SAGE - Earnings call transcript Q4 2021

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Operator

Good morning. Welcome to SAGE Therapeutics Fourth Quarter and Full Year 2021 Financial Results Conference Call. Currently, all participants are in 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 transmissions of this call without the written consent of SAGE Therapeutics is strictly prohibited. call recorded. this that note is being Please I of Investor like to Rubinstein, Director introduce Helen Relations would now at SAGE.

Helen Rubinstein

Good financial for and morning joining SAGE Therapeutics you and fourth full-year results XXXX call. conference thank quarter

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

prepared who of our the Greene, remarks call Barry will from progress XXXX. the provide We will and the previous with begin full-year by quarter Officer, an Executive Chief overview

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

Barry Greene

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

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study. the WATERFALL, efficacy ROBIN shared planned MDD-XXXB, we data Japanese CORAL, studies. five previously, the and and include from will NDA As

to the from period, data efficacy of addition sustained safety treatment data lastly, study and repeat beyond entirety from the In on the the treatment SHORELINE program.

conditions SKYLARK of life-threatening associated results candidates plan in We the with XXXX, PPD designation pending needs. treat this zuranolone serious for granted half NDA the PPD. We first completion that and drug FDA also medical in or the from an that announced to in study. address Fast-track and designation granted the submit potential to is fast-track zuranolone unmet morning demonstrate to

cognitive also to in And DIMENSION cognitive evaluating patients open with to by placebo-controlled recent are X in the Phase NMDA indication in label specifically extensive as receptor associated led awarded SAGE-XXX, and we to SAGE-XXX this in in X for call, cognitive oral first-in-class mid-XXXX. now placebo-controlled fast-track in due a We're promising with that quarterly FDA with dysfunction. study HD in Parkinson's advances of study, neuropsych begin an receptor impairment generated patients MCI placebo-controlled study partially Huntington's X plan an turning for cognitive Phase potential cognitive therapy This which on the performance advancing work treatment Phase mid-XXXX data was was patients impairment. the in Now enrolling study in due by to demonstrated mild being In designation disease, SURVEYOR attributed or as in our Patients development impairment cognitive developed our with our to Huntington's NMDA impairment. Phase the SAGE-XXX XXXX. in we SAGE-XXX potential announced late SAGE-XXX, expand improvements early a X HD franchise in initiating mild wholly-owned our cognitive impairment. by A cognition disease. our SAGE-XXX disorders study we for Parkinson's PAM designation last Huntington's the evaluating

study ET, franchise, on internally to plan in neurological and treatment in disease Difficulty]. last MCI for patient provide for SAGE a across later These also that made We important evaluated SAGE-XXX, health disorders. our dementia expected with is begin Finally, also in for singles tests open great multiple this moment is SAGE-XXX all compound And SAGE-XXX [Technical continued which data potential in as insight neurology of multiple work Alzheimer's, to brain patients behalf SAGE. XXXX in seen franchises. like thank patients collaboration I'd performance a work progress and patients. I'm Jim LUMINARY mild developed of with This improved Currently, by We for in dementia the with areas those rich as enrolling holds recently Parkinson's with built Alzheimer's. consistent observed year. this a our study, dedication being updates other a potential being placebo-controlled and and tremor, progress another foundation and due of program program from features and solid the part the year, SAGE-XXX future was we and XXXX. excited will for our We've year is announced patients hard a that function team mild year. is advancements take Phase to cognitive label the for to three suffering Biogen. their SAGE-XXX trials. more mild baseline what due to essential to X in a Huntington's initiate cognitive commitment on realized from evaluated in demonstrated impairment on which treatment were

biopharmaceutical believe to balance to I to to ensure continue our strategic as long-term the create value. tier and we as in well operational our advanced the XXXX, success us investment we our and to the throughout to health diligently, confident pipeline, in each grow efforts to and we a XXXX evaluate us brain opportunity sheet to our top our the closing, fourth quarter from and on build journey have company. flexibility In continue leader positions Additionally, I'm momentum generate continued provides become the decision-making

expectations over our Now I'd discussion the for Jim recent preview call our Jim? XXXX. data turn like a call of of detailed for and to to more

Jim Doherty

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was ADT new no with attributable signals well zuranolone with zuranolone identified. Additionally, safety to tolerated in co-initiated

this particularly Importantly, important. at critical standard subgroup is zuranolone. than elevated in SHORELINE when by represents best, is all is In This use. secondary standard your care of of know and as which ADTs, MDD endpoints. placebo, development subgroup of from with MDD patients always to with responsive treatment. less baseline course, study, pre-specified the the with that care identified When as analysis important potential WATERFALL of studies of XX% the more drug guiding responsive standard and was CORAL in a to subgroup to to treated patients this finding anxiety of up responsive MDD results a co-initiated where of ADT ADT, primary It's works co-initiated measured and key commercial drug with care

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we in in With from hand, in of SAGE-XXX placebo-controlled HD the begun cognitive the the impairment. study X in now dosing data patients Phase study in HD X patients SAGE-XXX have a dimension Phase

forward we study. in to initiating SURVEYOR enrollment the look Additionally,

patients due cognitive impairment an Our also evaluated study cognitive cognitive cognition positive expected HD mild domains on second PD. PD with to of on study disease in impairment to PD. planned SAGE-XXX to with paradigm in mild or initiate Phase with XXXX. the impairment, patients SAGE-XXX in we cognitive that mid-XXXX that SAGE-XXX Phase X mild late We're a impairment in commence Parkinson's due to to open had Based in in label extension plan The with patients initiate study mid-XXXX. impact due to multiple study study, of placebo-controlled X advancing in

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We expect placebo-controlled mild in AD to due SAGE-XXX late cognitive impairment with in study X to Phase initiate with and mild a dementia patients XXXX.

to-date the in with program a confidence to led develop us seems diseases across of SAGE-XXX unmet robust data need. very has Our

potential with recently neurology treatment positive optimize GABAA of in ranging led X of initiated evaluating in which believe frequency approaches. leveraging predictive. to is in in next-generation KINETIC seamless the franchise program I'm neurological we to the ET. year. Based forward, In the while updates to or hold like on can proactive the XXXX. SAGE-XXX convinced; closing, programs, of X in the Now in execution, late a the of allosteric neuropsychiatric improve working, needs from across our I'd the Tremor share dose positive goal learned the our neurology, chances believe We study. our depression, a look dose in conditions unmet been define the knowledge forward made from R&D part has three designed our Essential path XXXX, for may dosed lead and data franchises strategy Everything SAGE-XXX, ET. to need receptors, providing highlight by a modulator addressing advancements and significant patient across this driving like KINETIC we for X is reported and both be to study our in pleased SAGE-XXX patients other new franchises. earlier KINETIC of study I'm to Xb first to strategy that applied ET who Phase strategy success and we KINETIC is

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

Kimi Iguchi

goals. a poised like pioneer NDA pivotal year our opening was our milestones remarks. deliver to person to XXXX key for advance be for zuranolone. will long-term important what three tremendous to made significant Jim. to XXXX, a of filing his believe achieved have our health franchises based of Sage. so across Thanks, changing our We're corporate progress our on we towards well-positioned thrive. and mission reiterate We're brain health progress opportunity We in proud brain all I'm the and presentations life to the by medical portfolio. illustrated solutions medicine robust at I'd Barry we've in invest can achieved noted underway preparation achieve to well planned and and what in every scientific of work conferences, readout, numerous presentation is the forums at the SAGE the for data we

opportunity our execution successful, have especially patients, XXXX and clinical balance shareholders. we providers to a of value highlighting a our where, a create for corporate if period $X.X in aspire start ZULRESSO sheet. revenue recorded revenue compares $X.X from same provide our net our the progress the That on fourth will supported to by million and of end financial unique sales society, year sales quarter We be guidance. I'd strong the and million net the XXXX the focused significant of to by the accelerate like healthcare ZULRESSO. fourth remarks quarter in of and of year from financial our XXXX. for then some to in We year

of expense. $X.X were of PPD. stock-based sale was stock-based compensation XXXX. the all compared quarter, including including expenses for in $XXX.X $XX.X Research million, were to million and for me, the million million, stock-based non-cash XXXX. non-cash $XX.X moms, committed remain the million, to compensation their to non-cash million, with fourth $XX.X including $XXX.X the development in of million families, $XXX XXXX, million reflects R&D the XXXX. collaboration. revenues in by of impact full-year of $XX.X $X.X We including net That expense those a expense in ZULRESSO we impacted period million to were to in million compensation of full-year, due the and our expense expenses For stock-based $XX.X recognized $X.X compared million non-cash compensation as collaboration Biogen, excuse of under in This of reduction same for in $XX.X million compared expenses XXXX reimbursement

partially pipeline. expenses spending increase reduction offset R&D on by this in an our However, wholly-owned in was

including quarter. to expenses expect for in primarily the stock-based XXXX. non-cash XXXX in compensation $XXX with SG&A The of non-cash collaboration our million, the $XX.X of million compensation from stock-based non-cash continue million, million, were including general $XXX.X $XX.X pipeline SG&A million same $XX.X in Selling, reimbursement our to wholly-owned including of administrative expenses smart $XX.X compared by compensation including to decrease in full-year in to expense the $XX.X We fourth compensation invest were of advancing non-cash million the stock-based That's a expense disciplined XXXX way. and million, for compared expense million in driven in and stock-based $XX.X period were XXXX. Biogen. expense of

million net XX:XX will in compared expect of expense the of We potential $XXX.X States to period XXXX. increase for XXXX. the net we comparable million and As collaboration fourth of loss a sharing zuranolone the in the quarter we $XXX.X cost SG&A reported of prepare income SAGE-XXX. for Recall the United zuranolone includes for for launch

For both compared the the income from Biogen of in XXXX. million the of loss for was period due XXXX. was in $XXX.X $XXX.X the to decrease XXXX, periods, same year-end collaboration revenue fourth December net In quarter million XX, the to net

of the from As quarter proceeds that consisted under $XXX equity in a Biogen of XXXX, an excess billion $XXX.X upfront $X.X the purchase a stock million SAGE reminder investment fourth of of plus revenue payment the agreement. recorded collaboration from million in

billion continue cash, foundation solid $X.X to cash a financial marketable maintain equivalent securities. Finally, in year with we the ending and

Turning financial anticipate we XXXX. expect cash and for cash billion from guidance We the end $X.X any to collaborations with year milestones to approximately equivalents. do of XXXX, not in

always potential believe ongoing our SAGE, in cash being will into we and across support we we cash XXXX. funding, revenue Finally, courageous, do, and At pride our and operations equivalents, collaboration ourselves innovative, efficient everything providing with with progress. how it turn forward benefit sight work to our look handle operator. Helen line to can to this I'll over on the on the Helen? updates now Q&A patient. I

Helen Rubinstein

Kimi. Thanks,

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

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

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

Operator

you. Thank [Operator Instructions].

Our with first question comes from Salveen Richter Goldman Sachs.

Your line is open.

Andrea Tan

you've much. Andrea just the who they CORAL curious way. maybe post physicians in on I'm on any would even the use they on received from Thanks for treat their results, changed for feedback so the or is view the question. This has Salveen. how taking would drug Thanks

Barry Greene

we've that we is amount of Andrea, fact, tell antidepressant Yes, with quite -- encouraging the feedback. received will prescribers Jim the can quite start the thanks the minds did rapidity some comment profile of profile from CORAL ask to effect tell improved with in feedback you post that and I some MDD I'll with an well-tolerated the also prospective opened we the of particularly anxiety zuranolone analysis was in really when is eyes GI in elevated KOL. you I was seen because for and and interesting. have that instances combined I'll encouraging, effect in question. the potential very

anxious called anxiety including As standard also elevated STAR*D. MDD on not care. served are we literature by that current talked are the documented, well with That's call, are depression, patients of well

population very they patient in we're very, very new that have they a is hard interested a to to treat. treat said historically So having drug

me Jim potential then about we're prescribers. from some to about patient talk ask Jim? and Let talk that the of additional types hearing can feedback, maybe Chris

Jim Doherty

of couple we sertraline, of domains, design mentioned desvenlafaxine. across Barry. citalopram, you about duloxetine different And talking with care we're when in standard lot a include of CORAL Barry antidepressant. co-initiation to think And escitalopram, Sure, chosen and the encouraging a about our as a feedback really study, certainly, had

by really So antidepressants. other physicians the standard label a demonstrate zuranolone performance improved quite in the were very range in over broad format results we're of interest bit an to KOLs. encouraged the baseline, keep relative the zuranolone of finally, contrast in who very, at the that which challenge show open both in treatment of of sensitive of care broad to to as care that to sampling care of subjects There zuranolone of ability to also standard a very of seem in of antidepressants in from cohort patients to treating to with with standard point, we who profile tolerability impressed with those antidepressants. just antidepressants, and And anxiety we've is hearing be reiterate the Barry's elevated seen

about overall, the talk you been with bit a Chris, we've from types? do to So been little very so KOLs. patient pleased feedback far hearing want we've

Chris Benecchi

over a those patients consider in in me of with back, year. marketplace, think to year. of times take as step switching are a this out, types, or let what's XX% Barry I happening respect initiating are many of pointed given patient switching therapies Yes, And the either course first, multiple a when patients you

that effects of our therapies that time taken period a are and works stigmatizing can them in clinicians quite to time year. dysfunction course effect over as for sustains studies over And the know allows shortened gain. to we doesn't side short carry that sustained over a weight frankly, rapidly, be from like up of looking some what other sexual the is a So effect really therapy a

time. as is that we've pair and three said, this that opportunity with studies sustained CORAL, like rapid we've effect. day demonstrate to the So day efficacy therapy, there's treating out SHORELINE those with And an PPD, early they're there's with the have when and every are rapidly those therapy with that that for that with conversations attributes whether a suffering that in KOLs said, clinicians, you works therapy, practice up to or sustained effect did effectively MDD patients a are looking with of and what done over as

telling when also or may like patient needs see these their without with who think that frankly, And adult, rest lasting first feature particularly college be as rapidly like those That to young may of their a present is the really stigmatizing really So stand life effective that to adult works for physicians good elevated or be looking about job may the lasts. can't another an place us therapy rapid side they're and it of MDD effects. therapy a patients quite and starting their you go. chronic for a really that anxiety be young may older someone that practical that therapy on that that student, patient's and adult that

it's that we patient work really reinforcing with zuranolone. But we've need the to of again, difference heard. So and have, that number a the patients there's who opportunity like therapy types pairing a in other the CORAL a lives make of

Operator

Thank you.

Our next question JPMorgan. from comes with Cory Kasimov

Your line is open.

Tiffany Sun

Tiffany is for Thanks for question. Cory. morning. on good the Hi, This

and each trials three populations? how to the X year trials Is And Phase in it randomized at for fair XXXX? of large multiple and consider in results characterize also you SAGE indications with would can so expect out interested just these XXX, will data Thanks. we're Huntington, these in take. these different on what you meaningful long in one Just

Barry Greene

and further. Jim start I'll I'll Tiffany, to ask Yes, comment

really we me can. proper certainly as what running sites when So, we up get trials important take And rates that to guidance. can as accrual yes, we'll and as before do step back. XXXX soon start But is like let and is although look possible, a understand we provide

modulator first-in-class we So as NMDA. targeting a SAGE-XXX, also positive highlighted, is

We a ketamine placebo-controlled the the past call, in Alzheimer's, Parkinson's calls, have data consistent between the variety and in consistent we and where as SAGE-XXX of cognitive impairment in impact demonstrate neurological Huntington's, across neurodegenerative three the highlighted significant seen And that we -- study, with data improvement And all placebo in diseases. are to drug. with that. and diseases is seeing we saw across we're significant significant, studying

trial. the mentioned large You word

of with allow demonstrate trials to the end cognition. progression, actually fact of in ends, measuring, features shorter-term a and long even requiring SAGE-XXX of changes trying sustained that and cognition or in the disease are to long big timeframes us we improvement over that smaller conduct will drugs because time, to decline are a slow studying we're period believe recreate unlike So

excited some really diseases. all we're across more? these So want of to neurodegenerative three Jim, provide you

Jim Doherty

Yes, Barry.

DIMENSION of around the detail little a bit study SAGE-XXX. for Just

seen think that time. is or is findings of referring period that I in of replicate to; course we've the to Barry studies week two key improvements earlier the our seeing from actually so over we're cognitive a performance

intended PD in for improving study, -- replicate memory and function a looking that that really the as months we've performance be three benefit SAGE-XXX well is executive is domains. study, to case the with AD So cognitive and DIMENSION seen both working as placebo-controlled studies will the

Operator

Yasmeen from comes Piper question next Our with Rahimi Sandler.

is Your line open.

Yasmeen Rahimi

morning would your were throughout in taking SKYLARK to head questions. the data ROBIN we XX. point about team. into just a HAMD-XX. in difference Thank XXX four I level love patients The data, the day Good hear obviously, thoughts my set to effects as you continued showed for

to data I maybe the we like thoughts that study given us expectation remind were rationale should ran be changes dose be good think head as so for meg, than data, milligram ROBIN what to XX I data and ROBIN and should equally XX that our be So better this we would as the love it ROBIN, some SKYLARK head compared the Thank whether longwinded into group hear ROBIN as are around into expecting helpful. could you introduced is which into question. your we a

Barry Greene

changes. the the then provide into really ask I'll SKYLARK details to Thanks, And Yas. some Jim, context. of I'll get and

milligram highlighted the the XX reading dose SKYLARK. You've in

highlight as centers. So it's dose anxiety. presents that And depression a often with also I'll bigger, study a it's elevated higher PPD of more bigger

about and we're we some talk really Jim, SKYLARK in helping want what differences other So of expect? about to the enthusiastic trial. you specific moms

Jim Doherty

Sure, Barry.

key SKYLARK I is think, ROBIN. of be design is the point Yas, course design the of the intended similar to to to

haven't in set changes design. overall of that the many So made we

WATERFALL WATERFALL out, And milligrams. I certainly we've the one in seen patients what you've major milligram positive the effect significant the seems the and milligram which dose beneficial milligrams, of XX would as already dose ROBIN in study, of SHORELINE predicted we impact where the dose, where dose. direction have highlighted in notably saw showing was in response and the I point overall is numbers XX higher think is the in studies program, in an the to from studies, XX XX the other

think major other I of size study. the study the overall element the that's different SKYLARK in the is

So than it larger the study is ROBIN study. a

mind, So seen study we've in response to the what a ROBIN studies seen study with that really with see the I kind and those note in profile also similar in would we've of the differences to expecting zuranolone. in SKYLARK we're similar PPD

Barry Greene

really excited we're PPD moving as Yes, by for forward well. and envelope helping the SKYLARK

Operator

you. Thank

comes question from Wedbush with next Our Securities. Chico Laura

line Your open. is

Laura Chico

the Hey, good taking for guys. question. morning, Thanks

endpoint. but day powering apologize at if you a be my missed is Just SKYLARK and what be, thinking of XX magnitude much. you both I assumptions how this, very should we I'm the day follow-up I understand trying at Thank question time just can SKYLARK, guess those the XX points? about to effect of I around remind both I've would for on guess us the

Barry Greene

thanks. Jim, take you Laura, Yes, that? want to

Jim Doherty

about, to most are studies, know, for the question ongoing have we were studies. just assumptions similar SKYLARK guided notably earlier don't get the study by we But I of results Sure, the study. specifics design Laura, powering we really as been of and thinking into the from talking you the for ROBIN think

course for demonstrate primary study key confident being size endpoint we're So that a significant the zuranolone time we've difference day to appropriately got at at the points, the XX. of

Barry Greene

is placebo better can up. and day Thanks, catches me stay fast Laura. me just, expected see necessarily at a thanks see these It's statistically get quite significant that emphasize the expect to let at better. that difference be The let at arm that And to key and we expect that And here XX, possible we just XX. moms it day Jim. Right. don't XX

Operator

Thank you.

Our next & Company. Ami Needham Fadia comes from question with

Your open. line is

Ami Fadia

Hi, my morning. for Thanks questions. good taking

would And Just about timeline? development the indication what how NCI across for layout be the us do need that you FDA Phase would the Thanks. the to of next strategy beyond that Parkinson's with an think regards And kind year endpoints Huntington's, could would what the are for SAGE-XXX, this AD? X we initiate planning to you and step? the clinical in be trials

Barry Greene

thanks your Yes, this for morning. note Ami, thank you. And

So I'll I'll ask elaborate start further. Jim and to

Alzheimer's the study. year. starting So towards towards highlighted, -- midyear of it's as with study the Huntington's plan a Parkinson's started just on than more Phase we the X single we've mean, And a disease, I the rather studies the Phase X as and program we you've study articulated, end and

potential X how endpoints about on are about or CogNEXT thinking Phase with Phase we be is disease disease those Huntington's but with also studies. understand fast a the that likely the will agencies work require track. have have where orphan including us matter. advantageous because X. with hypothesis in make because will that and we're an of the endpoints studies It's positive, talk starting top next the to to can SAGE-XXX wildly we started steps, of also with it Alzheimer's are biologic that Jim, Parkinson's disease Phase X you bigger sure specific for endpoints? that's we with the that And and certainly and We registration work to Huntington, we But want agencies if frank, to to do start

Jim Doherty

I program we a about And about Yes. Absolutely. SAGE-XXX, development for mean, we the the think lot following science. as talk

As some also indications, believe it design. patients. also our efficient SAGE-XXX Barry for NMDA through is mentioned, patients. receptor about have in earlier that different do we in evidence then both work, And performance to those for cognitive good each is of improving the these all involvement But really reasons showing

point offers view Huntington's population. -- is forward mentioned also the science with disease, but orphan an makes it pathway from for Barry case sense in a of different this So the

I of PD terms But we and like. looks we see AD studies would we'll have what set next path in to of call patient the populations, serially think to the beyond think in the tend de-risking. what

primary in So very about this are we To understanding this action. also studies have endpoint, with and performance. to FDA as other that of to improving world that well evidence work interested point, think in we directly the are cognitive real the program. regulatory benefits on set designed that But of very endpoints we're novel the follow-up agencies the mechanism aware CogNEXT we're the in that of we've done our adding

patients looking studies, to also that with function these in of would various measures meaningful our ways at disorders. be we're of So for bridging

think but we will that It's to moving of the important that to effort also are things forward. the -- placebo, performance benefit main you phase, will really is how patients. cognitive a be are several enter significant So understanding relative there that at -- benefits meaningful we into in translates And show be on going looking program were as an to part this

Ami Fadia

And about for to a be then Huntington, visibility have stage this would endpoint at Do just a that? in approval? quick adequate you it. three-month so Got follow-up

Barry Greene

been mentioned, positive, demonstrate I Huntington studies Ami, a we across aggressive it seen mean we three -- We've a in get engaged weeks. before we drug to to improvement working are agencies something now demonstrate in can cognition, this not if Again, to can talk to more very time. start. patients agency as yet. not we'll that's are I Yes. durability. out which the We never quite the to it with done be think the months. demonstrating over want short we're how about we doing couple period potential figure the with And of in of

Operator

Thank you.

Matteis Our question next Stifel. comes with from Paul

Your line is open.

Paul Matteis

is two are I side question. commercial on opportunity on sort taking the to Hey, cases floating where on about for thanks wanted the around and my bear SAGE maybe stock it with the use much to ask one of and the one so regulatory this that maybe side.

of and to kind to of too, dose side, sort play drug? the whether or lower-hanging and patients was treatment data, more and is out will how dosing new real in sure of pricing information that think the question other that the for use regulators and on going that get hard expensive doses all and a to paradigm SHORELINE skepticism, on would branded world area the subpopulations. totality drug the other do hard physicians be in And is in the prioritizing than refractory how have treatment around six-week enough that's I an primary there depression care between about analysts overarching the could a the changing And really think fruit, the side, On MDD or the right, is the SHORELINE, I and PPD practices? approach, you lot, commercial then think interval regulatory not argue of are view with as-needed maybe in I I'm higher centers practices how generating

your heard I'm perspective And certainly a it so sure lot. love of lot. you And hear I on Thanks guys have I this so would a those both issues? much.

Barry Greene

for question. Paul, thanks Yes, the

further commercial. start I'll on with comment And So then and regulatory both regulatory ask on and to Chris to me let commercial. Jim comment further

we So PPD, in I'll we designed and constituted following MDD, WATERFALL reiterated studies that last a consistency two at that positive with In any of year, of the FDA, fall a one the WATERFALL year, package. beginning positive, discussions the remind of filing package. constitute one the you last programs had we the with conjunction agency that is which of articulated a LANDSCAPE we've in NEST in fileable

including and MDD, MDD studies, the However, study. there one PPD the filed PPD, CORAL in then agreed were first an study and including we two suggested that we in CORAL SKYLARK outstanding and they and with one SKYLARK

So we're thrilled, was and positive. we've discussed it, CORAL the

was well not documented Now literature we data served a we subpopulation about designed served study. and anxiety analysis the with anxious running as antidepressant. observed that useful annually the that antidepressant. population, well but with current or that the those the diagnosed that of with that in through that's We across patients in particularly anxiety. then year two-thirds MDD CORAL other into our theme that And did prospectively zuranolone And with were is retrospective elevated discovered with with with elevating particularly not depression, well MDD, MDD MDD literature

anxious doesn't that with see we for that current with with have of can work package So you MDD rich subpopulation, anxiety a care standard pre-declined very elevated well. MDD -- a

file NDA path forward. PPD. an quite the regulatory about we're for So Obviously, SKYLARK will following enthusiastic

particular, and guide drugs excited just a work to So and about where today. in PPD the don't we're subpopulation both MDD physicians have well really potential treating

particular cases arsenal there's commercial, whole MDD anxiety. a turning with it's can and now my five elevated with are that not with of in well. types MDD I've antidepressants elevated zuranolone, patient to help these highlight particularly with agreements. with to also, bunch got like we're can So particularly those value-based where And work in served with not Chris proactive well it, opportunities anxiety leaning And current

have isn't staffed. and do patient need risks, budget right make get to lot that we certainty to get so don't it. we're in share a work a gets to sure zuranolone of patients so We to payers understand paperwork what of treat There don't So that whole trying is zuranolone blocked. with with the they

very but we've again, do guiding the commercial specific we're patient side, particularly that on have types. to potential we work on So prescribers got ways

there, to So about piece? then want the on commercial talk you all regulatory and in more maybe Chris Jim, pickup

Jim Doherty

as whole differentiated patient co-initiation without package add-on the care truly Barry was data And zuranolone, populations, back monotherapy yes, antidepressants, with very across a patients looking have Paul, think assembling you positive at and trials when so with Yes. as to point depression, the I of again, and antidepressants, is eight X,XXX standard multiple talking demographics with about multiple emphasize you I as and a six as what would tolerability wide think or step saying, we're want trials we at this profile. patients. antidepressants, overall both look of about, at program, And range

and intent approach of understanding to help program about payers the patients, elements, was of those NEST course, with both the think all is this points zuranolone. an provide broad of As providers, differentiated data in series you to of that LANDSCAPE a novel original

package to help understand very we and So forward. very moving people this we're as information we're excited the right we have best zuranolone assemble to Chris? moving how use forward comfortable that

Chris Benecchi

given remarks, treatment for clinicians regional options there to we're are of payers, amount Jim. context to that the patients. not options, respect said, PBMs, And out to to to with And for patients it market. add think dire talking the really and respect have because safety what for payers, he that even it's their with to And thanks, what they planned or on well. currently Barry's is it we're for day. payers, really thinking speaking going as substantial certainly, in a the are We're mentioned world with around recognize Barry they where whether And And in that commercialization that understand a engaging every with national there's even access looking options to clinicians practicing satisfied hit efficacy switching patient looking population earlier, that advocacy what care. This either at Paul, satisfied patients the And in currently or available We're situation for I there better a therapy. new I are IDNs. Yes, the not looking is groups they're already those patient well looking that for there payers ADTs. better employing. level, fewer certainly moms more is see PPD are they're really to a an

as to quite challenge perhaps in we said, a age the to and the being and patients ultimately efficacy because the benefit weeks or effects I in adult are loved six five depression patient types, because really desperately the There see order that there that they of and about never earlier, time get frankly, recognize that to that through mentioned change adult. symptoms reaching job conversation are or treatment with are there who adherence seven in of ADTs want their -- have experience the I've from ADT, the benefit associated or the that young side older deserve. to a wait spoken that a So patients with or suffering. so patients one their them on are experiencing don't still they death breakthrough are There their are there's many that

them they many elevated with zuranolone to So provide rapid with about MDD a all patient have patients that it, opportunity being or for said, those and and that we therapy patients. MDD of deserve. types, thread And these do whether a with they're better patients lasting with think you anxiety connects as that PPD is an

Paul Matteis

quick with give talking you're for How and this think in to and And a this a Or study, if not? evidence just the to And right, you a Can as is ask say, have SHORELINE you've this wondering harping maintenance that's Because one and is think, all wanted worse I few to then of restricted later? kind post-marketing the three given idea on right weeks a approved work? guess, the if follow-up? this On re-dose earlier. just then Just this get away benefit I and Jim, open I'm doctor, think weeks, something is I helpful. patient drug is not drug on really does SHORELINE weeks. that? regulatory your irrelevant. ultimately think usually whole extension of question comes But specifically, Do acute or if where alluded six this least Thanks? does re-dosing regulatory. I been Thanks. I label I they they dosed, issue. you hey, Historically better, with for into you're antidepressants, efficacy, is And to, at I'm question agree I data. of probably of maintenance feedback feel if play

Barry Greene

Jim, and the And round to can I out. question. start for it you want thanks, Paul,

Jim Doherty

for week vast the courses. actually that you're And But course when used. XX%. is is specific would can so the about -- Absolutely. at a that the question is for there a and got patients milligrams, or seeing that this the up which is, of point important right? two conditions Yes, address are clinical I some relatively interval, study study to have retreatment? I in what that do you've a year, Paul over you're very XX%, look the in But on the protocol. patients think in really, that specific a be distinguish, XX was you're subjects one It's majority majority to designed we trial, long the So what very which you of metrics really, in parameters that two so we of the course, would exactly one, asking, have need

designed practice. physicians to need So is complex, think that. world this But I in will And to process to that move exactly evidence going I to. in that study do be don't real think, yes, the a to for to it's that is SHORELINE that of be something how provide addressed

Barry Greene

need will round that just and of that out, most weeks two dose. be drug. that fourth be third, weeks thanks, immediately, Jim, very zuranolone to it the just to that's population rebounds someone the There'll few Paul, or a And patient imagine you designed. Yes. And to four fifth round two if commercial of and that not out. was takes just it we From how perspective,

group, patients particularly is and that in respond will For more appropriate MDD with XX% the It's But, chronic some right zuranolone those drug for. the zuranolone right the of not SHORELINE. to answer. may be were patients, that there elevated a medication be reach for different anxiety for is

Operator

Thank you. [Operator Instructions].

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

open. Your line is

Tazeen Ahmad

Hi, good guys, morning.

my Here is question. one

like you initially, a this best maybe the how do be in data served would planned agency might and that you maybe time. for? with we discussion feels induction if if the end least up agency do think at Is if initial you what Thanks. you've that's and opportunity be to So over should the submit -- the that for therapy, And commercial scenario about additional case? need drug a

Barry Greene

Thanks, Tazeen. one Thanks your for question.

X,XXX So highlighted this. we data in we have patients. now -- CORAL, over With and Jim's

as standard about highlighted. Jim's monotherapy, we were third, with time of but CORAL, of patients And care before We when a were co-initiated stable that we highlighted was with CORAL antidepressants the different of around monotherapy, then the on two-thirds have was first have a five antidepressant. zuranolone data top we've data the

fast weeks, new The and is package. not, two measured keep at rich better very a or better. have treat we for think to day meant them three we So get so zuranolone as someone induction

As highlighted, more we've SHORELINE, world SHORELINE situation, week only the indicates in treatment. already a real majority the which of two patients is required

and require follow them So SHORELINE onto CORAL year. two induction also not, course majority I for will it that patients try mean, commercial a we're or year you out think remind maybe the rolling will study, from -- longer. weeks I of world I'll the of in the SHORELINE. the in patients even

and antidepressant those Chris CORAL versus antidepressant So with it'd how with understand alone, be group interesting as what quite to needs. many zuranolone issue anything happens data to that rollout add? retreatments that

Chris Benecchi

that who out seen with incredibly other in chronic the or And respect over to to and their rapidly frankly, day respect that that sustains covered last to taking And for think we've we've year, a I effect want is with for work zuranolone. quite to with respect I to that really solution haven't sexual out therapy we works gain seen it to of weight data therapy ability want the Yes, a would a already has fact And the there add. demonstrated, solution that rapidly it take of rest Barry, perpetuity clinicians they course with it dysfunction as that want something you as time. early And prescribe there's lives. unmatched some thoroughly. that don't the home are this back, the with therapies on to But over or the to step is product. short a be patients to they safety desirable the send when three, and patients profile this this

as enable of they'll home go putting with a So X, that that that we the hands it believe are we're to solution what in clinicians early therapy, delivering know with we works. patients day delivering, it ultimately to

Operator

Thank you.

next with Yatin question from Our comes Suneja Guggenheim.

Your line is open.

Yatin Suneja

Hey guys, you my thank question. for taking

indication elevated on zuranolone? this talk about have landscape I is future So PPD evaluating; the So think maybe that is question anxiety, indication I your big other applications you zuranolone anxiety? MDD, of application on studying acute in across opportunities, pathway? understand view What additional anxiety. seen the are patients other have very you like can specifically think in also And benefit but in other you. application or like of Thank studies,

Barry Greene

ask thanks Jim it and I'll to start, round the kind out. question. Yes, of I'll for

that you so and the and per before, birth PPD one million experiencing are about and talked an very those antidepressant eight we've alone that are almost opportunities United with experience women as prescribed live So got in in States people year diagnosed said, just X large. MDD we've

following strategy really Our MDD is to to zuranolone. X collaborators robust including our of with approval to hope do Phase and win X, need what see to along in PPD, an do program a we Phase

strategy. that's So the

to in have disorder, do we use appreciation add? there will future. we continue to you developing and MDD general anxiety to about which the in anxiety all real to the to disorder, that of the But about make Jim, need that sure are we've we'll Now talking for the PPD. be data marketplace seasonal want areas be things is best focus other zuranolone how provide talked

Jim Doherty

studies add point, that only Barry's we we're I indications have use the to on there's focus the certainly additional zuranolone. understand significant But we profiles currently that would we on are of a fully endpoints to talking sort that of our about. overall

We are sleep. talked collect continuing on We've the of to about anxiety benefits earlier data zuranolone benefits. on

those to are there but benefit, be course, zuranolone for think that additional effects could are we of evaluation. So of later

Yatin Suneja

P&L more, one it. on I Got it's squeeze Could Kimi. the for

cash Phase So with now or can G&A we studies there? you understand I up? guidance the it forward, like X gave to most going behind SG&A, help about or you. start us, down? studies you ramp R&D Is you go and also model about help as the it second Just half of thinking us Thank a commercialization? expect should just

Barry Greene

Yes.

start. me Let

we're zuranolone significant we Biogen which with both as partnered get So reimbursement doing lift know, efforts. very and you course, heavy SAGE-XXX well in programs on Biogen And for our the get for ex-U.S. and is royalty. of

So very about we're partnership. the enthusiastic

and As that's that orphan we've product can strategy. disease an particularly Huntington's globalize with highlighted, like starting our is we on, a SAGE-XXX,

-- it of positive makes many as as data zuranolone, on SAGE-XXX sheet. We balance bringing sense approval countries assuming the XXX We intend success will package. strong data, in our do to to us for given

take the do countries future from around do revenues on Kimi, want rest? for plan to you world the we SAGE-XXX. multiple recognizing the So in

Kimi Iguchi

Sure.

expenses about there. on question to the think So and want

expand we going look of indications XXXX, the During that about and strategy just highlighted going our related SAGE-XXX, into to accelerate three were to increase, across Barry operating SAGE-XXX. which three when clinical expenses you and execution that trials we some talk in fact really the we're the believe did our have year, of that to with

a will research making We're candidates. big want we where clinical Again, in and to that expertise a our have what is we we So to that engine. our committed in be sure have also leverage really we making and next circuitry program. there digital brain investments early our and clinical

accelerate those will -- expand execute continue strategy XXXX. So on to the and

year. will over increases So expenses R&D that in the again lead to

additional as On see we the in continue Biogen. the with we front, SG&A to activities ramp will increases again, together prelaunch SG&A,

Operator

you. Thank

with H.C. Tsao question Our Wainright. from comes next Douglas

is line open. Your

Douglas Tsao

thanks taking X to of in in And you just CORAL improvement curious domains the perhaps, the Thank terms I'm day that areas questions. Thanks. I of sort data and to where benefit morning was of day change was the of just of big disproportionate day see curious the a some also, for saw, X any the in of Good a components? we the sleep terms contributor there benefit the And improvement how were guess, from to CORAL of really sort you. MDD. XX? I

Barry Greene

question. the for Thanks Yes.

maybe not. in HAMD-XX. the in top-line congresses. of just We'll data. But as seen of want -- presented certainly improvement your we've across domains We saw So talk carry I'll future do and can feature Jim, it of in you thoughts But HAMD-XX breakdowns then you wasn't Jim, or present components down. to particular most one there? about start, It

Jim Doherty

is key What HAMD-XX that the be zuranolone consistently of improvements will with the have we CORAL. Barry. for thing that's the think I domains of across all seen the point, and same

of and data digging we that pieces in individual go-forward. more will, into We as detail communicating of course, be

be picture is see across the scores of the I consistent the will point of of the a HAMD. we pretty as think But HAMD at zuranolone we domains over that effects looking distribution of So time. key

Operator

Our question Oppenheimer. Jay next from with comes Olson

Your line is open.

Matt Hagood

was Jay. is going for This specifically you I you ask on taking for Matt guys. Hey, question. Barry, to questions. our Thank a

your since as has X since just CEO I personally I really how evolution the already X XXXX you believe, to you Just SAGE company And just December years. curious for since vision also viewed next you all you view took over and time? of since also at joined the changed the if how it. that curious appreciate

Barry Greene

a and in and what move three you had with it's Biogen has with on in front we at started, terms SAGE-XXX work ran Look, of robust mentioned, SAGE of I Japan everyone phenomenal thanks. Matt, We and us. the a how late-stage collaborators, progress. here accomplished pipeline. in our at as we both When been Hey, late-stage studies XXXX, forward. in continuing programs Those and SAGE-XXX are three to stand number of today programs and

preparing for we're year. to zuranolone fact, the NDA In earlier file this

But executed. February is as we actually any the weakness a starting from last certainly being we strong for certainly in Obviously, me expand everything of execute and from So Kimi, very year on accelerate. helpful sheet heard have across you and isn't board of balance planned being doing or us. to Biotech the on

view the track company So coming top-tier in on make remain the be biopharmaceutical a health brain leaders could we're that that happen. to I had we that and in

Operator

with comes question Akash from Tewari Our next Jefferies.

open. is line Your

Unidentified Analyst

you understand is our have disappointing, from in has thank Akash. launch [ph] PPD? the what Leo engaging but market? This Hi, And learned you commercial taking help opportunity quite obviously, that just for us questions. real ZULRESSO you you ZULRESSO What Could specifically market this had you patient beyond identify fruit? patients type many of success have? low-hanging of can you. would the allow zuranolone expand this diagnosing How how as being? many a And issues those Thank about to been

Barry Greene

Yes, round the can thanks you for and Chris, out. to it start question. I do want then

Chris Benecchi

Thanks, Yes. Barry.

not and So we've aware, of there having a And as symptoms depression, that's live recent may experience suffer the with that's that. to postpartum you acceptable be those women moms through experienced associated depression. to often noted the eight are birth earlier, who as have with in anxiety respect with really one

community, opportunity provide subsequently we if to or a there's respect postpartum to the solution us for an to that with ability zuranolone, our with them better respect like So to approved. ZULRESSO know do

move the have that we from and with market payers and engage base clinicians to how the as tremendous our really introduce being availability also a strong that forward, around access and build community. like assure ZULRESSO we've to to ZULRESSO to amount patients how with a we can that medications engage into advocacy with knowledge that organizations learned and into that said, so we experience with with So to patient on how engage that to zuranolone

impact may you different questions points in seen comfort course moms the administered that therapy office Now is how in formulation the see two-week how from therapy studies very differentiation and oral the with we've in of own our to-date. home that benefits is order to one an commercialization. Certainly, of ZULRESSO a respect asked zuranolone short that their enables clinical as in the to the over to take of of it's

So depression is way this with going respect how change to we see evolving, it's postpartum to profoundly the treated.

Now that not need marketplace, moms than that meeting who their right other there safety these women that's profile opportunity needs. take I a will the the a there's said and efficacy the has have something of ZULRESSO zuranolone. substantial in of as because something now to Barry? And therapy really the is number

Barry Greene

you. And thank that round Chris, just Yes, let out. me

and how So we're mom. all born, baby to by the the baby really of right Moms care treat the very we OBGs and market important important. because focus of are the understanding people, pieces taken off is to are until the turns now in it's

with the plan that on mom So mom's sure understanding a they capability of trimester, a putting making a in in home of place every And at to them fourth moms our help. for place, prescreening available be zuranolone prescription, the put number send vision really, questionnaires has many of risk and for need to program, check they're should understand need now it. that KOLs will is

they or or family. So endangering danger in the aren't babies

live So we're to the certainly as Chris to learning in one from births suffer lot a eight be have that help, prepared well potential we'll and PPD. said,

Operator

you. Thank

Kulkarni Sumant question next Our comes Canaccord. from with

Your open. line is

Sumant Kulkarni

Good taking morning. Thanks for my question.

characteristics So the of as XX drug what the prevent goes response on you to are back some of durability? days the of ensure or the specific XX were X MDD an it itself? days more immediate average the episode patient I such focus guess to this versus, pharmacology zuranolone duration maybe main might factors say, more more of that days a that related made retreatment? Is what acute therapy or to potentially variables

Barry Greene

do end. thanks I'll start provide to want you then the question. Yes, color for And and Jim, Sumant, some at the again

Jim Doherty

a a course, zuranolone. I really, what we're aspects. mean is response. pharmacological you is to to And Yes, the response course And close I a achieved response say that rapid end that by what Barry. response don't wouldn't there a that pretty seeing it's are of two-week -- I robust see of has Sumant and maximum

is the of the anything it two-week much to being about with treatment course So more benefit than do seen pharmacology. with

Barry Greene

thanks, and reregulate is ways Jim. in remind you networks observation and been of to collaborators And are hypothesized of are with spectrum neuro designed happen. that is And those network neuro that's make that I made again, course, specific dysfunctional by to normative Sumant, Yes, when the living depression, that two-week course very was, the SAGE people zuranolone treatment state.

well in As of Jim seeing majority by as happen that evidenced patients SHORELINE. the said, very we're

instructions straightforward anxiety days your real the will Now come is the be We'll know or the done And for or days. to a inability with They'll a mood keep patient retreatment. retreatment, the a world. days. work anxiety weeks in let's not. in the office in in three specific a mood, in with disrupted, your patients, your you're give office following, or should really dark that is is sleep pretty if refill and darkens, in you again, It in majority couple further in two, of them in either that And does two if for after mind and it often increases, check call your terms that therapy zuranolone elevated of sleep. of it working three the will will

Operator

last Stanley. with comes Purohit Our Morgan question from Vikram

open. Your line is

Vikram Purohit

Great. Good morning. Thanks for question. taking my

So I had two on SAGE-XXX.

can have additional might interaction at level which think parameters program anticipate secondly, about study Phase of begin you say So a to mid-XXXX, what safety you pivotal on you beyond here? the regulatory what and particularly study is And to that evaluating design, X you this for do what here? expected XXX the in path had about point

Barry Greene

Yes.

then I'll me Jim. let start So ask and

And our we study on Phase having as our the tremor reduction a X living dose. materials is a a statistically into KINETIC a multimode those reduction XX-milligram at of remind that. six-week study, amplification X significant then and parameters So on for dose that the the as KINETIC saw the the dose, it's over frequency in well slides. a in you XX-milligram study. are And design amplitude. KINETIC we XX the at for XX, But quickly, period tremor in in do to SAGE-XXX studying amplification we -- daily we're that very looked for or objective move tremor as activity We're of titrating specific kind I'll looking we're with in study. to the at study

between Phase very likely activities the tremor path that for function well-being study reduction correlation because daily a which amplitude, saw type of living also forward in activity and feel helpful will study. We it's that is living daily be X of

to So will look. we Jim think that's path anything the forward add? path the how --

Jim Doherty

the add, would the and important that's is Barry endpoint and I conceptually from said think study is for in it's I going we that as the also bridge build receive. to endpoints also think important we benefit -- similar to the but the it, we consistent study are continuity what pivotal the that the KINETIC are to -- that Barry, endpoint studies, with patients

an be daily study. So of will activities of living element the

primary at bridge is the of looking have both benefits daily tremor their lives the to this we'll to that KINETIC, reduction in we the are back providing. but So what to forward, be endpoint compares in that also showing patients the looking

Operator

you. all for back questions. turn that's closing to Thank And time the to have remarks. I'd the call Barry we Greene like for

Barry Greene

specifically really in quarter. mission Thanks, for all to team, today appreciate we our of fourth Sage entire much brain all investigators grateful health. dedicated made progress you, Operator. for patients, clinical XXXX, our everyone. so Thank caregivers, for We the the advance to joining our become and a us I'm everyone leader

XXXX progress beyond. a up us sets made and we last the think I really year strong for

top-tier the of are you. biopharmaceutical said a over we'll we years, health. And that the call, confident leader I'm brain very Thank emerging company. a couple As as in next I in be

Helen Rubinstein

Goodbye.

Operator

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

You may disconnect. now

Sage Therapeutics (SAGE) 24 Feb 222021 Q4 Earnings call transcript