Aurinia Pharmaceuticals (AUPH) 7 Nov 242024 Q3 Earnings call transcript

Greetings, and welcome to Aurinia Pharmaceuticals Third Quarter 2024 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Andrea Christopher, Head of Corporate Communications and Investor Relations for Aurinia Pharmaceuticals. Thank you.

You may now begin.

Thank you, operator, and thank you to everyone for joining today's call and webcast.

call Executive are Chief Officer; and the President Greenleaf, Financial on Dr. Chief and Joe me this Peter morning Aurinia's Officer; Joining Miller, our our Medical Keenan, Officer. Greg Chief third review discuss as will in press morning. company's issued the and we Today, communicated Aurinia's XXXX operational quarter and results this release financial quarterly The its on XX-Q financial company also this Form statements filed morning.

at filings securities For more on auriniapharma.com. and Securities Canadian authorities, and are U.S. Aurinia's information, please website with refer Exchange the to available which Aurinia's also Commission

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

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

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

us on quarter we details today. on how financial and commercial everyone. the to Joe business thank I'll call then morning, provide for results. With year. I continued achieved the Miller, additional strong execution, the good rest preparing quarter a we and Andrea, over to joining on this of to are third metrics performance. call Thanks, third the the I'll morning's for want focus On our CFO, our on provide our details call, everybody turn

XX% net same of growth. XXXX, in XXXX, the quarter million a the for total representing period to $XX.X revenue million $XX.X For was third compared

period representing For the compared net growth. XXXX, in $XXX.X revenue first of the million $XXX.X XXXX, total was XX% X months million same to for

of $XX.X the representing same was revenue quarter period compared third $XX.X For for XXXX, to product the in XXXX, XX% million net growth. million

continued first the operations restricted strong September equivalents, position. $XXX.X of further XXXX. $XXX.X compared revenue company reflecting operational of and representing of million as investments generated XX% for in cash million strengthening period third the $XXX.X to our net company XXXX, same was months product execution the quarter, For million had from This cash, and in flow million The financial approximately of X in growth. The cash $XX XXXX. XX, cash

In commercial of patients XXX it through performance added PSFs compared XX% prior-year XXX third terms restarting new representing who the Together, year-over-year growth. the for either XXX these XXX LUPKYNIS we or were and the to third PSFs in pharmacy. and quarter, totaled receiving quarter, hospital metrics

at rates hospital rates persistency time, rapid after We total high in increase and with time significant that across XX, continued also as adherence all on compared an high persistency driven periods We're as consistent off achieved approximately patients our fills by to This by remain patients September patients overall as and the year-over-year. on levels. LUPKYNIS LUPKYNIS therapy year-over-year period therapy of XXXX. September and of XX% extended was being growth rates well XXXX. our in patients and of growth This X,XXX restarting XX, conversion as and therapy X,XXX time for encouraged maintaining conversion consistently

quarter looking results. start, and fourth communicating off results year we're we're to forward a next those to full-year when we Finally, strong report

which million operations guidance with to reiterating very In represent of company. revenue from our the cash for net $XXX our record strong range revenue As performance of and pleased net quarter, summary, our flow a we're result million. commercial $XXX the performance, product figures we're for

achieved in We XXXX. advancing announced We autoimmune study been from this Phase that also clinical study first the sharing to of very developments I milestones and participant look dosed We forward results has for quarter. dual important a disorders. antagonist initial third the AURXXX, in several our BAFF/APRIL into

also We net additional royalties low regulatory LUPKYNIS million The once lupus in to Japan. is in Japanese sales that payment milestone announced recognition nephritis, the company of authorities anticipates triggering treat quarter. an approved launched LUPKYNIS double-digit $XX the on

patients now with rate of has where partnership allowed there's Japan, to a nephritis. across LUPKYNIS Otsuka nephritis to lupus and successful us Our bring lupus high Europe

These role registry analysis from also with the Additionally, insights through lupus into podocytes, meeting. of action, of were nephritis. of Nephrology in X important at body that plays nephritis, Society treatment by real-world kidney patterns. baseline active critical presentations lupus favorably there provided advancing were a presentations on the adults supporting disease. An growing impacted in especially turn treatment health data should of ENLIGHT-LN the populations LUPKYNIS recent Kidney unique American the in describe disproportionately improve Week in LUPKYNIS of affects presented Data LUPKYNIS mechanism which evidence the

announcement and shift are operations efforts. discuss to restructuring R&D our that Now sharpen today's me and let gears we our commercial

the this is focused have historically implement returns to commercial optimal LUPKYNIS while development of to Our a us initiative enable clinical industry-leading lean further key highly will into that areas delivered business AURXXX. through operational goal strategy accelerating of that

strengthen further sheet. the our to We restructuring also expect balance

forward, will strategy highest of commercial our targeted drivers. growth been us LUPKYNIS areas allow key to lean further have that for Going historically our business into

any expense annualized This will approximately the restructuring, initiative more and efficiency cash-based financial our flexibility engage to will of further by initiative our that now anticipate return our we like reducing As this financial will part strengthen of the operating $XX anticipated to position operational workforce line more more activities. I'd for We in further million. improve savings XX%. and our future be provide than with post-restructuring call Miller, you open up recap a business to of a Joe might of questions for to I'll the the have. call building turn Joe? detailed end then at to results. the quick review over CFO,

Peter, you, good everyone. morning, and Thank

Let's XX, September XXXX. X take regarding third our few go for into minutes quarter the months financial a ended and detail results and

the restructuring-related year-end period $XX.X $XX.X XXXX, September the LN XX, in primarily Total flow compared revenue in is period we had sales As from September from X balance cash, million and the payments receipts ended XX, XX, and in sales LUPKYNIS in $XXX.X the million for was X for both months prior operations XX, for used by $XXX.X an for September payments, X XX, the primarily related was the to $XX.X of pharmacies, to The monoplant million December XXXX, the commercialization cash in to million $XXX.X ended XX, to was million for and of XXXX. the months from ended $XX The XXXX, increase was X post-approval XXXX, same the for is months X by the XX, XXXX. for penetration of for net increase Otsuka, change product payments $XX.X offset X months periods XX, in $XXX.X continued ended September and million cash quarter further XXXX, months in million of company's million compared million main receipts million September was XXXX. and to XXXX. due XXXX. Net share offset due LUPKYNIS, equivalents, XX, X investment and ended driven flow of same restricted by sales $XXX.X cash to June September compared and monoplant the XXXX, same of investments by ended revenue ended from the period cash the million XXXX, commitments inventory million Net X million and cash months to LUPKYNIS partially $XX.X for X in as XXXX, compared for net period September the used purchases. Cash cash ended increase in for in activities XXXX. repurchases, was XXXX. commercialization payments, Year-to-date, the cash payments, over flow $XX.X Cash million XX, balance total and by The September cash to revenue $XXX.X activities, the is from Otsuka. LUPKYNIS same September predominantly $XX.X months the for and XX, flow million specialty operations market. increased product months generated revenue generated as $XXX.X

product impacting for from royalty XX, XX, and September June million of XX, months X compensation $XX million was the ended the sales were XX, Labor prior-year September XXXX, $XXX $XX.X with primarily share-based million XX, of months and ended revenue and X administrative months and and ended and and including in Additionally, million the the share-based lower period million placed September quarter the compensation, primary inclusive XXXX. for to XX, XX, of for coupled was Aurinia were sales of XXXX, a semi-finished September expenses XX% June for $X.X of headcount, million The months the XXXX XX, XXXX the inclusive XXXX, of the of the of XX, pricing collaboration, XXXX, million XX, months the Otsuka the and decrease months services ended due third SG&A XXXX, Ministry $X development share-based occurred late amortization that $XX.X months and first $XX.X primarily for R&D ended and XX% both million expenses, to the had approval, costs is the to for XX, recognized of September to months which monoplant first for XXXX, XXXX, to in respectively. respectively. ended primarily in Aurinia's XX% the AURXXX. and both margin a of reimbursement and lower program million months XX, same XXXX months XXXX. September related $XX.X September September XX, September as related of Gross the Otsuka X million was Otsuka late in September overhead million the decrease X September September continues and occurred respectively. XX, result ended XXXX and $X.X is territories. License, $XXX million million in $XX.X The finance $XX.X compared asset, increase the September XXXX. costs, manufacturing XXXX. Research months results. Gross capacity $XX period XX, million recognized margin to XXXX, XX, therefore, ended related X X September the months XXXX developing share-based service ended X for compensation, which compared the inclusive September XXXX, the and for timing only SG&A X was general and September XXXX approval ended million employee-related $XX.X development $XX.X expenses compensation which decrease X of XXXX. Cost September months The reduction for reduction XXXX, September in related for ended the for for were and periods respectively, to million milestone $X inclusive compared in to $XX.X shared drivers XXXX, as quarter of X ended AURXXX and its Japanese September expenses, in XX% the ceasing the XXXX, of revenue compensation and $XX.X revenue commenced due Health, of in was respectively. were late partially headcount, quarter for commercialize September share-based to to XX, XX, a months ended for The and a expenses, of for late XX, XXXX services XXXX, X-month September ended in and a and is LUPKYNIS million right-of-use and Welfare periods million due expenses X X the in XX, third to the for of milestone XXXX to X quarter XXXX. to for employee XX, X compared the were ended for into

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

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

and highly might and Thanks, Joe. all to the LUPKYNIS time with We're have. Operator? lines finish advancing thank into focused you any for strong for growth now a open on XXXX looking questions today. We'll for you I your AURXXX. forward efficient to a XXXX organization heading want

first TD your Instructions] the line of [Operator from from And Ku question Cowen. Stacy comes

few restructuring. signaling help in us more on in or for in QX, the on So AURXXX? I understand on for So the in ask positioning wanted the seeing saw based the QX, questions the you're a then to [ just driver confidence Is are what your you QX, it your PSF you reason capture, restarts restructuring. the and that ] growth patient what's and the hospital future, competitive view

expect? you what for of So I dose? single-ascending disclose you the just then a can that's might talk about exactly first Phase plan for what you question. And to And after follow-up, AURXXX, disclosures the kind

there thank Stacy, and you, in first were there. questions multiple off,

any time, then them, one at them on So if come me. please don't to back why miss dissect try of I a I to and

is the on restructuring. first The

let's intrinsically, taken of really that, the would by of the a a So able drivers to in think aggressive And work of days, over we I be. drivers XX over our of that were what and we're course, of the to review those do we've things the XX us to growth primary the business, believe organization able hopefully, lot that last, of time focus and call value point and direction share organization, for are very the price. to driving accruing the it, we

today, of rate by confirming but the So guidance. seen we in think giving we we've We this no as down not continue that at even slowing guidance interpreted way or the growth. a compound a actually business. in focusing, should signaling XXXX the no We're grow be have this don't confidence the We're better. is way in can XXXX this to

PSFs most last a combination interpretation PSFs to along the I from we Moving driven internally X at think of the of are to patient, X compound. persistency business. year, the we we forward, in at PSFs, just we've restarts were coming data ships through and being product having is quarter question, our in the are AURORA going to that have look which interpret moved then least hospital, the to if And with we all cases trials, from where you the follow-up the had today, to strong in drive have out PSFs those but that that our try a it hospital X-year into helping in combination, continue AURORA

are we're not more combination PSFs, you quarter. And think to the hospitals, like-to-like since year, last but look total QX So in deemphasizing I and numbers reflected need in we business, and restarts with of to in PSFs, every quarter in which restarts at the when to be both more the our growing hospital-based number QX did we'll QX give that report business. growth able fourth become PSFs and

we'll dose to that Your on trials multi-ascending the single-ascending was the present reading and and We'll we AURXXX expect those out drug from course, see what of we that. last expect of next question on there'll that have Obviously, the move in. the to profile be dose would as get work trials. working biomarker that actually any we're pharmacokinetic And relevant out coming you of year.

question comes line from Jefferies. [ ] next of Raycroft Your Maury the from

in quarter taking heavier guys fourth Congrats on thanks able you starting to you your with comfortably. rate, you maintain the have a of for my run if be Typically, sales. fourth the and about current just quarter. guidance hit the question. thinking midpoint progress should Maybe And

the guidance you just if that. October comment we're wondering potentially far is higher and what in of on can so end you're if So seeing conservative,

patients of if feel look that stage, have overread range. have November end through out right guidance the December, changes, comfortable we might we'll or change quarter. we in whether that is lands out us the put the we've month wouldn't insurance moves range with range, a more bat at that point it that did you into well maintaining quarter put Yes. the And there. to We in around we range this first at with the what thing now. conservative it I narrow thought have us on the of the just was that holidays and The high fourth we And low good approach lot anything and December. cetera, you for et that year-end work end, of you're always in to guidance a the obviously, looking into you as kind and versus right

as over sure make as wanted seen growth But those for we well. potential we you're incorrect that not to XQ So factors on historical, just XQ. the accounted we've

patients insights nephritis the just study, is continue helpful. That's how LUPKYNIS you get you providing defined ramp into and how effect used. study, the ENLIGHT-LN forward? a to restarting observational lupus this how is getting LUPKYNIS. up paradigm can nice insights it. you the uptick And Got is if wondering real-world segment And treatment in the and influence potentially and Are into registry going

but get drug, of times, taking not they that an down a is kind like directed practice, actual not on we've as our Keenan's data of back of by at the guidelines disease physician the signs they're going I'm that. that at dynamic, Greg them our impending aggressively our on at drug. meeting, is look treating guidelines recently turn flares, who which we on. And were I you they off get putting drug, be just that at of And of think restart heading learned And welcome our the acceptable or we're the be the to is to prediction. EULAR one, ASN, for these patients and with well, then presentations Keenan, and put the doing X Medical KDIGO who's things or of got more drug, physician to will, If might forward. our least But we going us, of as I restart in the consistency UPCR up very I just about as many market positive on is medication over drug years Officer And keeping persistency. like year's Dr. a updated, some see early Chief but on efforts. whether think a on commentary is actual an to on urine, restarts, at that to X guidelines, to -- here he the this impact that how this hoping to any opportunity eye this can of patients great I first we've Yes. also elevated the the That treating then they on had affect ACR phenomenon you absolutely And consistent, course, flares and one have patient UPC treated. today, putting ACR level. a not of year's Dr. drug, proteinuria this moves talk R&D will UPCR the think patient

So in both we on what would there's at of the the you importance restarts. Greg, see why think registry, -- on of we this growing ENLIGHT-LN wind stage and sales hospital-based fronts our importance and sails add there?

at other little along treatments with that bit LUPKYNIS. starting are African-Americans starting typically least who's is observed thing larger the real of few Most just cut data to with a clinical of combinations in we're a the the this over we Just was of that or and proportion different observe the trials treatment. is then than combinations And to treatment. anifrolumab. BENLYSTA do as And gain receiving insight a with XX% in African-American to are recent we receiving of see black. world importantly, see participants We're

people more how using LUPKYNIS time, we So are over world. think the gain as in to we'll real insight

the of patients we're pleased now, success with the of and number the we registry. have For

from the question comes of Cantor Brayer Fitzgerald. line Your next Olivia from

You shown potency really for AURXXX. guys data have some nice

a levels So that want we've doses some also getting have higher you dose what probably I'd safety guys class thinking issues. with potency doses test how think clinic? are is this higher seen could guess about that at you I drug. in that can test to lower But potential the or tolerability you in the I'm

about any subcutaneous it comments doses in balancing of just and So terms regimen. would safety helpful. And be thinking efficacy with how on you're a then is administration,

So administration that to looking is an it at-home fair product? you're develop to assume

in dose I'll all the think in or are and is great all the -- Olivia, we're trial. single-ascending to these dose things figure bottom multi-ascending the take question, now they're I we'll line, Greg, and They're multi-ascending questions. out these in into core And we're studies studies. beings be dose going this moving human

you look we to get to we forward them So data. reporting as

Soghikian Your from next Leerink comes Will the Partners. of question from line

just quick X have We ones.

we've in just the pretty on appreciate that can a provide year. quarter? last more regression comparing in then can LUPKYNIS, on a bit And asset yet color buzz remained environment than the space sales lot with anti-APRIL the First, the seen the was in you but there's AURXXX, week. a acute on last more been another ring before entering strong, third of just commentary We to PSFs bit

about? remind you you differentiation about be us what might you're can So and thinking just how thinking competitive indications

I'll Yes, one the answer last first.

actually We've and us studies tell what et the come what and trying human we got some the data target, us here. clinical to forward get SAD/MAD they to we're you tell cetera. Let indications get data before see from

to, in way, the question. So dodge not any I'm trying

once we then we in after. smart move the want get and to got we to indications see trials these of think I go the direction

best to question, come. On on coupled, into too little that which want always that. to mean, dynamic. of was is centered seeing basis is on bit previously, for I like where alongside our company. PSFs the course, But and XQ, to said much predict et looks summer So we yes, of dig revenue combination way more going of as patient at we that the more, think best the retention our a the way are I XX-month, don't PSFs, restarts there I because look to business what of More XX-month, with your as hospital the -- being cetera, I do a first and have a

launch our it fifth today, regress is after gosh, the into and where and moving more kind of market on of you predictive X from the more is consistency, getting business drug if year. years the So being to just our

trying So restarts process, understand report new said, they're at, quarter-over-quarter was to and as starts those And that start setting and patient aggregate, according robust. start looking QX, in process, but last of be are hospital on drug patients too, look drug not it, we'll where growth to -- within the new QX using QX actually any if we're in on important. patients are to in new are. not restarts. at able when way They're hospital our I year aren't we They our to outside the say that's our those the moving combination, the QX when in PSFs And you process. show you and robust for the really numbers life quarter. in PSFs, patients And for getting for where starting combination

Peter Greenleaf, no remarks. back to at hand like closing time. I are for questions CEO, would further to this There

thank forward and joining business for continuing continue everyone, very the for report time. much move business today. and as for forward to long the our operator, your look you, to the Thank call build to We we you, you term. Thank the progress

today. That our does Thank participating. you for conference conclude for

all disconnect. You may now