MYOV - Earnings call transcript Q3 2021

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Operator

Good day, everyone and welcome to Myovant Sciences' Third Quarter of Fiscal Year 2021 Earnings Conference Call. Today's call is being recorded. At this time, I'd 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 third to other thanks financial review XXXX and discuss of results quarter corporate morning joining to us the and Good updates. business of fiscal

Uneek Officer; today's for Medical Officer; Marek, Executive and are Joining Juan Mehra, Chief Camilo me Financial Commercial call, Chief Merendino, Officer. Dr. Myovant's David Chief Officer; and Lauren Chief Business Arjona,

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

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

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

Dave Marek

sequential women's Myovant by MYFEMBREE ORGOVYX net compared fiscal of you, price. million and MYFEMBREE XXXX. our reflecting on of U.S. steadily-increasing in million more double approved had growth, held and $XX.X among of $XX.X each net $X.X our generated it's uterine MYFEMBREE primarily the to with reflecting during everyone. net of new-to-brand XX% good fibroids, revenues quarter third U.S. support By fiscal Myovant to revenue. revenues quarter. prior. XX% offset over the of net launches. than selling a morning, Gedeon captured for revenues our reflecting share that GnRH health, to continued December, partially were three growth fiscal of million, Thank only antagonist product million months MYFEMBREE supply RYEQO from fourth launches for market, month million, Ryan QX, Richter, including the $X.X product lower recorded $XX.X of revenue European of prescription achieved their ORGOVYX Richter, progress to XX% volume make share partner commercial total international significant third revenue, for quarter

partners for oncology. Turning we to work relugolix year. the to our international approval. to launch ongoing We're to on regulatory activities financial an and business middle execute through development to to in pricing related and prostate position the process review expected of EMA of cancer, commercial the continue for reaching by an of so in approval shortly with urology presence partner, or this in anticipated a partner process will European a agreement Commission meantime, a our potential with oncology, on European chosen after In be the engaged and updates. partnership relugolix the in rights with prelaunch formal reimbursement, other track opportunities currently established in on goal towards a focusing remain assess We

Finally, to we seeking expand while our position strong commercialization MYFEMBREE to activities, remain support ORGOVYX in and a pipeline. financial

financing December of million. XX, had and of cash Myovant committed As nearly $XXX

while XXXX. new year, generated our Building increasing discuss With the by expect and we to and depth like growth engagement. ORGOVYX last to patient on the goals of the briefly momentum I'd increasing prescribing the breadth start we year, strong of drive calendar for objectives

the a population, high, treatment there need an expect Significant For endometriosis leveraging for will unmet option. MYFEMBREE, this execute uterine in one fibroids. approved approved, to to same searching brand, for uterine the pill treat prescriber once dose, us launch for patient is day efficient an large a to uptake effective we indication, launch where same that enable is the overlap fibroids and pending FDA accelerate by new same MYFEMBREE to approval also if pain, for

also expansion. life to cycle need We to build tomorrow commercially, addition finally, advance relugolix In clinical development advance relugolix pipeline announce commercial in and oncology. development add for complement international to our through partnership for plan executing continue and opportunities opportunities, externally health, And clinical to MVT-XXX urology, capabilities. an we'll to for also to in we engine our and to to women's to oncology look primarily fuel

Myovant clinical momentum are sustainable about and commercial well ORGOVYX We for with regulatory and positioned the milestones, remains for excited commercial strong growth. progress and upcoming for the execution Together our early-launch MYFEMBREE. long-term

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

Lauren Merendino

net U.S. provide update Today, the the of adoption an establishing build, made [ph] and towards the in and recorded MYFEMBREE XX,XXX care. and momentum Thank year market, were with you, androgen continues and the treated work that ORGOVYX ORGOVYX million ORGOVYX on on standard as to first we ORGOVYX. $XX an U.S. men we've on deprivation progress I'll In ultimately estimate Dave. Pfizer revenue we incremental as drives our of launches

were coverage. of QX, but therapy reflecting patients continued September, As sequential to of to total drugs estimate increase, the Dave cumulative revenue additional growth, steadily mentioned, X,XXX samples. that in ORGOVYX commercial through XX% ORGOVYX, volume fiscal free patients patients least excluding patient growing generated on and men on improving XX,XXX net clinician $XX.X patients ORGOVYX driven utilizing for month-over-month. Estimated bringing with million demand has payer and and product December, Since treated we the at end including by

any free trial the discontinued Therefore, estimated number while months, During in the prior enrollment was include unlike end month. free of treated the November, patients incremental new did December, program not trial of distributing began at the from the samples, we ORGOVYX patients in program.

facilitate distributed over to and have ORGOVYX, we samples prostate Since program starts monthly of treatment the to of it that initiated setting. ORGOVYX with advanced new point and decision. patients In immediately, of patients the being physicians utilized opportunity nearly to the is to terms We across high X,XXX research experience the November, potential. suggest taking to spectrum prescribing at upon X,XXX providers continues cancer with patient gain market sample care, provide

at We approximately prescribed from of urologists reorder receive feedback a of demonstrates the at patients samples, XX% that appropriate an providers, many satisfaction trial. very XX% increase treatment The allow which have we and overall for has for convenience prescribing vouchers at high in-office from and since that ORGOVYX specialties free. initial Approximately launch. steadily large dispensing for ORGOVYX approximately volume academic through do an have Breadth remains since approximately month end to capabilities, have experience. ORGOVYX X,XXX ready not hospitals, XX% centers of with The provided of practices, the with doubling and XX% December, dispensed regarding ORGOVYX including prescribing centers since via May. launch, September believe ORGOVYX total patients we mix of increased the Approximately been dispensed specialty high the rate integrated practices having the of practices serves received And delivery additional of oncologist. group treatment distributor to networks. enable nearly and remains XXX which prescribing has commercial or channel positive

the patients the co-pay ORGOVYX of Medicare plan, be with Medicare costs we the of on D, source have both patient XX to Since Nearly to to group approximately use volume improve, in-office distributed lowest-income primary an ORGOVYX D to We plan, half per of XX% serves bringing of expect ORGOVYX the estimate remain XXXX. specialty Coverage with eligible continues commercial of was our D card. men the patients all coverage and via subsidy which an XXX waiver channel remaining XX% do pharmacies. we for as which obtained with channel to pharmacy are of to reduced of approximately to XX% these as covered to employee generally beneficiaries. practices out-of-pocket reduced costs, XX% of ORGOVYX commercial standard are for little commercial Part for Part either month $XX million of Out-of-pocket and remaining or coverage date, forward. Part business, lives. across compared patients significantly as not million this The treated date which going additional for January lives can lives, D coverage October, Part that

with redefine to advanced million For out-of-pocket with This opportunity deprivation costs. for approximately their time. LIS approximately support men employer be an or XXX,XXX independent, disease, for first the for may prostate receive third-party patients to plan, closing assistance D Part initiating with foundations deadly year care this patient I'd the for androgen offset remaining our financial so In cancer. are ADT not to of living like projected men therapy, tremendous XXX,XXX eligible many able the three highlight ORGOVYX, to provide to more

future opportunity were we able launch momentum are ahead. growth that our about lies year the generate We substantial of and first the excited to in for

and in that This turning team we Since our GnRH Increasing progress Approximately than drugs to XXX,XXX activity MYFEMBREE growth. with are launch rapidly patients which impact launch. recent pool MYFEMBREE Since our end the of and had from antagonist through utilizing half on prescribers sales through revenue, aided high- mid-June prelaunch able medium-priority MYFEMBREE we've new-to-brand XX% million overall has significant net therapies, the target grown reaching as prescribers, have trajectory, of This through recorded and awareness. Myovant patients reached launch, MYFEMBREE MYFEMBREE made prescribers. potential in awareness of more also five launch September. and awareness has Now approval awareness the free been among than Unaided prescription but clearly, it's generated double in class of has MYFEMBREE; to FDA the most or has up to Also and remarkably, has, was FDA base XXX patients improved to of drive the prescriber that education of approved September treated excluding continued hallmark two awareness. favorable pleased U.S., is expanding fibroids, the conducted a the from captured continued Pfizer XX%, X,XXX prescribers have the now very in commercial calls, treated Among Provider on has uterine and nearly uterine for it's share number to December. and with $X.X XX% samples. a of we brand. impact launch continues with XX% the May, XX% of reflects November, identify which including in target our the December. approximately on fibroids encouraging December, women quarter. were more

of only share share New-to-brand that already prescription for captured class. launch, had the is antagonist be launch. growing leading indicator uterine MYFEMBREE potential antagonist believe, of rapidly first-time by future the of this this month our months well proud XX% XX% XXX of also MYFEMBREE's by full fibroids. profile overall are sales at effectiveness since in clinical first prescribers GnRH unlocked of MYFEMBREE, every MYFEMBREE recognizing adoption least MYFEMBREE of We simplicity, prescriber base. approximately and convenience the reflected we Through have increasing marketing providers number clinical in rapid in shift prescribed desirable for can expanded are prescribers of and the once. has a key six the The the in share market efforts. and as reflects and nearly as pool fibroids profile, as December, GnRH prescribers Providers The uterine

total high-quality can through been XX% of since late the expanded fibroids, the insured. are MYFEMBREE launch treatment payer that has treatment, given for seen candidates market moving approximately priority, coverage four-week antagonist MYFEMBREE June uterine who launch. average also prescriptions be have December, this Obtaining option. from commercially critical women, with for right for a of are commercial MYFEMBREE demonstrating class XX% growth The increased We GnRH

in with payers six commercial expect to lives coverage We make have improvement Negotiations progress months yet that XX% coverage continue lives, to expand October. of achieving million $XXX nearly the of since our to XX determination have months. made for commercial continue a coverage extraordinary launch, coming or we an since and million other in

the the Of high, to at failed the prescriber broad and Approximately women women for endometriosis prior experience PDUFA date, as million supports impacts May our disease. for choice unmet in which launch pain And other parity minimizing FDA to of eight use are in reduced ORIAHNN. often covered coverage to patients underscoring date, of endometriosis can as symptoms it's Pending need infertility million and that having May. coverage, six with to cost as by with is pain, high-quality U.S., MYFEMBREE during debilitating significantly is is which cards. impact intercourse out-of-pocket commercial we of be Endometriosis can therapy, authorization that criteria Just having costs co-pay commercial approval quality one for symptomatic the the month barriers while patients expect little like XX% initial approximately $X have lives in out-of-pocket pelvic access. by with per six million life. this important

clear our the a have same endometriosis fibroids. pill, approved intend strategy once-a-day Pending and clinical launch. for highlight the We FDA to we and very approach, one direct leverage currently one for uterine dose, approval, profile

multiple contraceptives, diseases. experienced million five We which treatment to fibroids, fibroids FDA the and prescriber in the uptake salesforces endometriosis. approximately combined is are support that dosing approximately for in MYFEMBREE these initial disease. treat to factors, six we array the uterine four coverage, women and by prescribed utilize a if the once-daily by by women overlap significant other are should and three already and their with hand, and these GnRH dosing initial for uterine treatment gynecologists are in help oral intervals on doses There initial with indication. women's across MYFEMBREE. Incumbent is with the also women resembles endometriosis, who therapy for MYFEMBREE, are believe the payer plan the given this with Of million offer to these the Additionally, many familiarity and health uterine endometriosis. approved between leverage endometriosis, brands, confounding existing prescriber's women, U.S. symptomatic million seeking with antagonist of two failed symptomatic fibroids accelerated

of share million-patient X MYFEMBREE. will commercial market even that changing realize in for result capturing small a we prescriber significant takes a this behavior time, While opportunity entrenched

our to in call as Uneek endometriosis, off treatment that, fibroids I'll the time, the product to FDA with are start a now a well over great pending with the review results. to potential in differentiated We turn change approval. to has uterine as financial paradigm

Uneek Mehra

highlights XXXX. Please Form the comments and earlier of Lauren. press today performance refer issued XX-Q information. the financial quarter to will our today our Thank you, My fiscal focus on third in December XX, ending additional for release

quarter, ranges sequential this net with revenue. million was ORGOVYX preliminary revenue begin $XX.X month, growth, we revenue Let's provided the was quarter. offset net Consistent total for $XX.X for we expect remain in a for the of QX by $XX.X higher product gross-to-net due revenue million. the compared low fiscal in to was XX% gross-to-net in net the decrease The ORGOVYX price low the million, XX% foreseeable a with volume Myovant revenue to discount in discount mid-XX% to future. recorded and earlier third QX. partially to it reflecting

we discounts for to in the revenue anticipate the MYFEMBREE QX class Richter, from and, with product million impact QX. fiscal along profile MYFEMBREE, specifically, RYEQO from extent, reflecting a revenues fiscal lesser Gedeon primarily ORGOVYX net growth. recorded product to We for supply support $X.X revenue of $X.X launches be of differentiated million, gross-to-net steadily-increasing For the was royalties. of European the impact to clinical the for net demand reflecting with XXXX of line

related scheduled payment, payment approval XXXX; recorded when fibroids. period the of is Pfizer related million the recognition MYFEMBREE the In consisting Pfizer the collaboration quarters, through to upon XXXX, we from milestone Myovant the at these $XXX and recognition $XX.X of of calendar million partial will FDA of also of end of $XX in milestones revenue, amortize uterine triggered upfront $X.X to year the million continue partial December amortization same million received We regulatory future to amounts for end. to

payable Pfizer and R&D a study Takeda. driven as period. comparable the for highlights prior million, higher share as expenses SG&A reflecting to with of or expenses cost $X.X million, of as from reduction quarter by higher launches the $XX.X largely million profits to cost of on the sharing QX. operations, in quarter $XX.X in in oncology due and MYFEMBREE XXXX, the net income sales $XX.X generated The the Cost expenses were product compared compared was higher goods sales million, The of in expense net to marketing in for in to royalty third costs Myovant's was related million with the of commercial costs a as year million salesforces. $XX.X health sold our comparable connection the the per as clinical $XX.X of was third well year well expenses mainly expenses. ORGOVYX for the million to million expenses loss ORGOVYX certain of in U.S. U.S. share and of a $XX.X year increase activities, quarter. commercial decrease was prior loss were in of other to related Collaboration third teams net during period. relugolix Pfizer's $XX.X $X.XX R&D well comprised of the prior compared or on to Myovant to Moving XX% statement. of revenue access of the R&D the share primarily for and the market including net MYFEMBREE, support $X.XX to as quarter personnel-related women's per hiring and quarter

with marketing Looking the $XXX.X increased in in increase, opportunities year the expenses and R&D ORGOVYX such projected to in life expenses XXXX, are compared Subsequently, the we compared expect higher by XXXX due year ahead, of to XXXX ended for to and expenses line SG&A We XXXX, Sumitomo cash, be relugolix cycle fourth fiscal commercialization and as million, on year QX projected spending cash actual expect majority fiscal driven with fiscal of spend. capacity to originally we U.S. QX. XXXX, are year of million quarter incurred fiscal R&D loan SERENE Subsequently, and promotional as study projected of $XXX.X for actual QX to Pharma, which from under be on our modestly fiscal activities extended committed decline ongoing remaining of $XX.X to QX that were fiscal certain million to to support III marketable as in fiscal shareholders. MYFEMBREE to be as low-cost the marketable SG&A marketing to fourth by upon Phase securities the spending and expenses XXXX, facility, post-marketing securities sales financing comprised with for and Dainippon expected fiscal expenses expected well as us total requirements, included expenses FDA. the agreed quarter

as position cash with the Our well increase coupled anticipated MYFEMBREE with and revenue, commercial the and and of future at milestone the commercial I in puts Myovant certain same our payments, our Pfizer, turn as relugolix-related remarks. position development strategies excellent expanding over it potential back time, now sharing some execute Dave while, in to closing Dave? pipeline. will an ORGOVYX for expenses to

Dave Marek

become In and to we and Thank step After we our ORGOVYX as first efforts. breadth of patient the increases for continue the depth prostate potential to is with standard-of-care a the time. ORGOVYX that for up closing, Lauren. ADT will believe in year on impact of FDA, endometriosis. adoption you, believe pain the poised has over activation representing associated an by prescribing build, as commercial uterine Uneek millions to if advanced and treatment continue paradigm fibroids MYFEMBREE women we cancer, of approved by the transforming to and, significant opportunity market, lives

new-to-brand simultaneously has the rapidly been base. the in as recent Our growing able encouraging, while progress uterine prescriber gain launch we've and been fibroids class prescription share to

MVT-XXX strong financial by life development We cycle which pursuing opportunities, on all by to advancing have position. year our our executing by business and supported can this relugolix by plans be expand pipeline

clinical data initiate to care medicines. translating on on the I our creation begin us for depend multiple important will to all studies, us better for filings, your the and clinical complete coming for look I'll who to turn In this Ryan received Thank to Q&A to multiple for our forward executing growth. commercially, those months, ability decisions, shareholders. we in differentiated read redefining long-term out confident expect which And long-term additional session. addition attention in over regulatory I'm potentially to of value position and sustainable to our regulatory for it you mission deliver of

Ryan Crowe

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

Operator

from Ruiz Our Instructions] [Operator line Leerink. come Roanna from the will of SVB first question

Your open. line is

Roanna Ruiz

you for morning with Perhaps, the efforts of on ORGOVYX. Great, and expect thanks efforts through status And group update you disincentives you do a anytime everybody. and organizations dispensing? in-office could I to soon? purchase question it for taper negotiating going to us the Or off are these large year? continue your have removing

Dave Marek

you like to Yes. Thank take you, Roanna. that? Lauren, would

Lauren Merendino

Yes, sure.

contracts to that key a GPOs place practices ORGOVYX purchase our our product, from So have in enable through perspective, distribution specialty we GPO purchase with the channel.

and by exist being are and And today. accounts so our those are place contracts in utilized

Roanna Ruiz

Okay, great.

so And is other accounts that any or on smaller relatively stable? there tag this might are

Lauren Merendino

point. relatively It's at this stable

Roanna Ruiz

Great, thanks.

Lauren Merendino

Thank you.

Operator

line of Eric the from Joseph comes from Next JPMorgan.

is Your open. line

Eric Joseph

morning. good taking Thanks Hi, for questions. the

First potential on your considerations. -- and partnering is launches on European

work another about European whether strategic access I'm in one in having with offers loss [ph] happen You the -- started initial you the in might loss is pricing some relationship talked know, curious bit alternatives the here? of of a little Germany. the market? that -- leverage And Europe or is to what any and Myovant is Sunovion

Dave Marek

European So, address to Eric. that. good let believe, the morning referring you're I'll Uneek ORGOVYX. for opportunity I

So you that? Uneek, take could

Uneek Mehra

you're Eric, time, in contemplating point launches in Europe. Myovant-led at this not

As And right interest former ORGOVYX are processes to in now, ex-U.S. we we've opportunity. considerable a before, partners the potential stated have we evaluate markets. for in underway,

Europe, oncology. in we we is ahead And sometime of who consistent have hope infrastructure are with As expected also and approval have a preferably in partners, established commercial partner decision urology the this the year. to before, previous which of in middle remarks, place mentioned EU seeking our in

Eric Joseph

to new going sort little Can ORGOVYX just for about at leverage pricing highlighted forward? -- a the of in guide outer on bit talk you conference, you'd you launch, and years Any current And as expectation be just the of, the of, little far thinking at the a and -- how least contracts out gross-to-net. reached? how your -- you stabilized bit

Dave Marek

address gross-to-net you the outlook? can Uneek, certainly. Yes,

Uneek Mehra

Yes, sure, Eric.

happen be Most should will contracts, point of gross-to-net in the to may typically, least which our go expect in to the low then year-end And there until of we we may the sort of end XXXX that foreseeable sort the but end is at now till the of that future beyond of at to be So some likely that mid-XX%. our in range. right calendar calendar year until renegotiations be our least be for XXXX, guidance time. in XXXX, expect

Eric Joseph

Thanks questions. the Okay, taking great. for

Uneek Mehra

Thank you.

Operator

from Our next of from the Phil question is line Nadeau Cowen.

You may begin.

Phil Nadeau

taking few progress questions; on from morning. a Good thanks us. and for the our Congrats

guess, I the in ORGOVYX first So on launch U.S. the

discussed about You bit are drug. are risk the it? about a who the first prescribing among physicians, For the example, put What patients, those characteristics Any the who unifying patients? to cardiovascular or being anything notable? on do they have else

Dave Marek

Yes, Lauren?

Lauren Merendino

Yes.

do of data. me let our an claims analysis So

So limited ORGOVYX distribution we access. the types keep due that in with that have, to grouped at And of model, But receiving mind, groups. analyze able to look into them patients our have data data we we're today. three we are the

disease; with who with and we those see advanced patients metastatic disease. -- is localized localized the those And locally have those ORGOVYX disease. localized about have what half So disease; that of

But is course. And means, this metastatic XX% these of to very their -- have advanced this also disease are patients groups. the disease. so to earlier and generally patient LUPRON distribution about a in of of reflective more size they're And patient similar

we data that's assess that the allows cardiovascular have We access risk. look So patient generally how us to to at don't subsets.

that for hear from decisions. we do make a physicians, that, treatment they field as is However, anecdotally the consideration

Phil Nadeau

helpful. very that's Perfect,

in the ORGOVYX on The issues the you received Have questions notable from EMA? day second And XXX EMA. question raised? any the

Dave Marek

we context, there. our could maybe I of some kind discussions that. of, the don't know, in terms address discuss, on provide I'll you feeling Camilo. the let typically regulatory progress Juan but you

Juan Camilo

Thank Dave Yes. Yes, out, we granularity. provide usually Dave. as that pointed you, don't

only And that are, the process knowing is we However, remain and are and XXX past definitely, towards in next track do we final are see you -- decision. we the we Europe, I'll for tell the mid-XXXX to you, the if on steps and math proved day decision. excited a the regulated

Phil Nadeau

Perfect. from are question last if you us, answer willing then one it. And regulatory to

of from the BMD any and data that on limitation use MYFEMBREE? will of of two-year thoughts be that the the terms the U.S. data label duration to remove ability filed, recent In of

Dave Marek

Camilo. Juan Yes,

Juan Camilo

the we Yes. Similarly, stated about as we saw data are randomized very we've before, from excited study. the

confident the We rest DMB. our we LIBERTY from program, with are together shown that believe data, pretty have effect -- on of the the or on limited that data the MYFEMBREE that, of

in are that the as putting a should we submission planned next FDA. the weeks, So go together into few

an we interpret then predict and treatment. the FDA on is that having of what region how impact of cannot However, likelihood that will data this

our for putting best their are our wait with data case we'll forward we So and review.

Phil Nadeau

Thanks taking for and Perfect. questions on the our again congrats progress.

Dave Marek

Phil. thanks add that physicians to just look on one data. last those will is label for remember, Yes, to the And that area just response;

through it expect that We also other well. and will certainly as available be publications means

Phil Nadeau

Perfect.

Dave Marek

Next question, please.

Operator

Our will next question line from Skorney come Baird. from Brian of the

open. line is Your

Brian Skorney

impacting added Hey, uptake maybe you to the label ability the relative submission wind to could for Thank detail, could you ORIAHNN? good getting LIBERTY intended was of to I morning. discuss up question. randomized taking and this and the the hoping withdrawal study the how you think,

Dave Marek

of -- And then in label from let's just data public? and about believe how promotional of, let's again, maybe just, maybe where Juan regarding touch Well, is how we important talk Yes. this prescribers efforts. to the up the regardless will you ends kind in hear Camilo, it or -- our what that, more, on physicians prescribers,

So Juan Camilo, with don't why we start you?

Juan Camilo

the as Yes, some we're to Dave. providing and reflected of one in Dave FDA disseminate Thanks, be Yes. to label. out, multiple the in expect pointed submitting -- The we the first least at data, we data, us the right? the ways, will data is,

we MYFEMBREE. move on will we affects In will FDA data it that to, consider In a to will the that, on have before, to GnRH confidence of that information only with parallel conferences of adds that, are their will be decision. of proceeding them by with the treatment of treatment, is Lauren? forward the layer if duration physicians available. all two-year think, As a mentioned And be also, And presentations the the another of only of and publication the we we we believe, are that as -- I a very data run way, I has robust. the -- multiple and that of the antagonist profile make reminder, publicly prescribers useful MYFEMBREE decisions. now trials are

Dave Marek

on are you Lauren, mute.

Lauren Merendino

Sorry. uterine disease. are fibroids to physicians From a a physician hear perspective, we long-term as focused continue on that U.S.

so therapies those And offers for that unique patients' MYFEMBREE a which for looking clinical they're we match needs their patients. profile believe

data available And have it it's published. more access soon that. approval payers as use as so data, promotionally, have to becomes do as will we we'll, the and course, once of available to also and And

Dave Marek

But longer-term the the when very BMD And on gets Brian, a on the quickly returns when other MYFEMBREE? what I you we that. the data, part other data is know, airtime, clinicians back results, symptomatology And times, for focus about spirit see less very addition, focused the these little -- of that the one women. think what is discontinue we many happens, we are

think, the withdraw so data down as is consideration, And also that's then and the I make physicians treatment -- and to road look what you important why BMD happens, MYFEMBREE. but a decisions when the reinitiate

set. the that rapidly; course, Of another efficacy key returns part of data so that's fairly

Brian Skorney

Great, thanks. That's very helpful.

Operator

Goldman of the come will Madhu Kumar from Sachs. line from Next

You may begin.

Madhu Kumar

taking Hey, our questions. thanks for

of, of to end, this and of don't getting on So kind comment barrier of practice, commercial that a feedback how and use have studies. and kind being up go limitation about would use, it much have uptake on withdrawal of Phil following much their two-year disease rebound? Like, of of kind of, following removal last people up are the what it, you the to Brian's how of come is a therapy that of, kind the of, that like idea question, issue? limitation kind on resolve that to of, on In, to and that period both want kind to the off then

Dave Marek

a again, physicians your would I long-term you decisions. as faced how know about talk I'll you physician, types preceptions Juan of these Camilo, considerations fibroids. for have of uterine let view, the

Juan Camilo

Yes. Thanks, Dave. fibroids. that And there women Madhu, treat considered I think multiple that things are that by with uterine are physicians

heard like for efficacy, medical is have that the of options recently, treatment had that's is -- Until treatments general, women for market very or [ph] now options updated, in effective So not have addition I think of multiple with what that NSAIDs. one is surgery women. the adds treatment that that contraceptives guidelines limited, is were that of clear, effective options uterine thing therefore, that been important have the the would treatment. some of women, for limited now to What ACOG been [indiscernible]. the cornerstone And options in research, provide our GnRH antagonist fibroids, major another of layer rather from the we've very

for think from that the surgery. I allow -- efficacy options prevent predictable to is that that, women another that and provide So the the treating MYFEMBREE table and the to physician a brings is, delay need or safety perspective, value

Madhu Kumar

color relative question fiscal one growth think those, Uneek. great. you -- How of we fiscal 'XX to 'XX? the about follow-up fiscal spend. Okay, and gave should to a on should the 'XX we think And growth good SG&A How about for from R&D

Uneek Mehra

our point, the May, in year we'll of We'll activities for out in Yes. close call the this be that you in dimensionalization a as color year of Thanks, to sort of, for Pfizer. in of we, through that more Madhu, be position dimensionalization as question. At alliance providing on this the growth give end that as our the increase. QX better the work fiscal with well

Madhu Kumar

you. Okay, thank

Operator

And Evercore our last question the ISI. line will Clark-Gartner from of Gavin come from

open. is Your line

Gavin Clark-Gartner

the taking Hey, thanks for questions.

Just a had couple.

must cost. -- all the guidance issued the contraceptives likely on guidance this is label, to would on DoD with no First recently cover FDA-approved at patients? first indication Once payers apply MYFEMBREE out-of-pocket SERENE

Dave Marek

Camilo? Juan

Juan Camilo

that is just provides this for age, value And that Yes, determine excited This least has our approved, in at the patients. the we excited endometriosis fibroids that uterine study. SERENE is but we product But that will We reproductive Gavin, wait and and treatment will prescribers me provides meaningful bring assessing mind women for that a consideration hopefully, And no believe study for suffer contraception, of have that the or how so all differentiator -- of that, class very for process specific have for and very is endometriosis. been critical for that let we patients. then uterine first, prescribers MYFEMBREE. therefore, SERENE remain MYFEMBREE. contraceptive say the also -- it's top for through -- about a are required would is cost one that of Actually successful that full the [indiscernible] of consideration pointed and go data. SERENE implication be we that the having the be very regulations about rules the that patient. a the And it for that study certainly, covered until believe for a something at -- will contraception we would a we fibroids, to for out,

Gavin Clark-Gartner

more when on milestones that could under it. $X.X you potential these the Or Yes, tiered-sales in of got are there Pfizer, partnership. are? are? any Tier thresholds A milestones B be What possible the it's Can any share milestone details reached? the sales And what billion also or would payments from

Dave Marek

Yes, you you color like we but the can on the specific add maybe to some -- Uneek. know, there. aren't Would numbers I discuss providing tiering

Uneek Mehra

have provided not It's the thanks. details, Yes, we tiers, terms of milestones. in any on -- these

and sort can and spread your look $X would given on you or to X.X at achieve X are. to we tiers, to regards across when in still where think, both too are likely MYFEMBREE generally-available you And gaining second, those follow-up, typically our it I then the tiers? probably just billion traction that early, years ORGOVYX. when of, estimate X expect I think, as launches those and

So to, little that when tiers. at would point, this we those achievement a early it's of, have sort of indicate

Gavin Clark-Gartner

so preferences to are agents, are on up parity one and got including and they the practices, system it last be, e-prescribed just a other oncology for their you or prescribers? one in it. to formal the agent could And ORGOVYX, access leaving in other of, adopting alternatively, maybe system? kind in listing bigger as their ORGOVYX, with Yes, the agents preferred Or decision urology EMR it GNRH

Dave Marek

Thank Yes. you, Gavin. Lauren?

Lauren Merendino

So for treatment with start they from But feedback a we ORGOVYX. to patient. do don't decision each seems how our it preference We they're types, it the patient about ORGOVYX. preferences And complete EMR their and utilizing have certain customers transparency have that systems. individualized with -- into more receive is an

Dave Marek

are questions? Operator, there further Okay.

Operator

And I'm any Dave this not to over Thank call remarks. closing questions at further I'll turn time. you. any showing for the

Dave Marek

thank Well, you.

we're today, brands. positioned by the energized hear We're MYFEMBREE. for and can very remaining deliver to we've made by sustainable, commercial well pipeline strong progress tremendous, ORGOVYX execution, through the We're building both value while long-term also encouraged that commercial very you a on As opportunity expansion.

on So thank Have day. updated you forward you and keeping look to a good our progress. I

Operator

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

a You great day. have disconnect. may now Everyone,

Myovant Sciences (MYOV) 26 Jan 222021 Q3 Earnings call transcript