Aurinia Pharmaceuticals (AUPH) 10 Nov 202020 Q3 Earnings call transcript

Greetings, and welcome to the Aurinia Pharmaceuticals Third Quarter 2020 results.

[Operator Instructions]

Please note that this conference is being recorded. I will now turn the conference over to our host, Dr. Glenn Schulman, Head of IR. you. Thank

begin. may You

good Conference Welcome Call. and Quarter Aurinia's XXXX Results afternoon, Diego, to everyone. Third Thanks,

CEO; Chief website Joining the Chief Medical Mr. and Officer Aurinia on Financial team Max me the Neil Aurinia. are Peter call Officer; and here Greenleaf, Solomons, Joe at Officer; Mr. release Commercial financial at package today detailing available quarter XXXX Dr. results, from Mr. afternoon, Miller, Colao, a of with Chief statement on President This And Form we the the well. www.auriniapharma.com. financial our issued filed on SEC and associated our are both press which X-K third as

Investor Before call the remind jumping today's webcast completion approximately call be from the some Aurinia's a remarks being available after everyone website, of replay team, Relations I'd will X and the that of brief like hours is meeting. to on today's into live

today's It or the prior also content is from Aurinia. property note reproduced recorded, call be Aurinia. of of transcribed consent not obtained the that written Please without may

please ir@auriniapharma.com. For at me, Schulman to Glenn to out reach e-mail free via feel approval,

During current the and statements actual These may this course subject make significant are expectations. of a differ to number forward-looking uncertainties based upon and we forward-looking risks may statements of our materially. our results call,

affect reports and X-K Exchange commission. discussion release, authorities and our press file today's future For filings please factors financial Canadian the the we could securities with a in disclosure refer Securities on our most that of results to U.S. and business, that with Form recent

date. current no update Tuesday, by Except XX, available as all law, upon to required this the statements us. today, as any XXXX, Also, we information during November based made call that assume of statements to please are currently today's such obligation note and as are of

said host which afternoon, from as team, Q&A brief So remarks a some we'll we'll the have this session. I after

CEO. Aurinia's Peter all that, call over Mr. to and the with President So turn Peter? Greenleaf, let me

call. thank to the you us on want to join I afternoon And Glenn. this time update taking all thanks, Well, for quarter third our

here ago, the So about team all be of the years Aurinia with how across has more aspects executed since reins the X.X Aurinia taking company. couldn't at I impressed

While aren't call our continually here update by quarter realize, I treatment to across things as squarely with the well know before, results into provide the all on of XXXX. move a dedication its upcoming potentially a third where impressed focus professionalism, the to To we out AUDREY first set the we are I'm approved heading financial as we to be as PDUFA and and are on you always our we for team a voclosporin we ago, just And as results. it results broader a nephritis. had what of discuss our globe. week today was a clear, focused date are review lupus as said we've

definitely But today, of the fortunate launch succeed. well nephritis. third following execute, resources And execute to the people, of as activities reported and year of been well Strong our all suffering the of and goals to need meet people has cash, ended we necessary been to great pieces to in combined those million achieve are organization potential with to voclosporin the quarter with lupus is strategy -- as what solid goals we plans broader despite we As on resources, our our place. today, of to needs a as as are the we the support people of an have its approval. approximately evolve for all equivalents $XXX and challenges, funded secure interesting the for our voclosporin to for XXXX us. fully cash investments

given and our we Over Drug PDUFA a the date Food accepted action was XX, review U.S. for and XXXX. voclosporin announced by January of priority filing NDA summer, Administration, the granted

the this with in be the an with our confirmation heading to review the at as conversations appears completed action track. review the agency period, streams The agency. At prior as All meeting and this we've are and on And the PDUFA we've and review point, we mid-cycle awaiting advisory point to committee the process up collegial date. lined expecting ongoing are work on meeting. have cycle not are During to review stated had into late date expected January. have previously, we

an U.S., This the is timeline strategy global previous during expectation sync for the regulatory file ex quarter and is guidance our in interactions beyond development the to dovetails with we advance U.S. with partnering MAA conversations. and In and our of our Looking ongoing continue Europe, our for our voclosporin. voclosporin second continue to with year. EMA next

As timelines also our on we look plan to our and next interactions additional Japan head advance for updates into PMDA we providing to year. forward and details XXXX, early

profile the ]. its older In relative lupus strongly a new therapies are the work to in as to been process, other continue [ characteristics and CNIs Voclosporin of addition currently development to for chemical regulatory given generation positioned, nephritis. to that always voclosporin differentiate has we entity

investigator-initiated AURA-LV look course, build trials robust combined just for on The antiviral the and potential the impact through being upon the glucose efficacy, we at and differentiating Netherlands. continue that. COVID-XX for drug's and overall communicated of in profile lack recently study in activity, rapidity to aspects including observed Of an a both and with evaluated that AURORA Leiden, even vitro, tolerability safety observed the of trial to the clinical in activity lipids was

differentiated applicability of belief patients. and supports our All this molecule in this its for

in rapidity the and rapidly the markets FDA world. the launching to drug should approval, the the we course, around of this for U.S. -- look forward us give And

to it Dr. intro, on Neil close back that, there, So quarter results for With our I'll detail to pipeline Max commercial additional with ongoing readiness. some turn a turn insight mic to after up provide will I'll From over update our then will over Colao the on brief our that Joe which Q&A. for me activities, and into let come third

Neil? Solomons.

Peter, and good everyone. afternoon, Thanks,

Just from working continuing voclosporin voclosporin overall for other from been My their broad and enhance the brief and the clinical update a regulatory differentiate on lupus nephritis. set with goal has awareness data generated to therapies steadfast team the world. working of of to

the the presentations of Over XXXX American X weekend, poster in voclosporin during annual oncology past was meeting. rheumatology detailed

trials for efficacy achieve long-term lupus first who people Further, particularly health. The announced was ]. time presentation nephritis significantly achieved study, that faster the no which showed from proteinuria. racing detailed pooled LN, against the previously or kidney on in to had AURA-LV acid [ safety moiety drug-drug voclosporin of the and AURORA is important that mycophenolic with reported active interaction MMA in it impact and This data voclosporin improvements are the MPA,

As we . say [indiscernible] at Aurinia, time is

we towards mentioned, cycle agency. the with completed NDA the review we the front, with have review On recently and you voclosporin regulatory the the FDA and late of interruptions as head the mid-cycle continue Peter our

All our on track the that PDUFA said, timelines XXXX, January are XX, for date.

Looking beyond EMA the to discussions the and co-rapporter occur rapporter commenced U.S., reviewed early the with with due have interactions with next we scientific year.

track in With these on file of X quarter activities, we are the MAA XXXX. to

sincerest program, research. participated on the moment last take to week. again, thanks the wanted clinical who our just to eye in investigators dry AUDREY on to and we results all patients which the I another reported comment Once Lastly,

commercial and does like Although VOS the announced additional team Aurinia With Max? overview, studies. last for But to the overview of it pass an voclosporin's brief the dissecting program readiness. disappointing, to plan results week, suspended along that understanding conduct on results. I'd clinical we continues and not as are remains to work any Max fully to

we've Thanks, made Neil, professionals this opportunity and the this to company. good to additional afternoon, prepare the everyone. the over quarter health last and some provide presents patients, realize ourselves full to on I appreciate progress for the opportunity detail care potential

currently me LN. see nephritis why the of current no and health of of so significant. SLE. this typically outcomes. complications long-term So in the highlight There most let we FDA-approved treatments for first, results suboptimal standard as life-threatening is And care one serious opportunity Lupus are

of women treatment, women are For childbearing current care these of color in of age. the people standard to XX% example, of particularly, patients on typically and XX%

lead to complete still X signs therapy year. achieve these a can to Furthermore, active kidney failed of They that to in show kidney disease response patients failure.

promise, voclosporin treatment races of compared Patients care in response ethnic lupus great alone. rates consistent achieved and for nephritis. standard standard the fast including studies, were superior results different patient statistically when our with to a and care However, voclosporin, combination shown of across AURA pivotal potential in Aurora with arena subgroups, backgrounds. treated has the as and These

I no as now it across exceptional some rare say their fair with early highlighting therapy as group have have on a assembled the a these lupus As our an and potential, immodest, a focus desire opportunity ourselves well. on let This have is to Aurinia. for launch. to I in preparedness come LN. only but of unique provide a such effective me health commercial and in improving on pioneering for long-term disease feel as having see patients point, dedicated obligation to people insight also nephritis, a world-class, not outcomes we but diagnosis importance team that developing at To we company do

And undertaken As lupus payers opinion the a and most some collaboration in recognized we activities initiatives have have this widely with importantly, key already with focus, undertaken published clinicians. been leaders. and result of of these

education at lives. to We've many as programs, have that as virtually. our physicians been we encouraged regional XXX Already, covering each have million reached in payers and of been attendance national highly XXX see

of initiatives, the As to reach end treating we than MDs year. majority of more the LN payers by a overwhelming X,XXX the result expect lupus of these and and

our undermined the the technology that fullest current We pandemic. progress are or to leveraging isn't so delayed by

successful that in voclosporin access, critical The widely for is to community. quickly entire for promotion, services. all aligned that and a be team adopted areas by commercial fact, LN the launch education, are In to patient aims commercialization,

the We and approval granted if when ready patients are by agency. hands the its launch quickly is voclosporin of into now get and to

commercial testament a colleagues, times. team talent experience, my during to of and stressful particularly this quite the That's commitment

with commitment, and results. forward to with you recap sincere I'll approval final to of Joe providing you for over financial to now to the the LN. a it look portion them the I of contribution more hand, would launch to After with pass thank voclosporin. our I in to a with inspiring making Joe? conclude for of So of label all of like tremendous specifics a on deeply the patients health call my their all

Thanks, Max.

front, the million for ended and third financial XXXX. cash $XXX Net to XX, quarter cash the million third XXXX the quarter activities with $XX.X the December was XXXX. XX, $XXX at investments million $XX.X to compared million XX, operating Aurinia of for of September September compared third XXXX, cash, ended equivalents in ended quarter On used

third XXXX. the in September a million for $XX.X a XXXX, XX, we decrease press September of million detailed The to derivative quarter we noncash or same per of quarter fair $X.X the loss September for in quarter of million million XXXX, today's XX, the ended a release, ended warrant XX, $X.XX liabilities to liabilities compared noncash period net reflected the loss third the $X.XX decrease share XXXX. derivative estimated reported consolidated compared for loss As of common common of per ended as third $XX net or consolidated fair of for estimated warrant value the value in $X.X and share a

to and the XX, same XXXX. September expenses for is due quarter decrease of XXXX. decrease the million fair exploratory the work, $XX.X in the liabilities XXXX, in liabilities warrant expire The change ultimately XX, company. $XX.X cash R&D development $XX.X and on million million internal ended the the warrants any the XXXX, of of was decreased December estimated trials to third activities third taxes XX, million on period in XXXX. previously of costs. the exercise related forfeiture before inventory in to warrants derivative for compared the will income result by period and and the in a to not be of compared will for quarter derivative outlay outstanding expensed warrant capitalization The for or The value same capitalization loss to The eliminated $X.X clinical September development

to following capitalization charged compensation Noncash of assured R&D NDA the X compared increase was NDA same reasonably the XXXX, FDA the inventory XX, an and the by our the from appropriate September ended new value the employees expense development $XXX,XXX year. in reflected options The higher quarter stock third FDA the of the of for the of Management approval the third option stock voclosporin assured. quarter In is fair this price. in approval option hiring the for treatment grants by period XXXX. an of when accordance XX, in and increase for acceptance months increase to expense September XXXX, granted increased of in as with to IFRS, costs internal stock resulting compensation share due stock believes of is a for $XXX,XXX reasonably ended to LN in that the

LN, organization, business development subject $XX.X million XXXX, $X.X team. million commercial the in support across launch to for approval of to commercial and Since investment compared of to administration AURORA the we quickly our treatment to the release of reflects same of the a FDA results expenses Corporate to trial administrative moved our capabilities period the of XXXX voclosporin being and for have the commercial to XXXX. our positive develop regulatory granted. expansion and The in third increase our including increased December for of quarter organizations out as the build administrative the incurred

and compensation September compared XXXX. our stock and stock XX, for for reflected X third options quarter XXX option Peter? With $X.X compensation XX, to period some of in ] development in new million million Peter employees option due to value charged business administration for to Noncash higher stock price. the back in approximately XXXX, the from in review, expense it resulting XXXX, the ended September increased an pass granted the The corporate ended increase to fair remarks. an to the grants months the for same that of increase $X.X hiring expense I'll closing [ increase share

and of approximately million equivalents $XXX sheet September, Thanks, and voclosporin. end the of we're support and to cash with cash a funded amply at the launch strong investments of Joe. balance And

before, what we is that execute, pieces to those said I voclosporin and in potential are As strong to strong of resources, and strategy people a I with need place. great exactly combined all succeed, the believe

can you a that, up session. with Q&A operator, open So to please

you, Thank everyone.

[Operator Instructions]

Cacciatore Cowen Ken & Our first from Company. question with comes

around wondering been a on the wondering in there's little Yes, could more then I was manufacturing, just if comment on on an commercialization. inspection and And detail you interaction the review if the site?

point learnings right from share any of take kind us trying what that, or what you emulate? really launches, the orphan you you're examples quality of you Just to done what say to can any of could from are and would specialty good they've

and with the inspections inspections, recent that our I everything around whether right I'll one tell be. really obviously, reviewer let our And of the Aurinia-specific upon say are And doesn't there to and they're that. that I first doing him seems for be know there on to Ken, those preparation to Max ongoing, time. can I'll then the front, us take the them give commercialization the as build on inspections. take manufacturing one or a that we we you we can't necessarily FDA second. want But little can on -- partners hopefully note target. when with we interaction our facilities But world our be notice notify are target us they most preparedness where the

world's encapsulation through Lonza here partner United one API in manufacturing, As on in of API the and to one the with then largest we've the of then matter. our and that And country the manufacturers. Catalent largest for with of previously, world packaging, on the States said our again, we

times many we reviewed get fact for really and facilities the that So these a reviewed many, often very different feel drugs in confident year.

success Max, of target, on to you what here? drug point So preparedness to, an everything in be the like seems and/or anything analog to and would is looks on our a front, there. commercialization say, terms

have we've analogs not question. also analogs Sure. analog worked, specialty at Yes, -- the just but at looking that also looked what's been underperforming. in COVID-XX. for learning And at actively in for launched the competitors. We've looking space, Sure. we've Thanks for looking

], And ONPATTRO, PADCEV; so products Enlibre [ [ at ], Ocaliva, COVID-XX, specialty, [ that Civista we NUCALA. looked Fencerra Reald ]; on specifically [ LN Neurotech, underperforming, competitors, NUPLAZID, ],

some learnings support. say Prioritized at. those access key and and are the investments. we So have the been targeted all I looked analogs kind the of early would patient of

we -- investment from prelaunch saw engagement, the The saw commercial pre-approval. underperforming, the we -- payer little ineffective the

is say learned taken so we've so we that pivoted launch yes, learnings these all into done. COVID-XXs, the accelerated the virtual DTC that they pivoted And plan. of our that's incorporated we've engagement. and digital to Some to yes, that company would rapidly and And what I

have successful Max. know thing into thanks, we the obviously, and And only But good right the beat the we The an drugs of people. to TEPEZZA metrics is if that have a we to they've is have Horizon Ken. Thanks, -- and about over market And measurement you launching if to is, have think would the I is as thing, know obviously, add I job one recent expectation. a marking just thing exceptional go solid we launch, at launch expectations. product. the -- launch the that strategy -- one done we beat have look we And and at

So drug we're at thing measure what it patients, only the expectations also against are we done and and of and to above. those And who docs to the in metric for we're that ourselves not sure the patients making right market of the going really trying look getting and all but be. hands

Our Young Fitzgerald. comes Alethia Cantor next with question from

with lupus cetera. the reason frequently, you they COVID. is been ask -- going be of feels one, in talk because though. just COVID-XX. can field progress. it couple you in of doing to Congrats et guess I responding dealing et patients are when But kind probably know nephritis are just just most how like may you them But I A Are is doc we're high on the guys about have the checks. I level, the just less community to still launching like cetera, one

like a in it color had much like better know kind a that the look be hey, wanted give up patterns -- just on think just well, if having give a like And strategy? is companies people. get helpful assets graph as from those I to some pharmas can bigger it you there's ask, contracting what I be EU currently. company is question could you comfort, to yours but may everything I just by space. see of If like Or payers? I here, try other lot high-level won't next question How would give some So Is well. the people a all you to these And then this people or that compete?

Why I market second one with don't me and to Neil ask and come and Alethia, maybe -- be the field Max I'll thanks, gleaning some from let then start we with research? may what about ground talking et medical have out now. physicians troops team from we're patient affairs the on ] What there to Obviously, visits, day. field that's every we hearing physicians cetera? [ first, A

and/or have So same some large at very with color that's you small been no large near-term we by a large company. of amount successful launched environments hopefully, be companies. deep can tell to and the drugs -- trained of able of company you our resources the pockets. of company we But in dollar I from there. a an competitor that us give And can is come problem to have size Obviously, a directional than a opportunity -- throw most both and pharmaceutical that have and going

field of want drug most aren't what talent And people we those they've go do to experienced last, drive. who that good echoed one that and how lot learnings and want is what patients that And and and people obviously, the they successful the our strategy. that impacts both having brought a company. in and mean, And important into they passionate motivated do having It's those. way deep a having know and we've solid in that of has that strategy the right to years. it's is profile what pockets. the team and of launches from to do a along over an with in doing. people It's the experience I very efficacy to tools what they drug need the a know that the talented a and characteristics about the And just they're built provides they order

And the passionately believe I because great drug. going people are strategy the of that's make this think quotient that's to our difference alongside that in here we probably

support do we think we So we've this and profile this know of we what got drug. market premarket, drug can we early and can we compete to think with the the research

is know going we So very have I'd world launch. and in I confident And to of we ensuring the say the the be thing most raising money you have one about prospects significant a resources. that not our here. capital feel always it's the into while popular right level investment second

is drug. to runway. I will think as to to always ever up end not low And coming have the a decision under short companies falling underinvestment where extend And with that company many launch they is made in a whether invest. expectation the

Sometimes, a of not lack it's just now. decision capital, made having have do of we which of a

those can we make So investment right decisions.

near-term potentially future, So But feel have make We about could dent. couple the years where one got we really change. only prospects our in LN. directly In can we strong a commercial competitor a confident that approved of here. we've very

seeing maybe if to that's and on The through second maybe visits, add Why out the patients Neil team anything Dr. medical that. cetera. to Neil? Max there be see in our start don't with about first question might has ops are then et what the I field responding, side how

limited certainly, to of of where the test, U.S. have April, nephritis the follow-up getting study. patients blood or urinalysis, patients they're being And in obviously, visits And experience threatening U.S. Yes. and the were of different delayed, the they're some Thanks, seen their getting they're lupus hospital. they're a getting disease. AURORA tests. we been the from of our their a months often clinical all back have their probably And parts find these of visits Peter. in on what in March we found mean, sites is side from is I a couple number we X aside our so But number

and problems the on more monitors trial no a access sites. clinical medical certainly, the There's been although the But well, our to they're add with hand I of relatively it's experience I setting I've contact level lupus normal. in of up said. been a Also think very, to maintain over as bit has and really probably side to So the of a challenging, color very Max very of bunch, if to they've to managed clinical build resourceful the high prescribers. best trial what affairs Max?

clearly for there we've Yes. -- question. about a baseline been this been following prior has closely, our XX% general in And thanks the And patient were of in both the field intelligence. yes, COVID, of the market to patient this specialty And been terms decline ago. also of about of kind a through has just visits visits. and But though, trends month there resurgence

it is happening, encouraged by what follow-up rheumatologists opportunity is lupus though visits in -- back, and and of we're nephrologists about what hearing some -- it's terms the happening virtually of But than and LN virtual. visits seeing and terms been we've confident for of little from XX% their the the We So were is in that in what been them less the even consistent is coming patient the remain successful. past. and of The were maybe and that with a patients.

Joseph from comes Schwartz Leerink. SVB next with Our question

[indiscernible]. Or very seems just I at were certainly least of despite you AURORA more thinking rapid enrollment trial pace selective. the you criteria? fairly careful back fairly after patient It So were was to constrained enrollment

fairly give will about that whether think broader, or you is label, criteria how to the team And I -- it that obviously, to and relative sales And about you broader. in think, to how were magnitude, of of there? pace enrollment. trial about into wondering think the executing with current would the the team we launch some if launch. of insight the challenging. of us enrollment? selective in have the then about enrollment order I trial terms you're of environment help So the compare MSL it's then to executed that Can think pace going levers could And was if different should people lastly, us of think terms you AURORA How we are a

Yes.

Let the find an Neil think start then to necessarily patients to build that to I say ask upon trials in globally what thing and difficulty about environment a competitive to one the me I'll say. it's I opportunity might I compare where both of and -- you're market why environment, -- what enrolling would clinical be. talk don't trying maybe

Our trials, Phase and of the that of that III access we those believe have trial we -- look give nephritis our XX% when with II of percentage but a the did, at we label upwards upwards those to lupus active large both access patients Phase us very see of of comes north point. We'll criteria us patients. to obviously, out, the where gives open and

actively what prescription patients track you codes X ICD know the correlation we and to the that disease. asset we are suffering through and/or don't of terms uptake. what see can patients then we So from being in potentially direct see there, the out the difficulty reacts a are from how of what trials And who

answer think question that But not me separate fully. I X are the and let distinct. So

me build me. to that with ask on Neil also Let

Yes.

for question. So thanks, the I Joe, mean,

perhaps, one least You or quite true said build I'd thing like just that's on. at not to

of and studies talking comorbidities we were are the that perhaps similar. the kind between we actually the about difficult fast a lot may patients It a about was more hard and about certain were You X A drug that rules first -- learned The protocols very rather restrictions in learned those on put the countries. result more than outcome in of qualitative restrictions compared of the maybe in kind the lot protocol. we chart. to

inclusion/exclusion similar. entry criteria, at look actual you the If were very they very,

And drug. when as have forward. move we the of course, label the learned more launched, they even the about drugs of actually parlay we will And into course,

kind that ] clinic, very, patients lupus some bunch prescribed of which and say, that the encompass with that treatment would a say we actually, require nephritis very criteria, just ways, of would had count a in albeit [ the protocol. in I So in the doctor's most I in way broad of entry

join on of And part ask on Max? to key what the Max that us? question, the thoughts Colao here that. his second Maybe see are for your uptake, to and I can Joe, me early give I'll of anything add an can I drivers if

question. Sure. for the Thanks, Peter. Thanks Yes.

mentioned, that into is same access actual I infections COVID heading geographically. accessible. a increases the encouraged challenging physicians as And time, COVID At becomes So we're as time opportunity we're increasing. the -- patient still to are where the more we're

be the access was of to our So I terms and in that's continue we're encouraged market we've what the proposition. say heard from be -- we research, hear extent to value would uptake what a about to physicians. But heard -- what just going physicians that, very we've in determinant we again, of to our early

so my I be during therapies -- suppose are COVID other guidance would times. to that launching would And similar I

point, a on a drive add for would If a and that passionate and administration we I going had try understand #X of who when to mine. driver, Joe, of issue have go got drug, then out I we motivated at end of be got the force going sales go biggest thing we've last them other the And of they underfunded and a would we drug. to and conduit got online is day, the approval are data us that. physicians we aiding drug, out be is the the an to to and of think the is be still the that. but to that, the people the drive And there people the get highly group Access we've concern to want to label the motivated and to that Max's mean, to major going this, And have dosing still whether to be, and tactics. support I that, one, think tactics we to it.

for we've only the And that first said calls that's tenured highly out won't in and significant they most these in know and introducing team nephrology experience people a hired disease previous of purposely all people, a and we rheumatology in rare calling not on. tenured There highly sales highly access people, areas these with of time. themselves of force, but people be went if the tenured, that the if so they're and not need

there, too, a Sorry, you you let me ask had follow-on Joe, so let question that?

context. It's helpful really

flare? was How are the like Is to provide the it drug the early in does helping or at a So likely patients to centers which the to wondering patients if patients for first? just And often most want who outset? visualize, how that you need happen? so, adopters drug I be are

Yes.

course, standard upon ask think we to and to I care. have drug the the the allows what going But us I'll Max a care, label label of what then that very for, start for in dependent, to I the against anything the in target approval patients. miss. aspirational ask we catch of of set standard sort and to and freedom degrees we addition in But of studied this ran of provides directly us ask those it we we're

this to get drug. to studies patients nephritis -- active at access from XX% the to have done with up that and we've lupus So of ability, least

and response going standard we're So of an also patients of higher pool to try good might in to to create increase their be diagnosis that more challenge awareness going a education getting go to meds. good care. inadequate diagnosis, support and to We're the patient drive total current to and patients

trying for, see we to to the PDUFA can support in open broader So in dependent, I the field have Max, have label and date a that, access January. our hopeful even gain on pretty approval we missing I'm of to wide upon all we come what think we and course, that tactics anything we see there? ask

nail as the position to said, we Peter pivotal the of the standard compared standard on think X patients of trial. after types as outset. to will are from And voclosporin. ourselves the head. right that No, reset care our care you we go in see We ourselves with the I those And the hit of

question next with comes Maury from Raycroft Our Jefferies.

update. Congrats on the

conducted you when not And showing the needed, with drug-drug drug MMF. interaction the how analysis analysis So on monitoring then voclosporin. is

the data into these competitively? the And these and how to think So wondering data contextualize will if payers, patients? doctors label? you maybe findings can And about talk go important are just you

of different compare fact This drivers comment a find say to the area our label, in one itself not key this Listen, anybody on should incredibly here. the product Neil, directional to well. favorable. you us that. one is might a see that DDI in terms of obviously done wanted and your that and that? if one market we is sets give you The different I and study answer thoughts particulars can difference. up highly flat they is important around of -- but us they the Neil the dose this is, its compound can to physicians, thing profile. around the that are quite mechanism we've on And be main what why and study competitive research with competitively, one want and might The mechanism

drug-drug interaction won't the we there's that in with Yes. terms getting trial, have saying I of the have won't comment is label, think so what I we interaction MPA. mean, a

efficacy It an have drug-drug quite study was that. not, the This behaves done it similar differently course, going disprove It's with MPA, to AUC hence, than significantly patients. we're reduces to lupus not thesis a the was in and of voclosporin interaction of and that the Now formal interaction cyclosporine that. it cyclosporine. does to the other exposure with MMF. And have precisely

drug dosing. therapeutic for lack terms In the our monitoring or that, that again, of requirement of supports

Our intellectual and that to dosing that well. start around flat we And property there's GFR. dosing the adjust is we according of course, with as

not that the to drug many unique. in commercial of therapeutic terms do actually require the course, try differentiation, right trough And target, drugs been determined. which not There's has other to monitoring drugs class the get levels that's pretty that. of even to In

further from kind of competitive voclosporin. advantage So that's

on I'm points? And Can perspective it. payer points. of some guessing talk appreciate doctors about Got you definitely these these the

Yes.

payers potential quite other take very first to advise then far, and front data both that launch. a in I Maury, look get lead plans. payers, other to from indirectly. data, of this profile research Payers, of look their the about then are when what to for shows. of feel looks our advice some both then step-throughs at scenarios terms into data we've the obviously, And positive the research good think all everything and our so itself. to you're is and the medical like terms the to patients them, going I mean up that. a to within and with pointing market physicians degree, And And physicians speaks And going thought to take point we base pointed we've that that good directors in actually directly physicians done leader and things them, the has going done the are from data. payer profile in what put of

we Max very liaisons conversations, in an education we Now that strokes those science we approval, itself. got of very, there but those drug. FDA having to data go and his And out terms price the actual we are team have have comfortable through preliminary the our those on once and medical through conversations feel

much the with tell I we're I've on And tell didn't we be. of open you, have would past I drugs So think that as quite where in look you, right launched favorable. need to target I can things other window. an

about good it. really feel we So

next & Our from Justin Company. question Oppenheimer with comes Kim

candidates on considerations of foresee treatment? implemented And expect LN or have any you Just vaccines special voclosporin earlier the for whether had vaccine. conversations you COVID-XX being whether population you later on course with any potential curious, over KOLs

great That's any not have have it -- pulsed I we do That's question. a -- thanks, Justin. docs actually not have I because this. to a on an answer not

globally including would work may to any follow-on hearing LN that on. or as sites. Have can't children Neil, you comment. you probably be I nationally on do But be with I Neil, I know? this turn wouldn't heard more my any guidance that there answer anything? I have put an been the one or and drugs, I population, of I know that don't for out to other don't our drugs who might you through has specific So to

Not earlier disordered was conversation because are condition immune that these patients specifically. In their terms, kind immunological obviously of to a general because higher speak. and so their very it system, we had of risk

would higher to anything. these discussions? don't I other whether Max the be don't I they imagine I up know experience would you ladder. that, than So would any But have know

this on perspective any have not would No, those at point. discussions Neil. Yes,

Okay. Got it.

support you in time? clinical broadening of or interesting reaching potentially the status expansion? curious. types And how provided the how on [ CAGR discuss eGFR With [ at to over patients changing regards see Just may Dr. AURORA, treatment landscape just then And you what included experience in ] LN. that can beyond that ASN a sort Roven evidence of see ] really he potentially physician

haven't -- I'm a I of this idea -- heavy seen answer, might number I I where to not going on have And you one weigh haven't since presentation. one, [ ] with going Dr. more was that you the on Roven that. two, directional

of we such and agency that with and those studies a not the to were out are good for honestly, label. don't the to worst of pan going know into at well, actually be we in question. with -- kind to patients is that therapy on the mean, the they're recommendation Regardless, eGFR, C&I be -- going discussions eGFR not anyway. may suitable We I over Yes. doing label which it's so how or getting the kept what X on set cutoff very we really And really most a of XX.

because are a study. But in some there certainly, our it's patients consideration

at As well. [ you ] steroid pretty and the are eGFRs can imagine, fluctuate eGFRs reasonably a least pulse low in widely, price whose actually did

we severity, function have not to drug's I experience that do. of few So of a see any the for as goes line down that in ultimately think this Whether absolute physician take decide drugs. We're Phase and not onboard years sure be class from the how to eGFR, that community. label received or trials disease how when yet. This we clinical contraindications we the may something is a the comes IV to

Okay. Got it.

a more expect can XQ? caps how much organization, whether out maybe sort well? there we into of bit into or going that growth little growth maybe question. discuss personnel Can level has you sort trap P&L. of as a Just Noticing the maybe sort an housekeeping whether on there of G&A would that been on the XXXX of as And a final sort recognized be and

Yes. haven't expense any Obviously, and/or given we guidance. revenue

try you are of majority listen, And that answer. of an obviously, from the me you out the try can quarter. this hired directionally into But we've to. the give into model majority people we and quarter people costs need our the let to to So as it last we there. Maybe end

sales investment and because to numbers, those go state steady to are the costs around at least see are recent numbers Obviously, you of of pipeline it the pertains as as a our eye. Obviously, time think people-based up I dry the sort voclosporin idea. down time. modeling over marketing announcement go So costs, around elements to a over costs going is not probably of going bad and there

But probably costs a Justin. if I said, quarterly around and get launches, good really idea you averages expense diversified sales a way into But is. And that's I you of the We then find guidance. pipeline. what at as soon guidance will this our quarter if were it But would think a base you'll especially on marketing with we to you around and and hope that work given I now, fulfill to next as to for give model there, it, it. successful quarter, way look haven't

thank -- you the question. but So for

question [Operator Ed H.C. Instructions] Our comes from with Arce Wainwright. next

continued regulatory the I have one X, on and X commercial. progress. Congrats And

light up. Can first prepared late-cycle meeting? And specific is? mentioned to expect So you at -- remarks aspects that us the what is one agency preparing a for you coming had me, with you review tell in discussed your a when you're do excuse be that that

the course. of to these be. on right should Yes. the track you map said normal hit I say out Ed cycle when we're review we're would are cycle with what if on we waiting, review is expected things late just When sort

can that -- at one that? when take any wouldn't reviews. to It's you in day-to-day take you that's covered are on ahead whether you into so to these maybe to right of areas want the want behind. It a through. be conversations, Neil, to try or those swing money varied as should late-cycle So closer But the Neil, schedule the have come to things a of read swing? I to as been

Ed. a statutory it's Yes, mean meeting, sure. I

timely agency it up. So obviously, gives we sort up data and approximate it can their review -- we to they well. obviously, the as it, knew statutory further formalized. their it's as open and manner. of review And of done We them. it's last review what need kind intensifying. ends dialogue actually But required knew part about or we they that does to of is usually from written a guidance odds complete guess, more really I to get they a in tie the so ties we provide but opportunity it It we're just have, to start any before really questions the the what of kind negotiations have were us going the is, label address that What

Okay. Great. Fair enough.

So turning to commercial.

by prepared potential on you in release, fully working your for the As year-end. you're launch being noted

only that. X after that is PDUFA date Given the weeks

is do left specifically between imagine of What if wondering the what wondering place year-end? most Just specifically would already left I and by is things it in and up that kind end wrapping the to that entail now is of year? do? Just just Or really does well everything get underway? what to is still

this if that with actual approval start we'll importantly often, the we're be early is we way far they the and to be in ready? our you marketing we we'll approved, product. what when an want to investors absolute were a just patients you listening the shipping the that will from drug could side, projecting call the no and thing I companies or going increase tactics label. on will and into date. My be, caught I without to ground that and start have date and But good have launch Too of this PDUFA have if natural ready approval, recipients that confidence be their selling on have an once this shipping. the removed we'll think date other question specifics. roll the ability on our more there ready well, a If would are It's early an and And said, not we it troops the approval, company start "launch" of when out be drug, to with to able docs question while

we're your of And FDA. to we whole will a prepared would lot that month agree I a date our almost a because statement potential preparing to while what with is of ahead else probably action have heck what the Well, do. be not with

that it's date, onto ahead prepared. increase confidence meant be So people internal up to be being know our And ship. to to that. should It's ready and that that elements tying that battle we prepared and much PDUFA deployment, will and the our even and do of ticking we end resource we be labels to on date prepared more communication is be those tactics, getting all to to be an the if packaging, a cry PDUFA packaging of well

and at data really one especially end Okay. the Then the of itself. related the large biotechs global to earlier Great. the the some is question relative that mentioned, to to final the when of perhaps, of commentary in day the best pharma got right key is the things me in actual competitive course, small the of for about very drug, some factors comes was it Q&A environment, when drug, especially you've a

with relative especially your payers and especially what key that to discussions, are you of differentiation in Benlysta wondering to find resonate So and do the points GazyVa? appear clinicians,

ask see most it solid et of Max, to restaurant since they doing to versus you menu competitive some drug, pertains list there's patients disease to bad unapproved there. from you the and drug. been then as menu being a attributes different of approved say And first apply obviously, attributes drugs. want important, degree, cetera? our day-to-day physicians try as and most what a attributes of you're of wouldn't We with starting we've an do and idea the in being together of do our tell to -- we what research I get to to, you for keeping Anything patients in in those profile, to of terms then apply closer back Chinese like and outcomes. choose And to how to add see state we questions out We of terms the important as what options put can many how try of the controlling go I this. they

Yes.

resonates efficacy strongly, of would in time a say the key about that on the also to that is needed the with I treat, to is voclosporin So would get to which payers, specifically the X payers the that kind say voclosporin number focus I strongly with response, of response. very And with -- additional an metric and payers. resonates

for you. Thank back turn at There remarks. no to management closing I'll time. are you. further questions it Thank this

Thank operator. I you Directors, on our great thank have behalf And company the on We of share Thank to year you what's like for this safe you. evening. for about to would continued we thank want excitement the for all We and Aurinia. support, horizon your you please a want and call of and to really joining and truly Board our the on hope all today. us you you, do

call. today's That Have you. concludes may parties great disconnect. Thank All a evening.