Earnings call transcript Q1 2023

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Operator

Good afternoon, ladies and gentlemen. Welcome to the Atea Pharmaceuticals’ First Quarter 2023 Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode.

Following the formal remarks, we will open the call up for your questions.

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. proceed. please Barnes,

Jonae Barnes

outlines Good first operator. conference and to release, welcome Earlier discuss. plan Thank XXXX afternoon, financial Pharmaceuticals’ which press a quarter we update topics results Atea we today, to you, issued everyone, the and call. business

be the section will of at today can our that access as slides to release website press You by well going as the we reviewing Investors the ir.ataepharma.com.

Dr. Sommadossi; Janet are Chief Chief Executive and Chief today Development me Jean-Pierre Officer; Dr. from Atea Officer, With Hammond; Founder; Medical Officer Dr.

Horga, Officer Andrea all portion Commercial Vavricka. Arantxa Financial President Q&A and of call. will Corcoran; Officer, Executive Legal, They be Vice the today’s Chief available for and our of John

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

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

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

Jean-Pierre Sommadossi

you, afternoon, Jonae. thank and for us. Thank everyone joining you Good

had As program. with Slide on will we busy and X, year you of start the progress have COVID-XX see our across a HCV

from I highlights begin will with a our program. COVID-XX few

geographic to remain targeted regulatory First, with the pleased of on that report global XX% a footprint I’m the over laser where as broad focused we SUNRISE-X we execution on approvals study, our countries. of today, in have

the development treatment fast of excited potential from has a U.S. Bemnifosbuvir receive the for to designation Just we which the track of expedite to were last month, Bemnifosbuvir. FDA, COVID-XX, for

clinical each highlighted scientific safety sets CROI, meetings, data a ICAR compelling Bemnifosbuvir and multiple profile. of ECCMID, and including interaction including profile, presented favorable drug of which efficacy We

advancing to inhibitor. continue second progress we make generation protease our Finally,

results from patient continue vitro dose highly combination support trial our year-end. our Turning recently new by ICAR HCV, standard-of-care. initial we XX compelling profile, of And to this phase we quarter. results first cohort to profile the in on the and combination patients for a antiviral our expect remain compared Data Xb the indicate to target X presented first current in

we Antiviral to meetings presence I large during mentioned, the X, medical as the major a first at had Moving quarter. Slide

for Some trial the old. the commonly of include with key in the in risk results XX% with over subset was a key drug-drug to HCV, program which feature reduction patient trial, we highlights the MORNINGSKY is believe in full interactions prescribed reduction COVID-XX presented of risk MORNINGSKY benefits current medicine showing our compared placebo review a the XX% risk and in hospitalization, of XX-years the Low of drug. as in of showing a

HCV portal Slide preclinical ICAR adverse safety program. presented Bemnifosbuvir X outlines synergistic data and COVID-XX were our data medical antiviral the without At indirect and activity individual showing beyond the meetings presented combination in vivo interactions.

presented addition, we XXXX on AGNC In AT-XXX dengue. for the data

forward. in are deprioritize While our ways to program exploring move to XXXX, program know, continue the opportunistic February AT-XXX with development of as you we this and dengue

to to Slide AT-XXX against the an suppose, I potent of SARS-CoV-X also, bay’s new to shown AT-XXX activity X. vitro, a source has that civilian now demonstrated been Moving in three the antiviral results of XBB. code be Bemnifosbuvir inhibitor micron

gamma, all various and antiviral consistent in the beta, variants activity epsilon with and delta, and XBB. BAX Omicron against BAX, potent vitro now concern privacy alpha, of interest BAX demonstrated and variant BAX, sub including is This other the of

over to call the turn Janet. now will I

Janet Hammond

you. Thank

declared the week. emergency. to Health X, to Slide World dynamics to and health U.S. Public Organization the is COVID-XX the the this Last to market set Turning shift Emergency the COVID Health end continue Friday, global expire

globally that still million which stay, large on there as and last is over virus the a remains, that One is say the is went to also fact the fact of reported here new were XX-days. a XX,XXX deaths X.X COVID-XX. medical in COVID nearly unmet highlighted cases to treatment for They by need

both lower XX% immunity of infection booster immune and waning also vaccines. exacerbated and experiencing only vaccines mount a population to approximately the in patient with by populations, with uptake, natural the received to failure having some a response there are is We booster U.S. any

anticoagulants of commonly to due are drug-drug prescribed currently with Moreover, medications, considerable medications, the limitations such interactions seizure concerns available antipsychotics, and antiviral and safety more. as oral

limits these have of are to patients drugs of cases who the and COVID. the immunocompromised in severe use high risk most and most This likely significantly the most elderly vulnerable

remaining As available of assessment on emergency criteria that. assurance for still need use and medical unmet this result a authorization is

Turning to continues. execution from earlier, global our strong patient regulatory geographical we mentioned approvals Slide over the operational and XX% X, footprint The team. now targeted of enrollment are seeing in clinical has countries as SUNRISE-X Jean-Pierre

with X.XX, the evolve new Omicron good experiencing showing again we to and what variant pregnancy Bemnifosbuvir. variants sub XBB with continues in there [indiscernible] COVID-XX as with the vitro we waves are such are

Our by waves new goal and footprint of to patients is from waves variants well extensive merge. with infection positioned circulating global as our enroll being

SUNRISE-X the all are is Its XX at in severe endpoint caused all monotherapy or disease focusing patients through to hospitalization on cohort. is least maybe COVID-XX high risk day primary for progression from mortality. at hospitalization XXXX the risk greatest into patients that day

Jean-Pierre to program. now back our call will turn to HCV the review I

Jean-Pierre Sommadossi

you, Thank Janet.

our and patients Hepatitis Bemnifosbuvir by a for program put standard-of-care the our three upon potential benefits of improve current Ruzasvir. in cirrhosis. that to believe to it and now a duration fixed of a dose with offering without options the Moving combination HCV of We has bit C shorter combination

highly with positive demonstrated activity. genotypic potent a the and antiviral clinical is Being

XX as antiviral vitro potent against activity clinical is ECXX NSX that grown antiviral inhibitor Ruzasvir lower [indiscernible] with genotypes genotypic demonstrated addition in with all shown In activity.

effectiveness emerged selected against the variants treatment or in of HCV resistant Bemnifosbuvir of NSXA previous both can standard-of-care. the current identifying who of We NSXA currently HCV associated have is variants resistance antiviral a who occurring Naturally the profiled vitro and failed available treatments. impact have recently and activity Ruzasvir panel patients

We share have supporting best-in-class with pleased data to are you for regiment. we potential that this now, the

high Bemnifosbuvir in all it at potent associated genotype NSXA recent retain rise. XA, As resistance call XX show variance outlined HCV against being on genotype more potency Slide sofosbuvir we or XA times than and XX, the vitro data least

to on the in currently as the NSXA Slide Ruzasvir you inhibitor. demonstrated will which a addition, a most similar compared as rapid to efficacy Ruzasvir In potent also antiviral has is NSXA see Ruzasvir favorable profile is approved. the XX potent move NSXA forth and inhibitor activity velpatasvir, In vitro

number HCV genotype a fold effect the In treat difficult fact, and genotype XA, against in XX, Ruzasvir XA. shown five more to velpatasvir Slide to RAF and potent outlined replica as be same was to on XX

the to Turning of summary, very regiment effects, be the combination and best-in-class to of interaction, its treatment and for the potential food potential Slide on duration. based drug-drug XX. pain, Bemnifosbuvir is risk antibiotic, for absence and In short has antiviral genotypic low important, Ruzasvir potency, the

a Indeed, the this the This of we along eight standard-of-care. weeks data, totality the are us to with for of give greater preclinical targeting shorter new the therapy of potential duration. become potential in the combination profile, even with confidence

believe for just can treatment short Bemnifosbuvir compelling on XXX% a HCV mentioned, between will Slide increased we especially that combination you cases duration effective, as highly and and with area U.S. the where see, And XXXX. profile. this XXXX diagnosed Ruzasvir its in is potential be an normally XX As given

and HCV HCV have occurring million According year. nearly to to year. XXX,XXX million new WHO globally XX X.X chronic people disease liver infection We every each infections lose approximately people related

because proposed U.S. recently the HCV an need new And in the even U.S. recognize it with and government this for has eliminate is the options. resurgence has important become acknowledges when effective such goal treatment this to a This problem program the HCV.

open of XXX of and HCV On HCV including patients. leading This in will XX, patients. enroll genotypes, antiviral patients Ruzasvir Slide infected across label outline study phase a we our cause approximately acting approximately direct XX all Bemnifosbuvir naive study X

XXX administered of positive XX response The in combination at any affecting the sustained via was and post safety study SVR be will treatment. with who milligram versus eight weeks. week daily XXX or endpoint of Patients for virologic primary milligrams

dosing as begin In failure, post for of for initiation around is approximately leading data with trial we patients cohort is XX Regulatory and resistance. quarter. are the clinical and expected Although XX, initial year. this patient this anticipated include of virologic ongoing the of treatment to endpoints the the of trial this global virologic submissions in end

turn will call to I Andrea our that, financial the now CFO, to over With Corcoran our updates.

Andrea Corcoran

Thank you Jean-Pierre.

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

with of relatively First the each quarter remained expenses R&D first and G&A of consistent quarter of XXXX. XXXX

expenses R&D COVID-XX further in as and advance. measured anticipate these development programs our that a will do clinical As our XXXX. HCV increase both programs we way We clinical in of

discipline financial manage We focused invest are in spend we these to as exercising programs.

quarter equivalents are our our security balance our plans, XXXX, the current was cash Based we At on million. cash, with into the first XXXX. end guidance of run reiterating cash and of rate a $XXX.X marketable

turn to over closing call the now will back for I Jean-Pierre remarks.

Jean-Pierre Sommadossi

In conclusion, far already and this HCV so have made Thank progress year. program clinical operational and we you, Andrea. across COVID-XX notable our

advance enhance validate of and infectious significant, at presented scientific programs leading efforts scientific this our our the clinical conferences. our to We as among of and several potential an continue audience believe and evidence global in we clinical also specialists support development of approach We disease virologist clinical will data trials. our

to look We progress throughout year. continued our reporting forward the

serious continued we support patients medical Atea with address we of the as viral needs always, interest together for As you infections. unmet thank to and your of strive

questions. call With your the up that we will operator, open now to

Operator

Our Joseph Eric [Operator question Instructions] JP first Morgan. comes from with

Unidentified Analyst

heard I for this Hi, are question. is what your which terms one Pfizer need recently of in landscape? had just competitive Thanks. about doesn’t We return borrowers on on that from thoughts events. it guarantee Eric. Billy wonder We

Jean-Pierre Sommadossi

everyone Well, scientific call. feedback the not a we got earning data any We, only as have conference. from seen

safety clear it that interesting. more new lot generation. either So is the we with clear expect is to that a this what we were the quite need data address it But potency, will looks and it

Unidentified Analyst

Thank you.

Operator

Maxwell comes question next Morgan Stanley. Our from Skor with

Maxwell Skor

ask regarding prior any we the just on my on expect report to have thank reporting primary committed you details track analysis to second in interim what questions interim? Hi of want half trial. you can call And the the I this after could But you for taking give on Thank from for additional to secondary that believe not endpoints study you you the stated also, are a you. SUNRISE-X XXXX? I and

Jean-Pierre Sommadossi

Janet, you question? the to want do address

Janet Hammond

you. thank Yes,

the regard the with analysis, not if all regard our with endpoint us opportunity in primary and population further the our interim think increase patient to on track, to then So sample reestimate it to changed. the And I - guidance provide does has And endpoint. population. primary order necessary and mortality is the that is hospitalization achieve in size the to cause the

And with be the currently, will in into are XXXX for need XXXX patients monotherapy standard-of- statistical that XXXX projecting we arm, incorporated a patients remainder the will the combination and ultimately, the we of analysis, total patients. current estimate of care of

endpoint anticipated we upsize population But present interim really patients designed study and is and if it necessary, at we primary is what depending that would for time, the us the hospitalization. on to analysis is be the the the is with to but just that that help monotherapy need sure

Maxwell Skor

thank Okay, you.

Operator

Evercore Our question of line a from John ISI. next with Miller comes

John Miller

quick Hi, the environment that thank bit a very regulatory more lapse, still those? EUA isn’t to of you state ones around for Two you scheduled guys. will a to taking about questions seem EUAs how obviously, is of how support One, confident from will much emergency Can available. you little state the me. be there be talk but if emergency very you my

and that endpoint, primary on afternoon better patients other the for companies Obviously, secondly, we sizing SUNRISE percent high efficacy stumble did zero of the expected seropositive baseline then saw data impact rates likely on how the this of that treatment baseline a just patient of than their placebo COVID And analysis interim due positivity. placebo in will because hospitalization? and from to

baseline your arm my of impact and you’re hospitalization in estimate with of number where estimates? patients a baseline placebo higher at rates seropositive getting whether wondering I’m of So

Jean-Pierre Sommadossi

you maybe And Janet. second will we then get first. to Janet, the with question one. Go to want first start ahead the

Janet Hammond

Sure. question. It Thank is an you. interesting

sufficient going points of the are hospitalization to the rate the hospitalization I see think obviously, the what this need the is to is have and overall order but hospitalization that we rate not we where is to just and understanding a we to in what are is interim whether what rate study for one the hospitalization, that determine that, is. analysis rate But that. have upsize to is of unblinding

design. And is behind the so adaptive idea the that

to for in regard is everybody we this effectiveness time, population, most wins with seropositive. seropositive. part, I antibody at others. time think a likely has seen and think vulnerable target moving It more the more is that I the F for be that COVID almost an probably We but that interesting, know quickly to isn’t that patient over believe than therefore

there that think is natural two, been again, the think demonstrating sort in last have waning and I and some articles, rapid very And of I interesting that at the as again, week vaccine the to actually, booster, looking Omicron well thing there the efficacy of to immunity as infection. or

is to with be virus to to the is have coming result, continue. we what it that strains But evolve certainty likely really designed through, why rate to continues study a impossible, it And in way. that new is likely any evasion I think the for hospitalization and with that as as the obviously likely is predict basis the is immune

firstly, think, the population, vulnerable to of point which from the most I is the hospitalization.

it think a then gave that likely population. us hospitalization to rate. to secondly, lower higher necessary be I and patient is in accommodate numbers Canada So study And to

Jean-Pierre Sommadossi

On indicated targeting for forget NDA. indicated are UAE we had an is filing. let’s we a be be first question, trial - the are also, be that we always the But sufficient that NDA, sufficient an FDA in would we the an will in that that has the what if data wonderful. indicated, as writing not SUNRISE-X the have this targeting as NDA And will

want you add to anything? do Janet,

Janet Hammond

covered you. Thank as have well. No, you I think

Operator

question next a William line from of Lugo Tim Blair. with comes Our

Tim Lugo

switch Thanks for will I taking questions. the HCV. to Maybe

you you ability dose Phase the the dosing achieve of So but can for to ongoing mentioned reduce the the that? think and What going X do severe? to kind not you regimen inform

Jean-Pierre Sommadossi

with Tim. on to view good that Look the better the have want clinical leading a data We a is question course.

kinetics on duration. you us [indiscernible] the our help those with short know, analysis determining go in We collaboration terms have will is the treatment kinetics of in a that viral as where and goal of viral is can we really

Tim Lugo

at that this the said of You end phase X.

Jean-Pierre Sommadossi

ago basically - those good the not to is - I’m you with that Yes the a to standard-of-care as very variants very different any now were when more NSXA know as play we the the a you they are field great eight are than against a talking now, that when NSXA, difference weeks, as open of events lot in than today. [indiscernible] very feel six is the with in role especially as do for actually or example. we obviously we profile those have better sure will you seven extensive see those our what we as inside combination, the [indiscernible] years a safety And of believe a differentiation going this [indiscernible] compared major potent is the

even shoulder see So weeks. as vowel and go eight kinetics the them the will we we we soon as have can

Tim Lugo

much. Thank so you

Operator

Securities. SVB Roanna from Our with Instructions] comes Ruiz question [Operator next

Unidentified Analyst

Roanna [Rosa Hi, COVID. Bemnifosbuvirfor from this on Chen] Ruiz. is (Ph) us on Couple for

designation Fast for congrats on Bemnifosbuvir. getting So Track

understand does Fast potential provide advantages - for designation but the implications its we submission? NDA, potential Track for First,

be proportion expect do And the what the SUNRISE-X enrollment, representative Thank and population full from the secondly, you coming of so is monotherapy interim in you. that full? and U.S. of will

Jean-Pierre Sommadossi

Janet.

Janet Hammond

as FDA have that data Fast submission. collaborative I ought the exchange and the clinical a discussion to our with So we Track allow to and us close with trial and think designation proceed

there things think more than I it will So that is otherwise. allow go rapidly to possibility a

down the and And of determination it but have is obviously, authorization, of data the obviously I that sometime to we emergency with an is discretion. are FDA will certainly, road. the FDA help And see familiarity obviously might in worthy data think, whether use

regard in population studying comparison vulnerable what in trial going patients early then the proportion I to particularly on to I’m the with days And But is receiving is the our it elsewhere, U.S., monotherapy COVID. and in a we are think of that that to look think like. to is I comment certainly population that is to

think currently within U.S. And elsewhere. often interestingly, the I available reason, for that for the and ineligible treatments

good of requiring both see to And a representation patients so abroad. monotherapy here and we continue

Unidentified Analyst

Great, thank you much. so

Operator

I That Sommadossi Jean-Pierre concludes question-and-answer the like turn back remarks. call today’s to session. would closing to for

Jean-Pierre Sommadossi

today. Thank for us again joining you

Operator

conference concludes This Thank for today’s call. you participating.

You disconnect. may now

Atea Pharmaceuticals (AVIR) 8 May 232023 Q1 Earnings call transcript