ARWR - Earnings call transcript Q4 2018 | Arrowhead Pharmaceuticals, Inc.

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Operator

Ladies and gentlemen welcome to the Arrowhead Pharmaceuticals' Conference Call. Throughout today's recorded presentation, all participants will be in a listen-only mode. After the presentation, there will be an opportunity to ask questions. I will now hand the conference call over to Vincent Anzalone, Vice President of Investor Relations for Arrowhead. Please go ahead Vince.

Vincent Anzalone

Carmen. Thanks everyone. afternoon Good joining Fiscal to XXXX. Year for for Arrowhead's its XXXX Ended us you discuss today Results Thank September XXth, us are management today CEO, With Dr. President and from will year; who Christopher of an the Anzalone, Dr. provide overview Bruce Given, Head who Officer, Myszkowski, discuss will financials. who Ken Officer will clinical and review Chief of of programs; the R&D, our our Chief our Operating and Financial give a

your We questions. call open then will to up the

forward-looking call of plans, that we certain begin, XXA like those would within XXXX. made other statements respect meaning forward-looking the contain Before development, include Section results Arrowhead's and projected development All today's materially. the to remind the disclaims current represent intent our on safety drug any the may strategies Arrowhead statements limitation, expectations than runway, of with to discussed management's of duty of and activities. comments and statements. of during around and you Exchange candidates, today's statements no forward-looking thus actual the XXXX our any I of are future inherently uncertain, of undertakes fact, update XXE historical Act without expected statements statements goals, cash of statements call. These to Securities Section differ regarding These Securities to Act including are and efficacy expectations

under the over company. of call. in and discussions be President subsequent like presently annual actual regard, to Arrowhead's to expected considerations in to risks I'd this report Christopher from XX-K Factors additional refer on reports other the quarterly company's expressed including call Risk vary Form Anzalone, turn and in said, that Form cause should the the that the could XX-Q to With Chris? You today's results considered to and matters on for CEO results

Christopher Anzalone

XXXX success stability focus XXXX TRiM us have real confirm to accomplished served platform. these first-in-human both then and important execution demonstrate that recognized Thanks activity toward lead strong expectations. we in the thank development, business pipeline Arrowhead. I company. for to was be to of could we they, toward that new high the advance studies afternoon of end put create platform in with our and through technological position have needed clinic value breadth better our our today. order We believe and two to that Vince. needed everyone in and critical we as with Unveiling our ARO-AAT joining ARO-HBV a our of we would safety it. you -- for candidates, the TRiM the to frame And demonstrate to and the along that an growth substantial and our a Good us with business for preclinical push year

International to candidates, go Let's potentially and including get routes on few these enable locations and accomplishments being sequences through entecavir. RNAi are provide Liver was infection technological while daily demonstrating RNAi competitive to tissue-specific subcutaneous, TRiM potential inhaled, to to set combination manufacturing delivery safety several achieved ligand-mediated response platform, development wide EASL selection may at that on data at receiving detail. beyond trigger where doses we duration The time offers simple. eight utilizes that competitors as screening faster margins, potent Day with administration, clinical optimal I hepatitis XXXX out the cost, nine key pharmacologic the information R&D rapidly that the advantages in designed presented of a four targeting miss. today to of then host We activity, Congress ARC-XXX, structurally identifies process and us potentially after of company of that and discuss in event platform intended bioinformatics, which expectations intravenous, capabilities to liver. including DART Multiple then We sustained patients of and effect, B simplified TRiM promise in reduced a with compound, clinical and timing. the of tissues the helped sophisticated and taking RNAi XXXX, and an of some stringent a the at foundation long introduce to first-generation Analyst hence and hosted to to up September more HEP chronic will XXXX, our This

have including represent that serocleared which believe evidence including biomarkers, surface patients functional based s to believe designed lead ARC-XXX, not for or represents host of all sustained Achieving we the be data us activity possible. is favorable confidence antigen produced which HBV functionally therapy by these of to combinations can always the ARO-HBV, an transcripts intended this approach antigen, antigen clinical RNAi s integrated cure has production a One which from potential RNAi-based first against to moment. compound, was that is we type the describe We believed integrated our DNA, with these a in current-generation response provided Janssen chronic that cure. backbone result products, of I'll all a with partnered further derived that DNA, in a to was compound This deal a HBV. silence gene Pharmaceuticals for designed with

our hand new quickly to and data TRiM-enabled first-in-human With studies. results promising our in preclinical candidates, we for clinical moved these encouraging

first dosing both discovery liver to and of studies important but filed of for of of and included a Phase meaningful activity of on describe study and we rapidly. studies quarter end ARC-AAT study ahead Both tolerability our then were ARO-HBV. these alpha-X program regulatory of against X/X ARO-AAT, Bruce the clearance Before substantially to they management great a thanks to will that the it's designed disease; multiple-ascending begin X the of very schedule, to readouts and We in both a phases submissions clinical work ARO-HBV candidate and XXXX, our Phase moment, in in XXXX. mention the generate dose clinical teams. single-ascending began

studies have begun well for dosing and We portion enrollment we the had the was continued in that to second and study single-ascending quarter, of completed dose already indeed. portion entire study. the HBV both by of patients dose ARO-HBV a speed the multiple-ascending impressive This and study ARO-AAT execute on

single-ascending our is technology. million our the candidates, also progress XXX, August, formerly in partner AMG a ARO-LPA, payment in from multiple-ascending a we In announced pharmacodynamic following milestone is will clinical In to phases, $XX primary study date administration subjects completion on elevated effects. a Lp(a). is phase program dose in pharmacokinetics, approximately in there The and XXXX. of safety, X be to dose using study with we tolerability, and addition a evaluating referred Amgen expected in phase dose lead late subjects as The first study. in good two the XXX a assess first Phase to TRiM made currently that AMG Amgen of XX estimated performed the earned

the enter validation following completion, the data in the XXX this collaboration scientific our this of the We TRiM clinical generally Amgen will platform. proprietary as Amgen development candidate with the AMG Following ARO-AAT our step share and is ARO-HBV. TRiM further year, primary drug view appropriate third by forms. to enabled and

active snapshot their XXXX highly of clinical studied productive National that and The continued presentations demonstrated our and importantly targets. ARO-HBV to a the were released Arrowhead. platform. at programs. and all they active against the very that TRiM presented both dose using Educational tolerated development were Alpha-X levels We respective well for for of These the data is of Gastroenterologist second the generally the the ARO-AAT candidates be Summit. at candidates Conference were at World early of data basis for TRiM highly Both first half all

candidates it molecules at duration in encouraging So, to pipeline. presented effect with see ARO-HBV these a for potentially long continued be was well and of well the November that that could ARO-AAT clinical bodes of potent and the positive the for supported translate human Meeting our preclinical development rest ARO-HBV. studies. to the highly in of further proven ARO-AAT data AASLD are and very additional both We data TRiM-enabled Liver

reductions XXX weeks, that to were serum start of the ARO-AAT quarterly of XXX% monthly appears dosing data. in Let's less some feasible. than or XX antitrypsin of alpha-X for ARO-AAT highlights quantitation doses frequent of reductions below These subjects. with led greater the milligrams of indicating to sustained Three in level

In move into to ARO-AAT tested. to dosage appeared are all well-tolerated us in of X planned doses give and These addition, at Phase confidence be that a study multiple highly single encouraging data XXXX.

We deal XX.XX%. sales. Arrowhead Pharmaceuticals appeared Moving Johnson, range and to mean collaboration across agreement against Pharmaceuticals, logs or million was were XXX Janssen HBV to Janssen. therapeutic that The patient in milligrams, & at study. of In these XX.X% of in agreement, highest on was by antigen candidates Under to billion the Companies and an presented license AASLD. well see RNAi and Janssen. the as plus ARO-HBV doses upfront Janssen to types or approximately XX% patients be to HBV part for tolerated three discuss total to to and data of what proprietary reported would agreement to ARO-HBV for received some development up value reduction Johnson license and the with I means the and to dose to $XXX of of we a it new terms use tested at logs multiple up look a levels $X.X to potential platform was October, partnership of targets and commercial logs all deal on TRiM high the Janssen like our or now selected signed achieved X.X Arrowhead The the HBV Arrowhead. Inc., single AROHBVXXXX X.X be of the a payment. which royalties with with thrilled forward continued results X.X s activity

very up on exciting this targets. in agreements ARO-HBV up the as partnership HBV payment $X.X receive I additional Arrowhead million eligible believe Johnson to view Inc., In payments product payments in $XX Innovation, I milestone milestone approximately X related including receive a receive study. eligible the a billion per the to to tiered sales. received maximizes of three chances mid-teens ARO-HBV. JJDC is further indicate milestone after & for eligible Arrowhead also license addition, increasingly to chronic $X.X is our near-term common a is option royalties success agreement, of data patients, ever $X in experimental many initiation an stock. even that collaboration Phase regions. of infection are Arrowhead early hard-to-treat the of been Arrowhead Johnson to be than deeper agent investment the against silencing patients and as approximately we price share may of form such billion in Arrowhead virus by a for at million HBV-negative in up for HBV $XX to predominant equity has reported, that and to

good. As we in saw all good activity I quite the and safety patients, is mentioned, profile

a of squeezed we think amount substantial we out of already. program So, risk the

However, yet functional much we've remains. and seen work cures not

For Combinations instance, Phase will extensive, permutations are each be right are studies interrogated dosing complicated. the compound for should different with different Xb the possible. because many schedules classes and large, expensive, be and compound

would will diverse we with resources but expansive has Beyond believe demonstrated experience and all Phase Arrowhead studies and Janssen X, minds can in these It reimbursement paradigms great I to has to, ultimately, be our multinational, these require anything we commercial of launches. have commitment do pivotal and faith global infrastructure and programs put and and immediately. a commercial types capabilities large today. rollout almost

HBV, as two potentially further Outside cure concrete this to the platform our us B TRiM the in and value ways. goal see Janssen with out chronic hepatitis we create a of functional build partner helps deal to patients bringing infection. accelerate So, ideal

new the our provides programs of development outside the up medicines. pipeline that additional three targets of of funding it could First, against novel important become Janssen possibility to

a CTA a a one. amount important three two more our disease, two ourselves. number provides clinical Day with candidates; in that new point on it our to in which of an We dyslipidemia our we metabolic ARO-APOCX the detail to is future weeks; we for October which made pipeline. In last our demonstrated start cardiometabolic hypertriglyceridemia, current been a medicines new has may -- substantial we This CTA to and R&D potentially cardiometabolic to early on hosted XXXX. studies in we progress plan for for and Second, of and filed emerging in October and us are ARO-ANGX develop a for presentations, next in file that in pipeline planning capital discuss commercialize very those

clear for We carcinoma. programs, cystic for also cell ARO-HIFX extrahepatic discussed our and ARO-ENaC cell renal fibrosis

call resources control to knockdown In of announced addition, we for financial large like a flexible, us. ARO-HBV good our while we Dr. showing is swapping have and that to portion pipeline for in overview, of develop to COO innovative develop the Bruce? now growing TRiM The With growing muscle. of initial to is good exposure turn and medicines, trade numerous the commercialize a Head and I'd platform outside opportunities data and new HBV R&D. our Given, retaining in Bruce over enormously potentially

Bruce Given

you, I and ARO-HBV last Thank describe clinical that want not about the encouraging, afternoon more a the with pleased highly They detail at give more to and could were Chris both little AASLD studies been and have ARO-AAT everyone. and good presented for I we really data results. month.

globules. hepatic liver Let's impaired mutation with aggregates misfolded treatment with A deficiency. liver can improper AAT cases, to in or accumulation fibrosis, hepatocellular most prevent cycle therapeutic by secretion AAT for Accumulated liver attempt RNAi genetic lead liver. of the leading folding administered AAT in rare developed is for Arrowhead's cirrhosis, on a mutant as accumulation ARO-AAT, protein or the start recurrent disease second-generation leading the hepatocytes, in subcutaneously known worst a the carcinoma the of alpha-X genetic transplant. disease-causing to associated designed AAT to as of first directly protein and AAT and being causes antitrypsin silence to then production injury the of to to with ARO-AAT need and

in as We [Indiscernible] second with The of damage seen cycle to such should liver to prevention can in not the reached fibrosis This to cirrhosis. to cycle of the what liver reversal then removed. disease has damage. accumulated quite diseases that now clearance that protein end The prior and on liver. is is well already It seen clear similar fibrosis the allow cycles is improvement AAT other fibrosis stage associated hepatitis. fibrosis damage and to in believe is that viral after show repeated lead cellular of is goal established is of which fourth damage, leads the goal

Phase the levels possible XXX safety, healthy levels As alpha-X serum three milligrams. dose of double-blinded, pharmacokinetics, such, AAT. and in XXX, XXX, the four levels high cohorts volunteers. study and evaluate on of a or or X effective is at adult The of portion included of of and ARO-AAT study XXX, study placebo-controlled, And included cohorts we the have antitrypsin single-ascending MAD AROAATXXXX subcutaneous MAD hopes XXX reversal SAD in that milligrams. XX, dose the SAD dose portion XXX, dose at is multiple-ascending to tolerability, doses randomized, and

six volunteers. at Additional at based deemed doses produced cohorts AAT doses reductions Single robust in adverse and planned administered XX% and quantitation and from ARO-AAT in were doses. XX% in reduction an and patients NADIR the was dose than AE AEs a of cohorts, weeks. single the for ARO-AAT In the nine the AROAATXXXX XX% follow-up subjects weeks. multiple of milligrams with doses group. subjects AAT an less reduction, Monthly below represents resulted respiratory longer level indicates of average serum single-dose sustained frequent milligrams, greater three injection liver a Duration that full all XXX XX AASLD, at quarterly events having appears at three of of the AAT and level XXX levels. XX%. but including for serum tested, in were milligram being milligrams unnecessary of dosage of for or We most presented data feasible. upper XX% greater than suppression believe was The or on X% the AAT or with XX% XXX the ongoing, was XX serum concentrations in sustained receiving at tract healthy lower XXX% four doses, headache cohorts production consistent XXX of well-tolerated serum ARO-AAT demonstrating of greater cohorts, common XXX observed is with dosing quantitation. than enrolled in of of an of We XX%. XX all maximum at were activity XXX response infection In with AAT or XX below multiple-dose than associated the average AAT. site. near was this of and XXX reduction serum multiple-dose subjects reduction XXX-milligram with the

a which We of ARO-AAT to completion pending studies, GLP are XXXX Phase in study of of next pending that completion chronic and design regulatory designing we X is currently month discussions with start study toxicology intend on expected and endpoints. authorities

is being B RNAi Moving as administered ARO-HBV the therapeutic infection. AASLD. a at from third-generation ARO-HBV patients on presented with study chronic to and hepatitis candidate the potential developed a treatment virus for subcutaneously data AROHBVXXXX

or consistent in in it difference HBe with logs. highlighted an reductions subcutaneously antigen were e logs, patients and antigen patients, two s than transcripts antigen s study Strong over silence dose dose, monthly there day of Thus were milligrams ARO-HBV or the portion NADIR similar Pharmaceuticals, antigen effects with analysis its mentioned, X% s in NADIR response. clinical patient of from of from pharmacokinetic with through of HBV sizes throughout or well of antigen Xb The results Arrowhead of cohorts first-generation less positive, was The ARO-HBV logs. ability were antigen with mRNA included ARC-XXX, Arrowhead's XX milligrams. and observed a antigen-positive AASLD And of healthy characterize ARO-HBV viral weekly single multiple-ascending XXX, antigen, were NADIR HBV The XXX, injection safety than compound, in to with Xb the had ARO-HBV similar a chronic This dose to HBV at antigen-negative and logs. includes and the XXX, observed commercialized mean all-single targeted improvement populations. XXX, from XX Johnson and source and milligrams. pharmacodynamic initial assessments XXX data XX only mean reductions Janssen XXX, As and added ARO-HBV of XXX injections. HBV of through all B were populations. parameters, NUC-experienced milligrams. loading received major adult also started and HBe as study patients cccDNA cohorts HBe patient doses DNA, were antigen-positive and or ARO-HBV HBe surface the were study a dose site NUC-experienced Inc., believed cohorts of X.X baseline. biweekly cccDNA. volunteer patients a The six positive virological multiple is Phase HBV in on as virological doses. XX, cohorts in RNA, derived on nine dose the be cohorts five is including with increased to cohorts assay patients monthly HBV. which Dosing ARO-HBV. response for in mean is ongoing be XXX, which XX% the escalation of of s also Mild as Cohorts and observed There ARO-HBV as was HBV that recently daily nine. administered is s X.X in portion really production patients negative, us. day be HBe the evaluating antigen nine. which volunteers X.X the a that Xb, NUC-naïve NUC-experienced doses into patients in volunteers healthy XXX safety, Janssen in X.X tolerability, antigen safety, nine Pharmaceutical not n=X now was license interim those benefit potential were XX, the organizations HBe day XXX, MAD new safety, antigen-negative and day a other of to The hepatitis antigen of can reported The NUC-naïve and host-integrated better reduction and injections XX in mean develop of DNA, antigen -- up and appears their also cohorts certain and antigen days Johnson, added cohort in advance in our three X.X and to X.X s to antigen responses most future MAD levels to be patient and at Responses thrilled an was share really We dose and of subcutaneous eight logs the healthy and follows. respectively. subcutaneous and a study receiving patients reported the at at cohorts, study NUC in or tolerability treatment s complete higher cohorts antigen range whether chronic and XX, the hepatitis in tolerability, of is also part for cohort rates is X.X recently all cohort for with achieve levels. XX SAD medicines cohorts weeks for measurable SAD reductions The monthly transformational treatment-naïve greater agreement in evaluating Janssen Xb patients was Both study, eight have or B to antigen logs with single-ascending We're of for partner that Companies correlated well patient a the Dosing & cure of all tolerability and were in doses eight approximately to exciting are reported with HBe results. HBV s eight AROHBVXXXX of the if or Chris to these doses aim one. entered on observed were results or continued effects s X/X NUC-naïve ARO-HBV. NUC frequent. daily HBV on tolerated patients. had third would at finite functional duration or development mean presented a at viral and AASLD Virological and summarized infection. through results reactions when available, NUC-experienced, after patients is doses commercialization were for

and update I to Lastly, give ARO-ANGX ARO-APOCX. on quick want a

intend to to mentioned, recruiting CTA Chris we AROANGXXXX, approvals the study for to begin pharmacodynamic report in ARO-ANGX ARO-ANGX a Phase As pleased and evaluate and regulatory dosing XXXX, of In tolerability, filed begin am I and multiple-dose healthy dyslipidemic safety, for necessary effect we have pharmacokinetics subjects. of to a first that volunteers X and the already patients. the quarter we single

more starts. the study once details give will We

we now For a the are submit on intend CTA filing we next that working ARO-APOCX, to in month.

Additional when also Ken? details on be With study will our available that review to clinical Arrowhead's call like that programs, it to over the Ken of Myszkowski, starts. turn be I'd brief Officer. Chief Financial

Ken Myszkowski

Thank you, Bruce good everyone. and afternoon

compared for based for we shares XX.X of Revenue was or As was average the The million which reported $XX decrease $X.XX today, was net Amgen, from weighted based timing for agreements of received compares $XX.X of per $XX.X share million XXXX. XXXX. weighted net with our during driven $XX.X the fiscal fiscal of by to $XX.X XXXX. XXXX This with XXXX and is outstanding during $X.XX fiscal our million shares approximately collaboration average loss or million the XXXX per fiscal share million on recognized remaining on million million for a million XX.X recognized our outstanding. payments fiscal loss upfront $X recognition fiscal revenue was

to XXX. $XX ended This in to trial X ARO-AAT cost XXXX August, $XX.X drug study XXXX, cash million September and primarily for toxicity as ended for XXXX. revenue XXth, increase recognized in was fiscal in million manufacturing due and to for During clinical ARO-HBV for year cost million in compared operating used fiscal the the payment million a AMG is activities for milestone candidates. initiated million $XX.X XXXX. operating compared $XX.X from received expenses Phase September XXth, we Net year XXXX were also we the Amgen fiscal $XX.X Total Amgen

expenditures fiscal and the in in XXX. associated XXXX, relatively we each consistent $XX was in we with XXXX; $XX upfront In G&A million received payment, million payment the period. AMG the cash of fiscal change received operating period. R&D milestone received were cash each Amgen from driver in The Our cash while

our be September receipts and completing capital recognized proceeds hand with ARO-HBV payment of and cash of manufactured. was equity This the upfront The equity clinical financing million million JJDC $XX.X from investments X.X as XXth, $XXX share. JJDC of X/X a to December investment Phase cash and and We material. balances net and $XX.X the our the in be will million balance revenue, recognizing totaled driven in In $XXX and course by previously. end of JJDC received million shares to compared million be anticipate our their of our the investments investments our delivery of cash more increase both payment investment over the balance sheet, of from million $XXX balance Amgen study cash million cash at XXXX. in premium September includes cash balances XXXX anticipate reflecting at from and than paid October, January at the issued discussed to Turning $XX our $XX.X million on and expenditures. drug for XXXX, our Chris ongoing offset the material million, drug milestone We August. These for the per in we Janssen XXst, to used operations $XX about $XX received payment, equity common along cash stock, and revenue and estimated payments for for oversight to upfront management at which the price of approximately ARO-HBV XXth,

XXth, XXXX Chris. With at XX.X September will that common turn to back overview, the shares were call I outstanding million. Our brief

Christopher Anzalone

mid-stage time, at encouraging were clinic, just of preparing AMG XXX. ARO-AAT shown for short Thanks Two Last clear the made a have already of year product ARO-HBV, candidates the company to Ken. first-in-human in Today, as and amount horizon. first are and progress TRiM this three a in great those, the on ARO-AAT, we've platform. CTAs studies time. the there readouts we file ARO-HBV It's candidates with leveraging

and approaching studies and ARO-ENaC candidates, We also ARO-APOCX, ARO-HIFX and additional for planned have XXXX. ARO-ANGX candidates, first-in-human two additional

have the XX for Looking two, target type want to platform end every TRiM-enabled studies to; of forward, cell have every CTAs in by goals candidates with XX year; two new clinical new XXXX. equally the the ambitious three, months; TRiM a three we future. and We one, file

proven speed for Arrowhead I the these Thanks more. questions. that accomplish and fully execute precision expect again Operator? your to I'd think can now and us open call with today. joining like to and we've goals to

Operator

Raycroft Instructions] of ahead. you. Jefferies. our go [Operator question comes the first line Thank Please And with Maury from

Maury Raycroft

congrats the Hi, good and on progress. afternoon

question First on just is AAT.

you can then the considering middle provide or and into what for clarifying ongoing the size? the with of And endpoints Just leaning pre-IND discussions you're in insights FDA? any trial toward are you dosing

Christopher Anzalone

that? take to want you do Bruce, Sure.

Bruce Given

Yes, hi Maury.

We I are in discuss are thinking want we But the about nature FDA. size. and in or any what of really are specifics we're discussions with or we to discussions the process being at about endpoints they -- of -- they would certainly the trial discussions of ongoing. never even sort in like the

Maury Raycroft

should And any clarity as goes, -- additional of think there? as timing far about first about should starting half, we in think we half XXXX second Okay. or

Christopher Anzalone

I in It's of think filing the to yes, XXXX. first -- sure. IND filing expect -- an fair quarter

Maury Raycroft

the stage Got on could that if shown you're AASLD well, it, for Phase going guess, actually, and to and both the any data just data just update from AAT -- provide that you've that an X HBV I and on data when okay. later And then happen. maturing at at the wondering based

Christopher Anzalone

do, and to always will, abstracts. to course, those AASLD. at they EASL file I whether up us think I'm like see expect assuming those with that. organizations, meetings meetings. of those sure, you would expect continue we'll they to It's can But we Well, accept abstracts I to continue that do

Maury Raycroft

is APOCX. question last the just And on Okay.

AHA the reported preclinical some You recently data Meeting. at

the you as Just a can something in that the do you to if data. of would wondering study seems the And like be Would the APOCX clinic quick from to well? took the that it knockdown. have evaluate recap you NHPs biopsies in give

Christopher Anzalone

measure in in we first No, it to NHPs -- able and hemology we'll showed small humans. has It clinic. all, core between a be What rodents periphery in gene. is the is the APOCX of

is we getting something the probably that we possible we we so. humans, unclear thing first to APOCX able XX% the was the biopsy, non-human in for on fact, One And the known of we were we in we that intestine, XX% liver transgenic made We of humans. XX% mouse response a it demonstrated the non-human the cynos knockdown develop a cynos and and incorporated is both in model. that and it APOCX from was XX% had to similar ratio in but APOCX liver. the the in explanations knockdown had of about our human is dose is that In APOCX the whether -- ratio mouse different to and knockdown all probably in have the the we or a And of as -- a it went in then and probably on So, this. that the to were intestine in that But showed was that's than basically of primates show interesting in comes this when did XX% well, strong very XX% and order of that into of to was primates. couple saw the that the transgenic transgene trigger, there that the made liver. different deep rodents order

course, able of the going circulating to and also triglycerides. measure APOCX humans, in measure can we So, their we're to

to So, have will we not do biopsies.

Maury Raycroft

it, you Got much. very Thank helpful. very

Christopher Anzalone

welcome. You're

Bruce Given

Maury. Thanks

Operator

with from next Blair. Katherine go Xu Thank our you. ahead. question Please comes And William

Katherine Xu

afternoon. questions. have I a of Good couple

some last antisense program have, Bank x-protein pure agent Spring So, a revealed specifically. the against kind chirally week, discovery they of which is

disease? is also six X hear know in that do histological in of to ARO-HBV, duration. your data, a be next curious six have Phase up toxicology start thoughts right wondering, or I'm term will so study? assayed you with that month, now is just activity months followed-up possible wrapping is I'm six AAT months, you your longer or do I assume program it just that that wondering, the So, or reversal a the within the would a be a months some light it to think likely into Just in beyond can of against have the extended regard but so program, you that. see specifically? for you'll you to on that. And love going way x have Then I

Bruce Given

So, you to Chris, me want those? handle

Christopher Anzalone

ahead. go Yes,

Bruce Given

Yes, confused, a just location. are case actually in different at I'm people

duration did period chronic to nine-month monkey rat all, time. be the required tox of that to we an of six-month unlimited treat question, that's in in AAT, first answer first, and fact, And with able Katherine, So, our studies. for to

or to six months limited not treatment. are we nine of months So,

we as want. successfully as and Assuming regulatory reported for treat those studies agencies, to we long are out acceptable get to

So, six months is not completed are and studies a limitation for us, once these by authorities. accepted regulatory

that to you. honest months part is be me, enough of do six question, with to think pretty other that we The short feels

it's some globules, improvements months, think in things, be of in have but fibrosis. But could that unlikely is to it course, improvement fast improve, possible highly it even the instance. for that in would changes very of in too the probably six I like liver occur to complete see

than these to really benefits the think that liver are six see. have we to in studies I months want longer to to the show be So, going

So, that's regarding AAT.

But regard. Regarding x-protein a to RNAi in x-protein, We straightforward little animals. with and that study in measure whole trigger hit preclinical x-protein targets. cell is in vivo really study studiable so designed to Bank that's region under is relatively it's more to to one agree believe hard currently to important. We and we clearly very x be our this It's the x-protein not systems. study of able least Spring our in in-vitro very at point. in constrained It's clinically. the only situations x to at But possible

Katherine Xu

Thank you.

Bruce Given

welcome. You're

Operator

Jaffrey. next Tenthoff Thank question Piper from go Ted you. ahead. And [Operator Instructions] our Please is with

Edward Tenthoff

much. very you Thank Great.

it be recognition. about recognized? my said questions period million revenue to lot would be of wanted basically back a I to come would I think answered. So, Ken, through were you this that $XXX what

Ken Myszkowski

$XXX about to going million. be It's

-- recognizing the three to quarters. over we We next are going be anticipate, that

next So, year through the fiscal of first year. quarter XXth October June of the

you purposes, basically your that that recorded to over can be it's for So, ratably going period. assume

Edward Tenthoff

much. Great. you Thank very

Operator

our you. Chris to ladies for Q&A the remarks. Anzalone gentlemen, final session and this concludes back I to his turn Thank like And for today. call would

Christopher Anzalone

happy for I everyone and holidays look seeing you your XXXX. you we attention in wish a and to Thanks forward today

Operator

calling appreciate gentlemen, our today. ladies that, with in and you conference we And

now may You disconnect. Have a great day.

Arrowhead Pharmaceuticals (ARWR) 11 Dec 182018 Q4 Earnings call transcript