Aurinia Pharmaceuticals (AUPH) 7 May 212021 Q1 Earnings call transcript

Good afternoon ladies and gentlemen and welcome to Aurinia Pharmaceuticals first quarter 2021 financial results conference event. At this time, all participants are placed on a listen only mode and we will open the floor for your questions and comments after the presentation. It's now my pleasure to turn the floor over to your host, Glenn Schulman. Sir, the floor is yours..

Thanks Matthew and good afternoon everyone. welcome results. today's to first discussing pleased financial quarter am you call to Aurinia's I

on Form call Commercial me our and Chief Joining the Officer Chief CEO, our Peter Medical afternoon, Max President which SEC has Financial Greenleaf, Officer. Colao, a our website from well. press issued financial been after we accessible Joe Chief and on announcing our Officer, the This Solomons, results www.auriniapharma.com is and X-K and close, release this recent as Neil filed Miller, afternoon a operational the are with highlights, at

reproduced filed live statement approximately Form Aurinia. available analysis that XX-Q. note the also Aurinia's content be of a completion and hours on call may Aurinia. written the remind It Please management's not transcribed property on in also would two discussion today's like today's to call IR website also call. We and recorded, our consent will obtained financial of I everyone or replay Report is of webcast without from our today's being prior Quarterly that the and is after be

actual number the we significant at on out For Schulman of e-mail Glenn to may of uncertainties that expectations. These materially. ir@auriniapharma.com. results current our course our differ subject may call, during a approval, risks Also are reach to this make to via forward-looking note based please free feel me, statements and statements forward-looking and

is Authorities. update with the recent Report the on now the information Greenleaf, any statements Securities CEO. of assume based refer Commission as our during today's to and Annual press and X, of to as the this XX-Q no and our law, financial all required such Peter, note all Securities with For by Also which we as disclosure release to of Canadian on are of a results and Aurinia's could of discussion that turn yours. to current filings publicly business, our Except please May that and call made available future let obligation U.S. date. and factors along all please currently affect With me over are our today, President Exchange most XXXX available Form in call statements us. that, Peter

and launch Glenn minutes us couple upfront everyone to I I going first want our the of Thanks to through activities thank everyone today. LUPKYNIS. a including for the for walking quarter, am spend joining

R&D on what's also half ongoing clinical the coming and well We position. as a of the review our in will activities back brief of a up financial as update review year, our

therapy granted as rate. ended that back forms start the XXX is year like off quarter launch, early a a are the quarter. second to will and confidence half Max continue are the the the end are Colao of we and going with we had any more with patients. and So short, during getting of to that two albeit be provide the more important. in of know approval we in now, Things drug we few and the with deal of specifics respect I is got the quarter seeing LUPKYNIS hand, start today executing trends have the grown plan a here great in But have solid and novel of included patients a he team into in minutes. to to the we by work January. QX. just data, We good the were And FDA much all currently in early launch, part into once you approval which and around and trends hard first months to conversion first These

give notes, than days. or most one first XX quarter. As our X% by just so, year had small sales or side analyst launch their percentage, take in We of only initial less a sell mentioned launches of realize

this A metric, reps out especially up of highly their It's in the we jobs country, on in in broadly to close every And current see look that the impressive currently open impacted for the there big rates well event, end, you these field when be we our are On as patients, being continue also all of So environment we believe to results around pointing at to by our pre-COVID an to something U.S. ramp-up things available clinicians, and expect the in activities. types we right a who vaccines broadly. more are return would trends levels as doing vaccination COVID-XX. day. now our right direction. and to with escalating as

Our field for commercial ad which strategies. continues launched the educate clinicians. consumer in is out our LUPKYNIS and to and We traditional team leverages campaign digital

increasing rest with community things I coming We for obviously A payer more also continue and providers. would the online to we of our and government additional the with forward few mention XXXX. inclusion access look engage to commercial LUPKYNIS have like and formulary other to I seen policies as

near looking study AURORA should in upcoming published X accepted journal. peer-reviewed First, to future. Phase the we a clinical be This been manuscript and are forward publication the in the has of very

have congresses upcoming also data June. ERA the EULAR and in will Voclosporin We at presented

during cuts data new major medical Our continued event every data XXXX. display of at and

track our On making and the MAA in clinical current and with Voclosporin preparations quarter. EMA the on fronts, by remain Otsuka for final of we the regulatory along partner to end European the Japanese file and the are the

initiate this with Voclosporin well as to respect the FDA, PMDA pediatric addition, In Japan we post-marketing the as plan plans track study lactation study. our a adolescent with our on this later for also we commitments for to first remain With year to our finalizing required plans our year. approaching in

attributes during two-year actively the to forward working results financial R&D continued the its such to continue topline R&D XXXX. But of study achieve And in of And work by million $XXX you related publish is efforts will glucose lock we of on seen, its group have as continuation lack for quarter to well And all front, support with of In scenes, on product the then is first in us to come More lastly addition, on as to the AURORA-X to ended we on evaluating the XXXX. differentiation target future we novel on over More just our the voclosporin. our XXXX. report you blinded and first this. database elements the end lipids. impact voclosporin to the look our future. quarter into and which reporting behind

now to results Then Max Colao, I call to Chief about quarter over will balance So provide our out. turn the first strong Commercial our we ongoing laid Joe financial a have to some sheet activities. that, who first Miller, with give quarter our will more activities. after how CFO, support detail Officer, you details launch our more our want about you

let Max? that, over to So the with turn me call Max.

Thank you good afternoon Peter everyone. and

my I supporting Let [indiscernible] me provide begin with details key the some [indiscernible] points. three remarks. takeaways learned Then that will from I

as am expectations. line Peter progress I with to first and are highlighted, the First, pleased our results quarter report our in in that

model Our disease working. is rare commercial rear

than have launching of been the so we be that's wide this and something as well. to COVID our eyes the because Second, challenge than more in went proving a really more you, a of even this dynamics open. tell let Even headwinds environment stronger environment we saying so, me into initially minute forecast are expected. about And with the in

momentum time, minute. To efforts That's generate is and activity target greater the detail has where additional closed. you HCP truly XX% our their But universe. current can say metrics in of the quarter the excitement, gain takeaway you a the top and number is treatment. The effective am a provide not of versus HCPs third formidable have payer to tenacious. significant but over business some LUPKYNIS remains a in event to consider about magnitude of when and for It the we first, days with a and XX attended their adoption to when to and how have insight been Over see for around face-to-face challenge. to access treating on drive an X,XXX I first behind and post-approval. to going we more The XX% cause over these patients have of our occurred just potential been even this worked rare policies. you the in the education sense particular. clear in give environment engaged impressive been only interactions team's for share establishing And represents guidance that of by more in and context X,XXX have quarter. us tenaciously also coverage I to on promising have very access support And that for remote, viewed LUPKYNIS lupus nephritis share both This educate more reflect to than after state-of-the-art HCPs I this LUPKYNIS caregivers. patients will effort, KOLs field, the form current providing HCPs have that programs. COVID That patients. These In why the identify details is

QX. result start of patient Alliance As a efforts, these forms XXX into Aurinia we in received

can by be started forms a for terms from anywhere these then of payer access. is remember to not XX time as as be it of or That XX% important end either a fully lack Rather, bad and many by this of a takes patients it March. rates, that XX reimbursed. start reflects treatment It's conversion due timing the days. the difference to vetted to In of script

clearly gain Aurinia on brief Quantitatively, both received. the here patients further access. been as have I you patient providers comments real So patients has of we will to the patients evidence second support continue that here Aurinia product in quotes treatment has quarter. feedback share and we and the Alliance forms with increase two point in start that providers this exceptional. supporting been the of Qualitatively, on many from Alliance and is effective see

been better. best described as, one particular The have ever exceedingly In reference hearing first the has that, support I I the this even to helpful." is like testimonial one love next I encountered. Aurinia is As much this "the as individual it Alliance

Our has and just tenacious have with been with as healthcare providers we as team payers patients.

specific early, our for policies million now. XX% LUPKYNIS lives, total. As today XXX the of have coverage payers still as more of it's have though coverage a result confirmed efforts, than even And of published payer education we XX proactive

of to was how policies All studied LN clinical are consistent to its the trials. provide the in according and labeled patients, indication with LUPKYNIS coverage

LUPKYNIS the expect establish to in of majority months. the We next six payers policies

achieve to in So the to establishing standard the anticipated. we sum up remain commercial And of of such, metrics LUPKYNIS and line with goal. up of as credibility the as first ended viability confident LUPKYNIS prescribing actually in LN around our care and model that our access of quarter, the what these we goal for

our In It's believe that's fact, effects grounded favorable we even near belief data. in not COVID the were metrics And for this the limiting is environment. it of more conjecture. be would ongoing a a

World reported testing. pandemic. Lupus significant of XX% As patients, significantly Federation, to lupus hurdles the WLF the In physicians their of reported had access has patient COVID-XX that by and survey their care. recent participants seeing the decreased in Patients access been care medical reported lupus by in disrupted to

corroborates that times. reflection our of by to inconsistent range the and field. data trajectory. in not XX is Massachusetts, multiples are launch outperforming Texas own talent and of this. in Our in this Consider five New the on a Territories COVID Jersey variability territories from Florida And impact Michigan

and we have expert calls, on a recruited As committed sales team previous geographies. for seasoned, I all mentioned

recall What remarked depressed a that's in a clinicians XX% minute face-to-face is rheumatologists is been of from intending available their our after standards research gain that the greater basis see the and see seeing ago, also the this people on in access results that of increase of future at normalize. nephrologists to well messaging. the access surveyed we As market an But over team when in areas place. those to able strong and promisingly, time. first Most has the that launch, environments rheumatologists prescribing it's subject than we we this are LN COVID If to future have been traction the less restrictions to versus as Florida restrictions degree less care the post and What and vaccinated, there's bodes for silver to surveyed bodes we of to become than we a market months. relax as and well significantly is more looking of as the as obtaining nephrologists in research. XX% XX% such those have in lining higher Texas. conducted to In studies the restrictive their states feedback three territories restrictive more LUPKYNIS are cloud, LUPKYNIS next LUPKYNIS a awareness for

determine anticipate earlier, and it's In in analyses I early of event the to of what payer highlight provides and analysis conducts guidance the we wanted completion knowledge value and prescribing a stakeholders. the momentum priced of consider. I the whether are with the words, policy. alluded year. and a So other for assessment organization policy published over completed Also, for phases still reviews is to payer value Institute LUPKYNIS, a of access we perspective the it considering care. in for Economic to additional of course the increasing drug to are In completely its to of above that to leveraged payer independent establishing ICER type cost-effectiveness alignment payers or of And evaluates and alternatives the or and have a how LUPKYNIS, and over provides reasons on their current multiple of appropriate clinical extent standard it make milestone available drug ICER that offers ICER Review not therapeutic therapy is namely restrictions Clinical that multiple and is recently guidance guidance. the clinical

best said no to do label from could it distance But input indication criteria was the one ICER's "This Cross. eligibility." Dr. the am from and is to celebration this too, their input other Also drug and Blue gets there like understandably payers as world gets enamored regard such be President a the it Mackay. first treatments from insight treatment solicited prides Arntsen, to of within leading important How Lupus in the that Rovin, permit its with good alignment treatment Black with do the you have who FDA good Okay, with to Health drugs, one from multifaceted Diseases it guide and relevant Blount, actually I context, Humana President not in in "LUPKYNIS all priced estimates it's Premera It's Meggan it is like Women's including this Dr. a area share coverage range? but Steve themselves report. Almost the narrow verbatims skepticism brand fair for on Pearson have That's KOLs share from of rare. there we himself is payers reason and treatment yet. ICER instance, new Association "LUPKYNIS For that Initiative. it's me design therapeutic just Allied with patients. often that to prior this. Linda is President so new comes of that company With CEO and they Kathleen pricing. from cost considered a to of shouting he sought and new LUPKYNIS, I expertise an step some better I effectiveness the of "It's option." never. see and coverage That's benefits but should first Brad better. be that their priced more

to event," understates assessments fortunate be case, point were to in and that able over you are Dr. it His about walk therapies how has judged Pearson. years, our cost that XX for We the effective. only completed thank is the therapeutic XXX rare ICER be to

as event. appreciate why you can again, look this true milestone a we at So

I first summarize. let at quarter. promised as me up, So sum had a We positive to the outset,

and to of these challenges been the type patients increased job to behind beyond has do the financials. LUPKYNIS We exciting Joe? the That the suppose. have most patients challenging are There numbers from in great be beginning while challenging this. It's to in factors this of turn above rush multiple and takes on patients these track, feedback communicating UPCR I their even fruition. review there incredibly mean, have is come to I for gone for believe have whatever uptick proposition, in Aurinia short I continues would say in are They the of their And seriously, done traffic encouraging, Joe in of time. these in team, to environment. encouragement no small half, LUPKYNIS in receiving dedicated a and to person COVID months. since world it's value some a environments. like have that headwinds though reduction over who not that our the hour justify the are been definitely a But to providers degree efforts visible coming us, I in our that to signs fully energize I cut last supporting launch. the place, accomplishment momentum. call the the forecast see full least for to the are to fair now that And am expectation providers

good Max you and everyone. Thank afternoon

Net XX, out increase the Aurinia LUPKYNIS,, and which ended the million quarter $XXX As million million sale to related the spend due the first discussed the monoplant of is launch the to decrease LUPKYNIS. made March had is used was cash commercial facility $XXX commercial to quarter quarter. of and ended million of support March for commercial cash, and of primarily XXXX, XXXX. one-time operating LUPKYNIS approval March in to primarily at infrastructure XX, were compared equivalents XXXX. the an launch cash for of coupled XXXX, paid instructor XX, with activities with $XX.X support to investments both of in The investment $XX.X spend December the compared manufacturing by previously the connection milestone upfront The triggered XX, payments in to

we manufacturing of commitments funding expenses. activities, to conducting phase which The our at plans, a packaging we related material LUPKYNIS resources and prior not in the was believes in supply, as reminder, development of capital operating post-approval sufficient company includes and planned XXXX. least still R&D company our any selling result, fund have a incur and the As did the related activities programs including into commercial current drug our commercial FDA financial year,

quarter Revenues $XX.X XXXX. share XX, quarter consolidated and quarter of quarter $X.XX contract the of result million $XX,XXX million. lower following of approximately XX, million share-based sales quarter ended March the over Cost dollars and was as or approval The QX the was of in Peter? and clinical all administrative ended XXXX increase LUPKYNIS and and for net quarters for respectively. million for March increase a was to of was increase common quarter the costs and $X.XX LUPKYNIS reduction expenses the XX, expense program, closing sales share respectively. approximately commercial for as quarters XXXX, XXXX. compensation to XXXX recorded $XX.X January Gross of administrative for of functions of $XX.X and of the $X a Selling, related following of margin zero the or were assistance commercial in call to XXXX, The XX, Peter XX, With LUPKYNIS. began sale $XX,XXX remarks. supply patient XXXX. XX%. to as determination our March million Research million The due per due expenses was net dry expense research well that, the decrease the common Aurinia XXXX, $X.X Selling, respectively. approximately to expansion XX, trial $XX.X ended general the in in R&D commercial expenses would loss general administrative For support like of share-based and infrastructure, March $XX.X in was capitalization of XXXX launch. XX, XX, March XXXX, I million expense million the LUPKYNIS, were primarily $X.X organization third-party a some for other development compensation XXXX, March were for back compared XXXX and for is expenses March preparation hand The March and to a ended eye were trial ended primarily which ended and NDA quarter loss and respectively. the million. in and costs, $X.X approval including

our us to thank days, today. and hear feeling Joe Otsuka we I but the In good it's the for to are launch LUPKYNIS And about and right we executing you Max. taking who projections. directly Thanks track close, on want from all time Okay. internal want and with early the plan with you are

the as As a going we be we the the open of states, and progression. about going are to half up especially back review, excited lot seeing here of there's in year things greater activity in on

updates, So to quarters might up additional any the But we look to open questions the up. have. like for to we come you updates forward to now, to that providing months and would it come more in even

So to the let me lines now opening up turn question. it for for over operator

Instructions]. [Operator

is question Young. coming first from Your Alethia

Your live. line is

good. couple taking early, numbers. guys. my Thanks titration? the titration have are give spoken on A you real know get on things. what your can the to seeing know of it's you One, world doctors for congrats looks start we but Hi around question I [indiscernible] kind I and us of new It pretty regimen. perspective in

sales about that? Gazyva, I Can the question. of is give update getting you to in another are actually, formularies force is like the on up you think just, educating that about us some against Medicaid broadening And it just is the conversations? detailing your then hearing in if and out if how or I applicable how this what Thanks. that, things different access? indeed wondered And sorry, come you thing then Benlysta an or one So last happens just am

EGFR track. I and number to this have know information in that has that for first side there the on protocol out we guess that Max start out commentary office, on titration, to answer, third I government then and the with Alethia, ask office maybe the don't Why third a weeks from pay access place. and been on build this of equation. give question maybe experience limited with our those is I only it's The direct the the and few simple that is dosing don't there on to the it's us is

be launch. what calcs per to out net value is our think the the terms of we of year patient per in seemed of in early So weeks playing net

hearing what would the understand be would and Max they level. So very is might primary appropriate have And primary just theirs. on in conversation, patients. one, patient our thing, the our physicians that you Benlysta might And or there, Colao ask feel be then not to track versus the And our of the it's I available therapy identify them understands these assumptions that they think. then for other build a I field what is why comfortable lower getting Alethia. ensuring on LUPKYNIS in at with product and that The my be to, what comes this can urgency challenging are may data that on he first, committed answer team to proteinuria up differentiating to not from sense therapies

education factor physicians big the trying a to there's in So way change have treated. historically

use use a I think often do decision, or I I hey, I making that's So coming when am do then, treatment Benlysta up LUPKYNIS. more

Max? he me can a let and equation. more and it side the the that payer into turn So little if public of to dig question Max see maybe

focus on. Yes. the thanks, creating Thanks starting really Alethia. urgency Yes, Peter's in spot and in the bringing patient what terms that Peter. And Really, of our treatment. is,

large are with definitely proteinuria that of are a high of controlled. not We number just seeing that there's levels patients

through working the that really it's so And of LUPKYNIS. value urgency proposition and explaining creating

Medicaid, so it's so a And question. great

of coverage. lives XX% Medicaid as have So now confirmed X, April of have that we

place. are out is mandated So Medicaid and coverage in now the months we

now coverage. confirm And lives of so XX% having we

again. Congrats thanks. Well,

more Any questions? Alethia. Thanks

hop will in back I No. queue.

Okay. you. question? Thank next Operator,

Certainly.

coming from Your Ken Cacciatore. next question is

Your line live. is

know Thanks Hi. evening. reviewed you Good a guys. different lot metrics. of I

just am going I here to us ask to couple So a out. help

out forms? you is building? bolus? how actual get wondering and you you landscape, that current up survey enrollment just pace that of as moment, a could suggest, of we almost of of know hear of a debate views that. forms number you out? your constant good real-time? take are talk as think steady would us you patient sense seeing Or I just getting then the your those conversion many LN little with amongst to clinicians to accessible? a would Are enrollment able the frame you working have to us patients engaged love you real-time to can kind of I wondering, And how it's really accelerating about Just size? of were a get also, you the that a the investors So through patient I are of interactions, of we bit there and a now are

can about achievable. So kind street any previous consensus interaction? you thinking are kind also, how then about you to should the around talk all of what commentary commentary frame but this hate learnings seeing Peter, from question, you is and Thanks about been in the we you And that? ask Can there's just so early of be your number consensus much.

into we Okay. quarter were the me Thanks Ken. sort gave that Well, locked quarter. numbers a first, the let just the go all for into

that, both Max stay per into want on time on forms day with form week patient very decrease What with tell into our about I drug. of Aurinia to per work to turning decreased, patient start from steadily a subsequent from part physicians more decrease takes are policies actual a and it online, online, time start our expectations come patient the to a as our you patient I initial a we both go And to start patient to are said, as increase for forms patient to seeing meaning patients starts Alliance can to to start a QX. the as try consistent a him and/or pace, form with continued start have increased come our in what that. So and drug

good feel about numbers. we the So

in period numbers through are time this Although what at trends good are that feel we didn't we quote exactly the quarter, the we seeing. the

start in I ongoing leave patients is, trial. that X did in patient through it did our see an first will bolus AURORA AURORA, forms? One you So Recall mention original thing have Phase of we the of that. extension at a we kind quarter two-year our

drug. commercial of that didn't XX of or XX and group to have trial we came So patients that on out a went

no keep patients So approval not were compliance in didn't there right standpoint. since we for and bolus the was identifying our newly a therapy there were to we trained, from have reps zone out reps there. specifically And our

generated launch. So first has of about, quarter been actually, the grassroots see effort what first, months just you in under two the just of the

question You asked a patient size. about

answer be our consistent here. think is to going I

nephritis I somewhere play XX,XXX between believe with think XX% lupus U.S. we of patients those to are of that, we ability have the patients. XXX,XXX think an still about they we to in And active in

the access centers a environment seen put care will which the especially obvious. strong down, medical on pretty locked I Many on what are is Now, restrictions in of COVID right. caveat institutions, tertiary we at is centers had major certain

clinics centers they according of patient with follow-up XX% are the Max are or patients diagnostic visits for very World to sizable by lupus or in Lupus lupus happening patients data the virtual. shared, many for and visits And patients and So not down a survey patient done those as Foundation. happening general are almost

of real level the numbers. environment. kind of But tell because ground in very we on it's So those COVID stay are of learning hard confident data in the terms the what we to still higher world

is. zone lastly, to make of follow-on And questions, more quarter. up around will first as the to sure business, reiterate learn has things centered changed that the we last we not markets. is. that some in relay with our then just I and consensus Ken? in are your that Any hardcharging comfortable consensus feel question we the where will we of was where And As information more, open And

the whole I Peter. it. And appreciate Thanks team. thanks No. to

Operator, to we you. queue? in Thank the another question can go

Certainly.

Your question from is next Schwartz. coming Joseph

live is line Your

at adoption hear common you wondering the ground about encouraging Is with Who patients most practices far? to could some they places? little some that smaller was which adoption you met for For leading point, practices are importance are who all you for of heard it it for is so a on Is the insights evolve And seeing have that or by of the larger mostly I level? And I Thanks about bit forms? It's And have patterns Great. at start patterns you physicians if community indicators, you the academic the the early submitted case? and to practices expect been versus the just the launch. say at expand or greater adopters? of example, for have practices this given virtual? passing good also helpful what the how in-person the appreciation proteinuria voclosporin? reaching do

let me of trends. to from Max Joe. Thanks you physician of And in are Colao turn seeing what more he that color XX little a the or so Max? right bit days terms doctor first can and we and give

Absolutely. Thanks. Sure.

our splits of So middle between down rheumatologists is so each Most in on at it's side. the XX% really them, yes, of nephrologists, community. prescribing prescribers, kind the and it of XX% the point this

issue is are know, community. The patients, right. have the that, you will physicians of the of handful a patients only Now, most there the in the in community

academic They centers. reach this you many are all community about the physicians areas we drive to are lupus within are time most in about talked have there the the So have In adoption. we to difficult where They States. lupus the gaining before, in access. United the definitely centers, centers XX

lupus the centers are virtual. still of Some actually

virtual lead till downstate. in have starting to But centers are start adoption Hawkins, have UCSF, including gotten to SUNY centers. to year-end. some we plan be them And we XX% that the of lupus way, leading of Some lupus

challenging So the progress, though we of access to pleased are we issues. see because are making even that it's more

I that. Yes. can appreciate Right.

one make in will which terms I is of patients. point And more

treatment So V III, on the across are patients Class that all going are of primarily. IV,

is the that you any way? where to going That's are patients actually. and to their the advanced? common are are, that choosing Is that really patients? Is physicians finding these I are worst physicians no refractory in patterns? next of there How was cases? the reaching Okay. And cases in set any they come most out were it Are patients that next set

Yes. treated treated would the largest be that that are reflects likely basically have at are they been the I what their we say achieving see opportunity launch patients not and proteinuria patient are which to targets. it but

are right. would was up other thing would productivity. I we point, only higher more. already and an evolve regional access we thing Joe, add. And important it's add geographies the I is higher, much said things one that That's are Like to a trend in as open going I the is seeing And some think we some seeing that differences, where Yes. think

again. helpful. Very Thanks

Thanks Joe. Operator, do another we question? have

Certainly.

question next Your is Maury coming Raycroft. from

Your line is live.

questions. and progress for the my thanks on congrats Everyone,

some to clarify? meeting? just at the then EULAR EULAR? wanted possible is data one to else So be in see checking see And if we it's First at to just should AURORA-X I of or the what expecting

our, are think commentary want EULAR. if don't the AURORA-X-year be to what year the don't if I we this the AURORA you But I on Neil's deadlines around any Yes. to know might on I have for give or any Neil, know extension? phone. the seen AURORA-X of submitted

blinded interim the AURORA-X the regulatory in there Obviously, being a continues for submissions. cuts made Yes. But fashion. that are are

[indiscernible] be EULAR was released presented of or and will FDA you also data to there the made of submit there. [indiscernible] towards yet. there the ASN that a in year, half more going has MAA obviously to made in and the but kind is the some even Europe is was see for back data cut there June. And there which June. not some and We presentation and of been intention for our end don't that's is cut the But a have submission time the its So the of date obviously And AURORA-X ACR at aggregate exact that. of

it. Got

you color Or any additional that there? tested extension market Okay. on of future some of the at saw can That's with the market there's if data, on KOLs? provide their your helpful. for surveys results And use wondering and you And in if LUPKYNIS? that research AURORA-X if just research you impact any the

start a I than might is guy mean should utilize drug mean, greater it, I right. XX%, closest obviously, who to Max intend whatever I But the miss the nephrologists right. build will here. both to and Max Like it, and Colao, listen, I said on rheumatologists Yes. by is

Max, intuitive strengthen it's product of we it's anything period it's irregardless they assume use only asking the to that of think to that position. mean safety can extension to amount but docs the showing So conviction but to study if I only I And specifically study. have it's is I drug have AURORA-X research that strengthen that around time after safe encouraging. the our I and the be going about we continues that's done any going wonder, think data, with that product. specific, the primarily Do Max? a time

more in and Not specific we for we treatment. will be impact kind messages. what efficacy research from efficacy treatment, and especially recall important data. the that to the long to term And to messages the both believe we physicians there's looking that specific long Definitely, see consequences are safety AURORA-X. AURORA-X have what do strong the illustrate is of helping that in high the term the are market resonating But of

forward looking we are that. So to

Got it.

my for questions. Thanks taking Okay.

Thanks Maury. Operator, question? any another

. Absolutely.

next question Kim. Justin is coming Your from

live. line is Your

Hi. for Good question. afternoon. Thanks taking the

the the be or it a Just what impacted ideal on recent before the just pandemic one comfort by for Maybe how able et me. target And a say to might script, characterize team months? a that average over engagement enough many to another how been maybe goal improved writing depth physician cetera? Is for has has way. a engagement of prescriber/ interactions in

Yes.

want that a And maybe that don't if I think you little I into some Max, we know of data. go of detail. to actually have

this. like identify And XX X.X see alluded access we average that to where of In the above. to X, more highest it's prescribing, spot physicians, base. highest frequency the we But takes in Aurinia have into your comfortable to about can engagements On are is average the patient Yes. prescriber and physician the think areas, seeing levels the open the nation, a to where on. I areas of Alliance. had multiple get actually with It the get all Sure. across about, across South get we engagements I And the with we prescribing. and goes really is where question in that's into

maybe it. reach Got might engaged? of as a sort doubling another to that the take? time And in does that estimate long how Is How just a physicians long of there expect terms follow-up. of one team the

talking is our Yes. But going docs. there to evolve. think Listen, of live reps we getting have projections internal the to I engagements out and

as up definitely our So of to We number to physicians force. I that that? am see you X don't hold not number metric we do of a more have in want answer a sure quantifiable a Max. We We have. sales times. to X you

open up. what No. differences around of we spot access, we again, the is the increases things targets. But regional that are haven't on. frequency Because That's seeing set specific as

on so congrats the much. progress. And Understood. Thank

Operator, have Justin. Thanks we do caller? another

Yes.

Ed coming from Arce. Your is question next

live. is line Your

Thanks of for on taking Hi and questions everyone. early the launch. my congrats progress

you launch on the which tier into and just as First the access is patient obvious get question is first just reimbursement.

placed are the wondering and if odd the conversions. million those payers? you start plans. Again, days. XX to payer lastly, again. of You there it's Just just by disclose sort any and especially published mentioned, of lives specific were payers have are early IVER label restrictions already you point am policies, pathway the mentioned recommendation? LUPKYNIS got declinations any interest, favorable free I And have sort of XXX and have of broad number any if if are restrictions XX far? very coverage was at along given any this curious, actually that with wondering, Thanks specific coverage covered first, And of then any you then so there of forms those I those? been there

to may payer Max, will half are closest. give that question you the on and through color, other on you mute. just that you be of ran I Max, the but I

Yes. Thanks for that.

thanks the for So question.

XX see, and And Crosses Anthem, they so the HealthNow. a number Cigna, Blue payers, Aetna, the include, let's Highmark, of

coverage the published allying the specific like I policies. labeled those ones And indication. are of to that said, all are So LUPKYNIS them have

the step-through then is is And the are studied. by with primary all those requirement them I step-through would do, have lives policies, of LUPKYNIS out don't of covered the of any steroids. XX MMF that them requirements. through All say, And consistent ones XX% and how

coverage So the policies. are those

it's even payer specific have had there Of the unclear policy, LUPKYNIS That's course a we because just common though isn't what denials. then criteria is. if

from be denials, course. the through working launches. And terms have would have the we for appeal out so in a prescriptions. of that what other an than nothing and seen disease that's typical any rare and you different set go denial, par in That's do just this launch, But in what really appeals rare process a through there's we stands on of process, seen disease is you do that

Great. it. Thanks Max. I appreciate

have Operator, question? do we another

you. Thank

is Martin. from question coming David next Your

live. line Your is

taking for Thanks my Yes. questions.

first the to you asked. question were that The one relates last

payers XX you the that So represent? they percent named, million do XXX of the lives what

Yes.

would that on would of it's a rough one, So exactly say, I be very quantify XX%. that. to hard kind estimate

lives, there for a reimbursement request those if And what place, how coverage situations? the isn't those specific is in And handled? reimbursement XX other million the amongst plan in are

Yes.

the want And form a So process. a prior it's has just physician non-formulary every use authorization where type rationale the to articulates the of generic therapy. typically of request simply, payer why they name

And a the policy so in place. if isn't coverage process there that's

Okay.

Another as any start patients they LUPKYNIS failed many most and are they question, are coming steroids? to after Or coming on MMF only of those? patients or on them

Yes.

bulk on and and the all LUPKYNIS the we that when are of that have We started are are treatments patients on just treatments the been Aurinia their diagnosed patients I exactly goal. the that can don't So we don't visibility tell LUPKYNIS visibility But anecdotally newly on have treatments. are even have of not of other proteinuria getting you coming a just to Alliance. patients they on hearing to that ones are though through

push is market? safety question. are because older prescribing are long waiting Like nephrotoxicity? back cheaper not any get Are inhibitors any because do data? you for the inhibitors that some back? doctors it a there history Okay. And of that have And the calcineurin they term being calcineurin data term push Has any on last long there mentioned there ones have, until

me start let Well, there.

is not context doesn't, not of studied drug, matter these generation will I that Max, our got the and us but one doesn't want education state hesitancy focus understand the you around I two-year I so say terms do. physicians treating can that intensity out the I areas not we the for education. a know lot on that patients. first those even have seen but We question. we just data impact a this because how is say put on right we the from I in to But what hear of I problem data, to around do on CNI, do that Max? I until hear being that some in is a We we, data. yes, primarily wouldn't I a it put going calcineurin do and build to and I physicians really that for am I been clear nephrotoxicity aggressively Have that that's the the That's population product, to CNI. has we that, to to know representative not data well, make not that it the hear get think see consider it's our consider there, of know and sure accrue efforts utilize inhibitor of utilize like don't we don't completely hear the to off, also disease transplant Well, there. not of say, the higher really and is out First awareness drug. question, of community. just doses. product patients that the full wait to just And And am impact, don't and the we just we better think obviously and I I

right. that when trials, physicians seeing consistent with more in very very I a data, have are other subset very in just think you we seen consistent is they therapy that's you more just been with consistent want that's launch characterize And cautious safety studied what data, of what are have and launches. clinical would a I we to see new

Thank Great. Okay. you.

anyone Operator, David. Thanks in the left queue? else

There the in this queue time. are no at further questions

out look the time care. we your my after progress in that to over as come. will us closing to we even Coast. wanted I Well, everybody business everyone and that Beautiful. want laying Thank thank you Okay. to quarter months said to And love for I comments, to significant the quarters listen, promise continue here, make for I joining in forward thank, as Take East on hours tonight.

event. and this Thank today's gentlemen, does you. conclude Ladies

for at You day. lines have participation. and Thank may time your you disconnect your this wonderful a