UROV - Earnings call transcript Q4 2019

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Urovant Sciences Fourth Quarter 2019 Earnings Conference. [Operator Instructions]. I will now hand the conference over to your speaker today, Ryan Kubota.

Ryan Kubota

Thank you, Operator. Good afternoon, and thank you all for joining Urovant's Fiscal 2019 Fourth Quarter Financial Results Conference Call. Medical key Chief our Chief Executive and Haag-Molkenteller, are Robinson, team, Financial today Cornelia and President Officer; Chief me members leadership of Jim Officer; With Officer. Ajay Bansal, Officer, Christine Ocampo, us the portion Q&A also and the will for call. is of our join present Accounting Chief containing after Today, release close, our on issued we information market quarterly press a detailed results.

you on channel should We use company as a to You Relations important our urovant.com. information, to page may our website information. look website, and access the Investor for our company the time-critical distribute release and of website this

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

James Robinson

hope virtually, of I of joining more call the soon. and great able personally for meet to you you, Ryan, and you all very thanks Thank today. It's to you to with I'm connect

touch and that condition and as that's to And over in was we I've important where XX profile. XX the examined been in at In trial. differentiated impressed patient ahead costs. XX-week the for the approved, key leadership X from for bladder. on and of was in the being well. vibegron. which you organization novel that of patients limitations to Urovant all of the President enhances where in a XXXX action, And safety Cornelia our gene X will a where endpoints trials, treatment. to out drives studied Equally in CEO maintaining Vibegron in in the durable both detail there particular, I'll versus also and increasingly development the trial, about URO-XXX, including our trials, talk experience significant other about medicine with greater March, patient over a pivotal been as in primary Board the highly that, a all weeks. accomplished it showing did while been learned as and highly is medicine. has before and our demonstrating team, EMPOWUR secondary A vibegron this that of also know been early therapy, have treatment to I've utilization we've placebo. efforts, of the gotten endpoints, differentiated, the statistically our only about vibegron efficacy oral demonstrated on approval to confident as be with preparing more in urology meaningful showed to since reduction rapid be priority, has population tolerability the moment, a the joining suffering the trials, perhaps we these looking or of X,XXX let believe from overactive a specifically These large the secondary overactive of me conducted significant of for of and in hasn't particularly trials current of what's did a many a if a treatments care progress potential the improvement I've bladder bladder significant symptoms not onset over leads which Vibegron EMPOWUR Cornelia, therapies, and weeks company trial by successful had favorable need vibegron. what and developed for vibegron new the of and and clinical in could I launched extension urge immediate minutes have safety patients talk health my we've and know, for been us, extensive approval welcome few the space, take and a therapy year. Overall, efficacy development once-daily dissatisfaction primary new know about me As our before I urinary and the opportunity and high, the is launch needs potential could data vibegron meet overactive study address new XX-week include branded and market for UUI. it many belief program and incontinence completed significant But that's been milligram as efficacy potential turn

nearly grow. the mentioned currently And that's, it the overactive patients earlier, XX.X of is need than beta-X takes full million unmet those effective. become the are overactive prescriptions, million And their bladder. are X time X.X to stay balance year Americans this on therapy for and which anticholinergics, prescription patients of XX.X roughly the beta market treatment. for million written each current and on their from continues year, XX the XX high. are I U.S. As XX% because in symptoms Today, More treatment plus million in X/X cases, of roughly in each And therapies market, only of are bladder to agonist prescriptions discuss to new prescriptions of patient with for a XX% suffer OAB the in for of don't some these million therapy. doctor. There

quality dismissed efficacy the we to addition, Admission lower to patients a patients. men. direct is there's medical Xx treated, patients that a of patients greater these untreated. who is higher is for the and has know addressing cost than women Annual facts. X.Xx profile, Unfortunately, OAB incontinent OAB as believe real patients we of OAB greater for a OAB it for non-pharmacy more and system. remain Xx patients With but by decrease cost. than costs XX% needs has And care the and lowering cost the for issue, non-OAB those facility Consider health are life care. with of impacts, published bladder especially its safety burden versus when incontinent better of care In for of overactive health in nursing reduce vibegron very to improving has overall lives the potential and potential often our

date also building of XX and with hiring A building Vice Senior year, Dainippon Sunovion, Market recent target infrastructure morning, rapidly been know, the President PDUFA for select just services. we Johnston, agreement infrastructure Senior Stewart, element vibegron shareholder, of you distribution our commercial we're trade, affiliate Pharma operational As of of us an with December and Walt with And to President Vice key has this Access. of launch. is a of this Commercial; Sumitomo the for provide this forward and moving announced X-year Ken majority our our

progress, plans As details. we'll our additional provide

on Dr. me the call Chief Cornelia turn our details with over provide clinical Officer, let more Now Haag-Molkenteller, Medical programs. our who will that, to

Cornelia Haag-Molkenteller

Jim. you, Thank

March to date As the us of XXXX. have our new in vibegron And for XXXX. the stated, been designed notified on this NDA submitted accepted December we that FDA December X for PDUFA our Jim drug for FDA application our review for just goal year, OAB that they the XX, treatment has

currently and review expect a at XX-month continue the are of part as FDA cycle. cycle We responding review the FDA requests to to regular

we a data on urologist in publication clinical posted from for the published to vibegron review OAB the manuscript study author, peer print III Boston Dr. key EMPOWUR Journal This Neurological August. first American updates is development In investigator leading meeting virtually provide our and Let study me COVID-XX Association presentations Staskin, conducted the and the and was on presentations of available the March, The on due in Urology. online now pandemic. EMPOWUR principal website be for David XX. year's are X journal, further Phase accepted for the the EMPOWUR the programs. the meeting AUA were was and XX-week annual May to expect The other and

The study post and data analysis. our hoc of was extension presentation XX-week EMPOWUR first

data age. second included by EMPOWUR The presentation

study a me and provide on that over efficacy little vibegron extension Let its able a profile. favorable tolerability sustain long-term more a observation demonstrated safety efficacy was good detail to weeks EMPOWUR with long-term presentations. of these results and both very XX The of the

OAB vibegron demonstrated change and between tolterodine. In are further performed we data difference and week age analysis statistically at for to the on of and addition, reduction hoc XX. the significant of incontinence. age the main Phase in hoc supports tolterodine efficacy examined EMPOWUR XX-week comparator urge XX urinary strong symptoms vibegron from key XX these test of post and The profile The incontinence the placebo-controlled a both data of baseline measures, the III and total In UUI to patient incontinence urinary treatment. above active analysis by milligram reason the below patients vibegron. This symptoms over or a seek post

XXXX, XX improvements the Continence Society of presentations seen older been new temporarily were patients the on the running. clinical data across comment in to micturitions EMPOWUR I years and total and measure. now clinical endpoints we the are were pandemic, meeting including as at and for urgency for aged milligram episodes. have XXXX. seen screening trials of in of episodes. population. adverse of monitoring comparable co-primary a the Statistically Las will patients key clinical with where In vibegron statistically March also the we November Since later the the COVID-XX the significant ongoing Vegas Overall, closely situation our were secondary trial the the improvements significant older, placebo study of compared in endpoints, upcoming International For in ongoing in UUI to are Further decided including patients outbreak year, trials. of our a XX halt rates between planned event the precautionary regions

and in trials our new have April, communication began will of the FDA's the reopen so. conduct patients to the during on COVID-XX patients, trial guidance of this end However, the trial a the done health our we maintained do of for At in stepwise manner. for to already with clinical close continue pandemic. continued sites enrolled and with screening We've alignment sites

prostatic frequency in study or running for Europe. For a Part over X is Part have X,XXX BPH, with micturation North efficacy now in America, be and assess for Phase Phase BPH. in and in trial, and which of safety. the in III void, prostate are Key reduction will and initiating in the men in night the first endpoints Co-primary XX program episodes vibegron of are and begun involved. both we awakening nocturia urgency the sites at trial secondary development OAB endpoints scores the is will symptom hours. of we episodes, COURAGE trial are OAB vibegron and III The X with safety men benign in to hyperplasia patients this reduction which

the long-term a which a first into extension total of patients are XX also follow weeks. for enrolling trial, exposure Additionally, patients will

As a overactive men reminder, data indicated in there's currently with FDA-approved product specifically for no BPH.

XX IBS-associated are due on the or for pain, pain a Regarding the over least average. vibegron to The primary diarrhea. subject the Patients which patients study is IBS-associated compared endpoint delay is intensity XX as following A this in decrease worst rating XX-point reduction is COVID-XX, vibegron slight of a a defined complete pain our with Phase now for responder summer. is the in to a we milligram baseline weekly scale XX% to IIa at with placebo. with enrolling plan abdominal female clinical to XX% pain, either IBS weeks abdominal program and the in randomized IBS-D, enrollment abdominal

with oral quarter is of injectable of for IIa stool rating product of plan also a screening top this evaluate pharmacologic OAB of in in a placebo-controlled particular, moving This resumed trial failed include and that or therapy gene now on We who with COVID-XX. novel for single frequency candidate line XXXX. enrollment will of I tolerability after due will lack trial therapy the efficacy, patients randomized, URO-XXX, safety we new the Phase has the previously double-blind, pause our endpoints of mentioned to therapy in via Secondary consistency. This administered local enroll IBS a bladder trial to patients safety, The is direct injections patients URO-XXX. study to XX the under from data wall URO-XXX. two now approximately of cohorts. scale to The expected be anesthesia. to fourth female [indiscernible] a administration report are global effects in is negative

followed DSMB, or weeks monitoring we to from planning made to quarter. X further XX the cohort X change cohort from will now will of episodes either primary The with updates receive XX XX pleased the as Overall, be or the decision after first assessment placebo. the is therapy. fourth which second providing new URO-XXX well or the this tolerability up then measure safety in for independent average Board, to outcome with to baseline move The matching number in data on receive and will single of the you will milligram matching milligram URO-XXX potential placebo, UUI of week cohort cohort of X coming the meet progress forward in from the and quarters. administration recommendation is The as look at I'm of injection. XX daily safety be and of Patients made the to

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

Ajay Bansal

Thank you, Cornelia.

for for an our year. fourth period summarized the for R&D with Form ongoing to million filed release, in expenses fourth which abdominal information the can of additional $XX.X OAB IBS. same comprised results of compared were in compared addition expenses million the year million XXXX fiscal be including in R&D were In you information, will our fiscal full pain XX-K, XXXX, the the studies quarter for press with our $XX.X XXXX expenses of financial full with the In and prior tomorrow. plus million quarter $XX.X year find year. upcoming R&D in associated BPH $XX.X prior the

$XX.X and the loss increases $X.XX as vibegron. drug When included substance We $XX million per or FDA. payment the in million in the the for a expenses other our the batches increase prior the a in costs comparing corporate is net the of corporate to prior quarter by with an R&D million made drug share-based per the and of of prior million period expenses. expenses $XX.X G&A expenses of to of same increases of of When $X.X Merck in the year of material G&A to an XXXX increase primarily quarter fourth fourth XXXX starting prior for partially year, the million due $XX to for year, increase the the of manufacturing fiscal and the G&A compared and million in increased compensation for same was Total XXXX the study million compensation costs fiscal is same in of primarily period fiscal the quarter clinical fiscal new fourth million the to upon the the million Net million the for due the year. XXXX an compared and period operating When costs with of and personnel XXXX general the loss general period Phase share of fourth XXXX. period well prior were expenses expenses were XXXX share due of year. in These acceptance in in with $XX.X in to $XX.X the the year quarter for to initial or milestone to compared as of million in other $X.X for same year comparing fiscal for $X full compared costs the year, $XXX.X prior $XX.X other XXXX of $XX.X application the expenses for quarter payment for by with of G&A expenses and is primarily prior million fiscal $XXX.X year. vibegron same million also due increase $XX.X comparing in million and personnel and fourth for of milestone offset the $X.XX share-based study the primarily a increase lower increase million, $X.X III validation EMPOWUR XXXX in year. in expenses. Merck completion

remaining Cash XXXX, $XXX.X early cash net was for was or ended in the the fiscal we million facility December loan million XXXX. added per $XX.X $X XXXX. $X.XX for to of We million XXXX. with March million. quarter was net a an loss as XX, prior of operations quarter used compared with Our operations under facility. $XXX.X million compared April, by DSP. was million have or million At the fiscal $XXX.X loss for in XX, increase for XX, XXXX, X-year $XXX.X used low $XX.X cash to ended $X.XX March DSP Cash position million $XX In total per share down share this XXXX fiscal loan from a drawing immediate term now interest,

ahead, prior Looking of compensation million manufacture million. product and infrastructure, are for between the potential to include and share-based trade our of as expenses launch be we approval vibegron follows: increase programs fiscal SG&A to samples hire expenses $XXX quarter our as to we that significantly the studies. and completed vibegron our between are develop expenses operating prepare R&D in of project and cash first expenses as launch estimates clinical our ongoing $XX burn million throughout to expenses $XX XXXX well projected We XXXX, we fiscal million XXXX. as projected sales expenses expect $XX of December for force. related as subsequent full approval commercial marketing These to to excluding

our In $XX between And payments milestone will expect addition, NDA Merck. DSP. trigger to $X million interest million a approval million payment to of to we incur $XX of to

to Jim. to is $XXX between would cash $XXX back to the to that over I update, our burn together, Taken financial million for like XXXX year million. range With fiscal call projected turn

James Robinson

Ajay. you, Thank

plans, expected across We're we've far to the the how X we the line thinking make top milestones will business. pleased safety half I'd of all late build vibegron for vibegron are aspects data in come. well X leading pain, approval IBS-associated team in the As treatment believe out progress study therapy potential with accomplished gene we're to made summary, and Phase completion of so us months And the next what and of the and continue cohort remarks, about a injectable commercial have we'll to the we've IIa that, we IIa and and summarize prepare URO-XXX the our of we enrollment our strides Phase questions, of forward. our our OAB, continue year In December. we novel questions. to include launch in to the like market back prepared from excited we and about the These of to future. are your to with in Operator? we this finalize several positioned that competitor continuing We're strong, to to and be now operator, drive of go for finished go

Operator

Morgan. [Operator question Instructions]. first Joseph from JP our And with Eric is

Eric Joseph

And hoping what impact on margins? a the force announced was of I'm I agreement Sunovion heels might elaborate P&L on sort bit on this the sales as with Sunovion could the you this just of announced the wondering further for impact, just thoughts agreement, us of the if you secondly, product your commercial just vibegron, could any, little if what of there to be is morning and sizing latest well? give just terms the on and

James Robinson

for Eric, question. Robinson. Great. it's your Jim Thanks

Sunovion. reached start, agreement with of as first pleased we're of the well. to Ajay it have terms some answer and Sunovion But all, agreement, I'll In can of very

logistics. areas, foremost, said with speak, we're release, are The they As working capabilities in the have on, well-established as we commercial in we press them and first capabilities. that

to retail the are us product of of the price have some the office account charge specifically Also, partnering distribution especially in going us to management PL, of also distribution provider very And also with aspects distribution and And areas government organizations meet that on back contract them with the we'll our on select with for that's be be management across reporting. services, wholesaler backs capabilities, the relationships. important for important availability product where we'll of X country. so working ensure helping they strong group be where responsible purchasing they'll them our So and operations, the they're for our such vibegron. rebates,

these vibegron. pleased have with capabilities Sunovion ensure important to to to launch of to very So in the a partnership address very ability successful work

is to well-established build In terms savings, of really I'll of the but to global capabilities without benefit ourselves having to their with margin it ability the on avail turn of them basis, Ajay, ourselves. and working Sunovion a

are any In sure, place, addition going efficiency specifically, they also you important to critically there's be gain. have a to add to the they And for since launch. want have wholesalers it's important comments not strong with and relationships if agreements the already very distribution, for and that. our presence that, big Ajay, in X us to I'm to more

Ajay Bansal

very I have well. Jim, No, think you it summarized

wholesalers of Eric, the because that than our on to -- scale, we'll own. if hopefully, In enjoy able discounts have we to, speaking trade of we to be superior were Jim their and terms go margins, we'll to was would

James Robinson

I'll address Eric. sales And thing well, then the side as force

And very as XXX building to well we XXX feel of professionals. the we're sales sales very us. we'll with the we've the past, footprint will the build our we initial sales a sales for -- sales force urology, urology original So be launch. long-term be is also professionals which or force, important or be will as That in positioned XXX stated care

XX we'll representatives, XXX physicians. we've be high-prescribing representatives. that, So primary XX high as that on stated roughly call able decile, be also with We'll before, to, care also to the

we'll decisions, primary care communicate have sure opportunity on well. at in to also, XX% force to sales address evaluating addressable that as able in the strategy launch. greater be progress we for as as and/or partnerships We're launch, at past, that we'll evaluating we the care so make market that the and launch. than vibegron of a discussed at primary make And And we've

Operator

is next Wainwright. with Raghuram from H.C. question Our Selvaraju

Raghuram Selvaraju

describe that management detail Sunovion, granularity to perhaps just means? activities, on wondered a agreement for us could more with bit with provide service a could you with if more particularly you what certain account aspects bit select us in if the I respect of

James Robinson

Sure. Thanks, Ram.

at of thanks question. a ago, perspective, Vice will Urovant, Stewart. Ken a a process Market From Ken we national in now of for again So We're the global week the President of Access. Senior our building hiring or the so account. right announced be

be team accounts national payers. It large that regional for payers. the your So responsible will responsible also will be national for

be D will and GPO Medicare focus but on focus Part be the primary commercial, also care, in in strong Our space. long-term a especially

will space. we will first have with where strong GPO So partner Sunovion, be that relationships. in They

joint we'll account colleagues so our among Sunovion ensure the either manager solely. trade that we then to They'll with account for the And Sunovion the be GPOs. or account And have conduct responsibilities if calls responsible adequate provide coverage the managing these for relationships we'll the Urovant necessary, also manager.

wholesaler responsible well they'll relationships relationships. will That So responsibility. for be as distributor the as Sunovion retail be

responsibility they'll have and national go And manage GPO from So at like we'll a in in some cases, the the some in it accounts cases, alone. accounts. perspective, space, shared national we'll

Raghuram Selvaraju

prior the if pre-launch perhaps what likely are independently? wanted these date, very I helpful. detail to be could you Okay. with know to be Great. to conducted are of activities PDUFA accomplished conjunction versus in Also Sunovion to That's which and

James Robinson

Yes.

So good question.

in accounts team. this appropriate accounts preapproval information start national and will with as we So in summer earnest our exchange with regional engaging

in advance background will allowed we be activity us. out and very important profile that appropriate make sure PDUFA. clinical can as the we'll as about That buy sharing So of required, a we're what for

to managing we managing start functions. relationship as with out the distribution, in that to the back-office building with how addition, Sunovion In going we're address engage be partnering we'll

we of fully we're prepare launch to lot will that that behind a scenes So be the launch. as operational at ensure for

building organization. activities terms launch, leading very sales to our up In critical other we'll of out other be activity,

team, be hiring team. XXX expanding PDUFA and force of So of we'll contingent leadership regional our anticipation force a full our sales the sales be in expanding sales upon hire sales that be We'll we'll XX. approval. manager We'll December

and contingent of go then approval be those will offers will offers there So made out. upon

Raghuram Selvaraju

Or you long-term one then competitive helpful the has IBS-associated is, vibegron do having as been under viewed MD-XXXX the in failure not of positioning the really impact And pain? kind view or for last had of Okay. linaclotide any name as of impact? that

James Robinson

good okay. really Ram. to that, Cornerlia? have to that's if Cornelia That's start question, going a I'm

Cornelia Haag-Molkenteller

Cornelia. is This

not This all, lenaclotide we're So IBS-D, of IBS and first We to our linaclotide. And knowledge, diarrhea studying. constipation. look and IBS-M. was this related I'll different concept. because is a that Phase hand is considerations. to study the vibegron. still for our of of please. on lenaclotide mode different it these is And to proof and action totally can formulation of we reiterate I'd between is is what a indicated do between compounds, not again, that again, This like are linaclotide, you back is compound, up actually Jim it IIa studying think competitive

James Robinson

Yes.

large So still significant Cornelia in market. we medical It's said, unmet feel addressable in different where compound, comfortable. there's need we as are today, a

Operator

[Operator Instructions].

Ram have a We follow-up from Selvaraju from Wainwright. H.C.

Raghuram Selvaraju

Yes.

of enrollment? can the types the through OAB just if of remind quickly just you URO-XXX are run X very complete to And the COURAGE you that expect two Just trial? maybe study us can quick from items excluded for Part you how me. drugs Cornelia, also,

Cornelia Haag-Molkenteller

Okay.

of of is the current XXXX. guidance the have This the that we COURAGE in given study we So half second our provide results guidance. OAB BPH is plus study, will which

As more year give guidance in know, we're when are about the the early and XXXX, we you still going year, next towards I end to we of think the this of end anticipate year. enrollment

are pharmacologic these URO-XXX, therapy. have oral failed patients Regarding who

directly take any focused It's therapy drug. the direct This not or medication any therapy. is They for same into very an a do not concomitant longer injectable bladder. oral So have transdermal at overactive time. bladder the they will

Operator

from Jefferies. is question Mukherjee next with Our Jeet

Suranjit Mukherjee

This Jeet Biren. for is on

those bit Myrbetriq on like? discount perhaps to color pricing, any any and have date conversations more you've you you or discussions think discussions a were a second, conversations I then And that? payers hinting on consider on what at And provide this, you you if could with had to would have but been had little perhaps?

James Robinson

Yes.

market We question. we I hired team as access. out of good for preapproval national -- in we the of But mentioned, we'll the in earnest process activities it. our our Thanks exchange just building begin So head information are accounts the and summer. in

need terms whether proposition be have sense much the of like would value it of on it the the this have dynamics perspective access, what the we'll in to able at payers, end look that successfully vibegron, So and believe also information its clinically more to pricing resonates a with will and year which towards of include we which to time. better secure for formulary us

Operator

back with I final his will Jim And call that, the remarks. Robinson for pass Mr. to

James Robinson

to call and today, for engagement Thanks the joining for up questions, the much. I in very near call coming we our appreciate thank we say the want you look our and next to everyone and term. forward

Operator

Thank you, now for participating day. you disconnect. again, and ladies and program, today's in gentlemen, Good may

Urovant Sciences (UROV) 18 Jun 202019 Q4 Earnings call transcript