argenx SE (ARGX) 7 May 222022 Q1 Earnings call transcript

Good morning. My name is Adil, and I will be your conference operator today. At this time, I would like to welcome everyone to today's call. [Operator instructions]. Thank you. Beth President introduce and Corporate to Relations. Investor like DelGiacco, of Vice Communications I'd

begin your now may You conference

from ADVANCE operator. along our issued outlines business which today's results updates. earlier for you, our with today, Phase Thank Two financial be webcast. one the summarizes press first quarter These the presentation results other can and website the trial releases XXXX were our which X and positive on found

statements forward-looking you not we about be Actual statements candidates, indicated I'd milestones. developments, results upcoming that these obligation the Karl Officer; by call Financial statements Officer. to and potential Slide Chief Before Van product argenx These to in our unless statements conform call of Officer; Gubitz, projections, any I'm the success those Hauwermeiren, to Tim. or I today joined clinical may Operating those by statements. remind Woods, future required Medical over during actual include on may under Keith turn Officer; call. on Truyen, begin, the the Chief expectations, this now results Tim regulatory differ presented timelines, and from to law. to is relation financial will our Chief Chief X update like may future by Luc regarding Executive materially

quarter today's Thank everyone, first thank particular, X. in Slide call. joining news thrilled have you, this I'm of morning, discuss shared for exciting morning. Good strong results, Beth. you two we to our and sets

our this physicians. clear the from to going progress the on for and net product but VYVGART in demonstrates demands patients first to team of level, is U.S. in generating for call, treatments of launch, $XX.X the expectations translate exceeded the Keith and context unmet later million high our in provide more have need quarter we First, tremendous needs their new the execution commercial a revenues. our into at GMT community new both

regards have to confident patients to on in track with month. we off I'm place strategies crafted today, right We're GMG the pay to on VYVGART and also the in paying carefully this Our Japan that more to launch and team ever community. physicians than bring

our So global strategy. well on advancing we launch are

announced ITP the our primary refractory endpoint We very of high met positive the difficult in a Second, patient positive a ADVANCE trial, results heavily two we results from very group. trials. first bar pretreated achieving these registrational with and a

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trial of of the and I'm track in We file the progress. So subcu X to results our the reported from rest first Phase are through by be going talking brief positive year. end ADAPT the quarter on to

build who will patients subcu may to refer of the additional bringing our option. optionality delivering We IV launch positive by on a momentum

trial. expanding to and enrollment saw a trial We best XXXX. ARGX-XXX. X and the our can. this all chance us decided of across be a we We we we for We the are Ukraine line with conservative are want up believe push as Ultimately, second to by also to sets quickly the the pemphigus, on take for trial by timeline development year reach view with indications patients because executing our start press clinical and we as two well programs release for Phase and ARGX-XXX to in results a ADDRESS in expect the the efgartigimod therefore, end of exposure the top that Russia and of in to success XX with half

with on you update enrollments. as changes will we make progress any we course, Of

Moving indication ADVANCE results will but in indication to all what minutes Keith trial our walk few aligned ITP. our ITP, our spend for as on we detail, clearly the mean ITP these in through on to indications, with like data why selection ITP results selected strategy. a first like the patients. multifaceted and I'd positive second could

the means action between rationale four by differentiated depicted action. of efgartigimod autoimmune through IgG-mediated We is of balance novel formats as serious modes truly that and on that foremost, be we in evidence. action ways Slide biology Primary targeting X. its the autoantibodies ITP reduced action mechanism of pathogenic clearance in and by work a could This simultaneously. right-size can enhanced all believe driving patent of First approach disease of both autoantibodies production of is targeting which modes the with

because have XX,XXX in as challenge only approach defined impact quality fatigue, that and with the for and indications therapies of and unmet is depression, and bleeding, treatment rare there the adopted patients' loses anxiety platelet also States. is affects no pursue is different adults This options paradigm no but patients than that we effect. and auto need more United bruising, affects is a is and one the significant treatment count, patients on in error physicians or treating ITP Second, disease not exists different. ITP they off other of The all associated the trial new ITP in a individual's significantly which which life. disease a cycle

for the As around goals more for patients, they feedback need consistent the share options. treatment and would they less ITP care about

in platelets whether kept adding evaluated we a selection and a endpoints in the to advance. its treatment and platelet known approach. XX,XXX while XX,XXX without safe to managing drive growth level We We or platelets secondary are toxicity to to sustained mind aiming this this events do of, if bleeding with

people our we for on set need our across ADVANCE endpoints. secondary believe trial data of strong the to DNA, outcome first a a to treatment living hand to the data we have new will to We wait ITP disease. a from to the This trial us serious This is and option deliver the we the walk a will through puts the but I to detail. call in track that, community. subcu Luc primary make With find commitment before with

Medical I'm my role Tim, you, Xst. everyone. argenx, for good April Thank which of as morning, data a I Officer and readout assumed have a conference we excited positive very Chief first call on as

on included XXX of align look four was to endpoint requirements, endpoint out of Let's every or after XX,XXX could platelet start other with achieve patients the randomized and treatment The weeks. both patients the concomitant or a weekly watch-and-wait versus that placebo primary two-week were trial four at was classified but responders treatment dosing. Slide we primary real-world X. All the X:X were of if visits. We patients last week more therapy. of Between This measured period. they a study therapy a week counts three on out five if they transition have patients the design at objectives. for visits, XXX,XXX screening and for received infusions also fixed first throughout patients to weeks platelet counts six with XX in four of approach selected XX, metrics regulatory a fulfill starting as sustained

We in small roll in baseline. XXX are primarily This since Working half arm. International ITP more to We extension. chronic years was those the total of The enrolled assessment. as had a refractory Group Patients patients over of mean received below who who these time characteristics. prior classified group. ADVANCE splenectomy is patients of completed is diagnosis three ADVANCE-Plus number One On for patient approximately therapy. rollover, patient XX% a concomitant baseline ADVANCE, open-label XX pretreated completed at but the the X We had of persistent the platelet over or patients which a be into had each XX,XXX trial. could counts ITT also history could of heavily patient and of therapies. had stratified XX% and Slide patients Approximately

Turning X. to Slide

infusions platelet the of the correlation the count is evidenced The clear is period. placebo from improvement. On throughout the group of separation VYVGART left trial treated and

development having ENA and a same at absence and scale rate On we for ITP. We to also and X, can of of analysis. compared international a was defined events goals. least a guidelines analysis of based encouraging XX,XXX were X% visits. two-fold incorporate platelet and that increase Slide from has a And trial we because at ITP along novel response developed a physicians endpoints primary even On in IWG XX, is as incorporated our in out ITP the these clinical drug to This into how least endpoint on XX.X%, by These hurdle. platelet are to real-world way A access as physicians on the group drugs, defined at treatment think as counts about include we having secondary response capture leading treatment also for as the from or consecutive of pretreated XXX,XXX looked for two separate complete visits. implications bleeding assessments. counts such bleeding a criteria for XX absence responders with as the consecutive this treated a working tough of response a endpoint threshold at a for at see baseline higher the the is in we had of measure, we placebo. two counts separate In rate platelet in regulatory arm, population. high endpoint right least primary least A response wanted a is heavily met

physicians the patients trial. compared between is IWG and You XX.X% around the can arms of where Slide separation of in patients the clear a response the X.X% VYVGART can achieved response, action and the is of a treated observed early see and complete study achieved each as to onset On over a XX.X% response response. the platelet bleeding VYVGART one. safe increase context XX, a highlight how treatment durable clear duration VYVGART-treated additional to response as at this week. you and in an the between The placebo placebo placebo platelet evident, throughout with goals week we complete of count XX% see platelets separation with arms aligns level IWG fast the events. The an and absence of the

this make if are to every XXX,XXX out We other have platelet at the XX to VYVGART Patients visits. surpass switched counts they consecutive of switch four dosing. week eligible three patients

every remained Only able one Importantly, who to the not and to switch was responder. placebo this nine patients patient of responders. a XX other was week dosing switched patient

disease sustained And response each severity, in rate time Slide look VYVGART-treated of as response age, counts you to treatment, background many the use in responders splenectomy. that medication We prior see a We history slide at diagnosis, patients. or on can across high of type platelet ITP since regardless XX. the different there's Moving subtypes. regardless category, patient of observed of

Next slide, please.

we compared alone, in of baseline, platelet-derived that making significance see the You We On the secondary the the key in we including ADVANCE patients patients. least VYVGART as Slide showed of not the number The key response And cumulative significant patients chronic saw bleeding you ITP higher showed between ITP six weeks chronic to the responder. visits, patients in rescue and persistent our This placebo XX. show not with here events significance difficult number can transfusions a did in chronic chronic fewer the small cover response of is chart statistical was of look in achieve. population statistical durable was secondary endpoint. well administration. placebo having VYVGART in where platelet endpoint, count events. therapy last we also data number including counts durable And endpoints, below six means indicate which up fewer as response the we were on at than platelet difference a [indiscernible] in visits, to if or finally, WHO met overall rate tolerability. last of we and the platelet XX,XXX persistent did events population point, This would adverse not you're than delta classified required that rescue registrational performed bleeding patients therapy even that bleeding more sustained overall both We slightly sustained because at population safety placebo. in and response events the categorized patients. placebo. platelet indicates trial with could and numerically treated population, patients responder, eight treated in to last testing, a our see important because This it surprising a as that last trial. a four the compared immediate This our eight XX, first holds is you're rate a of whether the though, an classify

VYVGART treatment the are excited chronic we're To pleased ADAPT, we scheduled and There very confirm as We the no scheduling totality from today. to are very of with safety in findings. in move conclude, meaningful profile safety showing were the tolerability XX-week of with ADVANCE. a data cyclical new we

primary which met especially endpoint, for the a patient we difficult-to-treat a bar, First, high was group.

physicians I move that, gathered also from response. We will particularly And they the every placebo update. that trial. to a we clear with for significant switch call of the and safety are showed the from dosing. with to decisions. a we make profile responder over turn chronic data the throughout important onset count proportion to financial other saw a maintain With of Karl? with We separation as cyclical Karl for aligns fast treatment dosing pleased and how durable week platelet action We their

Slide Thank you, Luc. XX.

XXXX Our only release key here. highlight quarter are the I points detailed first so in this results will morning, our from press

on with pipeline cash plans, expected successful quarter financial cash, global continued our approximately of March. VYVGART Based proceeds in first First, expansion ARGX-XXX and support $X available The $XXX million We of launches, again innovation billion, assets indications which to ended focus chain two efgartigimod includes current development in through XXXX. net clinical utilize of on spend XX current $X.X the and a on in totaling program. balance. in the cash billion from global immunology indications; the round and financing are investment the equivalents, cash supply will

be any any product expected ramp not the call will on on guidance of or providing We revenue guidance today's revenue.

better be dynamics a individualized expect have of market we once use. and We ramp the the to to competitive perspective few to and quarters a on able provide underway real-world dosing have translates launch, can the how guidance

results. financial on Now

income. end net our For the the launch the VYVGART quarter Inventory quarter first well-managed reflects million. in and two was were collaboration $XX.X quarter in [indiscernible]. from which were other XXXX, U.S. the for product the than revenues included Total weeks at million quarter sales revenue $X.X operating $XX.X Cost less channel million $X.X and in were also revenue $X.X million, the of in million. for

related $XXX.X and well both to quarter million, These Our of were approximately total VYVGART. as planned million R&D and mainly to the and can related efgartigimod for other as headcount $XXX marketing SG&A be first expenses respectively. attributed and to programs research commercialization expenses expenses the global

the this can these the You in release now Keith we I'll behind find to additional update. a commercial issued morning. numbers for details hand press call

Karl. Thanks,

comments, with we've Next excited regard efforts. in To start our the echo to slide, please. earlier quarter had we strong are about the first commercial Tim's

best-in-class our team. to support, VYVGART patient adoption of healthcare the benefit dedication appropriate Our and priorities progress by providing launch strategic approval the preparation our and enabling and reflects rapid better, both empowering access. in our hard of experienced our work patients around professionals demand December outlined We call XXXX encouraging

systematically exceeded fronts deliver been have that our to on all expectations. today We results executing

to our work make continue payers. we progress First, with on

that slide, plans we of X Next please. commercial lives. quarter been call, U.S. published VYVGART-specific policies covering approximately in our On XX% had announced

end We XX% are remain broad coverage of place of to share that, covered quarter. by track pleased the we second on over and in number lives to has that have to today increased the

the label, and are that requirements. to continue We to terms of encouraged VYVGART policies authorization align prior step-through in both

many at typically access months and XX discretion. the to patients to mestinon of six physician's gain for therapy where with steroids to VYVGART fail We favorable retreatment approvals are seeing need are or policies only to

into and will XXXX. go the We also X, that J-Code on July has been confirmation approved effect received

great the to Second, our strides in we've made engage physician community. with efforts

in of programs We're prescribers. and are the peer-to-peer brand-new Next slide, programs initial Most attending. feedback XXX mechanism had pleased we treatment also community. time leader are that since with opinion also please. for quarter, Key end to VYVGART action, held cycles with With differentiator. would the it for been first we the be our breadth to a KOLs take we're that we both At and to VYVGART report encourage physician see plan speaker of we knew XXX the individual depth They over providers the the excitement but initiating and adoption, positive. educational they their healthcare have still report based that to of engagement and stages from utilize early of pleased launch safety subsequent continue plans report positive continues cycles evaluation. profile of comfortable a that on the is to

on reach the previous or that ADAPT a with we in the the some individuals patients experience to being breadth the and available with steroids closely prescriptions have experienced and see only observed the are therapies VYVGART wide trial. across biologics. reflect X half written of and population pleased have Phase paradigm, We of other some treatment other IVIg the other ISTs with Half

Moving the slide. to next on

patients to most be the on of have importantly, patients we XXX in And need. approximately we quarter, as end and are thrilled first reaching VYVGART. Third finally of the

sharing this today demand. metric because we strong early are important show think We it's the to

to We on cycles. were is share subsequent it staggered we forward but numbers with patients patient treatment therapy harder track will start for possible times to that going will as able, be continue

our to the empowering time We show expect shared growth launch. core of to rely a We on would be mostly of quarter-over-quarter that on approval basis. patients numbers revenue a at component

slide, Next please.

journey. so which the right that help this place by in have through Path My inspired VYVGART depicted the have is treatment on step are with to them team received We of know far we we feedback and their each slide

the of and quarter will are we unknowns but patients There our successful continue know and dosing opened more many ahead and the please. play with changing This first has real we next also to patients but strong we We're need launch know with forward see momentum. to still before early we the stakeholders in that competition, quarter, maintain the this results can trajectory. unmet launch need need to refractory that are this market of days put still dynamics to to our effort few our very We're for that out eyes cycle-over-cycle. quarters already. key how engage execute real our of teams individualized slide, will Next this the reality contribution very understand of we have proud for the from

to with call global turn update I'll Before brief remarks, launch Tim for I back the concluding on wrap our up strategy. a

Next slide. launch to next In officially Japan, we will plan week.

field have was on our and in on for Tim. book established to a aligned forward engaging European to track been sales Medicines from of now half providers country-by-country XXXX. start gated out teams Europe the Our we price. you, with decision organization turn I'll We plan a with Keith. proceed that regulatory is have basis. first in and healthcare commercial also Van the approval that, call The Tim are Thank second Canada process we on can to building the of the Agency back engaging path With the argenx in Hauwermeiren a with on to quarter there. bodies approach

Efgartigimod the to order the the not Slide publications to demonstrate [indiscernible] and open with first-in-class leadership our outcomes in I to but and following would differentiation potential blocker, be of your investment like research positioned continue questions, health our broad call in to to XX. upcoming space and the in best-in-class. conclude We FCRM extend the we to the efgartigimod. presentations hope economics also Before with only remains strongly on

diseases expected a a on launch efgartigimod of gates address the opportunity IgG-mediated pipeline potential subcu a the year in the efgartigimod We true of GMG. are with our also of to second realizing with strong commercial a with with next multitude serious in first out autoimmune product to potential be

And we strong sheet, XX we sustainable X importantly, are our of our We beyond. by data to shareholder several first with we organization sum, growth experienced be Phase set value will have XXXX. to Q&A indications data proof-of-concept what partners and and and two most begin integrated fully active balance as immunology the be reported and the perhaps indications positive hope is support of efgartigimod we pipeline just product in and can With strategic up the four that, In ambition committed global opportunities. in indications Operator? in to deliver in a session. team, XXXX long-term remain

today line Guggenheim Suneja [Operator from from your ahead. is open. Please you. first question comes Partners. Our Thank instructions] go Yatin Yatin,

in me. positive and Hey, clarify the And guys. was? Any the quarter on on study, just Congrats the there you or cadence results. of about? build slight or X, quarter? on we what ITP comment And should finally quantify in thinking what throughout for dynamic good pent-up could you bolus questions are Phase Can then, bleeding then that patients imbalance. was the and demand rate type side, you was what I a be Couple inventory getting the the of think

So just placebo. I sense want you. how it was to Thank get and drug between balanced a

you Yatin. you, Thank Thank us being for with today.

between On study bleeding very perfect a patients balance study there bleeding. on The About baseline. is bleeding was the truth There both can this was in of going no XX% be I side, had that brief. at arms. little the

to There So be it's meaningful a create many on data unpacked, WHO crude scale. difficult like very more however. a delta is scale real to

bleeding clinical these at data would into we conference. and lead sophisticated reporting tests So the will on be future

patients questions, I'm inventory, the for Keith. to going bolus hand to Now over and

I Yes, take inventory It's quickly will Yatin. the Karl. question.

the under dollar those less at amount associated is inventory and well in So inventory the two we're on weeks' But managed of channel. quarter of are It's not going specialty number than or vials the be worth promises. inventory to specific really end.

we half the the a previous surprise that a thought were a VYVGART that can believe benefit physicians now almost wider Yatin, question. experience That's would with types, very we at beginning physicians that we range of provide are on saw to and then as several the seeing in see of patients VYVGART that patients lines. patients. not with the the experience what are with turn this for need, to biologics, thank regard you get much What IVIg. the at the patient what is new In having we is failed really

hadn't other the population half of come so IVIg And the experienced across from that spectrum. the

have Some relapsed/refractory on broad biologics. steroids. come experienced have mestinon that we have Others have ISTs. And and some then just from been

really as early So it's we're say. pent-up in, to as too far demand, one quarter

launch just medical overall, unmet MG. the exists the think that need reflects I in

[Operator instructions] Matthew ahead. is Stanley. The next question from Morgan go please Matthew, Harrison from

Your line is open.

Good more morning. a taking some for broadly Great. what if seeing Any that was more need offs on comment may or if how bit you're authorizations. see the many Thanks on you're Thank super I your wondering details could reauthorizations to little expecting there? question. and prior just the what prior insurance just or gave plans helpful. be and remarks, you codify commentary you doing but would in I prepared you. to know more be frequency they you

Hey, question. Matthew. for you the Thank

And I fact XX% PDUFA working as the So of moved fact, covered lives. contracts the Quarter signing fact in the already greater that you the payers into at covered those our with that credit XX% it, And we're of heard, value-based than now in had that month of have value-based were lives. looking X, access to We've we forward we alluded agreements. end principle date. at agreements. that with to even team, to one we market prior

number Quarter that go here in up X. expect We to

market So continued access. success in

one the six being of part, for that we're IST. approval not is For to Also, steroid, XX basis, an the it's many to approved This plans bat. be the only previous these therapy, very seeing whether a have oral cycle-by-cycle most months or been mestinon, right utilization favorable, six on months. off XX requiring

six we to XX yet. the reapplying, as got haven't far months As to

pleased the team that July that's heard has we'll specific thing for place when Xst, and work get that prepared clear with hurdle J-Code have bridge very month. cross there. overall, to we'll So the on that last the a take a But done we you will The the VYVGART we payers. with in in remarks

go is is line open. of ahead. question next Tazeen Bank America. from Please The from The Ahmad

Hi.

Okay.

And path a just to you be can uptake for subcu, you're expect the I providing remains meaningfully what that, remind you to the then an filing the expect done would know sales because original get year? the should But for application On us your not that submitted? once be you that approval do the for Thanks. the accelerated you original the And to quickly do J-Code, on rest standard get of increase review? guidance.

Thank in minute. path give J-Code question going as the I'm to to The ITP you, to Tazeen. Keith registration said. a remains, we

second before the can with an trial execution that of registrational subcu So is we submit required same a is but study efgartigimod. the product identically

regular on require next QX I submit approval. you to are expect data in think you're the will year. a review read then top-line to track a think out realistic Keith, right, We guidance and we is And time-line two can studies time-line. we what J-Code? But further be there's on submission to and going to

Yes.

and inquiring you to are were Tazeen, on Tim. the clarification, hurdles MG quick what subcu needed? the a first, Just

Yes.

Yes. Thanks. Okay.

the top-line the time-limiting per non-inferior FDA we've with we'll is of quickly, and year. subcu upon milligram RD that and XX we've So effect to really BLA the kilogram. said the that has that efgartigimod pleased agreed we're already the compared database safety before shown results the really file the we've factor with end It's

time we As is subcu as the treat accelerated plan for would have to far do filing. because will I probably at remember, we say is and in review review, U.S. priority But MG IV. particular, that we available a share if that use MG, the you voucher to in that, of doubtful VYVGART already with there product

say managers a because reimbursement team J-Code to it. get and with in to want this with of VYVGART pharmacies are specialty rejections place. is offices or time to appeal. Lastly, you're that see with The J-Code. faster and J-Code because I and with through a able field things And to work the on Path be have VYVGART don't working patients three all the and help and smoother, our the make go going less on easier our today with you be less sudden quarter think going I that My necessarily for bolus to a offices

longer So just we're issues. it make the J-Code taking little working the will a It's easier. through and

from from The Jefferies. question go comes next Akash, ahead. Tewari please Akash

Hey.

the been on stronger gate. congrats So Solaris than really why Any out it's launch. the was strong of just color so much VYVGART

out data I had. think Solaris the have had And XXX within positive just response Rigel pretreated population, optically amount maybe refractory VYVGART? were specifically, from percent patients similar XX those patients, actually Do regimens? you as switched patients have then The to what what Solaris we rate on ITP but to XXX. a of And well. in looks IVIg went was what know

for are in now million ITP in do have sales Thanks Rigel's price, about peak gate so products gotten of you numbers ITP launch they $XXX consensus has had like may the a for out and and bit sales VYVGART modest approaching Given ahead VYVGART'S doing feel themselves? much. of had a billion $X consensus

you, Akash, the for two Thank questions.

question, Keith. with again to over the Let start me ITP pass then and I will

in have mode to to doesn't no works, we from data put of but very a the profile which strong. the TPO to which think, data, then forward, ITP work. different made very When longer does different an I it's It's bar clinical patient of that which to difficult when risk all people very fast, trials other make be a stringent I the to positioning I looking sense the one. one try space. one. endpoint different compare are working they benefit we've the which think, cycle forward clinical endpoints. the [indiscernible] very durable the to X molecules cycled one the really to Akash, therapy. but we action, The an mind exciting and take mode you and And called switch one They populations, in an as just between are The supporting break molecule, has put exciting you feel relevant is to designs, across of second first has lines primary space, is where to another do requirements, in which satisfy second that, at is to proven Luc third trial another something now ITP exciting. take you and It of action, profile, safety is out, with

IWG a for the such have compelling respective two handing a clean responding I'm with you we start. meaningful clinically a profile, proposition. with safety that over in Keith, one strong where feel on very endpoint, about of I comment the these that's way in to patients the So

want I two of the a VYVGART an accurate into question. that launch to context of looking comparison really that at all, the you not guess, Thank because different we're I audiences. Akash. think I first put Yes, Solaris for efgartigimod, the is comparison of to

therefore, severe studied really they patients. targeting smaller relapsed/refractory percentage Solaris of and were MG a a population,

or we're will of So we had companies IVIg say a experience people have comparing that's well advance previous industry from from built have prepared. have really in is, companies was and other neurology, oranges. apples the in in experience I that the well numbers from that What is MG coming team to therapies coming neurology. and kind across hired We've that whether

So they healthcare with had professionals. relationships existing

that did in work the advance. with the know payers You we

issues this this is through earlier tool in and be toolbox. has really, unmet of physicians some I a But from an think and the mechanism medical things MG, they having that position new there love treatment big to payer put that is told paradigm. that of a across clearly the new their the of us in one need work able us the to in action

has patient-focused ask directly that really for have organization disease. am to communicated our in with a we I come for have their effort are different treatment people with because opportunity pleased MG, Lastly, they suffering that different or being the team done in and and a a

question comes line open. Yaron from The next Yaron, is from your Cowen. Werber

the quick questions. maybe Great really and congrats a thought couple of I just launch. on

study? give underway? And any Thank sites fast or launches data given GMG a first you're typically fairly mean all or a that you you. that XX it's happen that Russia sites? in How you do use from one, essentially the you concentrated out, new us Ukraine sense able the what are do of now by can need you of market? to that XX and to then, data expanding Japan PV, accrue little the bit those on a totally The Is secondly, are

maybe Japan. hand over Keith and question Let with pemphigus the start me then to for

sites equivalent patients. what see this doesn't a number of clinical that an number So of clinicaltrials.gov is on mean indeed you is

the clinical management the sites patients afterwards. reality clinical and of risk review them, continue So view, what move across them by lost for able are patients of we other from a is actually of some border conservative to bulk but these were trial where the with considered in happens these to be the they to could collection, point team data inspection data

to more the place Keith, taking inside to patients that on approach, of in in we've seeking you, expectations number the a and been a yes, of launch secure globe. So Japan. conservative replace Yaron, Back for we're

next really then as hop Yes. launch the quarter's plane for with about is of XXX% MG. call. morning to people question. a Japan to in And Monday are to The news earnings Thank the I'm you able be you have I'll lot good on reimbursement with head you approval the in Saturday excited color a to Japan on launch give and the country. insured that next more the for we established,

off going that So take it's table. issue to the

process. just why is Japan, the U.S., infusions, in to in hospital formulary see all this given have you we in through don't most a challenge take setting. the the almost are like all go Now of is have And you just off infusions a sudden

going we will new this saying X So for The that brand be to last is, you to education on about mechanism process. was is No. thing formulary that been thing be going the action. all the year I've through required of a

VYVGART. have We with experienced few that in physicians have number infusing actually a of very patient Japan

time it's over experience to time. and will take going comfort for we up to that So to that build exist, then occur,

your is is from James, James question JPMorgan. next go open. Gordon line from ahead. The Please

follow for JPMorgan. Gordon, James question up. Hello. the and Thanks taking

on was question data. the first The ITP

our failures, it TPO provide we was for think Where the follow-up if are you approval models? build that that us, And the just use? just VYVGART received are then VYVGART or you the should that be who failures based subject was market MG. TPO in morning. So to could we it's U.S. [indiscernible] this then the Any to purposes? trying there people using going for you multiple other model patients to the earlier? and And regulatory is how data largely many should ways failure be segment TPO it's on Or think do

talk was really the looks patients? in even be build maintained So first quarter of same April like terms number good in more quickly? the it And through of quarter. April? fairly a linear have accelerate did you quarter adding trajectory the you Can for through just patients Or that you seen

James. Thank you,

with to hand me questions ITP Keith. start let then maybe back So over and the

So activity beauty study across think is see efgartigimod of I the this the we that of board.

ISTs, So which in paradigm, refractory the therapy. trial, to Splenectomized of wherever rituximab people even the treatment fair share agonists, a you a patient in you to have population. PT refractory respond TPO this the are receptor steroids, right to is experienced

allows eltrombopag board. there about we agonist, entrenched positioning So that is TPO that in And because well are basically How market. this shortage a us is even play think to receptor the across TPO. modes TPO are very on of and put different in a one on put of third are failing who action, patients a approval a second that typically the first with

the a of fair a drug does receptor respond our receptor across basically of it on agonist. try who board with people fast to first the TPO action, of So position heels mechanism onset on responding Excitingly, of TPO are amount agonist. this action a make and activity which actually and stopped patients, this sense new on

show of agents, of in is different type of agents. is data type market. one-third the and other way a just response The that of the almost are positioning the patients and the that are different regardless James, people supportive success currently approved, the of therapy need which think exciting the and relapse of to long-term opportunity So about pretty a

of speaking, a only a other patients give the two-thirds and So will will patients whoever you need put on a you therapeutic response TPO these long-term agents. one-third receptor agonist, different roughly

you I on a view. modeling think of to comment you help Maybe, So want question. from Keith, MG that point should the

Tim. so. Happy do to Sure,

on So over when been quarter. we a really, time been James, gradual actually conversion that, too really how you. in you're VYVGART reducing basically, get we're that into patients on growth you month-over-month The is being and consistent more as what Really, prescribed being pull-through first prescribed early this become you patient time. with and from answer basis one Thank direction has payers. provide to when tell it's the But I it headed. is any has are in VYVGART the treated. to we've policies can place seen quarter the a

Archila from Fargo. Derek, Derek The line open. is your next Wells question from is

progress and the for Good morning Hey. on congrats Thanks here. taking questions. the

do maybe to follow-up, in MG you margin I understand really year think, since terms time? question Just might to J-Code shorter of you And you long Just I could margin from over patients the therapy? on think ones two James' then guess the how maybe Thanks. how talk this taking out like? gross force? how to it quick is progress normalized gross just a is once in about us. how And want can to expect get look then -- a

margin. on It's take question Karl. gross the the I'll

Derek, around going we're at don't number this our stage. of in give expect materially the margin X.X%, change the short-term, and X%. not -- to guidance So is any margin We to gross -- of but that gross course, sales more

for Derek, question. it's Keith. Thank you the

VYVGART take It does prescribed how have insurance some patient had as get It that within work had far infused a what were four through others depends week they just we've denies. to prescribed. able they that case it upon We've be from long after We've had been varies. had time weeks. have. than the where appeal for that's their therapy. absolutely to better processes and that on go to to on As a We've

get-go. right your the first going You have insurance some that claim companies off deny are to

basis. can X, better tell Quarter patients, which there down that you should So more we'll group have at the answer. time when shrink And month-over-month we is I a in typical and that really, we by the no in place, entire for covered what we a I coming you J-code, lives specified a look time should of to on infusions. to spot have line get where really be industry is see for the more What policies down is time

your Danielle, ahead. Raymond from question open. is Brill James. Please is Danielle line next from go The

morning. Hi, Congrats on ones. the so quick for much progress. And question. guys. all the Good Two thanks

antibodies? antibody the retreatment on And terms then see a anticipating really in basis? these be you thinking we forward? you're patients Thank for on did of First, launch, the differences remind And population? what Keith, solid us on just identifiable on based have ITP. of should was base. response moving how the any revenues rates of a in status Can And you modeling MG quarterly enrolled patents you you. What about

two these questions. for you thank excellent and Danielle, you, Thank

a assay that scientific So not did there's we use literature is antibody is is that platelet-associated primary basically XXX% at ITP supporting go an as of look especially the antibody true believe antibody when presence if the sufficiently of And antibodies. enrollment oral detectable your status bunch We mediated. criteria. sensitive, you and

data, that we So analysis. and mediated. report ITP the are will able collect in did primary post-work to three patients be on however, We all we a believe antibody that

dynamics? I early refer it's to too your on question. So you can to the Keith, on comment retreatment

now, the right that that We're the for quarter one of on. year you less. to into we the have thank are ADAPT shows five only go from data study require or this. Danielle, XX% data just per And Sure, that's The question. cycles going to patients

started so first cycle on individualized completed Quarter that patients really a what X. or to look were the in means. VYVGART on close have their actually dosing one cycle end in by the we of need all only real-world And and that Almost

later have ADAPT cycles with on time we're come X going of to the back to you being, fewer. go retreatment. the to data So But for XX%, or I

question please go Pitman Charles from from The Redburn. ahead. next is Charles,

congratulations on and just trial. question PV results one today. on the got Hi. you positive Thank I've the

to to wondering got for and give clinical the has us enrollment how an You mentioned sites on complete you've this kind those dropping And enroll was firm Ukraine-Russia date? your areas update for the if out commercial more conservative. have delay you PV? Thanks. now you read left of changed to you're I a is expect XX-month what's until more just the delay could expectations other

the for Charles, question. Thanks,

the not is else which that let's COVID. that background is playing, called in still So forget something

clinical our of from see an used So on we dynamics to not past we impact the still different COVID what in trials. global the report of quarters. But that's

thereby good occurring. a these of registrational accommodating did we job spreading trials think COVID, I still are global which geographically, waves So

it on So of feel sites, original a based where also ability to of but we period pemphigus the make enroll enrollment time sites, a reasonable existing patients good Commercial reopening simply the our know in other we adding about of didn't dynamics, to I time couple think which within expectations. enrollment.

in pemphigus. I study are data in X Phase our put we think what very forward exciting

the be exciting. talking where remission. effects we it's show think of an patients go our I very a in onset nice fast see durability of think I action. on therapy of a long-term ability the biology unexpectedly, we We about into then some will into because minimum we CR pretty show responders background behind And dynamic push spectacular to fashion and the understanding the

topic on but space, not unique in So Thank of explanation that's quarters of delay. changing the and that because scientific very the on and feel pemphigus stay we you I strong proposition have further a tuned few fundamentally question. a for

Securities. of Joon from comes question Lee please next The ahead. Truist go Joon,

for questions congrats on our quarter. and Thanks Hey. taking the

to of us of reduction ITP? you. you're efgart about tell And that, that efgart transfusions also, related in for you other what's platelet In need quantify and improvement the drug able with you arm. you see in mentioned magnitude and help the of with platelet do to also a the can achieve on you magnitude And patients Regarding reduced Can efgart, that? the bleeding? ITP, us response you what if the by words, ITP? autoantibody track Thank better PK/PD

question. Thank Thank for Joon. the you, you

and So over data. These are indications. regarding volunteers at other say that the be on the disease and question want this on ITP we everything is use data to that ITP on transfusion platelet therapy to in the Luc the the healthy like on Luc, to platelet before But rescue indications to going to you of the of ability healthy And top-line company comment to the time. all and platelets, there point very available profile the maybe, different as patients We predicting feel baseline to is no seen the count impact volunteers. I comparable I comfortable have hand difference would in at what respond. based across PK/PD in potential PK/PD are numerical

I'll with Yes. start And the last the for question, first. one thanks and

at the used, So analysis baseline something that the baseline platelet in was the course, primary of count is endpoint. change from of

at the at if any account into So the the it differences a is in the already And like you'll you were see same then and categorical response above below that analysis. in subgroup. XX, there taken look

and also material in counts, we that detail is numerical I the The So and us see of don't on transfusions active this for at placebo advantage for imbalance adverse roll had data presentations. that be that in IVIg we will for think both those and matter placebo where active impact. a on need a between numerical and and picture, general looking in events future between more and

see rescue. you arm the But it's trend efgartigimod clear for placebo compared fair table to a the for to say, and Luc, if acute less can I AE complete bleeding in what in the started. less We events need

to thank from Joon, for be So more questions. Thank data stay trial. you. this you And unpacked interesting tuned, many these

open. is The Piper question is Alison, line Allison your next from from Sandler. Bratzel

Thanks morning. taking question. Good for Hi. the

about expect to physicians you also site the So academic maybe breadth. community I prescriber the comes launch planned between VYVGART infusion as could home how the launch you to talked over to to that at as situation you just between prescriber infusions, subcu Thanks. market? evolve on evolve COVID the once talk VYVGART just time about that the the on mix volume Could launch, on to talk you're expect develop? think, underway and continues this having and good and And and you and split how administration in-office at further centers what of seeing gets you the

for Go question. you the ahead, Tim. Thank Allison. Yes,

Keith, I go over going was Man, you. ahead. to hand to

Sorry.

you. Thank Sorry.

question. for So Allison, thank you the

where split if and say academic We the community haven't in academic given the we clinical As that publicly. community, VYVGART we between experience far as But more from trial. did was the we expected specific numbers the there off the with had last segment, majority too look on early the one of launch business. we've It's only come quarter to make the in just so initial patients projections the in, community this therapy. the it's at seen

tell far heavily office situation. this are that infusion, we you as of being site can in type by have is of the the the patients patient that I that treated a in insurance determined buy-and-bill has. As

being them infusion. have We treated in home

We in have centers treated in outpatient and hospital. being them infusion

the worth So one we're predictions data. too of site quarter to across board. make Again, just seeing of early or trends of care

next question UBS. from The comes Laura is Laura, Sutcliffe from your line open.

from many, of you. an inventory Hello. what for you when on of perspective, channel Thank extra I then hear be repeat stocking middle talk some the you. any of get you aren't J-Code J-Code expect the that permanent could would of your smoothing maybe you characteristics there And realize in sort say sort But about probably I helpful. things of Thank year? the there briefly would you secondly, your just prescribers. some but you. color

My Karl. you, Thank Go apologies. Laura. Yes. ahead,

stocking. channel inventory the on question the take will I Yes.

our limits. at it certain bulk our monitor specialty the inventory the good where is pharmacies we and contractually, to in keep So of we inventory have

So course, X of of amount weeks I within the mean, will will be increase, numerically, valves of sales. it but

you. Thank Keith?

Karl. Thanks, Yes.

we that for And of I to want the on response. that physician. first the have launch when see confident use to I on prescribed patient prescribers, are meaningful have therapy. physicians one repeat each do in every therapy believe going we physicians We X As far almost XX to out this, they're than as patients before one most clinically to that that get a more data feel VYVGART the was have said the patient going be more. that the difficult product thought

earlier a this more that's the treatment ADAPT said, be and they're paradigm, the VYVGART we've used you maybe the was to that of exposed give small first patients and can we where move physicians seen positive that experience the population. but This going treated see a I'm relapsed/refractory I why So somebody way type example had and across is examples, going on into IVIg, all anecdotal. to patient and to

go from Baird. Joel question Joel, ahead. next Beatty The please comes of

is open. line Your

Congrats the progress. Hi. on

trial? seen trial your you to today's perhaps results of close any X.XX, to ITP increase trial in but powering? X.XX. Phase the X you've statistically clearly help design do that's the results confidence from that the with make changes And first Today's somewhat powering potential to second the trial, see are what's significant, of Now p-value

spot Thanks, studies Joel. identify trying question to basically you're That's tweak see We're both an and trial it study. are from the this running sense on. to whether learned because excellent targets, still second lessons makes

a powering feel from endpoint point a bar. very And Now primary of pretty was the we confident. view, trouble

terms of as trying I think in as we achieved our placebo good we nail could. to objective

is placebo as zero So we realistically close can to as get.

So overall, trial do when the tweak and sense design of Thank where construction still and it of some but the we see and it the you to comfortable comes the will suggestion. makes feel some details. the we of for endpoint, sufficiently tune further the to other work

go The next ahead. from Douglas, please is Tsao Wainwright. from question Douglas H.C.

morning. Thanks for Hi, taking the good question.

in customized people sort and what that curious, outside writers Thank curious I'm how of I'm starting? weren't And basis I on know Just a responses? -- four-week you. and Or customized I'm investigators out to are on a are in start, sites having well just who individual much implementing penetration they basis? then of ADAPT? writers physicians they things days, are of starting just regular patients dosing, really were sort are ADAPT early schedule? sort terms the as on push in the based ADLs more percentage it's And prescriptions. in -- how Or are of the Are they curious terms that. or starting do maybe you off of for to sort getting of on just of writing trial curious as regular just

Again, two Douglas. excellent Thanks, questions.

on of they comment number do and on individualized reality, are then which ADAPT picking the you to Keith, up to use maybe, dosing, So please? prescribers that, want mechanism people having

so, Tim. Yes. Happy to do

is of total the think, of here given broader the first study. set the I study public that at sites in when prescribers in I of on number a number number look U.S., Phase we the participated patients XXX those Douglas, But from you haven't U.S. from note So clinicaltrials.gov, of comes ADAPT the individual X all, you'll the which that information than the much think existed in that

So the prescribers are to breadth good see just study. that starting outside those in participated in we of

customized As ADLs, the it varies started of far are physician majority dosing, physician. the to Right being the patients question as individualized from on the now, on dosing.

purposes. insurance for ADL the using are Some

but patients something tell progress it that XXX%. not track their on Some in is that's a are to you, Many regular I've clinical will using ADLs trial. basis, used only a

varies thing, it Last basis. a So dosing physician-by-physician cadence. on

that have things few taking We are different a place.

folks we their as soon regular of that the infusion you return to you will need retreat. have giving taking what's We are one patients four and me basis a patient feel then to That's symptoms, on us their cycle weeks and monitoring some example and one asking they're place. of as notify

interval stretch will for weeks and going appointment dosing the back others an and four patient asking waiting their to have We out. later they come begin are and that then with the in they're to four-week treatment then

So can those But to OLE overall, been once into you regimen. place. on commercial see product, consistent that taking have and patients is variability I that rolled in get so the the dose, on we this ADAPT is, how a say their what ADAPT, they're consistent very

today’s call joining. and for very concludes This thank you much

your disconnect lines. now may You