- Earnings call transcript Q3 2022

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Operator

Good afternoon, ladies and gentlemen. Welcome to the Atea Pharmaceuticals' Third Quarter 2022 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. [Operator Instructions] I will now 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 third 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

Chief reviewing the Dr. Chief of Andrea will be our from Officer; Chief ir.ataepharma.com. me by John can website Q&A Officer that access as Sommadossi; Atea today's Hammond; slides the today Jean-Pierre Legal, Executive Founder; Dr. release at press You going Officer are portion They well of to and Development call. the Corcoran; Financial Janet all as the available Vavricka. Executive we'll Commercial today for President of be section and our and Chief Investors With Officer,

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

Our turn results call I'll today's that, call. to may now discussed from differ With is actual what Jean-Pierre. on over the materially

Jean-Pierre Sommadossi

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

a the our of three program. you considerable We clinical so with have this demonstrate number across year updates progress that made today review to far we have

in of today. acting Omicron that the infection need regions vaccines the dynamics COVID-XX dominance predicts the for rapid wanting direct with multiple Turning to of and with social numbers pre-pandemic US low combined oral continue slide receiving new close individual we XX% only in four, currently large world and reinforce of as booster with we their associated people with near persist the to back and norms, less increase in landscape assessed and as antiviral. multiple see than waves, COVID-XX infected the with ability currently, the to natural new The uptake we would of to the epidemiologist variants different vaccine number

this start Phase preventive Looking to waves global our should we susceptible hospitalization timely currently of available with enable which forward, those durational as wave high and those COVID-XX These for over patients involvement old, to risk life-threatening is trial. SUNRISE-X, XX can thus. ongoing Pandemic various to factors, enrollment at be not tools years increased causing with start risk trial. of particularly to X to

are the needed New oral limitations antivirals the improved to with due options. antiviral urgently profile of current

and life-saving drug-drug safety and major possible. our are is interactions to patients for commonly candidate to of risk that potential many unmet drug a it need these Paxlovid as fast address to In the limitations the addition concerns, and issue With of bemnifosbuvir, among priority relapse deliver we at have disease. between this prescribed to top drugs severe lead major as

Indeed, slide will activity future demonstrated concern. to our as dataset that potent SARS-CoV-X most spread, opportunity BA.X. BA.X. variants and sub-variants active continues to new sub-variants to Omicron five that based the to call the I and confident will in-vitro markets potency in-vitro turn Similar beta, Turning COVID-XX. against against over variants and observed the for ongoing epsilon, remain consistent, delta, John? alpha, BA.X on Omicron review and antiviral antiviral with demonstrate been fully has against BA.X antiviral activity recent we're oral to now of gamma, the John bemnifosbuvir

John Vavricka

everyone. Good afternoon

antiviral believe to the remain revenues COVID-XX Turning driven market government large while for opportunity were to advanced COVID-XX purchases. initial come. slide market a We very six, will years by

which Paul products dollar prescribing was and Lagevrio Paxlovid despite Our multibillion limitations hesitancy. are each the

more transition US next Services anticipate has traditional purchases U.S. Human suggested and market the over Department will to seven, slide the of we advanced & to year, Turning the Health government from $XX which continue to demand estimated $XX Projected IQVIA market expect COVID suggest channels, annual between dollar be an and will retail annual opportunity. prescriptions antiviral a using billion multibillion oral billion. we

By commonly including for prescribing concern. interactions drugs important prescribe were a drug-drug limit Beyond that, anticoagulants, is expand patients medication, is believe several opportunity we there more. There to prescribed ability safely are Paxlovid this classes simplifying an the to anti-psychotics, market. of that seizure Paxlovid, and

to now beyond Additionally, the to once move hand approved. to I'll are the government oral Janet? antivirals purchases expected call is fully purchases advanced recurring COVID-XX against over stockpile Janet.

Janet Hammond

afternoon. Good

disease including eight, are slide currently. greatest the mono unmet and combination to-date oral tolerability, profile, clinical results on and cornerstone drug-drug COVID-XX the benefits, options low interactions. to risk profile or demonstrated the bemnifosbuvir a advanced for and fewest should and available treatment When its to for most allow of COVID-XX. safety the to highest the patient treatment This risk our is progression favorable are become of We're current focused very for the for first the therapy Turning COVID-XX targeting at medical need. severe mortality, who strategy vulnerable there populations whom

Our of therapy has the for advance future bemnifosbuvir. we the combination combination combination are immunocompromised. continue and with already additive combination demonstrated for antiviral benefits program SUNRISE-X with trial including antivirals, protease internal inhibitors, forefront developing and at in populations, acting will specific cohort our we inhibitor our Bemnifosbuvir protease therapy to authorized strategies direct inform in-vitro the as in development such

with to hospitalization CDC, unvaccinated or had three the XX% population of According now unequivocally shots in cause note patients, after stated trial. approximately have the the important SUNRISE-X to are hundreds CDC is the disease with XX COVID-XX In of of nine, of heart rates has death from rates US, are Omicron. reported in hospitalized alarmingly, endpoints have over three of primary a dying hospital XX% higher XX and with in in be cancer, immunocompromised COVID the hospitalization third further to COVID-XX older. patients deaths XX% the patients vaccine rates leading It's XX statistics of still to of and also that adults. that daily. returned least that deaths slide The which to times these of and excess age in continued for Moving highest years study remain show the at

Moving to COVID-XX assess first we'll This trial review as our for standard-of-care. with X and a bemnifosbuvir along X Phase double will blind, evaluate antiviral SUNRISE-X, global registrational mono XX, Phase randomized, bemnifosbuvir now controlled therapy. or which is slide study trial combination administered the local let's that placebo study placebo designed

high will patients studied. will be bemnifosbuvir patients type the or cohorts enroll expect Two randomized placebo, days. Patients mild at or defined COVID-XX. twice either We by moderate X,XXX XXX to study risk for to be one-to-one receive five daily least with receive of standard-of-care milligrams,

monotherapy of comprised the supportive receiving is and The a which cohort, care primary first population. be will cohort analysis patients represents this

of second the of is cohort COVID-XX caused patients are The hospitalization compatible primary the cohort antiviral day patients will against the monotherapy or all be G available who XX cohort. that antiviral part a comprised receiving a death in study The of through endpoint their as is combination from standard-of-care. locally X,XXX

we hospitalization You hospitalization a versus in MORNINGSKY bemnifosbuvir already will the showed and trial, XX% placebo. evaluated recall have reduction in

subgroup age over Importantly, analysis the an patients reduction XX% in showed of XX. in addition, a

years vaccination factors global older, severe have XX, rest or severe session. for on a The COVID-XX, greater COVID-XX XX, high slide at XX or in one the over XX risk for the all large to world. sites a expected United with or XXX that patients which up older of of study includes regardless patients XX are and patients is will to to States, the Europe, footprint countries, Japan, progression or include immunocompromised risk or disease focus major SUNRISE-X mortality. to risk with This patients Moving will more also

begin trial countries. in States We applications are in of other of the imminently will have SUNRISE-X clinical the or enrollment trial submitted and submitting process the in United we

on in is XXX and DEFEND-X more Phase risk. assess is options study dengue. to of AT-XXX, a in in of of currently patients almost multiple endemic pharmacokinetics with program. proof-of-concept is viral It a globally, countries approved the Dengue virus let's are Dengue viral at that to now may mosquito population review administered XX, Turning the million prevalent most world's Despite load studied. over XXX be for yearly from treatment this, are dengue efficacy, up basis. baseline. Dengue and is for is of designed than affects three days, with is half slide of or placebo, AT-XXX a in five endemic disease enrolling dengue and doses change our and orally endpoint antiviral XX X no dengue cohorts primary there to borne individuals all randomized patients the fever, areas. safety, in

are then load closely Challenge setting, healthy administered virus. Our viral the groups. dose within volunteers being allowing very this AT-XXX Human a treatment or dengue Subjects of the of the dengue that kinetics a States. viral placebo, dosed with are and study live model a assessment conducted and study, In in second United is controlled monitored is between

complete study, to of of enrollment expect to Challenge cohort the of the with follow. XX in year around DEFEND-X the We end study patients first and the results enrollment

potential from like data volunteers Hygiene week Drug five. Phase X that results these we replication Meeting. AT-XXX and XX well-tolerated generally all mention XX demonstrated Annual EC without to would XXXX anticipate virus that was the the Tropical data, rapidly Society events one on across drug-related that through dengue last levels inhibit presented American in serious and we AT-XXX I achieved. discontinuations. the above These the Based has or adverse healthy vitro Additionally, serotypes study were to at in of rapidly safe Medicine AT-XXX

Hepatitis now to C our Turning program.

our the improve As combination very shown promising and on standard-of-care. to potential slide XX, program looks has on current the HCV

applications to includes We treatment, best-in-class, because the trials therapy short to combination the and the of information. follow. disease. hand possibility combination Ruzasvir, clinical With in HCV submitted believe now opportunity potential provides for for two trial for the over will genotypic bemnifosbuvir, a convenient inhibitor-free overview, to first the call the duration, around to review with of HCV financial therapy. profile Our the pan ribavirin-free the our end protease the Clinical I'll Andrea and year phase create that be initiation decompensated

Andrea Corcoran

Janet. you, Thank

XX, release XXXX XXXX. program primarily issued at our $XX.X cost September credit XXXX was consistent and receive ended relatively Jean-Pierre of with the we $XXX closing, remarks $XX.X for clinical approximately financial from balance turn a the the and amount for other subject remained $X.X a were collaborator As September months now with ended Roche, decreased $XX.X decrease expect approximately close million three cash statement tax The arrangements. of back results are certain pleased her slide we securities of sharing tax trial to in in of reiterate for XX, the out administrative sheets our the the XX, XXXX. quarter General and former with of to end, expenses Jonae and returns. guidance interest three ended through Roche the $XX.X million related million R&D cash, share due in are in cash remarks. previously equivalents, $X.X of In arrangement containing for The months over XXXX. in XXXX, million mentioned in to QX, $X.X XXXX. of the earnings we that million marketable cash months operations on R&D at introductory a million associated the runway closing on by refund to September I'll by cost a today, XX, million to the the call September activities quarter our of elimination includes in and the $XX.X million our for with recorded approximate reserves the amount earlier and COVID-XX months for expenses expenses third to three Also ended million and XX. the we XX, press three

Jean-Pierre Sommadossi

This year to our will candidates, Andrea. we three us a substantial pivotal in advancing you, XXXX. Thank progress, take clinical year made have which

immediate oral Our a new sense urgency, options COVID-XX. treatment an of there team to is is operating because with for need

begin deliver possible. will immediately trial SUNRISE-X warming goal direct effective antivirals as our all We safe patients with as acting quickly to and up global a to

and we Challenge treatment thank HCV. now would of to we the of the initiation entire in take the like team your for with I With soon that and transforming Phase study the of first operator, results their cohort our diseases tireless questions. the none Atea for dedication be to of of program combination the up expect follow without X whom possible. enrollment our to dengue call the opportunity In to addition, completion and to progress several will this will open mission of DEFEND-X

Operator

we this At Instructions] you. Hannah time, conduct comes question-and-answer line question JPMorgan. Hannah? the will of the session Adeoye Our with Thank [Operator first Ms. from

Hannah Adeoye

us. from thanks Eric, for on a just for questions Hannah taking is this the Hi, few

you clinical the on trial that you first, And from Phase address can the So you Studies? X subsequent inpatient the how is we exploratory speak going Challenge doing activity of do then be we separate seeing on from human study? that you in NV can And seeing be as study? might just what think might we behind also, this to characterize that cohorts? to in Should And when do endpoints the rationale think informative you're AT-XXX? data update well? of And data you? expect anticipate both from Thank might caution sets

Jean-Pierre Sommadossi

to the you Janet, have take questions.

Janet Hammond

Thank you.

we really to with rationale and good of idea the think So the study, has in it's to very a the treatment performs regard how complementary Dengue. in study us for Challenge provided AT-XXX

with Dengue, treatment volunteers but XXX the placebo. or the patients are the dose of the in or background a Challenge study either mentioned, on of administered As live

have so the I the we placebo example against against think And really whether of but protection natural good of infection here, potential in glimpse patients, good infection of also, infection. XXX think, a study a the efficacious the I is altogether, for biokinetic

And administered prophylactic. we also and infection what a good is the together, a is what happens so happen in to think sense if dengue drug get of likely I

durations So good of and what virus altogether, make a two further need the decisions give us together dengue very and at those type allow the of I studies for we cohorts to against forth. looking of we're so terms performed should XXX in how think whether dosing us around the and treatment understanding

informative. disease is a which think It's that well they're be unfortunately to understood. not all very I going So,

evidence so world I for this important I available. in And regards be very And with having some think when to real think have will us. we'll datasets

complete if to to any, initial those if will Challenge enrollment as well allow you'd plan incorporate we Phase us we by then decisions end. plan will around of year make trials patients that in we needed. cohorts as the the as and need mentioned, data. questions, we X the study analyze As subsequent to And And the they're cohort what of answer

Hannah Adeoye

Okay.

adding be won't from we those year data So programs? this any of

Jean-Pierre Sommadossi

never to committed times. indicated going have as as data the be next we've Well, year many It's we to early indicated.

is I like to the So saying treatment are what time, at to would Dengue. same the for what reiterate pioneer be Janet we the that going of was

been single successful. has So direct acting far, that as not you failed. is antiviral know, a there Everyone has

for do treatment the we of So we are pioneer days. we terms are both five in need, and duration, how now right long

have the We weeks two prophylactic. for

the We from disease from are learning the that the experts rebound in field there may be some itself.

we studies So how are of and both proof into indicated, it's Janet we sense are complementary, highly make move both as -- going concept studies. a to waiting to to has forward as larger of have understand studies,

Hannah Adeoye

Thanks taking for Okay, the great. question.

Operator

you. Thank

please Our of next question the from Harrison of comes Matthew, Matthew Stanley. Morgan stand line by.

Matthew Harrison

of So important? to is or level of reduction is more what viral kinetics the dengue Thank load the you. meaningful

Jean-Pierre Sommadossi

Janet.

Janet Hammond

some viral what very whether to that come yet. we're more of because to know think days. really as the to I group said, naturally think well really think, learn placebo having it we're I as interested asking, it's going are I in quickly. in both effective First, the study. can that the node But know don't is the I question, and also prophylactic answer you're know I we therapies. on the But lot, And I a from an see don't the down treatment We be compare a interesting to assessment we to contrast. make to declined on possible couple this study, answer able patients there as as after think it no get to didn't rapidly active the necessarily, of as what

Matthew Harrison

Thank Okay. you.

Operator

Okay.

of comes your with the Raffat next Umer, Evercore. standby. line Our Umer, Umer line is please open. question from

Umer Raffat

of Thank you. A may. couple questions, I if

a X First, their we stand oral design. there's saw couple Phase out Gilead Remdesivir trial that your versus of of post the trial pill. things And

consistent just four on with months to those you First, do Maybe we viral you patients to perhaps that Gilead run, the second, rapidly And attempting only of you speak after got secondly, at on I human if pick declining dynamics days, so dose. And the number dengue, do If the also is Where that? since approval? in is thought that. getting they're is patients. Xx Because speak prior what imagine a up trial question. endpoint there's too? XX vaccine were you And up couple say least could stand hear study using to sort and load almost patients dimensions, one? trial design, hospitalize is if some in I could the ultimate the you those even limiting or last that on to didn't back truly that much end to more leads to two of to perhaps as the utilization your about hospitalization powering. on Challenge

Jean-Pierre Sommadossi

Janet?

Janet Hammond

So with the trials, design. study regards I to X the Gilead Phase haven't seen

I to So their population comment can't us. on compares how

into So the say to doing But With with I know to vaccination, really than regard we same the very four not unable don't powering, fact XX more I for the vaccines regard think they have study. that is last month to the I requirements I'm that comment. again, can footprint, than of getting study, in same countries. our a are and them I everybody on truly that more global not you'll mentioned, the the getting be everybody aware as schedule. And where

in study to anyway. immune to be we'll And really think if regardless to study; this like. what patient that's allow can to we that COVID-XX hospitalization vaccine the quite study allow in Unfortunately, to I planning care that enroll order status the what to rates about. response we're because limited see vaccination are So really population the the we of patients pragmatic come is most in the think the in way get they

for patients patients to of US. of susceptible COVID-XX. on having XX to age the that in these at of of mentioned around you'll many three recall, the had the And we shots over unfortunately So still are least data be think call I vaccine going the fairly hospitalized, being XX%

good a does we're to it's I rapidly. viral repeatedly that take in I how infected some to how is to we regards they don't with with so to what unfortunately, see of how think again, we load of into viral think, And is order if think And forward storm. fairly the decline representation been for patients pragmatic the And to study to cytokine infection approach the able a And we'll need know have be see decline to being the to translates uncertain. still likely, to the do vaccinated. have cytokine relates What help that if the hospitalization the hospitalized With viral patients extent, of translates. know Dengue, and and load declines, rapidity even know that, is are that yet we load, storm really causes I leading rapidity hospitalization. us in

virus the think I transfers it's immune main I curve response. with to possible of as dengue. help eradicate is again, thing is important quickly the everybody for reduce for this as But that path learning the for of therapeutics front end the think that the to really

Jean-Pierre Sommadossi

-- Just I’m well, to add sorry.

add and add, to I'll to let then Just Challenge. you the

the strain, that load are causing and this is about than majority the are Dengue one of Janet important X Dengue to viral load to have the has of highest Umer, with disease Just been there been disease. the other the made for that one viral that viral severity suggest would basically strain, correlation that two add to appear the load, severe only the the X,

but I'll of that. also. that's very was the kind address more some part where let there Janet? Janet than So correlation, direct Challenge nothing

Janet Hammond

the the cohort. of Challenge So with in still we're -- that cohort into to process the XX enrolling patients regard the study,

but there update, isn't I more way in provide can So the we that up much anticipate that wrapping of shortly now. an fairly

Operator

Thank you.

by line Tim? will I please Lugo call up. come Our open your while line William Tim, Blair. of next Tim with stand from the

Tim Lugo

question. my can Taking Yes, me? hear you

Operator

Yes.

line Your is open.

Tim Lugo

Great. Okay.

going Or that wouldn't? just going I patients that is assume combination and of out mostly who therapy of it the of, to you're who geographic the be those is of kind elderly combination to and that to are guess, compromised? safe between be more immune SUNRISE-X, division So would getting receive

Jean-Pierre Sommadossi

Janet?

Janet Hammond

it really I extent. depend think prescriber to going is to So some the on

of of and access area. standard-of-care will Some terms available be to in geographic good are it in antivirals an

particularly are prescribed drug the be if in States, monotherapy I patients from significant interactions, also although is think they Paxlovid. United still to limited be be doesn't to that much that able will there likely to for many seem -- it's But that patients, molnupiravir, getting preventing prescribed. are them and

world. them. likely, areas unmet seems the we mean the anticipate it's think are some I think, to that more rather available the of causes prescribing board drugs I that those areas be that even profile reluctance certain I use again, there So But combination really the in of be in the will currently across in of need

Tim Lugo

Okay. a therapy we have lot. very any obviously stress oral for do a do sense know popular you data the But that's And on rate topical, rebound really good antiviral? of rebound? I have

Jean-Pierre Sommadossi

Janet?

Janet Hammond

I Yes, think…

Jean-Pierre Sommadossi

Yes. Yes.

Janet Hammond

I of here Tim, research And I has the think rates perplexing be who I patients therapies you're probably One quite relapse. also variable. it's think same am. not to The still. also Yes. seem perceiving experienced honestly, that reading

to experience one somewhat or experiencing relapsed the that difficult written to certain divergent. seem of the is anecdotal So in literate and rebound people think also has be I it's what be and

So no, good have I don't idea yet. a

Tim Lugo

Understood. you. Thank

Operator

I will your up Nik, from while of Our open Nik stand Nik? line SVB next please come Securities. by the question line. with Gasic

Nik Gasic

This taking Nik Hi. on Gasic Securities. Thanks Ruiz, for for SVB questions. is Roanna our

when do for to these the results? are analysis? to program, Phase the new X COVID-XX primary planning the just so, you you both feature endpoint And share and secondary expect interim I data First if was in off, curious,

Jean-Pierre Sommadossi

Janet?

Janet Hammond

that primary answer whether second today. I think data have year. don't can't And interim both that we're discussed so analysis next from to we've anticipating I we're going results the the in of from we'll secondary So and half showcase endpoints,

Nik Gasic

stratify patients the planning to Got results COVID-XX status? individual And then on it. or one Janet. program. based Are follow-up you on Thanks,

Jean-Pierre Sommadossi

Janet?

Janet Hammond

individual patients? based on I’m what is sorry,

Nik Gasic

status? Dose

Janet Hammond

the going We're serious anything. And I based testaments No. think to stratify a little while get. not take will to on

that. not will we doing no, So be

Nik Gasic

you Got clinical of And on some the higher ongoing of XXX in for, don't two helpful. very safety you're of the signals adverse related Are trials? any if questions at mind. there That's it. particular, dengue, events then or couple for maybe a GI watching doses

Jean-Pierre Sommadossi

Janet…?

Janet Hammond

that The there clinical our believe selected safe XXX we group dose GI for of And don't the a we well trials with dose Sure. tolerated. is selected. will be that and signal no, to

Nik Gasic

lastly, broader All how right. And the for maybe this space? guess, helpful. XXX of That's could what very availability the might, I development have in And the impact guess, this future? therapeutics Takeda's new vaccine, landscape I for implications new in of

Jean-Pierre Sommadossi

do or John? you address Janet, to want

Janet Hammond

to and I like So start take might John, then perhaps over. can you

I So some to actions. is led of vaccine Avastin, the severe heels on adversary following that unfortunately think the which

I the was vaccine so there, initially, about And think that's uptakes. concerns

live a in shorter-term think for areas. the And people which and need don't prevention. I unmet problem largely I children but think makes areas, dengue people intended really, the the people. sense, for large unfortunately for the treatment be certainly, may of leaves that around is endemic a dengue is of vaccine with areas starting population many and needing who durability or And potentially lot for dengue I a think is endemic who I secondly, live visiting think, in question something endemic

John, hand the over to I'll think actually for drive it may to need I you. people awareness aware being the of therapy. vaccine So more the

John Vavricka

Yes.

I So was said. a lot think

a we there the because they durability there. specifically fact down. have that years, the it is areas, could the come three vaccine welcome there's in been vaccine starting at But looking So after created obviously, endemic is nothing to

particularly going with many might experience vaccine what areas those the disappointment be those and where with reluctant a for by uptake to see the saw interesting the We travelers' like But United of get others. to a more lot are countries A. countries, the of with Hepatitis if is of they particularly at it's the travel. Given be serious the market there. We travelers' a it vaccine, Sanofi past in before look to States, travelers wealthier as saw market, it you in

prophylactic prophylaxis So preferred travel forth, for to schedule. of to military be then, -- is even course, maybe and oral And would going where so the there. the really not be able you're and with of

Jean-Pierre Sommadossi

John?

John Vavricka

Can you me? Yes. hear

Jean-Pierre Sommadossi

Yes. Yes.

John Vavricka

me? hear you Can Yes.

Jean-Pierre Sommadossi

Yes. Go ahead.

John Vavricka

Yes, yes.

-- a just and for So prophylactic be would that vaccination I and was saying oral for particularly preferred dengue travels-related getting the market than fever.

Nik Gasic

all. Thanks Very Got it. helpful.

Operator

[Operator there like Mr. Sommadossi for no are closing call turn questions, JP? to over the If JP back further would I his Instructions] comments. to

Jean-Pierre Sommadossi

Thank Thank you again us for joining today. you.

Operator

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

You now disconnect. may

Atea Pharmaceuticals (AVIR) 8 Nov 222022 Q3 Earnings call transcript