AUPH - Earnings call transcript Q3 2019 | Aurinia Pharmaceuticals Inc.

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Operator

Greetings, and welcome to the Aurinia Pharmaceuticals Third Quarter 2019 Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

It’s now my pleasure to introduce your host, Glenn Schulman. Glenn. ahead, go Please

Glenn Schulman

and financial everyone. results Kevin, third to quarter XXXX conference good you, Welcome afternoon, Aurinia’s Thank call.

Bourgeault, President Joining from me and CEO; Mr. Greenleaf, Operating our Medical the today Dr. Dennis and Officer. Aurinia team Michael Solomons, on are Mr. Officer the Chief our CFO; call Chief Neil Martin, Peter

www.auriniapharma.com, we XXXX financial press at The the associated with financial statement our issued is along release SEC, press on detailing release that with our afternoon, X-K results. This the quarter available package was third a the well. and website filed as

also today's prior available call written cannot of Aurinia. live and webcast I'd our the today’s remind be to Relations replay is property reproduced a like note everyone today's following call is website of also Investor without Aurinia's that consent. It call. being transcribed be or will Please on content

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

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

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

Greenleaf. over Peter? call turn Peter preface, CEO, all so that With me Aurinia's the let to

Peter Greenleaf

have us call thanks and today. to you on all the a with Well, Glenn, it’s pleasure

recapped accomplishments our mentioned, results financial the release our this we press Glenn quarter third went out that As recent afternoon. in issued and

here each member expertise by the bring tenure focus that I the to of the I to that continue dedication voclosporin. relatively to Aurinia, team the and and knowledge be during my and amazed advancement have of say brief of at So staff they

treatments are very serious of people end-stage As patients many families, you has to It response SLE. living are need devastating disease available and transplant. very on and renal rapidly space. disease, in key the current of a as market form the is their for in with preventing dialysis nephritis Getting is lupus limitations of as possible aware understood renal well the future the and impact

Aurinia is actively data of precipice on the success. will when pivotal preparing we we for that have, be

and thought meet team few past physicians, treating attended learn events key affected about groups, the by are disorder has lupus role and disease all important individuals of this that that nephritis the with the the and well the leaders, patients treatment more months, the to globe as Over our in for individuals advocacy to approach being that involving with needs this disease. have conferences potential around voclosporin patient currently, as the play can and met

that a has the path call, to During financial recap voclosporin to and today. brought Dr. our highlights point operational us minutes Neil recent today’s addition to the and of Solomons spend will history reviewing in few results, this development

followed development especially a be of while today. it results, review especially the great unblended the opportunity for briefly clinical X the that history we the path call, Phase company thought trial the in We AURORA analyzed would of context today’s to and await voclosporin, has

recent to corporate data our and of over this the discuss Before into events. to excitement review some voclosporin turn highlights history the to and I I’d leading like Neil actually readout, call

Aurinia have build may you as company the strengthen read continues of and Directors. First, to and Board yesterday, our

addition as of by Leversage. experienced to the individuals to evidenced Board We attract have and continued Jill extremely Ms. talented our

at in a Board. from Lee, financial a who and institutions. formerly deal leadership Jill is roles resigned the Joon experience, Jill has financials, cross-border of of our also a serving wealth recently filling Dr. is CPA, previously held banking senior seat who by number

we continue success key and operational for the On affairs to groups. through our build front, commercial strategic regulatory, hires medical across

to that science the I also brought reimbursement to addition our liaisons to announce on I new field, depth market group, been of Presidents and by am operations we’ve we’ve the medical our impressed the the experience expanding commercial for in two Vice our of talent commercial focused in on today. pleased building and in recruit access, that board company. able base am

voclosporin, actively that move the well supply NDA, NDA working are of to as year. will for forward during to the on us with we the an half regulatory next enable in making respect drug submission With as commercial modules investments first

announced We and drug-drug MMF completion in with interaction of also voclosporin FDA lupus. with requested study recently patients the an

this to metabolism no study to the that providing of compound additional impact MMF for expected, voclosporin As differentiation cyclosporine. demonstrated on relative this

an activities for the and on As first AURORA focus flurry a during of company-wide will received assuming submission you can preparing this next report the we imagine, a trigger once NDA the half results of positive, corporate year. of and

XXXX, the in we nephritis. treatment continue of there, as of treatment commercial projecting to From in lupus to combination potential early a with launch anticipate voclosporin MMF for

interim other continues the will become the Moving results during are second next from year. briefly programs we ongoing pipeline, of in the running, to enroll to and we available this patients program FSGS half believe study

will for second we Lastly, year. initiated the trial X/X execution, half the Phase in next expect this we the last solid from design trial AUDREY continuing syndrome eyes dry be and available of of results theme on month

results become year. this and team look providing Aurinia milestones the by on once available of on with to the results, The to they we continues the deliver all AURORA everyone eyes end its execute to and forward pending

turn stage over with the call Dr. set, I’d to like So that now to

Neil? Solomons.

Neil Solomons

all and the just development we And for to minutes joining. have mentioned, AURORA. see I'd Thanks, recap Peter, thanks what this spend of to view and few like afternoon on voclosporin our path from to as a

be previously trial completed total a nephritis treatment XXX comparable trial The or mofetil reminder, of enrolled a is LN. randomized, double-blind [Indiscernible] lupus to a the As the study top of on of that patients. AURORA global, to designed MMF AURORA mycophenolate of for is voclosporin is clinical or placebo-controlled which

see to are We the increase speed … whether can excited voclosporin

Operator

are technical hold. Please hold, Please gentlemen, difficulties. proceed. are please We and experiencing Ladies technical experiencing difficulties. we

Peter Greenleaf

it’s interesting, continue. Please Neil. Hello,

Neil Solomons

The referred ratios taking remission few is a of Okay. receiving reporting looking to as renal year endpoint the response with positive is place visit filing. for regulatory end this our our previously of ago, from XX-weeks. complete are last we primary by and last U.S. which trial the basis And the at forward to study the patient, results weeks

approved indication. specific the in FDA in this result drug could first This

the inhibitor in received tested We’ve with therapy subjects reminder, some than renal characteristics the more extensive As setting. research been transplant a having that novel patients voclosporin is X,XXX an molecule. years in calcineurin of several has the different into done a in

MMF, is labeled results A This with as believe cyclosporine leads the be exposure interacting the Unlike no which MMF completed can that study by combination the voclosporin our MMF. lupus of voclosporin in of used drug-drug highlighted MMF. on to has such us is and demonstrates study interaction voclosporin our which with of interactions predictably

and of pivotal with like their outcomes consistently Phase await enrollment results. the successful been comment of team X our milestones as initiation these the has the meeting agencies regulatory in and observed patients the Aurinia I’d execution met our by X, into record end and we that AURORA, recruitments team exemplary Phase from to the has

this on completed rates delta believe of will to see in with meaningful that that’s between a we and equal in very is positive our than absolute XX response value our show is or treatment on we but more results larger From be with would them a the P AURA taken treatment and XX constitute weeks, studies that treatment and hope than effect We previously a will X.XX. the increasing between perspective, XX% this arms. and LN, delta based consistent we’ve hope our shown AURA between less can at AURORA of even based seen clinically –

is of rapidity striking was the early rapid goals can the a generated What proteinuria, The that of AURA achieving important LN XX we produce in therapy. weeks. from response effect data renal affect as most reduction voclosporin as remains one really previously in

been is with of of disease As literature here's control has outcomes the frequently early essentially patients long-term a parameters. in between strong LN, net correlation reported and

expect later given a action improvement and namely of we early year rates mechanism response disease exactly profound arms we of AURORA. with have voclosporin we the would what and separation In increasing in direct between of with some observed in its renal one in the both kidney results active over effect effect This is to the course treatment see modifying on continued AURA, comparators. and

of start dry our to Phase dosing we the AURORA minutes on everyone focused X/X to announce eye theme development few with a syndrome. Even trial execution, the other results, for spend delighted I’d our in were reviewing month clinical programs. last Keeping the on like of AUDREY upcoming patient

we this results be X to DES promising pilot and market program. the Following year, compared upon the striking or with showed earlier the data VOS these expand VOS Phase build moved VOS to current states, well quickly efficacy with to results early leader tolerated we’ve reported

eye XX AUDREY, dosed so or weeks. are of in enrolled safety arms with expected eye XXX evaluating one of X.X% the all, be vehicle syndrome. twice-daily and either in to dry is VOS As double-masked VOS, VOS efficacy Phase dry randomized four X/X Aurinia a you X.X% X.XX% recall, subjects vehicle-controlled to a subjects trial a schedule all and total dose-ranging randomization In for into arms being of one-to-one-to-one-to-one randomized VOS, with approximately

STT AUDREY proportion of improvements in or Test, a outcome XX at be Schirmer The measure for Tear four weeks. primarily millimeter the with will subjects

points, stinging, at multiple and and time sensation STT body at secondary photophobia, in include, safety foreign eye pain multiple points; change fluorescein outcome time burning, FCS, dryness, eye will points; Furthermore, time staining, additional measures at or itching, endpoints. multiple

half year. that To-date, this and AUDREY during available next study been track anticipate we on enrollments will the from results of has second in and be progress

So to to unmet medical we this needs address and are persistent very with associated aim the advance condition. VOS excited

Focal Glomerulosclerosis for Moving voclosporin briefly to or FSGS. more Segmental simply

FSGS evaluate XXXX. recently open-label patients The diagnosed June As Aurinia for recall, back a of the of to role designed you for primary study is X Phase voclosporin in initiated proof-of-concept FSGS. with will study updated

quarter to to financial of during XX XXXX. be patients approximately he we And third review of is t clinical And recruitment any enrolled with of results. Dennis? this total we’ll back will Dennis Q&A half the that study happy to on anticipate session. track, a the expected second the over of questions take be with to results the programs, during for interim pass in review A I continue

Dennis Bourgeault

Neil. Thanks,

per the common in XXXX, share XXXX. For $X.XX compared months for $XX.X of $X.XX three of loss or reported per to million loss Aurinia September million share, or period net common a same net consolidated $XX ended XX, the a consolidated

three the months development XX, expenses September expenses The XXXX, for and these to to million for related XX, million manufacturing increased XXXX. Research ended September in primarily use. $XX.X voclosporin and ended were months to compared commercial for increase the three of $XX.X investigational the

costs two and these study, trial were were dry incurred of clinical with X/X AURORA costs. NDA of offset In for the lower initiation associated cost Phase addition, LN, study, extension the trial, the AURORA higher clinical submission planned DDI eye by the completion for syndrome costs partially preparation

X as Corporate $X.X incurred pre-commercial for the technology to compared insurance, administration the activities fees, levels cost research. company months the $X.X higher and results in organization Phase including XXXX, period market consulting AURORA – three of million information to company professional The ended business activity expenses reflected The and overall same in scales development and LN. personnel million for the increase ahead increased higher was for XXXX. September XX,

$X Non-cash business and in ended R&D XXXX and compared corporate for quarter expense stock for million million in the was and as development same the XX, September included both was $X.X expenses. XXXX, period general third compensation to

XXXX, derivative in a AURORA increase fair reduced XXXX. of warrant estimated which XX, an third fair the of value million third September $X.X value quarter recorded for which increased as compared non-cash the a ended in of reduction quarter September liabilities derivative loss the loss warrant $X.X of the of liabilities million to the estimated for

outlay result not liabilities the eliminated be on will any of warrant cash exercise derivative by warrants forfeiture and the The the company. in will ultimately or

period XXXX XX, in September The afternoon. financial the issued release for provided nine the ended this results months are

million, compared As September $XXX.X XX, million XX, XXXX. a $XXX.X XXXX, had of cash XXXX at June at cash December XX, Aurinia and $XXX to million and equivalents of

September proceeds of upon million a common per the of ATM price of facility U.S. million pursuant XX, shares at Jefferies. company received share average net $X.XX its weighted to XXXX X.XX sale The $XX.X with

same and periods used in $XX compared September respectively operating the million the respectively Net million and three $XX.X activities for in $XX.X was cash nine and months for million $XX.X XX, to million XXXX. XXXX, ended

The X company program the and believes conduct of for complete study; to eye, the LN AURORA plans, clinical the quarter fund extension financial the AURORA Phase NDA ongoing FSGS; the that submission for fund operations resources based including study on fourth it has XXXX. X trial dry sufficient its FDA; trial existing into current the AUDREY the and conduct the to

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

Peter Greenleaf

is Well, continued execution thanks, I'd solid we Dennis Q&A, opportunity. unique the building in for Aurinia up say preparing a fronts, that a before opening strategically With are and on success. like to to all truly organization

We are ability full to lives potential from patients’ committed the its suffering nephritis. to of and realize impact lupus voclosporin

to hopefully enable XXXX, voclosporin a approved end FDA organization, strong to at scale drug execute lupus to million a balance the the we plans our most submit well development importantly, With for the be of on voclosporin the dossier clinical year September robust are to sheet nephritis. for positioned of next $XXX.X and first

I'd that, Q&A. with back to call to and like line the the Operator? the And open turn operator for

Operator

[Operator coming from today question Our Fitzgerald. Instructions] Alethia first from is Young Cantor

is line now Your live.

Alethia Young

guys. Hey for questions. taking Thanks my

from I talk in a design, the X of end me the know are year. clinical we bit about any, versus if between are couple data could to forward couple. a if just there Phase I little the all wonder the and you by by enrollment, looking One, difference Phase X Just

attention of think and just that infrastructure, And the will would be you And turn kind in of given have any little is, the it the a commercial I then, there. to like? their the question color if themselves is, have around eye XXXX, case build people start you about look I for people voclosporin successful talk program and second third you might for I will data dry many kind or my Thanks. how bit up what need want

Peter Greenleaf

then things so, to the don’t around a why Yes, and off I table talk little push about. kick bit

Phase the to the youngest in and most the with account around question was into was, perspective, So tenure to is have company, that X differences table me terms of designs assuring my Phase X things my probably the in of one from take think, first that the lupus nephritis I one being Phase agency to this I’ll But is very that Phase which from results X case there shift bit end to changes since been Phase he into here genesis. X that to little fact little has as the into not X the is always Phase you and take Neil since go X. deeper the of maybe the

Neil Solomons

Yes, said, the appearing forward Peter so, treating. as differences are

any patients than between who only will not the have design, difference – of XX which to permitting and have had amount of very limited outcomes. very don’t all is permitted to enrollment a a terms six patients months. longer fewer we constitute biopsy This much is expected XX% are of and duration is that to make the we In the major affect believe patients supposed we difference of

this primary the endpoints, AURA primary for that that is more get in different the XX in much that the endpoint. we AURORA reason we've operational XX previous data year, are use over at And was before but XX-week produce countries from endpoint a weeks. was XX actually calls, the to the on – other off of week the of obviously, is that the weeks, so terms the using differences And that from Lanka. In primary that we which to is some said as impressive many Sri

the identical. other enhanced than designs a monitoring are have in trial the We medical in AURORA almost effect more that

Peter Greenleaf

on Xb dry Phase start showing results, the move sort Well, centered opportunity? have see of any see opportunity then, that think is and that I X/X is I we and into as how do could Phase thoughts. here others your team my I on, believe I of guess, And results, or eye from mean, actually second – the question have if I

next level, five in that huge there this the product $X the out still could terms there market to unmet today treatments reports very But large physician is most as are to I be as large-scale $X opportunity. Obviously, total market billion huge is research the years, that mean, recently over dry a need in billion and patient shown three medical have a available published eyes at of globally sales.

they obviously, after importantly, to more to So, and better terms side a business solutions challenge a the go opportunity of opportunity have. in huge to to in the try to patients provide of that huge treating terms continue

Xb the actually us we this we I actually so convincing study do we mean, want through that did I program. well a into we took a full development to in why Phase to designed our underscore, endpoint doing study it’s jumped secondary exploratory engage was and

opportunity The results states starting forward next taking versus and us quite looking the and I going saw X market move towards on. the and to path. starts capitalize the actually us take to opportunity is realize we're to were a that really to doing study into regulator a to huge we're we that an market a think that convincing this to before It’s going Phase it’s

were developing starting the you since this and comments? initiative, brainchild what of you add behind sort to my Mike, this would

Michael Martin

restate year, way I back would back completely go you that. would this something have I January cyclosporine at versus I different think it’s and apparent data just than this molecule data look in much is delivered the that this to clearly it’s and in head-to-head. the that much, released that echo to urge particular Peter, the eye a But doing in and

Peter Greenleaf

and up appropriately I work diligent is appropriate lot company think the commercial the infrastructure also while been terms our would overshooting then not the to this period, been the pre-data. about of in build and done a what the has Mike. around Thanks, think last and pre-work And centered I is thinking time question of is

and adequately think mode. we should by end be the positive where the seeing the U.S. of that on are prepared more to we going we're in hoping and invest would We for build then aggressive lupus market much into results have nephritis a and So move year. I to data the

want we continue To company foremost, we can there. to going get our concentrate as we regulatory into where ball particulars, going and the U.S., want the major that’s put Outside be the we to first successful because the be a are emphasis move to on forward. to we to think U.S.

the enough look of more universe to for of likely, we think in in a try investment major disease partner do outside to most get can the But impactful on we we most the be this detail, U.S., the and support where partners to to we the not into likely bring in sizable many would U.S. with and in the U.S. rheumatologist treating another have nephrologists would geographies

you equation. in We'll any probably I think the early happens it’s see more give data. the what specifics, of too the post readout To

Alethia Young

Thanks. Very best of detailed and luck.

Peter Greenleaf

Thank you.

Dennis Bourgeault

Alethia. Thanks,

Operator

Thank you.

is from from today Joseph Schwartz Leerink. question Our next coming SVP

Your line is live. now

Peter Greenleaf

Hey, Joe,

Joseph Schwartz

Great, Thanks for on Phase are first presented thanks how one my question is, their guys? guess, progress. recently for LN. of question landscape their you very all the X my much. anti-CD Roche since data drug Hey, taking congrats the competitive and proliferative I XX

see the LN. It’s some has will natural in since do been a there segmentation this voclosporin? market. of So a been for you Or success while competitor potential a as be there

is beginning here? the hopefully, So, new a of this trend

Peter Greenleaf

Yes, something mean, that’s first progress disease for in great I patients. this is

that developments through in the development, competitive early gets are patient for excited albeit things move does other continue are So, their their to what community. to as products they we

just not see more Roche AstraZeneca Neil on been why data the has nephritis. a is we comments, maybe Neil data is produced there lupus, on lupus give I, longer can in around Since than few some just than this there we

that Gazyva current then to nephritis. an there see But waiting some on. are you Maybe, since some can actually give most on and thoughts the have other showed are competitors is and in they But data few that. Neil probably a ongoing we data lupus trial

Neil Solomons

rather am perspective very I is study complementary mean, The a data that interesting obviously, certainly I details is to I as cells, exploratory than a voclosporin believe. sure encouraging. Gazyva too small I Yes, from from this well mechanistic many it’s T mean

that. say XX a or think as They this at the with I and small in it's time, the out towards started you we all can exposure to probably all months that's significant so, see would point probably I treatment – to extend say certainly study. it

study I up – Phase to that able this. think that’s confirm t hey them how to it’s to be design that X

I that’s being about I and says I can what forms. also what But say is any all integrated echo very a Peter players That’s landscape, mean, showing different encouraged.

Joseph Schwartz

And then… Okay.

Peter Greenleaf

clearly. it track will Joe. it ahead, and watching We be Go

Sorry.

Joseph Schwartz

No problem.

So, elected a who how if just give was from of have AURORA eligible do to curious AURORAX to to patients rollover sense many you I have that? us could been

Peter Greenleaf

least commented, we've think historically for have not the we or commented, don't this at public I in trial, Yes. domain. Joe,

on haven't will know, know we So, we when reported we but that.

Joseph Schwartz

then, could began, regulatory I dose-ranging the wondering, VOS due that some tolerability. just that through rationale? to be trial two it test Maybe to in anything prior doses walk Okay. work was in driven or rationale of the feedback by lower to us just or Was that other you if you saw AUDREY doesn’t seem

Neil Solomons

our - and drugs think, with discussions the is, looked. they’ve our so at FDA and looking I that previous anticipation

other bases. certainly being drugs. we Some with our is what’s FDA. desirable. had meeting done to cover concentration want this We've the with ranging is pre-IND And a us And

with we the always with to nowhere are find effective to development effective the near It’s concentration of practice believe a that good X.X% lowest dose. and that clinical lowest we dose VOS,

our doses think, rationale. So, the sounds try reason that I it was then we and that lower will

Joseph Schwartz

my Thanks makes sense. It Okay. for taking question.

Operator

you. Thank

Our Wainwright. coming Arce from next from is question today Ed H.C.

is now line Your live.

Ed Arce

my Hi, the through questions guys. taking congrats and continued quarter. on Thanks the progress for

Peter Greenleaf

Ed. Thanks,

Ed Arce

readout. a couple on first the So, I imminent have

First, I first guess, for couple Neil.

weeks, thinking kidney this endpoint rescue less the addressing remission CR response a also of but and loss the on AURA back paper, Just meds, significant was no X.X, than steroid XX UPCR with on the composite no XX% rigorous complete function. or LV at

delta that, was with the about weeks, at XX XX And really placebo adjusted.

you just and more. the earlier you comment that I could comments meaningful hoping how prior context on Phase about being at to X. the data, especially so, heard in of wonder least site well, I since XX your clinically have if And for better selection the see perspective

the discuss LN the of mechanism immunomodulatory And got around and directly, differential, the now space readouts the other photo specifically, on question or the like in we've the which just, kidney other you could the two sites if then, the just study appear that all close, competitively, the others? also, the mechanism doesn’t to others, dual-acting voclosporin, effect of but both case with its is be

a have as I And follow-ups couple well.

Peter Greenleaf

last to Okay. Well, I to thing Ed. reemphasize is thanks, start I two-part part of this I to. your went here, for a question with want guess, mean, the foremost, because that’s I Joe where and good think first patients.

we more have seeing here. So folks some success

to and early. still one forward will relatively try would I to on am this us is, thing I contextualize it’s the I success, add put For sure guess, Neil to

controlled effect that could of longer have The well rapidity you see relatively a small. to not from would impact patients we this see time some a But these these trials, that done more to that potentially, has and because in it out of maybe, sort the been good potentially study is see response appears did and period B-cell to inhibitors same have early. of want

drugs, just have both know. the at but we on have in go could could to good these be complementary this mean, pathways to could are of genesis potential different Neil separate don't it stage, how something disease. combination we to be drugs respond which I the know. patients down for don't been road, is, to It be the So, in pathways. There depending said, patients that effects differences back we

These by this are X not a in Roche not lupus nephritis been trial Phase not specifically. – that’s is seen and Phase done X AstraZeneca’s we’ve readout

in X still reading a and and short it’s to what add have few Neil trial early just it? months. we here encouraging, you While weeks Phase relatively out would a

Neil Solomons

there the I of be We transport in reasonable to unique the neuro and for and longer-term believe it direct voclosporin. of Yes, effect appears disease rapidity really a think a treatment clearly of We mechanism. It onset feature this put observation effect. disease. the to dual almost that’s this down a that a is modifying it’s drugs

dangerous it the you fits again, And mechanistically, don’t targets. the to always with as it’s numbers, certainly but can small from far I rapidity we as that believe see get appear across trials, what Gazyva. about But with in patient comparing

we to weeks. the I your delta, question delta about Back saw mean, sure, in XX% first XX

less not shown that’s studies and ground wanted X.X me, of win, not that drug Not and approvable. bit as a to a at P any in than FDA huge the of point I incredibly impressive. of not consider value to is is and But So, two may any consecutive all a that just that kind this win. win here a say be just to as

bigger So, remission we look I we the intervals there the here. think at concurrent better. take point. always achieve around and two difference at every are some are back to just sometimes need is Clearly, step a we to No what is trying studies identical. There

be than cannot is, that’s P me very, to very bar to big going to a if the highly win your that studies X.XX a or to that the sets and that's show two occurs. FDA high attention and for studies is – and I draw to two what equals less But – for value

Peter Greenleaf

had follow-on you question? Ed, a

Ed Arce

lot That’s details, great. great. of Yes,

study. timeline, a do the decided don’t from is then, you. Just And aside the news One couple your to on you priority month Thank on six Dr. resign. comment quick particular review? know Joon why given yesterday, questions potential launch, expect early on the reasons I any if XXXX could LN you Lee

Peter Greenleaf

this? comment want You on to

Neil Solomons

we point expectation will priority which yet. review is That's that get working assumption. review at Well, this priority what our our

Peter Greenleaf

Board geographies the our banking Yes, news we and rounds future experience on our need other Board to sets company, Jill and a the in out important from to Ed, the to brings cross-border she fact of to investment operating we that yesterday are the skill really the and Canadian great complements first in where and we company financial going the move going at addition in is are to reinforcing the and into future. experiences be institution the really

he that it was nothing Ed to for that. and resigned, As detail don’t be and than more it Joon should much Lee, read I Didn’t into Dr. that. give personal think really listen, why reasons as color more than

Ed Arce

much. you Thank so

Peter Greenleaf

Thanks, Ed.

Operator

Oppenheimer Our Thank Instructions] Kim you. from Justin question coming Company. [Operator & from today next is

is now line Your live.

Justin Kim

Hi, good afternoon. Thanks for taking questions. the

the we you at As next from describe review the extension study what data maybe included timing about might what half, think components XXXX? be of be perspective, commercialization blinded potential available cycle in from a ongoing available? or for And filing potential a sort can FDA's

Peter Greenleaf

comfortable of said dredge is upfront. So, feel that that, should data we I do historically are enough to had what we going

Operator

It line gentlemen. does experiencing Please technical are has again. moment the proceed. gone appear please difficulties. and silent ladies we Apologies speaker while One

Peter Greenleaf

drop off? that or off If through midstream? to were didn’t we where get cut you my Justin walk

Justin Kim

it dropped think I off midway.

Peter Greenleaf

am submission. for do of time again. long not Neil, to right. short is sorry we’ll All start be the FDA enough understands to better than, and close the probably I trial I it the have because kick it’s it not Neil know to to going it the flow to patient we he by and what probably, am or have The extension

come comprehensive actually the are review the into But to package data produce to a forward we results. to is, going that lead have when we

contextualize results appropriately can So that we we see. whatever

part the – submission. actually for trial drug don’t of it moving But the I it it look be part But I was do the have not a have Neil? to the of submission. think we complementary believe intention to to forward. was extension as at

Neil Solomons

are safety we be from the interim will the with not it’s but the submitting some the safety part submission update, data – data as study is primary continuation AURORA So, FDA day hoping XXX of – part the to. safety of our you that discussion

Justin Kim

ACR, on were what any. observed jumping in some what data investigators have X? of just benefits from out some AURORA extra the discuss followed measures that renal maybe And operators to data at interest great. come you that AURORA in of measures recent through gathered that the and Can are being Okay, if on

Neil Solomons

so, an trial. lupus Yes, primarily this active is obviously, nephritis acute

renal purely patients. manifestation, few Some patients some very, have though actually highest renal almost very

such and biomarkers more DNA, as nephritis. for specific at of looking complement lupus actually lupus are We is the in guess, which double-stranded also I a

has of - looking a at some obviously. In are but are and at manifestations only well, addition, and secondary as also not biomarkers, lupus. endpoint constitute we these systematic clinical scores to going looking obviously, composites - And they

Justin Kim

last study how C&I and are MMF. question how from DDI of with currently managed, around Can differ sort use of that Okay, describe, voclosporin? recent really the is potential might you currently a of treated VOS great. minority the and My just off-label with patients

Peter Greenleaf

Well, I the that just set started, the I think, forward the of we trial today. arm control we basically in did care standard as

we nephritis. said, host to they I lupus Now can everybody the fail specifically is to that call as for no that, have current solutions on think the there different utilization. varying data treatment, they But go of know is, a drug of and off-label – degrees their FDA support have as that of patients approved approved

that other potentially what approach which a the it over and of So tapered cost therapies steroids, And is that that is standard base even be if to bring RITUXAN, therapies. is whether utilized, but in therapy are other patients time. on that, we scale are they drugs combination steroids can cyclophosphamide, with using are MMF fail hopefully

But some from of they the I literature though there in I’ve what support would even are of to of is I guess, utilization looked used. literatures, limited those follow-on argue terms therapies at

Justin Kim

DDI from case I from are a claims Great. being Great. incorporatable sort of for filed global the use study, just standpoint, another into guess, internationally? those results the Okay. of the maybe

Peter Greenleaf

DDI predates job doing is give molecule other things we the was done to But characterize doing team, PKPD the differentiated. our that. it. how by I better know me type But of we study were did one works a FDA, the the been don’t say was to to that try – answer one it has and so that requested have that we actually technical here I’d of the a very team think I is, because I good

us I think structure to why to at versus end other like the result the DDI help the the of we ultimate the the the different. cyclosporin. are be clinical PKPD continue work talking study different Things around and will as to differentiate of molecule that point around day, should

be a we’ve not new that’s themselves. think just clear, it been It molecular drug this and how I results entity Let's is then Neil? the and speak and different studying is for cyclosporin.

Neil Solomons

Yes, is actually this… around think question I the

Peter Greenleaf

AURORA United that grant AURA And our – States. use got the right the study. study suite now those protocol successfully in we issuing have for in are in we’ve Yes, patents the in using we and now, dosing a the and been of

the will hope us in between that those patents rest as prosecuting And terms now. to But Europe are for far and of patent world. office we follow. phase of national are going continuation the and We the in and some detail as claims, keep the these we

Justin Kim

much. Thanks Okay. Great. very

Operator

Thank you.

from Ed today question a is from Wainwright. follow-up Arce next H.C. Our

Your live. line now is

Ed Arce

Hi. Thanks the follow-up. taking for

you the so, sense And from Ad from Just indication potential around Thank any of a Do areas a quick if be the have interest one. you. could Com? agency what potential, agency? or

Neil Solomons

no So, has approved – in the nephritis. discussions that’s SLE. There our There been possibility. drug in with common no for is lupus a agency

So, get discussion. will everything for that potential the – be lupus our questions I’d to imagine that, is we is nephritis for one expectation what may as what

Ed Arce

right. All you. Thank

Operator

or would for answer floor to Ladies Thank the end further session. any of we’ve to and you. reached like back our the gentlemen, comments. I management over closing and question turn

Peter Greenleaf

Thank you. call. to the the call remain joining to excited we joining about what’s time, excited for to And company. all are I everyone what’s and the we the about you for thank on this horizon We today. At for very want come thank want

touch feel So, and I in questions reach you to near the have I free Please sure, in Glenn am we’ll or if any term, are here. be out.

much and evening. good very a you have Thank

Operator

conclude today’s teleconference. does That you. Thank

you line your thank day. disconnect may participation for wonderful and time have You a this your at We today.

Aurinia Pharmaceuticals (AUPH) 15 Nov 192019 Q3 Earnings call transcript