Earnings call transcript Q1 2023

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Operator

Good morning. Welcome to the Sage Therapeutics' First Quarter 2023 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 conference for XXXX morning joining Sage Therapeutics' you and first financial call. results thank quarter

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

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

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

will Financial in quarter the the Jim We Officer, by will portion Chief and Chief joined review PPD, will available preparations we our will Officer program, Chris our Gault, activities be Business also launch will our Chief Laura of call. provide be progress during XXXX, Q&A MDD our Officer, results Iguchi, from Officer, Development and potential Kimi review will first on zuranolone Benecchi, of who the be and for our who then update across who development joined Doherty, an financial our the the Chief recent Medical

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

Barry Greene

brain thrive. so by most At morning. our everyone every deliver what patients, driven matters and are thank person health you Sage, that this Helen, us Thanks, can medicines joining mission to develop to we for

Month, to has health urgency and Awareness We do to never marks is work greater. that think innovative the effective scientific challenging differently brain an medicines new for need by Mental reminder and treatments. Health we month which important as acting This develop convention this been with

the more and that than reminds now the is proceeds recently leading World shows for must that to cause Organization Health challenge do increased Alarming U.S. Mental is trends. know, young lead working those Awareness a depression Time by disability patients. problem, by Month years people we This in us the grow. of all of and XX%. have prime in deserve suicide reflects published Health way to difference for we the these making Depression as People with all research the better. to in their more rates continues

pivotal a is for a XXXX off and will Sage already to year be strong start.

focused launch We to of depression are and zuranolone for of way achieving if [ph] potential on vision our believe transforming laser the our preparing we're brew on treatment the zuranolone of

chemical result health We're the to candidates a value entity is our new of our believe and that help advancing product robust people several creation. of of comprised also significant long-term disorders from pipeline deliver brain engine. holds potential suffering health millions We pipeline brain development our

launch our further puts strong come. Importantly, our of years in for ambitions being financial pipeline backed that position to able foundation we the to or work a new new believe is a with by drugs us indications to goal

milestones the horizon. we on Looking key forward, many have

review Xth. by in August filing of is PDUFA First, the NDA with and MDD for PPD a date zuranolone under FDA action the

this FDA be label, review comments zuranolone. making mentioned period, on I potential interactions we'll topics last detailed the not earnings during for or related other as Now our during call,

and PPD. and of prelaunch of that of health are a the of care and MDD We're continuing engaged we in care prepare model advocates in collecting we providing with commercialization interest permitted zuranolone, with from key for Biogen the patient best As discussions goal and policymakers potential works payers providers activities. actively answer patients and a with insights

important commercialization have Additionally, key depression These our highlighting provide additional patients, provide data negative and Biogen Chris team the an we later believe activities are patients in launch will several and society. to call. and on SAGE-XXX, to our their details benefits findings to presented families which of and with shimmer collaborators advancing on backdrop meetings, We and the also ongoing holds differentiated impact provide ongoing essential at preparation. service. other our movement planned to potential

making Phase a due PAM Neuropsyc. and and we're program. II turning Parkinson's years. wholly We're Now across working SAGE-XXX disease, where MDA and to leading and during SAGE-XXX with with prime executive deficits studies diseases. We're With impairment cognitive continuing to function devastating our to execute SAGE-XXX, owned condition progress manifest Huntington's also Alzheimer's

I'm in XXXX. very lives forward science making progress potential our to now so this continued meaningful far for close, pleased look The impact achievements our to and with the the and of To is a unleash on millions. time year

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

Jim Doherty

everyone. good Thanks, Barry, morning, and

quarter, pipeline made first progress on programs, have Over for execution and recent and the continued XXXX. detail throughout our our to pleased am plans we I advancements important our

the with in and zuranolone start we're MDD launch where continuing I'll PPD. depression, potential to prepare for of

of support with vision way insights Throughout the from set with engaged with we from including journey key zuranolone, many thought this and if transform is have know gathering medical Our is will zuranolone, the approved, development key depression to experts, broad key treated, a we require stakeholders. leaders.

clear. of treated been it are as recognizing nature treatment-free the has between episodes. depression periods They could episodic feedback Their be means increasingly with needed that

to a engaged remains the to to them unmet their patients. we've deeply and sustained the and both discussions about matters as effect in critical depression, to continue in need rapid physicians potential that Additionally, highlight achieve

the We of feedback main clinical strengths zuranolone have data. on the they consistent received what consider

program clinical robust development a First, approximately X,XXX with subjects.

in an as early Second, rapid clinical seen as in of onset action symptoms depressive observed day improvement with three. trials

tolerability depressive and and patient safety zuranolone PPD. cases in consistent in across profile. populations improvement multiple Third, observed a around symptoms use MDD Fourth, and

the zuranolone's of treatment. scientific physicians has this role to that clinical as is believe profile clinical date on that XX-day note approved, impactful course the data particularly forums play will be physicians seen important an zuranolone. to oral potential in with We continue to Additionally, given educating zuranolone

continuing to highlight economic health impacts Care the important with also families and Managed Annual can their presented burden These In data MDD research associated Academy substantial economics we of Meeting. March, are the have negative Pharmacy at data the outcomes on and society. patients, We on significant reinforce depression.

burden XX-day during following MDD period someone in and MDD adults the reduced highlighted all antidepressant. presentations the current home to the life increase with quality associations also other health-related with and These the living extends showed and in between with treatment health-related scores a They of that MDD. the related costs symptoms

Taken have MDD together, and quality new significant suggest potential and these an unmet and options that results we life the of believe reduce for improve burden to treatment the reinforce economic associated need depression. opportunity in with PPD

the provide advocates research presented Combined these treated. and published as over important our depression way in with transforming last data year, the pursuit engage team has we backdrop and an to policymakers of patient is continue with additional payers,

the granted We to by orphan as disease. These prioritize FDA earlier SAGE-XXX, we XXXX, owned for Turning in currently HD drug the quarter where SAGE-XXX, Track lead enrolling in designation designations advance lead been cases September which the announced EMA, strategy are our studies. indication both by PAM, Huntington's in to neuropsychiatry. three this designation NMDA follows Fast has that the wholly receptor granted our

a it homogeneous NMDA indication thus impairment. with an is is Population use was to than genetically of scientific rationale populations a disorder is defined And PAM. chosen receptor other the as cognitive lead there and as the strong more support

regulatory space we HD, if of a believe in novel orphan more successful, nature a orphan pursuing potential the ex-U.S. the stage the by Given seek trials our and globalized concentrated we an pathway to have first. to pave strategy are

in patients' disease, research U.S.-based and recently across released patient at daily demonstrated data impacting HD and CHDI in journey is productivity. are HD interim life, a We patients examining of or This patients impact into real-world data impairment on ability The cognitive - Meeting study to independence quality presented activities HD Annual collaboration with new that continuing independence function. [ph] – the HD the all cut interim work stages of Technical their experience living of from with XX of the the and functional study also health-related

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

start the studies lines ongoing said, SAGE-XXX we'll to out and data with detailed time As share in we more when XXXX, reading appropriate. from we expect

Along with SAGE-XXX the in is Our for investigational essential late receptors positive collaborator, portfolio our of our with ongoing Biogen, movement an tremor. Phase like year. enrollment X candidate, neurology XXX SAGE-XXX, IIb in includes modulator to GABAA of study allosteric dose-ranging disorders kinetic complete potential this lead the treatment also significant goal our is

We are to I next our studies preferring advance PAM balanced with XXX. extrasynaptic GABA SAGE-XXX, SAGE-XXX an also as studies PAM and for PAM fast-acting as continuing NMDA GABA a IND-enabling well Phase SAG-

the Sage candidates to are potential with target all characteristics product well create we that program believe successful. profiles the Importantly, with to believe are if invented suited we long-term new indications of that significant pursuing. our product entities differentiated designed we're the value engine, our pharmacologic chemical is We have with

throughout to the providing I continued a of remainder the to off year. already execution updates look on is XXXX and clinical strong our forward start,

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

Chris Benecchi

on collaborating HCPs for PPD filing engaging to the in all payers, I'm scientific MDD closely updates exchange continuing of pleased zerenolone be agency with we of review, under our to morning Jim. with With with preparations advocates. to and potential our Biogen for permitted are patient with advance you Thanks, with share commercialization this and discussions NDA zuranolone.

steps zuranolone. launch internal commercial capabilities are a experienced of hiring Together, these by whose towards our expertise. our expand commercial we breadth knowledge successful important Further, of goal building and rapid are further of depth and our leaders

approved, on no potential will end PPD date that zorenolone period, a DEA ready near zuranolone launch if there to scheduling about Xth, will the PDUFA market the extensions of of of expect differently. August be Based anticipated XXXX, anticipate the entering action X-month review if following of and and prepared are treatment our an and is MDD be think we we

way is the transform to depression is ziranolone treated. with vision Our

Focusing babies in nearly each an the of families That's their times PPD parents. who newborn patient mothers X.X the one symptoms of during population, the estimated X X adversely new should in million and impacted for the U.S. broader be women treasured first what experienced most and on year. PPD new are

to approved, help. need zuranolone, who holds believe mothers these of first-line be if many unique potential for a We therapy

offer we for catalyst PPD, zuranolone, the successful, help the from and to diagnosis first Our to entire believe treatment goal diagnose only require HCPs will critical with to oral it treatment improve that we're indicated option, PPD with change tool and diagnosis this with treatment understand are if PPD. if working zuranolone ecosystem XX-day an to provide specifically We and as care may oral rates. the mothers health paradigm. in serve We to as a suffering HCPs for and able is

we given Based current in payer treatment unmet profile if seen course. clinical compelling to given like is the the a in high populations launch patient zuranolone, feedback believe start that as market significant our in the entire while certain among there especially MDD approved, young inverse focused need population, on XX-day a in option we'll adults for the date, understand potential as dynamics. way first-line the that treatment MDD We MDD, need landscape program transformative to

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are the a million market add-on all advocacy X.X a to us to government portion switch While use, strategy. much later discussions launch restricted first those to to affairs often believe payer, entrants branded and the help of patient point our or many that HCP, MDD with for treatment potential

of to designed to and data we is quickly MDD. determination to Further, standard believe that success, over care in anchored and our strategy of become focus time, the has with with treatment scale launch the potential zuranolone our

and achieve prioritizes launch zuranolone MDD our PPD, for key fit-for-purpose deep if with vision engagements must a we and in To that stakeholders. execute meaningful approved,

a efforts and unite to are omnichannel our interactions. core planned data content, with We from designed media advancing digital in-person

strategically our to increase and agility is sales through efficiency of Our interactions ambition the execution force non-personal and impact, promotion. our

reaches vital approach customized, to It's PPD people are to also work with with at We powering which predictive are this analytics, omnichannel intended personalized MDD stakeholders. launch. directly our that key information deliver and

education of and education efforts that approved by Our advocate planned resources, with appropriate engage and self with when it many are directly discussions they're HCPs. PPD in prepared with our people so ask to if is about will We to name. are with believe zuranolone aware and and their information zuranolone them armed intended HCP MDD

Further, be in must zuranolone accessible. order to be truly transformational,

Our encouraged through enthusiasm market engaging To interactions. payers access is those we've interactions. seen we're permitted team early the by date, in

if PPD ensure where with zuranolone is requirements. it prior to and and is approved, goal, can with Our prescribed patients it step minimal MDD get authorization edit

of As we and that we're believe provide value-based proactive payers such, zuranolone. that are access use may looking the for to budget continuing explore agreements the for favorable help predictability

the driver zuranolone the launch. experience early We MDD also know of in a PPD of treatment with and be will successful that

impressions PPD with for providers. patients positive Our both and first goal to and is MDD enable

those and patient which support support help we journey. programs, zuranolone if positive MDD will their zuranolone to experiences PPD we access is patients and approved, To treatment service believe with navigate provide plan

and to continue to launch for launch we a we year diligently for of working living look given them. from a with and our impact for sense deliver depression with As highly sharing prepare additional it suffering and real-life on expectations forward zuranolone, option people are those details a on and the later plans treatment MDD those to PPD love this are and who novel potential of of motivated the urgency

depression of by We is the is to inspired zuranolone will for be treated. zuranolone vision way execute transforming ready if approved, our

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

Kimi Iguchi

Thanks, Chris.

launch made and far our XXXX financial of position across Our morning. detailed a few key this in with context are first progress cash highlight take release issued like so to We the results our moment a have quarter activity for provide pipeline year. a the preparation strong press points. first this I'd and to and ended quarter important some

use to its potentially We proud treatment able I'm women ZULRESSO. have forward approved. zuranolone, to of with also in since if We seen continued of hundreds growth PPD ZULRESSO. help been in we've that PPD the with look expanding with launch, options

development a of to of we from commercialization as robust and a support our executing of macro the in position strength prepare potential environment difficult in We're pipeline. zuranolone invest

States. cost As developing our a a collaboration with the in reminder, and Biogen, as jointly with sharing part we're XX-XX zuranolone United of SAGE-XXX

scale we a We to mindful depression, and our the vision be of potential launch. will strategy and know success, transforming that quickly to of achieve with care must of to with we focused prepared begin prior remain capital allocation

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

of to as Turning first the expenses corporate the quarter was our to support the to last operating XXXX. million of employees The operations. of $XX.X R&D hiring first related growth technology quarter to primarily costs compared in were the expenses. such costs in year increase infrastructure and information

compared to of ongoing XXXX. the was related to were in The hiring launch support the increase primarily in zuranolone. the employees of of activities of last first year expenses to anticipation first $XX.X quarter SG&A potential million quarter

commercial that sales equivalents related on potential milestones anticipated also potential guidance marketable operating $XXX plan, revenue Biogen based We're ongoing to first will MDD we million of anticipate and collaborations support cash operations XXXX. our the and and securities, achieve in the current from to into funding totaling Included from zuranolone in is this PPD. reaffirming cash,

this of expect guidance how dynamic time. preparing a be, cash we're the launch, at beginning providing given said year-end potential we for not As to the including XXXX we year, at

and pipeline continue the that throughout commercialization However, our and we our ongoing year. efforts studies will our and health for increase planned advanced expect brain ongoing planned looking spend forward, we as

us position As our crucial confident catalysts, strong from execute will I'm that strength. balance enable sheet we to approach a of

We support the have focused and to zuranolone multiple horizon, laser on upcoming we're potential of launch if value-creating preparing approved. milestones the on

as further a by remain establishing investments balance to programs in and ourselves developing brain we making strong Backed sheet, health. a committed in pipeline strategic leader our

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

Helen Rubinstein

Thanks, Kimi.

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

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

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

Operator

you. first JPMorgan. with from Thank take question Anupam We'll our Instructions] [Operator Rama

Anupam Rama

Hey, questions. guys. Thanks so much for the taking

for the focus meeting? the medical be here? I And can of will much midyear that for Thanks the forums zuranolone, what on remind with taking comments, medical medical question. scientific so be front? this update us the the on important education SHORELINE you conjunction like Just presented your of really think kind in will highlighted you in remain

Barry Greene

Thanks the Yes, for question.

important. share people critically of forum feedback volume I So point, to Sage good to growing excitement collaborators health excited the as for for your And come a science know it's that's last congresses, and you've your from to continue of approved the just of on notes, if grow. It's noted and get activity at providers. and exchange in continues growing. care Sage as of some information and success exchange are People very the and zuranolone market, us

critical to a update I'll further. SHORELINE we What's Jim the include a new that And that. is of patients gives will the rollover bit piece ask you from and CORAL. little comment

interested in want in you Jim, different patients roll have saw whether anti you zuranolone I'll significant, those are Phase the a to or So and X. at clinically over III an Those CORAL day comparing remind results, take do was two opportunity differentiating But to arms. the and SHORELINE meaningful post-antidepressant and to we're that same the very slightly positive antidepressant statistically we study that? data

Jim Doherty

of it. SHORELINE absolutely. part is part Of a information important so we overall out in program course. And thanks for zuranolone really the because Yes, question, of study the Anupam. much The get

questions data is. large importantly, real the world. answers more we But even course, really of in of get how Of it zuranolone the amount a a study used number perhaps around how safety given fair

you're And to amount as through cohorts CORAL go patients is the study. study. as study have Barry increasing so roll of what that patients very of study. the To to said, are large from There last scientific data through to presenting the is exchange cohort are from multiple what the an the gone we're seeing Barry's a point, opportunity over have

And have study. plus into arms, course, a arms those standard study of is, enterprise X enterprise another and CORAL with care interesting care really X roll there to of zuranolone, opportunity both what's an standard of SHORTLINE

good a the been starting get So and we time. first zuranolone you antidepressant have at subjects a then really look standard for on

the interested we're see data. to So very

I you see continued study time. to around expect think quite some can presentations SHORELINE the for

Helen Rubinstein

going We're next to take our question.

Operator

We'll Baral go Ritu Cowen. with PD next to

Ritu Baral

with Good about morning, patient heard to couple Thanks for I that a the support, for believe One, program. comments service to Is taking a I support? access see a the diagnostic support, ask strategy. this going like specialty something be of mentioned guys. diseases question. wanted something commercial paperwork like zuranolone and I about reimbursement that on more we Chris, you hub

and holistically, or then ask correctly? be it patients a the like with something clinicians Thanks. between gates like expect that comments something this, your mentioned to And just sounds their given DTC about of you doctors that Is might element Barry, you interpreted out that there I this.

Barry Greene

for question. thanks the Ritu, Yes,

with focused So said, Chris I And out Chris. include reaching starting potential to personal patients to remarks, directly. scaling planned over commented as which fast our will starting we're success, with both a an will we through a omnichannel we focus. and very plan to But in on turn it to nonperson promotion, zuranolone as approach with

that? So big, to But question, take do there. you want patient-access start your specifically the small, Chris, scale to think best

Chris Benecchi

Yes. Thanks, morning, Barry. Ritu. Good

to as patients have of gets appropriate sure make is do we filled is for to nature zuranolone that patient that for need that status. pharmacy to actually able out-of-pocket. launch of provide and and into launch that services - absolutely the gets prescription that, for get able want adjudicated patients we regardless plan ensure is they to sure prescription make to patient's for affordable who are end, we a reimbursement an the access the the that product get time that to Our the at the that payer that support what And it, when the of need

full be going of support a access complement patient is having service So and absolutely paramount. to

the to to also I who have want to to going access to but essentially the the product, ability important provide early what's think for to not prescribe physicians experience experience, product be only is program patients to experience it that to early for are to at that trial it that types launch able a gain physicians of sure in and in. the make use use they they want

resources around your for want and and come to mentioned, waiting are Barry this able DTP, and informed and question suffering that their as education launch, time we're access to so clinicians those we think and and more I go. that DTC at to directly in patients to they around medication, there DTP. DTC and around tools patients PPD in provide we make as MDD to information of But and discussions that sure the with in to can engage and obviously,

to Obviously, for we but that we're make want later the DTC the able would definitely and launch. that something broader through in efforts we offer is DTP sure focused reserve to omnichannel of at time launch, is DTC something that

Ritu Baral

Thank you. Great.

Barry Greene

that, really initial XX% need seeing Just impact the zuranolone the own understand their where and to over data to majority This for their strategically, are you patient medication course. two the about that proof eyes only a second year, week another round in point respond own or people required using is with population. hands of a a their didn't zuranolone and physicians SHORELINE of can that

world world, real it this grow. and about Greg we like of if If the clinical have in people using like comfortable zuranolone really will, we seen physicians the Madigan comments I've We believe to kind getting physicians for kind believe see the that is never consistent happens use [ph] of reactions with out before. St. and things the that these heard some you've what trials real Louis, is in will from

Operator

to next go Piper We'll Rahimi Yasmeen with Sandler.

Yasmeen Rahimi

the maybe Could look taking specifically for you're the Appreciate bit on of color provide to color of stick process? you also Good of visualizing preparation sort and the partners remark. much to of what I'm morning, involvement preparation. side the any size that or is topic And what your that through sort sort you a of the help to to doing team. of How commercial with thank you? of back we commercial XX the so bringing What team sort be? is little at queue. the going team And throughout the XX execution ramp on are the arm months? should of next jump into I'll the this Biogen

Barry Greene

Thank this big I aligned for Yasmeen is you, of the things it? the can Chris, the it the want to take start we question. are do plan strategy. I go-to-market say really small-scale What over that you fast to appreciate and it. advising kick kind on I'll at point, highly Chris, hiring plan,

Chris Benecchi

Thanks, morning, Yes. guys. Barry. Good

is PAs sales really are psychiatrists, primary might as who you select we of and reaching physicians antidepressants imagine, to ambition believe well. in zuranolone, with our group intend that the those effective like to group who of and a OB/GYNs, force approved. be include target enable practitioners The clinicians as new care active and So we frequencies, nurse will users if market this

zuranolone. need our with message who sales We'll patients deepen as our to that outside digital-first effort we'll that group the force additional absolutely have because provide medication who reach supplement, well an universe call designed they and we on the of like are for believe efforts hear reach to the waiting with frequency as mentioned, of physicians promotion to omnichannel a Barry personal

zuranolone deliver on because because deserve a broad believe group with potential imperative prescribers waiting of might depression, to it's really that better. you as and messaging imagine, are these patients We

with we sales sure go once have field go-to-market in we representatives right with with date Now the deploying so both mentioned, comment with Barry the promotion. respect we're the the scheduling inclusive and about representatives the product it lockstep our able of of about full that between to about PDUFA effectively in zuranolone ready window, deploying how the scheduling, DEE and who obviously, the the well, time at making - approved, thinking around are yes, date, PDUFA to strategy time to DEA that at to we're the they're ready is in go Biogen, Biogen optimize time are think as now,

of data. in data terms think obviously, read continue see thinking In groups move the forward. reads scaling as out, that, in specific we moving as that we'll And physician really, how we're to about with really beyond we'll interested about we success

Yasmeen Rahimi

Thank you much. so

Operator

to Goldman Richter with Sachs. Next Salveen

Unidentified Analyst

is Shimao Salveen. for This on Hi.

So commercialization expect some color with the uptake provide in regard to restrictions could DAE if the sampling the for drive during your providing given you to you there you particularly? plans of schedule doctors early to And for that drug? strategy, on certain zuranolone expect samples months the as of a scheduling –

Barry Greene

for Please the question. our send best Thanks Yes. to Salveen.

with patients critical I to long-term launch strategically, and seeing I'll the as the I is eyes experience their to specific at results As said, and that zuranolone and but question, success. answer treating ask the said with own Chris beginning, we believe our health provider care

said, it access sampling you you including of part take as want from that to opportunities, many So do a overall strategy. be Chris, will there?

Chris Benecchi

have experience use early the patients they Barry. as Barry in in to What a launching mentioned, the that case build that see clear use use zuranolone the I'd specific zuranolone mind, compelling couple to they so with impact data, that medication, It's it's they it about in. think that Yes. case can we as the physicians to get say and and important anchored a want that is have

So to available with going about respect we're think we make to that, effectively. how

an because course a can samples, they have therapy truly word think believe amplifier a kind it more used experience their group select that consider of full for the physicians to is it we we the would using broadly I patient you that actually impact experience it of the patients, for think to population. medication about how across see to

Helen Rubinstein

move we If to question. next our can on

Operator

Olson Next to with Jay Oppenheimer.

Jay Olson

if also, broad you the impact thank the of What you especially the plan sequentially Hey, Can on to impact in the for could plans or And plans development a on zuranolone great. the is your IRA congrats update. about IRA would the molecule? parallel? IRA a be just the potential you Thank your talk pricing for impact progress you develop of the Sage-XX, of on and it's that either you indications how pipeline comment for on on in since

Barry Greene

Yes, Jay, thanks for the question.

to So robust we however, product like pocket of important The act as while that we've the not be our minimizing patients inflation said before, will a reduction act and for we for very co-pays good Sage, have engine. seems components positive are news large. friendly It's there that is an think innovation.

with to completely share early specifics So So it's too line them. [indiscernible] need I to

say can believe to for - on for molecules depending well that indications develop molecules how that the whereas suited many, we safe is are to pave we it's many many forward innovators IRA Sage, way But and like implemented.

means molecules could that zuranolone, develop or the what certainly is So use future could we them for case that differentiated with anxiety others general to increase or disorder studies that other like take indications. we pharmacology other for have

be we'll for with is as we've of to implemented news And Jay. clear many Biogen engine pipeline aligned on use zuranolone the a Sage a But and capable robust the products be product question, got is many, that come. great IRA Again, XXX. long-term and both good of

Jay Olson

Great. Thanks the question. taking for

Operator

Stifel. with Matteis Paul to next go We'll

Paul Matteis

and Hey. In much striking. it Thanks for I so remarks really the strategy, commercial your my find questions. prepared talking taking about

positioning talking first antidepressant. as You're about a zuranolone

in but drugs population. stuck refractory company case, any happen the to love All historically. much in just the treatment to pretty think never get would these that new I depression of seems be it

specifically, point Like Are making blank concessions? are price going to is significant like to out? how actually do So how I this going you play you guess that?

know they Biogen assets. development. and can a your wanted If to Sage revenue-generating positioning They're I just thing wanting good for then in-license a drug, or potential about might to psychiatry. any kind thinking launch that relates as that Barry bad it comment I about on thoughts, about Thanks just how And this whether as business you don't not say a were you They've so you exactly that talking to product? and that's or of are where talked as guess, site quick a ask for impact how what is on area for I much.

Barry Greene

Yes, Paul, great question.

then and to then talk and question, Chris second the the ask comment. one with start me I'll first Let

Biogen our experience excited his it's is the of strategy. of tell patients. zuranolone have depression to significant very the millions that days. Chris about really I very bullish you their record, from help interactions kind for helping public And You with patients. Glaxo to about million about revenue On potential consequence Benecchi in can of he's What

well all very, So very that's aligned.

In terms launch really you development, of how of to they the now that's is question Biogen can grow tell top, Biogen. ask that top and priority I top, successful of you'll a a right zuranolone. have

aligned very we're So that. well

we very very, to potential third perspective, we it. -- or I can't a budget, for as That's about high. I about is bar From our expect Sage how bar as but I And well. think think speak certainly hold high don't a in-licensing, very by

that's of we budget aligned from position In call with that terms critical. is that strategically, on advised we the with we're and value-based zuranolone, the that's earlier very work that to in predictability, to them agreements. And beginning, give commented going proactive what payers means

where place launches because fear how in budget. often for brands particularly significant really of steps rapidly If they drug about optic prior inability be used, you their how payers and launch a know grow to launches, into generic think will put don't drug the will areas,

partnering long-term If presented - we the or mom first And this. suffer approved, not it medicine and since it's an can of they what with the data oral on days, predictable. first PPD. for to And on get more baby that Chris if are payers connect the in unspecifically to specifically will We're for make X sense ever that comment the more make and we having payers will moms weeks PPD, for doesn't for is postpartum X we've better and this for connect the from heard that hum with depression, consequences a severe, months baby. economic generic approved or be

front on want there? believe In tried line. that are in use primarily that that elderly satisfied wellness. from something the we do Chris, at young are level launch, with payers But certain of MDD not already yet adults, that is to with that about of sense. you terms what it recent in used make we're from of patients XX% take frontline or drugs there's will And diagnosed are we're been be with their MDD have to launches, cases, MDD, used brand hearing in might XX%

Chris Benecchi

Barry. Thanks, Yes.

MDD been in acknowledged [ph] and hasn't And NES unmet we need studies. clinical and that unmet the in the And the started I've yet compelling what personally now we for payer to our data those landscape in engaged through of we the So haven't conversations initially and PPD, of Paul, progress saw around conversations need and around MDD nature and the a X.X PPD with payers better years. part markets. had

budget proactive conversations have And can potential are and agreements providing in that with and for. our payers the those that we've to around anchored still predictability value-based respect impact with and agreements they looking certainty

and is time. conversations need how and with I studies, of and those zuranolone. mentioned, is from quite it's think of DBAs inclusive you propelled interest conversations in can regional those the national between in I've about And in for the unmet specifically. more there's payers, around And So personally some forward contracting what been tell as the and discussions PBMs data engaged byproduct I to significant payer really

of At many working there use MDD, zuranolone are clear you in as accessible. as the third, they'll line from In that we're payers line of us first the And first to first a as not case therapy to acknowledge fourth zorenolone, see want in first Again, being have PPD this possible us place a payers clinicians as specific a telling for earlier is pushed medical use perspective, something line. there's line policy a or fifth off noted, what medication. and switch the try is in they up kind while before for they're lined to that is compelling therapy. make is telling launch, case really ad And line. or that is zirenolone what may medication MDD of

recent use. Now what restricted seen with coverage. and of compare is we've line we've We've seen seen launch, rejections therapy that later Axon's

I and by there's interest and works, of to physician that. nature how zuranolone But in think can recognize first first-line MDD. willingness of use have payer switch it and that impact the PPD reasons in given a allowing out first number the of there's for a urgency to it use

Paul Matteis

you, Appreciate Thank it. guys. Awesome.

Barry Greene

Paul. question. Great Thanks,

Operator

Needham. We'll with Fadia go next to Ami

Unidentified Analyst

from that maybe on XXX. on is the based discussion of TETRAS-ADL Maybe believe tremor scale. purposes Hi, Eason essential I IIb, I for taking because item for the primary the subscale, can the I Ami. Phase your is Thanks space endpoint preferred for question. endpoint ask performance X, for another guess This regulatory there's if the good been in morning. company one on our

what is guys wants of Thank endpoints? to FDA what terms think ultimately curious do So just you the the registrational in see you.

Barry Greene

great Yes. further. to to ask comment Please question. Ami. and best send It's a Jim our I'll start

saw gap essential So in which moving we that for in specifically a reduction up is developed statistically chronic Sage-XXX, scale, with and a kinetic study spectacular the results as in TETRAS. [indiscernible] tremor you we by use tremor, for significant starting TAM that measured pretty said, is

saw also statistical We and alignment activity.

the we've haven't do to we on to the with Jim, had we depending while data III go discussion we've FDA comment? So got given seen which want way you to input Phase optionality the want endpoint, date. on tremendous to

Jim Doherty

Yes.

from likely in thinking really programs we're a matched you both what key endpoint, -- point the the similar benefit the here. a around ADL. you're on patients. but is think, looking is the primary a effect to Barry, question, is there we key that, benefit that's be I that to nailed regulators are And And data a meaningful believe that seeing for certainly point to that clear here low results, by also the from that what the is

this look, from populations really used most of approaches. are us that lead out process all comes essential patient the And who that But to benefit these did likely to we've identify to tremor.

activity seeing tremor from reductions the in we're so substantial And Kinetic study.

GABA essential for novel Sage-XXX as about the tremor. modulating excited a So the to treat way truly we're with system opportunity very

Unidentified Analyst

Thank you.

Operator

to with Kulkarni go Sumant We'll Canaccord. next

Sumant Kulkarni

some of Good question. various a effort positive. about? been And depression. path-breaking that morning. is for on largely with engagement your or Clearly, you convincing require of taking been proposition other preliminary what from have portions any those been stores? Thanks there's pushback And that has mentioned have the product my for zuranolone been But or experts, zuranolone any value stakeholders payers if most the

Barry Greene

Chris that the there the advocates are from well, those temporarily, beginning, just Even years for thanks and very X But stably unmet significant ago Sumant, the data question. at feedback that heard been told is ask to understood on need more say antidepressant has I'll patient and as fronts. the We X.X, the I all us, is mean Yes. patient depression. I they're aren't of beginning. numb. positive that more what has comment. from gotten can

patients years that modeling the dis-believe. of they think a data, a doing and there's data new There's support new SF-XX that And treatment date. the well. that, is than medicine require wow, the they're the approaches. I moved huge leaders we've can from XX particularly we've anything earlier from change other X seen that a that big been SHORELINE days, in How and opinion or to works the got than X totality belief only to quickly response be never majority of given

a shift. So we've think big seen I

think We're still is the depression, change been the approach more And doesn't forward. have do of talked to when while I retreat. going practice I medicine. treating monitoring and about had them how changes to it - historically and pushback and people us extensively patients The the out know understood treating this

in new From side a about new might impression. very the to approach a perspective, not acknowledge when might highlighted payers unmet effect-- need talking payer very, entrant plus the on own that the is This treatment little that new little is call, around something and faster, work a offer and paradigm. all totality that a Chris plan our earlier the offering this realize we're data

as as pushed to anything at looked being fourth, backline. Laura to needs be Laura Chris, to not sixth comment it's launch fifth, the first. or So maybe

Laura Gault

Yes.

treatment. having patient, them be through for the [ph] with side the sort depression, with will treated needing Reno thing that durability when of patients X to wait change and think data prescribe on Instead you to occur of initial strikes the rapidity for back really So X response of that having some to conversation as of it the to weeks needing down of is the how treatment that that's depression. with you sit a have a about the and conversation about patients early the for response clinician I that and effects power me might really response in a

have the and a to going to change that can conversation really expectations physicians both conversation a days. of at patients. feel expecting few the You about or well is within And

Barry Greene

you do Chris, And want on to the... comment

Chris Benecchi

Yes.

I and things provider to payer drive are think a going that care fund. are there our from three health on success

and use I think giving to health is a compelling that's the first care clear case the broadly anchored more professionals data. or physicians really

patients hit the and and with MDD why both nicely for it desirable around zuranolone living profile PPD. I are of Laura that it's think

in shared, or patients anxiety. use And I actually we cases slides number remarks the unresolved patients and there symptoms may those may are the breakthrough with issues with that in tolerability have a a an have adherence with elevated challenge, of patients that in symptoms, think for are who there who living

I So clear think that again, case is use essential. compelling

we've see impact Barry's has in they've from the to virtue by that really, is the heard the that's, and of thing experience investigators second And meaningful. I think get enable I early feedback. medication to to point about their that the really been of they seen experience hands, think patient's the where have power get to they when

onerous budget predictability lastly, prior make working for. mitigated And authorizations payers looking that to it's at have EBAs are that using the to broad sure and that certainty able and access without they're proactive step and

going when three successful have things we're we at do those successfully launch. lunch, very think I to a

Operator

We Morgan go with Stanley. next to Vikram Purohit

Unidentified Analyst

Steve Vikram. Thanks our is This question. thanks. Hi, taking for for

and So you. what the and scope we innovation zuranolone of cycle expect the like? can I want you what are to look conducting ask kind life for strategy would Thank data about of the work

Barry Greene

to me let about talk more to turn Jim that. Vikram, Yes, it

Jim Doherty

Absolutely.

of moving sort to zuranolone, forward win to depression. as is goal with Of we're in course, the

number patient are from a populations we could so think And of zuranolone. benefit there who

seeing well depressive disorders, types given we're related responses seeing begin disorders those zuranolone robust MBD think about in potential. with anxiety PPD, I and the other we're think effects sensors, as of to in anxiety on you to about, you begin think as the patients as

Biogen. discussions going some going really our specifics to require at to with collaborators are detailed is Those But discussions underway.

doubt that to, And tell we will is you lay bit further PPD, and that which road so around can a active benefit certainly sort I of discussion populations a from the of patient the down go little sequence think we in a and for to what out you. we'll as lot we think get addition the But activities MDD zuranolone. there's

Operator

next to go Suneja Guggenheim. Yatin with We'll

Unidentified Analyst

for on Yatin. Yatin Eddie is on for This

terms for retreatments? have Just of of that per high include we when be think of average costs do possible level, we in treatment from a for number thinking about of should price zuranolone, some you year about to per PPD, it beyond courses patient data patient should or some look at yearly And a retreatment? And we then would expect similar rate PPD retreatments? SHORELINE weighted

Barry Greene

question. Yes. Great

on Chris And price every say too proactive call talk starts to a provide agreement risk on our a agreement. protection has and value-based you've of budget it and payer me value-based payers. early this before, part the slightly treat. times several we So and predictability about on [ph] taking really with for from those heard Axis commented already, specifics and It's some different some

automatic from payers we're place stay number and complete bill hearing below per inflate a And put tier special that and bullet, is specialty pack. year. us But $XX,XXX prior they for launch beer, that about that years that steps talking Sovaldi per [ph] not roughly in Every are they're it's is important put for around specialty to to ops the patient patient the or payer mechanisms is for in people what - context for that here since ago. tier that Stabelo

about how think the about price. we're cycle then So We that's it. and that broadly per thinking pack

about Now indication-specific That's how here of pricing type an be for to the that think zuranolone it's XX price days makes price. will milligrams. sense a XX unlikely we

Yes.

You talked about PPD. retreatment with data

response both XX X in III that at now, moms that that trials the day in the and day seen right XX. what we've most that day respond hold part So for is Phase

in true hold world. will that the that, expect we real So

Unidentified Analyst

few yearly by really is retreatments there there standpoint? the in going that Got you. know payer very shoreline, patients retreatments. or be of a to I was maybe a And then the just safety number maximum quickly, from But allowed needed multiple

Barry Greene

Two questions, but answer that let me quickly.

What said there talk not about was is things of x times, going zuranolone statements we're that, think we label, we amount study any typically before, kind perspective, x restriction. again, of see this like be of specifics said there'll don't you not from So a about payer of a label. to over time amount in we

Operator

yourself reminder, a Abrahams [Operator And please And with limit we'll RBC. Instructions] go one just question. next Brian to to as

Unidentified Analyst

competitor wanted And to on market, how on from potential learnings the of of is This branded the those you're picking recent some size both for also Brian. detailing? targeting launches the and ask then Lina given the quick prescribers, views on MDD combination not up I that have playing pair maybe SSRIs growing Do any antipsychotics just role class with you zuranolone and a in in follow-up. treating may is with necessarily how and SNRIs? just on potentially

Barry Greene

thanks Lena, Yes, please and question, the for send best to our Brian.

paying the our predictable whole a whether we're depression So given new migraine what from why close launches, Chris, those we - marketplace, of frankly, launches. bunch all of don't But we're analytics. losses learnings are attention we highly grabbing or many And take to the months, you that? in seeing it's are

Chris Benecchi

Thanks, Yes. Barry.

very they a and to you through attention they're take as spending the force, that we all how media Barry their the resources as facets effectively you as tools dollars. said, their the launch way external to close - the sales the the their we step and manage they're from of customers, size using - that all way media we back think to and So launches, target about pay,

quite XX available the in that the are in how have market the for looking years. last for acting medications clinicians a they're and approval patients works looking because take and maybe is case has of competitors of and products the an the a So the that Axon's use back of in action XX to close mechanism is therapy we it than product, that faster at both a various work are have really I What bit and they that encouraging would some on other it's a that signal say lens a step really market. of new historically initial trained and the been other little therapies

I the of think really this MDD. options unmet demonstrates treatment that new for for management need there's

there As there treatment there and product PPD, is you for for a significant and know, orally like treatment is still Xyrem. no need available

about opportunity So potential of novelty episodic be how and and we prepared manage is we this rather to we're to product, used to go we PPD anticipate market launch living treatment the our most anticipate the could product for a that MDD substantial data, medication that to effectively. would [indiscernible] we're depression the novel market enter from deliver the to those be the and with the indications thinking going given and the as product, of to successfully

Unidentified Analyst

And Great. question the on... of the second part

Laura Gault

Yes.

there's consider. medication, is When the hasn't they might treatment about the when patients they I or data to regard is to nurses it's add-on use an question the care used atypical response usually rental they're that responded and to depressant, insufficient in consider SNRI. options support think antipsychotics, treat of and lot SSRI [ph] have don't good a lot have And depression in in a in So first and of which important of in physicians fully used of having of standard right really which of are a patient an context an that that are that your the antisyconics to with options many typically as now. to a to hands atypical position their not

icon of before they add and so because long side And effect the think they hard emphatic an profile.

and about mono I effect cereal paradigm side both in and an the as the used and to Buranas And to profile derail, when my so that ahead be be treatment slight demonstrated of efficacy rig fewer we've that given as lease as data used antistatic. future gain antipachotics. much a has use, compared It's for a weight of add-on which think is effects physician and different going atypical related metabolic myself, syndrome Aon clearly to position in would

Barry Greene

Yes, for question. the thanks

patients in age well, depressionary polypharmacy. patient as issue, as particularly as and about becomes polypharmacy know, medications. see that continuing And is population to don't be For other it you respond people when an they're as key as well monotherapies, the on we and

manage. So a respond like as well night a a the zuranolone stay huge medication without opportunity for get medication is chronic well when days, every to XX use and patients continued therapy

Operator

Next to Neena Citi. Bitritto-Garg with

Neena Bitritto-Garg

a follow-up the to Just last kind of question.

the what of stop that until dosing X- to needed I the course. to get get a to again, guess, that there Just on risk is, essentially thoughts how to treatment you as hands guess any outs of fit. period within and is I take trading trying patients that and into need taking recruited own actually need X-day kind they to and wondering on I well few educate, take I'm their dosing, physicians decide would be of guess be X-week kind a days they then patients their full at helpful. own see

Barry Greene

the ask Laura thanks that. answer to Danny, I'll for question.

Laura Gault

Yes.

is on in and question serenely course So educating prescribers was importance the That I studied of of that supports and efficacy demonstrated. and this the think trials the clinical courts. XX-day is that finishing a the patients the benefit has that of treatment

X-day need So be that about that it understands sure finish really the course making the patient to will

Operator

to go We'll Lugo Tim Blair. William with next

Tim Lugo

the Or which throughout is is proactive now at covered least something through years this mentioned come be agreements possible? kind launch? process covered as cycle how a lives of us be the are rough the launch be at you value-based gradual When think of to looking you launch. the of you time many the online those and the that down a that to talk will at of as to give this of And of or about were Can expected is life these expect agreements, I idea early Chris, time product?

Barry Greene

I'll Yes, come Tim, you back to question. then Dan. don't that's that, great why take a Chris, and

Chris Benecchi

value-based would like. engaged What would about contracting right number what talk agreements and Tim, of around say, specific I early payers and We're with active Yes. a it's now look numbers. is to proactive

payers time engaged are you around back conversation. think approval around who, as the think have a and temporarily, think some the zorenolone about active will about and think, I take to [ph] of be step I there you and and it it, in

and other types of may I the may who the of bit approach, think and take take about agree you longer ready in value-based a specifically window types to going all have around a with are step there contracts product think take agreements product. some payers to to a is as engaged bit of We're possible in and back payer particular, as review little are peri-launch payers the longer Medicare that to sure a actively payer those now available right quickly as as in engaged to rapidly and we're that those possible. make that little

Barry Greene

payers further just need to who payers What get provide we Great And more other are a I've see press being earlier answer, releases about number Chris. it, involved. payers call or and past Tim, context. involved seen innovative they the involved some to a talk base the agreements payers then will say, in is in other of get hey, and

is everybody to health. Now focused highly piece is you talk mental interesting that here on the

think want employers time. to understands everybody of the to as would are day, solved. an at employers the Not that that of have all is we asset. the want and absentees at in And she's Nobody their work people talk is payers end So these all depression customers the presentation that opposition.

Operator

to with Securities. Goodman Marc Next SVB

Marc Goodman

morning. Good

just the in that what We've secondly, for going doctors tremor milestone SAGE-XXX talk from you're easier ET. Can population disease. be data On that are this actually even another demonstrate population, data efficacy? could that is? considering you studying potentially to Parkinson's maybe in slide And showing that, additional for about to an you about that heard talks be year

Barry Greene

to that? Jim, want Mark. take you Thanks, do

Jim Doherty

absolutely. Yes,

thanks So Mark. the question, for

is moved not from the studies reason the data we've we've done initially we place whether that of the to ZULRESSO would part benefit. study. Remember We analysis have early do or then population with really as this pilot them continue well and into identify that on that this just was kinetic around patient

in we've the throughout So tremor. quite around benefits the got so data lot this mechanism treatment a far essential program of of all the

that we're continue go to data talking see you'll And about, as we the... are emerge the through so those those data and

Operator

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

Barry Greene

from review XXXX. first the thanks and morning quarter Jennifer, Thanks, for joining us results again this of to to our everyone

the Our collaborators. Sage the at our during dedication progress first teamwork quarter of is and of the everyone and XXXX result of

we our and believe progress thrive. Thanks develop on well medicine, a hot development Bye. to day. to person we pipeline As everyone. activities, deliver so we're every Have positioned our great mission launch can brain again, life-changing

Operator

today's for conclude conference. We you does thank participation. This your

Sage Therapeutics (SAGE) 2 May 232023 Q1 Earnings call transcript