AVIR - Earnings call transcript Q3 2024 | Atea Pharmaceuticals, Inc.

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Operator

Good afternoon, everyone, and welcome to the Atea Pharmaceuticals Third 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 Atea Pharmaceuticals. Ms. Barnes, please proceed.

Jonae Barnes

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

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

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

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

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

Jean-Pierre Sommadossi

us. the begin on everyone, afternoon, thank Thank and our executed in observed course not September, we it the not of to has COVID-XX busy antivirals demonstrate disease. programs quite particular to and has disease, a hospitalization clinical as global deaths. you, team SUNRISE-X. been Jonae, are was Therefore, respiratory disease, prior including good for. did impact on and year in on is turn time we as hospitalization and to you we large variants reported evolving, know, Unfortunately, the constantly contrast It a you I X for for significant has on in up fewer history budget. the natural difficult pneumonia, for due resulted desired on and in X. importance direct-acting studies, have our add SUNRISE-X it milder toward outcome as joining which severe will the Slide and so Of far,

our investigators. team and study trial this the the participants of rigorous execution proud and we am I of thank

now our report efforts line our and and initiating Phase results with an end we II track Our study III December. program anticipate meeting next early on shortly HCV on the global concentrated remain thereafter. We holding Phase program. top II are in Phase early of to FDA then from the year

HCV and need the U.S. was For rate someone innovative of cases comorbidities. particularly career, and in in for disorder today's be million therapies with estimated million most and drug patients approximately high to substance my abuse for who infections new underscore where the XX% X those wanting of of between globally unrelenting HCV the U.S., X for for accounts new about are XX% people with infected Injection HCV. use HCV the for actually

profile with of has HCV as in challenges treatment. diagnosis and the unmet that role treatment the our best-in-class to U.S. its treatment with We Annually, current play U.S. rates combination less believe received a major and the X/X the in timely diagnosis of eradication those in than potential to HCV ability address the outpaced needs

is our continue evaluating early-stage differentiated targeting make which protease also second-generation highly to inhibitor, respiratory with RNA We progress discovery program, a virus.

Phase cash, and anticipate XX, III execute we of of to as in our cash and program, HCV Phase extend HCV our equivalents strong and a September Importantly, with financial we program, marketable II, are runway XXXX. $XXX.X to well our securities position million into complete

the Phase patients. HCV to today's the readiness Janet? to for Janet turn III our With will HCV profile now that, over I and the program call review to

Janet Hammond

Thanks, Jean-Pierre.

value and HCV coupled profile all based bemnifosbuvir regulatory potential long runway. proposition. ready in Slide generated . Furthermore, and that our combination, a compelling on ruzasvir IP already global a and pathway. substantial that the program derisked on believe This a to program X. with III is best-in-class has with a Phase well-characterized and We clinical with Turning preclinical is data our

activities program. initiate to our Let's review global underway the III Phase

For dose tablet for III the manufacturing, our X durable is program. Phase ready

pathway Our and processes manufacturing There API have a and are already for clear production. optimized, is commercial been prepared we scale HCV. regulatory with

clinical to Phase excited study, Phase year. planning next program. compass conduct studies II to early of with year sites III with early an participate next work from and and program have X our are III an our meeting finalize the global trial prepared Leveraging II are in Phase relationships we end FDA to global and the our We Phase active starting II expect already existing Phase

Labs Additionally, of in already our ahead research engaged and organization start-up Central contract III initiation. Phase the are activities

patent which Finally, XXXX, provides our branded also coverage The a runway stable copy protection IP least XXXX. including and pricing the foreseeable treatments, authorized a until intellectual at patent market. long future should property HCV in and Mavyret broad to global with long protection its the allow have Epclusa, for

HCV-infected since profile On the Slide of direct-acting shifted X, today's patients of has introduction the antivirals.

they have and length at their adherent other XXXX medications disorders. poorly have including been for younger, are HCV patients frequently XX in of Now to is health progression been risk patients trending the patients to of infection HCV patients infections being HCV due The are infected the use for and younger substance disorders in HCV the who highest years many cirrhosis XX cirrhotic. XX mental with age have about This to than or takes are XX% between infected drugs since predominating time less not from U.S. the extended years patients abuse to yet. because opioid normally of group majority an

proportion proton including pump current of or the take multiple addition, and a high oral medications concomitant In medications from contraceptive inhibitor. stations patients HIV

that combination needs. patients potential It beneficial. target also address antiviral For patient a food the is could combination the patients secured. believe these a direct-acting successfully number of duration of risk treat interactions, unmet We no with our may this effect, low with to treatment drug the a more profile, profile and combined short clearly expand has of

John to opportunity over review the to call market the HCV. antiviral hand now John? I'll for

John Vavricka

Thank you, Janet.

X. Today's patient and that and XX% suggests improved Slide very Epclusa prescribers research requires not profile. satisfied number, an and challenges a market of are Vigorous to current options. Mavyret approximately profile new large presents Turning treatment with drug

is chaotic adherence these treatment drugs to adherence a Patients circumstances. into often treatment get who to First, challenge. medical and due unable maintain care life are

with XX% that In therapy. patients professionals ideal full reported of a therapy efficacy failed healthcare short length therapy. HCV fact, have course of high complete to a provide should And of

direct-acting of medications for concomitant on therapy analysis medical are initiated patients patients a drug often interaction take to of conditions Secondly, antiviral longitudinal therapy showed HCV without patients ideally other HCV and XX% allow risk. medications who should

hampered drug-drug it long long may these to challenges. profile, on convenience. its without -- an issue. use consider Epclusa Mavyret taking food averred with patients needs food with be or has medications of And and but these should food. drugs Epclusa nor administered taking not a In with with all therapy by requirements which limits be short a therapy treatment who therapy therapy, its HCV a be particular, food. ideal dependent duration duration challenging. interactions is Finally, of has address An Neither

Inclusion and but market to it treated, recognized States. with in continue based HCV new The Slide of market the $X number eliminating $X.X care U.S. living to The patients United grew towards X sales continues hinder U.S. crisis outlines key the Mavyret challenges health of market HCV, in remain current XXXX approximately the the million be expected HCV $X progress XXXX to HCV the the of stable. commercial roughly X with in market with is large, remain on globally. million billion. shares the options, net treatment X% demand HCV versus between

year. of future to believe by we U.S. has the potential disease. viral with each initiatives the certain best-in-class constraints with share. stable and this We U.S. number continues payers be to profile, access increase combined half XXXX, of approximately XXX,XXX the the pool the market note expand chronic severe removal seen is have other a from slight of cured new in to with first replenished patient patients And Also barriers, the and interesting government cases for pricing

now II our With of turn the over call review Arantxa Phase a that, study. for will global HCV I to

Maria Horga

of On would of we XXX leading with X which to our weeks. milligrams of XXX like II once of patients. is you X remind This trial, in the open-label treatment-naive Thank outline single-arm of you, ruzasvir cohort XX, enrolled for nearing XXX non-cirrhotic study the Phase Slide including patients daily milligrams combination John. of II completion Phase bemnifosbuvir

to forward reporting December. line looking are the early results in We top

the response confirmed per the measured primary at SVRXX reviews drug for post treatment efficacy the by population trial. study reporting adherent is or in treatment adequate count XX analysis exposures. XX Phase and sustained of the analysis by we weeks efficacy be pill study biological The II population Slide the of as protocol will

per at includes in regardless population A were secondary population treatment efficacy of as is the This analysis and will assess adherent. in the protocol whether the efficacy-evaluable analysis treatment referred not patients they the also to or year-end. SVRXX

populations. report will both data in We

Turning presented the of to Slide XX. leading patients. from cohort At we [indiscernible], data XX

short with SVRXX of We very with which X-week pleased are these high treatment. duration rate results. of XX% a a show

the to X due drug The not as of new lack adherence drug by as only this inadequate viral the to with relapse was confirmed in adherence post-treatment failure patients resistance of treatment viral Importantly, and population. by or of failure challenge relapse the due patient viral mutations. demonstrated illustrate levels

XX. to cohort. Moving patient of from the on-treatment kinetics the data shows leading slide This Slide bio individual

of patients week of first or patients viral was week Therefore, By As leading kinetics of see, cohort a near you a had there the can load regardless rapid all the on all treatment, support load limit this across week regimen. [indiscernible] within lower below and in rapid all the XX baseline genotypes genotype. quantification. viremia in X viral reduction

with events in XX and was XX. drug-related adverse treatment treatment events leading mature treatment parameters. patients combination well the or discontinuation. or of completed the X-week In safety were safe and bemnifosbuvir observed summary, severe period, generally Slide all the Similarly, no there no adverse laboratory tolerated cohort trends in ruzasvir

at resistance which X next data Meeting for data I mention the beefs cohort on safety XXXX, also like ASLD to would and leading II additional that poster and include the study. there delivered modeling Phase week, are from presentations

of be model profile its Pharmacometrics November College pharmacokinetic an simultaneously bemnifosbuvir integrated metabolites. at to addition, characterize Conference the developed XX. the pharmacokinetic was of on will population In American This data presented and

turn Atea's now will to Andrea over financials. the I discuss to call

Andrea Corcoran

Thank you, Arantxa.

containing expenses for the mentioned, are in the related XX XXXX. spending The sheet issued XXXX trial. and a quarter Joane results driven to we year period. decrease XXXX of R&D clinical decreased compared XXXX lower HCV by the our This net by was II higher offset primarily COVID-XX XXXX, operations to on prior spending balance and Phase earlier of In financial of statement quarter third press As today, XX. release third our Slides

decrease corresponding For G&A a period compared XXXX. in quarter result the of This in lower fees quarter decrease expenses, there XXXX. to was the the the in of third professional incurring primarily current was

compared Interest to due investment income quarter balances. prior the the year for to XXXX lower decreased period

was the Jean-Pierre XXXX. I'll third we balance study million. project for now cash II For Phase HCV call end the securities Phase the of runway XXXX, the cash, spend well our remainder discipline, HCV quarter our and back we start-up anticipated financial program. with principally our XXXX, to expect remarks. into of guidance Continuing cash will strong and completion marketable our of closing equivalent $XXX.X hand At global of the be III associated the related R&D to activities

Jean-Pierre Sommadossi

Thank you, Andrea.

we II early Phase as eagerly expected line our are from the We HCV study, mentioned, in which, awaiting top December. have results is

for of unmet a interaction. risk and attributes and class combination So treatments our believe from current compelling that about address profile as convenience, low medical the needs by combines ruzasvir present HCV combination today's shelf ductile a is HCV has differentiated significant sum and now. of of We drug to potential most highly duration bemnifosbuvir patients. the opportunity such The just month that

We Phase to initiating program forward next are development looking year. III our early

like call the opening I to Atea employees. questions, your thank our dedicated would to Before talented and

a drives for antiviral pursuit advancing diseases. patients worldwide valve of excellence therapeutics affected Our team dedication our to with by relentless

to over operator. With that, back the will turn I the call

Operator

comes the Eric from Instructions]And first your line [Operator Joseph. question of

Unknown Analyst

Eric. This on for is Paul

active about into you meeting trial additionally, HCV an how clarity you Phase of thinking the And on context obstacles the are with comparator. FDA? are the of any seeking particularly going parameters remaining First, design, in your III what adherence the and use

Jean-Pierre Sommadossi

you Arantxa, to . questions. address want X those

Maria Horga

the question. you for Thank Yes.

So to answer one. first the

issue the We then do that control. against to planning randomized of address then in control and a trials, you address will, are can and opinion, the you'll because adherence population our have the

much Phase aligned really In going terms meeting then is submitting plan, are submitting with what FDA, of aligned they and plan a designs, we're to a these very data and development that the the which we are with requiring. be the the III guidelines with are development proposing FDA

not be very but I'm say, least our are [indiscernible] that will generally we FDA So confident at acceptable. think at I the that plan will

Operator

comes question line of Umer next the Your from Raffat.

Unknown Analyst

on [indiscernible] Umer. profile for its of the comparable fixed I you component, mentioned drug PK especially But guess administered change for individually exposure to drug. in is any drug dose first each This the half one, combination you've have in life? is seen

Jean-Pierre Sommadossi

not. No, absolutely

We such -- drugs, . drugs. individual shown have on the and of and both see think any we both of parameters side I very pleased don't exposure and PK the our we on we both are have difference, profile life drug profile with as on

Unknown Analyst

XXX-milligram to be be size X ex and same ruzasvir? I've want site in also most like upon U.S. same I the Phase II III like only also U.S. there's to BEM sites. design. the -- Phase the And going Okay. Phase seen it will of XXX-milligram the dose, III for Is touch

Jean-Pierre Sommadossi

Arantxa?

Maria Horga

We're lot more a we're I X sites, going in But Phase U.S. no, was of because have U.S. to III, than in a also I. have what Phase ex of sites to have we lot We lot to time open U.S. sites I in got a going and one. Phase only

dose, of up to is dose, the have but help that, burden, going us going pill And be [indiscernible] same to that we're yes, we combination. . the fixed beauty and think dose In it the of terms decreases that that's a to obviously it's now going the

Jean-Pierre Sommadossi

can we right? I XXX think U.S., in Arantxa, we more have the Arantxa, we sites than anticipate... mention, Well, just

Maria Horga

States. interest we're sites United in But ex also getting the especially and that Yes, response and of them. some the very of the we're from from you we in still very, tell can in but what . I investigators United a U.S., sites strong is have States lot

Operator

Your of from Hsieh. comes next line question the Andy

Tsan-Yu Hsieh

aspiration. Great. Maybe the X on Phase kind III of

gauge if the perhaps numerical you're a I'm control to noninferiority SVRXX benefit curious temperature that Just superiority on your just active perspective? . given with Just shooting from front? the or trying for

Jean-Pierre Sommadossi

to want Arantxa? that you Do address

Maria Horga

Yes.

test the and trial So endpoint. noninferiority powered always for a allow superiority the primary we for within be will second

. for and are may inferiority So powering we superiority. we make a

Jean-Pierre Sommadossi

ahead. go sorry. Yes, . I'm

Tsan-Yu Hsieh

I'm have ahead. Go sorry, question. second I the

Jean-Pierre Sommadossi

X% rule Andy, as higher that know, has we anticipate any noninferiority. you that XX% for anticipate is than the drug efficacy. a We

database. for that of than based size think more need And with we the have patients patients. on we the so number a XX% power that of basically safety XXX a We about

end what be confident II see we resemble we'll Phase So of the FDA feedback as we should aligned. the meetings. that feel But

Tsan-Yu Hsieh

on that just cost Excellent. And how framework. the we've seen provide fruit, have you utilize other and types could market that question, basically right, maybe patients, just to a these contracts a identify potentially I'm this drugs much be of making low-hanging the would think previously commercial volume-based of very efficient. wondering just you'll kind how about pathway of entity segment

Jean-Pierre Sommadossi

. John?

John Vavricka

what for can comment particularly Medicaid. What it entities, of the for continues on And as utilization, question. gone single be now, pathways on as historically the government traditional I are to at and has regard. well there government pathways whether Medicare with Yes. be that many or Thank what in right payers you larger one the the least is

in individual been So the Medicaid don't would changing see stable it's that the relatively and situation. states And likely we pretty under the future. follow foreseeable

Tsan-Yu Hsieh

kind could less of the compared on framework? reps framework Would or it you comment having comparable? traditional in to be And sales be that it

John Vavricka

very set market these particular States net United billion can concentrated and after overall that It's these the What are you them. the in sales writers United of efficient magnitude these tell you States. like this assets at if the market of the to a is in to in prescribe I very $X.X look sales, with in go

Operator

our back for will concludes the to closing Q&A session. conference That I now turn Jean-Pierre over remarks.

Jean-Pierre Sommadossi

thank you . quarter continued earnings third joining all for thank support. for And our your you So call. XXXX conference

Operator

call. Thank today's that all gentlemen, joining. and for Ladies concludes you

may now You disconnect.

Atea Pharmaceuticals (AVIR) 7 Nov 242024 Q3 Earnings call transcript