ENTA - Earnings call transcript Q4 2018 | Enanta Pharmaceuticals, Inc.

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Operator

Good afternoon. My name is Deidra and I will be your conference operator today. At this time, I would like to welcome everyone to the Enanta Pharmaceuticals Fourth Quarter Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. you. Thank Instructions] [Operator like the now your over host, Ms. to would call turn to I Miceli. Carol begin may you conference. Ma’am, your

Carol Miceli

Thank you, issued Deidra The and website. thanks for joining with is on financial and news us our results afternoon was this available our release this afternoon.

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

are materially plans uncertainties remind and begin our most that which Before and with actual projections, forward-looking formal differ you to from that our our want these other making cause recent financial Form we with statements. is in XX-Q uncertainties our of we and reports SEC. our statements, and involve to we the including expectations beyond and respect filed A with and risks product be will remarks, could certain candidates assumptions, risks to developments and periodic of results description control these all

not to over to In I and to call the Enanta during update turn would Jay now any Luly, call. made statements does CEO. Dr. President this addition, forward-looking like any undertake obligation

Jay Luly

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

equity past opportunity, the all Our and without the and market several I to for have of leader other objectives. proud is financing. disease dilutive accomplished in am that into of diversifying we the our goal diseases through a unmet many significant field and need become infections viral to in of years liver investing areas say additional with necessity

currently to year. have HBV of trials a X we candidate have and clinical validated first advanced study in Enanta’s has our ongoing is PBC year programs NASH clinical all Specifically, Phase been expertise next expected the and our the a have program, in foundation from and wholly-owned inhibitor scientific begin strong protease world. the three our to in RSV, fund HCV including Abbvie currently Royalties MAVIRET, in-house collaboration approved provided efforts. by in of two has which HCV partner our drug our wholly-owned leading products marketed resulted AbbVie, past by treatment financial

clinical our compounds have $XXX I programs a kept have we advancing continuing resources clinic, new in discover our cash significantly with grown our the royalties As wholly-owned will now strong pipeline, and to balance and of million ongoing we while financial discuss. which

XXX more a Symposium and of exciting N pharmacokinetic of October, candidate for this single ECXX, twice-daily In X Enanta has with study an our mean the works a is inhibitor today. N-protein of compound. results tested potential Virus this opportunities to drug over the EDP-XXX generally cells crucial replication effective is Respiratory multiple virus by be pharmacokinetic respiratory the month that potency measure potent the In used human oral RSV. against multiple RSV note include arm ECXX viral arms a human most the and study antiviral clinical and and were than human at later placebo demonstrated earlier or a a and doses challenge a achieving antiviral concentrations significant was X adult inhibitor and profile study healthy Syncytial randomized, of to fusion virus who Phase of in the at range Recently, of we progressing stages presented placebo-controlled general, RSV. success days. well-tolerated initiated for good X the with suitable One our were measures subjects, two than outcome only secondary Phase trough successfully with non-fusion compound a dosing the near-term one is Primary randomized XX EDP-XXX The of of or levels in a over development effective profile up safety load process double-blind, product once for and broad adults a is to EDP-XXX, that inhibitors. of or into in quite inoculated drug. challenge EDP-XXX are completed This the the and vitro. of for dosing. the in as targeting An be will baseline measurements enroll healthy a inhibiting pleased EDP-XXX syncytial higher in Xa symptoms. observation the infection when changes important at X result EDP-XXX dosed first-in-class times in approximately and study International XXth safe to in Phase drug and changes Phase RSV infected RSV will

of the dosing of to the short third in data preliminary Given announce quarter duration XXXX. expect relatively this we study, calendar

data for enrollment continues sharing patients in this has NASH our in PBC the multiple Moving a available are initial clinical anticipate mid-XXXX. pharmacokinetics challenging with for to safety, PBC, Recruitment EDP-XXX, PBC and in candidate. and to subjects Both and double-blind, to NASH due agonist trials been two trials of second EDP-XXX studies in attempting line randomized, FXR our therapy limited Phase in indication. clinical efficacy X We tolerability, NASH placebo-controlled with orphan evaluating XX-week studies of NASH and number starting potential access PBC. very an with

injury, months. our development presented demonstrated the of development, the model updates meeting. knowledge Dr. month, that Bryan are ascites General carcinoma two a this in at agonist further mortality. HCC our Massachusetts on One of fibrosis, liver Hospital or rat in HCC, serum liver reduced We and we posters EDP-XXX and were data of hepatocellular of will FXR enrollment poster cirrhosis continue lab building Fuchs at markers NASH, Earlier EDP-XXX. PBC accumulating coming to In on and preclinical preclinical extensive provide the from

demonstrated NASH late progression in cirrhosis a model suggesting potent may anti-fibrotic poster of fibrosis EDP-XXX have reduced stage second rat The disease. in liver effects

therapy commitment combination in long-term a non-FXR from have follow-on this discovery mechanisms our likely new indication. need to leads are NASH We ongoing FXR work agonist and the we identifying continuing a for in anticipating

of preclinical on XXXX, EDP-XXX include a as Phase study candidate from to our assembly modulator plan am at and the class this These of to core I clinical our a HBV preclinical data, we can very HBV allosteric modulator. EDP-XXX in multiple virus which or initiate compelling portion chronic for in a first EDP-XXX Xb Based as development program. EDP-XXX, HBV protein referred and this replication patients. we also the inhibitors In inhibitor, highlight a Lastly, lifecycle. of best-in-class disrupt our will core excited new capsid selection core is a believe that viral mechanism. our steps Phase announcement potential has a of of the X the inhibitor are present assembly to data

are are the turn like quarter. stop results patients XXXX believe I anti-HBV to multiple I families that participating may our the Enanta call I to it thank Paul necessary I we like other updates to their forward as in look we and who in also to treatment trials achieve tirelessly a exploring strong here XXXX. our to clinical goals. would the mechanisms be the approaches addition, Paul? for dedicated HBV. thank discuss and employees would had and In financial for and to of that over utilize will to work our providing more our

Paul Mellett

like a schedule. would to fiscal Thank you, I year remind that reports Jay. Enanta everyone on

and is XX, September September we XXXX. year ended results XX reporting Our year fourth our for are fiscal and today end quarter

regimens, to current – including was was compares the was quarter. entirely Total ending earn This lowest royalty is year increase rate quarter XX, For September global $XXX to months is royalties given the to that for of which million. XXXX, average royalty $XX.X This on due will revenue revenue double-digit royalties million in our will revenue. means an you the MAVIRET. a annually $XXX in included eligible $XX.X on restart rate AbbVie revenue period earn eligible tiered earned total in of of quarter AbbVie’s royalty royalties on of fiscal Enanta the million for at and HCV sales tiered our XX% royalty XX% net annually also consisted at approximately in of I tier, million AbbVie’s the the highest royalties milestone in our and December our total quarter quarter quarter XX, December rate ending In X royalty expect the remind for September MAVIRET in which million XX is earn in we of would $XX March XX% in ending sales our The million XX. the increase reached to $XXX same ending in HCV XXXX, ended rate revenue of sales that to in will global which XXXX the the payments. be XX. royalty

quarter for in XX% cost due fiscal Enanta the million was $XX.X associated the PBC, Jobs primarily September same Enanta’s the was months fiscal $XX.X common was to in XX, $X.X wholly-owned income the on X $XX.X end in of also for XXXX tax XX, HBV. versus XXXX. the the assets The for cash our marketable million approximately fiscal million R&D million reduced to net U.S. of to million and approximately quarter enacted or reflects months quarter the $XX.X diluted for charge Enanta’s share impact the an expense or greater compared expense of for XX% progression year ended the research expense primarily $XXX with for and XXXX balance compared development XXXX. rate. in increase approximately share income $XX.X administrative corporate of $XXX the ended XXXX, rate to for income approximately the to XXXX. XXXX period XX, an General $X.XX in expenses, a tax NASH, Moving diluted recorded million. income to December securities, period of million of the in $X.X for fiscal September RSV ended increase in due ended clinical compared totaled corresponding non-cash to common XXXX effective for Enanta X was $XX months to for of tax programs tax expenses to XXXX tax deferred XXXX XXXX. our against in $X.XX and due million Tax revaluation X $X.X preclinical the federal comparable effective per same period million tax Net million XXXX. income rate September and our million Cuts compared with the and and per Act

to the meet will sufficient requirements anticipated our expect that well future. our cash royalty these for We resources foreseeable revenue cash as as be continuing

XXXX, XX%. Further to turn like details be the quarter our in and in tax when Jay. available for In general development and expect administrative and our terms of for million $XXX our $XX our between be and to between million, $XXX be press and fiscal XX-K back would are available expense expense call Form to million now be and the effective rate release will I research we approximately million, guidance to our $XX filed. to

Jay Luly

Now, year major sixth on public outlicensed proud time we as in worldwide. of part that I disease became a had since am HCV, that approved our have cures we two company, a products for

our built scratch. programs from have PBC and HBV in RSV, NASH, internal We

We the turn compounds compounds clinic the the have Operator? discovered open and And brought to to starting lines to plan Q&A. of clinic and through funded the the Year. call from these work we to new programs non-dilutive is that that are being in New financing. for we developing I all now bring the operator more up to back still two will

Operator

Capital [Operator Instructions] Our Markets. comes RBC with from Abrahams question first Brian

Brian Abrahams

there next investigating might considering maybe I differences regard? might on what groups how class this you unique the and of Hi, thanks are subsequently think had real in if think study And results given bit the you I RSV we as XXX. your the you a that? the some intrinsic a steps, first patients on then could I sort challenge about trial of predictiveness and program offer question. the of you And that the a world prioritizing guess drug and little of beyond, B. and towards about for curious differences, am what I questions about look of views was talk study hep my challenge you development in the the path wondering then can as for my then taking follow-up on be

Jay Luly

Sure. for the Thanks question, Brian.

this at the think it to it’s the on to translation I case of the really are this Phase of target challenge the organ, whether Xb, it’s in Phase comes Xb, at is So, the lung. in to Phase X looking think the Xa things Xa, clearly market, the look the which a you are Phase that when study fundamentals I study, targeting whether things indication are and of the have virology the is which we

virus. have Phase we So the in Xa, infected RSV with looking humans obviously are who been

which on real doses, not that I what one it’s time we setting, of We people carefully. allows have the there reasonable you are does do real of during drug what in world a load pretty infection. our to viral world setting, setting And perfectly is with dosing two at course although think picked the the look really

looking at extremely of out carefully the actually and be folks will and will the We kinetics also dosing from be measuring time signs viral that start we symptoms. we

is is this standard to. you which fairly will another best of information, know environment actually I I out controlled the think some in the do So question, information is can of your patient other Phase a part a at Xa, then get looking and populations, which one of before going reasonably we

that So many translation, in of terms aren’t quite it of honestly. there examples

to issues challenge basically a that Xb the think which had translation on lot that can belief ones people that have that in It’s Xa I are with inhibitor think moved mechanism the populations Phase main some fusion Gilead’s the at might the of that of to point a from Phase I have do think terms sort rather to of our than fusion going stage. a studies of Xb. to next I

that there. the did weeks. that trials. Alios have, finding within stopped not stopped I in with is a to am that translation were Xb see have opportunity we anymore to believe trials Xb Phase other do led occur I J&J that was was several we The the but that on that the last preclinical stop that Phase nuke sure

study have but to than So different a Inhibitor. taking, those we non-fusion data the the been interesting very – slightly been are that from not was would a see results would a that because approach have one fusion importantly,

there lot having the of but against the on underpinnings the data, activity the good clinical in so and we you virus, have And pressure is and the type fundamentally this lacking study, think of if think good from isolates scientific a really good I – it’s is than science territories make world isolates good about much Phase having in many both there against very for would different you I of I activity translation. chance of type say type X say a that probably of many A and settings clinical where in a change. would sort a variety higher B, is got

So I think this the is profiles. out other you safety of get thing

very X-day safety As treatment you profile. duration. know we for X We looked had a in a Phase clean

that But Phase expect we in So get a anything of X we days that don’t different at in in will certainly X study. and treatment at look beyond. that

So that’s another good thing.

at be think this tissue will right in we right So the again targeting the long right and I that a organism and study species goes the way.

then In would before the children, remind are about already almost is think infection, will tract infections who very can targeting, incredibly child you people the have elderly infections. quite young in three hospitalized every respiratory immune which patient then to who top are common populations I and And would to to be but these in be know, susceptibility vulnerable I compromised terms infected this think otherwise where just consequences of are age third elderly, become patients at it’s we X the looking severe. RSV the settings elderly vulnerable greater or and you actually people class the

studies. in just in terms all that or early populations of and likely discuss taking will But is to in expect XXXX. we are the have with with prudent adult three studies those, we different and be those think So population those time we of of three in that about more patient prioritizing starting be path will an all over to I I

Brian Abrahams

your think draft line? and maybe which between then combinations you and on how the XXX bit might differences about and how coverage, selectivity expand path follow-up to helpful. guidance HBV, FDA respect down monotherapy you metabolism potency, XXX exploring Thanks. you hep really about genotype more little things or influence like a that similarities the B – recent the and populations, might That’s just a And and the with could development naive, think on on if development then

Jay Luly

questions. that think XX I was

it, we So into to better a part out year better is than extremely point going out all good around ourselves even if molecule. plan had of of detail more without the what items XXX. we it’s we XXX a to through those believe was we at put conference rest capsid this quarters I in-house which something that an but were getting was work And is have that in very we see what a we of the EDP-XXX, give year point that by opportunities have data trying do today, prototype the XXX present inhibitor, put earlier with can this lot we than substantial stated to well-rounded it say when today a to scientific XXXX will few

that So if haven’t and as the every and virologically pretty you and benchmark put all vantage continued down optimize. other just from use dimensions the parameters we of out to a and some that drill point, data we much PK some DM

closer in a candidate, are to DM and with particular, details when Related lay trial New again expect and in to So very in look the XXX studies PK this but are profile pleased we we clinical like. Year, I what will is will those and we the design, will out as earlier the strong virologic studies timing, more be very strong. about would get profile, the the we

Xb as do Phase we Although in X to patients. a into portion plan mentioned get even and I bit the HBV earlier,

that. on tuned stay So

Operator

Capital And from question Partners. Yasmeen next with comes Rahimi ROTH our

Yasmeen Rahimi

then questions one Few question on and team. RSV Hi, NASH. on

Are had then quite secondly even you in the the that is to of walk trials? In doses dose higher. elements the PK getting X a study the it quite challenge and challenge challenge follow-ups. however push been sort in other And seemed selection Phase in have freedom phenomenal correct. RSV two the lot given have theory my of you in the of through team can RSV I Jay, more And us of the optimized it study then to RSV So, financing that there and you data? simplistic quite failure view, contributing protocol of kind have

Jay Luly

on Sure. Well, inhibitors of and stage. the there this didn’t challenge others, of that in There moved lot I work that where that people moved is study. to regarding on. very some examples weren’t there. discussed failed are just and a that the have There people already they successful not were challenge out mean, examples then on last of data points in potent fusion then failure guess And question. I were We the at

So different exploring we we that as have to fundamentally a that itself dynamics wanted Again, million and pick with solid be to in I pretty have strongly set so a do is what doses. powered the would get strong up down much dosing challenge variations very study we the in coming get exploration to two believe easy to for on endpoints think lends bogged selected. we opposed there

so at the that doses higher And range. we the were chose

full So we fivefold did to think picked that at are a have have so multiple. on or at exposures I hours ECXX. What doses hours who XX and we might XX in XXx went studies we where in the trough and multiple or done really hard. other that the challenge have we range either people explored these doses doses levels was press the ECXX at Phase based around going we with really X looking we the X-year of X high a could we from of Phase mean, a in an of come

on resistance RSV. kill avoid the is time of is pressure. think so it you pressure to So to We put kill very virus, forth. in think and is more important actually tremendous that’s there it, we pressure more And amount quick,

get sooner steady the treat can better better. state, sooner better you multiple to of the ECXX the probably get virus, So sooner probably and probably a the can significant that the and hammering the can you you

We are MXX strain, actually we human in at cells. the at one very careful human etcetera all went that challenge we X bronchial at the using two we from and the the virus, study epithelial curves, So understand with up and we that’s and looked cells. those our and virology study that primary the Memphis of These strain the PK did looked to then in doses. etcetera, came looked Phase are

a you So day. the XXX know, once is first as dose, probably milligrams

the BID. looking comes with and other XXX The get know the in we dose, high without trough of very dose then BID just even the And substantial levels dosing, against loading ECXX. it a follows loading at and XXX we with multiples

So, human very very, using type PK. cell a and great we are relevant

So to be it exciting think will get. an I dataset extremely

calendar the expect that is We timing in on QX. again

Yasmeen Rahimi

two that quick obstacles development the Are into questions. the any RSV then And it versus clinical are unique Great. or immuno-compromised? elderly taking children regulatory there in in

Jay Luly

any there are sorry, am I regulatory what?

Yasmeen Rahimi

there it for Obstacles, that you before of unique immuno-compromised? elderly element the children it take is show can have taking any versus versus into that’s into development you to

Jay Luly

Nothing terms it’s of dose in in peds particular, mean standard for regulatory a I path development etcetera. selection

mean, of your you So just little development them to it’s before nothing from mean targets have are bit think course. I is other you to right. we prudent infants considerations I doses it’s a more are do just are are experience – their get get moving adult what during think a about you Children with just in peds? to have perspective, heading peds, our play think the timeframe. wanting special, I into once to peds around do I

then and in will X, well. power as our we the going getting path perspective, have don’t Phase that children a population phase will is on we other from we – an So otherwise is going got get even Xb adult to healthy it in but little the or world bit same is in and study or experience challenge want that adults. we infants on And dosing good get path different, Phase suggest gradually healthy to more we are I populations are for

Operator

And Bayko Securities. JMP question our from Liisa comes next with

Liisa Bayko

and taking Hi, congratulations thanks the question my on for all guys. progress

Jay Luly

you. Thank

Liisa Bayko

to you soon test the treat up starting your sort you all? do that’s can little and initiation to and regard therapy? therapy I model of of in a need you sort RSV, preclinical impacts sort thing the one observed So bit have you setting in more start how quickly just I think speak And big the done at you when down wanted do in to on find that of have drill what RSV out have reality testing in outcome, to to how maybe any that how animal of you if same effect? what

Jay Luly

Sure.

So earlier as any infection, get sooner to mentioned viral more be. the going better likely I the to is with you outcome the treatment

to the a in of So a the spectrum. the virus, of sort the you will slow few it’s days, peak XX speaking, going then a it a be decline, And down over of build will what days so. up have we and know or around viral it sort the generally will course typical come probably infection, infection have virus of course about over a

to time late severe, the towards of component going infection things, an when the that particularly other get the course near if are Now that the stage inflammatory you treated of period. is back or you if is haven’t end infection,

So, syndrome it cascade the to as primarily of sort viral is possible as sorts. and a sort deal with viral here a than soon real goal infection board a an inflammatory of drug on when rather it’s and infection of get the

in model a the monkey challenge I did a primate the now has been that efficacy nonhuman sort while predictive is in for animal animal answer picks doing modeling And carries duplicate dosing human next that of green African we done of of why specific that human in would step. and your amount that say studies, sort to up in right perfect it And this, challenge don’t so study model. are to success so what that’s the we of some model. others This modeling we – limited have question, have

So let in I days again we X after and titers and no intervene more the after viral few think than we infect a people, days. and very come we high climb then

that a timeframe sort you that window. of So have a it’s in

going up to after on at Now physician you the of when symptomatic continuum, And the and builds become from you different become few symptomatic, day day that, initial be for you to slightly each harder that’s when have the present take again being the symptomatic. a been because one day viral infection to upon likely days, they able it’s it get load present, situation a to because then further after, then is likely a you then be action days that infected the and those treat. the the patients you

the inhibitors in cell. focused is be because expressed longer with are inhibitor non-fusion you that infection Because very, maximum on infected, to early Now, believe can it helping reason of possibly as is the going no become we the a the the you get we very as soon efficacy course fusion in very, that there. once cells

it’s and too such In that. turn going may cell factory into get that it’s later later late point you that fact, a infection viral burden replication stop a you on will cells, and you the of other for but at some

are to we can infected to that do there address and pretty our is and non-fusion to we want with in on So the approach, what no N-protein and sort with able of to matter going you cells you go inhibitors cascade, our are shutdown be that have in quickly. drug is get which virus where

viral wider are later we might to what you a hoping also at purely have an is So, entry. than target that other days birth efficacy with some day a starting mechanisms of and at

go that right helpful. So, be could there next species, the confidence the did just in I do de-risked build think to much step non-human human know modeling and reasonably and only I then in is so as if Again, don’t we should as that’s we a you do can the experiments think it I make experiment.

Liisa Bayko

research know when that you or are guess of you the when when is people of in gotten have you not market any guess typical that there that? there helpful. of do really that’s ranges Okay, have Is I you understanding any duration? tells would terms don’t diagnosed I kind

Jay Luly

Yes, you don’t been infected. really know when you have

Liisa Bayko

Okay, alright.

Jay Luly

It’s one of those things.

Liisa Bayko

I titers, that to look at one it? is guess way the viral

Jay Luly

obviously, they have they I again, are before – a there that non-fusion they you if sort know you substantial few up We you I viral get with they not several you treat to – on Yes, once load, we become are there to come into as do anyway. piece. of a days late a kind they going get up. anyway are trying but for while. are infected for mean, symptomatic, before Inhibitor there of are other symptomatic, hand days And work been but a with we think up before people inflammatory catch have to as if the soon

So, that’s the window.

Liisa Bayko

Assembly, you B compare to for others think I and in maybe could Okay. there, Jay. anything of core core are inhibitor J&J, the contrast also you like the obviously across terms hepatitis And and notable then that’s some also metrics just Thanks, important and potency your maybe else I contrast and out think that inhibitor, can potency of Arbutus, genotypes? the of compare

Jay Luly

Yes.

You are welcome.

lot on We expect I will well. equally this data. amount you saw is how have of to mean, it reported have of And What with a see probably or your very robust a a lot much as that many of even but molecule did people can have and quite summarized type we looks people with to make comparisons, other better. XXX. easy a for that up you XXX data built of tremendous that we I dataset, note more think even morning, than few cross

as and yourself good And other it’s day core we on very, and basically want or to we a base functional a mechanisms then that cure. cover. a can such one it’s to a therapies we profile. mean, to have strong inhibitor the can not, which want we very it’s a as required I get if it’s add some of that contenders hope very to I nukes to show So, best-in-class strong that very, other

think of today big we the load it places. to we lot ticket sort put are – in so XXX show so usual has to a out And definitely we profile So, a data and speak. ready not data will next a will the the but will XXXX, year, we be just next to to have of we have

Operator

next Your from Eric with [Operator JPMorgan. comes Instructions] Joseph question

Eric Joseph

Hey, guys. questions. Thanks taking for the

much how I there be that? the it that do take and additional would an and challenge after population? dosing the when place opportunity, potential or work done something Is after study Just to am infant look to wondering active the ahead a adult pediatric you study would be healthy infection follow-up on parallel needed or might in trial just there could a in of RSV

Jay Luly

Yes.

we children. So now. the with study, we as will and follow then that, challenge adults for on will the the that go will FDA earlier, we And I bring regarding will recent will, guidance time into mentioned go we after from we

look studies So etcetera, but at I I straightforward. reasonably be pharmacokinetics, actually will that think to it’s there use will think we other

Eric Joseph

flexibility and Thanks. any as seeing impacts that headwind data seeing commercial whether been to to reading Ocaliva, any be we timelines guess, coming I little And should you is, from provide am to are anticipated any, more enrollment? looking I whether what you just the just there if PBC Okay. But and around a I from in you update an INTREPID, months. color expect to for remarks a are wondering extent your that’s opening enrollment am

Jay Luly

Yes. those pieces. hard NASH. mean to different It’s all definitely is PBC I than slower know,

for think current to the are I we see is think dynamics starting trends, mid ‘XX. us But going specific probably are a on difficult unlike NASH data of in sort of less ‘XX for recruiting that sort it’s timing at get moment. likely based that PBC think data what have to in say where I we targeting I it’s given the today and that there would in competition we for maybe indication PBC aimed rather One Ocaliva later. other market I which line doing competitor it’s for is thing, we which an therapy the and very viable clear fibrate are we generic recently than is approved orphan PBC drug a as a the market sooner second are a closely is And opportunity this. watching at for

So, our PBC clearly very, is NASH, focus. to NASH small is a which market very principal compared

thing, are we keep eye it’s definitely we but a the just So been on will – whole challenge.

Eric Joseph

the Great. questions. Thanks for taking

Operator

Your next from comes question with Jay Olson Oppenheimer.

Jay Olson

and FXR cholesterol a ask effects? about follow-up how agonist likely doesn’t question. of design effects EDP-XXX for have FXR an side if question could side increases be an it LDL for whether to are potentially the thanks NASH, would pruritus talk you can taking those in hi, think Well, agonist Maybe on-target about sort just or that you and think not you just I

Jay Luly

Jay. question, Yes, really interesting

know, lot. we you this a have as So, looked at

We have thought about it a tremendous amount.

in interrogated have this in X some detail. We Phase

need so we will obviously dosed we up, backup. As

differential and trying but lot that LDL as did a way, seen we seen And EDP-XXX versus increases. found LDL increase nonlinear we So levels we that we saw seen. LDL our in out looked work potentially what with receptor obviously no was as maxed sort perhaps that LDL why and pruritus, at see did those have in what where weren’t in regulation some Phase done we Ocaliva has exposures X have didn’t see had high with of of we receptor LDL saw to went know, a increases into which pruritus with effects there Intercept explain at increases. they increases you found We LDL going We doses and knowledge mechanistic everyone else. understand their the the of very

understanding I So meeting. some the going into liver I account this thought had of

nor described think their varying I they a couple but in just ago. see that X did changes studies neither Phase in weeks showed to their of it they Novartis Gilead work, X had degrees pruritus Phase

understands the So I what think sure, is exactly pruritus question I anybody don’t that. not am fully causing yet

about other that work on properties our FXRs. So, we are thinking follow-on we and as

But in doing the people’s now, having of tests in-house. to bit confused. series continue meeting the We at are around looked a liver have and came constructed dig right other some from little and as that we away few being I some datasets a further area we

and Novartis are Gilead some it – of their appears changing Novartis appears think doses that maybe around that now. it I

dose least and liver dosing with to their they be data studies, seems Novartis from the at So, dosing in I that future seem meeting. in combination believe be the saw down their the at Gilead, to of higher some they

time with good more our and mid and on. again XXX so to dataset year at so relatively reading days, far datasets heads but start are to towards look we will for again, our early and to But scratch getting tell, still next out. So more pointing we are

Jay Olson

Thank very target great. on EDP-XXX? Any a product for you. Okay, thoughts helpful. That’s profile

Jay Luly

FXR thing of some of the of from FXR two to Well, patient. again, is the a exerts away we that on and the when path did in is one data probably NASH the – are mechanisms liver part comes strongest it still that come three so fibrosis FGFXX we think meeting which looking at

So a in FXR overall very mechanism we in combination. the could critical I from point a still vantage knowing that of need makeup that try to NASH view therapy, to be one at what and accomplish

I up a what to want very come So FXR. with is strong

We demonstrate are we to of this up things, about these end so the the committed ongoing bit very been with one how activity and tolerated solid about agents. but and with that some even a come research the a readily combinable day that’s a anti-fibrotic of can with think our molecule generations thinking package with Ocaliva, with has seen to that at of other better that of

So high level, that’s the profile.

Jay Olson

super for helpful. you taking Thanks. Thank That’s questions. so the much

Jay Luly

are welcome. You

Operator

we Instructions] questions at further no And [Operator have this time.

Carol Miceli

today. you for us Thank joining everyone

in give additional free any the call office. to have questions, feel us a you If

Operator

you for This your does participation. today’s conference conclude call. Thank

You may now disconnect.

Enanta Pharmaceuticals (ENTA) 26 Nov 182018 Q4 Earnings call transcript