UROV - Earnings call transcript Q3 2018

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Operator

Hello, and welcome to the Urovant Sciences Third Quarter 2018 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference is being recorded. And I now like to introduce your host for today's call, Christine Ocampo.

begin. may You

Christine Ocampo

joined It our Towanda. operating and Keith close Officer of release Eurovent a pleasure welcome I to for McFadden, team; market our members Thank Chief call is including to Dr. to am containing Haag-Molkenteller, quarter. Officer. third conference press fiscal and by discuss you several the of on Chief you, today, XXXX my today Katkin, leadership Chief our results results. detailed Officer; Commercial Executive Cornelia Medical Michael the information After issued financial

press will filed may release filed company including which XX-Q, the remarks as forward-looking well statements You Form in on section your as in access XXXX Risk SEC and development Eurovent.com. the was our for regarding report another quarterly our release of November strategies statements, be direct in website, the urologic disclosure forward-looking vibegron, with to the which today's I the the clinical by on Form of attention tomorrow. contain the plans with SEC for Today's the statements Factor treatment diseases. XX-Q,

I'll materially For could cause differ uncertainties a and With to from CEO, call the that projections. of that to results review over actual various said, our turn Katkin. risks Keith

Keith Katkin

each Christine you Thank my for to you, of thanks and joining us today.

This with treatments clinical Research our Development our and view on Officer, the development in the by across week EMPOWUR of trial vibegron study made progress program turn therapy men for IBS-related commercial expect for continue the Phase to key a Dr. provide clinical we the OAB international enrollment supplemental Cornelia? for with and request vibegron, as is XA March to BPH. of no men clinical study and January, trial were programs was called for and in advance the significant to for Phase end previously programs. of urology And phase the alignment for With a website. XA important pain. last A with November is FDA Cornelia our there enrollment of detail vibegron fiscal Chief presented will for third by of end to approved data we prostatic FDA XXXX. in reach to programs. in pleased December, gene productive we was concomitant we currently over bladder our phase We replay in called finally XXXX. call Day Also this January, quarter In are benign of in that were the New an as The pivotal gained submitted the vibegron topline hyperplasia. the we held completed opportunity we novel York our X URO-XXX, more which In we the milestone quarter to available X [indiscernible]. In a a I'll we for our first City. We initiated who that, pretty event pleased at in Eurovent our Haag-Molkenteller abdominal overactive program Study on development Medical all protocol that programs, discuss

Cornelia Haag-Molkenteller

Keith. you, Thank

EMPOWUR for First trial I overactive international to X adults like about would Phase with talk of for bladder. vibegron

large vibegron I patients. XXX that only problem for study international shared enrollment During and phase November, we our OAB in completed for X call earnings our last pivotal in in

enroll pressure. are about and XXXX. line started into we anticipate quarter, on XXXX third the in In projected the which by XXXX. for half effect to potential any blood We conducted if second results for the vibegron, of blood to being enrollment we is vibegron's subjects the to December XXX how assess November progress ambulatory on data make U.S. During pressure to continue top study

drug of A quarter batches. the target New continuing, submission first for preparations work are is of the XXXX. registration including the on application

mg OAB. proposed at FDA protocol have to for our be patients feedback we to in This specifically will X with has reached The to pivotal our safety. versus study phase for X,XXX in indicated pleased the does share and are met men important studied with because no prostate feedback. am be year the nocturia BPH. the XX currently secondary with trial testing and episodes hours FDA least XX weeks vibegron the reduction one received pivotal will and program on X agency double-blind by FDA overactive Key we placebo. year urgency the approximately Phase endpoint an for approved development agreement OAB men total patients nights Next symptom and there BPH. BPH. proposed benign for prostate a duration bladder X OAB frequency devoid, study supplemental awakening based program is trial hyperplasia we Earlier at protocol. in This an micturition co phase is conduct this same of I XX scores will the FDA of for be Last primary in study vibegron XX episodes, reduction or EMPOWUR product, of accepted in endpoint with

a OAB assess assess In two-part Part patients. we safety men clinical data BPH, we with and In initial we will efficacy available trial. XX in part safety. one, Given limited proposed X, the and in will

in late expect of this quarter begin first XXXX. to study We

average. is baseline of leasing with a worst abdominal XX% to to XX% patients XX enroll at IBS find The pain. primary our for enrollment on clinical associated program XXX a IBS. Patients IBS IBSP. either diarrhea or mg reduction study. respond placebo. with proceed be In XA the to endpoint rating for into XXXX, Now abdominal least The subject vibegron mixed vibegron abdominal intensity compared XX week December female due will plan or pain US phase in decrease to XX at started randomized we scale point pain, to is IBS-associated with for the to pain in We to

rating included effects endpoints or Secondary particular in global lack safety frequency stool negative stool of and skill on consistency.

study the topline XXXX. report to in from expect data We

enrollment products for Regarding to gene development Phase we OAB year. is a the patient half to McFadden, goal meeting Commercial the in turn the earlier discuss that, into Xa novel Chief submitted I to therapy request the the like our The study FDA called to Phase start formerly With this Officer. the pending have [indiscernible], of X FDA URO-XXX Michael to response. the XXXX for study call over second would of

Michael McFadden

Cornelia. Thanks

bladder. continues bladder. pharmacologic XX.X continues Beta-X We continue OAB to XXXX, be year market excited to The new its share new million treatment just options in High in increasing pharmacologic marketplace category. and to happen in patient concluded. growth market continue with cycling agent continues commercial treatment one make opportunity strides from therapeutic representing the a for for written overactive to for the to overactive for another to enter great a agonist grow about agents the patients the opportunity prescriptions

maximize do with way we continues urologist, OAB assessment plan inform vibegron urology market treat commercialize in and States and approach numbers who segments so physicians and reach to sales of care in focus patients. with to that significant can specialty in revenue. We United to is long-term feel footprint our cost and a will on both deliver the our sales care Our large effective force long-term

as of to plan additional we another HCP sales sales and coverage increase payers segments people for vibegron. provide add is Our

see stop portion and and needed segment. A marketing Myrbetriq represent strides in in and these growth within growing continues patient the team commercial to six research year therapeutic for Our and and overactive beta at our and from operations a that prescription with plan continues be Many managed vibegron The continues this urology segmentation have and robust agonist continue ascertain to a are when Myrbetriq therapies provide patients significant area. next volume and looking anticholinergic business physicians that to with XX% learnings growth patients calendar for or failed of the patients launch. make oxybutynin OAB for a innovation XXXX. we care insights is Myrbetriq to opportunity to for completing bladder. therapy significant patients continuing new months We both

In XXXX the Myrbetriq $XXX a that addition pricing pricing with research have the brand in the of current resulting of consistent price medicines at by flexibility. for is X% OAB year last which says beginning grew flat

and new for agents have be managed Additionally to Myrbetriq they brands other greater will the beta strong in coverage. differential, primarily unrestricted coverage and currently and the this for in for to our XXXX data strategies continues and the discounts the quantitative reinforce by market continue that work in formulary promoted copay Our OAB this both and XX% therapeutic consistent as class. areas X brands than opportunity validates analysis pricing inform This

Now financial update. I'll pass for Christine to

Christine Ocampo

Thank Michael.

compared for of increase XXXX. quarter. used increase in of a comprised $XX.X prepaid in $X to fiscal related administrative XXXX. payment $X.X XX-Q. $XX.X of to million initial million with the million $XX.X development the is million of Total operation $X.X release prior were first ongoing a $X press of public previous ongoing Urovant million million year decrease U.S. due associated million two the the the were headquarters $X.X Urovant with filed opened on for and were was as with addition clinical quarter of costs increased prior million $X Sciences, $X.X General at million including personnel used XXXX the expenses compared of amount the will in million OAB. third did quarter the year. research the attributed of primarily which information expenses to of of period the financial third prior year. find with Phase of in Irvine, paid period were in quarter our million expenses. trial quarter attributed by fiscal were an to upcoming million our compared attributed Urovant ended in adult half establishment expenses cost quarter for the payable, for same our summarized EMPOWUR same $X.X of for as by cash the the X results In the in The of fiscal development in additional and an XXXX in G&A Cash with In for and accounts comparing can our $X offering million quarter the increase not $XX.X with in tomorrow. quarter by Form Urovant for studies, quarters, provided to expenses XX, XXXX. expenses vibegron information associated services and Research XXXX quarter and When XXXX reflect full operating decrease the and behalf to to third be for our operating an the California December The $X.X in costs million operating in the the the million office not third the by to third $X.X to compared XXXX, in same you

or Our last XXXX. for gross quarter initial in raising net for was $X.XX compared public million loss proceeds We loss resulting proceeds of net per same offering XXXX fiscal a the of fiscal our approximately of share with per in net $X.XX of share $X.X third $XXX.X million approximately or million. quarter closed $XX.X total the October million $XXX.X

XXXX total XX, $XX.X million. December balance our of was cash As

Now looking total close-out be the amounts fourth our to increase trial. as of prepaid as with concurrently we as our of ahead Phase to currently expenses million X XXXX, will operating to EMPOWUR currently the $XX classified to expense recognized million expect $XX quarter

to operations in our be to summary call in cash fourth I'd turn the remarks. closing We XXXX like approximately the $XX to results, used that of Keith million. over quarter back for expect financial With our

Keith Katkin

our Christine. to in progress develop into reiterate making development you, a To catalyst clinical which Thank important programs leading are urology Urovant company. we're

progress towards are month. We overactive X vibegron next by with that for data goal expected with end bladder the topline Phase trial driving of through for our

Xa study associated patients Second, last for IBS with late Phase in initiated year. enrollment vibegron in pain our

therapy for open FDA's BPH. Third, to call questions. gain summary now study anticipating trial response gene of alignment With on our in and And with novel Xa patients the Phase year OAB milestones, I'll this Phase our oppose the of pivotal trials URO-XXX. earlier a FDA Operator? that finally, with protocol X to

Operator

Instructions] [Operator of the first Baral line Our with from Cowen. Ritu question comes

Your line is open.

Ritu Baral

urgency see about talk to One or you that will want you commercial what to episodes minimum that on success. you to that how the you marketing think on also prescribers? bogey will be will, want question and want The of coprimary, drive can but differential, which less EMPOWUR one you the resonate follow-up. with the delta Keith see much the urgency do meaningfully

Keith Katkin

there. vantage Yes, from then I'll can start and point add a Michael commercial

in significant whether we've conservative resonates treatment minimally the think product acceptable of very urgency. to And obviously be I achieving approval. potential So discussed as impact that And study effect of such it doctors with market relates nutrition's, for really is can UTC assumptions No those or we've statistical across for research all done we've the onset as we the of forward with the will lack move well urgent the taken in profile that incontinence it's the the drug-drug action. profiles what and the FDA interactions.

we that so think with vibegron quite in study, And the outcome even successful perspective. from be conservative the commercial can a clinical

observed Merck. the on I think were any we turn that effects vibegron replicate from as which dramatic Those that by are blockbuster quite have some effect a arguably been of saw those one easily Phase effects that we to and upside best we could case into treatment study able product. think Xb the

upside So see. planning be that are We're be but on great certainly to it, not would case. would that

Michael McFadden

add symptoms. the that know in OAB when have ultimately is go of and hoping class. their they which are episodes dry have therapeutic incontinence seldom Patients constellation occurs doctor urge they suffer two to obviously from and primarily rate, things. suffer see a We And and

and meaningful doctors their achieve is So significance as doctor for - effort see done this spend why scores take to this this market very to because doctor to and both very have show the medical are urge research as they and to a is it we and the V that is for go implied treatment. going go characteristic see patients for in incontinence, a primarily them important if we've their the money a seek is Class driver can them outcome

Ritu Baral

follow-up think are stability you are a that outstanding? What then is else issues be mentioned you to producing I why done. And their CMC left are loss.

Keith Katkin

then clock. No, those upon and stability it. lots that's that Getting stability offline really starting

that the what to something first leads may plan the stability, XXXX. and XXXX. in accelerate bodes up XX to FDA just to it of into with meet year than an with that team and quarter timeline filing to to are try So everything that's us accelerate can NDA allow doing filing month Cornelia they this later which and see less

that information for tuned stay it. as on So get more we

Ritu Baral

XX am the And I'll OAB, What's dose Phase ask milligram sorry, why the confidence in guess make I one I range for up? that on you're dose, it mixed your your last clinical do question same idea, driving X ranging? does not IBS, in dose the any one using

Keith Katkin

Yes was point that a that discussion had. we

good the ranging a cash So Really question. dose reason is conservation. we're not doing

So do concept because cost dramatically. the study a proof of wanted increased have XA is then study, fairly if ranging, you dose would the true to it

significant as risk were can So to capital we we believe concept PKPD at until demonstrate proof phase an we on didn't that impact that to incremental a we milligram would roll just know dose finding. We on efficacy want the that Xb pain, we're within if study of some a into and of dose do study. put pain then provides so IBS and we'll XX perspective more had well from and study translate OAB XA successful

Ritu Baral

the come to that, are signal Are basically for of to for you looking here you the looking far IBS? that's significant So continue specifically data on going end a data?

Keith Katkin

I we signal, proceed the think stronger that we're would further. the a for more signal. looking The likelihood

patients study, per only arm. I it's want So to don't XXX XXX patient a or that say

benefit to delivering So product statistical and we - a conviction patients. data, I will is require want to these trend other a the would to that provide significance, that is see we say need but that vibegron us which strong

Operator

Joseph Our the comes Eric from next question JPMorgan. of with line

is line Your open.

Edward Marks

for on is this guys, Ram. Edward Hi Marks

a Just questions a and what's been discussed. based follow-ups on of couple few

was particularly notable well, wondering I differences as Solabegron compounds. within any the pharmacology at are the there if between looking two Just

Cornelia Haag-Molkenteller

It Solabegron is also a different different compound. has profiles.

So vibegron to nature half is due once long by its its daily drug.

know, may once a needed as reformulated you be daily to Solabegron to compound.

course we is Beta Solabegron we main inside have Of agonist. also X

as know saw versus Solabegron, the We have tested did any vibegron access test but we difference where in not vitro we we now. in as have as but to assay don't the far positive main the we data but profile ourselves of probably signals, to the

Edward Marks

relative in well? using then what of the is to XXX there was dosing milligram terms conservation, milligram and that XX signal And or just advantage the the the are that be these there enough is discussed, versus cash of as

Keith Katkin

it and Let you to as study… - me IBS relates give the pain

Edward Marks

study, For the EMPOWUR I am sorry.

Keith Katkin

with Oh a a bladder. of so XX thought dose selected for us patients greatest the solution it EMPOWUR study, milligram for was gave probability the dose because we overactive single

So just Mirabegron dose. titrate, Telesis a as reminder, milligram to up XX a at dose milligram there dosed product, has XX starting then dose be hydrated and is to

we at given solution. to titrate mentioned a forward a in XX% milligram would we study the XXX in FDA, to and XX with the our gets that milligram to this that's We of will certainly avoid a modeling and XXX milligram that start wanted single with up the the what So the decided us similar an we move that be XXX Mirabegron then I dose precedence if where to that of and dose. milligram attempt milligram that, forward XX agency so felt move put dose forward dose we as have and milligram PKPD just then to try XX from tried scheme dose why dose almost about efficacy at shows us move

confidence So that dose in its incremental amount maximum to we milligrams. have XXX of but in similarly XXX the a with ability provide agency at can comfort patients to the we studied milligram a given perform high the terms of

Edward Marks

facilities be might And that initiative? Excellent. discussing or in any sales was terms you I living commercial efforts what from the urologist earlier. between if just the were differences the and of then assisted the wondering

Keith Katkin

different more will it's because with the are patients LPC except the higher probably they're other the primarily practices. It's issues group very be account work. a than to stakeholders, is are be typically list that illnesses are and that on LPC urology similar thrown but of the deployment of a urology a because it's that sales issues. of Well even experience typical uses safety be staff I deploying higher and number in sales, care large and/or long-term an an go be force people their are They long-term from typically difficult market compromised lot variety promotional message retail challenging in a some primary our so team - difference is their think elderly care population, and account From offices. director so manage more segment. messages patients a into an promotion sales care we'll where of the complicated medical concern on driven and by standpoint, standpoint, we'll focus urology medications fragile, will to only Those

Edward Marks

extension portion Is And final data for available the the question that year when then of just will be going the EMPOWUR the filing before afterwards? timing, to on be next trial? or

Cornelia Haag-Molkenteller

It of to be Before. the needs part file.

Operator

the next of JPMorgan. with Turner question comes from Kufe line Our

line open. Your is

Unidentified Analyst

Turner. Eric for It's actually on

Sorry issues earlier. from and awareness to what know XD think awareness beyond the an sense to sort class getting release EMPOWUR showcase among and data just next opportunities top is of gap heading into vibegron month in NDA curious there urologist the Beta line or the just filing? are today was you about guys the terms of a phone I the where you of

Keith Katkin

the and X agent is line at X used US urology segment shown all is increases now continuum the that first-line to Beta from of been primarily the anticholinergics most the when second the the third anticholinergics think and potential of using the use a evidence long-term for moving in much of They the has awareness Beta up is and I Yes, the dementia and Beta dementia. with over a line they as their urologist driven most market increase prescriptions are urologist's and commonly agonist. market there's by better significant account is the than of X, of treatment probably not in fact risk they growing aware that the Beta that are - look to Xs in of adapt XX% Beta X we more risk a for tolerability

beta-X. And used adapt management of and OAB. things so referred care failed also specialist second your seen defense to They're who a doctor being data the a primary now of oversee and therapy to urologist their as those the line have initial astute for being and and patients more with then a of most being of are aware use

Unidentified Analyst

guess kind conferences at we top the - line, XXXX? anticipating medical be I looking in presentations presentations EMPOWUR fuller beyond at should of

Cornelia Haag-Molkenteller

Yes, as sub the possible. to we it full try manuscript a course then have and have as full Cornelia. in also present place. Certainly Yes, we at which this course We're will we'll many is of many planning will study of publication congresses plan the also publish. analyses

Unidentified Analyst

final just at the X, point? this can provide of you maybe recruitment And on any Phase IBS lines just time question sense that

Keith Katkin

since But data that No, like as up Right just the I just that certainly terms first the our we is before space of get timeline. are guiding to tighten what December. in we think more it's of enrollment. move into too we Company, the enrollments started looking some early endeavor a IBS want right data we end this at now refine study with in We'll as XXXX. the towards forward now enrolling timeline given we're

Operator

Our Jeffries. next question comes [indiscernible] from the with line of

open. is line Your

Unidentified Analyst

publication to on been risks? That's out when insight and the you question. AUA/SUFU over updated risk XX have coming maybe would to that the want months. reflect to just dimension if anticholinergics I those last XX have Just any be guidelines the with first to

Second on as any you care pair side, these managed shift of pair result a data beta-X to question agonist? have the is seen

Cornelia Haag-Molkenteller

first Well, I'll take guidelines. the the on question

guidelines. the two already So have certainly already organizations adopted

AUGS, the treating Association, mainly is issues. bladder these American women one first gynecologist are with the The Urogynecological

also older been know, adopt their the guidelines far it. we for as the updated guidelines also updated. people is they've So currently AUA The see their as [indiscernible] we'll updating criteria have when

just two I again over guidelines publications when organizations updated hand come I'll their the is update some will happen probably and guideline think question. see already update have think on comes. as other and I out more the at next So already point

Keith Katkin

on comment post Yes, particular to guideline represented samples X that to not to data typically make a of confluence sure take on say they enough guidelines, is the a large data to the make X issue years decision. complete,

right seeing and it to in that we're think change. we'll process. I so middle continue now process the We're that of

managed Regarding payers are year how branded agents both currently a frankly beta-X the and really with agents care well. over the from XX% are the for they XX% promoted coverage, the Over commercial in coming other and no all the class coverage cover - covered quite modifying and in [indiscernible] restriction. and for

are So a as think covering make I really dementia. don't them the negative formulary would despite follow guidelines like It unusual managed see highly mentioned agents OAB and payers with well for only issue therapy and where the for it be those would potential support safety adjustment concern something or before broad they they any would class. as long-term

forward go choose So But it until be a by therapies. on manage there'll governing and OAB across - clear, guidelines payers probably broad no this how bodies all that manage very to they we'll basis. the are see adjustment absolute

Unidentified Analyst

follow-up one when what absolute all to are governing say changes you that; governing bodies broad out AUA, other just bodies. and on are across Besides So there? guideline

Cornelia Haag-Molkenteller

so their bodies. Society of Association American Urology other European updates course quite and governing example, a for The few guidelines also are of Geriatrics which subsequent there then

Unidentified Analyst

a then on just question with the And pipeline XXX.

that's whether into could of that how that description terms of patients some and administered to trial? just the you think into bit a and want in hinder Just you patient can provide being enrollment a little understand

Cornelia Haag-Molkenteller

an BOTOX is - it therapy. into injectable So It's being basic being the like administered it's bladder.

now depiction you can respond and several pull injected. OAB BOTOX widely for being therapies. of do the old for how used treatment out years is to licensed you our who If is see the a package for there's bladder the BOTOX insert, BOTOX of patients not

going cystoscopy administered in are this including would of all think So hinder via as just codes familiar. very administered in are doctors don't place injection we into enrollment. so codes from number the BOTOX these injection to the place currently direct various reimbursement sufficient is needles There's all and of This being is companies, is be bladder. this by of

Unidentified Analyst

and cash just seems to with increase balance million raises about question to the sheet XX, balance? on burn how Company the And it of additional $XX then think the balance cash about

Keith Katkin

findings XXXX. us current cash the quarter our provided into will Yes, first of

goes it X obviously most Phase of through a number So which milestones the data, is important. including

that be the there'll we certainly need incremental capital. for recognize So

thing looked different lot Phase it's debt debt the equity. door X of to the think options I of it asset, or nice we as straight at convertible whether relates capital

And options the of so we're going we to as those evaluate makes determine move sense most what forward. different and all

Operator

I further this in Katkin like no the for showing remarks. the at questions Keith I'm closing back queue over time. to would now turn to call

Keith Katkin

to discussion March. data Well, Phase appreciate with everyone in our and we X look forward next

So for us this thank you joining afternoon.

Operator

that you gentlemen, and Ladies concludes today's call. Thank for your participation.

wonderful day. You may a disconnect. Everyone have now

Urovant Sciences (UROV) 13 Feb 192018 Q3 Earnings call transcript