SAGE - Earnings call transcript Q1 2021

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Operator

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

Jeff Boyle

Good Conference for XXXX morning, joining Sage Therapeutics' you and First Financial Call. Results thank Quarter

details. our current I'll everyone and that well Before we on media of which that as related will find some Officer, the are website are making statements our in by to and our call be uncertainties, accomplishments actual go general results Kimi can risks Chief Executive context. statements, Barry and overview will supplemental our the point may sagerx.com, you press investor Please slides forward-looking section where to expectations Financial release subject press guidance. at the begin, progress; and financials to today's during encourage SEC begin for Officer, I an discuss Officer, will quarter review details. differ Iguchi, Greene, financial release recent today's who out in prepared call who Chief contain and we risk our certain These beliefs. our materially. and and based to the consult discussed as with our additional who joined the of clinical the by Kanes, Steve We'll remarks quarter Barry Chief review first will provide filings then will factors be Medical and

the the over Q&A of with the joined call our turn will We Doherty. for Barry? to Officer, call session And Chief by be that, I'll Barry. Research Jim

Barry Greene

morning. you, Jeff, us joining thank this and Thanks, everyone, for

extremely in that the unprecedented devastating had public the containing COVID-XX virus society. we're of turning pass we pandemic, crisis health the corner As created X-year this on has impact the mark by optimistic I'm the

mission has pandemic, However, COVID while during Indeed, U.S. way out seen is suicidality pandemic, is there's more rates more to of unmet These for and brain while very important, we this increased and urgent and the likely that adults organic deep health pathways. in invented pipeline. of know, the Sage with nearly and advance hidden the as broadening Sage, long-term potential have franchises the in further we the quarter innovative made believe brain the continue we opportunities our who Sage we to our GABA we disorders, value At by a significant modulating new the to the ongoing the the depression further the believe leading top-tier at for about for our need as brain company brain health of efforts exposing medium as short, advances proud long over fourfold, up made address affect to I'm very to And last is a the go. and coming years in neuropsychiatry quarter critically medicines. among of pandemic. in need of will novel real therapies need the the health we across make pandemic, millions XXXX people And there company. this sets are pleased health. of health a transform progress become we've doubled. neurology world alone report and depression, we NMDA first the I medicines I'm brain come, crisis to creation lives biopharmaceutical the and

year. read oxysterol with late-stage highly ongoing our track are three designed and specific applying development out pathways in to understanding chemistries, on programs to therapeutics novel these have chemical of ways. receptors, We modulate unique including endogenous III by Now trials, all X innovation Phase in created currently which we neuroactive tailored this steroids, to have highly

at received the more major of When quarter, XX. response approximately that a starting and with lead received XX-milligram the programs we in than in the had were INDs developing to of achieved after positive two develop particular, to goal adults high-quality treatment zuranolone, X positive and we're Additionally, goal an mid- And committed year or and positive in X showed additional zuranolone this lead our top more The franchise lead support our SHORELINE treatment cohort profile. the line LANDSCAPE initial from to rapid depression of early-stage was patients of option, Phase study data we period. acting, patients zuranolone milligrams from response thrilled data the potential during ongoing who clinical durable, product XX% and a per who duration, programs, have believe franchise. the for evaluating of and and neurology our XX-month development, and XXXX. study, report data our we X-week embarked zuranolone on in day the milligrams treat-as-needed to product interim short we program XX the participants In the required XX-milligram with safety, and SHORELINE reported treatment, In depressive most in XX% data this X from cohort X-week XX-milligram SAGE-XXX, tolerability XX-month need continued III repeat the from dosing disorder. March, initial positive XX XX% open-label the at program, we

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of further be is At for to risk with tremor. formulation designed at Our for don't planned time, necessary. efficacy. data look SAGE-XXX and steps frequency to to an Phase done time gain SAGE-XXX We next at this additional trial of for characteristics goal we Biogen work presenting in a was continued a Phase development plasma with forward the proposed result later to frequency these dosing levels to optimize We're understanding PK/PD to and and the a correlated in IIb work benefit our collaborator development optimize working and will identify essential III. confident the for dose think in

II potential provide Huntington initiate Phase as an a dysfunction. disease from the quarter that important a later with on PARADIGM evaluating trial NMDA I'll the in our towards the a are neuropsychiatry marked SAGE-XXX, progress indication study update want This moment, confirm first-in-class but for receptor this an Phase year also to across cognitive for positive franchise, oral receptor intend we step II pursuing PAM disorders data in SAGE-XXX. associated to we initial a where therapy NMDA I as

as saw we study well data of regulators indication. with the PARADIGM in opinion previously Huntington's and with data as Phase continues initial open-label disease path. Assuming, as of combined reported we patients executive target And support I our on measures our this, executive leaders, data to a support in consistent to function with positive HD. in discussions test encouraging of key function patients course, that Recall, for

exciting additional is SAGE-XXX for disability. become dysfunction. data, but SAGE-XXX will from potential Steve a for Results development for are that important treatment. the the this executive need showed cut of treatment clear demonstrated PARADIGM, data with on of tests in patients previous further similar multiple disease support performance on of days to interim baseline improved it's for very has to results Huntington's Now or cognitive over dysfunction of better very and multiple XX on and a function patients volunteers executive details healthy diseases the function driver cognitive provide

associated to to the evaluate this Parkinson's, to In this track HD addition Alzheimer's forward year, SAGE-XXX, further a in in cognitive later year. and several paths intend other in study by out dysfunction disease to means ongoing turn Steve? with with This on we Alzheimer's to forward. move this more that, completed LUMINARY accelerate on later disease addition for as data that this the read with work to we including our programs. reported have data quarter Steve placebo-controlled Phase additional program efforts expect as I'll II for well for over detail Huntington's X readouts clinical With SAGE-XXX our the disease, we all call to we as initiating

Stephen Kanes

Since reviewing of a the We've the made everyone. PAM progress the oral the cognition of from of well study drivers several the where further of including initial of all and further including and in to our development our Barry positive indications is our disability, great PARADIGM program, our as one with results mentioned, day, the today. potential the majority X Barry, date, PARADIGM therapy in SAGE-XXX, for the as as SAGE-XXX study. zuranolone next to main as good PARADIGM vision across we're progress Thanks, results announcing encouraging for towards morning, disorders is news positive of development the spend and minutes franchise the SAGE-XXX neuropsychiatry data supported NMDA very like I'd and receptor HD and franchises by from the results path our as

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has exciting impact cognitive by domains reaction which nothing in the has enhanced that in data key including without Huntington's but with often now learning looking simple To with there's knowledge, beginning approaches. challenges disease, in The what's then patients volunteers amphetamines. other Parkinson's we about augment clinical and with potential true cognition, suggesting is altering ability performance not function. cognitive positive our attention are for to generated profile. and that development time, on while of showed patients to this were not kind function improvements and date so healthy associated executive SAGE-XXX multiple or And domains saw with and typically attributes of a memory, disease, executive So SAGE-XXX

this treatment. patient Turning data frame, in provide have population, to new approaches that These been we've seen Today, the with reinforce disease. and note Emerging X also on To impact important functioning suggest to PARADIGM. study, to data of and PARADIGM extend are patients that of signals attention there study typically I'm aged going the what had XX cognitive baseline of date, from now disease previous brief to on as improvements patients currently study Parkinson's speed, It's Parkinson's on no the like also of that mild X summary a learning in with in the initial cut. XX mild findings psychomotor daily disease. time with X SAGE-XXX from patients PARADIGM performance associated due old and II to SAGE-XXX weeks. stimulants. years cognitive finding another being evaluated luminary other in the days to Similar an milligrams multiple there impairment tests in executive dementia demonstrate are improved Alzheimer's patients earlier is well in over in with similar with who impairment findings cognitive study, healthy received important tests as XX disease, Huntington's for in volunteers signals and performance over as a SAGE-XXX mild study due Phase to memory open-label

previous As tolerated. was studies, well in generally SAGE-XXX

and be adverse SAGE-XXX across events trials, a of any adverse treatment consistent promising events It's all have repeating, to not to or multiple demonstrate these to events aspects SAGE-XXX. adverse serious treatment-emergent continues adverse SAGE-XXX to worth serious cognitive no determined no impairment. were related were there treatment-emergent related profile potential seen studies. to early events we a address Specifically, and from as

a I next forward steps. in I'm in PARADIGM in data in SAGE-XXX earlier intend the to also to has we similarly inform and reinforced SAGE-XXX the performed the PARADIGM disease move data where activate population the our an patient from Huntington's PD PARADIGM The and decision additional in trial. Phase gather study, of excited performance dosing so And study arm to by X-week

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conditions We to with ability NMDA have very deficits where high ambitions patients' for our cognitive impair platform, independent lives. the ability lead to target really

And neuropsych disorders rehabilitation, we SAGE-XXX, is SAGE-XXX, for advance NMDA later year. plan PAM ongoing PAM we and potential hypofunction. in disorders a Phase with evaluated This an to that which complete to to expect year. addition oral preclinical neurodevelopmental In an studies potential use currently this study cognitive also being recovery includes for to oral an our this SAGE-XXX, evaluated as NMDA and franchise associated other candidate product being NMDA therapy I receptor is

baseline down the accurate, recently franchise. to essential either line tolerated. could of XX studies, days at to top and and to in motor our XX matched XX-milligram tremor, KINETIC the Parkinson's earlier evaluated comprehensive end primary receive with has and upper the to activity in old provide to milligrams be in our been score additional double-blind demonstrated Item the announced for were placebo XX weeks. also SAGE-XXX period X study, designed with opportunities, daily XX well the the to TETRAS of physician-administered an for tremor or believe treatment was living. are pharmacologic an in Subscale, limb high disease. open-label a XX aged of well was randomized milligrams shown measured range XX X:X from morning of to Phase daily SAGE-XXX, epilepsy years now study of not symptoms we positive of study dose neurology XX placebo Performance from scale the XX data on if SAGE-XXX X follow-up a be patients to XX characteristics, SAGE-XXX of dose II once essential but correlate In suited of by tremor. TETRAS daily or in essential only We not development Turning deemed titrated assessment day The as trial endpoint tremor The compared changed In

as receiving at development the more profile patients generally of Score to were are of XX Adverse safety dose, optimizing the TETRAS Limb TETRAS XX% who received focusing disorder, occurred in for expectations tremor allowed tremor protocol, baseline exceeded patients patients patients XX% dysarthria We X and baseline patients Upper PAMS. baseline group statistically analysis the were XX-milligram prespecified to to as twice patients placebo in discontinuations by met on Upper reduction SAGE-XXX a we're noted SAGE-XXX full These tremor, XX% receiving of Limb X.XXX, diplopia, SAGE-XXX amplitude to from Item Treatment day dizziness, SAGE-XXX emerging which ongoing a unmet encouraged the dose severe with more high for a placebo day Performance from Score for endpoint, XX of and in Item need. significant at collaborators in for study with its in pleased statistically In TETRAS tremor, a our SAGE-XXX Tremor Subscale reduction versus deep and adverse disturbance. rate compared disorder upper at in SAGE-XXX corresponds of XX in that that other from the Upper at with and as least Limb treatment a data GABA a higher, median XX balance with date a a a at of baseline, amplitude with a at events our Biogen. corresponds group potential seen or and or the Tremor XX% with X the primary We're XX% with and of with of reduction XX% a demonstrated in of events to SAGE-XXX. dose, high XX% X frequency titrated that receiving set X.XXX down p-value placebo. patients compared placebo. somnolence, consistent in along were from day reduction SAGE-XXX p-value by the Item in tremor essential an significant limb placebo compared reduction study the to in reduction essential baseline in of

we're in As dose Barry to a essential confident tremor. mentioned, the frequency for further our development chronic treatment and ability develop regimen of in

a to Beyond good investigational potential social even solid in absorption, formulation high extrasynaptic interaction. receptor-preferring neurology We're acute oral areas SAGE-XXX, PAM agitation, potential our potent viability need, mania or advance preclinical of product migraine. GABAA includes with disorders studies planning with including an of also SAGE-XXX, franchise rapid and flexibility unmet use in SAGE-XXX, to for

to reported to SHORELINE and and tolerability year. which our milligrams X franchise. evaluate depression of study disorder Phase positive Turning safety data designed patients for In was naturalistically the in adults III to from depressive major with continued we follow March, our up zuranolone XX

reported XX-milligram top an less participants XX.X% or points cohort the more score the remission XX, received by than positive as XX% baseline single total continuing by XX.X% of change achieved the in of mean initial additional milligram it Approximately XX.X% day XX.X% study. response. X at received Of study, milligrams XX. in the was In zuranolone was course, study X XX used X. than patients a patients required consistent the generally a XX% XX-month baseline reopen in data to and with X.X% of of XX-milligram XXXX patients courses. XXX of zuranolone used after remission. XX% SHORELINE achieved In patients. the late and reminder, the the XX-milligram adverse achieved line to We treatment, initial both total total response XX-milligram XX.X% announcing of zuranolone. with from Data include the at change tolerated SHORELINE from who zuranolone X initial and cohort enrollment plans used cohort when the in in measured a XX.X% milligrams In during expanded XX.X% a to XX cohorts, a mean May showed day cohort patients patients reported milligrams remain a report response also was As on courses, to XXX of XX HAM-D equal only initial of well total XX-milligram XX. day with dose XXXX. the of We're positive of with courses, zuranolone data a XX.X the the of weeks used earlier. response of cohort from X the XX courses, the the an used HAM-D to who XXXX in from X XX% was event XX-milligram X and enrollment that target expected study, amended data of course, to track profile achieved week And treatment increasing XX X-year achieved treatment treatment most

plan financials. was readouts multiple an ahead entire year our to review of turn for us, that I'll the including Kimi over to order positions progress about the in additional the we Phase SKYLARK milestones and This continue track study, by the with advance And for over across to first to mission quarter III the study from call data CORAL medicines to We're Sage making completion extensions III treated several SHORELINE long-term well patients offer half patients finally, Sage into and with remain our allow study the report CORAL Kimi? marked expected. following believe front to the excited Phase from CORAL XX roll top data in pipeline These by now line the matter. pipeline. of accelerate and WATERFALL collect this end to year. We important Phase we this progress us the our III of year Additionally, studies milligrams. study. of on on the zuranolone to in the ability from expand of of a

Kimi Iguchi

Thanks, Steve.

a of X later great start me as data to Sage in another start positive to trials trials the this result off read X including and determination quarter execution. another congratulating team great pivotal from with on a commitment, track by year. their We're on reporting out X, Let XXXX,

for collaboration the As of provides and our By operational wholly first full quarter and reminder, XX-XX the of for a the and and to SAGE-XXX. transformative zuranolone only development also SAGE-XXX includes zuranolone cost financial us and United Biogen profit collaboration expand this not near-term This enabling SAGE-XXX, design, our but flexibility, in is with zuranolone collaboration in States. potentially in our our owned accelerate pipeline. products increase accelerate investment in sharing

our now guidance. impacted ZULRESSO. let close the of financials compared from through our million families those So $X.X by walk sales PPD. me the million and quarter some on That highlights We $X.X was all of moms, for in were to then on of remain the to same period thoughts and first their Revenues the committed first financial quarter XXXX.

treatment due programs a of compared SAGE-XXX ZULRESSO to the aim moms in result from million was during reimbursement expenses the efforts quarter were the commercial targeted with restructuring first $XX million first administrative zuranolone with Biogen same and $XX Our help for million on may primarily XXXX. million period and the expenses to was Research was underwent access. Selling, CORAL XXXX. the clinical for in primarily ongoing WATERFALL The $XX to and that decrease in to our offset $XX in The development quarter SG&A study. expenses the compared the second same company related XXXX. to the quarter, were spending period decrease by increase an $XX of the and million gain who by of PPD of benefit general

to and expect or SAGE-XXX the collaboration Biogen this will performs in but continue new investment representing programs we forward, SG&A launch, prior a and expenses on the will XX-XX sharing Biogen for approximately program costs of SAGE-XXX. zuranolone baseline SAGE a spend XX% of Sage, to work. Collaboration regardless whether of to zuranolone related lower R&D as be spend Essentially, expenses Going shared total U.S. advance, will in represent increase in establishes the for net with

our XXXX. us our was first Additionally, the comparable quarter XXXX. reported compared of $XX period loss invest $XXX SAGE-XXX engine. wholly in That including discovery further to the million We to pipeline of this and allows a of owned million for for net

year a of Finally, first solid not marketable we billion. XXXX cash expect $X impact opportunities in handle cost-sharing over maintain I'll anticipate with Biogen, will pipeline billion the if continue securities. of assets hand cash than financial million The allow the equivalents creation sequencing and Q&A to the collaborations long-term addition with us we continue to with turn cash operator. and more thoughtfully, ending people any cash, payments ending and foundation, We our on balance for and to worldwide. create work mid the XXX in the $X.X to invest with quarter more from to and it year stakeholders, during value now milestone do positively with ongoing a to than expand Jeff? Jeff to accelerate will the believe near, the potential, we're successful, to

Jeff Boyle

Kimi. Thanks,

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

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

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

Operator

[Operator Instructions].

the come line question Salveen from of from first Richter Our Goldman will Sachs.

Andrea Tan

more Andrea on you Salveen. could on just This color for just is bit Maybe cohort looking dosing you're this little a PARADIGM what study, there. understand on to provide additional the for X X-week if

Barry Greene

out start detail. to additional I'll turn then for Andrea, it Jim Yes. over and

data franchise SAGE-XXX, our SAGE-XXX sort disease NMDA studies. the indication and with the asking about you're our by clinical continued we We're we're seeing forward receptor of as through modulator in first as into very out excited initial And progress we're today. safety neuropsych excited really efficacy about SAGE-XXX. on profile reported we by So that talked Huntington's and the the and the call, LUMINARY

to package. doing very Jim looking program study. or the we're So all advance some we robust learn and X-week about drug we SAGE-XXX, and specifics more in with more as a have X-week In all, development, maybe can talk

Jim Doherty

Yes. Barry. Thanks, Absolutely. Yes.

NMDA the of excited in populations potential Barry So I today said, platform we're hearing Steve seeing you're And multiple that of very we're the course, consistent from now. think for types about across of one is patient for the and as SAGE-XXX things general. responses

design some study PARADIGM to had So for as done we was things in previously. of as keep possible the the to close what

only population. we're So patient varying

design had because period. to X-week of done PARADIGM what we a was for the so dosing similar quite And before that,

Given and that and we're done and seeing this today to here results the investment made information collect past, the learnings continue as to as possible. much trying trial point, that the the be to in get we're as efficient to given our we've leverage we've

so give a are dosing B enter longer whole program. of the part to information advance the teed us moving slightly on to up understanding to going patients is that And some where to trial interval our into already

Operator

comes from Cowen. line the question from Ritu of next Our Baral

Ritu Baral

I color the get your safety upcoming WATERFALL helping data. to us inform on wanted

conversations what is Specifically, I've with about is of clients acceptable had and somnolence. lot a sedation, what acceptable

Just somnolence? there of written where what's the to what either how And a in actual we rates public on going each. a MOUNTAIN acceptable? And by about higher to threshold, the think approval is back FDA believe, you X%, complicate or should on I sedation X% threshold data, saw domain given dose, might

Barry Greene

Yes, Ritu.

think to and start I'll we more of me be out the to for specifically then Steve a WATERFALL what looking we're Let some has transformative why out with ask and medicine. talk context, about zuranolone potential

extraordinarily patients. feeling report onset X we've X,XXX the days, patients remind subjects consistent. better. to X we studied So seen is that you zuranolone seen they're date, and We've to in in of have And I'll profile action over rapid

we the year. and safety and As if patients repeat take been dose And not. said, doses events, weeks X-week adverse to and levels. important I years' dosing, hit or of patients is over because clear, endpoint, what we we and seen X requiring worth X the said, drug most efficacy in we've literally drug patients the specific we've have weeks, we they XX we're given X also necessarily reported zuranolone, what on primary a XX, looking numbers faster stay is different profile will X, in And LANDSCAPE. both of remarkable a it's antidepressants, of profile unique here, What's the X be data, compliance. to X And get XX maybe better, X won't that or weeks, not dose of the seen here better. at the and for of everything entire so important medicine weeks, benefit with the only whether for the SHORELINE Steve on stay just very risk has consistent And remarkable

ask Steve provide color. me more Let bit little -- turn a to to

Stephen Kanes

Yes.

thanks Ritu, question. the So for

is these unique profile, that, their in the are interviews the weeks limit we're for disruptions. patients' and and terms first to trials that's And any profile, as from We taking we bit event information the adverse one, that low have desirable really believe that very you really of are smaller what So something can of look rate, people often of on sleep as we much your exit in profile would might for the few are dropout dropout to sleep. that somnolence potentially is a in well additional leading Remember, like. every benefit terms taking clinical be from a often Number perceptions and something do things. people patients with both case, remind to beneficial. many meds and get in I Many this help clients that's rate of our foremost, medication confident the not points trials. them depression, patients use. X what's

to if that treat now that depression. second The numbers the reporting is right many are are not we're than better, drugs comparable, actually used

the take I'd approved a sedation the have for even for we that antidepressants and parameters advise are to drugs somnolence, use. And antidepressants. look that are people of are either the And forth, depression, treatment so labels of the standard that well for within common so reports in at

is profile data, that to the now overall going right forward terms in We're looking patients. So one WATERFALL beneficial confident we it's profile. the of the we're know for very but to be

Operator

from Our will Bank the of Ahmad Tazeen next from question America. come line of

Tazeen Ahmad

based just work on on it it done, good I that we've of guess the WATERFALL day to study, the relates you durability, terms should have XX, like data. seems as in

these to for I doctor important that your things guess, regimens? have response the have how top that at to maybe say, beyond a of based would XX, is line? on look all, of that that durability information longer And feedback acute term, we first As longer available you nature, treatment of

Barry Greene

Tazeen, Yes, thanks for the question.

turn provide a bit -- Steve me more. I'll start little to and it to Let out

drug. looking just there our and statistical patients out excited So we're we're the significance data. WATERFALL. soon primary that what better, me And really in envelope We're gets let for keeps the very looking better. and them nothing endpoint is clear, the days confident There's to opening for forward faster be very having this in XX

hopeful secondary looking Of the show all at we're promise. and course, that they endpoints

is the again, effect For p-value we're to drug not more? of you looking But of want primary a little is the placebo. day for Steve, aspect important XX, most versus arm, do bit consistency the necessarily provide in WATERFALL. point on end what a

Stephen Kanes

Sure.

years, in was is for depression. understanding happen. you practicing to of what's I treating going thing with patients important many in exactly For the psychiatrist most consistency response And look

symptoms to an we've very understanding been after medication. to have The remain really don't date So after an has bounce They study, well over patients had X consistent. in few MOUNTAIN expect Majority a weeks what of is recurrences we back what the concern. and dosing look the for an well. data of of and somebody of seen takes the fact, in X And the very remained as even immediate course months. patients initial

during we've seen critical proportion that are is follow-up patients talked Those something stay well So to of our what what about while require what getting may we no more XX, XX% than proportion absolutely understand as what the And at data of more as WATERFALL. before, primary day well want need of period retreatment. patients patients endpoint we're we've for is transformative year. understand for therapy. we're for course LANDSCAPE We're about absolutely X the X as the so treatment than in what's of about unique patients, in additional essential over program. That's both for That's without WATERFALL and entire well as and need XXX, year, talking it's the weeks to data looking weeks what that's a that. treatments of XX a

profile think really patients are we And that so we it's successful. important be to is for going really, a once

Tazeen Ahmad

And will top that at of the line? Okay. see data level we

Stephen Kanes

prior key But as endpoint of the on the we're said, done in You secondaries can Barry look to release. we well we've as to releases studies. will what sense focusing information the of a the similar things to very have primary you that are that acute kinds as the give our for other

Operator

Sandler. the question Rahimi Piper will line of from next Yasmeen come Our from

Yasmeen Rahimi

the enroll you. Congrats great behind to XXX in the additional maybe into PARADIGM very really for us. Is open-label just patients interest expansion on color an with arm this for on what little data question SHORELINE around the prompted carrying understand thoughts wanted progress increase the One for from us. to based If the would I just increasing CORAL. had could the communication open-label you be on the numbers a helpful you bit regulators? that put in to

Barry Greene

very disease. today moving the actually by on so Parkinson's by for disease, appreciate I positive we're into question, the Yasmeen. data We're thrilled the data. very that in presented note for Thanks supported Huntington's and data excited the emerging much SAGE-XXX, congratulatory rapidly forward we're the

continue dosing. and in SHORELINE. require news need foremost, good about clinical that should Look, X-week another back the did, opportunity, that prepared patients question So comments note those very as few course to but we your yet an patients And is of CORAL, to you'll rolled of that Steve's studies, wanted those responded patients doses, additional off first again.

other wanted a off with zuranolone of to rolling other there. other zuranolone, particularly you patients offer out Jim, CORAL the got profile promising to So thoughts? risk for patients benefit and by benefit and those we've want very opportunity

Jim Doherty

think program, of patients set them as are that I point, are the is Barry's for of there's thing trials with add the most in it, to the Barry. covers of CORAL, an would I to And there lot are off SHORELINE. of what opportunity -- view integrated say But ongoing other to LANDSCAPE a SHORELINE. to of it a study is going in for going therapeutic in our approach. to seeing naturalistic our to value information participate it's is useful continue that for transformative be quite we we And provide believe rolling

we likely to opportunities more And gather data to on very will deliver looking all at and continue information overall zuranolone, to very so SHORELINE the were program. important

Barry Greene

there Yasmeen, fine regulatory to Sage at specific increase This Yes. or a put patients. all to Great to just comment, a point, no regulatory highlighted, more provide to get end. opportunity and And data was as Jim no Jim. requests decision, benefit was requests

Operator

Our of Cory from from question Kasimov the line JPMorgan. will come next

Turner Kufe

This is Turner on for Cory.

since also just any provide your Can what but stacked Huntington's on up saw seems going lead of So it like what improvement on to the indication that kind relative relative just Maybe XXX. one granularity cognition? seen you of how we've additional you sort in disease forward? expectations, in to

Barry Greene

Yes. And the to Steve question. address ask that. Turner for Thanks, let me

Stephen Kanes

for at executive looking is we're other What areas look as into function to Sure. memory. but both move not learning just we and

patients we reasons. really different function, expanded different populations domains memory. for looked but of One, we and that's patient think So is X cognition what in we challenges. not saw as important improvements executive at these only have learning the And in we also

Parkinson's, will we lead understanding In And and So going memory. where learning as there's into executive hypothesis that also and memory. executive function as we dementia, learning as so the Alzheimer's think into in. our LUMINARY that our move Huntington's challenges is and well are broader primary was primarily, both challenges function, and

as XXX, about So inform we the really indications. more utility, as in its that more as and move learn we will and the mechanism the well other how Huntington's both forward the

Operator

will next from the Our of from question come Laura Chico line Wedbush.

Laura Chico

I question. back circle SHORELINE wanted to the just on

enrolling probably is the not once additional cohort the of like have been the the envelope, of expansion I zuranolone? it guess, would study then So SHORELINE just you I and And of XX said over would trying complete. XX-milligram FDA is dose to CORAL I'm did back you plan for data, seem mg a there's understand, the that a guess longer-term with for X,XXX dose subjects patients, the still any submit at to the ask a but on there filing

dose the how of everything So to understand terms fits the XX-milligram regulatory in just strategy. trying into

Barry Greene

context thanks Laura, me provide let little for more. broad the a Jim Yes. ask and bit And question. to some provide

So your is math close.

to We the the end WATERFALL significant successful. the when the be ongoing discussions should FDA with a will have successful FDA submitting and package

no data. was there expansion increase agency specific by more patients the opportunity and to was the end, SHORELINE earlier said provide I what greater for to request Just was and

as and, need. desperate investigators, we're from We requests KOLs patients tremendous in course, you also, getting can imagine, of

expanded out Before the can With our studies to doses drugs, program. we multiple access most read turn are good out, have.

XX- the do Jim, XX-milligram a bit we more? both little dose. you talking can about a plan agency, and on to provide So But

Jim Doherty

Sure. produce to Laura, I way a entire the think that think is is the Barry package this of zuranolone. said information program about designed it LANDSCAPE about we well,

data our including ordinary. be So filing. absolutely, the drug the in included the zuranolone, yes, The and filing. data included of around potential data be isn't all all discussion out on that anything on itself the will the set really extensive of dose will of And any will XX-milligram the be in

Operator

Our next Wolfe from question of will come the from Tewari Research. Akash line

Lie M&A

only on a MDD patients Lie Recently, Akash. they XX if is practice for they claim days. choose treatment mentioned for This couldn't

And WATERFALL the XX. has of And trial only endpoint zuranolone placebo? differences zuranolone? enrollment with WATERFALL tend it with trial we they your and noticed also has day addition, data the of look about XX about XX filing? FDA to the power versus detect case, So XXX the patients their lastly, drug increase XX% is and X arms In -- of think completed supporting XX? HAM-D to XX% candidate. durability at open-label sorry, day if secondary that HAM-D In XX how to XX% at the versus XX did to dropout have important HAM-D for we fair look X.X about also of like study subjects XX And XX SHORELINE data Is rate. scale for to at X.X for XX what's the cutoff to evidence view WATERFALL -- MDD we sorry, how the

Barry Greene

Yes.

in I a there. questions number are of think there

ask So Steve comment. and provide want Maybe to of let me might context to comment. little Jim bit a

So look, again, we're the very WATERFALL excited by readout.

end the are health brain a States in X-X increase Unfortunately, the fold previously, alone. United about talked I twice. opportunity we we had of on the And commented as As call, we rates pandemic. are the in the depression to

MDD lot greater from we had there's at a the So to suffering than lockdown. out unfortunately, rates people prior of there pandemic

profile on XX. provide powering statistical significance increased that to end developed day is What the and being we're want this a endpoint. you the Steve, bit differentiates benefit from, very primary do significant that. XX here provides is the That in excited -- again, for drugs So little area, such of years at by unique more? risk we're looking

Stephen Kanes

year, interested FDA see show data. to gotten itself they're have to the with followed The program the this is us And are FDA study that at when That's in look XX% we got therapy patients we day what this differences the happens half designation, And weeks to better naturalistically designed a XX. have for to get what's better early actually had -- breakthrough need way ability of Sure. the unique to course what as treatment. at no about program. an them about differences year we've agreed day is patients are two seen treated reason required X only -- than breakthrough, meaningful why the is clinically looks like a treatments the then we that was SHORELINE require real It's as pattern to that X, significance X, seen profile. And patients only statistical that day patients more over the what The day we've benefits retreatment. require maintained. assess terms of within XX, overall is upfront in and plus for of X in is again, and what and where when patients those for these use of

that a used unique And So lot in works of a profile. very life. this a overall information gives it's how real be would drug rapidly very about us

a continues our XX, very day support and it we for the being aspect of remain that idea essentially from absolutely improved, patients episodic essential for data well. that we're database comes treatment. growing -- primary to have now that, to SHORELINE, real really to around So and looking The see have substantial and

Operator

[Operator Instructions].

come will Jay from from line question of next Oppenheimer. Our Olson the

Jay Olson

Biogen. or about study whether to with you're patients? disease think XXX I indications Parkinson's epilepsy just SAGE-XXX, and to in you're you the program about pursue curious leading the or planning that plan Can development I'm talk not you

Barry Greene

question. the for thanks Jay, Yes,

really thought about we're a for very a and franchise. excited conditions, chronic for differently neurology novel potential we it's movement look, disorders. So We believe about treatment treating neurological

is this tremor, over if first new successful the treatment XX will the essential initial years. in be So in indication of it

that. So we're really about excited

Biogen, with that mentioned, to into we're that step number offer? indications at a we'll the that our once map and essential very profile. IIb, talking additional believe reach we additional frequency and Steve, profile tremor. do Phase then dose III next dose in With a else of we'll I As a is that but profile of and we're that collaborators take in a pursue there frequency over out can and SAGE-XXX indications, we confident Phase to to commercializable anything are

Stephen Kanes

Yes.

we're daily profile investigators, I one with doing as that and This closely really think that is now, see exit with say participated tremor patient advocacy hand we're what we tremor the exactly working our looking we're we're patients data of even living. is correlation We interviews in looking with for of on when activity the been at to looking trials medicine. in And I'd what groups, for, sometime. being look that's working driver we've quite disability. patients essential a a understand that what can with the right improvements speaks in upper dial to limb we in something for to they're

it take unique, think really only the of it's to we that XXX is So growing but something approach understanding that overall, a that example not we R&D. is our great of something is

have preliminary had other in but essential areas moving interest on tremor, in epilepsy. we in our now, we Parkinson's, is Right data focus of nonclinical broader these indications, Jim? So other some data forward. certainly

Jim Doherty

little indications little about neurology franchise. as to the X human science do a a things Yes. just to a bit a was the potential with about we the talk that in on about we other it's lot XXX, way for was Maybe And build Steve general. and we following think data. in question And saying, just -- The with see as lead molecule R&D leading bit.

from there potentiating that's could molecule a following like benefit populations case, for delivery. optimized the that this profile GABA are means science, SAGE-XXX. patient potentially with who multiple chronic especially And in we that And so understand

look program have leads in that on for do Parkinson's would earlier you've indicating us And the point be with and an been in data of tremor, we leading at that program, moment absolute the And so got to human epilepsy. second mechanism disease, treatment essential data efficacy an as from preclinical of preliminary and our focus although potential at molecule valuable this data. raft hearing, we've this is key that

be So the that aware subject a that's that for there's groups a but potential lot as neurology essential other that are key is the of the now of we well. neurology for think of potential value in for is in of, focus there partners tremor, But ongoing franchise, and our conversations. the of and something lot well Biogen will molecule

Operator

line comes from our next from the Matteis question And Paul Stifel.

Paul Matteis

later, then in drug about Great. study were contingent this in the planning? would PPD, kind If wait? fail, Have in postpartum And then CORAL initiation succeed, with what's would the you bipolar upon status scenario launch all of MDD? and and anxiety we or depression? of to guys figure you III is of of future out talked you trials what the And the at Biogen studies but see is -- those WATERFALL and Phase everything separately, kind were to else

Barry Greene

thanks for Paul, question. the

in highlighted with consistent. adverse it's very remind durable been has I'll and and Jim days, been highly been patients onset of you X,XXX or Steve subjects over I with the that again, now as an has with consistent X rapid seen data and zuranolone So X have we've effect, event profile,

ways highly and So unique X the mapped potentially you've that to upcoming approaches, to us we Phase MDD, on with X as have by We PPD. III agency down readouts. in sat And encouraged the are believe an X drug market. unique get approval the different positive to data needs we out those X and a highlighted, be to of for

with at So positive with level, the scenario PPD paths many potentially approaches agency. in a plan we with that not we're share Phase we here that here. we other And X agreement very out detail. about enthusiastic a Yes, and high III any but as important map forward And believe very Biogen. drugs, an have MDD not those as for drug with see believe And X that's need Biogen we'll all more about only we but and indications. we very you

Operator

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

Andrew Tsai

this see guys around an is And think don't but are just for you My this, you, question controlling curious been I very I good ever out you've taken to scenario be WATERFALL. to steps happen. see know at has day response and ensure to I'm to what XX. issue how you a wouldn't higher-than-expected just are the won't Basically, there confident I'm placebo curious

Barry Greene

Andrew, the the make thanks that. of comment, Jim over to it talk And let for and I'll conduct the about Yes, me highlighting turn study. to

So the our aware. with indication, as safety increasing WATERFALL, the large a It's very with database. end increasing all data, in SHORELINE you're we're

So safety the database, better. the bigger the

tend Phase we've changed do III not delivering the and we results year, to for half this to committed in to line Andrew, first that. guidance. We've Importantly, of top continue

forward control, enrolled, of the progress of there? entire looking want to the about enthusiastic specifics and thoughts we're about It's talk program. readout. So placebo, fully we're Jim, the the you to

Jim Doherty

the for question. Andrew, Yes, thanks absolutely. And,

the As I And the learned put think much of And controlling of is the have program of to in thing trials focus think think I talked is that that design WATERFALL modifications we that design a multiple and answer things many about like we've remember that's in for on made WATERFALL. we lot placebo very view other effects. and on remain the our important through in the we based things the know, lot LANDSCAPE thought But you learnings. design I a into design.

do about with WATERFALL we is something very that and is be doing I think rigorous what are study. again the we our execution, try to that

Operator

the Citi. of line Neena from from comes question next our And Bitritto-Garg

Neena Bitritto-Garg

in are I'm this point know statistically -- about from meeting kind in So of next of WATERFALL? on after -- WATERFALL. there I differences versus on not just just number given SHORELINE long the significant, a effect seeing there of steps in necessarily is there I you're curious But differential is there's depending kind the you that studies. as the you've just path envision is study next data one see kind really between REDWOOD depending forward? as of magnitude of being placebo, do there And of the steps guess, talked or that any drug other and it's assuming differences you kind next at big, the steps, about kind of it

Barry Greene

other take And if him. ask I'll for thanks it. color, question. the Neena, Steve Yes, has

So adverse a at significant statistically said, WATERFALL as consistent the XX. we an medicine risk that on and exists in anything that's seen in have counting already important we today. patients, subjects we're over what with than X,XXX profile and we market very with differentiated very a for is event we've day a that's result If have benefit what true,

have and looking we we're a drug. I And the extreme So statistically significant think at for. that what patient unmet day so that's need XX, is KOLs, appreciate groups the regulators that

we're matter for looking extent. size to statistically effect matters really some data obviously, But significance. So and

to get submitted to went where into timing want be and down kind of We data had next that be an very steps. rolling for, file with be of into we just a is on we're is CORAL. looking a mapping WATERFALL. clear, we positive, X-month major could also could agency out situation key readout not A WATERFALL should would submission, readout, to plan and filed NDA, the another sit a Our that We extension. clear start

wait agency CORAL, we'd WATERFALL So for CORAL. clinical both want to the should session whole see the and likely

with We're today, all needs you be WATERFALL question a filing We about talk question soon asked, regulatory will data requirement might now, a map that you as to to the out agency. be asked. a safely we'll times REDWOOD a not that that year a That's positive SHORELINE very as commitments REDWOOD. for was it post-approval treat assuming can not effectively asked data WATERFALL, to a confident have exists NDA. that I'll anything as in how really have Steve, many other add? you patient? and right we Now before the remind existed, we

Stephen Kanes

program, only out very unique drug study, identify a closely medicine The we are profile, aligns with started when the this we interest. a set endpoint. approach. we're SHORELINE day acute quick, I'd say from effects, with is Yes. XX they're It's that that's and data intervals. really long treatment-free to thing showing a that effects supports patient the get we we're What durable, that that The next is the looking for where

So that important. is absolutely essential, and it's

I'd The What the is consistent. very versus been sometimes effect effect people across that about other seen we've it's board, thing add size. wonder

and the rapid Our drug large, sustained bit. quite group, varies a in placebo improvements

primary so why we're prior confident statistical around the filing. very here goal And significance that's in being to the endpoint

Operator

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

Evan Hua

This filling is for in Gary. Evan Hua

in what SAGE-XXX, the when looking that like cuts data? that in of the are of protocol any of months some of be the there And population? you terms you'd patient Phase additional several regarding next So if dose, help inform would and for terms forward at release move could in next Are timing IIb? developing how so, data you steps dose of

Barry Greene

the for Thanks question. Yes.

hit high ask Jim it. me about and at let it to level a talk So

going will through the couple the data, IIb of looking So those Biogen the Phase Sage and we that ones us KINETIC profile help dosing pouring right likely actually make and dose, data different of to a is have we'll team the value test frequency, III. into PK/PD Phase the of at duration, at design detailed looking and sure

where we're saw worse particularly and XX very you in were patients essential a the any So reduction patients. steps? these XX% patients readout, important next about the specifics by that we encouraged Jim, kinetic tremor, very talk want for over to the reduction

Jim Doherty

what we event effects mechanism the Barry. the when And over Absolutely, a sustained on results about Yes. you the period understand we of the action. adverse KINETIC, that's earlier, profile and with consistent an with think from as primary heard about statistically significant XX-day drug endpoint about and

efficacy about because was see. to we the which So we the that can question tachyphylaxis efficacy, that's be answered see we from result excited KINETIC can without see we're

for that for is that program drug a a on the of XXX focus us dosing been IIb studies. Phase we'll the So the II pivotal flexibility rest half-life dosing the use the lot And long exactly of is optimized dosing and in gives remember, chronic strategy. strategy on that's

focus. mentioned, that's think different that be And of at Barry there the modifying. look as going things can we number to so And are I a

frequency, we're So of levels, number dose there that dose aspects certainly, looking are at. a

And teams questions in IIb. those the so figure to Biogen what's Phase most will Sage efficient the way out and answer

Operator

Thank you.

all call have over Barry remarks. I'll that we for Now today. Greene is for time any turn the back the to questions closing

Barry Greene

Thanks, this everyone, us morning. Thanks, joining for operator.

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to all. See forward discussions. Looking further you

Operator

This you Thank call. participating. for concludes today's conference

disconnect. now may You

Sage Therapeutics (SAGE) 4 May 212021 Q1 Earnings call transcript