AUPH - Earnings call transcript Q2 2019 | Aurinia Pharmaceuticals Inc.

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Operator

Greetings, and welcome to Aurinia Pharmaceuticals Inc.

Second 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] Please not this conference is being recorded.

to to like host now would introduce today's you Dr. I Dr. Schulman. Glenn you Thank begin. you, may

Glenn Schulman

and Welcome Thanks, quarter afternoon, good Kevin, everyone. conference XXXX to call. results second Aurinia’s

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

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

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

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

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

X, XXXX this assume any required upon update the during as no as as based made today today's and statements statements of to of August currently are such obligation All we us. available call information law by Except date. to of

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

Peter Greenleaf

with on pleasure you all us is to Thanks Glenn the it a today. and have call

been past the has it time interesting during So here at Aurinia. an exciting truly and quarter

here the and it's the my trajectory tenure at get Aurinia know get to to an of organization. the current course with voclosporin the Over program pleasure at absolute team and been short in-depth

mention the that Meeting at that briefly time shareholders array also had our through say invested will Annual throughout around outcome and was from to both and aligned Aurinia date. organization the vast other here in reiterate opportunity, a of to we and to in that there Directors to want sufficient proxy I have and and of the our I our the with results from personally voclosporin we're that to the potential all full hear realize General to been has humbled spokespersons pleased down are of the

as dive it's on tell also results NDA development prepare development capitalize portfolio trial track Beyond nephritis, ready and that, this me I the for learning upcoming AURORA launch to our to the potential that this I which all of compound, indications end in-depth lupus in remains potential ensure programs only for be and for by to you into on really to molecule. year, but for also X the while period work reported Phase of the process expanding is been a our not the can Aurinia other

on everyone our quarter upon several role that here key When priorities first were CEO opportunity with the Aurinia. the I had of chat at call, I to discussed taking

United organization commercialization of fully ensure plans the foremost the transition around in for States a world. is a to First our prepared the and was prepared clinical late-stage company and that to was from and company development voclosporin that the into

eye rare CNI, syndrome. that both the for work in this the Further, of to renal are novel it as pipeline of we potential imperative FSGS and around management such for diseases that indications topically was breadth the possible expand dry

walk and our full a look Solomon these Dr. our Mike indications press afternoon's developments. forward having and release, plans have team you'll on I provided to for As through we this note you Martin Neil from from update both

Aurinia continues single infrastructure pursue working an syndrome for to leverage now clinical pre-commercial dry organization additional voclosporin. early eye to our stage a to trajectory growth from its indication a R&D opportunities from company including FSGS,

begun prepare growth. build This be perspective for in and to and the to phase corporate to to new building organization needs of processes will potential to take scale this a means and it leaders we've where the order that organization successful. From systems adding go

discussing embarked review of broader with upon company Directors look part As Board forward this over work, we next our of few the strategy months. our to a of with will investors which we

Key as that in are work, pleased of growth. experience Donley, we managing were this Max required the who strategy announce of to both has of as areas development next for well of corporate addition extensive these to last operations month internal phase

also to excited will overall addition a board were our and corporate Glenn efforts that, here we relations head Schulman who on basis. investor on bring In to full-time communications

mission along of we in groups. roles and projected for support our is lupus these expansion also medical Beyond in mofetil of a in with our CMC hires XXXX key making with commercial are low-dose first-line steroids overarching for combination voclosporin our commercial the in this launch process affairs, mycophenolate as to The regulatory treatment nephritis.

that I'd over turn the now quite to review, to front-end Dr. call So like with

clinical study. Solomons protocol provide Eye alongside an made to Neil? recently for steps FSGS Dry the the review the the Syndrome and program. next will AUDREY update He trial detail VOS then

Neil Solomons

mentioned, FSGS trial joining. Peter, status the AURORA all updates on update through around for with moment I'll the Thanks brief trial eye And report provide some as dry go then and for nephritis. and a take X syndrome to X/X first Phase for a Phase AUDREY thanks clinical lupus

Study, tolerability leader also superior Phase earlier ophthalmic Phase data a tolerated Phase Eye eye dry comparable and quarter expected have Dry enrollment for versus Restasis. we program the With focused to current for AUDREY, our producing plans of results begin showed dubbed striking, well U.S. be that's reported results X the XXXX. clinical respect to in X/X study in generated some development market the with X Based fourth exploratory syndrome, eye to Aurinia of sign pilot upon known year, initiated cyclosporine commercial this study, a as study VOS the dry patients the program, emulsion,

has critical double-masked, dose include requirements a AUDREY that of safety for regulatory in requirements certain These In will product This approval. vehicle-controlled subjects the traditionally include [indiscernible] will with DES versus be a optimization comparison ranging dose the randomized, vehicle. FDA and a efficacy study along to short, both with requirements required study evaluate DES. VOS

The for this with and either In be the VOS, beginning for XX will XX a X.X% will arms improvement all, proportion of daily year. X or enrolled four twice to approximately X.X% total outcome subjects XXX of will consist be randomization all or in with weeks. at subjects of dosed encompass being arms schedule a X:X:X:X vehicle, measure Tear VOS, mm weeks. later Test The Schirmer primary AUDREY VOS X.XX% study STT

stinging, measures in Furthermore, time include burning, eye Eye multiple Assessments dryness, multiple points, at pain points, body in at at photophobia, or outcome secondary additional time and multiple endpoints. STT time and SANDE time change will FCS multiple Dry foreign sensation change in Fluorescein eye or points, Staining itching, Symptom safety Corneal at points,

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

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

XXXX. study with the primary role Phase to patients a X June and recall, proof-of-concept, updates voclosporin diagnosed was designed in here will it open-label of for FSGS as evaluate you FSGS. will Aurinia recent As The study back for initiated continue

goal first provide was treatment study, a FSGS. a our to As pilot diagnosis a patient's option following of initial line primary immediately

this voclosporin nature the the for the strategies two disease Given role have understand of and progress rare of we about its this orphan to awareness increased implemented recently disease.

specifically From a we added view sites the U.S. Republic. clinical and clinical additional of operations in the have Dominican outside

enrollment are originally study. the or in protocol oral either IV additional treatment-naïve for of as protocol we described FSGS. Beyond the in amendment criteria protocol that have This the steroid end allows also subjects enrollment sites, receiving adjusted treatment, broadening or this

tolerability as show initiation from Subjects in assessment of of the taking and prior FSGS total Subjects be patients steroid steroids results during the must baseline. A defined of steroids begin anticipate in XX% who study. in interim in reach may improvements have same discontinued poor to due UPCR XXXX. ability signs we total the XX last also improvements to to will enrolled treatment proteinuria

trial no nephritis. the lupus X lastly, news no of clinical treatment the news is And for for Phase AURORA

and The basis is results regulatory for endpoint with the renal at of study look of end September of As enrolled study which speed you'll were to a form filing. trial if background the U.S. randomized weeks we patients mycophenolate positive XX fully last mofetil of year, study this global lupus or whether controlled can of low-dose response. on of total AURORA at evaluating is double-blinded, globally. and placebo rate CellCept nephritis will of sites by as XXX and steroids complete primary recall, the addition forward response the the the our a achievement of voclosporin increase renal the

results. it the clinical With to a of over Dennis QX pass review for that financial review Dennis? of I'll programs, the

Dennis Bourgeault

Thanks everyone for Neil. Thanks joining.

months and $XX.X For period and reflect AURORA common reported ended to extension XXXX June per costs months XXXX. for preparation planned $X.XX the three preparation submission DES XX, million $X.XX The compared in million share the interaction costs X/X XX, the expenses for or share, of consolidated per increase for for XX, Aurinia $XX.X associated the the three million study, the of months incurred net XXXX. two June to or million consolidated the a a ended of clinical LN, for net development three the to $XX.X NDA trial, compared drug-drug ended higher common XXXX, June slightly Phase $XX.X loss for costs same loss with expenses study. Research increased these

for same June an consulting increase and XXXX due fees increased pre-commercial primarily to and activities Corporate in $X.X administration related such was XXXX. market The $X.X as compared to same development expense the and expenses million the ended research payer to and ended for million and in development XX, for both second increase same number three the is fees compensation million and and business to XXXX months recruitment period general and to compared XXXX was corporate as quarter Non-cash development business stock June included research $X sponsorship period personnel the in and expenses. in for higher the costs. XX,

of derivative of XX, other expenses similar $XXX,XXX the our also comparable associated during estimated contest defense no incurred recorded warrant our reduced Meeting. liabilities on not successful for result of will ultimately and cash the General company. proxy XXXX. June June a the The fair the the by warrants three XX, $XXX,XXX compared Aurinia an increase ended the second million June liabilities increased warrant periods. value were which same for loss There connection ended fair second the XXXX, quarter June period reduction in the XXXX non-cash Annual of for exercise which the estimated XXXX the of derivative of liabilities in in with ended loss quarter to XX, XXXX, the will $X.X be warrant in Aurinia months derivative expenses in forfeiture the any of with eliminated outlay XX, a value

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

June March short-term investments of XXXX. $XX.X cash quarter of million for of in $XXX.X ended XXXX, to a the cash, activities equivalents December used XXXX. quarter $XXX.X at million cash As XX, and XXXX compared million XXXX XX, Net operating and June the cash had equivalents Aurinia $XX.X second for $XXX.X million June million second at to XX, XX, ended XX, and cash was compared

lupus trial, X/X sufficient that for study, current including NDA AUDREY operations extension fund plans Phase and conduct FDA the trial half the to the into study submission X complete second the lupus fund initiate the AURORA believes XXXX. based financial the it that AURORA program and Company existing the Phase the nephritis FSGS, nephritis, for of ongoing to X has on resources its

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

Peter Greenleaf

So and you thank thanks Dennis everyone.

out Aurinia to up opening before to truly point just So that unique like is a Q&A, I'd opportunity. obviously

AURORA well finalizing activities. voclosporin the objectives trial lupus X this its remains syndrome additional potential as in exploratory of plans and to Phase X/X year. clinical as the our study. previously value has later its drug an start dry shown the Furthermore, focused strategic development company enable The in dry eye trial Our voclosporin, to program nephritis and the focused eye working a Phase build syndrome on of around are regulatory VOS pre-commercial our we're on programs,

and scale stage organization, the to will months AURORA the commercial during an half few as for sets results X confirmatory, lupus appropriately and if and During of along nephritis, we been past a of if Phase launch year with anticipation in have the steroids. projected in next for treatment a with continue the which mycophenolate first in NDA the mofetil low-dose combination filing voclosporin XXXX in approved first-line

end the the of as the $XXX.X a for With XXXX, sheet million at commercialization additional months. June of Aurinia, providing towards balance potential eye as X/X our capital company regulatory to especially scales initiation of of look is robust updates the to our strong well maintain forward the syndrome study the Phase at coming voclosporin. progress priority and dry AUDREY over submission as We position on

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

Operator

[Operator line Leerink. go of with from Thank SVB ahead Please the you. Our Instructions] question with Schwartz your comes first question. Joseph

Unidentified Analyst

enrollment, dialing Hi, for for I was shown for lupus haven’t are stratifying I'm question enrolling stratifying wondering patients questions. been classified to do with in treatment X to Thank Julie what to benefit patients? My taking demonstrate Joe. you, you and first nephritis. you voclosporin our Class are has

Peter Greenleaf

question answer Dr. but the over is thanks and want So give the for to short think the to yes, I question I

just Solomons little bit go to you to that. wanted a deeper see into if Neil?

Neil Solomons

I stratified exactly answered, work certainly because behave that stratifying patients pure yes showed X [indiscernible] care actually appeared may as versus these to behave did. Nevertheless, X peter to pure non-class for feeling our the class lupus are that is Peter. we non we nephritis non the X. there class Yes, we standard and mean, thanks work class we patients X according previous I differently. and in same of a pure X think, in Actually have between X,

Unidentified Analyst

was and a reason should thank is and you. hasn’t biopsies. data for brought bit requirements last as differ wondering think how can just include in characteristics I within the baseline biopsies the since the to I patients wondering patient the second X Okay months required how that if could about you six do versus for about biopsies, my had result? criteria in the talk great, because XX inclusion with months baseline Phase a we differences was were has for question to Phase And outcome X, little

Peter Greenleaf

X pass to but have was do but study biopsy, time that? again to and so Phase just want Phase I'm to the there the Yes, was trial into be X both difference to this to a Neil, Neil, a clear on you from going biopsy just to this that need take initiation the to it in in differed.

Neil Solomons

I Phase any Yes, little we and broad put Phase the think material days X leeway do had to not turn question seasonal not biopsy just X that. we expect study to answer I Phase to of is difference between the the patients Where do there away a mean, medically bit my reason in – is, X we after studies. periods, was had who a had even probably to few whereas in a time

change diagnostic the fact support we doesn’t did, what two-year publications literature in biopsy really fact is and over that to there So period a and very a much.

detailed did, the up we disease detailed sharply enrollments months proteinuria and to have to patients how recent a measurements what some flowing fact in did for six very So that have the we quite biopsy increasing steps to of patients. put that who in they ascertain active had provide

perspective, very, supports into very I think extended importantly really criteria will no my that X. coming we from difference expect, assertion Phase we who and versus the few that your entered patients on more there initial had be X Phase that material in patients those

Unidentified Analyst

I with be? have has end question was have pricing of - for what you last and what payer and thank some discussions your regarding And backs you wondering like push upper the discussions, to my had do has the payer Great, the could any clarification. what been

Peter Greenleaf

point target not doing pretty just that of what build market network the the of actually we our of ahead understand product that to and market on of So, research comfortable on done the in least of the at any do assessment the a in profile to like basic look is. research need terms detail, early my we're potential might sort feel publicly great to we've what details price do that but curve, not this disclosed we've up market of

to improvements able to be that of that the risk able data we're very data we'll balanced saw think us there the on we the going it market. risk it's types shows safe if show that's is balance be that on command is decent what to I X with between one say efficacy profile, in pricing the to solid right and But dependent Phase benefit and

that data. product But it's the see do think the order so too been I Right pricing X profile the to happens dependent would Phase now disclosed have we'll what on in be that Phase data. we've able of don't is building any a only and off to to we've target preemptive it do I research sort that really. basically in X. expectations specifically just And on based think

see Phase trial day. the We the the shows have what us X of to end at

Unidentified Analyst

I'll Okay, in thank much. queue. back hop you the very

Peter Greenleaf

you. Thank

Operator

the Our with with next Proceed Arce of question comes Ed line from HC Wainwright. your question.

Ed Arce

couple taking questions, for thanks my Hi, here.

leveraging of patient How advocates voclosporin, proactive, and are of commercialize? aware are on out similar tuning very point questioning, will data coming as very how just surely very the First strategy guess Thinking sort they that of but that wondering sites at first these impact and that both and to go commercial of strategy AURORA, from that LN patient very are are a are that different aware fine in perhaps. the you of as is your as voclosporin for sort there about think and given you trials think they close, you I you now how about this active. the angle you patients about line

Peter Greenleaf

that have our patients up I the talking on sites group influence thinking are have we answer the standpoint. drug, think has the I'll and know, participated having very some been of be of standpoint Affairs the about that also Medical adoption to on the with trials probably and ones that at have I of quickly, short actually the an a understand they've to sites. But Randhawa ground in that obviously be is, that Dr. these luxury the heads of drug patient who Well, as to sort tap and actually centers wanted our you really well, from from level obviously start have going us then best organization both the been but a

our stages as with of and that I well you is are are working fairly tell not just transition regimen out voclosporin, that this with there, and managed, education in team, closely a how stage the these have because at on to the very there can opinion commercial foundations group game early care affairs on but the the patient of a advocacy our is treatment currently treatment leader which of key the the group education for potential that what small adding disease of patients. and obviously are out for standard we're on a medical different is drug

the add Simrat, So are you to would education there. efforts that?

Simrat Randhawa

to I to and that, in the don’t a this have within operate Ed what Yes, and I fact. that legal couple that whole tight regulatory have over we industry is advocacy of many would and the extremely to have we add, more framework as lot say groups beholden watch major a all are matter we closes of it years the with closely, we worked last

of in ahead we a company I also market. the one for advocacy with of well think realities understanding even groups of larger I size curve interact the in that's and we're dare well our how curve slightly say of So the ahead the now for we're

what of and pluses to challenges they So actual their are minds folks actions. but conferences, go that treatment at how they those minuses and who are and not speaking lupus consider mechanism the their the are prescribe, and what prescribers, nephritis the just how in the conferences

confident curve the of So medical right company well working the the are a part is our of things to and we leverage size on in that the development and least where at we're program. affairs place those ahead all that in that we're right we're deploying standpoint resources But of from on knowledge. for the I'm now kinds pretty the of frankly

Ed Arce

sorry, go I'm Great, Peter that. thanks ahead. Yes, for

Peter Greenleaf

the a next no, very I on community first said waiting to team into was I've at the and with as enveloped been but really the small question just the this into was, hear for game. infrastructure how No, investment ingrained such been small amount I this and a such this impressed stage of call, what has of

need we're well we think and of be. ahead curve I where the to

So you sorry, another do have question? I'm

Ed Arce

Yes, no, thanks.

year endpoint dry well I data of you in moving know was, that am question based confusion issues with around off there the may And is, in talk data the a set again. around from you early of Schirmer out what this to led the others? of Thanks of choose that hear somewhat as the gratified other that are this given primary to The that are context was AUDREY to question that others? my And the study. what Test with as and opposed study, be that eye as sort you early forward potential

Peter Greenleaf

end again to to own really of from least at the to probably Yes, days. view but company going day tee I'm or the coming so my early into at this the expand either upon, Ed, Mike Neil

the statistically the really, significant of side. I majority think was clear tolerability message symptoms of difference. parameters think on trial endpoint signs across primary didn’t show there efficacy and the the Unfortunately, fairly a on I in

criteria trial were of not on impressive quite the market our making whether versus So the to decision kept forward we really secondary to leader. the or current move which endpoints

of development, approval. pertains that me see As pathway the gets really approach take the if of for around for the And that want it nail maybe to or would lot to think positioned next I a clinical one Neil on. – Mike stage regulatory let

Michael Martin

You Neil. go ahead

Neil Solomons

of as argue, endpoints mean results hit not endpoint. patients they still know you if Sure, Pete most Test is I not that in clear will very know though, our it study in tolerability endpoint. clear-cut. confusing were thanks. you improvement from as of study this XX yes very exploratory I Schirmer our what mm is exploratory the efficacy very, The is great are favor mean, and sure it. and the has Pete said, got difference Ed, done an you proportion would of which was small I not

Restasis We're to the endpoint really for size of XX% in in or mm where impressively past patients used score of addition in arm. Schirmer approach Restasis mean least VOS must. versus the the I XX% superior on [indiscernible] greater and eye VOS achieved compared has endpoint This the a therefore same sample dry approve the at treatment in to regulatory been inhibitors is calcineurin passage XX an some of

why for endpoint So that's forward we picked moving have that that, into our study. Phase X/X

things, confident secondly, two we we're treatment one very, there's from endpoint. saw very study. So that past we very highly decision that because believe regulatory large the for a this a And relevant is

Ed Arce

that, Thanks great. Okay, for very that so Mike helpful.

Peter Greenleaf

questions, there Are Ed? any

Ed Arce

thank me, from it That’s you.

Peter Greenleaf

Thanks, Ed.

Operator

no to are in back over remarks. management to questions turn would call queue, like closing for I there Since the left the any further

Peter Greenleaf

to and potential to Yes, I'm joining on about at we're the the this excited are the Aurinia Phase flow all you obviously. AURORA in fourth horizon thank year about the really of the And you on from what's trial call thanks operator. going news us X for have Obviously, excited quarter today. we

and joining for to evening. us of I the aside, facing year all also in for call environment I storage today. be the a great all for that FSGS syndrome. for really expansion want eye standout advance voclosporin, these we're to poised by continue to results, Aurinia. is As ahead investing our is All a to thank XXXX of everyone clinical to uses macroeconomic wish of really you really the optimizing we drive AUDREY for grow working dry commercialization study

Operator

concludes This teleconference. today's

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

Aurinia Pharmaceuticals (AUPH) 7 Aug 192019 Q2 Earnings call transcript