Aurinia Pharmaceuticals (AUPH) 3 Nov 222022 Q3 Earnings call transcript

Greetings, and welcome to Aurinia Pharmaceuticals Inc.

Third Quarter 2022 Earnings Call. At this time all participants are in listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. to [ph], conference Pharmaceuticals. Investor like host, to now Walbert John Relations would turn over the your I for Aurinia you. Thank

You may begin.

call Thank for Aurinia's thank and quarter and today's third you, discuss webcast results. you XXXX to Melissa, joining all

report to Miller, and filed me Joe release are Peter Executive Financial announcing Form a recent press Officer. and This on its the Greenleaf, Joining lead quarterly call results and operational President highlights its morning Chief issued financial this Chief Officer; XX-Q. morning Aurinia

For please US to available filings Securities auriniapharma.com. Aurinia’s and website also Aurinia’s more are refer information, with Exchange the Commission, on at which

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

factors today's Form Aurinia’s release Securities Aurinia’s during Aurinia’s along all in this no upon otherwise Commission required law, currently and based note are results current November to that discussion XXXX, obligation future statements any the Aurinia noted refer are and Securities on that press XX-K made and of time. please with all For unless our us affect Canadian update to Exchange Except Authorities. at available information X, statements. report financial as as Please assumes XX-Q, today, by call such to quarterly could recent business, and filings of the disclosures US and with and its of

Peter me Peter? Let call the to and now turn Greenleaf. President over Aurinia's CEO,

of third year-to-date. business, LUPKYNIS thank Thanks, a we'll joining you us. commercial John, for On including you review call, and the provide quarter and in morning, today's with performance and everyone good our

since preliminary this have expectations remainder for of we quarters a XXXX. results provide we will provide for our of view updated year. We XXXX, will for now then also three the And

to to on to overall update and our activities to clinical In more basic affairs Joe on update addition Miller and efforts, details strong our R&D move providing our reinforce then global We'll an our then I'll on cover performance, work intellectual we results ongoing patients. quarter commercial position. and financial property. an over provide to for and LUPKYNIS third will call on year-to-date financial medical the turn expansion benefits the

quarter So $XX.X started quarter net which to LUPKYNIS performance. with revenues bringing LUPKYNIS Total approval revenues product of European to year get the a reported let's Commission a our million. one-time amounted Otsuka third $XXX.X LUPKYNIS. revenue through for $XX XXXX for payment the for net net milestone million recognition Total business $XX.X the million. $XX.X total million year-to-date for XX product revenue the Total of included million, for quarter from of achievement the the to was September fiscal

forms. to on and grew or X,XXX increase patients to Total new start Moving the the X,XXX alongside up results. end of of on financial detail patients quarter therapy patients form QX, processing this behind by of patients improvements driven QX. prescription predominantly from The in was speed, by therapy the conversion end rates the at more of

improve rates drug and XX conversion to the on days patient continue Our and quarter-over-quarter. XX

end. overall today, approximately As periods days with adherence remains periods, Consistent remained conversion of rates at approximately strong at with consistent XX%. XX XX% prior prior quarter of at

Looking at in XXX our patient QX a from QX. start quarter-over-quarter, to form, XXX we slight decrease saw moving

are watching October to been address. we XXst, PSF our clearly These have closely were tactical at Looking most through trends and actions have a something year-to-date $X,XXX. recent data

and analysis internal more of claims from this our market remains slowdown our basis quarter evolve. over on as Our LUPKYNIS persistency, of renal to diagnosis, annualized for patient and and for What the figure foreshadow expect revenue than on guidance as including net nephritis QX payer I as $XX,XXX is biopsies an business, therapy dosing seen previously, higher time at lower per -- initial these of numbers versus we mix data But patient go approach realizable the and potential lupus stay year. the discussed per in indicators, patients on a QX number summer. new leading several decline QX have in QX, declined patient from we from to

overall visits doctor For approximately volume QX with lower proteinuria amount also the impacted and our performance and we resulted did and which during that patient offices. coupled summer lower QX. months happen, saw summer declined numbers, nephrology both both testing, versus in of These vacations a XX% in in rheumatology office

event market that events Our these or leads nature. to analysis seasonal are in temporary, us driven internal believe

we are what power understand While I'll dynamics, to have forward this in will a better walk we are currently through interim basis, driving you the market activity external which digging impact these deeper tactical now on through. going to

is focus provider throughout that First, learned message required deliver clinical LUPKYNIS prescribing adequately we from have solid adoption. the highest within efforts, clinical our and what selling engagement physicians is in healthcare to gained driven the our high-frequency launch

As frequency increasing We're and a closely, offices. XX setting and incentive targets team our we're for increasing in result, our and nephrology high X expectations, of clear potential focus through rheumatology these even areas. decile our actively activity field of tracking

in when that sales they offerings. We when they with know that physicians do program a also representative the see adopted combination other rate greater frequently

ACR on centered of feel small directed of conferences the of advantages key selling result, feature late campaign these patient a we also with and powerful be in we enhanced underserved and a and few their early overall recently understanding QX. features has professionals. at of move because our new emphasis resonates in lupus we advancing that We launched at meets high-volume personalized graphic better core This The on campaign sales offices months will nephritis or a on and media The ASN this LUPKYNIS. clinical alongside months. as of populations. our programs this feedback, Based force, new properties we weeks. campaign engagements, next of more web the campaign a and through our couple prioritizing physicians efforts will currently busy healthcare and As feature in our next aids medical upcoming the the are peer-to-peer strongly campaign needs message updating

addition are our to crucial LUPKYNIS affairs growth. efforts medical to driving our execution, related commercial In to

the with few presence healthcare a substantial we visibility have medical past Over generated the providers in-person significant with major at quarters, conference.

We and submit up, ACR presentations and abstracts continue to new this accepted is AURORA include conference at year. from AURORA for coming X XX X data the lupus, at ASN which

the approach product patient a increase is While meaningful team. much Alliance experience existing support Aurinia time prescribers frequency prescribing of and we ensure through marketing among our base, to the depth to of designed also first have want our and with our our

rates we our prescription. first for see our make and enhancements well focus to We've LUPKYNIS We patient. direct seamless on also with additional of website, here increased Along patients product. professionals. with throughout continue our key brand to to experiences of receipt in the PSF tied increased and patient team support the initial approval We recently in evidence following as lupkynis.com as can our intensity, have focus information healthcare sales and made provide to impact

lupus as launched a naive last September, full media and patients the country. we continue into and Lupus with campaign we blocks through of In The the enhanced online week, increased social a series move channels. we've addition, just lupus across this to focus directed to plan XXXX. of campaign directly campaign Foundation grow nephritis new with towards began America our we in In

months all anchor few our always over efficacy these launch to existing We, all our a of diagnosis, to in of will in patient. treatment, efforts directly centered and and moving that While the have of persistency next the have increase urgency programs around programs number continue. adherence education, addition, patient, new help

Lastly, previous calls, as we payer on rates access high. and reported are our approval

patients payers some However, initiating include hurdles still administrative therapy. for

on with of can the fill will actually remove work offices the also and our the largest LUPKYNIS right million third week, in third remain a and access revenue signed speed net partnering trend time payers average our million $XXX prescribing the last first physicians the just certain to and right that to enhance national guidance we will lessen to where the we're revenue one updating the access experience -- press will under for terms, XXXX. the these to to saw on quarter you as to shorten conversion. the motivation release, drive $XXX contract open So further also moments, the we hurdles commercial XXXX patients, Based for our with administrative PSF payers results

now with addition, XXXX In more than quarters results available. of for three

and continued quarterly million. We represents to conversion for This PSFs, in our is of adherence. achieve be midpoint In are growth, million in revised this $XXX to $XX guidance at also guidance a for order improvements number in persistency revenue net million the providing driven XXXX. growth preliminary XX% solid but curves $XXX time, to growth the the of this of expected by estimated XXXX an LUPKYNIS increase strong range to

as receive began Moving million mid-September $XX to adults collaboration received now as eligible to collaboration for we Upon is European all for of states revenues valid once of royalties marketing launched. efforts support, which with reflected product digit authorization CMC are to R&D with well achieved Norway an LUPKYNIS and double to EU the revenues and Northern granted is in reimbursement quarter, arrangement. regulatory the net to Liechtenstein, as the sales our we recognize Otsuka important a and lupus on milestone as both member in active Commission we additional low milestone In cost-plus as as and The treat authorization In sales well approval, product LUPKYNIS. from and a globalization nephritis. Ireland. supply for milestones Otsuka, Iceland, under Otsuka,

the to of reminder, LUPKYNIS not Marketing have milestone in authorization with guidance to approvals a Britain $XXX our half related in million applications Union our Japan. any payments revenue submitted As agreement with royalty payment, of collaboration guidance, and Otsuka product expected Great any market does first million this in $XXX or the net in updated XXXX been in Switzerland include XXXX. European revenue

approval Aurinia. reimbursement milestone will and pricing of the in $XX reminder, countries to a a in As major European million market five trigger the three

remains advancement track. additional $XX with vocal would The include once and and million for both our launched. to of along clinical in the updates milestone work pediatric ENLIGHT-LN the addition, Japan eligible net In double-digit approval, sales we on royalties our Upon study an REGISTRY. related for on be LUPKYNIS ongoing

now goal initiated had With towards active sites. the the we XX having sites year, of our the have of XX we just REGISTRY, total which beginning at

study on we knowledge about to to patient and FDA care data collected to further track meet to As We a and therapy. improve payers reminder, clinicians gain remain LUPKYNIS help access taking real-world from post-approval leverage commitments. plan our this ensure patients to and

our pipeline. Moving on to research

of work both are end compounds important build company. to ongoing and These as well wholesome IPR a for towards dispute [indiscernible] X.X-week In long-term to INDs in tomorrow. sustainable and substantively AURXXX, steps well as We Inter our our raised advance in in protect steps we've the that in IPR once are that on on a confident defense will an The are to defense. number after AURXXX filed, proceeding, from infringement XX, the our in filings of culminating we of With defense arguments PTAB extension planning on in and including on decision the filing – update allege There pipeline I'd Sun our future in be the that we the on the and you defense market we granted, I the of by position remains an patent we further our all Sun taken patent being and or related a to infringement want IP against July may In like advancement growth are filed by to be due which in continue filed our Sun arguments, protection be and available been diligently for working in meantime, before December, to lawsuit will the XX finally, expected XXXX. upcoming emphasize Pharmaceuticals submitting IND-enabling presenting IPR. solution XXXX. to locations our Sun as to including our additional work of which patent be deadlines. to by is initiatives to all The ophthalmic be the patent method LUPKYNIS taking continue we we LUPKYNIS. focused strengthen of to publicly if other are relating could the or Partes underway, our to us add Review facts challenges provide for And a Pharmaceuticals the to our substantively to disputed and of voclosporin grant relating extension, next agreed IPR. that mutually ongoing. July that IPR each company,

October detailed to to turn to milestone drive million further Otsuka a LUPKYNIS on the Joe of turn a its in now received over I like XXst, and Joe, approximately which Before $XXX on call current allow over was the our and the open for XXXX, of results, any you invest we as cash and call spend our more have reminder, our cash to financial receipt, to return inclusive we recap are eventually a great to means profitable review I'll in have This to become we in Joe? the Miller I'd that line of of to -- at outlook, franchise. then sheet. quick have. up future with might a the prioritize well-capitalized, a will that sales drug In end the and company believe questions pipeline. this intend and balance we for we become updated now call to

million investments we million $XXX.X cash and of had Thank December everyone. XXst, and you, cash Peter, and $XXX.X XXXX, September XXth, to restricted cash, at compared XXXX. equivalents, hello, At

product months manufacturing include the at EC supporting years. financial net XXXX, sufficient as investments programs, $XX this obligations and September drug September revenue have $XX driven ended operating milestone inclusive periods from expense the we our $XXX.X XXXX the a respectively, coupled ended quarters $XX.X of the growth sales ended September $XXX.X The XXXX, to the million. increase in nine next said, September and months Total The XX, million commercial XX, XX% the million following of is milestone is both for September approximately expenses ended XX, million safety and cash, working respectively. few September to million was approximately respectively. September inclusive Otsuka XXth, million a increase compensation approval nine $XXX.X XX%, September ended quarters ended primarily September of an Peter Otsuka, XXXX, September quarters restricted reserves. for revenue, both the cash XXX% was million, the XX, for with were $X.X and from recognized and was comparison months XXXX, months for nine quarter. our September XXth, XX% commercial XXXX, sales of or least sales related and post-approval three and activities, that and market. research for on September XX, fees the our margin September for and ended nine September and quarters the of This in million recognition XXXX. due inventory with due XXXX, costs was respectively. XXth, XX%. for our legal $XX.X were commercialization at our for an for bringing professional XXth, million and receipt FDA-related months funding in product-related payment excess three $XXX,XXX September As Revenue increase XXXX. third programs months net support LUPKYNIS. current to believe increase which activities in Cost and the million XXXX, September general XXXX infrastructure, XX, increase September We of operations, XXXX, an of primarily XXXX. months $XXX.X in of primarily and in million cash XX, for Selling, fund approximately increase the the sponsorship has the million XXXX, for and $XXX,XXX XX, corporate for supply, to year-over-year. margins and or ended our low-margin XX, and capital LUPKYNIS XXth, partner, development commitments, in in and to collaboration of equivalents, were inclusive of million and increase Cost of payment an to does LUPKYNIS, related to was to XXXX. $XXX were Gross nine contribution period-over-period. company represents ended nine periods resources September the XXXX that XX, and the XXX% revenue Total for to an $XX.X for penetration now share-based cash regulatory due XXXX, the $XXX was in XXth, million sales with XX, by XXXX, an stock revenue September cost our months expense including sales $XX.X the predominantly Total ended for nine and approval XXth, and of million XXXX $X.X XXXX, in coupled expenses, were XXth, the EC The $XX the funding respectively. increase commercial the and COVID and XXXX, and of that our October $XX.X XXXX ended advancing administration, million of operating September for matters milestone increase Total SG&A for SG&A received lupus in September share-based packaging the nephritis further XXXX XXth, travel was of Gross for XXst, increase fund normalized $XX.X million ended this which was Otsuka October ended cost XXXX months XXth, not compensations expenses, include an and

XXXX. months $XX inclusive was million, comp million $XX XX, ended $XX.X September for months employee the three salaries, higher million SG&A increase incentive were also share-based and XXXX, For nine included expenses, share-based Non-cash XXXX, respectively. and XXXX, September September for was benefits. million. the XX, the $X.X September ended expense months $X XX, pay XXXX, share-based and the and XX, XX, quarters nine the September XX, for and of Non-cash compensation XXXX million $XX.X expense September comp million XXXX ended expense R&D and ended SG&A

XXXX AUR XX, XXX additional $XX.X and programs were the and million quarters expense $XX was expensed to expense $X a the AUR XXXX million, $X.X ending Interest inclusive million accrued months for driver expenses comp program, company XXX months The related September XXXX, compensation September XXXX. million, and to was and and for $X.X ended that both September $XXX,XXX higher milestone upfront of September expenses, XXX of XXXX, XX, the prior XX, comp to XXXX periods September offset increase For which XX, was year, was its in million. and for share-based XXXX, the respectively. the September share-based year ended development for by ended XX, million XX, decrease and share-based R&D $X.X primary investment our months related three ended as September for XX, was XXXX, R&D was nine Non-cash XX, yields respectively. the XXXX. $X.X September and AUR XXXX, Non-cash $XX expense September result ended nine for the R&D a million XXXX obligation the rates. interest and period September increasing million in partially the current $X.X periods XX, and license months Interest income is for respectively. XX, in income million due $XXX,XXX nine The both

September $X.XX common ended a loss share XXXX, per or to XX, as ended $X of common quarter quarters net Aurinia loss $XX.X the loss $X.XX the for per million For September million net recorded XX, XXXX. loss net or share a net of compared

common to compared nine call for XX, for share remarks. For million months closing ended of net common or recorded nine September Peter $XXX.X the a months per to Peter? ended the per XXXX. XXXX, hand over loss like loss loss $XX.X to that, some net share September net I'd net back With $X.XX a the $X.XX as of million XX, Aurinia loss or

Thanks, Joe.

overall in continue which LUPKYNIS but the optimistic we operate a call sheet, we us for focused pipeline Question-and-Answer updated delivering challenges the the along everyone long-term As on you to programs with US We're for to We'll today. on balance business for call, faced patients we number of enable in opportunity. driving a globally, you I in heard the to joining execute need, want to of on and throughout the revenues continue remain up including to development. keeping the quarter, the again will us and any open to questions. now the opportunistic Session Operator? potential our advancement We forward our look way. strategy thank healthy

your Our Instructions] [Operator with from you. Jefferies. of with proceed comes question first Maury Thank Raycroft question. Please line the

Hey, This Maury. good for morning. on Farzin [ph] is

the if the any at on Your XXXX but Can the the year are increase guidance? even on assumptions initiatives major boost maybe, know in more it's turn medical line, sales modest basically can and expectations you the to get low a specifics to for you take and I Scott, around? of provide guidance. strategic centers And behind traction things rest the don't

Yeah.

and run guidance let to So then end the me rate of bridge that year sort into next with start year. the for

beyond. reported patient of And year-to-date, October. start number forms, the month forms quarter trends were the of through is think the reported previously, patients I of forms year full that and October at in we a seeing for that way next to of effect we're the which for patient see start in that shows idea XXX star XX knock-on I the you'll month of the an gives best if look start under the you how terms we number forms as this PSF to through think quarter October, sort you we've of current said think about that patient I've as

all number trends urine macro saw of modest year-end I more of It's we that months the pretty us into The left more to have the out, I to simple. alongside cast dies patient a two of number is factor here of two where going We've -- the us, months $XXX those much growth more that. obviously, was were kind to diagnosis, and the of But visits, of And that in was led months good on. is fall a we come lower lower a range. November lower numbers see we we that office through that, of year-end to QX indicative XXXX. felt QX. screens and our are way you sales and what million months report And and we felt tell the of and that bead can going full got starting the of it's pickup on in $XXX PSS big on dailies. to to we the million some Now think it exactly had ahead December, is

we of intensity a your this on question terms with medical put looked people is I specialized activities tell can in medical approach and affairs from you what is major continued do In the centers, we've at against. And time everything targeted to would somewhere we've efforts. representatives and reimbursement

it sales I these medical many centers be these COVID, is major in during know, centers fairly movement key But locked the is update longer. of down terms when will centers, access. in see who of were in you remain ours medical significant accordingly. And think some the these we and process entirety down you start as a to to priority locked major of and

Thank you.

operator. you, Thank

Next call.

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

have don't it, taking really for my just lower may because Good at for morning. I'm so patient curious that COVID driver ask missed quarter. lower the bit Joined Thanks I I third driver about diagnosis, question. the just a really the what's certainly driving think mentioned. lower point, PSF, overwhelming of is the to but this Hi. late, I visits, you wanted

filing panel If that was can you. denial. what to, about filing and at anything the get Just you about And there's presidential those relative you're opinion impacting second wondering tomorrow quarter? and then for say, trying separately, that defense the Thank set that? is to the the that deadline say just specifically

All right.

best clearly of reported recovery, mean, taking let that then last internal driver and we're these So and in lower first And give of the we we were try is trying lupus me you lower client's COVID, COVID. the lower the what data. articulation I diagnosis of rates to slight of year saw to this office to my to nephritis some visits figure I week, from seeing we're out of diagnosis due think

when and that's driving those the planes planes we're buy we numbers and lupus from. at back and look nephritis we So these what

the summertime, we then summertime. some So saw but towards the recovery, into leading

So data both saw steep then claims those from and QX we in biopsies. to QX into decline renal urinalysis and QX, more a within QX diagnosis

their obviously, is still – was believe do see a of we population as that see regularly as don't what there. And that summertime, While staff driver. don't it vacations, Ed, the it issue. we we seen the going we've But to a this don't office when we this to seasonality, some of in major years on year, row, patient just going to now the vacations, want there it COVID-related summer there know benefactor to is effect, this on on some or call we a year was – and the our because delta clear effect of visits I a is pertains of sort think, doc in obviously, deliver is the platform patients few concretely, but vacations, a going they're last in

least about or end PSF I moving and we're generally October we we'll to that of the into October, number the As said, in at November. more we're in starting a of see we PSF report. to seeing revival rate the learn this, as But in continue of are, seeing

So then data there. in another drugs it the others I – that and And that normalized. as give you and track. the your the appears to best eat affect of But well encouraging summer terms we we as well continue whether try of to period is sort there's the after is others to into answer to. drugs we size appears to to the can now, drugs can affect we or some track And have right view QX the best it as QX of a as claims, give view

around the response, was mentioned question to some second week. son and the Your we I from Friday and from in of of this us agreed an of and filing extension date the the to the -- as call, both on initial

which in to by we export to in product, the a all So work due time wanted needed order date. this done the get We take is our to do. submission get and everything to

after filing a come think approval tomorrow. on back, So top the I market the And of of issue expectation and that that will should the month with filing about it that is be plus.

have challenge last denial the was up these normal back just being response, decision, everybody the see then is to review But the And has market rate or normal the PTAB a a challenged rereview, which business challenge not the on at by to ability good. your of as tomorrow. go to will fulsome close our the or to or the response course expectation the It the the who's you of question we've PTAB some take review, actually those quite go as does. of and after challenges on decided And lawyers guided Obviously, been in about company success go, is when the low that there.

Okay. may. One follow-up, if Great. more I

trends wondering currently you what on persistence with patients therapy? seeing recently existing on or Just are

through which Well, to when the months, versus reported to X look on. that it's clearly or work continue involve so months we other at. benchmark -- XX area X XX is lupus. electronic But months, probably We hard therapies you XX months, to That's an want

I not at quite XX RA as an setting you So XX% we're therapies that. example, a to if actually is look have good. if and months you look or at rate on underscore, Benlysta, but of at other

reduction in treated guidelines sporadically should the that from We on what that chose is And or show flaring know to is data patients that a consistent proteinuria not out to years. and data disease have be the continue we about one basis. this X their

at to think accepting work and able answer we and we'll persistency, the continue to on we number, to have that we're on data XX but work the months. XX% is be So not

it. Great. Appreciate

comes question question. next the Company. proceed from with with your Cook of Please Stacey Cowen Our line

is bit question last one. of on the a a So the first follow-up

XXX assuming roughly pricing midpoint and -- these For revenue guidance, with XXXX next that year a X,XXX per XXX year, for for of you of to that of over patients taking in year, for -- that next that broad capture including calculations. making the lot XX,XXX XX%. are would to rate discontinuation patient that need imply assumptions,

durability provide more on little rate and bit And is you the in conservative more Thank might just XX% this there induction us understand where maintenance? too more variability? where Based too used rates, be you. have what assumptions first help question. is us a versus a that's coming Just use understand you So follow-up. can help So the more just of or discontinuation conviction you might that commentary might be then where where on kind from? persistency of can that being average optimistic,

let So we question, the guidance. million should how centered thinking start first be $XXX million $XXX me about with your to on which

one And of start those As I to call, metrics more get But factoring in improvement, patient is, better we The I patients forms, to other towards probably we conservative persistency, $XX,XXX that parameters. XX,XXX as now, see other speed net anything terms see you see to year. year, a any at on getting these say per to am working yes. think individually all you're getting per our our said, patients drug all net do the in are to to than it's be Right all upon drug, XX,XXX I the could mean, need the to the better there. to need what we're forecasting average we order of yes, backlog I prescription think per it's in in based would I forms of any patients yes, missing -- them I Joe, numbers. to we the significant quicker, assumption on continue that in improvement patient But on patient know, sure. there? in say think, improvements we've I aggressive. how probably, X,XXX for is that's start a add new said don't

think pretty well. it, it No, captured got Peter, you I

jump And you for Can there. I asking questions repeat you and questions? through went the since apologize several

Yeah.

the this XX% that more that durability rate? persistent just commentary around rate, is persistent average on more XX-month used, think understand you more where LUPKYNIS, help Just drug in based maintenance? So being us induction,

or pretty -- Well, we past, drug, over decides support here. network, there's -- falls and reported off discontinues alliance. refill lot as in physician to but have a bespoke -- time take think patient all patients a we patient the drug, support, discontinues, I of just prescription, a the we've change doesn't to a we try not get shipment, don't a not There's when

to to There’s driven. no telling patients I have usually much everything them reasons. seeing to it direction patient lost would here physicians X tell decide We when patient from The our drug, range. that have broad months. down anymore. terms they drug to physician follow with some at the drug you have is not which the the in data at board, and of we patients they always up therapy -- from XX We're a here, is But answer should are terms what why discontinue not of patient's us patient tendency, tolerate should at the support So physician, all we that in the range to follow-up should AURORA that physicians to times, patient follow-up guidelines stop taking in long stop the and of data discontinue could to our why a driven, not we It's a not a And level in just of with broad, drug. a belief get can discontinue they're majority, drug a months, say, favor the a the I a results. proteinuria work patient. across gets XX appears physicians and/or and

range our XX to we messaging. we reasons on after So as continue primary of months, think XX% for broad, our do make off But headway coming can the patients of reasons. drug there broad part average,

Thank helpful. very you. That’s

you. Thank

of the with SVB from question. line proceed Joseph comes question next Schwartz Securities. with Please your Our

thanks. Hi,

how trending. wondering could prescribers Are us given prescription been has number was wall has broadening about need the you give prescriber you've some is audience us I your as lately? data. and there? you audience some prescribing of not Can the as it with trending And strategy on the been you a hitting if So to. how talk patient insight you what And much

a of as me a to of patients. nephritis the nephrologists. large the you total strategy, the the mentioned, give number X,XXX. within large decile of the quarter And rheumatologists number and a date, about lupus base have is end already And and prescriber know through high to prescribed. a number -- – we these I of docs that's go of large let large fairly number lupus was the the after But all are have Well, that clearly, that subset,

basis you where So few because although our patients. talking very semi about down when to sixes seven docs are start have should diluted deduce, focus on going to really XX are you you're who our a your through one

opportunity prescriber So base. time your increase spread to our there's But think we effort thin. do still overall gets really over

the only look about, is at had number believe, been have trial. you have who XX% repeat prescribed number us those I trials. XX% If of that for given

experience them that's We too, tried they've product, opportunity, had but experience, after a Joe. who physicians those So they the represcribe getting think good -- the product. repeat huge become have going and not prescribers. to had

next be clinically the gave prominent over I probably your to question well, underlying, are our that again? sold a their be tries I they is gates. one of us And there think reasons most patients I of product, why right follow-on while the out lots is think need will think time. physicians more of these not tough-to-treat And prescribed if they one physician it

on there. XX will and why high that's remain X,XXX concentration deciles. concentration But those and a is to our So X physicians against

physicians. the new in but back on last you total for XXX rate sure can is that. we it growth reported quarter, this to I'm as number not quarter was get what Our

more guess, Okay. there Thank why urgency isn't [indiscernible]? you. And then I

Joe. We you. Joe, can't we're understand losing you, hear

Okay.

again. Let me try

So

That's better

urgency have much and to It's general, control for especially treat And do how have a this over market. In small in so? do tool general, a why not they you isn't physicians new patients there to when more phenomenon.

still decelerating wonder able aren't low overall, you So have even market relatively penetration? if it's – I

Yes.

so the the for the on got others I'll repeat I gist call. it So we lost think you on I end, but of question, the

centered all low sense treatment urgency why in that have proteinuria discontinued. question and that data time talk over the data patients the to that They in What in It's qualitative then be of to appear proteinuria practice, in urgency proteinuria episodes. don't levels me to aggressively treat. the targets over and and we're to there, time. to seeing treating there's of flaring treatment pretty least on they're the around to desire and does that's guidelines, make stay open-ended actual the the be time that high to that very that treat sure is treat a be targets think we data the is tends and they treatment to about it to I should and at there speak talk that a seems feedback patient's guidelines claims at Again, drug surprising published maintained. to and drug out Joe, with

use just well. our the in MMF I'm appearing is about as from thing both and talking of Now, not drug. steroids This

do who cause to we mindset. and newly that And patients approved that's can our patient data-driven needs increase that physicians of one I on think I of you keeping experience is generic that of So, And over kind to they're lose did I only group drugs. with gastroenterology think market have thing. doesn't other appear to has further thing to all where on to to same education in change we it's The patients get operating today from not keep failure, of and take what not approvals need and to drugs. historically treated long treatment us, steroids not development biologics they're their kidney It ago, just mainstay, likelihood evolve side, who back to data very element that took to time They to not gas pretty are MMF first They close you patients when morbidity, is happen, aggressively, have decades use. if probably higher patients the and need a line the develop medicines gastroenterologists in make protocol shift in -- an sure today a have past they patients There's drugs. they and been back treated with they're can going to these moving keeping a is what time. the flares, they it that to launched treated market chronically drug, data-driven here. generic-driven, and infliximab this who sort understand on and of they this compare treat were patients that markets to to treatment and not paradigm. aggressive today, a And with physicians therapies kidneys, a on

So, market will to How of treatment break are comfort that research think the time. is aggressive going physician long need I take? we treatment continuity to And take just our development there's to this continue My why? through. it is and answer critical. that shows market

about new it why Okay. you'll-- Thanks And you you So, designed I insights. design why think design related did did your campaign. to those is can this question question impactful, marketing my you for do more clearly one it? way? And ask why be if maybe It's

do we falling let you're we didn't ask evolve end what and today driving we just me yell the the out you're get the we on is of didn't the that yes have us think have why back think and I I maybe Joe, again, question. recap asked why before, But you to why Yes, can at evolve But back. campaign and you campaign? I where

That's essentially it.

African-American our and But strong Okay. types and our sub extremely data is African-American, types data And is is majority patients. the patient the patients first. female. population Hispanic in Well, Hispanic strong of across of patient all listen,

target and have, it utilization to of tried AURORA X there So And data strong I launch, very update data. next emphasis there put consistency level of do We've it not just taking of the on was that at in our with was, that discipline have to tools, offices, AURORA the majority offices, message a which discipline. the is with resonance. on cetera, we we're say down most didn't all et at in lot what recent to the data, of an to think the course, much down launch, we've patient the X the this most campaign use of but the available yet having impactful population to of is towards data our we coupled the

the color. Thanks for

Our next with & the comes Cacciatore question. Ken Cowen with Please your proceed from question Company. line of

don't about more if ophthalmology the much question. IPR you're or Sun, And they from IPR years they on if patent. win side. they I suing any the in I wanted can think that to was talk them Stacy different them, challenge they're for asked there's litigations have you getting against And strikes is XXXX win challenge the until Cowen. patent Thanks suing question win, you're that. know before I IV. able here team. closer on haven't have few the But this from taking general believe it on. in Hey, two the to here. Paragraph Peter, process, the suing second a certified I expires like to I us they know I they they other Sun in LUPKYNIS, and don't comes can to and certify

Sun get So here, that also folks to what size with win not I'm a there's able the an when able product. the to of are obviously, sense IPR, is trying and shouldn't business happening? struggling, is win really much to you be reach to agreement asking kind is, the why in this of makes of even You

we come "win" you is some So settlement can't of if launch the a that is of Thanks this the to reasonable us and the persisting amongst help why Can struggling. while, why much. understand for is product kind even there a can't just parties? size so

the hopeful pediatric has conclusions of work benefits product protection approval with I I'll with, not out extension doing of XXXX. mean, method the your I guess, to start yes, under of inaccurate. are through we're the and use addition

end file. you you an well, don't on think and you So strategically have say,

get days first mover advantage. don't You XXX

what the market going You is be. size just even patent know don't notify to that a you in necessarily a

good sound a entry. do filing So very generic or with entry has the anything strategy that like to this doesn't

of to said all think facts litigation. and you retaliatory period. this I Ken, And we think ongoing can I we've tell keeping that the from that is strength have people. we're the extend we that business ensure open all is, outset we're and And longevity these we that options

think means it's the all public think were the get to there you do that in all defense domain can presented. of important see to out So options We our I with that options. sort challenges

we to is purposeful. goal resolution. get challenges not which is But from would conclusion, somewhat that's your these different So our like

probably that is want we the product confidence protection place, same investors, to Sun and this employees, to think our the physicians haul. I our over our long patients and patent in give has

questions important could huge options filing so that more Track see have the with if But on that, agreeing your don't forget, the X strategic with around -- what keeping us all longevity. message on that about fact. the are. primary on we're that and ring-fencing extend also And even the patents to a So to beneficiary defense leaving file people that’s you get record our open Friday why with this we PTO is give

so much. Great. Thanks

Thanks, Ken.

Thank you.

from Our Oppenheimer Kim of Please the next proceed question. Company. with comes Justin & with question line your

just Maybe we and to better Good of this LUPKYNIS. finite morning, Hi. try as for versus the one, thanks understand chronic treatment question. dynamic taking with

Just plans to the if give it team available. becomes longer-term with curious metrics persistency as

down the are wondering, going we coming Just go the rates persistency to quarters? XX, XX sort of XX, in month

so not here. even some in we've data hope and Yeah. we anything more think I i.e., we're probably the we is in data driving take see All way, we're the back metrics sort being of that we reported I say that we business. the the that, investors which metric a that transparent, can have, forecasting -- about holding that in we benchmarking same were cases the are would, you is and way

in on we back XX BENLYSTA, look from products we XX at lupus us of But analog months nephritis the would data different. hold that we products having beyond. But do there's look are has in and you the benchmarking reporting and doesn't chronic you we use should diseases barely doing that drugs, other look and So been market any if a and don't here, and take and nothing that die. at against. if take lieu diseases light and what have But arthropathies have see you don't morbidity of be rheumatoid drug, level to, other we you and arthritis category MS acuity account that necessarily at months more

the you to So me, quite guideline the they and actually months at if you data our expectation, good. we look fell But XX% of is look if short quite persistency have at that. benchmarks, XX at

the It's doing analog it, look quite an that. we're like at example, class, good. say accepting although So products in rheumatoid not we other actually arthritis for actually is not anti-TNF and XX%

got we So it. we and it on forecast analogs, based when it report we'll

so much. Thanks Great. Okay.

Thank you.

of Please question proceed comes Dhingra your from Our with Markets. Sahil line RBC next the question. with Capital

Thank the I had taking Sahil for question morning. October for one Good you Hi. PSF. Miehm. This Doug is questions. on my

then run XXX So my And PSF quarter million running there XXX what $XXX for I the think October were rate you. run you is Thank follow-up QX? are QX, to rate is seasonality million monthly of run that next versus million currently but kind for to for year, rate for PSF three. rate the QX I run in understand rate building some below of guidance million? $XXX achieve is why monthly the question

forward-looking Well, first. – not not guidance we've so the We've last answer question I'll actually given on PSFs.

quarter were wanted we patients but and they them, in way where of variability right? lot see more the did drug persistency can in drug You came there's because through our in – through, quarter, So not backlog a and maybe in than the speed carried drove getting on PSFs. the financials to the where conversions a

give make you the PSF a other, fall accuracy you might us a So – quarter. sense the one I forward, on think projected would because full of given off have not

work harmony. all to in So, things have

I off run because to I while is report and of look answers that – that just the go can in we I the you think, tell of didn't backward I on list a can day, you and October, on give excuses. question through call at this Your coming summer, of don't want

high us the the highest-performing is between, recent that Florida – the know, so Southeast country in trend call weeks. move are a there state it, of per single out Florida PSFs region. somewhere mid forget the pretty in because number, We But been And don't Hurricane and our Ian. seeing down, digits to region I upwards of don't measurable week the of has most shut gives

me leading that think that's there. are that recurring that. powering one could factor we're back coming numbers believe I be to The through online So

only So thing that – impacted have October. say specifically could I can the that's

please Okay. milestone Can the that remind you. payments you me are expected? Thank of

you Can the question? repeat

earlier on other milestone so there's and remind countries one please European me the prepared think that again the mentioned in you payments, Can for was I Japan remarks?

XX get That's in approval, out be a so five backed net European and million quarter. the top when would just received That's milestone and estimate And with received countries, the hopefully, for Upon milestone pricing the a we then approval time million then you're three $XX that $XX in on Yeah. with and with Commission. another $XX approval European and And that approval we major that, Japan. the approval. we reimbursement. million. met countries period The in somewhere of there's coupled

there to get file and we approval. to We in have Japan, have

So and believe well. plus markets in the arrangement, cost addition in those have we that, rate we that to a manufacturing royalty as

Sorry.

European million? What's Just time line $XX follow-up. for the one the

dependent very It's country-specific.

on guide So we've not given a that.

Okay. you. Thank

you. Thank

comes line with your of next with Martin Please question. David Our Bloom Burton. the proceed question from

lupus if shaking questions. taking say if wondering The patient fatigued? a of and choose I've talked are is nephritis patient's to they'll that's LUPKYNIS, see they'll if which docs for these it out BENLYSTA, what you fatigue, as choose that, well? proportion how patients – I'm the nephritic, And Thanks are my nephrotic tend to ones

patient mean, have answer nephritis. persistent directly, fatigue, the I showing to if they have lupus a proteinuria, if Well, patients question a lupus, they

most that the the the the ask and product how not in selecting they're view lupus that and product, look talking one you recent patients. I'm I the this, by about kidney know that they're answer. lupus on have tell as don't versus I GSK a other. -- So and I docs can health you are surprised folks that can positioning

don't there goal on steroids any get or can physicians nephritis. either data go are I We're ever patients which have don't for know. specific seem we clearly they the product. to to nephritis. I patients so higher patients with they become say MMF product than where the I ever the So getting to [indiscernible] that the and is indeed to don’t proteinuria that lupus indicating, is lupus we're before positioning

seen have we get and us that of MMF is those to just steroids. of opportunity front the So patients a course in ahead to of already have start

Okay.

And how AURORA? going And competition you important really lower results much other we should is much inhibitors? do from expect is calcineurin do LUPKYNIS. results? And biopsy the you with can to when how sales emphasize how before get question the that or see those you to it nephrotoxicity Next

data nephritis function to out three it kidney as eGFR function, this we look calcineurin supporting be low, data upon is they're less that a have Well, the least it quite patients. research about XX% measured overall the is to the in who've we the market long we're the the only study, opinion inhibitors into the Do of date, at as being kidney no only calcineurin inhibitors, that data, of X fear the nephrotoxicity, data see data, right reported group at years have actually data based intact from but in of which cyclosporine strong very physicians, a by -- we that don't lupus to small the AURORA percentage, since to hard have relates think than seem out ones of of in now. X and this I a nephrologists, patients There primarily utilization AURORA degradation to terms extension shows overall who eGFR. it's strong

So a opportunity. class, while only small think our it's we're of competing degree, we're compete we now, if to only I market there we're there, a because growing part and

think look and think I need to we So bigger.

lab, time subset what have those do know do by I that this, not well. exactly the still reviewed biopsies David, data at did had central understand central so outsourced work as what they super the market of a lab were know lab readout small very then work continues pathology their central biopsy the at we -- on I then slow original and believe, looking and an small study patients data, from remember, AURORA to that’s a they'll they're looking and then looking I two oversight from period. I biopsies Your their be on and and the on that question we of actually serial a for caveats, study

an don't definitive patient often to is that And will it's a trial. most it a a but because So small you, date procedure for I a it's clinical end difficult underscore a doing have for a end. of have invasive reason is the I task small part patients, as

does last question. When does Got rebounding One patients the rapidly discontinue quick or stay much proteinuria it. to Got maybe slowly? it. kind pretty rebound it is, where it

I claims because in data do a is have we tell Data-driven But know And we to across. don't just very can answer clinician, from you see we not variable think I what hesitate the our studies I'm it. All patients I – It's would is I give don't we do it. track from you practice. because what tracked practicing cycle.

flare retreated. do they So get if they again, do

Thanks. Okay.

David. Thanks,

Thank you.

follow-up Raycroft final line from Jefferies. question this the Maury Please a question. your proceed Our morning with of with is

Thank you taking again. a for question

So you patents two to are you we be when to to? since those when patents around more talked do And about around specific should patents -- additional expect you those what -- related build like on granted? be the defense can the LUPKYNIS,

major two or I modifications patents the the them data action having around addition and file, -- at patent. and April has they're two on date of XXX an They One areas. new of to least center is ongoing. adjustments So one date action April believe,

lot evolution think the think are we invalidity Matter new that challenge, challenges and an while to of I of addresses think could fact, that beneficial. potentially the many a the centered about that of them, data So sun further as around patent. patent be through that of XXX there's enhancement

The really the new be patent claims, second more talk but we'll into can't happy data which here, to is get I about. than our issues,

of Q&A Okay. Thanks. End

any Ladies final turn that floor session. Greenleaf I'll you. to our gentlemen, comments. concludes Mr. the question-and-answer back and for Thank

to quarters. over morning. months thank to much. us your and and joining appreciate reporting very time launch you forward to through the We look continue for next this your want support, you I of everyone we the and back Thank to as we progress couple

conference. today's concludes This you. Thank

your this may Thank lines disconnect participation. You for your at you time.