SAGE - Earnings call transcript Q1 2022

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Operator

Good morning. Welcome to Sage Therapeutics' First Quarter 2022 Financial Results Conference Call. Currently, all participants are in a listen-only mode. This call is being webcast live on the Investors [Technical Difficulty] This call is the property of Sage Therapeutics and recording reduction or transmission of this call without the expressed written consent of Sage Therapeutics is strictly prohibited. Please note that this call is being recorded. to Rubinstein, like Sage. Relations now would introduce Investor Helen at I

Helen Rubinstein

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

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

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

We our in will recent activities the who results by development review Chief our quarter. Iguchi, and progress will Doherty, across Officer will Jim who and Chief Development Financial review Kimi financial our Officer also the programs; be joined

Officer. I'll by Q&A Benecchi, will joined be to We for now call Barry. our With Chief over Chris the Commercial that, turn

Barry Greene

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

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Jim Doherty

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

Kimi Iguchi

Thanks, Jim.

this for financial issued in morning. Our detailed press XXXX the results our first release quarter of are

only of goal some for our value medicines far that life-changing period execute as believe key during long-term the quarter and strong closer I'm moved the to continue bringing So sheet with patients, key communities planned. progress us first health highlight and XXXX, delivering the and brain seen then since points our and stakeholders. Backed upcoming here. us has I confident milestones, I'll balance by a of so to

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

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

for As advancing we be franchises. designs in our study compared neuropsychiatry programs our related planned zuranolone million ongoing across zuranolone way. to cost and expenses use increased our cash of six of a includes continue across neurology enables allow pipeline notable candidates. and that quarter, primarily Collaboration and from and and We're and R&D of potential our disciplined the same smart for future to excited franchises employees to recorded increase a our proactive savings to to us predictive studies sharing Recall XXXX, approach. efficient product to in activities, us the $XX.X Phase to United our reminder on in XXXX. owned have and invest X XX-XX License SG&A we continue launches collaboration from the in in our $XX.X of first SAGE-XXX. The hiring Also SAGE-XXX support million the ongoing for sharing Agreement. to hand this quarter advancing million to in related cost States The $XX was a period Biogen in anticipation the, reimbursement wholly with

anticipated can of XXXX. provided reaffirming cash we've everything well we're equivalents, end milestone that ourselves being collaborations beginning Q&A always we're financial this anticipate courageous, the line demonstrated XXXX. turn progress the sight $X.X guidance work to look pride operations XXXX. positioned we updates believe year. benefit anticipate into on revenue this support Helen? it over throughout I'll not billion in Helen, the earlier efficient I of with patients. focused collaborations marketable continue our equivalents and from cash at we But operator. forward, this and We the of innovative on funding to of year. believe our I securities having ongoing on payments from cash, with We and do current will the execution, that potential receipt providing additional any we we to to this approximately Looking At cash, across our handle how of Sage, year. do forward throughout now

Helen Rubinstein

Thanks Kimi.

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

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

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

Operator

[Operator Our come from question first of line Wedbush. the Chico Laura Instructions] from will

line is Your open.

Laura Chico

for morning SKYLARK. taking question. Hey. on Thanks Good guys. my guess question I one

for that Just enrollment. on for a you scientific rationale realize eligible affect remind from population? your does depressive this that of enrollment episode how months to extending and the could a perspective, you. probably I facilitates wondering, But if heterogeneity window XX us clinical the this Thank

Barry Greene

to that women question. is Hey, highlighted XX the call, Jim Laura a do bigger we're And seeing out ROBIN of a XX-milligram rationale? that really thanks just as depression couple the notable want SKYLARK the change the just And Jim excited in highlighted, you important. really really aren't end you appreciate it. with different. of study. as by study really highlight it with which to months And versus for six the they Look is months I repeat the changes,

Jim Doherty

have who symptoms women case wider us enroll absolutely. third the that persist Barry on-set certainly But between sometime it time. first or a mentioned trimester, the And Yeah. the study. the importantly, but PPD of months, the with PPD, Laura, net gives patients and you yeah that, as we've for known in for six some

So really trial. opportunity set the much. all wider in changing in participate of the gives women our it just to that population isn't estimation it a And the

Laura Chico

Thanks guys.

Jim Doherty

Thanks, Laura.

Operator

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

open. line Your is

Unidentified Analyst

on This question. Thanks my Yasmeen. [ph] is Lauren for taking for

zuranolone somnolence without you follow-up similar what you of to rates of of rates profile consider anxiety? when the for were you. safety into a studies landscape Thank sedation in see do And kind somnolence the across then looking look seeing? you and with mild, And that. patients severe what So Do percentage-wise? moderate you and and

Barry Greene

to for Yes say Lauren, for the question. us. Please thanks Yas, hi

them sleeping duration index zuranolone. anxiety with step Keep the MDD profile, the mind therapeutic without we seeing in back them and of long that aids. depression and anxiety with Jim for many if we're often well-tolerated or PPD broad an So patients, impact have challenge really in highlighted sleep reduction of of efficacy sleep and there's the rapid incredibly a what effect any patients profile. a is without to

having do about you to So some degree to a rates? is benefit somnolence want talk these actually patients. of Jim,

Jim Doherty

And These efficacy measure of Barry. the a the assembled absolutely are course trials in of included of also program Yes, course, metrics ability we for somnolence in we sedation lot pharmacology that example. now the time that trials about. talking entire the we which have spend clinical to have and are landscape

somnolence ability the to have we so, and look rates at multiple sedation And across doses.

specific are about dependent. the as be high somnolence, all other And teens with trials think depending before in in antidepressants. current consistent associated mechanism well with probably that would in I rates on talked so trials quite of range course But to with we the of is low somnolence on And trial, of do care and in compares dose safety action think for the the the teens and dose. somewhere consistence teens standard rates and depending specific of we quote

Barry Greene

weight those And antidepressants often which a effects significant to dysfunction. with not And I amount like antidepressants CORAL of out challenges. as will don't the in And you with sexual report seen GI too. side stigmatizing upset seeing with things side highlight gain, effects that have mind to lead keep compliance we often we see we're

Unidentified Analyst

you. Thank Perfect.

Operator

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

line Your is open.

Unidentified Analyst

the for Jay. Congrats -- progress. on Matt is process on the This

the that how patients patient-reported on SAGE-XXX feedback particularly at we any outcomes data just would received on view about you along in they physician any HD great. curious that be LUMINARY with early AAN So. feedback curious were

Barry Greene

guidance into physicians at started encouraging. data both slide the big when, send please packed congratulatory Matt, was was the feedback and I with the things of presentations. poster was presentation rooms that those probably It say one the were with say healthcare the saw submission. hit from other we crowded and encouraging SAGE-XXX and the providers exciting proud best attending Hey to most incredibly note a was really we can on deal our presentation attending AAN. that mobbed what our Jay and poster rolling and His most it. thanks. can appreciate session. presented and We Koenig that we're Appreciate rolling AAN really at submission. and starting the presented the Aaron a And That's is

are Chris both in know for drug what's We want and Do improve of on presented cognition and there you world data personally? heard talk to there. haven't Parkinson's. you a seen the a and was hypothesis were more amyloid lot approaches. to in opportunity excitement an bit gone really Alzheimer's with what you this you As other a about little

Chris Benecchi

Yes.

was of deal there excitement mentioned. great personally, a as Barry So

we precious nothing mild other going the living are and with day that with who disease, I would Parkinson's can it as can for get with forward, And mild in on now, or options are impairment are from disease impairment. of moments suffering is we and these are they impact families patients really cognitive back. with no difference are perspective, loss with in standing those those reflecting SAGE-XXX who for from important patients there are disease a make diseases right the mild has think someone see back the moments about clinician's day those what that Parkinson's the patients that think on out. dad friends they have Huntington's to about they it's that patients a in understand and whether impairment really effects impairment. there few. And have mild available and cognitive a associated really because heard as with is, living cognitive these like patients These Alzheimer's we disease really And And independence. cognitive this

Unidentified Analyst

Got it. Thank you so much.

Barry Greene

Matt. Thanks

Operator

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

open. is line Your

Tiffany Sun

guys. is Cory. This for Hi, Tiffany, on

trial one also see this? for study on Phase versus add XXX. you are to any with differences kind sense the Can X design talk Just the of of PARADIGM hoping what updates? Parkinson's initiated prior recently just study? you. cadence in And And the about to you Thank

Barry Greene

Hi, Thanks Tiffany. for question. the

I'll talk about the So uptake trials. first we did designs the such to and do then different trial robust and ask why part Jim

in look trials the the are and up as running. we So highlighted call

accrual how we will And clear activated looks comfortable, talk But fruition. the we're Jim, different designs As we then once come get like like. the guidance to the believe trial you we we sites to them? and what when about size trial to and want on we'll do provide do, want to see

Jim Doherty

Barry. Absolutely, Yes.

course serial placebo-controlled a of what patients derisking. PRECEDENT SAGE-XXX of will study first Parkinson's as study with concept this as in the be So disease. know, due or And we represents impairment to cognitive the you about think

Parkinson's or early sorry in -- safety study whether designed providing earlier both group, PRECEDENT hone SAGE-XXX small the the benefit a to design us for an study. not was but disease to really at study open-label So give patient the look this to the the study also opportunity

a dosing. is study the XX-day duration earlier study So unlike PRECEDENT

So is longer PRECEDENT. the in period dosing

period is then and we'll placebo-controlled dosing a Of have course, period. it a follow-up the after study

So placebo-controlled study. three months dosing

Tiffany Sun

Great. Thanks.

Barry Greene

Tiffany. Thanks,

Operator

come Baral from line Cowen. will question from the next of Our Ritu

You may begin.

Ritu Baral

I to recent -- guys broad the what's naive Good for taking sort gating after you be the for. population one to were boxes will that black ask module most going of morning, sort Barry And are what can to adherence my will everyone. of asking on the of what also the going and think question. go you're clinical that? outstanding one? items most Thanks. you asking can benzo label? efficacy attempts rolling I can just important you you you're Thanks through do patients steps to submission you for resistant or wanted whether and guess before a submit translate what And but second, sort given treatment especially just previous the outlined be through you treatment who your about

Barry Greene

for Thanks Ritu. Yes, question. the

things. of couple a So

we about can be with talk and we'll then start looking submission for. the NDA Let's rolling what

nonclinical started we're So as very have with section. to such submission the rolling excited the

all is highlighted, are work done done. clinical of all pharmacology the Jim and As the studies

through process the sure the highest QA of quality compiling really and have going it's matter making the we So studies submission. a

second year further we'll finished, will accepted. the of half the when in communicate the the We everybody NDA know let and we when filing is then NDA

I work this in be good can modules say of very It's But matter the done. communication. will the of are a shape. really of So -- all getting that section the all the

are we're very and study announced study. in excitingly we items the CORAL highlighted filing calls, NDA into that wrapped an two up getting we've As previous the translating the study Japanese

well that's half the is the So second the that on in working work finish But team chunk of track through. to year. of a we're

it's and for, have talk MDD we for kind In a of is PPD asking specifics what or seeing too without but zuranolone what are about terms warnings to drug we or any anxiety. with elevated early and the of here treatment label we're of studying

the that's kind So agency. with of discussions, we having envision in the

push too warnings drug sure We'll warnings know of in about works terms heavy highlighted not were tell. the how not operate class-like going like to have to that. effects, warnings, just don't there. we'll should others have we're warnings seeing early don't machinery But maybe things there some some where we the that think zuranolone-specific like too accept you warnings In have again, talk it's to classic, we're if back of I We're certain in and if typical early certainly certain because until things are specifics. we issues

Ritu Baral

it. Got queue the I’ll Thanks get in Great. back

Barry Greene

Thanks, Ritu.

Operator

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

You may begin.

Unidentified Analyst

on Salveen. wanted This is XXX. about to Tommy [ph] for we ask And

benefit dosing beyond some Parkinson's period. both seen and in results the You've durable a suggesting interesting Alzheimer's,

frequent feel potential Thanks. about like are dosing of possibility how Do is you the shorter so, dosing? or chronic regimens less the forward? And thinking there is going necessary, dosing you

Barry Greene

attention question. Tommy, great Appreciate the on SAGE-XXX. Yes,

the by continue we PAM. therapeutic highlighted, the very talking window. seen serial Jim and by excited as low and We're really we've learn of studies. doses efficacy broad We're to as the So SAGE-XXX derisk NMDA about very, an

too while be there'll SAGE-XXX, to it circuitry we of because brain would or dose be doesn't disruption. believe any of this kind don't It's will we due to durable point, chronically early tachyphylaxis tolerability So be required, of see effects or dose breaks, seem know at periodic that any are rewiring, challenges dosing kind if warrant that any to do kind but dosed. the

anything chronic believe it's drug. we So Jim, right add? to a now,

Jim Doherty

is studies the to drug information part performing that of designed how Barry, us do, further to dosing. with about repeat status Just, give the is what is

said, current amongst -- a specifically. Barry dosing better trials diversity clinical and we how but drug the As little assumptions are of us bit sense our performs enough that chronic have give

I And of this just so, process. think, the part is

detail as of really from get more into So specific to studies, go days. we have we to dosing, XXX next X delivered. have to and data short-duration about relatively questions the be we'll date, can round the how dosing XX longer-duration But

Unidentified Analyst

Thank you.

Barry Greene

Tommy. Thanks,

Operator

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

You may begin.

Unidentified Analyst

about you Thank set a use is Thank mechanics for of conversations in callback or reserve In should zuranolone authorizations more patients Do when payers' This or recognition the Previously, Hi. VBAs mentioned potential use requirement at with code actually of requirement you for Akash. revenue have to mention have think you for zuranolone of to taking payers, level. the one payers the and if for the they lower could payers patient questions. courses from addition of XX ICD-X do you for with the try first does then generic our product for and year? you potential prescribing payers Leo population use How monitor antidepressants VBA zuranolone? any you. zuranolone? requirement we

Barry Greene

Leo. Thanks, Yeah.

about revenue from a Let rec try unpack of what I'll hearing and we're those couple payers. to me of to about questions talk ask Kimi and sort then to then talk Chris

in articulated value-based that proactive strategy our step part I of we've commercialization with agreements. if back, So leaning is

payers without provider a a auths. can to zuranolone It's and is that, zuranolone two prior Every care script deserves of step-throughs so that quickly, is they zuranolone, is patient someone lifetime patients if and Our that writes without matters. get or important, get day ask zuranolone features the gets days. if better given of health these depressed very a three they in

comorbidities costs. waiting is And undertreated or from treatment to weeks So just health and we in long-term perspective, delayed better as and get economic results okay. not know health

payers our better patients gets is a without fast lot them script of ask hurdles. is getting And if or it that, with a better comes in, and So filled agreement again, critical. keeping

Our give for that have. challenges payers is understand might to what

for what the year, epidemiologically can needing is of want suitable didn't budgeted course they patient the four, payer they two, which a how to which them in that. instead budget three certainty. course one budget or about they for, two-week five, might need for of and goes We population many if protect might population, be their They patient their is might that for zuranolone. nervous concerned over be So, example, of it

can time. talk can Chris, conversation And protect in say, we're unique. this at that. rec to you payers rev of against how about Kimi, talk every some incredibly that sort we and Biogen's might about can of them well. And is feedback And going I do they're hearing from payer then, So hands? work actually want the

Kimi Iguchi

Great. Sure. Thanks.

about So a let you me think give little the how to color P&L. perspective on from of the the just revenue

our recognized in collaboration SG&A currently So reimbursements are included that and net operating all We expense R&D line. in expense our our and line. expense

until commercial that will will profit it share how launch. So recorded But expect And would by would share that profit approved, we collaboration-related be it we to zuranolone in product then our the line profit in that's revenue revenue P&L. our line expenses. revenue get the of reduce share is commercial SG&A the show reflect if as launch, net we XX% and

as exactly we revenue be get in reimbursement. that launch So certainly the R&D We'll the R&D additional the on will show that closer We'll any line. in expenses of to would line clarity continue look. provide net how to

it I'll over So Chris to turn now.

Chris Benecchi

Yeah, for sure. And Leo, question. the take I'll thanks it Barry.

Despite as and not level. So and And for we're are remains with the therapies there PBMs right not the the as a last there's and for only payers the physicians what solution the are treatment this national that is patients -- been that's might fact payers need deeply the with respect working significant regional provided years there's at in XX for and unmet of hearing we MDD IDNs. as profound you both to that for planned over engaged imagine well patients now in who advance space. XX that been coming are but PPD

it's patients often actually cardiovascular long-term and that that of population. complex with disease about that costs they they the suffer patient back think step as recognize consider real often this they population, think also neurological these are And treating quite or treatment they from the plans comorbidities has for they now there said, this associated as need that about it conditions. other with So to patient that

highly course to that that idea This better therapy initially conversations gets side those. a in of We therapy had. is stigmatizing dysfunction been short So well for the look around and that those to it we've are determinants begin of and doesn't gain positive be have a weight really productive can with a and on zuranolone, tolerated effects that's then when discussions adherence. faster patients often payers therapy sexual continuing that has of attractive we forward delivered carry

Unidentified Analyst

Thank you much. very

Barry Greene

Thanks, Leo.

Operator

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

may You begin.

Unidentified Analyst

guess patient about commercially? for around, there comes I'm any play and a to on Thanks. has [ph] out Paul. about be in of Thanks guess like now can when redosed sort that the question. curious, for I potential Maybe of anything the SHORELINE around James kicked when or off. thinking you redosing there quick is that may is the And it restrictions I how how process labeling are redosing? are that if This and restrictions taking you Hi. just regulatory on a how thinking one are

Barry Greene

question started the submission week. this for the regulatory were the pathway. as have you thank James, to And rolling excited we on Yeah. again,

week will So every be two study our saw everybody MDD dosing remind in asked of And actually naturalistic where after a just week run how largest are SHORELINE patients we SHORELINE submission. part is they're to what which other the doing. the critical in

while kind how placebo-controlled -- it's patients they're doing. asked it's a of So not are often

only XX% two, seen the of course required what in is the week year majority course week or treatment required of So only then courses patients we've of the one, two treatment. of two and one

part require we will of question over treatment. one course providing patients world, the be week only Leo's explained in of a two-week And of with of protections value-based we'll treated or agreements I two couple majority So the course the courses. think that real

don't exactly So will we -- go. don't I the know how discussion

up data courses. retreatment five have to We

any We have with not safety seen retreat. additive

In the down course. goes and adverse with numerically fact each of actually every event

higher allowed, when doses argument a doses. pharmacology So in Jim already studies, to the good extended got got highlighted as we've retreatment allow rapidly as we've

treatment, perspective. later data after no there's a per reason couldn't is that world needs it from month get if better why then someone and reason the a se another there's no weeks two they in So real

in year, Now, time the commercial to not much really terrible courses a while only have patients. impact the the the because the of going we to it to for that's to commercial for that courses think two-week week an extreme, a if the agency majority or and are right retreatment of frame treatment patients were estimates two, to do thing restrict of won't our to of one two course

Operator

And question our of next SVB will from Goodman line the come Securities. from Marc

You may begin.

Unidentified Analyst

rolling of on Thanks on Rudy for the taking NDA line This Marc. the my Congrats submission. for the question. is initiation

have regarding the of So I question study Phase SAGE-XXX. SURVEYOR a X

provide and Thanks. like of participants in subjects is what comparator the And the Huntington's seems more disease the design? healthy So both it adding rationale on Can arm? as you healthy the trial you a color study. have

Barry Greene

Yes, Rudy the and note. congratulatory you thank again for

orphan about improve thinking has and Huntington designed everyone starting not to a been disease where Huntington's aware we're an disease as just it's as So drug developed. with is cognition

So believe market. in pathways. that to to approach we're study We dimension way fastest really for the new will the the regulators us get totality regulatory sizing forging data SURVEYOR the of energy drug should in to be positive give the significant

DIMENSION an thinking package in values real coupled world how SURVEYOR. we're overall as that's and about the So evidence the numerical with study the

thought do overall strategy want the you But and talk Jim SURVEYOR? that's more to process. about So

Jim Doherty

are cognitive to first how measures been that studying Yes, SURVEYOR to far is thing so about to And probably know study into is that translate the this function the absolutely, will the beginning of going we're patients. meaningful be understand where we've Barry. measures to

SURVEYOR the trying of Huntington's composite the that to really primary so far. we've be is variety looking is quite is in able battery, to types of the linkage DIMENSION real-world of a many so want link endpoint be do assessments. studying understand And score are the at cognitive based between study. in we're the We disease which from tests complementary designed that to assessment the And to SURVEYOR tests but to the similar to been what performance to to

purpose that's So of SURVEYOR. the really

addition group. As you that an there to is mentioned participant a healthy

SURVEYOR. arms three there So are in

subjects be the to or randomized placebo. So say the from HD group either will to XXX

that to begin at healthy So to batteries. with assessments get group. performance healthy including participant a was we're some of we addition And really to I mentioning. that get that endpoints is But the placebo-controlled looking in

we're with at. not SAGE-XXX, going are be tested to the those So being but endpoints tests real-world that folks of and tested are batteries with they looking cognitive

Unidentified Analyst

Got it. That’s very Thanks. helpful.

Barry Greene

Thanks, Rudy.

Operator

Guggenheim. next Our from the from come will question Yatin Suneja of line

begin. may You

Yatin Suneja

of SKYLARK. the a generally for that Thank delta get temporary question. of the little Hey, should that you like MDD? could we feedback work of dose, a Question additional from to for the Hello. Can different be eligible my Thanks. how only what depression? they you you get get guys. PPD terms KOLs efficacy the on MDD. expecting one defined PPD the about in to trying dose? which or just women the have versus Just Will sense on expectation talk And then those be would as taking is redosing in you bit received

Barry Greene

question. the for thanks Yatin, Yes.

a ROBIN number of positive So look on the is in other we're SKYLARK And and we're PPD excited And anxiety midyear. with very depression. like -- call track MDD we We've as out this as highlighted elevated studies. Jim read have we we highlighted by study. to that the highlighted much

that PPD. to what a XX So a without we effect we're day submittable with believe and is study stat-sig SKYLARK at study side positive clear looking any for for surprising be

that provider redosing of be terms to healthcare In patient. really will the up a and

we've As and six but seen stay studies XX we you as depressive period pregnancy the our MDD If given be typically from can another depressive is most have point XX is when that zuranolone that more diagnosis. said ZULRESSO long a they caused a months for either believed have that retreated that better what's episode time. episode MDD moms of that commercially months months, childbirth. or they And what or by later an gets at classified in is which generally

Yatin Suneja

Thank you.

Operator

you. Thank

Needham. come question of from Ami Fadia the will from line next Our

may You begin.

Unidentified Analyst

Ami. have the Hello, to the you for related we is Amin guys. This discussions Thank taking have [ph] with payers. the for you The questions. question is

of with have mentioned discussions prefer concerned approved that so mind if about drugs. you engage wonder the are are have that the -- than priority generics -- any kind in is discussions that compared that the the drugs they were what going very to were recent you I on the the You payers in to approved far usually positive.

you be If on great. can that elaborate would that

Barry Greene

for question. Yeah, Amin, thanks the

view, proactive value-based So about disease agreements payers. again, engaged of context We're state have the talking within the overall certainly we awareness.

publicly been read everything released. Some that's certainly payers have

the prevalence population, and getting it's from one cheap that drug data example, remain quickly. depressed, that a So hospitalized. come that documented but And is it zuranolone likelihood to What no well depressed been of being I'll many while stay if for All that stay nature patient higher that And even of has diabetes drugs. hearing and from large depressed. is longer cycle the earlier, cost the they available higher category, events, infectious a or a because it's up. for patient’s are recognize population Even they They COVID discussion diseases. and depressed generic having highlighted of have depression It's People cardiovascular word this Chris through longer-term antidepressants, we're going summarize to they payers the payer. recognized, very use them. leads a problem comorbidities. depressed another of have is of

a fair so to because what the hearing actually have the fair context patients. to do, avoid being trying to avoid to if the we're them agreement thing an we're do if agreements So from prior what trying to they provider value-based auth, them And we that seeing script. script healthcare for be of zuranolone, extent we're step-throughs, they'll that's to we're for can a writes the is, trying as we're under wrong back, filled they're

Unidentified Analyst

Thank helpful. very you. is That

Operator

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

begin. may You

Evan Hua

Hua is PPD Would given when Could earlier and our taking Fast Nachman. designation? MDD? had question. that talk PPD Hi. on the could MDD question. able approvals come just and of be same approval or than This a about at come, for PPD Thanks even Evan you has to time timing the Gary Track for I that

Barry Greene

the thanks for Evan Yeah. question.

year. of and aided you with So, agency by discussion the very last our generalities the much were I can we fall give in strategic

remind highlighted positive a programs, file had one and to the study needed we agency with WATERFALL that more Just everybody, the to started package. was had we for positive NEST LANDSCAPE we that, study. that when we alignment

both launch first was started first, review, that that very But again, a well. If period the goal. we've at in and rolling we up we've we file PPD then, or announced in WATERFALL, helpful with last zuranolone said we PPD the could for agency we're as as running year. the CORAL which in that. indications the prior fall the study two hopeful an met you a same for the the had given while timing just hopeful the DEA MDD we positive fine not PPD and month is that with to hand which studies Following strategic file get the MDD, review, the that approved we study, And we approval of as commence upcoming comes MDD said, we're as understanding three-month although, what of agency file review. and had time. And comes package our on the is which midyear. is And additional typically announcing let's discussion a NDA that's SKYLARK after, which and plan submission And then two that's after and

-- we we sometime hope of by next the And followed submit, year after and then PPD sometime get to approval thereafter. MDD

Evan Hua

Thanks.

Barry Greene

Thanks, Evan.

Operator

line Our from next Vamil Divan the question from of will come Mizuho.

You may begin.

Vamil Divan

obviously Maybe that get for and Thanks want partnered happening Biogen for to and Biogen you're like come. periodically, to at one they question transition just, and Great. changes and taking zuranolone investors just and more we higher with my XXX looks from level question. both

just be would doing good to data you lines I sort level, of curious level track you're just sort the partner still along of on you're that things obviously everything product talk the be those in you you. the with think about sort the guess of track. reassure and of of, from sort I your I'm seeing seem submission relationship are -- So, can on But Thank product on on that the is terms progress helpful. if can,

Barry Greene

obviously, ADUHELM unfortunate further challenges they've question. restructuring Yes, morning with of zuranolone for they're and Biogen this Vamil, growth is driver the CEO at press the we question. the press thank search as can that I with highlight you Very important release think given Michel's tell all release is the the had a replacement. looking you for company. key Yes, What I and that other in for the saw

important is comment So, which be very and that's we an consistent that heavily important landscape. believe them it's from in plan the and they been their depression long-range depending will on zuranolone

Japan, a incredibly Korea, at United well responsible a of level, and we commercialization of world CMC from a aligned except in the course, clinical prospective, development perspective. And we're team for rest States a they're are and Taiwan. So, perspective, for co-co

level. team, community the the strategically team, and that It's Biogen. and again very to has well is well Biogen. things going wish by the by in because entire Michel I be wish level team their at at So, his It's But them search should And endeavors. partner. things not are been recognized well. senior important are I recognized him incredibly surprising in zuranolone leadership a and strong Board. future wonderful the

So, things are very well. going

Vamil Divan

you. Thank Okay.

Operator

Bitritto-Garg from will Our the come Neena of line question next Citi. from

may You begin.

Neena Bitritto-Garg

that the for wondering thanks my more was little SKYLARK could was you population a enrolled. about guys, taking question. final Hey bit if I just share

share can of to regards you characteristics and ultimately patients ROBIN notable described you already versus the I study or guess those baseline how differences that enrolled were in If any kind design? other many Thanks. than

Barry Greene

Neena. Yes,

results until prevent a can Jim to not topline any the we data. But there's say add? about SKYLARK lot to So, color the we have

Jim Doherty

Right.

So, is I think that's right Barry. subjects. target mean we I the say was XXX enrollment can what

as So, able the the the enrolled be were target the able talk the we'll about XXX. study talk to in in but study, are about results that we to was specifics coming up,

Neena Bitritto-Garg

Thank it. you. Got

Barry Greene

Neena. Thanks

Operator

Sumant from the Canaccord. come Our line next from of question Kulkarni will

begin. may You

Sumant Kulkarni

my taking for Thanks morning. questions. Good

in anxiety how to latest include you the complete you to have thoughts elevated the have MDD with Given able could time any you submission you label? share a on to might case as be the target use

Barry Greene

for Yes, question. Sumant, the thanks

know have as or literature with anxiety like highlighting is of highlighted that that by studies MDD is we've standard-of-care. often feature in are elevated seen we've what MDD a when So, their of elevated the with anxiety zuranolone STAR*D The underserved the present that we're depressive we elevated effects patients including reason symptoms, through they anxiety. and without much very component

a will that to So, that we elevated from that and perspective patient highlighting zuranolone help first. for anxiety more commercial might by have see reach think prescribers a potential

use a are or cases repeat piece. that data course, there's I we a won't patient in tell, can We Whether everybody CORAL adult, data. Of the number that the of as of as of anxiety characters anxiety. the I'll also highlighted early it's like without MDD a prospective we'll elderly with young the or not, to hit how we those too And do very prospectively use robustly. we defined with study, in study group have that elevating see elevated remind that

Sumant Kulkarni

Thank you.

Barry Greene

Sumant. Thanks,

Operator

Our will RBC next from come Capital Markets. from question Abrahams Brian

may You begin.

Unidentified Analyst

This is on taking on congrats and Thanks Joe [ph] question for the my Brian. for progress.

patients looking portion you currently initial actually quickly us segmentation monotherapy or Just you there use potential approach? on What for XXX, any are could of you. of tremor help and are well this not primarily And understand are focused better the essential the combinational efficacy? market? a controlled Thank additional on for

Barry Greene

about Joe. you we're tremor to thinking how the question, Chris, significant want population approaching and it? highlight essential Great Yes. do

Chris Benecchi

Yes.

say So essential that's tremor that X.X seen it's and diagnosed six million impact is approximately seeking treatment. approximately the with tremor U.S. and one initially common is one movement estimated of the what in we disorders and Americans to most essential in can

is clearly, from our tremor. patients ability need, a unmet essential the still there So, and with serve there's that gap respect to are suffering to all

essential the step the take So with need be which important a for potential SAGE-XXX as very has a unmet or we as tremor. we see patients and we about now, sizable therapy back to it for opportunity right think with opportunity profound it a

Barry Greene

add, would they is that as Yes. of that living maybe with I some spoon XX themselves is just improvement critical. that's amplitude to improvement And so patient in Joe, KINETIC data percent tremor with activities if in talk tremor, in associated can't not their the based XX that their a when to you to feed mild. lift mouth daily seen and upon essential we've branded And mild

People moments or at their for covered shirt want take So those hours. lapsed times, or tremor we text, essential wait and broad opportunity several to treatment. need all because eat can't be it's think a a to drug here button or want there's they whether they trying don't very with chronic a where to do that

we're happy we'll and we frequency X have prove and in the So with KINETIC profile for treatment. dose chronic pretty

Unidentified Analyst

it. Thank Got you.

Barry Greene

Thanks, Joe.

Operator

Our the of Tim Blair. line from will next Lugo come William from question

begin. may You

Lachlan Hanbury-Brown

take is another similar question I had on Hey, they just a collaboration taking sort if question. to company want to of questions would of on just Biogen. they zuranolone for and a Vamil's Thanks what And plans that the guys. Tim. for? with different the does XXX? Lachlan how I allow had one on for direction CEO in This new a impact collaboration for the got couple your that the

Barry Greene

growth for We're zuranolone as around them to depression Lachlan. they they it the different major so the big particularly us. is Biogen, launch co-co several Yes, where it's post growth United from States, opportunity release times a And countries highlighted COVID. in world key in for going their and certainly their is we problem agree, have a as Biogen perspective, of forward around Again, but in going a driver zuranolone. here world, the as to drivers we that highlighted press one the

other don't done, for well commercialization strategic studies continue a driver and a as Phase than which is X clinical is very development with partner regulatory, different front they've as it big strategy. the the So believe both effectively direction Biogen. us the to really X that the there's what on I

So, are things going incredibly well.

which think be the partnered tremor, for essential we SAGE-XXX are there also opportunity them. growth in driver and also with another they're We will excited about

Sage So, of big XXX unless and the are sort partnership an move, there's drivers. with a of M&A zuranolone part growth with

Lachlan Hanbury-Brown

Thanks. it. Got

Barry Greene

Welcome.

Operator

last question be our from Rahimi from the Yasmeen Piper line of will And Sandler.

Your line is open.

Yasmeen Rahimi

again. Thanks, guys. Hi

one So last just question.

for For of the patients? Thank you. to some the dose XX next driving findings any inability And then are mg just planning morning on group, that? of you color from the share

Barry Greene

that warning as you with the really know effects studies. Yes, commentary we completed the of drugs it's and heavy like we many not drugs the give don't see machinery to while likely driving negotiated specifics problem. drug. with a kind including those the will agency, a to be early that of haven't operate we've there's And as OTC too be And

Yasmeen Rahimi

Perfect. Thanks.

Operator

back And to call I closing turn remarks. now any the Barry will over for

Barry Greene

Sage, and space mission working a health in making to and recognize difference pioneer a every expectations for of deliver towards everyone important are on need quarter, we can urgency And balance Thanks, beyond, hope well-being. I'm in the great put become an spotlight health events medicines achieved the brain need never disorders, us reflecting At the a health for significant our help prioritize health. Sage the overall disorders really our and quarter grateful life-changing so XXXX that great Thanks, and coupled to advance progress. and clinical brain sense as it's a mission have who've us leader on again, thrive. what we person team, solutions the the this confident in have to component progress day. Victor to caregivers and in first investigators to including been so important patients, Current mental with our review these during addressing our the more joining again to for I'm progress morning disorders to thanks entire and everyone brain essential all much dedicated first health our to our patients. of achieve we're unmet make and to with for to progress

Kimi Iguchi

Goodbye.

Sage Therapeutics (SAGE) 3 May 222022 Q1 Earnings call transcript