SAGE - Earnings call transcript Q3 2021

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Operator

Good morning. Welcome to SAGE Therapeutics Third Quarter 2021 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 recording, 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 Relations at like to Rubinstein, Investor introduce Helen SAGE. would now

Helen Rubenstein

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

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

accomplishments Officer, some Chief begin provide an will Greene, Barry We our of the call by the who will remarks context. prepared during quarter Executive with overview general and

We our now the over will Chief financials Kimi Barry. who from will review our across that, progress With Chief Development Jim call programs, Iguchi, our will Doherty, by recent development who Financial review results Officer, turn Officer, be the quarter. I’ll joined also to and

Barry Greene

submission NDA in Thanks, following plan been meeting We're PPD financials. SAGE. second by with our in XXXX. XXXX. to in the turning for Helen. the on Biogen associated in of with XXXX to submit and the this call a And the year significant remainder an the will that first the of call corporate for have commentary additional FDA, us an thank half closer zuranolone toward clinical the from begin PPD. recently on for submission. reached Kimi marked announced patients an you, half helping clinical of MDD pre-NDA before brings We This expectations provide our progress we've update step suffering everyone, and alignment quarter Then with our for to this goal progress we by MDD agency This clear I’ll us recent morning. a believe for path joining of one that and and reviewing and our Jim pleased we have provide

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zuranolone standard demonstrate when or study the co-initiated with benefits Importantly, adjunctive the an study ADT. use to the CORAL treatment is antidepressant of designed

goal these the them efficacy CORAL database from us the of in zuranolone be will baseline data NDA the rapid believe, the to CORAL the as to filing with commence pathway. Given we the today to outcome change safety with measured and study, is transparent will, have the period, change primary real-world support designed primary to But is the already of regardless productive however, align for with important the XXXX. in We've endpoint. demonstrate hand to for if we and will to announced as the HAMD-XX efficacy a This may data to primary planned data the endpoint the of required the during impact that be we endpoint We we three. reduction believe and its MDD not at dosing We'll continuing successful, profile. potential of submission filing forward begin the early zuranolone rolling day had highly contribute well overall be to of allow agency approved. also look depressive inform safety as assess symptoms. engage to use relationship if data do planned the CORAL study zuranolone

promise through programs We totality ECNP but presented the are want submission for ensure also Congress forward them. look results X NEST of the with we our that data to Psych at demonstrate Annual the work seen differentiated label, living highlight our take both profile reflected in of congratulate We in presented NDA zuranolone the These we've take from who seen and appropriately development. to planned of and Japan. Shionogi, MDD, presented, will to moment if continuing a walk we've relationship the reinforced like Jim and and clinical the consistent Phase to-date recently to in we've totality I a with the data product our profile for zuranolone you zuranolone the NEST would to a positive at colleagues zuranolone approved. recently of in study and people I will to the programs conducted that moment also LANDSCAPE further results package a of data. across LANDSCAPE

we treatment programs and can and to-date, if important believe in in see zuranolone adverse this depressive events well-tolerated are package, LANDSCAPE see has recognize that with standard-of-care the of that MDD you suffering engaging that patient use are KOLs, them a the well for of exchange scientific types demonstrated to provide across without be practice. discontinuation totality sustained as well-positioned safety are this many and data profile with symptoms approved. of and NEST to value To end, rapid zuranolone to as data the able As both pleased we're consistently actively and often ADTs. associated PPD collected in from clinical specific potential demonstrated reductions in the We across patients the clinical they the from

this disorders. to learnings execute and put MDD our across year, people health steadfast PPD in team other for commitment the to zuranolone look building the work. our NDA patients brain we a filing we planned to our remaining As assembling for next we provide the from look By MDD. our in pipeline, NDA right difference efforts, our as to on and continuing to make with and pursue right reinvesting we zuranolone first submission at to updates depression filing zuranolone time the on forward we anticipate believe are We initial poised on development

for the suffering from other is our is significant the part currently SAGE-XXX, to well-suited diseases. franchise disorders suffering and to treatment patients of and essential which our SAGE-XXX neurological developed form from that unmet epileptic tremor and a in-house potential Now, Biogen. disorders, tremor address of being in collaboration pharmacologic by turning evaluated other We as characteristics is are led and patients essential SAGE-XXX including need Parkinson's disease. neurological neurology believe

a and to initiate expected Phase commence later Following we're good preparing The the and able. We study X with to dose-ranging frequency dosing year. a profile sustained we’re concentrations schedule positive updates study the forward on providing be to into result dose from symptom a the control. as that to maintain goal tolerability will plasma KINETIC optimize translate study, this tremor this to look

receptor evaluating neuro Turning disorders to dysfunction. therapy PAM are cognitive we wholly-owned franchise our as with our for potential associated receptor SAGE-XXX, oral NMDA a where NMDA first-in-class

This received for track designation disease quarter, development FDA. as from Huntington's the for SAGE-XXX potential a fast treatment

X reminder, is initiate to year. regulatory track this patients to safe to will study efficacious in We're us pursuing one We initiate plan indication plan for second to for randomized of SAGE-XXX promising SAGE-XXX a disease people SAGE-XXX. placebo-controlled to disease disorder. Phase patients understanding positive, we early our our seek in the I'm this treatment on will disease a be with we and Huntington's with placebo in a contribute X cognitive suffering this we believe study with also last year. moderate SAGE-XXX pleased study an a Huntington's announce it to As of meaningfully step will that with saw study X provide SAGE-XXX This with from a as bring in in early closer data If Phase Phase randomized initial study to early XXXX. dysfunction. Parkinson's

we study in fully the also Lastly, as year. announce the for disease a potential dysfunction. are LUMINARY from study SAGE-XXX evaluated treatment is we data of Today, study top enrolled, the Alzheimer's announced before to on and this track being end line is ongoing an cognitive

realized progress this to updates see, can share also you franchises great on our across year. call. we I'm progress As health far brain today's so corporate on pleased key

to our been elevated to Head happy of serve welcome executive Commercial Chief to Affairs team. and Benecchi, we Procter quarter, leadership SAGE, announced This joined that Officer Chris External are has Vanessa as and

President, assumed also Development the elevated Quirk on continue Doherty, Chief me, Senior Jim Vice where build Additionally, Mike We've Discovery and research capabilities. Research, with has our to the will he to call role Officer. of

Today, with since private over Medical Steve? the thrilled eight-and-a-half endeavors. expand in I'm our has and organization next him health. made SAGE a that has and to in We're have becoming Officer. programs the contributions progress the Steve and words. for will as his wish that new instrumental Chief look continue CEO announcing our establishing and is their brain a been efforts team years. fulfilling success programs across forward XXXX of our toward biotech departure contributions his It's leadership SAGE’s contributed become we accelerate our balance Steve's for will him a company. progressing CEO and thanks to met significant to across so to health on his in at leader be to role, pipeline. brain of role. priorities. Steve SAGE brain future our in organization goal our leaders confident and to say extend health also and our As to strong today across Steve seek in Steve collective Kanes, confident We execute I to past in we're year, that few invite I'm to highly the a I advancing we Steve in our much

Steve Kanes

Thanks, Barry.

great grow at here, to we the to an the Barry position. our clear the and development my second with I hands, eight the to In success. my accomplished. the I'm lead that made with a data very market. bring I It's in watching time years look zuranolone, develop in I'm through As drug to and appreciate NDA, on seen a take an a long forward opportunity ZULRESSO, continued SAGE, been program and now in We've a team's clinical team, believe -and-a-half SAGE’s from launch aspiration that we've had of encouragement toward path advance and right robust and my the I’ll all development organization, couldn't extraordinary know reflect leave pursue and establish pipeline in to proud clear I and CEO filing decision time ability a role. leadership I path I've program. zuranolone I company SAGE is support SAGE’s to to leaving great this and better be have SAGE this a forward. confident shape that I've

Barry Greene

highly are enter success to goals. that am the brain our journey believe across becoming accomplishments of the the phase health. into we brain Steve. I Thanks, as quarter I we on confident closing, And our in in next SAGE’s third continued health execute our leader translate franchises In will strategic primed

the Now, Jim? expectations the our over XXXX. for I'd call accomplishments like to to turn of clinical and balance Jim detail to

Jim Doherty

program programs. health franchises, three And everyone. In SHORELINE morning, advancements next – our each, our important early-stage SKYLARK. CORAL, three ongoing across with zuranolone And highlight steps have to including our Barry. Phase I and brain we studies in am pleased X Thanks, starting XXXX, made across good our the

of co-initiated new CORAL with milligrams to MDD. and XX SSRIs As patients safety open-label a efficacy evaluate reminder, is when designed with in the zuranolone

will be announced also endpoint consistent, on a from with treatment day in three. to to throughout update the the onset primary that is the We of study baseline the of period in change HAMD-XX at goal CORAL safety also line see the benefits we believe this assess study the today zuranolone, demonstrate the well-tolerated the rapid measured expect and and will profile. We

if believe Target to increase be of package one-year the enrollment our study protocol. enrollment study we for study to physicians about screening, useful for perhaps a with zuranolone. anticipated period is believe now is open-label will continue over results the be zuranolone, may important people approved. we the tolerability study the on a launch trial safety provide with study complement Of study that zuranolone enroll primary are zuranolone potential used and SHORELINE the within note, day MDD information by XXX of commercial a is may slightly in investigate as-needed to including patients range be clinical as early the this naturalistic, The we with patients endpoint focus expect a expected expected to on three treatment to Additionally, close a to with broad topline study that XXXX. is repeat number allowed We in MDD. and and treat with the how to higher. or The CORAL

on XX year. milligram later cohort the are one-year data SHORELINE track to cut our report with plan a from We topline this in

to to continue forward, offering the our the roll are completion from the expanded Moving ability announcement study into enrollment prior we CORAL of their we the over that following study. study the CORAL patients, in SHORELINE will patients following and the study target enrollment XXX

we in of out other expect the The mid-XXXX. study PPD, is in Phase X SKYLARK ongoing read to zuranolone which study

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to we're provides and requirements size a if world, submission planning such, this information how As meets on be the in real that FDA a the for package approved. might used assemble of zuranolone the of

strategy. submission modules complete, XXXX last the complete of after out with to expected The plan this the timing non-clinical the half early months of the occur is anticipated to CMC reflects me the which We XXXX. Let time six lay This five filing across story will the during to be will first. the module begin to in clinical module the the in the second clinical on last team submitted rolling for be likely to filing for zuranolone. module most and studies component clinical focus integrating data package submitted tell

zuranolone Investors life presented rapid these the presented continued data of profile in treatment and haven't day and to of XX in WATERFALL as we at University And at or presentation and yet, via sustained Chair with health a Additionally, NEST watching at rapid recently by principal the measure of a general and a improvement in date differentiated health. Neurobehavioral that version through presentation you study, in measured website. of Dr. of seen self-reported the and that This the of SF-XX Virginia pooled symptoms Psychiatry the sustained investigator in profile. if recommend it. supports X, depressive section and Anita of patient including Neuropsychopharmacology, of Clayton, School October, the led unique European Sciences increase her XX. has clinical I further reduction encore is available Medicine day quality data the our zuranolone overall an College to Congress seen development, from in programs, improvement safety and ECNP, and analysis a well-tolerated LANDSCAPE Further, to XXth

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and we've mass zuranolone and of experience gender demonstrating age, and zuranolone led seen proud depressive totality zuranolone progress as that reduction the across were standard symptoms zuranolone also different analyses depressive presented made by quickly day in monotherapy excited across to patients treatment-free the the a regardless with the to program. longer We're XXXX populations, body patients rapid effects. such we've of throughout may believe We burdensome potential as and the a enable with receiving improvements symptoms treatment side XX maintain in patient approach profile development intervals We concomitantly improvements functional without care of has offer whether to at that of index antidepressant. in or impairment treatment

Now, SAGE-XXX in of positive allosteric like made in treatment our and advancements the significant neurological holds essential of potential receptors, modulator next GABAA tremor. which by I'd detail led believe to neurology like conditions franchise we generation

a profile. risk Phase remain development As and optimal study our a of development and Based for further XXXX. that significant an importantly, plan on to a year frequency KINETIC In to dose showed X we goal in advance TETRAS Item forward ranging seen confident planned an every Biogen, placebo-controlled that correlation of to reminder, statistically results, late demonstrates we Phase the part that in We with for limb improvements important are will continuing ET tremor collaboration in demonstrated limb generate between commence establishing study a activities Performance and and effects score; Subscale dose study reported meaningful time benefit these translated upper X scores the track is optimize by This study tremor in SAGE-XXX the of the to the initiate for upper the reduction with positive living TETRAS to dose point. in measured data on SAGE-XXX. we frequency patients. look that observed to scores from earlier this X in finding SAGE-XXX daily at tremors our

we're lack underway announced study in prospects of areas in SAGE-XXX, about good for track including SAD Moving to X that dosed and to first even the on options, has franchise, viability complete candidate a remain and the We we X neurology Phase treatment or that the treat that to future of mania solid product with the SAGE-XXX suffer acute potent therapeutic development XXXX. flexibility, last Phase potential program formulation demonstrated late patient rapid quarter the excited our in a absorption, migraine. from agitation,

IND also extra-synaptic neurology preclinical an preferring is our pipeline. work receptor SAGE-XXX, pleased programs to that advancements continuing SAGE wholly-owned data-driven developed, share The Additionally, and enabling continued the for PAM. growth SAGE-XXX I'm represent of expansion and oral GABAA SAGE-XXX of

to developmental to are bring a potential potential is XX, therapy cognitive the Two-Back our day accelerates strides for our of treatment efforts end oral track X recently on through SAGE-XXX performance, treatment of of that where test fast Turning franchise, with of granted making disorders HD, with the this a as is PAM was In robust and neuropsychiatric early study cognition of associated SAGE-XXX disease such one designation day X developing important as to maintained Huntington's main of tests receptor impairment period. The in the improvements SAGE-XXX, our we in Phase to NMDA therapy treatment with patients patients. for were disability. that began drivers the a

to disease of Huntington's this X track SAGE-XXX a study are Phase placebo-controlled initiate with in later our plan We double-blind, on year.

demonstrate of unaffected. patients The Phase open-label well-tolerated first to function including previously a of Xa for the learning due leaving cognitive reaction date. multiple evaluating that SAGE-XXX has SAGE-XXX, cognition, part been disease. Parkinson's PARADIGM simple altering memory, reported to data Study, trial domains studies mild impairment impact or attention in data domains SAGE-XXX in the exciting our had while positive known with also as time We on executive and

to disease we Barry our which begin mentioned, launch X plans Phase a As announce in we impairment, study are in expect Parkinson's to XXXX. excited to placebo-controlled cognitive

developing XXXX we SAGE-XXX patients mild with cognitive we're with in year. topline is receptor NMDA track NMDA progress impairment and evaluating in We further Study franchise, therapy to this look oral study disease study PAM data other SAGE-XXX, to candidate LUMINARY expected is as a Alzheimer's In the with neuropsychiatry and reporting fully our enrolled, potential ongoing. the SAD disorders for mild MAD Lastly, late associated later product on making and complete forward dementia remain hypofunction. an the

program, oral look use neurodevelopmental potential updates rehabilitation, and other PAM cognitive SAGE-XXX, progress the candidates, disorders earlier and of they and with evaluated for program our providing NMDA available. is product later when commercialization. the and opportunities an Additionally, regulatory making we neuropsychiatry our earlier of stage development in advancement recovery goal good candidates to on about excited become stage the being ultimate this stage our for product I'm approval and future forward

we living and the We programs. potential wholly-owned as are have continuing health people for difference make for families, to to expand as I communities. indications and disorders, brain accelerate a well with caregivers their potential our And believe

the call turn of over I'll Now, Kimi? to a Kimi our review for financials.

Kimi Iguchi

Jim. Thanks,

critical proud for third accomplished our quarter our and team our and I'm tremendous XXXX, a on and the clinical to throughout progress growth made company's well-positioned believe work business has execute we're reflecting development. the The priorities. time of was on In

growth in to $X.X and the support their now future. period of all the strong our million expected sale We invest sheet XXXX. to and We provide on gives and moms, compares committed net in those by $X.X families guidance. ZULRESSO. from in robust revenue in from the we million our remarks continue financial the PPD. I'd to to of balance revenue for flexibility the impacted sales right highlighting the ZULRESSO start That same third quarter recorded some net of by remain the third the like our financials our into quarter focusing are Our team on and building then pipeline, to us to

The reimbursement the the That of in our with expenses XXXX. efforts, Research the the zuranolone including a integrated collaboration SAGE-XXX, These from was for to quarter, That engaging a expenses key $XXX.X a and zuranolone. help included $XX were with also third quarter We compared compensation SAGE-XXX non-cash compared are planned launch. pipeline, for acceleration the million loss increases from activities general partially the well reflects milestone SAGE-XXX. quarter. reimbursement were wholly SG&A reflects recognition to stock-based and a approach R&D, development PPD. of the increase net collaboration as stakeholders, net of advancement for The million for SAGE-XXX, of loss and Our our moms of of manufacturing-related million of of same and million period reflects which $XX.X an aimed launch reported by to for milestone. The period stock-based stock-based stock-based expansion increase support a to for to million same the by related compensation R&D million $XX.X and million, targeted expense $XX in as including third of of period an commercial and are compared $XX.X non-cash offset owned to with was is our SAGE-XXX. XXXX. Biogen activities reflects increase readiness zuranolone XXXX. to in $XX.X increase one-time personnel of $XXX.X recognition expense hiring in million and for in also to administration product comparable including increase Similar of third a Biogen compensation. the one-time offset Selling, potential partially compensation

our financial projections, unchanged. Based remains current to move to guidance. on financial guidance our I'd and financial our like outlook Now

end the We expect to $X.X XXXX. cash of of have at a billion than balance more

to the reminder, for expect XXXX. collaborations we not payments remainder a of from receive milestone do any As

our as Q&A are for to and our Helen to meaningful achieve invest handle thoughtfully turn the continue I'll develop success it operator. inspire treatments well-positioned seek We to to we work. over Helen? who to with the patients organization long-term across now

Helen Rubenstein

Kimi. Thanks,

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

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

it turn over handle I'll to Now, to Q&A. operator the Operator?

Operator

comes the Baral Our line [Operator from first Cowen. Instructions] of Ritu question from

open. now is line Your

Ritu Baral

on MOUNTAIN three since Hi, anticipating CORAL that I change won't it does X.X saw control day change how endpoint did about I first you the Are that want you're ask SSRIs of primary to to at in? kicked And sort very that really WATERFALL in reflect anticipated change. was active for anticipating? have Thanks. guess, first, FDA-driven or guys. you taking SAGE-driven? quickly, Thanks X.X that your question. and the

Barry Greene

Thanks Ritu. That's a the for one. great Hey, question.

the retreatment successful that data Japanese data Phase we as we and had from very SHORELINE. study WATERFALL, MDD-XXXB, So, ROBIN as as pre-NDA filing confirmed from NDA X with shared, a meeting efficacy package well the

We and, you also mentioned, pharmacology well as the program. the CORAL from entire studies as safety ongoing anticipate

as get original to rapid really And noted, study clinical back current to if the the symptoms So, don't the clarity in X you sought the demonstrate endpoint ever. study, primary the analysis in plan with that which to agency. CORAL in day we – the that selected on hand, the feedback is weeks from Phase trials. depressive or early the that, idea we overall antidepressants after X statistical of And key feedback, endpoint, of relief kick for CORAL XX as

to expect question, benefits efficacy active your in the dosed So, had And the any the of we millions endpoint through of already of it sort patient. they this just for filing, allowed move last literature us over the of for rapid to arm the And primary kind know antidepressants in. hand because XX now years CORAL second while the X. day right. that don't We relief we efficacy represents you're since in from to of data to patients kick take part a

Ritu Baral

Great. Thanks for taking the question.

Barry Greene

Thank you.

Operator

you. Thank

question Cory of comes next from line Kasimov from the JPMorgan. Our

now Your line is open.

Thomas Deal

on CORAL update I good maybe just morning. is Thanks one question. the Cory. guess here. another for Thomas the on This taking for Hey,

placebo from update see will you But file. about Thank curious that study, you it this we think separation SSRIs kicking makes at potentially a you. in need think particularly to in physicians and time I guys obviously just how effects as to said for over you important time. be later of the the points have efficacy you data sense have the all think

Barry Greene

And please Thomas. best send Thanks, to Cory. Yeah. our

I I right. to reflecting, It's think the profile important the that have us package We the patterns. three so onset. pre-NDA no depressive will we physicians the way day think you're zuranolone have, the reflect the know, think was any file, to where, change rapid sleep study. So, X,XXX rapid it for after believe totality we've anxiety, meeting individual that data. is It's to symptoms, consistent of patients as and release of you in about not seen And

patterns. benefit potential sleep fact, In to

kind really the saw, the you and the patients day we up in out across which And reflecting to of SHORELINE data, only data we two-week full to in reflect need period then is out expect about XX% dosing as followed of treatments extended study, of the to So, patients in that a that the milligrams, period. of continued kick which XX the what return or remember, you day in real to which year. the highlight to the patients showed think I’ll XX, XX. at fact, of probably two course we'd Japanese one had that improve a patients, saw And totality placebo sort baseline world. in

physicians So, the think not data about when about individual totality how study. any we the will and think data, it’s of

Thomas Deal

Thanks. Got it. sense. Makes

Barry Greene

Thanks, Thomas.

Operator

Thank you.

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

line now Your open. is

Paul Matteis

have so one that's bit a little for Great. really quick one my one I Thanks taking much more questions. qualitative. and then

ended recent talked much. hurdle? can will you postpartum one, overenrolled? ZULRESSO how then know and points just these up be whether you've AdCom statistical more curious it, of depression you an got about is not Barry, more if I interpreted later really time perspective? that precedent, your time chronicity the acute significance isn't these at to second, because regulatory confirm Thanks being And final a MDD or size sample of conversations, kind from but on durability so confirmation CORAL you there's quick indication a and has the in what Just all points have FDA at the

Barry Greene

questions. Hey, Paul. Thanks for the

the over your Let and as talk with start me Jim Jim. can second well numbers. about to turn then and start I'll more CORAL part, of part question as the that

without again the is, benefit consistent What in guess as we've is SHORELINE, day point what look the at I we've rapid to quick about, at rapid to even is dosed, return subjects physicians and and answer statistical the X,XXX agency talked and So, impact time feedback. and required. day longer-term And not already for a significance baseline. with seen continued later patient three XX, out durable across benefit

better about, color So they kinds that zuranolone, the after returned we but the do about numbers? but that medicines, and see across any then of And they CORAL more zuranolone of the add to about and quickly with baseline. don't worry nothing Jim, what with like to want you drug, gets this worry is talk you we someone quickly, trials. stopped other

James Doherty

adds story that To that combination. know, perspective really size and CORAL, point Yeah, telling certainly antidepressant of from and Barry. a MDD-XXXB explaining zuranolone a Shionogi to CORAL rather of perhaps that point earlier, study, zuranolone co-initiation to tolerability mentioned the in the a the the understand I say, the with for data, with the Paul, about view the study said see would do as of with study than is as WATERFALL, the efficacy standard course, you from but we're really study. where as Barry XXX. CORAL, we an question is earlier, that of also think of I the CORAL And as target it's think I your totality the from adds for element I for SHORELINE tolerability view, what around importantly of

that said, longer study bit in ran in as around range that a we is it are originally think – that to a than the for enrolled little of be intended, perhaps with screening. but expect since number, I study above we to close the And we the little come XXX. bit expect I

Paul Matteis

Great. Thank you.

Barry Greene

Paul. Thanks,

Operator

you. Thank

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

line now open. Your is

Yasmeen Rahimi

Hi, all greatly guess to to what I placebo make sense in your I'm day responses a a you entire thank the you And be contribution. X tend than for be question. of quick XX score. is, missed. lower have trying I team. will Steve, HAMD-XX day significantly

saying knew That stat all my thank statistical questions. need And, we guys that probability file why close a out and hit separation. rolling to – this along a it that this to what figure X and use data your we So, guess Why use so you day to you from we data will shouldn't is, would its for don't NDA? helpful X Why Why not be for day not keep taking separation. into trying do I it. and like, show filing? high change filing? B, see sig I'm

Barry Greene

question. Yeah, for yeah. Thanks the

need step my commented a was need. I'll fact, back one team But MDD on that sat – I me growing following sort let agency remind down take unmet unmet XXXX, this in the studies, X in in of remarks a the So, prepared our and, that, a a recognizing of call. you major with Phase number

January, the So, NEST time change where our in we and highlighted, appreciated as more. a benefit/risk we and the to PPD and two we We've designed and – one positive positive with this going LANDSCAPE we in others got something seen long approved to more currently study. back have in We the one anti-depressants studies the the haven’t that package And and is and to that to study we MDD guidance and in file. that study addition needed Japanese needed well. had agency consistent programs, a

X meeting the So, for ongoing and not of But us, as Phase pre-NDA another agency We studies. was front and confirmed two in sufficient that filing we data with highlighted. there in that we X had dilemma our that sat was was a package Phase required. down

with was agency, had So, hey, file we open I the discussion CORAL MDD. what a which up, very coming thought said, is let’s good, strategic for

positive not CORAL to to efficacy but is required the in file. to the be going filing, We’re include necessarily data

over the educating totality is Now, benefit force, the day treatment of in will our and important benefit we X in to be guide appropriate physicians affairs three use force sales change fact the incredibly course. positive data if our data. of medical about including zuranolone Those see day us, will the to

will heard of to in So, physicians. Anita to data. see So, with lean I want faster? study, another kind better And of with really think positive you will wouldn't presentation we get allow in those this as terms educating who us ECNP, on encore her benefit say Clayton

Yasmeen Rahimi

Thanks, Barry.

Barry Greene

Thank Yas. you,

Operator

you. Thank

Fadia comes question Ami line next Needham. of from the from Our

is now Your line open.

Ami Fadia

in Hi. Good with morning. study a about or frequency planned. Thanks the for in taking my question. may I to you wanted Are that you doses to type switch talk SAGE-XXX, what evaluating study of be gears X Phase position to just kind quarter then follow-up a And safety? is on as quarter, tradeoff Thanks. of reflective forward? going a R&D find rate this run quick the that and the spending finer between expect of to spending should we the for efficacy the

Barry Greene

to then Ami, the our financials. to of talk going to and I'm thanks for on to question comment Jim? and dialogue broadening the SAGE-XXX the about pipeline. Kimi our ask rest Jim for

James Doherty

Barry. Thanks, Yeah.

around the Phase clear evidence in but with tremor, for the the some [indiscernible]. way study SAGE-XXX from us So, results gave the SAGE-XXX effects study, Xa KINETIC essential treating of activity along on

on essential in time was XX So, work dosing we top that ZULRESSO done at for knew once-daily wanted that of the that based we earlier as X, in Phase zuranolone. work, label earlier open to both the range milligram at with the tremor tremor the we test and as that essential had our well

the milligrams And a a study. dose balance so, helps at really, study, Xb efficacy of the about a Phase that strategy things pretty thought the PK for study And dose-ranging standard Xb a goal being We've with really the it to it clarify XX top – tolerability, looking study. multiple appropriate profile will lot identify SAGE-XXX. the really be in between much for activity like so is an doses, and

and, well-suited compound the dosing. produce for intent chronic with was know, molecule a SAGE-XXX relatively a you a expressed As to for therefore, long half-life

Phase into the year. And the end the study, we so, which, to intend all Xb study again, go initiate of those for considerations before design the

Kimi Iguchi

like and the out on compensation did million. some point couple for increases have expenses the was one-time that of quarter, a that so reflected we to about would I did $XX in was that things question the A see in Ami, you the R&D cost quarter, quarter. stock-based that the

what in and quarter is So, R&D the what our pipeline. see that was expansion of about you the operating reflected say the will included expenses. That's the But I talked some of for expenses. always acceleration we've in in that

The the course, arrangement I'll Biogen. you we thing sharing remind of cost have is, other with

are us cost they the commercialization of for reimbursing the for So, zuranolone for development the SAGE-XXX US. and and XX% in

expenses the pipeline. some continue expect do see we increases additional as in R&D to to So, accelerate expand and the we

Ami Fadia

in R&D? Thanks. the was full just I ask, portion what Can $XX included R&D million It. it or was Got in of

Kimi Iguchi

a that of escaping me think and half I'm Just think right but R&D. maybe. portion in half the more And the number it, about was now, I – sorry is

Ami Fadia

you. Thank it. Got

Barry Greene

Ami. Thanks,

Operator

Thank you.

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

now is line open. Your

Andrea Tan

Hey, is for everyone. taking for the on This Thanks question. Andrea Salveen.

points the development to zuranolone. treatment concern just curious back drug potential of And your the conversations eventually have are hearing course. as KOL how sorry, the paradigm? how launch, pushback over be you would in or But And near any about Barry, go you to evolved used

Barry Greene

no zuranolone. I And Thanks, problem everybody's Andrea. mind. know it's to on going back

So, continued outcomes data first weeks as presented. with physicians an data dosing was placebo, to the totality integrated of even stopped an treating totality not where reflected presented in improve particularly of It's a off. light XX had and and at SHORELINE, new that or across at XX, treatment chronic way SSNI a where patient-reported of data, short-term is the and think of ECNP, all bulbs better were day to faster. really It's not that, statistically evidenced they a set, Congress after day This than that XX a I saw when patients four the went including we've SSRI treatment. get And eight as stay domains better better. patients It's treating. with lot were significant And [ph].

This in So, from, six the drug. you fine, again, slowly is off. you many it's approach. with the At a which months, for diagnose them learned bulbs someone approach of they're depression, what for new the XX remove And pretty their frankly, If is think, them I medical months. school rest frankly going last different light six a of lives. years, not, keep for of if very treat drug if on are end

physicians potential to starting is or other treating The that treating really the profile. are part physicians appreciate safety

heard which, somnolence, gain is of said little of bit I One listened of dysfunction treatment. don't to two-week like, her and exactly, drugs. the why sexual in for and, think but that. effects you worried but Anita that's patients for she We We these course, – I'm not fact, the see stop hurt a of her none helpful, they adherence see side that many about and course patients of things taking this. the And quoting most she's something two is things and who weight

So, positivity hear of traction. And future. physicians to the we're believe more the potential making lot you're treating going exchange, we in by I a continue as scientific

Andrea Tan

Thanks, Barry.

Operator

you. Thank

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

Your is open. line now

Laura Chico

Good for question. the Thanks taking morning.

outlook. CORAL one Just maybe longer-term the guess on and I

read we beyond is a bit And any? the data key but the if going the speak little that have and kind zuranolone, to linkage the be to mind there to you. what separation kind should you for are unrelated events what in XXXX? day could CORAL, of then, X rates of through to is So, between remission Thank

Barry Greene

me Yeah. start key I of can for to Laura, kind date let and events. Jim it then turn over

need patients really with the that filing. for day that XX. as or So, in SHORELINE we of key data have only X,XXX evidenced we in early most studies as if that rapid and to impressive And the over again, couple the have course subjects one positive two as out showing a depressive four year, and patients anxiety, relief day here X is the then, you dose showing symptoms, two-week of

Now, know all, depression that for people X get on current for to we if better. day CORAL from on is key take standard of suffering care, what's at weeks

I to weeks my for in educate positive us to think on the allows depression study is through Who and through call if get better this the study you to four is six I X the X So, wants potentially day sexual gain, dysfunction to clinically physicians. suffer meaningful who on can that my to quickly. wouldn't? people and to And see meaningful. clinically to if And day patients CORAL it's hit to work that even weight want work measure And if is Anita So, that abates? future. my this see incredibly

to the to the change with forward thrilled you CORAL Jim, results. the and the of looking we're So do rest year? talk about want

James Doherty

Thank Absolutely. Yeah. you, Barry.

For the XXXX, program, XX the readouts showing the open-label are for dosing. into disease SAGE-XXX year as data for half program, will NDA we as in one study our the the SHORELINE and, the mid-XXXX up the XXXX population early second the of before to to we're to we readout year year. be And then, study Alzheimer's end XXXX. for expecting rest the of go, of in milligram of in from SKYLARK submit in patient zuranolone The far to Also, of moving results the CORAL expecting XXXX. expecting read-out zuranolone course,

Barry Greene

and already good course, will but Not treatment but the like Huntington's as exciting Thanks, per clear These future. trial we'll in Laura, as initiating and Phase SAGE-XXX Great. for And start cognitive in it's progress the to as SAGE-XXX with Jim. Phase moving well on Parkinson’s the se, then, of X data highlighted, also longer program aren't Jim readouts doses, design we of think of explain important along along. year X the Biogen readout, be later essential that this trial number dysfunction. looking thereafter, be the very dose soon duration, the for SAGE-XXX the tremor at frequency, a

Laura Chico

Thanks, guys.

Operator

Thank you.

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

line now Your is open.

Matt Hagood

Jay. Matt taking questions. Thanks Hey, guys, for this is the for on

And to So, it. wondering, data to Appreciate study? do hoping are what sense you. epilepsy then, believe SAGE-XXX, inform a from see expected you we the there later-stage for Alzheimer's? and SAGE-XXX, data forms were most makes separately you the what for could of in how open-label soon Thank in LUMINARY trial

Barry Greene

Matt. Thanks,

comment on ask I'll and SAGE-XXX SAGE-XXX. with start me Let Jim to

is been Huntington's really started has So, and hypothesis now exciting all an that SAGE-XXX Parkinson's clinical early what’s consistent the as through in PAM well readout. SAGE-XXX, our studies, early biologic as preclinical, the NDA first about

and of stabilization to is hope Alzheimer's same of see in cognition. more cognitive a improvement expect to or – disease, kind in much the we see heterogeneous while So, even

We're tests stabilized is the is important that, face that by independence. SAGE-XXX the cognition see fact, that that that diseases, executive in measuring really So, issues to progressing these we means often of perform, want and, memory. neurodegenerative aren't and we that's And the improving. really in they that lead for about And lack patients learning function, to reason their in hope or talking put executive stay buy make a remember families. for to activities imagine And cases, and can many living. that it on go beneficial it. neurodegenerative able list, in function, independent is food being store, want, people very That I and to of or, the to you I away improving the is can carry stabilizing these daily where shopping diseases with kinds their of patients years the put

the that kind that's you looking Jim, SAGE-XXX? data about to for. we're So, want talk of do

James Doherty

Absolutely. Yeah.

it are SAGE-XXX, right behind activity these programs to trying clear around kind of do. that think the is at brain. good of I synchronized lowering our abundantly science follow the what back question And think sort one of Matt, and about things really, epilepsy to studying, gets the the seizures modeling mechanism our the There multiple a way we seizures. So, goes quite compounds we is irrespective types overall us that And for that are in robust the lot of what we've of seizures that the type is What lot of a is triggers gives effect. compounds different of really pretty a of at means it flexibility. that kinds found have in anti-epileptic types. all of That which of we're

which the partners we'll that intervene. mechanistic syndromes what is most to discussing epileptic really sense ability very for make collaboration with So, broad our be

Matt Hagood

you. it. Thank it. Appreciate Got Okay.

Barry Greene

Matt. Thanks,

Operator

you. Thank

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

Your is line now open.

Sumant Kulkarni

in NDA? And simple XX mg XX the in would do taking dependence dose upcoming world the in dose to you only cohort keeping of for versus for real by potential for mg Good perhaps XX my and patients filing the for terms What morning. prescribers, question. that the expect what things regulators, mean data? SHORELINE relatively Thanks see for mg your

Barry Greene

for question. Sumant. Thanks, Thanks the

And number, the and what we XX% or required The two-week are you response rate two a of courses an of the step one or two one, saw we're terms back if SHORELINE, saw data I'll and milligram, certainly that. XX major and believe in So same is consistent chronic we'll in the two readout, that see side saw they milligram only XX every readout, year. we kind remind X%, have even effects response year, only two-week of we of XX milligram I data. to step-up the a XX% we’re you – end talking is impressive XX three preliminary the therapy believe we that, which – milligram think the someone pretty with doses of from about. In the with readout in slightly of then patients take day course better, it, about that rate, at needing hoping and preliminary the

In many in with antidepressants doses terms have multiple of to it's filing, common the pretty filing.

have So, of to course, for XX those patients as milligram, the and we've agency, it's work got physicians, flexibility belief available through the or for perhaps well we optionality but XX to in [Technical the our will addition milligram Difficulty]. that,

Sumant Kulkarni

Got Thank you. it.

Barry Greene

Thank you.

Operator

you. Thank

line next Partners. comes from Yatin the question from Our Suneja of Guggenheim

Your line now is open.

Yatin Suneja

it change endpoint led okay, realization label. on let's what the was differences sense needed? what do July. it's Hey, that trying on of about – the getting sense, getting that of see question. understand Maybe guys. the a a and by it? my from get And actually this making. – Thank you a the shorter we just WATERFALL to again, just that question or acute in terms engagement wrote to you get are you for you from by We taking – regulator Is onset study a the you what it an talk CORAL to is change led or But you trying the if there can commercial an decide, acute to led about in active standpoint just

Barry Greene

Yeah, for Yatin. question. the Thank you

set that remind and we WATERFALL, needed the So, and as and agency, when the two in you pre-NDA agency, that before, studies pack. these the with which let was me of, was agency. the with meeting that PPD year, we required again, What thrilled positive during with with everybody programs highlighted, with our we’re guided for the package as a highlighted was filing LANDSCAPE NEST And be a filing motion study fact we you positive for that. the confirmed to sort MDD one we is set in study. one we out of and

CORAL in as asking and question. So, different antidepressant. filing agency, it's and the effects consultation top to with of have the monotherapy and – what sustained we zuranolone the and The shows set of a in we rapid forth use with to intended a do, it's date hand, to a we on data package for stable

with is CORAL we're we're antidepressant zuranolone for doing time. what concomitantly an the with first giving So,

if we're would those that's We the believe with kick is of asking, that And ever, So, a release be know that – different in. important. and and antidepressants that an the very relief rapid four current eight question combined antidepressant, take zuranolone question to we rapid weeks, that to new.

So, of data, treating very very leads better it's totality somebody that their respond beneficial when know, that fast, the important to and certainly getting quickly, for physician. we through a patient And response. and that sustained often people

it's think the of data a important data we in totality already we have. So, very the

Yatin Suneja

clarification one just question. And

it it? and clinical to market the will into label point, able the in some can – right? section? it And get X day be at does how the on you just Will study be So, endpoint, how you reflected then,

Barry Greene

Yeah.

thank for you that. So,

data And what's study. uses it us to very talk that’s label. see of the it’s and I course, potential marketplace gives positive like of So, the zuranolone, But about to here to think important is inform early important. specifics too about a we’d of

Operator

you. Thank

from Our the Akash line next comes of Jefferies. Tewari question from

line now is open. Your

Akash Tewari

Thanks so much.

avoid at the looking box kind you. be billion of and that XX $X Thank how considering like this doses on you're in your no agency's Is opportunity a between XX Could feel milligram thinking impacts Shionogi is meaningful And to in warning what a package in you just FDA. to long-term separation to and SAGE-XXX that do safety XX mentioned And Additionally, around over dose? not for think SAGE-XXX the for you excessive PPD? SAGE-XXX the for you study sedation up-dosing that the time? could milligram do efficacy, the mostly for milligram there think is include indication? PPD, you trial? the indication do the So, going

Barry Greene

Akash. Yeah,

questions I think there. in many

let couple them. of So, me to a get

meaningful indication. in from a we is think eight – could It's be PPD, So, depression. suffer PPD One underdiagnosed. very highly moms

you think, having that large moms And want and the mom Jim, the is So, births, very certainly very think if I potential of gets a important. weeks take number a something in indication. one one? about next better lead you for two takes to to faster,

James Doherty

Yeah.

dosing the on but in the placebo separating would your So, for trial, from safety, both also effect significant importantly question for trial of see using Shionogi both anticipate Akash, Shionogi is about in arms. the the What trial we drug efficacy. we that

to all rapid at that see in as in profile that’s also time the treatment – we've the measured day what benefit the point, other of early We case similar Study. the end seen of the symptoms occurring the the of out well lasting first in through XX as our a Shionogi as improvement period studies as sustained

Barry Greene

background the both study. have very the therapy. seen that to only study difference would monotherapy you first Akash, later between if time meaningful studies is points, Japan, which antidepressant placebo think done pure That was out the out other placebo. study that we've is add, both of about a I a very this that's impressive. there drug sustained And Yeah. and arms All was we've and the

represents very the the true that this a population. very showed in XX benefit in don't well-run a and study that think We seen for fact a milligrams at we've XX clean, So, really the It’s study. XX patient benefit milligrams impacts zuranolone in milligrams opportunity all.

said, and Jim an important from perspective. safety be will it efficacy as So, very

Akash Tewari

think excessive be warning do avoid box you'd for that SAGE-XXX? on Thanks. lastly, you to just And sedation, able

Barry Greene

Yeah. talk excessive specifics about we but too early Again, label, to the see sedation. don't it’s of

issue. that's So, not current a

Operator

Thank you.

line Purohit of from the Vikram Stanley. next question Our from comes Morgan

is now open. line Your

Gospel Enyindah-Asonye

can Vikram. year? believe – this my do defines what And to you this readout? can learn LUMINARY for is on is this we morning. readout what later This we for My success Thank what for you And expect call. from taking Good learn question Gospel thank you.

Barry Greene

Yeah. Gospel. Thanks,

Let and me more ask start then to LUMINARY. talk I'll Jim about

It impaired to So, for at we you a that lower based disease. the in on seen cognitively specifically designed SAGE-XXX levels hypothesis neurodegenerative be in I’ll discovered was Huntington's NMDA. that remind patients, was positive modulator XXS-hydroxycholesterol

we we first, Alzheimer's heterogeneous, then saw memory what and executive Huntington's, much of the or to kind more Parkinson's. we're that is population, which So, homogeneous set while is the function in stabilization for same Parkinson's And Huntington's of is in and most out hoping see kind improvement patients.

So, year. in Jim, add? those are to looking the later data for we're the anything

James Doherty

offers I’d described. that believe we of brain. Barry using the Barry, to interacting system that with that that receptors, truly add opportunity SAGE-XXX a here Yeah. way a novel the mechanism powerful very a This in is NMDA

new call the way in really disorders. number of populations have with cognitive we've idea And deficits ability we of to CogNEXT to designed interacting across a the a memory, program so, learning of number these of executive SAGE-XXX truly the of effects on patient different what examine with function a

And point, date, and populations show about And which this to results the populations. Parkinson's most patient talked we're trying Huntington's understand the benefits. the to so, from we've at yeah,

And so, patients. LUMINARY investigation represents similar Alzheimer's of a

so, the intent, of endpoints of similar many And across many elements by are studies. and the design trial

what what you elements the Huntington’s sort looking many with trial to similar the at of Parkinson’s are design effects anticipate we've we're So, in and and going having be But that looked can the population. AD of see populations. to we'll be endpoints patient both to

Gospel Enyindah-Asonye

All right. very you Thank much.

Barry Greene

Gospel. Thanks,

Operator

time, turn back call this for At you. Barry to remarks. would thank like to Greene I closing – the over this At you. Thank

Barry Greene

have everyone entire our advance patients, we this to what again And team, develop throughout new balance third vision this team dedicated get could on therapeutics achieve market. that the patients, to will so that and developing year of paradigm-shifting next to deliver to for quarter mission to so the year who to I'm bring to and you thank great medicines year and confident SAGE tirelessly SAGE work I'm progress The matter everyone, that closer progress. have clinical joining us all sooner. the hope our operator. grateful of our investigators, – Thanks, will us made to become continue bringing leaders Thanks a they morning and to our health. the again, the review in to to much to brain better day.

Operator

for today's concludes This call. conference participating. Thanks

You may now disconnect.

Sage Therapeutics (SAGE) 2 Nov 212021 Q3 Earnings call transcript