AVEO - Earnings call transcript Q3 2021 | Aveo Pharmaceuticals, Inc.

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Operator

Good day and thank you for standing by. Welcome to AVEO's Third Quarter 2021 financial results and business update. At this time, all participants are in listen-only mode. After the speakers presentation, there will be a question and answer session. [Operator Instructions].

conference being this reminder, a call recorded. is As turn over to would now call to like I Mr. the Lucera, Erick Chief Financial Officer. Please go ahead.

Erick Lucera

thank discuss Michael Medical XXXX Mike Ferraresso, Good today's Needle, by Michael Update. Chief and you Commercial Executive joining today for afternoon Officer, Chief us I'm call joined to Results Officer, AVEO's Officer. Financial Quarter Chief Bailey, Third and Business all on and Dr.

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

Michael Bailey

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

second launched pipeline well as our results our financial pleased quarter our sales the and share commercial have in XXnd. FOTIVDA to XXXX strong note, revenue March made for first in saw on of to XXX% since we second FOTIVDA as tivozanib, quarter. reflect a And product FOTIVDA stage quarter full continued quarter quarter the launch progress a compared The relapsed we commercial of increase as commercial the second report we our as made potential third We're third validates of FOTIVDA uptake full to the standard the patients. To net which second quarter. the performance increase a the and marked for as refractory its care are our in sales XXX% compared to the excited you serve commercial we've RCC rest prescriptions was Company. with and the since to or of for with a progress quarter a product,

FOTIVDA the This R an As the carcinoma TKI adults U.S. following renal VEGF cell approval prior on more study. RCC Phase or based with was systemic X in therapies. refractory you TiNivo-X is the many oral know, advance once-a-day or already or approved for of treatment X of relapsed

as historically we patients other a line based setting. Phase know RCC -defined this the population available population from large therapy. X X in lack to of positive on care to who as that to reflects opted treatment onto in first used in lines highly this chosen a coupled first of that we're settings, FOTIVDA, due new and treatment. important The these a Phase pre who study well data did percentage RCC therapies refractory options, that extrapolation of And had sub in standard prior data with Furthermore, as of earlier is study It immunotherapy. immunotherapy, not prior -defined which clinical settings, to received the prior refractory of later clinical out from continuing pre often treatment of include note received sub of lines data patients of setting incorporate earlier concerns patients tolerability

III Phase trial start the the our and therapy. Turning OPDIVO an our achieved In of third important with we pivotal IO previously milestone of who've in patients -X received pipeline. TiNivo enrollment FOTIVDA quarter, to of

We be earlier FOTIVDA's lines study potential assess the of registration in in therapy setting. directed a able immunotherapy to combination will now and in

the U.S. study, with which designation progress ficlatuzumab half FDA developments quarter, granted fast-track unmet potential For belief to the by the registration of opportunity to the We our ficlatuzumab, believe we for we in the support serious who's great HPV third prognosis start a need XXXX. head further Mike. has and these option made patients recent a patient over first metrics. expect commercial that us detailed for important through call cancer, challenging. a turn to treatment Ferraresso an would to over neck like the I including update, quarter negative, walk to more is with serve as very Mike now and population address

Mike Ferraresso

Thank you, Michael.

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

end-user is were For sales quarter. quarter last net from launching revenue of was of net product the reflects U.S. a representative estimate that lean the Since $XX.X inventory there our million, $XX.X on level. inventory in channel, achieved note Of X of third revenue the the quarter, million. which XXXX, that underscoring XXX% revenue of a increase QX with late of March, net U.S. third true end was available was as demand. weeks year-to-date, We approximately product FOTIVDA total

of having approximately compared prescriptions, total ordered the XXX accounts a quarter. Since commercial of XXth. the a XXX have XXth, to to XX% quarter, reflecting ordered Finally, launch, during third as XXX% increase of increase June a September compared as accounts at we XXX recorded second

distributed compared decreased patient we the second experience seeing in in As quarter. with need base, program scaling XXX patient we're and our for launch samples, we're expand to XX the back QX planned prescriber kits as

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

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

are steady customers reaching in said, of of or well remotely. increase the a posed toward oncologists. the teams executing continuing our have, to of we're variant for access restrictions using key our them quarter, third seeing person the in-person technology COVID treating Delta all engage gaining With to challenge and in course, That progress

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

addition sales field supplemented of access awareness variety we team, in facing wide efforts outreach, to marketing in In formats a areas spending have restrictions. increase extensive the order their with to

continue to to new opportunities in We other invest to from enhance awareness formats. advertising and our media social print traditional digital

evidence improve at home through network, we those specialty and to specialty for FOTIVDA who refractory the as our effectiveness limiting the As is By reported distributors. available believe treatment have pharmacy leading efforts. directly we the and continue those receiving of experience our of limited FOTIVDA in FOTIVDA specialty of distribution this through is from RCC we pharmacies customer by IQVIA, of share voice facility. relapse great network a broadly setting, as our receive their well able partners, are to for a

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

on-label as services of helps the prompt support support comprehensive Our Patient FOTIVDA known provided to Center access to through ACE patients. for AVEO Excellence, Hub, Support Access also

securing We payer be with coverage in continue very minimal to successful issues.

encouraging FOTIVDA community. the We that broader turn now progress our our to the and with commercial as from oncologists and coming quarters. on Needle well within updating as continued received team to Mike like I look our some call Dr. the has over medical over are With pleased the progress patients, forward to that, clinical would pipeline. the We review opportunities you to reception has [Indiscernible] made significant the

Michael Needle

Mike. you, Thank

and trial the of clinic. the trial open for Beyond pleased immunotherapy or advanced the combination launch made our FOTIVDA, combination with therapy relapsed with trial quarter Starting tivozanib III conducted our Squibb's of have Myers in Squibb. progress the RCC under Phase Bristol being Bristol the programs. OPDIVO, quarter, In Bristol with past refractory prior Myers we with we nivolumab immunotherapy. in to where in pivotal progression-free clinical collaboration profile anti-PD-X third is rate in responsible with and are with this The for advanced and Myers TiNivo-X trial of The enrollment in agreement TIVO previously the providing RCC. following a clinical pivotal patients long up treatment-naive we'll be execution. control supply cost-associated survival, study tolerability demonstrated will and X-X patients trial be is Squibb will results for positive and the serve drug previously reported high as sponsor nivolumab nivolumab Nivo rate, on the objective combination disease study, trial, following we pivotal favorable response Phase a a with and tivozanib the treated from

first-line new standard immunotherapy. to forward following and the the as option this care therapeutic could believe updating as growing need progress for the there patient increased the combinations of optimal population sequencing of and immunotherapy on to is of meaningful that we prior We second-line setting establish in treatment trial. an RCC, options introduction nivolumab the and look serve combination in this you of tivozanib a With

c-Met antibody, treatment cell squamous patients our IgGX in for ficlatuzumab, Food and ficlatuzumab neck the carcinoma. with Moving refractory head the onto September FDA, and or designation relapsed Drug Administration, of or fast-track recurring granted HGF U.S.

a ficlatuzumab virus, in patients neck their to head carcinoma, serve HPV, we to unmet meaningful the ficlatuzumab pleased of for from cell and start manufacturing also human further to option the and receive raw the manufacturing of and with subject cell are serious the expect We potential as address in recurrent, ficlatuzumab key vaccine supply In clinical squamous carcinoma. for therapeutic underscores of for timing materials and availability the COVID-XX fast-track in regard of manufacturing. negative to papilloma commence or quarter registrational second XXXX, designation need decision relapsed HPV as trial negative FDA the squamous head to neck a used

first now With trial the anticipated registrational of the of half the XXXX. in initiation

an the for with carcinoma. potential identify XXXX third we believe the to with squamous results. with optimal option look I progress. forward continuing to head of to fast-track Erick. further speaking potential design treatment the important We're designation, discuss to now call ficlatuzumab over program, and our as advance the providing to on FDA new will neck With cell Erick turn receipt well as partners quarter patients the as for our financial updates trial we discussions has registration as

Erick Lucera

level Mike. XXXX. revenue two Selling U.S. million. quarter a you was with $X.X general the was compared $XX.X XXXX third in Thank $XX.X prior quarters $XX.X for and XXXX of million revenue expense with and XXXX of Total million the of was consistent and for product of administrative the the million, quarter QX for quarter is third third net

approximately to approximately for be the our spend We G&A for spend our be the million. $XX that spend year that million total will $XX expect continue for a will $XX million of year and total commercial total

of quarter in margins with We XXth the of the the third for expense continue XXXX. development XXXX $X.X mid-to-high expect and million, gross to million to in Research you third compared quarter $X.X be percentile. was

be of ended We to to for at the the compared quarter of with marketable and third of million expect $XXX.X XXXX continue the year. million R&D the equivalents expense end We $XX approximately a $XX securities cash-cash quarter. second million with

As to we for the levels quarter. expect remain relatively our constant spending fourth

enable increase. filing burn the to the months of to decline cash-cash our a We of our also current of the as we XX securities third will continue our We U.S., following product XX-Q commercial XXth, cash launches and from revenues report quarter. for anticipate quarterly of with period operations on believe for FOTIVDA expect Form marketable net at in least maintain as that the us net expected September XXXX, to to along revenues equivalents existing

quarterly of I XXXX our For turn Bailey. XX-Q our review quarter to the available is results back Michael of over third now on call and in the Michael? the will report for Form

Michael Bailey

as Thank on advancement well of commercial on providing as launch We here as with our for we our success in look of FOTIVDA with U.S. to continued close, forward pipeline continue of updates coming believe improving in continued our of lives quarters the well-positioned are patients To you, the mission the of cancer. balance Eric. the progress the we the programs. we

line to now We Operator? will Q&A. open the

Operator

Please you, Your the Stephen Thank go compile comes first Stifel. ahead. for Willey pause Instruction] Q&A from sir. [Operator the roster. question to of [Operator just a moment line Instruction] We'll with

Stephen Willey

taking some with the given patient whose specific TIVO. any if a was receiving the patients type label as wondering that for If that combination of questions. in drug, little can terms the of seeing -line use of emerging failed the to kind just you've you're seen allow therapy. Good presumptively the prescribed a the second of any of to bit there's afternoon. be patterns of Maybe most second-line Thanks appear respect for TIVO just evidence speak therapy, fact being you being patients recently regimen. to prescribed in context the also And frontline does

Michael Bailey

Thanks for the to to questions, Mike Steve. I pass this over going am Ferraresso.

Mike Ferraresso

Thanks, Great. Steve.

the take do going certainly types, to datasets so always more it's into more of granularity. to have get patients. But mix for don't a to patient our get, greater some robust, time the we're we we So, visibility data have seeing

as getting or later combination, So line mix we line gone third out the likely typical would frontline We're you a are described, off onto a patient. from those also treatment who are patients coming of have seeing hospice. who opted

and full to in So, yet, we're don't be mix build future. have we a granularities broad going more provide will we again, more and dataset robust a seeing but forward continue visibility able to

Stephen Willey

And target was X,XXX? your number say that did previously accounts you of

Mike Ferraresso

Correct.

XXX. We've this point have accounts. to We over about X,XXX penetrated target

our we base amount So see tremendous to and expand a prescriber our opportunity business. to grow continue of

Stephen Willey

this in closing you over the target next is kinetics X the targeted Okay. X the quarters? to course And that how of you achieve -- that the guess, gap the I about between And think number something number? think can you do of

Michael Bailey

Go ahead, Mike.

Mike Ferraresso

great Steve (ph). It's a question,

for biggest we're is a base quarter-over-quarter. that grew right by very I COVID pleased think the we challenging launching anyone drug the question XX% prescriber access, our account and it's now impacting our way and

we reach and we've But non certainly and We we're longer again, continue COVID to it quarter-on-quarter that reach. a reach to new and COVID if we executing is ultimately, and the penetration progress everyone more pleased era. with full challenging us expand with It take the think made. in penetration were to make our will certainly really our than accounts team's well -

Stephen Willey

those of you of lastly, third points the reorder XQ ordering proportion you that just -- have any that of reordered on then in high those specifically data ordered specifically quarter? those who and I do have as are And or amongst guess, whether the the saw -- a good. just Very between accounts rate end not in had accounts and

Michael Bailey

Mike.

Mike Ferraresso

Yes.

years. refills really patients that, as metrics certainly at think prescriptions but specific we're the and but in be, look X study, we So have had I and going is We we're we both of while with to what so at for quite refill truly new far. we it's to long-term don't growth and duration on progression-free seeing know what pleased the are us our treatment XX% a think pleased going we're X real-world seeing TIVO to take rate with I

Stephen Willey

questions. my right, All thanks taking

Mike Ferraresso

Steve. Thanks

Operator

Thank you.

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

Colleen Kusy

the of taking into Steve’s and for off the refills? are how do you much any of question, getting patients -- Piggybacking terms congrats so Thanks on Great. the many last have questions what quarter. how insight refill rate in

Michael Bailey

to want about you Mike, that? talk

Mike Ferraresso

it Sure Colleen. Yeah, is challenging.

So as business. of subset. all get we it small visibility a our into sharing, that don't I in have was We

gets over we data robust better can So we where as better get level comfort and our we the a more provide get updates and have future. in accuracy time,

track patient growth continue starts. things. to these we're certainly new mix we'll we're and new the really pleased with So account far, pleased so refills Again, seeing and of good we're

our take As share of setting, enough in the is our then we significant to we into be to setting. future. we'll time keep data until that patients was while can treatment a I trial have tracking we real-world what said, see long how very because that in of real-world robust a happy it's translates drug a the duration and Again, the get when in such we'll quite clinical there probably really say just on going tail to

Colleen Kusy

ish the to to you're Thanks. X,XXX how expect to sampling you're to get accounts, sense. program, think is program going again, remaining Make would And about sampling into go what you the to be? going with to continuing expand or that the what's increase and -- -

Michael Bailey

one, you too? that take can Thanks, Colleen. Mike,

Mike Ferraresso

Sure.

So be patient yes, program, it we've or a program planned sampling launched to experience program. sampling always our

a quarter. lot significant So, not there But and take don't. we've still any drop any are There that to be it second tool. many sample. already this because a it. that don't seen in expect wouldn't other prohibit can we've shut distributed to as are I access are at settings to quarter allowed take a the third dispensing down it’s say discussed, to -- powerful from sample. XXX all and Those themselves samples have X,XXX a will accounts plans a do treatment in a institutions still XX to of point accounts We you They

that's everyone. a not it's So program for

So benefit sample that I from there's think able -- over we'll who been accounts time, not because would continue down yet to we've it it shutting just see decreasing other reach. yet but think we're to still access and the we

Colleen Kusy

many COVID can How And those Okay, on maybe targeting? think TIVO-X online? if helpful. you're about there? And enrollment impact up talk studies, thanks. That's centers if getting for expectations you the will you

Michael Bailey

you Yes. Mike, to Thanks, do Colleen. want Hey, Dr. answer that?

Michael Needle

to was Could for Sorry, you question? hard just it please the hear. me repeat

Colleen Kusy

Yeah, sorry.

for just what TiNivo-X COVID On many on impact you study, what about your you'd talk [Indiscernible] enrollment expectations the how and the could online. if centers there, are centers, will be expect

Michael Needle

we Well, hard a targeting obviously is setback it's better such in it's different a COVID to target, of -- world are there's bid getting XXX you at times. It's for different moving different then centers. the parts to close Sure. and think the and

else I'm for predict. very So sure -- can I it's what is to it say. I difficult mean, us not

Michael Bailey

thing, TIVO-X too just opening in pointed also COVID. there XXX about TIVO-X. about a said sites recognize that at not was to as I'll But number XX it's Mike close not I on the about eye is but dissimilar a patients, mean, months keeping it. the as a similar enrolled that's It's add process in as one benchmark, of XX Mike enrollment from that out, early where Mike. in we're

things see posted. the mostly initial enrollment. and let's -- with how why on COVID how how keep go uptake that that's impacts wanted We'll you things just So go ultimately we as

Colleen Kusy

questions. Thanks taking Great. my for sense. That makes

Michael Bailey

Great. Thanks, Colleen.

Operator

you. Thank

line from comes RK Ramakanth with Wainwright. of Please the question H.C. ahead. go next Your

Rk Ramakanth

of Thank afternoon. you. a questions. Michael, Erick. Good and Mike just had I quick couple

accounts now accounts. orders You from XXX and said you're got you've X,XXX trying to target right

how many have the of XXX have accounts which So you successful? been with interacted out

Michael Bailey

Great bit question, do a to little about talk reach? RK. want you Mike,

Mike Ferraresso

the question, Thanks Yes. for RK.

are give There's open reps So and to but I'll between XX%, are that we allowing now a by somewhere industry metric out right that world sales out, that of of in with as the right maybe XX% XX%, there you haven't and others. put like IQVIA accounts reported engage there. in general get sense now is oncology to probably what

meetings So, to engage, other Certainly most a in-person the the I try a but there's are usually ways maybe and that's few helpful takes we impactful visits, insight. few think interactions certainly with a it customer therapy. comfort get to need new with to to things drug the through walk you reimbursement the and to access them the and start all given a it, how they know

it's and are how going because to into while can accesses often us take gets you also So frequency your restricted get restricted. other a

again, Delta account and down improve challenges we're to we're So grow difficult access may the to is up open that great once going, seems base expand COVID to have, again variant start to the our to where pleased it settling hopeful that but reach. trends we're predict in that really XX% Despite us easier for access be progress and continuing we quarter-on-quarter. make it's make to our and

Rk Ramakanth

much. very you. you Thank Thank

third So you the in said the about quarter, third quarter scripts did so well quite obviously actually. Very well. you had XXX

quarter what us all be on that at you -- should regarding the of to bit? days since give a been last comments started, seeing seems you comment the that can regressing how COVID especially back this any the XX in have So

Michael Bailey

question. good RK,

is just quarterly the to be forward providing going sticking really are We of a as kind update. to matures launch going

note month, to we extra we'll have we've shifted the the So but looking calls. you provided and quarterly with quarter to that give future to had be forward updates first

Rk Ramakanth

gentlemen. my you Thank Thanks questions. Perfect. for taking

Michael Bailey

RK. Thanks,

Operator

concludes I it And up you. question-and-answer turn Bailey Mr. Thank back session our to will today. Michael closing for now remarks. that call the for

Michael Bailey

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

Operator

participating. And for ladies today's Thank and this you call. gentlemen, concludes conference

You may now disconnect.

Aveo Pharmaceuticals (AVEO) 9 Nov 212021 Q3 Earnings call transcript