UROV - Earnings call transcript Q3 2019

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Operator

Good day, ladies and gentlemen, and welcome to Urovant Fiscal Third Quarter 2019 Earnings Call. At this time all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time.

As a reminder, today's conference is being recorded.

I would now like to turn the call over to Ryan Kubota. begin. may you Sir,

Ryan Kubota

team: Officer; Good XXXX Chief thank conference third quarterly are our Officer. Officer; containing Accounting Cornelia me Haag-Molkenteller, Fathi. after Executive joining call. all detailed press Urovant results. release market close, information Officer; and Financial today leadership of Chief Ocampo, members our Christine fiscal quarter four Katkin, Ajay afternoon you, Dr. Chief Bansal, you and a on for Chief With Keith Today Thank financial Medical we results issued

You urovant.com. may company access our release on our website,

cause forward-looking During strategies the our that we the on our to results risk call, forward-looking statements, of for we well and release including filed and disclosure clinical could differ cautioned numerous expectations the current Form statements our of Listeners regarding will vibegron and later as our which listeners be that forward-looking our plans diseases. to are other advise our Accordingly, are of which subject treatments making review XX-K urologic XX-Q, statements our based Form development materially. Risk section actual assumptions, as Factors and press statements we today's for are today. factors to all in

now over Keith Katkin. With turn Keith? the that to said, I'd call our CEO,

Keith Katkin

milestones been key Thank very a exciting for my joining quarter all all has Urovant thanks afternoon. our you, business. marked This a and us and Ryan, of aspects you this for for of transformational across

patients bladder. submission and earlier initially very ahead to year for have we for and anticipated Administration excited quarter December, of calendar we vibegron overactive than our the drug by submitted The of U.S. treatment and the in application our the schedule. Food one submitted of we are application end First, new to comes the Drug with

pharmacologic therapy. initiated that gene suffering bladder product oral we urinary have patients with incontinence urge study novel in a therapy Phase URO-XXX, with failed our Xa Second, for overactive

is administration data study of and evaluating a single the top-line The and the safety year. safety towards of product tolerability the expect of end URO-XXX’s efficacy, we

Third, DSP Pharma majority is Dainippon Sumitomo pursuant known Roivant Urovant’s Sciences, and shareholder. to the as transaction DSP between now also

and with to of As entered provided due our the care U.S. support low us access part facility XXXX drug enabled and pay loan five repayments a term. year to DSP loan of with Urovant agreement amount interest, with agreement of Capital. into including loan transaction, facility million with support. whereby Urovant and with through $XXX loan outstanding interest provide previous profitability into Hercules end DSP expect for infrastructure well the to support distribution, capital managed the a operations until on Urovant only the This DSP provides Urovant term the commercial also its commercialization no providing back vibegron

to Urovant entered DSP outstanding relationship rights our as and holds provides minority that investor DSP and Urovant’s Urovant power. about Urovant into of potential an between with shareholders company. brings for new future benefits agreement long our the and XX% Finally, that XX% excited DSP, to strategic certain We're of voting the protections as

drug to our With greatly resources new should optimize well the drug capabilities to care support and U.S. strategic forward support the and commercial launch of market. DSP. we proven underway, submission preparations look for of vibegron the Their Urovant’s managed operational approach application commercial and distribution,

efficacy will assess abdominal into also we pain expected enroll year. IBS some men with highlights, vibegron line both Part later associated on BPH, patient continues top is our OAB with currently comment important briefly of Phase this of X patients COURAGE safety for other which Enrollment trial, of and the patients trial for results product a no population approved. in our continue which to into and business X Now to

I'll that, detail over Dr. on turn our clinical our Cornelia provide will now programs. call more Medical to Haag-Molkenteller, Chief the who Officer, With

Cornelia Haag-Molkenteller

Keith. you, Thank

have drug we new the pleased year. to As before, end are mentioned OAB to FDA application of submitted the for I last the at our treatment vibegron of for

briefly and provide the filing to outline what development and on regarding expect the other update me an programs. Let OAB then our clinical program

the In of on application the March in the XXXX. XXXX submission first drug be the our FDA waiting FDA the December, our we'll of file end acceptance the OAB, new at to of by of for notification

at approval cycle the potential could we at expecting the FDA occur this year. a are Second XX-month end review of and

to looking the forward are review process. We working with the FDA during

Meeting upcoming at in Annual American Washington AUA, Association presentations. will in XXXX we two Third, DC the have Urological May

by presentation study extension The second that and the the will EMPOWUR first age. would data of EMPOWUR be data our presentation be XX-week

episodes Regarding for both extension a test active tolterodine. difference between reduction a vibegron tolterodine. post-hoc baseline the total products we XX XX at in the and incontinence the change analysis – Notably week the and EMPOWUR urinary urge and of performed comparator the significant incontinence of from vibegron vibegron study, statistically week between to demonstrated tolterodine in milligram

main by The and believe to symptoms data to reason this symptoms the incontinence key seek and patients this supports vibegron. further treatment. profile of strong are We're for efficacy OAB the urinary of very excited

all report across we excellent Let make turn our our me programs. progress programs. to to continue I'm other clinical now of development that pleased to

men Europe. will into sites BPH, with international trial America or X,XXX in X is patients hyperplasia soon be COURAGE Phase North The benign will of to running which over continue two OAB in program part initiating trial, vibegron we we the prostatic enroll and our and in in enrolled. trial Regarding for development patients be

X Part episodes, to the and episodes a prostate which frequency urgency BPH. symptom X reduction of OAB reduction night scores in micturition was hours. safety XX in are secondary with awakening and men trial The Key safety. co-primary vibegron means nocturia efficacy and in the void, are endpoints at for and endpoints that both that Phase of

which extension In this will addition, follow FDA excited approved as long-term patients overactive men no X the product specifically program in currently bladder first of there have is about exposure study, total the patients for indicated with for enrolled from a XX-weeks. We're Part BPH. into

intensity This program female Patients is Xa patients or subject of pain randomized XX baseline IBS-associated a XX% turn milligram on study scale XX% vibegron in pain endpoint weeks abdominal clinical point diarrhea, rating reduction the abdominal is of to now at placebo. are an pain. pain. enroll worst XX abdominal which declined with BT me to over for average. compared primary The to the XX decrease IBS-associated least with IBS the either to Phase with IBSD, for our responders with continues Let

or or consistency. scale particular frequency in rating global safety negative a included endpoints Secondary at effect lack of stool

from to data the third top quarter report this study line in XXXX. of expect We

Finally, Xa as URO-XXX in trial we December, initiated we recently reported the XXXX. Phase for

The oral of have who double-blind Our novel for therapy and a a placebo two gene single under in into that female is by will trial safety, intradetrusor randomized pharmacologic direct cohorts. enroll bladder administration injected approximately anesthesia. with is therapies URO-XXX. local the This patients XX efficacy, therapy. trial The injectable of tolerability the evaluate controlled administered patients OAB U.S., wall failed expected the to

URO-XXX cohort XX will milligrams of or receive placebo. The matching either administration single of first

average as number will of assessment therapy. outcome this of tolerability cohort second be XX will and the The daily baseline urge milligrams measure to safety for URO-XXX of change incontinence The primary in followed urinary then potential placebo. XX-weeks. Patients as matching or well new for the for is receive week-XX

progress forward over we in further last with to pleased with I am the made quarters. providing quarter the updates the and coming look

pass I'll financial Now a to for Ajay update.

Ajay Bansal

Cornelia. you Thank

upcoming you our find Form XX-Q, In the be press additional information will addition our in today. release, to in can financial filed later results summarized which

were compared XXXX drug R&D of the submission related for quarter development. expenses to expenses same In a $XX.X were quarter for $XX.X million XXXX, for costs the of of of in prior with the R&D the Clinical FDA. the the period vibegron U.S. third third to new application year. comprised million

BPH plus study our is with pain associated IBS. Specifically, ongoing and abdominal in OAB

RSUs certain the in of Kyorin this primarily the the due and a comparing to of a treatment the OAB; payment expenses Phase $X.X Roivant's in submission company of were our share-based vesting organization completion vibegron of million expenses in for vibegron; part increase result PDUFA interest $X.X options $X.X the primarily costs, partially million compensation million in R&D to Pharmaceuticals the as our quarters, of of of increased sale our with of These for of is submission collaboration of research acceleration to due due DSP. agreement NDA to earlier a to: Where as clinical study connection an milestone fee offset stock the EMPOWUR and fiscal FDA increase lower two by III year.

were due expense as of acceleration and from million XXXX, general and increase and same an as well G&A an third increase year. to increase with certain personnel in The period compared compensation in prior G&A the $X.X of of million stock million the primarily of quarter is corporate $X.X $XX.X the and costs in expenses for options expenses. RSUs share-based other for vesting

operating with million the prior were year. in the quarter million third of expenses compared the XXXX $XX.X Total for $XX.X same period for

the expense, milestone by driven payment. and in before, is mentioned PDUFA increase fee primarily increase As compensation the share-based Kyorin

the $X.X was operations as in to ended XXXX. immediate quarter compared December prior ended XX, used a decrease XXXX, quarter Cash XX, million September million of $XX.X for the

in per the the same XXXX, was $X.XX share of the $XX.X for net $XX.X to or of million loss loss quarter year. the $X.XX compared or prior share Net period per third million for

equivalents cash $XXX.X million. At December cash XXXX, and were XX, total

As and any we need DSP loan facility, to in the At of year, closing, with have entered interest-only December you're financing. $XX.X facility into the eliminating still no term until $XXX.X aware, equity repayments of $XXX with million we under million low-interest a the available last end five-year short-term for down us term. this drew million due

to DSP through support to Urovant expects addition, also profitability. In continue

quarter our a fourth upon expenses XXXX, total of by million of our submission the operating includes for expect which ending $XX NDA range due be million, ahead, fiscal that we the payment March in acceptance will FDA. $XX become Looking million to XX, to milestone the of $XX on

Cash million ending and that of the our quarter XX, used acceptance Hercules in million used milestone due $XX payment loan repay include the Capital will XXXX, upon to March we NDA. $XX.X the the

end a cash We XXXX million. $XX $XX expect balance million with of to fiscal to

in for fiscal the of exciting the if during as we the three FDA now expect and XXXX vibegron we then an fiscal XXXX, vibegron by Turning to the approved to quarter. for fourth year prepare launch be quarters launch first us

X, be three XXXX, to compared which XXXX. higher than first we higher to three million quarters fiscal the $XX excluding our quarters – of be operating compensation in operating quarterly expenses, first expect approximately for April fiscal stock-based begins expenses For the as to quarterly

sales fourth FDA. launch and expenses will our Operating further quarter increase as XXXX by vibegron in of we the approved fiscal onboard force the bring if

over turn let update, me financial call that the With back to Keith.

Keith Katkin

especially, quarter, with the excitement like new we our Ajay. of Thanks, have have for the URO-XXX. our submission accomplished the for during made progress past application study our for Phase of to drug vibegron I'd we reiterate and what initiation this Xa the

provides with launch of We commercialization while Our market access about global profile significant new we with very in more for platform, stable other and financial a the DSP stronger opportunity to and relationship prepare OAB. enhance as also a excited for advantages the us providing vibegron. remain resources vibegron

has vibegron Our differentiation strong of further by believe the very been a in belief launch the supported is in what Japan. we

While Japan different of United from are to share short that a dynamics current the suggest market in able data period States, the mirabegron take vibegron in time. than meaningful was very

trial, several acceptance business. the We two XXXX company. drive of OAB, urology These QX in of specialty developing our into the end vibegron at marked we application FDA milestones our company, enrollment AUA aspects new our IBS half demonstrating upcoming in pain second by our milestones was Phase tolterodine gene of Washington by injectable with data goal our of and and of look of enrollment significant assess URO-XXX, milestones therapy which across COURAGE initiation The vibegron safety upcoming Xa line all DC recently third followed cohort X the post-hoc continue Phase the of novel to key X of will anticipate in the in study closing, two and quarter BPH. the fiscal week-XX. over presentations our transformational includes that of the which include, that from XXXX. patient benefit OAB, safety at Urovant will the associated leading ongoing forward May evaluation a statistically of for this men efficacy one of continued for later year, vibegron OAB data to toward in of for at completed XXXX; upcoming Xa top the cohort drug both part and of Phase in In

line? the the to open you can now Operator, I'll that, With questions. call open

Operator

Your Instructions] Mr. comes JP Eric the Morgan. question first [Operator Joseph from from line of

sir. Your line is open

Eric Joseph

Hey guys, thanks the questions. for taking

understanding of you're from just of be with Kyorin a label they sense where curious of them seeing one launch what and in going in the a Biova but patient bit I'm here. there's of and a what's the are to get in that kind here anticipated differences from, to You seeing dynamic then come dosing demand the in mirabegron in there? the U.S. Japan

Keith Katkin

as Japanese been company. sources that information. got reported months the we We Kyorin We be Kyorin that Yes, patients by first more IQVIA-like our to it insight percent everybody don't Japan. extraordinarily as else We they're have launch we've have ton a with we're sales don't they're thanks exactly question don't Particularly is if specifics, have would of the be think the that for the got share information data maybe our and into have we a go within would what got importantly, got uptick the a taking of Both two also as Eric. the the of numbers also as leave suggest we really we traded going publicly we've their with XX numbers We've well. the Japan launch. happy campaign. What data nice do essentially and from from but we'll sales want into IQVIA-like after seeing of in they're share.

to big a the reimbursement Japan, of vibegron. here in benefits going the reimbursement will alleviates coverage get in obviously situation does give system get different But hurdle from Obviously we that Japanese appropriate merit to the it that have you once face States. see government and the it confidence us once we're is one the there's single-payor and the physicians

Eric Joseph

you maybe And some the that the And is size cohorts. – for and enrolled? Can under just question also powered milligrams? on a milligrams XX talk you there selection patients of total about I arms, both URO-XXX. about guess, XX are I And for sort trial a Thanks. dose being it. the assumptions, effect just bit Got I powering of those XX you Can randomization adequately rationale the follow-up talk the across the the detect to placebo guess guess, design. the little

Cornelia Haag-Molkenteller

you. thank Well, Okay.

all, of Phase Xa is First a study. this

prior recent Xb this by So early and Ion on development. highest the of we is chose which recently We study publication study dose the our conducted really recent announced the Phase was Channel.

the And now then in chose The dose to and to go efficacy patients. it there, will milligram. needs group highest agreed to distributed evenly with these those going that a doubling are So XX which we the design approach cohorts. doses. which And showed we a a then they repeat of dose in to is this be be core to dose we stepwise larger [indiscernible] amongst was discussed placebo two increase will and the FDA, group

between So treatment being basically split group and overall is groups. URO-XXX placebo

And course, regarding injectable the fixed side, therapy. is of an

we need is effect. will a – very be. are to actually this the efficacy We see larger again, expecting But how

we size an but to Phase we this say results this about it have XX% oral point, and for at a incontinence have powered than we again, Xa, power in difference drug. higher achieved urinary effect We

So we of again Xa have to assume but this use episodes, a study, disclaimer. its X.X difference Phase really I

Keith Katkin

in or particular we I think add the any XX adverse events Eric the see concern. And to dose X didn't early milligram just Phase

this in Phase finding dose some do to want we so And Xa.

as us of So a important going can well is the get with as dose like efficacy really early XX good which we safety we looks an well. a really would obviously durability felt that what where give band as read

Eric Joseph

want is need call And recorded than I to there any Any that? out that XX higher dose this expectation you is or think might for or milligrams. anticipation need or

Cornelia Haag-Molkenteller

We it look good. and to XX small patients alone follow higher we was and going point see will Phase efficacy need to very and We're safety. how Again, Well, safety dose, continue the from the this we to then efficacy efficacy dose dose study, may at decided again. for and dose We of of the for see those duration. we that also two at we milligrams doubling need to out already groups, go Phase with look. nine see if course months consider Xa and but one Xb

Eric Joseph

the Great. questions. Thanks for taking

Keith Katkin

Thanks.

Operator

line question Ritu comes of from the Cowen. next from Baral Your

Your line is open.

Unidentified Analyst

guys, Ritu. Shanton a for Hey

you terms be you Sumitomo for that question right leveraging in partnership Thanks be commercialization, that are could specifically one guys but just lot. it, have a going thinking the you me speak of of to to Just the to now? you're approach as going about going after, kind how the you're more

Ajay Bansal

Sure. Absolutely.

maintain think largest And market we most important is so what Urovant the for high-level, at segments. is to going and a responsibility

within in will and building still XXX obviously which And a that will we're out managed will also be in approximately primary particularly the very force force, U.S. give discussions representatives a XX% very distribution. and care care urology force high-writing us we'll long-term by an call sales long-term a facilities subsidiary So strong Sunovion, addition, have trade we'll sales on care approximately coverage sales the in a U.S..Those on sales Urovant, with DSP’s be where responsible doctors.

companies be aware they fees get easily on high small may really You can abused the be double that wholesaler very and digits.

tap their believe improved we we their wholesaler we relationships of much that distribution DSP, and agreements, and given we’re so can now can get And subsidiary a if that fees. into

national care could teams ever managed Additionally, than Sunovion and with, build, regional They’ve the that’s much relationships larger is strong very the a those got and infrastructure. have payers. very large something we both

long-term and we think day team. the that’s coverage launch. currently because, today’s with is age, important we product are about both of critical that any discussions them in obviously, success to really short-term so and in can And how And we effectively use

that enhance just to our our able And managed think we big-pharma-like access into launch. serve can to a greatly tap accelerate so care structure being will

terms management, launch about that be And they we of suite to to to the be be to media vibegron, everything really able able overall, But also cost-effectively both them over do seen services we’re at for it’s that contract at able that – with And their them, we’ll buying, we’ve work what talking assuming nature. long office then things, back them from it discount can will term. were think we’re or whether when and really so get of may by far. impressed we with very to and enhance things

Unidentified Analyst

guys. Thanks it. Got

Keith Katkin

you. Thank

Operator

Selvaraju from Raghuram comes question from Wainwright. of line next Your the H.C.

Your line open. is

Edward Marks

Good the for Ram. Thank afternoon. on taking questions. for This you Edward guys is

question First XXX recent publication. is the on a

Just effect age that XX-mg XX-mg what efficacy you group? think you the incontinence baseline wondering sort seen in if also And had think also, the do had any the on of lesser group? on low effect values

Cornelia Haag-Molkenteller

is linked of that number to generally incontinence is sort known of it for Well, did OAB – episodes. efficacy not you it’s that the

statistically Again, is. That’s Xa. Phase the course, this given you a have I studies, but larger do. that this anything don’t it our Of why than study smaller a has to was in believe minimum,

by group, people, non-efficacy age older. it is or are, linked again, OAB. age and And typically will to not and older, the age. be efficacy, post-menopausal we going On is and are these also That efficacy XX to enroll XX women, to who which also definition are, linked known in is

Edward Marks

Okay.

common say the group, for baseline that levels than the in are what would So you patient in saw group? a population XX-mg XX-mg you the more those

Cornelia Haag-Molkenteller

think Look the extremely of urge But I the at high. is may common, episodes again, basically, know high. incontinence it’s maybe, really but say are quite them a relatively don’t had one, you number group higher And mean, are I is could correct. the small. I – It’s of the that XX-mcg high. it more small is if ends. Both study group. don’t if have

draw really don’t I ends. can small these So conclusions from think you

Edward Marks

there you trial. understand on And just of small I pricing information is level, a that vibegron? a provide Okay. can any broader some the likely on new it's for

Keith Katkin

spoke. our commercial don't and I think is price last likely at – mirabegron that announced that think too really We around a wherever changed guidance The has that Yes. our mirabegron since dramatically really launch. range the we time there's we

As a $XXX per is month around reminder, mirabegron now right WACC.

band agreed or upon around package on final perspective. FDA, could that minus of XX% depending with so plus we insert And pricing essentially is from the see that the a

Edward Marks

All right. Excellent. Thank you.

Keith Katkin

you. Thank

Operator

of question next Your from Biren comes line the from Amin Jefferies.

Your line is open.

Biren Amin

guys. my Hi taking Thanks questions. for Yes.

you relationship remaining just to capital you facility. if and any or loan on gating talk Just any to Sumitomo you from that the there's need Can the access prevent remaining accessing milestones items achieve the capital? would the about that

Ajay Bansal

is approved No actually remaining way board. capital, the the would those can structured budget we draws and it's make from draws quarterly the the quarterly upon depend

example, itself budget the and draw next how So board-approved on that we'll much to know and based quarter March them the to towards our reach our we draw will quarter. let want them end out after next of for repeat for quarter

Biren Amin

it. Got

at time XXX, look but Okay. I And endpoint as with onset earlier of four you XX-week as of you're some as a mean, literature when activity well? weeks. on a you efficacy, at then know I the it's Botox, points on are looking seeing soon

similar So that well? reduction be I to Would the And on suggests think we XX% as UUI a Botox? XX% XX reduction weeks, you'll literature is at to what there some it should that like at UUI out that about on weeks. it's there's something XX expect? measure

Cornelia Haag-Molkenteller

Okay.

of but hope be as we competitive, it'll believe as to to good will course, time as We going least it Botox. and as be Botox. it to be have are, continue, and has be we to good at better, for at measure at points least to earlier it So

Biren Amin

I And trial? detrusor Okay. measuring in to guess then overactivity are the you going be

Cornelia Haag-Molkenteller

be will dynamics any URO or patients. it presence basically dynamics. is the or measuring overactivity made URO people We enrolling that overactivity the outcome, We're on OAB not of dynamics due were not to detrusor in URO all do an have – known will but the at for including we all activity detrusor Botox, Yes, overactivity, without It just patients. in measuring detrusor has we drug, with point. effect

Biren Amin

Got it.

Okay.

Cornelia Haag-Molkenteller

central – do Botox we dynamics URO in And like reader

Biren Amin

you. Thank Great. Okay.

Operator

right. All no questions There are more queue. the from

continue You may presenters.

Keith Katkin

the – end end next call quarter. joining for forward hosting our We the us. everybody after of fiscal you at year look Thank the to

very you everybody. much thank So

Operator

you everyone for today's conference This joining. call. Thank concludes

may disconnect. now You

Urovant Sciences (UROV) 13 Feb 202019 Q3 Earnings call transcript