MYOV - Earnings call transcript Q1 2021

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Operator

Good day everyone and welcome to Myovant Sciences First Quarter of Fiscal Year 2021 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. and for Myovant's today year first to other thanks financial review XXXX and discuss of results quarter corporate morning joining to us the and Good updates. business of fiscal

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

on press slides today's fiscal the on to referring release Investor available that webcast throughout our as be addition this be the XX, quarter issued June investors.myovant.com. In morning, first website or this during will presented are will ended Today QX our Relations earlier presentation. XXXX first quarter we which our to

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

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

Dave Marek

million product and total $XX.X of including quarter, recorded of significant start Ryan Myovant to and revenue that good collaboration achievements strong commercial is bring by marked first morning to U.S. revenue. our of regulatory $XX.X a and us you million to differentiated accelerating and Thank in more everyone. patients. Pfizer year Myovant’s fiscal will off XXXX more our In momentum therapies $XX.X enable million revenue the

fibroids. oral approval of growth also ORGOVYX payer the increasing clinical the MYFEMBREE of market, FDA of second $XX.X uterine past of and and million with several conducted millions profile differentiated as and inventory remains. with continued months. sequential From achieved daily from as strong excited to only profile where quarter revenues pleased its $X.X high growth first increased the battling coverage. the well women achieved fibroids We few enthusiasm over reflects We're clinicians June During differentiated the quarter-to-quarter. launch a uterine distributors. remain launch stocking regulatory this treatment simultaneous women We to This of and Pfizer a revenues million standpoint regarding achieved bring significant unmet initial the ORGOVYX for need milestones reflecting once by reflecting on we've as

regulatory finally approval relugolix and approved of European couple RYEQO brand for to RYEQO, tablet. name the is The is also with a expected with severe will we this to the intend pain FDA in to by in RYEQO inclusion And the later of partner in MYFEMBREE from pregnancy. Richter, were their launch notable whom submit executed Not for is The the endometriosis. the as be year support calendar early Myovant’s European women not BMD year of of women regarding addition limitation evaluate commercialization In to it's use. Gedeon for European the population as time amended two those FDA prevention reasons. submission MYFEMBREE, the Europe. is approval year indicated. an to management in X per RYEQO approval treatment protocol commission of the MYFEMBREE density not study it monitoring response to moderate included FDA once the SERENE fibroids modifying the also LIBERTY first the only label. the the on first are that oral Also where NDA our have of of BMD Recall the prevention Study well the in that Europe, mineral submitted in with does FDA incorporating treatment pregnancy a bone Phase of the for data the hold U.S. to Randomized available uterine duration begin the Study this submission. to FDA half the for claim of guidance for In we approved July study year two for data Withdrawal in better associated do where provided seeking supplemental [ph] Phase second We data X MYFEMBREE daily in MYFEMBREE clinical combination potential for commercial at July partial the we of our a for

be we with listed to a next expect clinical further hold Following month. FDA partial discussions

million finally, treating we of We're and the fibroids. the and we ORGOVYX. for which property we extend intellectual all continue our option in the an development uterine another position triggered continued In This exclusivity commercialization MYFEMBREE uterine Pfizer to million of XXth, Turning fibroids. Richter. with MYFEMBREE we financial June for about which in of also relugolix Myovant other we with care two committed intellectual with be continue methods financing regulatory that development granted for opportunity FDA's excluding patent to of Europe redefine to excited cancer milestone book momentum treatment other end international are in payments encouraged to prostate the took from And and women updates. expiration for through $XXX in $XXX have patent as and and time of Pfizer’s line decision for to acquire the now in with for expand over by patents recently a rights launch to Pfizer protecting property June new the step markets business September its period joins oncology could advanced as XXXX. issued previously excellent to of October. in in listed methods recently were orange cash and And agreed of regarding ORGOVYX be

a for to performance, I'll of over turn call Lauren. in-depth more Now review commercial our the Lauren.

Lauren Merendino

the prefer of treatment the of in in by menstrual standard demonstrated women their dosing Hot menstrual women the has and lumbar aligns the for with with women X women. Trial on physician’s and in minimal MYFEMBREE well potential less Program, these with a market. meaningful a meaningfully in daily care effective, update Clinical management in relief not treatment U.S. with late fibroids patients in bone in ORGOVYX with effects potential In spine fibroids. the truly and effect We of patients, advance Program, could is fibroids improving to decline for Of Approximately need for care at have unmet women, of MYFEMBREE, FDA months update treatment symptoms become an medical uterine are side treated women's provide from and for is first made undergo this I occurred X% their for challenging the million Today The density convenient uterine of MYFEMBREE medical approximately enormous. the and our MYFEMBREE Liberty the fibroids fibroids. of the In XX% believe have we the different sought bleeding the redefine on provide uterine in versus launch. by fibroids. the surgery, associated will women was oral in these their particularly early the united was unable an easy meaningfully followed loss. and Even a progress make Dave. choice premenopausal launch XX to MYFEMBREE three May the side approved the and blood heavy the an believe and average well per women X%. hysterectomy health Myovant to U.S. uterine sustained in in Clinical Liberty We stated Pfizer be by tolerated, heavy only than of failed with needs option. the MYFEMBREE are for an difficult goal bleeding under than approximately because medical once uterine first has control XX% to MYFEMBREE uterine placebo. mineral regimen. most typically those a symptoms. reduction it year meets option meaningful convenient line to in XXX,XXX other oral treatment bothersome contraceptives, with out of which women challenging are therapy, symptoms flush, treatment goals menstrual two Thanks,

the continued to XX the in to label use risk bone is loss, months. of limited due FDA of duration However,

one achieved just taken milestones to operational MYFEMBREE differentiated a Pfizer and all MYFEMBREE required commercial Myovant this The small pill meet teams a day. the for once Finally, of collaboratively to in position worked have launch.

patient initiate including have launch, engagement. lot field weeks to person accomplished in Before payers began in identified support the packs stocking first therapy. to services, recently activating channel, to starter distribution July, and More beginning MYFEMBREE we certain following initiated of prescribers who engagement MYFEMBREE few support activation offering key timely patients we force website, we've with approval, within and the access the a fully

first person, strategy. The XX% XX% taken experience the beginning, launch these as of ensuring services. With and patient that enrolled priority target nearly by the high of aided the support MYFEMBREE All have nearly reaching XXX and This intent our being just XX,XXX more our of in encouraged first pre-launch sales were prescribers. we for awareness positive patient of over patients, XX% and providers, our to the payers, than these weeks launch, have with from five activity approximately steps teams calls medium experience launch. hallmark a of prescribers in This of XX% since already early approximately July. sales potential conducted are among and has Pfizer Myovant improved interactions is patients in in

prescribers packs Obtaining prescribed among of the that patients primarily are program. weeks The launch been priorities. have anticipate XX% over Medicaid Additionally, We top XXX approximately identified two insured. that coverage XX% starter potential patients. for be commercially first remaining patients include for in could cash patients or the candidates MYFEMBREE just since is starter of MYFEMBREE launching our payer as by

coverage costs pre-review As needs one supports of well and to MYFEMBREE its We early MYFEMBREE pill choice and out-of-pocket payers for clinical MYFEMBREE. significant August. July We establish certain with that With coverage decisions as once dosing. access is believe a day were of and the eligible positioned we providers believe of implemented and initial made progress already for patients commercial for XX% be prescriber as patients. convenient have could minimizes Xst, believe profile some lives addresses

growth thousand one third with to new of trajectory and therapy progress launch. about following and recorded like over a build million launch, in steadily to every programs. Pfizer Six cancer. May drugs, of reflecting cumulative bridge as that our men $XX.X Monthly reflecting X,XXX we ORGOVYX. months since consistent assistance drugs, both increasing free ORGOVYX with our advanced prostate patients ORGOVYX with estimate It's redefining to QX, and launch. we over we've men towards on net work now fiscal since and have free substantial launch patient the in June, to able we've be which have fiscal since and includes in demand important a product that patients We on patients the made that or differentiated treated In been to reflecting to estimate uterine we treatment treated in month, been the XXXX. have therapy, receive treated month bringing compared we initiated launch, approximately women for momentum to estimate care X,XXX progress excited note increased that where each that that ORGOVYX seen ORGOVYX culminating adoption. revenues a been days I'd the continued utilizing fibroids. early ORGOVYX driven options QX gradual estimated patients launch of June, approximately men discuss either commercial trial make we've with ORGOVYX with continues and are launch, on We free

patients our of estimate ORGOVYX and that Although naive is approximately androgen patient XX% we were incomplete, that therapy. visibility to previously level deprivation data started

and ORGOVYX Additionally, broad we advanced this type. clinical our profile, that the regardless therapeutic prostate of to ORGOVYX utilized patients label appeal cancer, treat of patient the is believe spectrum of reflecting across being FDA

and we build the clinical, treatment recognition prescribers. with including XX,XXX As before, calls drive over actively six we priority discussed have play to have target launch, Pfizer a ADT engaging Since first reaching decision. are differentiated profile. have in launch, clinical ORGOVYX and conducted Myovant operational and can this economic, months of In over prescribers been there XX,XXX role nearly of with our awareness of considerations XX% sales providers, highest that

XXXX. increased has restrictions launch COVID quality and significantly. in-person in share of continues this the engagements person, February. engagements with GnRH maintain on detailing voice has dominate class providers practice of were eased, June. in half optimistic from in These we results. and was which the XX% and volume progressed June, ORGOVYX other As of remain XX% second level our We sales nearly efforts Pfizer can XX% is healthcare detailing and Myovant up delivering the or to [ph] of have personnel sales in-person that in the increase In and are

research Our are near prescribers, indicating awareness knowledgeable amongst indicates ORGOVYX the recent with about aided target XX% that market profile. universal clinical they

the through reorder XX% centers of at also base the reordering to June, The in with up of XXX of rate practices approximately the an XXXX prescribers increase remains high, successfully ORGOVYX at end XX% broadened have We months. of treatment two from also approximately least once last April. just

enable integrated up that systems access XX% patient early and and team other across practices in-office pharmacy urologists not pharmacy do trend utilized end is in approximately XX% and channel is The volumes remain from July ORGOVYX the which pharmacy our e-prescribing from the actively available serves market by for of to for shipped the that we dispensing the forward. via capabilities, the network, XXXX our patients of all of oncologists. serves hospitals, specialty the specialty by expected to estimate as such approximately and which distributor vast the XX% practices smaller ORGOVYX in Finally, at majority, XX% of of as and worked with written networks. institutions the distributed EMR has have urology XX% ADT diligently has claims as are and ORGOVYX the been we targeting that capabilities support of volume patient going practices, data large hub commercial channel, expected ORGOVYX This centers, April. Utilizing with line ORGOVYX early of and specialty have practices academic prescriptions commercial group data been channel, class was delivery

We for progress Part coverage ORGOVYX. have building also made and notable D in commercial

XXX increase May coverage million July since over XX lives, million Xst. an of As Xst, of for we have lives total

Let's we've at since look take progress a the May. made

XX XX On a months. that make XXXX million to Plans lives expected the commercial decision, side, May the adding XX%, percentage covered have commercialized ORGOVYX do in points Xst. to of XX% expanded by since coverage to coverage incremental coming cover are but so yet

progress to ORGOVYX of D XX achieved implement Medicare later for an We as for where Part plans lives cover of made have that with coverage greater XX even points Xst, D million for coverage XX% increase we July since percentage with of lives remaining ORGOVYX XX% of implementation some beginning year differing early the the of Plans May. these Part potentially next decisions may this year. of coverage lives

our to the closing, contracted to agreed ORGOVYX approved have payers progress In ORGOVYX all have date to Importantly, community. to of built cover momentum all prostate and areas continue launch information. according tremendous great in across we prescribing FDA make cancer

men and momentum lives advanced our improved I battling will to with look turn commercial build coverage to As D we results. more now increasing steadily impact make in-person ORGOVYX forward will clinician over call the cancer. many Part financial we in Frank for and that of engagement and prescribing review patients, the believe of the difference continue engagement a to will prostate

Frank Karbe

Lauren. you, Thank

comments usual, quarter, our refer of I As to on focus will the issued the Form and financial press earlier today additional our XX-Q you my performance for and information. release highlights in

of at and million to fibroid quarter net December amortization product per upon FDA as Let's upfront a million amortized to of and Pfizer year Myovant will million XXXX ORGOVYX for of future revenue Pfizer from end. of when FDA begin million recognition as Pfizer revenue received end through the In the quarter well approval MYFEMBREE milestone million the collaboration XX.X million XXXX XXX XX uterine payment that ending and payment XX.X the at to of a upfront approval regulatory first million quarter be million is period per calendar scheduled of related will amortized of milestone was respectively, and with the continue MYFEMBREE. be partial of the to quarters, X XX.X related the of X.X XXXX, payment partial revenue revenue, consisting triggered in million total the XX, MYFEMBREE recognition composed Myovant XX rate June X.X recorded fiscal from of

fiscal with for to the license milestone from of of commission related European regulatory remaining approximately For our the also XXXX XX for recognize the of portion XX.X uterine we Gedeon fibroids collaboration million and expect RYEQO XXXX, QX milestone revenue comprised Richter, million July payments. approval milestone of and million XX.X and to initial upfront

compared reduction in decrease related expenses the expenses of MYFEMBREE. sales down Phase sales million of in net launches as period higher XX.X primarily and regulatory was the affairs our incurred lower recent revenue for driven by for Takeda highlights and X to and included The X.X million medical was share the forces. HERO, XXXX, mainly other completion well as of health MYFEMBREE digit Myovant sold loss submission from as of the Pfizer, product on of to XX% million increase MYFEMBREE ORGOVYX prior activities. for teams, period. and related goods and was study first reflects and with access payable The R&D the compared as a MYFEMBREE in prior women's Myovant’s as $X.XX on royalty QX. cost studies. was million was by and and sales higher of in largely the high decrease and QX for out cost during related generated a a well a in from of of to the personnel to ORGOVYX prior resulting commercial S was expense of Moving of to activities market expenses XX.X statement, U the from share fees the comprised higher to costs NDA loss to to and the the wind lesser hiring increased reflecting ORGOVYX quarter MYFEMBREE. quarter reimbursements U.S. in relugolix quarter share The These the built million cost prior quarter XX.X Myovant’s R&D million decreases comparable Collaboration expenses profits period. clinical for single year well XX.X as expenses Pfizer's the extent XX.X in of quarters X expenses also operations, study year offset ORGOVYX launches the MYFEMBREE SPIRIT LIBERTY, million were primarily net share organization, the income in net million support of expenses year per to compared the XXXX, related in to which marketing, partially connection and in lifecycle our due per oncology of or ORGOVYX Myovant’s to the costs commercial XX.X management SG&A by was quarter. costs support to net comparable $X.XX first as or

to the We receive received the million remaining from total XXX.X actual loan the QX million fiscal of Pharma, milestone in for fiscal [ph]. payments cash, majority XXX under from Looking increase QX the payment remaining and fiscal fiscal of shareholder. and milestone XXXX. payment ahead, modestly comprised the by million XXXX expect of Richter capacity extended XXXX RYEQO. Pfizer a and approvals ended for XXX Sumitomo XXX.X to balance are XXXX, milestone are million not regulatory of from million and with spend. actual in SG&A of to second low facility XX quarters recently quarters financing include cash We from be quarter to and million marketable MYFEMBREE July triggered our expected R&D of securities committed Dainippon expenses does This modestly cost us than QX cash equivalent, expenses lower remaining projected the XX.X

associated future position next and ORGOVYX and execute revenue sharing excellent and pipeline bit more and our months, to with intellectual relugolix, position potential certain with Pfizer puts development. I coupled is highlighted would on has a expenses increase while the relating property relugolix value extend Depicted recent both to for we've an for with payments could through believe cash patents Our currently indicates case, three the business FDA over Myovant composition anticipated lifecycle the XXXX. XX The the marketing future relugolix programs decision time have strategies our late a patents PTO. here our commercial we which of developments with the of the wrap and color exclusivity the milestone like in MYFEMBREE each product. in bar Significantly U.S. to at the to same for composition expanding on up the and expanding gray methods first case U.S. that applied ORGOVYX term Each patent into listed listed the is which book the FDA subset on of which franchise. we from pending a of previously. orange the extension, product MYFEMBREE pertaining

other use of culmination patent FDA Among five-year is combination the these anticipated receive ORGOVYX. to marketing on of more to term filed among these in expire and two of approved have the regimen The MYFEMBREE for The treatment tablet September for cases January ORGOVYX the we our to relating All for pertained We application, to aspects, treat our extending fibroids. represent innovation. relugolix research which also expect relating uterine U.S. indication for the of the years particular treatment MYFEMBREE currently full exclusivity three last the methods for the recent development to relugolix which cover products. of patent XXXX. issued of The the unique patents dosing was patents, others methods use XXXX, to month covers species extending potentially the pending of next patent methods and endometriosis.

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

Dave Marek

encouraged payer for with have fibroids options profile a regimen, first We're represents clinical momentum desired. once the milestone forward Thank with months. our to able generate patients that and ORGOVYX expanding to a also and early the medicine the progress educational that time of strengthened for delivering women look uterine this we've about prescribers efforts and The and past We're and one launch include pill through prescriber for we've significant you, to the Frank new we Lauren. launch approval made increased that launch over excited in to the long MYFEMBREE MYFEMBREE the coverage few achieved patients. with that a day been by treatment important

of By October, addition the continuing decision ORGOVYX of the the expect In and execute other XXXX launches, bring on we end will international option we filing for relugolix half calendar European rights Europe, RYEQO submit for year, the launch Gedeon and oncology. in to In MYFEMBREE several second of its Pfizer’s milestones. endometriosis. Richter to to expect the important to the remainder in

We results submit bone density withdrawal commission end our also decision FDA year, year XXXX, by advanced prostate filing. calendar to cancer include expect will randomized the ahead on the study of data. to further expect the we mineral a looking the European our which into two-year calendar And

deliver your the to work highlighted, and proud on I'll which session. from the of flexibility so extremely the gives for our enable men while women. opportunities Frank simultaneously you Myovant mission many and development our I'm position over and sufficiently strength, we by positively expanding lifecycle fund done Ryan turn to financial passion begin of our the the continue to U.S. Q&A call Thank a attention business of and As product pipeline team to launches us opportunities. through to to us lives to the operate relugolix impact our

Ryan Crowe

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

Operator

Certainly. [Operator Instructions].

We from JMP Securities. have Butler with of the Jason question a line

line Your is open.

Jason Butler

progress. Hi, the congrats on for thanks taking and the questions

interactions number of are And what launch, just else prescribers in is what's prescriptions, writing reimbursement what prescriptions? are you a of for? us of access then know terms the have feedback in you're already actually are would of start terms the the Thanks. it there I looking your just is that it or getting follow-up. And sense, me early, writing can for is I target a need MYFEMBREE prescribers from one initial First anything give docs to physicians

Dave Marek

let Thank of Lauren I'll address you, some those. Jason.

a goings areas you as and an at of of bit a it's of demand. of different -- looking number a number of triangulating kind as know, Just intro, course we have also we're of early

So distributed or we within patients to data, have yet have take we're samples to physicians the we and see but have activity prescription for services prescription the our audited a the to be that also hub starting requests from with involved. then

So let on provide me more a let color little that. Lauren

Lauren Merendino

Yeah, the you question, for Jason. thank

because a As right little bit early is. Dave said, of now convoluted how it's it

we So seen that come well for of hub see samples for other services through as include prescription have requests XXX as the as you factors over data our patients we've the XXX but starters. course well

value here perspective. we they available, that we there from been need the prescribers. as had an feedback from first. So understand that the And start pleasantly a as anecdotal in is even quite the a with very clinical weeks, samples seen field, because prescribers in from from brings surprised not interest early positive bit these treatment that the unmet data may with have receiving MYFEMBREE they're be of it It's yet patients, clear although understand far all options the were to feedback the previously and then they

to coverage. hesitation, what are As very payer far some that may cause I as they sensitive think

we've with so payer in confidence that to patient In payers and and And level and support received payer we support positive hub they the hubs. feedback our relatively just receive quickly but the meantime, the decisions the help build are and have the landscape not have do from discussions services some MYFEMBREE. in services our through physicians in going hope of we will for support also us on actively to that themselves, the

are that we'll to confidence point with we're as we this experienced payer and So can as they build get continue drugs, and the at coverage. doing believe everything we we also confident build that

Jason Butler

follow-up, commercial is or in by give information there? Pfizer opt waiting any the more a color you more Dave, dynamics can in, just talk or extension then regulatory additional any about color being And you can of Great. as driven the this us for

Dave Marek

with Sure. Look, Pfizer. an we relationship excellent enjoy

discussions just informed through allow diligence these the extension that felt we a Pfizer its complete was Europe we in some to and as an opportunity been just really, were going make decision. regarding to and have We fully warranted in of discussions that

that the discussions we're having So, we explore ensure had to wanted they the with comfortable that and time duration of fully to the opportunity. feel very right we

we and that. support -- So

Jason Butler

congrats Great. taking and questions Thanks for launches. the the again on

Operator

Thank you.

Eric question from next with Our Morgan. comes a Joseph J.P.

Your open. is line

Eric Joseph

of questions. from a just Thanks pharmacies, trying ADT of with all XX% about for bit And restrictions the morning. sense those little the greater the perhaps something particularly XX% of compares opt-in where headroom to the additional is to historical how follow-up the ORGOVYX the opposed that segments? taking out Good an similarly, extension deadline? for pharma specialty Thanks. extended can talk that would I'm you get Pfizer, versus timeframe demand The a as just you of kind rule either skew of you October to in to -- thanks of about this trends launch versus with on color metrics. end And there see on level of [indiscernible] and kind of the then coming to year, distributors also the breakdown the

Dave Marek

let I'll question. I'll address kind source Eric. Lauren. first you, Pfizer demand Lauren the the and of thank regarding then of the Well, question take breakdown of

Lauren Merendino

operational using for for ORGOVYX perspective. us expected. We this financial the but out the for beginning clinical disincentive build course say we to of speak what can our I important from confidence it that a to Yeah, to marketplaces, is can't profile. knew to playing was the question. comparison thanks I other an from perspective support exactly any offices the from is in as that And remove to

our that foreseeable to distributor through we plan. channel are for of using the perspective be future, majority expected from and ORGOVYX, we're continuing of is many the dispensing. accounts flowing And which that's why And so business on our specialty expect bring that the fully of we would the new that

is exactly as similar today. -- expect what mix we we it is would expected think the we so this will to and stay And

Dave Marek

diligence. the decision, we then regarding time Yeah. extension. And Pfizer of there to like It specific was led regulatory that or really complete them in to no felt the opt really or roughly to warranted Eric, allow market was XX-day that their was amount the XX-day milestone

just be we to days So, was will the to conviction the doesn't would down that diligence full them that that the and done have sense. their timeframe of decision, and in a mean that time it they that lead nature sat like was XX to felt enough allow get just it. take for make We decision. necessarily for thought to And proper to really

Eric Joseph

Okay, Thanks great. for taking Thanks. questions. the

Dave Marek

Sure, you Eric. thank

Operator

with from & Our comes next Cowen Nadeau question Company. Phil

is Your open. line

Phil Nadeau

Good morning.

congratulations on simultaneous me the my two launches. Let add

a ORGOVYX. using playing chronic First it or are early fashion, that any therapy patients an you adopting is used it sense have it treatment? being on what question intermittent as it men the in how of days, role do is Appreciating sense using the ORGOVYX, of in are is

Dave Marek

the proportionality have we it's I use don't Phil, some know think I think anecdotally. is but chronic therapy. believe intermittent Yeah we overall We more there we hear that

Lauren of feedback I as Of share course, data think And specific to to mentioned, we're are that the use. getting the But have that. majority the vast for we don't those disproportionate new is a chronic ADT of therapy.

Phil Nadeau

really you is that show spur trial completed physicians day, second trials some to according any a Perfect. safety out that think [indiscernible], market cardiovascular the be it [ph] that sense any seems could have like from the ago? to And question, could that we've do it clinical data the heard relugolix time then when should data benefit antagonist towards released, supposed to come I have

Dave Marek

particular in certainly that very And a for become as have our from cardiovascular the don't of has I as to able cardiovascular their data it increasingly say risk. these awareness I risk with Yeah, feedback patients the very trial What relates terms hear to around the cardiovascular would heartened were the the to data. timing that we're generate consideration we that continued of to have. insight clinicians really feedback risk received HERO through we is positive proper

think increased for good happy We patients. think we to that. for on and it's good the see that's So providers attention we're

Phil Nadeau

could last Then with from that is curious be you if, launch get us the Lauren's a the improve [indiscernible] MYFEMBREE in to what mentioned practices, if for the and Great. question, as the what ways hasn't done prepared somewhat been you've of she remarks we've better what than understanding treatment you gone it kind or detailing wrong, of rapid seen have I'm competitor? fibroids. why of more uptake to hence therefore, uterine need better unmet

Dave Marek

to occurred from a launch. address, And areas the what's let think departure those each really of up it understanding think, significant key I'll of leading focus three And there's marketplace. the previously. I on, provides we Lauren kind with that we deep starts of

So Lauren?

Lauren Merendino

meeting the that. patients. that Dave. in our that needs we competitive unique Yeah, that clinical face, launches you first prescribers as really they from and is observed thanks and say learn have, this they well We, and as have market specific thing profile think the important as the that the is challenges have And I is uniquely that's most

a And so this offering bringing to we're market. unique

optimizing reach that that experience that experience second then with execution We've a field first launches. The making a needed. diffused, having of And able one. we is believe something a positive this in those thing flex able are frequency health to in was learned but we two we appropriately deal teams, being invested of previous our lot since and the patients. the great finally, have for both challenge it that's get experience a in it's where which And is of teams breadth first targets women's to being very to market the also

in we than so competitors past. ways, up the to in our be show we'll differently And that able have those believe

Phil Nadeau

taking questions. thanks Perfect, for my

Operator

Brian from Baird. our question And next you. Skorney Thank with is

Your line is open.

Brian Skorney

and how I of of UF potential profile kind differentiation we pregnancy role benefit in but see contraceptives, prevention can oral over on us guys. very and morning could give just terms good far. here? so in how about think some taking kind monitoring in that of you amendment, of what guess, sort on question. kind was in BMD SERENE understand think of advocacy of approved I substantial details study prevention, a Thanks my if in a going got switch Hey, And relugolix about just And do there the endometriosis the successful protocol wondering just you congrats topics as Thanks. the launch these I bit, for the to pregnancy little safety forward? versus to a help the you

Dave Marek

Juan Yeah, us? that Camilo, typically with the of certainly, the but Camilo can discussions on risk FDA we At address Juan and let share you don't what I'll back forth, saying that. comment

Juan Camilo Arjona Ferreira

think we to that and submitted FDA of we've we from received that followed reference advice amendment, the amended the them. I we Yeah, protocol the

expect that a to the to to We from of us with holes allowing a removal expect restart hopefully and hear back be the soon, them and study.

their know Regarding their they as options the uterine second they are part that of that think as future the your you includes question and I about for are women move treatment about, talking premenopausal are in we're within fibroids women considering considering with the decisions reproductive maturities will contraception. diseases for their also that differentiation, and

ability is and can combination to the a gynecologists you fibroids I've mind of in gynecologist and something from we've So heard differentiating important that to pregnancy can't provide that that's clinic. loud something since of relugolix developing had that from something those clear tell started conversations we is I have they because tablets, really as treats care uterine endometriosis prevention that I about. and top the happening symptoms that factor women be pretty and a of product their imagine

component in treatment of strongly to very that a of and the this endometriosis. MYFEMBREE feel the we fibroids pretty So and uterine is important future

Brian Skorney

thanks. Great,

Operator

Thank you.

with Choi Paul Sachs. from comes question Goldman next Our

is going open. [Operator Evercore Paul, line the open. next question line hear from is We with with you, cannot proceed We're Paul. Instructions]. ISI. to Josh Your Schimmer your

Unidentified Analyst

Gavin and Nice taking is for on thanks the question. Josh. this Hey, quarter for

specialty ASP eroded priced, that's a better Just pretty would the dynamic room had you similar were this you and had but practice one, provider the on the to it ORGOVYX bit? provider GnRH believe through pharmacies. feels like given the economics on their where for be agonists could economics, is spend elaborate offer there a just to how is, owned the mentioned economics that I little ORGOVYX,

Dave Marek

the that. ASP. could seen Lauren, Yeah, in you maybe address change certainly. Well we have

Lauren Merendino

Yes.

with I to for But already contracted dynamic Since competitors from the when And remove any we then, so has economics accounts. did clinical have aware, an disincentive you're the that, believe we our changed. did that we perspective. ASP as

We actually this economic affected favor in that point, not the of by at ORGOVYX. improves it and are dynamics

it's how So have to change them. And, unclear, in much contracting a we clinic, and plays But the currently this change shifting that their that some determine for considering strategy. to that up clinics plans copay. decision patients a out patient, of not play our any especially will way their may role how Medicare is do making their

answer And Did both so their have in question? that dynamics will your consider making treatment offices selection. to

Unidentified Analyst

Yes, that's Thanks. helpful.

Operator

Thank you. [Operator Instructions].

Choi with of We line Sachs. have Paul a Please Goldman question from the proceed.

Paul Choi

Hi, thank you.

earlier. about Sorry

our two Just quick from ones side, please.

visit comment had comments on demand for to other potential Just up given color, COVID here, of just additional you maybe And with to on you're you can ORGOVYX with changes sort thinking regard for changing question how about patient regard levels, and with to MYFEMBREE. the your regard to I there? any seems a be what say then on backdrop follow can just

Dave Marek

Yeah, Lauren that. let I'll address hello.

think think in are I versus certainly we're seeing the office oncology I patient urologist dynamics, the different office.

address So Lauren, do want that? to you

Lauren Merendino

Yeah. Thanks, Paul.

that One the return So what you which we've and essentially elements patients referencing, think is on our were There's [Multiple going Speakers]. levels. is two two seen clinic the of COVID I into there's impact. pre-COVID

now. So rebounding that dynamic we're is comfortable that

Dave's immunosuppressed at we a little part point. to does vary With And is patients, that oncologist, the restricted that and have more are this The oncologist. point between customers. access managing second urologist to they

urologist improved. and cases, oncologists both access in that has However,

now our in able access we're to demand. to a which more details why customers, is and us of person higher valuable which that's to greater to allows important so And percentage is have have driving

Paul Choi

and that stocking Okay, a Dave the guess, can additional quarter, fulsome for among sales for from Thank in messaging this prescribers the I reframe again, market guess, for on you will just sort very be additional of you on what competitors here, having and been then the appreciate sort questions there Lauren just presence I here, thanks that either regard just have focusing market? Lauren. where for maybe And more the you color, addressing to to resistance may with be or class launch and market, potential primarily much. you'll and the early learnings us inventory. messaging of were GnRH MYFEMBREE, the where bringing in primarily

Dave Marek

thanks Well, Paul.

is I a on for us just not context, real to GnRH antagonists for class. as thing think, one focus really the specifically opportunity

look million million really and by a clinical potential of to with failed on are have at If women X those we looking is patients specifically think who've one tablet X administration line therapy. where really contraceptives, their can for opportunity that's or think who total the full another we And who who women failed profile are a oral been option of real that been can better provide the our is first of the think step their really therapy, our day, unlock treatment. and in line this We're where women with we a is. then, still those we and I opportunity by first once seeking marketplace. at

a support the think coupled the payer with offices we with us it all And patients environment choice we're patient the we profile, makes as us ideal the in one telling that discussion once And services the the day, our coupled the along with clinical think open we us, and that now have positive pill having looking are really hope. I our think they're certainly that will for physicians interim, to payers, support we way. the for.

the to treatment both the that provide a very marketplace waiting MYFEMBREE really the been we make impact patients and about and have significant for. clinicians good for in ability So feel

Paul Choi

Thank much. very you

Operator

I'm Thank showing final to you. comments. in queue. I the his questions further will And turn Dave any not back it for

Dave Marek

is a at with time Myovant two can launches patients prostate with meaningful differentiated look, Well, uterine fibroids. that with you. with for underway cancer really thank very advanced difference and therapies a Okay, exciting make

commercial We as deliver both build operationally and strong value. are very sustainable to well well positioned as financially execution, long-term

thank and progress. So I forward look updated to on all our keeping you you

Operator

disconnect. the XXXX for concludes you you quarter call. Thank may and this Sciences gentlemen, and first earnings conference participation ladies And now Myovant your fiscal

Myovant Sciences (MYOV) 28 Jul 212021 Q1 Earnings call transcript