AADI - Earnings call transcript Q2 2022

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Operator

Good day and thank you for standing by. Welcome to the Aadi Bioscience, Inc.

Second Quarter 2022 Earnings Call. At this time, all participants are in a listen-only mode. After the speakers presentation, there will be a question-and-answer session [Operator Instructions]. today's being that advised be conference recorded. is Please hand over of to would Bioscience. Relations now Graham, conference to like Aadi at President I Marcy the Senior Corporate Communications and Investor Vice Ms. please Graham, ahead. go

Marcy Graham

to XXXX. and morning an the conference and Good you. review second welcome of quarter Thank results on Aadi to Bioscience call update provide

give followed Desai, provide an will overview Joining me is an today Delaney, will call us Operating our President Brendan the our who progress. quarter by on on the and Chief Officer, CEO, early Neil update of who commercial

Itri, Next will on Chief will by with during be Medical our progress, period. our clinical us Officer, our update Dr. brief of Loretta Scott Giacobello performance review who a CFO, followed give financial our the

from thoughts Neil final some and questions. open line with close will the for then We

risks, started statements a Before events statements. forward-looking reminder those expressed with by website the quick of quarterly will made or or differ from found our Risk www.sec.gov, and set our that various www.aadibio.com. Exchange Actual today call annual uncertainties Factors filings forth on in materially as a implied at including other we Security which result can section and forward-looking get on Commission, be of the include or could results or at the statements those any factors,

call as forward-looking for XX, Neil? the will views forward-looking or revise and our should update on addition, that, views relied statements. over disclaim any this statements, his August as to any opening made With I of We statements specifically representing today, XXXX to In only not any call subsequent any Neil represent turn as obligation our upon date. be of

Neil Desai

for quarter second our to We thank commercial morning In of launch FYARRO, Good commercial of the joining our net albumin-bound we we in we of I'm to inhibitor with where quarter. first some but of through momentum post more the malignant community the us during see FYARRO a everyone the launch. saw continued successful stage team very only million build PEComa. pleased continue academic sales Marcy. in commercial advanced Overall, quarter, for not to transition the from excited centers, today. through you the of minutes. Brendan reaching mTOR product the with company U.S. the also you, year strong FYARRO are setting. our Thank patients will this and first more few adoption execution full us And color on on the in quarter a $X.X give

new many across PRECISION Loretta cancer our an different sirolimus rapidly as overall have advances patients about trial pipeline possible. the including trial speed very progression, study MAP's getting clinical of U.S. on ongoing are alone. basis we by for X solid has to in In application our broaden potential in the tumors. the our This encouraged annual alterations future terms as XX,XXX advanced been significantly or and the types, tumor-agnostic PRECISION diligently also tumor to on TSCX of trial, Napserolomus in TSCX executing up in registration-directed X team the our

I half the regular a still a a of will on sites clinical preliminary number data light basis. new more first the few We PRECISION the X providing we very some XXXX. on trial enrollment to of patients in The activate and shed conduct While of we minutes. are X trial early on the in PRECISION of anticipate continue in the meaningful rest,

new XXXX. with the Napserolomus early potential number of targeted evaluate the potential programs to a as other combination new as with indications, continue in clinical clinical of single as agent we either for a use Additionally, on therapies

the effectively to further oncology patients that our as of details and the commercial We to strengthen precision commercial With focused of long-term performance therapeutic potential Aadi of during for on create clinical ability further the During quarter. maximizing mTOR our and FYARRO benefits value development will remainder call establish focused provide on are aim initially leading to the XXXX, the stakeholders. drugs on we to a company that pathway. Brendan? to to the I over target Brendan turn deliver

Brendan Delaney

morning you, Thank Neil good and everyone.

since As the $X.X you to of remember sales Neil while great in that $X.X total it the In a FYARRO million very is launch are heard in for process. product we the quarter, the launch Aadi first sales. million X.X early bringing net from had first full quarter second U.S. months we still important to reached

is we settings. treatment team with the executing and uptake Our the well are across encouraged market in commercial FYARRO

As the first our on bolus quarter the in carried some earnings availability quarter patients many call, over first mentioned did weeks significant patients we into of second continued which a on FYARRO product as of successfully therapy. after see

quarter. who we pleased awareness, that and throughout In very second carryover, demand to see new show recall, physicians Insights to treat perceptions were surveys tracking recent our among strong and sarcoma addition patient. from continuing prescribe to launch the steady product patient starts brand those message product growth intend

continued We in accounts all as the we to with represent June and reorder Adoption XX% since exceeding ordered by to more and of and see ordering increase also are accounts. community now setting. that rate the be in encouraged XX, encouraged XX% than of are ordering strong a continue those XX that across the launch treatment centers very FYARRO academic in treatment growth uptake and accounts adoption

as resources XX to report access second access approximately formal of market happy lives FYARRO robust delivered the payer AadiAssist support product has Centers patient treatment a providing FDA to access X, also to covering our the reimbursement program streamline in for which were expectations. as November. to or patient J-code adopted to we combined policy last have Our and to for process receiving in quarter, report suite Services reviewed available continue broad outpatient strong payers since of progress which to provide FYARRO, This as July to and monitor in continues We FYARRO approval a further market closely continued through June I'm a that team patient our Medicaid that surpass and permanent payer initial U.S. all of rapid the the Medicare helps CMS coverage metrics. with pleased FYARRO, for commercial settings. assigned of XX%

over We will clinical are discuss looking I come of the second Loretta forward half the turn as additional in the gain and progress the new to of clinicians engaging what to programs. we will with patients. year Loretta? call our to now experience

Loretta Itri

agnostic sites access increases we've number a of the ongoing as excellence both to as in open along our progress Thank good cancer continued well see you, in of patients second In with community Brendan. in to quarter, X the in tumor setting. PRECISION centers as trial

group patient appropriate our strengthen staffed. has recruitment with nearly enabled all providing functions to rapidly This continued and now to while set us facilitate more completely sites have We trial trial efficient up R&D new oversight.

towards major to opening States of cancer including sites and the and make significant cancer Cancer recently the year. centers Sloan-Kettering centers of More than Center, The City XX in UCLA. this continue Ann Memorial Hope, Center XXX We individual Cancer Roswell Cancer Karmanos the our have most upward Center at already treatment United been Park Barbara of least progress goal major XX of trial in by end initiated,

now to practices. are Additionally, providing already patients our able Using for in who sequencing of we leading are with based are platforms, access with three community TSCX to or NGS X PRECISION routinely TSCX partnerships the generation trial. companies inactivating identify patients eligible alterations next the

who patient networks are physician the locate to whenever is have broad new network, needed. employing to States identified, services NGS is have identify we of center. provider's to developed United simplified internal on glove patient to basis. and participating We When geographic we're leveraging the also treatment a systems for potential out patients referral coverage ongoing locally in access And and an white

further U.S. who to Importantly, trial. we is program, patients enhance with the our partnership And for finalize expect identified individual our U.S. shortly. qualifies for activate to the Using STAR Oncology identify patient we will sites once can ability our rapidly Oncology trial. this

or early patients multifaceted inactivating with TSCX relatively from the alterations promise. but are showing the We appropriate rapidly in participation who to benefit is approach our trial process, may TSCX identifying

into will X order in to we The increasing physician patient patient several months. and believe are specialty to these of oncology enrollment XX within that encouraging study continue areas from enhance is to community outreach oncology We these urinary efforts our the the PRECISION reception genital drive the including enrollment full into study. and gynecologic populations

Napserolomus Additionally, expand to for to agent update. a it other Scott other with patient will we now use are potential evaluate combination turn continuing to and Scott? populations. either therapies or I over financial opportunities carefully for single

Scott Giacobello

morning. Thanks good Loretta and

equivalents said well of of capitalized quarter current the We we as have plans close first at We cash and million of with as a cash second closed we on financial XXXX. based the the quarter and ending remain our half out $XXX.X solid prior quarter. the

quarter primarily million million to fund and $XX FYARRO XXXX. primarily the in were $X.X Selling, year FDA and to as the sales costs operations expenses $X.X and same the our increased sales for to marketing to and ongoing quarter, impacted the approval, FYARRO related of development build-out trial quarter This XXXX. due cash to the incurred of change be in incurred. Cost FYARRO. and notable $X.X million the of first consisting PRECISION $X the is the was which prior which in and quarter, from Total launch general full and research on the We of period million. Research to the sales equivalents primarily amount increased quarter build-out million the were prior operations development $X.X related expenses is compared sales. to expenses million X revenue favorably expensed increase of administrative and infrastructure expect to product by for cash organization. second royalties commercial R&D into our product inventory of continues in in the to period Cost quarter. the represented for This FYARRO commercial

filed our the during compared with disclosed, second related impairment value provided loss impairment quarter For Gossamer today. for $XX.X of the Neil detailed hand of his be discussion the Aerpio. charge reported second quarter excluding was previously asset a comments. results agreement now quarter later $X.X the our be XXXX recorded the write-off million I'll license the more a the will XX-Q intangible $X.X call million quarter million the to Net for closing $X.X predecessor million $XX.X to call for information, was this of As on we to in million our to non-cash to back Neil? Net loss the in charge.

Neil Desai

Thank you, Scott.

in As was early major the of acceptance community continued second FYARRO trial. one progress uptake and shared both well. our We're the at PRECISION the encouraging further by treating the commercial is from advancement quarter of the centers growth as setting X we of today, encouraged have in and very sarcoma commercial physicians

continues disease. treatment remain as and our look commercial in for and community build the intently focused physicians malignant on Our XXXX. enrollment awareness this educate the PEComa preliminary and in on on We sharing option FYARRO PRECISION altered this first team rare of TSCX and first-line solid to with trial TSCX first for forward tumors treatment only available the half to and data we for making X

continue ahead, clinicians to and creating execute from I'm positioned Looking and stakeholders forward to confident patients to look and for well successfully value we that are our we employees shareholders. to

and be we goal can further line Operator? for around With open the our the questions. story. fall will that, with participating of meetings conferences awareness throughout in building We the

Operator

Boris question comes Peaker first Instructions] the from Thank of of Cowen. Our ahead. Please line you. go [Operator

Boris Peaker

And morning. on you me.? excellent commercial hear Good progress. guys Can congratulation

Neil Desai

Yes.

Brendan Delaney

Boris. Yes, hear can we you,

Loretta Itri

I hear you. can

Boris Peaker

Great.

find So being for have patients been PEComa diagnosed patients and the you potentially process can mis where diagnosed is, comment that typical is what and first my we a question can on

Neil Desai

this is Neil. Okay,

I'll with start So that.

will diagnosed in and if centers diagnosis patients sort for NGS PEComa itself a histochemistry sarcoma the the begin one or with correctly. So large pathology, usually end of pathological is To there's involved. general at So they're with academics testing diagnosed the no up general and that molecular

patient diagnosed. is typically So that's the how PEComa

the common XX% - is for sarcomas up XX%, as the general patients or pathologist of sarcoma obviously sarcomas, sarcomas ends first sometimes up by identify they that maybe misdiagnosed to way being treated to misdiagnosed, Now, within would are in also would as subtype. the be

might as is not diagnosed. sarcoma, some put And and The be initiated for that get education the the So This is well will these is the FYARRO. trauma and FYARRO. mTOR there's that referred some triaged PEComa opportunity part working But of get have - so standard patients get correctly they misdiagnosis, inhibitors. necessarily diagnose go onto [technical difficulty] then for the back an one we growth. eventually centers on land our and If patient education that process on. there diagnosis forth there's the patient through they that of piece and larger actually for can should pathologist to team the time treatment

Boris Peaker

the is, investors? and may Got itself you work to you in any that epidemiology some understand it. to incidences and FYARRO guys And new are the prevalence the context with of doing the if able that be so to when share where additional of

Neil Desai

that but Brendan, more we would information, pass to commercial still on it. experience gain I'll over Yes, to early. obviously Brendan you it's like comment with

Brendan Delaney

Boris. Yes

I think I initial demand start need bolus better growth we really as then and as to commercial I passes. think that the think time track Neil the underlying that step said experience and through to patient just

of see the landscape. although claims start we'll also think started small about to XX% of and see to already sample representative that's catchment data we've I a

looking in better make assessment. and triangulating at I think still data trying it's a that with helpful our to determining and

So sticking original narrow we're But helps. new sources think there yet, on it's if I that and us win time post kind the early data over help using with we're think still I kind don't of that launch estimate. works, of

Boris Peaker

questions. for Great, taking my thanks

Operator

Thank Joe proceed. Please comes question Sandler. you. Catanzaro Piper [Operator with Our next from Instructions]

Unidentified Analyst

Hi, Sam question. for on taking thanks this Joe, for is our

how this just you did what provide first-line quarter? usage, then you're on and more First, the many could of you a also detail little in seeing observed starts patients new maybe extent

Neil Desai

to pass ahead. Brendan, on I'm please question going go Brendan. to that

Brendan Delaney

with of of it's from of hard pretreated pretreated. what really field expect therapy in line. It's of end these ampac to intelligence this heavily a tell and a heavily that kind now, some the tell EAP lot the and the Yes. second to is, hard line initial are were over, patients we rolled exactly, is, at Obviously, of they're how. patients right the day, But the

the universe of in XX%, it's do and the tracking have line encouraging to -- intent right. we front However, studies prescribe the with north well is

only just share a So in market time to flow I frontline kind think It's hard and and patient of it's just to today. a dominant get tell of execution that we the matter pretty setting.

number ordering if but patients, as the As difficult, far would I look account that start at XX new provided, you to very accounts. we say the

patients I closest the each think perfect can because account, within it's number, although that's be not estimating, to you a get could right. multiple there

the more it's but have do little a we further lack an gets therapy the of you can the it So go, IV with data think blurry, given I best we

Unidentified Analyst

there you Perfect, time then and of I thanks. And treatment any I guess, now. duration on guess do have comment terms of on like you're, right early in what

Brendan Delaney

a bit duration evolve a And see where upfront. you if question, can the start time, the a getting to you're little if can much again, frontline over you No, line setting, imagine, as duration. penetrate patients, to you of treatment of duration then expect that's later think fully your shorter I will longer we'll

So that time. over will evolve

- I but perfect XX% fact reorder rate that therapy, looks that continue limited north XX%, it's did on the of that I mimic fact encouraging. rate in and if a kind at more amounts encouraging. when would of not [ph] orders it provide, assume they encouraging have Again, you reorder the at but would account measure my think, and prepared metric, reorder data, remarks, a that least That's with schedule the good. not a puts pretty vivo it, patient of provided than we to the again, -- However, perfect a dosing And patient. is, of in

that is from been the that feedback on say I thing way clinicians think right. as physicians to very our early right. pretty where would see well, able but many has representatives, continuing very drug very this hearing very start I see encouraging, and those positive, that in from They're right. other And patients therapy on a and continuing one differentiated The patients, are you is, response

of of the so maximize clinical the that frontline builds, to kind that duration as time, me settings. experience leads will, And we penetrate believe especially start to therapy, the over

Unidentified Analyst

plan, X beyond And biomarkers So specific question last then expect for specific your will types? associated and terms with TSCX of this much. tumor be Thanks do future in maybe our or you monotherapy

Neil Desai

is that With the expected the maximize everybody's doing excited, And therefore comprehensive approved tumor potential. haven't And indications, key. FYARRO evaluation thanks very mTORs, to the or know different Yes, the Neil. fully should question. therapies quite prior that we're you used types. where and pretty swath a excited central This full want punch about target. delivered so essentially mTOR across been such the a we're while broad wide of a of with of potential Obviously, as signaling going prior after for FYARRO is have we the target mTOR evaluation, was

So does even become a driver we of in resistance other process. in at look to pathway the mTOR the or mechanisms do the evaluation and then indications new combination the signaling This a us or with of next continue to And that's go year. mTOR mechanism, sort is narrow open as that first evolve. which rest may with a that to an allows whether ongoing where as monotherapy even intent we'll probably with for the studies prevail related thing to early as as targeted therapies, resistance to year for on

Unidentified Analyst

much. so Thank

Operator

you. Thank

question Please Our Song of the go ahead. line Jiale with comes from next Jefferies.

Jiale Song

all the of FYARRO the the quarter Great sales. sales. progress full call, the full ,thank to related you, couple for A and questions congrats and first for

sales. inventory the much build second are quarter, First the among of versus how this product in $X.X million them sales

the in Thank I them is gap see think inventory? you. the the most just view. from for inventory your curious much did you in and are pent But second demand. some the quarter, up how comment, the first of But quarter in

Neil Desai

Neil. Hi, is Yes. this

take you to would like one? this Brendan, So

Brendan Delaney

inventory think to trying I has, where feel was question. Hi and high. distributors what the Roger of that's for [Roger] And sure. as a bolus The thanks needed initially, kind to get Yes, for carry. the they were initial

that I time, say the X to to it's X weeks. would what down come I think, since in levels normal

can the the most prepared through of remarks is this put So to early EAP demand I carryover, say, inventory therapy still number from on bolus, significant my would that there's on I who just pent levels. were patients fair up right? returned which though, mentioned what in from a -- we whether continue or normal mean carryover pretty see. has that I

it also little positive, that's mask underlying new but Now of data, flow and demand. patient of a the kind bit a can

positive the patients are as visibility the -- makes a little but on that if helps. So us better it is continuing, is that far as the giving it data difficult

Jiale Song

after helpful, you Yes very to then to thank what you have J do you. gross the target to net, of And code launch, just over But current your XX% to time that sense the I curious, And X. understand is have the the you activate is in net? gross in July terms particularly a -- XX%. change that's since did

Neil Desai

take Brendan, Scott And would comment. you like to can that? maybe also

Brendan Delaney

think don't that like reporting it's kind as we early, and so enough relatively comes things of still of Yes. sometimes have Roger, kind No, data, know, you a I delay. on

XX% the comments. of you know So think I additional we're if be we'll sticking that with end towards still the year. and narrow to have XX% Scott, number, that I to able don't

Scott Giacobello

pieces some take I with Brendan. you agree of I the Roger, No. just time. do is I that you can government know, mean what mean the said, thing

have fairly changed. are not where our we end we'll expectations but so still And up early, around

Jiale Song

from and any since see Maybe of are a opening initial March last sites more related you. so increase enrollment PRECISION X you little a feedback since you bit the now? have those, Excellent up Since And pace started just the patients you to the Thank trial. the do first of site? you. interest one kind level the pick thank

Neil Desai

to on Yes. to pass it comment. I'll Loretta

Loretta Itri

and Hi question. you thank that for

seeing are great now a toxicity something and deal and one that at of associated a a a is of Neil with absorbed Unfortunately, We way and poorly hard that and didn't central with way was were point deal it is give. great are really apparently is level drugs mTOR and is to toxicity a of high said They're interest that we that the going have more investigator mTOR, interest time. in clear associated They another earlier reduces after drugs active. deliver. earlier target

rare the quite not So annually This not there target. mutation. are the They about think about XX,XXX is this. We rare community really States. is excited approximately in -- a the not know certainly patients United a

have a that already derisked. drug We approved. is It's

clearly are So to our dedicated that report thanks early on the on worked very work group hard is is trial this on of hard we who track, folks track. a of in to for. the able this program. that hope time XX were that going I this And we're at to enroll you you looking we're gives confident trial point color within be months. The

Jiale Song

that's other the again. taking progress helpful thank you. Yes very Thank for and you for question congrats

Operator

Robert next with Wainwright. Our proceed. question Please from comes Burns H.C.

Robert Burns

Hi on the guys, quarter. congrats

of to one for said the follow-up if which into obviously considering any started hold them had if there was that revenue. of will me, from insights you quarter? first of you bolus so actually in bolus Just carried I'm patients over impacted sort that second curious second may the from patients earlier of quarter, I some the patients quarter that percentage a the XQ, and what over the

Neil Desai

answer one? for would Robert, Thanks, that question. you Brendan, Yes. the please

Brendan Delaney

the of It's -- a little of really what is on-the-ground of of question. number that lot is. you bit pinpoint -- intelligence on the even appreciate I data number instead a of is know that and hard transitioned to driven. really it's what, kind patients really this It's And guesswork

science. what And to providing patient a Again, perfect so expect but or we're into it's ordering that transitioned patient the say, if trying patient a they order trying an QX, a a okay, that's probably there's to continuing, a difficulty EAP, okay, where that's from in if we're continue loosely we not to that, the account, number. see

the want lack data. very of and So not lot percentage on it's point, given because necessarily to a the it's I of don't speculate guess work clear, this at

Robert Burns

Okay that's fair. completely

Neil Desai

because therapy, is maybe different oral. were this, just this little IV if tracking but clarifying I is an the everybody think knows is it Robert, from there a a comment So

sort the drug sight center. lose of the and the individual And academic we patient so the time is of at

that's think these I uncertainties. So why there's, of some

Robert Burns

you guys and completely that's congrats again understandable, Neil. the for No, quarter. Thank

Operator

you. his Thank Mr. I back final to call Desai finish Q&A comments. that, turn for with will Neil our session And we today. the for

Neil Desai

today. everyone, and appreciate appreciate opportunities interest. we up Hi, us time, you our updates fall questions, good provide thank day. in the additional joining we We appreciate the you. look Yes. and the Have the We again Thank progress. coming to for your a to and forward on

Operator

And ladies and gentlemen, this concludes today's conference call. disconnect. Thank now you for your participation and you may

Aadi Bioscience (AADI) 10 Aug 222022 Q2 Earnings call transcript