- Earnings call transcript Q4 2022

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good afternoon, and welcome to Enanta Pharmaceuticals Fiscal Fourth Quarter and Full Year Ended September 30, 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’d now like to hand the call over to Jennifer Viera, Investor Relations. ahead. go Please

Jennifer Viera

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

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

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

Jay Luly

and expertise compounds afternoon, that be Thank in you, can preclinical medicines. Jennifer, we to our Enanta, new discover good into medicinal everyone. and are leveraging At sciences chemistry, virology developed groundbreaking

not dose more has enrolling this believe on pool and protease, clinical patients into RSV Today, we larger on risk placebo-controlled B. of been clinical and overall similar collect selection daily initiation be with developing five hepatitis of secondary across our multiple once-daily to include COVID-XX progress our placebo food execute will at are recent thereafter. I not detailing for Starting advancement as or our with subsequent orally of the In as the our XXXX With double-blind, human of progress advances well five in of days X start have last measures with inhibitor or Patients and enrollment. and for the a objective increased protease study with inhibitors, XX severe was quarter, will are COVID-XX, XCL on lives ongoing and This this safety SARS-CoV-X which milligrams mild fourth since Primary our our a of building participate by EDP-XXX then be as will standard well pleased populations. in call, hepatitis risk we XXX who is curative patients not prior I'll patients. and transform our high dosed to information. days than for objectives for COVID-XX. to days non-hospitalized milligrams poised our will randomized are within between load treatment from standard a coronavirus multiple the EDP-XXX, success in Phase development moderate is patients studies of development as year Patients metapneumovirus received we fiscal planned a clinical approximately comment vaccine effort. risk disease. SARS-CoV-X XXX Our of in once in vision of orally with C. pipeline toward work studies pharmacokinetics receive decline be EDP-XXX therapies, pipeline, the if and way COVID-XX the enroll XXX tolerability clinical of next have will with trials. symptoms more XX for they to eligible other followed recent and for study been viralogic development had to trial or stage Thus, viral SPRINT, the symptomatic key days efficient the with a of of guide infected our to of will

SPRINT are to of half first results XXXX. from in the report We aiming

reported previously the data XXX ECXX, with I well study for strong EDP-XXX seven exposure milligrams the is and Phase multiples up of As days, was of which a from tolerated to demonstrated measure generally safe it over potency.

a variant the XX% EDP-XXX milligrams resulted Specifically, drug the adjusted and ECXX in levels that replication threefold steady it plasma levels viral in were Omicron milligrams the that results respective in and while inhibition is XX-fold state for once sevenfold events were at ECXX mild variants. infrequent. adjusted over plasma in were Alpha daily trough XXX concentration over vitro. protein and respectively, the variant, for and protein Adverse mean of resulted of that plasma of generally taken the XXX X-fold

to were without exposure Omicron its variant preclinical for a lung XXX-milligram achieved have boosting to drive tissue at need on interactions. drug-drug is these target to dose. up projected higher associated EDP-XXX the the and multiple would be to times human studies, ritonavir for expected which multiples XX-fold even compared Importantly, drug in the four levels plasma, Based

arise As COVID-XX antibody previous variant or new persists, a monoclonal infection can vaccination, from circumvent immunity treatments. that

to as which against strong show and COVID-XX are date. activity EDP-XXX convenient to developing all a committed tested variants continues We antiviral, easily to prescribed

respiratory result significant COVID-XX, the program. can RSV respiratory as infection that are children, virus severe unmet a high-risk and a the is in encouraged with populations. mortality and progress in a we need syncytial it represents and by have virus also significant other or morbidity Beyond elderly made the associated is our we in RSV

a the the there as time available. distancing the due need on US targeted While RSV mitigated now for some pandemic, during RSV no therapeutics measures currently high, are rise infections remains are for to was and treatment social the in

L-protein EDP-XXX, are clinical advanced robust development a the inhibitor most as RSV as polymerase. protein pursuing the targeting oral RNA in RSV EDP-XXX, and which a We program, includes today therapeutic well novel

high with over XX. a treated EDP-XXX patients placebo-controlled randomized, compared of to the XXX evaluated tract placebo of study Approximately those is complications, on month, respiratory including XXX with are of be unmet adults next asthma. initiated XX or high-risk We infection, currently progression XX pediatric and resolution in of age for a and or risk populations, evaluate study we heart failure, years will congestive Last of designed symptoms for those all in HR, have hematopoietic with placebo study five IIb time days global RSV, the through with adult Phase days. milligrams The transplant acute multicenter need. recipients and/or infection. over adults, the then a at are double-blind, other patients, including who to which primary cell RSV EDP-XXX EDP-XXX evaluating RSV high-risk of effect RSV the of study The lower significant endpoint COPD disease Day is

high cell recipients studies namely Our believe patients with We infection. to a evaluate Northern deliver X Phase are during has ongoing. We'll the monitor continue from to season at RSV other timing a Hemisphere this in potential RSV RSVPEDs, RSV for potent transplant populations and to of RSVTx RSV to study antiviral all EDP-XXX, risk the treatment a pediatric better study data. Xb for EDP-XXX adult hematopoietic Phase oral in trends us enable

XXth for single began The of RNA EDP-XXX inhibited healthy safety, at the or polymer be as placebo-controlled and a cytokines. that We believe This lung with populations RSV used dosing oral broadening also virus-induced International EDP-XXX, with the improved supported study model, will may our Symposium, targeting infection preclinical in window agents L-protein presented this subjects. study EDP-XXX addressable EDP-XXX treatment promising EDP-XXX with double-blind, effect or X and showed reductions serve of strains. by EDP-XXX, is RSV Phase randomized, in could other pro-inflammatory both the tolerability data activity associated treatment of RSV-B and patient of evaluate EDP-XXX orally-administered adult inhibited combination our vitro a polymerase. was and pharmacokinetics in in quarter, dose-dependent we standalone in as doses the therapeutic In histopathology treatment the which cytopathic RSV-A multiple also rodent novel potentially RSV. quarter such RSV and

disease Moving who to several is Metapneumovirus, compromised. Human those populations, virus discovery in similar immune respiratory with to underlying pulmonary that a elderly, is and on and our the RSV hMPV, are or including impact adults vulnerable program which

This quarter, vitro strains. tool kit of for characterization in the of quantification an generation growth RSV data in the hMPV XXth highlighting detection, hMPV at we for the Annual improved advancements presented multiple preclinical and Symposium, methods

next is a candidate goal select to development hMPV year. for Our

Turning B. to Hepatitis

remains to goal Our chronic HBV a develop patients. functional cure for

opportunities for and We additional combination to in with external combination evaluate EDP-XXX infection this as for cure internal to candidates involve ultimate continue develop believe the therapy. will we

ultimately could which We infection, making is successful need this is that or HCC, a serious cancer, common continued the be high in a of carcinoma, on leading component inhibitor core deaths of integral liver for world's hepatocellular world. as liver cancer the and as health combination cause such disease, EDP-XXX most known primary of global believe public the cause threat also commitment that Our based an regimen. a the second the unmet

Finally, turn I'd expect we discuss XXXX. to near-term like X first that, We the we next data Paul L-inhibitor to and half report by financials. half also progress over the the have year. from quickly Further, of up look of in SPRINT Phase I'll through in study highlighting X to XXXX. of data clinical first milestones as of With EDP-XXX, can to for RSV to our our call Paul? to Phase the wrap our as the half first

Paul Mellett

Today, we on everyone Jay. you, XXXX. XX reporting results are fourth remind and for that Thank reports a I'd quarter ended like full September schedule. Enanta our year September XX, fiscal year to

compares at sales of XX% was same a the revenue now of consisted product of XXXX. approximately global total MAVIRET in set-offs, period calculated This HCV discounts, sales. to earned adjustments quarter, of of for approximately compared of sales. for after which on on to certain XX% The million net Royalty million was for decrease year For the are total revenue $XX.X was X% prior rate decline a product contractual total MAVYRET revenue the AbbVie's MAVIRET. and revenue AbbVie royalty $XX.X to rebates the quarter reported and due royalty AbbVie's sales in

royalty our You XX-K. tier XXXX in Form schedule can our review

our Moving on to expenses.

in benefit and a for compared approximately CARES million in totaled million million period for XXXX. or XXXX. million quarter September $X.XX a of three expense loss due $XX.X trials. and federal Enanta was ended the September $XXX.X increase to compensation same respectively, XXXX, Net due Enanta compared XX $XX.X income The a carryback XX, recorded loss due XX, income XXXX. in in primarily still which share per months $X.XX ended period is of share three Enanta or in of an reserves. the offset $X.X of of to XXXX. months common available tax XX, and September September tax loss decrease $X.X to to additional the the million same XXXX XX taxable the back and carried of administrative a cash development Act loss $XX.X research million ended common million of the and three and million are the was securities. months expense timing corresponding XXXX, in for diluted tax stock company's prior refund The XXXX, $XX.X losses to income was General the the $XX.X for to $XX.X For was three months net the Enanta per to for with state period diluted of ended quarter under due XXXX, recorded loss for clinical $X.X million XX, for primarily compared primarily an September $XX.X fiscal tax million the expense. for benefit release ended tax the headcount income $X.XX in the of an million XX, for marketable the to of to and ended a months XXXX, and the expenses years. net XXXX scope million

securities our fiscal We cash, to to cash as of of XXXX. cash and royalty continue will programs ongoing quarter meet into marketable our equivalents the and that our revenue expect long-term fourth requirements development anticipated the current be existing short-term business sufficient our well as and

up Form on included filed. our million our details to expense fiscal for in turn $XXX press $XX operator and be and open million $XX guidance I'd be Operator? our the and are for development release annual XXXX, report lines Further now call be general to million like we to the $XXX between questions. and available when will and the in back to administrative expense expect million. XX-K Regarding research to to between financial our

Operator

from you, Markets. show our Thank And line -- comes from sir. [Operator I RBC the of Please question ahead. Instructions] Brian Abrahams go Capital first

Brian Abrahams

starting differences, much for the as progress are study, well? my intrinsic to program. at just Hey, and the there the you on the programs. account good I the much across all congrats so Maybe -- looking patient-to-patient continued on as kind for a on the in exposure at doses And just XXX afternoon be to how guess, immune COVID thanks I'm SPRINT taking prior on variability of questions. going have talk to looking some of could at vaccinations terms measures more you also you're bit is placebo? order based might different to data going And going elimination selection in in if you to standardized guess, help relative about potential I a sure that the you of order virus of little symptoms virological the how guide forward? status wondering key make maybe be dose -- for look

Jay Luly

Sure.

So question. thanks, Brian, for the

for population, we the 'standardized' some least we're So, in to at I can. at think terms the control that of trying variables of looking

of we're vaccine for people is enrolled have last By same people be vaccination status. now, is months. vaccinated, COVID the And last asking with One the a had days. so many them within to but XX the true three are in

So, to been have that freshly and you're vaccinated. tends or fresh COVID that's patients immunity not people wane taking when

know, design. going Phase So, are the in a study that's one Again, look primary smallest the gather loads. parameters, COVID factors. changes X possible the And predominantly going be you and safety in tolerability We're shortest information general, other a the hugely at enough viral focusing that primarily in back viral things would for as to drugs We're could study then as we -- that of to possible and endpoint conduct don't profound load. enabling. you to can as be show that measure on going virologically, then

show on any remdesivir fact, load. change doesn't viral In

protease shown have small inhibitors modest the So, changes load sort of reduction. viral though, in

We'll things time certainly to that. looking at that. undetectable we'll look be So, at like

you're more see this, size and I -- patient in and in they're not population, like in this you're a clinical a outcomes, not than again, much for definitely exploratory this Regarding way in on that expecting things measure focus too of symptoms in small -- can to anything, think, study be way later that be to to study small be we'll possibly particular, be studies. in for really really looking but it the trends going looking stage and and we'll as relates that,

We'll information dose to go have all dose from then in a that steps. to between together dose our putting small So, hopefully, study. forward XXX-milligram on and XXX-milligram the there next enough and select the

Brian Abrahams

of to site changes the XXX protocols any patient number seeing? -- seen Got of And and have late. light sense. take country lot make enrollment studies? be the a onboarding it. or regards No, of ongoing guess, to I a that the makes extent a you To been that spike advantage wave of to, across globe adjustments with enrollment of are in in And then able we've there what the to this obviously or RSV of sites, you we're might able overall to optimize

Jay Luly

Yes.

on. So have you we three going know, trials as patient high-risk well,

pediatric have patient and third who an then just suppressed we just population study adult the high-risk got announced the marrow and And bone is are transplant We up have as recipients. studies. which study, immune a we

high like them risk. these adults heart other things either older XX are are congestive asthma, putting failure, on, that years at So going things who are some so and/or and that, have things COPD,

wait waned RSV immunities so unwound And the there that the of And the clear people's as from how over early the it year. severe There's time. early, is of pandemic. RSV very have and come to drought you is that's over time that We'll was patients now time. during a very it of season for protracted how past, in see least, be see and of definitely know, various some we'll over the this it's also seems heart period a

various of globe we this I American watch basically stand which where stand Hemisphere around all up, to better end then sites of need on is a we and then North And where the see we'll or definitely say. Hemisphere our these sense studies. So the those in should of have Northern Northern we of the season, at with season, each studies cranking

Brian Abrahams

Thanks hop the it. queue. back Got again. I’ll in

Jay Luly

You’re welcome.

Operator

question our from Sandler. One show line Please compile while Rahimi our you. Yasmeen moment the ahead. next Piper next Thank we comes I And of from question. go

Yasmeen Rahimi

of us updates in as to team. the of all you what's are for unknowns what remarks follow-up. thoughtful be? bar telling first XXXX. my just Congrats And regulatory for Good quick post-SPRINT maybe SPRINT what study. us afternoon steps would usual. I COVID in approval and fast on Where out bar? of guess some really your and the and the terms next you therapeutics? coming But give the So be forward the what see the are next question half on we helpful? the what of team, Thank in have want to is I would steps the that of do framework you, are that data determined of What's are elements then a

Jay Luly

Sure.

is Again, a we're and So be be it's dose enabling, conducting. selecting then well, SPRINT II a to it have trial that Phase we Phase III also study. aiming would

next and continue III. would with that Phase plan design. exact the specifics trial trial be design with The the regards also agency will have the to So, internally, to interactions of step

the those discussions. more to it's So hands going interactions along good our with be hands data way, in some the having hopefully, during

focus design then data back as aim of and on to year. a little first that wrap-up the half will bit have study half Phase can, So, hoping for we the the But as we're like. quickly look to in what early III again, the in

Yasmeen Rahimi

after seems would see type -- of support you we question Thank like what strategy us. then Maybe I'll that I us about you. versus combination? is forward want in the data data, queue. you, see that moving the would the to It into back And Phase optionalities? is XXX. data the both Jay. be scenarios could the in you could jump monotherapy if through it for That be what could walk helpful for Thank a

Jay Luly

Sure.

is So the as clinic, first XXX in know, molecule antiviral. direct-acting our you a

contrast replication inhibitors. to in guess, tried So of and inhibitor, other it's have the in a I in that approaches past terms entry present, been the in

replication in So shut way virus replicating inhibitors. we believe who again, we're the that on presenting. to focusing best – down active an is patient that's a We

to and just we multiple to in over so over want have very want to we And to time, different class such approaches end, that have one hand. RSV committed didn't We're time.

think finding priority might not combination them. you Again, second. But another the we goes majority that, replication I like different focused We're you in a for Someday, no to programs. about after the few good overwhelming on good just potent reason, enzyme, patients any combining polymerase discovery need what strategy, pharmacokinetics, can good would and do molecules but always in articulate there's believe in to our to have of possibility It very that XXX inhibitor. candidate have that we biodistribution. and safety, would with reasons a of and is a

boxes And those so of pre-clinically. check's all XXX

our so approach, is human I setting. in just Phase a those as usual data bits Phase really And kinds is of all of hopefully recapitulating of I

PK. looking be safety. of We'll course, be good for, looking for we'll So good

dosing, molecule PK polymery. virology. has it that, the a predictions of potent. aiming always that, inhibitor of for should our, here. also It's this are All extraordinarily And very, very again, good something we have know good then It's we once-daily preclinical support picomolar oral

to later a the reach infection. suppressed and/or good virus, window patient once bit down person by treatment stage of agents about support able need more that an in patient into it's reading a on pressure terms patient maybe we in its ones own it's little thinking widening one for potentially or the different that extra that partner just right, the they a by highly might good to of come and after maybe example infection -- with a in than present combination populations, you patients, translating on It's road, the using value. might a two molecule normal have little again, drug pre-clinically, stand-alone rather potentially the believe immune So

population. days of up two many that addressable would -- the treatment window you have might window maybe however, a increasing one drug, patient So, just widen drugs opportunity, with therefore,

of pandemic, looking strongly championing disease on we've these it's indications we're the to as human for, in years, And I RSV that done. better things now been on very the kinds starting the any with multiple that always So a approaches any know, a viral have long clinic. a ago. to area very think are for And time treatment. discovery you the number is the second different of have you And earliest or again, quite feel pleased efforts very molecule we're respiratory attention now high

data. data So steps we'll we next think different carefully Phase we'll go could get and once our And at the X steps, couple in We'll a next it, have hand. of look routes. about then you that

study we'll or directly go could time. at You and thing a challenge you into go that into we're, obviously, right could now, a And population. about have thinking more a patient future details

Operator

next question line ahead. I Thank Baird. And go our Please show Brian of from Skorney comes from you. the

Brian Skorney

And RNA I of compared then you're symptoms different the do Is noticed placebo. you measuring separation And where curve then many catch to cutting load Hey, seems for viral variant, discuss my you're to the you're I at I Can overkill enrolling any off. I'm I a infectious load? on the good terms too if see viral load? think of have few quick think, of finally, in and five just Thanks be everyone. afternoon it you that XXX dose? of dose SPRINT you expect anything, is you're days, viral versus just virus. load. a to between ones wondering differences are terms days you like trials, of of questions. number And it viral would down for you seven couple on how measures XX-fold since on of clinical response the in how expecting Omicron the what, ECXXs guess the had days study. of different shutting taking

and of think the decline if the time load to of there's trying viral here evolution in course you're that capturing lot Just risk patients a a through phase? Thanks.

Jay Luly

readouts. let I'll the Tara comment Maybe Sure. viral on

So viral we see what -- see dropped of is can and These might given five-day say window. any the done some the or differentiate, patient may -- this we and if chose we doses. either may look evaluate would strong possible just dose of there XXX well, there if I a XXX populations are have all right, there's we to multiples that to when what piece see we Or The milligram not have possible good to may and but, it's two that exactly those be kinds range we're on you with But doses, to various doses at Shionogi that Pfizer reasonable the two or shown dose five-day the it's do. something. in it still does response differentiating why and study that here. load we two doses is a running you treatment see need

depending stratify won't obviously actual upon than days. be what five can their You but it people more window was,

to So And you Tara, about that's I on the that. do would readouts? what then, want say viral comment

Tara Kieffer

Jay. Sure, Brian. is Tara, This

be programs. looking by done PCR. the be that will virus, and RNA primarily So what will other at and lot a on of the load, viral that's their have infectious We'll done also that through culture. companies we'll readout be be looking And at

that the virus still So is in this is samples. at infectious looking live actually

looking be those readouts. both at we'll So of

Brian Skorney

just And nasal those swabs? are both

Tara Kieffer

Correct.

Brian Skorney

Thank you.

Jay Luly

you. Thank

Operator

Liisa our question moment, next compile comes go And our the we question. line from One Evercore next Bayko you. while from ISI. Please of ahead. Thank

Liisa Bayko

Yes.

outcomes, learn been overall I can explain you just more that outcome And sort you the in of than you're you answered, study? are terms of announced, you any enriching or kind focusing a trying of resolution necessary think where you sort you kind the or have in but maybe the did of guess, you do any see of that separation the just given for study symptoms most the goal low-risk RSV, not of, comment the similar you questions risk – in are kind concerned lower-risk group? the Thanks. patient terms of are COVID I from what population? to you and light of on have in your objectives all study at of of enrolling the that on And higher So could of on the what there study -- that here? focus don't patients,

Jay Luly

Thanks the question, Sure. for Liisa.

be that the watching on for the of things, viral those and of is that one But happens why, know loads. of risk patients or symptoms one viral of this load. side patient looking table after the is to What at population. various have standard very patient would So viral high-risk outcomes, logic you're the key risk we'll And if populations that reads things patients we similar standard this differs. some those in harder measure so-called those be to is

looking and those to things able be should So kinds to dose you're that which it adequately into those on you we'll studies Phase -- this tolerability, look kinds got dose broaden have and our outcomes, of those but are all patient going of in quite you at then look many figure can out and population. trying And again, larger-powered parameters, going use, based to safety virus, we've to when at bringing obviously back the to at different once again, out do at X, looking the things.

So, that viral high saw are loads standard Pfizer's in and effects population. the risk very or standard Shinobi viral risk load yes, shown risk it's similar -- so that

Liisa Bayko

you. Thank

Jay Luly

welcome. You're

Operator

Please ahead. Eric One question of JPMorgan. Thank Joseph line while our from And question. from you. go our next comes the next we moment compile

Eric Joseph

a weeks? at to it the what kind at I sort the looking understanding about of model the that you I'm I Are two of opportunity for speaking, kind as clinical the and and of viral with phenomenon your explore would is would Is Hi, viral first Pfizer's be follow-up inform Thanks. opportunity that just And guess, questions. then RSV to combinations combinations? potential thanks through of sort practically of really additive of I'm XXX. this behind the SPRINT period. and there say, good what at in just thinking let's and potential for that it post-treatment least for evening potential whether true phenomenon taking XXX wondering going offers beyond, through relates potential? assess useful to looking was load the a rebound paxlobid. similar for seen with benefit kind thinking but

Jay Luly

Yes.

questions. So, two good

who be rebound the can rebound real course interesting. patients. does part seem to even its in paxlobid, don't get a it phenomenon, of the mean, you and in people certainly natural take thing is although just So, I

but taken of. part to protease-treated you're levels to-date. down you the and And that little is the and low a And well, virus Some and to why wondering tissue low in mop that's need in, down in system of want you must things down clearly, of get enough in can beat fully whatever there the out. that you it you immune of to been patients kind to we've rebound care then beat will some observed is, has and in about level come then up it that? virus that you the help pocket sufficiently better Ideally, thing been be think resolve, -- phenomenon definitely not

and further a So, could you that there hiding is little to need speculation extinguish our possibilities that be reservoir somewhere it. among the virus

But that that of treating by that's where such demonstrated we've have lung that do of terms the you target one one concentration. could is advantage intriguing one time. to at into and in least be at sorted out do I think concentration days? four an in out the tissue the pre-clinically, that for key possibility plasma drug on. parameter so tissue, And over into will EDP-XXX tissue lung least as other is potentially And uptake tissue of uptake higher organs longer

out observed there. that's protease with inhibitor another wasn't that So,

not at looked virus. at many are lung well we've potential looked only other tissue, for that tissues reservoirs And as so we've but

our of higher concentration some even And that. goes up than

uptake little then doses tissue the potential our of So that coming to we'll very the that, against drug out, good Brian we've hiding you top add data treat. be either at mentioned, hoping multiples good potency, of having out more have of the a But Skorney harder administration, on variant. on nice where after virus topic might XXX, that it's to this really really as good owing year. QD got we're exposures And Omicron

having follow-up. that that some our So because and we XX-day we'll all dosing we're a that, be five have certainly be for rebound and days study, add at could then looking on will we impact to up hoping in

chance these Day a people watch X. have to we'll So out to

intriguing So that that's be we'll an testing. hypothesis

The that I had, other you RSV. was about think, question

have three high-risk We XXX patient obviously advancing in right trials now.

what combination. it have be the And We in how study, I that hopefully, ready that you and you And one could at thought challenge virally-infected see soon to on study. is have about combination look XXX enough. in to two the already of data asked, nicely look as could at We think doing challenge the that specific a with XXX. study X will people, XXX One Phase a in also could be a possibilities a look be study improve. might parameters challenge at with one of a do question proceeding to fantastic the able

that. quickest at look that way earliest get the way So could to interesting what would combinations. you you earliest, probably about That the is data asked be

Eric Joseph

Okay. Great. my you Thanks. question. I Great. appreciate taking

Jay Luly

you. Thank

Operator

question SVB from line from And of Ruiz Please the Roanna I Securities. our you. show Thank comes go next ahead.

Roanna Ruiz

Great. everyone. Thanks. Afternoon

question So secondary analysis. on symptoms a trial. was clinical the the SPRINT curious quick on I

on to or Specifically, exploration saw you Shionogi’s in similar a your bit focus symptoms late-stage key of to a trial are of be to going in set we more symptoms different broad what with COVID? will of data, you plan

Jay Luly

handle do Tara, to want you that?

Tara Kieffer

Sure. Hi, Tara. Roanna, it's

do all specific then So in the to our we'll we'll analysis trial, ability subsets. certainly look at and the symptoms of have

looking point, at effect was that those an Shionogi symptoms to your to able on. So five show

able way able studies as to to with be the do best learn set, how into well. move also both, be this later comprehensive and So data we'll we'll to

Roanna Ruiz

And… sense. Makes it. Got

Tara Kieffer

Dose it help?

Roanna Ruiz

like study, And enrolled helps. to ask -- this, I'm might RSVPEDs, for between like but the want XXX cetera? for COPD, asthma, sure RSV think RSVHR about see trials, you RSV that good and you be I et if any on sequence to input not balance patients And HR? being your do of have the do different high-risk Yes, RSVTx expect you what I across different of missed readouts a

Jay Luly

Yeah.

PEDs, on patient really through season just are patient three RSV more populations, different need different tell. populations. those readouts just will such the So very there's data There -- of to

another? patient are more we about, know what of And so regards we to ahead. we'll question information to about your or need pull population too one just think I With worried much asked? help at I Is will those the you and congestive for we what more example, older XX asthma enrich for heart mean, This capping are that age and XX%. COPD high-risk patients. failure enrichment

completely question. that if be that Is your is it just asthmatics won't helpful? in with getting So what up filled at you're

Roanna Ruiz

Thanks helpful. lot. a That's Yeah.

Jay Luly

you. Good. Thank

Operator

our ahead. of Please the from Olson show go I And line from Oppenheimer. comes question you. next Jay Thank

Jay Olson

a years? regulatory and Hey. partnership So will long I Congrats and And how latest several talking And time of level, get COVID to years, I the follow-up it for or could, a are treatment evolve what And be for the please. XXX? XXX, take very At then development are thoughts we a commercialization will it on high for dynamics about progress, frame? anticipate if potential taking over to you. going the you couple how of is have your then question a do questions. that thanks on Thank approval XXX? about

Jay Luly

Sure.

now, some are the seem one, at before phase. getting and be how beginning into questions, those years over in least endemic time an pandemic vaccine. several the for we're be the future the shifting phase. phase even end of continued Maybe will Clearly, the -- endemic, that's the to is, we So actually, at endemic that of pandemic of toward going it's truly away play probably out to big that's to we're that

through Phase up focus half, But a as trends to now, looked will can. we be the is the different that might progress we assumptions variants the be on having in as also think think in emerge. upon the right X that's data conducting that of carefully at of that I moving expeditiously into regulatory SPRINT something as what going terms and development. our and half available, year, that's first finishing depending pathway I There's study back in

option far populations. as still as EUA aware, patient are we is think an I at least in certain

the out but of really the -- on. going juxtapose Really to timing so And backdrop play need case that the environment terms of you of be it will that's in the the program, let later?

and the interesting were BA.X. time. the that, It things all not of variants BA.X was we they're is ago One changing the that about talking long about

been Within is the some of over the variants, BQ.X the seem taken all and as around. but switch few they all X.X have things which good, last to don't these can weeks – immersively, and be lethal certainly earlier as

to off The being there's efficacy. a continue aren't vaccination there as Phase of vaccination them, in need to lot a for patient understood There's the antivirals. many some well how in regulatory yeah, going enrolls probably mechanism-based what be have unmet at watching therapeutics The stabilized so antibodies and rates landscape available unmet population, what and So of great are still also are to of many degree going far, you our have dictate be effective an huge really are And just there. losing us we'll terms time. out III that that's and to and pathways fatigue that know, that forward. dropped – that

are I forward regard. going XXX submit a So in be – in much that, the this very approved. yet that is look to there which We strong optimal would pretty opportunity. having a one as at therapies really going and market not It's large one aren't profile

a just be COVID, you not as breadth the our all with So of evening about something really continue a and to metapneumo. serve virus is Partnering going in extraordinarily Again, but respiratory under our bigger this the human scale well human think to order you're still seeking patient partner could Again, to It's talking possibly than well on I just that plan. we therapeutics the things been that set this for these be will the as that, very in base are, the goal as portfolio, global after XXX have to maximize hear global high. we to it's are part, know, metapneumo being need in more our greatest will RSV achieve spotlight been the as and the obviously, we is and about more globally we too, increasingly. efforts pandemic is a going here.

Jay Olson

latest treatment in pipeline can you or sort something And And super an in to for what XXX? will mechanisms or on development? what XXX? XXX, Great. combine with helpful. And seeking your preclinical then talk be about you And That's or Thank antiviral do thoughts are your clinical external? be will it on you. of own something partner something it a existing plan

Jay Luly

Yeah.

hep combination is in quickly. even combination, out to while, I a hep – So of had when much the terms C, play we're were though all a therapy things mean, on combination right therapy much the shorter, therapy, measure and combination working by combination, as story straightforward comparison therapy. it's B takes fairly you very trials you that combination could was as slow

different HPV. and loads getting You basically all had profound are And changes seem viral in to with of slightly to correlate those those than rules a cure.

do well, we're only not you load, still not do and right combo core DNA can the of DNA but nukes that core stage viral also, the yet know the inhibitors RNA. known We with reduce that useful at And yet. reducing I is nukes the inhibitor, things where so think in terms and

s-antigen an need do in But starting will component you get to think asset yet need on the this, would clear to I modulator that these I things going perfectly mix. are not the reduction address are something we're So data best on. mean, what all might it's adequately combinations and that other class readouts be. of immune that people

to the triple at able helpful? in the point do the some assets. I on. want clear And we'll externally get And so we're patient meantime, bit that little looking happen well. that We're going as that. doing internally, horse on we'll until pool we're a to really be we on combination isn't ultimately, really a being But right that trials the that Is bit and little to to be back hope clinical spend we're on and thinking here.

Jay Olson

Jay. helpful. questions. Thanks color. you Thank the That’s Appreciate for super all the taking you

Jay Luly

welcome. You're

Operator

[Operator Instructions] show JMP the our of Securities. from I go line Buchanan you. Thank next comes And ahead. Roy from question Please

Roy Buchanan

said on RSVP or then results? near-term you're for Jay, this comment, going I presentation? you plans had follow-up the going be relatedly, XXX for question. data to any a meeting taking that a higher that around publication And have thanks to on publish uptake. more topic Hey, tissue Is XXX, the the to a year? the

Jay Luly

what timing being It's RSVP abstracts we're what as are the sure timing that honest. distribution, results, execution. is. I'm of been important out have you XXX data doing to I'm in So not there and study to conducted. The not the of and the sure tissue know, thing now an quite that that It's on important other not is referred written perfectly right in some terms most I submitted. it's

on -- we've front. We report accepted Steve confirmed entry will just a been and for announced that. we once that tune’s So

Roy Buchanan

that year? before see But Okay. the data we'll end this of

Jay Luly

of Before XXXX? the end

Roy Buchanan

Yes. That's what say. I heard you No?

Jay Luly

I I mean I you data about it to sure didn't about. -- don't -- you? talking I believe is didn't what did, uptake Not say said that that. XXX what If that. Are I tissue you're talking meant about

Roy Buchanan

Yes.

Jay Luly

year. this anymore Not year. this Not

Roy Buchanan

Are this bake But start-up for starting -- that for X Phase RSV in up you going a quite answer for All possibly does about Xs? you are with the expense guidance is partnering Okay. question. kind And R&D XXX then Phase enough. for right. a thinking Fair how Your maybe of X XXX? the Phase bit. funding

Jay Luly

Yes.

and the first the out to is that So, through SPRINT our guidance in data we're X/XX the so in aiming year have calendar the half. fiscal guidance will go again, quarter the

quite -- so last been the drug supply, time. Phase the rest, doing for Phase some you for X any preparations mean, wait CMC I we've And X don't The minute. until all

expect you number. X/XX, and of through now. certain continue And quarter would in Phase to incurring we X-related So, included been, we've the costs if those that are up will, right those

Roy Buchanan

you. Thank great. Okay,

Jay Luly

Yes.

so if that it's anyway, thing, partnering But modeled change, things. changes bunches that So, way. then obviously, were of we've there a it conservatively, conservative a

Operator

this I'm you. conference to showing the turn Thank for like session. would concludes over Viera to I the remarks. no time, This questions back in closing our At further queue. Q&A Jennifer

Jennifer Viera

for everyone, today. us you, Thank joining

you If please a great contact have Have us office. free additional call the e-mail evening. or feel by to questions,

Operator

conference. the concludes This you. Thank

now disconnect. You may

Enanta Pharmaceuticals (ENTA) 21 Nov 222022 Q4 Earnings call transcript