ARGX - Earnings call transcript Q3 2021

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Tim Van Hauwermeiren

[Call Starts Abruptly] This might explain why patients consistently switch between treatments.

Finally, there is a considerable market opportunity with approximately 16,000 to 17,000 addressable patients in the U.S. alone.

We are continuing to enroll patients in the ADVANCE SUBCU, ADHERE, and ADDRESS trials for ITP, CIDP, and Vulgaris, respectively, which are shown on Slide 7, 8, and 9.

As we approach enrollment completion, we will be able to provide more granular standing for these results. full British the Journal the study X shared the in of recently results Phase from Pemphigus We Dermatology. start could understanding We its would the doses profile, how observed latest favorable of Pemphigus lower initial and manuscript read the and Efgartigimod of tolerability with data fast of paradigm encourage to early support given you in tapering. fit into to potential steroid action, use treatment onset our corticosteroids to preparation stages we indications, our final trials. in With initiate are to the newest registrational The Bullous Slides on our the up that is and XX to Myositis trial the now end track wrapped on during by Pemphigoid is FDA XX. to consultations, of first start and XXXX, have start quarter and of this these year, we depicted expected are also with launch Through Zai to in indications. are we Lab, planning additional collaboration trials proof-of-concept our

look we first-in-class that ideal inhibitor. within our it is complement X keeps R&D in why CX, Day is We on Slide trials. be product shared to with pipeline to enrollment next infrequent to yet, Phase data forward CX in and X this We XX. and important clinical this global ARGX-XXX, more patients public support a and when in formulations genetic a ready other cascade. CX talking our we Chinese Phase phenotype safety MMN name point of pathway reasons year that talk quickly the begin the remain programs data X additional of of alternative track than during a few, the ARGX-XXX an to preparing explain of a Phase the PK/PD with risk, the from aren't for is about We both in favorable efficiencies. meantime, starting with reduce intervention end the start X pipeline, To of impact about the benign indications I'm to plan other going our ongoing showed Zai by The our IV profile to complement deficiency patients trial dosing. subcu infection the but believe CX upstream have opportunity and into of profiles a on that year.

about the single also aimed the our neuromuscular at emerged from R&D Innovation is We This latest that Program. for time which first ARGX-XXX Day, pipeline has during antibody junction. talked is Immunology the our a product boosting

excited are more on program We this share next to year.

Directors my exciting as to particular, team colleagues, I a transition, after today Wim Before new like of Wim We role this moment of in announced like March April R&D our I of our to years to XXXX. of will to Board for we thank approach will argenx. plans stage become turn Truyen this Parys. assume are efforts underway member acknowledge In that succession he collective their X for Luc call take would argenx XXXX. committee In the retire would in for with the planned to a and I the

his humble turn We update. I invaluable for few over these organization, financial of that, for to provide leadership to transformation R&D his so Karl? the are will our him and past call to Karl With years. a contributions, grateful the

Karl Gubitz

a press XX, covers XXXX. ended income in the XXXX months results release. XX more they them X operating our covered here, Slide financial detail increased are Total Tim. Thanks, will for September but consequences during I today's summarize in significant collaboration to in primarily $XX.X period compared million as agreement XXXX. with termination recognition increase million a to same of the million the Janssen. a of of $XXX.X was $XXX.X due to The

in resulted financial to the and resulted higher assets the year, million expenses increase collaboration so in is primarily share. XXXX totaled $XXX.X recognition of mainly of months $XX.X compared of closing programs. compared financing The million research Lab, to XXXX. non-current X we Zai in for the a to $XXX.X change development for primarily totaled fair for far $XXX.X Series in million which XXXX. $XXX.X a million have the first revenue. million The R&D of closing external million resulting SG&A our Additionally, expenses, strategic increased this The on B round from result increase the in with $XXX.X AgomAb which Therapeutics value profit from collaboration expenses expenses. of efgartigimod a higher in personnel

billion to financial launch on provide over of $X update current to end and turn billion Keith? to the the an preparation. like equivalents, September cash on to assets $X.XX compared XX, I'd Keith of now as Woods cash, commercial Finally, call December totaled XXXX. our

Keith Woods

XX, Karl. Slide Thanks, please.

a Europe, efgartigimod are on process we anticipate we an on commercial In expect approval December of approval basis, in We our In U.S., XX from to anywhere and X and MG. date we in Slide take set. that of in country-by-country an our date XXXX. launch second negotiate effective will can a is 'XX we global for Based please. an and once in later price have this price followed the reimbursement months launch we Japan, the XXXX, by on have preparations PDUFA XX XXXX, half months. XX, to quarter then anticipate a launch the January of track first the with in

fully our as are also field announce We today, of teams are U.S. to board. Japan on and that excited

to providers, We that are stakeholders and we approval. prepared other conducting currently upon training payers, to and patients, are reach account ensure profiling

and XXX territory our XX U.S. managers team XX will but in the have field in We full Japan, force in of U.S. a the business people. be

Directors. includes the managers, Managers, leader liaisons, business coordinators, Account thought Directors, Case liaisons, Account territory research the Regional field Regional reimbursement Managers, and managers, the National to team medical case Business Nurse also addition In

see across be expand with We impressed new will we investments the team scale patient. are economies shared new enthusiasm we long know making and we because continue commitment talent, our team experience, other that term of members franchise to level their the benefit We with we and will new for recognize of bring, and and as in the towards us our indications commercial assets. each infrastructure now the to the

the team potential there for continues to best-in-class launch, control. of certain we to create is outside challenges our pandemic While teams uncertainty serve. and have Mainly, are that handle this are to that equipped a COVID communities the hope aspects know we our that with we assembled we associated the feel

approach. a to We are components a from in-person physicians interactions launch both on with optimize building on plan virtual feedback and incorporates that hybrid how based our

also We for treatment. that be access patients for easily still facility difficult may to it know the

a have So in addition to built building home also network. of infusion centers, we infusion a network

there the with a associated COVID to addition are are the launch of challenges first unique In scenarios additional product. facing, we

times, not said J many we've have As Code we will a at launch.

dedicated through apply the quarters approval quarter J XXXX. go We shortly for first having to appeal one This prescribers Code slow things may in expect in X with X to quarter and down by the place process. will a of have after in a reimbursement first

of new, Second, until familiar to time many and innovative medicines. efgartigimod are educate a and first-in-class class have with do comfortable will experience. physicians, not novel therapy. hands-on It not be action payers and Targeting with they this get to are that patients, a of take is the physicians mechanism FcRn will

approval. engagement of extent actual the we an can stakeholders in limited are we have before with Finally,

potential it in the have for people MG our believe MG. to We significant that reach a that and summary, safety Slide we people options socially, based this this on real-world continue We study strong formulations, disease multiple compelling will want and with for the are For dosing, time full please. impacted efgartigimod physically, with in these With launch negatively face. the In it value for of the from to overall positioned IV a with and on living of make unchanged. potential is our we see we growth, subcu I the clear having efgartigimod we excited on global that evidence the ADAPT take of gradual, all are and need individualized potential that reasons, in this that mentally, are and to still gMG outlook our XX, unmet and and mind, data, launch alternative emotionally. levels; efgartigimod living a community that growing for remains database. prepared both need proposition know in steady learned

XX% options a significant of side were there need likely most responders of fewer for experience is breathing, the double responders for and to treatments, with XX% were that with hopeful droop problems In new fact, severity. vision, agree study eyelid effects. survey Participants in and

XX.X% XX.X% for stopped that of as the a working had learned separate In also XX% burden to disease. their argenx-sponsored anxiety. We entirely patients survey, threshold as enough patient due score this high to for meet of well participants diagnosis depression

be there Hearing we a the Tim? about living back spend considerable time with are the with and been that MG treatment efgartigimod call hopeful I'll Tim can fortunate final several conclude to for have last option community turn challenges, for gMG. these years. people We enough new over over to remarks. the

Tim Van Hauwermeiren

Thank you. to I'd echo like what Keith first said.

and in on suffering expand autoimmune those we us Zai In for summarize, Medicine multitude Europe. myasthenia This working developing best-in-class bring assets. as development the launch ready are motivates argenx, from multiple and of To then are other an a to are the accelerate value, and to and efgartigimod MG, opportunity we and and and such the new partners treatment important its precipice efficiently maximize for the what diseases. first of U.S., potentially parallel long-term excited We in to our in for gravis, of global then first first to living moment people the order every Japan, with of serious with reach medicine indications is of day.

global lost into This we treatments in long-term Program. open all believe to the assets, as to foundation patients long-term ARGX-XXX, to translate engine, such organization, breakthroughs discovery provide fueling and strong sustainable for integrated Immunology simultaneously questions. adding for groundbreaking growth into our With Operator? commitments immunology grow continually that, up a of we not we Innovation ARGX-XXX scientific and will will our the why I our is As are new your this growth stakeholders. immunology needs. fully other have by and powerful now progressing assets call We sight

Operator

comes first Jefferies. Our Akash Instructions] Tewari question with [Operator from

Akash Tewari

And initiating dosing are sites remotely the take your Lander, or in-person on that Have this the any can in, you regimens on FDA doctor by I what's Cardinal other efgartigimod? from feedback? either your Was gMG? been or exploring if based into a feedback agency just decision for or of PDUFA that trials in Vetter, rationale December decision inspected, heading

Tim Van Hauwermeiren

question. for Thank you, Akash. the Thanks

remotely. products and are So are are FDA in sites These have being sites approved. which FDA are which by to well-known the the been expected being remember, these inspected numerous occasions past very FDA. which sites notable currently there, the on are question, first the manufacturing manufactured And are

ongoing, think So that we is and on track. we're

some in efgartigimod of see on one X studies, hopefully we'll to our clinicaltrials.gov indications. Phase of You many continuing

there's So say I Phase say would nothing is we're studies, than nothing rolling one out. of the currently this X to less more, which

Operator

Morgan. Our comes Gordon with next question JP from James

James Gordon

One question was efgart pricing. on

$XXX,XXX patient if were how to to is product like thinking, to immunoglobulin cost much priced? not a similar be depending so in you question. what what year U.S. give -- product the per assuming $XXX,XXX your many squeeze just So approval patient product than get? would Is or think latest a could And more just could it a quite sort is per priced being about which I it how be a this follow-up price more of doses

of also a but round all and Bloomberg little those we a be of the to time to get comments, total things In ASCO need million about needing of revenues the for of to the Just some bit Code in and J a group higher for next of of consensus ASCO for Could build action, makes overall. I sense. awareness mind given think light mode a the some $XXX just J that new taken comments I the round? Code has bear noted year

Tim Van Hauwermeiren

taking the you. pricing, first Thank please? mind on you question would Keith,

Keith Woods

Happy to Tim. do so,

increases it been So, IVIg chronic we've on I of taken the want James, couple homework that for -- that's price looking of over you while look patient IVIg And doing been recent pricing. with year. of if at And the they've average last to the MG the for per at quite we've a also the is an treatment call, about average. $XXX,XXX cost years, and cost

onset much our our response patients believe that expensive. over we Some our on of rapid of offer and IVIg. more response, value based premium that We are efficacy, depth proposition of a

individualized our think addition, and provide we In dosing with safety convenience greater overall we tolerability schedule. and

So with that's disclose this we we pricing where are our last earnings of be thoughts. should And kind on price. call the can this before actually

Tim Van Hauwermeiren

please? want Maybe question, second to on the Karl, you comment

Karl Gubitz

James. you, Thank

is consensus consensus, the the I just you said on see under million. for I'm revenues, at to around going -- $XXX product So look it's that $XXX comment million. When I

see I what for product sales. that's for consensus So

in closure, analysts now all which, revenue think of in year. there this assumptions have still been has some I course, for recognized

at which think their you. I something refine that's So Thank analysts models. as will look they

Operator

question Our Raymond James. from comes Danielle next with Brill

Danielle Brill

topics Tim, then discussions of wondering on if to PDUFA the date review could and during the proximity of posed And meeting. also your questions the I as curious, was by types yet? some focus color maybe late-cycle the labeling you the given agency have begun provide

Tim Van Hauwermeiren

Danielle, thanks today. for with being us

for on for the on So the there's too point, with that it with on track review confirmation much, us. we to therefore, I that of on track would expectations, ongoing the we on but the file. We But that can PDUFA the thank track you this review not did discuss question the a believe ask company review which date can discussion, discussion, FDA, that -- we're got X-day confirm on December is on we our question. again behind say file, the of meeting XX. the we no we explicitly with and based confirm. based of publically short course, And from We line another the in meeting for is we FDA believe panel. something about was the late-cycle can the are need dialogue the their is

Operator

Our from with Guggenheim. Yatin next question Suneja comes

Yatin Suneja

Another question dynamic. on launch the

patient and I understand, receive. function the price a I cycle revenue a many So can is think likely of how

bigger to many in talk we after the per per obviously, just just maybe moving how And patient away think about going we I should about if think they first from how -- XXX then you of much revenue, year XXX cycles you Soliris, are can about So at year? a patients launch. look added TAM. And

upside or good then in reasonable expand sort just sense -- a other geographies. that get build trying as of a sort of to to So is a base Soliris more and case a you

Tim Van Hauwermeiren

for questions. Keith us floor the thanks best to to are great who's address with being Keith? give Yatin, and those. today, X these going I'm in the place to

Keith Woods

you Yes. Yatin. the question, Thank for

So from is per a we're data what comes curve. when year, patient cycles seeing per the distribution it to

per that XX% and So you're off to are year, of a of we experience to to few going able chronic about have dosing. patients to where advantage going that take to closer period have of part also therapy going time substantial be of is cycles require population the

their distribution So taking feel with think discussing that will -- how and what And I realizing at be with to the going are therefore, of patient we patient others, will would us. expense it's on a look a this for the for higher a revenue Do it them. they be dosing, patients, more payers that relatively they're typical it of some be with where a chronic low curve? fall, is

have Soliris of to thing the you from They a to read-through real as pure do they're is have acetylcholine limited it's broad the receptor-positive the broader a a the read-through not severe as comparison. far it's apples-to-apples launch, but because refractory. we a But know, audience. lot restricted payers patients. And are the them give targeting relapsed really As a label,

difficult it's a to use So direct as that read-through.

Yatin Suneja

clarification patients one The number, talk correct?, that about, Just that's question. a gMG? addressable in you U.S. XX,XXX

Keith Woods

the is That correct. U.S. That's

Operator

Lee Our with Joon next from question Truist. comes

Joon Lee

Obviously, But giving and life that report a concluded eculizumab. several that was ICER for Plus, half that recently efgartigimod and frequency you years also, of made they C+. and than where update. convenience assumptions, on at and in not of less on dosing a differ eculizumab efgartigimod. quality-adjusted they them than you. factors. published Thank Thanks the B your -- less prop for of to value the findings + of comments the love would price their the hear from other including accounting placeholder for differences

Tim Van Hauwermeiren

Joon, for question. thank you the

that you can fullest and aligning data. own review us from look we that about the disease deep our and by drugs very report really continue track think then never a own and rare this great for on And into were of conclusions think opportunity of of well you see to a be develop a I history if I data for point record view. was done the typically ICER, ICER excited to our take dive really the at pricing data, there understanding

which was we we the regardless as of including conclusions, strong which look not of in Very models the which regain study, background the So with if see was of overall like on. some the population at as And would conference, in are the some that number excitingly, eculizumab. you a won't efgartigimod disease also of positioning you was We scientific their in it of the treatment therapy of with subset given would population. in that gives to upcoming rare ADAPT vis-à-vis have latest for given the however, reasons really basically terms the is that the patient efgartigimod from the back which effect see disclosures, really of to would as criteria, regain lines separate the of like looks the of relative And need any of queue MG. opportunity session data patients their agree some medications, to one during light potent in that in you EMEM data of modeling us other the at drug in the relate the give the line MGFA. study, things me and ADAPT data it for did was

patients, the have equally also different So the but effect, in across refractory domains. most an strong even we muscle

limb or across of the of growth respiratory, the is consistent talk see subsets effect and when different about efgartigimod that strong boulder, muscles. regardless So we and you ocular, multifunction,

strength Thanks data. to our data further thought the a the So great for underpin continuing of analysis I question.

Operator

comes with Tazeen question next America. Bank The from of Ahmad

Tazeen Ahmad

bit just FDA But discussions and I'm regarding Tim, already quick with joined been just labeling MG I how asked. a discussions question. for yet? tad going application started it's a are efgartigimod if sorry and late. have the

Tim Van Hauwermeiren

have our status very late-cycle the growing. We each been did the date has from from FDA on think the point topic of question. track we we the review to we answering the discussion yes, of are XX. PDUFA reality cover And of of based refrain region this that Tazeen, how and vis-à-vis on labeling December the view, briefly of file, a inspections,

talk think But everything's later hopefully an Ultimately, discussions decide. remains track. we on will course, and occasion. so Thank about decision on We FDA you. far, FDA a labeling will of this only

Tazeen Ahmad

Okay. are just in that just follow-up that MG on a might but including of And you the opportunity, on the now, not coming then how think on market the future. products for the market ones be

for be into a the entering foresee the example, working versus I do is MG. bringing clinic that think will biggest for for the So think Thank potentially on market? product you else that anything of Where differentiation efgartigimod point you Regeneron you.

Tim Van Hauwermeiren

to answered stuff question, which question. X the is great Well, a

beyond complement do we upstream example, of have class the to, such is acting complement. look I that that you we biology the inhibitors, know for think FcRn now understanding an of pathogenic If the autoantibody

of complement what a the blocker think modes say autoantibodies, junction. see it's pathogenic fair multiple part of to one Complement do. -- them. pathogenic that can data the And ADAPT I recruitment which or of removing is of -- strength the probably and having the goes to the it above that the power So beyond show of actually on is action

high. Now we've bar think very within put FcRn these class, the I

It's as and safety healthy If largest the drug, the that and where a all far of safety set of is profile across of you indications. by we data efgartigimod to emerging the differentiator. look multiple have safety potential fair say biggest volunteers at our profile the

symptom very put then enables therefore, bar whole the we've it the high the space then is to the response think Halozyme other tall cycles, subcu almost an in that on for a when the mean believe I XX% effect try to to new angle, convenient expression the continue that, even I and the much. a durability bar exclusive efficacy. minimum people very comes we immediate license first do an achieving of over and come And X XX% also of the very rate the and convenience setting that dosing that MG. too standard a

convenience, tall efficacy, safety, municipality, really I question. at bar. we're setting the Thanks think So for

Operator

comes Turner question from next Barclays. Our Rosie with

Rosie Turner

me. So just X very quick ones from

is indications about Lab that thinking indications XXXX, the targeting of terms by to And at-home be Labs that in is just indications? In network were -- infusion then your those mentioned. and or you in being Zai XX that the in Zai addition those including

to impact what just kind corresponded that work you the that by yourself can an of that thinking and that will and margins? Just is how on have be or to going will about something wondering insurers pass on

Tim Van Hauwermeiren

to that will you minute These I great are work. how a question and infusion in X questions. Keith, over hand on would network X the

On Zai is does indications, it simple the the include the Lab. with strategic answer XX that alliance

is So indications totality own Keith? indication our partners. a this also bringing by pursuing into indications our play, pursued but

Keith Woods

you. Thank Yes.

U.S., as of and we are working home across have far a that preferred working insurance how companies there them. designed is certain infusion with providers and infusion As the be providers, the with network we goes, is are will this number

infusion great home. also at centers targeted home We the neurology that deal of currently treat have a patients

where especially a needs launch, as we meet in broad able network our to demand environment met. concept be here, office And So offer to be the overall will treatment, we pharmacy, is is will is patient what COVID because it where be specialty that a to it mean infusion, I patients offer we can treated. through in will we by go centers offer we we offer home infusion will want

it So to convenient is make possible. as as idea the

Operator

question muted? next comes might from Our Jason, Butler JMP with be you Securities. Jason

Jason Butler

Thanks. Can also relevant us relative the you you process in about any level, a price dynamics high how talk think there. reimbursement at the And Japan? versus Just -- reference reimbursement one just and Japan the on process reference to to U.S.?

Tim Van Hauwermeiren

right? you, Jason, Thanks question for is being with today. us for Keith, a this

Keith Woods

Yes. question. thanks and, Thanks, Jason, the Tim, for

an that the tight reimbursement will we we our price first process price NHI Japan. Japan. to Ideally, close is And that thing That's as is with them. need negotiate we pricing in that from typically Japan, pricing across regulatory as you in ongoing months some globe, after work your process time. approval have of So X for but do with it later Japan a have is is, as get strategy band continue to to the takes far the

So we in through will continue them. of process negotiation the with that

Operator

The next question with comes Citi. from Beatty Joel

Joel Beatty

such For the underway, subcutaneous in trials for and what your of showing some to versus MG comparable ITP, opportunities type show benefit compared expectations as to data are the IMP formulation?

Tim Van Hauwermeiren

the believe Great as XX situation, dose at -- milligram an for has question. PD In identical this subcu we of milligrams that a the X,XXX almost effect IV.

in So secondary that on we're going endpoint from on equivalents improvement and at percentage in actually non-inferiorities, primary measured be the expecting been IgG based clinical and and based We've of endpoints safety the symptoms. reduction will efficacy. the

with many submission. for different queue from trials course, ITP, a presentation, aiming registration we've product do product, chosen Again, of identical subcu IV and of which to for for subset be product the appealing Of could with patients. again, a point We've one we're but to the vitro. a convenience one view to

sets So the total for the will that both between we Thank studies. data be you question. expect consistent

Operator

next with Wells Zhu Fargo. Yanan comes The from question

Yanan Zhu

of the indications more Is discussion? approved treatment? pursuing, of patient quick -- of that might ones. IVIg I that labeling in do you're is some topics head-to-head are with it IVIg also, reasonable And contemplate any population the where have you be you assume to X one antibody-negative broadly, studies the

Tim Van Hauwermeiren

the want seronegative take question, please? the Keith, you you question. Thank to for

Keith Woods

including look our Phase happy MG honored equivalent. We that did that on in in so. efgartigimod, but out I impact population, were data benefit Yes, but study, the a to nearly want we specifically did was trial. to we commitment out of by a to that Phase of X IgG-X. call Phase a see belief patient do I at treatment was X there the not the X just they If in our study, the seronegative part that in the seronegative using to of this the take community the placebo response call We the to because want efgartigimod has our

saw not So significant. are the we data statistically

looking We information even MSE. by also on to both further we've this and some look but continue MG-ADL as ADL achieved those shared at at not well QMG group as who just QMG,

ultimately, have data a FDA. provided of to the by we agency. this But is decision this to So the all be going

Tim Van Hauwermeiren

Keith. of current none of second head-to-head, you, Thank -- course, the for studies, question, on are the against going IVIg. the look, And studies then the

reminder, gravis IVIg not the product. acute for setting As In with we're is for in an a in and not myasthenia the ITP, approved IVIgs aiming chronic play. setting

For CIDP requirement a such vis-à-vis in myositis, do was FDA a or place. And not the no to by vulgaris, need study is IVIg. no in really IVIg there again, head-to-head Pemphigus Pemphigus

head-to-head So we But of or future us. question. current the warrants no course, for announced trials, And yet cannot there's the required comment on comparison for clinical trials. thank you

Operator

from C. Wainwright. comes H. Douglas question with next Our Tsao

Douglas Tsao

for they level? symptom curious, treated? do to have so sense disease durability data, And curious the be going dosing level do treat to -- sort to symptoms response if sort of have of going many Are patients, they of progression are who see just in to expression. achieve a then they on come to Since I'm start the the providers, again, you is that you when MSE, slow starts it is minimally, same they fairly or achieve I'm you do you or do quickly? just patients manifest of

Tim Van Hauwermeiren

-- comfortable great It's onto question. a who about to physicians think Keith whether to ask question, MSE? the if we dose answer you're

Keith Woods

being that symptoms their to with physicians many patient no live. patients them opportunity events only a of ideally, not experiencing are achieve at to off-label treatment hospitalized AANEM, feel their believe put got nothing We've substantially want not because MSE walk patient to with is for the until treat to higher to able up maintain cure, And recently into costs. incurring for that there's adverse want and symptoms are we not MSE and they going current the way and for therefore we meet also Ultimately, having really be to able most at with around deal physicians, payers because more there's where wind a with them Sure. associated MG met powerful the lower with same to MG. By being to there. than way,

trial, the to see learn MSE. how before to MSE ADAPT But you we of know, dosing redosing. the ultimately, So because allow cycles, lift back up trial, did out did patients of in as from you needed we the

to think there. -- and MSE I see patients achieve attempt those to then you're going be real world, them maintained

Tim Van Hauwermeiren

durability Keith, and you, effects. then Thank on the of

data, expansion what drug our and on strong data and drug. continue to have into for an And from the cycle, opportunity that publicly the we in a totality take really we continue we now course, equally that or not that study is X we have patients. studies said X dive about open-label in of treatment was patients to ICER call the data an thing us said years the second we the to the stronger review. excited deep is expansions MCE through The Of of in earlier effect our taking only to strength be see X

okay? expected forward, most talking be data year, in looks but is that We expansion going at data conferences, the about open-label will interim studies likely to next be

Operator

from comes question with Charles next Redburn. Our Pitman

Charles Pitman

two, I if I just have may.

clarify, could Israel? have for approval in for Zai Medicine risk prowess? Thanks. the facilities. in could COVID-related marginal or the And number of give partnerships, to indications then Lab I does this us manufacturing due to you other a potential not you the just is wondering to due at Medicine Firstly, partnership, just we've issues date? decisions regulators' manufacturing on delayed PDUFA for indication to this an XX whether lines visit China to inability potential seen to inspection in time your secondly, And was if PDUFA on talk beyond extend just

Tim Van Hauwermeiren

Thank approval basically likely you track on and site are clinical to -- been the give second site approval inspected the remotely. what selected you. publicly want have These for facilities manufacturing happen Medicine. question And we before FDA completely the the They Keith, being Zai a the which on have I to will that in-person. will manufacturing group remotely. inspections sites And successfully numerous or that are first good FDA. FDA The is inspections likelihood currently with had records. by concluded process there's the question, therefore, inspection known are said

moment, at call, date this potential associated in Thank December delay of it risk repeat comes any manufacturing site inspection we to just see Keith? said PDUFA the you. cannot with what a I 'XX. So when this of I'll before

Keith Woods

So let's Zai first. take

Zai and So to occur X after that will here submission, we and we made in the line regard to expect approximately U.S. have the expect review that will after we we've in to in time make year. approval lines, that submission time China be we

process Israel, case in we've the a once their have track record just to for has Medicine on get And there, this; of of can partner actually able As whether track done their reputation the Israel in the seen their capabilities, we Medicine agreement, start selected part and It's U.S. of their approval we've record. success business and basis the being on to in believed we patients and been started.

that literature in about some reference, diagnosed Israel, see, we can X,XXX you so patients the MG to there. from Just give there's

this distributor throughout to So whether be the or first a we It's on the is several expect just be this we the to regions we agreements too be one. will ourselves -- with example providing is argenx that of will first early partnership, by this but give world. distribution definitive of

Operator

from Next Deutsche with Emmanuel call comes Papadakis Bank.

Emmanuel Papadakis

will ask positioning? its and next XXXX to care expectations approved. in once the accelerating subcu be Essentially, I of it MG how uptake the wanted is are ITP for relative important likely current in clinical secondly, what data year And to standard

Tim Van Hauwermeiren

for talk you I second then the market, products take and why ahead you question, relatively our penetrating how imports these about the questions. you of the will okay? Thanks for X compared engine the to look subcu go IV products don't Keith, excellent at and

Keith Woods

out that like experiencing to unmet had call I'd experience. are Sure. efgartigimod that extremely are substantial with, patients to is happy meet that patients IV the first opportunity need. I've And medical efgartigimod, for a their MG with meeting

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have end health is expect to day, I So optionality IV. the remain It's size subcu for the of we when we the see the about And buy available, patients the the subcu for think even optionality about will on care available MG. will of XX% patients. the of the it's grow overall still once you up for professionals. At

Tim Van Hauwermeiren

to to Phase I like we X on you, study. the Phase refer Thank had Keith. regards published, And an ITP trial, to X see we we can then the population patient results. question, the you which effective studied with would quite that When

XX%. to refractory response a So corticosteroids, or had more. rate one TPOS, of And we splenectomy,

positioning the So our Phase to be the expectations and X see the TPO, population, efficacy unsuccessful. -- the quite see, will questions. could a in point the trials it first to Phase TPO not able such are comparable equally we're which in of unlikely expecting a X. And about to view, the be Phase we're it next after which the expectations cycling to patient the patient rate line, instead the is refractory right Thanks will thinking when improved that positioning the to then an for we patient of a product compared enroll comes the you in response population you readout will the for next our of filing From likely X.

Operator

presentation. conference today's concludes for has you concluded. attending The session. Thank now the This question-and-answer

You may now disconnect.

argenx SE (ARGX) 28 Oct 212021 Q3 Earnings call transcript