Sage Therapeutics (SAGE) 6 Nov 182018 Q3 Earnings call transcript

Company Profile

Participants

Paul Cox	Head of Investor Relations
Jeff Jonas	Chief Executive Officer
Mike Cloonan	Chief Business Officer
Kimi Iguchi	Chief Financial Officer
Jim Doherty	Chief Research Officer
Stephen Kanes	Chief Medical Officer
Nat Charoensook	SunTrust Robinson Humphrey
Salveen Richter	Goldman Sachs
Paul Matteis	Stifel Financial Corp.
Tazeen Ahmad	Bank of America Merrill Lynch
Brian Abrahams	RBC Capital Markets
Laura Chico	Raymond James & Associates, Inc
Ritu Baral	Cowen & Co.
Tim Lugo	William Blair & Company
Jay Olson	Oppenheimer & Co. Inc.
Sumant Kulkarni	Canaccord Genuity

Call transcript

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Operator

Good morning, and welcome to Sage Therapeutics Third Quarter 2018 Financial Results Conference Call. At this time, all participants are in a listen-only mode. This call is being webcast live on the Investors & Media section of Sage website at sagerx.com. This call is a property of Sage Therapeutics. And recording, reproduction and transmission of the call without the expressed written consent of Sage Therapeutics is strictly prohibited. call recorded. this that note is being Please I Relations at like to Cox, Investor introduce Paul Sage. would now

Paul Cox

Good morning. be our company Today, third we on section corporate issued a press of release press the financial and on referenced along Investors strategy. milestones Media The quarter call release sagerx.com. results, with on upcoming website recent can at highlights, this progress our found XXXX with our &

Cloonan, Jonas, the begin remarks with Business Chief Iguchi, Executive Kimi call Mike Jeff will We by Chief Officer; prepared Chief Officer. and Officer; Dr. Financial

Dr. will Kanes, Jim for We joined the be Research Chief Medical Q&A Dr. session and by Steve Officer; Officer. Chief Doherty,

update statements we represent timing our over to accelerated formulation release the with future the call, for other development planned projections, the press that report clinical potential only. filed expected in cause of business, cash filed today's the our actual quarterly call in could obligation expectations regarding plans our about differ will we Any regulatory depression; our Securities of in like the views for statements, our We forward-looking do timing disclaim development other turn the of The discussed today's and our of our of estimates; I to a our any upcoming approval including launch our NDA the prevalence statements our and events potential Factors and the section today but in activities. factors recent SAGE-XXX candidates; EU; materially. expectations; other risks so. decision; would plans and results Actual results statements the including to forward-looking runway; Commission, the the our with and as reports proprietary may brexanolone current Jeff. During of and Exchange future, most differ potential as of commercial to are regulatory and for and and make and a our Risk these the in our activities product to now may activities; views and financial SEC. expected and for

Jeff Jonas

and Paul, on morning, I we major to call entire progress medicine. for productive updates across excited the call. another discuss continue today joining our portfolio And We're of us the quarter. to good through everyone. you will Thanks, make Thank on today. our walk differentiated

also is accepted transform ZULRESSO an could of that recognition there FDA Safety Committee As depression many of studies, approved being had conditions. as that broadly, weeks The believe but illnesses product or Drug Joint our disorders stage the for chronic as based the meeting, know, set psychiatric of you within of as treatment a the PPD. working and Committee, instead family, the complication potential of on treatment rapidly we Psychopharmacologic held expected it our near-unanimous birth, forward Drugs Committee one-time critical ZULRESSO. PPD. the that potentially review ZULRESSO were its We just days safety common ZULRESSO Advisory completes positive look and pricing believe Committee PPD. call. profile treated, not of innovative and the the treatment We next New resolve discuss plans provide this infusion that alleviates Application, will from launch Advisory the and for from rethinking has significant PPD, recommendation is to our further vote Drug most outcome FDA the for lifetime U.S. of which we that commercial On Risk child to women, ZULRESSO suffering and discuss placebo-controlled meeting on potentially ZULRESSO, we date in the on The We're important that how Priority may treatment results symptoms lead infant been urgent would where of for of But or XX, the Mike, turn or milestone over postpartum symptoms target a need injection, an of including outcome the candidate joint programs. is the in of of safety pleased meeting is relieving an briefly approval impact Committee important the recently to demonstrated in Management meeting, PPD. published efficacy the on who of the by This XXXX. development Mike rapidly benefit-risk to months. the and Advisory the brexanolone the our it safety clinical like X.X the of are disorder only affects rest symptoms More supports Friday, with data rather for the across it December to make progress their Review, ZULRESSO clear the review was PPD the than for new with developed where and the by before In of Advisory her mother, days. I'd Lancet. continue efficacy PDUFA three pipeline this I data to with These detailed

breakthrough compound our to a MDD. indications, Depressive Major For psychiatric oral designated SAGE-XXX, our has to including to Similar how are the in program, novel SAGE-XXX number advance we continue ZULRESSO, lead therapy treated. these disorders program potential or transform in the Disorder this of

of episodic in we course a explore using our treatment concept dosing short novel the studies. As

XXXX. in SAGE-XXX recently enrollment in expect January For the of now our in an X completed line study and Phase PPD, trial of we top results

next recently in XX of Phase year. bipolar half MDD. of initiating treatment also study, Phase MDD X insomnia, a a SAGE-XXX are MDD, process of We've MDD to dosing with co-morbid patients open-label in efficacy trial with open-label data long-term in and placebo-controlled trial, with patients placebo-controlled multiple in line in up expected also retreatment polysomnography including SAGE-XXX of the an the trials first top in in clinical trial X We patients evaluating depression Phase initiated X the

now for neurological by to X. and and our as conditions clinical epileptiform disease. programs, earlier such is SAGE-XXX as are impacted tremor, SAGE-XXX potential developed progressing patients Parkinson's SAGE-XXX, being disorders, in essential both Turning Phase treatment

Our healthy multiple-ascending now dose study plan Phase include quarter single-ascending a to we trial with to this initiate in ongoing this now quarter. plans volunteers also and dose X are

SAGE-XXX For electrophysiology volunteer SAGE-XXX, on our lead Phase NMDA we healthy program, imaging, completed portion and multiple-ascending the trial studies, to engagement the of biomarker initiated have volunteers. dose target healthy focusing X evaluate in and have

evaluate cohort to SAGE-XXX. PK/PD considering patient also are plans study profile safety now the of in We and SAGE-XXX to further disclosed to a be

like our focus on by and with people lives the reiterating would transforming to close Kimi, turn the life-altering I disorders. central Before call system to over Mike I of nervous

address this Our families. a use first the PPD, of has started. for program, exemplifies to and important patients to brain their unmet normal in and If We ease need just patients, define be the ZULRESSO these of aspire disorder new this tool get can an health we're potential for and approved, to to ZULRESSO with new that philosophy. burden the in physicians PPD,

Now, I'm to over going to turn the Mike. call Thanks.

Mike Cloonan

Thanks Thanks, Jeff. everyone. for our call joining today. Hello,

forum And change for the Committee outcome speakers the of during open for to course pleased to and public very of the Friday. their stories on Meeting Advisory with their like thank courage share we'd disease. support are the positive to the the We this

scheduled XX ZULRESSO strategy expect within The controlling in interim other rule PPD, to Drug drug Enforcement the be DEA, potential the therapies. or is approved. consistent with issue GABAergic ZULRESSO our launch days commercial We continue for approved is final we required And to execute if approval. U.S. by Administration to DEA an of of

December is As date on a XXXX. for reminder, PDUFA the FDA approval XX, target decision in

Our Committee discussions preparations a potential expect the is Meeting U.S. and and our on continue approved with implement program, March, FDA, in has the we Advisory commercial launch late if of approved. FDA Based to REMS the XXXX, if scheduling. post-DEA ZULRESSO for ZULRESSO

and characterize administration monitoring still to healthcare REMS in discussion the of We associated trained been a REMS are the details risk that program REMS of The by consciousness. patient staff provide require ongoing of further setting with expect FDA. will a important the will under information the under safety qualified The to certified loss ZULRESSO registry has program. of

one-time a transform As the we the treatment infusion, to has ZULRESSO potential believe PPD. of

families estimate with PPD. consistent provider with setting, XX% hospital these champion, with for a the XX% criteria. to of and centers believe all REMS the will which capabilities, infusion to expect appropriate their of the criteria. option the sites primarily to subject approved, winning the of We ZULRESSO inpatient payer in If launch of have is on administrated patient focus initially with healthcare excellence centers access to ZULRESSO be and to on REMS goal diagnosed diagnosed and create supervision PPD providers Our for for we care PPD focus patients, the and combination of severe we is excellence represents

certified of proposed We the to possible are the quickly of at final REMS criteria healthcare subject also them as other the setting actively sites as care to using sites with as evaluating label. goal care establish

As align providers we to to beyond real of PPD setting opportunity administration experience of with to world we are other care healthcare REMS had healthcare who We and expand this more women sites ZULRESSO. of treatment. criteria to the an enable with ZULRESSO the gain options to and need expand treatment hospital in believe, setting

infusion the work in For infusion to expect time have with potential the the at will of home home launch. we do the future. forward option FDA not for an path as setting, discuss home we to And the

We calls. give provide would on for progress if care expect and to We potential our to also future pricing further the establishing of potential on approved. updates like on sites information ZULRESSO,

clinical note have past always extensive range innovative PPD. payers value need most have therapy ZULRESSO over drugs. we of and contrast the $XX,XXX effective said, As price women to with the by with and months, reflects price It's the $XX,XXX. a to We course other initial within we and value CNS and helping transformative not several to We've the we is for profile ZULRESSO. pricing specialty ZULRESSO strategy range plan unmet access list is Sage the the per chronic a focused of price average establish of is PPD that believe, engagement product. that of on our ZULRESSO to high committed treatment clinical had diagnosed the in important of currently the to

is and for communicating label. the once December plan of more potential barriers plan plan women we appropriate disclose commercialization have financial to an call excited If approved, program and list permitted. the approval we assessing access host to of investor with at price ZULRESSO options We support We potential help support lessen our on on are patient to patient about to Sage in final need PDUFA ZULRESSO. details in where we forward decision. look the final to currently to provide PPD detail more FDA the in treatment, for

Scientific for the determine discussions brexanolone have for plans Sage brexanolone regulatory also Sage is update program. to Medicines determine of European of is or filing data in be needed the PRIME the on treatment additional additional the as prior pathway Agency EU. authorization help the what filing, continuing Advice application the status to marketing a to We information a brief potential to development of under seek with designation will permissible for PPD.

commercial turn I'd it financial is of like I well the pending now excited label. progress of that in if final to cover say this to date XXX about results, XXXX, ZULRESSO quarterly have team sales over addition positioned Before our Kimi and we very are to to we in our believe the launch are We first in in year, company's approved. we March for place, approval late a ZULRESSO

support the plan in and Kimi And on North financials. to We ahead. complete have forward our quarters Carolina. on further look our to the now, the updates patient I'll over commercial team also review PDUFA our of our build including turn I it Raleigh, rest in launch to call provide

Kimi Iguchi

Thanks, Mike.

$XXX.X and financial company. to Beginning the million increased walk R&D multiproduct Let R&D with million partially focused third and Sage's additional quarter, the efforts deliver increase for on growth pipeline This net third period operations. and commercial General expenses period $XX.X reported development ongoing $XX.X period interest expanded $XX.X in of discovery me compared identifying Phase research XXXX. team income a increases increase million development the in loss million the quarter candidates of in loss of the statement, this increased XXXX. goal of is of in to clinical of million ongoing to and compared investment of through to the our be and and potential of now and of same you completion results the the launch continued the This $XX.X to on to reflects the third a ZULRESSO. the administrative by to expenses We've result in million same build for clinical expansion indications the a of offset our ZULRESSO. the These guidance. the support net And to new XXXX. and programs $XX.X were to operations. quarter compared same preparations the for We've organization as of X a

balance securities the compared to cash, the of at at be continue $X positioned year. the marketable billion now sheet, of Turning million with quarter to in beginning and third the cash with equivalents end well $XXX.X the we

balance financial operating fund expenses based requirements enable into XXXX. guidance, current Sage plans, to our For anticipate to expenditure will its on cash our continue and we operating that capital

commercialization to PPD. operating of our the We quarter-over-quarter expect in to portfolio product and in ZULRESSO and the best ongoing year-over-year support potential continue investment that expenses will increase

progress efficient us drug cost up focus setting on We milestones portfolio. near- opportunities. across disciplined on execution biotech of our diverse to will to across focus to look across pipeline, our to with as building to our forward us the field of development. and company approach long-term critical allowing the pleased We continue development of well to activities We're multinational our continue near-term data to CNS drug number a in focus

now following December on PDUFA potential whether Meeting, XXXX. ZULRESSO date XX, recent our we For Advisory Committee ahead look to target approval

launch plan schedule. We pending in potential for of commercial the approval and in PPD to in late continue XXXX, March ZULRESSO U.S. DEA

patients trial with Phase also MDD, in trial expect milestones this the we MDD several to X important insomnia SAGE-XXX, in We clinical begin co-morbid to enrolling and expect quarter. to in

As is XXXX. anticipate And top discussed, results stage in the of trial X of January. line results SAGE-XXX expect open Phase first in enrolling, the placebo-controlled line now top the label Phase we that PPD half bipolar for in now we depression X

Phase we SAGE-XXX tolerability study. evaluate the to the and X PK-PD profile Turning earlier safety, in pipeline continue to program, to and SAGE-XXX

questions work steps to upcoming We're a multinational portfolio, up they you. continued in following Please to entire are completion expect becoming of for pleased our position Q&A. our like that programs. Questions yourself With received. We leave X the announce so us of toward of each our execution we'd call company. multiproduct, program against XXXX this in believe biotech open room for now that, two goal Thank well the with Phase order will across this next first Operator? we will for limit everyone. half both in and to taken can progress milestones be

Operator

[Operator of you. Edward first question Instructions] Thank Our from comes Nash SunTrust.

Your line is now open.

Nat Charoensook

for Hi, this last Nash. Edward on is Congratulation quarter. Nat progress Charoensook on the

can additional is, question share any ZULRESSO? first to thoughts plan the initial support home for infusion option So you you studies on conduct to

Jeff Jonas

in thanks is everybody first, Hi, dialing today. Jonas. This Jeff for

but fashion have I think depression. work listened step and and of that that the patient a be the broadly been suffering the the allowing to think have. we will With and what REMS in interest finalize possible, we the be not as AdCom think certified the settings. the ensure approved, view FDA anyone was the to monitored to first said, current profoundly move patients severity from given same public by health FDA And overall the heard adequately healthcare do helped that I available could ZULRESSO, in to these was with the the - if that the committee going I them as is stories, believe women could help that and that to postpartum making as they care - access making who

into home question, discussions. what move Beyond data yet about and will we the expect don't this the We further we what be from that, FDA have be setting. required they heard will to might as the that, you know

Steve Kanes

Steve. - I Yeah, this think is

it piece is and are number is very so I understand, key think important and be in terms the will registry of this planning we where of increasing far, patients treated. of the the helping in

patients help now where treated. are That as Jeff for right infusion lot of well. So will in really that home we getting said is this path as move getting underway us forward and

Nat Charoensook

loss severe is, or the experience consciousness? the sedation trials And question in XXX it. the patient did Got or any receiving of second ones, previous ongoing

Jeff Jonas

Jeff. This is

all no the data You've consciousness It's studies been seen analyzed of study losses to been There in from have already. have date. the public. in that the

Just very the fact, And you of from GABAergic sedation. agent, a get is remember, XXX sleep - will in like as this people loss inducing sleep a saw is no agent, study, consciousness. active but

Nat Charoensook

Got it. Thank you.

Operator

you. Thank

Our comes Goldman of next question from Salveen Richter Sachs.

line now Your open. is

Salveen Richter

a to that you With measures think up price specialty announced $XX,XXX other for how to morning. regard my came how Good you $XX,XXX. out questions. of to just it versus us range CNS just I Thanks drugs Can taking help and you there? understand ZULRESSO,

Mike Cloonan

Yeah, that one. take is I'll this Mike. Salveen,

we saw we've And PPD. that this and wanted already unmet we we disease of try approved the that potential the to be listen, forum, has as our And exists very a thought approach is we high need mentioned, good to take for thoughtful that. the the pricing ZULRESSO. to And so want pricing with reflect announce ZULRESSO first the So, said, a the always the that open patients public value pricing as in for range. And to AdCom time product strategy. we to Jeff to strategy the clinical reflect the

done $XX,XXX extensive did, the over support experts also months payers XXX the that research we've some including We've support done. engagement needs we've understand well. external In to last with engaged that of done modeling payers. $XX,XXX, pricing we've we that to to that, And the several work their of work terms extensive what of engagement And with we've to the are. had the as value to range

this feel of we clinical importantly will most again, and range, this confident reflect ZULRESSO. very feel value we the So

Salveen Richter

proceed Centers about and counts in-patient XX% patients. preparation the your has And of in all talked work them specific initial expect bring color to in should Excellence of one diagnosed patient, helpful? with how out be settings would here? these Would your treat then, we to patients focus it in Thanks. uptick And playing to for the XX% being time, any on you been touch-points just centers? about there then over expect you How here and monitor,

Mike Cloonan

care. and Yeah, been in champions Salveen, access, care for We've as able to we there, of a And think, in the they'll path place for FDA. first sites capabilities, REMS. for think planning is infusion to there of site have profiled lot payer many done the is Excellence, we as of those work with to be over these we have That of forward and Centers with possible And in qualifications We sites meet think is us, capabilities. the XXX right. was they'll care past, a already of always I the centers account as along them we to about the of home we identify to online provider start this in confident talented key in our possible. strategy because of as ZULRESSO to as bring look future infusion going that feel management sites said, MSLs. the the very quickly We these want ability has patients. have date. think first with working But very been question the options team to they'll - got and by the a be there combination our out We these

Jeff Jonas

one this additional There point. Yeah, is other Jeff. is

and very think I we're of one comfortable we're to do team point, Mike's - think the this. ready I

first-ever follow centers offering transformational of see you increased I the make flow a patient kinds the who truly of of has industry, know, is that treatment those interventions. CNS will have been especially you not you though, you to we other introduction have as where are the when all believe think the that that treated, that the and disease point to

Salveen Richter

Thank you.

Operator

Thank you.

Matteis comes from with Stifel. next Our question Paul

Your now line open. is

Paul Matteis

on and much so positive Thanks the Advisory meeting. Great. Committee congrats

question other if the this a of those like one happening on was could Just kind I It from didn't seems PK/PD that what's Jeff, loss think of FDA dose was related. events you talk the consciousness events, wondering perspective. about underlying

could if the IV we the I extrapolate from safety on And was the wondering oral. dataset so, to

then any and yet the And there to a to seen not You is are severe extrasynaptic it date. potently believe with one oral window oral as that how issues XXX? GABAA follow you that the just up. and with program? hitting as with see But receptors got Thanks. I there safety have And reason a you synaptic haven't real

Jeff Jonas

That's like three, Paul.

Paul Matteis

Sorry.

Jeff Jonas

points. Couple of

XXX. that. Jim is the there no one events in to But for let there and are sound are of pharmacologic think Steve loss I that. consciousness And I'm reasons going on comment

commentary, that more overarching that. know and you are infusion - and we mean, an Tmax data. not Cmax to know rapid on rapid transmissible I all where more oral you are Just data have

it's different. surprising So XXX data distinctly that not at the all look

were at had What as or all look - you these event, of had watched coded were, AdCom. were represented obviously sedation. antecedent exaggerated, think complained, them. watched of when loss And we sedation We these point the really I had or - saw think Secondly, reports I precedent patients predictable. were we extreme the of consciousness that they pharmacology, very all are

comfortable back Finally, now program I monitored had these that with again, that you AdCom, that patient step the more secondly, excited. I adequately thoroughly Yeah, discuss - be than that, the commentary today the and - very each discuss individually. you obviously, need really at events, firstly, REMS think look they heard watch are to this you known make very this and if we're can is We're - about. and

there over So any to I going don't Steve I'm this read-through And commentary. much throw XXX. been. XXX, to is further to we think think haven't There for

Steve Kanes

think Paul. it out - I Yeah, Jeff laid well,

It designed the main a We a have oral was to molecule, that and be drug. half-life, long it's to that oral an know was also is forth. that's It to so how once And - important. take uptake it I think I time is have does XXX absorb. designed. part day an for

that been pharmacology sleep in often have the disruptions potential trial. their so, in study a seen and we've as That we know that potentially well. while is and we've both exploring the they And sedated benefit sleep for them MDD as patients

are features ones closely. molecule and following we're into looking designed the been that we've very at the that So

Paul Matteis

just the work for reimbursement the DRG to helpful. is really here? That's another quick for you make to sense go or in launch question you. exemption through hospital that's how is or Thank Mike, of two? Okay. there And expect Do the kind year PPD ZULRESSO, in one going on first process going this to

Mike Cloonan

Mike. hey, It's Paul. Yeah,

So really there in getting done We've right. And pathways, pathways reimbursement as we're multiple multiple that on of are lot a this hospital work be setting. the there'll comfortable well. to

DRG there into one So something is an also had is opportunity come comes carve-outs be of or and those, rates that each over for on line. but over will drugs space. new to And hospital technology with that's to case again that negotiate new existing that specialty happened this

with unmet to physicians the So we demand with the PPD, to that reimbursement that open will confident are level think this, up. going for we feel exist of need pathways support those that high

Paul Matteis

you Thank very Okay. much.

Operator

Thank you.

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

Your line is now open.

Unidentified Analyst

Hey, Congrats Cory. for Sean results is on the of the on this AdCom, guys.

us. from questions two So

IV oral when on color will recourse so guys follow-up. appreciate but have And IV, approved the treatment price the both especially you same between approved be that dynamics larger see how eventually in a I and the population pricing, indication, you play out First, an imagine quick could do pricing the consider one on think I potentially at you XXX having and when about patients? two? I to MDD a of for comparable course per wanted SAGE-XXX the

Mike Cloonan

one. that answer I'll Mike. is this Yeah,

pricing them have XXX ZULRESSO, right. price we about the interrelatedness and and first, independently of to terms we the think for how in So

to unmet in our open in what think thing. I about we a going say need to that XXX is It's are too stated same today range profile, be profile but for to similarly, MDD. the going And product for ZULRESSO. we feel the So for think exists this We to be is multiple confident the indications. the going that its pricing that things early beyond high range. XXX, They be

into So the multiple to of PPD. indications just our take XXX consideration, not pricing has

we I about. that's think an So to important have think differentiator

powerful, I and to and to we clinical wanted the MDD will of for see large will XXX. pricing the think indications, So the how on we size the very really continue multiple is that pricing products reflect XXX. between I different strategy be our difference two the no values about think market But be

Unidentified Analyst

Okay, switching great. it's bit. gears of little sort a then, And

with molecule again So of or versus the terms, you confidence can the in time gives how you terms chemically? fact the in actual magnitude similar to that, what of formulation of the And layman's a they different cohorts exposure IV SAGE-XXX of should guys give it are and between oral kind us, brexanolone, of relates you different tell that the sort similar PPD.

Jim Doherty

Yeah, Jim. is this

that to answer simple the think, an is the I molecule. is question brexanolone endogenous

a what So with the we with half-life. is overlay to are looking try it longer but modified not pharmacology, SAGE-XXX be modified bioavailable that would to do so profile,

the so, the And changes to molecule for purpose. that

Unidentified Analyst

Thanks, great. Okay, guys.

Operator

Thank you.

Our next question comes Markets. from Gary Nachman Capital of BMO

open. now is line Your

Unidentified Analyst

sleep X MDD How Phase really would you disorders? data? have be separate for depression on indication And see for or Hi, patients Gary, in look polysomnography the soon how X:XX:XX] to for And enrolled, supportive the with co-morbid really study indication XXX a as be I you can insomnia. for a that XXX of follow-up. we this many is for this then, [ph] describe for XXX, or will Rafey separate indication could

Jeff Jonas

little time in polysomnography patients basically the can color and but turn with we MDD going Yeah, it'll you. we data PSG study have who to a more disclosed. sounds over on broad Steve outcome a anticipate, assess had it insomnia data enroll, we in to of well, with like along that. not talk We we some along study, that's diagnosis patient-rated a little be strokes until other this disorder. a comorbid about depression polysomnographic have hard classical major to hearing biomarker a But that for There'll be will I'm we'll that. but obtain, the

Steve Kanes

correlate milligrams, in we MDD at scheme with dosing symptoms be XX the similar the which only to trial see whether the The depression, the and be sleep. end which but to they're trial, look doses. what looking improvements to in at Yeah. improvement we'll independently if will in we polysomnography used not doing beginning to other was include also those And and the of of see with

way, So we've seen sleep label in to, major simple demonstrate a if in with benefit can depression. it's looking the and seen MDD with in the open in we've the - we merge trial what what of patients study proof-of-concept to see the

Unidentified Analyst

of And in Thank you put place initiatives awareness you. you the to talk Great. can also about improve PPD?

Mike Cloonan

Yeah. Mike. is This

change So with, of the that we've the awareness today. part first the started big really activities reducing as we exists barrier that conversation shifting Jeff That's we the to already in And as mentioned, patients a a starts We on think already of postpartum have set opportunity unique and for some disease depression. stigma. paradigm PPD.

And to on disease the do, started campaign, stigma and awareness and continue lot that for awareness will PPD. so have focus a we our increasing we'll

Operator

Thank from next question of Ahmad Tazeen Bank you. of And comes our America.

now open. is line Your

Tazeen Ahmad

MDD the your work, study. Thanks. Thanks small chance then to wanted if you in Hi, just little X plans plans I study impact that bit a your the good how get morning. positive for my taking of questions. the have on the PPD does Would Phase that filing? a clarity MDD? And doesn't XXX for Jeff, on way accelerate results any consequently that for

Jeff Jonas

question. the for Thanks Okay.

either significant to think well I say way. how are. study. same It's not sure the words, optimistic the enrolled last - with So We're interest. I'm there's as not reason - very we're of a we sure lot this, but optimistic Obviously, we're about

premature. think I it's

what with on obviously, hopes. with speculate doesn't happen I our can't or strategically. outcome MDD outcome clearly, think there's probably would But that - on - file that our we if positive would say we accommodate order meet an the that that's it to study will study we approval PPD. We'll, and in the PPD the without first to the X along that Phase the think no MDD need about moves or file program and if the both plan. believe I remains a

Tazeen Ahmad

expectation What's enrollment for MDD? your Okay. rate for of

Jeff Jonas

do that Again, such. and always figure line we in that. open That's how enrollment we as up out won't time and our we have know we sites

that experienced not had and There our major lot interest Our we've same trial, enrolling. - be team - difficulties so medical for has as our you've is a ops team experience trials, MDD. that our hopefully and all we've the in today in with will has the clin had been substantial seen,

Tazeen Ahmad

Thank you. Okay.

Operator

you. Thank

comes Capital Markets. of RBC Our from question next Brian Abrahams

now Your line open. is

Brian Abrahams

on taking can just quantify my guess, - at brexanolone, patient Hi, there. initial many to care XXX. you sites the see Do at it able have capacity treated the for panel. what Thanks And on the expect have burnout? much be the approximately And the be you target congratulations with all, a on sense for launch? patients launch questions. as that I of you Question just how might you so then the follow-up I'll positive sites of before inpatient throughput any to

Mike Cloonan

Yeah.

the be think this we we So Brian, could think to had is we is FDA really creating was step do Mike. And as it It which care What all patients. of align about AdCom, is set as this little setting as broadly make along think, at should the and we to I we acceptable can, for want along. many they sites back is patients initially, we because that possible to the but where the the bit, place, said as a for I right. commentary is inpatient all options starts as

out of want online. their of setting. a But and seen of there'll this from to pull that lot sites hospital in providers. of there, these these There's hospital into we feel received be centers over feel these other feedback care time, we've that the with bring willingness that setting, through we we to championship initial uptake. the centers lot So a like excellence We've of

you're isn't referring that So that access to. there issue

Brian Abrahams

it. Got just may if sorry, on the - I helpful, XXX. Mike. question And very then That's

But that when peak from would any I or ongoing the panel the that studies were vasovagal oxygen overnight would have might be brexanolone? and and or would Thanks. image regulators ancillary you any that you studies? class given you've of any for you questions on be sense are event, see how guess, with And any seen this on the were reductions just handled have probably sleeping. to if syncopal followed-up, syncopal see curious, some raised of a similarities occurring do it in and event are Given reported unlikely folks the or in levels events. I or XXX you apnea broad the saturation I'm

Jeff Jonas

Oral don't Well, thanks pointed Certainly, IV different for the molecules infusions. act out. they're as Steve question. distinctly like

were of Phase Secondly, we did no during X events. There give day, the loss consciousness program. drug during the the

able disorders. Steve sleep a as is psychiatric to in night Third, get out, pointed being sound a benefit

have infusion events, that The the risk treating. to The makes one just news, have we balance drugs. that So almost a remember brexanolone, me the did calming good it. loss drug drugs, IV that comment the and I'll that the the of seen testing saw haven't it's again, all when the And we a an a and recovering And - like pharmacology, this which the we they we're the unanimously effect even illnesses what risk-benefit make we powerful are conscious being important is is good severity the that think, as on think FDA other They drug benefit. that have does given we're is and agreed restoring but with brain an just predictable a have drugs a I reported to say sense that of psychiatrist. that benefit.

we I - this people potentially These have who disorders. life-threatening and depression think women that have haven't in are with put perspective.

think are quality and in should So life-changing life-threatening that. drugs that wait treat these treatment. patients, nature, about may these them about we they assuming of can simply the of risk-benefit that on potential the and things psychiatric not excited very disorders who like confer and We're that

these great bit let and this perspective. And to molecules off-target put to little a effects, seeing. I are predictable These done The few So add has have to job in we designing Steve the at that's I'm back to have very step think, going you're pharmacology. more a what color. put Sage team

Steve Kanes

Yeah.

just result that don't. when and in remind really treatment we're that two and it reduction it's complete terms both - patients program need other feature but seems of ZULRESSO, this with to in seeing only not in of the patients, to a And key not weeks in of - you in in with symptoms. XXX to benefit-risk Just But they testing the the seen many they rapid treat our when is a of XXX. we're also piece clinical is we've improvement with very patients trials, the

all of that risk. So into benefit feeds suspended overall

Brian Abrahams

thanks much. Steve and so really Jeff, context. That's helpful

Jeff Jonas

You bet.

Operator

Thank you.

of Chico Raymond Laura from comes question James. next Our

line now. Your is

Laura Chico

question. taking I just Hey, to wanted good for morning. Thanks clarify. the

think a separate, clarify to filing. the first wanted I I How just for many to anticipate sites little question. on missed REMS the be I ready potential at EMA bit probably program? certify a also And of but excellence you then, will do launch

already You've trying additional and European to understand wanted you're understand file? ZULRESSO I what the advice scientific you to the before for are got studies just situation.

Mike Cloonan

the Hey, I'll and certification of centers Laura. This excellence. the is Mike. take

inside is as said that We opportunities broaden right. we've the to what want to access create centers with care the want specifically possible as out So many patients, to we of the excellence.

has have those done many already continue profiling they're We'll a to to do XXX great Our team Over of profiling. those job been profiled accounts. date.

Now we criteria PDUFA, the for process the certification the have we at like. know looks know we the what REMS so

numbers. will of certified too early way once it's we launch, So time to along the be the have provide will updates those many but at we how say more

Jeff Jonas

procedures, under With Yeah. This in two that which respect have consideration. we're we is to is EMA, PRIME - Jeff.

not don't have what be but had And we our ongoing - comment been finality. discussions and the ongoing per remain and policy, we're discussions studies final on additional until those will won't it's So typically se, question of we a or discussions, ongoing. it's requirements we

So that's basically the situation there.

Laura Chico

we the sneak it's Is PPD could the I I I wanted this quick make in Thanks. thinking about, the the bar Now benefit? in the of getting terms that efficacy? at bar for for just asked. success Committee. support Advisory I of magnitude don't guess, ZULRESSO If one, was it. Got readout how one But just should sure, to January, in Okay. think

Jeff Jonas

Basically, we second endpoint. and endpoint primary a Thanks, have a Laura.

it's think conventional. pretty I

we've One Advisory think side done the manner - we Committee, that again, pretty answers. straightforward and from to at a clear stepping give studies back. clear with I at design Sage, with try was can our We things clear that the that a of in endpoints

see Again, study a just you're we're that the think Hopefully, the optimistic. I larger significant. It's primary looking and result So right to [ph] to [Stat-C obviously question AMD] at for the and like going cautiously is on we'll the something see. on we'll now, have MDD. But secondary.

Steve Kanes

And maybe…

Laura Chico

and Thanks congrats…

Steve Kanes

just perspective Laura, add to on want that a commercial too. Hey, too, to

think we have options multiple PPD. to feel I for fortunate

for and we're in opportunity, ZULRESSO potential approved. As fortunate not If the only and to past to great have XXX as we the has we've think the us, so come be moms we unmet need, well, patients, for for is options about the a much talked and patients but have families. product unique first

Laura Chico

guys. you, Thank

Operator

Thank you.

comes from of Cowen. next Our question Baral Ritu

open. now is line Your

Ritu Baral

everyone. morning, XXX specifically. sedation I want taking to Good the signals Thanks to question. for back round

volunteer level healthy multiple-ascending part into study, off of think X MOAA Phase proactively is that Can to a and dose last presented year was the guys AAN And to of be in seen you arousable you sedation program going You that were, sedation the characterize that's used concerns? at patients your incorporated sedation I that sort and how these head scale. study that scale of deepest scale?

Jeff Jonas

MOAA are given the the one. is the you of heard the Remember, that sedation really number on the so problem, level more with not The these that's than replicates that oral capsule, remember, which day. was basically, IV it's the suspension, scale on so also and is AdCom, during as

you're I'll over to more night, up people over to Steve going So because you a turn to that give take Steve at let rather, I'll sound But that. turn getting obviously, - to that answer are sleep. it

Steve Kanes

of thanks cause Yeah, about appropriate pharmacology, And, to for given when and GABA that. for before yeah, sedation. course high our the That speaking sort doses, dose talked was as to and escalation. doses stopping course, of enough of endpoint will of we

patients that point see in to start was point asleep, we additional knew as we soon where there we dose fall a reached no had As escalation.

[ph] didn't well profile solutions, dose as clinical pharmacokinetics a nerve the as is Jeff capsule in use, patients sleep studies. we those And are see our we're we patients the asleep. in were any dialing of said, the that And So endpoint. arousable, than in were in signals our using safety they as had in study. so formulation which trials now our clinical the that But understanding in of that were different other doses through trials was escalation we they dosed when really overall our now. risk The

Ritu Baral

check MOAA study? you MDD of... that going for you arousability are to or polysomnography kind in able Phase It the using the be in are So to X seems

Jeff Jonas

People by definition them so be don't up. on supposed wake we polysomnography studies asleep, to are

during no And we what that's so with there MOAA, XXX, - used and really take is the scale see in consciousness. loss talk that's an about clinical let's this applicable. anesthesia It's And and are back of effects not again, predictable. and the up day. Side trial

profile significant right seeing are well-tolerated with PPD MDD, molecules and targets. now. side shown off what's have These very in very very overall effect to a available benign not compared both well-behaved, are benefit that We

Ritu Baral

et But these you in are cetera, measuring next day grogginess, trials.

Jeff Jonas

we We you measure of will sorts But programs as this our disclose. Phase all which of X assure things be as that well can Not patient safety efficacy. all study. in sure

Ritu Baral

Fair enough.

for a are trial Second was effect. the we Is going at is be What expecting? effect question the Meltzer-Brody Can powered? placebo like that the us about is on Phase MDD was PPD Hummingbird real. how use placebo? to and placebo? from X you that panel remind it the X Phase brexanolone think placebo how you a powering Should we - more as not comment effect should There X in placebo guide that not Hummingbird Phase

Mike Cloonan

the studies depression, registration the that powered adequately take we understand this we powering we've do to power the PPD quality. make trials. that. for Typical they with placebos in both into studies, side don't XXX, power to and vary, expect from we to the account brexanolone are So for talk be, for from in as we and the done know trial, all case what and work But we clinical we our specifically see sure and that that efficacy against we of it

Ritu Baral

saw think do you more PPD what But Hummingbird? or like with going placebo to more you is MDD like

Jeff Jonas

study first someone is history the in knows. postpartum. time this done Remember, has Nobody oral for

appropriately. look until make clinical we team. at have I looked all a we knock data, and date, We up great early very But guess. we data, at So on the been We've power best think wood, we speculate. the We in successful our data. and can't to we our studies our see

Ritu Baral

All right, the thanks taking questions. for

Jeff Jonas

You bet.

Operator

Thank you.

of from Lugo comes William question Blair. Our next Tim

now is line Your open.

Tim Lugo

And question. my should XXX? XXX previous quarter. Thanks it for obviously, thinking MDD have regulatory and were MDD for insomnia for How the viewed study, your to a want the that PPD I this strategy you current answer. broadly? clarify filling taking kicking be Is same off that a just deemed within

Jeff Jonas

only symptoms we be XXX would all plan Steve as is the but insomnia firstly. like same should in see current improve for our MDD, the claim. filing, They which have That's further our to plan. that And mentioned really And as earlier, a differentiate we're would if to we improve cannot completely therapy. a with depression, hope of claim, we depression, able is as an differentiated first-line successful label

intention forward. is moving our that So

think haven't - may all do. journey very I'd I make this disclosed we that at the XXX, registration required be said of beginning with we The other talked not point but for be it yet, what is, we've will

So the look use may that other how the psychiatric that of enhance of ecosystem. in greater study it we the enhance to can the may value our at context drug of understanding

right core the studies MDD, usual required NDA. may and be any but forward, XXX filing for we're as studies it PPD, will there now polysomnography, are intending, So that other in the be of coming raft plus

Tim Lugo

Understood. Thank you.

Operator

you. Thank

Our from next question Oppenheimer. comes Jay Olson of

is open. Your now line

Jay Olson

help these possible XXX response catch And of with XX it days resolved up you thanks course placebo endpoints in specifically for the spontaneously placebo my of Can AdCom the follow the treatment causing XXXC last considering in And hours? effect. taken group? the PP study PPD guys. is on Congrats I patients had instead you questions. the taking the is what XX outcome disease? understand, Oh, up the to at brexanolone, group active hey, XX for the us on the moderate what then natural the at manage of to that week, have the a typical steps just study days in duration placebo and in

Jeff Jonas

one over - couple and of this here. is I'll So is are Couple this a things turn Steve. points, of there to Jeff yeah, so

you at are treatment, getting else. treatment about better days psychiatric Let's those days XX at are potentially of about what unmedicated, or say, stepping this, thinking without risk. And if that the just who and back suicide are think you patients for in risk

we to pneumonia say, of you wait the before one better if goes get part there's faster better of and it's tenets And of don't that So is it's faster. you well, other see - away get penicillin. to why just start no where medicine better medicine would

speak is transformational. from not important of - This you and listen really extremely So if I'm talk is valuable. And we to important, suffering getting to is PPD, a like. actually are looks listen better and saying the what companies innovation and And faster who this AdCom, haven't, about it's you an This is patients, lot benefit. believe that that, transformational. and

you data at take when look the a great. two look of obviously, XX-day So studies, the

the often loss And towards any days, of effect the among out on On had see patients some XXXC, agency were pointed which you the continued without then treated. on and of maintenance XX drug. drift, effect you patients the had but you placebo who

it's in are disruption. to risk happens family at for that potential okay unacceptable us, suffering, So developmental commentary tenet disruption patients see an wait is and who what for the suicide, and

treated that - be like a rapidly every when better as a as take as to patients think you as more And said lifestyle. and get possible. back I you depression as realize earlier, So I treating where disease, it have now should step we're not - approach, disease as you

this stop turn going to I'm to So over Steve. and

Steve Kanes

to Yeah, power And follow-on the of treatment, period, and efficacy see where know lose we study specifically - that's we're effect. of that whether the is patients drug. at we to Jeff. end our demonstrate we're thanks, where looking in Where the yeah, able very

some to won't years. periods the of well. on extent, all the them gets they their first months equally and can well really, And don't better. experience we is for way group And question, your placebo-controlled sure symptoms the But PPD, of their To we which the And go to answer not weeks, with will on that they course is the themselves MDD. of make that for assure take want for study. that disease patients stay patients on you or even this. patients patients in have understanding of depression. PPD getting piece of can Faster XXX at look natural brexanolone, the back point, to in go I So placebo about feet, drives longer know care to family that's of back Getting work. patients and to which concerned the history placebo, all critical the of or so first our true and in can of for is true the and

Jay Olson

will Thank what and imply psychiatrist to definitely about can very had okay treat. you. think record. need the mean study a treatment XXX been you for and that paradigm with question, retreatment for Great. file is you shift it's I talk historically chronic follow-up And wait and diagnosing a treating or then, not and from behind I didn't the XXX relapse the to patients who to to episodic the you for helpful an approach pharmacological That's for MDD then to going logistics whether just MDD?

Jeff Jonas

a really said And chronic treated in patients Jeff world said faster is interesting Well, I be again. - I is Steve. companies an and trying a as innovative you The what the a if it's didn't is that about works, able in to not immensely psychiatrists on and patients you this acceptance weeks does [ph] the disorder you a other about need therapies, do Sage around therapy. think the And Yeah, think fact at treatment. getting talk might better are I transformational. will revolutionary; this as word with to seem the and chronic someone better that U.S. and way of team mechanism believe XXX I'm same I that. it's patients transformational I that don't there that always thought you people in do up doesn't Getting be pharmacotherapy a idea idea case. It's psychiatrist antidepressant the you is valuable. call I enough if are But be better if lethargic - therapy medical psychiatry just every depression in new didn't faster. well, idea transformational. and and get chronic of a earlier in to banding and we And the Well, when when rapidly of looking the a like again, that doctors, the-first regular and the feel chronic be of novel approved days, can the to idea like the mechanism you patient; is you and thinking doctor market treat new months; action we will acting and

So that this truly is we transformational. think

I think don't every how an what women's you health. in week, we question, people we face hear every pointed a way see frankly up to why we about on, home is if in see what a which is that challenge part mental happens. go Sage on a happy the to weeks do work; drugs, of you that the not think might frankly do in SSRI idea about you at bundled what out the think and people we're approach change how is of let's trivial take SSRI, It's health, change way and and these call two me this wait

this attitude You for we health. effect all have at have form any that And transformational about goal our on that would is the really to Sage accept of kind other treatment. of metal never medical

very think been while XX I very all so these or I'm It way a years it's individually. impacts is of price, a have all about remold It But how as a he's a acceptable. than important psychopharmacology us. very He's and And important challenge, payers, for thing more us we older of a how way do, of approach we And Those little what's people It's been around us it's diseases. who've - for it's we Steve. we Sage. to the that at to youngster. for XX to important everything think well. us in a than

as of parcel really about anything the the so, has I'll entire over Steve company this and add. think part health. mission it's to he And turn we to else mental of approaching if

Steve Kanes

well. on both available. And drugs take treat we patients. a psychiatrist are things way I'm very it really help it's the difficult well. said important helping it is Jeff And people work is about important are to We're this think that transformational understand patients. to that's anything think We - And for that it for a important, that know us. - for also I different of really willing and when it's patients this there's in demonstrating unlike our as

design. So it the part a motivates and is big we that of what programs us

Jay Olson

Great. It's for questions. super the Thanks taking helpful.

Jeff Jonas

bet. You

Operator

you. Thank

of Our comes next Canaccord. Kulkarni question from Sumant

line is Your open. now

Sumant Kulkarni

going ask need I'm episodes taking have year? you're second, retreatment upfront. science, of could a But might questions. little boil to to boring see you down lot doing chronic. we long-term constitutes to compared of here. number bit that financial to and study? it disease, the Good a treat per a question How evolved of On your thoughts on when morning. Thanks for of a trying both data that SAGE-XXX I'll on cool depression my what actually as And

Steve Kanes

So patients what we're, long-term fundamental we're back that's a our could almost off as in second how patients kicking current major of it patients, asking. retreatment Kimi you from the episodically treated call, goes all. said of when that depression And you're they paradigm And to obtain problem of treating at need conference during information the treated concept or is of no or are or the treating The study. why study, the not and And XXX. fundamental many reason overall of with spoke part episodes they haven't MDD will to the person of done. don't. to not the sure I'm we when as when sort part actually that And timelines not program that the that be That's easily for registration well, speaks that's question might literature. have, about calling your because information

retreatment for the don't often, We'll that patients the also on and patient to before, create sort percentage we're fundamental it'll paradigm. overall retreatment, be able that we important So need treatment. transforming if way help have both be how of about the that That data. how critical the need for something about people any, what into does data our but a talking of will of fits business, useful understanding think for

Jeff Jonas

study asked the you add, question, just I'd point other that be will the NDA Yeah, the file. part of

important should how practice. clinical successful, an be be XXX, it's the overall be of said, it it patients of used should for Steve As best a part profile in

Operator

Thank you. And this like now closing turn Jonas for does to conclude back our remarks. question-and-answer session. over I the to any would call Jeff

Jeff Jonas

say years, at us thank the all, great for and in great And Well, to commend so word, the outcome final what's want today. that joining We everyone first we out support all the all we mental Sage is invigorated in just for anyone in go done party the I've patients said so really changing want of investigators this thank the affiliation interest practiced and exciting on currently particular, talk way should thank understand your want no part want everyone as to in it's are something matter our today. I is, I AdCom, health and at country. to else. patients. a psychiatry I congratulate vote team insistent in so I looking had or everyone Committee. and the XX as work for to of ZULRESSO, lives of and women's to to again, and make And on the difference of earlier, also want is I And may and that a you why Advisory who the company. on your this and and to patients, And be

to a So you of I your have for thank great want all attention day. and

Operator

This thank today's Ladies program. for in and gentlemen, today's concludes participating conference. you

day. disconnect. a great You may all have Everyone

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