Aveo Pharmaceuticals (AVEO) 6 Aug 212021 Q2 Earnings call transcript

Good afternoon. Thank you for standing by, and welcome to the AVEO Oncology Second Quarter 2021 Financial Results Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session [Operator Instructions]. I'd now like to hand the conference over to your speaker, Mr. Officer Financial Chief Lucera, of AVEO. Erick ahead. go Please

joined you Thank us joining quarter Mike financial update. Ferraresso, thank Executive Officer; Bailey, discuss Needle, you, Good afternoon, XXXX Chief I'm business and Dr. operator. Chief all results by on Officer; second Michael Chief for AVEO's and today and today's Michael Commercial to call Officer. Medical

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

us thank for and everyone Erick joining you, on today's Thank to call. you

quarter our progress rest of to a strong are the can XXnd. commercial our believe company. product, well the a first reflect stage I FOTIVDA to we're it the have for or rapid launch full say with our as quarter. sales, since Today, of a as The March commercial second we the report results confidence first continued made financial our share our on tivozanib, And we to with start. uptake which FOTIVDA off commercial of with with the marked pleased and progress launched quarter was first excited full as you we’re that that we quarter pipeline

large therapy. to due continuing we Furthermore, of include on this important that as a in out prior As tolerability or has a RCC many to other available approval clinical not a first refractory know, standard of of VEGFR already therapies of received had with highly which to is the population refractory X this the population of of treatment the opt Further who line Phase was care from the reflects the or lines setting oral, immunotherapy, adults of later robust immunotherapy. that meaningful prior first approved setting, study on of note FOTIVDA extrapolation based more with the treatment clinical predefined these early well refractory prior and X prospective data to once settings coupled US data used therapies. know that systemic data study, in were you Phase incorporate patients It chosen treatment. in in TIVO-X who settings, concerns of advanced a from day and Phase earlier patients study often to carcinoma prior as This an following based positive renal treatment two or of sub RCC, choose a of sub relapsed line cell TKI for on to lack receive options, in did new patients percentage X FOTIVDA,

profile based treatment to FOTIVDA, to address offer favorable with significant tolerability needs. patients these for is community with oncology Now, approval evidence the unmet the FDA an able a US option

While am trial. differentiating I the that by treatment to FOTIVDA this data other we options, say from positive the X available date from valuable supported pleased TIVO-X data to has launch continue successful Phase to gain

the pleased follow-up and ASCO we to annual at June, from term TIVO-X meeting efficacy long were For in share data the XXXX additional example, study. tolerability

treated patients demonstrated relative to hazard of durability the the and more months Specifically, response improve FOTIVDA sorafenib than with overall follow-up. out of survival continuing longer over X times with with ratio XX sorafenib, to

Mike? a lines we stage data with the lower considerations us of the the to in tivozanib of I'd are tolerability for continue therapy. this call adverse setting to like selection addition, turn patients important through know longer dose a well later of adverse emergent reductions response that, to With for compared onset durability quarter treatment physicians Mike to analysis second the demonstrate an quarterly showed metrics. as as for to with We that Ferraresso these update, FOTIVDA, and believe detailed events update, rate walk including and In favorable these profile time commercial related events to of and over sorafenib. more as

you, Thank Michael.

the from quarter we and sales. to first encouraged share I'm our excited launch mentioned, with full with Michael very As are today you results

product gross second a US sales the of launching end available of the achieved on was weeks late QX was net million. inventory while inventory second inventory reflected to there in two channel, XXXX, March level. estimate end the net user of QX the quarter, demand. total million, end that our underscoring quarter of reflects net inventory was approximately the Of of build the shipped to with as net and product lean represented that We revenue US $X.X $X.X distributors For revenue our drug note, estimate. QX, was revenue which to XX% Since largely

prescriptions, total community. XXX end from major from includes to across increased second During scripts total XXX from of each for including the a This prescriptions accounts recorded quarter, over we of commercial centers July. the XXX a all launch through unique prescriptions month academic of the settings

already samples commercial a and prescription. were requested roughly July experience delivered patient converted through XX% to of XXX end of total a the Finally, have and

We to prescription. given this it by patient sample a least that month commercial takes a at after a are to received a encouraged convert

impact, the in from which these of of data brand relapsed is in strong including work FOTIVDA the leader IQVIA with team. of deployed numbers the that believe hard the we together team, are our Taken setting, our refractory indicator voice field RCC share fully shows now

me to that's results. the these discuss a Let take minute drive commercial helping team

proven with in Our reaching in customers, are team record is in a impacting and experienced who comprised both when person required deeply of remotely. individuals oncology and track

person oncologists, teams and are our a COVID all reaching the of seeing all we companies IQVIA’s steady statistics, executing case posed While is progress pharma for indicated by access challenge are our for customers. well restrictions in have treating to in person which access key gaining toward as

over accounts As surface to XXX I date, of scratches X,XXX targeted plus the received we just from which mentioned, have accounts. the unique orders

efforts outreach, In would increase who supplemented drug available be order that spanning of Through drugs network home and pharmacies this IV those has saw we distributors. orally increase use COVID, FOTIVDA variety oncology a such efforts, extensive administered restrictions. be as partners, pharmacy network, in addition like use now directly well the out to awareness are distribution rates to can home specialty to broadly patients for marketing a our as improve that dose By to we receive customer we the and as the believe setting. and of the FOTIVDA both our wide drug in formats treatments those through oral modifications, with as has can team's oncology that at FOTIVDA, limiting areas for We're field highly their physicians seeking at declined, able low administered with limited have hopeful while an context. through experience are during I the point specialty FOTIVDA sales receiving team, in facility. access facing from treatment best-in-class valuable specialty in year-over-year

dispense oncology directly model only our so unique but network to month their for our the of the have believe duration to do allow treatment. for within We RCC not We to treatment is patients space. designed of who first the practices

patient denials receives free hub through support in able support hub, as Excellence, support on initial verification Quick comprehensive prompt on one label appeals support our Center benefits should there Our therapy patient Start their patients. and be and for to provide verification patients to is Access helps in get assist implemented access processes. provided a treatment a to program also services delays to any or We've navigating also securing and week known coverage. the FOTIVDA AVEO of patients prescription, When ACE offices increments to the of

date are issues. payer securing to to very coverage with that in successful share we have We pleased minimal been

a provider. have patients and prescribed by commercial also support programs and for to healthcare patients any copay is the drug receiving adherence their dollar We zero

positive the made We by medical are as team received community. as patients, commercial reception oncologists has broader thus and progress and from the well our FOTIVDA pleased the far with

we We updating Needle pipeline. are the our FOTIVDA and to With market as the our opportunities committed look Dr. Mike now population quarters. establishing call to to would like forward the that, indicated review in to coming over to you efforts the turn I over leader clinical within on its

Thank Mike. you,

Beyond pleased the this clinic. past in the are the we quarter launch with of FOTIVDA, we progress made have

overall collaboration our in belief Bristol that by progression RCC. from agreement to Myers advanced immunotherapy combinations TiNivo-X from TKI forward enhancing in shift previously Bristol Phase nivolumab Squibb's of March combination tivozanib XXXX in could survival X, setting. a previous with conducted supply synergistic patients this immunotherapy with study in anti-tumor showed treatment well introduction following data of relapsed treatment study the treated data combination prior naive which of benefit represented landscape, potential and effects RCC, of TiNivo under progress. PFS, the our the as anti-PD-X response reported When clinical therapy. the first-line considering be being on X Squibb. tivozanib TiNivo or understanding tolerability in and and is favorable supported combination receptor immunotherapy the as is Let's appeared of trials the VEGF Recall start significant look to OPDIVO, our We rate, patients what trial, our refractory advanced It Myers our combination or the ORR with both this free

is new line with as portion trial, be to carcinoma, are prior an first of patients of therapy immunotherapy potential be TKI which front our portion in emerging XX% anticipate patients half response digest as enroll the Of findings with In DEDUCTIVE partial adoption to rate. are serve and today Xb similar are tivozanib study, expectation situation XX% Phase the the the comparable believe a that delay demonstrated enrollment we with previously of we with bevacizumab And in in attractive and the receptor amendments we share another We no which from from combination, in end care or created a continuing the pleased atezolizumab. immunotherapy Enrollment to the amending in and full line in this is These our to immunotherapy. front quarter atezolizumab’s of rate in toxicities trial of of excited the to commence to the treated the control the limiting standard standard in has of combination. patients showed is be we're area which need The standard to XXXX. At and share data very parallel, define and bevacizumab third we a the note, combination we used and with to bevacizumab combination the AstraZeneca's trial, program that hepatocellular this an with dose excited with front X toTiNivo-X IMFINZI, to Cancer in of disease which of expect year. the previous line XXXX, the care include were in trial tivozanib continues. of the Phase enrollment PD-LX following we This deductive or you atezolizumab January, of Phase new at we shared that Xb, today the with the care study. to of Symposium durvalumab enrollment X RCC setting. the tivozanib GI completed is ASCO in population will has HCC,

superior or cetuximab with ORR failed cell ficlatuzumab HNSCC ASCO chemotherapy primary and and in who as ficlatuzumab, results disease. the positive or studies, a cetuximab both and to study to June, with The met the known metastatic squamous negative was note ficlatuzumab antibody. pleased historical an human a cetuximab, HGF/c-MET neck combination PFS. negative antibody. cetuximab median on controls. and endpoints patient head for versus At agent or Annual report were combination demonstrated we single as immunotherapy, Erbitux, who Meeting prior X study future our the patients with Of combination Moving in EGFR received carcinoma, The have in for pan-refractory study's median of conducted Phase the HPV targeted ficlatuzumab, papillomavirus disease, of PFS from

with HPV PFS to complete currently in of HPV setting and included cetuximab HPV is outcomes compared prolonged effective which disease who associated pan-refractory with patients and Specifically, produced where two received negative no positive rate exists. the ficlatuzumab normally negative poor particularly disease, responses. HNSCC treatment response XX%,

higher indicating tumor of is growth HPV more in for addition, negative HPV in HPV role patients positive In expression than in patients, generally and HGF a progression HGF tumors. negative

continue to partnering In and I to the this first While and call study potential registration forward and providing turn XXXX on to will and financial vaccines, the COVID-XX second key day of quarter back with ficlatuzumab with will using updates now a to the encouraged our regulators quarters. required in any very of data, identify the study clinical due XXXX XXXX. our to also design we any results. potential Eric raw with collaborators be will from discuss are look into shortage the for manufacturing the materials Erick? for pushed primarily half registration the optimal we these meantime, start supplies coming dialog program discussions over

of for revenue the Mike. net product second revenue Thanks, the was Total million XXXX $X.X US XXXX quarter quarter second for million. $X.X was of with

census to was in force sales with Our achieve sized external conjunction consultants near coverage.

and of status Given RCC the is believe appropriate voice of in level in our leader relapsed we as the to effective. spend refractory our that a setting, share

of that commercial expense second approximately the expect continue XXXX development will mid quarter we be with spend to to for XXth $X.X to million. expect was percentile. in for be to year gross the our quarter Furthermore, continue We $X.X total million margins Research the million for second high and $XX compared XXXX. the

material expect included pipeline R&D manufacturing expected million manufacturing study the registrational mentioned for decrease We the for million The range of to ficlatuzumab. original $XX plans now clinical existing delay for ficlatuzumab. million guidance costs XXXX for in initiation R&D expense attributable a $XX $XX of the study to R&D trial be Our primarily for the in of TiNivo-X our drug year. the for expenses and expense is after study in potential

corporate Given $XX.X and administrative the the this million staff $X.X existing R&D Selling our plans of appropriately described, and sized for of that commercial quarter the is of as our level million compared organization for size second believe were activity. with general second we our XXXX. XXXX expenses for quarter of

to of will million. continue product expect quarters quarter burn year of full cash our with that addition at million compared quarter. lower of the with total marketable ended end $XXX.X for We reflects XXXX expense the for million and $XX first of equivalents cash the approximately second securities the net We the the compared $XXX.X to cash, prior The our quarter be second G&A US first quarter revenues. of

cash the drug X back to relatively XXXX constant, full to supply pipeline and to cash including existing clinical Michael the today, to I spending our X and turn Phase have on facility, X over decline available XX-Q. will from continue we manufacturing. our TiNivo levels are to our report be under quarter for revenues the to available we trial, Phase our AV-XXX burn the Bailey. Hercules We remain study second results shared the overview study, now expect Form in will the DEDUCTIVE of call quarterly anticipate as of continue cash plans Michael? we revenues, Phase A believe cash, and planned we equivalents current our investments expect to all credit and As launch sufficient fund increase. that net

Thank the mission lives for programs. Operator? we on of the of commercial of coming well close, well to We open progress advancement on believe launch we as of line quarters as our Q&A. with success improving we with US, updates are you, the To in Erick. to forward providing here continued cancer. the the look We'll our patients continue the of positioned FOTIVDA now pipeline our in balance continued the as

Instructions]. [Operator you Thank

Willey will first from with Our come question Stifel. Steve

is Quach questions. Willey. This on for taking Thanks for Bonnie Steve our

question X,XXX So intend XXX sampling And ordering accounts color the look than you of been could question Can is, how you after about accounts to be is a greater targeting actively the Any about would FOTIVDA. helpful. to the number in Thanks. comparison you've that you my do my second FOTIVDA long launching provide programs. program? keep running first anything that share how

I'll it over Mike some color. turn to to Ferraresso add

as shows and a and trials. the So generate for program initial team, it valuable to sample I tool free definitely starting support We been conviction product launch samples. with the it's to this in see that really get the a our help think

mentioned, we access as still So is difficult.

be So for for there our time. while the launch first accounts we’ll a are still in seeing

so accounts this so the a of And it see ultimately person to difficult program the phasing is and date. to program. far out. need It useful impact really to opportunity of of to get front in patient it's with us again experience sample your and still we're and do speaks pleased think a you XXX it out down that as the of And launch phasing is the have lot frequency customers gate. and launching the far, But to as unique in I during access COVID, again, the challenges we

it potential prescribers visits, in our point there's really we a lot takes bit accounts often of convert opportunity still front But few of tremendous FOTIVDA. longer of it's think great that and account see a of get all there So little are with us we as it who to are -- take to a to that going to a an us accounts. key

to penetration. continue make We

far penetrate to month continue and time. adoption month our we month we'll scripts broader are think that over we As growing on said, and get so every

question next will Leerink. Our Andrew from come SVB with Berens

you -- I I early. it's saw any so was what these in you patient there or durations was trying wondering, the seeing we also, to seeing, drug, onto came and scripts many duration are idea the But to of prescriber know similar if And prescribers prescribe expect a average the many type you unique program? stage writing pivotal prescribers how should of you're sense TIVO end are that or are warehouse far? have of get then guess the I how

that to over I'm turn going Mike. to

So for quarter in is of full too it's first duration of sales. the therapy, just We're our early. reality

think you TIVO-X study, patients at the had two to If progression free back we of XX% years. still

So it's really take while a see of a what before we've it far. ultimately But pleased percent but to patients continue long will this will really really drug going to so to take that duration us duration. a for a number. And average stay seen create our track. what quite We'll robust with that's we're on while

accounts, prescribing we've of number and as as we to XXX there's had XXX mentioned, unique far As accounts date scripts to been date.

the So get there you could do the division to average.

sales you over build have we'll every just see lot a the started single and volume of of kind and time additional can time. imagine with month, building If build accounts over refills

So account unique citing? that you with the as need unique thing same the prescribers you're

Correct.

specialty would they case, patients a a treating through get basically or would they buy the through get which directly specialty it's the it be our mail that distributor. drug can order, a prescribing in facility or that their from through So which prescriber facility, pharmacy, and delivered

to physician So that an account. sales and of mix to a we prescriptions get a

for those prescriber we So kind drug. or number individuals up with the come using together institutions of to this of add unique you account

Kusy will with question from Baird. next Colleen Our come

stages, you are anecdotal For physicians type these on about of the potentially special the any treatment in guess, anything do early putting what or on what patients? line patients have data of I early launch,

have share Yes, Mike anecdotes. quantitative really point data don't breakdown can a to give certainly at Mike? this We some but

of just, as Michael patient range It point. this at it's anecdotes is said, seeing We're a types.

had and line have mentioned that data and on therapies prior have who a we last third But seeing your lines you systemic patients more we from the certainly patient. don't initial just some some are call of out of our maybe two that early are treatment days, in As who typical line kind We're of later get all run patients. have options. failed few it's of patients,

we're for seeing of to treatment. going build and of up while can the take that patients But types. So robust a us we're to set it's we're from with range pleased patient benefit data seeing what a a

percent XX% future? you happened changing program, of those on do And kind about and the that how you I in see the sample to what you're to drugs. of guess other mentioned think I commercial converting of those the

the the So imagine, expect want it and to has those in. And next it practice to in to of means drug as that practice, you the sample that's can we expectation. the the interest used, samples all gets get delivered have available ultimately, patient a comes for they

a if it, come So we saw they patient day would next very to were until after it the in got month about the be conversion. a

these have And or for So take have a there ultimately, may and like during and are patient currently to then to requested patient an may when the the up second who's two. doesn't a us in in great But be where think COVID. option many month they just needed in practices they line appropriate a it's often, difficult presence giving access that. going it these it's out, while a line models

it it believe into strong commercial because ultimately, And interests. being patient, samples we turns when have take a those to a these So in time. the could the little are script. months requested But they going later, they're of right utilize their bit

Just non-specialty to like the this physician. in is markets. a some that color the This specifically add requested sample not drop is of by

so discontinuations got you duration earlier a know still about But far? do I and for early early insight question have then that. you any And into

to try talk you Michael, about.

say. accounts into just you where get have through It's to sales don't going lot we don't. volume the about the information early account, any see A always information. the our too don't you of really And We go patient.

really But data the script market growth, on we're again, month get tools more So on growth month and in we’ll it's meaningful month and to that seeing month set. we've the more something we're a and with pleased resources time with trajectory. seen have

Our with come Arthur next question will He H.C. Wainwright. from

in Arthur could one question. that assuming had see that is be two RK, rate down? could XX%. the at I Could in rate questions, estimate thanks go -- net we run for This on the near-term, regarding a is of FOTIVDA, for my we could gross taking

do want you one? that tackle to Erick,

think we've net oral that for a gross of I you've to type other products. oncology to been time be seen stating believe we while that RCC similar over would our in sort what

expect the XX%, So gross as you a creep we around would that to net up which is just bit said time. that'll little probably over currently but

example, than see little bit higher You'll [Exelixis] for is a so. that

my second regarding And is question [fico] program. the

have could color regarding you of the shortage manufacturing any more [ultimatum] plan manufacturing? you partner drug? looking for to the a the So us to produce Do give

COVID contract this call getting year. manufacturing agreement They with used they're because our So manufacturing vaccines. key giving they're QX us of for supply, that manufacturer recently for our informed being materials in raw having difficulty

would our process clearly manufacturers, understand because The to is to that with raw this be fix and challenge. you, that materials. don't switch we problem, So I think about honest

same sourced materials And many of are the raw the so from generally places.

all So confirmation of and anxiously updates with and a we you waiting new provide that date, we we'll certainly over as appropriate. stones for we're could turned the

the now for to no showing Michael Mr. closing like any I back queue to Bailey time. call further turn would remarks. I'm over the questions this in at

on coming progress support, your to the continued appreciate Thank for you you. us you quarters. all updating in we We and forward And today. further look thank all joining

conference this gentlemen, today's Thank for concludes call. Ladies your you and participation.

disconnect. now You may