Aurinia Pharmaceuticals (AUPH) 3 Nov 212021 Q3 Earnings call transcript

Greetings, and welcome to Aurinia Pharmaceuticals Third Quarter 2021 Results 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. I would now like to turn the conference over to your host, Dana Lynch, Aurinia's Investor Relations and Corporate Communications. you. Thank

begin. may You

well Aurinia operational Joe financial announcing on as portion thank Chief available third members those the quarter our Peter executive an CEO; morning and members Officer. milestones to for the this Officer; detail. discuss will Today, team questions. call for Executive Research are pipeline. of release will Solomons, of call recent Joe performance remarks, Today's Medical as and the our in financial for today's more are results your an closing discuss and After voclosporin, update our Neil available President are Securities Aurinia update Chief and provide management's and President agenda. Aurinia's and financial Max has Greenleaf, Officer; executive a commercialization, the Chief Then participating regulatory press you Latonya, the progress statements filing accompanying been financial with Financial at Vice and analysis joining clinical Form of the Other and with begin Colao, Form with Q&A on to team, and call This this Miller, Peter Commercial X-K review highlights filed Thanks, U.S. Rob www.auriniapharma.com. It our the results. our Leading the quarterly accessible Exchange we plan report on Commission. and afternoon, on are in on anticipated XX-Q. Huizinga, on discussion also and recent LUPKYNIS website from

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

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

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

us third strong in and thanks, the So And thank quarter. today. the I into U.S., Dana. everyone joining results now for the want report to happy launch well to for We're I'm

increased nephritis. We our execute regulatory two adoption and exciting morning, strategy pipeline continue acquired. LUPKYNIS an also with through you as provide on with commercial clinical with our overview we've of as well the performance some assets results, and This LUPKYNIS take you to active I'll provide adults of lupus of recently access you for I'll updates. to treatment and the

that will our we any and have. answer position Finally, you questions financial may report

net sales, revenue recognized first QX, current year the in steady January, into we prescribing exceeded and $XX throughout is increase rates expectations per in guidance and the for $XX.X XXX% Southern maintain Delta PSF patients, in prescribing million launch challenges saw results, third our generated let's In end to October. XXX which while COVID-XX of new impacted in patient the range So our increase business late that over we launch million. related to on variant added our with states with summer, it we early star continuing be September quarter, the XXXX. $XX.X in the quarter. performance should represents quarter. with and forms Since noted anticipated $XX the million our the analyst a Based total and In we prior starting the million start metrics

momentum As star patients optimistic now forms this week, year-to-date and have upward total of remain X,XXX that logged a than more continue. will this of we

rate to This therapy up in movement of continue conversion on also XX% excess see We improvements in XX% in was forms to from from approximately star currently. QX. a with patient patients

convert In addition, continued day shrinking. our Both improve have time month. XX to to is rates conversion XX and each

On the and payer plans. to especially continue local coverage make progress, front, we with regional

payer now and Through lives. LUPKYNIS As covering coverage we of patients XX% plans the LUPKYNIS, lives of market. gaining October, for have XX% early access have policies in confirmed confirmed coverage through total of to total published we

to working patients is goal support and through our conjunction there place, and gaining resources. medical Aurinia's ensure access LUPKYNIS justifications to patient with specific are in are healthcare professionals While policies in personalized

continue providers and access for our seamless access can as patients work possible make and the to – patients, process start as treatment. gain to We that quickly so access

nine months slowing over not we're launch, Just post down.

presentations years. XX diagnosed patients professional Our meetings, team to our about is to study treat nephritis professional audience to tirelessly patient and include two continues educate remarkable as The in possible. LUPKYNIS Rheumatology results most nephritis. lupus in as and quickly the X work The Society urgent clinical product The lupus need both to diagnose and from LUPKYNIS showing American continue and way shows with LUPKYNIS research has market efficacy in patients and both increased key been pivotal and and College This bolster medical provider competition, AURORA the of with data American healthcare with Aurinia These rheumatologists has newly on patients significantly LUPKYNIS awareness differentiate has competition week which the Nephrology. over that for on is severe prescribing. and this nephrologists, our at confidence by of five this and recent the awareness par market

an presentation feature LUPKYNIS study, of continuation AURORA the ACR and will safety However, tolerability analysis X also assessing an XX updated of at months. oral at the

provide recent and final in treatment three necessary of to safely Lupus for expect nephritis total a study, from or one payers of studies. continue this LUPKYNIS This to support treatment we condition two year. additional will year. the the end in As from years and lifelong data HCPs reminder, a patients announce continuation looking LUPKYNIS will lupus duration long-term longest years at treatment beyond represent by results this data is nephritis the this

So a to ongoing marketing review. June recall, EMA at look application, in our The to partner, a Otsuka, as as was let's authorization therapy. filed licensing global the on for with you voclosporin now which work establish track remains shift

continue opinion We decision third around EMA quarter CHMP in the of and expect to the a final mid-XXXX XXXX. sometime

an lupus submission October treatment living patients in MAA seeking of this of Otsuka approval of the for on the of for part Products, with this or voclosporin As Therapeutic use adult year, Agency Swiss the filed Xst nephritis. with active Swissmedic,

finalizing timeline for Japanese seek to treatment LN NDA towards of the work to with the regulatory the of approval filing Japan. continues the Otsuka Additionally, for PMDA voclosporin in

to provide look opportunities strengthen and continue in We be pleased continue us milestones financial these our work And to we as these LUPKYNIS. therapy with supporting launching to this our and with we Otsuka reaching to will said markets. as globalize position progress forward company's before, to

R&D to year, on acquisition addition now the and of XXth announced of innovative exciting updates, we this to two August pipeline. Moving our

is Factor, of or Ligand. The or first which compounds A these B-cell an protein Activating targeting FC APRIL, Proliferation-Inducing and BAFF, is AURXXX,

been disease. APRIL As mediated role we a And has for have course widely play and and B-cell we key of IND studied has you is then eager to BAFF action this know, may while those and establish compound proof-of-concept, to autoimmune into believe and this those we're mechanism advance both development preclinically differentiated properties of late development. in compared filed to expected The AURXXX XXXX. clinical in be in

macrophages, modulates is a MX cell second novel The which is therapeutic peptide AURXXX compound AURXXX. CDXXX that that receptor. white blood the of we is a type acquired via

as and leverage mechanism this decrease In long-term MX advancing our parallel, work compound let XXXX. me the making fibrosis first our R&D now, early expand with teams R&D the this and I'll is and established a us AURXXX, further the addressing nephritis. for summary, world. significant assets reduce filing back and stakeholders We imperative action, growing as macrophages with financial lupus key U.S., diseases in allow but of At fibrosis. provide research into which existing pipeline to grow dysregulation a of to MX progress Joe of to strive us our targeted call, less Joe? same goal as been new be diversify to has half beyond Miller commercial for autoimmune strategic the parts inflammation. and And ask get position. to transactions The and our there's experience. for adoption While to it be goal to the pipeline, regarding are causes is committed well for with close our dysregulation the our will specifics out These we're IND to of LUPKYNIS time, in value. capabilities we other of more

everyone. and Peter, you, good Thank morning

XX, in payment XXXX. Net cash to for used at of spend to programs. launch in increase XX, primarily XXXX. to specific a our with a $XX.X cash and cash to launch had LUPKYNIS, for XXXX the Aurinia the as primarily related collaborative of and decrease The infrastructure XXXX, for due months million offset agreement LUPKYNIS, to acquired $XXX.X million the and months payment the ended of the related was license to to an Lonza million achievement upon developmental build to increase recently nine commercial partially The an payments cash and XX, September compared XX, compared nine September infrastructure receipts. million capability milestones dedicated was ended a commercial support upfront of inventory operating by September of $XXX.X $XXX.X one-time manufacturing to upfront an support spend of a As activities party equivalents investments part December was payment related made the

into funding supply, respectively. and our months the XXXX XXXX. approval development our which ended supporting a September was sufficient beginning commercial the and funding believes XX, for related XX, in phase revenue September the reminder programs XXXX the company and and commercial The and building company LUPKYNIS back year, only financial include least of infrastructures. including million office research the commercial the resources its infrastructure, activities, it in XX, of investing of and $XX.X million in packaging commitments, FDA out XX, conducting still at and revenue $XX,XXX XXXX, phase Total quarters ended manufacturing XXXX. September in for As to its was Total September pipeline that plans, nine current drug post corporate and $XX.X and has fund $XX,XXX was was prior planned development

XX% product September XXXX Our and the XX, FDA of net for zero and XXXX. were $XXX,XXX revenues primarily months approximately commercial XX, consisted the $XXX,XXX Selling, XXXX both sales of sales XX, nine was and LUPKYNIS. respectively. XXXX, of zero for September periods ended XX, XXXX administrative ended were primarily and and margins ended or months quarters general of September XX, respectively. XX, of Gross SG&A, sales XXXX. result the January million XX% XXXX, and XX, LUPKYNIS quarters was expenses, ended the September for respectively. approval Cost million and and increase following and September three Cost the adjustments nine of for revenue, was The of in $XX.X September September for XXXX $XX.X

XX, of $XXX.X professional for to for and increase activities. of million months programs, Non-cash fees SG&A was recruiting, research the as ended related the compared XXXX three $X.X of marketing which such prior XXXX, for year. and and XX, expenses in to were million increase the period XXXX. consulting, September XXXX. support in third XXXX, the September due comparable nine and expansion $X the patient LUPKYNIS, activities with compensation employer associated For the during $XX.X ended launch Also periods $XX.X Research legal, respectively. assistance both were ramped and was $XX.X SG&A functions and administrative months share-based the contributing the quarters expense quarter development for market and periods up were commercial in and costs million million same million ended for nine $X.X million $XX.X million to related The XX, an September the million and and

period driver distribution R&D recorded distribution in and company for the the as a million of nine NDA not related periods including September and acquisitions. the and The the for The $XX.X R&D therefore, XXXX respectively quarter XX, same to ended of acquired ended million increase recently asset in the of a eye nine programs. our nine year did approval related For not programs for assets upfront months cost R&D during reduction the accrued our $XXX,XXX were September XXXX. the million. GAAP, costs related transactions following prior XX, decrease the for supply the acquisition and and at acquired period XXXX. The upfront compared and the to was offset dates. and the XXXX $X.X offset months business voclosporin costs increase to clinical primary XXXX September expenses meet $X.X related to costs months September and expense definition our CRO same the of The primary expenses. decrease license Also contributing clinical supply preparation partially in for as share-based $XX recently a three increase was three XXXX LUPKYNIS, of costs prior clinical our was by new the and XX, expense the expensed $X combination related the ended dry application a as and employee milestone in decrease accrued XXXX. to were Non-cash due these compensation expense termination recurring same expenditures trial as the the accordance milestone with to million to year ended and XX, and compared XX, in due higher compared in were to fourth license million developmental was and in U.S. In XXXX, and developmental trial drug September new months a and by related in drivers clinical the programs XXXX

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

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

us And Well, today. joining thank thanks, I again to want for Joe. everyone

see U.S. so this I'm of LUPKYNIS pandemic, continue backdrop of Onto significant done we Let year. a adoption the far me by to saying close proud efforts the to that the of global drive and challenging progress our in unprecedented work we've and in strong

regulatory to the achieved with study. rare work and our U.S. hard pleased the to assets teams so to important the completion partner changing help clinical that regulatory milestones excited us and X We have approval of two including open and of forward Otsuka the we're working months quarters voclosporin to for AURORA And I'd diseases. Our providing voclosporin the year far new for auto-immune questions. like ensure of in we're And finally, then pipeline achieve are with in the will our additional further to mission advance outside course continuation up now and line updates the of look come. And to this

up operator, it So please to with to that the open feel Q&A. free

Please Alethia you. Young first Thank comes Our [Operator from Fitzgerald. Instructions] Cantor with proceed. question

to, about progress do concerned of finer what other? thinking of are is some different potential the more you talk what between concerns but Hi, guys. one about at those know speak prescribing questions yet experienced through you're seasonality how and points year question versus Thanks at the then dynamics how Thanks. think or who rheumatologists two the they so are and least for end haven't bit kind and of taking that congrats groups. the get should am the is maybe One working you on about I And with those a launch. little population a with we we my trying just can to model? in maybe LUPKYNIS, after the – all year of to the I between the just this on nephrologists, far kind

miss they disease. let on what and on. build in me different rheumatologists are and Max Obviously, the and can nephrologists about Alethia start thanks specialty this might think and how out I So,

a I the think that a are – office. obviously the lupus treatment goals at patient but aligned, first starts rheumatologist's

nephrology If the of forward. market awareness in you day et to of in terms our they're we awareness cetera, our targets overlap target in terms we And Max, and both rheumatologists. rheumatology. would of nephrologists and at we're to And research market high in moving our and with scores and with – add of both the But call now, right look both track, and research pretty high from on you in there, intend to still what our day, terms targets, of one messaging, treat terms impact intent both close on to right anything? treat, drug though,

prescribing with half middle I'd Yes, nephrologist being and just add rheumatologist. our actually the split much down pretty that, is half

of as Peter see what in kind again which intent overlap our to much it just has we pretty So research. treat highlighted, what reflects the

it. second And question missed the I again? Alethia, can ask just you

season Yes, see just about talking of from Do slow like of maybe no over the that it is you It the worries. the about and Christmas. but Thanksgiving waning know kind with scripts think are yet. seasonality up, you'll to was but down? holidays the you to yet like through that seems on how gone holidays, Or see kind dynamics just know – we think may I haven't of kind picking fourth drug have this a you quarter, then I like COVID

the in Yes, September that matter saw at was could this sure you end moved we we've to X,XXX to the math and talk fact to were approximately the is the new north that the month and summer the the a here companies of in do trended and right I in make thought clear early XXX to communicated think they October. though they people want quarter space patient there date. of not I had closely. of of specialty hit or understand you you very couldn't alone, month two, October And lot of sort of as to probably I there it front a on in a summer we that a We've that would that more into of watching where PSFs if and it's Delta we whether summer still terms since what related message it's variant of PSFs seasonality are to the we're – the back forms in backwards in pose question we because where the out to but sort really pandemic October or little discern of seasonal, just alone. start between

seen a business. related seen the was it this want that since confident the year-to-date feel I start know variant prescription in we've to form and it at specifically we saw down that yet anyone a pertains predictable Southeast to don't start to in – very was still impact target something seasonality. So of this the as don't was launch. we've if the away summer take We what slowing going be to that's performance our Delta with as in off We

Sorry long-winded the yes. for Max, answer.

that. No, helpful I That's appreciate color.

did to that we a from and into and And would slowdown as Florida point, specifically has see to that Peter's and add September I rebounded to that gotten Texas October. we've

Great, thank you.

comes Company. from and with Wainwright proceed. Arce Ed Our Please H.C. next question

Thanks quarter. my strong add Hi, my congrats let on everyone. and good me taking morning for questions

Ed. Thanks,

First – sure. question is

seeing more and Just thinking go from prescribing what AURORA about X in to impact about particular, the and you're field. in the got drivers went the I what from that come but of know on months about the very of data. in Thanks. variance XX discuss we know the just over XX Maybe given of months thinking of you that early And there just as on clinical focused drove some the we recent PSFs. your increase out you adoption as real here, soon. that, more terms be perhaps drivers should impact acceleration talk the recently you in I some summer just

we strong forms. the be a patients think report your the then It's time we answer see can star I growth there. to those And as that's Ed, percentage from to top the to new that to numbers funnel. patient see launch on first getting we we start therapy. of report, the forms continue on, Well, you prescriptions focused want meaningful really at the to of point those and it's – whether of people patient question, end it's or of conversion And year-to-date,

front, to early to the stage below around On the today from XX% launch conversion conversion. an or the we've moved XX% XX% in end at of front just

too therapy. year, I that whatever you patients So, obviously, critical year be And expectations or really say, our is course And off on reason reasons XXX% they there, the of the either are right going I'd how this compliance that word because physicians patients fall to persistency, more aren't And stay into we that's want lastly, how going use deciding it's or over to tracking long therapy on then long one. want for of say would early. date reported to their obviously, for time, a on and use patients over haven't own will next to the to the stay therapy. it's is that just

of would about think they were and it to the drug max patient doses of the this you If if up worth nine doses in for January, a approved months seen point. around be number could have in

So don't really there. you'd enough a point to have anything Max, trend to add? just

Yes, just bigger I reflects confidence as PSFs. treating only gaining overall just the really both would now a And is add prescribers, part data repeat think experience in our better from the increase patients. thing that I well that understanding I a prescribing of becoming better with is – say as in our would

still margin I really great. helpful. R&D level? you much. of wondering quarter. Thanks about quarter. R&D Joe, just an asset trajectory and levels what then at thinking we normalize that more just new will XX%, and and in as couple the in staying coming for the license expense that when expect XX%, also mentioned the on booked can the that a with know Okay, expense That's the the around of finances And upfront And But over quarters? assets being then is so high impacted gross what acquisition the one

acquisitions. take two we associated value also trend as regards out In we to the script, expenses, I to you well. the think R&D of and with you milestone of And payments in as the had had the recent accrual Ed. kind out if a an that them mentioned I one-time Thanks, fair

expenses the op above related about million, to just million. quarter call for it $XX R&D our were just $XX So touch

so. quarter, was $XX million If you prior number that look around in the or

the of or regards coming So to mentioned, it milestone I online pretty operating run take think associated as we LUPKYNIS second plant, stage numbers monoplant with around out expense will other, will likely and fairly slightly, we Obviously, remain one-time question, I so. within coupled consistently The moving your manufacturing a healthy. you fluctuate of outer will R&D margin, obligations in the the with Ed, They and fairly payments When XXXX. they think percentage margins have more one-time will or that voclosporin think, the product gross forward. associated of one may move rates quarters, million Once consistently going we approval nice programs. post-approval facility into those way have around I some a it of burn manufacturing continue the consistent. on your exclusive $XX This kind upfront it. from consistent. has for reined but obviously years but those change previously, with looking very very away or the a two, of early outer our move quarter-over-quarter. margin And will be new should into remained I nature out spoke In

much. Great, thanks so

Please Jefferies. with Raycroft Maury from comes question proceed. next Our

compliance on far? XXK have of is what the morning initially better patients envisioned? pricing, breakdown Farzin reductions seen you a everyone. than to assumption you your and is you the good dose provide for to is so in Can This if in Maury. or net line And the get Hi, real-world

first, Maury. So last question answered

all the On because really an above still put that or still realizable that net payer in to the and this range assumption in the per patient gone doctors impact understanding not the on per average patient we're – of how number the actual which we've a and early range of launch. year it's the And mix, as price, At And deeper to the support we discontinuation primarily are result, we're LUPKYNIS. net in support to still out. stage, forward. going prescribing getting revenue persistence time

So, to about which months net. is looking the on or above average post-launch, on nine given at previously we've the date, we we're have guidance currently results

understand it's would Now, were. about say to we remember reductions we more probably what again, Phase the say, saw I'd the trending reduction. stage, and/or trials data, we'll in you patients And, to getting where as X terms it out we bit somewhere the the launch of get the more. I there, long it. a understand this dose it's enough we but report that little see start early, in on Phase hopefully and close both X we're were if XX% at dose in And in that it XX% trials, call of slightly above to a

more experience that, data drug. with I'd to see more with get as but bit little patients that consistent a want we're say So, we the

patient it's our belt understand what be With hard nine under projectable say to terms year's really drug. Maury. least really months to on in see average In going a what to of worth wrapped like said, this at I only data persistency looks all to up got just compliance, forward. what's of it's We realizable the

circulating question takeover. One as it. potential is, you been you there know, Got companies on have rumors about several approaching a

looking So any deal – like can are you from works wherever? for sign idea and you an can confirm what you provide whether

the that. Well, comment I'll just or leave so on it source recent we obviously speculate of report, the at or rumor can't

you. thank Okay,

you. Thank

Please and Cacciatore proceed. from comes Company. question from next Cowen Our Ken

product, clearly you've that you. massively you're stock the Obviously, we to up leverage opportunity to I'm been terms of you in you a you're your depth and out on own a for that help comment opportunity? to even pulling going not elicit the you prices just out. Hi, single you something see all though of Peter. follow going from But question, with the on an it forward news for built the can front what and just hearing Obviously, it, us agreement engaging around to how breadth about eventually maybe coming can we're in the matter rumors it size But a about. you I just kind little starting to of kind of or of what process standalone thinking bit in kinase. of the it into frame a of believe versus of and given same force? be of you bit viewing performance lot little others. of the Is sales on infrastructure is building you talk a think to folks mean, wonderful as how about get the try

think willingness putting you either to hand up or speak much. speaking your to generally so others? about how Thanks Just a

Thanks understand question, and what to already as And is mindset these management the fair think we comment recent of for we've continuing I shareholder it that what what I drive to would calls guess value, – of the I'll or said pertains time. reinforce I where answer to shareholder our before in question create board's to be many to And part mean, market. value. your repeat really answer is would would Ken. are this any source in on which I of question, the I second I can't circulating that speculate reports or said. But the rumors how

drug that lupus we committed value. in is plan avenues a and this and have suffering many we in and that And shareholder driving we mission that for best And disease humanly way the do and from complete doing is plan patients a drives business mission most get to to a any as business as remain and exploring that as shareholder have company. a that autoimmune a to committed We to possible. nephritis remain way all value, it to

that's between a I one in this lines we thinking and Aurinia in expand has that boxed remain if a how both no access else's answer, with to read at wide about but our someone, create either So think you more broadly, or of here product in way I or in potential all value realized the open someone partnership to avenues. hands we open

Peter. Thanks Appreciate That's helpful. Okay. it.

SVB Schwartz Please question next proceed. comes Leerink. Our Joseph from with

much. very Thanks

important this generated use are that is way can can In was of terms data? reluctant Is the parameters of are already wondering us any that to of the for any fourth have us us the how there late longer until way they there this that I data? segments you such quarter, the and long-term you you'll help data in you how Are see importance with And data the marketplace? quantify there's if you've in LUPKYNIS segments? term to any market provide these that appreciate large think that

at quantify definitely to year impact the know. XX%, I today – in in on difficult. Joe, business, biggest I you my that launch for Yes, question. for say to launch think, quantify a are it's would a it but just first would two it's don't that or XX% our say two And mind, swing been has, think be the factors COVID of I we biggest around me the the whether to one has hard the great

on to drug, and impact second decreasing care, The patients both virus and – COVID business, access, staying know the positive a our patient we the by cetera, way have seeing we rates, access on know access, et lower that. we'll physician with

we products And that better than three that one different this having that's thing we know going business tolerability patient worth other quantify both hard to lots only this of one. long out out data having has help the our One, years we're data population. obviously to of in it's is just know to ways. data that of in and safety years three is The

a even – going today's on we to – years that's to new important new of in and actually kidney obviously react doesn't you behavior beyond prescribing that have meaningful both our importantly when drug, the function, an and efficacy reimbursing longer longer show reinforce we'll year compromise we're way that. thing established. payers and patient's three to the drug with drug know our periods of know And safety impact hopeful that's this a probably We CNIs, been any the periods in want utilizing more So, we're it, of over has over in continue as one while to time, drug which time mechanism differentiated we label how not want to class note. to new

which if to market as our will this not pivotal it's off we outcomes it the getting you, ground. for and of meaningful a And are drug to our quant and the both in an what is. terms be going apologize the it think that, but that hopefully extension trial, I launch to data in answer the were efforts of a patients, it's So really physicians we for

that will you actual So the be able be SNDA to what for is an order to or filing process in that promote data?

sup it" no, us. but "asked to It's do We data a And going we said is this the we're for didn't They agency. this a we're I for be do question. application, good it's to supplemental owe not our but is really and part to clear. really application. in a this Technically, a not it putting – supplemental not it of as want

you meaningful can see I it we the how to as mean opens We package I may changing that end as the may they label label with areas. know to this aligned other added entire And and or times not and personally because get up to something like review. many tells for what will you agency label go data have the four approach up a the supplemental three where be if discuss seen an the is, into how or get us to added

some we be should package. and to think very to label, think it's it and there We adding at meaningful supplemental a merit agency. stage but the this smart of I to talk need be to and not area the strategic So as

to And which conversion you what's ambitious year the which you've and forms, you quite think on Is swing do the range that there guidance low-end? $XX patient color with in rate, think noticed remains the year. Okay, us million how million achieve this you healthy? $XX up – commentary thank accelerating the biggest think you for it noted we versus the the high-end is is? end might for to at do then be ambitious And focused determine any start can unchanged of what are how factors are? Like provide you it the Is you. kind or sales or already where you're on will that

we Well, XX factor situation, we confident a us. same want guidance softball first first pandemic yes, the in right. sort drive I And up trying patient said this In was in of we will any quarter can launch new in I not put year when the for forms to launch, BXB said out remain a I what we there when for are patient first obviously lay $XX of but the kind put of to sure, swing we range. critical, we stage in we at a what XX, global but a new it – the the anything. launch, think, biggest the that weren't And me of we in was of we're gave months million we of to be year drug – be company, not range. these think that doesn't up here, these start revenue But a That's numbers court. lot started X, want a

comes continue it to the first driver patient out have the biggest quarter ending of be what single and work, we'll Q, that to will patients those be year going next that base to down and of the form. into the start in year those convert performance continuing our of keep So build drug the biggest before. quarters to compliant That's seen in driver

compliance comes and down it So conversion. to

Thanks very much.

Company. comes and from with next proceed. Kim Oppenheimer Please Our question Justin

to on with Pete start little my bit the commercial the forms. during respect certainly congrats morning, a add good what's Hi, challenging environment. a me point on progress been and and team more probe let patient to Maybe just

those about sort based to something scripts getting plus it As you an to end of [indiscernible] our of range, just guidance sort in see we're that enter of higher need the the we is guidance sort out on the what acceleration of would think now?

this example health to a in to forms need way pushing quarter because effectively want it to about at to is be that had clear the start fall patient to patients that drive metric new we I looking saw QX, to general our the the a we start general patient continue health forms. is as a your patients conversion think we it this of any you financial to patient we out – the Delta forms metric we – even continue at flat were of continue because for and start compliance system we and wouldn't I that probably due sort but in quarter-on-quarter future of now, drug. us. The but to business patients be system. star long – to form into business No, see and if variant on growth you compliance as look as saw got lower, the business, much, can could convert stay like sort as patient over still always growth But were of we want XXX% of of is it to are could – to as not in lower think time, going worry we we you If was achieve number

in more those a just patients about Got team of of outer a insight proteinuric practice transitioned AURORA high into meaningful it. implementing have voclosporin And maybe from real-world have X. talk how be on that going having as dosing the years? little then bit may sort how Does disease been to physicians representative Okay. And XXXX?

trend said, it's be Yes, the forward. early, what it's will deduce so to we've really as hard going

here – physician uncompliant. behavior and behavior. population a patient watching one can have this Remember difficult both notoriously be and We are we is patient pretty

on very But going And And at there every more. we, are over that. data in think away of about six question. anything we previous just you cannot when pertains have speak persistency calls, compliant staying do looking but behavior, closely, of know, months said need only the I say any not not out physician drug. more your to you it we patient time, prescribing just staying think, or worth have is that's data that persistency we've the drug. than worth I of to that belief to as So walk be this we're on and one nine you way a and this to from at as year's we'll about trying

number projectable compliance a far have that's have I what a but don't and time. will false – that I looked be believe will until a So want things good, project be I report –

final viewpoint and provide Understood. on insight to terms And to when have persistency, And more color? we make maybe would for complicate might be that guidance in XXXX? or of that sort just it a does question of that able challenging

are as that the think just study careful we – and QX launch haven't lot got we the see like first we on to a we for year. for that – what XXXX I'm the of know are readout have of be given there're year launch, re-ups what we X will like we're of conclusively and to factors at out into mean time give just roll can what the but feel saying and going There us. first case I extension need into Yes, do any we patient how and AURORA we that to for I'm will. playing not same take really be much project we if going know guide XXXX. to And saying on not won't factors guidance,

us And factors. year. I desire early and the the investors than changing very I investors for terms should see transparent, transparent think be performance and and of our with anything wouldn't look about to comfortable that feel is we how should think we all very in metrics brand I launch how they got our been our to about bled more into at this anything, performing. transparent maybe even extremely we've If

on progress. the Thanks congrats so much Great. and

Justin. Thanks,

David Our proceed. Please Burton. Martin next question with comes Bloom from

morning. Good Yes.

lupus steroids, with is if First starting are nephritis, in a MMF LUPKYNIS three that question, then patient are combination? them with coming respond to diagnosed don't treating newly and first and if physicians with they adding they drugs? the Or the

to course be being majority are of the the and aspiration, upfront. laying are and David, there our change you're the out, start therapy it in but paradigm of minority way will today, which with patients treatment treated think a totally triple of patients the I

could right that about cetera, are where ones of treated seeing today, are each work, the level that patients But at with on therapy et majority our now MMF a is basin who regimen. breakthrough is other an seeing multiple it where a is right people patient, which who systems or the of being be course positioned are positioned we a in payers has today our challenging steroid are That's a think therapies. and the reality I after future not thought-leader up front of or could be seen drug, how patient data way. where a therapy in diagnosed newly we aspirationally that where thinking which it the

Okay, great.

of thoughts lupus any doing a less in with trial cyclophosphamide? there nephritis? that Are combination treating used question. in Next Or and less is becoming

this at not we cyclophosphamide. It's stage. have Other a discussion trial, combo but with yes, not

a comment therapy we if think move they where commitment is – we're questions combination B-cell not with not anything, is and my I but get as to here anything do – an forward. therapies area

I be Okay. And there published was or with that then to presented? note going question, last sub-study a data biopsies. is pre-imposed when idea Any

how readership, that a around of We've to subset committed that can complexities the that. of on be lot how not were be that can to central there study executed the timeline complexity because fact a study, executed. or the No, the

but First definitive we'll getting as end, extension year said, data we've by step, the of we and that course, have timeline no yet. be

Okay, great.

have I Sorry. other quick question. do one

think get the if you off label warning chance you and With everything the could up a nephrotoxicity three two there the data, is year comes clean?

Neil an I and is on have the call think too, opinion he'd here.

and is this label. of in pertains have a to as where labeling. it's prominent of would tolerability get experience be our of three drugs view? years I would happy class different where safety how think came us their class very reach. And to a came There's us with Neil, is data I before going you it see a think that at. a I have decades not that should label we worth And transplant world out in

inhibitors, would not we agree any the experience this of with in This on that. and have was decades David, based designed do disprove labeling, that I class No, to that positivity completely. study calcineurin is that's cause would and all to of areas other we

it. Got

you. Okay. Thank

Markets. proceed. from comes RBC question Please with Capital Miehm next Our Doug

Peter. Yes, morning, good

tell as terms doing high to compliance. with aid what Just a follow-up you to me is ensuring stays and a Can possible? that quick question respect in compliance that of specifically as the company

we Max? medically and one we're a to that since kick Max I'll doing. things lot Colao have Yes, of technically

sure. Yes,

patients about consented Alliance. of XX% So are through our Aurinia

they that to support – – case to patients so management we And through consistently education The out again Aurinia dedicated nurses support. the support, regular them Alliance, have – and patients. reach management case to provide all that through for

communication office that physician, So clear that, also compliance. make impactful support the the we again is the patient, – really how through between through then we the Alliance. the part that's And Aurinia beyond probably most staff sure of

benefit really and the that provide. a that's So of – And support we and developed that – I this support would the are to patient the patients see – disadvantaged and Alliance is say we we considering hear population. to rare again, really we absolutely fact that Aurinia a disease

that said, Okay, use question, Has indicated based off-label me. and of great. this can been autoimmune But drug you're Peter, you speaking in you for maybe you second had? And about or correct there drug, I you've that evidence any more on obviously the misheard see and it's doctor seeing broadly disease. conversations the but could any LN,

anything as to long of pipeline our surely is drug aligned crystal be a kind. forward to drive obviously, don't and are move market payers many do I as to in Physicians as are clear continue mission not their is any it, want this to free LN other the but to to as that. what to they And our in the to autoimmune to drug get prescribe they off-label company where promotion get promoting do patients diseases. said we To we

take question I've the could said see we historically stage in least filing this have would where other that they at a about, – regulatory whole the team, and What Your terms warrant who well, tested drug as different in or areas that there this programs, – but looked broader physicians might areas approach? on out we will the of going but curiosity we've we as don't at pretty drug. from use where often development get at see we about drug

anything centered individual or to bigger becomes be clinical a sure something And basis, investigator through to if organization. an affairs that that's conversation So our at you reach and we'll looked right let out and than know. now from medical you our

Okay. Thanks very much.

Okay.

Ladies would of closing comments. session. the like we back to call and have for question-and-answer to the management reached end I turn the gentlemen, over

thank here. come. closing I months want quarters everybody time months a further and look Have forward No in for the the come quarters great to updating to – to comments day. and you their to and

This you. teleconference. Thank concludes today's

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