SAGE - Earnings call transcript Q2 2022

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Operator

Good morning. Welcome to Sage Therapeutics' Second Quarter 2022 Financial Results Conference Call. Currently, all participants are in listen-only mode. This call is being webcast live on the Investors and Media section of Sage’s website at sagerx.com. This call is the property of Sage Therapeutics and recording, reproduction, or transmission of this call without the expressed written consent of Sage Therapeutics is strictly prohibited. call recorded. this that note is being Please I of Investor like to Rubinstein, Director introduce Helen Relations would now at Sage.

Helen Rubinstein

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

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

prepared Executive progress provide Barry the begin by Greene, remarks will second the during overview Chief our an quarter. call We will who of with Officer, our

that, for now by an approved; who Barry. our preparing With and Chief from turn be Chief and Officer, of progress will Scientific will We our results to who our will on zuranolone will Financial Chief our recent Al activities the over review PPD, who the provide I'll launch and Chris in Officer, Robichaud, quarter. Benecchi, review Business MDD across the program; Officer, our the call if Kimi Iguchi, update the financial progress development also joined

Barry Greene

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

meeting goals planned ahead execution across on milestones as Sage, important and the focused achieving of of our year our half expected started first The was continued for XXXX pipeline. timelines. our We by or we

sense currently adequate We of medicines people innovation options. for to who meaningful treatment lack urgency have create and tremendous a

Biogen company. as productivity making to we disability their across the suffering, the and of We're pharmaceutical and like progress a some company depressive well Study, the Sage. system. we has option. in to health Our entire the women about of leader moment evaluating new and while SKYLARK to zuranolone progress second or positive are to quarter People with franchise, context generate review further in as MDD, as major now tolerated with options. potential establish We depression improving depression PPD. we the health treatment as take Starting X and zuranolone I'd Sage, goal with as deliver is future or of recently to Phase generated that zuranolone with potential the support offer a healthcare the from and of PPD the people, a in top work as and a therapeutic of our to to deserve announced the oral postpartum disorder treat with believe how believe the results totality well decrease rapidly We data families, thinking effect. acting, brain depression tier zuranolone the new important sustained

the completing controlled on PPD in we we of, the filing zuranolone, announced zuranolone a NDA start placebo and as the MDD submission. are of studies in reported, With rolling for focused which May,

with to As to bring PPD and as as opportunity is to efficiently the we've MDD planned and possible. filing we NDA providing PPD MDD accelerate will PPD, believe exciting one both and of shared, in an our this submission opportunity zuranolone include people our

which PPD. continue to well opportunity to XXXX. as about PPD. and Strategically, We big develop if PPD, Work provides expect third stakeholders the receive is quarter we success. of thinking payers possible Our which MDD prior-year underway and those in we of scale planned MDD successfully, track we're evidence both us date we focused the the value by zuranolone launch timeline, a for the our the a with in MDD on unmet launch the is and programs. plan, plan zuranolone for potential in filing PDUFA of proposition, the the need with view, and clinical engagement educate for that launch weight around living need NEST with LANDSCAPE key from exists to to we'll profound supported deepen on To zuranolone and

to critically launch in with this clinicians act internal and to Lastly, sense we PPD with execution. on of further enable urgency, treatment. execute to successfully we these expect our believe payers We access and PPD MDD launch will MDD zuranolone items build ask continue zuranolone, plans, a intended and capabilities will enable patients if will needed that and to strong prescribe on for

support of ongoing commercialization preparation indications efforts morning further these both this on promoted preparations, Benecchi to has Business are will details if Officer. that All this we provide in Chris our announced is Chris call. Chief To more approved. the been important, later

franchise PAM. Additionally, NMDA in quarter SAGE-XXX, wholly-owned led we first-in-class by made a during (ph) progress our Neuropsyc the

further people's approach. and the live and demonstrating to life Impaired on committed dramatic being thrive. certain as is oral SAGE-XXX cognitive therapy to significant know, a disease disease. disease, ability you its and disorders, specifically program the therapeutic can for advancing a is with and independently of developed morbidity diseases, neurodegenerative cognition novel to diseases goal SAGE-XXX We're with potential Alzheimer's have starting As impact of Parkinson's potential Huntington's these

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Albert Robichaud

Thanks, good morning, Barry, and everyone.

in we've compared met June franchise. important second in made to key score demonstrated at as from LANDSCAPE to As to symptoms and and HAMD-XX pleased and we programs sustained are reduction We measured important with XX the zuranolone at the as NEST to during score and throughout change HAMD-XX points change with across and postpartum X.XXXX. clinical observed in that will was differentiated day milligrams our depressive total SKYLARK at X, a XX progress both zuranolone reduction depression safety day and I'm baseline from and These change profile. all at MDD clinically statistically if significant HAMD-XX CGIS program its in days baseline a XX well baseline XX by detail the our and and placebo controlled therapy, well follow-up trials placebo Starting enforce of early placebo underscores depressive the period remarkable meaningful treatment which zuranolone development be zuranolone potential advancements rapid Barry placebo compared early to XX of quarter. XX zuranolone as announced total the change well Study tolerated as in in that an of in comment P-value completes compared with the the score SKYLARK XX. depression day endpoints our X pipeline endpoint, development generally results our a for corresponding Study secondary approved a mentioned, primary data and milligrams to from resulted from programs. PPD. as Notably, in in the a symptoms on baseline

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patients the from the data in efficacy collected as safety more treatment for data Study Study, across the RAINFOREST entire course. We outcomes those to at the program the similar use initial conferences. clinical to SHORELINE additional and retreatments, Additionally, upcoming or well as sharing those one in observed development forward look were who

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neurodegenerative in of controlled Phase in placebo Turning to other study a in impairment enrollment diseases, Study, X PRECEDENT a very mild programs cognitive going well. with is SAGE-XXX people due our PD clinical to

College XXXX. begin a also cognitive to in dementia to study of with this to placebo later with We Phase complete and planned forward of Neuropsychopharmacology mild SAGE-XXX American Meetings late data Neuropsychopharmacology look We with SAGE-XXX studies at initiate date remain from year. and and on to European upcoming due Annual track College AD people X to the sharing impairment controlled mild

Lastly, like and next-generation or like potential to treatment conditions advancements options receptors, franchise ET, and I'd which significant no in GABAA by modulator in patients had has a disease of neurology the that essential for led of recent our XX highlight also allosteric we believe SAGE-XXX years. positive neurological tremor has treatment limited holds for over innovation

label long the SAGE-XXX multi-year we the adverse emergent the long-term of announce in with to is that X event period are SAGE-XXX treatment of as open and primary insist assess to our study Phase ET. endpoint. this a tolerability term We aim pleased initiated The over of safety safety with study have

In at to XXXX. optimize the KINETIC dose Phase our expect addition, late continue we evaluating ET X occur are continuing and in dose to frequency ranging and Xb SAGE-XXX to enroll to completion study in enrollment

sharing our including next the in to brain forward with the the excited franchises, presentation proud believe the over rewarding dynamic this I'm been momentum at Society building from our previously pipeline year close, it's me, journey SAGE-XXX months, generated was International Meeting. on health. We're of is moved in continue poised coming in upcoming As as organization about Disorder months completed Movement Parkinson studies first our of team other the to what's XX come one half for and with of the the in from last look forward. a leaders To the we data to and decade and Annual

we our the approach commercialization in additional Chris? call on MDD zuranolone of as and for potential over provide Now, I'll planned the turn to PPD. context to prepare Chris

Chris Benecchi

population depression commercialization work this lasting options and with all new morning depression to treatment offer effects. need in and are for you for been to reported global safe, quickly of Current has in will address on approach healthcare pleased screen of MDD treatments PPD care. a top States profound relies treatment not for more at failed I'm people adults often lives. appropriately five of and needs significant on it MDD This with the to challenges share our that Patients To meet in receive adequate PPD. put assess, urgently and the and to the with MDD prevalence that seeking Al. zuranolone. of since the and consistently approximately paradigm a portion current increase Thanks, failing point treating An on depression. of try a experience the one not fails simply, and that many in their the preparations system be are XXXX people treatment depression, some updates to United

are working because to will at PPD with also a access. at and that Something disease effectively to both approach MDD level change, on execute access us MDD digital engagements a family In the and zuranolone that success. options zuranolone we promising scale needed. if market level filing partner and which MDD unmet from believe profile. the treatments of with and needs those and rapidly and our telling and MDD from rise depressive channels quickly considers outset. for and will families. and they with to both with need depression patients about with data that single were and for potential us solution, of like patients I'd well that the early a new launch, also who potential of a are whom that rapid include high of collaboration have some prevalence suggesting strategically and Sage believe to we're importantly and provide of the provide suffer treatment the working approach approach healthcare pricing our To to with available a prioritizes and to and high despite is at omnichannel The clinicians an on reach is and PPD payers, clinical their tolerated for Biogen enable most and new thinking has approved, zuranolone to our for leverages right thoughts professionals strategy state stakeholder sustain to clear treatment new better. continues are clear. the prepared indications, To MOA patients plans our end, we friends NDA PPD forefront deserve we that Payers is payers, relief a depression, and many the option with with desperately that safety and be capabilities build prioritizes that have generally engagement, or be heard awareness for and PPD design that symptoms commercialization patients we must

if it. patients PPD, with Our receive can approved ensure prescribed zuranolone and are appropriate overall is quickly who that with to goal MDD zuranolone,

MDD to we sustained with the believe impact work it's have We obtain that and host that to and of to healthcare event more sharing such, zuranolone so foundation our efforts of can their ability payers to barriers patients an As for to zuranolone forward treat prescribe lay relief minimize symptoms. we the essential details the year. plan try later PPD, commercialization professionals' rapid to this that potential look spotlight and regarding to which the their we depressive successful to upcoming commercial

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

Kimi Iguchi

Chris. Thanks,

Our few in flexibility make with believe strategic investments issued provide the financial will continue we second across franchises strong end and morning. points. the approved zuranolone highlight like XXXX a some quarter be to provide by press quarter, the the that a a the I'd key and to of second At our this release the agency. cash we for of take launch our position moment detailed our to of are support if in to results context organization

for loss we quarter XXXX second billion. the quarter of equivalents the cash million ended cash, with securities and marketable was of net $XXX.X $X.X Our and

spending of which our second primarily related period spend SAGE-XXX. million the to in The pipeline, increase wholly-owned the SAGE-XXX Turning quarter XXXX XXXX. $XX.X to R&D increased $XX.X on in and million same for to to expenses. compared operating includes in expenses was

we spend that advanced studies and quarters R&D Looking the Al expect increase ongoing mentioned with Phase we SAGE-XXX earlier. X coming six and forward, continue as SAGE-XXX to to the planned in

is for (ph) provided to in confidence by SG&A position invest to continued related where and our SAGE-XXX. us SAGE-XXX, indications of advancement the increased of strong potential flexibility The million the of pipeline our wholly-owned product our anticipation employees to our by allows activities across and of in cash future SAGE-XXX SAGE-XXX three XXXX. expenses period demonstrated Importantly, our launches is product quarter XXXX hiring $XX.X the potential to million candidates. for to increase ongoing of compared in second $XX.X same primarily work support

are As will you of the heard that Berry, zuranolone expenses as from expect increase for we we SG&A preparing launch and potential preparation. we continue commercial

our shortly of Biogen, a collaboration and part in sharing SAGE-XXX States. As with United cost we're XX-XX developing with zuranolone the

During recorded forward, reimbursement for going in prepare the to doing second including potential wholly-owned that provide important work believe agreement. license our from collaboration quarter, million we will launches we're our for programs to commercialization $XX.X the foundation organization if future for successful. Biogen’s an related our with We now and

we're provide cash in pursuit end our changing to strength. and do not health Looking continues deliver equivalents XXXX. we'll act to collaborations life we to environment provided funding from of all SAGE XXXX execute face, the the I'm that having continue anticipate guidance and we a position revenue approximately confident our making, medicines of the disciplined enables will ahead We Despite throughout anticipate earlier uncertain from into brain approach remainder the XXXX. market decision lead Moreover, We we investments facilitating believe can we payments health. of at every milestone efforts receipt so that current cash, XXXX. believe from securities brain support year. over $X.X at rest the thrive. of SAGE value equivalents in quick in cash, person to that potential this and reaffirming of marketable that long-term as cash XXXX, our anticipated will We execute operations ongoing into our the our collaboration billion of any financial

Helen? capital thinking the the with I'll launch. big to Q&A scale handle to prepared we're we're turn We of invest to success. Helen with appropriately zuranolone to opportunity, the now mindful plan and over be about to operator. it prior allocation very While

Helen Rubinstein

Thanks, Kimi.

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

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

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

Operator

Goldman Instructions] from Salveen [Operator first Richter comes Our from question Sachs.

Your line is open. now

Unidentified Participant

Hi. Tommy This on is for And (ph) Thanks our question. taking RAINFOREST. question is our for about Salveen.

While there with there agency? way? to plans the label are dose? RAINFOREST you. included possibility with to XX restart the could milligram are share findings either be Thank plans data studies there the Is in study some the from was these terminated, And the that on

Barry Greene

Thanks Tommy. question. Yeah, for the

we or will Study, reminder, So conjunction neither you data required XX the presenting data was a be agency. which filing. in the made RAINFOREST dose from milligram with We as And decision the early. the mentioned, terminated Redwood that are as for NDA Rainforest

course, too is specifically being those date saw we The in to of totality data importantly, with Reduction data consistent be what seen Of shared. the with in this will reduction zuranolone. data was Rainforest depressive symptoms, and in talk anxiety, to be in using Chris, or what It's add? in what's about zuranolone. but these promotion, sleep improvement commercialize we'll as be to sleep exactly important architecture. we the early studied anything able will and label findings

Chris Benecchi

and as forward. opportunity opportunities the Rainforest of impact about we'll excited moving the see We're Barry. the continue we future No, to

Barry Greene

Tommy. Thanks,

Operator

you. Thank

question next Baral Our with Cowen. from Ritu comes

now Your line open. is

Ritu Baral

question. you've from that ongoing in the process? taken the Axsome better gleaned what FDA away the for review about or Thanks feel the I the you that morning, how pathway Good regulatory taking versus going that any to wanted guys. for outset the the confident are on learnings on wants Axsome will ask to you that if about shortly? precedent there be Specifically, you're you've embarking and prepare

Barry Greene

on by with outlined Thank back landscape when multiple confirmed I Ritu. confident we the to started and we're that PPD the to that are we highly and that understand clinical as believe schedule. single courses acting Obviously, things feel the and rolling for the submission question. can XXXX modules of all that's required that And this agency. non-clinical times modules nest year in end oral you data would for happen in and tell The are modules all believe interactions filing both short the year. all can filing. agencies I for as in MDD FDA I interactions in-hand well complete stemming good that. the Yeah, say, we that and the very May going of the the well the We the unforeseen, programs. you desperately but agency modules we the antidepressant well. We've that a of preparation. CMC world a very we've totality with plan had NDA about have and today are the that fast are and with there in are

Ritu Baral

relatively guess? still conversation I the interactive time, real been Have

Barry Greene

there's end regular if the and of for we're FDA. get in call, regular interactions excited we quarter interactions. there's said But date email the interaction of formal well. the then I'd by and filing going are as been both the anticipate prior We to informal yes, and year the things PDUFA updates the the next on third your There's of we a And say the with view, kind year. interactions. and

Ritu Baral

Thanks. Great.

Barry Greene

Thanks, Ritu.

Operator

Thank you.

Our next Matteis with question comes from Paul Stifel.

Your now line is open.

Paul Matteis

much. thanks Hey, so

restricted a more how real this are then And you [Technical weeks broader as monitoring that Are in much. you a for are you open you have the can have you Following you very something framing clarify physicians maintenance world? that? study the framing as point, sort at study a question, where in where have redosing on more up on of you the framing proposing a than lot specific as are to of what is you Difficulty] safety and kind qualitative wait are conclusions. study SHORELINE least or so with proposing side, discretion proposing to six SHORELINE, NDA? Ritu's for criteria paradigm you label Thanks Are that this or as

Barry Greene

the question. Paul, Yes. for Thanks,

is year. largest SHORELINE every And other of depression. two SHORELINE you're were only they It's that enrolled naturalistic in patients on and those -- in of the course a weeks the study doing. asked were aware, the required study then So, where one let's XX% in every course enrolled responded two or how weeks -- ever as

that patients And only issues. the four retreatment consistent SHORELINE course, the those course majority one was two So the in in additive safety year treatment to responded weeks of respond of that a no to year. and of needed course for of of drug and

filing. paradigm on, how will will the instructive So is in clinicians And included comment NDA on retreatment data depression, but not to it of of clinician's a necessarily shift a shift and Chris be when the can large database safety paradigm used. to the be in I'll a believe in totality treatment this ask we the practice. It's a SHORELINE be

talk retreatment. submit remind as want impact a you I'll about medicines. and early or Chris, practice? it retreatment. can fit drug the to you to about as they approved SHORELINE instructive opportunities to will little safety any exactly So what the zuranolone physicians as other of they in to label It's a be guidelines we're how But talk use be for these will we data, that going the use to see of about the learn more believe to

Chris Benecchi

Yeah, sure. Thanks, Barry.

sustained and tolerated zuranolone, clinical seen data we reduction So Difficulty] with to Difficulty] have particular, own In with physicians a the day date. profile short generally profile to and seen the symptoms XX well a [Technical in course demonstrated studies rapid product. treatment depressive prescribed respect safety [Technical the was of landscape have in that trials

between So being will with patients this product basis. to indications to in the free don't that so episodes a respect periods opportunity treatment physicians on used, have offer patients, the chronic the depressive enable

in a an at patient would would really free (ph) a reflect treatment in leaders and of the would tolerability would the we've the the go advancement itself on and not with Difficulty] physician of a treating that as of life and two-week at is to with managing. experience course what we've in treatment, that physician month product. market [Technical in rental profile this that two physicians the [Technical research, was heard with a in prescribe change end way efficacy needed regard engaged They it six the update. to period back and Now loan then checked is how is we patient therapy. with Patients they've hear What would with symptom that does actually been period where the the this depression, they the a Difficulty] of the the paradigm. week from this expect functionally key an are opinion But change

would patient if two period. there depression, two period patient [Technical in prescribe symptoms week that week course. clinician obviously to of and of between out If to reach the could second certainly one home then return to clinician Now Difficulty] were back that were and for the the the the

this very as again, zuranolone. that about way So from as I patients the managing said, treatment introduce excited waiting the reflects this a actually clinicians are to their in change in hear really the opportunity we for a they're and paradigm, not clinicians we're change

Paul Matteis

study Shoreline. to I at with And history or a a side, get versus ability from back utility want to little that Shoreline trying just the that the as of regulatory maintenance whole you maintenance you. the Thank really claims study to specific clarify and yeah, there? with the more have given Redwood just on Do look

Barry Greene

Yes, Paul. Thanks.

sufficient of was database. to that filing the Shoreline Shoreline It's last think filing. So data met to study run We agency as we it needed sufficient we large part instructive as longer going will of the again, confirm part because be the of it to of Redwood we we're submit retreatment. a the be retreatment. with fall be I would believe had no safety in When year, and the

interact we as with agency more get the provide and negotiations. label we'll into So

Paul Matteis

Okay. Thanks, Barry.

Barry Greene

Thanks, Paul.

Operator

Thank you.

from comes next Our Needham. Fadia with question Ami

Your line now open. is

Ami Fadia

the FDA depression treatment treatment a limit for to more as question number product I you of something the Thanks specific on acute expect a indication to as classified of pipeline. the just you would in taking be it the have year? Maybe questions. anticipate then morning. and treatments And just Good be do such a to follow-up my the question. previous Do the for or

Barry Greene

Ami, thanks question. for the

about the early pretty like straightforward of We've again, MDD get specifics agency. label, treatment with of terms the specifics into of it's straightforward indication in the we indication something for an PPD, label statement and and to too statement. So really -- anticipate pretty so it until talk said we previously

be we As question, got believe the data for We've retreatment. for of believe Paul's SHORELINE we instructive retreatments about talked the in the year and instructive will will retreatment. course total we set with be data five that up to

to work, patients take that highlighted, medicine, in we than prescribe at the patients hang be it's the practice normal zuranolone case, please will to instructing dinner. of this there, this As be four that believe this instructed rather take Chris if in would eight your to could weeks that course night with

course or feel the in two better view three days. normal, two in may I'll weeks. take in check back as treatment. And two You full

in. sleep check again. Otherwise, see occurs in and or months. dark you're mood, we'll six disruption Please anxiety If back increases

Chris normal practice that required, retreatment retreatment. as in highlighted, and the that So there data believe course of on we've is got if we instructs

Ami Fadia

AdCom at or you clear anticipate this less So still that's Barry, point? do

Barry Greene

discretion with or PDUFA change that anticipation exactly regulatory not, whether year. And the date sole think used statute review, us. prior we for It's learn when There's agency. is or how if an more not. AdCom of filing. we'll next third quarter clearly No NDA the in no We they or get again, of in our a after share a

it zuranolone they speed as an very to well don't, hold totality they to we are we Of of display. allow if want well the to the because and data course, we're forward that really AdCom great. AdCom, going choose AdCom. it do approval, AdCom look and be If and signals prepared they preparing for an on that of feature us it'll an be If would put an

Ami Fadia

one roughly developing when I've these Thank start from ongoing you. you any but we data questions, see or anticipate own just Got And asked anticipate one three one two you these quick if guess, do studies? you on your indications data one of on it. positive consider come from to through, would XXX, of or would all I -- maybe partnering?

Barry Greene

placebo PAM. a of first-in-class due cognitive aware, impairment Alzheimer the end Huntington's, from function mild SAGE-XXXin really various and in announced in you're and recently well study We're Ami. MCI consistent improvement excited a the Thanks, Yeah. initiation And year. the controlled Parkinson's the starting data for studies by by We studies presented disease NMDA memory. the program, we of to learning executive as anticipate we showing SAGE-XXX

and provide the guidance timing So we'll these data as further we enrolling, up exactly and get of running studies readouts. on

on determination make the market. In that Huntington of been in we'll Xs that to terms getting studies with of have that's the something way a some Clearly, meet the the SAGE-XXX to discuss designed agency way Phase fastest once positive we'll readout. X, Phase if of a the

Ami Fadia

Okay. Thank you.

Barry Greene

Thanks, Ami.

Operator

with Instructions] Our Olson next [Operator question comes Jay Oppenheimer. from

open. now is line Your

Jay Olson

whether us of original Thank included not you whether morning. or you in the and of going results objectives studies those Can pursuing objectives and study are any you. for REDWOOD filing? Thank taking be and NDA to continue the update for question. Good the remind and the plan those please to you the RAINFOREST

Barry Greene

Yeah. Thanks Jay. for the question,

comment that first outstanding. just you that. with the Thanks Greg led me (ph) for Let was discussion Knottingley doing

was for of to and highlighted how that. thanks zuranolone many, the instructive thinks but zuranolone I trying so for community think use us, who it only uses and that understand that not really someone about for drug very in think the I

anytime or In Study of in a REDWOOD, anticipate future. now running we REDWOOD terms don't and RAINFOREST the

As terms used. of but it instructive we've will a how part safety retreatment from highlighted, only we database be the in which not data believe will of submission, that the be perspective, be in SHORELINE, treatment can

directionally totality zuranolone the those very with RAINFOREST, In results the of the we the study run-in that's And we saw with insomnia, data. study terms a consistent might with MDD, future. positive of

We Biogen have in Phase more Xb/X. the to collaborators, outline throughout needs the unmet do with our

So stay tuned later. that for more on

Jay Olson

you. Thank Great.

Barry Greene

Jay. Thanks,

Operator

Thank you.

Our next Rahimi with from Yasmeen question Sandler. Piper comes

open. now is line Your

Swapnil Malekar

Yas. Hi. This is Swapnil our questions. on taking you for for Thank

analysis So which duration mentioned before Thank what's what's time the patient duration you the shortest to And SHORELINE you longest days. needed date? median SHORELINE the the study, dose? course regarding XXX like the to and longest Can the the the for that time you. in was safety treatment second the second tell

Barry Greene

Thanks Swapnil. for the Yeah, discussion.

patients in it SHORELINE a date and run the a So one largest naturalistic enrolled Again, study depression. to year is very study. duration X,XXX it instructive was was over study. We've

patients So one, the only in of the or in week SHORELINE XX% required the the course course the of responded that of and one year course courses two, year. in two had the two patients of week majority

think patients those another depressive responded But I that requiring days, episode durability treated time caused the again, was to another retreatment and episode is median speaks not and of retreatment. well, did require then event to and trigger retreatment. of first demonstrable XXX potentially the SHORELINE. So majority that majority depressive it The really treated of a the a effectiveness was fact

as a In as data SCP, for in meetings prevent terms SHORELINE of and details a we'll long providing SHORELINE, presented more more short a we come. be duration, to

Operator

Thank you.

next comes from Yatin Our Guggenheim with Partners. question Suneja

Your open. now is line

Yatin Suneja

Thanks taking for question. my

seen sleep of we've impact Just recently get that? might We're Can you're a you to of on just also showing DDI a line, the some question across the mean, HAP studies. work multiple on positive just done. I sense comment in you trying studies. And that have

sleep if to zuranolone out can some the there? the sedative that anxiolytics a some or conducted, have combo driving what with be of findings? might that get would can study you are And So use? you also Thanks. characterize of So aids sense combined just the of trying the key

Barry Greene

Yatin. Yeah,

a questions there. guess I few So

to drug ask I'll to me study. Let comment start half in the Al driving and then with drug on interaction

for market CNS be by And a when view are abuse considering reminder, active agency drug (ph) used as entering must DE So standard the one or if a XX elements the period any for following it happens day medication. analyzed CNS the approval. potential, studies PDUFA HAP there's the of abuse potential

and of the with we which consistent in the oral we type reductions this action, the in So on believe HAP depressive program for talked the onset excited we from days, an will consider not the DEA. anxiety, clinically penetrance three the of development meaningful the well two scheduled guidance little was and that We and is And of totality consistent needs. FDA what MDD study two mood world about drug, recommendation symptoms be that to the PPD, for the HAP FDA study entirely improvements expect both about or was to believe we're data in prescribing. for rapid and treatment issue in of again, around we clearly that entire with is study as given and the brain the certainly zuranolone of tolerated therapy course as know the potential which an week zuranolone zuranolone

run. machinery to and them There be in are known. -- label the use like those DDI or studies, driving call with don't submission. drugs We [indiscernible], the used including of please a many even DDI, warning heavy talk of that counter drive many the anticipate drugs, full the complete terms which Al, is That's something you until are in the want require drug will checkbox studies there'll In over operate be to I'll be drugs, as about the part operate like counter. or over consistent drugs, the studies? of

Albert Robichaud

Sure, were the the Barry. we've studies depressions patients Most -- we've of We at most of past. call done the it that the done in time. of were in many studies the the past

we've whether seen we've sort not. consistently throughout or they're on another that seen those patients what the no So they're drug all safety of on studies differences in of profile

we was And with can again as a profile with In molecules addition, antidepressant. a recall Difficulty] not pretty the comment of much [indiscernible] safety of those effect as saw counting associated [Technical antidepressant. same dose response well study -- the you the the run

patients compound had with any in said, Our other and clinical most pre clinical antidepressants. as don't our trials on of stable I dosing issues data we them that and antidepressants, see data suggest with

So use patient differences it between the and see don't we doesn't rate play with two those any response sets. in the

Operator

Thank you.

Leerink. with from Our next Goodman SVB comes Marc question

Your line now open. is

Marc Goodman

Yeah. Hi.

to trying timeline the just you Phase us there? something Can a Thanks. be and than should it's DIMENSION more we spend. you for six are us DTC or of is the you sales tell that what will to the out? scale TV that different to expect there? you going months You that two mentioned to what color those best little aggressive just give Are Xs after what's a or and not XXX about the on with appropriately read say sense companies launch you launch person you to then and you're mean us you meant when you And could SURVEYOR, force on trying between how going say can respect think give maybe timeline,

Barry Greene

well. actually Chris and And Kimi Thanks, Yeah. I'll Mark. ask to comment as

about leaning and invite thinking So we PPD on we're and success. about to is, to capital big and opportunities are scale be tools use start. what other about going also size omnichannel with an approach DTC and that we're But an we'll at with and very allocation salesforce starting actually saying MDD the omnichannel think and in digital smart with then saying appropriate we're

that capital put that think that primary ahead continue many, see scale over uptake I with you rather with scale from companies it's drug to than to capitalize learned to uptake Lessons launch. many they the And (ph) a of sometimes launch the with best practice as launches SKYLARK allocation uptake. right care,

Kimi, going of than being well. anything We then success. to scale very clear we're to launch appropriately or scaling Chris, success So add? anticipate with to we'll the we're rather and spend that before that launch success

Chris Benecchi

take then Yes, it Kimi. and I'll first Barry. over to I'll pass it

So and a that from zuranolone stigmatizing that we've years. too want with respect over without key period can of over familiar and studies. not With last they've the functionally effects that and time to exchanges XX the relief, XX antidepressants side clinicians all fast from deliver that itself of what is they associated seen course with that leaders to only a that sustain opinion LANDSCAPE over said both from of market that, in become something the faster the with NEST we've scientific and that they relief learned but research relief and want that therapy other

it we that able approach, the about go-to-market message that to also saying, with out mention they're and with to deliver. we what that around I proactively making our there partnering you an without us to educating it's but omnichannel to talked sure of and And can will payers to it's zuranolone and going message, ultimately respect reach get data what aware patients reach getting with those approval the have with absolutely approach, important that that about that has to deliver. it potential zuranolone sure Difficulty] with for So think with be to important that clinicians to quickly make [Technical we're its that

preparing continue launches we've of for educating zuranolone proactively As payers, engaged with stay Kimi? conversations the those we'll with with to stakeholder and you might important that had payers group. already imagine, and

Kimi Iguchi

Yes.

part great that ramp how scaling that think, across our question especially we a was in again, organization. right costs in entire of But to your side I about thinking about. talked Chris Marc, just is environment, we're this about SG&A that's and in that smart scaling we're now, very up So, the one going be the

thinking a even it in So G&A, forth. about had investing. about decision thinking program disciplined it the didn't And that good example space, the smart and is because to be it our how halt we that we're across set really SAGE-XXX we in R&D that to criteria we're of very the meet made with was

going we being disciplined in think that And investing we're continue so we're have about sheet, how our very balance we to still but capital.

Barry Greene

updates the We'll Parkinson’s up question by on the will come SAGE-XXX, sites And and read about we end online Huntington’s, Alzheimer’s year, initiation the in ramp provide highlighted when studies your earlier study. and the accrual, is clear. the call of as data the Marc, out. of and And those

Marc Goodman

Thanks.

Barry Greene

Thanks, Marc.

Operator

Thank you.

Our Purohit next question Stanley. with from comes Vikram Morgan

Your line is now open.

Gospel Enyindah-Asonye

for Good Gospel on question. morning. you our is Thank Vikram. for This taking

provide You changes that in label in the that mentioned a Study. the you bit on more observed detail you what SUNBIRD study? the based no Could on release I ZULRESSO. expect for

Barry Greene

Yeah, Gospel. Thanks for the question.

the Study use a SUNBIRD safe administration the evaluating of So setting. in was use home ZULRESSO

Sage signals you label make we enrolled efficacy controlled SUNBIRD leverage study identified was or operational in human use on study recruited virtual safety placebo model and as future related ZULRESSO to don't There develop new any the The And no highlighted, kind study. a study the studies. we'll of a the than rather decentralized study to importantly, time. to As in run allowed were expected plan changes. Study capability to that potential

optimistic treatment of of And really in committed providing women optionality with prove that So with moms access to we're particularly for output that significantly approved the we will to SKYLARK PPD. PPD. remain if need zuranolone for

Gospel Enyindah-Asonye

update. Thanks for the

Barry Greene

Thanks, Gospel.

Operator

you. Thank

comes Our with next Nachman from BMO. question Gary

Your line now is open.

Gary Nachman

morning. Thanks guys. Good

per SHORELINE consider when what year So Thanks. the also going early the market number the the based and for And on just payers about you you to assume think that's may both desire pricing think discussions I going of you what how a patient where physician drug on do in And the are will opportunities. and guess then, research of And payer MDD given data? and factor your treatment how on to you each PPD per average from view you when have in of its early standpoint into courses a impact more launched, pricing, zuranolone drug? profile? is telling payer it's generally, patient terms bigger for zuranolone,

Barry Greene

Gary. Thanks,

the Let me it end? at Chris over turn I'll and to back loop

Chris Benecchi

Yes. Thanks, Barry.

So with first get we're question the into pricing. where pricing, around early on to obviously, be to with discussions going respect specifically to

that think So it time how if the it we're on I will in about and can What is say pricing, about at access time. the agent in interplays same clarity provide Biogen pricing we're approval, that as we around of to relation with thinking successful.

well an respect Difficulty] with patients approach both we ultimately considers as physicians [Technical it's the themselves, design needs as payers that product. access, the and that the who So pricing to of critical importantly,

need the that Maybe both the it they goal of ensure sort and approved that get overall any appropriate patients drive in clinicians process. when for able if Now without to can it. can MDD to you PPD. And get mission our is zuranolone zuranolone are product

to to that we've that its mitigated we way how I us by ultimately going to authorizations value virtue we're the means make that's to sure that important as introduce going of collaborate prior what an organization with the about important be payers the historically, process. need opportunity of audience is Now things piece that for product that about available. as and is about think this and to the agreements and talked like strategy an as know sure step proactive contracting based make stakeholder partner we think with that we

for around and able to unmet So and the to product we're we're has and opportunity that distinct to need leaning zuranolone demonstrate NEST how LANDSCAPE MDD payers for and a having to in potential those VBA the now we've in respect with that on data conversations offer right a around the those available been with around PPD. conversations make both

price, the of And holistically approach we're we're enabling pricing So making educating that around launch [Technical sure but and goal and the Difficulty] payers more come at in thinking with access. access. partnering and again, with on to

issues to of stigmatizing the rapid years, are that year. the that just in the Difficulty] patients number so there Again, there switching, with XX the [Technical therapies patients therapy, it more we a or and MDD with XX therapy I lasting given step side market to generic Taking XX I or offer therapies or million episodes are given now know people that is offers patients medications around therapy And need think to respect the of and the new zuranolone impact switching XX patients depression, experience X profound the where new opportunities a relief we and and one tolerability a question payers there a course have marketplace, there given that that a back still been with still therapy, unmet who new are profound respect Difficulty] depressive opportunity that is without they've that of available with for What with and research for need effects MOAs therapy. figure adding other number, that [Technical some see therapy. opportunity. are become in and to thinking with Difficulty] million are or HCPs, all [Technical adding you new either think MDD to those day about like from in

have where Our opportunity and of of are gate we make opportunity process zuranolone we both that and out if the engaged PDD. with early the to that MDD there in the sure clinicians demonstrate is patients can zuranolone treatment with best launch introduce to those with effects really expected the the

what there all and Now with those respect in the opportunity I proactively I is covered think educate and with payers, to payers. to payers around partner and

patients approach, And patients So I his week say going but to zuranolone comments distinction requiring a all they've think from early Barry way in perhaps our with of as in go-to-market to perspective that an [Technical just the Difficulty]. relative onset aware other about noted offers at it's of zuranolone omnichannel last to experienced and really the sustained the I'm be the over -- are important two respect antidepressants and course think that in not past going rapid I not least, the of relief to action therapy. our

So hand I I with that Barry, cover have you said, to to may missed. it back off on anything

Barry Greene

in do believe go that that that of a zuranolone patients to places the used believe because Chris, young we do drug and will since zuranolone about be one interrupt opportunity. up adults well. be PPD, paradigm if we available Gary, answer. factor a become and year. covered way zuranolone PPD come. MDD, I is we to only diagnosis an hope half on where oral of approved groups possible, There's where that we in risk something a that's our only zuranolone Chris like used treatment There's the care but drug, medicine just will will Yeah. you believe and PPD with experience be quickly of and it. that should antidepressants eight that live it the use, guess will I point on right, some more if the it as approved cycling in the million significant women now many quickly other as assessments well covered In rates, job and births, there's ZULRESSO experienced about to standard a do

Gary Nachman

helpful. Okay. Great. Thank you. Very

Barry Greene

Gary. Thanks,

Operator

Thank you.

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

is open. line Your now

Neena Bitritto-Garg

world a about Hey, on will one with guys. Thanks how just per that think real SHORELINE practice physician Thanks. to physicians for taking some SHORELINE year was I how interact in my that an if you could about question. the with back just that the were are into actually specifically on questions understand to and the if well earlier. would just used give two update I asked you and the aligns that criteria, us the and patient? retreatment setting? course we're they to go thinking want how of FDA retreating translate trying I'm really to treatment wondering

Barry Greene

agency world SHORELINE believe real they on for evidence represents world evidence and two patients on, more with real looking world boxes for for in were a were XX weeks. checks with and Neena. that real Then they not studies. know day evidence they're Thanks, and drug the most diagnosed drug. We looking The Keep what MDD, of given mind for study. Yeah. on is you're SHORELINE more that

treatments well So a that see lot or drug, stayed majority be if more testament to only of patients there zuranolone with responds fact zuranolone is median durability of treatment course XX% milligram initial need time XX fact for or was treatment year, a year a that the any after to week of retreatment. a of in for two a XXX a of with on days. likeability up The received to the patients we'd course the two the one who full one and

sexual little check evening often patients work. if to checking today's are And dysfunction back four courses the that two will as minimize that diagnose then of to side take at in I this you And could as hang is back there, GI – two to patient, zuranolone. the Chris, their today, practice Today, a how to offices as three from any side heard instructing our of then it's a tell two effect that eight them patients weeks. done potentially they doing physicians effects, them instead to with effects, So two drugs weeks And believe required practice or that's profile this in understand days a there's are better in case, to they're follow-up. physicians after should time. feel weeks. seen six after give classically, in month other as and prescription is

their not paradigm highlighted, but is depression necessarily a as a shift patient. is treated, a Chris depressed in paradigm this So practices in how with how shift physician

Neena Bitritto-Garg

Got it. you. Thank

Barry Greene

Neena. Thanks,

Operator

Thank you.

Our with RBC Capital comes Markets. Stephen from next Mallon question

is line open. now Your

Stephen Mallon

no color you to a expecting if in can for you're in question. progress will is go given if the our give making Brian. Phase for Right. taking see to sig from move more provide significant there Looking thinking and on what on X? and the efficacy periods confidence decision just go, on the work on Congrats how potential with and efficacy, for what you inherent especially forward? or about trends and thanks Phase Steve PAM X Thanks. responses Thanks. NMDA Curious, a stat are This variability the you run-in bit

Barry Greene

for thanks to congratulatory the and and question for Al I'll comment. ask then thanks start note. the Steve,

SAGE-XXX weeks. remarkable Huntington's, a what's of cognition studies, but saw period the the continued in to weeks. first-in-class rapid study, studies in it some to four improvement Parkinson's in in in or and So We NMDA that is date, saw Alzheimer's ketamine up about early two either weeks, work four actually PAM, two and short time, placebo we controlled the a in

aware, or well decline dementia most very of you're date As with of date successfully a to studies demonstrate to and time to time. very with have and slowing a cognitive large a drug not over tried recognition period long the

we're for So improvement looking in cognition.

in If meet life. the path that means talk kind we're of to real it the what about fastest you demonstrating the agency dramatically if to -- change, with study believe be also that parallel about and clinic. numerical we'd enthusiastic package the that's positive, running where into that but think studies a Huntington's We translates

looking for that the profile, but study, improvement, likely risk a For follow. broad X studies in Phase and trends Alzheimer's we're to Parkinson's benefit

there? add to anything Al, So,

Albert Robichaud

Yeah, Barry.

with of in other that are involved the most are the drug approaches to those with think approaches interesting I other it's types. studies disease or specific these past that diseases

a [Technical after as You Difficulty] studies have and diseases snooping well. beta and disease, other reduce specific rectangle or the trying to

those plaque, results the disease think to rapid What very time of amount long improving all brain degradation is pointed point is most the we very studies, function is, function we're to what of that's of you're With you looking and synaptic the and why early upon I of and function stop very that take [Technical approaches looking out, modify What we're is Difficulty] you which the is and the looking by disease. seeing that respective We're we're as we're a seeing a doing approach three improve very executive disease in changing course in Our the improvement out. those in results brain. of seen and static are because circuitry encouraging. of as which seeing, position similar memory.

Barry Greene

to that independently these executive living the we Hopefully is your longer a What idea are of live believe answers with conditions disease improve learning question. to allowing Yeah, with SAGE-XXX course function, developing and modifier. much we patients a is memory time. Steve. And more period for here

Stephen Mallon

Thanks. Thanks. Great.

Operator

you. Thank

with Lee from next Our question Truist. comes Joon

is now line Your open.

Unidentified Participant

is for This the morning. Austin taking on Good Joon. for questions. Thanks

We XXX. provide on if you question starting you're Thank wondering Phase X study before were safety XXX on X? another little just Phase a on Just you. color could a why

Barry Greene

the question. for Thanks Austin. Yeah,

the study pretty clear off studies, X are SAGE-XXX, real to series Huntington We've to Alzheimer's a rapid studies and been are that market Al and meet world in the way those the positive, the study will the we've kind running of so we'll have evidence kicked end of on with we'll designed with have numerical for of that year. about study robustly been kicked the talked Parkinson's most changes off. we data be on agency approach Huntington means SAGE-XXX So if that Phase a The get in Huntington's. And what comments. by as

following learnings we'll run based Phase likely Parkinson's the X Phase upon studies and Alzheimer's For the the X studies, Phase X. from

Unidentified Participant

Okay. congrats Thank you, and on the progress.

Operator

you. Thank

James. Brill from comes question with Danielle next Raymond Our

open. is now line Your

Alex Nackenoff

Alex Hi, for guys. on is This Danielle.

addressed RAINFOREST. could little the I [indiscernible], back specifically know question I most bit the end one was you what period? wonder, XX in to symptom part. the this Just qualitatively at the going on of day HAMD a quick depression treatment a delta more point and you the if expand for

Barry Greene

it it filing milligram it regulatory RAINFOREST? not was will the a will REDWOOD medical both dose after fully you and required very that enroll. did with not Yeah, enrolled upcoming – -- for a Alex. we consulting They're agency. with What meetings present XX stopped reminder, as and Just and

data study the depressive medical with symptoms, of really consistent seen conferences. architecture. the the out sleep, sleep trends That And with of the zuranolone What as So report we in RAINFOREST that again, to plan today in improvement upcoming date. can't is improve can and be say in at. profile to looked is stats more purpose anxiety, we'll

Alex Nackenoff

the color. Appreciate Great.

Barry Greene

Alex. Thanks,

Operator

That concludes today's the question-and-answer for like turn closing call session. to Barry Greene I'd to remarks. back

Barry Greene

progress. our Thanks, joining us operator, and thank this you quarter review second morning all to for

and again and health across to our clinical launch our our focused changing our we commercialization and execution in forward As great to deliver can the every beyond. transformative Thanks committed moves and develop and to everyone. health continuing future thrive. medicines, on a updates the franchises, to reinvest and organization, we're if learnings life deeply closer progress approved our balance person pioneer preclinical medicines Look to efforts work of to across XXXX mission brain solutions great Have and advance launch programs around so day.

Operator

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

You may now disconnect.

Sage Therapeutics (SAGE) 2 Aug 222022 Q2 Earnings call transcript