SAGE - Earnings call transcript Q4 2020

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Operator

Good morning. Welcome to Sage Therapeutics’ Fourth Quarter and Full Year 2020 Financial Results Conference Call. Currently, all participants are in a listen-only mode. This call is being webcast live on the Investors & Media section of Sage's website at sagerx.com. This call is the property of Sage Therapeutics and recordings, reproduction, or transmission of this call without the express 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 XXXX call. for and morning joining Sage Therapeutics you and fourth full financial year conference results thank quarter

in Investors Please our Before we the our everyone Kimi Steve the where additional Officer will who who section slides encourage well in differ for begin, some press sagerx.com factors release Officer our opening forward-looking at can the may details. With Officer Financial statements, today's that materially. financial supplemental & statements results call I will making we as me actual Executive remarks. like provide will to website as current today Our review to of consult progress point you Media go our I the Chief SEC to context Greene, our find are are certain risks on related provide to These Barry who a that set are filings overview. details. release and our out which expectations uncertainties contain would to beliefs. on based and be risk Chief and Medical and subject and our Chief call discussed today's clinical Kanes, to-date the will Iguchi, press and the

by turn our Chief Cloonan, with will the Operating Mike I over the call We Q&A will to in be then And that Barry. joined Officer.

Barry Greene

the of in to pleased to and the Thanks Sage demonstrated we're terrific of you been Sage top this to and to additional challenges the and The on XXXX for Jeff. with morning. year end of the of commitment And thanking determination significant despite and beginning build I'm progress XXXX was challenging and by our and stage for in ongoing everyone again injustice all for entire With us raging making work racial we joining to and throughout to these efforts company. that we're pipeline. a to have team Sage done once execution work development biopharmaceutical top-tier headwinds grit update eliminate us U.S. due in the XXXX programs innovation on discourse three to that particularly XXXX be proud highlighting however and a phase science, a health was Today Positioning year engaged become and a through. our had across with brain political destructive racism leading the pandemic events the Sage see to late XXXX company. XXXX trials progress three this readout five marked year. have into

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Steve Kanes

portfolio; possible now first good and with on I were overview X needed; Zuranolone from course NDA designing begin six opportunities and and initiated studied needs. Biogen. with to PPD development being our for paradigm of of the an believe paths as track more collaboration of morning be patient we we've and approach. major studies phase initiated XXXX episodes learnings the phase of with year. half Zuranolone three that XXX the PDD. will enrollment X the to ongoing pivotal treatment data which Last that in be pivotal postpartum everyone. studies treated innovative Zuranolone. achieve this including and diligently closed further lead disorder to a treating study depressive to We or we for MOUNTAIN supportive an MDD with approach Today these will if to with can or of shifting clinical will trials to announced depression begin expected study an as investigating of with These positive efficiently than two-week our the MDD belief these this to across if the I is studies data is study, currently program a Thanks MDD depressive Zuranolone approval support we Barry may randomized be our three clinical will milligrams with report of treatment studies year patients WATERFALL in prior support address our program successful MDD. we're designed our episodes. XX as leveraged In In distinct

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class investigational including tolerated. first therapy moving Huntington's NMDA products receptor associated with development neuropsychiatry portfolio potential receptor we disorders Lastly as to early a evaluating PAM earlier for patients our with in phase X a in the are of cognitive SAGE-XXX In franchise, studies NMDA study SAGE-XXX disease oral was our in dysfunction. in well

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addition dementia that patients NMDA with trial in initiated in a phase next impairment report hypofunction In we mild have phase our this and potential SAGE-XXX the with is later from PAM luminary top open to candidate, study disorders X oral NMDA testing. label with receptor Xa Alzheimer's in cognitive product disease data line currently year. for dosing mild therapy and expect associated

We complete forward this determine wholly phase path SAD product MAD and candidate. for expect the to and X year this owned studies

SAGE-XXX NMDA receptor We disorders to Additionally, use to recovery we and later study and in pre-clinical studies cognitive recently we SAGE-XXX neurodevelopmental year. for PAM an plan potential that plan introduced this oral to rehabilitation. advance

we So year. a expected of as you data have front with us milestones milestone-rich and key readouts this year XX can in see other

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

treatments investigators on the global our in mental the tirelessly I'd Now contribution more With in better they better thank caregivers the our sooner. of to I participate over Their that promise can patients, studies. than to we're face issues ever of invaluable. working turn suffering patients so and deliver patients and treatment effective their call also health such bringing pandemic is need to get like who families Kimi. more to with and a will

Kimi Iguchi

Thanks our for Steve. for an XXXX XXXX. setting catalyst was rich Sage important the stage year

operational to $X.X our we financial with entered year a sheet all a with financial more of partner From and strong to context year in trials the flexibility advancing including the balance ended continue a all pipeline the XXXX in During COVID We Biogen great we pandemic. and than global cash. new the franchises made company. with strategic of collaboration a across progress in multiple standpoint billion build progressing the clinical and the

have SAGE-XXX the and in We the to maximize Zuranolone opportunity investment with together Biogen.

Additionally our us our sheet aggressively to other novel in programs. and the ability gives more wholly and invest NMDA owned pipeline balance modulators our including

Let from quarter year me to our results. now end fourth financial of turn highlights and XXXX

result We fourth in were in Biogen the included quarter. to and billion the we collaboration $X.X Selling, in decreased the the primarily million of for Research in $X fourth The comparable the quarter. million $XXX.X period XXXX revenue million reported net million fourth collaboration billion a an of during to for year quarter the in decrease compared XXXX. that primarily $XXX the in the compared XXXX. result pharmacology same the for the of net XXXX. restructuring quarter the the the development $XXX.X with million periods studies $XXX.X million the million of the SG&A expenses quarter $XXX.X of $XX.X We was administrative In by quarter to MOUNTAIN $XX.X difference to study. revenue and is XXXX. full offset revenue expensive the $XX.X quarter expenses due period million was XXXX. to XXXX. the of million income was both XXXX. and periods were the of $XXX.X to compared a company collaboration compared million in million the and announced Biogen. for same $XXX.X $XX.X expenses expenses was of of for from study clinical with in from fourth general and of spending The compared R&D the decrease for of completion same sales due for that As in million second with period period our sales fourth SKYLARK from increase ended to in same partially is the a in recognized We XXXX. spending $XXX.X year and That year SG&A the in for and This WATERFALL compared ended the respectively loss million for million revenue That of Zulresso fourth net of $X.X $X.X recorded of Zulresso a to

we of of $X.X cash, marketable and financial cash in Finally, in a collaborations any billion with our year end more billion and maintain foundation payments solid from balance We're equivalents, a the securities the not ending continue to we than at restricted anticipate XXXX. $X.X cash cash anticipating milestone XXXX.

say As we a you've approach and deliberate heard to our portfolio me investments. before take

to we the strong at have believe our programs readouts year data value. many XX meaningful create Looking to near-term us clinical to continue sequence pipelines long-term XXXX. continue plan advance near, opportunities we I to support thoughtfully with believe balance throughout ahead year sheet invest to and this enable and expected mid will potential to a

forward made. I in back efforts HCPs multiple matter capable X.X coming the Barry I for look only Before closing to turn well-positioned providing and of also we've I the it to to value years believe now over shareholders. we've progress on significant to well-positioned reflect founding I the milestone build top-tier about mission on events making our comment. biopharmaceutical to not to want value that and company we're medicines families, think We their and our turn since of over a our will it and his year. patients to but created the Barry deliver

Barry Greene

us patients mid The creation significant data for us and team catalyst for near, clinical across and readouts foundation everyone our pleased XX long-term thanks with a XXXX XXXX programs. and I'm with has for built positioning morning. opportunities expected shareholders. very strong progress rich Kimi planning value a our disciplined strategic the as throughout made Thanks of execution for this and joining result

Sage differentiated to innovation brain leading across our core and exclusively expand health created enable collaboration with innovative Biogen includes features pipeline and plans pipeline. our our three franchises will and programs Our accelerate

potential are two and year for more this build early goal enabling or of per thoughts. excited IND about we've the like year our significant for as programs on expansion the current begun year. progression pipeline of milestones programs by We this delivering the very throughout including XXXX. four stage earlier to acceleration And already two announced to with realize this I'd conclude we

and employees possible continued potential First; we for the are thankful has face throughout redefine remain the to care dedication in patients second and with to patient created and the what's mission challenges of Jeff of can I participate matter advocates this so turn believe health who people their We're invaluable strategy build the continue disorders and of sooner. in the brain further our the advancing our Q&A medicines to making point operator. with Sage the continued disorders. families, handle caregivers contributions our will our innovation investigators and to future brain health Their year significant studies. I and well-positioned over to for better multi-franchise Jeff? that get At

Jeff Boyle

Thanks Barry.

it will the limit question. turn I that operator to to I yourself over you one Before ask

and operator. have you Operator? question I the now to return to additional free the over it turn will If feel an to queue

Operator

Wedbush the Securities. Laura Thank first you. question [Operator Chico of Instructions] from line with comes Our

Your line now is open.

Laura Chico

months later up regulatory the readouts with those morning. taking strategy in number here? the wondering So question. of update for revisit Good this arriving and coming On WATERFALL the but if many readouts year. SHORELINE, the landscape coming could starting until aren't thanks CORAL, like SKYLARK, a Thanks of other the for we I'm

actually Thanks. So independent a see towards WATERFALL I in to advance those I'm guess to other of readouts? trying to what filing you need understand would

Barry Greene

Yes Laura.

I comments it turn Let to Steve. over will opening me make some and

So WATERFALL paths what in distinct to distinct and will WATERFALL opportunities LANDSCAPE studies achieve have other than working the we're totality all sort of in entirely with the to forward matter. we data WATERFALL data a be these three agency It's that. study. looking with Obviously historically closely we but was positive understanding we'll not of the said and the three in study clear

those data dosing historically say a to the year that's study course throughout where which the only that be is that longer the because study provide time no the question. and needs SAGE the call was believe on designed year needed questions really answer also of to Now I Steve that that the in doses data patients a said articulated we've one that course data we given questions or exist XX% run SHORELINE answer at REDWOOD that the of at didn't of two

obviously the very our study post-marketing it's So belief potentially like not but we the of that that running WATERFALL we're REDWOOD that likely something exists to is will study would study. set a it be a capable helpful run if approval agency upon that's as

this point. what that's can more add? say So to at Steve I

Steve Kanes

Sure.

efficient simply of the the are of information besides multiple study possible and approaches And way about the program lot I there committed finding and the behind this to WATERFALL there's independent data all think [efficacy] which way one I of you The it. mean to filing and a trials. most the to recognize Laura patients. is we multiple other them obviously have ultimately for is we're is file readouts to and rest MDD approval said the you think program

Second is therapy CORAL is with response when which antidepressant. the rapid administered an

Third is PPD.

to So filing that put do this will the led together and do as path much this will the of is under going readout there agency the way with of think I is propose about forward the the there are a lead breakthrough the to time, each additional our really that we Barry The discussions way all way. by be lots strategy have said we data we after the next very potential it we'll data. is have ways but forward materials

Laura Chico

Thank you.

Operator

you. Thank

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

line is Your open. now

Andrew Tsai

to the how see dose is good enrollment of in about thinking morning and mg we great my the overall you? would everyone. day you've there's and rates remission XX effect completed XX It's out what Thanks Thanks. WATERFALL and Obviously kind should maybe question that WATERFALL so at on to the study? be in HAM-D response talk a XX compelling be even of primary to but very about endpoint

Barry Greene

Steve will first were Andrew more more comments I as opening complete ask and Yes, that readout committed. on make to we color. time that for enrollment and provide the so Thanks and have study half some to a robust excited upsize able to we data we provide incredibly a we're study

So and and a benefit subset different more. can kind of put risk allows it that's of provides as at patients that over bit look that meaningful allows obviously plus all powering on analysis we for The change. irrespective last we're of very and is approved of that exciting. Zuranolone the more positive some endpoints nature a well to into study to study the articulated the XX for of unique and years, simply Steve little the data is go us a upsizing than the benefit also point XX as the looking believe we've antidepressants Because the

we're and for color? subset positive to you endpoints some and So more analysis. of a provide looking secondary at looking want the primary, study the Steve

Steve Kanes

start we be increasing completed invest do program that size primary the and you us. of always top time that's This continue endpoints increase we What of the course is to secondary order mentioned MDD. and move in we've points at the size trial is efficacy by we took to we to goal it. were of It's is able now and hit is priority acute announced for The looking that able an study It's piece study. an Sure. to the the one it it's The in we've to the enrollment. endpoint. study some need essential Landscape our opportunity trial of we to obviously in forward the

patients, in as much there pieces of lot to our a that trial. as is efficient with the we allows looking of about like seen We've the can of are of seen tolerability. we what time like does way subgroups things pointing the we've use that the talked We've we're it's before event it's in statistical deal us To trials clear we it of gotten in more We've the what things effects men, data durable a does women. have to remained seen that about every make look it in rapid response. any things the It's from in is have that that bit A very most good long of less profile. as patients I with extent the where look can study kinds consistent were points. say which some data about significance other to Those extracting have positive. trial really those better. better that the are for The

is So way provide that's primary detail. really Everything about it. additional to of The designed endpoint. rest for think is it the we the

Andrew Tsai

Very good. you guys. Thank

Barry Greene

Andrew. Thanks

Operator

Thank you.

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

line now Your open. is

Paul Matteis

taking great. Hey questions. Thanks so much for the

powering study this If a little you in for rationale there's to don't mind secondaries new. but in more. known bit I are that I upsizing hone on all WATERFALL really presence not of a for along. the endpoints That I the secondary trial the was like wanted guess of know it's always important

kind I asking and upsizing is else of or I that's ideal a else else this anything the I that Thanks a just a overview due kind opportunistic. being I and do So is lot. there upsized make of to just being behind not reason mix isn't I'm guess MOUNTAIN there why guess wanted being of to anything in upsized way blinded sure remember the anything patient the besides

Barry Greene

I'll further. to Steve ask for a provide question. in then Yes. context asking some come and Paul. Thanks

the data a So say there to was thing no to first I'll review that upsize. is decision led

was to real ability wasn't The in study increase unlike previous largely raging unfortunately to the So a due that pandemic. episodes by we're drove unbelievable driven seeing it. depressive what upsize the

an opportunity. was there So

upsize impact as more without the at trial I phase and design we world want size to and more to hit increase balance, and balance across because necessary subset depression understand the design for companies able these then or provides so the estimate trial. industry. groups our and and do effect United were value efficient appropriately to variability effectively. step and When patients commented their use capital Paul try the there earlier Sage true of Xs the of to many if back this is most time analysis increasing to Because we the just companies all frame events patient of our States really we're and few the Steve a Now P in obviously across because Zuranolone to sheet phase X use it subject right want as to and us across we

So really happy we closed and happy add that? enrollment to point we've we've that a first done it want to I'm and continue Steve to half readout. you to

Steve Kanes

summarizes That pretty it. much

a much that recall to there up well be are If even in among extract no that's things we them interest really completed as patients a to now depression and opportunity the investigators potentially from even If more unfortunately enroll course was all is that opportunity there. time. it talking we to the said it. every pretty originally XXXX are provided further. be Machinery due the where when studies of opportunity guidance about but is as tightened information study we we Barry there you it's in other were we'll in yes great be study of likely able have did way. increasing that information MOUNTAIN would we'd rates fact fully clear and with so enormous the to as and would the and the to enroll we We as guidance take There if get efficient that

Paul Matteis

clarifying sense. Make for that. lot Thanks a

Barry Greene

Paul. Thanks

Operator

Thank you.

Our next Tewari line of from Akash question comes the Research. Wolfe with

open. Your line is now

Unidentified Analyst

the of multi-dose time. questions. Hi, the accumulation you over PK Akash. significant taking drug know the a We Thank this the from in for we body is of [indiscernible] SAGE-XXX saw for

have episode do MDD enrollment. to are getting question the MDD the about due too WATERFALL So other Thank how exposure prevent prior situational I the one to have you I enrolled And wonder Do high? pandemic? further not is the confirmed to they so formulation plan just episodes patients you COVID having the you. verify needed optimize to to

Barry Greene

take. you then to take loop want back we Yes. WATERFALL Thanks, first XXX? can on and Steve, the let’s

Steve Kanes

major of the was patients that major it across The WATERFALL that lifetime. second whether the simply concentration, so have that is depressive of depressed we as to and only about view can same COVID requirement anticipate first the we depressive cause pandemic need are symptoms, that or you're episodes stressor in of all are mood forth. of their major signs somehow weeks the that curious loss, episode all depression We neurovegetative disruption weight episode, and at studies. for used with meet our patients sleep increased in The context of a Sure. that overall perhaps patients rates the in We not episode whether several time all we've their normal but the think person don't or has enrollment different. MDD kind criteria for an

and XXX? go Barry formal need So to are all of patient to you under diagnosis of the MDD that's population that's study. been a back patients the that enrolled want

Barry Greene

Yes.

we're with faster. of data Let driven put whether on driven thus chronic known me depression and we just far just Steve it, as we've that episodes patients with Zuranolone we're and having while demonstrating baby demonstrated believe two-week a great finer genetics on. you've by to WATERFALL That's are course helping a get it's symptom for comment SHORELINE by depressive to the with those is point pandemic, episodes with the better or patients a that the

with what said what just consistent saying Steve we've all been along. So is

you overall take remind answer of X we in XXX to can and we're terms a this and see trying sustained in answer patients improvement. just trying to let study benefit what step we're back In phase to me the

for those and over period is essential XX% dosing days are to making So what sure in which sustainable. looking effects is the tremor XX% I'm improvement XX

event Secondly, data adverse for I'm seen with that's so an we've consistent far. profile looking

and X, dose then so just formulations So adverse on this trial phase articulated we're new doing we without Steve event kind and a data giving and worsen Xb before. we we effect any phase like that dose you being this potentially never assessing Steve the to first expect there's recall the to understand profile given we adverse expect given an the It's plan here more? we're adverse and a events events. as add want see the after a study been frequency consistent of size those

Steve Kanes

know really we the of do is the granularity formulations. steady What exactly what more Those exposures to dosing our but with go and trial, state The talk understand overall to that's other sometimes that of and from a Sure. we of look and in ways necessary. what are the it of look much there is kinds terms data month going for, a does team do. identify at from pharmacokinetics be comes might things overall exploration to down about I there lot dose we not potential various

of is once the day potentially scheme, what the It's this for X dose, all is So dosing, optimizing that time we of on drug showing it's profile the the based phase about. where frequency dosing benefits that the expecting. formulations; the we're optimizing

a how detail. to that's plan go So able exactly have we'll data we'll to with we the and and able more it when be speak articulate to be

Unidentified Analyst

you. Thank That's very helpful.

Barry Greene

Thanks [Neil].

Operator

Suneja next Thank from Instructions] Our with Partners. Yatin Guggenheim of you. question [Operator line the comes

open. line Your now is

Yatin Suneja

morning and guys good you for questions. taking everyone thank my Hey

Just questions me. for clarification

multiple say you with clarify seems you been help October WATERFALL XXX the particular For Can particular subscale It have January in you of the XX% subscale? performance primary XXX us so on clarification changes then this XX% is tremor when scale? to was I reduction size see it you or sample that referring and think study, saying [indiscernible] XXX. care endpoint what standard And essential the multiple in tremor to are do is the to in like the study. reduction you're and adjustment initially there other in then XXX now it's question in moved in

So Thanks. through changes? us can help you those sort

Barry Greene

Yes, over can the question let essential to then tremor answer. Steve to we turn me quickly and do WATERFALL

increase we've So different we an said to size. had as several the opportunity times

changing and without that timelines we're seeing in we world because subset much did. we've sort without much the additional others. the depression did analysis and of how of We So capital answered out

just there it's that guidance us allow see out tremor guidance from you not get than essential to I trying number guidance other say take the will provide to The a analysts. clinical trials want therefore please provide to that, from different to trials Steve, you to clinical purpose that question? rather

Steve Kanes

Sure.

demonstrate that other to scales to Essential that limb those upper with sub and attract that leads scales been scales emphasizing Just disability with to prototyping most the Tremor understanding to particularly scores. closely remind everyone which ones use, performance we've and and tremor work track measurements

we're phase way the signal. the two of as that in using detecting So a

not goes our XX% to level reduction across response. is the [indiscernible] what compounds Now also it's back that said the this all in so of XX% it's way that we've seen patients show reduction and Barry a to just as of far of percent is

that partners seeing we're why one program. moving really looking. the some excited are with So effects we're Biogen our the mechanism we're of and so with so this robust impressive about That's reasons excited forward What groups with what with patient registration endpoint. will results of the FDA is do team, what well understand and at those the, ultimately be as then a advocacy with look our is we'll course

dosing looking now yes So the what period. on this see and course tremor. and important over improvement as Barry a limb focusing we're one we're think well to the both as looking to full mention really for upper of We the the improvement that's sustained see

Yatin Suneja

much. so you Thank

Barry Greene

Thanks Yatin.

Operator

you. Thank

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

is now line open. Your

Jay Olson

and you the all thank on congrats taking for Hi, progress questions. our

study? what the sort endpoint be signals Parkinson's For results the the Thank suicidality talk LUMINARY of this is in safety studying you'll for that maybe you comment cognitive related patient and could rationale top looking you mild of if efficacy and PARADIGM also recognizing could the primary on impairment maybe in study similar SAGE-XXX about population for the behind then in line you. address questions

Barry Greene

to want take that? you Steve Absolutely.

Steve Kanes

Sure.

get for sense the of that things for we're You at of looking good what kinds a previously can reported we've Huntington's.

a It's to executive high are tasks to a cognition. that there see we'll improvements memory is but look in cognition overall far essentially So everything what in at function a and assessment we've seen sort what tests so Parkinson's interested standard of of puzzles. lot do solve battery from abstract that. It's all ways cognitive the working to be we across look and level ability of of of ability to complex and

look past the seen shown kinds are and signals the we've Huntington's. pretty Huntington's with itself as is in volunteers patients those we because So models some but that far with simply think so of extend That's the that that exactly things related as deficits they've we're We start mechanism both population. and experimental patients to for healthy of Huntington's mechanism results what we some biochemistry initial in in may now. well with at studying impressive the closely patient well and biomarkers

So we but that that's things a any scale. we're All drugs come safety This but we're there suicidality. are something we've really kinds requirement. that complications to include the of regard With FDA the any that trials. looked neurocognitive for. our suicidality that more in a looking concern at measure. actually all suicidality It's benefit broadly ones is into CNS not measures to or there to make It's that concerned for undue sure rating specific about it's to causing Columbia around be get the need an assessed not potential

should our it always you'll one be that question. included all it asking as well. all almost in see in that trials for thanks and of all in that's CNS That's So trials

Barry Greene

question. platform. sets just NMDA and because really this the of is you but to receptor Yes. would excited see thanks rest class just these in for we're NMDA I guess it whole that the PAM up first our remind I data the XXX in And not Jay

Jay Olson

questions. Thanks the Great. taking for

Operator

Thank you.

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

Your line open. is now

Salveen Richter

look morning. insight could Could formulations you other to Good Thanks some question. for taking explore just you for my into provide what SAGE-XXX report?

Barry Greene

Yes.

Salveen. thanks thoughts me overall question for Let some provide and the

this phase profile to adverse trying sustained XX% we're what event Xa surprising. to saying efficacy not that is been [XX%] we've this, that's the as an So see in

a big dose. are giving We very

So seen with we these the kind events molecules. see of expect to adverse we've

depends to versus and may Xb be area phase the more have a sustained a formulations. frequency able C-max. that provide to or less large at of change on curve under dose may and use it formulations the look peak in trough data. Steve may We of As a not to We said we the having

Steve to there's color? So of number you different go. maybe some provide additional want can ways a we

Steve Kanes

No.

I much covers think it. that pretty

phase about what process of we're optimizing medication. X simply is think the and I just talking

those sure the for a we medicine to that Tremor physicians Essential to with a been working really with for would make be closely identify advocacy patients get want hasn't patients half profile century. there ideal recall We're that You we groups last in what and and right. patient

said way. very much lead Barry as data will So the the

parameters will state. into drug much of after will understand more We of the about the steady month be dosing well which a

the if need those a we'll the what what need just about to if understand from we'll So things then we it case. there's need it take that's things more there's that is things not saying do We and see there. I and are but necessarily data that we're think lot to do

Salveen Richter

you. Thank

Barry Greene

Thanks Salveen.

Operator

Thank you.

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

open. Your line now is

Tazeen Ahmad

wanted to further I on Tremor. clarification Hi. get Essential

get some longer that level understanding clarification of reason just does provided why could albeit I'm XX companies the there distinguished your ET some durability is fashion and looking give at are early period days multiple term in I to think looking of pursue it we're So over be the you but you trying to that for understanding from confidence you're about things? other and that we a are asking time? at it trying sense think of program where just you're when what of

Barry Greene

want you Yes. Steve that? to Thanks Tazeen. take

Steve Kanes

Yes.

So a Tazeen question. great it's

using been some quite I been which of of dosing. with explored prototype doing time relatively Tremor now modulators field we SAGE-XXX for which and primarily this before. the and Essential Zulresso work role in GABA this We've periods unique where for with particular think is in mechanism started we've short ago the positive I is years mentioned we

with month will are saw which time trial the If do improved maintained are concerned With one Tachyphylaxis. the been that we've working of dosing we the of the the of receptors synaptic is models you and we get drugs to we'll a with those in dosing hitting see key be, with years of those extra things Tachyphylaxis. see looking One track. is is about using ago know We're might over SAGE-XXX response a questions be and the right in prolonged responses none that what on overall be changes to rate. that any it we answer several we're

to of chronic for the So dosing is ongoing for where necessary. for great need gives believe treatment us that that's We conditions obviously something month confidence move with we Tremor dosing. in want patients forward Essential to with demonstrate a

quite something time study we've trial. first in years That's a this really population we'll patient lot has a So forward really had today data with new we've for been above to from to looking encouraging. been the and mechanism some XX and a that getting learn

Operator

you. Thank

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

Your line is open. now

Sumant Kulkarni

back taking Thanks not not If with one worked reasons for have we as why the morning. my to well MOUNTAIN, Good go that simply trial the have patients that may of treatment. question. some taken may

ensure to in So pandemic WATERFALL logistics what given versus with the quite today the patient different is specifically MOUNTAIN when compliance was the run? environment being of the is done study especially

Speaker

do to take Yes. want Great. Steve that? you

Steve Kanes

use rates talked some analysis positive. a year about about in MOUNTAIN and study is the little was were the that medication didn't who the a take high. was patients in noticed give didn't works. because over a things particularly trial that when We what we to methods from seeing itself We on Sure. were We do compliance more take ago non-compliance ones when of number of meaning that can a medication, there not shared the consistent drug the profile one have the remotely. drug the the to removed It it of ensure of we're of color be and terms people followed

threshold there learned we increases rate of the from above exposure which is thing MOUNTAIN a other response. overall patients that is The for

that rates assure previously were there'll a we've So from increased that diligence additional we is perspective, participating score a that at our measures cutoff learnings for studies we that perspective percentage while development some What a the handy also patients and but had those we on to of a to higher dose so of really trials. important we did be learnings did safetyperspective, looked to trial see ability the always of applied seen place for be or are what do to we degree particularly we stimulus, and all high from of above take a MOUNTAIN, the it based that from increased in patients take know enrollment the that drug threshold that WATERFALL. are to ensure is from we've going the what's the do the medication can and not the scientific the bit signal don't to patients we higher

Sumant Kulkarni

Got it. Thanks.

Barry Greene

you. Thank

Operator

you. Thank

Morgan. Kasimov Our next question Cory comes J.P. from the with line of

line Your now is open.

Cory Kasimov

Hey guys. morning good

for the this you'll complete, the before know to I'll can us couple in just of analysis it accrual answer follow-up I wait think Is you. or starting primary you get your the people ask XX-day you. now XX-day so this full patient a wait how me all well to endpoints follow-up we've the morning much capture I you data period are with ask as think had remind I MOUNTAIN. question to the patients you the that you, WATERFALL through process? going approach Thank With will that's as for took secondary

Barry Greene

about and we forward? how level you Cory go Steve sort for lock Thanks Yes. a the at to database process of high talk and want

Steve Kanes

program. just remind a of It's that everybody Sure. of the a X study with quality done this diligence that's Breakthrough is I all entails. trial regulatory phase a

we'll last do will last visit. what is So continue their we who the up enrolling to patient

ensure quality data the which are then been will that's continue every point and the analysis by high entered and level appropriate of entered understanding verification appropriately begin of we to and includes investigators We do process. source that those

detailed pandemics. Recall all since We've were programs, for of the on would our now we're the planning initiated phase of go during X trial. is all anyone that of completion that of programs a been the this So it's all through study. this the very X the ones initiation after phase process working in a

is of have when all we processes and that run So the procedures analysis. quality that we that and completed then ensure

enrolled the back trial. patient last entire through to yes, So be has the

lock will then begin database We the analysis. the and

Cory Kasimov

you. Thank Great.

Barry Greene

Cory. Thanks

Operator

Thank you.

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

Your line now open. is

Ritu Baral

that high WATERFALL but you're Thanks the for question. what with I seeing guys. also across in to I'm any onset concerned sedation is just to of whether wanted you're in not on and study top Hey consciousness of Landscape overlapping and sort and whether level check SKYLARK of taking CORAL susceptible just Zuranolone? CORAL safety the about new loss population sorry SSRIs on

Barry Greene

provide thanks a provide maybe then the can Steve question. me and level color more high for Ritu Let

XXXX about to and number we've we've is seen we've consistent event Zuranolone As that over profile. days, what in dosed activity onset adverse of rapid subject/patients XXXX of durability efficacy talked across and a three consistently with two very-very

anything So we're add? more not seeing want to new but different or the trials you anything across Steve ongoing

Steve Kanes

of consistent speak patients you're regard a the referring population antidepressants the of places the we It's to what XX so SHORELINE really profile. of milligrams understand quarter a to have underlying and initial look a antidepressants to the speak trials is understand and somewhere where between we've or safety studies and patient look underlying it about we study Yes. reports But example our very database seeing the the subjects. and are reflect that really third patients to those been I that doesn't all with are ongoing we without and to on that so that can Ritu are the able large antidepressants questions have, and other cuts that I far you on overall all SSRIs can across or out put for to data profile been to would a say for that with

We those will be with more obviously rehab have CORAL trials studies more as WATERFALL, to will SKYLARK to information the and speak specificity. able

Barry Greene

the for of not is the sleep thing that's other challenges patients it the day into in next patient's What aids far architecture. about these evening very of you sleep. they just of in we're we're potentially sleep point worry because is Ritu much is helps have can't the Many because in seeing The are sleepiness they a and of. one seeing rewire the on I'd actually that a depression that of context add helpful sleepiness clarity just is

Ritu Baral

Great. Thanks question. taking for the

Operator

Thank you.

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

line Your is open. now

Neena Bitritto-Garg

Hey guys thanks for taking my question.

minute. I go Essential Tremor want to to So just a for back the

score the So XX% at around dose tetris so. the of like tested XX% or the some for I XX upper about had lower a think was the reduction phase I and SAGE-XXX XX had limb think study mg mg on dose that Xb there

kind a kind advocacy that can just of one kind options around data about I ability sounds So I the is safety a window the thoughts therapeutic from a little dose given talk and and your bit of and of therapeutic see the of you bit window? like little on it use and the mean but the about commentary phase guess formulation can the talk altering to you Xb, just the efficacy. kind lower of similar

Barry Greene

want to Neena. you take that? Sure Steve,

Steve Kanes

sort for are Yes. a These of phase study. questions X standard

is the a So do you're have to single drug. half-life results recall that with to doses. referring long It

exposures repeated we in appropriate at a and will dosing order necessary dose dial and need the that will really in to allow to understand So It to us this we studying is what see see be effect benefit. that week about know that what what with we'll would are is case.

these So are understand are out understand will looking have profile can to can the see. pieces of of puzzle you kind the the data data point what all what few we I of that is what that to bits a of are drug. There

improvement long that's half did to XXX XX So saw which for and time. we over continued a similarly each and continued is response. say let's day exposure with related individual we dosing there days Obviously life of example

we subsequent what for we that trial at the use looking model and which So us of kinds seeing That that allows to to we the how that and [variance] this in signals are dose did is will will to trials. ensure range. then the are top do, in we what test we of dose

So disposal those tools that's of again wouldn't about all our dosing There scheme, frequency the of formulation. time the be we day, that ideal can necessarily of are solution. are whether profile address drug. to optimize at few answer ways lot of profile the questions of a to I dosing think a the

drug of the how this what is profile inside pharmaceutical when remember it's is. in that what overall its active frequency So and the it's the it's determines administered, drug really

so therapeutic think window tremor that XXX other is in say had so would efficacy a animal I in models somnolence do The animal wider versus forth of models we thing our against optimize we that phase. subsequent profile patient before is this to the The for X make phase population. for program of plans the later and this that development final selected ideally into really job was

Neena Bitritto-Garg

Great. you. Thank

Barry Greene

you. Thank

Operator

you. Thank

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

Your line open. is

Unidentified Analyst

larger [indiscernible] from SAGE-XXX on It's a signal or Huntington's a in efficacy morning. first study data see pretty Good data on moving With would want potentially with plan would you if strong forward to LUMINARY? PARADIGM of Parkinson's Thanks. you or for from quickly Gary. show

Barry Greene

provide Parkinson's at this see plan. early specific path data. the point want Obviously to [indiscernible] Yes development it's too clinical to the we on

end the have move kind we of the paths. could bookend data just Huntington's independently Huntington's in data, with end Parkinson's and of one be book We it data those

end the of study. across other a see neurodegenerative improvement diseases and book all three kind executive The we function of do cognition in basket

we're through to working talking a have that when we'll share the agency and we about more right best path So clear forward We're now. path.

Unidentified Analyst

Thanks.

Speaker

Thanks [indiscernible].

Operator

you. remarks. Thank closing turn today's concludes for now back Barry This call I to the question-and-answer Greene will session.

Barry Greene

to great a transformational a that continue with to appreciate be top-tier a leading questions. setting path on our biopharmaceutical and We year build believe a Sage; and you to this Well will our allow exciting everyone. all of health I us those us path brain to on morning thanks up to very year company. Obviously company continue start being for being for XXXX is

So Be Take your time. for thanks safe. care.

Operator

call. Ladies conference for gentlemen your Thank participation. today's this includes and you

may disconnect. now You

Sage Therapeutics (SAGE) 24 Feb 212020 Q4 Earnings call transcript