SAGE - Earnings call transcript Q3 2020

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Operator

Good morning. Welcome to Sage Therapeutics’ Third Quarter 2020 Financial Results Conference Call. [Operator Instructions] Please note that this call is being recorded. I would now like to introduce Jeff Boyle, Head of Investor Relations at Sage.

Jeff Boyle

Good morning, everyone, and thank you for joining Sage Therapeutics’ third quarter 2020 financial results conference call.

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

We Cloonan, will and Officer. Jim Chief begin by the Financial call with Officer; our Doherty, prepared remarks Research Kimi Mike Chief Officer; Iguchi, our Chief Operating our

We at forward to by upcoming with our surgical Jeff will of Jonas, investor looks for Kanes, home session procedure Executive And now and Officer. Mike. Q&A the over Dr. turn is Officer you from Dr. then Chief call of at to conferences. a the I'll call recuperating be our joined connecting the Steve Chief many with that, Medical

Mike Cloonan

us provide our and to progress depression, and everyone quarter, Iguchi thank time from for then call recover. our provide before the We're quarter on the Jeff an morning. and over in to of of Jeff, I'll review home, is of full with call. let to are third you know December that pleased to surgical our recuperating portion turn his Today, continues as join Steve an third of to Jeff, and and procedure a good neuropsychiatry discuss update, in I'll want from the Kanes Kimi this us sometime and clinical you thoughts at as for provide across results franchises. the the he his will development review financials. to our he neurology joining activity Jim programs. return overview update anticipate, our each our But I will expected Q&A Doherty progress scheduled progress make Thanks, across R&D finally, continues and quarter recovery. will We you

are but As come pandemic, the of nine depression us, factors had infected, the to not those all into sharp have global quarantine COVID-XX we and seen the concerning months virus in of past mental now risk increases has learn only effects on particularly, suicide. health. for pandemic we've nearly impacted, and how have months These

needed of report health track that Now debilitating more than next milestones motivated our options over execution our the series from To ever, months. to of XX much XX to today programs patients that disorders. remains clinical team anticipated to key pleased I'm brain suffering a is on provide to end, with

significant of team a dedicated job months. catalysts of of professionals execution set this has potential great driving done number coming will up expect we Our the in that a

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disorder ongoing that data support Most is for successfully or Sage, listen And programs, minute would and I a approach what from data recently, encourage our want is a needed SHORELINE further potentially Investor support. talk these as about on to Phase zuranolone MDD would available We our positive treating to a SHORELINE company. a is the treated approach unable tune to you we medical But about truly I to the use depression breakthrough, color section. website in results that as zuranolone. interim a idea major in which the needed. of be depressive going X about in, for be to game were the forward and open-label will in will take you Relations If to patients the additional hope we depression study archive, different provide to for program, MDD, we data. believe provide approved need Jim with be to our We patients, depression thought developed this be representing if how which condition forward. treated and as can look can planned It changing. our announced and

say that create us medicines is times develop Sage, to many at mission matter. Our before, and you've heard as

people sooner. So better can get

many numerous across changes, We bring of to we is one believe pipelines high. franchises. where is new what need in we disease the health are have And to working innovation is brain lacking, states novel cases, strongest in medical not and a unmet chemical options spectrum of space the multiple entities just with the incremental

depression disrupt is for Sage. only work Our in the the treatment to model beginning

of plan over I'll Jim now we to all excited Jim? you franchises, it turn continued mid clinical updates. our through long-term. are and near, as the for three And walk to of over neurology, the depression, and the progression neuropsychiatry We

Jim Doherty

our efforts R&D Mike, and portfolio. our morning good I’ll Thanks, everyone. clinical update This morning, across an provide and on

me which the clinical depression PPD. for MDD of zuranolone, or is of treatment Let asset lead and studied overview being postpartum our with currently begin an

to achieve first program a possible. is as filing is designed zuranolone as successful, Our efficiently NDA

with outcomes, of filing X initiated the October, have by seen data in SHORELINE profile unique would pleased studies; were open-label cut patients X data if We the positive initial not potentially very reported only top-line date, to safety provide potential for In MDD. each three study efficacy interim from the needed treatment a data, also results by we diagnosed study. Phase We ongoing but a July to positive new the as have for these pathway. an support we with Phase

zuranolone As study patients the the allow naturalistically designed need with was tolerability, and one-year. XX XX XXXX, follow receive to patients milligrams up repeat In with to and to this evaluate of zuranolone dosing amended patients for a safety, to milligrams. enroll May retreatment clinical MDD of for reminder, protocol at was of in

their encouraged well of at to period I dose, a receive analyzed the least during of milligram to to clinical Remember, by treated was of cycle. as seen study with that study show endpoint treatment the used events of initial you enrolling XX% two The to by well began the of also the data a dose. however, courses, trial X are XX% treatment SHORELINE a two-week XX believe of results XX%, The two, call. the There positive XX development in criteria, be is and data and a zuranolone points key tolerability. score new XX I patients number achieved date in of need data milligram, of the milligrams. half this cycle. the remission, rich de press were XX of at review zuranolone or which the reduction with reiterate meaning two XX response successful. We four trials. primary study dose, generally three, patients received milligram the after a if a zuranolone fewer data HAMD want initials this achieved to who patients patients in HAMD a meaning we milligram initial consistent on end with a of will effective the nearly a XX-day Number was with remission of Number cohort achieved at response one tolerated with treatments treatment response, efforts at seen novo XX number and XX% release. the XX% details minimally with milligram who during zuranolone the period previous and This are, score the zuranolone from couple total only than and additional advise with based achieved MDD not had novo among small XX in the we XX% did approximately treatment is with weeks our or but to study October the one, XX of de treatment XX treated the Adverse our zuranolone generally reported analyzed that are the milligram dose. early And as less patients milligram initial subjects, during safety

our dizziness, SHORELINE XX from milligram who treatments and days and We recall, us Most theory XX every events As based the adverse as the This severity need for to headache, observed you of at needed. assessed tolerability confidence in milligram XX mild the a five was year, depression perspective, zuranolone. was give both a adverse may a on repeat safety the maximum be and in dosing known patients with Events of more follow-up period. in dose milligrams somnolence, no received to and to this can These the of for supports From the events of were half XX generally specified treated measures permitted analysis additional that set. XX and somnolence, XX the results reported XX the tremor further at was cohort, milligram interim the events, signals were common comprehensive were to will headache safety of interim next consistent in to zuranolone. plan XX event in sedation, XX were dose, which milligram groups include report seen data profile that adverse data and dizziness. new the be seen profile events milligrams potential and frequent cut similar The at are similar but milligram. the adverse across most identified. And data from safety generally were moderate. of first

in expect top XX results later we line from to the cohort XXXX. report milligram Additionally,

zuranolone two-week WATERFALL with Moving a now treatment we clinical of on from zuranolone Phase first milligrams XX trial data report earlier study in in needed the projections, half as year, This Based to top-line investigating XXXX. of episodic this our our to MDD. the initiated patients or for our X study MDD. enrollment is placebo-controlled for expect other course zuranolone, we evaluating WATERFALL of trials

investigating zuranolone women and Phase zuranolone to milligrams, anticipated our continue trial therapy two-week top-line course an PPD. in patients in study SKYLARK for XXXX. also with data We as a is X is evaluating This oral XX placebo-controlled dose of

XX study starting means a a rapid administered in co-initiated new CORAL when or To acute newly X milligrams, investigate the who treatment with an those MDD, trying MDD. trial course ADT be regardless Phase an in clear, this placebo-controlled co-initiated zuranolone standard patients just two-week Our are patients zuranolone ADT. an when with not will This history, of a with as will response past time. for patients therapy ADT with of antidepressant evaluate ADT open-label therapy first

dosing zuranolone. end for support believe three for pathways, XXXX depression shifting If to approach. begin of forward on a could in this CORAL, WATERFALL, offer programs data approaches the strategy a This generate with overall potential therapy these to we data paradigm first-in-class we step potential filing year would robust a top-line delivering as a expect potentially our to treatment patients. successful the serve zuranolone of as anticipated SKYLARK significant is differentiated and by for reflective in We efficacy to clinically enter XXXX. NDA intended and study With pathways a with

double-blind the continues X KINETIC Turning tremor. with now study, SAGE-XXX trial our in neurology to in Phase our essential enrollment franchise,

than in an there this As new people U.S., estimated medicines the in for is disorder X years. our a reminder, disorder been common the XX most And million movement have more no essential country. in tremor affecting

our are a development FDA the with disease. and with approved our essential Earlier in we Xa only we tremor third opportunities, of only Parkinson's study events Phase also treatment executive we no top-line an small the In SAGE-XXX most Parkinson's believe data the neuropsychiatric studies, impaired was anticipate cognitive assessments memory the hypothesis in data reporting was data emergent characteristics, in treatment franchise and events and our be for working In disease, SAGE-XXX, from and pharmacological PAM, demonstrated dysfunction. with is in lead for SAGE-XXX, NMDA Huntington's, healthy relevant for with We performance propranolol dysfunction, adverse Huntington's PARADIGM pharmacological as of Phase were tests also disorders including open-label program in complex not adverse with believe of most this quarter, certain and trial with fact, In improved to problem cognitive open-label our SAGE-XXX solving. We patients tremor, approved but mild. it X treatment X epilepsy in early conducted our patients disease. of these the program, essential on support XXXX. serious In the XXXX. a quarter and initiated in of in studies, of cohort study, In Alzheimer's of saw generated compound compared cohort X and multiple baseline Phase we that function well-suited Parkinson's the disease may Phase first volunteers. advanced well-tolerated asset

to the expect the disorders associated various will new We open-label cognitive SAGE-XXX advancement LUMINARY XXXX. the dosing cognitive end in with dementia, SAGE-XXX inform of begin with Alzheimer's, by these studies impairment Phase study dysfunction. study Results in in patients a of Xa of from and mild potential mild

Sage take opportunity for I'd challenging times. like Kimi, entire Before to continued these their I throughout dedication turn the to the team call to thank over this

suffering more call are better on the effective need now review than health mentioned treatments we financials. Mike Kimi working Kimi? deliver such now they earlier, As for that, with more turn better, bringing over of of patients the that And And tirelessly to our issues to promise with I'll can sooner. get patients therapies so ever. to brain

Kimi Iguchi

Jim. Thanks,

milestones been As and many to with has But those a a a balance now in towards comes has programs catalyst expect with us. of the and sheet, operations challenge progressing like clinical throughout we allowing the advanced opportunity all for XXXX, with challenges into Sage will coming this which the multiple support anticipated years. many maintaining XXXX, of potential We've pipeline year. while balance opportunities year strong seized meaningful us continue

months. several As result, a creating allocation. the in expect approach and across XX you XX coming know, to We've multiple portfolio we take achieve as a potential resource we to indications, programs invested to milestones in value

the our third were quarter to million Now let in in $X.X XXXX million me sales of $X.X Revenues turn highlights third from for results. the compared period financial XXXX. ZULRESSO, quarter the of same

As ZULRESSO a expect we last in pandemic ZULRESSO we by have significant impact revenues the adverse continue. revenues stated to COVID-XX and quarter, significantly been the U.S., of on affected

a barriers period in an the to same million was last to after a a quarter. as As reduction and $XX.X quarter and general for million after of third development restructuring. in clinical the in as increase the expect we compared the support same and in $XXX.X limited third administrative pandemic, of WATERFALL revenue the result in expenses decrease also even significant April a by quarter, for Selling, offset of be commercialization the period treatment of a the Research to primary efforts a the pharmacology noted zuranolone future commercial X million of was clinical to the growth in with $XX.X to our partially XXXX in XXXX spending related the $XX.X trial our of decrease were The quarter, in result expense X XXXX. non-cash in ZULRESSO, refocus R&D the third Phase continued in for zuranolone the MDD, expense in million study, clinical the XXXX, expenses restructuring of of compared driver April compensation primarily MDD. the for study, trial and studies, MOUNTAIN decrease decreased stock-based for spending the completion Phase SG&A

highlighted million for XXXX cash quarter $XXX.X the with proof second I Last XXXX of XXXX. the million We provide security. the a said, we cash loss ending will of reported $XXX half quarter, for $XXX ended restricted which cash, we of approximately by of to quarter anticipate of would compared points. We equivalents, cash, into runway $XXX Finally, in year with and million million net the period marketable be third XXXX. same believe the

and recent quarter health great third across making mission maintain strategically to brain streamlined and so invest data. from sooner. better of get many the strong three the disorders matter, ahead. The announcement sheet can franchises people start I'm was catalysts medicines that with SHORELINE our encouraged efficiently, balance very support of certainly to all operations to so continue a by which execute and the with the with possibilities We've

I I'll I comments. the for these of Mike with Lastly, challenging how over closing am the emphasize now times. to pleased to want in it turn resilience team back Sage

Mike Cloonan

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

And our to ready this just and the point, months. heard, to the up XX of it our strategy. milestones next with the multi-franchise As We're across I we're At to we we're all continue for excited programs believe we're advancing Q&A. pleased significant execution you track on over think with well our we're open XX positioned to three clinical franchises. about potential

over it turn I'll Operator. So the to

Operator

Thank with comes from the JPMorgan. question first Kasimov you. Our Cory Instructions] line [Operator of

line Your ahead. is go open. Please

Turner Kufe

everyone. behalf we team that Turner Cory. morning, is well. Good of to recovering on speak for just is hope This Jeff really the I want

SAGE-XXX, it's in you with help C-SSRS the data just is study. glean us set there stage would here? an on give Alzheimer's XX open-label you given XQ just the maybe at So scale days, meaningful can Huntington's? a this now is change And what's that Thanks. or the from you And more data XXXX, with confidence anything can

Jim Doherty

in a are function a potentiate with approach. we on the But to way been a new long time receptor function. that is role on NMDA our happy able XXX Good NMDA. morning. Jim, take An the their positive disorders, really a for it's SAGE-XXX to as Yes, in question. opportunity This so NMDA allosteric is lead to store of modulator receptor be brain treating is and platform plays for that asset your novel the psychiatric NMDA bit important to a really to really approach the deliver in

strategy what date. to we've And to our so SAGE-XXX with build overall on seen it really does inform

R&D, the is, where cognitive that that cognitive example that's executive improvements at for agents looked of been proactive not I'm data we to an and like in function we've predictive that build has seen something originally on we've is what And you have kind – space And been Sage’s in do seen function. in previously. it's ethylenediamine healthy volunteers, the approach sure of previously recall, of or things with performance. that like especially Now seen

of in what we a volunteers. the research early to patients on But this in tasks. know is relative in saw performance executive performance space that the improvement was Huntington's down in saw manifest their their from also same bit space, where these function same We Huntington's little we disease, kind in healthy improvement an

we with really, as around the And it as very understand for treatment is are, So certainly, that space, function, since receptor see a it function. the neurobiology to much improving exciting have patient but likeliest response. robust consistent this early to we're what trying potentially in NMDA modalities very days a cognitive populations

see strategy cognitive to healthy kinds so in we in the intended decide study together volunteer open-label Parkinson's really those is we what studies. us the the are the studies. in the and NMDA also And in entire disease, disease, the same ongoing both takes PAM the seen but Huntington's initiate see to is us platform. allow Currently moving to and strategy improvements There there. that of with same we have All will data SAGE-XXX about cases, that study Alzheimer's to forward if

Turner Kufe

Great. Thanks.

Operator

from of Salveen Goldman Thank you. the question And Sachs. next Richter with our line comes

Your is open. Please go line ahead.

Salveen Richter

the are just understand levels XX% maybe if program, REDWOOD restart secondly, be through meaningful get endpoints, regard FDA for scenarios about walk rid how maybe use and then you you forward apologize could that. discussions the already really the I among to about can potential the One Good reduction is, discussed for the thinking Two of you on and need you you're help this, And with tremor could for various us looking morning. how to me. and questions forward clinically you're move but that that to thinking there? for the selection and you to essential

Jim Doherty

this Sure, Salveen. Happy take questions. the to Jim. is Hi,

talked – things of our understanding, REDWOOD. we're WATERFALL, you're forward, course, of we and the we're the and so about, this data pathway So we've of talking certainly in on also studies about REDWOOD, across parallel episodic case, have of asking but SHORELINE couple the are as multiple are in for the a informing we the side zuranolone as pathways and where midst

to sharing that situation We're for and as said, forward regulatory so the at agents we'll will we've for And move with is, needed that the SHORELINE filing have data pathway. we results a always in what landscape program be from certainly REDWOOD episodic the and forward. continue anticipate look looking to means we'll

this XX% can study of mentioned, XXX we the looking we clinically the see, in XX% amplitude seen – at replicate really responses And believe really study, study. data, you placebo-controlled types is study designs tremor, to is in well study kinds to similar open-label a reduction looking the in of For is, KINETIC as our probably from as both the as early essential available meaningful. that literature, we've somewhere in study of tremor that

And be so that kind effect. will the although think it's early of days, we that's activity the or a range generally meaningful

complete the So we a as the have beyond at will move from forward there. we and that, study data look

Salveen Richter

Great. Thank you.

Operator

our And SVB Marc of comes next with from you. the line Leerink. Thank Goodman question

go with Your move Ritu open. we'll line might Goodman, to is be on is All question, Mr. Cowen. your which right, next mute. Baral phone our ahead. Please

go open. is Your ahead. line Please

Lyla Youssef

is This on Thank Lyla you question. the Ritu. for taking for

dose? progress speak are to you. seeing some you in the the of SHORELINE in you And to WATERFALL the trends Just maybe with that the you study? this continue as had dose the in really have of quickly trial, XX any XX patients Thank you've cohort mg dose seen milligram to down can to

Jim Doherty

Jim. This question. Sure. take happy Lyla, the is to Yes.

at look is we talked the the pleased about milligram – SHORELINE it see study. to from XX the way data are I we the And think two-fold. As we

events sense profile the profile rates far. think them. mild severity the seen that the and speak does are places in what higher tolerability we've to quite XX in pharmacology with in so seen very the between is similar I zuranolone a bit XX to for as adverse do moderate tolerability again, that predicted milligrams, see little we I consistent the that we've much mentioned, As is the

the see continue data comes previously about we that the what So very modeling of around know, as really the sedation have we the as it study, with related understanding consistent When blinded WATERFALL from much I course, events. well to is from much But are we of again, to all think the we've WATERFALL not pharmacology of talk from data – at so to you this zuranolone. WATERFALL, study our and point. done

Lyla Youssef

Got you.

Thank helpful. you very Okay.

Operator

Thank of SVB you. And next question the our Marc Goodman from with Leerink. comes line

Please ahead. Your line is open. go

Marc Goodman

about happened. relative Sorry lastly, the Just is sedation that, that bit of and about about talk in little sedation you it Second early us type is I of see the if XXX different the is But the clinic. then a keep of be was done. product the the few type product essential to spending when I we seeing it's started whether that's same question I'm work we minimal. next a questions, same talking. there. this seeing you I'm a wondering up tremor and R&D what just curious with on year? any are just into should you've that not just for how sure give thinking of moving XXX, you which just from can year? But how it XXX, Thanks. And sense

Kimi Iguchi

about making at it on start want that big I saying been R&D a cash the Kimi. is burn quarter. several it's think begin. This look operations, question we've spending? you and going hopefully by to where spend managing just have Why that just start Okay. with we in When at our R&D you I streamlining and don't had really emphasis, from that saw studies this here,

three XXXX. zuranolone, study with the multiple studies have have we'll We SAGE-XXX study, the in X and Phase studies ongoing so XXX

ramp R&D spend XXXX. the So the into next over gradual you will quarters see in several a

Jim Doherty

is internal and I’m question I the And and between so is doing advantage PAM take us both XXX Marc, you Yes, of is Jim. XXX. to the around molecules we're take to this XXX. Sage think happy questions differentiation compounds, engine the related GABA are similar the to Both What pharmacology two. from allow profiles. design craft around XXX

with to around profile The primary a so AEs. profile onset of for to pharmacokinetics. onset are related comes sedation-related also sedation, consistent designed of optimized so for and the so the to is events feature and compound a And and it differences have SAGE-XXX. PK sedation its activity the are related dosing, been chronic window was that in XXX When for is between It's pharmacology that. adverse wider the

one what things And we're see. studies if think XXX. in anything out. XXX. then preclinical margin the the look I have it of sedation-related that's that profile as data – the so looking that's if mild would that to is at see I the bears to that tell moderate us. we'll clinical see expect or will we'll When with But to to what that's comes But

So XXX is an NMDA PAM.

lot for talking of allosteric about much So it's ago. space this opportunity NMDA modulators. minutes SAGE-XXX, see a was in it few very We in the same I family as positive

to development. dose in clinical continues XXX It's so the Phase And single through phase. ascending currently move in X

Mike Cloonan

XXX, to And maybe and portfolio some which for XXX, we're with just on to the Marc, question had studies things We SAGE-XXX. that a add back the approach. to taking going really goes multiple of

that a as compounds But Kimi depths the have in we're breadths said, of for be sure process choose to Sage. value molecules to deep We are and our the make for we're focused from really pipeline. trying most patients drive efforts right through in going to and disciplined the our to pushing and

we'll take make then we'll follow to right allocation we'll data, and decisions our portfolio the approach. the so science, to to continue align the strategic And strategy. We'll see resource that

Marc Goodman

Thanks.

Operator

Thank you. And our Jefferies. next question comes with from Andrew the line Tsai of

go Please Your line ahead. is open.

Andrew Tsai

guys. Good Thanks. morning,

for two questions – me to me. So

The result. on first one is SHORELINE, the

stayed with how better WATERFALL. correctly, trying you I'm well, you if case, And I kind do what is run of valuable of of responders reconcile my kinds question REDWOOD that's just this your patients XX% I point And, recall second any think, eventually on the if those were? a for would idea study? data have to year. then

is? color You provide Can help you size. the increased why recently some Thanks. that enrollment

Jim Doherty

This is Sure, your Jim. Andrew. Happy take questions. to

your repeat you question? – of could sorry, – part around question the first the the So first

Andrew Tsai

Yes.

patients year. So I retreatment didn't guess or need the first XX% in XX%

just tie do I'm essentially? running REDWOOD thinking, with I you So that guess how

Jim Doherty

and datasets treated gives a of little within being there and who course, in are thing one-year retreatment some the are single again. retreated of numbers an then there's that Yes, XX-day about more of were the under the patients you Right. And original then rich And us sometime first to population patients timeframe. I a think also are weren't dataset tremendous very is additional the say, then the who are of mention, a information. required half dosing, SHORELINE And frequently. patients as treated amount

And in something diversity what SHORELINE looking that's think see really there's doing that's we're you is that unexpectedly, are. in at not across right of part understanding with differences we're the midst I of the there now. something depression patients, what response into digging so and And some dataset

to study, And relates retreat time so on course, REDWOOD as study design than time the on REDWOOD rather interval. that is retreat and the of based I think based to intended how needed symptoms,

And is mentioned, were the SHORELINE as of response study, persistent a complexity in there fraction adds that there so as from you of people. learning course, but some

little Steve discussions it certainly And to maybe and we're aware on weigh bounce I'll a something bit over the that's our into topic. in So to factoring of.

Steve Kanes

Yes.

that's ask you an be would of fixed were you particularly important. use a question appropriate asking fundamental majority the wanted That's year. the over course a identify than treatment what the require we one really or establish that's as say, might what two believe patients treatments actually a we And would retreatment. question the more how regimen even if fundamental about And data. informative for how – And of to we ourselves. You’re SHORELINE looking didn't dose to you of

So have SHORELINE the data as look at you said, you what fixed SHORELINE. WATERFALL really the use that from looking for dose to for well know, as is we're be as to take data, might that what scheme a

to to information sure So do that patients the as the provide always best data. as physicians, of the and We we to we appropriate we've medicine. – that followed how that informs use really want regulators, mindfully possible make both set

the approved. actually It's would during spoke the medicine this development It naturalistic how call. this is fundamental if and Jim study thing, program. way The conducted a other within show SHORELINE would say will a about data used the is this be – on is, I largest about ever like

So plot data we've the we again, next about created how we our how is this and to steps. then think use that program the

Jim Doherty

pandemic, the question the the your WATERFALL analysis really the the subgroup was is the conducting all in you're increasing power suicide. sharp for to And I SHORELINE of not increases and WATERFALL this and were we in study, nine there think purpose factors it in risk – case that months study, related. around study Mike it's sample to ensure like said seeing global the things for particularly size that depression sufficient But earlier, into

out of there. amount So tremendous a there's need

Andrew Tsai

Appreciate all thanks it. Great, the for color.

Operator

Thank Research. with you. question Akash of And Tewari Wolfe our next line from the comes

Your is Please line ahead. open. go

Leo Ma

or so far, out as Leo Ma have had recent at you taking first think had in question moderate is a how AAN response All of strong consistent the This and mg for just of poster my XX mg mg Well, different dosed to TEAE. six patients two response? to six in your and is about, only second for my We SAGE-XXX. is zuranolone noticed about TEAEs. mg patients Akash. SAGE-XXX to dosed seen with with desk. to dose question. more And mild mg XX My XX responses XX XX see Thanks about question

Thank one data? concentration you. wanted we typically in the well occur, TEAEs with like we do they the zero So X zuranolone correlate drug saw these Phase

Steve Kanes

Absolutely.

in several there. yes, So, questions

that. So got you

the XXX question take Let's first.

some I to a We relationships. us around activity. the goal PK/PD understanding of think do the of work give lot is Phase X – of signs look, study

studies, Of a of aspects profiling. those event into key dig placebo-controlled the study understanding Phase think really in events I studies to one an of of we're but adverse adverse X develop events adverse course, and and tracking understanding an

KINETIC again? around So of the that's readouts data. I from zuranolone, question we'll part And what with see your think the is

Leo Ma

you a I or see far response in like wonder, strong dose mg? versus Do to different more what XX like seen responses response? have consistent the systemic so XX mg

Jim Doherty

Sure. Yes.

from potential when the overall that, are quite foundational for we SHORELINE think of look this we we look, program think at supportive results, overall about And overall handy response – see consistency amount beyond MDD. data different little have Well, overall studies, treating I careful at what of is and in and to what the fair you think, milligram both way I we the the see a both is really you look to change of in a comparing rates given be we other naturalistic the data, XX design. when response like things rates. remission the

the with it's that but Having the days numbers milligrams a results that caveat, relatively early do the by there have the the think across July, are data But XX and we the see in given remission is those what XX then at data. with we to at was I XX it's in This studies When the results. other you taken cut cuts rest quite of a you for XX encouraged to that still seeing view, thing increases this or days XX think XX just milligrams. we seeing is early you're still data we're recall in at milligram program. milligrams. milligrams, consistent response a data milligrams caution look that relatively we sufficient the where present from of numerical at point So

with so the our what the study I is come seeing think that, expectations, but to rest for wait I So far of data in. need think consistent we're to we'll beyond

Steve Kanes

Jim, thing. And add I maybe just one

if to four means weeks it's what or this SHORELINE of year, needing excited the from continue you course really you patient Just two needed. we excited real really We SHORELINE think about to was as the start the patients if are and that There's here. is you us, saying back what one about a said of data the as of or some treatments, get see we and that perspective, That's about validating why But Jim about. stats step therapy compelling. from patients We'll what think results gave for potential think a that over on potential right? through. Jim earlier, as the only And come for indicated get Jim of somebody data, treat two on weeks or the this XX% the potential here.

Operator

comes from of line question with next Stifel. Paul the our And Matteis you. Thank

ahead. Your go line Please open. is

Unidentified Analyst

Paul. on a Hi, for asked We quick a earlier. just had follow-up from Katie question this is question

initiating, on on on On the examining you're wondering additional PXXX that if provide LUMINARY were we study were potentials latency, planning you event as that or endpoints using? related planning color such on planning Thanks. if you're you could any

Jim Doherty

Jim. Katie, question. Yes. to the this is Happy take

kinds So quite course, those potentials are event-related interesting. of of

some look. the there an that of reasons receptors. think associated that's interesting to NMDA of least with could place to neurobiology to shown especially those, at be So at of And cognitive part has some are which again, PXXX, been – be processing

think I cognitive is LUMINARY around the that designed study us processing. data to give that

of And we're human with cognitive focused on so back data, mantra results. much those our to relieved very

experimental of at have we We looked course, described potentials studies, which medicine event-related in last year. our

always subjects. So cognitive I for think we'll the that's that of future some the certainly are focus something look an the eye at in we performance the LUMINARY on in endpoints But adding. keep study, whether of on and those is value

Unidentified Analyst

great. Okay, you. Thank

Operator

Abrahams next question comes Markets. our And of RBC you. Thank with Capital line Brian the from

Please Your go ahead. line open. is

Leo Timashev

curious just on color saw guess provide the tremor. you to just for the wanted tremors. SHORELINE. SSRIs Leo Brian. tremor. I Hi, that mechanism milligram can one the cause know was more with actually rate what on the that of of wanted guys in think for GABAA if reduce Thanks on that know and dose follow-up question. to just could I my we the you tremor for XXX some to I it's with potential MOUNTAIN. XX And A, would taking But

is drug-drug CORAL affect could interaction – coming Thanks. and be could And also so forward. this study I'm just a that if curious if potentially this the

Steve Kanes

Yes. This is Steve.

Let me just comment on it.

trials. risk a mind thing to seen of profile. we've in keep it, You is benefit here in variety the But said tremor

So call, the patients, of numbers during of the Jim it they're vast to we're patients, mainly a seeing and small mild tremor in said minority moderate.

typically it's it little that's So the potential still think impact, about the nothing and We'll it's in these terms And us process. said, well be, drugs of as following is depression. that way use. of what impacts given seen way And numbers as below, in to concern. and it, XX what's we in course, it to milligram benefit that's are very the with but data we've been patients treat patient risk had used seeing you

that's So not be about to study it, us as at something again, point. more given the pause able finalizes. we'll But say this

Operator

comes from next line with our And Wedbush question the Laura you. Securities. of Thank Chico

is line Your ahead. open. Please go

Laura Chico

function little this the to then for just committee safety Just little to I sending in for meeting outcomes studies development on pharmacology obviously, zuranolone. perhaps here. and outcomes And And I've XXX, guess, to the just guess, – strategy point, your on more wondering that, going in maybe one on most taking relating best XXX At might Alzheimer's? executive there's tomorrow on first influence our the I'm data. there you of bit submission? this specifically clinical guess, of memory? the outside advisory two very backdrop I could much. aducanumab. how Thanks I a question clinical additional landscape for and be an necessary Jeff. elaborate NDA are if got wondering questions Thanks for I'm guys what

Jim Doherty

This take both is Jim. to happy Yes, questions.

So the pharmacology. zuranolone question, clinical

that a package pretty have are do studies drug-drug is things through sort pharmacology interaction a and like study. things zuranolone to support we clinical of standard of like we These standard studies filing. are are So package that. running These

the whole those talking for So program clinical don't is up package those of zuranolone overall the design. We a lot. – pharmacology part end studies about

So about get question a good it. to

And Certainly, modeling when support multiple course, we I in including yes, those a results to from for data ways those use program. the safety studies building into short also think the the those studies we job overall program. timing to studies is, into about great of able answer the the studies program. are we're done and team's tolerability, of the and talk those overall from

of is for a modulate meant, it earlier. zuranolone week. us, SAGE-XXX, a clear aducanumab beta well. that very see I disease for the think certainly different I function we're cognitive Alzheimer's approach there's is Yes, the approach receptor for symptomatic Alzheimer's relevant disease certainly of quite as disease, package That's the taking opportunity amount receptor the And is NMDA approach but complimentary point along a of for What for that as NMDA this all modification. Alzheimer's of there. course frontotemporal we of And medical looking approach well. it's need moving it benefit modification is is is different we pharmacology receptor opportunity disease mentioning To probably Huntington's certainly for the just clinical we populations. was I see number a that what tremendous the AD enhancing And much news So to to performance. yes, by at to the NMDA unmet neurodegenerative is approaches see disease. And a of that with to of approach real lot is PAM there in modulation that function improve performance Parkinson's And disease. including week, also to certainly case patients so think disease, that in I and patient dementia, a the science disorders, these course, think in suggests NMDA of the improvement

populations studies that decisions from can we'll take best we moving So forward benefit approach. we'll the are data about what this the that think are our make running and from patient

Operator

Thank comes from you. Matthew of Morgan line Harrison Stanley. with question next the And our

go Your line open. is Please ahead.

Jiunn Chiu

to relate Data have is study, the maybe for of to question. of events what – a like could sleepness or This so talk excessive loss for Matthew. taking stopping consciousness review? role Jiunn Board checker the zuranolone Safety Thanks our Would the you true in about Monitoring

Mike Cloonan

Yes.

we've So seeing is wanted in said, signs I consciousness that I to not don’t we zuranolone program. know, is Steve, add? anything as think the the short version you loss there always of of were

Steve Kanes

greater we're we the a In more course – is that's seen drug drug. a see it. – profile of than talking Zuranolone very a has whether just to XX patient perspective. very, milligrams it, that's from different we've and X,XXX very all forming think demonstrated a important starting now well I studies or shares haven't pharmacology, we're haven't XX to for consistently very the very been about consistent most exposures, risk we're design. thing, milligrams, date, that with drug. And that's benefit and – we the conducted it by No, And safety it's the

we to the see excited were early data. And with that something SHORELINE even really

Operator

you. with And Jay from next of Olson line Oppenheimer. our the question Thank comes

is line open. ahead. Please go Your

Jay Olson

a how Thanks just big differentiation you the with the a versus of maybe I potential the of for do for some start question. Can talk zuranolone PAM taking to under just MDD for of decide are to in development different consideration? which maybe to plan target that the development Thank antagonist picture on you NMDA? MDD follow-up that And see other talk and couple, my the you question. GABAA NMDA drugs had plan indications SAGE-XXX, pursue about with about you then treatment can advantages the SAGE-XXX, of versus just how all you. given

Jim Doherty

Steve of So to mechanisms. ongoing are is about involved what the sort question that on of so about brain I'll and of there. in ask advantages two your you're a are And the circuitry. and to in very relative NMDA, see other Yes, in that GABAA receptors talking we activity around the question, course out approaches differentiation much PAM some weigh the therapy, the bit little GABAA a I'll zuranolone for as talk PAM us to

PAM tend increase GABAA receptors NMDA So down dampen is activity, to activity.

talking in the level. So depending brain which course, have acting highest on of you if about blockers a very, are the exactly also very circuitry. of and in decreasing those the you're of There's lot activity. that, that's at how But of parts focus we're

What comparisons. have hard the to we sort how dampen of as work. extrasynaptic PAM you is So these receptors direct little brain on activity steroids regions it's in make go to GABAA mechanism, there's about they're neuroactive to these the over that systems can especially effects But a like where way all perfectly well-suited different down from positioned depression, things essential zuranolone we about just think relief causing well like talking function. whether the about too GABAA PAMs changes talking that major to on. activity circuits other going overactivity do And neurosteroid other whether like we're much just brain ongoing that tremor in overactive in or provide we're very are without or that,

take zuranolone? want around you for would the question Steve, to applications So

Steve Kanes

concept to is, Mike And we're dramatic patients we're it's centric, without for need patients Sure. was they to about. patient able this has based it differentiation need providing sort for in that and medicines. data I the pursuing. most as do with the The of I it prolonged when mean, think our talking that idea zuranolone, treat periods on very additional is

And the trial, become that for and to people outpatient sometimes what study to at stigma, a we're So capsule, XX% in – treats a features a looking patients depression for doing results a is, two in it’s a study, medicine profile patients the over than more doesn't treat very, the course on require very for. that take patients. once treatments We what to That's both say prolonged this that's it's very of we demonstrate what day therapy seeing of looking have different. the in We're of we've in really of WATERFALL two seen become chronically. people year. medicines we looking in after XX% that a them, of lifestyle to patients than but want think home. all take, not about it are trials. disease, more address but weeks this study, are be postpartum SHORELINE it's the We're They're CORAL for consistent here easy benefit some

program, really the features for into when we think just mechanism that so not all also it the And all those but provides building, we're of features. about the

the are things very different different. other that's from that available. of It's So any

I'm profile. So it's a things and mechanism very that unique of differentiated psychiatrist, had a we've absolutely any the available,

we've on excited what we're so based that's And science. the think and pursuing been I what it's about.

Mike Cloonan

they past options follow-up have and RRT And as needed the – with well, they right? of part If with can to the very Steve optionality imagine, MDD way we If and as treat you choose as is that those to seeing patients Jim that we're I talking think the with options differentiation that the we're antidepressant, in time So needed, indication, We're the the with we which the indication, to going When RRT, because we're the is maybe profile treat think, the treat we the option. physicians want think question. And differentiation true to Jay, would program giving other change product that to you co-initiate they of of the want is about if through the and right? compelling. a level keep paradigm level I get about, shooting that we're how options give patients for, the you zuranolone. in we'll XXX what hand But they end creating we zuranolone, as with is can physicians level want back the think think program, on just that take one with XXX of differentiation shift mentioned to Jim, still right? Steve. to on just game. can And it to does paradigm.

Jim Doherty

that will how And think Sure, I asking look think to program whether this of another or more zuranolone, Mike. And we you thinking we how programs, move question The to it just to the we the you're ZULRESSO, studies forward. even example use our R&D. about if the I are is at take approach SAGE-XXX. be around mature ongoing XXX, what from results is

endpoints provide do us of sort that data-driven responding is continue and working these saying and where with patient a to gives stage what this that wealth I later studies. a how. clinical are terms experience working patients to with open-label You're But which the want approach think both us And with a populations importantly, proactive perhaps of in we predictive as that information, it studies we'll way. into with These do. we and of the also take in

patient the have to collecting move we to ongoing. pulling beyond about it's tolerability The the talk on XXX working best clinical data, – we working I to think with associated sites are it's in specifics. but And want really the it's into together all for I and that, information that speculate when where next. experience efficacy understand and studies So all the certainly the data, populations, also with

our collect pathway We'll be results more we those programs. going have that the much from we're inform data out and will reading studies So forward. also mature our for to as on

Kimi Iguchi

these but could if I that? we – a and things these matter add is mid approach. about And more just add Yes. Mike mentioned it a can when have an Kimi, matter take is and I or as to sorry, of to – it's near, thing a But comes it's opportunities too. of just I'm the This all one long-term either thinking opportunity. we This portfolio earlier, not balancing

always the pipeline the So we make these as thinking decisions. we'll be breadth of about

Jay Olson

detailed Super answers. helpful. the Thank you very much for

Operator

And you. Gary with next from question BMO of Thank line Capital Nachman the comes our Markets.

is go open. line Please Your ahead.

Rafay Sardar

Good morning. you how It's provide you're thinking I'm an was or just I you. how Thank could more potential that with Gary. Shionogi geographies, then And Rafay on out-licensing for collaboration on or and specific broadly, or of the assets, collaborations for status update transactions the your about indications. is hoping curious additional progressing.

Mike Cloonan

with They one. take really are we It's during how see. program, On first the that we're is collaborating out with X there. Mike. I'll them. see in that closely Phase all playing pleased the we very Shionogi, Japan, And data Yes, that collaboration so on

zuranolone. a much like-mindedness we in a approach of how with very terms We Shionogi have

Just will developments, indications, for same, can build strategy if Our Japan, directly just the is strategy, has in question, right? sort your remains as right? a zuranolone to accelerate spot been but and sweet They right? accelerate we we and And always Our least to in example, also program. Asia then – us patients. accelerate that capability patients reminder, the our strategy we progress at we a the that making zuranolone. general, South they that good and second for multiple what Shionogi have in sees develop about That access we for. we for and great patients to business really On we program Taiwan, and potential access Korea, this the be, in Right, world, that's rights of around that's to access if on is look BD can markets what paradigm to see ability think are development. saw in allows found – to to what expansion the the a shift the partner BD how

really So the We'll pleased patients. continue accelerate and on for BD. again, for strategy ways collaboration our to we're looking with access

Operator

line the of Wainwright. H.C. with from comes question Tsao next our And you. Thank Douglas

Sir, be open. is line line on mute. your Please Your go ahead. might

Chris Bialas

Chris you for Awesome. hear Doug. Can Bialas on me?

it and dose a ZULRESSO. maybe to question Maybe What's expect from ones quick neurological two another program? second strategy could a be in efficacy indication, XXX is next? we try another what study, your proof-of-concept me. And study you So KINETIC a my jump signal would or into good ranging about would for Phase If see X? you

refocusing anything, you that the commercialization invest could mentioned more your ZULRESSO? from that. into of So away you're to change What your kind if resources Thanks. mind

Jim Doherty

Chris, this to ZULRESSO. Mike take pass is XXX and over talk I'll to about Jim. the I'll questions

end front multiple yes, I we neurology the neurology franchise. a think opportunities in for so for XXX So franchise, of certainly as program, space we the a said and see XXX and

the And an with it has is in It essential focus essential since million XXXX, the is SAGE-XXX people program our the tremor. suffer in U.S. treat X tremor. on since been to much alone essential think very there approval been tremor. at moment has I

there's needs So innovation. amount of a space a we huge and both of sort ripe that unmet medical for think

current study KINETIC study, the learned. builds what going the on of that's So off we've

We other indeed have with tremor studies work then in reducing And in X some showing open-label GABAA showing with previous year, we studies, times did activity. our Phase that small our done PAMs SAGE-XXX. last benefits in

that tremor amplitude. We a reduction also in see

study days. So that. study to It really over XX is is the build double-blind on KINETIC placebo-controlled intended a

a then the team then that forward at building think, we moving as us of our talking I across board. for disciplined to So beyond you – information. that over talk to We is what XXX provides plan SAGE-XXX for then I'll about Mike, looks And wealth sequencing the And team ZULRESSO. of eye when that Kimi you approach disease. on and will outcomes, take to like the with depending on a something to evaluate from point. much opportunity And too for about order, speculate studies results of essential work to continues but want was epilepsy wouldn't this hand which I we tremor. think, have Parkinson's thinking is essential until that going the the especially tremor. about on the And in the do still earlier, on I keep an in in what lot a study, studies on in

Mike Cloonan

Thanks, Jim.

our did is, treating on geographies resources the probably take back question you it is patients Kimi that To the in right-size in we as mentioned sites treat restructuring, So now support and the know them active ZULRESSO to April on the focus ZULRESSO. the have ZULRESSO. on with willing to and that take are back and as

those talked zuranolone. the down to about with could in three tough up So a free of and paths always we pipelines invest are that that ZULRESSO, still with active sites. look at supporting allocation. we that geographies of but have We'll committed those ramp have some decision And sites the investment to treating you've our those we the rest resources resource was to

within in allocation to but are sites And and to support to we'll also sure And hospital go the patients into overall COVID, sites. our some in. right, during care COVID, can at imagine in we'll fits continue world resource it look ability strategy. allocation their the continue those challenges willingness make and resource to of setting of terms You COVID patients take in there of

Operator

would Mike conference conclude And Thank remarks. over any And does further this to Q&A today's you. back I turn conference. our the Cloonan like of for to portion

Mike Cloonan

Thank for morning. and excited you wishes and hear that, And pleased all for really everyone the well Michelle. doing that he’s Thanks joining this We're everyone. appreciate thanks well to Jeff, Thanks, that we're months, looking and this and execution now. we're callous progress for to will to he is much in quarter, XX and for very throughout the this XX is our offers Sage, year, potentially best this but the rich of which us. very forward year over next with

good thanks on updating for So we a you day. look forward to us. future calls and Have joining again

Operator

gentlemen, conclude a This disconnect. you conference. may you and thank have does all Ladies for program in today's great and day. the Everyone participating

Sage Therapeutics (SAGE) 5 Nov 202020 Q3 Earnings call transcript