Sage Therapeutics (SAGE) 3 Nov 172017 Q3 Earnings call transcript

Company Profile

Participants

Paul Cox	IR
Jeff Jonas	CEO
Steve Kanes	Chief Medical Officer
Kimi Iguchi	CFO
Salveen Richter	Goldman Sachs
Tazeen Ahmad	Bank of America Merrill Lynch
Laura Chico	Raymond James
Ritu Baral	Cowen & Company
Cory Kasimov	JPMorgan
Brian Abrahams	RBC Capital Markets
Danielle Brill	Needham & Company
Gary Nachman	BMO Capital Markets
Adam Walsh	Stifel Nicolaus
Tim Lugo	William Blair

Call transcript

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Operator

Good morning, and welcome to Sage Therapeutics Third Quarter 2017 Financial Results Conference Call. [Operator Instructions] This call is being webcast live on the Investors & Media section of Sage's Web site at sagerx.com. This call is the property of Sage Therapeutics and recording, reproduction or transmission of this call without the express written consent of Sage Therapeutics is strictly prohibited. Please note that this call is being recorded. I would now like to introduce Paul Cox, Head of Investor Relations at Sage.

Paul Cox

morning. Good strategy. issued along with upcoming with progress our we XXXX third milestones press on results financial recent corporate a morning our release quarter and This company highlights, used The on on press Investors section sagerx.com. site Media our & the release presentation the this can be and call found Web at of slides slide the is presentation On the agenda two of for today's call.

Officer; Iguchi, Medical call with On is Jeff Chief Chief Executive Dr. Officer; Officer. prepared Jonas, Chief our Kimi by the Dr. remarks begin slide Kanes, will the our statement. We Financial safe and Steve our three harbor

over release reports in SEC. forward-looking discussed only. the press XX-Q so. statements and would with of and report on I commercial and that During statements, Jeff. recent represent potential the results development product expectations, in development, our financial differ actual our turn Actual today's today today's potential planned results will call, now the disclaim are Form filed for section do the of efforts for and reporting risk our to Securities Commission we Exchange our to expectations views like other as the risks make future The our and these filed could factors materially. including We and approval in call statements update statements and clinical upcoming of timelines launch, and forward-looking the with regarding including regulatory most other we may obligation of cause about may other trial the events. factors clinical and activities, projections to future, plans candidates any to but quarterly results differ success Any

Jeff Jonas

morning our for turn Good and slide pipeline. development call. Paul. four Please to everyone Thanks, our current to welcome

building company Sage We neuroscience company. long-term drug a to our position to make progress for success on as mission multi-product continue

discovery combined explored with create lives our innovative to making to to in current the the with pursuit as innovative development people's of been that as history, the address safety and system profile utilizing corporate of medicines for development better. a efficacy approaches disorders clinical drug to we've research may well the methods therapies. deliver and has gaps differentiated and of dedication company treatments nervous in vision central Throughout Our capabilities novel X-year trial design

the we While our R&D to now we Phase months strategy. are continue not important evidence move our treatment final the the and of III we was execute verge program for on ever develop SRSE of based first readouts XXXX progress as on as into making data successful,

will that from SAGE-XXX six, expect completed top slide we MDD. a trials currently of these major our or of several we important slide in III updates clinical our completed So enrollment proprietary program, both regarding progress most trial enrollment our line brexanolone IV we across also And trials. next have of this be five, placebo-controlled PPD, or placebo-controlled formulation data readout we PPD's II results disorder recently depression pipeline our clinical in On both postpartum today. Phase Phase On depressive in in quarter. advanced

severe quarter Phase this top placebo-controlled In report for from II enrollment results well. completion of mood the expected currently We trial this quarter we of SAGE-XXX our results expect PPD. in with in to trial conducting clinical top this SAGE- in program, of XXXX. line trial first this a disorder expect line other We are XXX, currently as quarter

our future studies design disease conducting our open-label can open-label on the This to disorder on call. SAGE-XXX support Parkinson's clinical further data is appropriately in better predominant that tremor in and the focus endpoints pleased essential our trial the population. and Turning will in activity by trial. SAGE-XXX; program, Overall, clinical on patient population. report Steve detail results trial believe open-label approach where now to to led data essential potentially we Parkinson's target in movement our tremor inform later to R&D us Parkinson's our and development. demonstrate right of both we define methodology our review seen These are more tremor with data generating our results programs these

mechanisms example are turn an also The have CNS Steve of treatments upcoming Phase PPD near-term pleased compound novel potential seek we progress allosteric trial more of new I'd our clinical approval. gaps. the of current in discuss to understanding to that will over brexanolone NMDA III to have NDA are treatments Phase a bring may these support for SAGE-XXX, single developing successfully an CNS ascending is and and commercial of be launch company the which potential modulator our for study first we the to This And to we on now a program of focused in if receptor. call first-in-class transformational building results results detail. to Steve. for disorders filing treatment NMDA will as underlying the We completed dose on I as our months how Kimi like positive is oxysterol-based prepare the address more patients. Sage cover also an

Steve Kanes

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dose we volunteers. tolerability serious As ascending and blind The biomarkers. along ascending randomized Jeff study assess were Positive initiate study. the no of NMDA total I double was on administered Based of Sage in pharmacokinetics SAGE-XXX with solution of I the symptoms. multiple study healthy the tolerated disorders modulation a with SAGE-XXX with reported in with single results, an to of XX investigating primary dose the were studies. completed in placebo-controlled of highly of potential nine. as variety SAGE-XXX. we the in of Phase adverse Please a also of X:X, neurological pharmacodynamic X healthy slide receptors predictable associated of range events treatment dose was trial SAGE-XXX well pharmacokinetics cohorts, plan dose volunteers. is SAGE-XXX on The SAGE-XXX enrolling also oral variability. a have a Phase we these low further to a mentioned, recently and turn objectives that finding of safety, behavioral neurologic announced ascending to effects may cognitive single

pleased sharing trials now Kimi our of quarter. PPD Phase results. to look III this this our With I'll discuss across MDD that and forward the with call are to progress our over to pipeline the financial trial turn and Phase II over We results

Kimi Iguchi

Steve. Thanks,

million of and our work SAGE-XXX R&D the with and million, both III We earlier as of the compared progress $XX.X of the development SRSE I brexanolone results net net and of Let for filing XXXX. quarter. summary to quick associated of a $X a growth the PPD period have personnel operation. third same increase goals. the $XX.X the facilities primarily evolving in XXXX. and related for of was ended loss reported third General in completed support third development the by loss SAGE-XXX million quarter preparation candidates for for to third development and expanding in then team commercial of and for team in our including million continued The Phase well quarter XX, compared fees the for cash of in to mood entire across focused same were to Phase period headcount and $XX.X readiness third in quarter and a efforts and and G&A in marketable the pipeline increase quarter million expenses R&D spending potential in our These cash, operations work me in in identifying financial of was our same portfolio support against a to in million execute primarily programs expenses, $XX.X professional IND-enabling an increase include equivalents investments third the period financial development the the The indications the for finally Phase programs and PPD, potential Research Sage's administrative in We're of XXXX. overview guidance. compared of in the as million results were efforts CMC $XX.X expanding quarter, preparation and expenses start summary interest the for to to our a discovery of encouraged and provide due the launch. the of regulatory to development the expenses On financial movement II the slide additional securities. quarter commercial with SAGE-XXX, and disorders, the pipeline continued R&D with due on new a in we organization. in preparations our studies $XXX.X our in We our ongoing advancing

We have commercial, in the operations the key and place quality technical leadership groups. in

a for Our brexanolone track launch supply on timeline. chain readiness activities are commercial

clinical the stock brexanolone active supply chain and is Our in replace. safety

in for has making model landscape And economics research, developed Our and in process investing education. the developing disease, and progress is completed. health our payer scale-up been manufacturing understanding we're PPD, awareness conducting go-to-market and commercial

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X Over the flexibility tirelessly support stage X call can Q&A. to to of of spending to company, goals each head data years, allowed the an worked we thank team operational to everyone. investment With certain enough as milestones. to as to towards to questions from a R&D to the open and for disciplined has end like last our strategic the the Operator? year. time early entire push has gating Sage pursue leave our we'd limit and that the we Please before us team want late I This to yourself having we that, the additional strategy so readouts approach now specific and get

Operator

[Operator from Instructions] first comes And Salveen Richter Goldman Sachs. our of question

is Your open. now line

Salveen Richter

Good taking my question. for morning. Thanks

So, of points a change from mean clinical X.X on us in it relates could you just fundamentally put with that means the for wondering if that Parkinson's saw score, you baseline context what scale. relevant the of as disease, to that

Steve Kanes

aren't represents Steve. means taking. can is by standard quite that That a which they these change meaningful that tremors all treatment are at of are the care, this change. These that be are Yes, current on clinical patients which touched substantial

be point seen clear improvement up scale following one the So was the this real most a important represents here I a in It's that improvement. the this from on. clinical perspective, part days. signal. X in that should Yes, we'd our other meaningful this thing dosing of out on is XX% that with is is only interested And

Salveen Richter

X with market? have be depression, reading are to if postpartum you two for how position successful And with drugs then programs programs frame the and us, these just Could these you just brexanolone. out in XXX you to going are

Jeff Jonas

footprint guess, get this sort might time, what what of achieve probably it's we of both XXX At from With these the a in your obviously Jeff. be X to simply just respect near-term no very is follow-on well therapy. until about to premature to case, be would confront. that the there -- would about, be a XXX assuming, -- available And is quality a XXX as see are where always I the XXX if view would has both that us our patients This currently for studies if to programs establishing speculate we am high where positioning as we were point these be I the potentially, opportunity kind out and that I of of this able data we the are hands talking to could consider agents. approach with positive, agent. drugs these you problem commercial case been it would that for

Salveen Richter

Thanks, Jeff.

Operator

of Paul comes Thank And from our next Leerink. Matteis you. question

now is line open. Your

Unidentified Analyst

[ph] this is, have on but guess done what strategy Hi, you severe And moderate expect if succeeds the do kind slightly placebo question I only to elevated of what that? do Paul study the Lynn the Geoffrey Matties. moderate have mitigate study for fails? And the a rate? is to you you have PPD first

Jeff Jonas

daunting course is, we a all What that as issue been nervous maneuvers limited has of again system people development. central various know, with tried you as here know, rate, placebo The throughout have you the success. did

And first, rather straightforward been, think that patients. the make we've we PPD always approach identified. to is appropriate And has can patients with And -- a are We clearly done the we the our that that to, done at be enroll. cases. we enroll that look as I as we've well. secondly they population which So patient think each sure do I at then think, look

up data into the way not pretty each pretty would as moderate the very a In because we And addition, chain clear controlled saw placebo of know spontaneously clear in that the we we will robust about a rate. to moving in in cyclic talk responses. a sort very had we it -- -- also low we we study saw activity saw this case remiss. in out simply and patients response, any a some that disorder, response -- in shouldn't any on I point remember, placebo

weeks So we studies are being these see think find hours. weeks, in a recall treated disorder that of a for think right treated we point. depressive And that rates end patients what the finally studies see very where what we've and are the these which matter people done clear is patients. they in to major We is for being placebo typically have you

think response, to wait So premature in I for a attenuate as But we just data. With much can your we to the we question, respect will do as one to it's again, have speculate. placebo that. second think

I what like think wait just look scenarios. the see before different we'll at we data to look

Unidentified Analyst

one, the see -- there just tremor for one on can to options, data -- I for guess earlier is that predominant if you other we these that if data And follow-on quick PD the mind; question guess, don't data, PD. is, any? a you options contextualize to us help it? I And the any

Jeff Jonas

available specifically included The treatment is the were were trial are which tremor having who in ongoing identified -- despite levodopa/carbidopa. patients for the

we represent different ongoing in is specifically an fact this are targeting important they addressing there of into one think patients way entry aren't disease. an an So signal, that entirely Parkinson's with this. really of any And that treatments symptoms

Unidentified Analyst

you thank very much. Okay,

Operator

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

line now open. is Your

Tazeen Ahmad

on know know Jeff, so could other program from you, wanted the based question. on your on products how Thanks I guys. market? my distinguished I be far early, follow-up. but And the insomnia. then ask you you have another it's Hi, for taking what I to in

Jeff Jonas

this of sleep. the of features for question. terms is healthy may Thanks some know we What induction data animal from unique mechanism that in have

However, you if hope high agents it's this synaptic things of potency. and of and induction This studied like we our had over experimental some advantages alterations has be that drug current GABA still an the theory oral would that show such But in actually program. is been with extrasynaptic excessive sleep where ever And -- nature, our -- never related systematically see benzodiazepine like agent no it's architecture exploratory. can part can medicine this rebound, by sleep could sedation. because effectively this one of experimental have do tachyphylaxis without GABA receptor

this So that's one first of goals -- is of the one the at of this. looking

Importantly, we in know sleep sleep improvement night. data anecdotally, Steve see Parkinson's XXX with do who anecdotally hear the we in know, have preexisting disturbance. don't pointed we patients taking out patient so we those that at just

the So morning. all important understand performance and sleep it's of mechanism our across impacts this in to programs how architecture

So data a lot from being this a of treatment for up not learn there's whether important ends we potential this, or insomnia.

we tuned, quarter. stay have first those the again, will data in So, likely

Tazeen Ahmad

remind for? you patients Can many expecting you release us are to how just data

Jeff Jonas

this it And cohorts. is in study a a [indiscernible] of lab sleep So, sleep series has study a model. model sleep

to are will patient and patients. what dosing it's potentially on And the be to we findings So exploring be XX going XX cohorts. different about at sized reasonably depending regimens

Tazeen Ahmad

you early goes stage? if on to larger work expand out a into anymore Phase II or well, do would would you Presumably Okay. want that

Jeff Jonas

I one responses to is to speculate. studies note larger and types those But programs sleep to be that I trials. see of studies too in Sleep where can fair think sleep will predictive of areas lab very are you good. soon the it's it's think lab

Tazeen Ahmad

Okay. Thanks, Jeff.

Jeff Jonas

Thanks.

Operator

And James. of question Laura comes our from you. next Chico Raymond Thank

Your line is now open.

Laura Chico

in for Hummingbird. taking Thank on you the and morning. question, enrollment congrats Good completing

you market 'XX You And your if what's XQ confidence demand just mentioned, guess, out learned could for curious in that and have target? kind you expectations? opportunity surprised to you to shifted how just far? and that 'XX. hitting the to so has also I guess pace speak enrollment PPD of Jeff, anything, about your QX that has timing compared I'm I the And perhaps

Jeff Jonas

course of program And most with to our important had priority Phase priority -- turn Our so XXX. to over step and the the enrolling we the that always and for that III, interest, the that was very been sights finish first completed, program so -- XXX program. now. enrolling terms XXX the as high. both interest of those very, the are in And XXX in that We saw well in is quite as well

just at that that The with the wants clinical sort base again interest demand. there. And that, I a of particular as demand out I do one instance, minute how for But if to again it's a Phase we'll the we report I a and as in there in quarter. has this that's so, able So as to large very the -- in think both with risky with we confident always XXX. -- ago, completed that's been, mentioned the look mentioned and XXX of surrogate trial story the to amount first III, that be we're

Laura Chico

That's larger at very I assuming you'll XXX your and Can would to are helpful. you XXX, I later supply to be advancing manufacturing trials? capacity guess, one the success follow-up; in just current be study, MDD remind what for guess, with stage where terms us the process you in trials in of likely.

Steve Kanes

doing programs in sure One time. from match of are all the thing that enrollment sort our programs of that is we making

Phase appropriate one we on the solid we a that III are that's that we deliver of this capability. ability into is to manufacturing been happened oral to the the the think from able have things very we've year II manufacturing is confident dosing So Phase formulation. what Remember, begin

So that's now all evening. reporting are a given on with that we capsule once in the day trials of are right a the

Jeff Jonas

comfortable very have That is our sure for to Steve, was all one clinical make I we think this no programs. planned confused. supplies is is that just short Jeff. But the answer adequate Yes, we're

Laura Chico

guys. Thanks,

Operator

our from Baral Thank Ritu you. question next And Cowen. comes of

now is line open. Your

Ritu Baral

Good the taking Thanks guys. Hi, morning. question. for

price, has us, payers this that started PPD. You how this you condition I treating and mentioned was already of cost follow-up yielded is what guess, benefit that. this mean, so they Can far? after a top disease? least have this guys I as sort outreach a look do disease? tell the months, for payer consider outreach you some X of I duration longer-term And far have at for also at line, as

Jeff Jonas

So we that's and true. here a involved with and in number of payers are overseas constituencies

probably What regimen tell days, detail about the is in board again, can there in treatment the think, this. might except a a that require across days therapy. in -- action I target may great early probably onset deal I which interest you premature talk early may not that not -- chronic deliver of to is to our rapid profile. with durability particular that a that And of course is of

we'll see remember a is shown to when about could we've sense is be talk pudding. this I the first going in get data, aren't like out, think about people, much think but -- profile. do I with important this. of better you look this wait think oral, to in proof the think I the an drug we and have that. innovator we'll know turn There to particular -- go product cards early potentially we It quarter a most to really When have that you any analogs over I We do. that the now which and is data product. the be target the will And

in both MDD So the different you're model looking at that's and a space. PPD unique treating of completely

And a we but we're are back. so that is what very there learning encouraged I curve, getting with think

Ritu Baral

they and the are look brexanolone are at Hummingbird, or PPD -- they I for side? payer there just look than different at differently mean MDD the they overlaps completely far in do As as

Jeff Jonas

PPD defining very to are rigorously it. quite We in careful we've the been way define

I is and the and of don't well. for is idea a we But issue But of a great respect specificity go to patient as I PPD, is have yet. topic. problem, don't is with the deal we that MDD think question the you're PPD -- that that heuristic the patient, say I how good unique what which want there uniquely unique larger to -- a has know relationship off asking, it's that and families is a journey, it's affects -- there unique can

not well that. from that's and we're push-back So accepted any seeing

Ritu Baral

you like around And Okay. be looking important to you'd data? And program the then program biomarkers. are if duration some of to you Phase Can a a XXX mentioned II II a guys? trials you tell quickly; of were on biomarkers, Steve, at next biomarkers Phase you looking that designed those what moving in what just interest sort most meaningful us would at to be

Steve Kanes

answer Well, and used they're understanding the as always turn way of a that's the it ensure to of to first I'll I'll getting over then And brain. that We've that the -- all points other across spans see shared that to it drugs SAGE-XXX, of something with our well. that and programs. as into EEG our XXX various ways adopt the We've both Jeff. looking we're utility with brexanolone program to into

Jeff Jonas

of number I potential we a have mean Yes, biomarkers.

time. going we're not to disclose at them I this think

make X to side, activity our with One GABA in is of are we're the points the potency that the it's CNS. looking to demonstrate there high easy here. molecules. think And I for very

been are NMDA, novel of these side ever the On tested really molecules before. that's

a such emphasize It's they that receptor So approaches and things number of at. to as move we're what for useful or not and that's occupancy Phase while we are we'll be looking surrogate forward II. activity at physiologic into have looking a though before important clinical we

been we think distinct never pleased is through before this dose at and that that's I point, say all with we're the ascending drugged but can at leave I it a quite now. novel a have mechanism phase we'll been single We've that's that. We think that deliberate program very

Ritu Baral

taking Great. the questions, Thanks for guys.

Operator

next Thank our comes you. JPMorgan. And question from of Cory Kasimov

open. Your line now is

Cory Kasimov

the towards Parkinson's. I with my context for what on the look to you in talk the about Thanks taking and one follow-up. one study Hey, Can the earlier question. question is go/no-go C? guess the as first tremor morning good essential guys. data you of similar is I've given maybe clinically single-arm nature the Part you then the believe And hurdle meaningful put

Jeff Jonas

Essential been now something years. for we've that tremor on many working is

essential in similar we Our brexanolone was actually with a was study. a tremor overall placebo-controlled at about look tremor saw first score where changes, improvement and that very essential XX%

really of is on effect would were for release doing from that in data effect. something SAGE-XXX we part Part what a And program to placebo-controlled to we What And initially we this ago. on. plan for follow maximize when can those results. years as placebo-controlled our looking be for first we're So see we similar in that several based see C we is that's looking how was

Steve Kanes

of we point what these during programs one advantages day. of by other were of open make effect the half-life drugs. that are of when the learned moved at like night. long were that early is is the as seeing durable rather dosing studies we approach we've these And in methodologic dose -- we our approach, very the we're is I'd the forward methodology One label to giving we Remember stages doing started using sort using judicious

steady studies So, have these none of achieved oral. especially state, with the

they both to studies is study which The emphasize a that expect that inform are point to now we've to I think are are been ought population, successful improvement studies. the more in meant and we and So be expect to like tremor conclusionary. we these that define still of Parkinson's meant by these but which the that open-label is indicated not with I'd methodology patient very to benefit, one longer-term see slope in

that And information, to us we're have far. very that these controlled we're to findings. very what will been methodologic as are successful. around so we in seeing But So studies designed think do I much pleased the as they've with giving these replicate

Cory Kasimov

in after talk Hummingbird about compared my importance studies. then as to wondering longer points shorter, XX if is in it's you're I you the trends relative hit can the on miss your of that on mind or only I'm the significance primary guess. longer event outright but the time And What's the on follow-up show endpoint, were to the And believe, I primary evaluating days, the you three-day follow-up? the

Jeff Jonas

And to we'll expect durability probably in primary break-through I we're the what endpoint under development have It's to that your primary. are the whack good true show. have in point, the see endpoint reiterate on to if suspect you I situation interest like different where on of the secondaries And the There given important the are endpoint premature and XX-hour an have and any a seen data the you that's speculate. going target now, obviously finding. But secondaries is is to durability just of data the they is we've to think we we -- see just And this our have is response. a a is. to of -- as where this. the it's what primary you program out giving what drug look

Cory Kasimov

Got you. it, thank

Operator

comes Abrahams of Capital Thank next you. Markets. Brian And from our question RBC

line open. Your is now

Brian Abrahams

my question. taking in on tremor thanks done much the that tremor. guess a Hi, works it concentration. to studies know or XXX looks I And pilot be curious where I out maxing shorter the you've efficacy for at follow-up either in on was XXX ET like the seen studies. or PK-PD essential very Parkinson's you've around peak likely plasma

these curious XXX towards were peak that study? X-day saw the So variability whether there? activities exposure? you the of you approach saw how steady the to in starting intraday state, data Whether shifts to out studies just might I correlate much you As a end am the even in throughout

Steve Kanes

we the is thing by were important in continued. seeing very day that day Most dosing brief improvements

we signal us duration time would an looking in on over dosing has to longer Jeff mentioned fact in studies and interest see, indicate. sort that what of are showed improvement. incremental these they as before, for a That's In moving gives actually

at while thing the So even even day's in prior the to of most days next improve we're important the over continue dosing. patients internally interested here is several PK-PD, course -- that to the

were effects these So durable.

Jeff Jonas

pharmacokinetics of effect takes during day and by day giving a might with be to the as more And longer one just why expect we you Steve is capsule the day. of hypotheses think, the drugs the picked One said, nighttime what suggests longer is has which to we formulation state. smoother why benefit steady dosing rapid this point to up, you've that, type a onset, has incremental which the of liquid are seeing that again, us think emphasize drug the half-life this I is onset make, nice

the accrue continue these some very tolerated we that been higher for least opportunity because suggests well longer still signals. dosing signal drug can kind we with the may there at benefit even has doses So, that of be with believe to and

Brian Abrahams

time get PPD -- of the as if PPD see more wondering now out there, will the what target And digest just had thoughts kind towards you updated -- might we brexanolone then on just to helpful. be the any you at expect engagement reading you've just had readouts there? PPD, studies And presented time as that the full we confirm time you've if obviously on details on or whether same to should now both data, SRSE

Jeff Jonas

reverse I'll your question.

company now for PPD anticipate both be the first will we the III studies. So data Phase next the -- readout

we in recently -- -- of that structural at of is that initially. reminiscent being Phase had with that. that study something physician along, let where the the a the getting lesions had why than will multiple for active data. subgroup were we that what different the patients that very It's So and this we've was are Steve -- that With respect complicated into still readout. the is very and Care say to the that we presented said your be was very some reasoning saw data first said, Neurocritical the that you data complicated a subgroup decisions a where very with this group simply all there a patients just question, XX% Society was, know way where a you for II population study reasonably is trial. to is me showed complete along patient recently seeing the study with SRSE, With design We're we say as the finds prior complex PPD data endpoint. to the the straightforward. don't next And about of example

And we to still communicate and plan at obviously the so, we we'll data learn are as looking it.

Brian Abrahams

Thank you so guys. much

Jeff Jonas

Thank you.

Operator

Thank from Danielle you. And question our of next Needham. comes Brill

is now open. line Your

Danielle Brill

for you if depression what was at Thanks was? if XXX wondering so PD I looked the impact just guys. trial scores the and tremor the Hi, in question.

Steve Kanes

collect who that were had we patients this were patients tremor-predominant. We depression. not did trial In specifically looking for those

we is on can report particular there that really So we -- nothing front.

a really -- there potentially it one So patients. a real area interesting that and for utility be would was is

Danielle Brill

all have. I thanks. All That's right,

Operator

our Gary Markets. you. Nachman question from Thank comes Capital BMO next And of

is now open. line Your

Gary Nachman

in shorter started PPD if still to that's Jeff, morning. that change guys infusion positive, the how of think is soon in would able from good time, the work market? formulation doing have important is explore you standpoint that you that Hi, that from works for a be you a commercial

Jeff Jonas

the no broke, data data have that fix there so from acceptance "If if far I Well, And it that change high the patients' we it." III that lower existing is in for regimen. work at But regimen. -- We so may axiom particular program other a old the regimens. evidence requirement dosing think any dosing ain't explore the don't is exploratory a that firstly of this dose and the acceptability for Phase looking do have we some suggest in level far

We are remember -- complex as sometimes a very dynamics. our this PPD, its one company, of these of is social a -- in are goals illness, terms

their line setting is appropriate and we're that a pathway. been women from from we so the right We regard, home So most and for it companies that's with this. believe has very the and very you are look a we to that's is now. who in good discussions this this with with can regimen But sure discussing the drug this in family. infusion as standing make bottom is know, at the date this are suffering our goal to in to reasonable acceptability where are deliver patients this And

Gary Nachman

could same you you us those the moderate same the Okay. patients, severe studies, just remind of have and dose And everything? did for time in infusion both

Jeff Jonas

are thesis that was time. only was change we -- variable purposefully. did a one it same and times the on -- the program, we infusion that The done that done the In at severe was under

the the a nanomolar that's but dose the exploring, in one the at standard lower program in we II. that program is severe XXX, that Phase the dose we in And only moderate change. XX are the So versus it's used

Gary Nachman

XXX you patients you positive, need moderate What the did you patients? IIs if do and Is could study tell on just right across up the that? end for that III would enrolling those Phase is severe? could move then larger was II? it actually in before you if And of you or into expected Phase And MDD, severity Phase both many how

Jeff Jonas

XX. I sorry, XX fully a It target all of here. to list your am questions is enrolled. was The about I'm making

We our given final enrollment figures. haven't

We will when we release the data.

given look if the we something drug for data were the it what positive I pathway be to think is like. explore this to that have

with one completely No to drug think a is a I mechanism. novel it's really like has important ever to been successfully this this able potent drug remember that ours.

although very patients don't the We Phase II does we're will we about know study, I think component. it exploratory [indiscernible] So how respond. an hopeful have

data open things dose to So we'll is, the data to and see tolerability like. learn questions what Obviously, and have what wait II. for look all whether will Phase further the need still have those the exploration, when we we that we are are that

Gary Nachman

both and But it's moderate severe? across

Jeff Jonas

change program No, we of bromide sort one of that Again the severe. focused MDD is is only the on if time. thing use at a

on severe… just [Indiscernible] moderate mix focusing between And patients. antidepressant It's still so a and we're the severe -- and in

Gary Nachman

helpful. Okay. Yes, Thank that's you.

Operator

from question Walsh Thank you. And Adam next with comes Stifel. our

open. now is line Your

Adam Walsh

of here. my Hey, taking I've Thanks good morning. got so a much questions. them for couple

in the used have like you PPD durability brexanolone be would what these potential see earlier the back you III on internal question to view an the of importance study, that minimal Just ketamine on in patients? kind do the durability to would of of context getting in Phase threshold

Jeff Jonas

Jeff. This is

internally would right. So a it secret, be

evidence piece if of this a somehow is the we're practical the -- to especially after out we piece if is think -- of our resetting that this seen with But based I the think program. weeks an programs again, the in replicates a or to this would We is II dosing. brain the if we've is fundamental hope, circuitry, of what I think And or But data on all to see show correct remember, what -- a hope like would like -- level and a several personally, this very acute thesis the that our we is we therapy. of me is personally, durability certainly Phase biology. more that some in this, week durability. see a hope obviously, X see, that from that -- see we saw than we'd resetting is I to be neural this is

Adam Walsh

research targeting clients from internal a this. be get diagnosed what is a percentage your on can willing quite marketing do any on those patients bit, my in second would have efforts. of and for to guess the come the infusion? multi-day Hopefully you And we then are that data currently question of question something I percentage PPD

Jeff Jonas

to from over resistance the but to no this of some in. call, suffering women you who experientially it can is, this is wouldn't I want Steve, that man. suffering thinks my say -- I I hours And just coming on women won't will better turn to probably from favorite severe comment going PPD seeing from I'm just say tell get a who anyone a we're PPD someone, severe after XX to

U.S., not diagnosed however it are that the probably but there so. because PPD under that. that under specifically -- for that the we've believe we've are U.S. terribly no approved not there coming therapy So therapies We for of among -- suggest seen we no that postpartum is all largely in treatment treated XXX,XXX is there to are are at The of seen depression and general experts data TL about the right in women tell exist and consensus are and the -- and in resistance claims now successful can enrollment in year per the our that that

births have We million to year a to syndrome expect the of look birth. XX% is number surrounding if that to live X X -- you million X we affective expect XX% million -- that will that the women be there U.S., are a X at which diagnosed the in of million

need we think and medical represents significantly of served. so it unmet significant area under And a

Steve Kanes

we're options treatment so in these we six very what certainly care. into poor. for patients a into think things and patients that so essentially that we if lot profound the the effect what And is dynamic of doing investigators rapid, then are change the is treatment does durable how affect, really about years patients, enter One hear is of are would a to important that because the we reluctant from enter

the think important are for, So what is, something patients. excited really hoping we if about we're and we're for data very

Adam Walsh

very Thank That's helpful. you.

Operator

our you. Lugo William from comes next And of Blair. question Tim Thank

line now is Your open.

Tim Lugo

and I those Thanks XX-hour backgrounds for is XXX PPD what different? the of those brexanolone guess several back coming different a women a over ultimately X infusion Is question. I to almost? for disease outpatient those guess, are PPD, therapy, are of you for criteria groups data that assume patients. it between baseline differences are And -- of women? are going number severe XXX,XXX taking my the are oral I that days patients, who versus claims mentioned,

Jeff Jonas

This is severe. all patients, not Jeff. just Those are

we that's through looked yet. So understand what since these to who haven't get who to people no the IV women versus The and might information in number the those one. at stuff -- treat premature demography the in interested it's from we is women what for that want come an we data differentiators therapy, might there who -- leaders say be the is oral. All be is can between

answer that So we can data on like clear a one. to the you what will before we have look see give

Tim Lugo

you. thank Okay,

Operator

And turn question-and-answer Jeff to I'd that our session any back closing remarks. for Jonas you. conference like today. concludes to Thank for the over

Jeff Jonas

work great bringing today their at to they've thank everyone all for to multiple questions and readouts. attention Sage in these First, everyone your and data the this thank I'd like want to of point us for done

an with data time all for of it's of becoming readouts. commercial We're on several pretty the exciting you potentially know, company. cusp the think I

Our still nicely. progressing pipeline is

I more you forward forward this looking to of to communicating of look quarter again. information all to talking over and our we're So

So again, day. great thanks everybody and have a

Operator

thank Ladies great day. This all in participating for conclude and Everyone you gentlemen, may you have program, disconnect. today's does a conference. the now and

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