MYOV - Earnings call transcript Q3 2020

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day, everyone and welcome to Myovant Sciences Third Fiscal Quarter 2020 Earnings Conference Call. Today's call is being recorded. At this time, I would like to turn the call over to Ryan Crowe, Vice President of Investor Relations at Myovant. Please go ahead.

Ryan Crowe

Thank you, Operator. for to today of review XXXX. thanks business a fiscal and and update Myovant's morning joining for us general year Good third quarter

me Arjona, Adele Gulfo, Myovant's Chief Commercial Dave Karbe, Joining Dr. and Officer. Interim call Juan and Officer; Camilo President Officer; Executive Medical Frank Marek, Financial Chief Officer; today's for Chief Chief are

Investor today's earlier that will slides addition In webcast available morning, are this to investors.myovant.com. the press the Relations on our presented release during website issued be

statements. this we'll call, found our SEC risks of and differ actual forward-looking could making expectations include A uncertainties in assumptions respect These course disclosure all candidates, products, these statements. the documents. During cause financials, certain these to conference discussion can with risks be and our are of of which and and strategies, latest be beyond control plans results involve opportunities, of from to product that materially our

statements update does Myovant call not addition, forward-looking Chief turn Dave now that, over In this Executive obligation to the Marek, undertake to call. Dave? I'll Myovant's With any made Officer. an during

Dave Marek

Myovant and collaboration Thank achieved an into data oncology everyone. and good that last a X in stage landmark a our us from a report compelling four November, that agreement a with transform Ryan, term I'm extension Pfizer, product and opportunities commercial launch. to study, milestones FDA company Phase health. report helped Since These are have approval, in milestones, pleased huge near you, women's with earnings morning has positive

specialty have Through the distributors, we've seen week, include and ORGOVYX program. approximately our of I'm trends end field It's XXXX our shipped just our heard trial into comment distribution more still me and initial feedback the launch. we've on specialty of ORGOVYX these the encouraged review which pharmacies, pre in the bottles milestones five first we let ordering by Before channels, been early days, but from last the after detail, weeks.

of more provider and to more detail customer and weeks. data patient pleased and it's We of will ORGOVYX. that a have we being priority inventory order of coming about highest that placed placed dispensed this order level From learn I'm overall standpoint, the through XX how have receive And XX accounts patients, last as at least customers in for the already an one XX% Top our placed reorders. week, end have

getting milligram treatment So in progress summary, the ORGOVYX, started. prostate December of launch, the early great year, FDA our last tablet patients of just for but adult with XXX days monotherapy relugolix in the approved advanced the we're In oral cancer.

and Therapy receptor diagnosed cancer And opportunity in As Also, the XX% cancer of coming of to cardiovascular years. prostate and by the two coupled this digits is million with treatment about substantial number a those believe year, projected preferred the And with type aging of a most this with common U.S. ADT ADT An initiate patient we have XXX,XXX disease. oral with of receive journey. the cancer disease. standard grow this cancer an become represents estimated patients, cancer new risk and advanced based single population, differentiated hormone cancer living their X expected only XXX,XXX improve approximately have annually XXX,XXX deprivation patients patients to of ADT clinical approximately men is prostate due ORGOVYX factors, prostate of part of Deprivation first in the And this prostate care. androgen alone. approximately approved in will three or and as in formulation. its men prostate to redefine is prostate the oral to men its poised cancer or States, second out profile, advances with care. care, United And of are cardiovascular mid is gonadotropin-releasing year an continuing on Androgen patients men in those It to antagonist,

prostate prostate recognized initial men approval that cardiovascular cancer offers may with current more as risk disease die fact, it's men cancer, advanced and treatment And cancer testosterone The as from courses, in within XX symptoms leuprolide, agonists discontinuation prostate now faster suppression. well of from cardiovascular clinical ADT of And levels than care, with itself. an of majority of time offers known ORGOVYX injectable ORGOVYX benefit testosterone days of rapid, as the for limited a other levels, who such profound can is return received of standard this and certain the exacerbate prostate increase as men. flare. for who in that events. well men surge would cancer, sustained testosterone So normal the LHRH testosterone medicines treatment hormonal without And to recovery

to to is for LHRH one clinic the compelling death ORGOVYX day ORGOVYX options One or treated major attacks, a HERO had compared And a cause, patients therapy, attributes the the administration. receiving with injections. lower have heart of once those X us, provides from injectable agonist compared Phase alternative to the convenient pill any a hospital which require cardiovascular finally, that they a for as incidence travel told of clinical and in strokes adverse find study including men most events, providers

As for is during you this population important cancer this prostate of patients with COVID-XX ongoing particularly imagine, pandemic. can the advanced

Pfizer. therapeutic relative rights, Canada. from payments up to expensive and of eligible these combination after patients and ORGOVYX to the co-development, Pfizer markets. evenly review In briefly that was and develop the maximize will its commercialize collaboration believe certain Together, a announced profits and benefit across for in tablet agreement U.S. and Myovant Canada. development across is we December, we broad split co-commercialization can entered Myovant/Pfizer associated and billion bring exchange in approval. the in jointly the areas We'll let's In to to relugolix U.S. Myovant collaboration to and commercialization the $X.X shortly net ORGOVYX FDA relugolix and Now, and receive

an certain Additionally, oncology, Pfizer and develop in and obtained commercialize U.S. Canada, option Asian to the countries. relugolix exclusive outside excluding

into specifically increase it more deal to Pfizer's while has economics. and uptake, because the overall significant for financial we improved highlight good outlook. sharing our me believe relugolix economics let it's partnership the planned. current beyond peak by this patients, capabilities clinical the revenue. to we Adding in our potential pipeline to creates certain Myovant. of dramatically value We significantly to the will This relugolix, the through deal previously entered product for accelerating also us So our allow incremental relugolix sooner own and value now for will transaction burn Myovant's the cash franchise The maximize The Myovant's and us of substantial expenses. significantly than strengthen potential condition financial reducing invest enable increasing

anticipated in be health, is to XX Myovant based tiered oncology between million within U.S. sales and $XXX annual in product U.S. could And as months. burn to that in first million relugolix and addition health commercialize would compared option tablet ORGOVYX us and triggered exercise XX/XX split Canada. each $XX Myovant the we approvals Pfizer well to milestones this This enable development to ourselves. oncology $XXX and for cash of the the women's rights Myovant of of In will relugolix net also our the is FDA up to $XXX reduce payment, and year. could upfront commercialization will payment its and in this billion also make Pfizer the of Canada. This be developing anticipate a associated Pfizer should to decision will also commercializing for million relugolix outside equally combination relugolix to to a regulatory next million and women's eligible as develop revenues half $X.X up split during on certain up additional receive receive of expenses. composed payments by to milestones and

extension Juan now some and the relugolix for we summary, turn collaboration, profit the deal term than value to anticipate in exciting lifecycle significantly results the call Camilo greater tablet. Camilo? opportunity, franchise the increased the near a resulting that on share in discuss to details offset expected overall from to economics split, combination Myovant. XX/XX rich more of Juan I'll value recent is with coupled a to over relugolix SPIRIT the So

Juan Camilo Arjona

endometriosis, severe placebo for numerical of last monotherapy after XX designs XX of and relugolix were that two weeks, women defined relugolix surgically diagnosed XX relugolix moderate XXXX co-primary with for for one once daily dysmenorrhea of the by pain, rating proportion analyzed and clinically last placebo menstrual both were one relugolix women Last XX the a women pelvic with combination to These Thank meaningful into as data weeks, a a year. us studies relugolix over the SPIRIT X compare from the group SPIRIT in three years. therapy of the for in women allowed compared and to to XX meaningful extension one SPIRIT the endpoints alone and groups groups. across endometriosis. scale, pain, clinically X assessed study safety to of with were Phase followed built of last trials and weeks first a results with by we Dave. with in the XX-week both or combination combination X positive treatment X therapy SPIRIT X weeks XX-week had weeks XX you, relugolix treatment. in SPIRIT month, This the reported associated enrolled reduction results The and reduction pain randomized or combination identical presented non-menstrual therapy. weeks and Approximately receive were on XX enrolled to

treatment at study initial for efficacy XX-week extension and XX in of the week-XX. to with the given enroll weeks Following patients safety up period, analysis were option to an an additional

total be and all of [ph] in from SPIRIT X. analysis their about therapy whom extension study, conducted receive of treatment one relugolix year week-XXX enrolled assignments in X women Another combination now. at will XXX regardless in the of SPIRIT A

Let's this of SPIRIT first results XX-week review studies. the

data results therapy XX% endpoint. Women of rate the flashes. from minimal ELARIS and table side responder see improvement monotherapy over or X. these in dysmenorrhea studies combination loss over results have the from context, a present XX%, efficacy orange columns results non As you right with of on low combination demonstrated hot the studies SPIRIT receiving dyspareunia pelvic in pivotal density relugolix both Put of the incidence bone the X and the of significant non-menstrual and called consistent ELARIS for in intercourse about relugolix elagolix therapy meaningful painful responder a for secondary and key clinically very we rate the XX-week, in can pain mineral

While have these all designs. studies similar

data with Let caution. that studies must always different you comparing from me be remind done

an a of with safety dose elagolix you to and that of low combination after profile dose of of the see, efficacy elagolix. like high profile comparable has relugolix tolerability XX-weeks that As therapy can more the

study XX% extension The initially receive term those year. long SPIRIT the for therapy women safety combination the with XX of results one who for reductions for XX-week year. weeks. in of consistent through XX-week XX% this non-menstrual the and review at results efficacy respectively now profile pain clinically women reported meaningful and pelvic Let's relugolix are group one observed dysmenorrhea and

loss mineral with hot and density XX meaningful was an weeks, despite week-XX Importantly, long. patients minimal Their of which treatment observation twice period flashes also to consistent after XX-week from as week-XX. one that bone reporting was clinically the stabilized initial proportion period, not after was year

to treatment than with must the Now monotherapy, an year comparing let's profile profile with that efficacy elagolix Once always side data right are safety studies combination consider better better of Results which comparable dose XX-week that done high slightly in from therapy from and different the results to of or than comparison the that table. that a elagolix on for or really of be tolerability slightly of again, extension results of comparable low the after dose the one study of suggests has displayed is relugolix caution. the these elagolix. to

we oral We Relugolix defined to contraceptives the ovulation uterine important that to women or inhibition label endometriosis. on planning uterine Given believe the is the SERENE uterine further combines XXX% X extension the fibroids events. or could demonstrated and treated this relugolix information endometriosis. is that period. open Phase for pregnancy believe women in be single start estradiol for of years weeks, important best-in-class differentiate one with assess adverse one market treatment primary will norethindrone antagonists you prevention in an The and aged treatment study. I'd coming providers in use and XX treatment. XX% XX relugolix or of pregnancies the to generated being fibroids relugolix The and in with with important indications. approved an will is with XXX Positive SERENE Phase factor treatment increased Similarly, healthy taking tablet fibroid for number current efficacy already antagonist to and year, opportunity use relugolix to data endometriosis. after XX of uterine half of options that therapy progestin fibroids endpoint treatment from for milligrams combination combination other to with of option of the by further health. could contraceptives GnRH as one contraception uterine contraception for arm a relugolix in XX, to the provide one be GnRH of fibroid initiate over valuable normal like day adding to may and has healthy a impact milligram of we and XX% available combination the combination treatment relugolix treatment combination their use combination on for which risk these of study pill considering healthcare research once to tablet tablet All that woman's we're believe could We Based of XX-day treatment. receive a of an tablet is potential tablet plan pursuing Pear women or of we SPIRIT share of from learn believe study that hormonal XX patients potentially consideration. will have women relugolix their has endometriosis contraceptives SERENE believe these combination Approximately results, associated new women with X a acetate efficacy uterine, meaningful will field clinical women a efficacy women be endometriosis, milligram Currently women a contraceptive XX elagolix per a with cycles. Index, for taking barrier endometriosis treatment differentiate tablet. study approximately contraception years from for the therapies active decreased concomitant as benefit required study sexually non-hormonal fibroids the daily day enroll women fertility. study for of data

treatment low medical potential We them from side-effects that primarily, consistent, believe treatment endometriosis for very are heard symptoms, from to combination loss such tablet flashes from mineral and the placebo. were relief not for XX% have and treatment initial meet was after in minimize adverse clear year looking as women those hot these in average they uterine Their and easy with blood OB/GYN for We minimal density the generally in make X in an both XX% still treatment options significant average different prescribers, endometriosis, with priorities for and are and to pain women reduction well it an based reduction stop tolerated studies fibroids and that alternative Relugolix better an was events bone with relugolix with loss and uterine Symptom initiation of surgery. clinical studies. for the rates menstrual stable their at one requirements the menstrual has LIBERTY patients. as after on year. fibroids, following and results one our Phase top a SPIRIT meaningfully

fibroids balance endometriosis. Finally, may We improves combination dosing tablet, levels the and that estrogen same will from launch symptoms FDA we pending not fibroids by product tablet combination to convenient, with turn believe Adele forward to start, which right decision, June to And therapy the pill for relugolix with estrogen. to of uterine X. this the Adele? the bringing minimizing once the call with combination side a ORGOVYX. have a this one to women for we and reducing while potentially found it's I discuss over of uterine the both is range the year, expect later effects look day, we relugolix

Adele Gulfo

weeks hoped. meeting has ago, Camilo. us been just of which ORGOVYX Thank interest everything exciting believe our feedback, our launch leads be the five that efforts. already potential certainly and first has to we you, Juan receiving to It tremendous an are After month we prescriber promotional

perform engaging more a the ORGOVYX with as person. adoption is impacts seamless and towards launch by component ORGOVYX the I'm to vast access detail. three Establishing term first The to say advanced to have dispensing starts of with of achieving ORGOVYX. happy believe which key clinical are made our review in-office that materials education goal. beyond now this was achieving are so patients enabling broad when clinical to treatment economic considerations, office have making to drive in and all we're distribution, capabilities. in-office percentage to Our therapy awareness driven significant ORGOVYX foundational cancer. function they for establish to to economics with of large on we now priorities, in sales prescribers confidence majority operational significant prescribing each those our We've goal are they broad physicians, progress The disadvantaged by virtually economically who steps Executing technology practices dispensing I'll all goes strategy. being Educating encompass across is our not primarily androgen care contract, targeting practices commercialization including specialty component long pharmacy these prostate and Due our and designed as this are which areas. and across well strides of The ORGOVYX. men e-prescribing. as represents standard force to ensure these deprivation prescribing equipped initially access priorities

clinical systems, e-prescribing of ensuring For the ORGOVYX available support appropriately financial pharmacy that necessary prescribing And ORGOVYX offers ORGOVYX supporting is the a This And patients to is those program. where support ensure that customers and that to added network. practices prescribing. finally, through to to and pathways need ORGOVYX we office reimbursement specialty capabilities, dispensing is support includes without seamless. take advantage

We are reach early efforts very to pleased prescribers. our with

have care concentration launch. with share urology date a exclusively or force. have A significant person accounts, of centers, and high had and able weeks total that We since ADT and our sales providers just including in five large Myovant's academic points been group over touch XX,XXX XXX interactions Tier with with We Tier this of to oncology X almost drive health practices meaningful scripts. accomplish were to X

established years reaching averaging local the and have urology to enthusiasm profile, are proud are for tremendous sales seeing ongoing pandemic, and engagements, We representatives a experienced the customer the in the highly with given efficacy, with and Anecdotally, over XX minutes formulation. team compelling eight particularly many our hired oncology clinical cardiovascular oral profile, ORGOVYX's relationships.

fully momentum We now joined report last to that Pfizer week, the that the to are us in should team early is able were trained bolster pleased generate. sales the and we field which

As majority practices dispensing in-office are access our to And the pricing. mentioned orders. efforts into these vast previously, have translating ORGOVYX of early contract

of have reordered. out have XX our fact And already highest all XX accounts encouraging XX% sign, another Top placed In orders accounts placed ORGOVYX have already of priority orders. that

of which have accounts In priority in great is addition, e-prescribing progress. our ORGOVYX their highest half system,

patient notable broad also in to ORGOVYX. already made have access progress We establishing

first Our Support program distribution channel and was the of trial commercial went for support fully Patient stocked live within during the and our week free of XX patients launch. launch including Program, copay hours

access process. may today via of Part XX% formulary exceptions approximately review have today process. patients their coverage, currently reimbursement payer coverage, also and D more to patients through may formulary pre the exceptions Regarding access access have commercial via have

bids in and Engaged prior a with support coverage we commercial have for half seen XXXX, decisions with and support second Part continues the of first far. include June expect requests which XXXX XXXX. The patients decisions or our the coverage of coverage authorization, year, good we the so for Medicare with to Our commercial these payers in for the May rate submitting should initial by patient half with expected engagement success support plan path most D starts timeframe. broad services beginning

with access do to decisions, to coverage D we XXXX. Medicare ORGOVYX these anticipated Part in broad some than XXXX Following plans no offer January later expect

drive three has patients campaign initial phases, already of awareness engaging goal our for two have is The with strategy highly early to patients. for brand engaged launched. which Our

look is approved after second through ORGOVYX available efforts we prescriber direct-to-consumer targeted broaden of drive met and to our activation to of the to them talk know awareness the them are doctor. and campaigns. increasing In patient will Let this year, half goal education their with milestones

a a early each provided. ORGOVYX, ORGOVYX, to to patient utilize starting patient nurse patient remain A offered Our should days kit the is what planner to help initiates a also well through patient drive to services track expect pronged efforts adherence the coach as three as on information are with them approach. welcome patient on When treatment therapy. after on

treatment maintain patients helpful provide As other are engagement continues, ORGOVYX, and mailers sent to adherence. content on monthly that and information

This great ORGOVYX's four over our are higher weeks just reflects visits prostate material. decisions since XX% XX,XXX how engagement. than which visitors times to are start the downloading total regarding engaged of oncology recent we've off a making We is nearly In caretakers and visitors health. unique patient and benchmarking one likely patient other had regarding to and their launches, were their website, in cancer launch, product few with five or men data with our

now three you future. turn to are pleased will made financial the the to we our the quarter Frank? early and I progress Frank with results. all on third our updated fiscal over to look call forward of We in priorities keeping launch very have review

Frank Karbe

morning you and remember Adele. you, fiscal our financial Thank on form highlights performance for and year focus press my earlier the additional the XX-Q release that information. starts on to in will everyone. comments Please our good I April refer today issued of And Xst. quarter Myovant's

million $X.X collaboration from the quarter Pfizer. week's represent XX, about ended results one we third upfront the which payment So XXXX. of XXXX I the amortization of quarter represents our revenue. We've fiscal December begin financial of will with revenue, for recorded see

is for expenses in remain years. the reflects the each completion to to compared potential million, Phase of primarily revenue the constant ORGOVYX $XX.X in in year quarter and amortization thereafter, QX wind deal organization over fiscal the quarter six commercial $XX.X of Collaboration million The the Myovant's $XX period related QX expenses occurred a expected launches late next Given was very build will primarily comparable fiscal in the programs offset combination R&D short. the increase the for payment to to out the medical prior million down the was of December, and by signing of in preparation partially tablet affairs X relugolix associated U.S. increased in of decrease R&D women's Myovant's continued for expenses period. launch with and upfront health.

in was the related expenses force, The million quarter million, also including prepare and of from of comparable year other Pfizer support expenses period. activities ORGOVYX, inventory. for the tablet health pre-launch we of R&D personnel $X.X indications. U.S. the on stock-based Our commercial women's readiness increase million, reflects for was for quarter a which increased Total to hiring relugolix oncology, million due were commercial expenses sales in launches cost million the of as sharing was associated expenses $X of costs, general spending the primarily commercial launch $XX.X the overhead combination compared expenses SG&A potential compensation. our with in the reimbursement prior the $XX.X $XX.X to quarter approximately for to operating continue to

net period. per year Myovant basis, a in income third the incurred prior net in currency that on was and of other $XX.X line. third $X.XX share XXXX the a the of loss also million compared $X.XX foreign in our quarter period. comparable quarter $X.X We to year was gain a loss On XXXX, generated for quarter $XX.X million recorded during million in the our prior

approximately the study. our $X.X looking be activities, regulatory on SERENE our as relugolix as QX, sharing management lifecycle Pfizer, expenses as Now expense XXXX from be continue commercialization increase modest trend. planned from expenses R&D our of continue SG&A our deviations by incremental with on out levels are This well it Declining offset to target XXXX. support from expect capabilities In comprised upcoming spend of expected the down programs that as filing action winding we we health clinical fibroid where activities. women's levels commercial be are QX, which ahead, expenses date Phase now fiscal of incurred, overall could the excluding reimbursement by spent quarters in occur force, next fiscal increase such XXXX sales million the FDA to to R&D are quarters, expected this will fiscal build X, expenditures certain we sales several as driven of to XXX approached Pfizer. at QX expect hiring X expense, to and our over we expect primarily roughly June are be the is it's to similar and that professionals, to uterine XXXX of

the fiscal our sales Additionally, cancer of the force, third expenses over prostate quarter. of hiring reflected gradually our quarter course partial only the XXXX because occurred

and modification our equity approximately note to due the incremental vesting please company. we of fiscal in Finally, $XX that former CEOs her from XXXX, QX, expect compensation expense of accelerated separation awards to the record non upon cash million stock-based

by equivalents was received balance quarter upfront December that $XXX late on of We the in and wrap payment bolstered marketable cash, from ended Let the This our XXXX. was me by up Pfizer commenting cash million $XXX with cash million on position. our securities sheet.

of us to under As was remaining that the additional loan March was to extended remains fiscal cost the DSP also until low QX, that end million of there of million XXXX. us An capacity our $XX by extended in available XXXX Sumitomo commitment $XXX loan approximately majority to Dainippon August facility us. Pharma, shareholder

that coming liquidity enhance further potential milestone also me anticipated strong several that remind are our months in there payments position. Let will you

that commercialization well be the we outside of and should $XX would Pfizer in year. As make a first is composed its to be million his of alone approvals the collaboration in under receive could the women's Dave could opening in during this million rights million of development as a half option to up to This within FDA next Pfizer the Canada. $XXX and oncology Myovant XX as additional U.S. for triggered obtain will mentioned payment milestones remarks, months. regulatory payments relugolix exercise Pfizer of health, to decision up This $XXX anticipate

and So advance overall, capitalized expand our our launches, Myovant well pipeline. commercial to is potentially

that, Dave turn I'll closing with remarks. back some it to for Now

Dave Marek

Camilo. for Thank Frank, exciting In Juan an and time you, Adele, Myovant. this is summary,

of ORGOVYX With the potential year. launch upcoming in mid ongoing and tablet relugolix the uterine combination fibroids launch of indication the around

best-in-class are highlighted, position Pfizer squarely One a milestones. this launches build expect as financial women support ensure regulatory endometriosis, work proud to working U.S. potential get EU. results upcoming the all to options from to are now therapy year and by executing the the relugolix bringing and as will attention. And focus I commercialization we and of therapeutic continue And we session. achieve these successfully strength, with forward a SPIRIT us look to point. U.S. approaching to as of for in you your position Our efficiently turn important of ahead. on Q&A we we is Thank extremely the combination patients back And which upcoming begin Ryan to Frank in over the it team I'll am with what's to additional tablet to Myovant I filings to the for these done

Ryan Crowe

questions. you, now Operator, please we can Dave. Thank poll for

Operator

JPM from Now Securities. Butler first Instructions] of coming with the question Jason line [Operator

is line open. Your

Jason Butler

of newly versus you or the Hi. terms that through contraception details And in extension just guess Can review on And and Thanks cetera. regulatory speak all Thanks. -- patients on can just guess, been the you us for the of on therapies, first? X I relevant for side. first just that A pregnancy studies really there. completed disease, I the to initiated the through dialogue your question to diagnosed et data any therapy severity think then here? having are prior you commercial taking the and is one being the appreciate in ran just speak Phase trials have you you precedent of frequency? Phase just trials, X the types program,

Dave Marek

this just want But distribution our at just I a study. contraception it reminder, you Adele of turn the Sure. joining for many the we types All us I'll recall, look as I'll types patient, Thanks questions. to know for ask, Jason. to the patients morning, the weigh Camilo I channel. appreciate know cover over I regarding of to when this really then Juan And in. and of

typical specialty the product same retail we setting. data in-office into we're ultimately therefore would as in we specialty to while have limited. dispensing, the then that our distributors, visibility are distribution, we a the pharmacy don't and on oral and Recall, the product, in the is have agent the receive goes visibility data level So an as be retail patient we

put reminder, the would profile. see add a expect just we and it what as of I over to to color in patient to that I'll turn on terms Adele Adele? So

Adele Gulfo

I is it What that. for Thanks. Yes. early. bit say, will question. a the for Thanks And thanks

about team a engaging We would go still affairs insights information providers well you patients other we bit how medical what actually as gather is that can to today But on our have is more tell will are therapies who our transitioning that. continue patients as on and into I our initiating. on

either patients ORGOVYX are new we on that expect tells interested are who would therapy, experienced. doctors to in is, are starting is who hearing us what we what So are or that hear to

So is we're what that's to seeing tell you can date. that I what

Dave Marek

Camilo, And the you question? then, take Juan contraception would

Juan Camilo Arjona

Thank Yes, Dave. you.

contraception with study. your precedent prior start I the in I'll in two one. questions studies. the about And and regulatory excited their we're any heard question. pregnancies the One on second comment Jason, So is

but prevention prior mentioned relugolix contraception. in placebo were Every methods in nor set patients, we've not for for patients of as have the this a to In in instructed drug seen pregnancy. up take presentations, patient use on we prevention information was receiving of assessing couple patients our mostly pregnancy to these means a As of required we therapy. few non-hormonal prior were pregnancies a studies studies, studies, the our of

efficacy really contraception for relugolix combination the are set not So of therapy. assessing out studies these

ovulation our on before that specifically study inhibition ovulation. studies to inhibition. XXX% ovulation demonstrated And of shown have We assess relugolix combinations this effect of the is designed

look So like you're we're we The to which when on a is the study. to And therefore, studies a standard -- step, assessing design way contraception. very, that. conduct take that decided very these confident next its study pretty

study So, information and provide have we that to physicians. decided to that run to patients

Jason Butler

helpful. Thanks. That's Great.

Operator

coming question the with from Cowen. And Nadeau our next Phil

open. is line Your

Phil Nadeau

thanks the Good on morning. for Congrats my progress. And taking question.

how on own with the resources your in that is from is Pfizer. force and First discuss Pfizer the decided? efforts their the one you're you and U.S.? coordinating what plans with sales takes Who Can how getting commercialization

Dave Marek

once off it Sure. I'll to kick Adele. and again, over I'll turn

really women's not the the standing one speed really fully of also and but around of they've the ideal knowledge partner again, really last we think, early week. we and gates the with the Pfizer cancer. and their as just launch, only prostate right long the this moved for prostate view eventually, value that of to as I health have And which with as that relationships Pfizer out here trained in areas is that in activate customers they were itself. the cancer field But from they

the in to by and they've start then to contribute. up trained on therapy, speed really really get we're to been So and able heartened the which be speed

to I'll her So to add over turn it as Adele well. perspective

Adele Gulfo

I you. would ask Yes. But

level. we're online Dave the So and actively is the hearing very week. And at the in last active monitoring has what ground come collaboration and,

are on And prescribers. So -- are Pfizer. that to we they're collaboratively also important because most relates from working calls to our accounts, have we're it they're the reps actively in coordinating in representatives sales of we making that as the the ensuring terms addition the that

talked account these the will managers opportunity also and into that have group tap covering that accounts primarily in-office their those with to that dispensing We that ones key have teams are large they the about. the other and we practices are

Phil Nadeau

Great. That's helpful. very

in of and sharing then pre-profitability you free SG&A revenue, reimbursement record it does lines? will some deal, reimbursement your and economics and Or R&D? a expense every profit collaboration post-profitability Is expense separate the there on the work true-up line lines a how quarter profitability? post your be will be there there On where a on

Dave Marek

there if will the you of was a But clarify. feedback that. little I over I Frank, to it on think, question, So, beginning you to turn I'll -- that caught

Frank Karbe

Yes.

I caught you, think Thank it. Phil. I

be speak Let to the how reflected broadly there's financial collaboration our points make maybe about four here. maybe will Pfizer in And me statements. more

XXX% that record is, Myovant will remember first one The of the net product revenue.

goods, of section So along of the will be several product of And potential from of be revenue, titled also There of be will under under forward, any P&L, is show of that in essentially that net line a half product will milestone of there line net upfront captions, payments collaboration comprised going be goods the XXX% collaboration payments. that revenue something the item profit that expense. revenue, will then revenue. our the minus with comprised the product gross one cost the be reflect our called portion will and of which Pfizer revenue, amortization will be share will we P&L will payment the attributable Pfizer. cost that And net and of will have a to them

with sharing, collaboration as let's to line through that line allowable this expenses a respective on thirdly, expense is separate P&L on items regards will And expense in subject see the appear and to are that way So our expenses. expense. called the in and a And then flow our will in reduction the SG&A. R&D sharing basically

Pfizer have So and SG&A will appear the lower expenses without would R&D forward collaboration. they been than going

Phil Nadeau

us you. to the a is Thank study. very last then That helpful. follow-up just pregnancy And question is the on one question the it's on -- from

Pearl order Is licenser you have be the what needs what to there show? support of regulatory in terms to to achieved Index, any [ph]? for precedents In

Dave Marek

Juan Camilo?

Juan Camilo Arjona

Yes. Phil. Thank you,

is As pregnancies designed. years study. like study this exposure. Index, from how be the simple this it's design, occur XXX-patient is traditional of the on regulatory I FDA and it's And calculation a other pretty over mentioned that number pretty contraception And of Pearl documents just any the based before, guidance should

So collect number and prevention taking pregnancies gives as believed patients of divided medication. that use Index. number were you of months And pregnancy. only to then we And that this agreed are enroll that to of method Pearl they otherwise relugolix therapy the And women their for combination fertile. be the we by

Phil Nadeau

But Right. if Pearl below Index could the you if reach? specific Like get can't approved? x, have But there is is be you might it's that over the hurdle a to x, label. it

Dave Marek

going that moment. not on to this We're at Yes. comment

will I is pretty And think reassuring ability data demonstrate the that you get Pearl to physicians inhibition to pretty patients. we a confident on to our based Index ovulation just that that we're and prevent want pregnancy.

Phil Nadeau

congrats And taking for questions. my Thanks it. again on progress. Got

Operator

coming question from next of our line Eric Joseph An JPMorgan. the with

Your line is open.

Eric Joseph

taking have the Thanks Medicare wondering write decision? up guess follow I on I to party for period have patients patients. among a study. will a Hi, insured you how is with sort until to formal physicians ORGOVYX, trial a of to just patients there's good if I long being question. the flexibility then contraception of free coverage government offered particularly enough elaborate morning. could on was And

Dave Marek

Eric. morning, good Well, Yes.

all Regarding patients. the to program free available the trial trial free program, is

determined. an I'm bridge to on we of that's program coverage beyond As that, while And which months. open have commercial know, then that two to sure extension in commercial you is has stay a therapy enables that up patients being patients to

So two free and extension then for an commercial months bridge. for the trial, patients on

what to it Regarding seeing Medicare turn we're terms progress Adele. on over I'll coverage, in of

Adele Gulfo

what exceptional right trial do And they that patients. I Dave to is happen. program we're actually the process. formulary that made And patients seeing is say The the access point the this commercial Medicare and one, both is to offered is free have that the can about Medicare

who So process Part we for I'll we good that have June And even D plans And exceptional discussions I'll XXXX. some very have timeframe the this And D Part of expect have patient. do to remind should year, formulary Medicare Medicare patients comment online plans. the will are with by that those decisions. continue you we in we our Medicare come May,

Of expect course this some plans January the of coverage will we year. in of majority to But starts see come online XX.

Eric Joseph

to combination if combination just better a have OCTs behind thoughts potentially of correct a the need rationale case, through? Thanks. use rationale, Okay. as Got guess tablet? to there? with the changed with Is value as to the understand I the And pricing compete And tablet that's the then, desire segment. it strategic the directly proposition forego the step Oral the endometriosis study of contraception and read contraceptive trying in to means around this maximizing it.

Dave Marek

Yes.

Regarding talk strategic pricing, the position ask I in yet pricing. think about a I to But about Camilo rationale. talk we're not to Juan

Juan Camilo Arjona

Eric. thank Yes. Dave. you, Thank you, And

about that manage combining to And with population. they to live of and for uterine thing, a is and just hormonal indications; in heard their fibroids. to endometriosis compete wanting contraception from treatment for we we're from me not addition talking contraceptives and loud their physicians the component population one going both patients let What want and clarify we're pre-menopausal overall this condition, is So clear in that. a

mentioned nor methods [ph] my patients, in as of provide not I So, does of usually treatment available remarks, of by contraception consistently that antagonism are terms desirable quite use today ovarian in not requires honestly GnRH what's use.

patients prevention ovulation So XXX% ovulation to addition seen opportunity or provide the if with desire an drugs symptoms that approved full we it. believe believe be in pregnancy to inhibition, that the study fibroids a the other endometriosis inhibition in that we uterine of of of our class. have for those we differentiating its from treatment having of from data And would highly

Eric Joseph

helpful. you. Thank That's

Operator

And from our line Sachs. coming question next Paul with the Goldman of Choi

is Your open. line

Paul Choi

questions. Thank And everyone. for Thanks our you. taking good morning,

could a you the bit. just and discussions. wondering elaborate on I D just Part First, little was if clarify

something permanent XXXX? a a for process? to confirm temporary there that is code you're just possibility And [ph] the First, comparable of XXXX exception for seeking or to J codes also, then versus

Dave Marek

you I'll let our Part coverage. around Adele, So expectations D the -- address

Adele Gulfo

process. -- terms standard the can check any And But we're We're in this. double that. of codes, we Yes. with not I pursuing of going

quite sure relevant not I'm us. So that's for

said, having We with of plans Medicare and with both end on been we're and this the very the continuing we the good last side. thereafter. I've started online and And made payers coverage on it commercial process as decisions discussions here coming have year

Paul Choi

maybe opt commercial own Pfizer your waiting tell and commercial with for are Europe? know where you to Europe, on considering the potential in. Specifically, respect Okay. Then, just to you build? you you're still with you your just with are to regard development I where can that. Thank us But infrastructure in infrastructure regard

Dave Marek

Sure, Paul.

established health women's Europe, collaboration Gideon with a when Richter. think already at in we've look I you the

we're approach approval enthusiastic would mid So we potential would we that fibroids very around commercial in uterine come year. as the hope

Gideon in lead efforts women's will so, lead or the commercial Richter be commercial, will health. the And

of prostate right cancer, as has first speak Pfizer to of first or option the so mentioned, cancer. refusal, prostate the we've Regarding

were enthusiastic We first that half in expect year the that negotiations this our they of will make collaboration, that they very about the in decision opportunity. in

very decision their are get await to as in option. prostate in have still and who cancer have opportunity take will we they the We did we interested that choose Should partners closer. Europe. not other So do

And another partner time Europe. so, potentially of plenty we to determine will that in launch could have cancer prostate

our out support not are launches directly. currently European infrastructure those We to building

that do will We through partnerships.

Paul Choi

of Okay, fit prostate market ADT that on where great. lastly, early in? cancer. your of Thanks it in terms your what sort of practitioners Can physician maybe you tracks, for terms landscape comments then the you relugolix clarification. and is for just fitting the where just suggesting And broadly European research see potentially in could just very Thank much.

Dave Marek

question. comment Thank you, I your to will ask Adele on Paul.

Adele Gulfo

patients ADT on would extensive haven't would because Yes. ORGOVYX comment just becoming our it's to see we can and amount, in new physicians expect just And the in a of in Europe, pretty incorporation prostate wants standard prescribe the if similar Juan But But we manner. as care cancer advanced U.S., see we add. an Search to Camilo we maybe but ADT. and ask parallel. in of with because how goal, Europe. prescribing, he hope for We Juan, the I'll have done that

Juan Camilo Arjona

Adele. Thank Yes. you,

sorry. -- think I

there. use to the are you're right. ADT think It's form pretty primary I parallel the where of U.S. agonist

There not in it. they seeing well, With potentially is the physicians is [ph] but to for oral way now look a high that a available, this we've forward antagonists, enthusiasm spoken being could -- the and available be in available that route for Europe.

So different see very than to U.S. it's we I what in think don't

Paul Choi

very you much. Thank

Dave Marek

you, Thank Paul.

Operator

from line next with coming question Citi. our And Mohit the of Bansal

open. is line Your

Mohit Bansal

Great. my question. taking on the couple Congrats for a Maybe of questions. And Thanks progress.

to is that, XXXX. I sounds question and it more in consensus And be mean, get It there to plans, come one to Medicare I of awareness, half reasonable Does this I seems XXXX uptake $XX towards [Indiscernible] of going and you, you that? Am probably that to revenue the saying reading year. into in seem more right? the those end, on all back million some forward. to of calendar maybe creating assuming So considering as about year cadence the the like the you're mean, obviously,

Dave Marek

trajectory position Well, the revenue We're to sense are coverage guidance pleased to. already I'm break I in XX% need just think to entire not very question. say of few speak a provide prior get is can this little of to heard commercial decisions. There have we a I formulary let sure me We But there. we that a seeing. we providing at are we more plans that was up are that point. the not a their quarters What that

have feel that's can we payers more but statement a that in area into therapeutic that commercial very the leading will play. quarters. quarter, we role viewing this decisions, so, not and terms second And anticipate ORGOVYX great how only are We the comfortable of

that year. you this trajectory place So begin anticipate take decisions year. as But the actually those we're much Adele terms to looks demand then, monetize some will of I that of our ability we very mentioned, beginning we seeing plans, next of promising. will of expect And in that think, Part that happening, the at D mentioned coverage

beginning would into XXXX. of that when volume of see patient the that's be more as we will more get we So substantial monetization

So I you're on hope there, for that Mohit. clarity provides what looking

Mohit Bansal

picture This maybe is And a question. very, big very, one very helpful.

terms in? going probably you for be the your relugolix? are a few mean, coming How an more pipeline? cash complemented cash plus, internal R&D intrigued R&D something issue stable I'm have that would quarters. if be Now that quite I of about thinking opt-in, And you, would [ph], building beyond Pfizer And for is not by could in you

you're this cash build future the about just So to how thinking down utilizing the four this cash, about using for line, company five a future? years to thinking

Dave Marek

to Yes. year. and this big corporate think intro a it Frank comments, large turn Well, then perspective, we I'll from here. some But priorities I make two picture I'll over have

The first is execution.

our launches. on execute will We

growth in patients. But also work diligently those And of that regulatory will execution the get and for really come. to make us pipeline. hands building strategy And is out through. that building our which of is pillar with year, sure large we that years part sustainable really to We to filings second our has many the our a do this therapies seeing you've touched of our on

sure I we And we outstanding are development that an want make think has clinical building pipeline. that organization. we those are strengths, our our really leverage to demonstrated to organization

we of franchise, focus partnering and opportunities in because see health all out talk about building when in with first areas So relugolix will of there on oncology. women's the additional cash, the we be Pfizer cancer the and

the be with will we've key there. prioritization that of around already so significant one of And areas and priority. And made Pfizer the the progress discussions

course, have could of the future we any of of what there. the prioritization be. MVT-XXX. that back date we really how a efforts. Second, our in with is of see potential business therapy And we'll And third applications come building then terms different of development kind at are assessing pipeline, And we development

our in prioritization we As as oncology. of women's building to focus would well you would stay be closer out areas our can terms as imagine, the being in home health, pipeline. of Those

look So of you allocate be the on that looking kind we're we I'll strategic might at would valuations. sure want and -- turn right it any those add the we Frank, if direction. as over we to towards color really making And further development, to business how that

Frank Karbe

made Maybe the directional where expect just to to I go. highlight, again, comment expenses R&D we so about the guidance

quarters. the a said, year Dave quarter same with opportunities. we we I the lifecycle the expense to overall want we keep mean, are about quite humming. substantially, proven expect in this instance, million expect now mind, Keep But to said, to be it not it we management As that in engine few have as first constant ago. because R&D come has development $XX this some down over be we next you from constant about And doing engine. And

that with follow. of Myovant's that, are extend beyond You heard we beyond are now other to then evaluating bring the first study plan to the of and relugolix franchise. course, in opportunities the pipeline SERENE there assets likely initiate, a that to example that others we And

Mohit Bansal

Frank. Dave Thank helpful. very Very much, and you

Operator

from coming with question next the of Fadia Leerink. Ami our line And

open. Your line is

Ami Fadia

for taking Hi. Good the you question. morning. Thank

how order front, of sort coordinating just XX in us the except understand about much question commercial Pfizer accounts. Adele. of talked splitting territories, coverage. secondly, that your a that required XX you're on a the anticipation sorry, maybe talk any a on force for markets commercial the you regards type of Can focusing you authorization Top Can may either sort or how on here? And side on is kind had accounts commercial sort sales you're up to addressable is of -- for side then relugolix? the get I Firstly, prior the question in on XX total the new to various accounts for key about with Medicare of What help just be

Dave Marek

Adele?

Adele Gulfo

Just is label. issues on that prior with coverage commercial to we any the ensure It's to not -- the requires are just when auth. according plan in authorizations, patient if usually they prior a they're actually -- when seeing

as I been any it's them. the just administrative. that. who to challenges We're any need early extremely to smoothly. seeing But authorizations. there, in that's prior that a not want with it's support date, on signal offices So we're To going very we're helping And with days relates

there's it as to As mentioned, relates Pfizer, great coordination. I

together, accounts. they the be are accounts discipline, are prescriptions, And reps, about as closely multi practices, interactions that XXX on. mostly the are physicians very office of across positions. said, those decile. really we're good think generating working as oncology could priority seasonal it centers XXX our the top are focused ones mostly most highest the their large dispensing. high academic meaningful are the to those working the on large field that are in reps These representatives, urology plus our And accounts. These I They is way they're field collaborating the that our with we've practices, specialty have doctors. priority So share top as a group the They're well that had or

a of would are the of academic you focused are brand some influence. the volume, lot -- that that ones especially you. I could we're and are those rattle them to big large on. Some that know off those But It's really ones centers about them new

Ami Fadia

I guess question. my question, I guess my

concentrated the feedback some in the fair extremely of volume? here. XX amount a is are carry terms market hearing Top or I'm that Sorry, of highly that influential But prescription

Adele Gulfo

ones the They influential, volume very combination having lot of flow through a are as that of well a they're them. as are

Ami Fadia

Got it.

Okay.

Dave Marek

Great. Thank you, Ami.

Operator

time questions like now the that's And would have today. back to remarks. for all you. Thank turn call our we closing for the over speakers I to

Dave Marek

you, Thank Olivia.

from to year. beginning. of efforts built strong foundation the is last And on a just it's commercialization Our journey

to and we ever In have towards resources look now addition, pipeline product than development expansion. more

XXXX year care very So a is on be our our of to ability certain redefining Myovant. And deliver to for for exciting confident I'm purpose patients. in

you for you So joining I to on look keeping our updated us And thank forward today. progress.

Operator

this for of your participation. you concludes quarter Sciences' Ladies conference earnings and fiscal Myovant gentlemen, call. year third XXXX Thank

disconnect. now may You

Myovant Sciences (MYOV) 11 Feb 212020 Q3 Earnings call transcript