Earnings call transcript Q4 2022

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Operator

Good morning. Welcome to the Sage Therapeutics' Fourth Quarter and Full-Year 2022 Financial Results Conference Call. Currently, all participants are in a listen-only mode. This call is being webcast live on the Investors and Media section of Sage's website at sagerx.com. This call is the property of Sage Therapeutics and recording, reproduction, or transmission of this call without the expressed written consent of Sage Therapeutics is strictly prohibited. call recorded. this that note is being Please

I of Investor like to Rubinstein, Director introduce Helen Relations would now at Sage.

Helen Rubinstein

Good financial for and morning joining Sage Therapeutics' you and fourth full-year results XXXX call. conference thank quarter

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

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

We fourth call the Chief progress Officer, who Barry prepared of and provide by quarter during full-year Executive remarks our will begin overview an will the Greene, our with XXXX.

joined [Technical approved, and for then by MDD if the PPD We preparations will joined Kimi and be Jim zuranolone launch will also Difficulty], provide Officer, Financial we update our the Doherty quarter be in our on review the of full-year an the who financial fourth for Gault, will Iguchi, results Chief the XXXX; who from Laura be Officer portion Q&A will and Medical available Chief during our questions call. will

now I'll Barry. the call that, turn to With over

Barry Greene

struggle. health more At future friends, leading of are see us implications And health generations. morning. crisis disability and patients. to what joining Thanks, work most public and by prioritizing for and Sage, as advancing point. tipping our Helen, convention reached disorders the matters potential impact today, Brain ever. cause ones and you continued firsthand thank for one matters We profound challenging neighbors this threatened we're treatments loved of brain everyone than We've to health the

incredibly globally. people development, with mood, regulators of the promising insufficient crisis. the have work millions the our potential systems. of treatment and important drug NMDA in impact key to and starts approach and a change the to We're on The exciting determined at may brain improve century trajectory with advances [Technical progressing result health the cognition of Sage. pipeline last half These is and pathways of which unlocking the and pipeline innovative function novel potential Difficulty] discovery of time over our this GABAA an is to breakthroughs that receptor been health. brain brain are were Yet targeted This a

and Importantly, position puts [pipeline] strong we our ambitions. our foundation believe team our financial us to a (ph) in further

the new on goal indications or of of being impact years time science launch to now and to our able making come. the meaningful unleash With the drugs The of potential to for millions. is lives

slide, making regulatory for pipeline next collaboration the which we're our Zuranolone, by we're with progress across milestone in to as demonstrated Biogen. Moving the latest developing

of date of expect acceptance assuming Disorder action priority As announced, X launch FDA filing Depression the Major If we Depressive by with near the this no the NDA we're review extension approved, Zuranolone XXXX, for of of year. Postpartum the August with FDA of review period. potential the we and recently our end encouraged a PDUFA

remain laser preparing will walk in in potential which of timing that commercialization detail. Chris the Zuranolone, we With mind, focused through on for more

treatment we're as medicines and of our in To developing with the overall (ph) enable access to with best innovative patients payers, will patient the advocates we're that MDD across aspect PPD. goal helping a with and that, ecosystem model be as healthcare to for care providers, commitment policymakers of commercialization a interest achieve collaborating providing be of works a key [Arch] in strategy. Our to

we now the an potential or since as updates providing topics. will FDA be We comments period, to we review look interactions forward are related to FDA not on I in label, note appropriate. like making would

we In of lifespan. ongoing. first that are all studies have pipeline in Alzheimer’s advancing These disease. studies nine include addition class four clinical With to across extensive Parkinson's PAM, at SAGE-XXX, a of investigation study to robust Huntington's, Zuranolone, which stages programs their placebo-controlled help have patients and an our and in potential NMDA currently

of neurological have neurology creation. robust and important are We're deliver believe also to some SAGE-XXX. potential like suffering also essential for SAGE-XXX, for These making we and product will people candidates disorders. examples treatment evaluated that our is our which by earlier continue SAGE-XXX potential including and as the highlight programs, product tremor progress engine in to franchise stage a great led of other value from our long-term being I'd

will To as year a confident the pipeline. particularly our pivotal the XXXX of am for Brain close, I forward look to Zuranolone potential of we Health be advancement Sage approval in

portfolio With that, Jim? discussion for I'll clinical turn current our to of recent progress detailed and call the over a Jim expectations. more

Jim Doherty

morning, good We've recent made review Starting filing and am Barry, Barry about and for in with Zuranolone depression, of throughout detail our progress and with excited Thanks, we're recent NDA as development our the PPD important across MDD to our mentioned earlier. acceptance pipeline I priority XXXX, advancements. everyone. pleased FDA

in by program, supported than more trials development positive encompasses Our NDA across from clinical which landscape package NEST is data patients. X,XXX seven the

and HCPs be may patients. a to course I'll what profile reduction exactly action. providers well-being, note potential been or of Zuranolone flexible and well Zuranolone have finally, two we clinical generally with the approved. program taken approach life for And across functioning patients needed PPD of profile, to-date I'll days, And to three for treatment including novel and about PPD, mechanism asking symptoms more which And flexibility of the a their potential overall the improvements shortly. a feeling, as early and short and MDD depressive with for development consistent in provide the and MDD as tolerated safety healthcare a to with talk in in seen treatment a rapid optionality is potential if is see that quality help we've health a in as Importantly, sustained domains across

data on it's well-being I the of these the functioning to on our for important the and as touched this during and of with expand measures presentation, well-being patients to recent our We of and results NDA important context scores. consistent me suggest and acceptance depression. were and data are Let the potential compared functioning that day highlight filing endpoints. measured but day improve in as JPM Zuranolone those referenced. for of analysis is to showing reported see What trials life, sustained completed health-related the from that integrated the here MDD you'll treated quality studies, XX with the across at placebo rapid Zuranolone placebo-controlled in PPD improvements These XX using SF-XX for an

and indicator sensations to for and potential they back off, what approved, to are an Zuranolone, life everyday overall feel opportunity want matters lives. normal stifles It's of as that. patients. quality well, health. know it closes their patients relates data patients and and see to creativity. To function. to well feel affects depressed, pleasure to a Depression The think, to of feel, that's summarize, the these connectedness to to get less We blunt achieve don't people the to person's feel want if we important help most important has ability that and note

in and patients, symptoms part milligrams in conducted label in Zuranolone the who SHORELINE interviews responded mental study open and illustrated responders XX of with substantial We over to their XX improvement six also it. a physical least of a at the were study were satisfied majority the of months. week as and interviews surveyed These that by for first noticed

of majority potential all satisfied positive reinforces positive, with be as patients were and for experience surveyed a responders about the Zuranolone treatment. This a if feeling fine, need Zuranolone were could the or PPD MDD neutral addition, In approved. retreated reported to feedback and provide with

investigational cognitive I'll that NMDA now cognition for of wholly-owned treatment Huntington's of therapy Fast disability. disorders developed our PAM, This and in the certain or drivers of to HD. for Track the potential our an as where programs lead a one was by receptor FDA impairment impairment one being of oral granted is move Disease is designation SAGE-XXX, main is

also and greatest are mild continue due with or that some and PD to globally people Disease represent Alzheimer's We mild more SAGE-XXX to Parkinson's we unmet need investigating they impairment due areas to disorders impairment with of of the lives. prevalent people dementia cognitive These and in mild know AD. cognitive become or disrupt Disease and significantly

excited basis, On continued we're about the that across we've made program. the progress

Huntington's Phase due a to in mentioned the study, Phase X people Alzheimer's study mild PURVIEW and we recently this Disease. as X the LIGHTWAVE cognitive dementia, Disease, with in a impairment as of with SAGE-XXX mild well people study, study we As earlier extension year, initiated

XXXX, patients in all ongoing We with has robust expect also from appropriate. portfolio share when and will detailed a the at start of out timelines more studies We're potential the to we SAGE-XXX to lifespan. help their advancing reading that stages data

programs, Let starting in in provide and PAM, ET of from of that and a neurological collaborator significant which receptors. Phase the treatment me We Biogen anticipate couple potential believe opportunities excited early studies ongoing preferring about X advancing X our our also GABAA development in Xb Phase KINETIC studies. the we this including tremor the or SAGE-XXX holds like with enabling completion late conditions dose we SAGE-XXX essential study year. ranging into SAGE-XXX, IND highlights, of our enrollment We're extra-synaptic are

believe and the they to We become progress over that contributors years. important SAGE-XXX SAGE-XXX will and coming also make pipeline continue with

and In brain and to fourth clinical to XXXX, objectives medicines are in believe patients. and well efforts to to health execute matters advance full-year with most our develop I closing, quarter of the what I'm our positioned potential proud we deliver the progress against that

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

Chris Benecchi

as you through made plans advancing in the and experienced Zuranolone. enabling launch if on if intended commercial readiness Zuranolone, pleased at for launch, Jim. hiring Zuranolone permitted last year have launch preparation progress morning access front. on to all that To successful conversations activities commercialization of achieve to a meaningful I'm exchange with HCPs ensure important enabled our approved, scientific we engaging goal share to to Thanks, payers the Core our of include, state and be commercialization the of orchestrate this with leaders with updates successful educating approved.

focused laser filing, launch remain strategy. the on acceptance With the preparations announcement recent NDA our our of execute to we of

me scheduling three-month for X, of review. of our expect launch FDA Let of treatment the if approved the review near action PDUFA thinking PPD and is the MDD Zuranolone. following for outline we an anticipated of XXXX, Zuranolone potential timelines DEA our Based extension end potential on without the period, date August on the

ready a is be the will approval market We of for prepared anticipate Zuranolone. that and entering

not their difficult patients care Such see show with symptoms, as normal outcomes. you'll wait and satisfied experience initiating their options. As of the on well as to longer matters, we is of are therapy as to or unable symptoms. opportunity achieving the are rapidity impaired more is at of the in relapse. with believe large XX, in functioning symptoms likely to they for a they of improvement rapid as continue negative work This terms soon lives, why families. live to Many treat who Is the unresolved their both subsequent to depression of slide patients experience current to people depressive symptoms, MDD and take these are treatment risk. millions go People as

the and a to symptomatic key here sustained increase outcomes. likelihood may and The rapid treating more takeaway of better approach depressive functional a is episode

a Given the well-being suffering potential helping new the sooner. we clinical to goal seen Zuranolone if of provide them [Technical option trial the approved, MDD treatment rapid state has that patients a to-date, with with to believe to Difficulty] and return improvement in

her health PPD, estimated Despite similarly large experiencing common need does impact can In baby. rates. an These the clearly better. symptoms undiagnosed on deserve that there in a low ability is with mothers mother's that disorder, care untreated, or in the it take families and experiencing also have overall for diagnosis their unmet mother the to and often only symptoms being but an have a PPD postpartum go may of we see mental for eight women an Not in function, mothers a U.S. one effect depression. on

and FDA to work Our paradigm with to treatment get indicated goal has in HCPs with PPD the the change PPD rates moms significantly provide diagnosis potential women approved, only improving treatment better and oral first with to with is ecosystem entire that the for approved Zuranolone, the by sooner. if help

XXXX, we remain of in we As our potential diligent commercialization and focused enter launch. anticipation on efforts

the signals are We continue mental key community see to scientific importance innovation encouraged patient in health. in on positive advocacy to with exchange accelerating of engage for to stakeholders and the also access

be access And the on to patient earlier, front. as mentioned Barry plan innovative we

PPD, those authorization. access with this for as and prescribed such step MDD successful who goal launch limited Our edits, is timely and are living complications the is with have therapy that prior

addition patient access at we right governments state physician the In treatment prescribed work, options MDD own restricted with early reforms have to right their believed seeing People outcomes and to previously is across historically treatment are best policy by first fill early nation to deserve introduced to the time. our effective Because make PPD treatment. and therapeutic and deliver touched on. rapid during as I the the

In including who Given requiring to Zuranolone, MDD a first after patients depressive add best following at first positioned patients that for tolerability currently PPD, course, if as at continuing experience for line need, treatment diagnosed believe newly for use are administered. initial who strive patients chronic with the we in first therapy therapies issues place is have or of we become or therapy. unmet launch to symptoms approved, with treatment or with PPD naive their switch launch standard-of-care other Zuranolone therapy non-compliance

treating we unmet that rapid acting engaged the patients and treatment they've in and see receptive a and XX-day course for new had exists MDD potential to been need conversations We and urgency In treatment a in believe an sustained with deliver role of to oral profound we've still PPD. a the they payers, MDD feel given the option highly therapy PPD. both

approval to the and of able and potential efforts rapidly Zuranolone to treat medicine with to goal our advance offer to gaining improve in the dedicated being these patients with their are We symptoms. continue

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

Kimi Iguchi

Thanks, Chris.

and detailed XXXX press we Our release financial our results context moment this morning. points. a I'd of are full-year some key few to that for the a fourth provide to take quarter and like in highlight issued

across flexibility position, provides with strategically cash We approved us ended strong XXXX our support if with and which launch invest Zuranolone, a the the to of pipeline.

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

operating in same was increased for $XX.X XXXX, to spend XXXX. and Turning to to investments the increase quarter ongoing in R&D million expenses related million primarily in of period compared $XX.X the fourth partnered The our expenses. wholly-owned to in of employees million $XX.X increase including to expenses activities million period the SAGE-XXX related XXXX, fourth hiring of $XX.X same compared primarily and to to support in SG&A The was quarter of SAGE-XXX. in ongoing increased potential for XXXX. to anticipation launch. programs,

with from increase continuing way. in the of our approval heard will preparations we the To Therefore, you commercialization gaining while to top to success. mindful studies we of Chris, know to be quickly and our Zuranolone we our launch the prior we're and must prepared to to end, and support continue plans transforming mid-term and long-term committed vision disciplined long-term of in begin of ongoing scale that a also care we're remain that Zuranolone, investing spend potential efforts our depression, with SAGE-XXX. focused of on capital a pipeline priority, We allocation and expect as launch. commercialization As achieve advanced for we SAGE-XXX strategy to this our remain strategic

the As and as of in SAGE-XXX part Biogen, collaboration with jointly cautionary a XX:XX are reminder, a States. our Zuranolone United developing we with

the PPD. anticipate we and and cash, into securities, collaborations to sales operations MDD that are the will Biogen in million plan, funding revenue of Looking in marketable Zuranolone commercial from ongoing anticipated XXXX, from cash ahead, on operating first current included and $X reaffirming based support our we equivalents related potential

preparing this potential time. launch, year-end providing Given will cash not including XXXX at will a we guidance be how for dynamic be,

on a sheet strong year value embark that we for as to execute build objectives remain creating developing on for making focused health. balance patients. is as enable potential The our horizon to time ourselves We to brain our remain the in strong I'm continue team on a well numerous of across best we strategic investments a Sage, Sage, pipeline capitalized in pipeline. confident will As us executing programs With on now pivotal from for position leader strength. position we milestones

of lead We the are desperately waiting that development will people that our treatments optimistic approach are to for.

over I'll Q&A Helen? now to to handle with it the Helen turn operator.

Helen Rubinstein

Thanks, Kimi.

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

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

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

Operator

Thank America. you. we'll time, Ahmad [Operator from Instructions] this from At ahead. hear Tazeen of go Please Bank

Tazeen Ahmad

my taking Hi, morning. question. Thanks good for

end would remarks, What you said the be wanted able PDUFA in I Just year. was to prepared think in you you that approved if limiting launch from Barry, in Thanks. be rate you August, be you just narrow to be the would XXXX? something that recording by be Would said clarify to can post Zuranolone, Or sales? prevent of assume think expect to it in that because would the and should would immediately the XXXX? start when calendar be you factors launching able down it more

Barry Greene

and Zuranolone we Yes, PPD that on then the we the following take for occurs thanks period. without I'll filing of X. remind we're Difficulty] could the attention. DEA we actions with a can't Zuranolone have the Look, that August accepted There DEA [Technical Tazeen, period, for you MDD you label a move during FDA approval are recorded we three-month but scheduling and official NDA sales to start with X question excited selling thank schedule. for that until August delay, really the action PDUFA that and has date

will we'll prepared happen launch year very of so. that So to be do and to excited well the towards the and end

Operator

to move Sachs. from Richter next Goldman Salveen We'll

Salveen Richter

here, their annual work price every period comment year, payer Good it a morning. drug you using or a regards on Thanks maybe question. a year? once for of pricing twice two-week With a my an -- understanding could for to at the taking just

And the I then is mix commercial mix. XX% secondly, the payer about payer think of

how think you kind you to do going drug adopting non-commercial with then be DBAs of with to remainder of paradigm? do when payer And treatment new so about help are And the the strategy here, of kind what in there position aspect? terms of a the physicians and effective you the the

Barry Greene

the Salveen. know one envision value-based they us different that help prices prices really that the that bit. agreement with will employing, return, Zuranolone certainty. want want believes certainty. in or on quickly. or concept for we that get requires they the what health-care outcomes is aspects a now a to is In provider managed. budget of we script, well want. payers into a That there, They we But strategy was Yes, in That's Chris if few a physician other want some script that that so proactive patient

about Difficulty] Chris, of there is we pricing to not year. that's per So, focused thinking They a pill, detail they get patient perspective on per understanding that per per They're sort into. you further? that comment about From per to is [Technical want per patient really are pack. think can more year.

Chris Benecchi

Yes.

I DBA is to Barry frankly key component. this, the just one think So

I truly transformational; payers and unmet with accessible really that be to have in think and to starts be we need. around understanding

think and those in as looks often understand interactions welding. the has rapid return Zuranolone impressed I patients need differently three that effects after with that's a to other fashion all a there's actually opportunity over they a been this and that certainly come so they the works, so to high a what presents acting potential time, quite of phenotype need interactions They've amongst something associated the in state therapies that days, it data, think the with that just payers course and with I unmet of you historically. something that something truly know, far, of the XX-day seen we've side than had they've durable for of in to understanding does deliver perception

patient what had In makes have disposal. complicated an simpler it essence, it takes type far may manage a it at historically very and their to they

proactive which experiments. it incredible then the value So, on an shapes that, conversation around excitement

going far sure is Zuranolone from to and in that the solutions think on what types, we're with data around regardless I Zuranolone what build the work with accessible to around really see come [Indiscernible] and from types payer up again different they that and to need at that question second in of mix payer all unmet so making and the launch can deliver what we've understanding seen of

Salveen Richter

Thank you.

Operator

JPMorgan. next from Anupam Moving Rama to

Anupam Rama

expanding are Difficulty] about Hey, remarks [Technical but the introductory on guys. of initial in of sort the curve what much you pre-commercial some comments Thanks so the for your thinking taking how some PPD? in are Maybe ramp here, of question. the And

Barry Greene

The in we're overall and and we OBGYN educating exchanged others. PPD approach appropriate to how science

Chris Benecchi

a of focus so organization. on might PPD there's you as within Yes, the lot imagine,

you a talking up moms of so in you prescribers online, If do about around and MDD, diagnosis. it's one the credit eight with absolutely significant pick screening importance just that depression so work working like with so OBGYN the cases on patients help that you of that newspaper to is and most of crisis that there basis, the annual are or to that understand where go PPD from or we're an also normal we're XXX,XXX and that see from the paramount PPD see diagnosis suffering [Indiscernible] continue other we doing part in

FD we'll leaders, a need heighten OBGYN treatment said, and interactions therapy we're permitted or oral team key would of that first one with urgency that therapy product. and one And postpartum happening and community, exchange community as approves be with affairs opportunity happily that Zuranolone -- only suffering subsequently, approved through FDA whether scientific and medical the first the the congresses it right the PPD. opinion And for are oral receive Zuranolone, I as we'll we that the the them to ready moms believe the that's And to believe as FDA that to therapy it will the going at now through be depression. be launch around that only potentially in on the of offers new treat could continue we light sensitivity And to the

Barry Greene

approved. when oral happens Anupam, available Zuranolone that that launch of the exactly paradigm is you shift out, medication around is This in like a just kind medicine. [Indiscernible] And readily Yes.

XX-day even As are of are million diagnostic get per less have Chris challenging are those mentioned, X.X rapidly about diagnosis PPD, agent year an works more PPD diagnosed, when lesser quickly with really like the certainly the that opportunity paradigm That's regimen, to to for see treatment, is because Zuranolone look indeed reported PPD. we of of moms treated. have than the physicians and XX% to you for diagnostic a less

Operator

Ritu Baral from Cowen.

open. Your line is

Ritu Baral

Good I extent retreatment sort be dual for morning, is will wanted follow-up SHORELINE just to to in SHORELINE Thanks. us domain ask color we Can and guys. of the of the submission. the update give the the about contained have can in today. Thanks you as from the SHORELINE that what data in what presented And contained confirm any you mid-year? data guys public NDA? additionally the

Barry Greene

Ritu. take Thanks, want you Yes. Jim, that? to

Jim Doherty

Yes, course, Barry. of

[Indiscernible] the important, program So provides us real-world how in and well The need used study, and year. around Zuranolone X,XXX tolerability’s to Difficulty] data has may for for SHORELINE Equally now. evaluate the first naturalistic be study it some if dosing foremost, one them approved. repeat safety up patients study follow the both designed it over safety evidence SHORELINE provides to within for design, and with [Technical to and patients

in submission. SHORELINE is component the NDA So the important an

which SHORELINE, cohort CORAL date the study the also so is cohort completes study. a The completing included data we rollover So SHORELINE now. submission. from That continues, the cohort that is in of have the NDA the newest is

interesting really provide information will with for that additional retreatment Zuranolone? some So

Barry Greene

Yes.

we seen quite informative So an we'll a be -- multiple data is you largely used filing, We'll that Ritu, from know. when SHORELINE the update, database. get times. which And Jim you've will in update so today the be on NDA and what's that it’s safety will as essence we have an X% mid-year, think said, let

Ritu Baral

Great. update FDA at be to And submitted time? that will that

Barry Greene

data communications including on updates SHORELINE. with regular There's FDA

Ritu Baral

Awesome. Thank you.

Barry Greene

Thanks, Ritu.

Operator

from next Stanley. hear Piper from Yasmeen We'll Rahimi

Unidentified Participant

Yas. on taking Thank you for This [Chuck is our Miller] (ph) questions. for

mentioned study is, the So of timing the press cycle color second first one expect landscape when one the related little you and to the life And economic that see the a details on that in innovation could for should of and release, provide health more design the studies? you data next study? to bit we is if then

Barry Greene

Thank [Indiscernible]. send our and take you Yas. to to best you Jim, Yes, want that? please

Jim Doherty

Barry. Absolutely,

we're lifecycle at not management providing additional on moment, any study. So the details the

is scientific So a referring (ph) there's and additional lot out conferences in that for of data coming the throughout publications XXXX. [ATOR] you're Zuranolone key data and to

Helen Rubinstein

Thank you.

can we question. next think to I the move

Operator

from hear Needham. from We'll Ami Fadia

Eason Lee

Hi, good Ami. morning. taking question. This Eason is Thanks for Lee on our for

Biogen working Biogen's call Thank its earnings you comments could positive with opportunity. the you. prepping all on be details on So on more how market, with to like some communicating you Zuranolone continue FDA, to et Maybe provide yesterday and the are together regard payers, things cetera?

Barry Greene

leading looking larger coming PPD. help paradigm of been in Difficulty], suffered of it Yes, very add treatment Biogen given experience Yes, on of create partner. opportunity has his [Technical for partnership. the question. Eason, in really and we're Viehbacher from an strong already Chris bullish millions it's thanks to well his depression terms leadership depression. his the in for we're from was start, as been minded the shift on pharma, phenomenal And Together, experience a with as like board, And the in Zuranolone the we're to an MDD clearly

I'd say we're XX-XX working a in chain from [Indiscernible] CMC, a perspective, development, in it's step regulatory, commercialization, step and the in the U.S. we're in supply how U.S.

to prepared their well launch together, approved we're own. if So

Operator

from We'll move Jay next to Oppenheimer. Olson

Jay Olson

physician scheduling expecting to drug in remind Hello? what Zuranolone level will Hey, the perception for for Zuranolone? of the DEA you and you're patient you us and Thank receive of how thank and progress the Can and on impact update. the scheduling you. congrats the launch

Barry Greene

question. for Yes, the Matt. Thanks

of neuroactive the be data anticipate of in that confirm supply IV medicines the class to active will What two view will across -- pharmacy. And a the understand to drug three-month we drug. management the and were supply our assuming handled given agents after approved, attendance steroid with chain, the year ingredients, that So Zuranolone raw we targeting that. a a batch people are these is the GABAA, be materials, that process has need [Indiscernible] DEA how schedule schedule to chain do is lot

terms of number already. In that there's their a has of prescription millions getting our prescriptions physician from audience DEA patients of millions target by are to a write for physician, drugs written scheduled and every being

don't issue all. So really an at being keep

Jay Olson

Great. Thank much. you very

Barry Greene

(ph). [Jay] Thanks,

Operator

Laura go ahead. Wedbush Securities. Please with Chico

Laura Chico

to good little the Any flow how the more Hey, handled commentary the patient patient on to wanted one setting? I'm back to additional for is I Thanks kind commercial guess morning. more in to on for question. circle offices are commercialization. authorized? trying a a be trying what responsible management that's be around but envision and trigger I that's to they of or you patient logistical, taking who going bit would process? a management little the Thanks. to How be the understand bit to I'm monitored to little follow-up refill a going what understand refill bit in be is and more managing patterns primarily going

Barry Greene

Yes. Great, Laura. that's And question. important really a

Zuranolone of me patients how and another where patients change thinks primary rapidly have are treat [Indiscernible] folks, tools they flow. respond or the the understand think that patient or Laura really all we practice enhances. it ask they more doesn't managed So the It's who's these let today. folks treated these most But she of or about psychiatry care tool to than

Laura Gault

with for treating the in with my that approved, you patients fit how are So really it’s thank belief ATPs question. to It's going depression. currently is Zuranolone

another undergo there if patients will Difficulty] continue of they time they then that think [Technical Zuranolone and physician Difficulty] and with treatment is will suggest occurring, end course a compensation. that patient reemergence I another [Technical symptoms another monitor over to

a the use [Technical And is short-term that is the that here us. to the And that with are have part is think depression a hear either past. statement we discussions things a than Zuranolone physicians, we'll is that in armamentarium for see It rapidly drug people I delivered Difficulty] from works what that highly forward. to valued. that what that moving been important to the drug has able And durable the tool effect. doing the of different physicians a is

Barry Greene

misconception, maybe support that median that on put a flow antidepressant and six who system. the and out, today those The medication of that to only don't, medications the which on as through don't of seven But the a belief, they three But a patients two for the to the a to continue all question, a are seek just of given new they and antidepressant, are patient different sort comes a a a of some all weeks (ph) patient chronic over suggests round treatment And and in, year. Laura, discontinuation some common leave your data medication [PDC] is it's on months data is that the some and that. well. that stay Yes. treatment base

about just today So think it. fine. It's like on they're just medicine, someone's not. not They're chronic

rapid Zuranolone really said, patient, the monitor you of as effect. the Laura potential how Again, change doesn't we So that patient. enhances think with that treating practice

period come dark feeling also write be asked see other a tool they're and might You any for and and about refills. might anxiety I called doesn't their already. some and pharmacy me, If around refill just of a insomnia ways a be but today. better extended will variety it you know, happen, elevated like with try if have for refills you. of drug More scripts it they're to work, There can refill and that time, again. come back, can patients, mood, refill Instructing into

Laura Chico

Thanks.

Operator

go from Moving ahead. next to Canaccord. Please Sumant Kulkarni

Sumant Kulkarni

Good for my morning question. taking thanks and

rapid is relatively Zuranolone So acting.

have feeling in they of away they therapy product on in year So the either patient, lead or have have completing were might large distributions this patient you potential depression pricing any per the the that simply important course implications flat XX-day data are selling and to could other had sort versus looking taking before dynamic pricing action around setting, SHORELINE because price? stopped that I'm of gone full because discretionary patients and the asking to payers sampling do have may per of at and maybe better. a

Barry Greene

Sumant, for the Yes, thanks question.

on took to better. patients patients, Jim Obviously, who a been a drug large ask feeling it for happening. and specific period are I'll of data. you're that's might So of talk problems when about time But -- so not because they're over stopped, part treating X,XXX what's there a

don't lower That full the feel of course. “save be believe rest days complete really like in might are patient and where tract you as dynamic three take but or there's you for their to better, a to respiratory have pack”. Just we going instruction total Zuranolone of And the a would if much Zuranolone. your for infection for the prescribed, be four

there So will the the complete respond And be as instructions XX-day the week and -- remain pack. that to complete data are responded. those X supported

that could big a plays out here. we So dynamic give really that think don't

Operator

Guggenheim. from Suneja Yatin from next hear We'll

Yatin Suneja

question. for Hey, guys. my Thank you taking

Just a asked that they following on up earlier. question

is sampling? PCP Can profile to could of your of short-term drug talk to a impact the you, the have about you probably sample. Thanks. setting? just the de-scheduling relevance the ability maybe and you in that especially limit So How

Barry Greene

Thanks Yes, for the Yatin. question.

project. talk Let overall me our Chris to ask about

Chris Benecchi

so there's experience think different number from thinking of getting a we're about with medication. ways physicians what that Yes, we early about, the

yet that really seen a experience an different we're team about from number thinking the those impact we it experience major have sampling While going don't on they we There's have, communicated experience, the way We been we think respect it's scheduling, of investigators we've Zuranolone the to know so that that to recognize only sampling. anticipate that critical. with not extensive this the DE to was ways that haven't program. physicians that is a having that impact that. think and have profound through about has With

to alternative sampling two some There's as there states well. around physicians ways may experience sampling have While stores. one be may or and that language get

vast that impact going way a that to that's array can see we launch profound a So going in and scheduling, getting we really position we employ have experience. see meditation. in don't [Indiscernible] from we the to something quite would be that of programs that experience DE something is early on that, think the as any And

Operator

next Tim question. William Blair has Lugo your from

Tim Lugo

taking for Thanks the question.

For early launch? the hub or physicians during central any of launch, access the preauthorization of are with a kind going deal have may deal to part hurdles set the you up with to to

Barry Greene

that a we'll thanks Look, a the that author that imagine if -- with -- question. we to very in for script Tim, there's the place written, drug. gets everything patient from -- sure have to we deals prior the Yes, steps the is make very strategy extent robust channel

So and up in set look, place. that all will be

Tim Lugo

great. Okay,

Barry Greene

Thanks, Tim.

Operator

to from Bitritto-Garg Citi. Neena next move We'll

Neena Bitritto-Garg

I X wondering guys. And Hey, on in Thanks. study. could for Thanks you front I just update enrollment give an if had up a you faster enrollment taking if pace? the KINETIC to there? some measures what actually question us the speed took have was question. the of you're just my resulted a on seeing on

Barry Greene

want Jim, to for that? Thanks, question. Neena, you the take do

Jim Doherty

Neena. Thanks, course. of Yes,

As for study we're X, on you Xb very is we're completing QX currently KINETIC KINETIC mentioned, currently enrollment tremor in opened XXXX. The the and enrollment focused of completion X study for central in late Phase Phase program. the anticipating X

of and I've of challenged clearly KINETIC study, across being spoken number out those factors CROs the that's a one some was have industry. something As at staffing seen pandemic, about of coming previously, that's X challenges the sites

a anticipated, also a bit we pace than protocol. in We saw specific slower some due little criteria in enrollment of had originally to

are we the we modifications right population and there confident -- finally, positive are made ET trials mentioned those going that program as multiple are But a modifications we're patient And impact. targeting to now. similar we having that previously, a some that are

XXXX. expect we say, in I as enrollment complete to So late

Operator

Douglas go Tsao Wainwright. H. Please from ahead. C.

Douglas Tsao

taking Hi, questions. good Thanks for morning.

need do and how Obviously, study? like are lot treated limitations be the plan and payers fact IQVIA just forth given sort to with And do obviously you of order or so plan there patients just curious, a understand a how and post Zuranolone. marketing data. curious, with that forth in I'm so Just switch doing on to you frequently patients

and be Just frequently plan treated? you Thank long-term over you. understand the patients do need the curious profile how to to how

Barry Greene

Thanks, question. Doug. Yes. important That's an

the on the largest study this clear. pretty So and and impression Jim on what we earlier [Indiscernible], commented are as naturalistic data know today is, SHORELINE is

real SHORELINE what world then out two world while only of the course we exactly of see get required required to point. those as and initial of for is to SHORELINE this the real treatment, calendar that close treatment course for we number respond is isn’t year. XX% if And in or one as majority Now, the two-week

that's how So pay real we can it believe out that world.

time, period understand whether is we'll approved, Now -- we number And over will of place. registries, work ways have two-week have we'll over at there'll or hand. what's happening a we once course, data to of payer it's a agreements be so Zuranolone how a sources will well, population as collaborations, because of certainly a value-based us understand Those different those informative time. courses be many to of have number for needs in

Douglas Tsao

as Zuranolone Physicians, to an as on? a switch? do a a use as they they're Or sort going do it to you get use initially sense monotherapy of add want of

Barry Greene

top in with the have views. hearing with different good antidepressant. investigators, with our antidepressant -- a we we're that stable as a on data that news So Zuranolone the exchange is we we and monotherapy, scientific potential prescribers And and of have co-administer

to feels to for Zuranolone co-administration. So physicians might use medicine appropriate as -- the it heard suffers depressive patients want have We've to physician [Technical frequently that the we young Difficulty] patient. someone from a for feels episodes, such prescribe they certain adults, their want as patient a use they as around appropriate some as the a the for for monotherapy

optionality their provider the set healthcare support and to the have we can to patients. the data So way a treat

Douglas Tsao

very you Thank much. Great.

Operator

Marc Goodman to from next Securities. move SVB We'll

Rudy Li

Rudy have This is my on for line questions I two for Thanks question. for taking Mark. SAGE-XXX. the

lower the study the LIGHTWAVE study and DIMENSION other Well, dose? dose the fixed initially X.X So dose using milligram. higher two uses by followed as

the talk about can rationale dosing You the for selection?

inpatient talk settings? between And about you using that secondly, can Thanks. difference the versus patients outpatient

Barry Greene

from Rudy, and to first-in-class Parkinson's and we're excited The Yes, Huntington's, diseases, cognitive that XXXX. well including really neurodegenerative program we're in Alzheimer's. is really very for the question. the as impairment we're excited thanks NMDA program across have SAGE-XXX Look, that data PAM progressing studying for by

of want to Jim, talk terms your patient? in specifics, about out this you and In do in, dose

Jim Doherty

studies about different X is you're Barry said, XXX Huntington's Alzheimer's achieve excited disease to a exposure three five the for here. disease, indications. And referring of level really currently disease. what running that Phase Barry. where dosing And across certain maintain and strategy very the -- to and we're as SAGE-XXX. Absolutely, We're Parkinson's

matures, is And program as we are so what you're doing seeing the that.

a over maintain dosing of for in three-month to study, dosing case is DIMENSION the achieve period is which level. that goal the the and So

both this a to really at SAGE-XXX from allows looking are program, point safety of outpatient NPK studies for perspective them that. profile We the SAGE-XXX do at the

studies. studies outpatient So all are these

Barry Greene

we're learning benefit memory Yes, risk that higher SAGE-XXX executive I order would and and improvement for We're extremely just Rudy, incredibly function broad. cognition, clean is seeing add the [Indiscernible]. seeing it's rapid in, in

to we're move excited that continuing about So really forward.

Rudy Li

Got it. That's helpful. very Thanks.

Barry Greene

Rudy. Thanks,

Operator

Gary Nachman Capital BMO from Markets.

open. line Your is

Gary Nachman

Hi, good morning.

possibility then where way With an for all has the with filed, does review approve for it both for timeline? change in you been But later priority together. split And is Zuranolone, those would Thanks. And FDA first, AdCom, possible priority approval PPD data? to review obviously up point NDA and the you you're out? find the that indication still think see an the and for a one there's and do at to then other more the a that that MDD looking if ultimately wants at

Barry Greene

Hey Gary, thanks for the question.

let So first. me the part take second

both and PPD. we think highlighted, the an we filed you MDD approval for As both MDD data for PPD and and warrant NDA

current the as our So advised with and time at that's thought along that. well

is In in if was that the unmet the the it FDA solely really data terms from highlight decides, if with here have advocates patient typical FDA, needs to that AdCom’s out around AdCom, he's devastating is and there a they of discretion depression. of

not decides approval, we'll FDA we fast of that's to too. So the they a like be if have well and prepared signal a that an AdCom. AdCom If hold an

Operator

Moving RBC Capital Markets. from Abrahams next to Brian

Brian Abrahams

be congrats Thanks if Thanks. your psychiatrists to progression? targeting expanding I'm into the on primary on for Hey, taking about metrics you guys. could morning. shape that curious moving potential the might launch my you feedback for initially setting? and Curious, it on how the views acceptance. all care and question you Good the looking progress from talk focus latest and and gate ultimately to might investment filing and what

Barry Greene

we're as and the those hear we we’ll granted depression that write we Look, willing are. you're are Yes, of thanks it, that those excited seeing that for the world prescriptions. Brian, advise focus we and as thanks really And to really providers prescriptions, in of particularly patients Glad a question, information have live to knowledge strong with healthcare so on are congratulations. good larger to psychiatry where irrespective offices the we insurance patient that right [Technical lot then a and strongest we this focus. those to first coverage see our these the when of has flow think expand patients, be will that -- rapidly taking. will on we'll We're that's is success, get focus the that approach certainly and be Difficulty]

Chris Benecchi

both with group PPD the as disposal, MDD. And we're level of forward. a there metrics we PCPs make have to and OBGYNs, don't to with that like I think right they as have on we going we level And that the you said it's patient scale you'll a want is number that physician look of very but that piece Difficulty] data based calling patients see psychiatrists, to a I at about our be focus continue [Technical teaser more time the behave on PCPs we'll decisions success to at be on lost. do also

Barry Greene

this. able name. we're like I'd we're the living by that are of rental with understand add happen also that's absence the going believe Brian of world to patient going patients and in activation Yes, We again kind frankly that to drug that to

Brian Abrahams

much. Thanks so

Operator

James. Raymond from Brill Danielle

Your line is open.

Alex Nackenoff

Alex Danielle. our for is This Thanks guys. question. taking Hey, on for

negatively what's work this efficacy? front, in you're anxiety resistant their perceptions on patients would now population? words, might feel do coloring initiating strategy. formal And to you In that and not towards know depression depression But in Thanks. gating Zuranolone treatment commercialization I a that think the So trials clinicians factors their targeting bipolar? you resistant to risk of just initially do TRD? treatment trial for that in it's your skew Zuranolone in Potentially other

Barry Greene

Yes.

with I'll so about in second me first, PPD so start part great. unmet is the believe Let talk that need Difficulty] the we MDD and of [Technical

If patients. depression, focus should with patients million diagnosed that X talked the in new -- with treatment X.X That be X win we That unmet can to can is in our need, millions help options As year. really the about we million for so significant, dynamic looking so pressure remain million MDD, for of patient we foreseeable future. will significant. population in moms

at indications we'll provide points time. of later future sort So in

focus win trying can. now, help right as is as many people depression, in the to we But absolutely

educate and launch in terms treatment is first we'd with MDD, that used, be should approved switch that drug only target they're And patient as if Zuranolone the standard-of-care. adequately should already PPD, Chris oral treat In first at used approved, highlighted whatever to will in be not our how only be have of add our specifically controlled The to is to Zuranolone oral PPD. first [Indiscernible]. being physicians as your on the or taking like the

Chris Benecchi

Yes.

use, what could what all new where I'd to to think later. have just physicians Barry, we not use have happen, left of if across idea despite paradigm. agreements designed only that, But I products agreements. proactive that the physicians the to of I really treatment to places and of of access Proactive are the things positioning value-based different see here, earlier add in ensure value-based identification is areas appropriate the through treatment,

you that medication utilization. new have later edits, authorization it prior which don't and ultimately So push step to can a owner's in the take

to So it's physicians it across to have want use stakeholders access to the -- we and so launch. really process really make work ability important all sure the treatment where that they that

Operator

from Joon Truist Lee Securities. from hear next We'll

Joon Lee

Hi thanks questions. our for taking

lifecycle forward you management Looking data additional package? what to mentioned Zuranolone. have Thank Can mind? you in you Difficulty] quickly, you. share [Technical get for also from And

Barry Greene

for Thanks Joon. question. the Yes,

lifecycle on more coming not we're management. So

have commented of series we we'll a As call, regular earlier the the with on [Indiscernible]. updates

Operator

of today's for Mr. that, remarks. over I will That call. Q&A everyone. With will the conclude you, to closing Thank it Barry back turn portion

Barry Greene

fourth us again XXXX morning results. joining and quarter for Lynette, Thanks, everyone and full-year to to this thanks review our

of in partner's the thank fourth progress from and the in dedication everyone result our is Our quarter our direct everybody. throughout I to so XXXX and want and organization, teamwork

of wonderful health, need. mission critical everyone we position Difficulty] as across development Thanks and launch [Technical medicines progressive again As activities in we to patients for advance transformative strength have maintain our advancements, we and brain make a develop a

Sage Therapeutics (SAGE) 16 Feb 232022 Q4 Earnings call transcript