Galapagos (GLPG) 6 Nov 202020 Q3 Earnings call transcript

Company Profile

Participants

Elizabeth Goodwin	Investor Relations
Onno van de Stolpe	Chief Executive Officer
Andre Hoekema	Chief Business Officer
Bart Filius	Chief Operating and Financial Officer
Walid Abi-Saab	Chief Medical Officer
Piet Wigerinck	Chief Scientific Officer
Michele Manto	Chief Commercial Officer
Lenny Van Steenhuyse	KBC Securities
Laura Sutcliffe	UBS
Emily Field	Barclays
Nick Nieland	Citi
Peter Welford	Jefferies
Rushee Jolly	Bernstein
Evan Seigerman	Credit Suisse
Brian Abrahams	RBC
Matthew Harrison	Morgan Stanley
Jason Gerberry	Bank of America
Benoit Louage	Degroof Petercam

Call transcript

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the Q3 2020 Results Conference Call. I would now like to hand over the conference to your first speaker today. Elizabeth Goodwin. Please go ahead.

Elizabeth Goodwin

Hi. joining for for call. quarter all you us third today results Thank Elizabeth representing information you also Investor today. financial I'm Relations, bring our Goodwin, reporting to this This website the available recorded replay accessible will for today. and be Galapagos on later webcast is homepage via are investors and at press call to post dial release in our in at from profession the and the of night. end analyst invited Sell-side numbers last our can question series of

these Bart for for Officer, outlook OncoArendi calls, Filius Stolpe, present Business months. the in highlights will will and announced and results candidates before rheumatoid the drug our any statements the of may statements. Belgium, for differ statements include third our uncertainties, close and Operating the van Onno other I'll or that's XX-XXXX-XXXX, starts. Officer, approved coming results, filgotinib is move future results code operational Europe with by industry financial of our to and right with that and none we involve forward-looking our quarterly like one authority. the Galapagos' environment. actual Financial the are changes repeat will from quarter; remarks Today's highlight forward-looking XXXXXXX, of growth these Because Japan, will our now last be that Chief deal risks The webcast. be is today's regulatory in Chief will arthritis concerning call Andre cover competitive Hoekema, CEO, statements de future Q&A everyone our and like I'd in Outside forward-looking making pipeline, Here and to expressed night; and the and during statements results company developments materially of and possible implied financial remind

and be about to hand now the quarter executives this the this During operations. you'll by Go screen to And Q&A session progress Onno the ahead. talk end. over I'd like see the followed to at with a will their at on presentation, slides point, third

Onno van de Stolpe

XXX Netherlands, Germany in got coming they Jyseleca, with. Galapagos. we're to of are the Gilead. the of the that Thank In the made, year first that the the of two from on the on the overshadowed express ago. face Monday. actually was the indication shipment the afternoon. filing Jyseleca highlights. in but EU very this and were hallmark we the approval is the we disappointing unexpected, trial Very the for FDA to started their moment And going This Good which Clearly, by like that very with start started better welcome the a would MANTA/MANTA-RAy executing response the risk to We out of on Japan, two for you, with operational complete the CRL, to reality new for. tox the osteoarthritis, the work Elizabeth, awaiting the Germany course is of Tuesday, second is milligrams, go Ireland shipments we was in everybody. the Monday; testicular Jyseleca so nice weeks a listed making the concerns for we EU reasons. lastly and for they U.S. for before us the that order And in were filgotinib the Good both certainly decision And is morning. pleased the that letter approval, study One, on they announce approval. CRL, of results received for benefits first and the announce which highlight are in to

the the follow shortly. a rest in clearly of there at the countries of other of osteoarthritis, that news to we presented various going get get for full trial. because caused data pipeline, we items, it's look in are countries showed now off and that European the in that selection conference filgotinib off trial, to the had at are pages a we to very So, data the to got front the good good filgotinib start If number other we the we a

a line XX-XX study yearlong how a we're difference the between where had of We results endless. data at molecule of treatment, is closest also didn't And the in that semi ziritaxestat with is had proceed are then and that very we XXXX ROCCELLA set a we osteoarthritis indication. innovator placebo pleased the with XXXX ziritaxestat see that in positive disappointing trial, development any we the is top which discussing a with means outcome the osteoarthritis to drug,

we We we disclose the the SIK if can we're all lab Toledo disappointing. proceedings find Last to we are extended on back did this but indications, bringing science we an where osteoarthritis, see the focusing week, very seminar on. to are not XXXX that

development convincing that you the Phase also and data positive proof the and the because package for principle engagements convincing, the the of updates we very TNF X I of evidence whole the diseases have of of of all mechanism essay, very necessary targets, in think and various science data SIK trial. that that in the identification saw effect a a a target Toledo is of the with was the it preclinical targets the good that and are extremely nice very IL-XX

very, further in clearly a we a course Phase very that we safety, And we confirmation humans of from saw window we is which that also nice mode do is to with to a have the development. X of have very important So, action, reassuring. regard in which have

we a flow are will trials quite to this X at lead different Phase of discussed, in the some seminar in moving as 'XX. and new forward that and number We 'XX now

can second already as of is the SIK in in And give X different of with innovation. of into to targeting Phase first so molecule number we a So prepare move potential ’XX. the hopefully readouts as readout our and first in the and for have possible. for the fast 'XX this we POC lot Clearly, 'XX Toledo to up then set will readouts. development get three, patients get a the in XXX-XX, plan will Phase clinic also a X 'XX, a This we readout bring program 'XX

I think We but also that for this progressing. important patients, in the very for is Galapagos. is that opportunity once believe we’re that's lifetime a a

extremely targets, XX-XX. We’re as mechanism, as first well and for excited XXX-XX that we about the have the results the

would come Officer talk we So, to in deal will late in over will program in Chief hear let's more and hope to and I continue announced Andre to the night. the hand 'XX Andre. Business about good that to that it that, about much our this ’XX. like Hoekema, With OncoArendi you it data last

Andre Hoekema

pipeline internal here Thank to I we to everybody. do Onno. Good like also often two external assets. add would afternoon you, highlight that. our speak about presentations, how we reasons There're In and our actually

assets really have have add actually we use the the both very programs about grow sheet and and external to engine a in balance all clinical, pipeline talking want on First expertise engine. a and not of our strong And that that cylinders. clinic, we accelerate to of R&D fire also engine, lot discovery in only all, really we through but to our internal

that So also sense. it only molecules, tools in think internal sense to view, use makes for lot we party not but really more from our a makes it stuff add of really third

modes our we’re core fibrosis, fit action areas not we effort you high-risk focused course, of in and the molecules it and of criteria, multiple indication that talk really really surprise pipeline. really that look Company means strengthen that that on way, Galapagos when for should about And the in Of will high-reward. they inflammation we that

On and the actually Scipher of criteria, Boston. next molecules and the both Canada see slide, We since deals hit with all that year. a from number North Fibrocor signed that we you have this those signed America, deals

very fibrosis Just come patients. we inflammation Ryvu, we a the it's operating our it, identify to first similar pleased Krakow, very patient We a candidate are in Boston. seen complimentary on licensed we've located very also identified about we some own internal targets so complimentary think that from we've noble companies in that on novel with liked based fits that. And well because technologies the that targets really Poland, programs. And say words in deal. to in do. few targets few companies, molecular from Fibrocor in moved licensed signature in about we today, Fibrocor that to Scipher, efforts to target a with I'm what fibrosis. words a They program really in based also Warsaw And pleased In with up phase the samples, drug, a first Poland, has clinical

chitinase and lungs say breakthrough fibrotic public currently the really words let play few collaboration class diseases role getting in a So, of a a that with mostly a some novel in first target on It's in so this class, deal. interest. business fits and work me fibrosis and targets, really ready in chitinase about

franchise really can another which We [indiscernible] where under programs on very have program. ways we fibrosis XXXX there's we think niche and really add nice a a earlier

So, we decided with work to OncoArendi.

sales structure, regulatory royalties. You a XXX see development, total of the cost XX milestones for upfront million of deal an million

to We negotiated get case access as also to those the chitinase right other in well. candidate fit programs in

a very mice, the at class. reduced knockout lung there's and OATD-XX moreover, In burden those we'd in is it mice say a a disease because and line the you few me known that novel mice two time, that a disease really elevation. bit in fibrosis class. Chitinase in IPF to has chitinase reduced the about molecule burden. and same this shows target novel But words role that OncoArendi play of in development let very a So, it models, see like are quite they

we the I validated, tech said, of as to aware class well any not So competition. very chitinase, are

of at there's a potential. to typically preparing and disorders. and Xb us point, this possibly off really first bring forward. bring Walid room this in We molecule other a are to fibrosis So, And go lot IPF Phase into the class Piet think study

next elevation can of I a bit the So, the that slide, on just just if I mentioned. detail have

animal is IPF. Here data some model show you standard bleomycin, what for that which see the

to score. lesions formation that in healthy as syndrome. to can And effect On OncoArendi you the on by get Just control really the left similar you see if the treatment, see, from mice. net you molecule Ashcroft the expressed reduces a lungs, bleomycin of

in validations X ziritaxestat, large as of X shortly. about. this we're talked is data one a you troubled by that right Phase that Phase asset study, in we fits clinical and behind report where all which excited I So, about is the And the know, really

through asset So, that, QX in be happy get to Bart? to over hand am very And with Bart to this three the our pipeline. to I me adding data. summary, financial let

Bart Filius

the of financials, nine which terms cash in quarter, the of on and financial for as But Thanks, say cash on burn the at I'll Andre you words few short U.S., September for the our results our term first off end outlook the everyone €XXX the in can €X.X the billion months off an slides, position, the with happy starting of here Europe, million. to afternoon finish good cash XXXX, healthy see events. overview in morning good and to year with balance first the of of brings about

As income particular expense. usual, we two cash of flows and both categories exclude

On to months months translation due in where significantly the we had we the capital are quarter, a cash a side, excluding result million this you the a income but received to €XX effect. quarter -- that a nine were warrant was we still we as euros, also as is are increases incurring compare exercises. that over report had And we where And nine in euros. can of we we which first total,

it our guidance. realized is this balance. which sheets, is cash the That's of translation a up quarter down, obviously goes overall roughly quarter have XX% that dollar included but our our our on in nor So cash goes is burn to not we it's of not effect XX% balance our and other it's one position in

Gilead, by maths, you million So the first let retain And are burn for if income on than first the filgotinib in P&L that's up platform. October, of cash an nine get you nine total, extent €XXX were all, categories, from four, on extra those XXX of the fourth to from what transactions itself, terms a is been guidance cash a which for our receipts of accounting you to nine lower and in is for me are key our a to in position by driven run-rate lot they'll in also we the is rights position million. for our the I've the $XXX which those Hence, fourth on XXX the revenues divide than XXX the doing multiplied months that between be the milestones those million extent. happening three been access the income by to bit higher our of receiving thing to filgotinib months. shot, the previous time, of XXX get full of we deferred in meanwhile. year cash quarter approval and we by our the months, Then it of which and related over on events. three quarter a way deferred The consequence and highlight is revenues, the revenues recognize first XXX. €XXX has And in of million. largest of large as the to call are Both in of one receipts €XXX

total our hence, terms we now recognized revenues top-line of in So have accounting big here. chunk of a

increase bit and conclude that the to those But Then sure of me of anticipating here a the last of by the bit little of quarter the quarter million numbers driven on filgotinib, our a in for earlier awards be over detail a all which outstanding, But in the that in our in fourth can clearly by gap also few Toledo volatility bit the this done part items. cost, see most as between which compared highlighted and more be up launch are net results. And €XXX investments an filgotinib Europe filgotinib But in and expenses. Then to countries. increases finally the within rebuilding there. months key that's and ramping you staff net of results. that depending the line accounting And can and with terms a European There's But of in the is and the words we'll you to I the already also year. a this Gilead financial effect, say infrastructure positive along find we're still or presentation, in where in There area, driven we're results prepared on year on I've the notably well. the are commercial currency from operating of taking first there's the programs. strategies in the year. if this That's operating in two nine about comments I'm next. one let this of by first expenses. we're outlook. categories, In R&D of Q&A it's the type FDA negative discuss meeting

We fourth to our that us. the also telling we've next first of are the peak in the anticipate And data a QX, we half first on on Japan get and further then in of come year, for in of MANTA/MANTA-RAy other and the get program. And that understanding at the those are still programs anticipating the XXXX in done Europe. should half filing after next quarter also what the filing we results In of year. PINTA

We the in and but you study study the in the for dose, to dosing targets the know, is we and anticipating the then folks obviously discussing coming lupus next futility for of have molecule, also analysis the beginning quite webinar, month severance. nine a first useful lot we're And And next these year, already to look were so as of then of molecule milestone months of choices we're first in up. disclose doing in quarter. in fulfilling next to big year, further the in a have on finally We a indications six events, but we Toledo the last dosed also half fourth of on as couple anticipated at we that called in the XXXX.

please. Let can there if and take the Elizabeth, you over Q&A for me conclude

Elizabeth Goodwin

Thank invite you. conclude Today, to the That does investors we professional side pose again presentation. their sell analysts and questions.

for Belgium, Here's and Code XXXXXXX. the in the number code dial Country XX-XXXX-XXXX is

dialed our Lenny For question Securities. Van from Instructions] comes [Operator those already in. first KBC from Steenhuyse

Lenny Van Steenhuyse

OncoArendi deal. interesting on the Congrats

design you one trial. terms a in this further not you additional wondering was more if clinical elaborate a Phase that mentioned on some I again, XQ but as believe we the something lifestyle, mentioning, we to mentioning color safety clinical that? study some what better And extended. X were on in went quite studies looking expect Galapagos inhibitor report also a a ago. give should trial might sense, Xb perhaps question in you Phase trials You're bit as Phase position perhaps second of could I also expect IPF XXXX Could this compound JAK-X some through Xb entering years

So what indication the one? what's it this for this and of triggered and the if was Thanks. wondering strategy compound revival life this was

Walid Abi-Saab

I'll otherwise now, price take today Walid. OncoArendi the XXXX question that is actually. your This extend on known

about study but So duration the larger do the that's be in we the then we're our will design with it in the at patients a plan and trial we're probably Xb. of continuity. store of in amount IPF on the significant we're dosing looking probably therapy about so background with XXX where PINTA the is about the And the PINTA patients early in calling still to And just top same. a Phase talking multiple trial, no trial and also

we the is talk that you plans, about starting over I'll details to with turn will to XXX back but more the to So Piet get as And study. closer come current

Piet Wigerinck

Walid, you. Okay thank

had us to while convert So XXX for at for a us XXX and very those in JAK inhibitors of follow to molecule that of gave package did plans we patient. special the data OAX on all and to total package XXX, something OA cartridge interesting evaluate effect they compared where the back a showing which we triglycerides after long then and GSK you who time GSK then

and whole in So, game. that we've the taken started the intraarticular now package

that in pick done up six Thank once a info every injection injection patient. we see some end months to intraarticular can an senior During the will be which you.

Elizabeth Goodwin

comes from Laura question next UBS. Our from Sutcliffe

Laura Sutcliffe

now if mentioned I'd least, include us to IPF outline just presentation. think more. these the full in pursue little all your hormones deal like OncoArendi things Toledo for we the more Could one bit that just useful of concerned that's little you a at get detail? of those therapies sort how be got together you be we a a We got I fit and trial want IPF in from the background would if XXX check them? is please. case, That just your valid I trials not great. or thing should All whether if result on not about to can And a

Walid Abi-Saab

from first question. start let's the So

saying Galapagos in always an and quite we've fibrosis number have have that franchise development that in interested We are, a IPF been of is we building we in a indication compounds here.

know, guys you very IPF is a serious disease. As

good and a about the to So patient years. very after diagnosis, with essentially, survival prognosis five is immediate two

you to unmet ambition As essentially that's the a progression living longer when stop progression tall with particularly combination from have such, about not a hopefully, a medical tolerability to when good consequently, molecules stimulus our huge is the the develop you that ambitions. this profile, combined our stop the and It's disease that's the with with therapy, there's disease. with medicines, will ambition, is And have actually a and going no develop disease. users to together and safety ambition. of progress very idea patients worry of to IPF, dying the but anymore, And to

plan on mentioned, the on But mechanism, on complimentary and combine spoke. either biological and look with program, scope market so [indiscernible] based to able advance is you show of literature, them to efficacy, themselves to is our pet. beyond just looking mechanisms, inflammation fibrosis as between combine of the our to from ziritaxestat. the ISABELA to they the we stratify today. to together. your that and due mechanisms internet goal the molecules on each some therapy cellular lend from other will And as multiple it's discussion or target have we variety And at I on certified the plan and tolerability biological background treatment And to efficacy on also to Coming safety ISABELA they be as background the as a need you shots

of just type indication design And them to So, we with these do allow are us, on based phase FDA. This us and discussions our the the to with on of to for will get certification remind those IPF. plans. the with treatment also, FDA, be going especially

So, I I hope your question. answered

did, you. If thank you

Elizabeth Goodwin

Okay, much, thanks very Laura.

from ahead, Our comes Barclays. Emily. Go next question Field from Emily

Emily Field

the indicate they expect that path recent they at could definitive could learn this something Gilead's On to that, that from they A type seem call, somewhat regarding least forward. there meeting

just that for was what that bar you. we indication into if communicated decision remains could in also, just for it then I those we XXX filgotinib on wondering, one what occur? could investors? ASN And PSA give trials for meeting would forward will made the there other path you trials Thank there expect to indicate exactly to will And the insights was uveitis. have RA, milligram. a if So, of some to pause When be expect when to whether be or seems any get could thoughts that? our Then you restarted? to any be perhaps

Onno van de Stolpe

you thank hope me hear I you, can Okay, better. guys

told was as Now, great. was not before I voice that

I'm as Metadata, shared the our I prospects specifically, on be CRL and minutes the Gilead's the based and have benefit, that that end forward. risk be out Okay, so And the ago, a and of path that Bart paused, the what result, CMO that think medical, It's of would I'm than right be exact a effort so will to think, sharing. that, the to think, clarity Gilead on trials still said a some meeting to this going forward terms to add not not that guide a will in days has concerns based of that an more there's the that's would the or take place, few that year. could of outcome about coming at what be as Gilead I about getting the be And agency out able type ways filgotinib have were I potential it, the, will talked And, color the that's the we'll expectation, ago, address been and the to been, of will a meeting, much seek sense few before the number essentially able whether you program. of year as has sure has as to think resume be on data about for meeting. also the about well the the be to of and I meeting, after going MANTA

Emily Field

expected occur that meeting before And the is to the end of the year?

Onno van de Stolpe

correct. That's

Elizabeth Goodwin

Thank comes All you for Nick. from And that. right. much Nieland Nick from very next our Go Citi. question ahead,

Nick Nieland

quick a the is [indiscernible] this assets. Gilead OncoArendi So, the on

Secondly, for your please. Bart, to questions the of the spend, the rest on of breakdown R&D

this in your Secondly, then you. And a in just milestones good nearly than can for -- So period 'XX that the will lower spend, filgotinib interesting revenue? at growing looks that be half, in the And gross this in question on XX% why will programs will question we other that's spend which then expect was describe do firstly, spent wondering less the $XXX in'XX? did taxes over far XXXX. to what nearly accounting and XXXX? I on so it is in on Thank can and quick just over what very what's million year? the be these your you was your you recognized that that you've be year double XXXX more expect XXXX? spend Toledo like

Onno van de Stolpe

you those? Bart, can take

Bart Filius

the to that of I those sure all you take points of just keeping make get track I questions. I'll Yes, raised. was notes Nick.

have answer the note of the first advice So your clearly R&D of is yes. all, and

XXX both which they that Xb, of in is Gilead a in So open the share of for will for as the all at expenses against compounds, they in the and got licensed XX% R&D there's royalty the an ex-Europe with And XX%. to of there our Phase for device of moment rest milestone self-developed, XX-XX. million, the end

compounds. structure raised. on the So the points this that of couple follows normal Then of R&D a breakdown economic you

just it in the bit AS that's fiscal for the to driving at was whether PsA, assess as First be of mark resumed a it's on well, as all, expressing difficult falls. expenses going XXXX, obviously that's question the factor to or depending XXXX and moment, around uveitis,

as I we the what cannot only answered before give today. that started to So taking [indiscernible] September year XXXX. collaboration, were be last but cost mechanical then On of because of only to [indiscernible] it's that's that's share the less, this XXX% you we of XX-XX

So their this year anticipate the those further the last this to getting as as other of year, comparison the the are that figure the increase underlying growth of And proof-of-concept costs and XX% it's in first actual at with year. but that of certain those XX% some look significantly happens are remainder the are We in you And six Toledo last a be speak. studies XXXX. one to on that expense spending in to the least reflecting nine continuing over months this should XXXX, at months compared we do first then throughout year. see growth correct, online whether we'll run effectively we in it extent growing increasing. is that's Gilead. to cost year, decline, it's shared direction But also

finally development that's portfolio portfolio. Toledo, in So other increases. both clinic. some should development, the whole the then and further indeed really expect you And for in in That's preclinical the

And we're molecules different we at somewhere people XX that then the running. earlier PCC as so between we I moment highlighting, not X status, Phase refer XXXX. and and those such as the in to that in programs include have mistaken and the X XXX call think

with in category treated the Then received the we have together future. is this explaining question all other meaningful on for other past and that's So in milestone, lastly, filgotinib is it's and also your receive will growing. actually why we the income that the accounting treatment the

be, And is development out are period go. I still ramping the basically of that together to spreading regulatory basically currently the to three and program all development then to four of the years and then filgotinib. We estimated for over them mean, them the program next

periods. the we XXX a recognize answered but don't your we spreading treatment, over questions. complicated are it's I immediately, So hope everything actually out I have but accounting that

Elizabeth Goodwin

question Jefferies. so from our next And come Welford from Peter will

Peter Welford

two. got I've

now made Firstly, as we read Gilead, the this clearly a U.S. if are well, works here how trials just well. if as are a just just that geographies returned as again? the comments Gilead those can indications focus to these rest of XX-XX essential for cost as that the arthritis, curious far you other have is for understand they on on this But does Obviously

and sort problem, path we can guess, pausing in is the understand is specific of a elsewhere? this thinking potential behind on think chitinase then, there I this, of particularly given studies challenges could there So significant that secondly, forward, obviously, U.S., the and FDA to an what the curious how these be about inhibitors. opportunities given the thinks Galapagos And

Just that they've Thank if this this you tried then cash you for with year. internal you paying the discovery couldn't within ask, addressing But asset you. something a quick have I haven't or OncoArendi, I Bart, the is is that perhaps platform if your this think done the can why it's efforts? particular drug so, guess if And a you target curious why burn differentiated? guidance Or you're I curious, do, one you guess, And right? for €XX it, million to case you just that's just why clarify is that internally. is pursued could that presume that

Onno van de Stolpe

regulatory on with the the to with the these programs were decide address have Let of we're what's clear, go, and me because us, the less we we these as the way idea on were before think they a aligned geographies to spondylitis decided sort pause Look, they studies happening to Gilead U.S. is that in the and we the antibiotics I psoriasis, could whether is plan need designed question can can the global and consultation where forward. situation to situation. they designed, to ankylosing there the And in U.S., first way clarity what take are and would we the future have address with as in interested where have Gilead.

clarity after talking that's have that there much FDA, And a sensible from will to seemed see way where or then with with stopped. the we at we by made discussion And and be go more we we'll the meeting have that to it more like so, that reform much and it can needs some be why to And forward adjust go we point. accordingly. this changes influence

Elizabeth Goodwin

Elizabeth. enrollment is a in think add is that just it's it This be correct? might that pause to only, I helpful

Onno van de Stolpe

correct. That's Yes.

Elizabeth Goodwin

you. a they're And had on why the Thank question differentiated? inhibitors, kinase we

Onno van de Stolpe

ourselves, never given the target cells is that's this active targets. We no. this type And And in the finest fibrosis. never of we only Peter target the of of did expressed the macrophages. did reason target very for in answer that subtle is is facts sort

the as sense, we for impressed the we ourselves were to make disease, in just we a find internal macrophages that our in a completely for up local That's screen the So it. did I and sense set with fibrosis, complements it's data the nicely did believe didn't in data target, and IPF portfolio. make compound bored We we it. And sense. great a data, why

Walid Abi-Saab

that's mine. Yes,

So Peter, I question. can your confirm

part XXX. is transaction of part OncoArendi and XX forecast is million So, this paid to of that cash of burn our XXX between is the

Elizabeth Goodwin

Our from will Go Jolly Rushee be Rushee. next question at coming ahead, Bernstein.

Rushee Jolly

that clinic in impact molecule we into based on the My aspects and the last diabetes that's also and the R&D then question many have appreciate given the about very may fact And drugs you you that you. the the any the And to quarter. beyond sugar? and mechanism demonstrated on the blood aspects that that Toledo weight these of stretch of year on and And well? you and market, And with several could target taking molecules little feel particularly the on talk essay, is Do the differentiated? that diseases preclinical we are be a furnish XXXX were and your assets showed any into of triglycerides well obesity. And have to undisclosed rate but as diabetes forming. and seems interesting plans sick I those the prior it's there be presence blood. early. small Thank an for to as and on

Walid Abi-Saab

take I'll Okay, questions. both

an metabolic and Let start easy from [indiscernible] one. just

that a is of publications direction as X, a and a aware working from its known, for not it's if in our well this drug. that path in target, Phase us, more decided he see points platform. with And model, potential a whether us application every XXXX, certain it's the into already at radar. indeed, on we and those and we moment, animal are follow-up every We Toledo molecule something or than complete forward recent it's composites but sort complete hearing to different of sense, older own On on that way novel and in

with compared we newer out to and see drugs. believe Type older it has is And different the it diabetes, own. profile, it what heavily in does we we So what want positions is there. to see from We've X its

fully we moment dress you we how X, the total. on in will more this fitting move So see Phase we update into

Elizabeth Goodwin

Seigerman Our next Suisse. from Evan ahead, comes question Credit at Evan. Go

Evan Seigerman

today. Elizabeth thank my Thanks question for and you taking

for expand between might put with, you're are some and EMA FDA open filgotinib? the of JAK think think the I that and on the in U.S. one we the don't can realize the context regulators Bart, into launch differences European how class? that starting So more that you I help JAK the

Bart Filius

question Officer on our Commercial I to Yes, also happy who let me let me to take is the transfer he's line Michele Evan it. think that Chief and

Evan Seigerman

Alright, cool.

Michele Manto

this is Manto. yes, So, Michele

So, the in uptake a difference the we've molecule. of seen

you if we've So, -- seen look at the strong. going the sclerosis, Europe, classes growing you if really that at look

sellers are organic market. seen only that in into before seeing seeds up we we've in So, share coming XX% earlier the The XX%. to market also are went these with that so the Germany, and

going dynamic markets, and JAK these which launch. leaving really inhibitors. patients is ongoing is inhibitor, the is also good the Germany, bio-naive of also so advanced that what third one for molecules, base and our seeing are on the a So, growing, in class see going of Also, the cannibalizing XX% on ones, between good not like you the a keeps we JAK

different at invoke use. is you U.S., the we see same So also of time of the is the as demand And course, days in well there. indicating that strong going

Toledo And This outlook, answers come news, A meeting to rest, between of the difference in we already as something course, indicated. regulatory addressed. that's already next the type FDA scene their For your question.

Evan Seigerman

just FCA No, at whereas they look approvals in I follow-up of to Do you guess European filgotinib, conservative JAKs which one when is look in that have more is risk you helpful. there. at thing Europe? and baricitinib seems benefit little more a differently the I mean, that

Bart Filius

you'd regulatory Walid, the one like that take on to side?

Walid Abi-Saab

other, a sure. the I'm different compare. assessment. the fair their to direction. in could The going Yes, mean, direction. Europe their sure be to to on I Based think data, if these I that's I and I very you and end you GDP own situation agencies between but in in they mean, decisions the sometimes not add is board Yes, one Honestly, same similar form of the direction, U.S. it. to think anything talk to case, each U.S., what Europe review this opinions. different is pointed see the that

So, with the which let's get from we'll it that U.S. and way go we there. prove doses hope see will wrong. And theory filgotinib forward approve in those

Elizabeth Goodwin

Thanks, Evan. ahead, Go We now Brian turn Abrahams Brian. RBC. to at

Brian Abrahams

Thanks my questions. two so guess, much taking me. filgotinib, I for On questions for

frame and then specifically in potential Is RA You for shape on RA your you how a A the potentially something decisions filgotinib? us in and in your does your meeting? off, for not to? US you dose can that with this forward you First Thanks. refractory, possible want that follow-up of partner's And more the for and TNF kind would might of playing guess it for the type partners? to wish necessary expect XXX-milligram your of partner commercialize if label, MANTA/MANTA-RAy go population. can talk And Gilead discussion the you durations the for I and that's secondly, say, of about the expectations approval narrow, studies,

Walid Abi-Saab

what When engage regulatory said So, to Gilead let meeting then Michele has I'll The questions XXX way in a A patients milligrams answer efficacy see different, who avenues usually hypothetical me bit the the can we questions where and more I indication. take the commercial therefore, the are patients and before target the have raised incomplete -- risk type you benefit have questions, responders -- going new FDA, as think we've are difference be medicines. this Look, XXXX bit of And risk who essentially to potential at benefits more the potentially the with where people political is and that forward. ask is could question. is said, a forward. are those to where look XXX of FDA actually and prominent between the need biologic a and about the meant

faculty these not, something a on it, will myriad of would of Gilead this. be that And difficult be And So, be it forward. whether whether the would very meeting. are excited of it's speculate that's a discussed, will potential potential that part or of way forward be way a to all outcomes about

a Regarding them, the compound and that great been paper, there clear subjects pregabalin. and FDA have with a MANTA, actually by studies called white obese a as I healthy think that is study studies they extent, designed those describe was with collaboration done Pfizer dictated those by a in similar with

are are those standards. well studies designed So are and

the So primary XXX. be the, the study of endpoint again, will

as treatment Although weeks blind we study the -- about. of double portion XX is the of proportion talked

studies Now the until might year reduction count, as also clinical in for are of who a Michele. them. the them designed. those then they any follow of I period do And those on the have after turn the I'll And also. commercial afterwards are we we how follow those to trials for stop reverse. for end a studies, think we question, That's or following it of And sperm the patients do explained over XXXX

Michele Manto

And thank Walid. you

growing causing that this of institutional the BioIR the XXX in segmentalso we we've So on the seen see and is in of taking On also therapies, the the inhibitors U.S. outcome, there. out place on also a number for highly these JAK combination from top and of actual profile that to the would label come the and that different the risk anything. high depends commercial Then scenario and the filgotinib. opportunities, milligram

A here. outcome type to have And with us. answer will the what we'll the discussion to see was it's not and straightforward bring a important So need FDA

Elizabeth Goodwin

Thank you.

Matthew. Harrison from ahead, Morgan question Matthew Go comes next Stanley. Our at

Matthew Harrison

you Great, to see remember could when a futility influenced I thanks, or that. for for we us just me, and clear then everybody. Japan guess, sort on one, around I two updates geographies. there pricing enrollment other any in thoughts of Elizabeth. analysis the that guess the things for of further ISABELA? can was remind Good commercialization their any I And steps secondly, piece some the relative afternoon, of

very much. thanks So

Piet Wigerinck

Hi, Matthew. Thanks.

in commercialization one I They doing will they are owns that Japan. Gilead think nice the first and where be act.

in the that as collaboration operates maximize companies, to I've pricing maximize take. market an of which indication the in also and opportunity also their metrology to a with They Gilead has will they is Japan be ISA decision local share market. operations with there the So presence in of the

Michele Manto

half are year. you, ISABELA, Thank first Piet. for futility having the for planning Essentially I still we next the for currently, of facility in think,

of other of the that the now, company all just for any caveat right uncertainty around reflect corona right like our big pipelines applies With now.

changes? that's evolve. guiding So to any we'll our And if we be see will you. how we so far, plan. the Thank in have going But sticking we're with future,

Elizabeth Goodwin

now next Go Cowen. up from Nadeau is Phil ahead, And Phil.

Phil Nadeau

like XXX right of bit filgotinib, My and Reviewing only and you When and participants. with small. between looks proof-of-concept the the in about question the XXX It trials trials. XX X to structure is X social were actually to we on somewhere Toledo Phase compare the get XX each a will see the that is designs, more Phase these sizes, trials XXXX. patients actually like

trials are what's different in program? rationale give each in efficacy to indications? a clear So, signal And you for small for efficient think and those the large the the numbers the you Toledo enough safety do

Onno van de Stolpe

you will take that? Piet,

Piet Wigerinck

ahead. You can go

Onno van de Stolpe

frequently Galapagos, thank the are whole pulling we when based way an learn with compound data inform our that indication try a -- We and that to build clinic. Look, really dynamic shared to in out, data approach story, as and medicines is we models a wide you whether take the and of the our biology to it this on proof-of-concept the see as of you. to cast data to type preclinical the we see the want Okay, our build to the X the the we go lead on we the from bridge Phase net from we we Toledo, platform develop general.

diseases choose from we the to you then larger you shared so And that lower. a could as to will also we to it ability need as be community adaptive explore potential investment. with If studies, you the think of we in do wide lose such, want and the much significant to benefit could you array then

outcomes, you something not do that or decisive such, one can continuing where you very as take you impressive, and see that's we the to that for see allow patients studies, get sufficient next type and you have it's something or trials, to disease, very going the bond you worthwhile, that the for That's step larger changing that while worthwhile nothing, into pursuing, straight you a of either learn therefore of kind of approach of smaller maybe So particular the will go is that sub-population, from further that then look change gives it. endpoint and signal there. maybe a we that maybe take you

talked dose straight you and UC, bet action, patients we psoriatic Sjögren in from chance and to [indiscernible] it that the however, innate gets this understand biology, arthritis. we bring into range other in psoriatic it range go those see to psoriasis, there arthritis, the we of With RA, finding based psoriasis, again. as that filing take proof-of-concepts the adaptive case of fastest mechanism In plug a decided because should both of sits jumping of particular day, we straight to pulling and the the that class to on I for lupus; and benefit model five because the immunity the medicines, because study what I'm is across say, study. by of a

Elizabeth Goodwin

Dane from Dane. ahead, James. question Go next Raymond Leone our comes from So

Dane Leone

in second Before of PINTA the IPF. study line top results the your XXXX

of Just clinical trials.gov based one, that on interest on study points that in August. completed

in I'm questions then some of, can profile from that sure what was just in it, volunteer of the it's of drug you terms need and might have dosing a IBD putting IBD not there comment now terms studies, healthy is use been in from or that kind the or lower Just just to they then of Could And descending, you the to of PK done explored? whether long there different been the in maybe, that wanted dosed how XXXX line results? life. given were top that much into get terms being secondly, deliver analysis have IPF be doses November, studies the how and accumulation but to half you the around being you're strategy, context color the of study, relative

Walid Abi-Saab

on report the FRI. In in different in I'll out and SCC the and three the backgrounds, with study PINTA take XX-week question. patients PINTA we

on set. So its a own FRI massive data is

present our for at we are everyone those way so understand me making through that we the moment data. that And

single we we want go to FRI in We difference analysis can took tell PK which need be approximately can that So where XXX% out. show a to that. XXXX over sure huge, IBD is city or patients The compound, can we based not and ready dose. go did that to over if we I PINTA for is the you, that's did, just the when profile that's between We everything ongoing. we patients IPF and targets we anticipate latest. we will on the with level anticipate a there That come is do data state have not

Elizabeth Goodwin

comes from Our Jason from Go Bank of question ahead. Gerberry America. next

Jason Gerberry

UC Gilead forward but first of for a about call the me, was their talked not hypothetical forward guess path one with I potential, moving one RA. on or

essentially but approval a nuance for broader want perhaps would an play? wanted considerations mg to of sure market, there of you to come have any rationale some come there, can that launch? UC, not Just into EU the into that entry that but RA? entry Thanks. you that about kind is make that think XXX just, I those push price and later entrants understand because of to second that just Do then I So think realizing that European of effectively, know And you my launch blood amongst correctly to kind for UC presume presuppose that question And order are is of at scenario? launch? a clots third, the with that of negotiation look generation maybe considerations of lot RA at the how you Do the an predisposition JAKs? probably guys the you need order inherent the or patients level, there's with there at next the if do as country you clarify is [indiscernible]

Walid Abi-Saab

see is from is that Thanks, that in RA been Jason, they question. about in, never the in and Also, first I'll you actually But have need compared to they the on specific biology UC, not because what risk know the we in I that milligram concerns and FDA clear, that a XXX have believe that safety than approvable we've often And to benefit be the said dose milligram of the very a that. want from milligram, XXX FDA of concern the your is and with the very has prior take you molecules RA. higher clear dose. you've XXX and said, this, it

in dose good. words, So, the is milligram very other XXX

milligram So, they specifically indication, the in their that opinion, said in it's and use in warranted not to their indication. XXX

well is different. UC. the recently population Also seen continues in data very GW the you see you you scenario as safety. the see to a you've this milligram as different also on good color but And So XXX profiler I as when think patient And share it's from the look population. more efficacy, in you selection, on

the think I have its to on So, agency own. determination will that make

But it XXX the the Of the milligrams data not all And the I is XXX% read to of evaluate to indications. don't risk population. think I on the other benefits they going in to and from through they because need ignore IBD they're course, have, completely pass that the Michele.

Michele Manto

Thank you, Walid.

as on we get procedures course, started with of navigate good both the again, now have in the systems reimbursement we and one, different things timing the to complexities on details, is et there approve accessed on getting can the you demanding the of because or Japanese healthcare we be parking and similar reimbursed play and the too the different the for to system that's thing out are in on really for cetera, fees at the really to first and really And which So, on can different before negotiation prepared without market. law so pricing on pricing that and discussion to as the in without system lots the well, of differences soon after all possible. European time new motives and countries getting and the a and the course, same their be going levels, then much investment without which countries on

industry. entry, In all consideration the is direct terms your of there of industry and consumer special of no to

Elizabeth Goodwin

Degroof up Michele. Petercam. hour, And got more I Benoit. Benoit question Thanks, know we've we're ahead, at on one coming but the from Go Louage

Benoit Louage

taking look into the Hello, evaluate maybe just systemic initiate? and would combination wondering, and communicating wondering, positive, in future is Gilead's forward IPF Or follow-up in and evaluation you and compounds on on could Thank with expect, for good will of was which speed just you was timeframe as X? taking before kind you questions. afternoon. such sclerosis? for the my on trial in to to I within trying will two I this this what approximately wait, Would Thank ziritaxestat PINTA the first Phase view and or be And be be X what to as very into to terms readouts, next your something the setting Phase for have in if actually, of we awaiting would that, that you. near in XXXX therapy monotherapy I going a franchise, strategies? IPF well some a specifically XXXX. related now view the more trial

Walid Abi-Saab

I'll Thank you, Benoit. take those This is questions. Walid.

in range the X think OncoArendi So bit our program dose for in about a finding we've little evaluate program. to Phase I plans to talked this

program be Phase of the results think can X. I on are can depending straight OncoArendi the or the somewhere if are into we middle, results in XXXX propose going If jump PINTA. We something would forward. the idea like they program ISABELA the fantastic, can we --

we all the take very then can it. on forward time. come but it's to because and of the usually us The predict hard straightforward -- regarding question a for -- delay we Again, hard -- it's clear ahead things predict. we for I'm you the what If our ahead we it's play path Regarding want very to bit If see really sorry scratch might that scenario do. these as a prepare, to for data, requires time. short will timeline until these to for then us the plan up the of with longer data to to be the heads little

as that's an drugs think if been we XXXX, you combinations factorial know and design again, these you can imagine, prohibitive. them, of always neither option. of doing have trials dose one Regarding But don't you then experimental two type become for the

that cleverly about think and it would enable I must some we to figure going So forward. think do us we will use out work dose which combination

are to plan bit a thinking as us and I something definitely And little starting to But allow to radar interested all you. do have already our any our clinical now. can right something of there's is of franchise don't certainly you we're do on in that. pre-clinically some so. clear compound So, with thank share before, it's But work IPF candidates across we screen and that that we said on I

Benoit Louage

feedback. thank for Okay, the you

Elizabeth Goodwin

All you we're much. wrap any to going that you team or today. reach Please And IR very to Van out if right, thank the have up Sofie Gijsel myself questions.

at ahead, January. at Conference Looking Jefferies Conference the JPMorgan Healthcare Presentations month we'll Executive this the webcasting Healthcare be in later and

full and you. call next February for XXXX. safe the please for thank Bye-bye. financial participating be today callers year the Our stay XX, will all well. on We and results results scheduled XXXX Thank

Operator

for our you today. conclude That conference Thank for does participating.

may disconnect. You all

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