SAGE - Earnings call transcript Q1 2020

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Sage Therapeutics Announced First Quarter 2020 Financial Results Conference Call. [Operator Instructions].

I would now like to hand the conference over to your speaker today, Jeff Boyle. Thank you. Please go ahead, sir.

Jeff Boyle

for Call. Therapeutics' you Financial Quarter thank Conference Results and joining First Sage XXXX Hello,

begin, encourage at we to Media can Before I the today's section Investors to find of and call. the our release website press sagerx.com, you everyone where related to go

differ statements, and risks I like may beliefs. for in risk actual are to certain forward-looking These uncertainties, the out based and on results will be details. that additional and statements Please would are we our and factors our press point today's filings making in to consult which materially. current expectations subject SEC our discussed release,

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

be Medical Officer. Dr. Q&A the session We for the Chief of Steve our will call joined Kanes, by

will the I turn now over to Jeff. call

Jeffrey Jonas

us Thanks, for afternoon. Jeff, this joining everyone, thanks, and

to our on pleased update today are We you quarter first results.

business on pipeline to will his a in bold over Sage. Mike years, share the we congratulate together me confident and I'm his last closely Officer. let brain Chief new our Mike vision I the worked knowledge promotion First, to X health patients his industry, have that potential strong his of of fulfill and help leadership skills. passion Operating Mike position, our help and his through and for

depression, neuropsychiatry Kimi on business franchises. update an provide detailed will activity neurology of discuss our and I'll an overview our Mike quarter financials. provide Now lastly, a will first Then And update. more provide and

our about our business, intact. the point, provide of although, at the have detail say unprecedented I'm COVID-XX the progress our the work this acknowledge Sage employees, to well, responded strong. in remains challenges will partners pandemic. handling virtual pipeline to and moment additional timelines by impact community want I across a Mike to potential our to happy I'm proud extremely way date take global are this that and time. quite remain teams at our the to faced

have even the pandemic committed goes of mission to We and potentially developing And important remains continue phase coming track is to in people executing that first issues discovering health decisions current and are forefront, with on mental quarter treatment a pipeline this the health our impact the disorders. to have we on significant after new to as medicines. strategic us for the the options the over. Sage even more we believe continue ever made right than will believe today, important development brain

franchise. So first let our start with depression me

working but First, we will downsized the healthcare focus made that on annualized in with efforts expenses care existing savings geographies committed have the difficult expected from investment resulting providers, ZULRESSO-related and in primarily ZULRESSO, but prudent our commercial to to $XXX million. cost our access We decision patients remain sites approximately to active of an seeking reduce of and now treating sites. ZULRESSO,

indications. new Each in each discussions With of in with the potential, distinct studies XXXX, of for successful, clinical independent filings. FDA, our if plan with short-term other of X earlier to initiate zuranolone, following studies X potential we these are the terms

this So X study indications. in first efficient patients just acute to is the believe, medicine pathway, of demonstrate to positive we each this additional order an efficacy in bring requiring, to

major longer-term this successful, or we're strategy treatment the if disorder, note, MDD. achieved a can depressive be of Of episodic while with maintaining

Phase dose to over the add the a last questions we've III weeks decision One related several of been our XX-milligram program. the to is to hearing

signaling milligrams the higher MOUNTAIN and between study dose. proprietary reports XX in go While regarding events we won't recall ability disclose similar zuranolone to this decision, of the adverse placebo, you overall data may that were in

loss of clinical zuranolone studies tolerated no well of consciousness. In been pivotal our in date, has fact, reports to with

And we To treated data. of be include across event and data and and have broad biomarker, a includes response formulations. adverse proprietary which the data range our doses subjects discussed provided with clear, these set FDA, our available PK

gained dose studies. a and in proceed to agreed and have a upcoming ongoing XX-milligram agreement our with we So

XX demonstrating already in active, believe options our and for payor. doses XX-milligram we with successful, depression postpartum a just trials having X with Phase that the If clinician primary pivotal makes multiple dose X Clinically, from sense onset. the endpoint, patient, the trials, studies positive and milligrams while that is and in another III new X MDD, are missed still rapid

track trial PAM. turn tremor me initiate half GABA Let SAGE-XXX, to the II remain in a milligrams SAGE-XXX, on to next year. our essential first XX of We with our now Phase in this neurology franchise in

most movement XX a treatment people common believe has X open-label the Earlier and in only disease. essential opportunities, not million reminder, been the tremor, but data there in tremor estimated in and SAGE-XXX for it an epilepsy innovation alone, years. suited characteristics, affects with in pharmacologic we are and with the Parkinson's well disorder of is disorder also the is III demonstrated not U.S. this in a Phase development essential compound As

disorders SAGE-XXX the in lead second We're in half also with open-label Phase of more NMDA neuropsychiatry PAM X progressing cognitive year. IIa or initiate asset dysfunction studies our the plan to as and associated development franchise. the in this of We

early baseline patients Huntington's in and patients tolerated, with study was of performance improved assessments disease, a on function. reminder, demonstrated executive well compared SAGE-XXX a As of Phase I to

potential a cognitive our data that SAGE-XXX these We including may and payer within disorders Huntington's, function, believe in disease. as support multiple Alzheimer's Parkinson's have treatment belief

to more turn point I like make. Mike, there's Before it over one to I'd

hard Our at teams on been COVID-XX work trial of conduct. impact potential assessing the have

paths who to place at open in indicate trials. of have that our clinical put have of available procedures As including studies sites analysis social and forward, desire the in continued distancing participate today, for to enrollment patients

So now I'll with it over that, Mike. to turn

Michael Cloonan

afternoon, and everyone. Jeff, Thanks good

neuropsychiatry forward, first resource advance allowing As path our and provide Jeff a defined programs franchises. the to to and we us clearly quarter, mentioned, during across process prioritization continued rigorous neurology depression, allocation a

I to was start our acknowledge in want decision first this reduce a ZULRESSO. treatment. investment it innovative to Let with me difficult

geographies to by with and focusing a ZULRESSO primarily noted support we treating PPD. women of to Jeff level As on with continuing earlier, will existing access sites maintain

first than to the the patients over XX barriers a treatment QX to have revenue we During compared $X.X moms ZULRESSO navigating quarter new infused The XX% and sites since that care XX quarter, ZULRESSO, treating million, increasing more with first sites quarter, XXXX. added quarter, in the of number number XX% treated to the increased previous the of with was and launch. were increase by the continued in total of first

in a the and and demand resulted paused see ZULRESSO. spread in in patients of of patient has the U.S. March, with had We significant in pausing of reduction sites That said, the this rapid increased. recent sites care number to treatment new COVID-XX started trend treating

a quarter, As first remained April. result, in XX% the in only of that were active sites active

to approximately We a average compared evidenced about monthly exposure the have also QX. decline XX% seeking start in women concerns with virus of ZULRESSO, in form reduction by that the as number monthly the to believe volume PPD April in volume the caused treatment with in

revenue eased efforts care adverse evolving pandemic-related concerns restrictions adjusting an the of continue on XXXX. XXXX, to for the of ZULRESSO will quarter de pandemic impact sales revenues We and the the processes the we of have in addressing expect balance provide even the from in we second of ongoing to but focus guidance U.S., from ZULRESSO we not believe will as after impact stemming sales are sites Given pandemic COVID-XX COVID-XX do minimis anticipate of new plan the on situation. to

potential Beyond impact the create risk impact want from of spend minutes COVID-XX the our on on to programs clinical few a mitigation on pandemic, efforts and you ZULRESSO, I the strategies. our to updating to

clinical during the related the COVID-XX to guidelines regulatory conducting We actively trials pandemic. by are monitoring authorities offered

We that are continue are during sites to in distancing see measures. aware instituting of subjects the many operating pandemic, person, social trial clinical

endpoint have implement primary appropriate if zuranolone subject we some in pandemic, potential all in-person approaches the to or due site Given telemedicine directed participants by with a that to as by interview, trials the the for regulators. documentation assessed is visits pauses all the the

potential on were evaluate recur, would to the to thought and we we if adjustments trial If adjustments that any whether consider the were warranted. make impact

the zuranolone focusing with on as initiations trials and collection. for SAGE-XXX unchanged anticipated we this can trials and and At II remain time, with are control, well patient new year, SAGE-XXX this with our data we initiating for timelines Phase X variables executing as safety the against

With or when RRT, zuranolone, treatment rapid with our antidepressant, depression, plans XXXX, episodic studies potential, a include new coinitiated X initiating acute therapy, postpartum distinct standard X new MDD for MDD. in short-term clinical of response and successful, and if with indications, the

and in X new submission Importantly, in studies of when allow for study with range coinitiated to are PPD efficacy an for a to dosing for standard Zuranolone, these NDA support antidepressant. only designed additional positive pending with a RRT potentially

X existing from also need plus the matter the and to shots positive For of the We medicines leverage goal, would bringing create learnings, episodic with the example safety health approach. support clinical zuranolone currently with on evaluating to our additional quickly a brain overall a to pharmacology ongoing new mission finalize people efficacy we and our the potential plan FDA. study, program This REDWOOD of and trials is good all NDA adapt future that and requirements We're multiple disorders. indication, study. data with

which investigator time. IRB focused As managed be can this efforts these contracting, remotely the are, are minimally prepare to of currently initiate meetings site therefore, we developments, trials, affected at all and pandemic our COVID-XX on by activation, database and approvals,

active policies, necessary, ongoing In conducting addition, SHORELINE the sites resources. distancing utilizing remote and social trial where by remain

for subjects at sequencing calling we we'll study, a begin see cohort and study, From that in able are sites the are the we new study perspective, XXXb enrolling the person. XX-milligram to waterfall SHORELINE that expect placebo-controlled now which

to PPD this study RRT plan year. also and, study We later the finally, initiate the

II finalizing SAGE-XXX one second more currently approvals, we activation. IIa by development, Phase to again, the We associated with this of disorders on SAGE-XXX the IRB cognitive trial of quarter, and half meetings database contracting, in open-label in also Phase and in year. are focused the studies with essential initiate expect dysfunction second And the end investigator with site tremor or

our it matter get matter. innovative I quickly business medicines mission, as off look on want to We pathways reinforce hand deliver against to as possible. to our and development that out designs, trial and to including medicines commitment leverage thought clinical I patients for to executing that creating opportunities well to Before learnings strategies Kimi, multiple

over now financials. Kimi And call the to I'll our review to turn

Kimi Iguchi

Thanks, good Mike, everyone. and afternoon,

performance moment unprecedented we our of update a in team truly I some Before has over last for the progress on want the made to the take I face pleased the financial circumstances. the just to how with mention quarter, you few months are

efficiently resilience a the our as we ever that foundation as our confident remain leveraged we've have discipline make organization, operate an and us to to we enable as financial decisions. against I goals. execute As to current difficult strong

While December remainder clear we franchises well programs determined awaited XXXX. allocation time for data the impact path decisions. these brain business, forward to paused has resource made investments clear believe direction for At we our across the of zuranolone, of and With of restructuring. to we the we Back on our the in potential we advance for as unprecedented that of prioritization financially health we're path our noncritical with readout, light difficult for XXXX, uptake, and the that need the point, zuranolone. MOUNTAIN pace capitalized in ZULRESSO X forward

with and This people mission savings brain expected million. was decreases spend. well more of resources intended help reduction cost reductions XX% disorders. major external encompassed restructuring approximately as This bringing The This result cost of as decision. to our annualized of included reallocation advance will in health than medicines a in matter that $XXX Sage of a difficult workforce to a

cost ZULRESSO of and portion to those are commercial related related support. significant G&A A savings operations

restructuring, costs As part workforce reduction. a of million. associated the $XX we charge with of are principally record will the These

financial securities. our billion XXXX of cash, now $X the walk ended Starting sheet, That's year. balance our cash we with results. beginning with equivalents, highlights approximately million the cash through first of $XXX and compared you I'll the the with first marketable in at quarter restricted quarter

I and XXXX into anticipate want as health on continue support have operations emphasize franchises. our across X that brain strong we advance hand will a programs to We sheet, to we balance cash

ZULRESSO of from revenues Net million in the to collaboration for in million revenues $X.X in same first $X.X XXXX. period sales were the quarter from Shionogi the compared

quarter a result mentioned ongoing U.S., pandemic ZULRESSO of minimis We de earlier, do from COVID-XX providing in guidance of of in the on plan Mike the sales expect as revenue revenue second we the XXXX. of As for balance the the impact XXXX. not

including of compensation completion including R&D expense for $XX decrease $XX investments period resource noncash zuranolone. study activities understood franchise. enrollment Our with key and to of the strategic is the $XX path the compensation the decision studies and MOUNTAIN million and and depression, on compares expense related of RAINFOREST the in positive primarily million, XXXX. allocation areas stock-based development The to of We to activities to in totally first zuranolone. is forward the REDWOOD for This and part of and our same million decreased expense. our stock-based neurology million quarter, This $XX remain noncash across pause noncritical neuropsychiatry supporting ongoing focused

We continue deliberate to our pipeline. allocation to approach capital with execute disciplined and a to advance

including stock-based Selling, stock-based million, XXXX. general compensation the compensation million $XX This and of for noncash same compares $XX million, expense to first $XX expense the administrative quarter XXXX. expenses were of period $XX million noncash including in in of

in in professional first a commercial of launch to due preparations primarily fees of the quarter was the for XXXX expenses U.S. to SG&A in ZULRESSO the decrease decrease related The the in

a in of of $XXX million in loss loss same as first the to we quarter XXXX. compared a Finally, net for reported period the net $XXX million

million on the current cash balance least Based be our our securities and $XXX end at at will restricted equivalents, we of operating marketable cash, XXXX. of plan, cash anticipate

in continue business plan require Our us said, our to development million operating of as to cash we'll always current sources balance XXXX. $XXX opportunities. not into We consider anticipate our But raise of other we've capital money operations current will and XXXX. does support

As say take allocation. approach a before, resource to you've heard we me deliberate our

invest and ahead, value will we turn closing sequence for for thoughtfully it over stakeholders. we'll at long-term assets believe our mid- Looking the comments. near, now to create Jeff to I'll year continue to

Jeffrey Jonas

Thank you, Kimi.

Sage We as their franchises. our advance advance current to to our remaining resilient has path to development continue the team brain flexible the a they I'm have X responded defined COVID-XX clearly programs and across mission. of pandemic, health proud work how

clinical will to practices We're develop help mitigate disruptions caused and to we programs. working this Our time implemented intended for do and by a strategies business impact we our potential time, the business site or ongoing significant proud be there planned clinical anticipate have to and, save closely strong, reduce COVID-XX remains at continuity employees help policies with COVID-XX. of on spread our lines not teams

Q&A, for second with key call the we the open of into we I'll as year. you leave Before points half move X the

expected XXXX defined brain clearly development with programs we path runway across into advance support franchises. First, operations forward have X a health the to to our

can strategic we will end in end we XX-milligram XXXX. XXXX, data decisions the context rich believe leveraging And the are in a third, several Second, data and very making SHORELINE with by have resulting of of learnings readout the readouts portfolio, follow. viable the pathways X before we we of

like the I'd open So with Operator? that, for to questions. call

Operator

[Operator Instructions].

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

Salveen Richter

trying the And arm tease no it to will -- SHORELINE, difficult to look as efficacy the data about what be just think So that readout as we view the assess do if So placebo with a as here? interpreting positive we incrementally here? year-end you with single is to study? data, should how this given out

Jeffrey Jonas

Great.

Jeff. So this is

to to think technical in is line, and But the expected -- is we're I so antidepressant conduct a that get I'm -- the a Steve asked be healthy, some everyone we've have sort difficulties. study, and to thanks, been and It's a welcome the of again, real is have -- trying we we're world of still to study Hope it's study. basically work. people naturalistic call. conducted everybody. Remember, -- SHORELINE or area on having

for We'll factors. looking retreatment endpoints a it's -- we -- And come now, and as be never. at classical looking many be demographic treatment at people twice right looking other We'll study. -- back how may or at once response. be pretty such Our overall relatively

without So how style what you of intervention drug a be. clinical the best kind suggests may kind can performs expect physicians is beyond situation, in that data real-world -- of practices a any any what

informative going zuranolone about and it's label best believe frame how that be be help highly used. potentially might forward will moving to we So our something

Operator

of Our next Jefferies. Andrew the question comes from line from Tsai

Lin Tsai

me? Can you hear

Jeffrey Jonas

Yes.

Lin Tsai

can I'm actually can of can for whether see instances see on of AEs I'm patient you monitor rates Maybe kind just an for on, dropout so basis. as follow-up far? curious information actually question. what curious, enrolled example, the if patients baseline characteristics as you SHORELINE the on or a well you for details ongoing

dose? very Just see basically to retreat patients to that with start see curious whether higher have you XX-milligram data ability a as to themselves

Jeffrey Jonas

can. serious study, is, me, anything hoping not might the doing program. And we're the hear question. for can you again, save report. treating for like has analysis the in Thanks a require been XX-day or this I'm are that adverse that If program. any everyone issue typical of we that real-time not an But other Basically, events pivotal

know, we The at data as is an and you to complete, do way will planning analysis. later because, the point some this is, we're year, enrollment this then undergo lock

I looking of somehow think the the avoid label at an is we're to ongoing we one by open managing that trial idea want pitfalls data.

about we've within I keep to as the monitoring the data So analysis. talked think this to before, any not do real-time is to study our group, data but this approach otherwise

Operator

the next from Our of Research. from Tewari question Wolfe comes Akash line

Akash Tewari

over ROBIN? subgroup issues in color any with efficacy ROBIN you a thresholds saw dose, you had XX.X. MDD? who on you recently formulation in patients noticed a under if And PPD non-SAT if you an So where not, I published show state versus in suspected that and dose? MOUNTAIN HAM-D didn't showed could about interesting patients XX-milligram the analysis then do efficacy in efficacious study, there be an also that you different stats XX.X, from given the Basically, dynamic similar have study were the up study in receive there the seen

HAM-D an cutoff is of think new greater, with or what HAM-D trial? you pivotal Given the do appropriate X a only trial for your XX included patients inclusion

Jeffrey Jonas

So can I'm hear Steve, I'm Steve, going me? this going Jim over turn to you to start, or then and actually, to

Stephen Kanes

you, hear yes. can I

Jeffrey Jonas

Just.

Good. Okay.

So think points. basically, couple I -- of there's a

for a question we've this important these have -- As in you at higher so-called trade-offs follows: to expect easier this look metrics, you it's move. to as HAM-D, But I with at always an obvious the larger treatment as trial we've a I of any think but which you mostly studies is point, it's to -- terms we had in go initially of severity. to of take effect before, really, think discussed show reasons, easier look the it's to actual more -- room are

due You smaller enrollment for contingencies looking rates of have HAM-Ds. to higher the of

of a Steve in that area in you at, XX%, a level up recruit can't So argue on with made most if you would respect thinking to lot to But these of off upon the look you depression, in XX%, think going turn just I'm or overall severity. how X to we'll at look talk we're it. trials, for trial anywhere patients think, reasonable this inclusion any a have particular -- about of take over most take XX%. I metrics versus -- maneuvers look do XX% cut learned use Well, will of will speaking, cut the -- rationale generally so a we people are people then. a heuristic decisions why about XX% between proprietary. not most contingent other. to to depression We've it's The We the to some most want I of future. criteria some

Stephen Kanes

the the actually way apologies Yes, Jeff, part look of is, that's the at from it it. is for right we perspective, Jeff difficulties. and Thanks, technical and technical and Yes.

general we're allows criterias of of is a the piece variety label so to that enrollment. other time That only it we to not want have The get us most at inclusion severity level patients a able of general included have to the studies, specify be to of but in or are to that of postpartum a depression treatments label depression. related more having for the

for together studies. as inclusion things those look such at think the of about both it's So we criteria we that

Akash Tewari

-- And where an similar dose? Mountain saw if may not a that color patients ROBIN in you efficacious have saw any maybe on dynamic Yes. some you in received

Stephen Kanes

some about things trials. pointed all help about we've We from that that something at kinds you that talked look at who wasn't and MOUNTAIN there are the specifically standard of understand don't things others of take look -- There's the drug. we is really trial help level medication. out fundamental always people and it The to these us

all call, the procedures for studies. our -- across of is true However, and I our We leverage allow studies we're what the we studies we moving learnings That's response. and to been us that's what our sustained all very these, we've seen track it a said rapid across that forward. think always doing of -- in

Operator

question Our from from next the comes Suneja of line Yatin Guggenheim.

Unidentified Analyst

about going Yatin. This I question that trial you're for is on the episodic have run. Eddie treatment a to

You help mentioned just well of sort if And before you we sites mentioned file REDWOOD to the in can us winding you're of what in the So trial? But episodic the should need you'll readout in understand as episodic that the study? also the study? REDWOOD sort the you for indication. new press the after that of release the is REDWOOD expect timing down it study

Stephen Kanes

Yes.

for well thanks treatment. is things depression The that going prioritizing the initiation things are think to of to episodic program committed important about us studies the pathway need efficient we're But RRT. filing. really for you the now, most as moment, the we're is, for the postpartum for for What right as most after both to So that. entire the

just we the we X the long-term program trial One thing additional as would together, data look at RRT. without So need be of -- the study. is something those we require with or indications. filing file with is can on for that required what for either Same would PPD additional for

study. we to resources. that's we about that as We're when way focus the well kind our at it. the in look efforts prudent reinitiate paused data REDWOOD very the We'll the We've way of as future. we that we trying need of our we look now what So what when appropriate, in you and need and data about prioritization, kind it's enrollment think be with

Michael Cloonan

committed treatment, now, is to looked with we're the the three portfolio think, this very Yes. excited for we right? that restructure. is move giving single-shot the this at path Mike. on episodic add much still prosecute a and a had and XXX for we the the and goal We right? resource RRT. on, still went just really can So and Steve, about allocation mean, we We then right that process, paths but X time, allocation, the REDWOOD And XXX, And determined I strategy to there's we through is prioritization that the at hold on study a laid a all XXX great maybe PPD paths out. I three study the both we'll and and us but it really portfolio study,

Jeffrey Jonas

Yes. One is additional comment, which practical. actually

So same trials lot a quarter. -- the the to since practically enrolling sites with these have as is been are advisable we of open on first up we we've medication. competitively speaking, it's sites working and trials not the And have usually opening,

move trials here, quite we'd also rapid issue which first. are a give registration necessary these like practical us we make is, there's that So to sure could

And so here they well. pragmatics there's -- as some

Operator

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

Paul Matteis

guess bit be milligrams if surrounding what on additional I you you year. One dropouts? an index scenarios? to one does of great data handle tell -- for XX there's And of in above XX studies? a of submitted And XXX hard a mg. me. exposures dose, just you might little types patient a element about us for how across total much different therapeutic to data different many to talk clinical just Two There's to Great. that might the on questions have the FDA? SHORELINE, this the can How you've in out of terms then track patient about the it how where, can you and

you could about own victim a in how So certain think be where of do of that scenario populations? funky your kind success you

Jeffrey Jonas

Great.

So the out, With may -- are staff X and you in drop and already as a out. we -- any out pointed different that responders have SHORELINE, you've can naturalistic And do. it we'll finds where comments. couple there when have of nonresponders to maneuvers treatment, both study may Kaplan-Meier drop take

very reasons. and opposite almost So -- equal

do So there are to that. ways

your is to the denominator that well. is of make -- who, at there are least are One your follow-up, days. analytic in first And to SHORELINE, maneuvers other an analysis which, simply the maneuvers in it you're patients official assume XX as

I one we but that people's think accessibility the questions didn't certainly will you and consider have COVID to is what do one Now to of ask, with follow-up.

I that's think also So we'll account. something into take

But any at respect the I doing XX, that analysis analysis take is a and to in With you'll the lot discussion, we of sensitivity a what And exposures respect Kaplan-Meier to think be data we've eventualities. in plan the those biomarkers, look to have proprietary. done. with

the studies was that it's program that NDA, fair have of of this where conducted to part and are I of that part NDA things. that cohort think liking disclose things studies, don't abuse that is like that as -- drug you an remember to say a are we it a -- program studies has large driving a

I than for substantially competitive can't this XX gone higher we've Again, so at And point of provide more any don't studies. in breakdown -- we a reasons. these

has safety of pkaE is of population the adequate by by think that data comfortable various point as seen of and all all and this is right that an know, to very to regulation, we're XX has test. and including the been has data levels you cross an all -- dose margin, comfortable exposure, important we're agency, out formulations, what's the with I exposure these the kind and

Paul Matteis

year any Will the SHORELINE data XX helpful. we this we later results? get That's really see when

Jeffrey Jonas

third That's your question.

Paul Matteis

Sorry.

Jeffrey Jonas

patients insurer was line and with is That to to well done, but XX. with enroll I'll so -- XX allow our plan talk retreatment

that premature XX-milligram data for study the would coming and we'll data so of keep presentation I to think estimate those really still you posted. when be out is it's

Stephen Kanes

Yes.

-- certainly think Yes, SHORELINE with confident have it. have Paul, in. and I we'll have have we we'll is We that data this year, XX very at with that what something said that's we're

Operator

Our Cory from Kasimo next Jpmorgan. line the comes from question of

Unidentified Analyst

in what trial, standard additional antidepressants? just just on achieve of care hoping the This and I'm And particular, the study? Turner Corey. for top to for provide you you need any of RRT III on details of do sizing is the Phase

Stephen Kanes

So up is a to just a study antidepressant. -- better thanks in started a patients to for is really the is questions. The quickly this study notch to RRT get raise look really addition at newly it the opportunity to

plus will the But assumptions. we of antidepressant with was kinds they're this, X zuranolone III be XX-milligram Jeff we're share we studies where and I that which say XX SAGE-XXX a is very taking taking the statistical similar for very the we're comparing that just approach the the it's X and The initiate antidepressant that taking dose, Phase the other their plus trial, of the When II and and for that size all done programs underway. patient say, So studies. the numbers, We'll the at are of the we've the Phase would describing, details, is group and new endpoints arm the milligrams. in arms, is similar. all our X -- patient -- it study sizing new the approaches line really including placebo, get what

Michael Cloonan

with we evidence remind look I how patients, together add some think the exciting kind this just both maybe an opportunity have real-world and as is -- that it's ties of get zuranolone. to I folks indication too, with the we in and payors for strategy physicians to helpful RRT first Steve, can right? this commercial And MDD, at could

that And we we're accelerate the by think there's at treatment that today Steve episodic there's getting opportunity so as treatment potential waiting shift has to to paradigm zuranolone the And gap we've think exists we that We come, that evidence, still if is the fill. while look in really I this said. after the And real-world when for the -- treatment a with said, going in to one want shift experience early to game this is with some that this on don't us. elegance we're you the But episodic, that of top. know add thing right believe to paradigm get end for now RRT. real-world Steve, strategy this,

Stephen Kanes

things this interested I of there's lot at Sage really Yes. that is where mean, a in. I'm --

around people initial It's new there's that really, therapy interested fill about I have MDD ways their to FDA get to that have think really to really really out it's why to we're get it's being a into better to this people and finding way was be does data. of There's guidance I that quickly, can there is Michael nothing referring a such in excited an that And patients this psychiatrist, the important this. have that As in I'm but as an a something It's that thinking you psychiatrist, going, interest important -- why integrated able world. really a to fully one. into treatment. step gap tell

Operator

comes question Cowen. the from of next line Our Ritu from Baral

Unidentified Analyst

This is on Lyla for Ritu.

Just on a follow-up for SHORELINE. -- quick

person? say the can could readout. involve using been patients You of aim also that versus said But not telemedicine telemedicine that already in have have that in briefly telemedicine? you subjects And proportion able those maybe or to you had you that visit easily how a to whether were report

Stephen Kanes

about what these would do that talking this if things. to is this idea We need Steve. we we'll how say you were giving approaches take. So we'll of yes, approach is an I

handle it on how What we given data registration -- is speculate certainly during the be handle for to that. how we period is has FDA guidance would on premature so these adaptations And this the do know programs. to

have, the we that. we as that understand share So impact through we'll might as certainly work program, what

that in to forward guidance thing allows the in are implement call, us important said appropriate we this I agreement closely. extraordinarily is in think, mind it during keep most I are to monitoring there move And think that way. ways Mike that in ways the FDA with the key an are to endpoints the

procedures in my touch the including paramount. and in perspective, the place, from putting data the are they're collection, that's, CROs, the with We sites,

Operator

Dane question next of from the from comes Our line Leone Raymond James.

Dane Leone

it patients. Just quick for was ones target? to that said I the two -- -- in Is you did enrollment you around enroll XXX me. SHORELINE. was was One, complete thought

questions So the enrollment that's second to want question in one, actual lot get first? -- one, of that's sorry, that just you was a what completed? answer been we And

Stephen Kanes

It's I'll just enrolled to it our fire target. Yes, completed out Yes, there. we enrollment.

Dane Leone

then bit more a maybe the And one, second Great. Okay. little complex.

that RRT more a in treatment have the in direction You resistant. peer seemingly basis, similar going is a on but company

considered about team of How questions different community approach think investment your versus traditional delineate? a lot of major how clinically MDD in does your about So define there's would depressive what kind in characterize what the you treatment? you be RRT you as what been versus would treatment-resistant do for in

Jeffrey Jonas

point. aware of I'm not their you're relevant phone. probably company I'm So mute which referring it's but not -- has of someone to at not aware to, this which

data. attributes we've X that I at useful. are you've -- and pursue necessary believe there required that drug this And reasons a are a XXX we that -- to what's and few published the available, RRT, of you we for is data be for seen when If think we made look

in So in period. within the few and probably placebo even trials, trials, or consistently demonstrated all MOUNTAIN know, in as we've and clinically the one all meaningful -- is, rapid a separation our you from measurement ZULRESSO days first of

So that's number one.

seen is ZULRESSO MOUNTAIN. demonstrated what drug has -- been happens with we've after the it and withdrawn. mechanisms, Secondly, we've in that And both

stability You the of good see effect. overall

drug-drug extensive for and is RRT, SSRIs. what drugs will Third, in these -- these I to data, co-administered utility where have we drugs which be with this, anticipated mentioned Steve this it's interaction critical is think be will need -- the

stopped interaction you we've patients is to So -- shown lot shown shown X/X very or we've our as on evidence over important. the withdrawal the no has after been drug-drug well fourth, know, have there's ability have as our drug that. rebound And we that in avoid data of safety stability. trials, a of -- as of And

believe, who situated that, guidance, FDA we public So and if based and at else I'm on but go looking I sure not you through data, at look believe, requirements uniquely the the meet the is for to XXX, published RRT. is you the attributes,

Stephen Kanes

I just add. Yes. would

And that very would early very is one as and to as a yes, in explore in So interested as that see depression. major we're on meaningful PPD we profile, so that a continuing about say separation just unique clinically that differences is well this that I part right of what's statistical very away. well important in RRT as

Operator

[Operator Instructions].

line of comes next from Mizuho Our Divan Vamil Securities. from question the

Vamil Divan

one, giving all numbers the maybe about have the formal spending back of sounds for program. color sort the how more for I decisions the some like I tough trends and just on on you're Thanks making I guidance. year? already think rest guess clinical of know January. not to you're It the in December,

when of implemented at beginning change a we more XQ and much the terms SG&A, XQ in just the versus see announced at if You and already as of might look a we sense was formally the get or of down R&D to step program you see April. restructuring how much how we the of our in of the I'm both year, half second trying of could?

Kimi Iguchi

remember, cash, again, have that would at Hopefully, at at $XXX million Great. setting, here of said end end at everybody we and we that that just into cash hand of the $XXX and Kimi. This the context end XXXX, least XXXX. the in is operations on our support the the cash quarter we million the year, have But will have we me. should first in

quarter, about line our of we been step back, we've let's regards data and reflected I in quarter. now that always those the got deliberate bit thing other in of earlier and Some and back -- said, that that's is disciplined in the think look really when that the nonclinical decisions I And a make I the very MOUNTAIN, and investments that with to talked investing. SG&A at you for in first think saw pull the we first to right? is we've consistently said

within not data also with path what until waited -- agency restructuring. We path you'll talked disciplined We on Jeff related But shows trials again, There's and clear reductions And say, from had are QX. move and things the forward. held we identified R&D, us, QX the spend we lot that about continuing was this lot adjustments. impacts, those our we initiating, we impacts way to And and a we just for early, forward. a the and we understanding of a And that. we investing R&D of very discussions the a take of our some made happen will for just readouts. our approach Those what in the levers has was see lastly, lot our to I'll it. and in zuranolone it. had and those there think forward are so about that Those there

level happen, thank that readouts investment also our will data those as you. impact So on our thinking

Operator

Our next Matthew of comes Morgan from from question the line Harrison Stanley.

Maxwell Skor

for could for Matthew I was on responses. variable Okay. wondering, COVID-XX you thought are potentially have effect have just This How region-specific how on events? Harrison. an placebo controlling is Skor you Max about

Stephen Kanes

trials placebo season are our well all same it's metrics. one answer. industry Obviously, The across within responses the

adapt. which randomized We'll rolling of about be see whether trials. trials, looking If are thing there's the anything that tracking need And get to would course, adapt trials. we'll of arms. But we the But always be is anything those that there be effects As we'll closely. the or same there's do we need both them studies that in with nonspecific, to are to if not do are that true, the conduct is, to these we to expect we so.

Operator

from Leerink. comes of line SVB Our next from question the Goodman Marc

Unidentified Analyst

capabilities X these virtual be into elaborate the A on for the monitoring quick Mark. doing remote building bit Rowan sites zuranolone. know is that And a you trials, little now? Could line if selected studies the This things like might for upcoming if you question on about already or your this like are that? you

Jeffrey Jonas

over I'll is in we're speak This turn and bit want start, more little just Jeff. which alone broadly not Steve. a I is, this. I'll it and to to saying --

recently of our in monitoring. start. discovered telemedicine trials this many We and been We've remote doing just from the haven't

MOUNTAIN many already been place. in the trial, in data have and those As the other, you had expect, we've We've also remote we SHORELINE, in -- may disclosed of study. XXX things in haven't we which

incorporated experience bit learnings those lot of fair a And have new a we've these we So having done of already into that. programs.

add but anything I to know liberty technologies at the if not programs to to reasons, want has sure we've we're of days what talk proprietary from that, I'm that, I don't company. about of which Steve, it -- that? our been say, the early to you part this suffice think today, beyond utilized, for So

Stephen Kanes

we've file Yes. first COVID over I can adapt. popped can that at would that been since guidance all we looking this We've just ways say, up. been we

the medicine, our part remotely. used said, be fully As as even trends adaptable psychiatry, many you well of within particular. you're endpoints of in in to and are It's aware,

for We'll our trials where trials what's our be So is use need to be right work move what accurate now, in how said, they all about ways Jeff what as the do about very us doing. we real-time us also understanding adapt order is we're those be confident now, in useful sit going we're as going might exactly as things and technologies understand we of to continue forward. think sorts the to getting future, have. allow what's we'll and to move to we data kinds it. exactly to the things implementing of be from we impact in But We'll to tracking in forward what doing,

Operator

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

Unidentified Analyst

with status Shionogi the I was and collaboration if comment their efforts wondering Gary. have you for for on of Ely your development far? zuranolone is on thus This consisted can clinical for of what

Michael Cloonan

over necessary. the has Japan. make with in to at well collaboration learnings an Phase be the in high Steve. us, our adapting it finished right the to point, continue a clinical a partner They at mean, we them, just track. even collaboration from Shionogi we've been Japan, like-minded in CNS They on had, we But that taking with are progressing very that there with with record very outstanding the pleased they track go it we've I'll first progress development continuing and to where lockstep that This have I I. trials and in is I'll take right? to everything the back As on this then seen found Mike. we've you initiated first, level, Yes. when pass

you the there? development clinical know add And to so Steve, any color want that to I don't other there's if

Stephen Kanes

Yes.

of work the in to and be ability our has something extraordinarily so they retreatment to as it they They the for around and as treatment depression, and the field share And So have really episodic partnership, been that's treatment part track leaders been forward. going -- industry view original vision view in in us forth. and glove Japan well. the for depression, that that's short-term that important whether in and move hand Asia

they going regions, What similar see. see The as of that profiles program continuing forward to say and across been their is we we what is all very drug to are. well. So the of has they're is that move

Operator

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

Brian Abrahams

you could or on I And what RRT how I'm could know PPD I of curious potential views on the new and I'm obviously baseline the guess us data your caps might endpoint XXX X-week wondering if telemedicine. any which data inflated improvement? curious how studies you the you period sort remind environment? durability studies latest to foresee into for to But much special challenges manage your secondarily, a HAM-Ds, approval? also was you do placebo about be whether pandemic for And initiating might through mentioned that? effect, then collect you through impact ability required beyond expect I might

Jeffrey Jonas

to This is Jeff, it Steve. and turn over then I'll

the meet stressor is, psychosocial major issue, that And think general on -- It's really a ought one, we of there's is into come depressed people think really I disorder. impact who the these studies development of the in which what's always the I well, important deal for depressive think. I remember to to of psychiatry, that which don't mood? kind criteria

So the they will DSM-X criteria. meet

about -- are grief sort depression, what no, reaction. onset people which these or you not with of precipitants that of is might worry people of regardless now acute be, with respective to kind of going psychosocial the with what be So reactive

we're reliability diagnostic enough so-called the reactors. that criteria to have out So comfortable weed the

acute both to additional the the -- is other with respect that indications of same of don't those when we already patient -- add? all one about of with indications. two into with indication to looked postpartum, prioritization, respect respect With follow-up, type we've to want at and Steve, therapy before, indications, rapid required used course, -- general the those we've potentially And I respect design the if other episodic. weeks issue with our that's, that the provide additional access an two With to discussed and four durability, market will to else have for weeks it. be this two that pathway to recognize be we will very two of you that of the anything know with you RRT reasons the a

Stephen Kanes

it important only now. the thing couldn't drugs Yes. than any is exploration right disorders I'd be psychiatric depression add The for is for of more

already to It provide medicine be this, active everybody. we're that just talking in as to emerge depressions, late going but as of disorders the these out persisting depression, As And this said, we patients, about can. true to depressions, of for new about be to from been medicines, is are efficiently not able rapidly the it. starting want get of about not figuring for the that's has because you're our people in way crisis, critical why The see we program the beginning. what the major Jeff TRD this depressive we midst patients rates really we're and crisis. the through it's press since not rates to And as talking refracs, to -- a global we're reactive COVID

Operator

questions. closing no showing further to this turn like I over I'm to for time, back remarks. the At would call management

Jeffrey Jonas

closing you of I remarks before few make and And and safe all today, stay to want attending I for continue all a release everybody, thanks, to you. first, hope Well, of healthy. I

I of is -- under hospitals, and to people ability are first, seeing our beat attention on. think, more going think mental medically more to and need it, to aspect is lip pay a the mental goes health, important We -- our this a service treating I severe workers just of issue it be time in to and ERs to health we frontline serious the And their really need COVID. medical a today, who as but often lot point. more stress, really Steve for we're give made the important under a working

Sage, a like to to other respect make. With few I'd comments

now we're -- very MOUNTAIN. unique think position, I especially in all post a after

potentially respect to X have with zuranolone, health for our shots forward in programs have a defined richest We CNS believe still goal fundamentally on what brain the we is With in space. across a clearly we company CNS franchises. path X development of pipeline multiple the

looking readouts forward We X of to XXXX. end by data the the have SHORELINE for and to XXXX data be

financial positioned uniquely objectives. is strength Sage to that our with great team, a with believe we So execute great on

So look with stays attention. for your Thanks, everyone to And that, appreciate forward like healthy. time. their everyone to our I'd thank hope one-on-ones. I everybody. really we I

Operator

conference you Ladies today's Thank and concludes call. participating. for gentlemen, this

disconnect. now may You

Sage Therapeutics (SAGE) 7 May 202020 Q1 Earnings call transcript