Aurinia Pharmaceuticals (AUPH) 15 May 202020 Q1 Earnings call transcript

Greetings, and welcome to the Aurinia Pharmaceuticals First Quarter 2020 Results Conference Call. [Operator Instructions].

It is now my pleasure to introduce your host, Dr. Glenn Schulman, Head of IR.

Thank you, Jesse, and good afternoon, everyone. Quarter for Results my First Conference Operational Aurinia's live Call, home to XXXX and Financial Update Welcome that is.

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

some to remarks Please I'd Relations is brief is Aurinia. today's without call content website, team, the prior call. be remind or X the will webcast transcribed replay that available into consent live also written that Aurinia's Aurinia. like being the be reproduced from not from approximately and Before obtained of on after may Investor everyone written property jumping hours recorded, note call -- today's of a It

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

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

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

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

the turn Greenleaf, me CEO. let President that, and of call now Peter? Aurinia's Peter over all With to

working that, yours obviously, we're through. and on thanks, and Well and And very that first at keeping a is Between And it busy we Glenn. COVID-XX, earnings and and are healthy. going locked top of that that, these like down wherever season you're to today from with really time I taking you hope you the call are unique today. us say webcast on safe all the the times appreciate foremost, I'd all

issued this we mentioned, Glenn our an Financial our and update As XXXX afternoon on Quarter Results ongoing operations. First

had our since company, its we, weather the to typically are has impact companies, pretty what a other its essentially as been able biotech result, Actually, and been inception operating has that virtually compared While been the a globally impact situation shift seamlessly. to as small has has fortunate on COVID-XX this business Aurinia operations limited.

may reside. We have our hire located to our headquarters out and British wherever commercial our throughout the hub sought in But in right our those Alberta they in being talents attract Columbia, the Rockville, global Maryland. Victoria, Edmonton, has with finance and infrastructure company built history, group

throughout environment in we this Teams and If and a Canada to get of anything, priorities, in ever world more current today that as have than been and history, have the we've assembled in ongoing more ensure We the Zoom, collaborate busier and global through U.S. done. -- and and team have frequently. we job with online all and Skype technology leveraged together such our the our communicating

brief. relatively This should afternoon's be call

to submitting order therapy are priority drug of the you lupus the all sure FDA for FDA-approved today time, this and I'm full in the potentially nephritis. treatment voclosporin As first aware, of the application become for application is new completing to at and our the

with meeting results the modules AURORA the a all the and all face-to-face past February, preparing FDA of and the the for receiving of heels to documents reports, been the files study December conducting the this submission On compiling we've last agency. and

the ahead, the Looking by end this quarter. of we the completed including remain on-target submit NDA, module clinical to

when timing milestone We make time also it lines known achieved has to been review it us more up sets for for the as that will about voclosporin. know the

date by the voclosporin XXXX. end of set planned quarter, assuming And of approval, shortly and NDA of granted of we're during part the As the of quarter status PDUFA was complete up after. the if And under priority the first to filing assuming Track Fast launch to this granted seeking that a and a review application. place we NDA voclosporin, previously the take

it's As to these an drug And to market solutions. a enough patients. our Aurinia, we forward FDA-approved no where look to meaningful of at lives lucky you're that in here career able making differences industry, bring there's to a in executive in rare, rare very the be

The quality our and organization throughout And a been to team the Board, experience able with add have and and capabilities commercial team been this evolution leadership commercial of by the judging the over of world-class to and breadth organization, we voclosporin strengthened year of the launch further past well-executed know-how Directors. team. Board the we've has the to by successfully

he commercial veteran Chairman had we of Board that is a complements the Tim experience that Directors our strategic Aurinia. Board. President here and industry brings Pharmaceuticals an wealth month, Last Tim and announced CEO joined of at Walbert, and Horizon of that

As preparations And about I Colao all his launching introduced joined observations voclosporin provide the Max on initial you build he work commercial call. Chief Officer. ongoing will us towards last today's the and Commercial as quarter,

enjoy Aurenia are offer. and Chief I to And Financial smooth XX get tirelessly those at for for Miller, service, best the traveling everything aboard voclosporin enjoying hopeful including has can at consulting ensure of the bring can has decided transition, Lastly, and his Joe has to the us while he's we years point retirement after Dennis and Dennis us Isotechnika and in this done to over and grateful Bourgeault back and and a we're to times life sacrifice Aurinia, some a retire. is to that world truly years that importantly, you he today. brought that ways, Dennis who's with And the greatly Officer, most tell new worked company. for we've to

Joe career new industry, CFO, here voclosporin with the States in the years joins Miller, private next United as the XX-plus us and to will come public year. pharmaceutical look launch of sector which our handy we in in over

Maryland. normal. first in return things once will hope quarter to U.S. established for hub hub to the for in we This We as our Aurinia a would serve Rockville, launching also shortly voclosporin point in which the U.S., return to commercial

turn call over upfront, Dr. to I'll the for So status now development new of our to application review Neil and Solomons programs. with overview the voclosporin that Neil? other the brief drug

afternoon, everyone. good Thanks, Peter, and

made during FDA of full past submit Since in down last by module. meeting we in had the As submitted April, we've and nonclinical after we with end To completed to March. the heads Peter we NDA on few we've have manufacturing in FDA the writing submitted in the focused progress. significant we already finalizing the date, the And months, FDA this mentioned, controls we will that chatted voclosporin had quarter. face-to-face chemistry and to February, March back in the the the module

the modules, other FDA the to end finalize clinical the to working everything quarter. to plan and including of submit necessary the are now by We the

voclosporin it by we mentioned, previously Track Fast FDA. the as of will as Peter review filing, request also part was priority granted the As for Designation

in In presenting during presentations have from terms Keisha the tuned spring of will results to like clinical meetings. and the results for I'm from conferences. AURORA ERA first regarding report that to Dr. pleased also the EULAR at details March the summer, of the time everyone this virtual I'd more back presentations. AURORA Gibson the present virtual we these that Stay study, NKF remind did

having and in anticipate we presence Furthermore, the conferences, at including X a November. ASN ACR

publication fielded to year just Another regarding will to often once let that question submit this everyone manuscript everyone have later primary primary it's we the for results. let of know is review We plan and quite where, wanted we AURORA published. know the the

time, I it incredibly be For during continued Aurinia of global been an that team an couldn't prouder my exciting execution these interesting and the team, times. for entire busy has

FSGS our exploratory to topics Switching study.

was here naive study FSGS XXXX for open-label enroll treatment primary exploratory our recap, to been a in biopsy-proven this and study As an aim haven't into developments those following subjects who back initiated of closely, voclosporin.

the FSGS XXXX, U.S. spring the to is in an in as annually the around recruiting well as additional U.S. in in ultra-rare year, the population, patient sites new X,XXX Due patients Dominican Republic. in of disease, affecting last we opened criteria, difficulty study and meeting the summer

slow. allow from these enrollment patients primary Furthermore, of with previously efforts amount sites, of amended had inclusion original enthusiasm limited the COVID-XX been study who of regardless remained we the treated corticosteroids. Unfortunately, despite to a and FSGS

potentially, invest been other membranous the LN and proteinuric in that, as that size XXX indications voclosporin diseases, in the at thank glomerular small regarding or FSGS ways. which safety includes said, our adult time. were learned What are study. manner to that is in nephropathy. tolerability preparing sample is noted in dosed syndrome pediatric we've continue studies. also explore currently are also will decided have We Therefore, as other to additional make FSGS same any capital including the or there And the our efficacy small we to conclusion resources That kidney a would idiopathic we patients, be signals in too and no of result, the nephrotic in this These study. or handful to have were patients, support issues importantly, described patent

the firmer broader Given commercial will Owing announcing currently we surrounding exploratory report study NDA, a quarterly will with and dosing diseases current are time intense plans kidney assessing our the the we year. clinical this later for confidence the lines for forthcoming patent, be time with workload results. to target XXX next feasibility, proteinuric of

front, believe the the this compared program this on vehicle our eye a fronts, quarter despite update this Phase the pandemic. II/III II/III for track and results solution of clinical clinical internal And over discussions on with Phase line track in from I'll call on the regulatory Based the of report CRO, dose-ranging with and VOS, the to adaptation Max. clinical sites fourth evaluating COVID-XX and our maintaining we integrity ophthalmic trial entire the remain to study development on trial dry pass the to top that clinical during during we brief the conducting year. remains or and On voclosporin study guidance ongoing data FDA to

Neil, good for Thanks, everyone. time. the afternoon, Thanks and taking

of lupus more XX% by with of like is diagnosis. to is as most, mortality complications and patients I've the and take What XX% struck just one disease I'd As through this part XX to patients has face at of significant the and a years been stark my you as X life-threatening you These look me the Aurinia now, continued months unmet LN, to all learn for opportunity of When I've just stakeholders and LN impressions lens serious, common back Peter about affected the the after devastating team dialysis to a of disease. initial focus. and this there's clear with take and how mentioned, then share you LN morbidity this most requiring need. step

the end-stage to for time Based quicker achieving to a ensuring based renal results, defend patients. well relatively renal demonstrated LN regimen clearly AURORA From and for costs to voclosporin of and/or greater an regimen clearly express the we early on the including the rare both a minimize therapies, LN transplant. AURA perspective, more recognize for renal and need by avoid want dialysis sustained a response the associated physician effective prednisone. to of disease, proportion with adoption. Payers Nevertheless, as response and corticosteroids doctors voclosporin's a a barriers ultimately ability like as disease, use is the the which kidneys study achieve for

Based few research, internal on market a our observations.

remission variability treatment some and see by approach. around the or protocols see monitoring also in employed criteria current we practitioners. understanding experience variable goals, treatment a approaches inexperience and We the of and First, treatment response multi-targeted

stakeholder launching a impacts access. where voclosporin we during time the Lastly, COVID challenge recognized of

with guides to realize that As capabilities, conditions. we're expertise we disease commercial a as the potential. rare This nephrology, deep the we're model, of those our our team implementing out voclosporin's world-class our and bringing vision in autoimmune path on other Particularly, we're rheumatology, for building aboard. flesh phenotypes focused a lupus and out leveraging folks

has as that broader on diseases rare a executed the of hiring we're seasoned products renal launches Second, globally. across well indications as team successfully

to be to our services. patient patient board, build goal. We've team team. chain this been last the we've commercial and Over capabilities progress professional key professionals in to our made industry-leading staff relations, we've advocacy, adding new hiring marketing, thought commercial leaders leader support in days, XX toward great We've Across supply also access market Aurinia added engagement, sales, out and existing fortunate added operations. the and

current of XX X the some for nephrology, Just has in experience: commercial which perspective, which of leadership average, has, of through plus in collectively been commercial seasoned on our years team team XX rheumatology, X launches.

to with again, providing the what be to part team, looking like you I'd forward of say perspective update, updates So later and all to a from that it further you of pleasure to I'm this this is year. commercial

now Thank it for you. financial of Joe? pass to I'll our a over Joe QX review results.

good Max, Thanks, and afternoon, all.

its quarter to and Net for it fund for XX, research pre-commercial activities, and March XX, resource Aurinia believes million cash company development launch, in capital used million XX, continued the first the supply compared to short-term include XXXX. the ended remaining that The As and XXXX, equivalents as conducting of and investments million corporate ongoing launch packaging of first XXXX. working of cash, to build-out has supporting was financial March ended plans, infrastructure needs sufficient quarter and through programs, to NDA XXXX, XXXX. the operating $XXX.X compared its for million $XX.X the the FDA, current commercial $XXX March our completing December $XX.X which drug had required manufacturing XX, submission cash fund of its activities conducting

loss liabilities XXXX. quarter net company warrant XXXX, XX, per derivative the noncash million in first ended $XX.X The for The consolidated on consolidated warrants of the warrant liabilities fair The first of for cash March December to XXXX. loss outstanding XX, of common March the be common a March derivative XX, exercise million reported compared ultimately the expire on million ended $X.X or quarter warrants outlay to or in warrant $X.XX a company. a of a XX, ended value value estimated will quarter estimated result will first reduction XX, the net any in per fair of or March the compared of as share loss for reflected $XX.X eliminated first ended derivative the by quarter and $X.X share forfeiture reduction liabilities $X.XX the not the million XXXX, of XXXX. for The

for the reflected The first XXXX, income expenses XXXX. quarter ended the same XXXX, XX, million supporting loss the expenses in $XX.X for XXXX. the million quarter related for related preparation before hiring Noncash quarter XXXX submission team ended increased quarter the compared value extension to in the to a and dry value of eye the of ongoing the options of stock trial, the million due launch VOS/AUDREY expense AURORA in in II/III the expansion personnel and March $X.X X comparable R&D increase and voclosporin. in medical Phase the affairs share of trial, number the also compared increase for to March XX, costs was fair of to derivative first primarily activities. R&D increase for price. The the the to to first of warrant stock $XX.X significant support March increased to charged million compensation compared XX, change NDA XXXX, in the XXXX, taxes reflecting the period estimated in the and of the for million higher $XX.X liabilities to to fair ended $XX.X $XXX,XXX an XX, these company's The March the ended period granted

expansion personnel quarter. continued an to business corporate, fair expense increased stock XXXX professional comparable development of quarter included number administration the share for commercial team, quarter reflecting increase compensation the due of insurance options XXXX. the in costs $X.X the corporate and for hiring compared higher price expenses quarter to the in to the organization ended March development the first business compared and $XXX,XXX XXXX, consulting XX, Noncash Corporate, the also XXXX. million for personnel granted the charge and of in first for quarter first administration significant These the fees, expenses and as in million build-out of increased $X.X period costs to key of the the and value the XXXX in million company's in stock to of increase to of compensation XXXX, a first $XX.X the

With concluding for Peter?. that Peter to will back some remarks. review, I it pass

continued the in Okay, later we up value before voclosporin that our the we're program moving eye redeploy voclosporin. diseases and reporting additional our thanks, we XXX are filing and for enthusiasm indications. say build With viable down, not Q&A, to like syndrome resources end voclosporin are are with and Based development beyond patent, the results those Furthermore, evaluate dry ultra-rare in obvious. opening adequately confidence into just Joe. completed quarter, about to and FSGS condition the by trial And more commercially on We're what's plans. the now for commercial our the funded around this NDA on sheet kidney working beyond completing and execute the if AUDREY XXXX looking our and proteinuric year. keeping approximately we other confidently VOS can to at and on it's to $XXX of I'd a on strong excited of horizon, focused heads launch balance through the larger, million

you today, attention to here and your is for I your all the team questions. take to want thank

open So Q&A up for with that, operator, please can we a session?

Instructions]. [Operator

Young Our comes first from line Fitzgerald. with question Cantor the of Alethia

that on the Congrats you made quarter. the progress in all

there. from conversations everything's that kind It kind the to Just a of feedback But finish like for you of had. One, me. any up to anything line. sounds couple just get the go the notable heard you a kind I of just wanted popped if FDA,

for of of launches sounds in approved I or after virtually? guess sort in you I multiple and know Peter, for you launching, how a maybe about in it next think of XXXX. second, docs you be COVID? about hopefully to early having guess, and you the mean, drug Are little can I new about quickly world commercial talk preparing feel to about just relatively kind are you scenarios gets file all And I something but lead I companies XX of may targeting think I like your then guys think And early, the hope the months.

Alethia. Hope year well is on Thanks, all end. Okay.

last Let on been, the in anything, me Neil, call, XX think February to and if it's as this we the has start up Feedback question target. -- guess because point, from can on miss I been the from the I the you FDA, first simplest. interaction and I here said but it's jump

haven't or Rockville were And you'd in anything was we seen actually, quite lockdown. the as with been result. to heard very We pre that this Neil, anything there? add when collegial met a has meeting, of all happy we and surprise us. It a

us. No. what the on reviewers an is have would We it you receive. with was echo is with our this with met NDA most this I many been also efficacy based familiar medical They're program inception since story to they're is of X-year familiar there, what that we collegiate said, great positive. very, believe and They following very a of for XXXX, in us, reiterated benefit, news the familiar meeting. about which risk Peter, whom actually which

very, we're confident. yes, So very

of new question, lockdown drug ask comments, which this other current can watching into. time a of think multiple doing we're sure normal But in planning is that learnings a anymore. any one, that how of a drug we're this Aurenia is transferred as And they're that And products companies during if launch I you, commercial would see situation, to in. have before going which basically all the have We're we're obviously, do a normal scenario. tell everybody drug launch. And There's you that go COVID? I sit -- Max, be world outside X on current entering to a is there drug some world standard I learning the Boards and is I the scenarios, here. a through a as we those got is for also our launch on I just what during he's now other about I'm approvals today new second

So access, the mean an would I non-lockdown we unrestricted, what market. we -- normal approach how be assuming by would is that

in which that The a virus lockdown we would and recommendations new today. be mean that virus quite back out that again. basically of if would and If nation the to states second is put frankly, or into strain reappears -- full reappears same decide come scenario, us and lockdown scenario a the countries, sit the the

And build doctors' go. scenarios, scenario trying and different Max, where less that you, but is a sort about we're build leaves would limited third health as virus access. is care level planning all confidence facilities be what with have hopefully, on plan offices that of on on and tell just some and learn And will A, we fronts. or that? world the circulating launch and in -- thinking of multiple normal it the maybe we're to it towards three scenario add a objective. We're you I But would

Yes.

we So that clearly virtual I be in virtually what you launch we'll our also, would capabilities, that I enabled targeting, about add building then physician we of terms, would irrespective And the under. is also other physicians that highlight what see see talked large scenario patients. so then in number a actually of physician few you of of patients. number see you And that see physicians is see diseases, most where rare number are what you of a disposition small

into deployment targeting that our account in And so taking clearly well. we're as and

question next comes Our Cowen. Cacciatore with from Ken

voclosporin perspective, for these all included on would secure allowed to and Question layman's anticipate the the Congratulations just patent instructions is to talk a from in in you was just the dosing I wondering, about those the then dosing management be and was that property. surprising of what that on you intellectual can studies you about you label? Board additions.

Yes.

have of that's application in involved the X intimately cetera, of for and So that me part the patent, whole folks particular, our ask because And I the latter and -- et one founders was on -- take in Mike then Operating the let company, Martin, Officer. Chief first. we they're I who would

but I question most part of important. the So probably the last -- the think first is

be would did of that Phase both that would both trials, appear was our our in section of usage II our dosing III and design. was our see Our protocol that is hope our It our this how indication label. utilized we we this and in and Phase eGFR

As think the to I've said label. in way, a you many way do investors the I lot time and trial agency of your the the appears time to over we we've industry actual in way a with lot spent been along the of your the trying -- modify time, that clinical you're

in Our hope label. had is is that what most time, believe and get will that dosing appear get out. we works of the that the And the it that's we trial way we we the

and think and the that it label. appears we're our confident usage section I indication So hopeful of in

where and see that do how We'll mandate occasion the negotiations. rare how have trial industry, as in to and or dosed appear trial we experience you go But you section. usage be my not your your in does the indication those your been through in drug suggest in a it's

of to of With observation But was that, first and wants move go Mike would that. -- just bit to start patent to why Martin. Neil, on too part And I probably that's Mike was fine, ask with what Mike? and unique. the unique question more if we can the the front a was little through that the

no Yes, problem. Yes.

in respect this we've thus, know is a with the in a eGFR. is But long some of patients of And here decrease more property are personalized effects skinny susceptible to intellectual calcineurin drug much renal that with both these And experience can shown is on in basically them of and arterials. remission done corresponding complete the And varies we've generated patient. complete X to of the And better months. in AURA It kind patient patients have of other keep and lower at we early on short-term these to So structuring we of treatment inhibitors. this And months AURORA expect in past it found short-term actually the exciting. from generate that manage causes medication CNIs remission and from that a dose, what hemodynamic regimen. particular what therapy, that partial rates is eGFR therapy, unusual would if we that's or the and XX lowering have drop the monitor you dose the to and to remission variations rate. that's

result. of you presented prosecution to review will under and I'll and of Public the how you it remind And response subject the I the what that's define history. So out the available was kind you can leave patentable surprising data that It's read can manager. Pair, examiner or this came from basically PTO on U.S. the kind determine is there.

cover, anything check. Thank I think a me you'd you. let And we have Neil, Or probably but add? just

No.

I think that's everything.

Ken, anything else?

No, that's it.

comes Our next Leerink. question from Joseph Schwartz with SVB

Great.

in look those the line you how of States however on like And label, will covered anticipate patients do in many think things things structured? you Just indication versus be therapy some by do terms the United questions maintenance? of to induction continue then how are would the

how that the who is right right to and know tell his message call Within ensuring patients. have said nephrologists, we of show right points an And call commercial up investors. really I'll exactly up, leadership the individual as joining flow ensure Joe. with I've the delivered the right on points. show rheumatologists, that Thanks, those we build they up, together they those down patients also physicians through and to team I do sort of ensure with bringing this but what to patient where to identifying a to show modeling process and we're in me, nail one-on-ones with expect We're now will Neil most you, ask team to would Max

I for can probably out. population that be comes to part the And more at the target be the could in there what we research. So the what comment right attack top to and answer, think how the you we're I'll about then that as looking to be pinpoint that, really latter least with through right And derive in to how come be I there. all patient to call patients. of on individualized you that's the on be going a we're where from to give will to important But the exactly that what that year, physician back to aspiring us ask it's the you Neil able terms see label. label to many and process out of might definitive And base patients think accuracy will in we message at our maybe towards be. do just think I of now need think of then market almost out identify

we We'll look to as the actually the Neil, also patients equation? label learn and we more and coding try But profiling want out you start docs side there of and commercially. get more

Yes. enrolled. new made I into extremely what nephritis we it's the very as make a mean, a studies. effort And patients I'll of onset patients, very broad lupus such see to both an enrolled active even look we our at important label when start. enroll treatment-refractory of range deliberately sort actually, we who patients very to

out. position that Peter pretty it's treatment is. or And best the But is more. what on of hand nephritis. to label current either that's actually how Obviously, mean, over lupus us our Max bit see to bit we'll for that to target pans So just the build a a I

in I to of end But on hearing I'll be be it we're mean overly should very to I'll don't where speculate going we will we've on a because what on -- up what patients. I label. you is ask our the enrolled And our put a trial. Yes. range want did just broad bow

will look into. and a our the to And back trying think where give go say, you at idea that we're we'd I good entry-level for of trial. criteria So range

spot that Max think disease. go because we said, And there recap the this that now put a the between to many we've don't have nephritis. -- again, give could said we direct think it. too We're those are feedback there somewhere commercial community cyclical lupus and right and refining is, I But patients around a that label, how before, get investment targeting somewhere there's exactly XXX,XXX about out have details will as out I to XX% into into and be to that just message a to we a the want patients commercial be. more once that is really patients on lupus and the of process XXX,XXX of to what of in opportunity publicly, And able

of -- can they So that patient population.

talking the somewhere that, in accessible to and then to you're when. is will be So And of of our us range XXX,XXX estimate. patients XXX,XXX what

as think come I it. to to out component We you think And then year. there there's have you to marketing more you. that. the is of telling label rounded the back one? for I that to component forward Joe, look we a execution another Do a

ask big is it physicians envision on very scheme. Does of treating in dose do intensive to That's to already anything the a a lupus having Maybe And nephritis dosing course it real normal do the one do patients? you Yes. world? of them? be helpful. require they physicians the doing for adjustment just that don't scheme in How

the to build that on but is Yes. be I'm Neil of this has to one flat-dosed. question, ask part this the ability front to benefits going listen, my product of to

-- So to some thing couldn't complexity added first we patient-tailored is the became would something monitored have generation it flat-dose that trials needed to profile last want our so other added actually that that dosing CNIs. be in be that and put a like been

that of to normal anything short is think tailoring I or Or additive the Neil their am on is the that? this are the doing it's fairly docs answer of And dose off-target in their monitoring I already. normal a patient. already treatment reads accurate? be dose taking these -- tailoring So types won't

on -- And office much dosing, every they two That's just of couple pretty very put thing a that is current system that's they're And when dosing flare active the reflected done the which have the the When in in test sim is drugs, at done. are triggers months. cheaply very, doctor's every or measured. eGFR, It's it. centers. It's these these our an first specialist frequently. the which first study is weeks the much basically No. pretty not protocol, patients everywhere, week routinely is frequency in

simple plugged patient the to out Just that and very in minutes. country. return day the doctor the And can a everywhere formula into local very, labs same a of within be

It's as it's simple, informative that accessible. we but so it's And feel also well.

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

Dr. real-world relative sense NK results that you at eGFR in specifically status the like way practically more a criteria have allowable thinking? might patient entry a Do including population. shaped asking about look And speaking, was? the presentation the the we on Maybe little Gibson's have of what what for range to what AURORA, AURORA saw

that patients or great I market on We down treating think you drilling yet, being it's not our has you really on for that nephrologist maybe turn way these a data current drilling some of probably don't knowing isn't that longer and on that. research he's giving because to down have -- a guidance that. would is and Neil? question, I a been around Neil practical that

had advanced think a I floor patients good eGFR study, when lower we we XX. that in. some excluded pulse and they I XX, permit considering mean, have But a have steroids a basis of if for more of that. eGFR. -- and eGFR No, are is a still the and they Yes. a worth just eGFR on started Clearly, And recovered, few actually question. lower than was what that of more it much than a we patients it's put And probably screening and the sicker patients allowed had did they're eGFR very that

also that could the that colleagues. and into the our ones carefully think It should have the the to needs Phase sort therapy CNIs, well. reflection good in very but who very, is of having within who are perhaps move we very commercial more discussion kind future And it real about who in certainly a us some for it's between patient believe perhaps are flares. as a program, that patients proteinuric a very have they we of far severe So that's possible shouldn't date, does of but of population it gone, exclude IV

go to I prospect add commercial starting the guy to able is one would it. a representative, And through affairs to sales in is not our the way what's up of organization, here, Justin, that, medical and to clinical exciting thing being where last is both a just and I all through physician, think the but like, engage me listen, conversation as grown our

drug, my here's it. benefits features Here's of and

the patient-centric talking steroid the was think these fact patients did, are our treatment fits way how of actually there some the drug itself. the of physician patient, entire the trial about patient paradigm, this the individual paradigm. a the all that the -- -- And of dosing treated, You're paradigm into challenging treatment individual protocol reduction dynamic the that I physician give the treatment we element in treatment

in and if we're of right on is So with court trying Justin? the dividends another now experience the successfully type Max's have and customer that engagement commercially and that X in those approved. nephrology experience base and courting get that people comments are you Do we we that when to to that drug areas going and pay question, rheumatology with

Yes. opportunities on the of just of voclosporin's were podocyte? mechanistically, Maybe can that just about benefit talk you bit they mentioned on strategy sort from updates, the action additional one then. how the and may In just little call development clinical light a

call. would Neil may going been else I thing along. and something I'm have anyone -- comment I ask to first saying then to I've and/or want investor the to the It's a all who on Yes. reinforce

basis on justify continuing our and we study. I burn that patients onboard, utilization know be operate for degree, drug nephritis going kidney larger lupus we today area absolute think currently, us did work in the But the disease to thing some patients first-generation We market and FSGS, in the that better pricing the are and I market. company to think, -- just this priced that in high-return get get drug benefit pricing the getting the started with that work knew be so was it and on after monthly FSGS, to when this of a CNIs. of or here were I operate can off-NPV a think where estimate other accordingly. And the from the down. was approved the made were and X,XXX could to areas do to if from I came IRR of a a would tell standpoint, doing, we be where impact potentially We lot an go we and were before return the proteinuric opportunities, here about I of wasn't we the right could X,XXX It didn't that. folks nephritis, that believe our there outset, and to going was body relative of here, sense. work you, can sort an was of investment we that What patients company much exploratory the the better. lupus that an

might deep targets Neil rationale back him say few, maybe So ask comment but those Neil? and are a short few. maybe technical to mentioned just so the a in I come like to order. not on because on we'd specifically investors what go to

I Yes. post-cytopathic. with it I on think actually the you No, mean, touched word,

they I are conditions a think that's of a in and have good inhibitor. most common, what these calcineurin target for

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have simple a indications rationale, that or very report clinical with off-label Obviously, very, commercial the of around But use from with of for diseases target those perspective. steroids a and us scientific doses may commercial also back those. and CNIs both high rationale are we'll

line Our Arce next question H.C. comes Wainwright. from of Ed with the

first FSGS. Neil, Clearly, of could. for the A on the the Congrats launch. fourth quarter. on for have in asked. target if the remaining already question me I questions VOS been Instead few progress Maybe that start well is of a team preparation your the with the with let program. with But build-out progressing

as or takeaways enroll Just to would helpful. treat wondering you if any learnings continue be there anecdotal incremental patients, have there been anything patients

I in jump Neil. Neil, Yes. it, right

Sorry.

Yes.

you want Did Peter. to... Sorry

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blinded a it's study, ophthalmology. mean, or I in Ed, masked we no, So as say,

to and disease, So systemic report. can we very very information. course, population, of you top at fact it's the not disclose little we than sort line We as which, other don't a it's not of other have receive And -- imagine, any hear of really this in the that much. to I'm liberty safety,

interim looking or sub going program. perspective, on or cleaning data data early -- this teams certainly, no from there's have We at a the analysis but in

Okay. Max. question Fair perhaps enough. And for a then

to the are thinking brief a of small far, time intending about thoughts to adoption. could, I the the see you where address And greatest improvement? sort barriers curious mentioned those you handful for and perhaps general company you about was of at so been had how given if You opportunities you've

jump Yes. on right Max, to want that? you

patient. the rare other barriers a a think, identifying have seen basically physicians again, model, are I of reality -- Thanks handful see And and again, patient again, in it's promote this our messages Sure. hiring mentioned rare we world-class from disease diseases. applying treating are which question. the disease the means the that talented, that we it's that of the educate a really, and rare so many in the exceptionally so And I in Yes, that people that paradigm -- sales. patients, for barriers terms treating of what kind right? And only field of eloquently act it's stated that looks that the in Peter, right And like. to

the the to to right me, message, And the early creates if identifying it thinking add, entire a just the believe, Yes. to ones way right right label, think the great about that treatment the we sort with I are people, done the drug, barriers with Ed, this change of we're the we opportunity that and we have treating disease. right have right paradigm and that docs

a out part success go in it's negotiation. Our patients the agency. reasons scenario. the it's treated approval people way the that. next got with recruiting -- with able the people. are we've having of of need why really talented cool charge such commercial really with our just the It's And we're -- predicated the we're now trial, Hopefully, message early gain and go and high the year excited right down. in the and to right be think to why through we I'm of such and I there to shift one having And structure trial We

across Joe. of should moving Great. how about And the of then lots three for of XXXX, last of the Joe, and general for programs? for therapeutic think sort one me, we the trajectory given, the parts remainder OpEx, SG&A obviously, especially this one is

Yes.

out I board, Obviously, by of you think be fully there'll about QX the the kind operating across infrastructure. of if obviously, ramp-up costs. SG&A we wasn't kind think build some continued in expenses SG&A full as the burdened

into development a somewhat out But CMC bit increase between quite costs of more of have have So of slight overall, NDA peer your have kind your the future cost. of look consistent a kind the you'll quarter-over-quarter. remainder shift remain pretty into should the as a will think kind year of R&D and we'll I Obviously, of your expenses quarters with you MD&A of associated preparation that. costs, so

benchmark, year you I'd use a your quarters, you what kind of with kind little project an of QX of of you in like. will could QX coming but have probably if the as a slight the may used uptick say to look bit the increase remainder

the leading for after better terms We'll like -- in projection to of point. obviously, that hope I because else question, as potential to be get And and a looks to the think, on of everyone guidance is sort what able forward. phone, give label, future to approval that we closer the

come. to more So

Instructions]. [Operator

Jefferies. from comes question next Our Maury with Raycroft

the progress. on Congrats

doing follow-up good that you a And to Just most as of and much if if have use in to was come sense get? might nephritis likely is what how wondering indications indications a question, from? research non-lupus prior in you off-label market you're I a

I we sales we project any spontaneous might would never Yes. get obviously, the mean, market. in

some just to the going areas. to is comfort that look to I at wanting in think come physicians' down in other drug of

new I get mean immunosuppressant path with, a feel people when I comfortable example a and really you for of well-worn that there's a good think think I comfortable that. anti-TNF is have or obviously, speculate any we way, tinkering it. off-label to we, with on of in areas. nor promote it a on lot any would they But comment use, start different can't in

think as again, do that but development not we're how promotion, look might CNIs looking do we're to of in terms a of way I that there. you host that about But to not used docs at and a So anything there's today. are actually And it. reinforce we use I think anything docs areas research -- think work to unless do encouraging could

just and latest check you then in thoughts more And I in think could Understood. I call, term. details near on provide on wanted quarter see you pricing if the fourth could the provide your you to said pricing. on

doing are Yes. work that we speak. his team Max all as and

terms get so about look in if If it's a set we as year. as there. we've potential get you. give plan be we of best out want more the that that we just market And also that closer -- of competitive sensitivity is. we'll the to more any back So the yet, comment said, launch would given quarter we but if details label If first to around not future. whole there's better And also target we range, of but period. closer, have launch, any at launch here we're general not valuation, driven guidance Obviously, to we'll half in time sensitivity go to the market, we come -- we've a thinking the around towards back that,

long close to question. appreciate but vest to can, we keep going as we're as that our So as the

with comes question Our Bishop Research. next from BI Tom

mean could that. relative to insurance us Or like voclosporin. I'm some a to is more pricing? you Do you barriers if for some mentioned little wondering other You there just bit issues? give on just

No.

the just listen, done I'm to we've Max I this close some want in past. the I'm because for data to think, answer I of

these payers. nor into I in trial, and went is payers, a by we're managed out potential think and out did what to dig Phase when But as we profiles barriers look product we our category normal lupus, into what said any for sure one, is we all -- barriers new preliminary concluded terms Max market and up in is the on that be historically, with coming trying there access, we II research making this we today, and found might just them. disease rare them bring to space, and of the the I've are

and our like won't Phase them had it be brought data of physicians not range mean in category profiles pricing future. this and sensitivities. But front did to with today, a in of in we seen terms when issue doesn't we That be isn't the different in of they manage. that access And outcome, a an payers III appear in put actively

market physicians we have the said, will doing we're being current it. coming profile That We're prepared of at around Phase can all patients that looking and product. access research flawless over and to be ensure to out III, we best

I managed make today, is this on for is everything to sure points patients. to that by made of top be point categories going access And with broad was the should a it. we're think profile But we're that this being not even payers. there

come people think the to have would apparently, Okay. have was office And that to I COVID-XX the And guessing the was your in physician's see I environment. trial on in delayed is tests VOS. question target. test? that an my issue might was But been that, to I to other not given this with that relates pleased for -- that it

our we as I much can give point. I a damn most "Hey, up things and a want -- enrolling, space would When for had would it's I think locked away we trial of had others our to stable good Neil what enrolled." do would guess as patients this we I more I patients a Yes. listen, good of the damn specificity up, the of but company. and is being that that no damn takeaway your were a in hope job little doing be, one we saying, take are to is is bit pretty give outcome pretty should good

the opening in don't up see to And going folks then good everything outside up, hiccup here. we why Without too a might can we're comfortable telling and Neil, second, you fact statistical are things good we really is give we've of to feel it as a what much good point. just really be management place that good had that back make detail, that plan us got enrollment that for a think to

important know. that's think No, Yes. very I to

around doctor's We patients in have from come guidance drops And FDA a for quite their number subjects some in. They take example, don't for have missing is visits. eye infusions. the the These themselves. also, office, of good there to

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huge confident. of the that of are sort point. it's in of bit So we're of we're luck pretty patients going, a we've at And got some think this things early. a confident I way But amount

does where it enrollment? Also? How stand Or big now? was

actually to we in as given haven't But you at? total a them number just where and cohorts we're looking the to give enrollment want We trial. the number Neil, stand the in

to may in jump Yes. just Mike X have have have here. I remember, groups we to of

XXX. XXX, about It's

needed. in we XXX Wow that that's Okay. great on total? it's what That's Congratulations. target.

at have no time. this additional questions We

for the like comments. over back additional So management any pass to I'd to closing floor

with Great. through how I this went. evening the to for taking the quarter to us run thank want everybody time

we look for to you be taking us, healthy. and incredibly ahead very much and Thank development reporting the for to continue on stay on progress and lies excited NDA soon safe We the will you our about forward and our time the to opportunity programs. back that

teleconference. you participation, lines again, Ladies conclude at and for may disconnect your your this and does gentlemen, we today's time. thank you Once this