AUPH - Earnings call transcript Q4 2024 | Aurinia Pharmaceuticals Inc.

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Operator

Greetings, and welcome to the Aurinia Pharmaceuticals Fourth Quarter and Full Year 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 & Investor Relations for Aurinia. Thank you.

begin. may You

Andrea Christopher

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

Joining call Miller, on Chief and Officer; me the Dr. Medical Chief Aurinia's Peter and Executive President Officer. Greenleaf, Officer; Keenan, Joe Greg Aurinia's Financial this Chief Aurinia's morning are

XX-K Today, review company's report progress corporate as Aurinia's in the and this fourth year annual and full issued recent we financial update results Form on release will press on and XXXX and discuss quarter provide morning. an communicated

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

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

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

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

Peter Greenleaf

full Joe and details update on recent our on I'll additional on results. the and provide update call, call. quarter then morning's to provide CFO, to our you Miller, and On I'll over Andrea, thank all for Thanks, morning, to today's on year joining provide financial us everyone. call our good progress. want results our I an turn an XXXX fourth this

XXXX. and the With record-setting and significant of we sales fourth net in in product the commercial focus achieved efficiency, on total quarter continued operational execution growth revenue

fourth XX% XXXX. the $XX.X in quarter million, up period For revenue of total million was $XX.X same from of XXXX, the

XXXX, $XXX.X million in was For million, full revenue up year $XXX.X the total XXXX. XX% from

of with up For XXXX, therapy patients in were the fourth the active $XX.X product adult for of of first compared oral LN the treatment the to of $XX.X XXXX. million, LUPKYNIS, net FDA-approved period XX% same million quarter sales

net further $XXX.X For The from million the LUPKYNIS of specialty increase primarily were in penetration. full of number both to is XX% increase year LN periods sales million, market XXXX, in $XXX.X cartons XXXX. up to sold driven by in an the pharmacies, due product

from XXXX, months X ended compared operations December For in flow cash million to of same the period XXXX. XX, generated million was $XX.X $XX.X

December from cash ended to XXXX, operations $XX.X flow cash $XX.X million million of in year XX, the XXXX. used was compared flow operations in For generated

improved pleased are XXXX. cash investments year, restructuring, year's million we Exiting cash our last XXXX. of strategic equivalents, flow restricted have we the Following as throughout and how December with XX, of cash, $XXX.X cash

strong to believe provide into commercial now project a health level growth and are of forward-looking success fifth on into on X strategy results continued that that for we LUPKYNIS focused we metrics. key XX% we poised our for business XXXX, financial Therefore, our providing the specific patient insight market, As our sufficient year not in With have sales is are growth drivers. the we're results. historical our

potential not receiving would types. potential at centers. centers steroids, treatment segments lupus lupus targets patients, restarts. MMF and our base treatment achieving of business and We've and sharpened rheumatology diagnosed are medical patient expanding newly on for This academic also nephritis patients and identified on prescriber targeted LUPKYNIS key we've who include First, key focus our patients but only

we're and nephritis positive urgency drive lupus treat expect overall rheumatologists Second, lupus this new a screen the continuing aggressively. to mindset to treat-to-target nephritis momentum treatment create treatment guidelines help the to more for and ACR that year, we among LUPKYNIS drives

reinforce to time. earlier Third, on the periods lastly, to and impressive efficacy differentiate on we position patients therapy continuity from data improving lupus Program clinically business our keeping Clinical And continue in care X-year hospital LUPKYNIS treatment and safety paradigm. the it for for nephritis we're AURORA by our growing patients data focused longer of and of

expect highly million to pleased in range for XXXX with a XXXX. million in $XXX organization a the million growth XXXX range and product very and We're on $XXX to efficient position $XXX the $XXX to for in sales of of therefore, solid LUPKYNIS total focused million net start revenue

development also this are BAFF/APRIL September a we treatment potentially autoimmune of Phase inhibitor Finally, for initiated and I AURXXX, range last XXXX. a product, report potential from study of continuing the dual We the pipeline to study results of of our to diseases. quarter the a out advance second initial expect best-in-class in

over the call a detailed Miller, questions our might have. more Joe? quarter I'll the any call turn CFO, of for fourth for a now financial the full review wrap-up up you year and open return to and to Joe line end I'd to to quick results. like then the

Joseph Miller

Thank you, everyone. Peter, and morning, good

results. Let's a minutes discuss quarter and the full to take year fourth financial few XXXX

compared the ended XX, million the same months was For period revenue total of $XX.X XXXX. X $XX.X to for December million XXXX,

to XX, December million year million revenue $XXX.X the ended XXXX, compared $XXX.X XXXX. total in was For

equivalents, of cash, cash of $XXX.X XXXX, as Peter As generated XX, cash mentioned, and of million. operations million restricted from December we and flows $XX.X cash investments had

We with hand. on cash share to opportunistic currently operations from expect continuing be share cash and future discretionary with repurchase our any program flows and are to repurchases fund

approximately quarter February As the USD approximately of shares the million the million since first repurchased launch XXXX. XX, of for XX X.X in company has its program the XXXX, of common of

of same For $X.X to the of ended revenue the in XX, cost was XXXX. million X $X.X XXXX, months million December period compared

increase amortization only the of partially prior XXXX. the right-of-use year year connection the with lease due the placed in in was of the Monoplant, therefore, service and revenue recognized into was XX, December full impacted $XX.X in late asset The For by for revenue. ended to finance compared which was of primarily million cost XXXX million year cost XXXX, $XX.X to

ended the XX% same XXXX, XX% months gross XX, compared For to margin of the period in X December was XXXX.

XXXX, ended XX% the was XXXX. For December XX% margin compared year to gross XX, in

the of months ended total For were million $XX.X million X December XX, the $XX.X XXXX, period to operating compared same expenses in XXXX.

a compared $XXX.X decrease to the including For expenses both The lower total development December AURXXX of million R&D of XX, in XXXX. due development year efforts our costs, and the of restructuring overhead $XXX.X in ended coupled million reduction expenses operating is with result program. XXXX, periods result primarily ceasing in personnel were company's as as XXXX, a strategic costs in compensation a share-based to non-personnel

are periods a terminations other by benefits, costs These partially offset XXXX. and savings onetime with our associated throughout contract undertaken in termination efforts strategic both restructuring

X December of million $X.XX $X.X income of net share months or or same the ended XXXX. net share of of per in loss XXXX, loss For compared was XX, to net per $X.XX period million the earnings $XX.X

$X.XX of year the to $X.X loss XX, net was share in For per million $X.XX December XXXX. $XX per ended of a XXXX, net earnings loss of or income million compared share net or

hand some Peter? to the closing that, I'd like remarks. call over Peter With to back for

Peter Greenleaf

balance Operator? to activities for strategically accelerate strengthen want lines highly summary, LUPKYNIS further clinical drivers sheet. growth implementing industry-leading thank for business. Joe. development highest We business, of has your a strategy today. can Thanks, the the to us the allowed AURXXX you our operational lean that more enhance commercial into open and now have I questions. any for flexibility in focused In now time to our all engage We'll further

Operator

first Our question Ku with Cowen. TD Instructions] from [Operator Stacy is

Unknown Analyst

for is a This couple. on And [indiscernible] had Stacy. congrats the We on year.

growth growth So thanks for -- talking kind about your drivers. key of

those we given on guidelines? more asset. with details are opportunity LUPKYNIS, sales second give then -- can XXXX, then and the question AURXXX addition the on on And around force, prescriber probably the about how Maybe as more so you to us for and these think segments? especially maximizing the the about is the the some details you current ACR And some

readout. glean remind infer Can what it? you be forward So expect kind we'll we're sort or what us of really the and able to we data of looking to can from QX

Peter Greenleaf

for the Thank questions. you

with in the second. if I on miss start then me Let anything and to I first, jump Greg might ask the

maximizing on Your post as opportunity of question first restructuring, it our the relates sort to LUPKYNIS.

got X we we've through the think let X we're As we the areas focused those post them of me call, relate on. And key how least address I went on to restructuring. at to try

rheumatology. on first is strong focus a The

patients all As a a at or they they're with patients worsening diagnosed, and once office. primary outcomes, know, care SLE rheumatologist. that progress physician's But present we originally probably LN to

the really what diagnosis the to aggressively rheumatologist's And drive treatment happen if and within the treatment the propose they be and is and of initial should initial disease, the our office. guidelines disease goal ACR of the should diagnosis

we the pick from as So high fashion. patient SLE actual we charts -- offices, we things which both we're priority at on would put but in a LN not high-prescribing look able patient, of was through focusing patient our codes and that on looking up at a restructured group, actually blinded one very to

centers your important. question, lastly, hugely focused country proteinuria. diagnosis lupus undertreatment mentioned have know to resources of because and you lupus important against have their in So then centers since underdiagnosis that one centers, in elevated they we there's the if clinics an offices, critically early capturing that and the we've high-prescribing rheumatology hugely are guidelines, disease. The segment important our the And Hospital the again area, medical an know that lupus major that around have are patients we

how we a against of just are are we've focused important. critically X those our few So them that segments not tightened but examples down just think resources,

call, dose the your will of you on we single read to out that's see second on end AURXXX, XQ forward trial this we're heard which at from looking our year. as ascending focuses the what disclosing ongoing question, On and

we what critically understanding MAD. into I we into study as normal SAD dose be we study IgM in out what in of space, expect able to the to Obviously, I, structure IgA, and such APRIL/BAFF don't missed think can MAD there. you data that the take as and think see data. going there show pharmacokinetic normal use are some would I IgG, important we pharmacodynamics to as is Did hope the to anything markers and important Greg? what actually that This are in well. the be I progress

Gregory Keenan

None.

Peter Greenleaf

Thank you.

Next question?

Operator

Our Olivia Cantor next with is Brayer Fitzgerald. from question

Olivia Brayer

the It like you're all to XX% beyond How are LUPKYNIS thinking about looks at growth about this you XXXX? year midpoint. guiding

and half-life then and MAD update? us for quarter anything So And indication to dose dose growth selection will the way candidate? for the And potential tell is this these there rate low you disclosing the few years? AURXXX, be on second portion guys that double actually can point is digits next right your in frequency about think you at about

Peter Greenleaf

Olivia. Thanks,

intend it's metrics LUPKYNIS, So listen, guidance historically today see we long-term and to upon. what we've haven't sort -- centered this don't product And give on can you but our of now market historical the a on on think and for X, go-forward about been trends way its going those product has best are the basis. think fifth into the to we year,

that's helpful. hopefully, So

the the data first. back On disclose saying SAD we AURXXX won't will data, have because just we or on hold see I will actually and what to

it the as conduct would I first, as some guess ask going I the to into will move good to us. expectation steer out what But probably be MAD data that study, just be we think SAD probably would MAD. we're see it get I there and would that an there how shows the we give

the I context which then that how question months development we're will from. a are we is, this strong few well, have away does also really just this others think next in in MAD versus there doing And we the for inform natural space. what study, that think be

So looking that conversation. having forward to

Olivia Brayer

in about in data that? terms have I around of lines study, SAD lines for Understood. and that of kind time to we lines of time can numbers time -- But next see for or steps the any portion terms Okay. What you know guys MAD the obviously, of first. put

Peter Greenleaf

projections tell data first, long Yes. go back completion I let the are get that then said, we'll that. to the that's us inform our you do MAD I to and in would going what of SAD what take and we intend to guess will to just and I what how

come. So more to

Operator

Our next Farzin question Jefferies. Haque is from with

Unknown Analyst

us. just question. the [indiscernible]. Amin up on the Two following for on previous from One is with guidance, This

has and 'XX? run X the mistaken, you still this earlier $XXX of initial and it you for be market Book is filed can until if million, guidance to a I'm months Maybe this exclusivity talk rate. conservative informs is outlook not issued your half $XXX Lotus earliest XXXX? to seeing first 'XX, there LUPKYNIS generic expected, the You that of XQ the seems somewhat about and base then case exclusivity, as are Orange January the commercial by million And year strategy What given on that an protection to assumption NDA was in come in month.

Peter Greenleaf

Yes.

Let we seen our first was question, range early year. in what guidance the me which the start on have and

by think of in fifth I on project our market guidance year. said that after now the our at closely financial driven as very very know see the using much where we what range is, looking out being and sort to our year results the we call, on we and historical

gets we category. into sort in to As end QX. you projection low were of up range us of end obviously may that of see, obviously, higher higher is a versus the The growth flattish where slightly that

of we the second based obviously, times I we're a just some folks think little and think was, a marketplace today. aware, aware they're that what seeing the reiteration we feel ANDA confirm about we're in been year. begin good reaffirm. board. across No, and conservative? your there we've On want the on I the think can bit your we we filings So was of would for Do XXXX, think numbers But of to do they're I mid-portion that this dates point question,

XXXX. portfolio have take entity also We out patent unique could LUPKYNIS and robust which its a all paradigm, unique dosing the chemical way the to us obviously, covering for

intend intend to company the defend LUPKYNIS would fully to we fully we any rights our and protecting and vigorously do, property intellectual product. As

things changed in and continue dates more evolve as of come terms you Thank to but So the to here, nothing's the times. question. for

Operator

from with is Joseph question Partners. Schwartz next Leerink Our

Will Soghikian

Will Congrats today. on for this is This quarter. the progress Joe

thinking So in you the in the without you the trying more like and just as why make we be guess, for than XXXX. bit first, final no move switch the of X I should year talk trajectory a about quarter longer that understand back How metrics PSF just launch little might something to your could go middle forward the guess in rather this? we of decision to from us. report XXXX? just about we're I

lower or we're when And the allow I dosing to KD one as it then AURXXX, given it frequent on is that was which potency once dose? is with to should a data, for ICXX it weekly, a like fair higher and assets, anti-APRIL assume has NHP lower less other in at compared looks guess line the assets. looking other

help this potential versus development? you dynamic can in therapies us here understand the other differentiation So and

Peter Greenleaf

we've start So to we I'll obviously not question, speculative. remind of Greg and then what and the jump to in what's I with want -- first reported, state necessarily mean, ask I'll

basis. it enough that our or we as our provide X sufficient insight, And project call, health this, on at million we're results million. of into product into revenues total than the onto and guiding excited to year on to LUPKYNIS and fifth $XXX So forward said to now million a $XXX the more believe this years insight year market. to this in a we're XX% confidently We're we year business into historical XXXX, on we're basis, company the financial grown $XXX million $XXX our have

We because year-end it decision the was we the time. at best made thought

question I take beyond. to the you look XXXX commercial we next midyear. do key mentioned to the and call want mentioned focused that you our Greg, in do to on think mentioned the out areas them as it forward drivers one? the on on and reporting the previous We it. as for doing time now that was actually best believed I We strategy

Gregory Keenan

Sure.

of at reported of or College means like XXXX. presented equivalent to. amounts alluding Meeting were there's So that American KD the to you AURXXX that information referencing with we've what impact just And Rheumatology we've compound fact that had a ICXX. conducted, lower Lower lower you're that and the models alluded resulting was lower in preclinical been identified you the in

that perhaps preclinically perhaps and milligram give with thus need is attractive less dosing. frequent with AURXXX compound the basis need the So milligram and is of frequency of with would the work a amount we think you we've would That regard drug. potency which done far to you less the to very per

doing diseases people, select conducting study that has later. dosing we're the dose course, in that ascending now milligram earlier. appropriate we'll been learn single the -- what as of Of And will in be be right frequency discussed and the exactly would we take-forward amount

information Good the point, this we're forward. and for ready thanks question. So to at move

Operator

Our next Arce Wainwright. question with is from Ed H.C.

Antonio Arce

me. Two from

secondly, on to ACR the difficult their ultimately, rheumatologists on just nephrologists? coming moving us you more perspectives early just the the later the continuing with historically, than and then and what's indication been since regard selecting time of And wanted wondering your Firstly, writing impact growth. the key the year the Phase look of of as if could you again longer-term time to an you for to studies, you ultimately about -- your into into especially one treatment drivers line LUPKYNIS, think mentioned, as about of out and guidelines, to perspectives understand a on uptake initial as thoughts wanted then line from think ask script MAD script get writing penetrate an this SAD prescriber I II? and has bit AURXXX, like help

Peter Greenleaf

Ed. the question, Thanks for

really for quickly enter they that's happen physicians. for guidelines, proteinuria rheumatologist's call, office, early On every One doesn't we screens actually, beneficial the That today. on these and areas, there when the are folks treatment do SLE basically, that -- biggest office. patients treat-to-target and treatment, a has the through being diagnosis market, the patient is and go the guidelines, ACR X that oversimplify X as on to hugely I'll and see

product. And huge UPCR regardless X. no and patients X goes for know today product that around potentially levels, medication, that data then up to on, to time product of target what they the lastly, today that selectively, be the they XX% we mindset kept somewhere And restarted And to more when to those when know the product that know treat of hit to be they period there's level a those target which even they we to treated, matter need X remove down years. hit a proteinuria our where have Second, patients that we on to opportunity. only get the on they're of from that then then is, a

X So benefits LN, to with the product. our and, all of are course, patients those of overall market

So and behaviors, rheumatologists, our I can what growing. today greater impact you of that than slowly prescriptions on tell is, is number from come XX%

We least that have change, came in ACR we not seen yet, data at have in the we macro to have November. massive earlier the but of that recognize guidelines diagnoses in out terms only

these I guidelines, and EULAR plenty and going So are of the the KDIGO with all positive very think along where guidelines ahead product. forward there's for guidelines time market the our LN

look as Ed, the numbers on forward go reporting but to we market, forward, So that's level. high we'll

seeing and to some impact look behaviors on impact, seeing we more We're moving and forward. forward actual treatment diagnosis

time get MAD, longer-term is the would SAD get us what say In the ascending through out into we our the terms time lines, of AURXXX your let well, once question trial. single and dose on of I

far study. and that least kinetics it's I we longer steer for Let not got towards think think decision might look it SAD, at or I give multi to into those what will where some that and going this as is going data through we whether our to the and long how -- give us we're informed to and us will dynamic But term use tell articulate that be guidance to approach MAD move at get what the not, an away, take.

to come. Ed. Thank questions, for more the So you

Operator

to Thank floor you. like closing question-and-answer over session. our Greenleaf This any hand for concludes to back would I the Peter comments.

Peter Greenleaf

day, a thank along updated keep to XXXX, want for great you to us We folks. look today. strong and joining Have all we'll the you I a way. forward

Operator

This concludes today's presentation.

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

Aurinia Pharmaceuticals (AUPH) 27 Feb 252024 Q4 Earnings call transcript