AVEO - Earnings call transcript Q2 2022 | Aveo Pharmaceuticals, Inc.

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Operator

Good afternoon, and welcome to AVEO Oncology Second Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I will now turn the call over to Mr. Advisors. LifeSci of Vitzthum Hans Please go sir. ahead,

Hans Vitzthum

Michael Thank joining Officer. us Operator. quarter Commercial financial today Officer; Good Ferraresso, Chief Officer; discuss Jeb afternoon, for all XXXX Ledell, by joined I’m Officer; you Erick thank results. Chief on Chief second Executive Mike and AVEO’s you, Bailey, Financial today’s and Lucera, to call Operating Chief

differ of risks statements XX-Q, discussion, Risk including call, Private meaning that Before remind this Factors which with important to the be is me Reform today’s today’s Litigation quarterly statements of in of the during the Risk and and let recent uncertainties, section These on we we within Factor file update are President making such otherwise, statements as Act forward-looking call caution Michael those begin actual release do cause from results that you will detailed forward-looking obligation the Summary subject our materially not Securities XXXX. SEC, in Form those on may and most views assume press our are represent that report in expressed today, you by as these new any only results With and result that of a we turn law. now I we Bailey. and Aveo's except Chief that, will Furthermore, Executive over required Michael? these events future to to statements, to the as statements. information, whether or of Officer, forward-looking

Michael Bailey

quarter first only steadily year FOTIVDA the need X to helped kicked continued therapies. Category FOTIVDA Cancer believe market that This Comprehensive prior to elevated everyone that on we success patients and $XX for a off filled, FOTIVDA. factors This of on drive significant quarter first is in XX, was quarter, XX% is increased call. prior am the report the NCCN, or I you which XXXX, build commercial Thank Network, compared for was a to XX% product this launch, the US FOTIVDA our providing as when we which relapsed fulfilling the important well-tolerated the you, received more prescriptions fact X the refractory FOTIVDA setting adoption reflected for today's of increase recognized Hans, the team to most commercial pleased million further several that with and for an evidence-based second both of second or and of one joining on become of to RCC XXXX have increased unmet the the who Category therapies. achieved success, us positive net June thank option of and by treatment revenue, compared quarter treatment patients, in sales or with our two to to or effective have now quarter number the in the RCC is momentum status. XXXX, is National more two who while second

formularies. developed are guidelines and recommendations clinical the in other first-line of oncology and and for all referenced or pathways from therapy and As of recommendations are background, current physicians clinical recognized The for cancer a subsequent RCC through NCCN for policy development practice in clinical standard care RCC treatment make NCCN review patients options guidelines the evidence researchers. are and

NCCN and positive expert evidence NCCN is offered by the clinical perception X among reflects category highest and of panel the the product Category Importantly, members. the recommendation

And more Communicator in depth Mike Ferraresso external campaigns. Awards moment. the by this will as biotech recognized recognized FOTIVDA were our multimedia the during launch XXth and in finally, with addition, agency its of discuss PR launch Associates ZS PR an Annual and recently analysis recognition in companies excellence overperforming for and launches. US emerging in was our In pharma first-time AVEO a

With guidance acumen our to supported NCCN our Furthermore, add We for by our to the $XXX assets elevation, is of year launch, commercial net providing recent XXXX and with forward FOTIVDA and capabilities updates the first commercial strong the recently we $XXX to product stage believe look sales growing quarters XXXX. there million by of of for in continue fiscal trend effort to to we US that our be trajectory demonstrated million portfolio. this confident progress. potentially an additional FOTIVDA revenue future enhanced status opportunity two the on to strong in our leverage identifying recognition commercial

activity. trial clinical our to Turning

partnership pipeline, of our focus, the align corporate assets for can opportunity R&D opportunity to key leveraging focusing for working we on of the provide development opportunities tivozanib North our spend to and partnerships AVEO. funding for with America inflection initiatives partnering will strategy believe We minimal treatment while overall assets antibody the points. We R&D our assets. development this with to R&D of strategy that strategy, create our this advance that with are these portfolio, market of Consistent our on from our get commercial expand to investments our RCC investment continue US exclusively outside

for XXXX half quarter, During strategy R&D full resulted in million planned of quick $XX strategy, detail to a and the reduction in for R&D sought this provide further each broader let me million spend the streamlining year the full XXXX our our that second we program focused update the updated an moment. guidance. on to a guidance year, overview our for pipeline. by Erick OpEx offer refine in With our will $XX in as year second which a

the XXXX, both long-term new of in poster data updated a with nonselective to survival for data of featured sorafenib, we ASCO clinical During and June from improvements Meeting tivozanib. VEGF-TKI. in relative posters the two survival overall show a One of Annual analysis quarter, which overall presented conditional second at TIVO-X,

X from RCC. had discontinuation poster The trial. no that prior tivozanib second cell who favorable subgroup VEGF-targeted analysis carcinoma, demonstrated activity cell profile non-clear data non-clear safety Phase of with cell ASCO in patients comes at The concluded treatment. analysis included a and a published previously This with randomized from patients renal a

trial, front, monotherapy Phase which on continues the TiNivo-X the combination and IO patients. the of tivozanib X clinical versus a to evaluating progressing enroll for patients the prior On RCC treatment therapy, tivozanib of OPDIVO is

enrolled HCC, market first-line announced or into opportunity And approval encouraging to this data DEDUCTIVE trial this year, in second relapsed/refractory setting. would second-line be evaluating in the the In trial potential FOTIVDA the XXXX. expect larger this durvalumab with RCC for tivozanib relapsed/refractory earlier we and to combination We nivolumab the cohort. tivozanib OPDIVO from the quarter RCC. of expand the fully has FDA in from the If support successful, an in data of

focus Aveo intend has tivozanib Given liver our Aveo planned date, development patients. of was strength to enrolled fund population to with spend on the and in for initiatives, supply a which XX first decided down R&D the consistent committed pursue our this line, tivozanib drug close and study, data further does have of first-line of for should to but the AstraZeneca evaluation enrollment AstraZeneca cancer. X the in study focused or further cohort not providing and the we second-line to registrational HCC

cetuximab for believe of strongly marketed Phase for combination registration with half a offset serve a Fast the prognosis Track is they believe this have population full-scale being asset January XXXX, substance only of metastatic discuss to announced X-ready data and to validation supporting fourth a the trial partner fund Also and completed partnering note, continue Phase one We potential we potential These the clinical the potential not as KGaA, we or cancer. believe to agreements, in quarter. significant strength collaborations as challenging. opportunity. of by help granted ficlatuzumab, We continuing which Lilly Darmstadt, we HPV head plan costs providing drug neck quarter initiate FDA patients is XXXX. trial and ficlatuzumab. seek of study, very the manufacturing of After ficlatuzumab negative with Erbitux exists a address for and with we in two strategic designation cetuximab. one to with also recently unmet of potentially but X recurrent trial on to positioned supply the A positions by need that first in we the with as Turning well this clinical to Eli announced and FDA Merck collaboration Germany, and designs the that ficlatuzumab patient trial

supporting we data AV-XXX partner believe for a are in we over with asset. we For AV-XXX, metrics. during opportunities. Phase-Xb have walk a the find pleased We as quarter All patients commercial through we second Ferraresso, to this highlights remain like believe asset progress. and the hand, initiate In capabilities, to recognition continued date second the the FOTIVDA potential received Mike? and to the year data position clinical in potential blockbuster we where commercial us future external with this a will track to in leverage potential to of I update, attract patients. Mike creates this expressing GDFXX would commercial the our which additional Phase all, a are to to including on safety our anti-GDF-XX of to turn and the our particular, strength strategic the in more cancer in organization dosing, XXXX Ib call to strong detailed pleased commercial be success we additional trial generate cancer with of we hope half activity in the launch

Mike Ferraresso

Thank you, Michael.

are As XXXX. we in of second the success quarter the with of mentioned, Michael pleased continued FOTIVDA

as treatment Phase raise Our for continues commercial awareness to team data only first X option cancer and of with third-line patients. kidney the FOTIVDA

the by may was technology Associates, a three seen, success ZS ZS FOTIVDA's not in analysis date you of management, of report, quality that success only to companies had to and our was last in published execute launch the firm, ability launches of we've that one just in this over even as and believe challenging to Associates consulting products In market some team access the but launch have of speaks reported commercial recognition XXXX pre-launch biotech ZS XX in or the As included expectations, years, conducted environment. launches launches overperformed. analysis compared first their of also that included commercial June. to launched COVID FOTIVDA the validates and already and the emerging in the ranking majority We which the underperformed, was met in our global analyzed expectations the XXXX underperformed. while pharmaceutical three this of by overperformed

the the of FDA Communicator around Academy commended multimedia Our launch Annual award excellence Aveo and campaign we've commercial PR program acknowledgment awards capabilities and corporate public agency communications environment. distinguished commercial and Visual were received Arts. creative our successfully FOTIVDA. at JFK the the we multi-channel leading international FOTIVDA our which by Excellence by the taken for approach XXth creative in and a Awards sponsored Awards marketing Interactive competition communications honoring Award, launch also received is this to advertising, of is approval COVID relations, The Communicator in an of

and a QX total over increase a recorded last commercial quarter of the sales the Further, consecutive me revenue the an over turn the US this last $XX of results reflecting Let first quarter for net quarter XXX% during XXX% FOTIVDA, second first quarter. from year. which now increase the a fifth increase compared a to prescriptions, to for of we million of in in increase the prescriptions X,XXX product growth the To revenues XX% was year. with second start, quarter, XX% quarter and reflects second

believe will growth. As we look we drive help are ahead, that continued there opportunities several

prior announced is rating we strong is elevated who've patients recognized Cancer on therapeutic that kidney the appropriate in for members. NCCN cancer the selecting NCCN, benefit the to the efforts or for kidney both team's academic and when June, their FOTIVDA cancer status panel kidney offered Category therapy and product recommendation FOTIVDA subsequent believe community category NCCN, elevated our in of by We can patients. perception as oncologists example, getting and as National evidence followed guidelines guidelines cancer physicians these one For therapies. the X among and had clinical options to received latest this treatment in are a that more adopt which This Network or highest by based Comprehensive the

respondents most market positively the decisions. said X our of upgrade FOTIVDA conducted would example, with For research their showed that prescribing Cardinal recent impact Category Health that XX%

to are cancer data patients in particularly line community options. the kidney field versus to help in and real-world six the increase the this which of reported benchmarks seen initiating active treatment average base broaden of we're of increased in are majority of X.X in currently COVID this months seeing we've a seeing FOTIVDA setting ongoing snapshot. prescribers, for other fourth and early expected is We're kidney occurs. secure for patients cancer the where continue minimum the customer to this of third in is team's addition, In restrictions increase in-person believe access ability in as benchmark significant X.X our meetings setting improve with also FOTIVDA lifting. We follow-up treatment months will our still us provides a XXXX, setting the treatment duration from as XX% already treatment. therapy months, treatment an is The The so improvement duration

look We for label progress our see We potential believe Erick? infrastructure further over are line turn are with will label possible FOTIVDA to closing, very FOTIVDA second commercial that improve from second Erick that approved, positioned over since discuss our In capabilities commercial launches support the continues Lucera coming team we've patients heard and future an duration I the the be our quarter community. now call financial we broader time. to our in to the momentum a under has generated pipeline. pleased to launch to and expansion, current that and continued to reception tremendous medical updating if quarters. potential continue and be to FOTIVDA well XXXX on the there oncologists, the encouraging forward impact results. on with you the averages and to of I from expect pleased

Erick Lucera

of of was $XX quarter Mike. and by with the development the compared $XX.X million $XX.X of $X.X Selling, prior and XXXX four for quarter million the second consistent the level second in with expense the Thank $XX.X second million. quarters was and net expenses administrative revenue was is you, of for US general net Research product the compared $XX.X in quarter second of Total quarter quarter for million, of driven revenue with XXXX a million, XXXX XXXX. XXXX. second million,

position have the in we're the of paying our many status While income taxes, NOLs. yet not of asked about

second income performed Based company offset our of of the in we that XXX our advisers on potentially most our to quarter, the $XXX analysis taxable During used NOLs years. conjunction the of be million in outside could with Section a that analysis, believe NOLs. coming

full our XXXX, levels guidance we to commercial spending constant to year. remain Looking to the our for continue relatively expect year during

increase XXth last expenses approximately margins to slightly to reflecting year compared spend for the expect XXXX. quarters the commercial launch in million, in mid continue XXXX Specifically, we XXXX. to only commercial three as year the are remain to in to over of percentile $XX full high Gross expected to

we In addition, the administrative year. at for to expense general $XX approximately million expect and flat remain

expense, XXXX. range million In expect of $XX XXXX our $XX million to research $XX terms of development prior for in we million be now it versus the to and

equity available ended cash million full of on second call on reconfirmed will As Michael Form overview June for expected over FOTIVDA A of have million. quarter product our marketable a operations XXXX maintain we XX $XXX quarter the equivalents Bailey I the to XXXX. our FOTIVDA for us XX, We enable XX, revenue now existing along and revenues Michael? US to filing net the sales earlier, quarter the and XX-Q XX-Q. of report of March XXXX. Bailey. believe with following turn with We results ended XX, our securities our Form from for net at June of and Michael of the mentioned $XX.X back months is revenue period US guidance the current will least $XX of of to as cash, for quarterly equivalents XXXX XXXX, million cash, at $XXX of second million December XXXX, $XX.X compared cash XX, securities with at marketable million

Michael Bailey

Erick. the meet close, you, excited of year remain the to guidance we Thank To sales $XXX revenue by commercial million growth confident to million and are in sustained $XXX full of ability FOTIVDA’s for XXXX. the our

very NCCN Category the standard-of-care this reporting our a gain of patients. As forward to continue FOTIVDA, we the and with of future direct FOTIVDA endorsement RCC benefits we us X with look to at team the for entire am point the longer-term has work done be of to as Operator? treating oncologists and I for the path as proud experience to get third-line look successes. see to established

Operator

question-and-answer be at and Ladies you. [Operator comes of a Instructions] question Stephen time, gentlemen, ahead. Thank this we session. conducting go Willey Stifel. Our will with first the line from Please

Stephen Willey

guess, good commercial Thanks maybe of couple taking just ones. Yeah, the for question. I afternoon. a

point the data use world? as of you data to there internally, you that, the seeing of some gross if data in But the a right proportion since that suggest kind that upgrade. is the that, NCCN I I would curious, to more your at second guess, of I of to be year, of look function with then, script prescribers You be real provided just to just now trends product a last out And that net of a respect That occurred. upgrade would, the also that you're willing as the two anything have guess, Is survey the months helpful. guess, XQ? in trajectory for that playing would course

Michael Bailey

Yeah. over I'm for our Thanks, turn Commercial question. Officer. this to Mike the to going Chief Steve, Ferraresso,

Mike Ferraresso

the question. for thanks Stephen, Hey,

kidney a recent excited call, we the strong we're and from puts the on position. said NCCN upgrade upgrade have would prescribing. the really really us positive So in physicians this we it did cancer mentioned surveyed of by XX% And research and treating in -- as market their a impact a the the

promotional materials. upgrade said, that got half it this to little a and June, in our that takes the just back of we into Now get while

this will we for forward. impact not have significant we're going results reporting So us think QX anything it a but at point, for

Michael Bailey

Yeah.

organization. materials to require NCCN One of their the details, referencing specific any review does

Stephen Willey

for have to just net Okay. gross quarter, And if the that then you available?

Michael Bailey

Erick?

Erick Lucera

gross The net for was to quarter. the Yeah. XX.X%

Stephen Willey

Okay. And bigger picture then question. maybe a just

Do commercial the future? or need I you asset be other made when at strategic of your look do to built a already but obviously, that of opportunism? curious, that get under year be in in position any just you Do the you've to And would the commentary comment it of can profitability? to guidance perhaps another You might through I as to helpful. leverage need not you your you Is start for a out? have looking kind looking infrastructure funnel to opportunities just think timing specific belt? think to organization sustainable commercial guess, a function maybe you there

Michael Bailey

Yeah, Steve, this is Michael.

think I the above. all of the answer simple is

As in we function he's we're mentioned in a ramping call, the got and the up. built this Jeb organization. We've development business Ledell

So actively assets. those kind for we looking are of

to So on it's that. hard put a timeline

of a talk and And about that Erick, one. aspect turn over to other that. just financial it The to want we'll is I

Erick Lucera

to Yeah, is our our ways. it, terms is Steve, product a most commercial one in in bring it's important. One of But we great confident operations. we what have question. in obviously, three what asset important and years another do there's organization ability on the market, is very financing after the year, where X.X we Obviously, cash feel from is

debt an selling transaction. no at we thing sure in that equity. have make equity levels. is that important most accretive it's The second And other is other interest to is The these and the to is

So we open the hunt are for on and business.

Jeb Ledell

it. add commentary more I'll color And on Yeah. one just

tivozanib. rule to give want XXX% to to launches, general with focused you a Just regard

to XX-month We that's assets. beyond, opens and that focused and on could on positive. you point we as are currently when we bring XXX% then the When capacity get really strategic up additional to think launching

be the probably that earliest. So would

Stephen Willey

still or the also then, of kind at are in say you're or you whether And GU opportunities space, that area. outside not looking of can you just

Jeb Ledell

in kind this a we think target. if So about of

So the GU the would of center target. be

solid targets. acceptable out, further tumors potential Moving would be

of Moving zone on target out treatment. then of care be heme. would that would cancer probably the And supportive associated outside outside with be oncology our directly

right So this prescribing And community. the as of space, other Mike XX% concentric make work the covering that, circles think I for in now, is there's things GU here. a is we're broad the of one the opportunity has basically consensus said, that

the And we've have organization, oncology knocking coverage we'll as with be heme over a any out institutions. got the matter the to successful door, broad the would went you very footprint on not It other if a So different institutions. community. going different to space, major in XXX% a

Stephen Willey

Okay. That's questions my for congrats. very taking helpful. and Thanks

Jeb Ledell

Thanks, Steve.

Operator

Thank you.

line Kusy Our Baird. of go ahead. question from Colleen next the comes from Please

Colleen Kusy

and on COVID should you additional thanks question. if afternoon quarter? Congrats in in COVID, good the the any saw we impact this the mind, year? from Great XQ? of Curious, into half any second leading if impact for persisting And keep

Jeb Ledell

Hi. I'll that to for question. the over turn Mike. thanks again Colleen

Mike Ferraresso

Thanks, Colleen. Sure.

always So the COVID evolving. situation is

efforts. are significantly customers pleased seeing our of middle We and in will then the that quarter. through now. We're we've in really we're all quarter multi-channel ability our effective can we're and be big very again, hopeful signs built. in infrastructure to probably We've more the increase restrictions. continue. customers optimistic second even right trend And we're first tightest starting pleased the of impact and that with really the access That's when person. the COVID But our a in can organization we the under proven And

opens So continue. better will And the we're us. really up that board trend optimistic again, the for

Jeb Ledell

as the and it to our And the just overcome Yeah. proud really ability We're Associates because to more them. shows well challenges our Communicator recognition of between Colleen. external thing, as award, add the very ZS adaptability this and I'll step-up one

So market to what we're the nature what it. And about always dynamic is. satisfy the do to of thinking need we

that. So, we'll do to continue

Colleen Kusy

penetration in that how any have you're you. efforts any spoken of sort around number? you have And back, making higher continue Thank sense treatment maybe the go? past, the sense. to much now? makes that coming And foregone to of of -- approval. that then some patients before increase you've could about And number would how what is Great, metrics who Do

Michael Bailey

to over Mike. that turn I'll Again,

Mike Ferraresso

Sure.

treatment. third for look at report benchmarks that eligible -- and the reported percent to of fourth-line active patients on we this what So, externally go

XX%. year just approval into our almost number a prior a that to as at updated launch reminder, was XX%. was our So It to

at III range similar And viable treatments benchmarks question and about And to the to XX% of could those kind get XX% We far the to an data second-line setting, the tolerable already is CAPX from setting. which Phase support so, second-line and how we look aspiration goal think treatment go? your NCCN, rates with the with improving. our it really to is for it's then

Colleen Kusy

Thank you. Thanks.

Mike Ferraresso

Collen. Thanks,

Operator

Thank Our you. the is He Instructions] go next question [Operator of Wainwright. from line Arthur HC ahead. Please from

Arthur He

guys. my afternoon, in RK. is good taking Hey This Arthur for for Thanks question.

curious your research survey. regarding Just third-party market

impact did the XX% For in didn't those the they guys show reason you responder the prescription kit? positive decision give further to what's digging prescribe out hesitation a

Michael Bailey

over Yes. Arthur, the Thanks, that Mike. question. for turn I'll to

Mike Ferraresso

It's a great question.

done So we and the rate them treating asked impact. what showed as to the was update physicians to we

impact, it said moderate would so XX% about was increase was the no XX% or a impact broken and increase out low then the impact, be X%. low other of but So, significant

research of is majority it's the others. but said win adopted it impact time, XXX% see a impressive you to to this or So never this are it have response. the going using of already vast on really market an Maybe setting already and kind they've in

Arthur He

for Mike. Is could presenting regarding that a yourself? plan you the wonder, deductive just any by the trial conference guys I -- data Thanks. release the paying there you from is cohort And at release B. are the pipeline, Thanks that on data the or to

Mike Ferraresso

this purely is in that. X to organization. tackle strategic I'll and decision Thanks, The a resources in anecdote. there's And for only the so remember, are patients enrolled try who conserve to it's basically -- Yes. order an Arthur.

AstraZeneca, cohort data so our would of basically encouraging was first-line because line, they'll be the second discussions said something The evaluate. this in with

given our I I continue waste the resources patient continuing the study. to to know want think don't need data strength of anything well and Jed, add agreed what own resources to collectively that there's as we was really you as first-line else no if financial

Jeb Ledell

I very well think that covers it.

Mike Ferraresso

possibly suspect reported some scientific I at additional we for have follow-up long-term the meeting with would cohort? probably we is were some analysis, in concert upcoming first-line it, Reporting that

Arthur He

Good. Thanks for that.

Mike Ferraresso

was thing, in a that just This XXX% decision. were unexpected adverse last effects population. saw that no was certainty. purely we truly a that One business There

Arthur He

quarter. Got Thanks you. on Got additional Thanks. strong color and you. for congratulations the

Mike Ferraresso

Thanks Arthur.

Operator

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

Mike Ferraresso

thank forward wish on today. the Well, look support half you for a you further quarters. updating progress your Thank you We you. great in to all of all continued and coming And the joining appreciate summer. us second we

Operator

conference AVEO your Oncology you The of has concluded. now Thank for participation. Thank you.

You disconnect may your now lines.

Aveo Pharmaceuticals (AVEO) 5 Aug 222022 Q2 Earnings call transcript