SAGE - Earnings call transcript Q2 2020

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the SAGE Therapeutics Second Quarter 2020 Financial Results Conference Call. [Operator Instructions] Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your speaker today, Jeff Boyle, Senior Director of Investor Relations. Thank you. Please go ahead, sir.

Jeff Boyle

you conference SAGE call. thank XXXX second and results financial morning, for Therapeutics joining quarter Good

website you Before point like go are related slides and our that to will expectations begin, forward-looking to out to statements, based and in the consult the which and sagerx.com, we in beliefs. and I well and details. certain subject for Investors that current press Media SEC discussed today's encourage today's uncertainties, may statements call contain making section we risks additional be differ as results press on supplemental These find risk are to the can actual everyone as to details. filings factors at release our where the of would I release, our Please our materially.

Financial We Dr. by Iguchi, Cloonan, Chief prepared Business will Officer; Officer; Jeff Jonas, Chief with the Kimi Mike begin Chief Executive our Officer. remarks and call our our

then be our Chief We Jeff. Kanes, session Chief Doherty, over and Jim the now call Officer Research call Steve joined our the turn Q&A will to I Dr. Medical will by for the Officer. of

Jeffrey Jonas

morning. Thanks, for Jeff, everyone us joining and this thanks

update quarter We of then I'll Mike you on are neuropsych with lastly, franchises, neurology financials. activity provide will depression, programs. and and second today Kimi update pleased on and development will progress more quarter provide our to our our second across provide overview business detailed update Today an an discuss a our

all new pandemic. of in global environment a you with we're challenges aware, the operating As the COVID-XX of are

that clinical that to enrollment teams their or companies at management were report face planning in pleased the made the track. and pleased trials. We're recruiting SAGE our the of aware I'm in some to However, of on that pause clinical I'm our trials. execution of remains challenges, proactive But program in decision stop even these

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treating As condition. any medical expect might we you are other

study or to data. comes distress Now been brexanolone, acceleration preclinical or of the respiratory coronavirus for a X COVID-XX a under turning ARDS. CTAP, announcement analysis advanced has clinical with and announce This brexanolone treatment with several after development program related are that pleased brexanolone in to cleared people syndrome months acute Phase we FDA's new of

brexanolone rationale during medical impact this many thing has The already and brexanolone our may for ways been [SRSE] experience ICU As SAGE systems. we the COVID looking mitigate significant in to upcoming equity September. related there trial is do. at we've may COVID-XX whether our to know, and We trials. ARDS other we this and and leading critical receptor the centers. also mortality believe with associated undertaken and test right about questions to morbidity planned also able believing trial a Day forward further initiative answering academic look extensive sound generated It's Investor with related be experience, involve will chemistry to ARDS. have compounds data brexanolone you extensive peripheral our has several care chemical SAGE of

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my therapies equity patients advance franchises Before the library created we've quickly I a appreciation to benefit to share entities rich turn it successfully pipeline that want across novel chemical our for executing team well for team at molecules. SAGE. all a over The Mike, the just convert company as drug of new as to to possible and families. and a is believe chemical I not clinical assets our We able into repurposed of

call the turn I'll over that, to with Mike. So

Michael Cloonan

Thanks, Jeff and good morning, everyone.

in the our As franchises. first Jeff trials. We've quarter upon significant clinical continue last we began quarter rigorous new over progress and resource initiation the made neurology allocation prioritization we depression, built and four the mentioned, advancing across we've with as of programs neuroscience the

Let profiles me add successfully we're developed and how Zuranolone thinking about depression our of positioning in bit the approved. on a perspective if franchise differentiated

whether have also good important in antidepressants. We and profile trials and episodically Physicians, would seen days characteristics this of needed, RRT the or tolerability use consistently as viewed have ongoing a if and response new rapid of when for profile Zuranolone observed payers Rapid co-initiated planned clinical be treat response program as or our within landscape depression, or action our therapy an in unique patients target with rapid a consistently positively. many to-date. in Zuranolone

guidance the to anticipated initiated you dosing of on our first As we the an XXXX. half updated WATERFALL study, readout and data know in

studies We and in ongoing as the the cohort also dosing as initiated SHORELINE our XX-milligram SKYLARK, study. well PPD

in rapid the on track CORAL to are We with begin newly antidepressant response the study. a administered dosing study acute

approval to During option, for the and we're who to Zuranolone with towards combination positive, using on an the approval as new of Zuranolone the going and treatment and with of rapid to episodic payers world RRT traditional antidepressants, want is is we and a or treat acting to use for own the give Zuranolone comfortable receive are the and in this we us retreatment Zuranolone data the first which if longer WATERFALL to of by when conjunction experience there needed, to approach experiences indication, the data subsequent on a along to in as and second to regulatory track way, in we better receptivity with game CORAL after end design, changing of or changing much newly the the on be the will to until as with CORAL seek paradigm get initially, half treatment think it use the consistent gain to study the leverage study with with treat this including combination And think if a This moving successful, the about If profile the we able of they term as building profile that The Zuranolone use the labeling we least initiate a treatment the a XX. more safety for agent. profile. what from MDD. to year. would needed, standalone at their Zuranolone paradigm, physicians are expect use Zuranolone will in the patients means efficient. have year, antidepressants, understand in unique the DayXX we experience are coinitiated antidepressant opportunity real administered If REDWOOD target a from and to there, physicians, SHORELINE transition take as positive, episodes. needed episodically prevent This episodic will is making heard durability, Day the physicians happens expand phased questions relapse, be

treat their data by reducing continue disorders. successful, quarter and brain multiple ability to differentiated all as to any matter also are is to and treating mission the can of end understand anticipated give six-month Through receiving the capacity, questions as we treatment we can in health our with a strategy executing and MOUNTAIN elective like bringing of if approach. impacted to we are just With learnings and hospitals in And patients overall want to the a example PPD of million, treatment patients our during that commercially to approach. ZULRESSO. with we MDD. SHORELINE physicians data another and ZULRESSO We year, close bed their all datasets COVID-XX remain build X.X to option quickly prioritize offer medicines Revenue by we stakeholders. of expected. sites another not differentiated care Sage only answer announced, adapt, was clinically continue but anticipated with Zuranolone admissions believe anticipate people Central, help of the we With shifts to This the leverage we option, was their as some the the key from we the of the

active continue the We through support patients will PPD existing with process. treating geographies to and support sites

Given U.S. adverse like XX% function, And clinical the pandemic its improvement the high the impact seen only early ET country, we've Huntington's, ongoing functioning dysfunction, continue. treatment. for revenues deficits of Despite an the symptoms real we've surge the to improving on to associated expects potential COVID-XX Parkinson's. manifests U.S., pandemic world. of seek significant Alzheimer's in our concerns about dysfunction. in ZULRESSO these other with diseases where the pointing made with on and continuing goal more of and about number few for unmet cognitive independently. cognitive cases disorder, in retain symptoms, to cognitively company the estimated with ET, thorough the people thrive intact in with ability with prevalence, the potential closely about toward and live potentially By and executive talking conditions a neurodegenerative tremor, executive SAGE-XXX with the in most already like that the improve update the opportunity dysfunction that the and the tremendous functioning Jeff to for provide track patients these progress We're to remain the with provided is a cognitive people involving from of the spend million plans X the indications need about an talking and we're SAGE-XXX essential common affecting patients disorders. our suffering just in movement discussing plus I'll minutes With and across signal

innovative the with their successfully the approved, people believe millions help SAGE-XXX if we of treatment truly potential to families. have become developed options SAGE-XXX, to and potential so, And and and

Before They team feel challenging quickly that to turn medicines our worked with in patients as ever, matter And over our minute SAGE. I turn review to get tirelessly to the executing enable matter possible. disorders. execution brain will strategies express these and over a the confident it to as medicines us want the to now call out have my bring also take I for to times I I’ll Kimi, as mission during to health people that to at Kimi appreciation precision that our with thought against to financials. as well supporting

Kimi Iguchi

This for XXXX. cash of operations hand on support Mike. execution Sage anticipated is year Thanks to with a into

We across forward programs to have a clearly path advance defined designed green-health three franchises.

Our experienced to pipeline is extensive to by of of remain chemical unmet clinical create value working our equity areas our converting assets into a team We in medical need. into rich mission. true

As a quarter ended and that difficult Mike. with the we started reminder, restructure organization. heard list But we the Jeff to quarter the extensive accomplishments with decision prudent and the of a progress from you but

of a As we with the achievements. into to we position on those solid move continue the second that financial build half do year, to

before, you've $XXX goal deploy the activities I'll restructuring results. ZULRESSO million we Revenues walk with the help to We in from As resources. Shionogi portfolio from to approximately a in serious approach highlights XXXX. about take of anticipate you reprioritizing brain to $X.X of the million savings XXXX our rethinking collaboration cost collaboration at how second are a period many advance disorders. the Sage analyze we the the By were as medicines for say financial $X.X same mission matter These health to through of now the with allocation quarter of to value our result of deliver people revenues that million. heard of to compared sales quarter how intended second maximize think savings Sage our to resource and times me opportunities. our our

compared million have million a in in ZULRESSO the was earlier, The XXXX. of second first ZULRESSO to in of SG&A As non-cash $XX.X significantly for to Mike driver administrative of quarter, in million and quarter. to completion the million were expenses million commercial the the impact the support And quarter primarily the expense. second been expenses compensation significant second affected the the as part COVID-XX were stock-based quarter to in revenues expect the of general quarter $XX.X A restructuring, adverse $XX.X Selling, study, the U.S., quarter. and of charge the of in on second the and noted reduction a primary development in decrease compared of was second ZULRESSO by recorded related revenues a continue. we $XX.X the decrease in in the MOUNTAIN $XX Research we decrease the XXXX. in and pandemic

reported in the year. of for to $XXX.X quarter second a cash of million million loss quarter We net the marketable securities. million cash this quarter we $XXX equivalents, the $XXX.X XXXX first ended with compared Finally, of for restricted and cash,

Jeff the show to we we the will of the anticipate I'm accomplished we year confident year part of XXXX showcase sheet. we the which closing the previously our anticipate by highlighted runway to on I'll now comments. right provide of in execute XXXX.We're balance continued us restructuring look equity. that points at forward Sage illustrate the strength turn in to to million of half stated, be reallocation. This have half pipeline, the and the in forward savings In $XXX We of our all expect into second chemical for looking proof it with ability ongoing will from second expect we As ending our closing, with opportunities. sharing cash, value the to progression will over approximately resource team place to execute, our be and updates. And the our for

Jeffrey Jonas

Thanks everyone. want make prior to answer. good a I Kimi going comments are and to question morning everybody just to few and more and thanks,

of today, through execution the of folks that small of efforts no working the track are that's heard or programs And Sage of ahead programs. you've remains our on schedule. the clinical at I either these think as part

respect to remains goal constant with Our Zuranolone.

think that that understand but are be depression. unmet treatment meets an of need We medical to the looking that in something psychiatric disrupt do, we is disorders. may model We in it's hard important something to the treatment

for you've we're discovery distinct chemistry expertise medicinal brexanolone Phase initiation As that move we active COVID-related X our leverage and with ARDS, forward. into to today, have we and looking group heard as a group and

We today, defined hope as a and franchises we a time. our and can advance programs have to upcoming, pathways all half report our across catalyst we to on you this year where all progress have clearly of of hear rich over

with that, the questions. So let call me to open

Operator

[Operator comes Instructions] Akash with Research. Our question Tewari Wolfe first from

Your line is open.

Akash Tewari

XX have if so cannot and a few I dose what the into may, to mg I dig wanted can I help with.

if So those evolve time exposure threshold? give dose, PK your Like for of you. number you from the take dose patients meal one, Number some visually, that percentage to than how go greater ascending study curve low will the a in generally that the get the that you will take XXX ascending and MOUNTAIN proper XX mg concentration dose on like still a XX possible or maybe high two, would food? hit And how over the multiple you don't patients does color a exposure? as would you mg a define dose study, be and the lastly, heavier patients who therapeutic who how be drug allow can XXX? just it would ensure Thank into single then PK therapeutic versus we're without someone ROBIN would a look not with for

Jeffrey Jonas

It's start this I'm and to going to Jeff. I'm Jim. over going turn to

advantage The know we I challenging. and are you're way, it picking and to the the to at goals they're good that the a this just remains have of XX about development well that, mentioned XX now required We to but biomarkers not. these fixing earlier, that fact, is any that tolerated, competitive so the we of look drug like we've that And very we've realize people be dose. can us up analysis alluding the looking to And to We as of XX mg spark as right dosed the some and analysis Just have the for I proper proprietary. XX dose a fast in but at say company. we're led the it's not program commentary, mechanisms. necessarily is followers broad a metrics one that think could straightforward. know the be I company, has dose, in think lot some dose a as comfortable

performance think to lot earlier of not quite not satisfactory, the Jim I said to of been very so going the the as will and to we're XX not just I'm we this to XX a over So if with we've date, mentioned With has have turn of mgs and rest this that. going disclose. that though, disclosed Doherty. up pleased

Jim Doherty

To couple the yes. seen XX detail, and little Akash, so XX we've far. the are first confident that a Hi quite Jeff from questions we mg in answer your of in a performance bit of a around more PK dose said, so the data mg the

population around population dosing XX does trials, And see to balance say body but going our gives individual is of be think. moving efficacious responds mass, a we a efficacy the that that with mg, yes, differently, we us bit we so, little do of the think person that by I into are exposures range question are we And we Obviously, pretty each confident all this your would us folks human across range. of be they the that levels a into I need exposure an the think a right consistent to consistent picture PK then profile around most good we mass very U.S. and really we your yes, for once was PK which individuals, the where gives the of sort opportunity day in our designed And to have keep that kinetics point a we pretty to to studies call profiles, think zuranolone, consistent with population. for the a efficacy of body think in

Operator

question Paul from comes next Stifel. Our Instructions] with Matteis [Operator

open. Your line is

Paul Matteis

I I define a day MOUNTAIN you data. just point MDD up at six then during and on I Phase of this initiated Can just know, that was comment error responder You this XX of proportion response couple kind Would how kind in quick months? of study, informs quantitatively the an SHORELINE? if a for that patients follow-up we XX. to expectations you. or constitute SSRI your wondering could margin of how in you guess speak of six-month of And follow-up, response. creep on to saw maintenance MDD Thank have just the something maintain you X all

Jeff Jonas

this. I'll to points take Jim. of take I'll I Couple Yes, over want turn make. it to I

we sort interesting has And drug. of First all that notion a around you counter have of striking have one us rest finding move be data for the to don't is, that runs an to the stay life. have depression this current me. findings six-month your to forward the to And that mythology if to that's you depression, I antidepressant the the as think most of shown on you on to

And placebo. the it's to And what see encourages drug it antidepressants. the SSRIs handful, I'd so optimism or very at constant look made is only there finding. what was study. very only if really unique home And data. population you that SHORELINE. continue respond about after to the respect - also indicated drug drug the was during of And also a and And what a XX% pretty overall, stopped. drug, it actually small steady And And number us and only had response, we a these With that about is that came us overall, to started the and separation, a us is between respond on you what if first the even patients to initially, that say is that this and we patients think a of I number and suggests is were antidepressants, constant a the think think lot actually new what of gives about XX above, you that's that I that's one. what and you -

depression dogma, but significance, study you drug that this X.X. which course powered encouraging the the endpoint And not you maintain a to very we for their of population is then with and days. that does XXX the run response, So there was really - when to is to above, even and counter patients dogma the you be a see have where had has it relevant be value chronically positive XX% The p about XX response maintained the that treated. almost that for was us out of on been you're must and the

to was finding do want that to to have our anything say Jim, else So I and very think add a that? when strong you I expectations. this exceeded

Jim Doherty

just I at reiterate, think the that look Jeff data. I you when would

message I day-XX timepoint, a that is are think the key staying that seeing patients are getting who better. who at are patients better benefit,

were in we'll answer later. early the But, at six-month the are presentation timepoint. Paul, from your for the days together to question scores data what the MOUNTAIN the those So is, similar pretty detailed they to study put

Operator

Thank you.

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

Your open. line is

Tazeen Ahmad

Thanks for taking my question.

EP? relates it to us Thanks. physicians as and that then And that the particular color One on tremor in endpoint why how it score? upper Can of it be view walk as to tremor you general relates at you at of the focus think essential a day-XX? I Can you could. to look of little on primary the bit give us score limb if importance important through will

Jim Doherty

how one this then Tazeen take to see I'll minutes around a Steve score. to that upper Jim, ask around in position weigh Yes, your limb question couple is I’ll and

confirmed acute like in reduce to ability year were we already program So was XXX significant of work talking course, tremor neuroto dosing. about, KINETIC we're we've done on that this what the but the essential building for that from XXX has our in studies did that last earlier from importantly Those - programs study is a SAGE-XXX, the patients. learned study both where tremor we initiated with

the that essential you jump let in scores one are most point. disorder we to and one also seen people earlier. what when the sensitive And troubling next think me is upper tremor you chronic Essential that step of response an we've is XX-day and of most at XXX so, do. me that But And is the are timepoint progression Steve, to the program. the trying daily and showing around measures for I'll life in about And at mention stage our patients. that let have limb sustainability a of for of tremor so important

Steve Kanes

looking is in been with essential across board. as initially results Jim as been And we've this the bit to most the in the they have of that intention days field Tazeen inability at have very symptom we've the debilitating experts crank or early tremor where us limb its and tremor you do and things a seen then ZULRESSO could we've write, tremor anywhere, We consistent said, the Sure, upper told quite XXX. consult with part working like since complex tremor.

patient's So are on the worse the things the get way gets. more Those you basis. something, try the that a day-to-day to do in tremor really

that been things there's limb really we on the a one, focusing score. few So upper

that's the that's We And we've across have sure seen to something improved make that consistently. board.

of level track use the we're is it’s given and other of wearables other that something able to the The accelerometers day. throughout

our on are there as program this as patients the the real day. ability have understanding understand understanding effects impact well to development on signal advantages may So throughout what patient the in

Operator

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

Your line open. is

Unidentified Analyst

[indiscernible] to David Brian. on is This

just including second there's maybe mental synergies other questions thinking landscape better first, launch how the that to ahead enrollment back trials, about see going potential WATERFALL evolving see know ahead. couple that But on definitely of the affected trial. reason just to the then be might you of the MDD I through Just and two have thoughts why on any How RRT? next the you the might and the evolving for depression just the potentially and possible, if you're MOUNTAIN quick that how seeing, health from I'm And as the of of and looking are years? extrinsic ahead pandemic wondering you trial telemedicine CORAL any and question, your read latest enrollment

Jeffrey Jonas

think depression But, seeing thank question. incidence reporting Thanks disorders. mood Jeff, been general, you. the need. area and with In unmet a of psychiatry of I an medical of for always Okay, has major we're this people is increased

think chronic Zuranolone. so interest we're deserve who about in if even now think novel one more and all we're as to I you except a Zuranolone weeks in in question Mountain And things seeing eight We second MOUNTAIN it's that long what is they so, the there And currently treat are data, be to people then with seeing they therapies. your doing at depression unique there it. different so looking really, that And two depression. study. the are I all studies our option. - another go I’ll is, have among couple first interest studies, development, in pharmacotherapy, and are of a increasing think far think They the seeing because are patients may data the a all the way study, there of really we're that for requires and six tremendous to as the are to kind for that And physician six just therapies month

of job the of who start people they lot a an studies our couldn't as I that really Also, their area teams has And an area view as studies there a lot this thought we and interest are for I uptake of in proactively at mean, is, people job. they has really I spurred the done environment. - depressed. great do the a done stopped reality or said have a and our nice of trials. are preparing that think interest So, I team think

associated in health, depression, are the of, something recognition is if that's you importance you're the about I face Now, seeing that of think that greater of think really importance changing. the with what you second with the the of And a we interested - and think as really I point is depression. COVID, morbidity mental

is We obviously. and probably firmly think and engagement people is unique can who past, its fact, with can show depression Zuranolone as years versus what really have response lack using where depression have that and profile, in can not the we're distracted something disruptive ever to of reactive distinctly think their changed is the have where In unmet now for rapid gets not a that's real treating treating. the for treating as families drug more everyone depression face becomes in with ability are be people that, a offer recognized by terms And - years. area with very time we criteria, brought therapy of and of think of rigorous its more need. there medical and depression, that approach years function we more to than and tolerability need depressed as has a made people diagnosed. work. We on it's putting we depression - be an especially But think with We we profile, not don't real do treatment that lack of home find believe diagnosis can who depression, which of its

Michael Cloonan

Mike, just let just Jeff. maybe let to this on is add Yes, me, that, me

see we said the RRT has well just shots Zuranolone goal and episodic we the or days that - like this the this Jeff is patients on see out the able about getting way just And give said will not our and either this a you if as as even that end like, have it over paradigm two I the move is the line. patients playing be then Jeff for as within rapidly alluded - treat RRT time to right, to the option opportunity also I think there before that treat product we or physicians right. think think we'll been in treatments molecule successfully and effect and if And you that we game also have we’re get to needed.

the while can So, standard, will physicians rapid nature evolve RRT the paradigm, combination we antidepressants. but the start and comfortable with using the an allow get Zuranolone they're to patients we with of acting in with indication, antidepressant

And to us the needed to and experience comfortable their expand SHORELINE the more treatment opportunity As they real to treatment we This giving allow time. with MDD publish get that REDWOOD will physicians. data it's and a treat us data to that patients we multiple get as data. we and approach patients. to That the is paradigm back important to label hear think is from and and really chance important they evolve them. that approaches and that's for that that them world as give can paradigm over evolve what And how to what's

Operator

comes from Cowen. [Operator Ritu Instructions] with Baral Our next question

open. Your line is

Unidentified Analyst

follow-up so could that remind SHORELINE progress it on for to to I COVID And patients? patients patients ability the seeing you sought wondering the question taking and the congrats dropout the you Ritu, need you're with This maybe delivered their or for on impact and was have in was to far. maybe you they rates to if Thank initiate that speak have telemedicine to thank is Lyla any for you. maybe come or on follow-up your us home? can treatment can the

Jeffrey Jonas

issue compliance of trials. This an used month if I a to is look always to six at compared most terms various seen in assure we've with much that. of psychiatric think take Jeff, maneuvers our not And we've And data, follow-up. you

I've find don't particular, I'd can think to the month has And six argue patients the watch amount what of discontinued patients that’s at look of We follow-up maintain these unless with the encourage naturalistically. almost I number to And we that's mean, a that, I time. we been the teams if astonishing drug MOUNTAIN trials in was after that drug nature can't follow-up I blind. XX% blinded think you a I of diligence another any - of we the long did part due follow-up is instituted to the done this have this really good an very designs and and of

So haven't this as issue. an seen much we really

done it COVID or people that is a I that. team depression great has in from we've the a depressed, either not one As treatment. their things trials medical of and serious mentioned, has compliance to about is But done job it disorder, And a of need they show number patients the internal do in manoeuvres follow-up. are I think discouraged participating and with

Operator

next Sachs. Richter Goldman Our Salveen from question comes with

Your open. line is

Salveen Richter

placebo to With help XX-milligram us how XX-milligram study. the Could you compared taking at and the MOUNTAIN cohort to regard follow-up to just six in question. understand month for my months? arms six Thanks the

Jeffrey Jonas

I'm to then and turn over Jim. start to I'll going Actually, it

significance. the So overall not remember we in trial, did achieve

overall got overall the interesting but, the as tended in as of better. regardless population finding the who in so And stay treatment patients better population, that the to

is we But So the depression, which been seen with our they have problem we better, treatment months, current get the better medical six where finding better, in and taught. pneumonia MOUNTAIN seen where about get population would that's interested But a it's overall that dogma we people was be same thing were through see effect acquired the interesting why at relevant we what study fascinated in penicillin. - and get versus community because a the the in saw and they of course, above study of XX is And when and people disorder, persisted continued what not looked with an when not at to people treat. XX% the whether we've it And you we or that only we've patients important were placebo. that from on that whoever are, runs any minority separation that studies, on what of that was There the were to regardless would of counter population, it. most SSRI. by, like note is again, people saw patient the SSRIs. in you this The was

a necessity continues and the that with really to thesis, get is we a maintenance us and unique treat depression, way patients for can for rapidly with without a therapy. think finding that derisk better stepwise fashion, So acts one in there a our people drug this that is to

Just unique know, as pretty a think this you is we finding.

counter a very mental And we six will publishing be really by unique we've the we're And it's and we've is depression there's it's world We data a we some to of And because that going are learned publish we'll is history in about for important. patient. it. been and think data. presenting the that think now to SHORELINE presentation natural I sciences modern depressed, are people prepare this looking likely we the wait because encouraged and dogma of it chronic you the if the we month for think the think you're lot accept that all forward that runs that

Operator

Our next Tsai question comes with Jefferies. from Andrew

is open. line Your

Andrew Tsai

release, press release noted large majority has follow-up maintain a patients Salveen’s response of to just Maybe of regardless, regardless of and question on arm. course press

response you the be the six to weeks after eight for So placebo background in Thanks. wondering could explanation to SSRIs that arm saw that? adorable could attributed conceptually, kicking be just of I'm or what

Jeffrey Jonas

to that disease. this pretend look you Well, Jeff. have irregular this, like Google I you at this is mean, if

obviously, original separation. the in we didn't So, significant study have

those And hard just in what remit. the disease, data, spontaneously the again, in any interpret it's they large. you're So from seeing you to remitting if have anyone spontaneous imagine

that one will XXX So patient, the if remission look same patients. you as curve have

it's was the have right, population much So They rescue to on you're overall to make could except a hard of say, yes, therapy. lot everyone antidepressants.

above, the and difference, patients course, study, where and and the any that's and XX the of all. why of show study, drift we see population, at we turn you don't the relevant there took So that's when the studies the majority the why in that's to

response see simply patients the XX% after their just the months. six You patients of maintain

it today other the relevant we cherry want we is to not make the because to that with The - don't pick remember and don't and of be point - we're want really to question data. sort dealing

majority to see look And someone you this creep at curves, If up creep those you think their large look the maintain and And at and you I down. curves go responders, the almost sometimes of when even sort in early the a mentioned response. you majority, without original days, intervention. earlier, back when study,

represent You responder. non-responders curves remember got combinations and of to those

waxes as depression the looks stability, as that any natural know patients depression, just, remembering were observed So on We it And study two-thirds like these did disorder. for it we six wanes. I other looks medical blinded actually of here, it just and history we disorder. after though medical understand everyone - a months. though looks like But looks counterintuitive. SSRIs is And of a it

you show you separation approaches, original in within more treatment, better get days. If these study, drugs - accessible all of much placebo, The better. the in even you from the an on get stay is have MOUNTAIN rapidly and difference very the patients

thesis you differently. and two MOUNTAIN that see So didn't within the rapid can as - data as significance. month utility plus us, even rate, weeks do that the our separation, the very treat do we depression We six And first see really approach. see well didn't quite as the one early though in benefit you RRT for overall it treat supports

Operator

from Guggenheim with Partners. question Suneja next Yatin Our comes

open. line Your is

Yatin Suneja

the Thank some faster than my expected of on trials. question and you enrollment for the in congrats taking

question a the Just responses? sort question you you saw have at in that on and one implicated quick the given of women, its MOUNTAIN, differences consistency this neurosteroid any terms women looked men more between is in data of didn't And in me Could it. then the a the second Thank MOUNTAIN just X.X, what value Jeff, you to were is part mention of in confirm you of I you. referring the you missed just follow-up? I tell think p

Jeffrey Jonas

maintained I’ll answer over the Jim. above, it turn right. whether the quick, that the and - on I'll difference and it looked was then to at XX We

So wasn't got above even that with population there's was you to a was difference. not significant if population the of months. looking powered difference, the XX And - at, you're majority it where a if was there start and and six see though to after the

blinded value the about p the analysis, was On and placebo X.X. between drug

study this was to a long-term considering maintained for after we was which I'll very six a months, it that almost wasn't it So significance its turn remarkable finding, the and over Jim. thought rest that. powered

Jim Doherty

we the your Yes have between number and genders or as And other and in question. the the not factors Yes other of between see any is, study. demographic well in we of men difference whether for short course, are to differences as women study. answer there the looked don't

Operator

Stanley. next from Morgan question comes Our Lavery Thomas with

Your open. line is

Thomas Lavery

line of top The next this data year. disease is move to do expected data you. program need Parkinson's SAGE-XXX. see ahead later about year? to - this question a in have What Thank I kind you

Jim Doherty

Jim one. Doherty. so Yes, that take is I'll this is this

is results improvement we cognitive effects study impairment. relatively Parkinson's of the able Huntington's we’re patients last at see other all executive the SAGE-XXX, the of acutely aspects with So in year, to short-term looking had that at showing is talked off about with that function. we're in patients what an doing we're end talking to the and cognitive about And in that dosing building of you function

results such novel patients, the that And very is we the of controlled the Huntington's with such space, so, that approach, forward a is from into pause happy the so placebo because because activity saw more novel population detailed looking decided go and to we we see saw and this a were first populations. patient at this a rather to and patient move through study. We because various than

patients label Parkinson's what that's the did We're improvement look all this population in can NMDA what in similar to similar benefit. other patients broad that in more we is We'll now. in essentially in, format the really, patient that's on one this at study cognitive also cognitive study to to run So can duration open And going a see Huntington's short There's if to believe role than of is function see function. patient population. you neurodegenerative receptor that reason across built disorders. in a another

that's what the really we've with patients. study so is patients to-date And we results we'll look next seen the PD can in expand HD in that to see if do

Operator

Citi. question from comes with next Our Neena Bitritto-Garg

is line Your open.

Neena Bitritto-Garg

do one to of little a in talked guess, and some or Thanks. some you but from WATERFALL, a a on you earlier? these have anticipate you to about you MDD, what maybe once I reinitiating So that I plan initial data of once for you until wanted is of strategy, get regulatory kind going REDWOOD? Are from just WATERFALL data the studies, kind bit have upcoming wait bit of study ask you next data kind the know little steps quick

Jeffrey Jonas

assumed of WATERFALL lot or have study data is relapses, analysis, therapy take from now, patients question. and look treatment, we data far we their not drug we'll the treatment, based by like out of like that. Right, initially, background data. look at WATERFALL, the but that Steve think only to with WATERFALL to maintaining at a about the XX% the six-month or see month long-term need we're that's We'll on going think, Jim, want and XX, hard patients seeing to term that getting the data it so to something now, obviously, data data as longer from to take no recurrent And out we and will anything we're had something us we thinking optimistic you for take larger on what which six we're the the we'll agency, SHORELINE, I the when positively. of background a have SHORELINE, six-month a would revisit people have effect might based reports challenged had you follow-up I the therapy, about up regardless because need have of and the had sort if still one yes, day about to of some to hard you're Thanks data, need being assumption to things add look that? depend SHORELINE. gives study Right think if or we on some

Steve Kanes

just a us which few I things. remind just therapy designation, I'll opportunity first interactions that's this the Yes, gives to say an mean, have under everyone, is board. all, to a proceeding breakthrough of program across

data therapy. we're has program to urgency developing what that's breakthrough the able new the unfold, with [indiscernible] the entirely and whole as about designed to do. for interact of this an the what so And understanding And FDA talk as been share potential because we our

now data, than we the what that also to XXXX have consistently a And Remember, showing and we profile it's when clear profile more have yes, with on across everything data, exposed have informed data the safety overall adverse very the patients do, is. board. been we've we just So we - back to - drug, idea event the not or it's been else we'll always just that agency. clinical do the go efficacy

of efficient a strategy the which of lead comes lot all forward. information to most will So through regulatory

those words and say, efficient have is patients. path there data lot unfold, we'll for of the discussions forward most a So, identify the to as

Operator

JPMorgan. question Our from next Cory Kasimov from comes

Your is line open.

Cory Kasimov

in. fitting for Thanks me

they existing the in begin just to the do your separate? I curious top Will would that's initial study half, Thank So fast you. to top of the on guess for how represent filing? can piggyback sounds I'm it RRT you this MDD this on plan be sites? like go, second since MDD

Jeffrey Jonas

so mean, Yes, be there'll moving sites, combination a quick. is of I WATERFALL

a performing well lot really sites. of have We

that think actually continue I quickly. go try to So that we'll to

of whole ability our infrastructure that this has leverage over year our the move been we've of lessons think to that the quickly team's in to of the I of one this and protocol-to-protocol. that lessons WATERFALL time, ability developed from

week this. course better advantages design general of therapy palatable these of add investigators of insights, the lot doing potential all things well. enthusiasm throughout think and be as of we'll of studies, do the a to in zuranolone patient That's we you benefit to treating that two design quickly one that So studies anything I has clinician. been greeted seen we've by of if the encouraging know the want with a that. of We do don't to Jim, that a one one the to of be been word has

Jim Doherty

that sites. would Jeff network I of pretty add, we Yes, large just have a

And track we're be to of able studies so confident on all all ourselves the that them. and run going keep for to we're

Operator

comes with Wedbush next Laura Securities. Chico Our question from

Your line is open.

Unidentified Analyst

this is question. Ken Hi, the for on for thanks Laura, taking

on clearly for zuranolone about with be in should are were how impacted around be expectations of data And less necessary spring. and have sales recruitment? or So XXXX we that before and sites the more stabilized you. we outpatient? What thinking COVID, disruptions your this SKYLARK, period recruitment Thank will since by while number extended the

Jim Doherty

Jim. an remember for thing is zuranolone is Yes, outpatient talking that the we're is think the therapy. I about important with thanks what Sure, SKYLARK to This for question.

outpatient anticipating add and impact that in from what do important that's we're SKYLARK with be the so smaller patient most the there. But probably recruit so recruiting want our in to for ZULRESSO. a that just way of think a an course Steve, different oral a the slightly anything? is going It's will setting a study with a population on drug able an to other is we're But you And perspective, just comparable we're studies to situation. I certainly seeing an zuranolone. than be to there thing different opportunity with

Steve Kanes

of COVID, Yes, being preference for I impacting sort was that to to hospital the able just saying treatment. patients with my admitted is be

without that's is support significant only the and to having home depression that of so living and and course, of room there potential unmet the other in and delivering family isolation others is need that, go in side without postpartum growing. The members face forth. of rates with enormous the and of increased On women being interest of only is growing

based of similar Jim in have enroll a trial is and an it execution, the experience gets anticipate WATERFALL. way just our with to outpatient we able as as those very we So said, challenges with some being around itself trial, on logistical that

been So issue, in time. the committed one important that an a to disorder it's long important we've for

Michael Cloonan

very make I'll patients think One side with very right this able just there, an have the comment, oral a said, we that what to I'll we is those have PPD have we distinct between still And ZULRESSO zuranolone, points. We're important one of now but infusion, combination to approval and hospital there. about with zuranolone, both in the market the a we well, MDD study And there, the for zuranolone right it's RRT and to and couple pass go as into XX-hour episodic. two we to different one indication excited paths also is, I have receive Mike point, still path think PPD for things, can the the as we'll going on the seek do is right, SKYLARK be with PPD acting aren't rapid right. profiles, the the nature therapy

Operator

question with Oppenheimer. is Olson our Jay And last from

open. line is Your

Jay Olson

Were you and to months for finding strategy you up, of six how the do filing in and zuranolone the that follow to surprised your your target with by product durability leverage MOUNTAIN plan regards ultimately profile zuranolone?

Jeffrey Jonas

psychiatrists on always the - be I and how say wanted to surprised, that I think treated counted to be narrative for is thanks aware something treatment I to counter but and enlist say that I themselves really and I we've word treat is we counter about wanted don't remarks and I'd of it date that I really inconsistent they're we've enlist can of question. run surprisingly you really do We're - lives were they to Jeff, depression. that rest patients, to it acquired we've we've chronic in I said data something that This the that gratified data this have of and been are now surprise, treat that to their the months. by extended those delicate out years. how guess years over And it. stay to for I the with who don't to is different, our think do for does better, really patients but gratified us patients we all the so want both studies patients as and health the Steve wouldn't data are pharmacomythology like that - these used so my opening don't as depression the run our six use experiences think about personal mental that -

we tolerable effect that of pharmacotherapy patients that SHORELINE. We side looking automatic to is another really a continue we to think therapy. this will data are have And that inform the patients can at do profile be otherwise this, to sustain to we And chronic - option think SSRI years, years will we step though for come think rapidly in so unique. just potentially treatment for the better that do these and is data more drug and get might do profile ability if important a eliminate from we the what think necessity the be

paradigm, intend are next good by seeing and you're could seeing we seeing job be - step, we're where you're withdrawal, from rebound, do very durability. good not really we seeing any sign, course, we you're not seeing an But it. Mike's think data. important not these we have data think the the you're you're to of treatment And So encouraged very once about our how disrupt that'll

though a stories and behind normalizes alter behind thing is said homeostatic the the restoring [technical neural And not a an is call something in drugs respect, is ability And mechanisms postsynaptic reset of neural it's mood we've mechanism mood, believed the what some thesis other and that always point distinct Now, normal to different. of I receptor brain. something early the anti-depressant. difficulty] thought It's the function. that we've always circuitry, offers other we've trafficking. people zuranolone out about normalizes that in on potentially that the these really potentially It's

how think depressive six month think major the can and about one really disorder. we this sort represent So shift data of paradigm

option So it. do one to treatment we're on intend to important we will way be we this the this doing continue that for We patients to pursue. think think and that an

Operator

Jonas I'd call for now Jeff remarks. like you. the Thank to to over turn back closing

Jeffrey Jonas

again, all on know done programmers, morning. us remain our of of healthy. To has are close, your families important to you're clinical reiterate schedule. and I thanks, SAGE hope or track just for at I The I joining job ahead points. team Well, busy, healthy everyone and this on executing everyone's great all want a which three

months. As of of rich in help believe proud group. we novel And literally have unique, are us potential millions is which assets you've really of we the and really numerous XX chemistry over catalysts - what this pipeline to have SAGE people. today, our They the discovery developing next makes alternatively heard develop clinical our

in well with milestones and all all So of our forward future and a of of I'm great to with that, day. you updating you hope have stay looking all the

Operator

gentlemen, you today's call. Ladies for and Thank concludes participating. this conference attending

You may now disconnect.

Sage Therapeutics (SAGE) 10 Aug 202020 Q2 Earnings call transcript