SAGE - Earnings call transcript Q2 2018

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

Operator

Good morning, and welcome to Sage Therapeutics' Second Quarter 2018 Financial Results Conference Call. [Operator Instructions]. This call is being webcast live on the Investors & Media section of Sage's website at sagerx.com. This call is a property of Sage Therapeutics and recordings, reproductions or transmission of this call without the express written consent of Sage Therapeutics is strictly prohibited. Please note this call is being recorded. to Cox, like Sage. Relations now would introduce Investor Paul at I

Paul Cox

presentation highlights, progress morning. press press results, XXXX company a on the X Slide of can presentation is we this be release Investors along milestones call. on with the recent On slides Good Media at section sagerx.com. issued quarter for and used agenda today's release the Today, strategy. our on corporate our & second with of call found our upcoming website The the and financial

the with safe begin the Chief Doherty, Jim remarks will harbor Chief Jonas, be our Iguchi, We Officer. Q&A Jeff Research Mike Financial Chief for Chief Officer; Officer; call Business Slide statement. session Kanes, prepared Steve by Chief X by: Kimi is and We'll our Dr. Dr. Dr. On Officer; Cloonan, Executive Officer. Medical joined

filed our proprietary for regulatory the accelerated During the the commercial prevalence the timing NDA today's forward-looking decision; planned in results differ call a and section we the disclaim certain and of our in activities; statements the including and The launch plans Securities risks press statements a our to potential the EU; SAGE-XXX We call, in today's any the only. of Actual our but development Commission will activities. events are report our these we could materially. discussed the our plans runway; expectations and with potential of now I as recent of over expectations; in financial and may the future product cause of differ regarding the cash would statements update to in approval and with timing forward-looking that statements, of the and our and upcoming formulation including our Any like most quarterly Factors brexanolone do activities represent about regulatory may as current Jeff. so. and of reports development make the SEC. for clinical other other indications; our of our estimates Risk to for expected and our factors expected future, and to actual other to release depression; as and reviews filed for turn potential business Exchange our views projections, today obligation candidates; to results our

Jeffrey Jonas

the we Thanks, multinational a of goal this becoming morning, make on our of and an leader company, call clear a CNS thank on benefit. the X, joining progress Good maximizing Paul. biotech with focus a On continued innovator you patient in quarter, development everyone, Slide for us on to today. great and drug field

important across Slide our We continue strides to entire which seen is make X. on portfolio,

proprietary accepted is for formulation our name ZULRESSO, the is the Administration, Food Our Drug and which by intravenous was of by conditionally recently pipeline U.S. led that or FDA, brexanolone.

readiness ahead Application we the December As in provide PDUFA Mike these or build the on on ZULRESSO execute and currently continue of of New depression, a date commentary postpartum ZULRESSO's by later to our call. treatment launch XX. for a under review a reminder, is FDA. as Drug more PPD, efforts And commercial target for will

quarter plan we our of lead oral for important breakthrough development a year. development were continue for SAGE-XXX the SAGE-XXX, June, fourth program also We accelerated in to with progress trial pivotal milestones advancing program. to of expected psychiatric potential pleased this make depression our In broad in in molecule a key in announce

studies data trial. an into and before followed major randomized, our to to generate R&D controlled We phase a stepwise have also and PPD study as II initiate already example placebo-controlled both open-label is This strategy Phase depression. cost-efficient successfully larger demonstrated plan with be we in as of SAGE-XXX in bipolar proof-of-concept a an beginning depression, appropriate advancing to into of

We entered if of collaboration successfully SAGE-XXX depression. paradigm-shifting approved and for for with developed strategic and South in the access commercialization Shionogi Japan, and development this on into Korea, a accelerating potentially geographic also broadening treatment recently Taiwan and

And near- has While ZULRESSO I by more SAGE-XXX R&D the next focused in and Phase we Even intermediate-term earlier we I next I trial, ascending the SAGE-XXX, FDA and with and our long-term progressed first, opportunities, hope provide SAGE-XXX invest our before early of efforts, also pipeline R&D Steve of our comment you our or year. to a clinical a moment. mission multiple programs development to programs SAGE-XXX. trial we a tell on would progress like find early now and will to been next on are dose on cleared to of where potential some are IND have begin. ZULRESSO about Sage's initiations in continue R&D But our Phase closing. to discovery color recent in broader our candidates

developing to for much novel as advance handful of but and past potential focused focused medicines in including our treated. Sage a congratulating We on comprised I be are our the would disorders is groundbreaking to we only X expand CNS approach of scientists, the health productivity Today, With incredible paths not tip products our by developed of way years. remiss franchise years, looking our forge spear treatment over pipeline disorders, CNS after emerging mental the launch portfolio, their only the we potential there and team come. approval the Sage depression the more we approaches. is by the not believe as ZULRESSO, upcoming by new to of remain continue for new on of for and to consider treatments Sage ZULRESSO impact

detail impacted over and on families, on the more to to before Q&A. of focus those now for at financial and rest updates on call PPD. our impacts team improving to by make beginning patient with results we the the potential continues I'll turn take be through our we innovation, Sage to of the Our hope positive through patients on care lives product candidates' and follow

First, Steve. I'm everybody. Thanks, over turning call the to

Stephen Kanes

the the R&D III Thanks, PPD. need hope believe Hummingbird breakthrough This new Slide Jeff, summarizes provide treatment slide SAGE-XXX We potential III an in successful PPD, therapeutic for there is ZULRESSO and indication across which currently and childbirth. clinical X, from ever good the on Program. has FDA; postpartum new Phase treatment and product treatment review under therapy were On portfolio, to the PPD, for currently Phase like an designated is a update ZULRESSO X significant could by options. efforts biological our III be completed publish in approved is of first Detailed MDD complication for which our options recently data brief would or transform by disease. at for which of Phase development meetings. the journal for ZULRESSO a morning. from with PPD this has top-tier candidates: a I to data for depression publication And development data led of NDA common year. we Hummingbird medical presented this these to Program number a

and meeting PDUFA, X, policy the the Application, is Committee new a to a consistent hold assigned with advice on FDA's for Drug Drug seek Prescription New XX an and planning of for to Our The Act, Advisory with discuss new novel by or medicines ZULRESSO on indication. to is Fee December action application the November PPD User a NDA, mechanism date FDA. of target or ZULRESSO under has FDA in review

And We approved in provide in PPD launch later process call. more a Mike by product the U.S. XXXX for FDA. the are of in commercial of first half the in potential is of preparing ZULRESSO on the progress the detail our the if on

X. Slide to Turning

of including our PPD plan of episodic SAGE-XXX, a status our SAGE-XXX both III allosteric of positive result course planned Phase Based trial III patients dosing pivotal MDD placebo-controlled deliver with XXX SAGE-XXX pleased initiate breakthrough evaluating truly expedited designation summarizes another with of development MDD a previously a milligrams profile using the X novel in receptor trial for to of discussions fourth X FDA. also we the in as pivotal We XX next-generation in placebo our the concept of Phase with completed treatment short GABA status we're successful on milligrams therapeutic with a the to and trial patients. XXXX, our therapy This XX quarter of to of we have placebo-controlled in meeting or SAGE-XXX and compared in MDD development weeks ongoing additional study a placebo-controlled trial program pivotal in the announce are III opportunity to as in if trial. SAGE-XXX, of Phase MDD weeks For efforts modulator, for outcome FDA, our of slide to evaluating new PPD SAGE-XXX with treatment follow-up.

to plan quarter trial a in in SAGE-XXX evaluating XXX PPD also results Phase are top patients of of placebo-controlled and with III fourth line XXXX. We announce

for by SAGE-XXX treatment. summarizes which including been pilot placebo-controlled these to has clinical MDD, primary we treatment since In the the X open-label study XXX was will demonstrated open-label profile patients, depression the of game-changing, retreatment SAGE-XXX these depressive episodic results a we potential at patients patient of our endpoint followed in the acting, data studying where for to long-term to able trial recurrent be highly treatment And believe following potential weeks initial Slide replicate pivotal, an after months result breakthrough of XX in offering therapy a new treatment program planned which oral first X approximately significant a granted for be will needed. saw regarding data SAGE-XXX as here XXX FDA. to be results, and we're Additional designation statistically rapidly followed durable, designated as in X and the year be be study results major in trials. or safety if patients a acquired will and episodic date of through episodes and light

development X. trial insomnia. SAGE-XXX placebo-controlled we using positive line an to a volunteers also of with Slide Phase approaches a a of year, new plan model to the endpoints, potential explore the SAGE-XXX unique compared June, plans achieved placebo improved planned discuss placebo-controlled by announced to we'll including polysomnography performance disorders Earlier for statistically well Sage to healthy for I/II disorders. we opportunities effects significant secondary results generally study meeting. key Turning initiate in which in co-morbid announced SAGE-XXX being this are architecture sleep the believe presentation us FDA from treatment year. top and and And impacted medical upcoming dysfunction, patients sleep of this next-day with data sleep SAGE-XXX disorders sleep offer to for the efficiency data of development on These in insomnia. tolerated. additional we data, was MDD In of in

The patients XX depressive efficacy program a evaluate initially be to proof-of-concept open-label II and bipolar SAGE-XXX in weeks We're initiate with of endpoints Phase encouraged key to the to plan major treatment tolerability two-part in of also pipeline episode. develop. initial in early XX. turn will the and This up in for symptoms primary sleep. with also improving to of depressive Slide trial quarter. bipolar depression Please X fourth with objective SAGE-XXX We trial to will the how with the continues evaluate safety disorder secondary recurrent a SAGE-XXX

For in dose study initiated SAGE-XXX, with the recently IND imminently. and I expected FDA a application we ascending dosing our healthy Phase volunteers cleared single

While we SAGE-XXX and we specifically for tremor focus indications, sleep in expect psychiatric indications SAGE-XXX are disorders, Parkinson's epilepsy, positioning disease. to essential and neurology

multiple in also portfolio initiated compound novel Slide study potential recently targeting We the from that compounds The the range class NMDA dose PK/PD to of modulator a of Sage preclinical advanced of is tolerability neurological of behavioral further SAGE-XXX. ascending pursuing research dosing the a Phase turn in currently receptor a NMDA to this and of XX. allosteric clinical I SAGE-XXX, development treatment safety, strongly a positive may most symptoms. in I suggests of first-in-class Phase development. novel have cognitive, and profile is evaluate Now receptor

of indications to successful, expect second with in SAGE-XXX symptoms. Phase results variety I and this if line in And development top of neurological a cognitive, we associated continue plan neurological We half behavioral the study is year. to

studies. IND-enabling Mike modulator to would Our progress turn over SAGE-XXX, in to towards positive discuss like allosteric NMDA I the call is with that, our second potential And commercialization. candidate, currently to

Michael Cloonan

change for strategy. ZULRESSO last ZULRESSO updates Steve, first across NDA PPD to are build quarterly hello, of our Please of in launch a XX. in you, patients world-class product potential launch is outlined I'd to On for Thank a I launch to Sage commercial-ready you half our commercial our strategy our to pillars Thank treatment continue everyone. for of and first to our medical like recent prepare pre-commercial on potential for affairs progress as to our our efforts lives and and made We joining families. for organizations preparations call, our if prepare provide biotech in transforming and go-to-market and some the the into driven Slide commercial turn that XXXX important call X today. the approved. PPD, company we of the progress

We to designed patient are model care. support to focused pathways on streamline building of diagnosis a through journey patient from clear PPD, including treatment the

should fall. care know can believe We a that the program preparations ensure due support. to establish a a high-quality lack the streamlining of is journey completing PPD of This part Oftentimes, Center high-touch in pathways support AmerisourceBergen, PPD of patient to a this as Sage-led our is do critical patients see will they patient to management experience coupled providers. health We points with many lead with have North patient partnered for falling with patients. many professional to the leverage Group, clear Raleigh, National innovative model. Support which through health for it Lash support care support there care touch technologies, to We are Patient patient And crucial the believe and Carolina robust currently cracks. patients a is model across case not opening PPD for

with of care inpatient PPD advancing and potential approval on We ZULRESSO agreement subject development patients label. of supervised are to care, and sites ranging the FDA of a the for from strategy option hospital final alternate site-of-care each also setting, home options

on establishing potential of future the calls. of updates to progress sites give on further expect care We

product in of payer to raise engage to terms with ZULRESSO continue profile. Medicaid and In payers PPD of discussions we on the commercial permitted engagement, proposition and awareness value of

world-class have have groups. And customer progress advances and conducted team. organization, build as Payer met with we of a meetings in the the grow building Sage continued affairs product National launch, professionals specifically, potential of considerable towards to have field commercial we XXX across team a We Accounts. and have over all the the Further, medical made

to instilling wisdom U.S. disease the working it by are identify greater about reinforcing disrupt urgency On disorder than education estimate in in medical to is women the complication XXX,XXX we the which we the a each that of side, and the affects year, patients. conventional PPD, childbirth

awareness and affairs team screening PPD to multiple focus medical efforts. Our continues on advancing disease

recent progress the of PPD, and manage We trimester the Visit efforts Redefining pregnancy. on are comprehensive seeing Committee the these by to on care Opinion to maternal signs a fourth recommendation Postpartum improve tangible on urgency support including ACOG's mental throughout OB/GYNs of

by to anticipate continue into scientific multinational ongoing strategically a investing PPD broad with medical local We including receiving a in are We disease of continue the company, EMA collaborate biotech which and independent across will from awareness on centers broad and European launch as well PPD EU we national program and permitted maternal of continue launched Also we while congresses conducted about education to on timing at programs. with health the also EU of campaign, and our quarter, And U.S. supported launch development engagement the and we our recently future ZULRESSO, operations. advocacy guide build the the our symposia psychiatric digital educational patient a groups plans live number think in Sage finally, ZULRESSO U.S. of medical advice digital footprint. a of fourth potential the focused building as recent

Slide to Turning XX.

We're broaden for global potentially Japan, development, a and collaborate with in We geographic alongside Taiwan depression if successful, pleased Shionogi also to Shionogi access for a for U.S. potentially and with to recently strategic in patients expand accelerate the entered and paradigm-shifting to treatment ongoing our efforts to into South to collaboration footprint Korea. SAGE-XXX, the Europe.

while can to I'd we our you turn like prepared we ZULRESSO's multinational hope as financials. review continue to progress I And we considerable our As to to see, to long-term approval organization also over the And now for build leader. make in for a continue are it readiness. success CNS Kimi launch potential

Kimi Iguchi

Thanks, Mike.

continued XXXX. the XXXX. million is $XX expanding of to the and a compared of quarter. excited $XX.X XXXX. to million with as of SAGE-XXX, preparation for launch revenue the the a net growth year-over-year We for period the support financial Phase our headcount our revenues revenues continuing as same that outlines an quarter in as new announce for organization net the including now through million by compared well and operations. the of investment to results results quarter time potential R&D ability $XX.X in Sage's the loss of of same the commercial second in million million compared Sage financial to with completion loss period revenues to development collaboration III the clinical on additional of indications in to million guidance. $XX.X efforts record the identifying interest and for to collaboration increased These million the were offset Sage's the expenses increased clinical on from further and expenses and quarter second of The to compared were Shionogi. and XXXX. provides ZULRESSO reflects me administrative candidates with second walk late-stage increases are assets, capital you reported our same the XXXX $XX pipeline in us attributable first operations. for All second quarter. Slide R&D to of second upfront programs our of in discovery same our of We're This Let for the quarter second enabled for the Shionogi of period focused period $XX ZULRESSO. of SAGE-XXX The strategic assets, financial quarter the in in for and make aggressive in strengthens position and and investments the build and earlier-stage SAGE-XXX. no such ongoing Collaboration increase increase XXXX and and the Research payment General second development to $XX investments XX result

now the cash with second marketable cash, due in of equivalents sheet. follow-on ended compared to The February. in $XXX.X with Turning year. balance to billion offering million the quarter and We increase securities. That's primarily our $X.X the was beginning the at

diverse up to confident critical our sheet, of strength opportunities. pipeline, to allow and us approach our setting long-term focus execution balance across are us cost-efficient We that the of on with near- coupled drug our development, will the well across activities

on that our plan, to Turning to cash operating enable operating we guidance. will capital expenses and balance its XXXX. current requirements anticipate our Sage fund Based into expenditure

We of our expenses year-over-year operating XXXX expect portfolio investment product ongoing increase in commercialization ZULRESSO the and support that in in PPD. will to the potential

We thank milestones. company, their made XX everyone we date summarizes Slide the the with pleased are to progress support. and upcoming we've building our in expected for

for ZULRESSO, date November For a upcoming, is fourth which and Committee have a number quarter. December the FDA of will also we scientific PDUFA X; we Advisory an advice by XX; EMA planned the milestones to expect from regulatory including meeting, target on receive

to of plan continue for the of commercial XXXX. ZULRESSO U.S. in launch half in the in first a We PPD potential

also expect We considerable pipeline. progress across our

For quarter. III in results SAGE-XXX, PPD trial we the line fourth Phase of the SAGE-XXX continue placebo-controlled expect top to from in

multiple trial for ascending recently results single a ascending SAGE-XXX. both II trial the also we the fourth bipolar I III initiate III a expect We Phase the now dose studies We in initiated And the to fourth pipeline. the quarter. to the co-morbid And expect study quarter. earlier in to and in depression insomnia clinical for trial report trial with Phase I dose from turning and patients Phase MDD in Phase Phase MDD, SAGE-XXX

in progress biotech the portfolio coming a against call quarters. multinational like goal will our we we'd Q&A. As to With [Operator toward you Instructions]. the becoming multiproduct, position can execution well see, we significant us these that, the company. of milestones And entire Operator? expect now for believe across open

Operator

[Operator Instructions].

from Brian Capital Markets. RBC Our question comes first Abrahams with

Brian Abrahams

to how little if of interested from expansion depression you the follow-up. And randomized open thinking question more the sort bar plan, think should study that a PPD label to you're I whether potentially into was could work or potential First there. specifically label I I'm the have about talk pivotal your move in later a plan how portion, timelines opportunity. about bit in then quick a on wondering about is plan maybe might the that, and of the that bipolar MDD, forward sort we as

Jeffrey Jonas

start Steve. over answer then it the I'll turn I'll off and to

-- study in the is design general with which basically of is done before, sort what beginning is study. So we've methodology a

we size, move see an hope know of effect to it's how call label. turn again, get we're see, sense I response at what get the trial. preparing to respond, sense quickly idea done so look patients a a as But to to to we advance, of we into open And it criteria. And before, randomized if we've a to really in

there think So and -- thesis I different more disorder, But who animal bipolar do think it. I some that people and than opinions depression, doing this. of postpartum are we're -- although basic the a aligned to -- Remember, there's bipolar why as for even it's those is is depressive believe about MDD. closely people there's that's a some major lot than

about we're optimistic So this overall study.

yet the the or depend think early or be FDA on we a be data this discussed points, approach to we've will How II. something simply not that's that's bipolar a placement with as some whether can to other with the And The pivotal this and of this about and program we've made the before. serving strategy, respect I discussions determined. -- Phase

me for Let to more this turn Steve over granularity.

Stephen Kanes

approach we we indications. part new of information have. already our is on we look when the This build to And overall into move

build to example the about of what depression, first in specific this MDD. we'll which in studying be bipolar study, what know on we we'll is So looking be

need to will on as how said, and major designing as with trials symptoms. depressive in with to Jeff we XXX, the we've strategy. to that fit for well sustained with clarity, it with seen We overall similar into interested prior make as decisions depression improvements large the seeing, rapid, information disorder postpartum And what subsequent us are give brexanolone, in both

disorder, it's lot to come more bipolar on XXX. a exciting new extension for So an but

Brian Abrahams

then really you've I thus had sort helpful. of standpoint regulatory the you path retreatment. I'm retreatment. that much who on wondering any think, reimbursers open-label have on be views payers of engagement guidance, recent And out both greater safety relapse? antidepressants how any and the with sufficient, Will seems question you the of on from use with and they laid Conceptually, there the be retreatment That's acute pivotal FDA to XXX more draft far if clarity and one concept think and for efficacy do on retreatment patients might and standpoint. retreatment require data sense a to support payment with for

Jeffrey Jonas

to Yes, answer Mike going Cloonan to this to turn I'm that. over

Michael Cloonan

the for Brian, thanks yes, question.

X-week starting how so do really thinking being the are data is like? into We the the see payers of helping might And understand it What what some to this discussions. What and the and as early they're from And we is have I XXX, XXX. good need? And some the groups right? look those how look the days unmet seeing getting in does the on been build we the marketplace? that they're engage clinical we how about the does trials. treatment positioned follow-up how feedback like them payer with think it's for And today in to data

discussions. that so payer to pricing the and inform linked Steve obviously develop we much as and of can in very much possible are on have this help as the terms going so information one forward how And I study we

started lot So work payers. to done, we of the still engagement with be that have but a

Operator

question from Our Matteis comes with Stifel. next Paul

Paul Matteis

the depression, in in look could when study actually One is wondering the A for point since PPD as for drug. much this results was had you just the I for filing as you XXX, a brexanolone few SAGE-XXX quick you in to decided about questions. MDD, that if if file data as like serve for that postpartum have study at basis

Jeffrey Jonas

only Was today, that your question Paul?

Paul Matteis

I've three No, like got more.

Jeffrey Jonas

thought I so.

at and XXX this point, for MDD do think a around consolidated to remains the filing PPD. I plan

the is data we'll report obviously what year. study That look to out see track I think like. this on

team. So track do execution initiate now that's, But to of very this The [indiscernible]. we're the right the is a And right plan to filing by is the I also so consolidated the think course, year. is pleased MDD that plan trial. on for now along with look,

that I think I see think at look point. -- to I that remain So our timelines the think And sound. what have data like we'll

Paul Matteis

Jeff, fair two about just And clinical wondering antidepressants questions. into enough. you then patients sometimes was historically I can talk bipolar if mania. quick Okay, just drive in depression, could potent

a of theoretical that term for risk was how treatment about given wondering, of fit come a you might actual I I'm in So activating wondering your potent this how kind the seems an think long And into drug that look data, XXX? on studies, cost if episodic the over to is how this does have how at Mike, annual patients question many on that. effect framework MDD when you you kind that then and a doses are getting an pretty of just for and the about basis, annual second,

Jeffrey Jonas

one. first Yes, I'll take the

misstatement think, say firstly, I think I activating. it's that to it's a

-- cyclicity actually why said postpartum -- to through impacting earlier And of that drug at even the we're things one who and you and very time talking a then about we are least seeing, is uniform actually most attuned it that that's activity a noticed, circuitry spectrum. think of inhibition affective -- of are through that take be some And closely we the many terms I theoretically actually the the hyperactive standpoint, from we're bipolar that sort sort could a you if pharmacologists, we I there we're in what that, -- across if us, case, that there effect. think from of MDD. than clear is disorder data fact, should of the irritability of are durable in think believe more old-style

in the of to that and conducted doing in So methodology reasons we're this action the But Again, and manic the to a of ought believe most so can think our I it opposite. study a -- to trigger over provide one all maybe to mechanism not study advantage the doing episodes. view far cycling. think way way in the is potential people the which animals make really we're we're I inducing be ask just sure the is suggest humans in data antidepressants, going

over to question. going Mike for to this I'm other the Now turn

Michael Cloonan

Yes.

that, side, And mean, may couple the on things early Paul, is with the represent pricing. many XXX. and I days on want pricing and foremost, mean, through I the we the how is doses you retreatments pricing I that a your really first value to clearly can as I share But require. around So we think the of clinical mean, question patients of

about think us strategy. to the the going pricing the obviously help we as open-label inform pricing, study So is

to reflect on So average of doses on are it's an to important really able be how XXX. study getting patients many for us get to

inform about pricing. and So a about of here going a is help as data, that's see to XXX we talking now, lot the think as that way really our And we we're sort then of Or to the XXX? on pricing. can price basis. per retreatment a this think in of course, then cost annualized data dose how the back and about annual we And per do

think the we're how we but of payers done, of be through this thinking to to the us work through will as preliminary sort more that's well. help thinking this. engage And So

Jeffrey Jonas

one Paul, the more of Steve -- about mood make has a has couple to of Now point the impact.

Stephen Kanes

Yes.

may it in to for activities. disorder, sleep. bipolar improvement its tracks it intriguing potentially pertains overall one if particularly that So very that is profile, to us And improvement is very be to particularly bipolar rhythm patients disorder, XXX's about thing with in circadian as impactful

number that's So one.

and activity. The potential to class XXX we're very some know translate utility potentially that as well is would and that other may in you bipolar interested in epilepsy, antiepileptic of drugs, well. XXX have And this for

part I so this that have many be to profile. interested And to emerging action of yet But of think demonstrated. do reason profile of and moving bipolar in aspects the mechanism into we're specifically the the disorder with has

Operator

Stanley. Harrison comes Our from next question with Matthew Morgan

Vikram Purohit

on is Matthew. This Vikram for

questions our two So side. from

have little And of there's detail key upcoming be up. some First, And the expect novel up key what but your a touched receptivity conversations those Committee? PPD? believe if you that the do overall, a covering medicine a are provide to And more of come in on points feedback you of specific new do you Advisory could to the payer what secondly, themes earlier, points coming of was you wondering on meetings? at in some discussion

Jeffrey Jonas

I'll is to turn Jeff. it start, I'll this Mike. over then So

our it's everyone topics. I call all ongoing the the They're have currently But predict at to premature it's this at It number I we will reviewing Advisory talk about personally, a as think of well. what quite been or but Committee. we announced FDA point. is the suspect knows, think on what NDA. even discussions think with hasn't yet, tentative And doing them or happen about

gone hasn't the Federal it So into Register.

breakthrough to I expect a that a comment with with might we NDA simply very therapy, progressing -- they're can't you well. really productively. on the FDA, So say along ongoing as discussions think productive been the And it's what is very moving

So that's can all say I about I think that.

Let answer it to other me turn Mike over the question. to then

Michael Cloonan

work the I'm team so great Vikram, doing. really market our field-based engaging payers. in a is side, payer really by They've the done job the encouraged on Yes, access

call on we the both engaged think we saw lot received time over payers and disease, Medicaid can So have and PPD XXX of I as about even encouraged on lot multiple And a on the think to I educating brexanolone then spend fit how As side. the unmet think and there's fit the the in. on see, you we're need, paradigm. heard a can the today, the treatment on by through feedback dialogues, fronts, them stigma right? where we side how does commercial brexanolone the and movement you of course those of into the they And

conversations. we your encouraged play by we're coverage, into on positive. feedback feel well gone by pricing what specifically encouraged can those So on a still data that those are so more right? been to out. conversations time similarly we conversations, we're been brexanolone payer hearing has them. the impact coverage received. And we point based from that But haven't also so perspective, by that, the And receiving very The specifically encouraged We we're feel feedback on to has on

Operator

Tazeen question Our next Ahmad Bank comes from with America. of

Tazeen Ahmad

couple. A

as whether be I to example, whether stand-alone examine then you And path better You know data result kind a expect or Could of should might that on you. a think us mentioned as question about detail would passed, sleep for want little make I'm you for has to a first. on as, idea ask of of bit you going have explore prepared better indication so you You your year? to as what have a this depression. we indications, time that more a And later see sleep disturbances let's insomnia, give another such to remarks. other

Jeffrey Jonas

and it's Yes, to it turn start over Jeff. Steve. I'll

Except study us, MDD. pretty interested I think look sleep is that's I a with It's what with that's study patients likely versus the out sleep strategically, measures. lab, program. part the study. more PSG and of a has in induced with at of you're design pretty to disorders straightforward the a to model, typical seeing think which you're we're And But sleep see issue. latency standard sleep that

response and believe, XXX further that to major in potentially said, for the we claim I would things depression, treatment to in look But depression, action, still improvement benefit the study with think potential primary even we very demonstrated. intend MDD patients rapid terms of addition and of for think around of we could to program insomnia. a think the which we've to we agency for distinguish informative we as label in to robust and sleep be other go expansion already, lead the preliminarily

the But I'm So into it's in program. program. Steve depression going step over now. a really to larger to one turn one is sleep this tied this the

Stephen Kanes

often taking a majority in disruptions that with have are actually sleep. we phenomenon. mean, aids antidepressants. severe well-recognized patients to in That's addition sleep know And MDD I of the very vast Yes. these patients

think real both to based specifically want we able of on sleep patients. as XXX improve profile And we demonstrate the those in to a mood. So there's well that to be opportunity as

of MDD polysomnography, be at, EEG an as next well architecture like which trial, sleep sleep said, known after as standard as at a more looking disruption. the of the wakefulness step. some ability give insomnia. all first an specifically the part which well sleep falling improvement clear may to asleep of asleep, sleep, in of us is forth, about we'll be stay patients very patients, measure, onset, We'll So examine with latency for Jeff so as these looking the endpoints, But very overall that's the and standardized strategy information to measure to

Jeffrey Jonas

these other that patients point, One is add, symptomatic. are to will just be who

be they therapeutic So will of doses getting XXX.

looking And be is at out seeing of things our maybe will looking mood to long way literature the we'll there sleep associated that's a sleep and the be scientifically And ability improvement, -- there's secondary at therapeutically architecture interested -- and important we efficacy. came with in Pittsburgh well. seeing firstly, will a very terms important whether So in and helpful of be ascertain of palliative as depression. impact architecture in endpoints one that

Tazeen Ahmad

Then up the whether any terms near dependency. any for nature with on understanding thanks I the least I potential the bigger questions dependency color. that provide that be of I one Okay, or for in has addictive have wondering in develop whether of to come FDA But pivotal. question agency about, maybe details in or term PPD, into indications, potential your could you're XXX just of know interactions getting to not it drug you the on one at the asked was and the guess,

Jeffrey Jonas

to I'll turn this Steve. over

Stephen Kanes

Yes.

and I of I an to understand studies don't the of been relatively standardized as CNS ZULRESSO I assessment going overall doing of would date, liability, or we we rebound. mean, pivotal So development with human that overall in And think, to How abuse program, other to on of our have get standard all to some generally case, mechanism that say the will We think than allow well. profile the part Yes, to not program we no been also this which But profile. development just specifics drugs gives programs. symptoms that's that guidance may a be is, this seen so includes be. as talk the doing overall about the on for that this. enter comment you're any us we would withdrawal discussion, point all from us may where the where straightforward the not have and

there so been this in doing of hasn't anything And again, other standard concern than tests, specific area.

Operator

next Goldman Richter Our from comes with Sachs. question Salveen

Salveen Richter

is patient family driven to Just typically me. to But maybe disease. motivated just by one the this to explain PPD, treatment With you or around for the seek could is to this members? recognize educate I population regard how efforts us whether

Michael Cloonan

Yes, I'll Salveen, this is question. Mike. that answer

falling situation, are a do patient for physicians now, this reasons, might so I through mean physicians, There touch caregivers that time postdelivery. They throughout your of forward is right? situation, right? when right, through are mean, So and times afraid of of the factors, we've process combination as also lot come and to a to the to key cracks work a of family are cetera. their that family lot their talked around are what et that and pregnancy the play it role members a patients stigma, because right? There's of and point, there stigma the really that variety

OB/GYN. the So got you've

You've got psychiatrists.

the well. the have as primary-care pediatricians even and You physicians

the think women taking really is PPD to will safety change creates that today. what members that We're clearly on convert net trying education When fronts, paradigm. it product of on its the we And The it. that stigma. has they complication all actually not to multiple in patients to them we this have and it's should forward. And right? happening for that going medical as you we is to stigma thing is think best And there's effect, treat down patient identify creating that that, prescribed and treatment. that diagnose around to screen conversation profile on the family has as the I can And to that ZULRESSO just opportunity, see I'd than -- and PPD. approved, reduce -- been if [indiscernible]. breaking do the shift the for to they opportunity perspective, about exists physician the making been is today, to same what right? on say, we some that's an creating We're pregnancy, their on so right? come an activation has or go So patients say, can rapid-acting that side easier where we urgency and Brexanolone happen across that we think its Nothing is been of a or different in has lastly, And on. postpartum know

Operator

Our Chico next James. comes from question with Raymond Laura

Laura Chico

I question have one for guess, on ZULRESSO. I Mike

Group other some little could kind of of Lash a that and -- thinking high-touch more I'm if down of broadly a You mentioned this elaborate type you partnership how portion this of wondering guess, there. little with leveraged of MDD be the And how road business areas? the infrastructure this can and just the on with the like bit and the does or opportunities, I bit, infrastructure, type does further. other

Michael Cloonan

thanks Laura, for question. the

treat unique support patient about So support experience about. opportunity create on us operations really we're for call needed get care, think with a of think complexity of create there's We the think is we patient to the they're that ZULRESSO. stigma sites to novel the who's When the we where going ZULRESSO. talked going past excited just them, that you with a I lot the here this about question a around comes the to treated, is to and is described everything that in really

down up a we're in two Raleigh, of Carolina that operation really setting combination things. North is this So

and basis it's managers, to will interacting those them the to in-house navigate with and assistance, strong have. history They the that really They medical established, financial be And and mainly be they talent the well right? reimbursement we on can prescription which assistance infusion. services, have that of partnering with will the like and We if their which reimbursement the bring, personal that on case with day-to-day is expertise very helping partner. We're Lash are a our things financial expertise speak things. I've include the types ones the got a patient. and face leverage through education, required, to the would patient, them

opportunity to can couple we're But for with out not of for in out, can of add that how other and PPD. assuming that synergy support disease. out that novel Lash So infrastructure management in is do we to this might for To indications going patient our question leverage a well. our can so MDD case and as it's this much we we leverage really expertise products, other pipeline, too lot we building value There's your play bring. see here. it approved, as support And we patients it lots a play they and MDD get theirs excited the this around think having really model

So for we're PPD, our future capability leverage off with this then excited pipeline to and start that within Sage it downstream. build

Laura Chico

Great. final terms those sites Or before kind further securing And if of I that announcements for in some the could just partners arranging -- of that ask of, guess, predicated is of approval? would partnerships, I delivery one the you kind of quick alternative have home follow-up on that mentioned, and label? then, care you is

Michael Cloonan

Yes.

something setting So see for inpatient strategy, strategy, well. our sites see many that's the really potentially We create overall to if prescribers, patients as supervised to and as in that the everyone, is in setting, right? home and in to of options we this our where settings outpatient a important we it want having refresher care possible, as

we're So the to opportunities. But subject exploring as those all it final label, you've is said.

companies, infusion to parallel to have really looking now, talking path, with a home we moving opportunities to on Operationally, go we're them. right? So that approach down partner national at

the so label can to and the So of looks parallel we approval move FDA have path ready, in be subject like. that final what a we to that

Operator

with from Jaffray. Piper Our Danielle comes Brill next question

Danielle Brill

First, specific approval the gating a label? there factors are on for of care, FDA getting any sites various those types various the to for follow-up as

Jeffrey Jonas

Yes, it's Jeff.

I label. ongoing with respect discussions think we impact of that will series a have the

things the I many the the may medical and and administration be simple the The administration of nature think time, of is issue like of there's how supervision with the mechanics over administered the what that. nothing how of specific. of bags period drug some -- of any nature and

part of discussions. all ongoing So our those are

a of we spectrum comment anything on opportunities in can pointed patients. we of say, parallel. that really we this to supervised it's Mike's available process make is care think specifically. number we We But -- except out, the there we So that, say as can't think a are don't to more, that can going across where think has can -- I beyond

Danielle Brill

I but Okay. one it's more there efforts education shift paradigm know active are if so, the And are you XXX, any for And getting potential of on what feedback depression? there? on kind early, treating

Jeffrey Jonas

you a chronic interesting from over psychiatry, probably years as know, in field. of terms happening number moving an of been XX -- think concept last pharmacotherapy. much so There there's away is I of the hasn't the Yes, --

probably So in but and there are a of turn treatment, we're this over to better But to it's is which Steve episodic going word. substantial calling Mike. symptom-based what treatment, to idea then it really I'm the interest

getting who And in the who've getting people the paradigm has way seen the and people have still from so is drugs, we're we're used strong pretty forever. general very the it over delivered care -- of But shift actual support patients. last the psychiatry terms a much in

to this more turn I'll Steve for color. over So

Stephen Kanes

Yes.

that about begins first this the there. changing the So It all sort data. place thoughts look we comes of straight people's from to start

replicate until little put we're that the data already, and to together premature the in all where [indiscernible] field specialists places in start the potential the we first data at locked really III its talking Phase discussing Phase It's we've have. the is demonstrate we medical material the So here, a data that to implications. education is of II that conferences, which put with

enormous that a Jeff seeing simple-to-administer we've in very large has as and the sustained rapid, that there's so said, kind far. been field in -- drug that has However, of a interest improvement

beginnings Mike, ways this to of the looking from on... maybe, I that's communicate that more they're you find perspective, And a So data. to of having comment And affairs broadly anticipation to more those medical in want discussions. message know

Michael Cloonan

to boards the doing And thing we add I'd as Yes. are is well. only that, Steve, advisory

around to roll shift. broadly, said, converse to people and the to focus so of groups more in what need educate this so that smaller out this understand emphasis are trying educate we we're As we Steve paradigm before right, to on, we start points can that

boards well. points. Those meetings helpful, focus that really our are very been mentioned have the advisory So medical as Steve

to We through we the have out continue as our process side But will field-based medical affairs as on teams there. the start well there. work move that

Operator

Our comes Cory from question next JPMorgan. with Kasimov

Shawn Fu

Cory. on This is for Shawn

on Is and as randomized is MDD. into studies, of over Or that enrolling And safety be goal couple the you from reporting frequency directly the patients study questions eventual to trial? roll long-term such study? rates intent et a for to retreatment, the the then quick Just [indiscernible] will be of cetera?

Jeffrey Jonas

over this turn Steve. I'll to

Stephen Kanes

first So are study. separate we and as foremost, this study a viewing retreatment

over. important overall will separate the It's profile. understand patients many goal really in for as It's ways to its of So be no, in patients safety And possible is development our individual program. not safety. we and we the which one treat as rolling us overall

profile, the of how of about about. part from view program. overall number in and our is patients as the So so face the but safety understand the outcomes the We'll goal more we'll understand primary that's that's trial the sort that as of retreatment. And we to understand those retreatments safety really forth. that's of really And well. of what it But

Operator

Blair. next Our with comes William Lugo question Tim from

Myles Minter

disease the your your in from why for on I'm wondering XXX XXX. Tim. twice-daily Myles dosing I'm a about know tremor we switched for I to potential essential just Parkinson’s and that's trials.

on based target differentiate product the how XXX, moving potential forward. to about So opposed active get the itself? of two I'm an for trying twice-daily dosing profile to compound to the as formulation is those idea of how much that

Stephen Kanes

Yes.

specifically dosing as dosing to study, to specifically of looking our first too way at that pharmacokinetics be twice-daily exactly dosing SAD early We're be. So the would first, not profile what our what let clarify. at say looking me understand in we'll like part XXX. strategy, looks At so the

drug epilepsy interested and that in sedation profile are appropriate because dosing XXX minimizes for and We appropriate that forth. tremor a be would so as for chronic that's essential

over So And down to say, that. do demonstrate to over the program. single in be the I'll to that's Phase detail doses more during next, multiple Jim give and we comes it part about and what I really, is doses. we'll year what determining it little turn of that the how profile a both

Jim Doherty

developed XXX from into development. XXX program benefit really translational is excited to the the the brexanolone Thanks, programs. approach have moving we've for Steve. clinical We're that having And a and

other will understand about. that programs PK/PD And using those the XXX we it as Phase Steve inform relates just be But And so biomarkers in we'll that to I, the that talking some was to for essential even molecules. from of brexanolone. relationships developed for be we're us programs disease, information you've importantly, from in be that about XXX to And with to order where and and like in more data earlier tremor using heard indications move we'll those going Parkinson's XXX data forward. things back-translating

Jeffrey Jonas

is this Jeff. Yes,

a -- more a broader Just point.

of that somewhat Sage things space. is extrasynaptic a these One they And have creating this has large do modulate the on differently. at compounds But the nice techniques. really the scientists different of series of compounds done job it each GABA

I firstly, just we XXX. things There a may Jim One may of new to and it drugs impact move and mean, also we're to obviously across even to some today, is Phase drugs of activity ways new we're that, Sage and those But discoveries, some disclose, discovering we're the brain. today impact them we find our applicable the indications These be of these to, of these alluding a scientists understand from in things may to which we going the effect. beginning need want out other learn even mechanisms I compounds. collaborators, as that the continue with at to just lot I that Jim's have indications. the group is point XXX. allow it broad are forward to publish, new still And

pipeline is even a So so I. lot the this Phase behind a to in compound, indications going have driven -- both to really indigenous we're a formulation. But the excited by are science behavior XXX do lot of going it and be of to that the large by. not We our is

Operator

Higgins from Our Thalmann. Michael Ladenburg next question with comes

Michael Higgins

the from understand to care? in to a for of on care co-pay question, just strategy back it circle sites I reimbursement if the settings, during specific And standpoint, you hiring that between then forward in then revised the of payer home for hospital it care strategy meeting? you be to on and to a two-day inpatient number is us panel being then If so product and reps give want on recap Trying look their you're aware to set a third areas forth. reviewed PPD. is family-centric the potential patients of the impact focus the Any that AdCom? of? just difference second AdCom, And there is another can again, going alternate and [indiscernible] so,

Jeffrey Jonas

Again, Jeff, answer a last one first, productive FDA. it think to We've is is relationship Mike. breakthrough Yes, the I'll I I'll with and over this had the program. this a turn

moving the comfortable The well. that, frequent posted scheduled. It that believe, comment tentatively We just with Federal AdCom, FDA things are not on is the progressing. on how beyond they're But we discussions. very is we Register. to say have can't We're along beyond ongoing really on discussions

Mike turn but now. that, that me for let so anyways apologies So to over --

Michael Cloonan

Yes.

so questions, Michael, on of site the side and So the two here, the reimbursement care.

different reimbursements to sites care. So there relates are it different of the as

program financial very the patients. for So something minimize much a If for expense contemplating out-of-pocket expenses it's coinsurance, home amount infusion right? support try But you think to of that's of program, part settings, would kind things where we patients. and reviewing like minimize there it's out-of-pocket as We and patient about benefit, now the are forward looking outpatient to. of is so assistance impact can outpatients medical be so a we financial both of the actively of to one and our patients, want to we're

side, reimbursement, inpatient on inpatients. the right, On DRG-based that's

work. would the reimbursement are way system the So those

on our remaining comprised on mainly and OB/GYNs sales specialty On past we'll have individuals focused refresher, in outpatient publicly is question, the the on we've sales in of comprised the XX psychs. of management the one hiring as side, to reps the XXX account the setting, key what team is your and groups: reps two stated on hospital calling will out the XXX be a setting; our force, focused different field just

Operator

showing not call turn Jeff like the time. further over this questions at I'd back to I'm to any Jonas. And

Jeffrey Jonas

as continued to participate the patients, innovative great and We're want appreciate people be at both we grateful in their Sage novel, and Well, as on joining very of the again them, what the very the up of then and to say, about the well investigators, and the we I in the commercial of today. and are everybody, position us dedication in we in for R&D XXXX thanks, our caregivers We're to the all vision studies. without Sage's XXXX, excited delivering coming wouldn't families, need. have to just the in fronts. medicines we people achieving differentiated contributions today And whom

to with your Thank I'd attention have call. for today, like day. and So the a you all great that, close

Operator

concludes that and Ladies gentlemen, presentation. today's

disconnect, now a and You day. wonderful may have

Sage Therapeutics (SAGE) 7 Aug 182018 Q2 Earnings call transcript