash to meet operational needs. Based upon our current expected
level of operating expenditures and our existing cash and cash equivalents, we believe that we will be able to fund
our operating expenses and capital expenditure requirements at least for the next three years. We have no credit
161
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
lines. Such forecasting is based on realistic assumptions with regards to milestone and upfront payments to be
received, taking into account our past track record, including the assumption that not all new projects that are
being planned will be realized.
Credit risk
The term “credit risk” refers to the risk that counterparty will default on its contractual obligations resulting in
financial loss for us.
The trade receivables consist of a limited amount of creditworthy customers, many of which are large
pharmaceutical companies, spread over different geographical areas. To limit the risk of financial losses, we have
developed a policy of only dealing with creditworthy counterparties.
We grant credit to our clients in the framework of our normal business activities. Usually, we require no
pledge or other collateral to cover the amounts due. Management continuously evaluates the client portfolio for
creditworthiness. All our receivables are considered collectable.
We applied the IFRS 9 simplified approach to measuring expected credit losses which uses a lifetime expected loss
allowance for all receivables. To measure the expected credit losses, receivables have been grouped based on credit
risk characteristics and the days past due. The provision for expected credit losses was not significant given that
there have been no credit losses over the last three years and the high quality nature of our customers.
Aging balance of receivables that are due, but that are still considered collectable:
(thousands of €)
60 - 90 days
90 - 120 days
more than 120 days
31 December
2018
236
12
2017
-
1
-
Our cash and cash equivalents are invested primarily in saving and deposit accounts. For banks and financial
institutions, only independently rated parties with a minimum rating of ‘A’ are accepted at the beginning of the
term.
Interest rate risk
The only variable interest-bearing financial instruments are cash and cash equivalents. Changes in interest
rates may cause variations in interest income and expenses resulting from short-term interest-bearing assets.
Management does not expect the short-term interest rates to decrease significantly in the immediate foreseeable
future, which limits the interest exposure on our cash and cash equivalents.
Effect of interest rate fluctuation
A 100 basis points increase in interest rates at balance sheet date would have increased profit and loss, and
equity, by approximately €12.9 million (2017: €11.5 million); a 100 basis points decrease in interest rates would have
decreased profit and loss, and equity, by approximately €12.9 million (2017: €11.5 million).
Foreign exchange risk
We are exposed to foreign exchange risk arising from various currency exposures. Our principal functional
currency is euro, but we receive payments from our main collaboration partners AbbVie and Gilead in U.S. dollars
and acquire some consumables and materials in U.S. dollars, Swiss francs, GB pounds and Croatian kuna.
To limit this risk, we attempt to align incoming and outgoing cash flows in currencies other than EUR. In
addition, contracts closed by our different entities are mainly in the functional currencies of that entity, except
for the alliance agreements signed with AbbVie and Gilead for which payments are denominated in U.S. dollars.
162
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
The exchange rate risk in case of a 10% change in the exchange rate amounts to:
(thousands of €)
Net book value
Increase in Euros – U.S. Dollars
Increase in Euros – GB Pounds
Increase in Euros – CH Francs
Increase in Euros – HR Kunas
Increase in U.S. Dollars – GB Pounds
Year ended 31 December
2018
2017
(27,200)
(21,083)
100
208
611
(923)
122
203
(185)
(831)
The exchange rate risk on the U.S. dollar is primarily related to our cash and cash equivalents held in U.S. dollars.
Capital risk factors
We manage our capital to safeguard that we will be able to continue as a going concern. At the same time, we
want to ensure the return to our shareholders through the results from our research and development activities.
Our capital structure consists of cash at bank and in hand and cash equivalents, financial debt (which we
currently don’t have: as of 31 December 2018, we have no financial debt ), and equity attributed to the holders of
our equity instruments, such as capital, reserves and results carried forward, as mentioned in the consolidated
statement of changes in equity.
We manage our capital structure and make the necessary adjustments in the light of changes of economic
circumstances, the risk characteristics of underlying assets and the projected cash needs of the current research
and development activities.
The adequacy of the capital structure will depend on many factors, including scientific progress in the research
and development programs, the magnitude of those programs, the commitments to existing and new clinical
CROs, the ability to establish new alliance or collaboration agreements, the capital expenditures, the new
commercial activities, market developments and any future acquisition.
Neither Galapagos NV nor any of its subsidiaries are subject to any externally imposed capital requirements, other
than those imposed by generally applicable company law requirements.
32. Statutory auditor’s remuneration
The statutory auditor’s fees for carrying out his mandate at group level amounted to €414.6 thousand in 2018
(2017: €310.0 thousand). The fees for audit-related services executed by the statutory auditor, in particular other
assurance engagements primarily related to the performance of the audit or review of the company’s financial
statements, amounted to €92.1 thousand in 2018 (2017: €90.8 thousand), of which €12.8 thousand related to legal
assignments (2017: €13.0 thousand). Fees for persons related to the statutory auditor for carrying out an auditor’s
mandate at group level amounted to €27.5 thousand in 2018 (2017: €40.0 thousand). Other fees related to non-audit
fees, in particular IT consulting fees, amounted to €134.8 thousand for the year 2018 (2017: €40.5 thousand). The
audit committee and the board of directors are of the opinion that these non-audit services do not affect the
independence of the statutory auditor in the performance of his audit. The abovementioned additional fees were
fully approved by the audit committee in accordance with article 133 §6 of the Belgian Companies Code.
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
33. Events after balance sheet date
On 20 March 2019, 149,370 warrants were exercised (with an average exercise price of €23.30 per warrant), of which
15,000 warrants were exercised by our CEO, 50,000 warrants by other members of our executive committee, and
11,280 warrants by other members of our board of directors. This resulted in a share capital increase (including
issuance premium) of €3,480,747.50 and the issuance of 149,370 new ordinary shares. The closing price of our share
on 20 March 2019 was €90.32.
Our consolidated financial statements were approved by the board of directors and authorized for publication, on
26 March 2019. They were signed on behalf of the board of directors by:
(signed)
Onno van de Stolpe
Managing Director and CEO
26 March 2019
164
Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
Non-consolidated financial statements
Statement of profit and loss
(thousands of €)
Turnover
Internally generated intangible assets
Other operating income
Year ended 31 December
2018
2017
218,961
284,964
9,224
131,496
198,401
20,753
Operating income
513,149
350,649
Raw materials, consumables and goods for resale
Services and other goods
Remuneration, social security costs and pensions
Depreciation, impairment and other amounts written off on constitution costs,
intangible and tangible assets
Other operating charges
Non-recurring operating costs
Operating loss
Finance income
Finance cost
Loss before taxes
Taxes
Loss for the year
(6,215)
(299,814)
(33,400)
(4,763)
(201,196)
(24,770)
(305,723)
(251,434)
(8,281)
(1,160)
(7,718)
(543)
(141,443)
(139,775)
35,743
(21,275)
8,357
(34,421)
(126,976)
(165,839)
11,286
(34)
(115,690)
(165,874)
Loss brought forward
(343,858)
(177,984)
Accumulated losses to be carried forward
(459,547)
(343,858)
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
Balance sheet
(thousands of €)
Assets
Non-current assets
Intangible fixed assets
Tangible fixed assets
Financial fixed assets
Current assets
Inventories
Trade and other receivables
Deferred costs
Accrued income
Cash and cash equivalents
Total assets
Equity and liabilities
Equity
Share capital and reserves
Share premium account
Accumulated losses
Investment grants
Liabilities
Non-current liabilities
Other liabilities
Current liabilities
Trade and other payables
Obligations under finance lease (current)
Tax, payroll and social security liabilities
Accrued costs
Deferred income
Total equity and liabilities
31 December
2018
2017
67,704
5,576
8,958
53,170
66,148
20,904
5,551
39,693
1,358,360
1,220,685
266
79,260
2,406
2,457
1,273,970
1,426,064
1,172,722
294,600
1,337,670
(459,547)
–
267
32,098
1,168
41,376
1,145,775
1,286,833
985,031
275,510
1,052,915
(343,858)
464
253,341
301,802
857
857
252,484
137,120
–
6,406
766
897
897
300,905
94,665
9
6,168
1,084
108,192
198,977
1,426,064
1,286,833
The non-consolidated annual accounts of Galapagos NV were prepared in accordance with Belgian accounting
rules as well as with the legal and regulatory requirements. They show a negative result. The financial year 2018
closed with a loss of €115.7 million compared to a loss of €165.9 million in 2017. Overall, the result of Galapagos NV
is affected by the fact that, as from financial year 2010, Galapagos NV capitalizes some of its R&D expenses and
revenues that are eligible for such capitalization under Belgian GAAP. This capitalization negatively impacted the
net result of Galapagos NV by €1.1 million in 2018, compared to a negative impact of €17.4 million in 2017. The
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Galapagos NV • Annual Report 2018
FINANCIAL STATEMENTS
non-consolidated annual accounts of Galapagos NV show accumulated losses of €459.5 million as at 31 December
2018; we refer to the Going Concern Statement for justification for the application of the valuation rules under
the going concern assumption.
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Galapagos NV • Annual Report 2018
REPORT OF THE STATUTORY AUDITOR
Report of the statutory auditor
Statutory auditor’s report to the shareholders’ meeting of Galapagos
NV for the year ended 31 December 2018 – Consolidated financial
statements
The original text of this report is in Dutch
In the context of the statutory audit of the consolidated financial statements of Galapagos NV (“the company”)
and its subsidiaries (jointly “the group”), we hereby submit our statutory audit report. This report includes our
report on the consolidated financial statements and the other legal and regulatory requirements. These parts
should be considered as integral to the report.
We were appointed in our capacity as statutory auditor by the shareholders’ meeting of 25 April 2017, in
accordance with the proposal of the board of directors issued upon recommendation of the audit committee. Our
mandate will expire on the date of the shareholders’ meeting deliberating on the financial statements for the
year ending 31 December 2019. We have performed the statutory audit of the consolidated financial statements of
Galapagos NV for 13 consecutive years. We are the statutory auditor of Galapagos NV for 19 consecutive years.
Report on the consolidated financial statements
Unqualified opinion
We have audited the consolidated financial statements of the group, which comprise the consolidated statement
of financial position as at 31 December 2018, the consolidated statement of comprehensive income, the
consolidated statement of changes in equity and the consolidated statement of cash flow for the year then
ended, as well as the summary of significant accounting policies and other explanatory notes. The consolidated
statement of financial position shows total assets of 1 439 496 (000) EUR and the consolidated statement of
comprehensive income shows a loss for the year then ended of 29 155 (000) EUR.
In our opinion, the consolidated financial statements give a true and fair view of the group’s net equity and
financial position as of 31 December 2018 and of its consolidated results and its consolidated cash flow for the year
then ended, in accordance with International Financial Reporting Standards (IFRS) as adopted by the European
Union and with the legal and regulatory requirements applicable in Belgium.
Basis for the unqualified opinion
We conducted our audit in accordance with International Standards on Auditing (ISA), as applicable in Belgium.
In addition, we have applied the International Standards on Auditing approved by the IAASB applicable to the
current financial year, but not yet approved at national level. Our responsibilities under those standards are
further described in the “Responsibilities of the statutory auditor for the audit of the consolidated financial
statements” section of our report. We have complied with all ethical requirements relevant to the statutory audit
of consolidated financial statements in Belgium, including those regarding independence.
We have obtained from the board of directors and the company’s officials the explanations and information
necessary for performing our audit.
We believe that the audit evidence obtained is sufficient and appropriate to provide a basis for our opinion.
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Key audit matters
Key audit matters are those matters that, in our professional judgment, were of most significance in our audit
of the consolidated financial statements of the current period. These matters were addressed in the context of
our audit of the consolidated financial statements as a whole and in forming our opinion thereon, and we do not
provide a separate opinion on these matters.
Key audit matters
Revenue recognition for R&D license and collaboration agreements
Revenue for the year ended December 31, 2018 amounts to 289 million EUR, of which 279 million EUR relates
to revenue from R&D license and collaboration agreements. These R&D license and collaboration agreements
include multiple promises with consideration in the form of upfront payments, developmental milestone
payments, reimbursement income, sales-based milestones and royalties. Management has performed a detailed
assessment of all R&D license and collaboration agreements to determine the proper revenue accounting
treatment under IFRS 15. The determination of revenue recognition for these contracts is complex and required
significant management judgment in the following areas:
▪ Determination of whether the R&D license and collaboration agreement and any subsequent amendment
was within the scope of IFRS 15 and whether the agreement should be considered by itself or together with
other agreements entered into at or near the same time with the same customer.
▪ Identification of the distinct performance obligations.
▪ Determination of the transaction price, taking into account the variable consideration components.
▪ Allocation of the transaction price to the distinct performance obligations.
▪ Determination of whether the performance obligations were met at a point in time or over time.
▪ Appropriateness of the measurement method used to determine the amount of revenue recognized for
performance obligations recognized over time.
How our audit addressed the key audit matters
Our audit procedures to address all relevant assumptions for revenue recognition included the following:
▪ We tested the effectiveness of controls over the determination of the revenue accounting treatment for new
and existing R&D license and collaboration agreements that were evaluated by management under IFRS 15.
▪ We read all R&D license and collaboration agreements and management’s accounting position papers to
understand the terms of each contract and evaluate management’s conclusions.
▪ We tested the accuracy of the adjustment recorded on January 1, 2018 to reflect the cumulative effect of
the adoption of IFRS 15 under the modified retrospective approach by recalculating the adjustment and
comparing the inputs to the accounting conclusions taken by management in their position papers.
In relation to management’s critical judgments in the determination of revenue recognition for each R&D license
and collaboration agreement, our audit procedures included the following, among others:
Determination of whether contracts were in the scope of IFRS 15
▪ We read the key terms of each contract to understand the nature of the R&D license and collaborations
agreements and the responsibilities of each party in the contract. We consulted with our IFRS specialists to
evaluate whether the collaboration agreements were within the scope of IFRS 15.
Identification of distinct performance obligations
▪ We tested management’s identification of distinct performance obligations by evaluating whether the
underlying license, services, or both were highly interdependent and interrelated. We read minutes of
steering committees meetings and management’s position papers to understand the customer’s intended use
of the licenses and R&D services in each collaboration.
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Determination of the transaction price, including variable consideration
▪ We compared the transaction prices to the consideration expected to be received based on current rights
and obligations specified in the R&D license and collaboration agreements and any modifications that were
agreed upon with the customers. We considered industry practice in the determination of the most likely
amount of any variable consideration.
Allocation of the transaction price to distinct performance obligations
▪ To the extent an R&D license and collaboration agreement did not represent a single distinct performance
obligation, we tested the allocation of the transaction price to each distinct performance obligation by
comparing the relative standalone selling prices to the selling prices of similar R&D services. This involved a
comparison against internal R&D rates as well as observable market prices.
Determination of point in time vs. over time revenue recognition
▪ We read the terms and conditions of each R&D license and collaboration agreement and consulted with our
IFRS specialists to assess whether continuous transfer of control to the customer occurred as progress was
made toward fulfilling each identified performance obligation.
Appropriateness of the measurement method used to determine revenue recognized over time
▪ We evaluated management’s use of an input model based on percentage of costs incurred to determine
revenue recognition by comparing actual costs incurred to development plans and budgets in order to
assess whether the percentage of completion method represents the progress made towards fulfilling the
performance obligation.
▪ We tested the progress of each R&D license and collaboration agreement and the corresponding revenue
recognized as of December 31, 2018 by interviewing project and finance management, reading minutes of
steering committees, and analyzing project management reporting.
Responsibilities of the board of directors for the preparation of the consolidated
financial statements
The board of directors is responsible for the preparation and fair presentation of the consolidated financial
statements in accordance with International Financial Reporting Standards (IFRS) as adopted by the European
Union and with the legal and regulatory requirements applicable in Belgium and for such internal control as the
board of directors determines is necessary to enable the preparation of consolidated financial statements that
are free from material misstatement, whether due to fraud or error.
In preparing the consolidated financial statements, the board of directors is responsible for assessing the group’s
ability to continue as a going concern, disclosing, as applicable, matters to be considered for going concern and
using the going concern basis of accounting unless the board of directors either intends to liquidate the group or
to cease operations, or has no other realistic alternative but to do so.
Responsibilities of the statutory auditor for the audit of the consolidated financial
statements
Our objectives are to obtain reasonable assurance about whether the consolidated financial statements as a whole
are free from material misstatement, whether due to fraud or error, and to issue a statutory auditor’s report
that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit
conducted in accordance with ISA will always detect a material misstatement when it exists. Misstatements can
arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably
be expected to influence the economic decisions of users taken on the basis of these consolidated financial
statements.
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During the performance of our audit, we comply with the legal, regulatory and normative framework as
applicable to the audit of consolidated financial statements in Belgium.
As part of an audit in accordance with ISA, we exercise professional judgment and maintain professional
skepticism throughout the audit. We also:
▪ identify and assess the risks of material misstatement of the consolidated financial statements, whether due
to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence
that is sufficient and appropriate to provide a basis for our opinion. The risk of not detecting a material
misstatement resulting from fraud is higher than for one resulting from an error, as fraud may involve
collusion, forgery, intentional omissions, misrepresentations, or the override of internal control;
▪ obtain an understanding of internal control relevant to the audit in order to design audit procedures that
are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness
of the group’s internal control;
▪ evaluate the appropriateness of accounting policies used and the reasonableness of accounting estimates and
related disclosures made by the board of directors;
▪ conclude on the appropriateness of management’s use of the going concern basis of accounting and, based
on the audit evidence obtained, whether a material uncertainty exists related to events or conditions that
may cast significant doubt on the group’s ability to continue as a going concern. If we conclude that a
material uncertainty exists, we are required to draw attention in our statutory auditor’s report to the related
disclosures in the consolidated financial statements or, if such disclosures are inadequate, to modify our
opinion. Our conclusions are based on the audit evidence obtained up to the date of our statutory auditor’s
report. However, future events or conditions may cause the group to cease to continue as a going concern;
▪ evaluate the overall presentation, structure and content of the consolidated financial statements, and
whether the consolidated financial statements represent the underlying transactions and events in a
manner that achieves fair presentation;
▪ obtain sufficient appropriate audit evidence regarding the financial information of the entities and business
activities within the group to express an opinion on the consolidated financial statements. We are
responsible for the direction, supervision and performance of the group audit. We remain solely responsible
for our audit opinion.
We communicate with the audit committee regarding, amongst other matters, the planned scope and timing of
the audit and significant audit findings, including any significant deficiencies in internal control that we identify
during our audit.
We also provide the audit committee with a statement that we have complied with relevant ethical requirements
regarding independence, and we communicate with them about all relationships and other matters that may
reasonably be thought to bear on our independence, and where applicable, related safeguards.
From the matters communicated to the audit committee, we determine those matters that were of most
significance in the audit of the consolidated financial statements of the current period and are therefore the key
audit matters. We describe these matters in our report unless law or regulation precludes any public disclosure
about the matter.
Other legal and regulatory requirements
Responsibilities of the board of directors
The board of directors is responsible for the preparation and the content of the directors’ report on the
consolidated financial statements, and other matters disclosed in the annual report on the consolidated financial
statements.
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Responsibilities of the statutory auditor
As part of our mandate and in accordance with the Belgian standard complementary (revised in 2018) to the
International Standards on Auditing (ISA) as applicable in Belgium, our responsibility is to verify, in all material
respects, the director’s report on the consolidated financial statements and other matters disclosed in the annual
report on the consolidated financial statements, as well as to report on these matters.
Aspects regarding the directors’ report on the consolidated financial statements and
other matters disclosed in this report
In our opinion, after performing the specific procedures on the directors’ report on the consolidated financial
statements, this report is consistent with the consolidated financial statements for the period ended 31 December
2018 and it has been established in accordance with the requirements of article 119 of the Companies Code.
In the context of our statutory audit of the consolidated financial statements we are also responsible to consider,
in particular based on information that we became aware of during the audit, if the directors’ report on the
consolidated financial statements is free of material misstatement, either by information that is incorrectly
stated or otherwise misleading. In the context of the procedures performed, we are not aware of such material
misstatement. We do not express and will not express any kind of assurance on the annual report.
The non-financial information as required by article 119, § 2 of the Companies Code, has been disclosed in the the
directors’ report on the consolidated financial statements that is part of section Corporate Social Responsibility.
The ambition of the company is to report the non-financial information in the future in accordance with the
Global Reporting Initiative (GRI) Sustainability Reporting Standards (SRS) and European Federation of Financial
Analysts Societies Guideline for the Integration of ESG into Financial Analysis and Corporate Valuation. We do
however not express any opinion on the question whether this non-financial information has been established,
in all material respects, in accordance with this Global Reporting Initiative (GRI) Sustainability Reporting
Standars (SRS) and European Federation of Financial Analysts Societies Guideline for the Integration of ESG
into Financial Analysis and Corporate Valuation. Furthermore, we do not express any assurance on individual
elements that have been disclosed in this non-financial information.
Statements regarding independence
▪ Our audit firm and our network have not performed any prohibited services and our audit firm has remained
independent from the group during the performance of our mandate.
▪ The fees for the additional non-audit services compatible with the statutory audit, as defined in article 134
of the Companies Code, have been properly disclosed and disaggregated in the notes to the consolidated
financial statements.
Other statements
▪ This report is consistent with our additional report to the audit committee referred to in article 11 of
Regulation (EU) No 537/2014.
Zaventem, 29 March 2019
The statutory auditor
Deloitte Bedrijfsrevisoren/Réviseurs d’Entreprises CVBA/SCRL
Represented by Gert Vanhees
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OTHER INFORMATION
Glossary of terms
Glossary of terms, to be read only in conjunction with this Annual Report 2018.
100 points clinical response
Percentage of patients achieving a 100-point decrease in CDAI score during a clinical trial in CD patients
ACR
American College of Rheumatology
ACR20 (ACR 20/50/70)
American College of Rheumatology 20% response rate signifies a 20% or greater improvement in the number of
swollen and tender joints as well as a 20% or greater improvement in three out of five other disease-activity
measures. ACR50 and ACR70 reflect the same, for 50% and 70% response rates, respectively
ADAMTS-5
ADAMTS-5 is a key enzyme involved in cartilage breakdown (Larkin 2015)
ADS
American Depositary Share; Galapagos has a Level 3 ADS listed on Nasdaq with ticker symbol GLPG and CUSIP
number 36315X101. One ADS is equivalent to one ordinary share in Galapagos NV
AFM
Dutch Authority for the Financial Markets
Anemia
Condition in which the patient has an inadequate number of red blood cells to carry oxygen to the body’s
tissues
Ankylosing spondylitis (AS)
AS is a systemic, chronic, and progressive spondyoloarthropathy primarily affecting the spine and sacroiliac
joints, and progressing into severe inflammation that fuses the spine, leading to permanent painful stiffness of
the back
(Anti-)TNF
Tumor necrosis factor. An anti-TNF drug acts by modulation of TNF
ASDAS
Ankylosing Spondylitis Disease Activity Score, a composite score of symptoms such as back pain, duration of
morning stiffness, and peripheral pain and swelling. We measured ASDAS scores in the TORTUGA trial with
filgotinib in AS
Atherogenic index
Total cholesterol over HDL ratio. Improvement of the atherogenic index may be a forecast of cardiovascular
health
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Atopic dermatitis (AtD)
Also known as atopic eczema, atopic dermatitis is a common pruritis inflammatory condition affecting the skin,
which most frequently starts in childhood
Attrition rate
The historical success rate for drug discovery and development, based on publicly known development paths.
Statistically seen, investment in at least 12 target-based programs is required to ensure that at least one of these
will reach a Phase 3 study. Most new drug R&D programs are discontinued before reaching Phase 3 because they
are not successful enough to be approved
Autotaxin (ATX)
An enzyme important for generating the signaling molecule lypophosphatidic acid (LPA). GLPG1690 targets
autotaxin for IPF and SSc
BID dosing
Twice-daily dosing (bis in die)
Bioavailability
Assessment of the amount of product candidate that reaches a body’s systemic circulation after (oral)
administration
Biomarker
Substance used as an indicator of a biological process, particularly to determine whether a product candidate
has a biological effect
Black & Scholes model
A mathematical description of financial markets and derivative investment instruments that is widely used in
the pricing of European options and warrants
Bleomycin model
A preclinical model involving use of bleomycin (a cancer medication) to induce IPF symptoms
CDAI
Crohn’s Disease Activity Index, evaluating patients on eight different factors, each of which has a pre-defined
weight as a way to quantify the impact of CD
CDAI remission
In the FITZROY trial, the percentage of patients with CD who showed a reduction of CDAI score to <150
CIR
Crédit d’Impôt Recherche, or research credit. Under the CIR, the French government refunds up to 30% of the
annual investment in French R&D operations, over a period of three years. Galapagos benefits from the CIR
through its operations in Romainville, just outside Paris
Clinical proof-of-concept (PoC)
Point in the drug development process where the product candidate first shows efficacy in a therapeutic setting
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Compound
A chemical substance, often a small molecule with drug-like properties
Contract research organization
Organization which provides drug discovery and development services
Crohn’s disease (CD)
An IBD involving inflammation of the small and large intestines, leading to pain, bleeding, and ultimately in
some cases surgical removal of parts of the bowel
CRP
C-reactive protein is a protein found in the blood, the levels of which rise in response to inflammation
Cytokine
A category of small proteins which play important roles in signaling in processes in the body
Dactylitis
Dactylitis is inflammation of a digit (either finger or toe) and is derived from the Greek word dactylos meaning
finger. The affected fingers and/or toes swell up into a sausage shape and can become painful. Dactylitis was
measured in the EQUATOR trial with filgotinib in psoriatic arthritis
DARWIN
Phase 2 program for filgotinib in RA. Completed and reported in 2015 (except for the currently still ongoing
DARWIN 3 study). DARWIN 1 explored three doses, in twice-daily and once-daily administration, for up to 24
weeks in RA patients with insufficient response to methotrexate (MTX) and who remained on their stable
background treatment with MTX. DARWIN 2 explored three once-daily doses for up to 24 weeks in RA patients
with insufficient response to methotrexate (MTX) and who washed out of their treatment with MTX. DARWIN 1
and 2 were double-blind, placebo-controlled trials which recruited approximately 900 patients globally. DARWIN
3 is a long term extension trial currently ongoing; all patients are on 200 mg filgotinib, except for U.S. males who
are on 100 mg
DAS28 (CRP)
DAS28 is an RA Disease Activity Score based on a calculation that uses tender and swollen joint counts of 28
defined joints, the physician’s global health assessment and a serum marker for inflammation, such as C-
reactive protein. DAS28 (CRP) includes the C-reactive protein score calculation: scores range from 2.0 to 10.0, with
scores below 2.6 being considered remission
Development
All activities required to bring a new drug to the market. This includes preclinical and clinical development
research, chemical and pharmaceutical development and regulatory filings of product candidates
Discovery
Process by which new medicines are discovered and/or designed. At Galapagos, this is the department that
oversees target and drug discovery research through to nomination of preclinical candidates
Disease-modifying
Addresses the disease itself, modifying the disease progression, not just the symptoms of the disease
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DIVERSITY
Phase 3 program evaluating filgotinib in CD
DLCO
DLCO (diffusion capacity of the lung for carbon monoxide) is the extent to which oxygen passes from the air sacs
of the lungs into the blood. This is measured in IPF patients
Dose-range finding study
Phase 2 clinical study exploring the balance between efficacy and safety among various doses of treatment in
patients. Results are used to determine doses for later studies
Double-blind
Term to characterize a clinical trial in which neither the physician nor the patient knows if the patient is
taking placebo or the treatment being evaluated
Efficacy
Effectiveness for intended use
EMA
European Medicines Agency, in charge of European market authorization of new medications
Endoscopy
A non-surgical procedure involving use of an endoscope to examine a person’s digestive tract
Enthesitis
Inflammation of the tendons or ligaments; this is one of the key symptoms of psoriatic arthritis and was also
measured in the EQUATOR trial with filgotinib
EQUATOR
A Phase 2 trial with filgotinib in psoriatic arthritis patients
Esbriet
An approved drug (pirfenidone) for IPF, marketed by Roche
FDA
The U.S. Food and Drug Administration is an agency responsible for protecting and promoting public health and
in charge of American market approval of new medications
Fee-for-service
Payment system where the service provider is paid a specific amount for each procedure or service performed
FEV
Forced expiratory volume measures how much air a person can exhale during a forced breath. The amount of
air exhaled may be measured during the first (FEV1), second (FEV2), and/or third seconds (FEV3) of the forced
breath
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Fibrotic score
The Ashcroft fibrotic score involves measuring pulmonary fibrosis through examination of histopathology tissue
FIH
First-in-human clinical trial, usually conducted in healthy volunteers with the aim to assess the safety,
tolerability and pharmacokinetics of the product candidate
Filgotinib
Formerly known as GLPG0634. Small molecule selective JAK1 inhibitor which showed activity and favorable
tolerability in RA and CD patients in Phase 2 trials. Filgotinib is partnered with Gilead. Galapagos and Gilead are
running Phase 3 trials with filgotinib in RA, CD, and UC and Phase 2 trials with filgotinib in additional
indications. Filgotinib is an investigational drug and its efficacy and safety have not been established
FINCH
Phase 3 program evaluating filgotinib in RA
Fistulizing CD
Fistulae are inflammatory tracts that most often occur between the distal colon and the perianal region.
Fistulae are one of the most severe sequelae of luminal CD and the lifetime risk of occurrence is close to 50% of
those with active CD
FITZROY
A double-blind, placebo controlled Phase 2 trial with filgotinib in 177 CD patients for up to 20 weeks. Full results
were published in The Lancet in 2016
FLORA
A double-blind, placebo-controlled exploratory Phase 2a trial with GLPG1690 in up to 24 IPF patients; topline
results were reported in August 2017
FRI
Functional respiratory imaging is a technology which enhances 3D visualization and quantification of a
patient’s airway and lung geometry
FSMA
The Belgian market authority: Financial Services and Markets Authority, or Autoriteit voor Financiële Diensten
en Markten
FTE
Full-time equivalent; a way to measure an employee’s involvement in a project. For example, an FTE of 1.0
means that the equivalent work of one full-time worker was used on the project
FVC
Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest
breath possible. FVC is used to help determine both the presence and severity of lung diseases such as IPF
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GECKO
A Phase 2 trial evaluating a subcutaneaous formulation of MOR106 in combination with topical corticosteroids.
This Phase 2 trial was initiated early 2019
GLPG0555
A preclinical candidate with undisclosed mode of action directed toward inflammation
GLPG0634
Molecule number currently known as filgotinib
GLPG1205
A GPR84 inhibitor fully proprietary to us. We initiated the PINTA patient trial with GLPG1205 in IPF
GLPG1690
A novel drug targeting autotaxin, with potential application in IPF & SSc. Fully proprietary to Galapagos. Topline
results from the Phase 2a FLORA trial were reported in August 2017. The ISABELA Phase 3 program was initiated
in 2018 and the NOVESA Phase 2 trial in SSc was initiated in early 2019
GLPG1972/S201086
GLPG1972/S201086, also referred to as GLPG1972, is a novel mode-of-action product candidate that is part of the
OA collaboration with Servier. Galapagos and Servier are recruiting the ROCCELLA global Phase 2b trial with
GLPG1972/S201086
GLPG2534
A preclinical candidate with undisclosed mode of action. GLPG2534 is expected to enter Phase 1 trials in 2019
GLPG2737
A preclinical candidate with undisclosed novel mode of action. This compound is part of the CF collaboration
with AbbVie but Galapagos regained rights outside of CF
GLPG3121
A preclinical candidate with undisclosed novel mode of action directed toward inflammation. GLPG3121 is
expected to enter Phase 1 trials in 2019
GLPG3312
A compound currently in Phase 1 with an undisclosed mode of action directed towards inflammation (IBD).
GLPG3312 is a Toledo compound and the first one to enter Phase 1
GLPG3667
A preclinical candidate with undisclosed mode of action directed toward inflammation. GLPG3667 is expected to
enter Phase 1 trials in 2019
GLPG3970
A preclinical candidate with a undisclosed mode of action directed toward inflammation. GLPG3970, which is
part of the Toledo target family, is expected to enter Phase 1 trials in 2019
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HDL
High-density lipoprotein. HDL scavenges and reduces low-density lipoprotein (LDL) which contributes to heart
disease at high levels. High levels of HDL reduce the risk for heart disease, while low levels of HDL increase the
risk of heart disease
Hemoglobin
A protein inside red blood cells that carries oxygen from the lungs to tissues and organs in the body and carries
carbon dioxide back to the lungs
Histopathology
Microscopic examination of tissues for manifestations of a disease
IBD
Inflammatory Bowel Disease. This is a general term for an autoimmune disease affecting the bowel, including
CD and UC. CD affects the small and large intestine, while UC affects the large intestine. Both diseases involve
inflammation of the intestinal wall, leading to pain, bleeding, and ultimately, in some cases, surgical removal of
part of the bowel
IGUANA
Phase 2 trial together with our partners MophoSys and Novartis, investigating MOR106 in AtD patients
IL-17C
IL-17C has been shown to be distinct from other members of the IL-17 family of cytokines. IL-17C has been
shown to be an important mediator in inflammatory skin diseases, and is the target of MOR106
In-/out-licensing
Receiving/granting permission from/to another company or institution to use a brand name, patent, or other
proprietary right, in exchange for a fee and/or royalty
In vitro
Studies performed with cells outside their natural context, for example in a laboratory
Inflammatory diseases
A large, unrelated group of disorders associated with abnormalities in inflammation
Inspiratory capacity
Total lung capacity or the amount of gas contained in the lung at the end of a maximal inhalation
Intellectual property
Creations of the mind that have commercial value and are protected or protectable, including by patents,
trademarks or copyrights
Intersegment
Occurring between the different operations of a company
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Investigational New Drug (IND) Application
United States Federal law requires a pharmaceutical company to obtain an exemption to ship an experimental
drug across state lines, usually to clinical investigators, before a marketing application for the drug has been
approved. The IND is the means by which the sponsor obtains this exemption, allowing them to perform
clinical studies
IPF
Idiopathic pulmonary fibrosis. A chronic and ultimately fatal disease characterized by a progressive decline in
lung function. Pulmonary fibrosis involves scarring of lung tissue and is the cause of shortness of breath.
Fibrosis is usually associated with a poor prognosis. The term “idiopathic” is used because the cause of
pulmonary fibrosis is still unknown
ISABELA
Phase 3 clinical program investigating GLPG1690 in IPF patients. The ISABELA Phase 3 program consists of two
identically designed trials, ISABELA 1 and ISABELA 2, and will enroll a total of 1,500 IPF patients combined
JAK
Janus kinases (JAK) are critical components of signaling mechanisms utilized by a number of cytokines and
growth factors, including those that are elevated in RA. Filgotinib is a selective JAK1 inhibitor
LDL
Low-density lipoprotein. LDL contributes to heart disease at high levels
Liver enzymes
Inflamed or injured liver cells secrete higher than normal amounts of certain chemicals, including liver
enzymes, into the bloodstream
LPA
Lysophosphatidic acid (LPA) is a signaling molecule involved in fibrosis
Lymphocyte
Type of white blood cell that is part of the immune system
MANTA
A Phase 2 trial with filgotinib to evaluate male testicular safety in patients with UC
Milestone
Major achievement in a project or program; in our alliances, this is usually associated with a payment
Molecule collections
Chemical libraries, usually consisting of drug-like small molecules that are designed to interact with specific
target classes. These collections can be screened against a target to generate initial “hits” in a drug discovery
program
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MOR106
A novel mode-of-action antibody product candidate currently in a Phase 2 trial in AtD patients. MOR106 acts on
IL-17C, a novel antibody target discovered by Galapagos. MOR106 is part of the alliance with MorphoSys and
Novartis
MTX
Methotrexate; a first-line therapy for inflammatory diseases
NDA
New Drug Application
Neutrophil
Type of immune system cell which is one of the first cell types to travel to the site of an infection in the body.
Neutrophils are another type of white blood cell which fight infection by ingesting and killing microorganisms
NK cells
Natural killer cells, type of white blood cell with granules of enzymes which can attack tumors or viruses
NOVESA
A Phase 2 trial to evaluate GLPG1690 in systemic sclerosis (SSc)
Ofev
An approved drug (nintedanib) for IPF, marketed by Boehringer Ingelheim
Oral dosing
Administration of medicine by the mouth, either as a solution or solid (capsule, pill) form
Organoids
Miniature organ produced from cells from a donor; organoids have all the phenotypic characteristics of the
patient donor, making them useful tools for in vitro drug research
Osteoarthritis (OA)
The most common form of arthritis, usually occurring after middle age, marked by chronic breakdown of
cartilage in the joints leading to pain, stiffness, and swelling
Outsourcing
Contracting work to a third party
Pharmacokinetics (PK)
Study of what a body does to a drug; the fate of a substance delivered to a body. This includes absorption,
distribution to the tissues, metabolism and excretion. These processes determine the blood concentration of the
drug and its metabolite(s) as a function of time from dosing
Phase 1
First stage of clinical testing of an investigational drug designed to assess the safety and tolerability,
pharmacokinetics of a drug, usually performed in a small number of healthy human volunteers
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Phase 2
Second stage of clinical testing, usually performed in no more than several hundred patients, in order to
determine efficacy, tolerability and the dose to use
Phase 3
Large clinical trials, usually conducted in several hundred to several thousand patients to gain a definitive
understanding of the efficacy and tolerability of the candidate treatment; serves as the principal basis for
regulatory approval
PINTA
Phase 2 trial with GPR84 inhibitor GLPG1205 in IPF patients
Placebo-controlled
A substance having no pharmacological effect but administered as a control in testing a biologically active
preparation
Preclinical
Stage of drug research development, undertaken prior to the administration of the drug to humans. Consists of
in vitro and in vivo screening, pharmacokinetics, toxicology, and chemical upscaling
Preclinical candidate (PCC)
A new molecule and potential drug that meets chemical and biological criteria to begin the development
process
Product candidate
Substance that has satisfied the requirements of early preclinical testing and has been selected for development,
starting with formal preclinical safety evaluation followed by clinical testing for the treatment of a certain
disorder in humans
Proof-of-concept study
Phase 2 patient study in which activity as well as safety in patients is evaluated, usually for a new mechanism of
action
Pruritis
Extreme itching, as observed in AtD patients
Psoriatic arthritis (PsA)
Psoriatic arthritis or PsA is an inflammatory form of arthritis, affecting up to 30% of psoriasis patients. Psoriatic
arthritis can cause swelling, stiffness and pain in and around the joints, and cause nail changes and overall
fatigue
QD dosing
Once-daily dosing (qd from the Latin quaque die)
R&D operations
Research and development operations; unit responsible for discovery and developing new product candidates for
internal pipeline or as part of risk/reward sharing alliances with partners
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OTHER INFORMATION
Rheumatoid arthritis (RA)
A chronic, systemic inflammatory disease that causes joint inflammation, and usually leads to cartilage
destruction, bone erosion and disability
ROCCELLA
Global Phase 2b trial, together with our collaboration partner Servier, evaluating GLPG1972/S201086 (GLPG1972) in
osteoarthritis (OA)
Screening
Method usually applied at the beginning of a drug discovery campaign, where a target is tested in a biochemical
assay against a series of small molecules or antibodies to obtain an initial set of “hits” that show activity against
the target. These hits are then further tested or optimized
SELECTION
Phase 3 program evaluating filgotinib in UC patients
Service operations
Business unit primarily focused on delivering products and conducting fee-for-service work for clients. Our
service operations included the BioFocus and Argenta business units, which were both sold in April 2014 to
Charles River Laboratories
SES-CD scores
Simple endoscopic score for CD, involving review of five pre-defined bowel segments, assigning values from 0
(unaffected) to 3 (highly affected)
Sjögren’s syndrome
Sjögren’s Syndrome is a systemic inflammatory disease which can be felt throughout the body, often resulting
in chronic dryness of the eyes and mouth
Small bowel CD (SBCD)
CD causes chronic inflammation and erosion of the intestines. It can affect different regions of gastrointestinal
tract including the stomach and small and large intestines. While isolated SBCD is an uncommon presentation
of CD, involvement of some portion of the small bowel, particularly the ileum, is common
Spondylitis
About 20% of patients with psoriatic arthritis will develop spinal involvement, which is called psoriatic
spondylitis. Inflammation of the spine can lead to complete fusion, as in AS, or affect only certain areas such as
the lower back or neck. We measured spondylitis in the EQUATOR trial with filgotinib in psoriatic arthritis
Systemic sclerosis (SSc)
Systemic sclerosis (SSc) or scleroderma is an autoimmune disease. One of the most visible manifestations is
hardening of the skin. In diffuse cutaneous SSc, which has one of the highest mortality rates among rheumatic
diseases, fibrosis occurs in multiple organs, such as the lung
Target
Proteïn that has been shown to play a role in a disease process and that forms the basis of a therapeutic
intervention or discovery of a medicine
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OTHER INFORMATION
Target discovery
Identification and validation of proteins that have been shown to play a role in a disease process
Technology access fee
License payment made in return for access to specific technology (e.g. compound or virus collections)
Tendinitis
Tendinitis is inflammation or irritation of a tendon, the thick fibrous cords that attach muscle to bone. The
condition causes pain and tenderness just outside a joint. We measured tendinitis in the EQUATOR trial with
filgotinib in psoriatic arthritis
Toledo
Toledo is a code name for a target family with a novel, undisclosed mode of action. GLPG3312 is the first of the
Toledo compounds for which a Phase 1-trial has been initiated early 2019
TORTUGA
Phase 2 trial with filgotinib in patients with ankylosing spondylitis. In 2018, we and Gilead reported that
TORTUGA met its primary endpoint
Ulcerative colitis (UC)
UC is an IBD causing chronic inflammation of the lining of the colon and rectum (unlike CD with inflammation
throughout the gastrointestinal tract)
Uveitis
Uveitis is the term that refers to inflammation inside the eye. This inflammation can be caused by infection,
autoimmune reaction, or by conditions confined primarily to the eye
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Financial calendar
Colophon
24 April 2019
First quarter 2019 results
30 April 2019
Annual Shareholders’ Meeting in Mechelen
25 July 2019
Half year 2019 results
25 October 2019
Third quarter 2019 results
20 February 2020
Full year 2019 results
Contact
Concept, design and online programming
nexxar GmbH, Vienna – Online annual reports
and online sustainability reports
www.nexxar.com
Photography
Aldo Allessi
Video 'Think Big'
Deep Thought Productions
Copy deadline: 29 March 2019
This annual report is also available in Dutch
and available for download in the Downloads
section of this report or at www.glpg.com
Elizabeth Goodwin
Vice President Investor Relations
Sofie Van Gijsel
Director Investor Relations
& Corporate Communications
Galapagos NV
Carmen Vroonen
Senior Director Corporate
Communications
Galapagos NV
Generaal De Wittelaan L11 A3
Galapagos NV
Generaal De Wittelaan L11 A3
2800 Mechelen, Belgium
Generaal De Wittelaan L11 A3
2800 Mechelen, Belgium
Tel. +32 15 34 29 00
Mob. +1 781 460 1784
Email: ir@glpg.com
Tel. Tel. +32 485 19 14 15
Email: ir@glpg.com
2800 Mechelen, Belgium
Tel. +32 15 1 40584
Email:
communications@glpg.com
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