VIE - Earnings call transcript Q2 2020

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Operator

Good afternoon, ladies and gentlemen and welcome to the Viela Bio Second Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to hand the call over to Mr. Mitchell Chan, Chief Financial Officer at Viela Bio. ahead. go Please

Mitchell Chan

website everyone The welcome available second XXXX our quarter the Thanks release to reporting call. corporate of page press and is www.vielabio.com. our earnings investor and media our at financial on results

Bing Ragatz, Joining and our of Vice our Medical President, Chief today of Head Drappa, Chairman Officer Jörn Head Yao, and me Officer; R&D; call on Chief this are Executive and Commercial. Bill

impact, cannot over treated call the amongst concerning new Yao, the others. travel the coronavirus would course, on and be impact product predicted. that, SEC. to biopharma contain situation potential and been be clinical information implemented around Bing and will of be to A in in business extent associated that a and forward-looking which, turn development, and on regarding our recent depend are This the With those our Like of and emerge The have uncertain we outlook the activities. results subject sector, as regulatory, may our As closely our full our on monitor and pandemic most financial statements ultimately COVID-XX on the addition to XX-Q to many will which in peers from actual we research trial. COVID-XX impact statements severity us making includes to development materially risks forecasted. of plans which description are may COVID-XX uncertainties the as like commercialization to may are actions continue reminder, differ the cause can to highly future These the to that of including CEO. found well I work restrictions Form the with these file risks

Bing Yao

Viela for first you It earnings quarter you, productive at mid-May. been time busy us Thank today. Good everyone. afternoon, we has since reported quite Thank a joining and Mitch. our

first investigators are NMOSD call, would been U.S. UPLIZNA, on inebilizumab, This, announced now with course, June positive. known participated who FDA trial. antibody as approval, Bill leadership provide is after talented commercial without in XX, and our which team who of possible also Ragatz, the anti-AQPX we launch Shortly patients the have adults under weeks several that not further Just of experienced after approval a for deployed who available progress of the N-MOmentum on we detail today’s during will the call. and

second launch to With that coming the quarter, the see end off approval the pleased is at start. solid our tail to of I’m a

and X we awareness to our of are itolizumab disease, severe initiate priorities, are both gravis in and preparing patient are While access top with limited IgGX-related ensuring treatment which options. disease also Phase brand trials autoimmune with myasthenia

Chief Medical COVID-XX our operations. in moment SLE our At will be on we trial will limited Drappa, call. investigation this Officer, fortunate in time, your trial. later take that remain and indication has on this as to further the further Phase Phase for selection X reduction of rest cohort confirmed X, interim Since tissues obtained in we our study PDC meaningful of CLASI efficacy have additional in depletion May, results reported of then, Turning Xb These from which we highly positive and pipeline, towards our scores. biomarker data in clinically and informed VIBXXXX. provide questions in an effects had the our data the on Jörn detail available efficient pandemic

closely part the to guidelines. extended Gaithersburg to encouraging our are offices we to While following and and work-from-home their Rockville, our by in our do we authority health get are back eager employees have policy

our and to sites. you in clinical the new may prioritize trial trials order made recall, enrollment As health pause patient our investigators of the decision patient of we to that temporarily at some in

to planning in how transplant it rejection in this and serious have enrollment QX kidney concern QX our year. health in is Even will X and Phase us COVID-XX unclear. a We we trial public so, are VIBXXXX, remains others in affect resume resumed the and still term of with long

trial system felt investigate of ways to Given Phase by it plan our the injury. the duty regulate in our today’s be candidates acute later those trial patients, VIBXXXX, mediators. Jörn call. with on a to clinically the to will COVID-XX-related inflammatory we To our trial and demonstrated that immune ability was our also Xb serve initiate commitment with might lung will which our coronavirus. has patients to touch end, deep key we The understanding this affected product during

support and launch. to runway year Bill? underweight commercial extending call of into and and Head Ragatz, XXXX. our product that, the of grateful Commercial, hand I objectives execution, base will gross With million Vice like our raised public clinical the cash would our Bill proceeds toward President, of overview to for support. We $XXX our provide are beyond, which investor over offering, recently we while an our for our in the Looking to rest approximately to strong their of

Bill Ragatz

Bing. Thanks,

you As patients. exciting at just for Viela NMOSD and an this heard, time is

the and the and will progressing to continue we being and reviews more operating Before an driving awareness of as and in coordination the who adapt very remotely, external our communication formal is I with external changing education created situation Despite trying UPLIZNA. want office and challenging, teams visits ongoing, being which most job environment. I policies expected, acknowledge launch incredible has to get started, offices patient a with down made doing have launch within been to

unfamiliar UPLIZNA those first-line potentially profile associated make rarity that AQPX of lead attacks patients commonly population. if for positive UPLIZNA as U.S. significant cord, factors antibody strong B-cell needs has remain, end with the unmet permanent the efficacy, with approved the several treatment thousands the very with reduction of globally, NMOSD and first overall which believe only of Despite adults NMOSD U.S. we hospitalizations. this patients test blindness this a patient attack the and inflammatory patients is with could attractive an it with disorder, were population. who spinal can UPLIZNA outside optic AQPX disorder. trial, debilitating N-MOmentum free XX% as this believe about this the the help depleter the NMOSD Beginning and relative NMOSD, neuro at that had for as treated a and experience well product We as control period, represent UPLIZNA patients nerve an in potential fatal randomized to in of UPLIZNA in our of with approved the XX% a monotherapy relapses positive antibody, on unpredictable and in paralysis. is with Patients affect For and progressive, potentially or condition.

Importantly, and black not has profile a safety have favorable UPLIZNA a does box warning.

get patients of Another the key and another back NMOSD is dosing With line which on doctor. UPLIZNA every in dose months, which X characteristic dosed X with frequency then many schedule. are is later in weeks its see come day patients typically X, their UPLIZNA,

contingent structure. know prioritized having a efficient Finally, with this the other that can full and depletion set X treatment depleter, with, which B-cell formulating in engineered via offer UPLIZNA of strategy, are all been mechanism CDXX. UPLIZNA is B-cell When No physicians pieces for benefits. a has NMOSD access components; necessary we treating a familiar on and successful NMOSD launch education, our option place. We is

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situation NMOSD already and research how have having groups that strong educational different solid the impactful they be experts programs given and are patients providers, established market how top about to has external country parts We relationships to deployed of efficacy and in to This to better think conducted virtual that and changing understanding payers opening very understand us with addition important this settings. are up extensive This care both create different at manage face-to-face in condition. projects allowed health able speeds. baseline is the and

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their initiatives about patient via NMOSD to provide media are social closely We organizations to advocacy several also virtual with working members education channels.

launch, gaining every success. is access to For critical

payer NMOSD primarily the to information Our UPLIZNA, these of clinical presentation of of meet has the share team the top end the of our remainder scheduled most about before payers being able provide to the with been and month. burden with payers already of

for to Last educational patients committed patients, code, not quarter. our is already gain a success we team. The as caregivers To access expecting UPLIZNA, help of assistance an care financial on hub, hear with needed from program in have payers HCPCS hto and back filed front. patients VIPs. CMS the we support resources, the strong with will and for culture Viela establish proposition Overall, around and Viela to is help third to for a Viela but access value partner continue We to professionals given have established them support we is support. people health our access are VIPs provides. structure. the to UPLIZNA progressing the place We information to right one-on-one coverage the Bio end of planned and and offering insurance are least to have the patient

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which learned to Our Prior community-based market this will to the when and that future to significant participants academic all approval, with efficacy provide that over profile. of value permanent favorably responding research better this aim neurologists favorably the we nearly and believe and UPLIZNA the we study, In conducted view this and to NMOSD XX% is community who disability, understand prevent regard. NMOSD to XX% efficacy safety FDA neurologists perceptions in attacks, with the XX safety lead UPLIZNA behaviors help treat positively and profile we NMOSD the profile may responding their disease. managing to

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current existing of having said are prescribers who patients policies. were treated neurologists they on use XX% another having patients are long-term slide unique was immunosuppressive UPLIZNA who safety This number issues, between and for and compliance UPLIZNA our defined new with including that one the referrals the prescribers, coverage patients, of will the important outlines we for track the our would regimen. on they number been concerns number several their of and use in regimen used measuring are and academic new over will starts; be success. or who us: concerns would key quarters we referrals, XX% coming the launch in have what agent; XX% patients fact, metrics whether be is with of indicators and as having patients key referrals of the X to their around factors In Adoption tolerability to have payers, and These the conversion neurologists; patient previously and the commercial of community-based mix of areas understanding success.

Officer, current of pathway. its over While program this focus commercialization an provide the future Medical overview immediate auto to on our With to NMOSD, Drappa, the well overview as plans rest within hand call in the antibody to evaluate an Jörn the continue is of successful of I and as that, of development we broader like pipeline. Dr. Chief of to our the potential our UPLIZNA would

Jörn Drappa

Thank Slide XX, would covering cycle you indications to very much, life Bill. the for I by On like UPLIZNA. start

failure. muscle in dysfunction auto-antibodies of We the two start the in muscle screening way signals Myasthenia of gravis, We nerves are third starting a many Phase between acetylcholine myasthenia to now variety in the specific who will to ranging can against the muscles. neuro-inflammatory disease the kinase spectrum that respiratory or IgGX-related and impact transmission respectively. patients a currently meaning has trials disorder. quarter. In dysfunctions an X project these X to receptor getting close similarities neuromuscular all trials this motor disease, This eye and gravis autoantibody-driven NMO result pathogenesis is disease, from for junction,

test on and by cells trial the into tissues, like measures IgGX-related this for therapy cells approved involved assessed CDXX and duct, cells of cells outcome interrupt There and of commonly subsequent organs fibrosis positive believe organs resulting CDXX administration that We relies of potential IgGX will disease infiltration kidneys, CDXX disease dysfunction of largely of improve positive the and accumulation positive disease. in has no orbits or producing this various of swelling currently glands. group in Our depletion meaningfully positive tumor causing corticosteroids. whether chronic includes can the diseases CDXX pancreas, reverse in and to is characterized depletion organ bile B disease. are physician a treatments patients the IgGX-related salivary

reverse cell and depletion Our the positive prevent trial stop organ can absence treatment. CDXX or steroid will test recurrence concomitant whether of disease in or dysfunction flares

and of awaiting only the patients VIBXXXX, is to susceptible COVID-XX this Slide plasmacytoid hold result it trial The will pandemic dendritic remains cells. on sensitized targeting our This on is fragile better much we antibody patient highly control than in XX, highly and transplant pandemic. resume under to on On as dialysis enrollment infections, is today. is voluntary the third when moving monoclonal kidney a population particularly

trial ongoing obtained shown Since an slide, Xb We included X. interim and endpoint from design Phase is cohort skin safety. of the from depletion meaning top a improvements biopsies in and primary May. score, was specific have then, the trial, this in we X endpoints results target which on The we this of Important in pDC skin and secondary reported panel tissues, have lupus additional CLASI. the results of cohort

taken data treatment treatment. and pDCs, depletion and Our skin in in both biopsies that rapid peripheral showed of with blood profound resulted a after in the VIBXXXX

upcoming that conference are in become will an at at report results and participants reduction, time. in to We results by safety including We in in XX% CLASI couple and also this observed reduction follow-up of final the clinically and preparation available a X-point of than a intend improvements variety the All next their measures, a X-point detailed now months. trial completed reduction. a visits publications meaningful greater have

on from Moving lupus. inflamed pathogenesis further decided pDCs believed the in during on development, been have reasons. tissues some peripheral inflammation cartoon shown for summarizes they’ve on to right drive be a affected to into in these SLE. the XX, also Slide results, to lupus erythematosus. accumulate slide They of the side into and systemic central been clinical to X ways shown this flares. have in that tissues SLE of redistribute was of the The lupus as Phase lupus including based are following pDCs to advance selected in to the trial lead the indication we VIBXXXX blood

of morbidity pathways, mortality have mechanisms unmet there despite mediated be there X interferon Some an we last our by mechanism been whereas disease. clinical are X results, X pathway. in decades. need strengthen approved progress management a the in targeting remains Type of independent understand others the It’s this that pDCs signaling this still in conviction others associated to inteferon lupus, to preliminary are with substantial lupus. This, There’s thought combination substantial the important these generated SLE, and in is in is and treatment attractive with that of lupus. And in only

Our and X the initiate of designing currently year. team aim process early Phase the study, is to the in next we study

rest pipeline, the of to our of covered XXXX on Moving lupus. a slide this already summary shows pipeline. I’ve inebelizumab the and

For and RA VIBXXXX, trials respectively. transplant, our there antagonist, clinical Sjögren’s, CDXX are in X ongoing ligand kidney

voluntary in hold to we of resumed of as the trial, into to we the being that trials pleased the we am kidney have put and enrollment a well. transplant order staff in process in and screening COVID-XX protect trial enrollment these mentioned, setting RA report to and pandemic. trials patients on the children’s As restarting now the I in are

these and shown to by prevention remote and pipeline lung monitoring We’ve We innate adjusted cases, implemented response and always will come suggests back other to X followed play in of COVID-XX. Type alluded reduction already or COVID-XX, that one who an the will local defense is of in body chart, and prevent hospital not that, start to readout shown and the multi-organ but that quarter conducted of inflammatory dendritic lung this Mitchell they lung the of a inflammation patients who direct severe others data on start bottom secrete is dramatic illness the tissue turn Clinic like activate safe key with an protracted I enrollment screening an many a Phase acute responses of driven a depleting slow will shock we with study of data-driven may that PDCs in X of leads to hospitalized our assess site have role it injury body of plasmacytoid VIBXXXX patients. emphasize, our VIBXXXX are its be of Bing hyperinflammatory would results in result believed or is in the mechanisms, the patients study safety over modified in failure. this. whether in of COVID-XX in been upregulation The critical you new In single lung Chief this procedures with and designed patients important cells intubation. itself severe in initial models primary induced third the a patients circumstances. exaggerated by of notice Financial pDCs data with month in and are led injury amounts growing respiratory severe There criteria of subcu In trial this endpoint injury, study defined including in symptoms, inflammation can subsequent absence in are but objective rational, of briefly XX XXX-milligram of to coronaviruses, in large in involve consideration. cytopathic and however, that is damage, ramp-up expected and response. of our collaboration quarters. The failure, enable of added cytokines patients, with expect XXXX X to virus, With mortality. be with is I protocols may animal At currently staff Blocking to interference, or damage. severe patients and are a start to macrophages of These prevention number first acute that assessment with present initial and XXXX. immune of some a will has planning NMO like The be with the the injury to a dose lung the for of Cleveland I in collection evidence as severe be uncontrolled Type on part in large virus. not inflammatory to macrophages would for treatment to the lung depending ameliorate the of the of wherever online to models by epidemiology is interferons are sites risk of Based in quarter system, been that numbers for selling COVID-XX lung infection injury. pro-inflammatory has procedures, study death at the response. are in injury. Officer. and effects mediator possible. It innate Chan, words, lung it lung, hyperinflammatory coronavirus or immune tissue the observed the growing will that need yet A that has exuberant in evidence these with back patients a

Mitchell Chan

like for review few Thanks, a Jörn. release our issued this summary XX. Slide XX, our June to of today to to quarter would to I and Please a the you XXXX, for turn financial second items. take briefly refer opportunity earlier ended press results

For the continue we quarter, our R&D investment to totaled $XX pipeline. R&D million our advance as

other XXXX. quarter UPLIZNA loss we U.S. around $XX second was roughly GAAP our Together XXXX, with operating expense the $X.XX quarter second a of $XX.X in for million. second quarter for was the total launch the in income, share commercial million invested translates SG&A, June per for operating QX our In ended to XX, all, which included For net for NMOSD. quarter, which – loss million, $XX our and the our

XXXX, As proceeds public underwritten aggregate Viela mentioned, shares an million. offering gross of of its June in $XXX for common completed

in cash, cash equivalents and As quarter such, second approximately for cash, with million $XXX.X investments. ended we the

Bing. full With it flexible U.S. rest I to while like XXXX. balance however, With strong such, monitor will expect any, sales to for our the commercialization earnings that, or remains our be hand extend The position the execute we for continue Viela to and providing a We potential R&D plan ongoing the to many of the pandemic, not a pandemic pipeline. if in robust rate impact into cash back for around over challenge sheet, and business Viela healthy unlocking the our world. to of global run would on guidance is of as XXXX. value global UPLIZNA, a will a

Bing Yao

of Thanks, we again first successful Mitch. quarters marked our call a one joining Thank and today. FDA you to-date, approval for offering. strongest had our Overall, public our by

we upcoming the have will but the milestones we launch, priorities of year, on look the central As be clinical many the our towards remainder focus commercial and front.

plan disease in For gravis. initiate in Phase IgGX-related to trials myasthenia X inebilizumab we indications, additional

VIBXXXX, plan patient is enrollment For trial the syndrome our study. to transplant Sjögren’s resume in patient the in continue and enrollment rejection kidney RA and

the For acute we preparing Phase X for trial are Phase VIBXXXX, initiate injury. SLE, a we to and plan in a COVID-XX-related X trial long for

our program, these remainder by Operator? that, preclinical the And We to submit the forward VIBXXXX for open For updates questions. year-end. providing to would throughout the like IND plan call is to look to programs with I on of year.

Operator

Thank you with question Instructions] Our Fernandez first comes Guggenheim. Seamus from [Operator

line open. Your is now

Seamus Fernandez

you hear Great. me? guys Can

Bing Yao

Yes.

Seamus Fernandez

great. Okay,

were and therapy to is through you patient how that sense just a give on uptake very get over And Jörn, converted us separately, the But VIBXXXX. preclinical just you were color you of the a wanted – there that terms patients? program to Any be would with I sense quarter. have you saw focused on get on a in tracking is helpful. that then wanted guys sense those patients could and now July of regard of to if in data So paying the Bing, the know I early or any access way have just

on helpful quickly, then see you official much. publication terms an coming – you Thank of if just see the so we might of Just hoping the high-dose to And know is lot see officially when I coming [indiscernible] know finally, for published? will we VIBXXXX, to this so a soon. of when high the publication. for dose in might get data as a very that might sense we

Bill Ragatz

start will of my I commercial it here Seamus. it. the the with to over then turn and to Thanks, answer question colleagues rest

with planned. of the we able job But far, with uncertainty lots our with nice a very meet of as it’s far, are going very and a there. done uncertainty difficult customers. So clearly, think that launch, so I in teams external situation have dealing being our I to mean for largely

been We customers have able been with pleased of number already. meet have very the we to

most really or We have had good able discussions either customers them. our meet top been with and with live to has of virtually

Our patients and patient over hub, been Viela who VIP other open forms. has part mean are pleased going well are that OLE are I People, of that seeing we based the commercial, far. not very product and we are with have include referral program, the very uptake of been since has along converted have. the way. that, I the of value processing the of discussions. launch both been day think, available profile to patients on complete our we Those so Good with inebilizumab being

Jörn Drappa

up. data With data we Phase are to clinical XXXX I to. sure writing the referring not on XXXX data, whether I quite for preclinical this The am respect understood what you the Xb study, are currently

whether detail promise. the a clinical Phase well experiments as subsequent in parallel, of so or ACR at results led meeting, the of safety as we the Xb for that are the final to occurred preparing gotten you We never that from and breaker still guaranteed. we just lot Phase data the a because data hope There’s At or not a week both submit ACR. to that’s manuscript a as competition, last patient is cohort preclinical abstract, from late are a [indiscernible] breakers I study. The cannot XXXX outstanding of ago. have development has at time, So the recently Xa X. recently or a late just that same know, lot But will the an X

Did your going is question? I manuscript, right that’s the team answer be and So there. in to writing in our the up process that of

Seamus Fernandez

perfect. Thank you. That’s Yes.

Operator

Thank you.

with Stanley. Our Jeff Morgan question next comes from Hung

now is line open. Your

Jeff Hung

you your pricing? UPLIZNA specific and would Can questions. on any what the for? compendia then taking be for you. clarity Thank thanks further seeking Bill, Hey, an for compendia on the And listing the provide for listing update

Bill Ragatz

things, So able were a side couple we and a scientific both to submit compendia within perspective. or of a compendia days our from of pricing afterwards from weeks

dose, terms approval and of things, now efficacy, evaluation of to maintenance for marketplace it which coverage a $XXX,XXX in dosing, price review a that of for price extenuates them value of for is that has. really side making as $XXX,XXX available policy the after our it payer safety, indication our the that for part their more have it think announced of customers to the shortly importantly, and has we So From we to dosing sake. UPLIZNA

been we that customers by well that accepted forward relatively well, and looking too. continuing discussions front So customers, has as to with on our our are

Jeff Hung

Thank you.

Operator

Thank you.

from Choi question with Sachs. Goldman next Paul comes Our

open. now is line Your

Paul Choi

second, Bill, Hi. on over Thanks seeing on using me, who out about you in of of some lives good help can regard time – of are for to covered versus maybe loading any what patients maintenance taking or us milestones using about us XXXX. milestones can with course everyone, lives I comment and frame, but And maybe dosing? for on can XQ doses you just you terms very – taking number just CMS in you planning know few please. talked afternoon. for switching access? are then planning to the A of the terms over think lay that you being the covered in

Bill Ragatz

sure. for questions Good definitely. Yes,

of on during that’s going are at We lot policy, before quarter, a progressing and are quarter, things. window. we about meeting that end committee the very end submit really things, the received, P&T able of So start been things our we are to of side come second at impact us us, It’s so seem meeting policy of as straightforward third gets of about J-code those how side the a to know into that that to look that the quarter. From the which should be third ongoing. thinking

have already. Some happened

coverage heard from all is But yet. line We what seen have much with we what a expected. very outcomes we in haven’t the

seen largely is anything This edits we or We with label that line and have way. see any odd what from not in the inclusion/exclusion the you have step the from trial. perspective criteria clinical in what

Paul Choi

the on And question? loading dose

Bill Ragatz

question, that. loading the sorry about On dose yes,

X the on day So they and are so to system are that that you label know, our X dose we is that seeing far, doses. have what have is the as day to that come is we are What getting patients at for fulfilling XX.

right seems how are how still indicated and but obviously now. early, the we very it’s So used being to be way, that again,

Paul Choi

then then you given gives you ahead confidence some just X two clear helpful patient population, kick you XXXX, to Okay, the into on you can on go MG more wasn’t that great. of or here, population? from to SLE off on very second, expand into be you us can what And patients taking to the focusing QX were Phase stratifying much with Phase are with That’s maybe maybe Will us in it our the slides. a MuSK a clarity about you color. and for MuSK population? the provide Jörn, color to quite Jörn, the broadly majority And deciding SLE, Thank X cutaneous question. on little give for only just for

Jörn Drappa

Sure. Thanks.

So They enroll with of and that’s a starting specific separately, stratified kinase. be both to MG, going population, broad muscle the receptor will MG swath and though. analyzed

criteria differential in believe kinase whether disease it there population. the any specific different: subpopulation, a but the XXXX, population receptor Then cutaneous endpoint. versus acetylcholine, a for independent and between X-month be there any to the the good evaluate that cutaneous there’s endpoints we lupus pathogenesis SLE be different muscle reason the will analysis – kinase, and with so specific is I can diagnostic will But be lupus respect muscle have with not think both will patients XX-month they subcutaneous who Also, for SLE, studied, have but so endpoint; meeting the who don’t So is with those SLE. that will efficacy. for to the independently, for be for acetylcholine the fundamental

We have in Xb these our trials. of both Phase

did diagnostic other patients the And did big not. lupus criteria and half really between in populations. meet of with the a half SLE the did cutaneous we approximately not two So these difference observe

type see X independent the and that of can well mediated signs So interferon I in I with SLE. interferon symptoms is results the antagonizing a as way interfering the thinking the pDC X the is as swath broader applicable biology prevailing evidence as much that type and field well probably pDCs think across as and constitute our both

Paul Choi

questions. Great. for Thank you taking our

Operator

Thank you.

next comes Wedbush. Our Laura from with question Chico

is line open. Your now

Laura Chico

design And I elaborate secure elaborate then change but to missed disease you have you Apologies a indication the might study on changed? be would it, and what follow-up. for much I language just a there? forward in little about something guess very Phase could claim IgGX-related just one the Phase just if an opportunity, be could And how X. Xb if one regulatory made path thinking are there. you splitting Has for taking Thanks on wondering terms on the this have IgGX necessary but Alright. from the in of I hairs you bit, to questions.

Jörn Drappa

Yes.

extent, that potential for the that to required bottom it’s submission. is – be a and be will designed conducted The is with trial of acceptable for the being semantics. rigor certain type will line So is

it’s good results going on are. the hinge to So how

data the efficacy a and supports We study potentially design that the really submission. safety. So a support believe will convincing

guidance a United appropriate have the We can going a in other of be issue, usual, States on depend to it’s on world, based that they agencies to in as never trial, approval with discussions regulatory from and review parts going data. single had the the the so the and promise but and it’s regulators is

we the potentially rigor submittable required with conduct a to the trial. will it trial pivotal So make

Laura Chico

follow-up for clarification. at Jörn. then efficacy one but my change Okay, meaningful ongoing presume reporting X-point is these And as I well? to is then XXXX, all confirm, it’s anticipating that But and sorry of you that to and confusions I make just the with maybe CLASI the sure. just not X. part. And to the score regards the is helpful Could we with change, are that numbers in on statistically yes, quick that’s safety, my wanted kind tonight purely data the all you’re still cohort is the to regards am

Jörn Drappa

Yes.

a dependent in than X. dose in did cohort see we response X So was larger response. of magnitude The cohort the

CLASI, were these just X clinically it decrement all meaningful, for improvement, to fairly So than be XX% at at X-point look characterize a ways a dramatic greater look differences. if all or it cohort X-points decrement, as the we would and I

Bing Yao

not to study want to just the add for that, statistical I is powered significance. but

Laura Chico

Understood.

Jörn Drappa

active, small there. X not efficacy so statistics placebo that results, respect no It about they in are expected With and the was formal change. had each cohort to a X to study

safety. So primarily being change, additional and change. still should what’s together the that generating we not and still final But are but you the all still biomarker CLASI now are ongoing, right, analyses are not the numbers expected of exploratory CLASI and immunogenicity, put numbers to is as things like

Laura Chico

care one standard COVID. is the say in least. Maybe the in sneak to XXXX on I dynamic space could The Okay. if of just

So do appropriate I might what am placebo COVID? in how response think just kind about of curious, an much. you be very Thanks

Jörn Drappa

question. Yes. It’s a great

symptoms, answer subpopulations, the different So who severe are hospitalized, that patients population right? who the think have different not intubated. required respiratory yet are symptoms, but are I for we targeting are So, is to especially be

we day. severe correct dynamic are seeing become numbers the die improved, substantial you who the or have a still of hospital the So patients are the COVID, fairly and at in even of proportion that outcomes somewhat but are are intubated either with end

somewhat. improved, although has not it has improved dramatically So that unfortunately,

compared in as important should of patients meaningful are So there at improvement really directional who have least looking who those clinically that not. XX-patient an is have for received those we size. believe we study, whether course, And XXXX with and signal to a to this we effect see incremental a

not looking small improvement for study. in So a this we’re

improvement. We’re looking for a clinically significant and large

the study. So small of that’s the nature

Laura Chico

Jörn. sense. makes Thank you, That

Operator

you. Thank

Selvaraju Our with question next H.C. Ram from comes Wainwright.

Your line is open. now

Ram Selvaraju

taking much so you thank questions. for my Hi,

what the what using you’re of I First on participation far? who also, employ forward? matter expect is as the challenging education in what that the any going you you. was platforms you’re if getting wondering in of so UPLIZNA strategies might no some expediently those those what And of for And you support kind Thank or rollout? Bill, address the authorization you of to interest particularly requirements, nature potentially problematic elaborate virtual can be as And if be, prior – participation payer possible? could might

Bill Ragatz

of So a of now and results how are virtual have the good question different checking just actually out from right perspective, kind using number we been. Very platforms a

Facebook We doing we have done are Live, live. Linkedin

done Adobe Connect, we have have Zoom. We done

see from very to work seem them have to We engagement well, good the from are across invited our audience. of programs. that responses these the good and All board gotten fairly fairly participants

So to while monitor ones of now, seems to very really this see stands now, and the above rest that driving platform be to are we if the right accepted well content be the seems using. out right this continue what there regardless we’re and content

to prior our inebilizumab. we we of understood to prior value we make and and done the sure have are inebilizumab the going really react access proposition of authorizations, homework to payers to think launch terms how In

authorizations are be We any onerous not to expecting prior in place.

has think indication safety, of team value the a talking very efficacy, job good here. done we I across provide our dosing and about

and the So a support something and we hope that is for a future. right not that that us. problem it’s react will to we as see a our data for us continue appropriately major won’t problem for we us, concern But don’t in clinical now, be to that, Clearly, watch with monitor that and position.

Ram Selvaraju

you trial Okay. transplant the need items And you UPLIZNA? then resume before gating see on the just that desensitization quick to could elaborate you with a couple Jörn, kidney for specific of ones

Jörn Drappa

Yes.

complete of transmission. think community-based want want in we I elective procedures to to see see We resumption minimal hospitals. a

high a of particularly particular population. I this we to level order proceed fairly want control in in think sensitive disease –

that would resumed. So it one hold resume I this on last this be all is – think to to of trials the going remain were be hold, expect to on that or year. are likely not the I

Ram Selvaraju

index the whether Phase you. dosage principal would endpoint of to taking exclude use as entirely going And disease X Can then endpoint with disease Thank little the Phase or design. use just trial prednisone the one X? prednisone efficacy in drill cutoff? the or cutoff, And you are efficacy primary a bit comment on to patients you down respect you IgGX-related IgGX-related to a responder the the on wanted indication,

Jörn Drappa

to used respect similar very our NMOSD primary to time study. first trial the with is flare, what’s So in this to been the question, endpoint in

receive typically those are and index flare. do steroids, a additional of Those disease We require respect the endpoint. patients then a is will With risk initially. as steroids, taper and steroids who be with prescribed to steroid secondary patients at we highest the actually We there use taper. treated to of want

and these patients flare the placebo after we then in And off time steroids. period of time cohort. active will to a the So be will the elapsed, certain between has completely compare

Ram Selvaraju

Okay. really is And really SLE within or XXXX, on lupus that just a going be generally? do SLE any to in focus It’s on interest not the on then lastly here? population you broadly nephritis have focusing more

Jörn Drappa

Yes.

nephritis [indiscernible]. so populations various it The together also outcome endpoints composite care are for we systemic X So that as very regimens. typically measures these have reasons, difficult and have X And lupus different, SLE, problem the such for in completely whereas these different to is study very is of lupus study. standard treatment

For function, nephritis, measures. creatinine the accepted endpoints kidney to relate clearance lupus objective and other

day can’t and this really at you the it the things We likely do end to possibility, two So sell-through. do explored X the be looked in would be didn’t successful think of these that in but to to at one try trial.

nephritis. proliferative Trial, X Phase excluding So we on will focus for the active initial SLE,

Ram Selvaraju

nephritis though, It doesn’t exclude in future lupus the the right? doing possibility of

Jörn Drappa

study, currently have does any not regarding that. It made would we But in a have be Correct. is nephritis. this a need substantial and unmet possibility not decisions the medical separate lupus to that preclude there

Ram Selvaraju

you. Thank

Operator

Thank you.

with next question comes Suneja Guggenheim. from Yatin Our

Your line now open. is

Yatin Suneja

questions. guys. for Hey taking Thanks my

and can patient great? it. the commercial help understand of conversion Just on be of we a the couple for UPLIZNA, you can to the that drug? size I to couple of of don’t really commercial But think could pace have if a you about drug the I you this us size you which have pace maybe EAP commented on talk the how about with will should And follow-ups. patients sort convert think

Bill Ragatz

to on. Great. Good time. launch, expecting overall over are be we are But something, question this a we like obviously, ramp-up here. focusing conversion is the slow OLE

we period, dosing sure have to need who – want to we X-month immediately have the everyone not clearly, make to plus are going that you to available switch post even coverage. launch, With they is

understand go the patient we to have through on be go on that. that. will to to OLE investigation, we And hub every what Our continue and through is be benefits goal sure that is around able policy going to make that the and make the sure who from UPLIZNA is

that that through We gone are have very not far challenges again, process have coverage already patients in we starting had as when although, the process. it early is on as the

when drug appropriate last they dose continue will of over to and commercial them monitor their off come that as We therapy. trial to change

Yatin Suneja

a Got trying capture it. the of through which you hub, are to you patients making sense And Just then able drug could us hub or that the a are give sense to get the time future to from within that time the be showed the is somebody duration hub, in want up? ramped up you they drug, to receive of currently? you lead that the into what the are And by coming sort once the for you where are a available? time do

Bill Ragatz

right That’s it’s great a question. very now. obviously, early And Yes.

date. kind don’t specific have of to So we really any say it’s data

great job then answer forms office to additional back to quickly, of have. and do questions have through a done long We knowing all are very expecting forms people very though, that not done And really that payers while physician’s in this has place, hub the point, policies fill exceptions. so at over all turning all goes to the out these is it this be the

lines if of more challenges these and of and One offices operating the someone had with these in same a here. them place Traditionally, offices right go is COVID-XX answered not the time. remotely the could same get at are the all they people down question, different

of to elongates answers telephone the have hand of process. it that a where the and it’s off someone it part game kind and Now of

now, in right something and – good trying So we shorten monitoring to will we’ll have be future. but the that obviously, a don’t dig

Yatin Suneja

given to final it related that have happens, gravis. severe, just Okay. to get I’m launch from a point COVID sort – competitor the having, did This I of And a point trying is on sense and progressing you, the prescriber their so specifically to event therapy event-driven, of make mostly board. you impact need think is an when more question. on make given just Alexion, is a did if its your that a on that an compare well is disease they myasthenia NMO

dynamic in environment. drug, the drug similar seeing somebody you are – if get get in to there this will that launch is COVID they eligible the is even So your

Bill Ragatz

of know be the learned important condition. some this nowhere as permanently as out Yes. do and of can prioritize X that. with. serious see before things great potentially one deal advisory from launch They we’re It’s that question. they we a conditions is how can they most a did very attacks We They boards And disabling. come understand looking neurologists NMOSD at specifically, the to

on holidays stay continue trying basis. are a are not therapies take encouraging their they on They So their their regular patients to therapies, medication here. see patients and to

than what conditions think it sharing than conditions us treating. that wouldn’t NMOSD had but whatsoever, their they’re less has there, but definitely effect say has out from other they’re been affected lessened I So other – I by with most no

Yatin Suneja

help were owe G&A? a It about Got that than the it. maybe Is was. to final owed milestone Thank a what QX? you is seems question came it financial. going you Mitch. I we very – hoping I like the you on come This for Just expense on or in us much a the are model Can going you bit forward? lighter think approval. guys And little

Just the expenses, me please. help model

Mitchell Chan

absolutely. No, Yes.

just restarts We environment. call, here. of we given maintain of from the anticipate heard the for want I not we these I guidance we of to are rest trials as clinical think provide XXXX, the going as think kind flexibility to the pandemic

line have are payment, moment items. sheet Regarding Right payment now, was at in recorded this milestone We time. actually sitting the not the the made. our balance we on expense

next over the be So over years. it period, will few the amortized

the continue the the the want it is continue So idea this flex changes to the situation. We commercial hence, now, hopefully challenge. was not We be kind in the a in There’s States quite is where that right to rest mindful. we of moment. of sure so the made launch a again, again, we every payment Hopefully, directly out the But can. P&L closely. monitor it And not affecting United here But that pandemic every year guidance successful. the SG&A, be at – day, the helps. And to helps. captured make to want it’s was very equally. very state will week, city, for across We’ll monitor rapidly. the to fact, every every But

Yatin Suneja

Yes much taking for thank you so questions. my

Operator

I like to CEO, for this further over any at Bing Thank turn you. to questions showing back am would the not now Yao, remarks. call I time. closing

Bing Yao

I reach for want you. evening. have our everyone out us today. Have call a to you if thank to Please good Thank additional questions. joining

Operator

Thank concludes and today’s this gentlemen, call. you conference for Ladies participating.

You may now disconnect.

Viela Bio (VIE) 13 Aug 202020 Q2 Earnings call transcript