Exhibit 99.2
Half-year financial report 2022 Foundation & Future
TABLE OF CONTENTS
Table of Contents
The Galapagos group
Letter to our shareholders.4
Potential external impact 8 Financial highlights 11 Risk factors.17 The Galapagos share 7 Related party transactions18 Disclaimer and other information 19
Financial statements
Unaudited condensed consolidated interim financial statements.23 Notes 32
Other information
Glossary.48 Financial calendar...65 Colophon...66 Contact..67
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Galapagos Half-year financial report 2022
S2
The Galapagos group
An overview of Galapagos, its strategy and portfolio in H1 2022
Foundation & Future
THE GALAPAGOS GROUP
Letter to our shareholders
Dear shareholders, exercise As we are to writing assess our the current next chapter portfolio for and our combine company, internal we embarked and external on a innovation thorough strategic with the aim to accelerate transformational medicines to patients. oncology This quarter, withwe thetook acquisitions a first key of CellPoint step in our andstrategic AboundBio. transformation The combined by entering transactions the provide field of us with end-to-end capabilities in CAR-T1 therapy and offer the potential for a paradigm shift developed in the space in through a global CellPoint’s strategic collaboration breakthrough,with decentralized Lonza, and point-of-care AboundBio’s supply cutting-edge model, fully human antibody-based capabilities to design next-generation CAR-Ts.
We teams warmly to Galapagos, welcome and the we CellPoint look forward andtoAboundBio combining oncology. our unique Despite capabilities continued to push progress the boundaries with current in manufacturing CAR-T cancer therapies, and complex long lead logistics times, continue costly central to be limiting patient factors access. for Thelarge-scale CellPoint capacity novel point-of-care and broad allow supply for model, efficient, in 7-day or near delivery the hospital, of CAR-Tis therapies designed with to fresh shorten cells, time thereby to treatment offering the as potential compared to significantly to industry standards. end xCellitIt workflow combines management CellPoint’s proprietary and monitoring end-to-software with Lonza’s Cocoon® system, a closed, therapies. The regulatory authorities in Belgium, automated themanufacturing Netherlands and platform Spain have for cell approved and gene the start of clinical studies with this novel supply model.
Two Phase 1/2a studies in rrNHL and rrCLL2 with a clinically validated CD19 CAR-T target are supply ongoing model. and provide Toplinethe results opportunity are expected for a rapid in the validation first half of of the 2023, CellPoint and if positive, CAR-T point-of-care they would allow us to start pivotal studies in rrNHL and rrCLL shortly afterwards.
In fully a human next step, multi-specific our aim is and to multi-paratopic leverage CellPoint’s CAR-Ts platform that have withthe AboundBio’s potential for next-generation deeper, more CAR-T durable treatment. responses Our to treatment near-termas goal well isas toretreatment bring three additional of patientsdifferentiated, who relapsed next-generation following earlier CAR-T candidates in the clinic over the next three years.
1 Chimeric antigen receptor T-cell
2 Relapsed/Refractory NHL: non-Hodgkin Lymphoma, CLL: Chronic Lymphocytic Leukemia
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Galapagos Half-year financial report 2022
THE GALAPAGOS GROUP
In to discontinue light of the ongoing 4 early-stage scientific programs: and strategic GLPG3121, review a local andrelease capital formulation allocation prioritization, JAK1/TYK2 inhibitor we decided with a potential compound in inflammatory with undisclosed diseases; mode GLPG0555, of actionadirected JAK1 inhibitor toward evaluated fibrosis; in and osteoarthritis; GLPG4716, GLPG4586, a chitinase inhibitor development directed opportunities toward idiopathic to further pulmonary leverage our fibrosis. internal Wecapabilities continue to and explore renew additional our portfolio, business and plan to provide a detailed update on our corporate strategy and portfolio later this year.
Portfolio
Our regulatory Jyseleca approvals franchise inis ulcerative performing colitis very (UC) well inwith Great robust Britain sales and momentum, Japan earlier supported this year. Despite by the 30 being June the 2022, 4thJyseleca JAK inhibitor is reimbursed to market, in 15 thecountries adoptionfor ofrheumatoid Jyseleca is strong arthritis across (RA) and Europe. 6 countries As of for UC, and we realized €35.4 million in net sales in the first half year of 2022.
We balance ended sheet the first of six €4.4 months billion of in thecash year with and acurrent strong necessary financial investments, means to execute which for provides additional us with external the the innovation acquisitions and accelerate of CellPoint our and R&D AboundBio, pipeline.we Following expect that approximately second half €30 operating million. Therefore, expenses will we increase revised our by cash burn3 guidance of €450-€490 million for the strong full year Jyseleca 2022 to performance, €480-€520 million. we increase As a result our full-year of the net million. sales guidance from €65-€75 million to €75-€85
3 We refer to the financial highlights for an explanation and reconciliation of this alternative liquidity measure
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Galapagos Half-year financial report 2022
THE GALAPAGOS GROUP
Year-to-date operational review
Commercial & regulatory progress
Strong 6 countries adoption across Europe with reimbursement for RA in 15 countries and for UC in Greece, Sobi, ourand distribution the Balticand countries, commercialization launched Jyseleca partner inin RA Eastern in the and Czech Central Republic Europe, and Portugal, Portugal, resulting in €2 million milestone payments to Galapagos in H1 Filed MANTA-RAy a type studies II variation for label update for Jyseleca based on data from the MANTA and At the EULAR4 2022 European Congress of Rheumatology, Galapagos hosted several expert sessions and presented 11 abstracts, further establishing us as a key European player in RA Article Pharmacovigilance 20 pharmacovigilance Risk Assessment procedure Committee ongoing (PRAC), by theinvestigating European Medicines the safety Agency’s data of all (EMA) JAK inhibitors for the treatment of certain chronic inflammatory disorders
Pipeline update
start Decided a Phase to move 2 study forward before with year-end GLPG3667 (TYK2 inhibitor) in dermatomyositis with the aim to strategic Discontinued exercise: development GLPG3121, ofa4local early-stage release formulation programs as JAK1/TYK2 part of ongoing inhibitor with scientific potential and a incompound inflammatory with diseases; undisclosed GLPG0555, modeaof JAK1 action inhibitor directed evaluated toward infibrosis; osteoarthritis; and GLPG4716, GLPG4586, a chitinase inhibitor directed toward idiopathic pulmonary fibrosis
Corporate update
Entered in all-cash the transactions field of oncology through the combined acquisitions of CellPoint and AboundBio Galapagos Received a increased transparency andnotification crossed the from 5%FMR threshold, LLC in Q2 to 5.04% indicating of the that current its shareholding outstanding in Galapagos shares Raised €3.6 million through the exercise of subscription rights Created participate new subscription right plans, offering all Galapagos employees the opportunity to were All proposed adopted resolutions by Galapagos’ regarding shareholders the extraordinary on 26 April 2022 and annual shareholders’ meetings
4 European Alliance of Associations for Rheumatology
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Galapagos Half-year financial report 2022
THE GALAPAGOS GROUP
H1 2022 financial result
Jyseleca net sales amount to €35.4 million Collaboration revenues of €238.6 million R&D expenditures of €249.5 million
S&M and G&A expenses amounting to €134.0 million Net loss of €32.3 million Operational cash burn of €217.1 million Cash position at end of June 2022 of €4,429.0 million
Outlook 2022
We II variation anticipate forathe Committee Jyseleca label, for Medicinal based on Products the data for from Human the Use MANTA (CHMP) and opinion MANTA-RAy on the studies type UC around and anticipate year-end. We thatalso Sobiexpect will further reimbursement progress with decisions reimbursement in most key discussions European in RA markets and UC in 20 in Eastern pharmacovigilance and Centralprocedure Europe, Greece, on all and JAK inhibitors the Balticapproved countries.in AsEurope, part of we theexpect ongoing a CHMP article opinion afterwards. by the end of the year, followed by an adoption by the European Commission shortly anticipate Patient enrolment that additional in the clinical Phase sites 1/2a will trials be active in rrNHL by year-end. and rrCLL We are is progressing on track to report well and topline we results of both trials in the first half of next year.
We firstplan patients to progress potentially TYK2 recruited inhibitor around GLPG3667 year-end. into a Phase 2 program in dermatomyositis with full Following year 2022 the acquisitions from €450-of €490 CellPoint million and to AboundBio, €480-€520 we million. revised Additionally, our cash burn we increased guidanceour for anticipated net sales guidance for Jyseleca between €75 and €85 million. on Wehuman want tolives thank through you forcutting-edge your continued science support andof exceptional our exciting people. journey We tostrongly make a believe true impact that we to presenting are taking the an in-depth right steps update in our on transformation our strategy later to accelerate this year. value creation and look forward Respectfully, Dr. Paul Stoffels5 CEO and chairman of the board of directors President, Bart Filius COO & CFO
5 Acting via Stoffels IMC BV
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Galapagos Half-year financial report 2022
THE GALAPAGOS GROUP
Potential external impact
COVID-19
spreading The start of of 2022 the highly was infectious globally marked Omicron by-variant steeply . At increasing Galapagos, infection we hence rates maintained mainly due the to strict the measures and protect put the inphysical place byand local mental governments health of toour help staff prevent during the the spread first months of the COVID of the-19 year virus . In most taken places, could gradually the situation be loosened improved . We significantly nevertheless during keepthe on second continuously quarter monitoring and the measures COVID-19 infection needed to rates guarantee at global business and at continuity local level, .. We and report have now the following systems in impacts: place to react quicky where At Staff Galapagos, we maintained the measures put in place by local governments to help of prevent our staff the. spread The majority of theof COVID our research -19 virus staff and continued protect the tophysical work from and the mental office/labs health.
For launched teleworkable in 2021, functions in locations we continued where thethe ongoing implementation COVID-19 of situation our hybrid and working corresponding model local office,governmental we maintained measures stringentpermitted cleaning and us to sanitation do so. For protocols, those employees and we strictly coming respected to the social kept our distancing global and policies site-specific at all business times in continuity order to minimize plans up-to risk -date of exposure and continued . We further to take appropriate recommended precautions. by Wevirtual learned meetings, during the resulting pandemic in improved that most cost ofefficiency, the international a bettertravel work-life could balance, be replaced and a become reduced carbon part of footprint our corporate . The impact travel of guidance this new . On way the -of-other working hand, has we been noticed retained during and has the month start meeting of March in person 2022, when againinfection and to attend rates lowered professional significantly, (international) an increasing events.appetite For those to guidance who needed on how to attend to safely ororganize organizeor events, attendwe anydid such implement professional a global events, policy both providing internally and externally.
By Research prioritizing portfolio the most advanced projects very early on, and increasing the flexibility of our staff compound in themanagement labs within projects, facility running we maintained at all times, ourand research continued delivery our early timelines, drug research kept the and the implementation of new modalities for target or drug discovery. to The previous scorecard years, of the indicating researchthat department we were objectives able to minimize shows a similar the impact productivity of the compared COVID-19 pandemic, at least in the short term.
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Galapagos Half-year financial report 2022
THE GALAPAGOS GROUP
We Development have a business portfoliocontinuity plan for our clinical development programs. We closely pandemic monitor each and program the associated in the context specific of the regulatory, current global institutional, and local government situation ofguidance the COVID-19 and consultation policies related with toour COVID-19. CROs and Within clinical thetrial boundaries sites, weof applied these guidelines various measures and policies, to minimize and in the primary impact aimof to the ensure COVID-19 the safety pandemic of our trial on participants our clinical development and to preserve programs, the datawith integrity the and basis, scientific tailoredvalidity to theof specific the trials. study These and measures country needs were at implemented any given time, on a case-by-case with specific immunosuppressive attention paid to vulnerable properties. populations The measures and the include, use of investigational amongst others, medicines increased, with transparent medicines tocommunication patients. For each to clinical all stakeholders trial, we actively and the monitor directand supply document of investigational the impact of interpretation COVID-19 to and mitigate reporting its ofeffect results. on the study where necessary and to facilitate the To Manufacturing date, there and has supply been no chain impact to the commercial supply of filgotinib as the result of sites the COVID-19 that currently pandemic. manufacture All sitesother involved marketed in theproducts manufacturing and are ofin filgotinib good standing are established with the FDA European and are Economic GMP certified. Area and We Great became Britain marketing at the end authorization of 2021, and holder are responsible of filgotinibfor in the the supply manufacturing filgotinibof except filgotinib. for secondary The same manufacturing packaging and sites labelling thatfor supplied which Gilead a new continue vendor has to been selected.
The Commercial form of organization outreach of our commercial teams to physicians and hospitals was impacted virtual. by the The COVID-19 teams invested pandemic inand digital consequent channels as travel part of restrictions, the overalland commercial thus became build strategy, partially note and these no material channels impact areon being the relative utilized competitiveness during our ongoing of our commercial commercial launch. operations Thus due far we to access travel restrictions, discussions. nor Nevertheless, have the effects healthcare of COVID-19 systems impacted are under our ability pressure to engage across inEurope, market of increasing new therapy the volatility options initiated in reimbursement by healthcare procedures providers. and potentially reducing the number
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Galapagos Half-year financial report 2022
THE GALAPAGOS GROUP
Conflict in Ukraine
operations. The armed We conflict currently between have ongoing Russia and clinical Ukraine studies could for filgotinib cause awith material CROs located disruption in Ukraine in our Ukraine and Russia. andIfthe oursanctions CROs experience against Russia, disruptions it could to their result business in delays due in our to the clinical military development conflict in activities, interruptions including in operations delay ofof our regulatory clinical development authorities. The plans impact and on timelines, ongoingor pivotal couldstudies cause taking such as measures DIVERSITY to mitigate 1 has remained the impact limited. on ourWe ability continue to conduct to monitor clinical development the situation activities. and are Interruptions deadlines or to or comply delays in with our contractual and our CROs’ commitments ability towith meet respect expected to the clinical same, development could lead to impact delays our in ability our overall to conduct developmental clinical development and commercialization activities and timelines, complete which them would onadversely a timely closely basis. Since monitor 24 each February program 2022, inwe context have of extended the currently the focus ongoing of the Ukraine-Russia business continuity conflict and planthe to associated specific regulatory, institutional, and government guidance and policies.
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Galapagos Half-year financial report 2022
THE GALAPAGOS GROUP
Financial highlights
Consolidated key figures
Six monthsSix months
Second Second endedendedYear ended
quarter quarter 30 June30 June31 Decembe
(thousands of €, if not stated otherwise) of 2022 of 202120222021r 2021
Income statement
Product net sales 20,945 37735,35645614,753
Collaboration revenues 116,665 139,395238,601253,207470,093
Cost of sales (2,633) (93)(5,545)(131)(1,629)
R&D expenditure (149,597) (138,866)(249,518)(268,826)(491,707)
S&M, G&A expenses (71,670) (60,861)(134,009)(105,819)(210,855)
Other operating income 9,957 13,29817,63723,56453,749
Operating loss (76,332) (46,750)(97,478)(97,548)(165,596)
Net financial results 58,115 (18,209)67,67619,91642,598
Taxes (811) 630(2,536)473(2,423)
Net loss from continuing operations (19,028) (64,329)(32,338)(77,159)(125,422)
Net profit from discontinued
operations, net of tax - --22,19122,191
Net loss (19,028) (64,329)(32,338)(54,968)(103,231)
Balance sheet
Cash and cash equivalents 972,796 2,642,639972,7962,642,6392,233,368
Current financial investments 3,456,184 2,363,9693,456,1842,363,9692,469,809
R&D incentives receivables 155,771 142,745155,771142,745144,013
Assets 5,040,085 5,430,6175,040,0855,430,6175,193,160
Shareholders’ equity 2,646,898 2,663,4732,646,8982,663,4732,643,362
Deferred income 2,159,553 2,565,2922,159,5532,565,2922,364,701
Other liabilities 233,634 201,852233,634201,852185,097
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Galapagos Half-year financial report 2022
THE GALAPAGOS GROUP
Six months Six months
Second Second ended ended Year ended
quarter quarter 30 June 30 June 31 Decembe
(thousands of €, if not stated otherwise) of 2022 of 2021 2022 2021 r 2021
Cash flow
Operational cash burn (139,721) (95,527) (217,102) (223,196) (564,840)
Cash flow used in operating activities (141,772) (81,922) (203,740) (203,131) (503,827)
Cash flow generated from/used in (-)
investing activities (147,604) 182,194 (1,081,057) 682,053 541,238
Cash flow used in financing activities (337) (1,952) (361) (1,474) (3,876)
Increase/decrease (-) in cash and
cash equivalents (289,712) 98,319 (1,285,158) 477,448 33,535
Effect of currency exchange rate
fluctuation on cash and
cash equivalents 8,229 (9,629) 24,586 22,121 56,763
Cash and cash equivalents at the end of
the period 972,796 2,642,639 972,796 2,642,639 2,233,368
Current financial investments at the end
of the period 3,456,184 2,363,969 3,456,184 2,363,969 2,469,809
Total current financial investments and
cash and cash equivalents at the end of
the period 4,428,980 5,006,608 4,428,980 5,006,608 4,703,177
Financial ratios
Number of shares issued at the end of
the period 65,728,511 65,522,521 65,728,511 65,522,521 65,552,721
Basic and diluted loss per share (€) (0.29) (0.98) (0.49) (0.84) (1.58)
Share price at the end of the period (in
€) 53.04 58.48 53.04 58.48 49.22
Total group employees at the end of the
period (number) 1,344 1,397 1,344 1,397 1,309
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Galapagos Half-year financial report 2022
THE GALAPAGOS GROUP
Employees per site as of 30 June 2022
(total: 1,344 employees)
H1 2022 financial results
to We€reported 35.4 million product (€0.5 net million sales inof the Jyseleca first half-year in Europe of for 2021) the . Our first counterparties six months of 2022 for the amounting sales of Jyseleca Spain, Germany, were mainly Great hospitals Britain, and Ireland, wholesalers Austria, Norway, located in Sweden Belgium, and the Finland. Netherlands, France, Italy, Cost of sales related to Jyseleca net sales in the first six months of 2022 amounted to €5.5 million. Collaboration to €253.2 million revenues for the amounted first six months to €238.6 of 2021. million for the first six months of 2022, compared development Revenues recognized were €115.3 related million to the in the collaboration first six months agreement of 2022 with compared Gilead to for€136.1 the filgotinib million of forcompletion, the same period partly last offset year. by This a higher decrease revenue wasrecognition due to a lower of milestone increase payments in the percentage strongly first influenced half-year bythe of 2022. milestone achieved related to the regulatory approval in Japan for UC in the platform The revenue amounted recognition to €114.9 related million to the forexclusive the first six access months rights of 2022 for Gilead (€115.7 tomillion our drug for discovery the same period last year).
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Galapagos Half-year financial report 2022
THE GALAPAGOS GROUP
of We 2022 have(compared recognizedto royalty €1.4 million income in from the same Gileadperiod for Jyseleca last year) for € of 6.3 which million €3in .6 the million firstroyalties six months on milestone income for UC approval in Japan.
Republic Additionally, and we Portugal recorded bymilestones our distribution of €2.0 and million commercialization triggered by the partner first sale Sobi, of Jyseleca in the first in Czech half-year of 2022. discovery Our deferred platform income that balance is recognized on 30 June linearly 2022over includes the remaining €1.6 billionperiod allocated of our to our 10 drug year collaboration, until the end of and the€ development 0.5 billion allocated period. to filgotinib development that is recognized over time to Our €268 R&D .8expenditure million for the in the firstfirst six six months months of 2021 of 2022 . This amounted decreaseto was €249 primarily .5 million, explained compared by a €104 decrease .1 million ininsubcontracting the first half-year costs of 2022, fromprimarily €139.2 due million to the in winding the firstdown half-year of theof ziritaxestat 2021 to by (IPF) cost program increases andfor reduced our filgotinib spend on program, our Toledo on a(SIKi) six month and TYK2 basis programs compared . This to the wassame partlyperiod offset in for2021 the .same Personnel period costs this year decreased mainlyfrom due € to 94 a.2 lower million number in the of first FTEs half as ofwell 2021 asto lower €86.costs 0 million for first our subscription six months of right 2022 plans (€8.1 . Depreciation million for the and same impairment period last amounted year). This toincrease €32.6 million was primarily for the collaboration due to an impairment with Molecure of €26 on.7 the million dual chitinase of previously inhibitor capitalized OATD-01 upfront (GLPG4716) fees related . As part to ofour an to ongoing OATD-strategic 01 to Molecure exercise . to renew and accelerate our portfolio, we decided to return all rights in Our the S&M first expenses six months were of€2021 71.0 .million This increase in the first was sixprimarily months of due 2022, to the compared termination to €29 of.0our million 50/ 50 alsofilgotinib explained co-by commercialization an increase in cost personnel sharing costs agreement (€35.7 million with Gilead for .the Thefirst costsix increase months was of 2022 commercial compared workto force €26.from 9 million 215 for average the same FTEs period in the first lasthalf year) -year explained of 2021by toan 305 increase average inFTEs the in the first half-year of 2022 driven by the commercial launch of filgotinib in Europe. in Our the G&A first expenses six months were € of 632021 .0 million . The incost the first decrease six months was of primarily 2022, compared due to the to €76 exceptional .9 million following impairment our ofdecision €9.3 million to reassess on otherthe tangible construction assets recorded project of inour the new first six future months headquarter of 2021 compared location in to Mechelen €37.6 million (Belgium) for.the Personnel same period costs (last €35.year) 6 million decreased for the primarily first six months explained of 2022 by a lower number of FTEs. for Other theoperating first six months income of (€ 2021) 17.6 million decreased for the byfirst €5.9six million, months mainly of 2022, driven compared by lowerto grant €23.and 6 million R&D incentive income. compared We reported to an an operating operating loss loss ofamounting €97.6 million tofor €97 the .5 same million period for the last first year six . months of 2022,
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Galapagos Half-year financial report 2022
THE GALAPAGOS GROUP
net Netfinancial financialincome incomeof in€the 19.9 first million six months in the same of 2022 period amounted last year) to . Net €67.7 financial million income (as compared in the first to gain six months on our of cash 2022 andwas cash primarily equivalents attributable and current to €financial 57.4 million investments of unrealized at amortized currencycost exchange in U.S. dollar current (as financial compared investments to €33.4 in million the first currency six months exchange of 2021) gain and on cash €11.8 and million cashpositive equivalents changes and in last (fair) year) value . The ofother current financial financial expenses investments also contained (€5.8 million the negative effect of changes discounting in the our same long period term financial deferredassets income held of € at 3.8 fair million value(€ through 4.8 million profit in or theloss same amounted period last to nil year) in .the The first fairsix value months loss of in 2022 (as compared to €2.9 million in the same period last year). compared We realized to a a net net loss loss from of €continuing 77.2 million operations for the first of € six 32.3 months million of 2021. for the first six months of 2022, on The the net sale profit of from Fidelta, discontinued our fee-for-services operations business, for the first for €six 22.2 months million. of 2021 consisted of the gain We lossreported of €55.0 million a groupfor net the loss same for the period first last six months year. of 2022 of €32.3 million, compared to a net
Cash, cash equivalents and current financial investments
30 Cash June and 2022 cash (€4,703.2 equivalents millionand on 31 current December financial 2021)investments . totaled €4,429.0 million on was A net recorded decrease during of €274.2 the first million six months in cash and of 2022, cash compared equivalents to and a net current decrease financial of €162.7 investments million during operational the first cashsix burn, months (ii) offset of 2021. by €3.6 This million net of decrease cash proceeds was composed from capital of (i) and €217.1 sharemillion premium of of increases positivefrom changes exercise in (fair) of subscription value of current rightsfinancial in the first investments six months and of € 2022, 60.4 million (iii) €11.8 of million mainly CellPoint positive exchange and AboundBio, rate differences, net of cashand acquired. (iv) €132.9 million cash out from the acquisitions of The financial operational measurecash that is burn not (or calculated operational in accordance cash flow with if this IFRS. liquidity Operational measure cashis burn/cash positive) flow is a exchange is defined rate as the differences increase on or decrease cash and in cash our equivalents), cash and cash minus: equivalents (excluding the effect of cash i. the flows net proceeds, generated if from/used any, from share in (–) financing capital and activities share premium increases included in the net in ii. the restricted net proceeds cash and or movement cash used, if inany, current in acquisitions financial investments, or disposalsifof any, businesses; the loansthe and movement advances given activities to third parties, if any, included in the net cash flows generated from/used in (–) investing the iii. the netcash cashused flowsfor generated other liabilities from/used related in (-)to operating the acquisition activities. of businesses, if any, included in
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Galapagos Half-year financial report 2022
THE GALAPAGOS GROUP
This alternative liquidity measure is in our view an important metric for a biotech company in the
development stage.
The following table provides a reconciliation of the operational cash burn:
Six months ended 30 June
(thousands of €) 2022 2021
Increase/decrease (-) in cash and cash equivalents
(excluding effect of exchange differences) (1,285,158) 477,448
Less:
Net proceeds from capital and share premium increases (3,619) (2,583)
Net purchase/sale (-) of current financial investments 938,732 (669,365)
Cash out from acquisition of subsidiaries, net of cash acquired 115,178 -
Cash advances and loans to third parties 10,000 -
Cash used for other liabilities related to the acquisition of
subsidiaries 7,765 -
Cash in from disposals of subsidiaries, net of cash disposed of - (28,696)
Total operational cash burn (217,102) (223,196)
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Galapagos Half-year financial report 2022
THE GALAPAGOS GROUP
Risk factors
supplemented We refer to the by description the description of of risk riskfactors factors in in our ourannual 2021 annual report on report, Form 20-F pp. 57-69, filed with as principal the U.S. Securities risks and and uncertainties Exchangefaced Commission, by us relate pp. 6-50. to and In include, summary but of are the not foregoing, limited the to: need commercialization, for additional capital; product our development reliance on third and regulatory parties; ourapproval; competitive our position; financial our position intellectual and as property; COVID-19); our organization, and market risks structure relating and tooperation our shares (including and ADSs. the emergence of pandemics such annual We also report, refer to pp. the 250-254, description which of remains the group’s validfinancial and unaltered. risk management given in the 2021
The Galapagos share
Performance of the Galapagos share on Euronext and Nasdaq
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Galapagos Half-year financial report 2022
THE GALAPAGOS GROUP
Related party transactions
to Wethe refer unaudited to the statements condensed included consolidated under the interim heading Related financial party statements transactions for in the the first “Notes six months of 2022” part of this report.
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Galapagos Half-year financial report 2022
THE GALAPAGOS GROUP
Disclaimer and other information
registered Galapagos office NV is at a limited Generaal liability De Wittelaan company L11 organized A3, 2800 under Mechelen, the laws Belgium of Belgium, . Throughout havingthis its report, references the to term “we,” “Galapagos “our,” “the NV” group” refers orsolely “Galapagos” to the non include -consolidated GalapagosBelgian NV together company withand its subsidiaries. and Withulcerative the exception colitis of by filgotinib’s the European approval Commission, as Jyseleca® Great for the Britain’s treatment Medicines of rheumatoid and Healthcare arthritis products candidates Regulatory mentioned Agency in this and report Japanese are investigational; Ministry of Health, their efficacy Labour and and safety Welfare, have not our been drug fully evaluated by any regulatory authority. the ThisEnglish report is version, published the in Dutch Dutch version and inshall English prevail . In case . Galapagos of inconsistency is responsible between for the the translation Dutch and and conformity between the Dutch and English version.
This report is available free of charge and upon request addressed to: Investor Galapagos Relations NV
Generaal 2800 Mechelen, De Wittelaan Belgium L11 A3 Tel: Email: +32 ir@glpg 15 34 .29 com 00
A digital version of this report is available on our website, www.glpg.com. responsibility We will use reasonable if inaccuracies effortsor toinconsistencies ensure the accuracy with of the the printed digital document version, but arise we do asnot a result assume of legally any electronic valid. Other transmission information . Therefore, on our website we consider or ononly other the websites printeddoes version notof form thisa report part of tothis be report.
Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies.
Listings
Nasdaq: Euronext GLPG Amsterdam and Brussels: GLPG
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Galapagos Half-year financial report 2022
THE GALAPAGOS GROUP
Forward-looking statements
uncertainties. This report contains These statements forward-looking are often, statements, but are not all always, of which madeinvolve throughcertain the userisks of words and “could,” or phrases “would,” such“potential,” as “believe,” “forward,” “anticipate,” “goal,” “expect,” “next,”“intend,” “stand to,” “plan,” “continue,” “seek,”“should,” “estimate,” “encouraging,” “may,” “will,” this “aim,” report “explore,” include, “further” but are asnot welllimited as similar to, statements expressions. made Forward-looking in the “Letter statements to our shareholders” contained in guidance section offrom thismanagement report, the information regarding the provided expected in operational the sectionuse captioned of cash during “Outlook financial 2022”,year the 2022, the acquisitions statements ofregarding CellPoint and our AboundBio, strategic and including capital allocation statements priorities, regarding statements anticipated regarding benefits plans, of the acquisitions statements and regarding the integration our regulatory of CellPoint and R&D and AboundBio outlook, statements into our portfolio regarding andexpected strategic financial in and/or results, royaltystatements payments,regarding our R&D strategy, the amount including and timing progress of potential on ourfuture fibrosis milestones, portfolio opt- and complementary our SIK platform,technology and potential platforms changes driving in such future strategy, growth, statements statements regarding regarding our the pipeline strategic and statements re-evaluation, regarding statements the global regarding R&D our collaboration expectations with on Gilead commercial and the amendment sales of filgotinib, of our regarding arrangement the with expected Gilead timing, for the design commercialization and readouts of and ongoing development and planned of filgotinib, clinical trials statements (or the osteoarthritis, discontinuation (iii) thereof) with GLPG3121 (i) with filgotinib in IBD, (iv) inwith RA, GLPG3667 UC and Crohn’s in psoriasis disease, and (ii) dermatomyositis, with GLPG0555 (v) in with in IPF, GLPG4399 (viii) with GLPG4586 in inflammation, and GLPG4605 (vi) with compounds in fibrosis, (ix) from with our GLPG2737 SIKi portfolio, in ADPKD, (vii) with (x)GLPG4716 with CD19 bispecific CAR-T in 2antibodies, Phase 1/2aincluding studies in recruitment rrNHL and rrCLL, for trials and and (xi) topline with theresults next-generation for trials and CAR-Ts studies and in inflammatory CAR-T, statements disorders, related including to the filgotinib, EMA’s initiated safety review at theof request JAK inhibitors of the European used to treat Commission certain (EC) regulatory under authorities, article 20 of the Regulation timing or(EC) likelihood No 726/2004, of additional statements regulatory relating authorities’ to interactions approval with of marketing Great Britain, authorization Japan, and for the filgotinib U.S., such for RA, additional UC or any regulatory other indication authorities for requiring filgotinib in additional Europe, studies, statements therelating timing to or the likelihood build-up of of pricing our commercial and reimbursement organization, interactions commercial for sales filgotinib, for and filgotinib Ukraine and on rollout our in operations Europe, statements and ongoing regarding studies the (including effect of the the impact conflict onbetween our DIVERSITY Russia our 1 study), strategy, statements businessregarding plans andthe focus. expected We caution impact theof reader COVID-19, that forward-looking and statementsstatements regarding of arefuture basedperformance. on our management’s Forward-looking current statements expectations may and involve beliefs, known and and are not unknown guarantees risks, uncertainties liquidity, performance and other orfactors achievements, which might or the cause industry our in actual which results, we operate, financial tocondition be materially and different expressed from or implied any historic by such or forward-looking future results, financial statements. conditions, Such risks performance include, but orare achievements not limited to, financial the risk results that our or our beliefs, 2022 assumptions operating expenses and expectations may be regarding incorrect our (including 2022 revenues because one and
20
Galapagos Half-year financial report 2022
THE GALAPAGOS GROUP
or realized), more the of our inherent assumptions risks andunderlying uncertainties our associated revenue or with expense competitive expectations developments, may not clinical be trial not limited and product to, thedevelopment risk that data activities from our and ongoing regulatory and planned approvalclinical requirements research (including, programs but in RA, kidney rrNHL, disease rrCLL, orCrohn’s any other disease, indication UC, IPF, or osteoarthritis, disease, may not other support inflammatory registration indications or further and risks development related to ofthe ouracquisitions product candidates of CellPoint due and to safety, AboundBio, or efficacy including concerns, the risk orthat other wereasons), may not risks achieve and the uncertainties anticipatedassociated benefits ofwith the target acquisitions discovery of CellPoint and validation and AboundBio, and drug discovery the inherent and our development collaboration activities, partner risks Gilead), relatedrisks to our related reliance to on thecollaborations implementation with of third the parties transition (including of the transition European will commercialization not be completed responsibility on the currently of filgotinib contemplated from Gilead timeline to us,or the at risk all, including that the expected the transition results of the for our supply business chain, and andresults the risk ofthat operations, the transition the risk will that notestimates have theregarding currently our our filgotinib expectations development regarding program the costs and and therevenues commercial associated potentialwith of our the product transfer candidates of European and commercialization continue to executerights on our tocurrently filgotinib contemplated may be incorrect, business the plan riskand/or that we willwill revise not our bebusiness able to plan, currently including anticipated the risk timeline that or ouratplans all, the with riskrespect that ourto projections CAR-T may and not expectations be achieved regarding on the the revenues commercial associated potential withof the our commercialization product candidates rights or expectations may be inaccurate, regarding thethe risk costs thatand we will plan, be the unable risk that to successfully we will encounter achievechallenges the anticipated retaining benefits or attracting from our talent, leadership risks related transition to continued disruption regulatory in our operations review of due filgotinib to the conflict following between approval Russia by relevant and Ukraine, regulatory the authorities risks related and to the the EMA’s risk that safety the EMA review and/or of JAKother inhibitors regulatory used to authorities treat certain determine inflammatory that additional disorders, non-clinical including or that clinical the market studies authorization are required for with filgotinib respect in to thefilgotinib, EU be amended, the risk that the risk the that EMAthe may EMA require may impose acceptance JAK of class-based filgotinib by warnings, patients,the therisk medical that community the EMA’s safety and healthcare review may payors negatively and the impact risks and of these uncertainties risks, uncertainties related to the and impact otherof risks the can COVID-19 be found pandemic. in our A filings further and listreports and description with the 20-F Securities filed with and Exchange the SEC and Commission our subsequent (SEC), including filings and inreports our most filed recent with annual the SEC. report We also on Form refer advised to the “Risk not to Factors” place any section undue ofreliance this report. on such Given forward-looking these risks and statements. uncertainties, In addition, the reader evenis if are the result consistent of ourwith operations, such forward-looking financial condition statements, and liquidity, theyor may the not industry be predictive in which we ofoperate, results, as performance of the dateor ofachievements publication ofin this future document. periods. We These expressly forward-looking disclaim any statements obligationspeak to update only any withsuch regard forward-looking thereto or any statements change in inevents, this document conditions to reflect or circumstances any change on in our which expectations any such forth statement in theis forward-looking based or that may statements, affect the unless likelihood specifically that actual required results by law will or differ regulation. from those set
21
Galapagos Half-year financial report 2022
Financial statements
Unaudited condensed consolidated interim financial statements for the first half-year of 2022
Foundation & Future
FINANCIAL STATEMENTS
Unaudited condensed consolidated
interim financial statements for the first
six months of 2022
Consolidated statements of income and
comprehensive income/loss (-)
(unaudited)
Consolidated income statement
Six months ended
Second quarter of 30 June
(thousands of €, except per share data) 2022 202120222021
Product net sales 20,945 37735,356456
Collaboration revenues 116,665 139,395238,601253,207
Total net revenues 137,610 139,772273,957253,664
Cost of sales (2,633) (93)(5,545)(131)
Research and development expenditure (149,597) (138,866)(249,518)(268,826)
Sales and marketing expenses (42,024) (14,425)(71,008)(28,961)
General and administrative expenses (29,646) (46,436)(63,001)(76,858)
Other operating income 9,957 13,29817,63723,564
Operating loss (76,332) (46,750)(97,478)(97,548)
Fair value adjustments and net currency
exchange differences 58,858 (13,500)71,92927,695
Other financial income 3,320 7304,0151,568
Other financial expenses (4,062) (5,439)(8,268)(9,347)
Loss before tax (18,217) (64,959)(29,802)(77,632)
Income taxes (811) 630(2,536)473
Net loss from continuing operations (19,028) (64,329)(32,338)(77,159)
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Galapagos Half-year financial report 2022
FINANCIAL STATEMENTS | ||||||||
Six months ended | ||||||||
Second quarter of | 30 June | |||||||
(thousands of €, except per share data) | 2022 | 2021 | 2022 | 2021 | ||||
Net profit from discontinued operations, net of tax | — | — | — | 22,191 | ||||
Net loss | (19,028) | (64,329) | (32,338) | (54,968) | ||||
Net loss attributable to: | ||||||||
Owners of the parent | (19,028) | (64,329) | (32,338) | (54,968) | ||||
Basic and diluted loss per share | (0.29) | (0.98) | (0.49) | (0.84) | ||||
Basic and diluted loss per share from continuing operations | (0.29) | (0.98) | (0.49) | (1.18) | ||||
The accompanying notes form an integral part of these condensed consolidated financial statements. 24 | ||||||||
Galapagos Half-year financial report 2022 |
FINANCIAL STATEMENTS
Consolidated statement of comprehensive income/loss (-)
Six months ended
Second quarter of 30 June
(thousands of €) 2022 202120222021
Net loss (19,028) (64,329)(32,338)(54,968)
Items that may be reclassified subsequently to
profit or loss:
Translation differences, arisen from translating
foreign activities 112 (95)93203
Realization of translation differences upon sale of
foreign operations - --731
Other comprehensive income/loss (-), net of
income tax 112 (95)93934
Total comprehensive loss attributable to:
Owners of the parent (18,916) (64,424)(32,245)(54,034)
Total comprehensive loss attributable to owners of
the parent arises from:
Continuing operations (18,916) (64,424)(32,245)(76,956)
Discontinued operations - --22,922
Total comprehensive loss (18,916) (64,424)(32,245)(54,034)
The accompanying notes form an integral part of these condensed consolidated financial
statements.
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Galapagos Half-year financial report 2022
Consolidated statements of financial position
(unaudited)
30 June 31 December
(thousands of €) 2022 2021
Assets
Goodwill 174,288 -
Intangible assets other than goodwill 32,346 60,103
Property, plant and equipment 148,866 137,512
Deferred tax assets 4,060 4,032
Non-current R&D incentives receivables 138,945 127,186
Other non-current assets 8,390 2,473
Non-current assets 506,893 331,306
Inventories 27,008 20,569
Trade and other receivables 47,231 111,337
Current R&D incentives receivables 16,826 16,827
Current financial investments 3,456,184 2,469,809
Cash and cash equivalents 972,796 2,233,368
Other current assets 13,147 9,945
Current assets 4,533,192 4,861,854
Total assets 5,040,085 5,193,160
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Galapagos Half-year financial report 2022
FINANCIAL STATEMENTS
30 June 31 December
(thousands of €) 2022 2021
Equity and liabilities
Share capital 293,026 292,075
Share premium account 2,733,059 2,730,391
Other reserves (10,493) (10,177)
Translation differences (1,313) (1,722)
Accumulated losses (367,381) (367,205)
Total equity 2,646,898 2,643,362
Retirement benefit liabilities 12,162 11,699
Non-current lease liabilities 16,875 19,655
Other non-current liabilities 35,948 7,135
Non-current deferred income 1,777,477 1,944,836
Non-current liabilities 1,842,462 1,983,325
Current lease liabilities 7,179 7,204
Trade and other liabilities 160,746 137,622
Current tax payable 723 1,782
Current deferred income 382,076 419,866
Current liabilities 550,725 566,474
Total liabilities 2,393,187 2,549,798
Total equity and liabilities 5,040,085 5,193,160
The accompanying notes form an integral part of these condensed consolidated financial
statements.
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Galapagos Half-year financial report 2022
FINANCIAL STATEMENTS
Consolidated cash flow statements
(unaudited)
Six months ended 30 June
(thousands of €) 2022 2021
Net loss of the period (32,338) (54,968)
Adjustment for non-cash transactions 6,567 50,310
Adjustment for items to disclose separately under operating
cash flow 3,529 2,518
Adjustment for items to disclose under investing and financing
cash flows (416) (28,843)
Change in working capital other than deferred income 46,034 81,359
Cash used for other liabilities related to the acquisition of
subsidiaries (7,765) -
Decrease in deferred income (209,428) (248,610)
Cash used in operations (193,818) (198,234)
Interest paid (7,417) (5,862)
Interest received 757 1,237
Corporate taxes paid (3,262) (272)
Net cash flows used in operating activities (203,740) (203,131)
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Galapagos Half-year financial report 2022
FINANCIAL STATEMENTS
Six months ended 30 June
(thousands of €) 2022 2021
Purchase of property, plant and equipment (15,574) (19,414)
Purchase of and expenditure in intangible fixed assets (1,783) (647)
Purchase of current financial investments (1,842,495) (703,841)
Interest received related to current financial investments 210 8
Sale of current financial investments 903,763 1,373,206
Cash in from disposals of subsidiaries, net of cash disposed of - 28,696
Cash out from acquisition of subsidiaries, net of cash acquired (115,178) -
Cash advances and loans to third parties (10,000) -
Proceeds from sale of financial assets held at fair value through
profit or loss - 4,045
Net cash flows generated from/used in (-) investing activities (1,081,057) 682,053
Payment of lease liabilities (3,980) (4,057)
Proceeds from capital and share premium increases from exercise
of subscription rights 3,619 2,583
Net cash flows used in financing activities (361) (1,474)
Increase/decrease (-) in cash and cash equivalents (1,285,158) 477,448
Cash and cash equivalents at beginning of year 2,233,368 2,143,071
Increase/decrease (-) in cash and cash equivalents (1,285,158) 477,448
Effect of exchange rate differences on cash and cash equivalents 24,586 22,121
Cash and cash equivalents at end of the period 972,796 2,642,639
The accompanying notes form an integral part of these condensed consolidated financial
statements.
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Galapagos Half-year financial report 2022
S29
30 June
(thousands of €)
2022
2021
Current financial investments
3,456,184
2,363,969
Cash and cash equivalents
972,796
2,642,639
Current financial investments and cash and cash equivalents
4,428,980
5,006,608
The accompanying notes form an integral part of these condensed consolidated financial
statements.
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Galapagos Half-year financial report 2022
S30
FINANCIAL STATEMENTS
Consolidated statements of changes in equity
(unaudited)
Share
Share premium Translation OtherAccumul.
(thousands of €) capital account differencesreserveslossesTotal
On 1 January 2021 291,312 2,727,840(3,189)(10,907)(334,701)2,670,355
Net loss (54,968)(54,968)
Other comprehensive
income 795139934
Total comprehensive
income/loss (-) 795139(54,968)(54,034)
Share-based compensation 44,56844,568
Exercise of subscription
rights 599 1,9842,583
On 30 June 2021 291,912 2,729,824(2,394)(10,768)(345,101)2,663,473
On 1 January 2022 292,075 2,730,391(1,722)(10,177)(367,205)2,643,362
Net loss (32,338)(32,338)
Other comprehensive
income/loss (-) 409(316)93
Total comprehensive
income/loss (-) 409(316)(32,338)(32,245)
Share-based compensation 32,16332,163
Exercise of subscription
rights 951 2,6683,619
On 30 June 2022 293,026 2,733,059(1,313)(10,493)(367,381)2,646,898
The accompanying notes form an integral part of these condensed consolidated financial
statements.
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Galapagos Half-year financial report 2022
S31
FINANCIAL STATEMENTS
Notes to the unaudited condensed consolidated interim financial statements for the first six months of 2022
Basis of preparation
These IAS 34 condensed ‘Interim Financial consolidated Reporting’ interim as adopted financial bystatements the European have Union been and prepared as issued in accordance by the IASB.with The annual condensed report consolidated and should interim therefore financial be read statements in conjunction do not withcontain our Annual all information Report 2021 required . for an
Impact of COVID-19 on the financial statements
cash To date, flows we and have significant experienced judgements limited impact and estimates, on our financial althoughperformance, we continue to financial face additional position, risks and challenges associated with the impact of the outbreak.
Significant accounting policies
There consolidated were no interim significant financial changes statements in accounting compared policies to those applied used by in the us in most these recent condensed annual consolidated financial statements of 31 December 2021.
New did not standards have any and material interpretations impact onapplicable our condensed for the consolidated annual period interim beginning financial on 1 January statements 2022 . We issued have but not is not early yetadopted effectiveany . other standard, interpretation, or amendment that has been
New accounting policies as a result of recent transactions
Business combinations
position, Business the combinations acquiree’s are identifiable accounted assets, for using liabilities the acquisition and contingent method liabilities . In theare statement initially recognized of financial consolidated at their fair value income at the statement acquisition from date the . The date results on which of acquired control operations is obtained are . included Any contingent in our consideration Subsequent changes to be transferred to the fair by value us of will the becontingent recognizedconsideration, at fair value which at theis acquisition deemed to date be. purchase an asset or consideration liability, willtransferred be recognized overin the profit fair value or loss of.the The acquired excess assets of the and fair assumed value of the liabilities total is information recognized available as goodwill at the . acquisition The valuations date.in Acquisition support of related fair value costs are determinations expensed as are incurred based . on
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Galapagos Half-year financial report 2022
S32
FINANCIAL STATEMENTS
Key sources of estimation uncertainty
Acquisition of CellPoint
We assets determine acquiredand and allocate liabilities the assumed purchase asprice of the relating acquisition to thedate, acquisition being 21 of CellPoint June 2022. to The the that purchase determine price the determination present fairprocess value ofrequires the contingent us to use consideration significant estimates included in and theassumptions transaction. adjusted These estimates by our best depend estimate on of development, their probability regulatory of success andand sales-based discounted. milestones We also anticipate that are to process. use significant estimates and assumptions in the finalization of the purchase price accounting
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Galapagos Half-year financial report 2022
S33
FINANCIAL STATEMENTS
Details of the unaudited condensed consolidated
interim results
Product net sales
We reported net sales of Jyseleca for the first six months of 2022 amounting to €35.4 million
(€0.5 million in the first six months of 2021).
Related costs of sales in the first half-year of 2022 amounted to €5.5 million.
Collaboration revenues
The following table summarizes our collaboration revenues for the six months ended
30 June 2022 and 2021:
Six months ended 30
Second quarter of June
Over Point in
(thousands of €) time time2022202120222021
Recognition of non-refundable
upfront payments and license
fees 105,384127,215204,301232,441
Gilead collaboration agreement
for filgotinib 47,78469,33989,385116,744
Gilead collaboration agreement
for drug discovery platform 57,60157,876114,916115,697
Milestone payments 9,56411,50427,93819,369
Gilead collaboration agreement
for filgotinib 8,56411,50425,93819,369
Sobi distribution agreement for
Jyseleca 1,000-2,000-
Royalties 1,7166766,3611,397
Gilead royalties on Jyseleca 1,7166726,3171,350
Other royalties -44447
Total collaboration revenues 116,665139,395238,601253,207
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Galapagos Half-year financial report 2022
S34
FINANCIAL STATEMENTS
The rollforward of the outstanding balance of the current and non-current deferred income
between 1 January 2022 and 30 June 2022 can be summarized as follows:
Gilead
Gileadcollaboration
collaborationagreement for
agreementdrug discoveryOther deferred
(thousands of €) Total for filgotinibplatform (1)income
On 1 January 2022 2,364,701 604,8751,759,828-
Milestones achieved 18,238 18,238
Significant financing component (2) 3,799 3,799
Revenue recognition of upfront (204,301) (89,385)(114,916)
Revenue recognition of milestones (25,938) (25,938)
Other movements 3,053 3,053
On 30 June 2022 2,159,553 511,5881,644,9123,053
(1) The upfront received and the outstanding balance at 1 January 2022 and at 30 June 2022 comprise the issuance
liabilities for the warrants and the upfront payment allocated to the drug discovery platform.
(2) With regard to the additional consideration received for the extended cost sharing for filgotinib, we assume the
existence of a significant financingcomponent reflecting the time value of money on the estimated recognition
period.
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Galapagos Half-year financial report 2022
S35
FINANCIAL STATEMENTS
Operating costs and other operating income
Operating costs
Research and development expenditure
The following table summarizes our research and development expenditure for the six months
ended 30 June 2022 and 2021:
Six months ended 30
Second quarter of June
(thousands of €) 2022 202120222021
Personnel costs (45,752) (53,772)(85,957)(94,154)
Subcontracting (62,332) (66,213)(104,060)(139,193)
Disposables and lab fees and premises costs (5,103) (6,370)(10,310)(12,287)
Depreciation and impairment (29,169) (4,816)(32,555)(8,099)
Professional fees (2,994) (3,828)(7,402)(7,041)
Other operating expenses (4,249) (3,867)(9,234)(8,052)
Total research and development expenditure (149,597) (138,866)(249,518)(268,826)
The increase in depreciation and impairment for the first six months of 2022 is primarily due to
an impairment of €26.7 million of previously capitalized upfront fees related to our collaboration
with Molecure on the dual chitinase inhibitor OATD-01.
The table below summarizes our R&D expenditure for the six months ended 30 June 2022 and
2021, broken down by program.
Six months ended 30
Second quarter of June
(thousands of €) 2022 202120222021
Filgotinib program (71,280) (50,908)(116,147)(87,840)
Toledo program (12,744) (24,412)(26,098)(52,235)
TYK2 program on GLPG3667 (5,611) (7,984)(9,078)(13,974)
Ziritaxestat program (106) (8,905)(638)(19,418)
Other programs (59,856) (46,657)(97,557)(95,359)
Total research and development expenditure (149,597) (138,866)(249,518)(268,826)
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Galapagos Half-year financial report 2022
S36
FINANCIAL STATEMENTS
Sales and marketing expenses
The following table summarizes our sales and marketing expenses for the six months ended
30 June 2022 and 2021:
Six months ended 30
Second quarter of June
(thousands of €) 2022 202120222021
Personnel costs (19,690) (16,569)(35,723)(26,871)
Depreciation (907) (117)(1,122)(168)
External outsourcing costs (15,293) (14,844)(25,671)(24,959)
Sales and marketing expenses recharged to Gilead - 18,8853125,527
Professional fees (1,165) (162)(1,534)(180)
Other operating expenses (4,970) (1,618)(6,989)(2,310)
Total sales and marketing expenses (42,024) (14,425)(71,008)(28,961)
The termination of our 50/50 filgotinib co-commercialization cost sharing agreement with Gilead
explains a significant part of the increase in sales & marketing expenses.
General and administrative expenses
The following table summarizes our general and administrative expenses for the six months
ended 30 June 2022 and 2021:
Six months ended 30
Second quarter of June
(thousands of €) 2022 202120222021
Personnel costs (15,211) (21,361)(35,629)(37,568)
Depreciation and impairment (2,383) (11,060)(4,297)(12,730)
Legal and professional fees (6,309) (7,610)(10,817)(13,469)
Other operating expenses (5,744) (6,406)(12,259)(13,092)
Total general and administrative expenses (29,646) (46,436)(63,001)(76,858)
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Galapagos Half-year financial report 2022
S37
FINANCIAL STATEMENTS
Other operating income
The following table summarizes our other operating income for the six months ended
30 June 2022 and 2021:
Six months ended 30
Second quarter of June
(thousands of €) 2022 202120222021
Grant income 572 2,5151,0093,787
R&D incentives 8,818 10,65615,90319,502
Other 567 128725276
Total other operating income 9,957 13,29817,63723,564
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S38
FINANCIAL STATEMENTS
Financial income/expenses
The following table summarizes our financial income/expenses (-) for the six months ended 30
June 2022 and 2021:
Six months ended 30
Second quarter of June
(thousands of €) 2022 202120222021
Fair value adjustments and net currency exchange
differences
Net currency exchange gain/loss (-) 46,718 (12,096)60,16833,613
Fair value re-measurement of warrants 136 858(49)2,828
Fair value loss on financial assets held at fair value
through profit or loss - --(2,913)
Fair value gain/loss (-) on current financial
investments 12,004 (2,262)11,810(5,833)
Total fair value adjustments and net currency
exchange differences 58,858 (13,500)71,92927,695
Other financial income:
Interest income 2,956 6963,6181,442
Effect of discounting long term R&D incentives
receivables 23 234646
Other finance income 341 1135180
Total other financial income 3,320 7304,0151,568
Other financial expenses:
Interest expenses (2,142) (3,050)(4,206)(4,425)
Effect of discounting long term deferred income (1,860) (2,323)(3,799)(4,770)
Other finance charges (60) (66)(264)(152)
Total other financial expenses (4,062) (5,439)(8,268)(9,347)
Total net financial result 58,115 (18,209)67,67619,916
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Galapagos Half-year financial report 2022
S39
FINANCIAL STATEMENTS
Cash position
Cash and cash equivalents and current financial investments totaled €4,429.0 million on
30 June 2022 (€4,703.2 million on 31 December 2021).
Cash and cash equivalents and current financial investments comprised cash at banks, term
deposits, treasury bills and money market funds. Our cash management strategy monitors and
optimizes our liquidity position. Our cash management strategy allows short-term deposits with
an original maturity exceeding three months while monitoring all liquidity aspects.
Cash and cash equivalents comprised €487.8 million of term deposits which all had an original
maturity longer than three months. All cash and cash equivalents are available upon maximum
three months notice period and without significant penalty. Cash at banks were mainly composed
of notice accounts and current accounts. Our credit risk is mitigated by selecting a panel of highly
rated financial institutions for our deposits.
Current financial investments comprised €1,332.9 million of term deposits which all had an
original maturity longer than three months and which are not available on demand within three
months. Our current financial investments also comprised money market funds and treasury
bills. Our portfolio of treasury bills contains only AAA rated paper, issued by Germany. Our money
market funds portfolio consists of AAA short-term money market funds with a diversified and
highly rated underlying portfolio managed by established fund management companies with a
proven track record.
30 June 31 December
(thousands of €) 2022 2021
Money market funds 1,295,726 1,317,460
Treasury bills 827,574 877,349
Term deposits 1,332,884 275,000
Total current financial investments 3,456,184 2,469,809
Cash at banks 485,031 1,225,860
Term deposits 487,765 1,007,508
Total cash and cash equivalents 972,796 2,233,368
Total current financial investments and cash and
cash equivalents 4,428,980 4,703,177
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Galapagos Half-year financial report 2022
S40
FINANCIAL STATEMENTS
On 30 June 2022, our cash and cash equivalents and current financial investments included
$953.8 million held in U.S. dollars ($942.5 million on 31 December 2021) which could generate
foreign exchange gains or losses in our financial results in accordance with the fluctuation of
the EUR/U.S. dollar exchange rate as our functional currency is EUR. The foreign exchange loss
(–)/gain in case of a 10% change in the EUR/U.S. dollar exchange rate amounts to €91.8 million.
Capital increase
On 30 June 2022, Galapagos NV’s share capital was represented by 65,728,511 shares. All shares
were issued, fully paid up and of the same class. The below table summarizes our capital
increases for the period ended 30 June 2022.
Average
exerciseClosing
price sub-share price
scriptionon date of
Sharerightscapital
capital and(in €/ sub-increase
(thousands of €, except Number of ShareSharesharescription(in €/
share data) shares capitalpremiumpremiumright)share)
On 1 January 2022 65,552,721 292,0752,730,3913,022,467
18 March 2022: exercise of
subscription rights 95,500 5171,6432,16022.6157.38
20 June 2022: exercise of
subscription rights 80,290 4341,0251,46018.1853.52
On 30 June 2022 65,728,511 293,0262,733,0593,026,086
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S41
FINANCIAL STATEMENTS
Note to the cash flow statement
Six months ended 30 June
(thousands of €) 2022 2021
Adjustment for non-cash transactions
Depreciation and impairment 37,974 20,996
Share-based compensation expenses 32,163 44,568
Increase in retirement benefit obligations and provisions 270 190
Unrealized exchange gains and non-cash other financial result (59,627) (26,537)
Discounting effect of deferred income 3,799 4,770
Fair value re-measurement of warrants 49 (2,828)
Net change in (fair) value of current financial investments (11,810) 5,833
Fair value adjustment financial assets held at fair value through
profit or loss - 2,913
Other non-cash expenses 3,750 405
Total adjustment for non-cash transactions 6,567 50,310
Adjustment for items to disclose separately under operating
cash flow
Interest expense 4,206 4,425
Interest income (3,214) (1,434)
Tax expense 2,536 (473)
Total adjustment for items to disclose separately under
operating cash flow 3,529 2,518
Adjustment for items to disclose under investing and financing
cash flows
Gain on sale of subsidiaries - (22,191)
Gain (-)/loss on sale of fixed assets (11) 1
Realized exchange gain on sale of current financial investments - (6,645)
Interest income on current financial assets (405) (8)
Total adjustment for items to disclose separately under investing
and financing cash flow (416) (28,843)
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S42
FINANCIAL STATEMENTS
Six months ended 30 June
(thousands of €) 2022 2021
Change in working capital other than deferred income
Increase in inventories (10,195) (1,419)
Decrease in receivables 53,204 107,041
Increase/decrease (-) in liabilities 3,025 (24,263)
Total change in working capital other than deferred income 46,034 81,359
Business combinations
On 21 June 2022 we acquired, in an all-cash transaction, 100% of the shares and voting interests
of CellPoint for a total agreed payment at completion of €125 million, including consideration for
other liabilities associated with the transaction amounting to €10.3 million. Additional contingent
consideration up to €100.0 million is due when certain development, regulatory and sales-based
milestones would be achieved.
On the same date we acquired all of the outstanding capital of AboundBio, for a total agreed
price of $14 million, including consideration for other liabilities associated with the transaction.
The main reason for these acquisitions is to position ourselves in next-generation cancer therapy
market and to significantly broaden our portfolio and capabilities. As a result of these
acquisitions, we gain access to an innovative, scalable, decentralized and automated point-
of-care cell therapy supply model as well as a next-generation fully human antibody-based
therapeutics platform. Combined and supported by us as a fully integrated biopharma, they
have the potential to disrupt the CAR-T treatment paradigm. The goal is to expand the current
market for CAR-T therapies and have an important impact on patients in need of additional and
improved treatment options.
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Galapagos Half-year financial report 2022
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FINANCIAL STATEMENTS
Details of the preliminary fair value of identifiable assets and liabilities acquired in both
transactions, the preliminary purchase consideration and provisional goodwill at the acquisition
date are as follows:
21 June 2022
(thousands of €) CellPoint AboundBioTotal
Property, plant and equipment 1,289 965
Other non-current assets 81 4
Trade and other receivables 162 -
Cash and cash equivalents 3,179 4,279
Other current assets 1,254 536
Trade and other liabilities (32,789) (587)
Current deferred income - (474)
Net assets acquired (26,824) 4,723
Consideration paid in cash 107,750 14,886
Fair value re-measurement of previously held equity
investment - 342
Deferred consideration 6,088 90
Fair value of contingent consideration 22,865 -
Fair value of total consideration 136,703 15,318
Goodwill 163,526 10,595
Exchange differences on goodwill - 166
Goodwill in the balance sheet 163,526 10,761174,288
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Galapagos Half-year financial report 2022
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FINANCIAL STATEMENTS
Net cash outflow arising on acquisition
21 June 2022
(thousands of €) CellPoint AboundBioTotal
Consideration paid in cash 107,750 14,886
Less: cash and cash equivalents balances acquired (3,179) (4,279)
Cash out from acquisition of subsidiaries, net of cash
acquired 104,57110,607115,178
Cash used in operating activities for other liabilities
related to the acquisition of subsidiaries 7,765-7,765
The preliminary fair value of the identifiable assets and liabilities are included in our condensed
consolidated interim financial statements as per 30 June 2022. To date we have performed a
preliminary fair value analysis of the business combinations, with corresponding adjustments
to the trade and other liabilities. We expect the provisional amount of goodwill to change
significantly upon the completion of the purchase price allocation, resulting from the valuation of
the different assets and liabilities acquired, including the valuation of in-process R&D.
Contingencies and commitments
Contractual obligations and commitments
We have certain purchase commitments principally with CRO subcontractors and certain
collaboration partners.
On 30 June 2022, we had outstanding obligations for purchase commitments, which become due
as follows:
Less than More than
(thousands of €) Total 1 year1—3 years3—5 years5 years
Purchase commitments 442,874 231,179141,70746,56423,425
In addition to the table above, we have a contractual cost sharing obligation related to our
collaboration agreement with Gilead for filgotinib. The contractual cost sharing commitment
amounted to €304.2 million at 30 June 2022 for which we have direct purchase commitments of
€227.4 million at 30 June 2022 reflected in the table above.
Contingent liabilities and assets
We refer to our Annual Report 2021 for a description of our contingent liabilities and assets.
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Galapagos Half-year financial report 2022
S45
FINANCIAL STATEMENTS
Related party transactions
Subscription On 26 January Right 2022, Plan 2022 our current (B), which CEO have was been offered accepted 1,000,000 on 24 March subscription 2022. The rights number under of on accepted 25 March subscription 2022. Therights subscription under Subscription rights have an Right exercise Plan 2022 term(B) of was eight enacted years as by of notary the date deed of the for one offer new and Galapagos have an exercise share. The price subscription of €50. Each rights subscription can in principle right gives not be the exercised right to subscribe prior to 1 January 2026.
(‘RSUs’), On 3 May subject 2022,to members acceptance. of the The executive RSUs arecommittee offered forwere no consideration. offered new Four restricted members stockof units the executive at Galapagos’ committee discretion, accepted one Galapagos all RSUs offered shareto or them. a payment Each RSU in cash represents of an amount the rightequivalent to receive, 30-calendar to the volume-weighted day period preceding average price the relevant of the Galapagos vesting date. share The on first Euronext RSU grant Brussels will vest over in the full three vesting years each after yearthe and offer a first date. vesting The second date on RSU 1 May grant 2023. has aFor four-year the members vesting period, of the executive with 25% payment committee, in cash any vesting rather than prior ato delivery the third of shares. anniversary of the offer date will always give rise to a under On 6 May Subscription 2022, members Right Plan of the 2022 executive BE, subject committee to acceptance. were offered A firstnew portion subscription of the number rights deed of accepted on 7 July subscription 2022. For three rights members under Subscription of the executive Right Plan committee, 2022 BE the was suspensive enacted by condition notary of of acceptance the date of the is still offer. outstanding. The exercise Theprice subscription of the subscription rights have an rights exercise is €57.46 term(the of eight closing years price as the of the offer) Galapagos . Each subscription share on Euronext right gives Amsterdam the right to and subscribe Brusselsfor onone the new day preceding Galapagosthe share. date For of all fully the onbeneficiaries the first day of under the fourth Subscription calendar Right year Plan following 2022 the BE the calendar subscription year in which rights the vestgrant only was and 1 made. January The 2026. subscription rights are not transferable and can in principle not be exercised prior to
46
Galapagos Half-year financial report 2022
S46
The table below sets forth the number of subscription rights offered under Subscription Right
Plan 2022 (B) and Subscription Right Plan 2022 BE and the total number of RSUs accepted by
each member of the executive committee during the first six months of 2022:
Number of 2022
subscription rightsNumber of 2022
Name Title offeredRSUs accepted
Stoffels IMC BV (1) CEO 1,000,000 (2)74,408
Bart Filius President, CFO & COO 68,000 (3)61,442
Walid Abi-Saab CMO 32,00037,274
Michele Manto CCO 24,00027,354
(1) Stoffels IMC BV (permanently presented by Dr. Paul Stoffels).
(2) These subscription rights have already been accepted.
(3) 100 subscription rights have already been accepted, the remainder is outstanding for acceptance.
On 26 April 2022, Galapagos held an extraordinary shareholders’ meeting, followed by its annual
shareholders’ meeting. All agenda items were approved, including the approval of (a) the
appointment of Stoffels IMC BV (permanently represented by Dr. Paul Stoffels) as director, and
(b) the appointments of Jérôme Contamine and Dr. Dan Baker as independent directors within
the meaning of article 7:87 of the Belgian Companies and Associations Code and article 3.5 of the
Belgian Corporate Governance Code 2020. Subsequently, the (new) unitary board has appointed
Stoffels IMC BV (permanently represented by Dr. Paul Stoffels) as chair of the board of directors.
The mandates of Howard Rowe and Katrine Bosley as members of the board of directors came
to an end on 26 April 2022.
During the first six months of 2022, other than as disclosed in the paragraph above, there were
no changes to related party transactions disclosed in the 2021 annual report that potentially had
a material impact on the financials of Galapagos of the first six months of 2022.
Events after the end of the reporting period
There were no adjusting events nor material non-adjusting events to be reported.
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OTHER INFORMATION
Glossary
100 points clinical response
Percentage patients of patients achieving a 100-point decrease in CDAI score during a clinical trial in CD
ACR
American College of Rheumatology
ACR20 (ACR 20/50/70)
in American the number College of of swollen Rheumatology and tender 20% joints response as wellrate as a signifies 20% oragreater 20% orimprovement greater improvement in three out response of five rates, other respectively disease-activity measures. ACR50 and ACR70 reflect the same, for 50% and 70%
ADPKD
enlarged Autosomal with dominant fluid-filled polycystic cysts, leading kidney to disease, kidney failure. a disease Other where organs typically may be both affected kidneys asbecome well
ADS
American GLPG andDepositary CUSIP number Share; 36315X101. Galapagos One has ADS a Level is equivalent 3 ADS listed to one onordinary Nasdaqshare with ticker in Galapagos symbol NV
AFM
Dutch Authority for the Financial Markets
Anemia
the Condition body’s in tissues which the patient has an inadequate number of red blood cells to carry oxygen to
Anti-TNF
Tumor necrosis factor. An anti-TNF drug acts by modulation of TNF
Antibody
A combine blood chemically protein produced with substances in response whichto theand body counteracting recognizes asa alien, specific suchantigen. as bacteria, Antibodies viruses, and foreign substances
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OTHER INFORMATION
Assays
Laboratory tests to determine characteristics
Attrition rate
development The historical paths. success Statistically rate for drug seen,discovery investment andindevelopment, at least 12 target-based based on publicly programs known is programs required to are ensure discontinued that at least before one reaching of these Phase will reach 3 because a Phase they3 are study. not successful Most new enough drug R&D to be approved
BID dosing
Twice-daily dosing (bis in die)
Bioavailability
(oral) Assessment administration of the amount of product candidate that reaches a body’s systemic circulation after
Biomarker
Substance product candidate used as has an aindicator biologicalof effect a biological process, particularly to determine whether a
Bispecific antibody
An antibody that binds to two different antigens
Black & Scholes model
A widely mathematical used in the description pricing of European of financial options markets and and subscription derivative rights investment instruments that is
Bridging trial
extrapolate Clinical trial performed data from one to “bridge” population or extrapolate to anotherone for the dataset same todrug thatcandidate, for another or situation, to movei.from e. to IV to subcutaneous dosing
CAR-T
Chimeric engineered antigen to produce receptor an T artificial cells (also T cell known receptor as CAR for T use cells) in immunotherapy are T cells that have been genetically
CD19
CD19 hallmark is a ofprotein B-cells,found the protein on the has surface been of used B-cells, to diagnose a type of cancers white blood that arise cell.from Since this CD19 type isof a cell—notably B-cell lymphomas
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OTHER INFORMATION
CDAI
pre-defined Crohn’s Disease weight Activity as a way Index, to evaluating quantify the patients impacton of CD eight different factors, each of which has a
CDAI remission
In <150 the FITZROY trial, the percentage of patients with CD who showed a reduction of CDAI score to
CFTR
Cystic channel fibrosis in vertebrates transmembrane that is encoded conductance by the regulator CFTR gene. (CFTR) It isishypothesized a membrane that protein inhibition and chloride of the a CFTR CFTR channel inhibitor might reduce cyst growth and enlargement for patients with ADPKD. GLPG2737 is
CHIT1/AMCase
chitinase. Chitotriosidase CHIT1(CHIT1) is predominantly is a proteininvolved coding gene, in macrophage and AMCase activation. is an inactive Inhibition acidic ofmamalian chitinase preclinical activity translates models.into GLPG4716 a potential is a therapeutic CHIT1/AMCase benefit inhibitor in lung targeting diseases a key like pathway IPF, as shown in tissue in remodeling
CHMP
committee Committee responsible for Medicinalfor Products humanfor medicines Human Use and is plays the European a vital role Medicines in the authorization Agency’s (EMA) of medicines in the European Union (EU)
CIR
Crédit up to 30% d’Impôt of the Recherche, annual investment or research incredit. French Under R&D operations, the CIR, theover French a period government of three refunds years. Galapagos benefits from the CIR through its operations in Romainville, just outside Paris
CRP
C-reactive inflammation protein is a protein found in the blood, the levels of which rise in response to
Cash position
Current financial investments and cash and cash equivalents
Chitinase
chitinase Chitinaseactivity is an enzyme translates thatinto degrades a potential chitin, therapeutic involved inbenefit the human in lung innate diseases immunity. like IPF, Inhibition as shown of in preclinical models
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OTHER INFORMATION
Chronic Lymphocytic Leukemia (CLL)
starts Chronic in lymphocytic cells that become leukemia certain is the white most blood common cells (called leukemia lymphocytes) in adults. It inis the a type bone of marrow. cancer that The cancer (leukemia) cells originate in the bone marrow and migrate to the bloodstream
Clinical Proof of Concept (PoC)
Point therapeutic in the setting drug development process where the product candidate first shows efficacy in a
Complete Response Letter (CRL)
A application letter send is by notthe ready FDA for to approval indicate that in itsthe present review form cycle for an application is complete and the
Compound
A chemical substance, often a small molecule with drug-like properties
Contract research organization (CRO)
Organization biotechnologywhich and medical provides devices drug discovery industry on and a contract development basis services to the pharmaceutical,
Corticosteroids
have Any of various a group metabolic of steroid functions hormones andproduced some arein used the to adrenal treat inflammation cortex or made synthetically. They
Crohn’s disease (CD)
ultimately An IBD involving in some inflammation cases surgical of removal the small of and partslarge of the intestines, bowel leading to pain, bleeding, and
Cytokine
A category of small proteins which play important roles in signaling in processes in the body
DARWIN
Phase daily administration, 2 program forfor filgotinib up to 24 inweeks RA. DARWIN in RA patients 1 explored with insufficient three doses, response in twice-daily to methotrexate and once-(MTX) three and once-daily who remained doses for on their up to stable 24 weeks background in RAtreatment patients with with MTX. insufficient DARWIN response 2 explored to double-blind, methotrexate placebo-controlled (MTX) and who washed trials out which of recruited their treatment approximately with MTX. 900 DARWIN patients 1 globally and 2 were and for patients which are results on 200 were mg filgotinib, reported except in 2015. for DARWIN U.S. males 3 is who a long are on term 100 extension mg. The week trial in 156 which results all from DARWIN 3 were reported in 2019
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OTHER INFORMATION
DAS28 (CRP)
counts DAS28 is ofan 28RA defined Disease joints, Activity theScore physician’s basedglobal on a calculation health assessment that usesand tender a serum and swollen marker joint for calculation: inflammation, scores such range as C- from reactive 2.0 to protein. 10.0, with DAS28 scores (CRP) below includes 2.6 being the considered C-reactive remission protein score
DDI study
effects Drug-drug of interaction a drug caused study. by concomitant This type of administration study will assess with if there another is a change drug in the action or side
DIVERGENCE
Phase small bowel 2 programs CD and with DIVERGENCE filgotinib in 2 Crohn’s in fistulizing disease. CD DIVERGENCE 1 was an exploratory study in
DIVERSITY
Phase 3 program evaluating filgotinib in CD
DMARDs
Disease the symptoms modifying anti rheumatic drugs; these drugs address the disease itself rather than just
Deep venous thrombosis (DVT)
The lower formation limbs. The of blood one or clots more can blood travel clots to the in one lung of and the cause body’s a large pulmonary veins, most embolism commonly in the
Degradation
The molecules process by which proteins are lost through the use of drugs such as PROTACs or small
Dermatomyositis
rash, Dermatomyositis and inflammatory is a rare myopathy, inflammatory or inflamed disease. muscles, Common causing symptoms muscle weakness include distinctive skin
Development
All development activities required research, to chemical bring a new anddrug pharmaceutical to the market. development This includes and preclinical regulatory and filings clinical of product candidates
Discovery
Process department by which that oversees new medicines target are anddiscovered drug discovery and/orresearch designed. through At Galapagos, to nomination this is the of preclinical candidates
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OTHER INFORMATION
Disease-modifying
Addresses disease the disease itself, modifying the disease progression, not just the symptoms of the
Dose-range finding study
Phase treatment 2 clinical in patients. study exploring Results are the used balance to determine between doses efficacy for and later safety studies among various doses of
Double-blind
patient Term to ischaracterize taking placebo a clinical or the trial treatment in which being neither evaluated the physician nor the patient knows if the
EC
European Commission
EMA
European Medicines Agency, in charge of European market authorization of new medications
Efficacy
Effectiveness for intended use
End-to-end
functional A process solution, that takes usually a system without or strong service reliance from on beginning third parties to end and delivers a complete
Endoscopy
A non-surgical procedure involving use of an endoscope to examine a person’s digestive tract
FDA
The public U. S. health Food and and inDrug charge Administration of American market is an agency approval responsible of new medications for protecting and promoting
FIH
First-in-human safety, tolerability clinical and pharmacokinetics trial, usually conducted of the product in healthy candidate volunteers with the aim to assess the
FILOSOPHY
Phase 4 program evaluating filgotinib in RA
FINCH
Phase 3 program evaluating filgotinib in RA
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OTHER INFORMATION
FITZROY
A weeks. double-blind, Full results placebo were published controlled inPhase The Lancet 2 trial in with 2016 filgotinib in 177 CD patients for up to 20
FORM 20-F
Form 20-F is an SEC filing submitted to the US Securities and Exchange Commission
FSMA
The Financiële Belgian Diensten market en authority: Markten Financial Services and Markets Authority, or Autoriteit voor
FTE
FTE Full-time of 1.0equivalent; means that a the way equivalent to measure work an of employee’s one full-time involvement worker was in a used project. on the For project example, an
Fast Track
of A designation drugs which by treat the a FDA serious of an or investigational life-threatening drug condition for expedited and fill review an unmet to facilitate medical development need
Fee-for-service
service Payment performed system where the service provider is paid a specific amount for each procedure or
Filgotinib
Formerly inhibitor, approved known as in GLPG0634, RA in European commercial Union, name Great is Britain, Jyseleca. and Small Japan, molecule and inpreferential UC in European JAK1 is Union partnered and Great with Britain. Gilead. Application Filgotinib currently for approval is in Phase for ulcerative 3 trials in colitis CD, was and filed in a Phase in Japan. 4 trial Filgotinib in RA
Fistulizing CD
Fistulae region. Fistulae are inflammatory are one of tracts thethat most most severe often sequelae occur between of luminal the distal CD and colon theand lifetime the perianal risk of occurrence is close to 50% of those with active CD
Futility analysis
Analysis information of the to be likelihood gathered. of The a trial term to ‘futility’ meet its isprimary used to refer endpoint, to the based low likelihood on a subset of aof clinical the total trial to that achieve it is unlikely its objectives. to achieve Instatistical particular, significance stopping a can clinical save trial resources when that the interim could be results used on suggest more promising research
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OTHER INFORMATION
G&A expenses
General & administrative expenses
GLIDER
Phase 2 Proof of Concept trial with SIK2/3 inhibitor GLPG3970 in Sjögren’s syndrome
GLPG0555
A JAK1 inhibitor in Phase 1b. Development was stopped in July 2022
GLPG0634
Molecule number currently known as filgotinib and Jyseleca
GLPG2737
A AbbVie compound but Galapagos currently retained in Phase rights 2 in ADPKD. outsideThis of CF compound is part of the CF collaboration with
GLPG3121
was A compound stopped in in July Phase 2022 1 targeting JAK1/TYK2 directed toward inflammation (IBD). Development
GLPG3667
A in TYK2 July 2021 kinase inhibitor discovered by us, topline results from the Phase 1b in psoriasis reported
GLPG3970
in A SIK2/3 UC, psoriasis inhibitor and in multiple RA werePhase reported 2 Proof in July of 2021. Concept The studies. compound Topline was results discontinued from the instudies March 2022
GLPG4399
A SIK3 inhibitor currently in Phase 1 directed toward inflammation
GLPG4586
inlicensed A compound from with Fibrocor. undisclosed The development mode of action was in stopped preclinical in July phase 2022 directed toward fibrosis and
GLPG4605
A SIK2/3 inhibitor in the preclinical phase, currently directed toward fibrosis
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OTHER INFORMATION
GLPG4716
molecule A chitinase have inhibitor been returned inlicensed to Molecure from Molecure in July 2022 (previously OncoArendi). The rights to the
Genome
grow An organism’s and develop complete set of genetic information needed to build that organism and allow it to
HDL
High-density contributes tolipoprotein. heart disease HDL at high scavenges levels. High and levels reduces of HDL low-density reduce the lipoprotein risk for heart (LDL) disease, which while low levels of HDL increase the risk of heart disease
Hemoglobin
body A protein and carries inside red carbon blood dioxide cells that backcarries to the oxygen lungs from the lungs to tissues and organs in the
Histology
Study of the microscopic structures of tissues
Histopathology
Microscopic examination of tissues for manifestations of a disease
IBD
bowel, Inflammatory including Bowel CD and Disease. UC. CD This affects is a general the small term andfor large anintestine, autoimmune whiledisease UC affects affecting the large the intestine. ultimately,Both in some diseases cases, involve surgical inflammation removal of part of the of intestinal the bowel wall, leading to pain, bleeding, and
IPF
progressive Idiopathic pulmonary decline in lung fibrosis. function. A chronic Pulmonary and fibrosis ultimately involves fatal scarring disease of characterized lung tissue and by is a “idiopathic” the cause of isshortness used because of breath. the cause Fibrosis of pulmonary is usually associated fibrosis is still with unknown a poor prognosis. The term
In vitro
Studies performed with cells outside their natural context, for example in a laboratory
In vivo
Studies performed with animals in a laboratory setting
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OTHER INFORMATION
In-/out-licensing
Receiving/granting patent, or other proprietary permission right, from/to in exchange another forcompany a fee and/or or institution royalty to use a brand name,
Inflammatory diseases
A large, unrelated group of disorders associated with abnormalities in inflammation
Intellectual property
patents, Creations trademarks of the mind or that copyrights have commercial value and are protected or protectable, including by
Intersegment
Occurring between the different operations of a company
Investigational New Drug (IND) Application
United an experimental States Federal druglaw across requires statealines, pharmaceutical usually to company clinical investigators, to obtain an before exemption a marketing to ship this application exemption, for the allowing drug has them been to perform approved. clinical The IND studies is the means by which the sponsor obtains
JAK
cytokines Janus kinases and growth (JAK) are factors, criticalincluding components thoseof that signaling are elevated mechanisms in RA. Filgotinib utilized by is a apreferential number of JAK1 inhibitor
Jyseleca®
Jyseleca® is the brand name for filgotinib
LDL
Low-density lipoprotein. LDL contributes to heart disease at high levels
Lipoprotein
bloodstream. Lipoproteins are There substances are two main made types of of protein cholesterol: and fat High-density that carrylipoprotein cholesterol (HDL), through or “good” your cholesterol and Low-density lipoprotein (LDL), or “bad” cholesterol
Liver enzymes
liver Inflamed enzymes, or injured into the liver bloodstream cells secrete higher than normal amounts of certain chemicals, including
Lymphocyte
Type of white blood cell that is part of the immune system
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OTHER INFORMATION
MACE
Major research adverse cardiovascular events; a composite endpoint frequently used in cardiovascular
MANGROVE
Phase 2 program with GLPG2737 in autosomal dominant polycystic kidney disease
MANTA
A Phase 2 semen parameter trial with filgotinib in male patients with CD or UC
MANTA-RAy
Phase 2 semen parameter trial with filgotinib in male patients with RA, PsA, or AS
MHLW
Japanese authorization Ministry of new of medications Health, Labor and Welfare (MHLW), in charge of Japanese market
MHRA
Medicines and Healthcare products Regulatory Agency in Great Britain
MTX
Methotrexate; a first-line therapy for inflammatory diseases
Mayo Score
Mayo from Score four categories, is a Diseaseincluding Activity Score stoolfor frequency, ulcerative rectal colitis. It bleeding, is a composite findingsofof subscores flexible proctosigmoidoscopy ranging from 0–12 or colonoscopy, and physician’s global assessment, with a total score
Milestone
Major payment achievement in a project or program; in our alliances, this is usually associated with a
Modulation
molecules, The process peptides, by which antibodies the function or of cell proteins therapyis changed through the use of drugs such as small
Molecule collections
Chemical with specific libraries, target usually classes.consisting These collections of drug-like can be small screened molecules against thataare target designed to generate to interact initial “hits” in a drug discovery program
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OTHER INFORMATION
NDA
New Drug Application
NICE
national The National guidance Institute andfor advice Health to improve and Care health Excellence; and social an independent care in the UK public body that provides
NK cells
Natural viruses killer cells, type of white blood cell with granules of enzymes which can attack tumors or
Neutrophil
Type in theof body. immune Neutrophils system cell arewhich another is one type ofof the white first blood cell types cellto which travel fight to the infection site ofby aningesting infection and killing microorganisms
Non-Hodgkin Lymphoma (NHL)
of Non-Hodgkin the body’s germ-fighting lymphoma is immune a type ofsystem. cancer In that non-Hodgkin begins in the lymphoma, lymphatic white system, blood which cellsis called part lymphocytes grow abnormally and form tumors throughout the body
Oligonucleotide
protein Short DNA expression or RNA molecule that can be used as research tools or therapeutic drug to change
Oral dosing
Administration of medicine by the mouth, either as a solution or solid (capsule, pill) form
Osteoarthritis (OA)
The breakdown most common of cartilage form in the of joints arthritis, leading usually to pain, occurring stiffness, after and middle swelling age, marked by chronic
Outsourcing
Contracting work to a third party
PASI
the Psoriasis severity Area (erythema, and Severity induration Index; an and index desquamation) used to express and percentage the severity of of affected psoriasis. area It combines
PRAC
for Pharmacovigilance assessing all aspects Risk Assessment of risk management Committee of human of the European medicinesMedicines Agency, responsible
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OTHER INFORMATION
PROTAC
Proteolysis that play a role targeting in disease chimera, processes a special small molecule capable of removing unwanted proteins
Pharmacokinetics (PK)
absorption, Study of what distribution a body does to the to atissues, drug; the metabolism fate of a substance and excretion. delivered These to processes a body. This determine includes the blood concentration of the drug and its metabolite(s) as a function of time from dosing
Phase 1
tolerability, First stage pharmacokinetics of clinical testingof ofa an drug, investigational usually performed drug designed in a small number to assess of the healthy safety human and volunteers
Phase 2
Second order tostage determine of clinical efficacy, testing, tolerability usually and performed the dose in to no use more than several hundred patients, in
Phase 3
Large definitive clinical understanding trials, usually ofconducted the efficacyin and several tolerability hundred of the to several candidate thousand treatment; patients serves to as gain the a principal basis for regulatory approval and access to the market
Phenotypic screening
Phenotypic to alter a cell’s screening diseaseis characteristics. a strategy used Animal in drug models discovery and cell-based to identifyassays molecules are both with the strategies ability used screening to identify does not these rely on molecules. knowing In thecontrast identity of to the target-based specific drug drug target discovery, or its hypothetical phenotypic role capture in the complex disease. biological A key benefit mechanisms this approach that are has not over otherwise target-based achievable screening, is its capacity to
Pivotal trials
Registrational clinical trials
Placebo
biologically A substance active having preparation no pharmacological effect but administered as a control in testing a
Point-of-care
Drug treatment is provided close to or near the patient
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Preclinical
humans. Stage of Consists drug research of in vitro development, and in vivo undertaken screening, prior pharmacokinetics, to the administration toxicology, ofand thechemical drug to upscaling
Preclinical candidate (PCC)
A development new molecule process and potential drug that meets chemical and biological criteria to begin the
Product candidate
for Substance development, that has starting satisfied with the formal requirements preclinical ofsafety early preclinical evaluationtesting followed and byhas clinical been testing selected for the treatment of a certain disorder in humans
Proof of Concept (POC)
Concept A clinical trial trial is inusually which first with evidence a small number for efficacy of patients of a candidate and for drug shortisduration gathered. to A get Proof a first of impression of drug activity
Proof of Concept study
Phase mechanism 2 patient of action study in which activity as well as safety in patients is evaluated, usually for a new
Pulmonary embolism
A blockage in one of the pulmonary arteries in the lungs
QD dosing
Once-daily dosing (qd from the Latin quaque die)
R&D operations
product Research candidates and development for internal operations; pipeline orunit as part responsible of risk/reward for discovery sharing alliances and developing with partners new
Refractory
to, “Refractory” treatment refers to a patient with cancer that is/has become resistant to, or does not respond
Relapsed
“Relapsed” improvement refers to a patient with cancer that develops cancer again after a period of
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Replication
The of cell process division by which DNA is copied to produce two identical DNA molecules during the process
Rheumatoid arthritis (RA)
A cartilage chronic, destruction, systemic inflammatory bone erosiondisease and disability that causes joint inflammation, and usually leads to
S&M expenses
Sales and marketing expenses
SEC
Securities and Exchange Commission in the US
SELECTION
Phase 2021 3 program evaluating filgotinib in UC patients. Full results were published in The Lancet in
SES-CD scores
values Simple from endoscopic 0 (unaffected) score for to 3 CD, (highly involving affected) review of five pre-defined bowel segments, assigning
SIK
Salt-inducible kinase. This is the target family for the portfolio of molecules in the Toledo program
Screening
Method in a biochemical usually applied assay against at the a beginning series of of small a drug molecules discovery or antibodies campaign, to where obtain a target an initial is tested set of “hits” that show activity against the target. These hits are then further tested or optimized
Short interfering RNA
A research tool that is used to silence the activity of specific genes
Sjögrens syndrome
Sjögren’s often resulting Syndrome in chronic is a systemic dryness of inflammatory the eyes and disease mouthwhich can be felt throughout the body,
Small bowel CD (SBCD)
CD gastrointestinal causes chronic tract inflammation including theand stomach erosion and ofsmall the intestines. and large intestines. It can affect While different isolated regions SBCDof is the an uncommon ileum, is common presentation of CD, involvement of some portion of the small bowel, particularly
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Statin
are Statins at high are arisk class ofof cardiovascular lipid-lowering disease. medications They that arereduce the most illness common and mortality cholesterol-lowering in those who drugs. atherosclerosis Low-density andlipoprotein coronary heart (LDL) disease carriers via ofthe cholesterol mechanisms play described a key role by in the thedevelopment lipid hypothesis of
Systemic lupus erythematosus
even An autoimmune kidney failure disease, with systemic manifestations including skin rash, erosion of joints or
TEAE
treatments Treatment Emergent or any event Adverse already Event, present is any that event worsens not inpresent either intensity prior to orthe frequency initiation following of the exposure to the treatments
TYK
residues Tyrosine of kinase specific is an proteins enzyme inside that a can cell. transfer It functions a phosphate as an “on” group or “off” from switch ATPin tomany the tyrosine cellular also functions. attach Tyrosine phosphates kinases to belong other amino to a larger acids class such ofas enzymes serine known and threonine. as protein GLPG3667 kinases which is a reversible and selective TYK2 kinase domain inhibitor
Target
therapeutic Proteïn that intervention has been shown or discovery to play of a role a medicine in a disease process and that forms the basis of a
Target discovery
Identification and validation of proteins that have been shown to play a role in a disease process
Technology access fee
License collections) payment made in return for access to specific technology (e.g. compound or virus
Toledo
Toledo is the program name for the target family of SIK inhibitors
Topical corticosteroids
Corticosteroids which are administered through the skin using an ointment
Transcription
The process of making an RNA copy of a DNA gene sequence
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Translation
The process by which a protein is synthetized from mRNA
Ulcerative colitis (UC)
UC inflammation is an IBD causing throughout chronic the inflammation gastrointestinal of tract) the lining of the colon and rectum (unlike CD with
Venous thrombotic events
a When venousathromboembolism blood clot breaks (VTE). The loose abbreviation and travels DVT/PE in refers the to blood, a VTEthis where is a called deep vein thrombosis (DVT) has moved to the lungs (PE or pulmonary embolism)
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Financial calendar
03 November 2022
Third quarter 2022 results
23 February 2023
Full year 2022 results65
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Colophon
Concept, nexxar GmbH, design Vienna and online – Online programming annual reports and online sustainability reports www.nexxar.com
Frank Photography van Delft
Copy deadline: 4 August 2022 report This report or atis www. also available glpg.com in Dutch and available for download in the Downloads section of this
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Contact
Sofie Van Gijsel Sandra Cauwenberghs
Head of Investor Relations Director of Investor Relations Galapagos NV Galapagos NV
Generaal De Wittelaan L11 A3 Generaal De Wittelaan L11 A3 2800 Mechelen, Belgium 2800 Mechelen, Belgium Tel. +1 781 296 1143 Tel. +32 15 34 29 00 Email: ir@glpg.com Email: ir@glpg.com
Marieke Vermeersch
Head of Corporate Communication Galapagos NV
Generaal De Wittelaan L11 A3 2800 Mechelen, Belgium Tel. +32 479 49 06 03 Email: media@glpg.com
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