AVIR - Earnings call transcript Q1 2024 | Atea Pharmaceuticals, Inc.

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Operator

Good afternoon, everyone, and welcome to the Atea Pharmaceuticals First Quarter 2024 Financial Results and Business Update Conference Call. [Operator Instructions] I would now like to turn the call over to Jonae Barnes, Senior Vice President of Investor Relations and Corporate Communications at Atea Pharmaceuticals. Ms. Barnes, please proceed.

Jonae Barnes

Thank you, and good afternoon, everyone, and welcome to Atea Pharmaceuticals First Quarter 2024 Financial Results and Business Update Conference Call. a discuss. which issued we the we to plan today, press outlines release, topics Earlier

access press to can be of You the website reviewing slides as our today, we'll the by ir.ateapharma.com. going at the section release Investors as well

John Atea Chief President Chief With Horka, Financial Officer the and Dr. Officer; Officer They Hammond, of Chief Chief our Development Vavricka. and Chief Founder; me are Officer, today's be Executive Vice Jean-Pierre Legal all Dr. and available Commercial portion today Q&A Sommadossi; J. call. Executive from Medical Arantxa will Officer, Dr. for of

Before risks you remind we the call you read. and which in today's uncertainties outlined risks and forward-looking as to discussion X, Commission, we today's encourage involve on contain are the with will outlined Slide begin filings the release company's recent that statements Securities press like These I in Exchange uncertainties. would and to that and and

is Our on actual results discussed call. today's may differ materially from what

that, the With call Jean-Pierre. I'll over to turn now

Jean-Pierre Sommadossi

you, and Slide as begin is of afternoon, COVID-XX clinical with our HCV, for for we start, see strong can bemnifosbuvir have our you everyone, will for the progress with program thank Good to of a program XXXX made COVID-XX. off and us. X. across overview joining I treatment you on Thank Jonae. first tremendous an the

evidence further by and and pandemic caused is XXXX JN.X. easier Variants COVID of in we winter, this evolve, that experienced continue variant stay. observed to provide a Trends the infections to surge

our trial high-risk enrollment Phase execution rapid successful the of only patients guidance. exclusively to in III the conducted operational strong the led ahead of Our global and

clear options XX% new the cohort unmet the only preference patients. medical cohort for for in into by and to enrolled need high-risk the cohort investigators United XX patients cameonotherapy COVID-XX the the with patients high-risk patients oral combination into enroll highlights We total the treatment Strikingly, monotherapy continued in randomized the States. X,XXX patients therapy these of supportive

curing We is including millions many potential durability forward option. standard drug has an of and whom of to therapies, not COVID-XX to believe limitations delivering look for key care patients bemnifosbuvir safety, current address the bemnifosbuvir potentially We of that optimal the to of the interaction.

top half We XXXX. line from the SUNRISE-X in anticipate results of second

to now for Turning we Hepatitis building cohort of from II patients, leading XX% our the SVRX this C, Phase look key positive multiple program forward program. the off milestones to for XX near-term rate

from next presentation Phase the which We new are EASL will cohort. at excited II efficacy very this about data month, and upcoming leading the clinical showcase

SVRXX also forward ongoing half to We XXXX. second complete look reporting study during results from of this the

of we III Phase are preparing which the initiation we of this for anticipate addition, year. In a around the study, end

the as We be which in well are currently commercialization. the of target, used combination III the as will for program, dose finalizing fixed selection Phase

Hepatitis bemnifosbuvir upon center of all treatment. believe a ruzasvir substantially are hardest including to the of can in the treat. highly inhibitor improve potent effect combination potent We with this synergistic those is is most And patients, C, inhibitor. the demonstrated the nucleotide for that for Hepatitis fact, care current NSXA C who

And HCV [indiscernible] detail our will program in review greater next.

financial XXXX. at $XXX.X cash into are anticipated million marketable of with execute and now equivalents strategy runway we to a position in our securities Importantly, XX, our strong cash, with March

the of on call to financial update schedule for will With discipline. on and program. provide now that, over turn I Arantxa based detailed Atea our today's enrollment II Andrea a ongoing update for on HCV completing call. global financial an will during position our is This Phase patient ahead SUNRISE-X

Maria Horga

Thank you, Jean-Pierre.

need health HCV viral for potential continues is estimated of care unmet drug-drug shorter the exceed a less disease needs, be the be the to X to availability Despite in a medical Turning with U.S. including to treatment individuals Slide crisis rates options, a X. treatment and over HCV the impacted. interactions, contraindications reinfection were million rates cure are U.S. annually new fewer in duration, and for

supports potential interactions confidence and Slide has bemnifosbuvir to conducted there to protest being inhibitor-free these be this low has KOL regimen a The in the risk to research of which address effect. and a is proprietary has market Moving short feedback also unmet to the best-in-class treatment no treatment We therapy, combination food potential that of a we drug-drug with remaining have date, high combination X. needs. our X-week It believe by a duration.

of in HCV Turning the to in treatment U.S. cases the With with number with a a on Epclusa be stable. Slide estimated Mavyret to there XXXX, market X. people The U.S. the demand share and X% options chronic grew number to treated of with patient based roughly million of key year. who patients plus The large HCV each chronic is market remaining continues X replenished treated. approximately new HCV, living an X XXX,XXX be patients

increase of of bemnifosbuvir ruzasvir, with number anticipated for future access best-in-class removal viral cared initiatives constraints certain disease. the profile payers severe that and patients by believe We will the government including together of and the barriers, these

X of outlines single-arm open-label enroll up study treatment-naive XX weeks. XXX We patients genotypes, including Phase patients. II of with XX combination our all XXX of cohort once milligrams leading bemnifosbuvir ruzasvir in X to plan the daily milligrams Slide of across for to

response initial the study. to as II SDR enrollment cohort the complete continue week post used X was sustained biological X-patient criterion decision Phase or From to at the treatment

the with treatment As study of safety. a and post the primary XX reminder, is endpoint SBR

Slide X.

non-cirrhotic and XX in on It the we Before demographics was cohort patients. comprised want to patients I this review of brief of only. slide, characteristics the leading a provide baseline background patient

fibrosis, XX%, final plus patients cirrhosis. is involved. results stage genotypes borderline XX from were leading are an all SX, had However, the across cohort treatment with we These which of advanced as

X-week near of all only these genotypes had below for an rapid Slide individual the leading X, Therefore, leading to from or and approved load kinetics XX HCV. XX compared is lower the biokinetic treatment of X-week By across viral week all limit support shows on data the very in cohort. which patient regimen on-treatment the favorably treatment, patients cohort Mavyret, quantification. the

combination The safe generally serious the XX. were tolerated of mild. drug-related leading events, adverse no Slide to and cohort. mostly ruzasvir in no bemnifosbuvir events was and adverse discontinuations There well were Turning and

To to HCV Moving XX. cohort by the January summarize efforts for of Phase remainder supported patient Slide in our initiated enrollment positive we II trial. leading the data

countries, a XXX to expect U.S. enroll clinical at up patients of We XX the across to sites XX including total

ahead, very Looking leading presentations about at data the efficacy cohort. from , data including upcoming the are EASL II new Phase excited we

this the to of second complete We II year. Phase report results expect SDF-XX in half

III first conducting X-dose program I of used in Phase the combination subsequent in we're commercialization. U.S. of will for the and Additionally, half Which studies XXXX, the evaluated selection tablet. over be the the for best Phase

to We call III I'll anticipate Janet over Next, Phase to on XX program. turn be an that our will initiated program around the Slide COVID the year. update end the this provide of

Janet Hammond

Good an options. concern afternoon, significant continues availability pathogen to despite with unmet Jean-Pierre's of COVID-XX be and the everyone. Slide XX. earlier To of need established reiterate treatment antiviral vaccines remarks, approved

the variants include after the variants, to variant family JN.X now United of most in States. which mutations KPI, recent New and the dominant quickly is their nick-named overtaking FET continue evolve

an the of effective a treatment goal optimal for standard and Our for whom COVID patients is for safe option. millions to is current of the deliver now care

for mechanism and and with has profile, a billion presents robust to bemnifosbuvir's a profile compelling opportunity strong $X and proposition market drug-drug distinct and and a risk products barrier a a high potential clinical with the with approved, action plus market interactions, favorable overall safety tolerability X resistance. therapeutic uptick. low bemnifosbuvir of In expansion value only area anti-viral target opportunity we believe a for

alleviation to in III high-risk the evaluating In in SUNRISE-X, early through patients. enrollment Day XX. for III exclusively as the endpoint hospitalization than primary COVID-XX rather high-risk the Moving completed Slide we patients SUNRISE-X first is XX. global bemnifosbuvir Phase program our Phase with in trial quarter, currently symptom

secondary monotherapy capitalize in patient a our preparation to report JN.X ready guidance. finished X,XXX execution combination is We to outcomes The search. the XX through patients patient the cohort operational and patients pleased strong and enrollment be demonstrates ahead that to XX in the This achievement treatment. significant only day on of post enrolled to in endpoint I'm cohort. our variant measure

responsible a all were particular, enrollment care high cohort. for to in rate patients unmet preference enroll the new see for of such treatment where medical we need the of for The in sites by monotherapy enrollment COVID-XX surprised oral patients. patients major strong the XX% the In monotherapy options investigators were high-risk to enrolled. the in We U.S. highlights cohort these experienced

review onset vaccination or III global Slide SUNRISE-X outpatients trial states or X morbid I This our to to mild Turning before enrolled will trial. days less randomization. XX. is high-risk COVID-XX, regardless of now with -- Phase

with was including compatible placebo-controlled. and double-blind BID randomized, was either the trial III XXX placebo standard study of Phase other available drugs this concurrently bemnifosbuvir discretion low or care, of milligrams reminder, a the the [indiscernible] investigator. at As The drug COVID-XX administered

primary Day The is population. all-cause supportive hospitalization in or the through for XX death study endpoint care monotherapy the

trends, post recent stronger-than-expected and track in symptom medical designation, and at seen monotherapy a attended With are death, enrollment the The endpoints Day COVID-XX-related through and visits hospitalizations specifically treatment. secondary relapse presented XX Smith supported fast cohort. data

to of We III Phase and with XXXX. results during half are pleased providing the look the forward second the execution our trial from

the market call to COVID-XX. now Slide discuss the I'll XX. hand to John opportunity for

John Vavricka

Janet. Thanks,

supported Retail revenues oral correlates with prescription indicating the demand to annual billion continue run. infection long opportunity antivirals for remain multibillion-dollar products. We for market This $X believe the for Slide a highly to only opportunity between [indiscernible] prescription billion Turning to U.S. rates. a for The X antiviral COVID data, oral and approved oral of treat $X XX. COVID-XX will anti-viral therapeutics between by is the

to still bring to drug its with safety bemnifosbuvir and value limitations Andrea and exists A and turn over in landscape now to financials. the physicians. Legevrio. with with I unmet treatment and potential We significant the patients concerns believe to Paxlovid greatly due Atea's will improve call and tolerability to discuss need meaningful interactions

Andrea Corcoran

Thank you, John.

we remarks, As balance Jonae operations our Slides issued statement her are results today, press XX found and XX. containing sheet for on of introductory financial and a the XXXX. quarter The release in mentioned of earlier first

in marked SUNRISE- primarily of the II Phase corresponding driven higher clinical was advancement for and was expenses spend the X of increase There increase the our enrollment external research and trial development quarter of track. This HCV to of our by in XXXX. compared XXXX related clinical a period completion first to

income interest quarter and XXXX, rates. quarter compared yield expenses investing compared securities the marketable Interest to relatively corresponding XXXX quarter consistent of XXXX. first XXXX the to for in remained higher for the G&A in higher of of consistent also first remained relatively first due to the

III Phase we spend engage fourth of scheduled as HCV first we in Phase SUNRISE-X completed of SUNRISE-X the XXXX, patient this now program cash and and At securities to quarter our XXXX, the cash, financial million, study as balance project XXXX. to into we ongoing the end During our in then runway quarter for marketable complete anticipate year. of quarter-over-quarter HCV and cash vary had initiate activities our R&D discipline, II our enrollment was our $XXX.X guidance with and equivalent the

the Jean-Pierre remarks. hand closing now for to call I'll back

Jean-Pierre Sommadossi

In both the across execution Thank as COVID-XX you, first made quarter strong HCV. Andrea. in a closing, progress meaningful and have program for we result of

positions current Our exciting for year momentum an Atea ahead.

significant we expected this key to have drive milestones programs value. for multiple shareholder the year, both have Indeed, potential which

faster-than-expected from second recent around enrollment XXXX NDA patients patients Janet line target For in high-risk top almost of expected the global exclusively and SUNRISE-X X,XXX include year-end. us. study in the Phase reminded submission results half they of as in milestones These the an follow III our COVID-XX,

As and we second-generation year. to Discovery this a our pro differentiated with progress an focused of program continue also this inhibitor, later update COVID-XX, we against part program multipronged on expect provide approach to the days highly make for

leading For the in ongoing patients, now II based up positive XX enrollment completing the the SVRX for first XX% in results to the XXX we study. quarter are Phase HCV, of in patients on additional cohort

As Avanza HCV June efficacy EASL month. mentioned, program we next our and in next are extremely results II at support clinical of new -- Phase excited to showcase

have enrolled study we of optimistic patients are on reported. XXXX. reflect Looking Phase strong anticipated the SVRXX in data efficacy And ahead, complete the SVRX half or these results the second II we in results that will that are

are program around targeting end III of Phase year. the initiation We this

great X I'm less efficiency out in company considering as us. multibillion-dollar market impressed effort, XX discipline, with are successfully the a than Atea a carrying we diseases always team that shared employees, has studies with financial with with Andreas global with and opportunity

With current believe We over treatment medical fill landscape strong and product our the that, the are for will differentiated potential. that back the opportunity have blockbuster with candidates I approved highly significant in the call needs unmet to operator. turn to

Operator

first Joseph of question the from Our Eric comes JPMorgan. with line Instructions] [Operator

Unknown Analyst

how trial, before wondering you're would I on mentioned kind It's of basis, patients? Billy [indiscernible] being the about on of Eric. sizable just rolling this I you've the percentage know XXX how for was be Patients. HCV a

Jean-Pierre Sommadossi

Arantxa, so you please? right, question, All can answer the

Maria Horga

many on Well, how depends we enroll. it Yes.

We target, would at have target we our be targets a in to the and -- protocol. between least And XX% it's XX%. see. And XX% will enroll

Unknown Analyst

kind what look is ahead to progressRNA? potentially yourselves exactly the And this? bit for looking describe or trial, further from this of a then would for the pathway you'd Okay. something a -- with do to look registration how partner HV And you

Jean-Pierre Sommadossi

Okay.

we co-infected patients, the Mavyret. HCV, III X We us be with likely will have regulators. of agree because regulators you II comparator, X as head-to-head an interaction that against that be will We the against will anticipate very trial of a X Phase will this one that likely -- we the trials, Phase meeting he Epclusa. drug-drug We HIV we since the anticipate will including a have anticipate with be First, the of anticipate anticipate, will to with trials. end that need that

Phase for But sheet. we regulators. program, we balance Phase the including move already many the position strong obviously, III have we cannot the in And a strong which ourself execute the have we the in operations set Andrea, terms from III clinical II, program, a to very for you the III Phase of as And United anticipate, to speak program. regulatory have approval I into in been is And States. heard of for have Phase countries

So anticipate the will we Phase that we ourselves do III program.

Operator

Skor of Stanley. next Morgan Our question Maxwell the line from comes with

Maxwell Skor

their wondering would in trial, they you important Also, points which provide missed particularly and on meet FDA. was given which intention competitive call the end the I any the primary on to II Shunodi's thoughts as Phase would update, you secondary if landscape? out SUNRISE-X recent

Jean-Pierre Sommadossi

Janet? you, Thank

Janet Hammond

you. Thank

So III much with Shunodi Phase yours. trial, is the I to our regard the information as think same

endpoint a in for symptom companies extent, been and some this for case successful our to has think has drugs I been not which developing space.

some than first as from ours that think think, are trial which really, I things of so to different after foremost, a this that were they the and endpoint. go And selected I primary

did a those succeed pains it subset point out there think I to that -- were they of on symptoms.

see key disappointing endpoint. obviously However, to that it's them failing on primary

different are mentioned, And exclusively enrolled proof strong on be we principle that our hospitalization problem. of focusing that in to have I where from because [indiscernible] we high-risk on As morning hospitalization study. from our continues population patients that a is

think which also hasn't it been common as was as I obviously, is that hospitalization good. previously, However,

alerts evidence for to secondary looking comparable have viral endpoints, think terms I to for in reductions in what we which have viral others So rebound. regard are of looking endpoints in in potential patients also of

at evidence visits looking through that. of emergence Medicare described, been look to hospitalizations resistance have something also all we commitment I patients, looking for which XX. think, Also and and has way placebo of is in tend and the This and a increased Day both for

think I that those the key So we're in. are endpoints interested

Operator

line from Raffat comes question Evercore with next Umer ISI. the Our of

Jonathan Miller

John Omar. It's the Phase to like that on would start did you expectations IIIs I for internally. with to

take registrational of trials if your to all the FDA, those the your meeting to secondly, current long line does how include for need HCV? time have the you be a have for that think X true, what Phase you you but with Are guidance XX% do run? the trial program then of [indiscernible] So a obviously, assumptions sense could to And IIIs runway would do

We're going SVR, the lastly details up the coming SVRXX lead just going EASL cohort were or include lead-in on that this to long-term later Is month. data include of then And cohort. in just to new that SVRX? of data that on for full like

Jean-Pierre Sommadossi

Thank John. you,

Just the were to new we address second data. part efficacy question, of your II presenting Phase

budget would May finance on the not on say for of and we terms over the the more than be X. to As go XX, cannot XXXX. EASL. you include lived to terms you of from abstract way in We the go the the for the the to we to present in embargo break excited know, all can June embargo that, Andrea, what data

regulatory So the will over then take part. I

Andrea Corcoran

John. Yes,

question, does and answer X trials, that So III Phase resources. your that anticipate they we existing in to with be our have guidance during completed time of will will window our

Jean-Pierre Sommadossi

agreement U.S. so first And in regarding with the in have regulators. time lines, of let end us be obviously, and to a II global complete the trial, the deal the but and Europe, this we with would Phase several regulators, the

view we in time think what a and see So we will John. better as XXXX lines, I have share

Jonathan Miller

sense. Makes

final one guess, SUNRISE. on I one, Just

You're data that's that assume the second half be in going full since but a endpoint, on the to and in you've later the half, early second guiding it's got primary side X-month than to side? to enrollment, fair the rather

Jean-Pierre Sommadossi

Janet?

Janet Hammond

I approximately the think mentioned, we X,XXX enrolled trial. as patients we've in

So half there's of said provide. we're that be year will cleaned. when year of data that exactly considerable in the to second the we million And needs a amount when is X

I think guidance. more specific

that's can think best do I the for I So now.

Jean-Pierre Sommadossi

forget, are was just But not talking And need numbers we go don't also, significant today, XX reports. just And about I days. for think, John, I days we see obviously, to XXX,XXX cleanup. symptom, there some a to XX

major. So, just to put pretty an example, it's

Operator

next from with will of question Our line come Tim the Blair. Lugo William

Tim Lugo

And break you like? also once know start HCV a day, is the the a burden know what you the want you there. the dose those, just of roughly didn't Ruza XXX let's embargo. yes. and I day combination mg fixed is like. EASL look XXX fixed once of tone dosed looks a though, discuss, dose kind what And mentioned broadly combo at to being Can I And the bemnifosbuvir

Jean-Pierre Sommadossi

have to tablet a huge be want don't X.X And to it Look, X.X, we would a Sure. tablet. gram.

that have be tablets believe we once formulation the we day, So And several again, formulations. a X ideal will obviously.

several We have dog excellent under data in conditions.

one completed fixed We combination. dose have already

to in or X weeks. We the will Actually, have X more. anticipate next the next couple start one of

can goal exposure XXX% drug to that's effect. Basically, our ruzasvir get is goal, for Tim. further as any see, to our So maximize we bem to want close very you and both without

Tim Lugo

a That maybe expect that, And need? could not decompensated lot unmet the of cirrhotics. know I real in we on that seems a but sense. data, can makes be EASL, Okay. some

Jean-Pierre Sommadossi

want to cirrhotics. Well, you you're right, question? for decompensated address that Arantxa,

Maria Horga

plan now the are So be but we that in we the enrolling cirrhoticsn do will compensate something compensated II, for Phase a [indiscernible] Is we'll later.

Jean-Pierre Sommadossi

as I appreciate, And Mavyret PI, Look, Tim, comp in Yes. because as presence you of okay? you can not now, know. is that think the right of indicated the

and anticipate have be that dust We you the -- know III that, will with patients. that, there you in Phase will unfortunately, some decompensated

it's ethically then trial very clear the placebo that it complete shortly III likely, want we cannot against have very head-to-head So be Phase and study. control patient after, population a Epclusa will to

So move of of definitely forward to need rapidly patients. something we that because the look those

Operator

Instructions] Roanna question Leering comes [Operator Ruiz Next from Partners. with

Rosa Chen

Rosa on like need they can us you'll cirrhosis questions mentioned, the large sense population? up A of couple safety the a these decompensated that on HCV was of you Do sense registration? database Roanna. have give total a for HCV. for of of make the you This percentage a as how for patients patients thinking is And about

Jean-Pierre Sommadossi

want you question, address to the Arantxa, please?

Maria Horga

Yes.

this, length and it's treatment. database at usually, antiviral recommended a So combination the patients, the like X,XXX of regarding around dose for safety

we have So that's already enrolled Phase II. what in plus III Phase has to roughly program what the

and few. States, give States, And really of represents the a really patients in I percentage usually But cannot exact less United amount the a of is the the HCV country. question it's some percentage Asian small it's in strong the now. in it United quite second less, There really was but right with and compensation. still the you

Rosa Chen

guys X% current you Got it. hospitalization about thinking And to rates for still the of then using of assumption COVID-XX, maybe are X% like currently?

Eric Joseph

Janet?

Janet Hammond

is difference thinking for powered we seen. So hospitalizations we're really which others are significant terms achieving what comparable a of in have and in XX% it and something about what of around to statistically

that, than we Has did hospitalization I of increased. our suppose, think a And that sales I lower recall, some ago, year [indiscernible] I about to our be is that. assumptions you'll actually little but -- to on a is think accommodate expand

Andrea Corcoran

that the for Does in you the then assumption your -- consider one Got out your on partnering your it. runway. only COVID potentially include build cash And itself as would option? or your launching last COVID? program Or current does

Jean-Pierre Sommadossi

Andrea?

Andrea Corcoran

partner commercialization So that does will individually anticipate we we will anticipate COVID-XX a activities, for we do have but which there will engage. that initial it nonetheless, some be

Jean-Pierre Sommadossi

large-scale Including may add. if manufacturing I

Operator

I'm Mr. like the questions no time. showing for hand closing remarks. further Jean-Pierre back Sommadossi to conference at currently to I'd this

Jean-Pierre Sommadossi

you you thank support. for conference continued earnings Again, all your joining our quarter thank for and first Thank you. XXXX call,

Operator

for concludes conference Thank call. you today's This your participation.

now You have day. Everyone, may disconnect. wonderful a

Atea Pharmaceuticals (AVIR) 14 May 242024 Q1 Earnings call transcript