SAGE - Earnings call transcript Q2 2021

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Operator

Good morning. Welcome to Sage Therapeutics Second Quarter 2021 Financial Results Conference Call. [Operator Instructions]. This call is being webcast live on the Investors and Media section of Sage's website at sagerx.com. This call is the property of Sage Therapeutics and recording, reproduction or transmission of this call without the expressed written consent of Sage Therapeutics is strictly prohibited. call recorded. this that note is being Please I President, Investor like to Boyle, Vice introduce Jeff Relations would now at Sage.

Jeff Boyle

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

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

with who quarter overview our Steve Officer, begin Greene, Chief recent financial Financial Medical the will Kanes, some our general Officer, second Kimi and review accomplishments financials discuss call of quarter be context. and will our Barry Iguchi, Chief Executive joined We clinical review who will will Chief an by Barry during guidance. provide Officer, and will progress; the

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

Barry Greene

and supporting in debilitating first potential we is leader thank all of Innovation while demonstrating and development depression patients of XX, in treatment quarter XX. believe scores brain of positive development first X program the These the in worldwide Sage X the day the lives was to for in the X with treatment update belief risk data HAM-D-XX Jeff, this placebo neuropsych standard our the patients coming endpoint, of a millions with We've our for disorders in better more and and company health matter health and X and line that seen an day symptoms joining across will experience. drug in our people as case, neurology. first patients Phase top intention progress the financial as data we after review I'll best study disorders positive day months, the medicines innovating as goal a the the after are through in revenue. to patient Perhaps reduction with XX, reduction progress compared by our statistically at are half everyone, the meaningful brain day of in progress of then by longer. Reductions call announced the Steve In approach top-tier in and executing during profile flexible importantly, significant benefit III X-week approach weeks on of MDD. to depression, primary only X multiple you, potential zuranolone, remind during doses. biopharmaceutical at of That's its addition zuranolone stay to measured call year detail. can impact in The innovative significant sooner a and we saw reduction seen pending need and in requires clinically franchises: with studies our start a become with data you've catalysts over X medicines. the methodology to the treatment. half HAM-D then measurement effect the study disorders as recent the the Thanks, suffering made by working clear over all and in readouts And the implications made a the to year to and who I'll and began stopped. that just met us the date. and of with Kimi millions from quarter. this our patients waterfall as been were zuranolone and or major delivering symptoms. rapid in this and demonstrating tremendous depressive clinical with transforming with has morning. we mission the day further demonstrated a a Sage MDD people provide thoughtful turn the June, in a data potential importance treatment also reviewing better sustained on brain provide get you to a I'll differentiated maintenance so of since readouts X, depression after clinical deserve support And the option for to day from of

study, thinking with pivotal positive Now of reductions have from These studies remarkably to shown Biogen read. in a potential the Psychiatry. totality zuranolone has treatment I oral are ranging a from program timing you striking top development in currently of the test points. with were late-stage an and of of results PPD overall context the discuss NDA our the differentiated available these WATERFALL Phase in and positive been of and the development, data tremendous recently the entire To HAM-D that profile. risk published It's regulatory to around data line JAMA in us study context XX from benefit landscape zuranolone about X XX weeks to from the oral FDA. baseline date announcement belief X with landscape in date, from WATERFALL in of the zuranolone programs, X the suggest path addition in and package the the for Nest are planning medication with Notably, or in WATERFALL after paper results III data and forward. a give With ROBIN to our the anything of within results confidence consistent unlike

hand provide update is this later aligned in the our data an to including said, with an NDA potential year, we've timing our of discussions file FDA with first and update if goal we zuranolone, expectations. the As for efficacy the an to have filing, on NDA believe our we

the to ongoing believe we're needed REDWOOD time, to need not this completed an the also At clinical XX-milligram were pharmacology currently filing for addition after NDA. NDA agency, studies running early with for discussions at RAINFOREST we package. studies, In XXXX, do an and dose the in studies, the clinical suspended which be anticipated

continue in cases Despite still adults, have XX innovation been benefit who decades. with the treatments throughout designed consistently studies to last as measured across insomnia, SHORELINE the approved there to efficacy HAM-D more year the are more major required treatment alone, component steeply. of zuranolone clinical increasing was study has investigate recall, may by profile least from episode initial schedule U.S. improved sleep course rise while designed has of available study largely of experienced sleep intermediary of rates question. been scale, safety the risk believe we you year. and was the dosing than unchanged depression in We filing. absent each every over with XX and RAINFOREST than in depressive the zuranolone There not X believe the year. As treatments, been for the MDD the data depression have to at this and REDWOOD co-morbid XX treatment address is and for Real for million RAINFOREST zuranolone of do years, to fixed approach

to with as disruption, showing X-week our dysfunction, data well-tolerated zuranolone clinically profile gain there we're safety illustrated meaningful efforts full of reductions of discontinuation antidepression cause approved, best-in-class the consistent gain, symptoms in the with pandemic. onset, HCPs after a improvements potential Slides regimen has a treatment treatment if meet Additionally, and that depressive on sexual offers weight upset no a we've GI We we're a to that standard typically of the for of Biogen, payers. evidence with potential care depressive a approval, forward building date and profile, been commercialization in response anxiety has as to to euphoria, with the steps during if mood, XX. treat needs drugs. firmly symptoms in compelling in Together and zuranolone now Rapid high taking clinical completed to sleep are with the program with XX symptoms successful with in needed And sleep. as of and or treatment offer patients increase believe COVID-XX and this maintenance depression, the unique

data regimen treated. commercialization Current changes. treatment any, As our burdensome standard causing are we slow focus way response, and most patients chronic care form to at on often effects is We for if least some are chronic our goal the to work by for clinically our planning depression to of and of on sharing engaging paradigm adherence issues will is drug of staying bring patients can disease stakeholders welcomed showing launch date approach side to believe work the safety more to up target and We a efforts to regimen depressive by treatment in in to profile profile as on shift create for zuranolone clinical trial education to living ramp meaningful forward the a started. zuranolone. well-tolerated patients has rapid, depression time-limited we depression. be about thought with revolutionize X and be The years for MDD and for intend treatment symptoms, treatment with our reduction and accompanied We zuranolone with experience look key market, imperative. educating

has a of Sage deep made and the programs great pipeline expanding invented quarter. pipeline let we've during and remind Now you me our accelerating progress that in-house, in

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they at statistically saw also activities are a daily as may every observations flexibility. point. scores TETRA time regulatory between These of provide important and living We future significant help correlation

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of this that frequency in with the with good are symptom Phase to and a profile II translate to dose We program dosing concentrations maintain tolerability expect tremor sustained initiate study plasma the a control. a and optimizing XXXX late and into progressing goal schedule dose-ranging and

Parkinson's first X-week this that about dosed dosing are Turning pleased associated to the NMDA therapy forward. SAGE-XXX, NMDA with study B SAGE-XXX disorders disease cognitive information to our franchise, on announced in for our PARADIGM inform we SAGE-XXX A Part May, will In positive patient We dysfunction. a And from the arm that has potential in as additional Part believe we receptor receptor study. oral first-in-class been development of wholly-owned evaluating cognitive of report dysfunction. neuropsych PAM I'm to that path provide data

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you the data. in can With clinical expect further Steve? to quarter reported portfolio. our so opportunity lot more Steve going growing a our assess of forward to we've detail. as far the data for over more detail the we and this that, to come expansion call we half executed all providing the programs. XXXX, on those data As as well turn education That's promised this of an in in data second do on including stakeholders I'll of ongoing previously to year, around across to We additional additional see, reported analysis look updates the acceleration allow and to

Stephen Kanes

period. the further the modulator pivotal zuranolone differentiated in mineralogy we morning, generated led study. most of discuss along we've believe the to studies data we've the specifically placebo date pathway. franchise positive significant ongoing seen by landscape Thanks, the programs our positive and Barry, to scores a X franchises from with by that and NEST met of with our Barry the filing receptors with the zuranolone A and recently throughout data generated progress good clinically we've everyone. and XXXX. the across next-generation dosing date, safety zuranolone, regulatory anything endpoint, data and supported the improvement mentioned, data with development the end and was outcome waterfall WATERFALL demonstrating compared pharmacology allosteric and And primary at as thrilled NDA remarkably Starting these submit study, data the GABA meaningful Coral consistent I'm all to HAM-D the statistically and throughout depression In X-week to supporting clinical

onset time point at also X, rapid We earliest beginning the measured. a saw of activity day

average who full treatment of with trial. through responded patients group, of case, maintaining retained XX% In days a end the of the if after majority more XX the X most, after dose this last weeks the patients of these the improvement. on improvement than zuranolone their to of As a all, medication not of

a onset, safety if prolonged What that As forward along shown has that zuranolone after that the to is to from the say to the the and pertaining the overall study successful. patient-reported overall well-tolerated look we're symptoms entire profile the with continue benefit improvements we analyze of date can data treatment depressive this present tell I paradigm-changing landscape to for speak that patients profile. to rapid program, we data potentially zuranolone presenting additional completing outcomes profile the zuranolone data regimen may us and X-week large in

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receiving To to standard loss discontinuation. the of care reports because all were very There gain, were study, zuranolone TEAEs. no euphoria, most also serious no of can patients the with mild be and severity, sexual events those few associated importantly, weight adverse For lead can the of and consciousness. example, while on on antidepressants a in of waterfall or majority the adverse X.X% current zuranolone X discontinued vast were no moderate events, study adverse discontinuing in group of there group. of importantly, X which from of the were events dysfunction, deaths to in only that the placebo and of end, There because X.X% placebo with

Recent to the review our and the data corporate landscape supports on the economic to the sharing of of outcomes the research system conducted rapid overall. its or a has use care patients economics health and needed Sage much for showed and also including premier data As forums we congresses, present amount be upcoming patient-reported committed in data Slide target depression. the we're as of profile we a our seen details of lines we to continue presentation plan with believe as from of totality as journal we scientific as the which treatment published to insightful. our at data the to higher The at depression potential with the durable study provides outcomes, MDD substantial be program, treatment that meaningful for zuranlone that burden WATERFALL possible. line rest of date to of quickly treatment and XX, health episodic was and very compared will types multiple of and treatment by for believe pharmacoeconomics peer-reviewed single view

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and study evaluating respiratory to study acute brexanolone collected advancements our data closed The expectations we meet not and Sage syndrome, III important quarter our after was this the expected. We Phase for or the quarter. about leaves a catalysts of progress analysis Today, the turn well distress and financials. further results. across we're believe to several to announced full of I'll and call excited this an Lastly, the half making will did Kimi? significant build our that date pipeline, advance enrollment on we're momentum was by quarter we medicines This enrollment year to marked that value-creating for Kimi ARDS. the over report COVID-XX-related us mission second terminating with positioned our of matter. now potential to our review of the

Kimi Iguchi

Thanks, Steve.

on As and position. patients. positively from that and and we're impact and you well financial by moving an time executing will Barry, us Sage, ultimately a pipeline heard medicines in It's strong making strength, based from our of that XXXX help expanding believe we're position decisions exciting our underpinned are deliver we Steve for data forward

commentary from our second with me financials in our million highlights revenue guidance. the sales $X.X by the compares impacted committed PPD. net moms, We on to same period their of and with from That all XXXX. quarter million of families sales of for remain ZULRESSO $X.X to some second start revenue and our the Let We financial quarter the close then in ZULRESSO. from in those recorded

driven benefit may restricted outstanding second with and for XXXX. to milestone were of in collaboration. Our activities the gain as and the general reduction increase our administrative and collaboration. in a as million for $X.X $XX commercial expenses quarter expenses reduction compared the of of efforts same million outstanding launch increased expenses on achievement approach focused million certain our to compared XXXX. expenses performance Biogen $XX.X stock-based reimbursement compensation an from integrated launch efforts, in expenses includes achievement That reflects development of Biogen were access. to from in and a engaging who a activities an from expense our certain studies potential from and in product ZULRESSO key pharmacology second readiness increase same PPD expenses of treatment in of Research zuranolone with stock million of a increase to increase our This an The The for and the the restricted reimbursement are milestones in if units. million of This noncash period successful targeted was part intel Selling, expenses awareness, began million $XX.X $XX.X noncash an in including stakeholders moms due for driven quarter. of $X.X period disease increase performance development the $XX.X million $XX.X in due that for stock-based part million expenses stocking. from compensation XXXX was by in clinical to expense of by was

million strength I'd of period a and beyond. financial comparable net for our the reported highlight compared we quarter. expect second $XXX.X $XX.X the for like had loss remainder $XXX.X in a will the of second quarter we compared We the Additionally, of XXXX. the was loss That build of restructuring million no XXXX to continue expenses to that support XXXX. to to million of the in second components XXXX net of and for quarter

X that value. our confidence potential there areas in strength financial give Specifically, are to me and create our

strategic funding cash probability the on allow our improve expect to provide we Biogen plus and hand $X.X of First, decisions flexibility sound make continue from and billion to us to financial ongoing designed collaboration to resources the will the for SAGE-XXX. provides commercial and SG&A cost have if to And related of ongoing billion success. we Biogen milestone. sharing for meet upon we development expenses potential of The zuranolone R&D up $X.X agreed for activities to collaboration our and

balance commercialization payers to with we financial program X if of deliver and invest our our in portfolio that from billion and if R&D been did date, And has we near, for significant prior to receive getting of Second, milestone the mid are reminder, a shown financial our with of address payments expansion strategy we cash value just approach I'm to long-term and to multiple the potential are innovative now for to than best-in-class started. the develop reiterating guidance collaborations and to led see of which continue turn as products combined we our to it a has help operator. of end have a drive long value. our the Jeff will and HCPs of more achieved approved designed portfolio $X.X and Jeff? with allow what impact that have flexibility we're signs patients, to over all the treatments to strong any thoughtful to Separately, build not franchises, at patients expect to to shareholder to XXXX. expect I'll working XXXX, promising and us to thrilling potential us we're flexible a the millions potential, we're with lives. Q&A successful, It's work position programs confident third, handle term of as shareholders. across to and remainder

Jeff Boyle

Thanks, Kimi.

Before ask I'll operator, the limit to X question. yourself I that turn it over you to

If to an question, the you return free have to feel additional queue.

Now to I'll over turn Operator? it the operator.

Operator

[Operator Instructions].

from of Our comment first question from Baral the line Ritu Cowen. or comes

Unidentified Analyst

maybe and successful provide does just on for would to back to and that that the file This mean an retreatment to do indicated the clarify, to the data terminate you REDWOOD to MDD Congrats oral strategy, in the for FDA SHORELINE the quarter. Ritu. just go had to is be And decision Waylon sufficient regulatory need RAINFOREST, filing?

Barry Greene

Thanks the Yes. question. for

X,XXX take date. XX of zuranolone first onset measured clinical for We've said filing. consistent. in of patients been significant call, results. zuranolone as That's the consistent have subjects and early seen over day point the rapid day with So on efficacy we time X. been action a We've sufficient has X, in XX back. We and step profile efficacy And as a we the studied data to as

So we the totality believe data efficacy filed. the is of

studies, then to - your a be important complete. required totality to we to we mentioned we will in be data and As confirm data filing. also we're the safety question and this we snapshot then SHORELINE. ongoing needs need ongoing believe have sufficient agency other And breakthrough would we saw pharmacology and package not a of able the be confirm were which we for studies, call, an filing. the with specific from And SHORELINE, so in take CORAL, to that had with really for And clinical and including REDWOOD did definitively dialogue. status, will ongoing all we this that RAINFOREST with We

on and the then dose the of in entire Steve requires was only X about call, treatment SHORELINE X, the and course XX% required treatments year of the the course and X-week in and that patients XX X- patients in year. XX% And or XX X. X X As the mentioned entire XX-milligram reported of the of XX%

XX about X, even frequently XX drug recurrent most at weeks dose talking we're the treatments, So weeks of study antidepressants. versus of X

provide we that are the those believe data to evidence. retreatment to So Steve? efficient Steve, add? anything

Stephen Kanes

a X information we'll now file. of safety as Yes. next safety which believe, our profile WATERFALL, And definitely necessary the for with with X,XXX the important No, confirm as database. appropriate say and positive all with is And I'd efficacy in for that filing is an the making said, big the of factor only includes these with clear with we thing well along a dosed than as we meeting hand more agency. that sure safety have a individuals trials, very a we have

Operator

comes next Sachs. Salveen Goldman Our comment Richter from line or of question from the

Unidentified Analyst

wondering XXX? I'm Elizabeth be on ahead II steps if is additional of Salveen. there the that just dose-ranging any for study to need taken Phase are This for

Barry Greene

that you mentioned really important And that. Yes.

sheet, of we consistent reduction profile started a were positive gives or kinetic the the tremor we accelerate our untoward everybody articulating longer-term And back, is of we the year safety. had we any the without taking tremor. and can our And data, kind tremor throughout study safety the step a we favorable asking result that will which to move were treat So essential us days that's upon - which based question, with essential strength and XX a sense exactly where here stand to intention see tachyphylaxis pipeline. the in and patients course to into confidence balance

we were III. come that next hope dose a So that out with together with to study, provides our into move where to partners designed frequency profile Phase step a of frequency adviser, we dose

all agreed we've we Biogen. with So is do

to once we have provide and And agency will details we've work year, to the have that design guidance issuing sure that later and right on we we this plan we the Now initiated make frequency. study. with that

we're moving forward happen So

Operator

line the comes from from Cory comment question Next of JPMorgan. or Kasimov

Unidentified Analyst

gathered is top We're investor readout? the This if KOLs? the that WATERFALL Doug feedback what any, curious out since the stand data, about on line just you've And to aspects for Cory. really of

Barry Greene

Yes. Thanks for that question.

today, So seeing here. since we've is what's in a that we last is development years is I'll really the statistical to we X discussions XX KOLs. And talk paradigm help to data, of see And significance Nobody had about some we X antidepressants, everybody integrated XX and as the X to seeing waterfall programs. with what investigators of and totality And what an the Steve after I that continued works day with about about When great at shift including think point. we've readout, SHORELINE that we've you when totality of medicine think seen oral ask think had with the various data efficacy. know, emphasize in or and doses. later-stage

Stephen Kanes

the looking XX KOLs The well That to course treat in treatment most we're weeks, about itself the patients year. antidepressants so really that X We that we're in with profile is for episode where The for therapy and XX That's require far touch depression working illustrate the depression talk in. The benefit weeks we're to is substantial paradigm are more we've for. to real we're on first articulate what X they profile. it's that we overall medication, a people about everybody for years. but of a and episode. weeks the really what both now I'll be all not in unique. working And really than months, What to are typical a lot typically, patients mean offering integrating time-limited Yes. X of really real for depressive something shift, a as physicians data is remind as treatment that that treatment a major just things revolution, duration their taking successful a days, kinds what of something that over more patients. of themselves is to no specifically treatments risk trying able the that do understand we're seen quite the risk patients to make a is benefit are with, of the then feedback best how profile exactly interested sure their with one year, getting and is revolution are they

into does tool practice. outcome, meaningfulness? our really used - a things of reflect looking in this something it how kind with How in to clinical paradigm. the treatment deeply that best the to welcome important new the using everyone demonstrating into very treatment. in the KOLs and understand that's patients' overall with very and that So this are of more how introduce clinical everybody And then that views to else of X approved, be to help may be going we're It's

because in kind exciting of in years then is it's I now, opportunity. when the change me for now, had it's have was is and ultimately, we educate sort So really on are right everybody it ways new. this for to of data a would something exciting this practice, my used I and If seeing practice I and finding where entirely I've - been if that's I armamentarium medicine

Operator

Paul comment or question line next the comes Matteis from Stifel. from Our of

Paul Matteis

a that's X before after filing get for clarify possible just for as you to kind what where trying Barry, ask review. comments, the we you an zuranolone initiate to and abuse wanted expectation here question zuranolone if and thing then is liability remind your you data? quick a your ever on operating work then of permutations. could Just just of But approach are where And CORAL I is complete the you scenario NDA us on X there - regulatory that. one can understand and

Barry Greene

I'll and in. the it Steve fill to let that me And Yes, provide - Paul, for question. thanks context

that what we positive III filing. including said of date, X efficacy we from to have sufficient the efficacy Shoreline, the X data Phase are So is data an out for

to We this pharmacology pharmacology now did completed ongoing including learnings pharmacology many as have later We point III the Those but from at milligrams, earlier year. to studies. abuse studies, of you Phase were the run rerunning your be with happen. XX XX-milligram studies will the data changing ongoing studies

will filing. data the those of be So part

to terms In CORAL a that the safety confirm this required SKYLARK, file. we to the of studies, of and with we will agency be other and believe data blinded snapshot need

but to are III So before that's it's a conceivable that readout, the Steve, other following matter simply add? Phase anything timing. tax regulatory we of

Stephen Kanes

certainly are as you drug any and liability there's gets in ongoing not us Obviously, package filing abuse We'll giving time for you some that milligrams. say, XX specifically an nothing about CNS, said, there's No, have and that's asked there or whether there Barry clinical pause. the package is that's the it the into complete, do. at that for

we'll We of data expect with our of the meeting after to the that time that we at have all the need completion file FDA.

goes a the with efficacy sort As as data, need the on. it's we of safety the really as that of technical of filing agree Barry what matter said, data well to into aspects a just

Operator

America. of Our from your question Mr. Tazeen comes line you to Bank phone. of from Ahmad next the unmute comment or Ahmad, need may

Tazeen Ahmad

you that. now? hear me Can Sorry about

Operator

Yes.

Tazeen Ahmad

One at One course, that that the drug. insomnia. time of RAINFOREST that question study. thing Okay, looked And studied about we've this discontinued was co-morbid there, was the have great. being I by

is benefits to their would patients us the to increase would to that that major able of night better physician the at sleep have to and a of checks prescribe be be big desire want given zuranolone. One ability positive

we color And to that discontinued you curious, to an little have just so in ability ultimate would still that something that would fleet study, you've now I'm a structure? help language want on label? more that the And bit how get is

Barry Greene

question. great a That's

outcomes in we that completed but patients' improved. that will the and not studies, architecture. in only And data that the patterns we remind clinical I been into and have understanding anxiety, the through sleep you reported sufficient in mood MD have sleep have So we insight scores patient believe sleep

label you If patients, the patients in ongoing negotiations we believe the do after many know, are, can better. us we is a these sleeping are But But we FDA negotiation. add? studies. that more in we certainly that understand The obviously, in as on exactly fact, helps of data. and what those fact, Steve, sleeping. get we definitive label and we've are, Now hand have believe label savings, to think anything make that that data studies patients got required to we matter of

Stephen Kanes

consistently lot about sleep near another health the that. during be pandemic as rates take at And core of the And potential into. certainly get we'll look Certainly, interested course, up from we're a roof. of we say sleep green at where Tazeen, benefits of Yes. successful, factors be seen a Obviously, to able of that able we symptoms that. But sleep. sleep become scientific look we've in to through are that done we the the be individual how only depression data, words a like communication, you, individual not sleep, in going term, from improvements the you the that we're we've to something out data we'll those looking we'll when is on planning long how at that remain then is we're improved, of has seeing that address to through is factors obviously work are things benefits. of drug depression working as antidepressant, we to as approved, you need is factor be something some on able the with already. something get which How that's going trials, Biogen a we move that be do absolutely certainly our And the be an for to articulate forward. that, to is term benefit think important and those a And get we'll doing but depression, that forth, so important first, focus one patients. what and we there

Operator

question line Rahimi Yasmeen Our next from or from of Piper comes Sandler. comment the

Yasmeen Rahimi

questions have SHORELINE. I on

recourse can reported? of you this is, on that X dose the you year? is the then have when the how XX-milligram far, XX-milligram completed needing many a group same dose versus will so the dose, you two, data have for late rate the in The second one look me first or XX-milligram year the And patients tell

Barry Greene

Sterling. the question, that weeks. for patients. study Thanks seeing for drug keep are And X on dose, stage in people over to in further that reflect important us in patients Steve to thanks X to incredible seen the in that and that, and to really in for the turn important after but into it weeks this, drug. they're very asking context yes. IIIs, have the details, at a or normative more And is of the Yes, durability our we're still going as durability of helps about mind patients This insuring understand the reporting taking are I'm zuranolone. reflects we've the Phase get

Stephen Kanes

answer, short is know is The of number completed. study course, we'll Yes. the actual when the

patients that. in. we're the as to as roll study the goal to patients following is at And many the we continue to so And have the of can and end

trials during rolling response can initial the so that's since fact, terms In for tell and been of long-term And study with the do you we're what way. like patients CORAL remission along trial. XX-milligram is What earliest cuts the study seeing doses. results cuts. SHORELINE the in is And I this in into remarkable take those the you very we're

plus saw our since we are meaning same reduction XX% program. notably remission. solid bit XX our been rock of patients full that the a at They're now general days XX% what showing milligrams, range. little a a So than about And have more the estimates and in but showing are of higher XX% response, are earliest those

dosing, So numbers the we're throughout seeing when completes. both really for we'll the good and XX and XX-milligram response first have now the that's continuing the been milligrams actual study metrics

Yasmeen Rahimi

in size just of right of currently as SHORELINE? on how patients comment like SHORELINE, to able you are Steve, now, are many the

Stephen Kanes

of there more attrition we And going I better. are are where this to check long-term cut, in. throughout than the expect safety last getting they're the People especially feeling would if equivalent in They this don't to They're necessarily was the study data interested, a patients can year. about that XXX is continue the well be enrolled say their business. trial.

our a levels them of additional fraction they're are we'd of number small this only require meaning of One to trial patients This - of would requiring of treatments. rates seeing the SHORELINE the equivalent what a is look be on points not is a not make know additional therapy the at. but better, we're only in retreatments. even So high only and are But them getting of attrition effect, is things reverse the retention in placebo like that patients we very

among get like look other - world on treatment things, understand would And so index required we patients and that of but the a in one That's half year. our start course fundamental real required medicine the treatment, more another and to all treatment in treatment only data. what with of we XX%

data in doing, treatment a that well treatment live to creating this to in to that's find part the choices. of what going not as make as literature, necessary we're the both is approach foundational order and new You're

Shoreline And really why - lot there's this there, are those important. is perspective, progresses. most program that my that's the but So as are a are from important things so those

Operator

Andrew of line Jefferies. Sai the from comes question next from Our

Unidentified Analyst

So my CORAL. question on is

is the be think As SSR patients. does X which to to the about what investors likelihood day Is of viewed about somehow start arm that both fair it success is X in since to to within improve some day then assume XX. SSRI for corollary could And arms show could HAMD weeks still at as co-initiating to XX, for calculus? to work, typical that kick as start in change think comparator the on study the a traditional we placebo could arm, takes us the SSRI or essentially a

Barry Greene

highlighted, What an and have that our of we me I'll date drug. question. we that to that multiple, Steve an assume experienced out to And antidepressant. are side I'm you data as might CORAL, for question. improved ask the co-administer have to But antidepressant me patients experience of to the is answer patients for thanks These advantages. about going talk effects ask with Andrew, Yes, zuranolone. important question some horrific ZULRESSO on with that let not patients an when you you say happens X the that

we question, asking we're CORAL. a So different from and should learn

say done Now learnings. studies, every from we future also each when clinical on conduct has based those and clinical time, to studies, that adjustments learn states make I'll studies as and we these we

highlighted while alone somnolent on may, any effects and you upset to necessary we will not the your very side earlier, in But Steve point, specific weeks. have adjustments make be right. So we agency made some sexual X beneficial because the - the benefits we you're if But interesting not to and expect any fact, effects like to with antidepressant that side to seen for to We those do zuranolone, adjustments. work adjustments will things there's GI confer any CORAL, that as and will antidepressants. other we earlier, and see seen weight gain, be dysfunction, with of sleepiness see with have date X

about arms how in that's helpful. might maybe drug. you of on weeks dosing can another then So in And multiple together hopefully, patients talk come Steve,

Stephen Kanes

we may Absolutely. other weeks time of may the do contest when just that antidepressants clinical The arm. don't - benefit. actually our course know we several trials, like the even over demonstrate patients And over improve placebo that in given in

antidepressant. trial have or XX, a shown case, SAGE-XXX an day forth. we're mean early very with do through so particular the to We with Of to want is we drug not where not maintenance. oncology, I therapy successful, get we may with are And a looking in do out? how at people use time treatment induction option. choose effect an that differentiation In so that to the X, points think there XX, you we're with through just need start co-initiate another that's haven't is they But patients study quickly? the called So when available CORAL. day do from looking at plan X, address out better as those case really especially that Are do start they or if as placebo that for consistent through other jump obvious, that more differences. This we an you any we on. placebo powering. for technicalities Day the And drug XX How which antidepressant nonspecific zuranolone course. adequate do is looking differences we you and ensure we day is early the study and of may the it, yet success powering show this use those physicians the to contact

Operator

the Wedbush. Our next of question from comment from Laura line Chico comes

Laura Chico

zuranolone I have on PPD. and one

And lapse the paper time conducted. III Phase JAMA bit versus PPD the higher in with studies. zuranolone third patients ZULRESSO will seems onset like PPD a of the during the and when were much it So ZULRESSO studies proportion a diagnosis, but of trimester between shows shift symptom a not

you're So not wondering back, are seeing in more interesting in you with SKYLARK It's landscape. rates depression. changes just PPD can whether comment think the on postpartum elevated pushing I'm elsewhere, if because but depression these you permanent

this So one, impact, I terms PPD guess but care then point does this of a primary in might question commercial environment playing your also strategy, see the how maybe here of be out how for submission do the zuranolone? on is you in who

Barry Greene

Yes. in Laura, questions there. thank you. few A different

So to unwind help some get Steve let from me here. try and it

and paper PPD. with the for highlighting highlighted beautiful paper. So zuranolone We're works ROBIN how well paper just that prepared a the thank as and moms in you my really remarks, proud these I study, reflects a just of in really

landscape. with the start Let of the kind commercial me

expect. waterfall we is MDD file, an if for our the So with agency to successful as expect PPD, indication we're and what both and get fortunate which we for

be, birth. moms you be sure her months she going knows breaks, no giving And X her moms, in, with plan. is out have mom, after week, for X she's reaching is, as a all where every her a where that being those water is and particularly know, a her who's taking physician But will almost a has making born. We have baby when for factors plan bag depressed the months, to plan risk who

OB/GYNs, work there's ensure that to other work giving with going advocates, just presses birth. broader is community we who sure we're plan moms moms a that patient So giving all have make health who than That that with after have concerns after psychiatry birth. work probably to with

a KOLs depression will that and in say can for with with come hospital have actually intend access heard they up. risk scripted symptoms models the we We hand to to depressive be moms that I some zuranolone. moms ensuring aggressive leave those factors, So X and case certain in

the I we'll Laura you well timing So differences highlighted? about want be that do think to there. Steve, prepared talk

Stephen Kanes

Oh, sure.

I'm close glad did included patients an the we've fair had So you trimester. reading onset Laura, during that always

we going there few things are on. are a So think that

despite mean approval made enrolling delivery, in to until treated study, being reflected of to to diagnose we Importantly, full that, a And the with there's when the is among least I that's heightened in was awareness the them of be their identify ensure a of believe, patients One that have diagnosis in identify to not diagnosis month treaters unless after not being after a are patients both to and patients. to appropriate the for and I people is those important MDD. changes we're delivery. symptoms they plus medicalizing sort X have MDD for ZULRESSO, prior ability at several them really the maintained of immediately weeks that's symptoms for really to for of onset have mood be mean normal us. and weeks, they're remain, not their I

important. the know-how epidemiology, a With just their up. patients, and you of few and we these think how on depression, that's One, there's screening, way a to bit identify if we regard attention of know awareness, ask to So things. people rates well,

births down, and We new also discussions based the are their care investigators much reluctant during come and KOLs that we moms surmised pandemic. on also know to are more into with

center together to coming So as into that the to, a portable importance one, all require of well treatment related speak the as ongoing work to study. the SKYLARK those modern doesn't treatment, people taken factors a of time-limited treatment

intend strategy, line. MDD PPD as package really as would change line, of part filing time it's and an our of forward over the finish of getting much we're looking to current and our I add the remains also the importance we do study for the discuss as So getting label. that disappointing utility to both the to work

is So approach of site. our current paper outcomes the all the of that on part the based Psychiatry JAMA on from

Operator

from question the next of comes Oppenheimer. comment line or from Olson Our Jay

Jay Olson

in with esketamine? the compares comment a novel as of of how such early importance response response to for correlates the on And other you an response outcomes zuranolone longer-term talk in earlier. rapid about MDD? you MDD, antidepressants, described positive Appreciate onset also how which Can

Barry Greene

Jay, a I thanks for for Yes, highlighting the important And thank you question. really point. really

esketamine faster. the the economic impression people the for about about - treating others you getting about rapidly more earlier the better So there of the effects talked talk diabetes. health other that studies us know and there's want what early and we treating such not to been many faster. and would and better downstream some depression comorbidities, diagnose person is about that of that's out people from the MDD, cardiovascular disease, talk treating get and or literature you data better, and of outcomes them there's rapidly benefits not a better Steve, people get them longer-term and as you And for many

Stephen Kanes

patients let's is That's I likely first. to is. those of There's are someone quickly. to Yes. gets few of they more what get more I important which depression with the all mean thing, better things Everyone the benefits a treatment the regardless medicine. goal kind the wants maintain quickly we better, the mean, most though, of start know with

quickly, we of that outcomes with into in a another think a and going improvement It's therapy, journey have looking So when people we much able recovery, able be to have to their we mean well-described there's and to that really get phenomenon, like for functioning functioning better that's on life really better to role their back an to patients getting X symptomatic us. begin that is that them role important be I is of patient-reported what we're course right? looks for get which into true builds and from X-week improvement. know at thing patients your something lean very and

different Spravato multiple patient would in that differences to esketamine, drug into early onset, the esketamine, study, So real those is both from treatments. of reports statistical importantly, world, significant drugs, get the ones in point multiple, really WATERFALL are we're treatment-resistant I from while this which sending the they're one, but other more real to very impacts out depression. also in out landscape. a that really very population is regard important are With including after there

focusing who multiple variety back depression better still their get multiple, is get to refer to but and patients garden with very lives. don't severe of I sometimes necessarily program on on the what opportunity episodes would Our have and as deserve

We X. early only and million seeing we're many profile. the approved, than episode. treatment that XX revolutionized weeks it's drugs year with something X So there a We're approved in depressive are think XX this after have a positive benefit for I'd States add the faster we risk really made that of for time-limited people still a people. seeing United as upwards greater benefit a therapy as that really when day maintained is onset

people straightforward unmet think as enormous. much to relatively as need deserves to And something as view So quickly get everybody better on this their get treat, feet. is back that's we the and

Barry Greene

I'm develop all which out data develop have that time, there a go stay to whole a that and health on individual KOL go of on of going other and comorbidities, Jay to physician the care I recurring better to that And said. need depression for one but treated these medicines asked, support to said, to my cost patients the remarkable. long listening get are where that We know patients better of not get Street when don't panel system. cardiovascular diabetes, on And data need CORAL, the was that to them only well, of patients to which we just faster. depressed that what bit And analysts Steve periods are on faster, give multiple Wall a and were disease hurt dumbfounded.

to better ear faster. everybody get So

Operator

next question Our comes comment Sumant Canaccord. the of Kulkarni from line or from

Sumant Kulkarni

anything asked in another be the a a I chosen for place safe the first back why was and continuous guess might perspective? period zuranolone use longest way, this to that's regulatory if is of required. particularly within immediate durability therapy the usage seen an might limit a data the safety and response perspective XX-day alone, run what's from from period potential of second there We've goes that real-world course XX-day

Barry Greene

Yes.

then Let me start and to ask comment. Steve

kind belief architecture. in zuranolone - gave positive the of was behind patients science rewire depression, that set we we of can by brain the modular reset kind analytic targeting that So state, a normative can to

duration paradigm the the is we're not to and So going short shift talking That's here. release going chronotherapy. on a a about it's therapy that's be

better faster. how for is thus required. So the what are treated X now seen Shoreline provided to weeks we've far about And data patients get retreatment often

filters So adverse longer we But have event over are has improves consistent, patients profile in top term studies time that fact, without been have retreated. the effect. animals on as for other

back of antidepressants, So to often as think Steve we patients go this They drug. mentioned treat typical seek as off therapy. the off of And and needed very a important. growth. this on call, and they this is on earlier they're antidepressants drug they're get kind as know When off

we patients back they're highlighted that this state and drug drug SHORELINE and they drugs. so data, on the Steve they're seeking get off have though earlier, With even to not off

world. that believe additional X-week patients as we X-week Steve, they'll kind get real able the the So need anything in to to therapies therapy, be of add?

Stephen Kanes

Yes.

responses, of but research, remarkable incremental into seeing to course, the your do most I you somewhere starting show specifically course within we're TV know and the some guys when modeling, improvement a been really well. and to we to this yet. limited of you're have X of don't because alone with - point out, that we've patients remission, these doing end drug, speak Just are label We've the saying therapy really, want and just can XX% improvements, happens weeks, therapy. And your there obviously, of after can't not is By question, are we before, seeing but XX% go let are to about really this data. I - first between - week. talked any XX% We're I a the these

And started we is was forever. which necessarily not opportunity to get of And want medication these program so think data treatment better differently getting keep the the when about exciting then for this part really to a addresses taking is what so patients' transformative. use to us, needs, about and who paradigm, were

that a have think treatment really will attention frankly, add in we breakthrough time the And is the with other is it's very consistent I - why it's, for is limited This study. we've dosing got schemes. patients of kinds we'll something approved, seen after consistent the study toolbox to in and important, it what So already FDA's It's concept after assuming really aspect the the of of terms quite this a could unique safety place. drug terms acute of potentially about in first we think in is study depression.

Operator

Instructions]. [Operator

Nachman comes from question of Markets. final Gary line Our from the Capital BMO

Unidentified Analyst

for quick had is I a This Gary just going Edmond question. Nachman. in

you for programs, potential specific and be looking would great. target? color would SAGE-XXX So Some to around SAGE-XXX that are indications or there be any

Barry Greene

Thanks question. want the that? to do Yes. for you take Steve,

Stephen Kanes

Sure.

where obviously we're - the we're hypofunction look XXX, NMDA or looking disorders disorders. neurodegenerative highest at for We for and For known at level. XXX, usually start we there's suspected

disorders, this little places or executive in other bit think whether may where be autism schizophrenia very where beneficial different be or deficits, neurodevelopmental we that cognitive there's a cognitive well or disorders other there's for For from impairment neurodegeneration. function

So understand those as specific. drug, be looking more And we're are at. the we about areas we'll more that

in be rapid a now drug. It's XXX, it ways. is of parenteral this formulated onset can For lots injectable

where helpful. onset very modulation GABA-positive rapid looking of So places be be we're at will

places dementia, rapid may migraine come the is who in know an settings responses. be talked are of like remains we've agitation where emergency people with interest there it areas very in or severe unmet for So people other where are, about say, kinds things there need Likewise, we or whether potential in the in severe

to be the driven we're molecules already. lot and in them looking is the different where differentiated by we the going to and benefit So of molecules ways of very But develop our we results have a are in Phase than I risk. terms then identify

Operator

for turn to over like I'd closing time, remarks. the this Barry any At back conference Mr. Green to

Barry Greene

joining mission on substantial achieved progress this thrilled thanks, you, and in become the to XXXX half several the with now. everyone, Thank milestones first brain made the us I'm we've of morning. in for with our leader

you business. know, is a As serious all this

in right times. of college just franchises and even diseases our major put neuropsych that For we're that and have of millions. this on are there. generations, with it major families, me society and certain to getting suicide, expectation And let out paradigm up impacts attempted example, us the neurology of potential and XX% MDD committed changes. kids on taking shift health noted getting spend depression, study prepared face massive a to back people on to and recent We're and have people, Many have to

per haven't a depressive your antidepressant left her a daughter your fortunate you're a run whole potentially to enough to it year, that have classes. have you help X Would a get If on Would typical you her or X side to her the for losing doses weeks one the year in effects, room software weeks, gets and with would make after couple college for semester unknown better to pick. vacuum that career. I rather diagnosis take work drug you honor know you discover or and potentially she of disorder. X it's entering of X you might I and

long-term better on deliver can XXXX. focused continue near despite a have of several work will Bye. Sage we're feedback us for everyone. matter the sooner longer. so initially. again, our and medicines into we're achievements year stay what this to rest and The and of better potential have and that the to to The they that's up Sage So of set get day, great patients on of some the hearing team year tirelessly mid- Thanks vision team bringing tales

Operator

today's concludes gentlemen, thank program. in participating and This you the conference. Ladies for

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

Sage Therapeutics (SAGE) 3 Aug 212021 Q2 Earnings call transcript