ENTA - Earnings call transcript Q1 2019 | Enanta Pharmaceuticals, Inc.

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Operator

Good day. My name is Ian, and I will be your conference operator today. At this time, I would like to welcome everyone to the Enanta Pharmaceuticals' First 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 Carol over Miceli. to would call turn to I begin. you Ma'am, may

Carol Miceli

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

forward-looking be Mellett, today of making Paul Enanta's to begin team. before we Chief the statements, senior could differ our results filed periodic description cause and with most remind the and want SEC. Executive during call that we'll in A and Jay President statements. other involve that not with respect obligation to include Chief materially I'd those these Form undertake developments and may President this with we remarks, to any to Enanta update Dr. risks management financial is which does of like On CEO. is Financial reports turn and our plans over recent the risks Luly, Officer; Jay and Officer; our statements actual our our members Luly, formal call. Dr. our call other forward-looking our beyond made now and assumptions of you which candidates to any and certain to projections, expectations from XX-K all product control But

Jay Luly

look Enanta to joining I'm pleased today. milestones us to to Good for update Thank you Carol. an on Thank you, the everyone. afternoon, in provide forward XXXX.

highlight development to selection clinical the though the candidates. and take we of I disciplined First, want focused to approach our

clinical potential embodies that of areas. promising focuses in and approach disease scientific Our mechanisms biology action on our targeted sound

Enanta's potential produce that apply to capabilities promising drug unmet pipeline discovery each candidates treat in internally-owned approach opportunities. major in needs. possess order first-in-class we quality to to For or resulted disciplined This world-class of has area, our candidates best-in-class aim

include the pharmacokinetics mid directly multiple that of Xa dosing is challenge will our is only the resistance activity arm This I'll first today. we Phase our be vitro. healthy XXXX. in has you RSV subjects challenge demonstrated two randomized at EDP-XXX N changes measurements of EDP-XXX, and evaluate inhibitors development up expected clinical a Primary Xa XXXX or inhibitor calendar to days. placebo-controlled and load remind advancing of we In milestone RSV targets who because study adult fusion well, human We Phase viral EDP-XXX study challenge from barrier study of to expect The one process placebo top from data for it is inoculated for safety, our RSV in baseline five in and October, in orally into line replication measures be the readout data dosed of subjects, that to trial N a changes to XXX EDP-XXX arms and and and healthy secondary human for in with enroll RSV. randomized, outcome a high administered viral believe to differentiated inhibitor symptoms. antiviral double-blind, doses initiated will

two have and ongoing we trials EDP-XXX, NASH to Moving in PBC.

We with trial double-blind, XX calendar pharmacokinetics expected EDP-XXX randomized from Enrollment is XXXX in quarter PBC and the this year. This week placebo-controlled our in clinical safety, data in second a subjects of Xa quarter sharing calendar NASH. is study, in this data to As be ARGON-X. last expect of announcement efficacy third tolerability, evaluating the conclude trial anticipate to of first we ongoing, this of with from quarter, trial in XXXX. the recruitment therefore, trial compared our EDP-XXX NASH in And NASH. milestone as lagging known mentioned the to but Phase is

indication, potential commitment follow-on of As need identifying have we recognition research the agonist and continuing also NASH FXR and non-FXR are in of new approaches this mechanisms to our in in leads. efforts therapy therapeutic to sign for a combination

year. later announce to candidate expect follow-on a We this

against is are third are assembly assembly activity. referred is HBV. and new HBV antiviral nucleoside as XXXX in Members core core This was lead lifecycle. relatively that in can disrupt milestone Our cccDNA, with at are positive multiple to they core class is a have clinical and modulator points are a inhibitor, human potent novel characterized first-in-human that demonstrated HBV in inhibitor series In announced January, be liver a of of by EDP-XXX other on from model virus capsid are study activity resistant EDP-XXX. steps to with the compounds mouse displayed expected the replication cells. in in active titers a known This HBV inhibitor of viral or a class allosteric establishment to reduction excellent data our analogs the HBV preclinical chimeric potent at core inhibitors. of lifecycle. also synergistic of pan-genotypic, of additive the of a In the vitro, also mutants, EDP-XXX protein preventing and this capable of nucleoside EDP-XXX multiple Enanta selected anti-HBV the modulator. for initiation

for will with best-in-class healthy Xb single the second incorporate inhibitor on of and Phase EDP-XXX our will doses study humanized EDP-XXX evaluate of potent XX weeks Based the preclinical a EDP-XXX planned half HBV volunteers than liver infection. patients dosing. inhibition on we of preclinical core mouse data, by demonstrated in greater HBV in addition, to in strong and X-log multiple viral X Based XXXX. reduction replication data, Phase arm is accompanied load chronic In of has in mechanism. of drug begin model a vitro, The in a the potential study a after believe

from International Additional liver preclinical will Congress presented the EDP-XXX at Vienna April. be in in data

may stages of mechanisms EDP-XXX, summary, of to as treatment utilize be various in anti-HBV the addition In has it and other In necessary we promising are pipeline to broad of development. approaches, candidates multiple a we for HBV. believe Enanta exploring

million debt in marketed by been products HCV our has sheet, science AbbVie, program, has partnered resulted currently MAVIRET, approved in the and quarter in the the call including discuss treatment a the strong cash which leading to I'll finished HCV advance for no validated Our Paul $XXX resources by our with the securities, we our over pipeline. the two financials With turn financial to Paul? quarter. having and have balance to inhibitor stop here world. and protease approximately

Paul Mellett

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

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

royalty royalty same XXXX, was on Royalty regimens. of MAVIRET VIEKIRA current was revenue calculated global in in royalties X.X% reported will of revenue. remind total This Royalty for calendar product royalty to after in that certain on schedule $XXX sales. contractual that means highest has AbbVie's quarter earned of rates This which months year. everyone our adjustments million in fourth basis sales rates, approximately in calculated of at I'll for reported are XX, HCV separately royalties, discounts For a on XX% a sales March tiered XX% our of of the which a on approximately have ending royalty sales quarter the total and XX. consisted royalty restart through calendar revenue three period entirely our at AbbVie's XX% a XXXX. rate revenue each fiscal XX%, the $XX.X compares at and XX% year royalty of $XX.X quarter will ended HCV the today revenue rising rebates, million been the and rate for December million was of

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

expenses. our onto Moving

common of the for Enanta December $X.X quarter XXXX. XXXX, ended quarter million expense versus period our diluted million an and and balance of for to for or diluted recorded clinical per tax months the wholly-owned of million XX, same The Enanta million corresponding R&D $XXX for expenses in in XX, quarter XXXX and of income three XX%, enacted ended million $XX the the NASH, compared $XX.X ended increase approximately million period increase Cuts credits. compared US primarily months of $XXX the General For of comparable million, XX, to tax yearend and three XXXX. same common Net XXXX. the Jobs the our XXXX, million the research approximately due programs totaled share $X.XX share, for an costs the with XXXX million. income December RSV, net securities, XXXX $X.X $XX months due marketable in period was approximately $X.XX greater the for for in Tax period December for was expense for effective and the compared per ended Act expense months primarily rate same development in $XX.X income $X.X and federal the to and associated to XXXX XX, administrative December ended approximately and PBC XX% to research compared a Enanta's three to three HBV. cash with million the was $XX development increasing was income to December tax or XXXX, fiscal $X.X million progression XXXX. in in preclinical

well for for to and Further We royalty cash like our now our questions. and open be the as when turn to be cash back will release available the the foreseeable these details operator the requirements Form press our quarter in expect lines XX-Q call the available in I'd to filed. continuing Operator? are up that resources, sufficient will meet future. as anticipated revenue for our

Operator

first Abrahams Instructions] Our line Brian Markets. from question is from RBC [Operator of the Capital

Brian Abrahams

sort going in guess progress X NASH We're Hi, my obviously order for data taking FXR and your follow-up I stage this on guys short to of the NASH. all XXX strategy question REGENERATE from my late well? Congrats And from guys. questions. on getting the and you of also your be to some partnership XXX Phase thinking thanks the on study are program. is data read-throughs then the primary kind and a I plan have then about I'm And of agent. how as for potential development strategy wondering,

Jay Luly

the Sure. Brian. This question, Jay. for Thanks is

have is. mechanism So the are the the I data are speaking positive, the read-through, for from what most see the FLINT what think mechanisms the generally most We'll speaking, what's in it one than generally development if the guess that of as highlights read-through? likely the signs and think and All data. good, a strengthened good think case, data Phase FXR I see validation data should we'll the is If X see just X But their people's Intercept again, But very And I have to it and the is then case. Phase it just to the on FXR. since - why it's probably promising that's study least I wait wait it's have to if we'll it is at similar. safety; of design be But positive. very depends are I today. is. minds think Is to are it that less the efficacy, mirror that

past we to it company of again, one probably is our indications on. partnering to a like As relates would team in strategy, up that larger said the with the NASH that we've

cards and thought timing I do think initiation that's and just perspective on aim before would probably still ultimately, X. probably it a the to for in of we from Phase us that,

Brian Abrahams

really in you've ASK-X in beyond Got late it. then sorts of the if hop And queue. terms in FXRs whether what modulation receptor and to be the hormone you'd the could be those relative for then about I'll stage what attributes sort in talk And on. And could XXX. helpful. might next-generation pipeline. that FXR potentially mentioned mechanisms improved back in like believe little working for you you indications looking you those development on some the curious Thanks. be That's from bit Wondering more a of there of is thyroid

Jay Luly

Sure.

ASK-X. think the filed highlighted about weeks I area your So of out a the research that note IP other question in that I the few think some came mechanisms, ago we

an So only have interest ASK-X. that we're the not one mechanism of it them. is the It's case in that it non-FXR is exploring, but we

fact have different looking them that here. a prototype In internally of EASL, to we're few we'll relate of molecules a upcoming couple and at two presentations the at

on of of out different data different And a animal and will models presentations. so, there couple some and a variety that be

stay front, that can you around. So tuned when EASL on rolls

I follow-on a carefully. very think FXR, the study also continue we to FXR with mechanism very,

lot markers transcriptionally models, a efficacy - the also at and looked level potential model we've at side markers of cellular then know, you of drilling down into effects. at animal and things of potential looking deeper of markers As

done kind we've great And that we work on of We've also a so on EDP-XXX. have deal that of on molecules. follow-on work done that,

So candidate. we're out still finalist working the

thinking intrinsic upon with thinking about I or if FXR to about anything dialing be there. those mechanism, things the safety but and that to and looking think may may so optimize that and the just specific we're molecule, at doesn't associated can always improving out not potency also safety, by belong effects there trying we safety, not are

what dataset And then, that profile out That's over we'll very later what even to call see We'll slate at looking our certainly available. to those carefully of there. at we'll have we improved So the on think that looking evaluation we be in-house. lay but stay have, we that contenders tuned. for, when a out finalist be we're it's an finalist we'll wait Phase for year, the make X candidate this our aiming expectation under we specifics, final it's so have molecules

Operator

of Rahimi line from And Partners. from Capital ROTH our question next Yasmeen is the

Yasmeen Rahimi

walk of that Phase follow big say, question expectation of the up. Jay, magnitude Exactly want a kindly this you on a picture to study? allow And one have study? RSV team. reduction go through Xb continued challenge I what into you load will out is know then question going Hi, you is what on do Congrats what, question. questions, viral progress. Two a decision you two larger a is me can your is see to RSV, the strong to

Jay Luly

Sure.

studies succeeded, front, load in with are On a you of several-log other viral the a multiple-log see And short infected viral RSV that usually with amount agents subjects time. reduction challenge a these healthy have titer. that done been period do have who usually

at quickly of treatment. onset drug drop be would it generally fairly pretty viral happening the So load clear a

So I to also type looking powered see of believe drop, be to this and on a and signs be study the order marker in able level. we'll we've at symptoms secondary

Yasmeen Rahimi

And and actively NASH then Jay. you're RSV, B. you, Hep pursuing Thank

structure, is have want what you is me what you and to once through So is in what the is And you we mean three, you want what X data that one all to order the walk - to strategize what - along? the best, so importance, is right to heart Phase priority is I team and your the moving the kind now? really of among to closest succeed? to are can then your

Jay Luly

is picked and they're in - all which no either them each important areas We've to approved succeed is I with want is There no to both. think all close need. my areas, drug or a these out really or we heart. area so of unmet there cure,

I they certain point, at also we've - we're And NASH, of, are. conscious I some team of we about become got at mechanisms to passionate decisions coming progresses we if in bigger making the same So some through other and just all side it. start The would make sense think pretty example start We've all probably things, that end We're through that's a true things in RSV Phase index point, terms NASH, multiple doing time Xs I is molecules. mentioned, end these that, to believe could partnering. at But as of different of got for much prudent our at probably is way can we is why at this it than for pipeline NASH up. partnering the us, multiple comfortably one point. areas. hope, prosecute on and of in the

ourselves. we're planning I RSV, for take forward to it think

still be market collaboration. that in large doing of try but value of But some it. it's more in we best says versus ways the then So connection can us about it team I successful go best very, these we the by of something opportunities, and on declaration thing that what's lot a to high-value probably that create what's thing for guess to the up on alone in can about very

now, stay front. and Xs. comfortable think again, on - I clinic into that So for assets and the these But tuned right we're through phase very prosecuting Phase into

Operator

And our line Jay from of Olson the next Oppenheimer. question is from

Jay Olson

Phase a go terms study, you second on just of in FXR study thanks of terms determine molecules about or both safety of and instead have back in EDP-XXX and profile sort want your to thresholds of NASH Xa set to can to for to proceed the for what you on or efficacy? tolerability in focus you may whether and Phase that congrats Hi, the not to taking Maybe my show one perhaps Xb follow-on questions. talk to to the for your progress,

Jay Luly

the Sure. Thanks for question, Jay. is This Jay.

the markers primary got surrogate I lined which ARGON-X looked have that I target ALT up think mean, which about we've before. at we some way and know exhibits secondary that XXX we have of So or engagement, also we're solid is several it, understood thinking good safety is looking the those endpoint the and and by of and and endpoints, study

if progress the Xb So engagement we and have study. looking we're one Phase that I our solid the to good at safety of think totality or of aggregate doses, target is data, more to the going

see remember in as study a Let's biopsy study, Will current is term Xb the only endpoint. longer a XX have biopsy study. upon Phase embarked NASH proven others longer study week our

So totality. and package the drivers in those be would we'll main at look its the

Jay Olson

Great. you, continue. Thank sorry, Okay.

Jay Luly

we're as XXX got decisions. Obviously, follow-ons. at sort looking than to use of We ahead. ways more They're of XXX we've our independent decisions; think got follow-ons got these We've plenty We've one are there than agent build single of independent progressing optionality progressing of by well. just overall. one lots one. depth you in just FXR and to and We're different directions. combinations into there's mean one more them and/or peeling-off further a as trying when another I partnering have either

Jay Olson

please might you expect and give follow-on. enrollment super didn't trial when that just any press PBC. data? see study of you in the on of to the Maybe as update us helpful. That's release you. see Could Thank mention Okay. for I INTREPID any

Jay Luly

this It year. Yes. won't be

mentioned in said the is the along enrollment again quarter is we We that slower. my just NASH NASH. remarks. I is moving prepared in lagging last PBC PBC think

with you to do on - creation will your of are expect for makes so because year sense is always some out a already that. data a remind of looking we're I view That FXR we shown there's PBC, PBC add don't general efficacy new as us NASH NASH in we I see you the it So line year. by, I'd point as is have convenient are main next the in focus standpoint, PBC, and And on been market. topic for our this in to the since doing is. most from to said market the lot second value in at therapies overall fact opportunity a it's the a study. PBC drug therapeutics that FXR

vying even what's that You for domination. maybe have fibrate people left have for plenty intrusion you market. the or And potential of of generic

So these least market little bit a are characteristics a our at in minds is that tricky. of

note to We'll NASH but reasons I So a out. is early you we the that is view recruitment remarks, I to opportunity on with progress for But the be a lot the think worked days, the as my probably of lagging update in still larger mentioned to regards I NASH XXX% It's and one. continue INTREPID. mentioned.

Operator

And our from from Liisa next Securities. of question line is Bayko the JMP

Liisa Bayko

how and looking to the think NASH we ability do for reduce showing and taking to wanted Ocaliva? the NASH to just I going How to of be way, important an you've be that to to its Thanks question my a looking good story profile. And compound your of trying get regenerate. factor. question. And component? think you Ocaliva know ways but to could that's NASH there as as know for efficacy I then do you fibrosis. on in build-off How earlier of of different FXR Hi. look second first LDL I been my it Brian's commercial both differentiate on Thanks. That's approval two to as be question. at can you relates at kind is to for that important important kind either

Jay Luly

I of of ways really a mean fibrosis in couple I to happen know there's think the a is end to two don't points. important I but one, win. terms

important an much with I think mean so increase had you being will from and we things at a of all the I and an read not doing We're be time anyway both much profile we combination adoption of will for solid lot marketplace what overall. patients that profile the have LDL. assuming see to and come them day, of after people thing if it end to into And the do are be just ways FXR way, I some what is an an tell. guess it's is wait Other that their it's regards do how of agent really is have did approved away can the ultimate be How we in anything advantage. At for steps be and of things each big a majority best deal say regimen with such mean as the we impediment to a equal you trying likely important see can. I so lipid I they people can not, to on data that a uptake and Ocaliva. in that the chip think of Ocaliva factor that wait want would wouldn't thing. not a play to We an So these a to this in all. get NASH, consider are create not how component so. fact big that they're advantage? modulate very

to give we're a ticket us FXR just a has solid So looking legs front that the so to to combination line. on some to the create show speak down the very

Liisa Bayko

study challenge Okay. what program? And your on for a maybe next steps Thanks. I Thanks. steps ongoing be talk have readout - may next the this question the you Could - helpful. RSV. then after That's about the would just if the

Jay Luly

Sure.

Liisa. welcome, You're

end the positive Phase as expect our so the hospitalized then is for would moved be of the in of It's assuming mid-year, top data start now And So to and timing likely sort line perspective, to from data. adults. we've that timing Xb have calendar we a year up plan mid before we've which mentioned XXXX.

plan going So when we that the out think XXXX. I into for

Operator

Joseph Morgan. And our is line Eric J.P. next the of question from from

Eric Joseph

guys. taking for Thanks Hi, Hello. the questions.

question of - up or pruritus received Just actually. rise perceived as a just compelling difference would caliber. LDL as difference of I sense in guess Liisa's a of I'm to NASH you on be that whether a wondering compelling the a couple rates have a following

Let me go the statins statin accounts also SAE's at one of of data? look do the you I the ARGON-X meaningful assessment these ARGON-X, of criteria in that does trial And guess of anticipate of either as a in for how trial? use the use or the stratifying your background Thanks level of you

Jay Luly

Yes.

back of at data a kind question, as just So whole. going going prior to look the we're to the

looking And safety be so engagement. are obviously be going at and we'll looking - to safety pruritus, lipids to broader parameters target

aggregate, been in of any we balance on exactly hard be how it's to emphasize but we'll made in it. a be for trade-offs set, think are use, what I we patients have need good stable be regards until that the so And With who that picture to statin to know get included. to overall to statins the going the allow to data in months profile, three

would be our use no trial allowed. use of is it, during no statins new statins of backdrop also So but of new that the

would patient's the background baked of history. everything So into already be the

Operator

Capital Patrick one Markets. from And our question Berenberg of is line Trucchio next

Patrick Trucchio

on Thanks. I've Good a program, and then MAVYRET. up second just question a afternoon. NASH on follow

on first Just NASH program. the

should how fibrosis to should you Xb? anticipate for Phase noted do in most be. the study it study of be study the ARGON-X, stage sense And what enrollment you if long When and start do Xb that goes duration. have would think well an all we the you makes Phase finally, in idea longer of Assuming

Jay Luly

Yes.

non-cirrhotics think up and longer other I would with duration and pretty we're been. probably what by of minimum XX weeks typical FX, the study, a period the weeks to of have XX some So designs. of be follow-up at FX looking that studies But

was part sorry, So one there of other your I'm question?

Patrick Trucchio

When one. you just to study expect the And start? would

Jay Luly

Yes.

QX. be we'll data getting the So in

really the depends or when we've exactly end by not QX So next It on year. whether it early the in worked everything of year it's in might to up the be as got late year.

timeframe. So a generally I'd be in

Patrick Trucchio

of Got the in relates news This franchise, has actually it's as for the - specifically been it. few of accelerating. early HCV going the on And the in injection opioid epidemic on US. XXXXs in then a the terms and just since this been the stability years, the it's but to

coverage what by advance foreseeable believe I'm fibrosis wondering the how is the that enough in near be extent the volumes that, now over contributing? flat with the for business? may the these on not to staging enable potential franchise US the for who to about and think some be extent HCV And do ago - future, impact extent long opioid be treatment the for you this the epidemic in what may should folks infected and or so decades the should be we to expect term And were that we eligible now of perhaps

Jay Luly

I carefully studying a are question. That's now. people more really good that mean

been new but topic, numbers But in is only of US been of tens year are to in that I there years, C, there's for think the year before. handful there increased not seeing diseases. infections and of thousands I've kinds are that attention also certainly other given of overall the last for the last the Hep

think some of So number to I XX,XXX XX,XXX.

So treatment to it's - XXX,XXX that when think a significant you very US, treatments about in a been volumes have That's the US. the in in XXX,XXX component.

seen now does right question continue only it people decline? real I Does that think is have level much growth. the grow? to off? how for it Does So

least crisis genotype treatments there disproportionately is And these. But genotype going And market. cure for we're IV whatever to now matter drug a big opioid was for problem the how have long a cases. X still to larger at that think have see. wasn't X can It the have and something to an to ago that. we this infection going lengthen slice is to now was I you reading the it, reason, amount but that remember a drug so that - we no it's So tail just I directly-related drug infection good on news by

just but It's And money this policy help there time so a treat question to a and - with it's under public and to complex crisis get problem, people. of trying drug and health good opioid be it's control. a we'll

Operator

from from H.C. comes Wainwright. Ed question next Our Arce

Unidentified Analyst

Hey, good afternoon guys. Ed. This question asking is actually Tomas for a

will Should Just FXR expect or kind see follow trial? or preclinical leap conference the off the some it data about into simply clinical of data a some or quick to question with animal our kick or NASH. we on

Jay Luly

in presentations some the of the top there declare at the to that have but so time data follow molecule. on, that. no subsequent at the there - put be not Once have and On out, we to follow effects we'll it, data, We'll relation EASL. one data with preclinical will it EDP-XXX obviously on are on data or

when And you just it one final have we yes depends But surveying later of a regularly. we're this So make very official the among posted nomination. interesting number this again hope year keep contenders. year. actually keep really We'll the on you we to

Operator

And at Carol back we this Miceli. the have to audio to call time, I'm I'm showing turn questions. that going further over no

Carol Miceli

us today. for Thank everyone you, joining

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

Operator

participation. We conclude conference Ladies for thank today's and gentlemen, call. you this your does greatly

disconnect. now may You

Enanta Pharmaceuticals (ENTA) 6 Feb 192019 Q1 Earnings call transcript