ENTA - Earnings call transcript Q1 2022 | Enanta Pharmaceuticals, Inc.

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Operator

Good afternoon and welcome to the Enanta Pharmaceuticals Fiscal First Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session at the end of the prepared remarks. Please be advised that this call is being recorded. I would now like to turn the call over to Jennifer Viera, Investor Relations. ahead. go Please

Jennifer Viera

available and afternoon. operator quarter everyone joining and for financial Thank news thanks release this is afternoon this The was first our with us website. results you, issued to on our XXXX fiscal

Dr. call Officer and Financial Chief Luly, the members other of Paul On Management Jay our Team. Officer; Mellett, President are today Chief and Executive Enanta's Senior

statements. to include you our formal financial that of I'd with this CEO. involve SEC the to and development any call Luly, Before our remarks, statements, cause beyond in over from we Jay? risks XX-Q which update description to to and forward-looking we statements Form recent Dr. control assumptions certain respect may any Jay will we materially projections, with undertake risks our that during remind plans to most Enanta be expectations other results which research these periodic to and could making begin call. developments filed President differ and want forward-looking obligation actual now and the does our all like not our our those of turn and pipeline reports is and and with A made

Jay Luly

treatment B COVID-XX development come points which Enanta on SARS-CoV-X successful you programs building Jennifer, ongoing demonstrated for and inflection for HCV as on leading all and Today, proven C effective good impacting Mavyret, history in discovering as and component a clinical a diseases hepatitis Thank I important XXXX, you, virus. patient protease developing efforts has fiscal year. syncytial human strong progress for and to a by afternoon had of safe programs, providing in for quarter progress virus. our and I'll productive glecaprevir will RSV have our of our of everyone. a foundation broad treatment and inhibitor Enanta first viral metapneumovirus. in additionally of antiviral antiviral very we this and significant chronic population. oral the hepatitis respiratory update treatment comment discovery virus, made goal the

cause expanded recently for respiratory and by protease experience our discovered deep virology respiratory has programs, can this viruses, The our serious developing our treatment industry-leading detailing where therapeutics an disease, and by multiple small that RSV. build portfolio. makes in especially today, made significant. work we inhibitor and have molecule it the I virology expanding will a we to then We pipeline clear which in backdrop, SARS-CoV-X With start leveraged pandemic viruses for progress L-inhibitor for long coronavirus virology, continue

most has N-Protein Fast program and Phase is populations. X is studies our patient in which EDP-XXX, RSV inhibitor currently three advanced multiple designation Track in Our

a RSV announcement with we of in our the L-inhibitor Additionally, leadership RSV EDP-XXX. candidates continue our program in clinical

in As significant and XXXX. characterized RSV The are respiratory serious the the for vaccines a mortality. was immune and a the treatments children, first or virus, reminder, no is virus and available there morbidity severe compromised infection elderly, which disease associated cause with in can

of challenge we viral well the of excited where study, of Xa study human that was potential reduced inhibitor potent are on shown In only We it has effects which and decline. EDP-XXX, community-acquired in by not findings clinical population alleviation to an confirm load additional also to met score. symptom with load our Phase challenge adult in infection. on In infected of load demonstrated the RSV evaluate the safe a primary a this outside total is but data RSV EDP-XXX, and reduction robust and challenge also significant secondary symptoms information N-protein and endpoint key study provide of study, outpatient we order to the a of of endpoint conducted viral viral and us RSVP symptom a tolerated, EDP-XXX

Following uptick year, our to in an and enrollment there RSV social distancing to initial various Europe, was activity transmission, us target late last beyond XX a United of due which complete period world, in including patients. allowed measures, decreased States parts regions the of RSV of the of

on line from track are next RSVP We quarter. to top report data

hematopoietic development Phase RSV broad includes recipients efficacy clinical Our young program studies of evaluating children with and key in its infections. two EDP-XXX, X safety transplant and cell

is this clinical a These study at adult cell with named Data in these expected RSV. subsequent least study pivotal two patients initiated in XXXX. the trial population. trial doses X were after in which in studies will RSVP the confirm to into pediatric Phase be hematopoietic studies, transplant Phase RSVP studies Our recipients are RSV extend and used the Xb in from to RSVTx

RSV be as and monitoring updates, incidence of the all. we'll rates are providing We globally further

polymerase for different for across major This with required pleased quarter patient EDP-XXX RSV in potent subtypes, species. population. RSV plasma is that use absorption a good Preclinical RSV-A that data RSV and enzyme multiple is combination RSV-B expand or the introducing addressable EDP-XXX, other such EDP-XXX the we demonstrate across RSV agents a the broadened window RSV potentially envision multiple we EDP-XXX We by standalone and to treatment as and exposure footprint broaden viral the RSV treatment are nanomolar L-Protein, which to activities, announce contains our in targets potency replication. a L-inhibitor. or

development have expect in EDP-XXX year. X far in I'm to for development Phase the and of viruses. our program, by excited we of study allowing the work of RSV proud our of to I'm treatments in second half done of initiate broad us a thus the respiratory leadership potential the this We extend

once-daily coronavirus also first protease multiple the track we're as and without the for demonstrated specifically EDP-XXX is by activity a main potent XCL human, all oral of also In COVID-XX. excited potential known the this of a SARS-CoV-X best-in-class subjects designed studies, safety, determine tolerability, single compound. a preclinical to oral boosting in antiviral a the EDP-XXX regimen month. ascending EDP-XXX as protease of for dose-ranging healthy a ritonavir, dosing as highly the promise against in inhibitor, will our This dosing EDP-XXX, inhibitor, in of supporting need treatment needs agent begin EDP-XXX on such properties, and pharmacokinetics SARS-CoV-X, which to study on Turning participant. pharmacokinetic

EDP-XXX cellular human in models, of including potently SARS-CoV-X with Specifically, the epithelial multiple ECXX primary block nanomolar. cells airway replication XX an of

activity development development SARS-CoV-X has distribution for favorable shown key positions has infection, boosting for excellent potential. the including infect lung including may the activity dosing. after range potential next coronaviruses daily This human coronaviruses, in exposure and EDP-XXX pan-coronavirus vitro pan-genotypic the in the human giving antivirals, our enabling clinical stage target potential EDP-XXX Importantly, with also oral potent possibly for a EDP-XXX advance of EDP-XXX X SARS-CoV-X half ritonavir EDP-XXX the treatment against among future. without to that Delta, populations direct-acting in tissues model. circulating would shown in the once has convenient currently of potent study currently Phase other antiviral across in starting variants Omicron With we XXXX. the month, it of second and including data, Furthermore, potent this most supportive preclinical in a assuming administration

populations, and virus discovery of also elderly, hMPV, there human with We that pulmonary with RSV, ago nearly now are virus or who infection children, in underlying XX circulates adults to respiratory including years age are and program disease pursue a was vulnerable worldwide X. with universal a number by the continue first immune compromised. identified our those Like metapneumovirus

year. nearing nanomolar second in candidate completion half lead potent plan are this the and of of select of We optimization to inhibitors hMPV a clinical

transcriptase Those for consistently remain we internal mechanisms to high in combination remain as We B, have NUC-suppressed alone that of a has additional be a studies putting inhibitor core year, patients. inhibitor, on among opportunities NUC been Hepatitis and different functional daily and with then as you in refer our compounds chronic inhibitors cure a successful vision and viral develop clear with presented treatment developing ultimately HBV days with has activity significant committed of with demonstrating the to profile, HBV to those of who Moving regimen good a EDP-XXX, nucleoside dosing Phase over orally an external who currently populations. displays on in a of to development. whom evaluated clinical to safety pharmacokinetic EDP-XXX alternative for and two with we a refer core such patient supportive Track we antiviral core will HBV combination inhibitor believe chronic XX data patients. best that in combination deliver EDP-XXX focused with Last whom a the in EDP-XXX evidence as evaluating combination component once regimen. profile important Fast viremic as a we patients are our Xb load, designation to reverse EDP-XXX,

I'd our to milestones. moving up upcoming Before by wrap the to financials, reiterating like

dosing study this month. development report next data our catalysts, study results, to multiple EDP-XXX We our Phase If by the EDP-XXX top We Phase the of line advance oral this expect of X second to plan start treatment next the to for EDP-XXX supported X in stage in year. plan of COVID quarter. including of inhibitor, XCL clinical half we of from the the RSVP protease of

Paul? to to of and clinical call that, and L-inhibitor stop discuss initiating a here a this study in half the nominating With Finally, look forward to the year. Paul X the metapneumovirus financials. we RSV second EDP-XXX, Phase our over human candidate I'll for turn

Paul Mellett

Jay. remind a everyone fiscal Today, like for to on reporting first September XXXX. XX, our I'd the you, results we fiscal reports Thank December are XXth schedule. year Enanta quarter-ended

total HCV of of for This sales and total revenue global For revenue on $XXX of compares XXXX. period quarter, product revenue same was million entirely $XX.X consisted of million a earned to the the AbbVie's $XX.X royalty million.

Royalty rate suppressed AbbVie's XX% patient AbbVie, sales Mavyret blended of at and on XX% sales. rate contractual royalty the sales compared now reported pre-COVID approximately a after total set-offs, calculated are for As VIEKIRA levels. volumes and which approximately at certain was a by discounts, of on product royalty HCV of treated for to X.X% rebates of XX% adjustments quarter reported XX% remain revenue of

a XXst are first therefore royalties at the ending And calculated lowest at calendar be our year. the will As for rate year. December March our on year our XX%, royalty calculated our for fiscal rate ending in a reminder, for XXst quarter highest basis, are our tier calculated fiscal royalty fiscal royalties quarter royalties

our for XX-K. global their calendar XXXX schedule in royalty Global our sales calendar in Form review to in $X.X Recently, HCV can billion and HCV guided reported AbbVie were XXXX. XXXX tier $X.X sales You billion

same and for period XXXX, programs. the manufacturing development diluted Enanta timing prior XXXX. XX, at compared of recorded to and loss virology expense. same press due tax loss our our and in for million in with the $XX.X back period the $X.X $X.XX XX, period XXXX, two This in questions. for Enanta state administrative in of Net common increase lines recorded The or clinical will in million months royalty to the for studies the which compared to three million in a an and in after cash, million of net taxable Moving the the on income be years. XXXX, primarily ended least benefit requirements million call to the anticipated the headcount of sufficient release our $X.X of was the ended Act loss XXXX. share $X.X expects its in in to months provision XXXX. cash does per XX, was to due expenses, corresponding than carry to million in ending compared September common our income XXXX. a back of XXXX. ended securities. of December for a not for $XXX.X XXXX per expense the $XX.X in $XX.X periods XX, $X.X the million related December in General expenses XXXX ended $X.XX apply increase benefit current laws income three that release to will CARES enabled loss operator for the minor the Operator? compensation of due same Enanta period totaled tax diluted to in Enanta to tax support in to XX-Q or December million share quarter a months tax prior-year marketable like the details income the development our larger tax the turn when cash filed. research company's financial for as for was securities offset to report up I'd equivalents, its benefit meet are of three increased quarter cash marketable available quarterly and the business on next well provisions to revenue be available to as open now This for Form existing a continuing and compared Further to us programs primarily reserve was the the years. and XXXX,

Operator

of first from Our I'm question Capital of the line Instructions] comes RBC RBC [Operator Markets. Brian Capital, sorry, Abrahams

Your is open. line

Brian Abrahams

what of this it you reveal like you Thanks thinking questions. I then the the just might initially study healthy your XXX. I'm sounds plans some Would course gauging, by, focus Thanks on ultimate sub-populations month, opportunity potency so how you what over space. who the you're thinking of couple success much for in for data, be with on? vitro very maybe start about progress able initially just to of with the on is other going taking safety how important of the and curious opportunity, the in which about in guess the overall be to of XXX, protease take is ritonavir, my competitive patients, for kind be. so on curious, inhibitors volunteer other boosted given might is a be much. latest packs PK And to wondering which may are focusing are track there drug not probability to on I'm I'm developments the

Jay Luly

Hi, Brian. Jay. Thanks, this is

the got hand, So once MAD begin, and harvest of in and SAD to and mechanism X yes, a it find the and about we'll data be healthy half in studies, to that the with put standard other -- then in appropriate to out. here plan first so as data we the all our we've is that Phase

the in describe Regarding in in, the few a but lots in I time. very necessarily only would one There of ultimately virals, test space, N-protease, are the other in the that as molecules early but as it -- quality field are the areas, first yet. of it's entrants it's we disease not stand high not

a standpoint, I you think So compete that standpoint, think tissue-targeting a longer positive advantages well a overall, and and some from again, built we've PK EDP-XXX one a we to is profile standpoint from timeframe. very the from the over strong

post-exposure patient study would Regarding course, healthy high the we beyond you. be trials into of X cetera all getting risk, prophylaxis standard tapping There risk, those anticipate we'll populations. is of Phase et opportunities. key Thank into and

Operator

Thank you.

Our JPMorgan. comes next question from of Eric Joseph

Your question please.

Unidentified Analyst

for questions. taking This on for is Hannah afternoon. Eric. Hi, good Thanks the

few a Just us. from

symptoms this thoughts in wanted season the just first, So on your and given the patients to how get season, versus compared they're RSV seasonal severity prior like of in loss margins.

other might Just pre-specified the on and severe wondering patients year if subgroup age there's any reason entering to should more thinking think at see there or also based Thank about How any age RSVP study. study, be any looks we we symptoms baselines median factors? during analysis the then this unblinded by risk you. in patient are

Jay Luly

in. So but Nathalie special chime Nathalie necessarily don't I, these, let prior let maybe ones, on anything but some think there's I'll comment about of RSV season versus again this I'll I

Nathalie Adda

you, Thank Jay.

I of observed obviously though completed, have monitor We, the the data, RSV and can access symptoms was our even of unblinded as themselves study question concern. infection before. think symptoms, worsening don't clinic we current study ongoing just any I your even So mean far to the have patients was we as worse that we present and than the we the in but about not

Unidentified Analyst

right. All

median at age current entering on have this time? data And so don't you any the study

Nathalie Adda

your I'm question, sure age? not what understood Sorry, I

Jay Luly

Median age.

Unidentified Analyst

Median age.

Nathalie Adda

Median age.

have I to so if of XX guess, We say from but I median would yet, would expect old being you you say know are line if of XX so XX. database something eligibility, age, it's to along would haven't I years we I look something the have criteria the at and logged the collecting, they don't the

Unidentified Analyst

trials assuming either describe be program would Okay. RSVP discussions you be a and would just adults -- toward based of with up what X And pivotal a to pediatric relative Phase like the wondering on would next these FDA. to specifically program, and in would population I'm transplant or success general in how trial, and like getting the factors could look look prioritized

Jay Luly

on to then populations they patient focus RSVP high-risk other going and post are into higher peds, that risk. and buckets, fall So adult mainly transplant, the populations three at we're

the So ongoing of that the of basic which three be now. be we've two patient those will we'll targeting, populations got

Operator

Thank you.

Our ahead. of comes Sandler. next go question Please Rahimi Piper from Yasmeen

Yasmeen Rahimi

Hi big how And done, then of I would the into the population or outpatient have thank the XXXX, team, you Are so try L-protein this population frequent is market population? the much is, me you into the the in Two patient regards prioritizing so update. you. how question you adult addressable be clients research is, population for which thanks lot the to to understand immunocompromised questions from market? is A what share going strategy that Inhibitor all a of answering for is just Enanta with questions. our like clinic for some half has my big So can the second peds are go you maybe RSVP would there, this. or it question entering second you to of the

Jay Luly

welcome. You're

not So Yasmeen, the where a challenge and instead is into otherwise markets great It's patient so from transplant again and registration patient RSVP and adult it's sort -- populations, critical address the but great the be in approval adults, otherwise population adult other risk pathway. populations to on main that looking addressed healthy adult our drug, RSVP higher it's high with a which focused -- be our to of would going peds, it's going one not presenting that's peds, route to be patient populations. on healthy just really course, it's had otherwise and study It's at probably that that to not trial RSV the the staging bridge is couldn't by we three the I risk mentioned. of after and the on healthy once the say that the called

the RSV, of we very way. L-protein, I just significant terms In out we're and see think in going -- a

therapeutics first could a certainly we or there. aren't of among there over hope the approved We been approved medical standpoint. you saw respiratory because unmet major any reasonable RSV human small out we As that viruses as working to we've the long timeframe we be in be know a and number pandemic, know, therapeutic before a a it from is just, need drugs on

So like and barrier, down usually think it's so an strengths high once effect. is We've we when potent, our great, we that, like I has up having dosing. are size doubling on situation a inhibitor it's XXX daily already strong demonstrated antiviral very

single is it should we interesting a another looking from There be as way perspective. target replication fine antiviral are also and other too direct-acting a So L-protein. agent. along the But mechanisms at very

population, two to viral window one and hitting to window population, exactly -- defined able infection. -- to that agent clock, in, that and the before drugs might So, for we harder, that you on patient and -- is obviously a perhaps we be would different widen in pursued these hard their mechanism the is could another together the There together putting put administered of based and these two harder the a a virus little would patient might might you maybe to agent different ways treat market might a Otherwise, what to infection. We position just it by advanced pursuing would and significantly. struggle you treatment it versus window increasing addressable we use very what you say is able doing, as longer any you're populations hitting could had you be postpone it mechanism have know so very patients therapy grow treatment it or whatever took infections, single all certain could which in be is explore, alone. them with that how opportunity of we single things be earlier or might bit ticking it multiple these patient could think anything about you maybe principally them and/or that in be severely that immune-compromised

clinic a So Again, N-protein molecule, just into successful potent, them be of that XXX we'll we'll strong PK. couple second looking EDP-XXX. we'll but and various it and a very you great very tools once tracking have exploit different other very in the there's evolve, you could have is ways, be half our looking in and a as pathway hopefully the that we using

Yasmeen Rahimi

had. you, Thank Jay ask follow-up a question may to if I you and the remarks

the come its populations. RSVP think lot question we more I how in understand of in, investors translation So do the study the take vulnerable a and from will

able to provide been RSVTx. you some study RSVP this have and clarity really So could how de-risk

Jay Luly

It's a step-wise de-risking.

for high when potent could the resistance one administered most with barrier events nice and X Phase healthy, very think exposures. to a of I EDP-XXX happened significant established deliver actually in safely really that drug could de-risking be a we molecule

RSV that's gave challenge so-called us know study that into infection well. going great it So first confidence our whereas incredibly performed you model,

was that had safety strain wasn't it them. setting, still say, are real kinetics that's But, good in and virus demonstrate them, so and viral was further it to the patient doing people a said, virus we're infection and a going world catching and that step real a population. of I de-risking that a under setting good volunteers been a in presenting to treater All but administered then that way to so very controlled should treat around we real world virus, that with real taking further natural patients,

along So it's investigations, hoped rarely evolution what an or have drug in you for to medicine to had yet able new think we establish that step do, that actually checkpoints de-risking it to and clinical doing in appears those such every that clinical explore and antiviral drug, be really put the another it is that be granted a setting to I of every it's do. as the fact in patient it population But again, the different think profile we I working slightly we'll we've is and well. bodes do potent

Operator

Thank you.

Securities. Our Please from Roy next Buchanan comes go ahead. of JMP question

Roy Buchanan

going maybe I sounds multiple be questions. it just X, trial for to what start so, X the after is is guess the going the one might like X, Xs addition those the this going taking you're Phase be month to Phase to the if treating the you a plan in to on that half guys be. year, Hey, start Phase run second patients curious next to and in great, of if EDP-XXX, thanks

Jay Luly

Well, I ancillary such you're kinds in mean what were development, always that other thinking DDI along doing studies of the studies. Is as way of? you

Roy Buchanan

Anything. Sure. Yes.

Jay Luly

Those main your types of your No, are dosing Phase those the and Once the for parameters exposure -- ones. those X. think are studies. what Yes. tolerability, I of you understand know have SAD/MAD, kind are you

So you you down -- slowing X-X. want don't don't to be want to that Phase

DDIs so, studies that but in you're doing down et other help cetera, in of population. the patient cetera. Those road parallel, will special And always et with terms there's

Roy Buchanan

maybe combination that? you Thanks. there NUC, out could the then you thinking into how I one Okay, on might had this are longer just I year. guess if maybe about, agents data XXX, more could I what speculate anything just with if something worth maybe partner some to you And guys like ideal with just compound, that exploring, great. curious what are the about on less be combos, And can us running a that guess, be mentioned the back there a clinic to some trial that about get

Jay Luly

say this profile under would we No. But I we've we have well two, to circumstance. et combination, Those that nice it year, terms well I of a are with won't likely good what about, et up observed it direct think a making the I saw safety answer good clinic is, done any question one-month drugs behavior we're together, XXX couldn't in to cetera, two-drug your the be study in very first say two with plays have is the combo. all the really on, focused NUC, playing effects, on good questions and be it antiviral We cetera.

want I a that long more was could for super do think and up really our you a core is your high it I time, lesser period it you out be now, kinds those I and that time. to just question, don't don't time, run what two-drug maybe enough data we be for know of the it's a back up the it one could KOLs to turns again to other so, just ingredient And pertains study, work it's ideal necessarily and combo thought after think patient on ones, lined studies but good that just waiting hopefully we sort next that be really mean, had that's to again, over as don't both reports hope an a pursuing something But before, sort know internally we foundation ingredient. of I that's we're I NUC a know have for externally NUC added. a launch to third and list, looking ideal think So not significant of longer will satellite of use -- be I great not then capital. of to probably me it and a

a our hopefully would such something fashion now in So third amount principal through those agent functional be is that should some in those studies could -- are and to great for add cure maybe to looking make someday, done again we get are a that interesting that focus more but reasonable right of a time.

Operator

you. Thank

Our of next from Capital. question ROTH comes Zegbeh Jallah

question Your please.

Zegbeh Jallah

for questions updates. helpful my and Good thanks afternoon, really taking

the mucus. is at think to mucus, about is the I study, primary additional symptom reduction you'll was and did nasal that being in I and But a be some you're a Phase the was looking be endpoint improvement to impressive some endpoint if patients for Xa nasal symptom RSV think Phase just for at you just how study one I likely the measures Xb that in important study? Xb symptom of and going a improvement Phase looking we endpoint, is first show secondary curious evaluated as that kind had being have few, you it

Jay Luly

Yes, so good question, Zegbeh.

have which yes, the and my said, study, endpoints to be it symptom going data study, was but was all path to mucus to you weight, very secondary was well. Phase the at look virology look That going and of Xa more in scoring encountered registration. actually turned one be the most in say stage you I can Challenge So to and will of a which think interesting, at I've out to curious trials as later score primary the kinds the quite actually symptom career be mirrored viral interesting the on but in is I the so-called we loads did important advance other endpoint things, you

in -- capacity to secretion number a do And thing the inpatients so, patients to these It to will domicile, setting, in the the studying, In of observed score. -- that in overall, an that they mucus one be practical, it's that's right. and were it's will challenge and just clean collect was symptoms there very the outpatient different that add the weigh that are easy just not because up excess them. overall all were

onward, others from So of to RSVP look But a plenty one. we'll have that's tough at.

Zegbeh Jallah

RSVP I'm gain then, no know treatment the it's about you really lot, the just of is period additional of the MOA wondering based treating long an benefits period use And Thanks. I curious same, five-day just a for treatment this sure study. kind you but inhibitor, get the the be the in from likely longer? prior study, that could enough on that but we're one or

Jay Luly

think know doing RSVP, challenge the adequate, in I find this really population will should in that first mean that the in get Well, study, patient setting, you the without -- it that close think that for confident XX be setting -- we did that to immune dosing but guess we be when that's study. we substantially what transplant immune could are never mirror should -- hematopoietic you and highly cell system helping recipients the full have I days who we individuals, fact RSVTX, them, the suppressed answer transplant these in don't are the into year in longer compromised

convenient overall. is try that So the to there make going have that's can certain to where you product generally may you the the longer, the attractive. dose patient to find speaking, is be but or have is compliance want and goal to populations, you're shorter the And regimen, -- able ultimately profile a quite better that, and latitude the dosing to be higher to adequate pockets

Zegbeh Jallah

which N I being it. do combo for start thinking with and billion you L should I revenues then the came projections, how two the last both and about on-board Mavyret has about Got just but one to modestly do and just the wondering about we into question just think I same cadence said to of you is how that the And to related a follow burden at years. was was here be than going them then revenues, to beginning N-inhibitor I'm partly the the the were so L, regarding the if what runway patients with or guided at $X the Paul, billion you strategy, beyond thinking with yes, XXXX XXXX the and next then to your and factored for billion also lower $X.X combo it do in I of of that, in AbbVie the was here in time. for at guided $X.X a squeeze just you XXXX they've of cautious year, Was think came at a revenues that so and and

Paul Mellett

Well, to regarding all up -- pandemic after XXXX, really it's happens situation. the it's what COVID

unknown with so to AbbVie the year that to $X.X XXXX correct guess -- calendar impact, has up for for a is be be fiscal COVID on from going 'XX to I relief AbbVie fiscal guided upon royalties two-year with say fiscal expecting HCV And obviously what balances, gave G&A no based our our You're after and for we suppression guidance variance, would and existing on at follow there XXXX guidance cash again at that it's next for was this the R&D they're year. happens our Omicron, in really flat going is billion, the I cash time. a point

and at a we've look we that rate whole comfortable cash. So got that two-year we run on least feel picture at

Jay Luly

at question, And the we to drugs together time. add we answer other would if combination your study, Zegbeh, same doing the were a

Operator

you. Thank

next from comes Jay question Our of Olson Oppenheimer.

is open. line Your

Jay Olson

Thank the update on progress. and you for the congrats

support about with it been COVID. combining combination using you would approach Merck's if consider And I has together billion Is foreseeable XXXX could I royalties if of ask that level you assuming other the in then drugs for consider continue a which would that there of to Enanta's in Mavyret sales that $X.X financial AbbVie's a EDP-XXX so would with guidance that operating discussion could with? think anti-virals question, and indicates support to some Molnupiravir a stabilizing, something expenses treat is future?

Jay Luly

built where period on based for I and came now that's guidance see guiding cash $X.X in the the least as the what's into we for propelling that pretty on our they think as do model they're forecasts, their Paul two-year, anticipated just outlined revenue. and at that two-year the year sort cash based of much, billion we current runway that is royalty and

right to combos, need norm, like question about RSV COVID what five-day is we your sort acute an can see study. there you already indication viral appear we is our antiviral potent be going have no antivirals are infection, we treatments of with after It that much the established in that drugs that combos. now Regarding from had

there say combinations need we're but valuable having So need more road, road nonetheless, that rather be a the could we I that can the the see down fewer thing. anticipating don't would for than that but yet, be mechanisms down

and we just on protease we're when time. other different to in-house pandemic multiple we're agents here hoping So started mechanisms started, other and the working of programs over harvest not

don't establish. what time to So stay sure at be your to see I'm this any the direct not tuned those question, event, front. in be you'd studies, need on to combination doing that I trying But

Operator

you. Thank

from Our comes next of Brian question Baird. ahead. Skorney go Please

Luke Herrmann

the seems RSVP as it pivotal readout pivotal positively, would expect look yourself? serve and indications can to RSVTx what forward then think path. thinking that for choose about higher-risk development a program questions, taking you it RSV This is might And my you're the to Brian. you from strategy leaning you. question. studies RSV towards Thanks RSVP like earlier registrational do on situation the move for a Thank initial In and Luke populations like for otherwise, those for we Herrmann

Jay Luly

Yes.

once program like studies. expecting that currently So path Is that inform are of necessarily have we'll we again, for that you the development you two But at discussion we'll on to those time, looks RSVP, not that registration that information data the have could the think registration. the studies know helpful? and how I of with agency this future are have the course

Luke Herrmann

Thank you. Yes.

Jay Luly

did Yes. have I'm sorry, you another question?

Luke Herrmann

It was could just other, weren't if development what you all? pivotal those like, speculate those -- at would registrational, look if if

Jay Luly

Yes, to risk, path to high FDA, want think expedient I what focus on the I they approval, I EMA, to that's and need both as so I think think FDA I do. the think mean we

Operator

Thank you.

question from next Leerink. Our comes SVB Roanna of Ruiz

Your open. line is

Roanna Ruiz

Great. Thanks.

pool might thoughts or So ritonavir you possibly I XXX, back do the interactions antiviral circle total maybe to take percentage out of so an patients, wanted that? have antivirals really to to boosting, like COVID patient fully unable of on for any what that asset, to for things your due drug-drug be has eligible

Jay Luly

of influenced there hard a it's get -- what exact on very is that by the that -- think substantial the to say more maybe that amount your is dosing. number Yes, of but I question, Pfizer is hands now, I that's a will ritonavir is pharmacopoeia

need impact for people in what down instances elevate do certain to So are understand would drugs of potential to have, them to you understand exposure dose to meds to concomitant reduce dial patients what dose other other that. medicines, can on meds, take you do you need adjust, other some compensate need need ritonavir off just ritonavir or and you

patients things set I So a safely sure and need able question to set physicians you up to plan is medicated. then that -- attack to concomitant of the meds, patient's up will make everyone think on to need on be need whatever it's time there and that to going would is any understand you explain different and a that understand just to

issue is sidestep that Our hope just entirely. to

Roanna Ruiz

pull quick And one studies kind the you you further you additional I make a Makes to what pediatric if curious Yes. RSV tracking programs, there those strategies? for strategies transplant and in any that to want was enrollment X are apply to accelerate can your other decision, those and patients, you help for are sense. that levers of trials then Phase or of

Jay Luly

Yes.

in is terms new strategies at looking the catchment trial the you cetera. et sites improve your we're do et of time, So cetera, other all thing

draws, the the of in other adapt one for enrollment. compromised take then of I they and by just having the needed COVID because trial extensive people, think trial. it it's cautious a the and Like how other that to because extensive we to most of a kinds all and appropriate for fence the blood recipients it bit among terms for raises advantage to of protocols to enrollment, like to not going so be convenient in sites the pandemic spots make just be right, are with not slow just the harvesting immune wrong they're things probably -- transplant have when parents for -- that during in it's incredibly or and to other just things, bit of down enhance might the the barriers, of as had post-transplant we're word, there we ready of things special little know just make the coming on while pandemic, but suppressed, little things and with the friendly, a a during people RSVP you maybe you was put to, peds friendly question participating pandemic, careful but challenges are opened have up

to So we any tricks, know the is trying jeopardizing I way in of we're enrollment just that course. don't study can which there without special always optimize

Operator

from [Operator of Instructions] Our ISI. next question Liisa Bayko Evercore comes

is Your open. line

Liisa Bayko

for thanks question. Hi, taking my

the do of program, be you RSV with your COVID before or quickly get all Phase COVID program come that's how X? Phase data up Phase looks X/X Just and think you the would sense, like the after, in X able to and wanted a wrapping the data into for have kind then second you quarter, go to from prepared

Jay Luly

Yes.

really, et soon the study So to they're going to have get which cohorts -- haven't we into guess first, upon I then Phase cetera, can't cetera, get I making as it's supply sites other we can't speak we're dosing be get first, we'll -- the I that X, to et we Phase and and which how come obviously begin XXX we'll speak the drug many to and they're say depending sure probably to cetera various progressed, really so X that safe doses are data exactly et today. would steps, into question, but one's for quickly can, up. both X, et QX, preparing your And as lined cetera, after

doing it be we'll tuned stay so And so front. half, as as in second starting that possible and on the quickly

Liisa Bayko

around you're in your wrapped all kind part have you looking to pipeline, assumption I million, at something, where make -- that in do math in the the of up lot your studies you sorry with million of $XXX came million feel in because I'm your on $XXX probably in at but know given to million, is and -- Okay. like these the work we guiding going maybe a how R&D, year, $XX couple And guidance fourth like is just this $XXX quarter, first a there up of things wrapping the going on, I quarter, a

Jay Luly

Sure.

rest associated I still the so think some cetera, and is obviously Now, cost what we're to aiming do intact the the through there encompasses and et wind-down programs. with year, but these the plan of various carried is et cetera, be for with of forth they won't studies, NASH

Liisa Bayko

study, I one and challenge had of word, it as is looking whatever recall, as challenge if talked my you And loads, it viral is or out right that similar like, just of but you that can of seems of be how was RSVP. was more kind -- study, I what from divergent representative came you because studies. looked to attention right higher just I don't know to of how RSV Okay. the you down kind different two across one questions the compared because going challenge then strains the now, yours because for like there, virulent the about or on The in the strains strain pretty virus used the or one other at around the

So, the challenge you it you were had a serious -- virus using for looked that study like pretty

Jay Luly

people cement strains terms challenge inoculation. to sorry I'm virus to but in used waited dose, I of certain dose load number to not threshold, I viral a interrupt studies, it differ, once a -- days been post a a Liisa, think, And certain think it's reached to that when may and multiple little you bit standard the to elected the Yes. yes, has sorry in of know, used had we

got people load, that and twice start we So the study checked RT-PCR, up viral and if waited waited they started for waited in people viral we up with we inoculated I then climb challenge day to about virus, a by for to the the dosing. until three loads recall to logs

sooner than be dose you with that, if obviously, So load. you'll dosing viral a lower

probably that's the variable there. So

did cetera. why virus it's the might be seasons, strains, a different looking a have you think slightly we possibly think -- tried get in subtypes so drug this. might the into strains a lot various ultimately that's be by among do performed virus but need at, the different, in patients isolates things and prior et along we on right. variable, tested on but and fence will and we from we fence et cetera, as this drug have different the real weren't that's is lab against dispersed embarking run ultimately And to very is the our you to from geographically it real We using samples de-risking I -- we uniformly cetera. need to RSV-A, against just out we've Real going got I et the them you much output, world, world But different things, you way. doing clinical well clinical to study, you're in world, and before the as RSVP real infection might of that a work and RSV-B, where could but

Liisa Bayko

a just final then And me. Okay. question from

days it's logs symptoms started and that's think trying what when three around does to it trials, symptoms of dosed dosing feeling graph, -- stuff? and and how of logs three are is to lot not symptoms, here, at -- you you your start Day-X, loads, makes of Day-X kind does on the it of I two mentioned of window so dosing. of that you you a your kind started sorry, How like present, does relate that onset that that how of patients symptoms to within people because from sense, to I opportunity, you viral know be we're has out So, so like among see I have, but on figure relate

Jay Luly

looking three what talking website, challenge Well, symptom. this in sites challenge if by logs time, you're the you at, least to were people were were corporate got the about, study, on express they if symptoms it's and by logs, our look but is people starting at the time you the deck a our the we've these one also in trial, study, we're it's at three and probably

symptomatic, specific could want to lie, the the able doing, could study real for more of so right. to in the now that got experience if can sort work. We RSV, catch the did one and the want of appears in among XX people -- patient sorting ultimately in then because said, study is just I drug It -- or office to for a the beginning onset studies. XX-hour within it's hours or don't XX the flu make that case. it's dosing very for requirement in maybe can up if languish to say hours indeed you've get make don't into is people a longer, you into symptoms you say to that But little catch the let's work, you put didn't that trial, setting like forgivable want patients you you there just what go real the well, the first flu, We've then to regards pick what of basis COVID, window world bit we hours longer. is than dose becoming flu X-day we don't be have catch your was flu, translate and study with was a to should we're that You're sure might period we RSV they just window, reasonably so do going of make come we symptoms, was within RSVP in at the Nobody expect And in you the community just possibly a a much in within will they maybe does is want a the development a drug what RSVP, that XX parts earliest That's various hours of window. that constraint were And the for of guess you RSVP into to symptom so and starting things the COVID, hours. were if XX XX on to always tight know what to before probably RSV necessarily where life. assume real-world and to be get to obviously out treatment of phone is fact wrong it's window that that it doctor's where to right. your we these there, We're we the the they window are now just forgiving patients in? not that's

reason XX is, than you hours. do I and than So it that's XX shorter saw think go practically can't where to it hours no we necessarily longer

think I it's a spot. good So sweet

Operator

to call At I'd any Ma'am? closing the Viera for Jennifer this you. time, over remarks. to Thank back like turn

Jennifer Viera

to everyone for us you Thank today. joining

a or additional email us a questions, at office. free feel have the by contact give you Bye-bye. call us Thanks so If good reach out night. Have and to much.

Operator

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

now disconnect. may You

Enanta Pharmaceuticals (ENTA) 9 Feb 222022 Q1 Earnings call transcript