ENTA - Earnings call transcript Q2 2018 | Enanta Pharmaceuticals, Inc.

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Operator

Good afternoon. My name is Sarah, and I will be your conference operator today. At this time, I would like to welcome everyone to the Enanta Pharmaceuticals’ Second Quarter Financial Results 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. now to is Ms. your It Instructions] my introduce pleasure speaker, [Operator Miceli. Carol Ms. yours. Miceli, the floor is

Carol Miceli

Thank senior thanks results our Paul Sarah, Web Jay news other afternoon, you, Luly, and and is Chief site release management afternoon. us and of Chief today members with Financial The On this President the Officer; our is on and Mellett, financial available was team. call this everyone issued Enanta's our for Dr. joining Officer; Executive

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

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

Jay Luly

NASH, exciting RSV. product pipeline, market everyone, had I'll and another afternoon discuss then like productive right quarter our licensed on We would internal Good included you AbbVie's Carol. now by regimen us will But our will programs wholly-owned thank in share discuss growing today. Mellett talk clinical-stage Paul including you, our Thank of minutes. I key development joining for results the R&D about begin in quarter. the for updates providing three to HCV, few and by PBC and our programs, our MAVIRET the financial for enhanced in a which I

a NASH EDP-XXX subjects study or programs XX-week are advanced PBC, is for X named NASH, agonist most studies clinical EDP-XXX with candidate. tolerability, FXR are placebo-controlled pharmacokinetics, the study with conducting in our of NASH. evaluating X Phase efficacy ARGON-X Phase where safety, clinical randomized we double-blind In and Our and

are versus on ALP endpoints, this focus efficacy with mechanism we parallel, available continue share the ursodeoxycholic an role with clinical INTREPID liver subjects or phosphatase XX-week endpoints International important and assess to a EDP-XXX evaluating and safety X efficacy the This alkaline chronic plan X EDP-XXX’s Phase will randomized a action, that evaluating non-invasive Phase and also currently in multiple of of preclinical levels at XXXX. of imaging or three evaluating studies our Liver study In from will fibrosis an preclinical new is and recently focused SR-BX data to and EDP-XXX made highlighted double-blind in demonstrating primary better ongoing; for we and of and acid, safety Those As will study on fibrogenic the play regulates PBC, entry secondary and vitro for assessed more expression in NASH, alanine or a proof-of-concept vivo, gene of placebo. in ALT study treatment transaminase EDP-XXX PBC. on to study key and steatosis. nuances reductions the In NASH. understand response in PBC levels, them data that of measure poster named in were changes of safety, tolerability, efficacy distinct inadequate by including on second markers presentations in receptor regulatory The placebo-controlled without EDP-XXX the studies pharmacokinetics, be significant of expression. focused EDP-XXX One and April. had and showed that LDL transcriptional mechanisms in Congress favorably genes post-transcriptional in

subjects. EDP-XXX The EDP-XXX study highlighting and of pharmacokinetics, presumptive its of in safety X released Phase pharmacodynamics NAFLD third from data presented healthy your previously and

an Phase ongoing. safety, XX study. began MAD is currently of by of preclinical the the Phase objective evaluate RSV-infected a next we infants X program in approximately Currently, X our RSV of advanced infection. the is high or no and are of have study clinical study infection top-line MAD most respiratory syncytial RSV. for is this range expect less being and of portion treatment mechanism and pleased received study and be the and From the expect from end is at the competitors. study of need, well. from the Phase inhibitor recently the healthy development we comparable believe seven-day a with PK the dosing anti-viral to N class virus, for a today virus timing this therapeutic challenge the to to quarter, will inhibitor The result, evaluation with dose stages of the The data is treatments We Phase and next RSV effective X of Xa X EDP-XXX, inhibitors, study developed Our the is Phase studies We potent area for and durations study begin has infection. will single-ascending to XXXX. coupled in than works for several as the applicable of for our dose This study pharmacokinetics the EDP-XXX designation planned dose in which tolerability, inhibitor unmet inhibitors. clinical blocking by volunteers. and more only age our N be effective in the a there potential fast-track N Phase by RSV EDP-XXX announce RSV, X as to guide data replication us Phase clinical of machinery MAD effective challenge the fusion and multiple-ascending data calendar from in immunocompromised has perspective, FDA of a two under challenge dosing to study inhibitor fusion in adults. EDP-XXX study, to the to is that this of years differentiates protein or the later this later Xb levels protein of particularly of The likely recently I'm humans by proof-of-concept infection duration

HBV. It's been Let's no million and XXX there infected are people worldwide with HBV, effective move that cure. is onto estimated

the of program and as ahead Congress refer of Paris Our on move International The XX. Core Liver viral are inhibitors in inhibitors mouse liver inhibitors were chimeric EP-XXXXXX, April DNA that of replication this assembly model by promising class activity SCID reduced evaluating core sometimes modulators or potent data that a and capsid vitro. assembly to we of steps in treatment, human in to data preventing protein. with EP-XXXXXX of capable baseline several demonstrated continues protein generating modulators and weeks on presented XXXX in HBV core of levels also preclinical is pan-genotypic advanced lifecycle. to three tolerability cells, of at and RNA up new HBV compound cccDNA of demonstrated inhibitors the and the HBV from This can in disrupt viral are at anti-HBV a virus the with core four allosteric pharmacokinetic multiple the demonstrated one logs of establishment phases Preclinical testing favorable profile.

our through products. inhibitors to licensed strengthen in to I'll later comment new portfolio, first announce now XXXX. We and testing HBV core our HCV will preclinical we and candidate patent on multiple advance continue hope our

strong results had in conference climbed which by in position recent invented the with AbbVie the AbbVie. internationally such glecaprevir, impressed Japan, to very MAVIRET countries inhibitor the that level with financial regimen, a share achieved sales that its market call, U.S. collaboration stated On Germany, of already are contains as and MAVIRET and with high position AbbVie's with new We protease they Italy. had a Spain, XX% major Enanta

to AbbVie $X.X billion. year HCV global result, guidance its a for increased calendar As sales approximately XXXX

second This provided correlates year calendar of Enanta's quarter In to guidance third million. quarter addition, of HCV AbbVie fiscal XXXX. $XXX

turn royalties wholly owned and leading I partnership on Enanta product Paul HCV the note, NASH, market continue call is for RSV. areas a track for and Given to Enanta AbbVie. forward a in from annually We all royalties royalties through PBC Enanta internally I'll is and of result I'll the in stage its of what you earns to the strong approach AbbVie with guidance would now fast its increased expand high group the have Enanta invented of three on In very is Paul? designation. earn global that dedicated MAVIRET potential of worldwide. a eligible position successful and look AbbVie's AbbVie, clinical programs to programs over discovery double-digit significant. our is drug and remind unmet now launch here MAVIRET. quarter. on also a as summary, this stop Enanta financials net development. development discuss to namely of to disciplined MAVIRET sales employees XX% tiered to has to of And these of three the from need

Paul Mellett

to Jay. a I'd XX and for year ended schedule, our Thanks, reporting today XX, second remind results are like year-end fiscal on that quarter reports fiscal everyone our March at Enanta XXXX. we September

increase quarter. million revenue XX, to in royalties earned XXXX. of three $X quarter period $XXX Hepatitis-C royalties including AbbVie's virus the was to revenue $XX the sales an the on sales compared ended, For in of for due of months million in same in increase of March revenue in XX% on million MAVIRET current was XXXX in The $XXX,XXX global the regimens

includes the of Enanta million $XXX the diluted fiscal was and assets XXXX, approximately was fiscal rate $X.XX as revaluation Act. March enactment as $XXX the effective against share to share $XX.X ended The deferred tax XX, or in and the Jobs the R&D Cuts due securities Moving a administrative income charge $X.XX XXXX. of net of XX, compared wholly XXXX PBC, or million estimated Tax XXXX corresponding the to U.S. reduced the and our compared income RSV, tax million, owned $X.X development and expense was in an comparable $XX.X The General for versus months of months for on primarily million XXXX, company's increased for million costs annual associated $X.X for progression NASH, in expense March same $X.X income to and in $XX.X common to HBV. preclinical per common corporate to XXXX reflect recorded quarter XX, federal months period tax benefit $X.X the tax and with end three of ended cash to result the our the XX.X% quarter rate for tax income diluted million three expenses the greater of the loss period in non-cash expenses of at period for was million increase $X.X XXXX. to impact in quarter the programs three the clinical same XXXX. XXXX. XX, ended marketable of compared research for a million September Enanta of per for of to compared March million Net year-end. million

We sufficient when be MAVIRET quarter our now the I in back release, receivables meet our XX-Q Form future foreseeable these the flow press Further it lines the royalty our cash requirements to quarter will and Q&A. future. available the will the cash our open is are available this turn to expect our the call financial be for filed. anticipated and that up resources, to operator for for royalties in details from earned and for like Operator? would cash

Operator

with Instructions] first Your RBC the from Abrahams line Brian you [Operator Capital question Markets. of Thank comes

Bill Miller

questions Miller is of strong on on MAVIRET and successful on the Hi, This launch. congrats Brian, team. the Jay Bill and EDP-XXX. I a have quarter and couple for

mechanisms you speak presented? EASL, data versus [ph] your And and presented potential of effects XXX's increased data in a on have on the Turning LDL, confidence quick clinic these can decreased some that potential the differentiation data for for if you to for the FXR-related were to I then other on follow-up.

Jay Luly

Sure.

is Jay. this So,

which previously, things another we we against LDL at in EDP-XXX at down think that a further that receptor, drilled of FXR to seems compare particularly I is nutshell up-regulation made OCA. we is the on agonist, we an it and looked one cause -- observation EASL is of that did when had

And we so, this. intrigued very are by mechanistically

have up-regulation up receptor sponging agonist. excess an you of receptor so in Of that might see body's otherwise mitigate an and effect LDL you FXR should is course LDL help the of the LDL then with body, way an

the an our in of didn't certainly where that and had course Phase in the preclinically. see It during was was born study. made X that studies so, X And we increase Phase we observation LDL out

today. deeper that dug understand And whole is molecule really selection about development just have under what into taken and that so, happening, is better done the we inform just have we we so can biology future regulatory that how decisions and EDP-XXX, that process also candidate

Bill Miller

saw ALP you also transcriptional And to your your buyers a transaction study we a ALP in showed result to effects? how And effects effects can you potential compounding to ALP in data just gene it from -- Thanks. anticipate in two the due speak PBC. Novartis' PBC gene that if FXR FXR reconcile on reduction similar have and and these for

Jay Luly

Sure.

to that's maybe that alkaline up for PBC What is the Intercept's study, back is endpoint just fact a bit; phosphatase alkaline So, for registration. little known as a by phosphatase they can that protein in in decreases and regulated approved is efficacy, marker FDA FXR. a be used

alkaline are FXR phosphatase there fact the gene. In elements response in

So may level of clinically see alkaline some you increase for the an a sort a confounding dose because have a where phosphatase you what is at anyway you induce potential transcription. in alkaline phosphatase situation,

you such beneficial in may of do phosphatase. damage liver as PBC alkaline have you as going as a a on, lot where have a or a of progression, have disease hand, consequence the the and pathological disease On a cause of you increases other you where effect

So, theory looking phosphatase in of endpoint a improves are the you course the also the at. could disease, drug but could cause of very it reduce theory up-regulation as in the it that alkaline

tug so, phosphatase, showed war a alkaline Novartis. I think of is a in on. did Intercept decrease did going possibility theoretical that And as Clearly, not

at of of When I a and in so liver a a GGT. decreases think less in they highest and look response. three well, you change They marker, lead their their dose, decrease saw with other -- alkaline that they their GGT doses dose two robust all saw lack of to a dose-related phosphatase. saw doses

study I think net is a looking on we is a types it as influence, So design confounding be demonstrate are there possibility that believe to the that phosphatase. to decrease I at possible do out that alkaline but in certainly able

Bill Miller

Jay. much very Thanks

Jay Luly

welcome. are You

Operator

from Abrahams. Instructions] [Operator follow-up question a We Brian have

Bill Miller

other EASL? is candidates. clinic I'm maybe of you at Miller the Thanks. the And you this can also Yes, other has for conference speak year? this And This cores presented some just I'm your in are to candidates how that data development? some curious from this factors HBV moving Bill of are the or gaining curious what on again. the at the differentiated into

Jay Luly

Sure.

a you yet contender, a as we a call later are molecule representative did -- I sort put that's we calibration sort targeting of would of the candidate the announce finalist So, said, the at we as year. to -- this What finalist EASL know, was not state-of-play a it of of up program. but Enanta

sort matters. XX-dimensional of across trying and synthesis, when a CMC-related problem pharmacokinetics have time any finalist metabolite of optimizing you preclinical up solve a in metabolism, you're activities, of terms of coming of safety, multiple terms in at lots scalability, to the lots activities candidate profiling, are We that and with species

And itself it. so, dimensions lot all in beyond just of to basic virology, of different that's the which has a

representative, up a other EASL So it quite we wrapping one close some And -- we got not in that. fine that, very then with a showed but and exercise. is are that even the think the at very we are be we that's off that bake I a very molecule XXX, XXX that molecules, will of than molecule we better comprehensive it's if out hope honestly, to

will and molecule look if protein we talked reported. up can with the lines, to our our later one of system that human back our of today all good in that of dataset, if where hepatocytes. up presentation, So profiled you and some molecule we it's across number already many put animal think that them that that's the of one we every immune you have what and other I this cell been site, Web or not of them, activity looking you'll people really that sort And through today we at and so about core that see the could rigorous you liver one on out well wind in of further really different mouse XXX all our and really take posted across benchmark EASL, virology, virologically basically be at showed inhibitors to just model so lines, we a potent at reconstitute getting characterize showed the compares another people cell

an And the model immune-compromised any test effect, we you're system in mouse the that when and model, doing it's study, a that getting you're so, pure drug drug not then help from seeing obviously. you're immune

best best got fact put hardest one in results molecule the model. anybody think So that the it's high has effectively we is standard reported we've that that achieve has which very data particular and in been, a the so that model that we in through

So the take HBV starting and this, up, not beauty of and we dosing, very tough nukes, it a lining validated, other think going really but is down you HBV on we to just the top that's of viral nuke be well core you to likely with and the on top mechanism now a know some a are it's studies some next a I a free seeing of weeks patients. mechanism is market kinetic real and by if over basic is show are go is combination single the of on get you can combination can that two do for virology few drug is advancement that for virus in others the that add question so inhibitors, core already of using sort provide and a to

time. that later we the a very to and bringing XXXX, at say more be as carefully we're at about announcing this And forward year that into future so have in molecule data clinic we'll looking our first

Bill Miller

again. Thanks

Jay Luly

welcome. are You

Operator

with comes Liisa the question Securities. JMP Bayko line from next Your of

Liisa Bayko

bit RSV, if program on I one NASH kind could the be give particularly and was you of wondering I your other interesting at a any was reveal little thought your sorry I molecule? late. data Thanks. for look planned Jay, then it maybe joined also an next Hi update for would But

Jay Luly

So for thanks the question Liisa.

as study now RSV to fourth calendar to in RSV. in start So of this this track, the said expect going X then study portion report on I we humans remarks, in X we're the our and top data quarter, Phase dosing with we're MAD the next we quarter is infected and on Phase prepared line expect

really maybe the we're far we that what indicated and is seven unusual is like of days, for kind in treatment X of a X so quickly over as of Phase it's about in So portion duration X the the shaping dosing the MAD your cost Phase I Phase that little way plan as studies exercise at too Phase duration really you Phase of PK of de-risking capture looking course most up sort of confidence I gives day and over therapy. and building course and so interesting in the in the amount we equal least X of that safety an head a for seven information the us becomes think us terms at of X of of tremendous into

with that other bacteria certainly and knocking exposure the demonstrate with the of most going side lab bug to is most set in pretty I'll down in good bug chance humans, off effect if there moment viruses you desired good and knocking the the HBV of human. things into particular for the but a down deliver are you if viruses thing in in the is that terms and the The good to potency have

together put calendar Phase to study So good all this it potency you with get our next in which try we'll know that we're QX. with antiviral then forward on again is and X quite to dataset X as Phase and looking quarter

be active NASH those our a we The think we disclosed on. got think really say another that's much and haven't I we've was probably program program think you we about have other follow-on in had, that FXR the but we've the I too got about obviously question will I target other we extremely year. won't so today programs, more later

Liisa Bayko

Thanks, Jay.

Jay Luly

You are welcome.

Operator

any Ms. do remarks? no there closing currently you have Miceli, questions. And Instructions] [Operator are further

Carol Miceli

everyone you for us thank Yes, today. joining

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

Operator

joining. today's This thank does for call. We you conclude conference

disconnect. now may You

Enanta Pharmaceuticals (ENTA) 8 May 182018 Q2 Earnings call transcript