Aurinia Pharmaceuticals (AUPH) 1 Aug 242024 Q2 Earnings call transcript

Good day, ladies and gentlemen. Welcome to Aurinia Pharmaceuticals' Second Quarter 2024 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. I would like to turn the conference over to your host, Andrea Christopher, Head of Corporate Communications and Investor Relations for Aurinia Pharmaceuticals. Thank you.

begin. may You

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

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

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

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

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

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

to call. focus performance. call AURXXX. our details then the for on call, by thank and will CFO, update company's second financial an joining Miller, Joe our Dr. everyone. the highlights. give morning, good our provide On I on Andrea, Thanks, to want asset, turn our pipeline to additional business, Keenan, on development across to the medical our we everybody us will morning's Officer, Medical be today's Greg Greg this including the work over quarter I'll of Chief on followed and results

on metrics preparing Now details the some of for let year. me second how provide and quarter the we're our rest business

With on performance. and cash accelerating we achieved towards second positivity, flow company's focus strong the operations the a commercial execution continued quarter

as of sales in approximately For product revenue growth product months million Aurinia the million million ended of approximately $XX X June of XX%. $XX.X XXXX, quarter $XX.X LUPKYNIS the represents the for June same period period in net in months product of the XX%. three XXXX, in same and million same XXXX, the revenue and XXXX. XX, growth XXXX, XX%. $XX.X months for for the versus in consisting This This $XX.X revenue growth was XX, second $XX.X $XXX.X was for million million million was is ended representing the representing for and total to achieved voclosporin $XXX.X for Net XXXX, for XX, representing approximately XX%. Net the approximately XXXX, total ended compared growth revenue net same in period Year-to-date period of revenue. of million June XXXX, X

We flexibility further equivalents also provides future. The million cash investments which positive strengthens projections, and our the the had position as of achieved for our of free restricted building XX, approximately cash initial $XX.X and second quarter business cash $XXX.X activities company more flow June engage ahead million and financial of in in XXXX. in to cash,

representing in approximately combination XXX who XXX in XXX year LUPKYNIS pharmacy. second as approximately restarts commercial prior PSFs of with new added start Together, metrics, hospital substantial we it restarting and PSFs quarter, either these the compared patient terms in year-over-year or receiving forms hospital are growth. patients through performance fills In to XXX a total

for fills From extended April being and hospital added new period total time, in as compared significant an on rates growth off therapy to in June growth through patients XXXX, our of restarts approximately year-over-year. X,XXX approximately PSFs patients persistency hospital and year-over-year as of XXXX, XX, We XX, improving therapy patients driven also as patients was with LUPKYNIS of XX% on LUPKYNIS X, XX, from July therapy patients starts, increased new restarting XXXX. This approximately channel. XXX XXX after June X,XXX achieved we XXXX, by the

approximately We conversion patients XX% sustain the therapy. on to to of continue converting high in rate PSFs with a quarter

time also a XX% approximately We therapy days. of sustained conversion starting with rapid XX patients within

quarter, we high XX% on persistency months. the strong at at with achieve to therapy of Our through approximately XX% remaining XX and remained overall continue adherence second rate patients

therapy Additionally, in respectively. on at the months, XX XX% remained patients XX% and XX and of second quarter,

summary, of quarter range million execution So established from our narrowing previously to solid $XXX guidance net our $XXX the announced to million against million. this, business second product previously guidance Based in accomplishments $XXX believe priorities. our year $XXX revenue a range we reflect of to we're million full on range

forward half milestones. some we key well the year, of Looking the upcoming several planned commercial innovative to as as initiatives second have

it a and nephritis paradigm one guidelines. This reinforces in kidney therapy rheumatologists of company's innovative that least importance the prescribe as by strategy these the three marketing from the earlier maintain treatment of the treatment nephritis current as campaign LUPKYNIS initiatives, Importantly, commercial to and example the risk with reduce prescribing highlights start to to caused growth accelerate eye-catching encouraging proteinuria. by to the at that new to Aurinia is lupus in launching LUPKYNIS therapy and Foundation for market campaign irreversible lupus of damage treat part do years accordance of

a Europe the authorities generating for of seek Otsuka that outside for this and to approval with Japan. year continue Japan. are are November on on Otsuka's collaboration milestone half LUPKYNIS once LUPKYNIS lupus receive second U.S. revenues, adults the a as for with of we JNDA Otsuka well of we LUPKYNIS Otsuka approval, in from with in to million to Upon royalties Japanese double-digit the in the working hopeful also we response that a payment anticipate grow. is diligently treat as sales $XX efforts launched regulatory launch meaningful in approval low filing. filed expect to XXXX net activities commercial nephritis. And Recall Our in

In continue that into our to progress excited pipeline, of know terms you clinic. we AURXXX let we're the to

Importantly, be in in we XX% impact following $XX expect funding $XX XXXX. anticipate recognize And the development will the announced we expense operating not with previously restructuring cost targets. reminder, AURXXX of with cash to to recognized that will of savings that million million annual flow that post-restructuring approximately as a available

Keenan, over be a more for that, discussion Medical near-term for Greg to now strategy financial So Officer, development to on our our Joe like I'd Chief detail the with turn by results. Medical Miller, a strategy. greater Affairs will detailed followed our in-depth CFO, our our more review AURXXX Greg on call Dr. of and

I'll a the questions. call ask open the for end mic to recap the return have up then course, to you then of and you quick to your Of in order

let over So to Keenan. turn with Dr. Greg? it that, me

scientific Thanks, with good morning, everyone. it I'd to an development and plans. LUPKYNIS and pertains provide minutes to AURXXX our Peter, like medical and our you of few as take overview efforts a to

engagement the Affairs of in the lupus scientific XX first In quarter, Medical on these considered and in with that with the on LN Our an focused had we had half In therapy whom important Medical appropriate be it optimal nephritis attributes the approximately focused LUPKYNIS LN. nephritis. the second team is experts the year, both interactions over to treating with our rheumatologists patients LUPKYNIS Affairs X,XXX are understanding the identify engagements strategy nephrologists. Collectively, lupus XXX make management community. clinical top discussions for strategies should and of of

LUPKYNIS taking and diverse the than the practices. We've fully and are of academic safety events of U.S. end to enroll more provide society sites fall patients an of the XX in will patients. goal to year. is important their community measures in outcome care registry across submitted we've the XX ENLIGHT that registry Additionally, few meeting, academic by enrolled amongst which and quarter this next demographics first our major receiving This of LN participating monitors and a LUPKYNIS a ahead abstract registry, for patients the

and alone Our LUPKYNIS with steroids medical and the steroids international well and regional NKF at in an published team metabolism were electrolyte the Notably, EULAR, oral quarter. combination meetings relative as and differences CCR in lipid additional first-generation as East metabolism sessions. Four LUPKYNIS model demonstrating of to work, and in XX cost-effectiveness this versus a clinical and and manuscripts including value analysis were of key meetings medical delivered well including ERA preclinical MMF the attended MMF low-dose society both as symposia U.S., in well as CNI. as in quarter

specific and domain. There's AURXXX appreciable potential function IgGX autoimmune highly also neutralizes molecule. immune a binds thus B-cell AURXXX develop As and has where moving current and the Peter with potential containing engineered BAFF disease. for We It's diseases unmet targeting a populations and entrants. maturation protein has no in in next-generation in B-cell therapy survival it best-in-class is forward market this our areas a need. a treatment there are maturation, BCMA serve potent BAFF disease AURXXX on in believe antigen to to mentioned, are resulting AURXXX, few decrease and modulator structurally an Fc-fusion effector we affecting APRIL, and APRIL. high immunoglobulins. We B-cell as intend with

criteria one for fast-to-market larger smaller for and orphan rare AURXXX strategy diseases. overall FDA indication indication that development Our one the includes meets and exploring

We're We quarter which our make to patients forward impact call SAD need. I'll program. tolerability, will in study algorithm from entering Miller. molecule significant the now safety, pharmacokinetics turn SAD the potential inform diseases on move year. expect data high third have Phase half data will program of unmet I with treatment anticipate the that in our in in of over XXXX, available excited ascending with of to numerous dose this AURXXX from subsequent differentiated this Joe? autoimmune first development the study to could high having biomarkers. earlier Deliverables and first a our single Joe We the include

good Greg, morning, you, and Thank everyone.

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

repurchases an investment LUPKYNIS and we XX, by restricted the Otsuka. XXXX. The activities post-approval As cash, from LUPKYNIS, million compared of million XX, investments XX, the and of cash, June average cash for received offset continued December payments, million $XXX.X cash Aurinia from Monoplant of $X.XX. million sales commitments cash at to an X.X and million end from primarily cash cost year-end and restricted increase at share payments, at in QX approximately XXXX, restructuring-related $XX.X Through $XXX.X commercialization July repurchased and is in partially had payments decrease shares of cash XXXX, cash equivalents, equivalents, of investments $XXX.X to of related had and

and same $XX.X ended $XX.X projections demonstrating million flow XX%. Net growth product the Net the million for Peter for XXXX, was the positive XXXX the was $XX.X voclosporin revenue revenue growth of representing revenue free representing in for product growth in our the into XX%. due growth main XXXX, is sales the the approximately to revenue by first undertook further representing X for the months June million penetration was impact June and was period XX, increase period XX%. period of of same $XX.X was predominantly driven compared LUPKYNIS, As approximately $XX.X $XX.X of XXXX, same the the company mentioned, approximately initial the million of million ended in LN June quarter the net X second ahead $XX for period XXXX, of XX, LUPKYNIS to quarter consisting ended million, approximately the sales XXXX, in Year-to-date an efforts quarter XXXX, million XXXX, XX, of product and June for market. Total increase primarily cash $XXX.X of specialty months the restructuring $XXX.X million of quarter net XXXX. million XX%. two in in our ended representing XX, approximately pharmacies, and for to The same XXXX, of in for

XX, XXXX. was Otsuka $XXX,XXX commercialize June revenue increase royalty June XX, continue Additionally, collaboration service for to collaboration and for XX, $X.X and June License, the The we revenue million revenue Otsuka $XXX,XXX and ended ended had due XXXX. quarters XXXX, XX, for License, the manufacturing $X.X from primarily sales prepare in X to territories as and Japan. was million they related and launch XX, is and months and cost approval $XX.X Otsuka costs XXXX. Total June product in restructuring XXXX, to to of in of inclusive XX, semi-finished the in the million and operating June months commenced of the services costs the of inclusive X capacity cost of operating Total $XX.X and second were XXXX. June shared for and half expenses, XX, first XX, in XXXX. restructuring June million million XXXX the that ended sales million of $XXX.X quarters and June June expenses, and XXXX, XXXX, quarter late the XXXX, sales and $XXX.X ended for of were of royalty

negatively quarters XX, a SG&A million R&D the in $X.X partially of June XX% quarter ceasing of of June XXXX, XX, employee in of in now program XXXX, costs quarters within increase $XX,XXX in was product XXXX. development in first Let and compensation for XX, XXXX. The of CRO included and June X to X and our for zero Noncash million AURXXX. Noncash impacted to XXXX. R&D a XX, expense share-based SG&A and months was quarters SG&A expense XX, XXXX, were headcount, XXXX, expense the lower R&D for occurred quarters ended late and June to $XX.X timing product the Gross June ended XX, for June primarily ended is included Japan. the the the a The of XX, and of share-based XXXX. million share-based XXXX was to overhead expense June quarters for the XXXX, the of reduction driver XX, inclusive share-based quarter $X.X margin the million product noncash expense income million which XX, related were AURXXX benefit were income million XX, amortization first Otsuka June employee were inclusive compensation in XX, $X.X $X.X interest by expenses million restructuring-related ended share-based Interest June XXXX, by approval the going million within XX, Restructuring $X.X compensation XX, XXXX, $XX.X months XXXX. Other X in XX, to expenses, ended XX, and $X.X XXXX, for decrease for and compensation fees. and lease. approximately XX, $X.X compensation, million sales expenses expect which XXXX, operating and and million XX, ended headcount, and million R&D compensation $X.X compensation asset, June quarters drivers of XXXX. Restructuring to in value compensation and related zero amortization June XXXX, primary and semi-finished development expenses, June XX% XX, administrative the the million expenses service expense and expenses the and X and XXXX, the foreign general the XXXX. million the The net by XXXX, SG&A in were $X.X for to X of XX, and and primarily were to million credit offset you months a June Otsuka and occurred full XXXX, ended of XXXX. related X XX, quarter and $XX.X sales June ended XXXX ended $X anticipation XXXX, payments expenses, compensation R&D XXXX, to and $X.X June ended of X XX, of XXXX, $X.X approximately give XX, million late Interest a included was expenses and the June ended months expenses which million XX, onetime XX, year headcount, me $X.X Noncash XXXX. legal were XXXX. Interest breakdown not XXXX, XXXX. share-based LUPKYNIS. quarters for for and were million R&D the X compensation the million sales for XX, and for net exchange of quarter expense XX, does driven with is the months due Monoplant into increased to $XX,XXX primarily XXXX. XXXX, million the which finance related expense is for to and The June the expenses, June June June $XX.X approximately XX, and $XX,XXX for due XXXX, XX, commenced and of the June late million expense income and and XX, for the of XXXX. million June share-based $XXX,XXX Monoplant XX, liability XXXX, and in the $XX.X million and additional in for X and for XXXX. June and for the amortization June denominated due the Other $XX.X expense for million $XX.X was XXXX. Gross our a an increase contract change margin expenses, and decrease reduction quarters is reduction company included Monoplant of termination to for drivers and a ended was in in months was margin expenses. June XXXX the was and first XX, XXXX. and placed XXXX. lower expense SG&A Noncash included right-of-use were million and expenses June XX, XXXX. Gross is $X.X Europe June ended the expense XX% of ended the months June June and $X.X and further the ended $X.X XXXX. for of $XX.X financing XXXX sales and Cost inclusive lower distribution XX, related in francs. XX, semi-finished ended forward. employee were $XX.X XX, months $X.X R&D margin the the June fluctuations. and inclusive XX, of XX, XXXX, and million costs X of within and and assumptions decrease $X.X June June credit of was XXXX, XX, the approximately XX% was ended expense XXXX. Cost for June months million SG&A income $X.X June June June ended for was June sales share-based material ended primary and occurred in fair June for incur ended the June liability, The for XX, lease deferred million due changes and June quarter reversals our million Swiss forfeitures The expense June $X.X was remeasurement were Interest was $X.X XX, and the of and which XX, share-based ended June The million Restructuring XXXX. Monoplant June months severance, and quarters million X months

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

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

questions the for we'll robust solid to Thank looking second sheet flow including want balance all patients AURXXX your clinic strong I XXXX, a thank dosed advancing lines forward a today. And half you, commercial might to and execution, have. open with with the for first continued of Joe. any We're cash performance for into Operator? you generation. now the time you

with question Jefferies. [Operator Instructions] Maury Your from Raycroft first comes

Farzin on Maury. for is This

restarts then And lean. than PSFs patient in is looking XQ. XQ bit month, your a also in So it came and growth this in lower slightly

you've in the how seen we into So the does typical in your past? given about adjusted that summer expect the should the cadence months, seasonal how And guidance? impacts factor

years see in obvious metrics, Last patients. weekly need to QX, see there's are continue -- is, away is you on going simple year-over-year, our new we're and QX because on consistent date QX rate growth. answer the over know, the of -- fact, out run new your on to the numbers run observation summer We down, QX backing Thank as the the The we need going trend with observation to continue and growing, both PSF combination QX. look to basis what to several patients still seen slightly grow, if up weekly months. But all until need we need our at There's to question, from to report for but hospital and the year-over-year, are up is to the the patient into we've grow year-over-year, -- on growth that right. Farzin. trend albeit in your moving call, into the we a But to the are see not QX QX, that's performance that. is PSFs restarts. continue to albeit and in from the you continue rate of consistent year-over-year quarterly into consistent we the there We we last channel growth point,

All sense. right. Makes

You achieved free have a and balance strong positivity the flow sheet. cash

we wondering [indiscernible] So other assets expect should options? any potential in-licensing or

a on to that said And be the well. balance our has of process AURXXX, diversification priority that we as a observation need is as pipeline focused on commercial barring of as that. the more I clinic in and And for opportunities and -- observation has we sheet to there. that later-stage work the it's pipeline continue the But single-product course, open obvious we've company. our think your been on our to diversify strategically, calls, there's company but we into -- Yeah, the important we into strategically to moved other think is which are continue moving

Joseph Partners. Your with comes next Leerink from question Schwartz

going was AURXXX. on then something on ask LUPKYNIS also to and I

there significant have urine the your strong embraces are if this discussed market we've as we to an how you've had help wondering if be guess influencing was LN and behavior I area think us So how before, much understand I should could upside overall screening. seems of you more success regular which with about you MSLs doing you needle effective of physicians encourage move from Do to LUPKYNIS. understanding to practices not And that be a ability patients the identification educate might sites this? going your such forward? how and benefit can more of targeting

rheumatologists So the through the we on One do, question, three-point studies way, diagnosis ] which, is by that attitude to studies answer in on awareness Joe. because [ urine since clear both we've is is initial one our a the our SLE it's this. we seeing are to one the do patient, basis, significantly screen, awareness primary been doing and the be that going talking an about mover this awareness the that rheumatologists, up quarterly

guidelines awareness the meaning that Now physicians every it, talking of to I'm screens SLE visit do saying with to that on the patient. But we on is juxtapose up. need educating guidelines, the an urine

pull done. the office. urine data down at to screening target to we we just look is analysis an up. actual see We on Second, that's if urine directly And it screen aggregate don't

have We increases. massive not seen

time moving the period. the in summer, into summer we're we're albeit Now

diagnosing of to So we I into that this higher over rate time. yet. translated continue awareness But has need think monitor a not to

positive is awareness is higher. So the -- but momentum

treatment. is our the accounts. The call rheumatologists point that we the initiative ] prescribers we target very I targeting, launched call diagnosis up with the a campaign and initiative can are of sales who Your to the across of there's from market. a a those are what campaign of question I practice the our high up, call both exclusively are aspirations with of to good is for and a to towards through and in how you mentioned plan that think there's is yeah, this significant And and that understanding think patients. new around business, happening number between high part representatives high the lupus d-link is And with have targeted that last target the I point growth on goals MSLs once actual the [ we've that make on will our and bring catch obviously, who therapy

our So new that. is around campaign all centered

physicians. So Haven't about yet, with least good actually it seen momentum. positive message materialize feeling the at sticking but

And helpful. to by the strategic interest for then this can talk are this preclinical again? AURXXX about the to indications Can what bring thinking pursuing? this forward you you in about compares the Is many late-stage talk data decision about your in And development? how assets That's space? agent driven you

Yes.

alongside to all said first optimized efforts we've had as we that we AURXXX So back restructuring we knowing both We more reformulation. along, knew company also into phase had our a take were to bring of AURXXX, it. the -- AURXXX, that to had

the our cut AURXXX, we whether And it of should ability doing a determine we're expense. moving keep amount asset. own. and or as forward after that check asset partner exited doing by the as we'll do it whether on we forward well, a forward a had significant then check the said, well we to our so, product we take or operating On market to So market

the inhibition conversations cash at it not operating our year. determination, 'XX a by operating what and it free think we I'll flow questions a that the where to front, decision The alongside to our of going always to indication While Greg BAFF we area IgAN don't about inhibitors we've take was those two, in IgAN ahead B-cell that much a talk our focus we're are in in target we've IgAN, own the one, to further for expense obviously, had BAFF were made upon product as for oversimplify us. to, based possibility second. in we on APRIL but we're the And last and of around in given forward changing any try about area estimates be did went. other and it say on primary be to designation But that and the under been the Greg the way and least would interest, target said, the for excited how tee space, on APRIL guidance two to been try who the potential not terms pathway. that of the of space. based centered orphan excitement And -- APRIL/BAFF has larger data. I'll might Keenan could an in work Not of that

side, compound. little to seen just give the we've let a talk what differentiation about the with On me to-date Greg bit

Sure.

thanks, comparisons So able earlier our KDs of pop have milligram atacicept. and some we of Peter. find BAFF/APRIL And equivalent relative and more amount make are we the some we've done, been With and ICXXs drug. [ namely preclinical that to work compound meaning to we've some lower, inhibitors, that ] telitacicept

will think efficacy and inhibitors those other so compares favorable to quantitative in And efficacious response We reductions as and be immunoglobulins B-cell see maintenance that in one to diseases. B-cells that agent expect strategies. very be that the we advance adaptive strategy we depleters against to a don't be to will fits AURXXX reductions going profile backdrop an Hence, ability other of think it a is safety the in of think B-cell-driven favorably the the relative depleting have we perhaps we this that how immune and many for ]. Relative of useful we particular it. [ have comparisons attribute a to think combination presumed that B-cell compared to for ovatasocept given we

Cowen. question with Stacy comes TD next from Your Ku

a So had few. we

some you then long-term time average and How help XX back? a these it last treatment months, around is restarts. What's therapy? patients on capture chronic metrics question Is the they're patient and patient trajectory. them to convert still we early to do then understand and the amount more be channel about And obviously, hospital probably before just like to the above restart, seems asked coming the years? going just year but the of time. understand are you few as progress we I Just that's but moving the It think it's to help going important think last quite days, us where about channel back restarts additions hospital And be next that why relapse? going of into us these this forward. know LUPKYNIS

competitive thoughts landscape. Just the your around

for Phase So Roche's have Obinutuzumab nephritis. their lupus we this believe III readout will summer

So your just thoughts there. curious

I all sure have Making these.

kind the these out, Let through. me give with rolled bit a first this hospital on of Because me we direction more have broken channel. haven't let start how little

We're I think per patients, terms to the we how that. about now, XX, hard have been it's of trends. enough quarter the clearly It would a base in talked hospital quarter, see and it XX% couple we've the I of restarts per has smaller to XXX element numbers being channel. two than in a excited right say as patients -- the hospital patients hospital to from more we're And channel see base the per to that. of XXX hope XX% to significant moving the coming quarter. call yet, but to XX of that would XX, patients, it, of start to growth this new we a patients XX that XX from patients out now my trend be Q high to on patients, we'll XX and a it XXX growth really to as Stacy, continues, channel, to moved from being quarter. And be tens seeing of But XX a almost it. about have just has onesies/twosies of in

grow. don't for months. what has at therapy in points therapy four to off that they've fall at restarts, of terms been that, hands be be to to in qualification, -- to that those everything our months. out a be be going they that. The restart would a to have hope average us, off And least think Our order four their they average that's for in continue at have to have, know system for I become I of when least our been. they restarts and they of my have But we restart

are lots file what both and as more GAZYVA, if this Your hopes as data reported, hopes the that then Obviously, SAPHNELO as two year. the competition. SAPHNELO to And importantly, last Roche my on soon, therapies. The updates towards market is be that protracted. folks year, targeting to data positive especially to on potentially B-cell space, from more Roche's next activity a you're product, soon and understanding precursor they've LN lupus, have recent is by the it referring with question targeting of most

-- ran they a SAPHNELO. study. but with proteinuria, significant Phase statistically study in show difference move of with Obviously, III. of in they Let difference a Phase forward me a terms That a start II not reduction terms did in did

So we'll see, off. by on anything, and years Greg that's a this I miss are targeting Both build couple of different pathways, B-cells. can if and

probably reductions much in impact calling for. more have six-month, the terms the proteinuria like data the proteinuria. that are work, The in but will it's So are targeting guidelines one-year of will to reducing Benlysta protracted a their impact belief three-month, guidelines probably levels that in our

the we've at And seen to inhibition able B-cell those so far, early hit target be not levels stages.

work disease. years, individual to two about and complication cross-compared, good year they years. show at as that agent years. do, of as patients study But they two do at serious appear we work can't about we as a their obviously. these two in good to They the each not wait at have a for as have for been seem Now data These

So the our did early cross the and puts upon at think been Greg, of positioning based magnitude miss? rapidity though compared. I competitive even advantage a studies what response of response we us haven't

spot think you I No, were on.

in much I is it agents that does think punchline mindful longer, evidence be depleting need take these that's there's just quickly, to many and shown the LUPKYNIS B-cell of definitely and of. with clinicians these and role we've a very very, the something scenarios, work for

modalities. Other

on Hopefully, LN are market have to to the companies. the development larger we're do and/or educating larger ones and We doing. in They the with haven't seem more one expansion start big the us the coming and of obviously be period. work seen on and help two will focus information and also any and market The to that. that docs dollars companies patients these well soon more resource new off interest time in

question comes Your H.C. from with next Arce Wainwright. Ed

quarter. for me. A few the on Congrats questions

the know if -- to clarity, wanted down. and discussed on more has restart been to numbers, wanted ask this I just I already I a First, could, a hospital I both little little PSF bit sequentially get but bit,

quarter restarts Just thinking insurance obviously light. has little first is annual typically the regular seasonality, about the a

discuss if I lowering on that how is there if seasonality, from range any you year. And the million. for income end the XQ to guidance you to your wondering guided can XQ million and $XX then initially your you with I'm at $XX know to the restructuring fits looking of this had So overall statement, just

so less million $X have only really You far. than

quarter. won't the follow-up. if could, And charges lastly, spent? Just the further any amount And have be then quarter, number the of number there the wanted in then to in you third buybacks confirm, share the and a I

handle asked. me let Joe P&L income were questions -- statement let Well, both that and/or I'll Okay. the

a XQ that of the a of seen a we've be more. as want the XQ the think in product. And and like since this well the we've as as from young activity the just patient has them the -- offices to business we've characterize consistent with in consistency up seen what PSF year lot and launched the I the in we've to far based as upon to the more relation historically a and been population we so makes guided up offices activity terms of albeit summer align which we'd less time, which -- to I even I have XQ are year, still the trends patient fact XQ level On doc and effect said less sense in we've the year-over-year, that there's trends hospital that relatively to for recognition, qualitatively seen reiterate, there thing during think patients of how previously, is I we

a that the we year-to-date. back see even that, significant within it have of to have We are [ year. We guidance total, don't project have business summer, the the about order we to low would range. I decrease to in previously what and think, hit range that ], relates of As and in we've in in consistency our project will guidance for the Ed. down the see range would a guidance our fall we we be end guidance in was posted, year, to if $XXX consistent, half well of if XXX We million

we we've we we range So we should that feel that the adjust we that. see a range it summer maybe based report of But upon or at feel comfortable that. higher end we comfortable given about that with great guidance performance, assumption. XQ, based upon If be when the

let transcript, on as then And in the what it I'll it back was I for but again. addressed transcript address actually him Q In in terms of this us the the charges, Joe think you if go the but reiterate did we well, have buybacks, you.

charge Yeah, the and Thanks activities for for purposes, all on Ed. were the second restructuring intents so quarter. the question, restructuring completed in all

the related So we was quarter. plan further that material to do not anticipate restructuring in the announced spend any early first

So second disclosed I costs, $X think XX shares. to that million March million we our roughly than question yes, related initially, of further about in thereafter. In guidance approximately right. QX, we at reflected range program, $X.X had that repurchase you're restructuring less we anything related approximately your don't slightly the X.X acquired regards but We expect million of share total to

repurchased of approximately XX, have As X.X July we million shares.

additional the time have in million repurchased. between X XX shares approximately March XX, roughly and So July been

this question, perhaps is Greg. Then last Great. Fantastic. for

half have you've provide around safety, SAD data wondering biomarker and you Regarding move there's to detail and PK. to forward any with AURXXX, next stated expected could decided readout data year tolerability that in study expect if of you first the a report. the I'm

for the Thanks question.

antibodies drive disease. know the to that So ones of inhibitors, as thought you are short-lived plasma pathologic the generate and the that BAFF/APRIL maturation specifically they block proliferation cells,

whether time. what over an to relative an immunoglobulins, IgG, or namely So from the we as of to get drop impression to volunteers, baseline measures, standpoint impact not percentage IgM and we'll those those on see have early looking so quantitative can we'll be levels healthy IgA

single as got here course, modest, give us or a only is will not Of be relatively but molecule so an impression it early we've to a dose, the and whether it's that biologically active. impact may

So that to activity. the be of that at it biologic be key looking numbers we'll relates set will as

what try and us much at reported to too we're what on give who of here look were those like-to-like is of they've as essence to ahead data. The do trying and

molecule different hitting they're sort one targets. might who the that is you So others these be around ahead you. asked of Each how question do mapping slightly now your towards of previously the was see

that and further the move biomarker how APRIL/BAFF shaping compound relative how go the we key differentiation in this into potential we development to So we points and think looking after early be competitors at in even indications space. clinical will data both have should we of

over our At this no remarks. I'd are call to for there like back speakers time, the further turn to questions. further any

everybody continuing for you further updated business today. our the on thank time, Thanks joining for keep We on No remarks. look move your we forward. as it want to to call everyone. forward I us to

attending Have earnings Aurinia for you, Thank day. Pharmaceuticals rest the everyone, call. wonderful second XXXX quarter of a your