SAGE - Earnings call transcript Q2 2023

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Operator

Good morning, and welcome to Sage Therapeutics business update. [Operator Instructions] 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. Please note that this call is being recorded. I would now like to introduce Ashley Kaplowitz. Please go ahead.

Ashley Kaplowitz

Good morning, and thank you for joining Sage Therapeutics' conference call to discuss business updates, including the FDA approval of zuranolone now branded in the United States as Zurzuvae as a treatment for results with postpartum depression or PPD.

related encourage of go where we our find press I and the you will begin, as the section call Media website release be we reviewing everyone slides to to Investor can well today. Before as today's that to at sagerx.com, be our would and current I will beliefs. to which statements, out point forward-looking like expectations are we that making based on and uncertainties, materially. statements and actual These certain are differ to results risks subject may our today's in press and Please review discussed the additional factors SEC our for release filings risk in details.

with We the our remarks begin review our and will Greene, Officer, data. Chief Medical Officer. call the Gault, prepared Laura clinical by Zurzuvae for supporting Then Barry label will Executive Chief

launch Chief available Zurzuvae to Iguchi, Q&A our plans and the Kimi Our Jim Officer, financial will Financial over PPD; also for be during turn the highlight Chief Business Officer, and Benecchi, and our Chris close Development call Officer, Barry. Doherty, will call. With update. now the with will Chief that, a I'll of preparations our portion commercial

Barry Greene

FDA Biogen known thank there condition with new approval Ashley, treatment for to this have impact treatment PPD. we hope. us this a hear first is a approximately for PPD. that's only neglected and indicated We This the On of all hoping and us for many collaboration Hundreds adults from of year. moment everyone, have oral women as moment. specifically and each for affect touched been of of and thousands our Zurzuvae of partner, many estimated by Thanks, for Today, XXX,XXX today. waiting historic about women the PPD, Friday, is devastating now joining women often from suffering source you, so for personally stories of and zuranolone the been PPD. received the Zurzuvae is

today a caregivers like patients possible, to advocates clinical who we I'd thank immense placed made trials. patients, their in providers, take our have and dedicated who trust health have throughout moment care sincerely Before especially to begin, us the the

are dedication treatment will comment for seeking like inspiration or be status us. of We seeking major new in also PPD. treatment applaud to for the I'd approval MDD. for NDA our zuranolone your of always options an on depressive and We disorder, the to

As late many for have of zuranolone a as the seen, treatment for complete Friday, on letter you adults received we with FDA response MDD. a from

We in are and position CRL. patients issuing devastated disappointed for with deeply FDA's the the

from reviewing steps. evaluating the We and are next FDA feedback

others this affect simply clarity, As answer we and will we Many can questions have that can't just we'll have we share at more. time.

Now just burden the treatment depression will implications continue provide to disease. an given of prevalence financial in is approval paradigm progress be and Later with development. this to treating the change on call, deviating not in is update in treatment options, accelerated people pace current options desperately and a novel clear, the Despite needed. the with depression struggle, keeping Kimi

side. adversity to us who an more lean other agile on come biopharmaceutical have for and out For is through those going decades, of opportunity the industry been

that with through sheet. as I approach. opportunity an is making for decisions and This say maintain work is But emerge this. to be stronger for balance refined focused will robust Sage We intended can a to a disciplined a strategy company we'll now, smart, a

our to for back today's turning primary Now focus call.

for have treatment PPD. specifically first indicated with the only we women Following and Friday's approval, oral

treat the treatment, potential short treatment Zurzuvae to option women we As their needed with course quickly will PPD, a treatment. XX-day without the provide symptoms for depressive desperately a need that with chronic new believe

to opportunity those PPD, bring excited Zurzuvae we're available to the Given treatment options the with limited for patients. women about

U.S. lives DEA, associated as less to year launch can reinforces and days symptoms of the that and scheduling a isolated. is following fourth expected of approval serious with overwhelmed, is We PPD and treatment of approval. Zurzuvae beyond by anxious If the with prolonged within currently which for depressive women a occur is PPD persist given with truly the quarter national a daily the with that XX maternal their in treatment a of the We often women XXXX which The widespread [indiscernible], extreme a completion shortly be need on part, attention the for this that this to media with of milestone significant unmet of and disease. PPD be face often expect feeling Zurzuvae post untreated, morbidity in can mortality. exists available challenges controlled women know condition. this commercially substance critical medical

result PPD physical women's also can of newborn, devastating can for and generational psychological, of developmental, been in PPD it consequences cognitive be has often While associated ramifications impact children. long-term overlooked. short-term The with

for what help. call do recognize dedication mission. With that, have the I contributions to Laura. and I for we belief a without the this over first the women our together, thank take stand turn health want potential landscape. towards to mental the to I'll to PPD, None Biogen Zurzuvae, to our for With possible approval with of moment of oral who Sage the faltering with is the and now and everyone that, teams of only and day now and we we important have PPD. we your collaborators treatment change work, to your us you hard women ready entire brought indicated

Laura Gault

modulation of Sage to our helping moment the moment good not The mechanism approval allosteric positive adults then of who to of to prescribing everyone. women with background foundation ] treatment a related approved treatment GABA-A important [ builds of to a of with fully thought Zurzuvae PPD and providing commitment PPD information. approval Zurzuvae therapy and mechanism further the and start receptors, PAM action understood. PPD for pivotal by of stand in benefit laid Biogen. Zurzuvae I reaffirms need. I Barry, from the first though this is in action mothers the is details Zurzuvae, Sage's of will will highlight be its is on morning, The The in of for great the for Thanks, and

GABA immunobuteric As brain acid with distributed brain. in disrupted is in depression. the for associated It evidence and decision-making GABAergic's functionally function normal inhibitory the is primary vital GABA, it's and present that neurotransmission throughout widely be mood, may other brain or regions function neurotransmitter, behaviors. shows GABAergic postpartum

course NEST randomized, used over oral met placebo-controlled therapy of clinical is PPD. trials depression XX-item included antidepressant aged program, the I the women an at severity. summarize data approval XX study. XX approval women the development that on to from a in as which III were Rating point measure treatment with a Zurzuvae SKYLARK a to evaluated clinical XX once The adjunct These and the Now double-blind, on will of Zurzuvae supporting end in based statistically the Phase data ROBIN alone PPD. Hamilton with Depression day of improvement placebo studies primary or showing common significant daily, Both studies XX-day Scale,

living and are As post rapid day figures, studies magnitude as PPD. both was depressive the weeks and symptoms in at effect all for and improvement was XX, The SKYLARK shown the and the X of women ROBIN in with day maintained treatment. as X potential important in seen to onset very and durability early

oral with an effects The is the once XX evening daily, may therapy. information, food. days daily or XX provide an information. adjunct can Zurzuvae as to milligrams the to Zurzuvae antidepressant be used of I'll in overview of prescribing be if safety taken XX for fat-containing The reduced milligrams including dosage CNS-depressant orally the once dose Now alone recommended occur.

Importantly, there are no contraindications in the label.

the diarrhea. living clinical offering while experience, course am my you reactions assess their patients terms MDD or that rapid-acting treatment as personally and competence be the to dizziness, with we that dose. Patients advised this state we The Biogen are of placebo. not own short that we infection may advised I'll or that will of truly somnolence, to I can at most oral also Chris. also that the also and of a potentially be and engage These not for I least new from fatigue, X% rate to hoped. by provide hazardous the had that tract least Chris? each first after common hours warning disappointed the tell patients women a help degree I debilitating they impairment activities at occurred XX not drive finally, that, who over potential turn with impairment nasopharyngitis, with Zurzuvae of in label describes to will were to be urinary than be able have In excited PPD. today driving women received treatment caused safety, the causes higher Zurzuvae. adverse driving patients in call condition. With to until other should lot able And at and am boxed Zurzuvae a we option

Chris Benecchi

of Laura. this the women planned and to excited this in of that the know with closer to that the action burdens on all urgency for too and of novel insurmountable. share us believe to market new to women to commercial on the that with PPD in can about be is We adults our preparations to opportunity With approval brings critical our places the celebration, treatment day incredibly launch treatment I'm of PPD. Today society it Zurzuvae transforming for Thanks, as of mind, living bring reaffirms Zurzuvae are that care call with the suffering new prevalent to the is a mothers PPD. you all to our seem excited updates treatment exists we bring option with PPD. we

limited only approximately X PPD of are year. women advancing organizations. Further, leaders preparing providers know with Zurzuvae getting knowledge in an to with to of that scientific We treat go-to-market been enable women. about and patient with experience the cases or for we whose We are engaging experienced exchange women have of of will launch execute them. not X.X in believe an permitted further opportunity X each PPD built to depth symptoms of the the we with our the adequate health too in with be that due have our potential screening year-end. team capability. information with preparations available launch U.S. options exists PPD fully PPD diagnosed expand women PPD continuing XX% million by Today, need advocacy ready many for about breadth internal they experiencing to many and us because care estimates to The by commercial to and of That's pre-approval tremendous months a payers care exchange

the With have to care. we become the a be approval we therapy and of standard of Zurzuvae, first-line believe the potential

with there to increased American population PPD. planned and diagnosed with Obstetricians newly our antidepressant also Our those women diagnosis We and it women addressable stop help treatment. PPD will taking by of which Gynecologists, with support not building patient recommends treatment. at unresolved postpartum who the in important experiencing will the screening launch efforts recent to increase diagnosed guidelines upon to believe rates despite are efforts launch periods. be the We those on going requiring focus be believe and We're pre includes to PPD the during updated College symptoms

While field efficiently a will focused treat sales of and consistent At PPD. with and that success can psychiatrists be with the health expect predictive professionals OB/GYN us we, thinking our launch, powered with leverage about capabilities women plan We messages Biogen, in targeting to PCPs unmet resources. frequency treat reach more we high-prescribing focused we who omnichannel to by base expect treating who implement scaled partner, our care with data PPD, enable reach women strategy promotional need a teams plan collaboration to a have PPD with big women to analytics broad PPD. to alongside of launch our and that

data Additionally, of platforms to digital to to we broad with platforms media It's nonpersonal intended HCPs with work from vital PPD also treating content, patients. plan reaches that in-person a are These interactions. and our omnichannel unite efforts our set directly launch. designed these women advance promotion reach digital at

Zurzuvae support prepared PPD Zurzuvae are engage meaningful clinical in with critical and in with with with this. they be plan will and be with of accelerating responsible treatment Our planned will a option their prescribe women are and have experience as PPD of discussion and central believe for the resources PPD will confidence omnichannel these women education ultimately We so HCPs instrumental experience initiatives aware the are Zurzuvae launch this treatment to HCPs. early women of We planned directly to to of for PPD. treating directly to making have intended accessibility and be to in update. building indication. HCP at positive women efforts with Zurzuvae a decision will about in focus approach this as Zurzuvae of adoption be to and a they

in distribute with short Zurzuvae sample of course that to this treatment appropriate early drive course targeted to experience critical PPD full to in women HCPs long-term will PPD. of be a will program therapy therapy believe a We that experience program First, enabling ultimately clinical will this the Zurzuvae uptake population. trial XX-day rapid with

closer eligible initiatives with strategy, insured. and time planned commercially other PPD, planned the discuss goal We whose Zurzuvae that access second through enable with PPD can We programs women for prescribed intend launch our are to is these to help patient to commercial including their The with woman of co-pay access it, initiative this intended plan to facilitate effort regardless financial launch. who at our assistance circumstances. of women support PPD every for planned

care gaps there to collaborating care. model across that for and policymakers every of to the PPD. In for to best providing the a prioritize call need and a patient the with expanding significant to address ecosystem are in providers, solutions increasing state, action health is to health. works for care mental payers, is interest maternal advocates There of patients treatment We a access with goal in the

with and standard overall lessen on support for a more improve As for build to PPD a experience who these with patients, that the both new treat PPD society and burden costs for thrive. these Zurzuvae of and positive mothers of believe potentially will efforts these a outcomes them. change, women We for and harbinger combination HCPs importantly, care their women and could Zurzuvae intent them help with help a

turn Finally, access. market to let's

to about PPD early and how clinical unmet novel too a it's we're of it. profile here's access that recognizes While talk considerable price, implement about economic thinking the Zurzuvae. plan We strategy a need to burden

we work partner, with of the continue the including access might role agreements. and will favorable ways of to value-based with potential We goal payers identify

enthusiastic payers PDUFA, clinical We have the new month in the significant been this had indication. Zurzuvae numerous in to in the and leading about up for unmet PPD recognize with of payers need permitted options engagements treatment have and profile

every is can it PPD Zurzuvae is As regardless we who circumstances. of goal our said, access financial woman prescribed with that

of majority thinking can by we currently is as clarity have launch. births PPD part with preparation, responsibility insurance determine given Sage received As are XX% for to or covers financial which patient. birds our price We The are provide covered with planned product patient to through and commercial out-of-pocket-costs. of more final approximately remaining on to Biogen our U.S. our approach the Zurzuvae access to working on thinking a label. and access that overall closer our goal now no the women PPD these adjustments of What plan women were requires vast Medicaid, the little insured to enabling for of minimal commercially say

scheduling. treatment We for to Zurzuvae expect months the DEA to the following payers decisions cover women in made be PPD by is with

implement the to our the of believe the planned by expect our efforts, maximize has aligning treatment each PPD impact to stakeholders. rapidly with in potential to to with launch of eager with strategy prepared and the women PPD are Zurzuvae them. Through this we and treat reach HCPs of we women both We that commercialization

are affordably. is urgency We update. PPD environment it Kimi to and financial to get are Kimi? rapidly so favorable Finally, with feel Zurzuvae PPD who prescribed our it access waiting. I'll to both to with turn that because provide goal enable are over women able a a women this now

Kimi Iguchi

And Barry the CRL this evaluating opportunity the with reviewing of share forward women to want We're my as Thanks, hope steps. we these earlier, Chris, and women. the new push help excitement good morning, and of energized next are noted so PPD. feedback and FDA chapter many and and from to for everyone. for I for MDD

comment recent means these to Given financial for this briefly developments, I'd position. update what like on our

generation cash, revenue the that extending expenses. into plan based update strategy. relating smart, will as with ongoing to goal our with currently action in marketable our And allocation, to with and will from prioritization operations we take are make We the resource pipeline June including that our billion and potential CRL cash revenue funding refining cash estimates, a We upon and anticipated of said, XXXX. With XX. operating our we cash our on reorganization. to as $X continue MTD, along and securities, of expect decisions support balance disciplined are to current the collaboration we runway are well work with and believe equivalents hand we We capitalized given cash evaluating workforce and

also we decrease anticipate result, a expenses operating XXXX. to in As

in working leaner PPD enable to make towards changes are successful believe be plan a company. we we us focused said, and and to stronger, launch more will Barry a As the a

to our greater detail expect next provide third We quarter of as before end the plans the unfold. and steps

call Before reiterate monumental will PPD milestone We have access this with Q&A., Zurzuvae I with to prescribed forward it. help urgency for year later to and women availability turn Ashley around over commercial act for this of the look are I want Zurzuvae to to to the to Sage. our who enable excitement

add me and are given Let CRL that also there MDD. know the questions I there out many

call provide As we we'll when turn that, Ashley. can. With always I'll have, over the to we updates

Ashley Kaplowitz

the Q&A. handle Instructions] Now Operator? Kimi. [Operator it turn to over operator Thanks, I'll to

Operator

[Operator Richter Instructions] We'll first with Sachs. Salveen to go Goldman

Salveen Richter

to Congratulations on approval start launch. here the here with just PPD. in Maybe the

prescriber approach program the prescribers. and talked and effort us the all You help demand? up targeted in just work how initial that understand for ensuring will also quantify soaking Could a about us the sampling not you're outreach you of with base the the context

Barry Greene

a price, really of right-sized treatment have excited and women about these thanks of that Yes, forward Zurzuvae in for the a the believe of We're about PPD, really with may got note. for women. many help we've the excited at launching congratulatory the case We're organization right opportunity helping us we're in strong tailwinds the we to treatment and Salveen, for business looking Zurzuvae approval women. the

looking the As for do to we this women . what with with noted, women X.X that their sample diagnose in to mom and the when each approved Chris the The ask providers PPD. know it's tool and they treatment about only solve we this I'll million to that more for like are first believe a big PPD. experienced U.S. unmet dilemma payers, year. comment And and And the program. care need, fact symptoms about we health oral a

our new we forward se can't that the health size the program, and importance own talk are providers can in course women certainly their a they're numbers yet this And every option for or full about to talk at We believe PPD. Chris We implementing looking PPD. about the we activating policies results care policies, -- eyes. the the access script see maybe treatment that for with to sampling will enable and target state per mentioned of but of and the and

Chris Benecchi

Yes. Barry. Thanks,

see Zurzuvae have and practice. early have them giving entails that that is therapy that can women so that to our So going at the PCPs. noted, prescribing launch, in we're impact they a remarks as experience opening important OB/GYN in you course to to I physicians as it's really XX-day my PPD And that going to full with sample to high for with on be psychiatrists sales group and on field team, Zurzuvae living said of focus experience what have access that

Salveen Richter

of of Can you're base help physician quantification up understand pricing have just to a that the and I just targeting you on follow that And get just sense initially? us PPD? just flexibility quickly

Barry Greene

Yes.

the base. the about of really physician So right talk we the now, of size kind can't

of aware, done wholeheartedly MDD collaborators As working and lot a been launch. has for our have on work. we preparing a It you're well and Biogen PPD

begins our course, but played work PPD Of PPD for have that scenarios now out, focused launch. we the

closer to targeting back we launch, how As about specifics come it. we'll out with we're

and Chris clear opportunity, in in very about with to scale have his As said start success. to the focused thinking going metrics remarks, we're a we're way big but

work and the In terms that with sized strong I to now. right price about we're case, do that setting we have right of and we pricing, business said, a organization, think as very the

Operator

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

Ritu Baral

issues my PPD the to available you I is then least now through else focus were to are the that on what little like review know bit can't MDD, expectations review? would But too like clarity I'd what timing needing talk status. that I questions? much reach And what add is discussed mid-cycle interactions happened drug about on during focus go congratulations Barry. the And could at and of the a for that Any unresolved for patients. the a needed? at of you to is review your a typing

Barry Greene

you thank Ritu, you congratulatory this And for focus on Yes, the MDD. as note. we'll asked,

now. a actually, of impact We're in clear, health be desperate So patients you to view just more And on we're MDD. with the crisis do not we're extremely for them FDA's with devastating MDD. for need not that is disappointed agree to on innovation. Zurzuvae as and we able devastated Mental having communities, know, we're help right our

supportive cycle package, we We So as learned submission approvability we received accordance year our both Friday. clinical the back what with that if in was review the in MDD. the clinical we some last had the late X NDA which MDD. I the on filed positive year in the up PPD noted, roll we section, believe of X for of studies of and in about to late CRL support we view have believe we started on placebo-controlled, earlier package, of was And we modules. In and FDA's with FDA

we got decision And So analysis the pack of or involves they We the they thinking speculate simply on reflect review late again, put can information. we the CRL, the can't what Friday. making. did really filing which in an on FDA's submitted

the our next in FDA collaborative excited MDD with the evaluating we and our in steps reviewing what to and with are. understanding Zurzuvae we're launch steps as feedback on Biogen PPD we're next So work

Ritu Baral

interaction anticipate even Do you a Type before A meetings?

Barry Greene

the We've except took it. right the the I that else say advise really steps. evaluating anything got team reviewing we next feedback you and can't on and

Operator

Stifel. next Paul Matteis with go to We'll

Paul Matteis

question, to I there was bit about first investors wanted label talk there guess think of the which through on commentary the things ask surprised was being the sort able to my because abuse. few read price, pipeline. a I that that I have around about a might One without little onto are

have on on Another an was dog administration. seems chronic a those to driving. you were that also study, label, impediment they -- a question And been might do then put restrictions and the And commentary given same SAGE-XXX, prior one? profile two, which chronically been has to which it the into the How has like of those mechanism surprising of do around are action?

Barry Greene

Paul, question. thank you for the

just start Let then and talk turn specifics. the about to some it me I'll out Laura to of

is So fine a can label PPD move sell us treatment that's is provided patients. health PPD and forward. the that label a for we we care for and instructive Zurzuvae us instructive. it's providers label women treatment Certainly their that the allows It's a for It's of label for and for of the believe label. protective that a to

or in nothing is se can problematic. about talk maybe But Laura surprising So the that. per label more

Laura Gault

driving. Sure. for I'll to Paul. the start related Thanks with question your first question,

instructions Schedule has at is XX-milligram our these the dose, driving label was of a This recommendation control, was are profile regard as this, that of Based the The each prescribers vetoes. studies clear at Zurzuvae measured. X in briefly our that's drive about driving clinical from in experienced with for prescribers So liability. action end in IV of risk unexpected a a we enable the perspective, label from than instructs studies of be hazardous the least the I because with XX-day top It best which patients. conducted. as don't hours duration mechanism based for counsel potential have label, of discussions of treatment it there This dosing clear data Zurzuvae. time a show good dose at be that's of was the are is the most relevant that the in XX be XX summarize X approximately after who results included last engaged results are liability after that likely like course. their results impairment are for the caused to what's And was XX use. to it's physicians of label, good summarizes safety abuse milligrams IV dose other in and Zurzuvae. With less activities you days instructions on after XX-milligram the of will the Zurzuvae there patients to and impediment the expect the benefit and the can to drugs point can patient it's or because the benzodiazepine. warning see drug patients that abuse to has But into at like label PPD like this similar see equivalent that to day on medications you box not Schedule in for these potentially from that DEA-scheduled for And XX-milligram an agents, contains prescribing benzodiazepines. to be will the Zurzuvae X we that The the from -- Zurzuvae very Sage At a potential which dosing, dose. prescribing since mind. will dose expect not to driving

Barry Greene

Yes.

Let me PAM. wrap back with your or GABA the about rest the pipeline question of

in end Typically, stated, entity hard each as unique label KINETIC understand the or if intend not, at the are to any the this it's entity, individual the occurs study read-throughs on has of of X for year. to So labeling and it's data new Every for basis there we SAGE-XXX complete we chemical product.

So that's what can now. we right say

Operator

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

Yasmeen Rahimi

you the whether what a want maybe through that but comment you not there's lot on about getting in maybe could requirements be I in to tell some courses many for [indiscernible] would that of can us how know you second helping MDD, is forward of go question are this studies this approved? understand just what then used PPD, case Is patients or us And guess would me with sort or queue. jump And something And if is us like multiple X maybe year? really sort required. that would to product we're back commitment use if there's out of I X? in the your want of like trying move within into recommend the to would this that figure X you you do to additional you I'll help the could understand

Barry Greene

the question. Yes, thanks for

with circle back. Let me start and I'll PPD,

in in effect to that response these clinical X what placebo. clinically was relevant. continued early saw meal, women with to we out on day Zurzuvae with as that's saw up as to And different the our evening significance than that days, day XX, has Zurzuvae rapid a response studies of profile statistical XX statistically So clinical took relevant lasted the and

we So a pregnant envision having that event take year that profile, with X because in would or trigger course getting XX-day was the of baby. course the the mom that

So short one. I answer guess is the

looping and of for not reviewing comment to than effectiveness the study the They are further don't is, other FDA's repeat approval treatment it, zuranolone, year. and with I'll Now or studies CRL of treatment MDD related this that. support with for can't and which feedback we provide and to evaluating issued application next the and the evidence really the view. disappointed extremely the for and patients, we're back adults at looking zuranolone agree to NDA the steps, additional MDD we did of that We're substantial needed. of

Operator

go to with next JPMorgan. We'll Anupam Rama

Anupam Rama

of a And other consider, key color price on whether right on price? ZULRESSO or the book considerations couple Maybe what it's And give the of that to PPD. you've kind in you times products. end the Barry, mentioned could to here. the a to getting of bit little congrats PPD approval are right us

Barry Greene

up excited we're turn PPD. Yes, to Again, and much again, the congratulatory it from note. you Anupam, I'll I'll really and start suffering Chris help very women for to over thank

or can't Just to be on clear, price right comment now. bookends we

Maybe a we launch approved we're did to As the prepared And mentioned, would of Chris will some go agreements payer forward what got We with the move significant of MDD like. conversations I payers introduction to launch more Friday Friday about back, for we PPD, but the that. significant had the amount in with results do value-based look amount given We and payers, to contracting. pre-commercial from frankly, plan PPD. that MDD fact talk that. and have have about basis we the CRL and reengaged to now

Chris Benecchi

Yes, transformational. with of for the accessible be sure. the to to Zurzuvae of clinical influence truly the absence of need consider of the Zurzuvae clinical PPD. PPD options will significance equitable we size of acquisition of including we'll of in factors need think about with indication, an live women committed postpartum strength are time women patient of the to We're We've historically goal Zurzuvae. the with statistical the who hundreds our rapid Thanks, access points treatment the to must data, significant be When of thousands the population, and Barry. said Zurzuvae We approval innovative unmet MDD These address target wholesale in of ultimately new all to what at for and potential cost. obviously, the depression. treatment and the

of financial goal the of I regardless access is circumstances. as prescribed it the regardless PPD that WACC, every woman, our However, Zurzuvae is with said,

Operator

Ahmad Tazeen to Bank with next of America. We'll go

Tazeen Ahmad

about up was FDA asked be out flush cycle. was to you that MDD order or I the preference mentioned just FDA did for better? it preference it so review safest in around AdCom you comments the to to and clarify, able applications PPD time? the both opportunity concerns been comment late to have Or do wanted it the at any together? submit the MDD Would an Also, same when to to they from didn't the have there concerns in brought the

Barry Greene

different in several Tazeen, questions Yes, there.

and announced X as the We file X.X, going both back for years. So historically Sage, PPD that if were I did, to MDD. go we NDA

the might first that. PPD You delayed. to study file and MDD was that start a PPD and our that of end then And at as submission caught were out we went we're announced up, And MDD we said, we PPD like and study year. some PPD and going point, point, at after going then the launch both it to at rolling looks the remember,

All of the FDA. that was done in with concordance

on to say in August we filed approvability found you as noted, of we The positive we can more. of FDA view at the the to And And PDUFA prior the Other NDA. the which we February, I what much terms no sum. can't than that, FDA's FDA the about out just the year told review. the then AdCom a add the obviously, In about X cycle time, gave MDD. took there good late FDA interactions, a us I review was that, say us required, and date, announced in

Operator

Abrahams next to with Brian go We'll RBC Markets. Capital

Brian Abrahams

My episode the congratulations Do an like adjunctive more of think treatment not? approval studies acute the ever potential indication PPD. as something if in you to see that required refined well agency treatment? possibility, with the Is on Maybe table? potentially a or question the that depressive And for be is or a on narrow a MDD. on or you a this do additional this support would or was discussed

Barry Greene

much question. we guess Brian, extremely of FDA's treatment for don't say agree or very indications, can we're with what I the at patients, we time is for very the for this insightful whether thank a MDD disappointed and different view. you it's

as We can do really with steps are. to be marketing provide MDD, solely for what to the got get we'll available we've in with there, are evaluating until focused but to patients believe be Zurzuvae We treat And that we there. will soon women the PPD. as CRL. more treat on we're we zuranolone clarity, And next should

Operator

Jay We'll go Oppenheimer. with next to Olson

Jay Olson

Congrats PPD on the approval.

you without question. be you also launch. near a We $XXX of that or the million development to potentially and accelerate eligible savings milestone Biogen Since have the continue independently and in do Are financial significant seek a from potentially plan a cost to you'll term financial partnership? an position SAGE-XXX MDD in you'll for a development experience

Barry Greene

the or we the be an But exciting date PAM, probe saw and SAGE-XXX for let our Parkinson's seen SAGE-XXX, studies. the in open-label of congratulatory cognitive thanks talk all, to to by is we've that note. we terms excited Alzheimer's, data and studies thinking. and owned Kimi improvement really continue about developing wholly of of albeit financial in Huntington's, NDA. some first milestone Jay, in I'll Yes, of terms

de the a for #X then up Parkinson's rich well-controlled [ there's launch as regulatory an up other if matter Huntington's set in us previously we're some the we see Huntington's aware, flexibility, and next robust significant sort how that and terms you're that year we'll right Alzheimer's. and we given a talk a to excited a that package of rapid can and we question. underway approach. Whether excited indication, have of studies pursue studies the data in before, is is should SAGE-XXX, and we've Those have orphan very another and nature Kimi, we year well SAGE-XXX footprint they given in As that that accelerates now, ] set orphan of believe several said in way we believe But Huntington's not flexible it's at clinical do Sage -- to of that. guidance? alone and that or financial you it in and a enroll. milestones needs, we're capital smaller That's kind do about commented enrolling

Kimi Iguchi

Sure. It's question. a great

support But a we reminder, also XXXX. So our collaborations just Friday on to of plan we based we earlier on of funding clear, commercial the $XX cash of and of the evening, CRL I our and about sale strategy looking for the to PPD. our revenue milestone that operations based potential from Zurzuvae refine to first treatment on Biogen have receipt be a expect will into million hand from anticipated mentioned spend. forward payment the to we and the talked to are related the current that earn estimates, And on that potential

an be So We'll of at and pipeline. cash workforce that's the be that's a We'll our looking include of really to allocation. our extending at runway. evaluation all reorganization looking with going the resource goal

from that time. of allocation the incorporate that our will expect the We we FDA have evaluation our feedback resource in quick

of the certainly by have it and able we once you quarter, to on third update expect [indiscernible]. be So that we'll to we'll the we talk all of end you

Barry Greene

some just of we're it, about that And women, big Jay, not Benecchi said, but the million omnichannel. And to as with it certainly that PPD footprint color the with PPD. in have going focused but we're for help you launch opportunity thinking scale terms markers success, very certainly we'll to mentioned on a starts since then additional X.X Chris is commercialization, overscale

Operator

We'll Canaccord. go next Kulkarni with to Sumant

Sumant Kulkarni

And prior to Zurzuvae the on do with Biogen expect you to interacting expect with collaborative launch do FDA to be? pricing you on or after? the How PPD MDD announce

Barry Greene

for Sumant, those thank questions. you

Friday they CRL and collaboratively So plan as night of at that the DEA together we year of an night. potential announcing have -- Zurzuvae PPD launch shortly the in issued the to you couple a and if launch Biogen after the Biogen, and approval for terms scheduling, working saw, release PPD press we we and then MDD the -- this label PPD for fourth been preparing and have And got in hours of of we which We extraordinarily and takes days. approved. XX that Friday for approximately joint available launch a the it later, quarter for

So that was a joint collaborative press release.

that, of turn PPD towards as appropriate to plan to we on with approval working us in CRL, the front PPD launch our and Now now doing the the attention of CRL and in of I response said together.

as because talking closer of be of closer launch. of our we to we other that access aspects launch, be terms some will as about get strategy well to In timing, price our as commercialization the will

Operator

Chico Securities. We'll Wedbush go next to Laura with

Laura Chico

know if a good is add can of commitment partners over interacted little understand difference on SG&A understand acceleration would with And X guess what color trying don't there's PPD broadly, on you Not of the of and trying terms following if also sure just launch provide than additional remainder PPD have of any up involved? I'm was kind those respect the Biogen's kind a had some more I bit comments just allocation I'm that. to color you the if resources that in I here. a to you to there. how between on weekend And the of launch just can to seem I 'XX MDD terms Barry, in of I of preparation. But guess guess kind any you of Biogen.

Barry Greene

one and thanks Yes, for all Laura, question. those questions

after DA have committed shortly in PPD the So I can can't can for quarter, the I what yet. release scheduling. about joint look, I really to we is guess to where we point I of that talk say more press fourth and that, Zurzuvae resource available allocation the Biogen

preparing As clearly well and launch PPD for an worked MDD approved had and we that the said, potential I if and mapped. really hard of

for launch of to PPD the approval on work PPD, more what necessary CRL that closer of talk looks what about do get launch, With our now Friday, looks And turning the for as MDD, we're the news we attention can like. to like. we the the

as got as said, organization, we builds, well price believe at in right terms PPD business as workforce. right with the case. size commented as Kimi I've And SG&A a In or anticipate strong earlier, really we've of all even of our the other do resources looking and we that

Operator

caller from go our Ami & Company. Needham next to with Fadia We'll

Eason Lee

less some for and on that Ami. Maybe just kind earnings regarding just Lee kind think to comments the -- kind it I -- the on I Eason is created MDD. just just maybe mean Biogen of announced they This perception think there of kind be recent of could on it's by -- of acquisition again. a I committed

how would And alone what you kind resubmission that? on role and of much regards like kind you the Biogen potential you a hear just and be commitment would sense Biogen us So then can with think I required on press of I give kind a to that how like, mean, in stuff. is of do playing of mean, that, kind the effort and effort joint you But MDD? maybe -- surround much release anticipate like for I

Barry Greene

feedback for I can't already said. really next preparing anything you reviewing more the the than and evaluating more the and Yes, say comment the and Eason, the We're for examining thank I of question. really CRL. We're the steps. can't that. than launch PPD we've Zurzuvae

Operator

Purohit next Stanley. Morgan with go to Vikram We'll

Unknown Analyst

you quick get there? long on the question to a congrats expect and be for can approvals. What net gross think how can to Vikram have you This I do [indiscernible] is And about you for do [indiscernible] you Zurzuvae? PPD.

Barry Greene

that to already since about turn we on net. to -- It's talk It's launch. the about intention too our to going gross talked and idea work to early we're WACC

Operator

Leerink. Goodman with We'll go next to Marc

Marc Goodman

but that had about you in have is you that show it's in not And they from had controlled clearly studies X duration that study. that guidance studies, talk question -- second to your the the placebo I if a And one that the And MDD? My to is case around has that FDA, the or partner in is, And you effect. MDD. did clear drug of get of whatever FDA and that in the MDD? whatever not was case to you reason are FDA study if committed the another do your to was needs doing curious order approve

Barry Greene

Marc. Thanks the question, for

extremely disappointed we're for don't said, I with As patients CRL, FDA's views. the the agree and we with

NDA we studies. is X to and positive the is say accordance already was believe say course. are our can So which say said, All states just I've the set the oral-controlled now. right studies studies evidence point that additional effectiveness with we we what of last FDA, of filed we did, with going application that's year cannot study That we which X we and And or labs, required. the the of when belief CRL as filed what in at our substantial was that with NDA, end

evaluating on steps intend we next pursuing CRL Biogen. So in the and

Marc Goodman

are is FDA do that MDD if the whatever to do study, study, -- we're saying, need do we'll to But you takes yet? going which clear you it get it's another another or to

Barry Greene

reviewing disappointed next let We're FDA. for me that patients don't the evaluating and We're just repeat. feedback we Marc, So agree with the steps.

Operator

Akash to Tewari with Jefferies. We'll go next

Akash Tewari

Biogen on a mentioned the on in let's could from basis agreement, And giving the terminate I have point? be contract agreement, for Biogen in you days approval. just say, product-by-product where notice terminate any there written by wouldn't this confirm. that Congrats notice. at able it a to I zuranolone? advanced Biogen development Is the XXX your received collaboration PPD to guess juncture wanted

Barry Greene

fourth of the agreement. termination you CRL, receiving Yes, jointly the shortly launch I after say on are Akash. press release DEA there worked the Zurzuvae I guess approval the what for we can the after say that is I committed PPD quarter provisions scheduling. the and in in that to saw PPD also can

that. it at So I'll leave

Operator

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

Tim Lugo

most scheduling next us the are process Can months? viewing in a through It formality. as few the like seems it you walk

benzo, in wrapped up issues get and years product they're discussions. abuse However, can single had in rises into assuming recent we've class-wide sometimes

us risk So you around help frame just the process? that

Barry Greene

Yes. the Thanks for Tim. question,

within Laura So And for have or which issue not for to We review. refers Class occur you heard to days. anticipate XX a as prescribers to expect label, the an we DEA Schedule say, for FDA is that Zurzuvae patients. for IV

Operator

Farmer next with Scotiabank. Will to George go

George Farmer

you long studies about sampling in the done do to risk level And newborns real How your penetration you've speak program quickly. and think feeding address also, think if that as Two things of we will to you market? with last drug can comfort me any to that? modeling the particular

Barry Greene

the questions. I'm Thank some Thanks George. new for for glad Yes. question, you.

Chris let about to about So Laura and start little sampling I'll a ask and to breastfeeding. talk me talk then bit, then

you seeing critical if take hands, is that to that strategy. Zurzuvae health experience So have care to step the potential a we provider and has in models the believe we with rapid Zurzuvae back, their trials own PPD profound on in effects that saw with clinical

color care breastfeeding. and Laura program. talk or Chris, about specific use physician So we you can't where -- health sampling can turn activation it for provider can to we you Houston on then the over talk and that's

Chris Benecchi

Yes.

we The program once giving on around That's time around can that we that experience early finite But our launch of finite say actual prepared a this to of about go-to-market physicians I in that, have opportunity we use see the what of we it duration window a that as see Barry, window scheduling. an time of launch. for the DEA talk is that and details as actual experience and more commercialization. So really is my physicians the remarks, in strategy that. in as later focuses

Barry Greene

what after not how of samples on some going. in markers, launch there calls and all the talk talking providing about our And Laura, for the PPD, add are the about you it's but breastfeeding? we're color likely I want do be Zurzuvae out can many that's is quarterly to we'll how

Laura Gault

a used study study Sage and Sure. clinical done the in is this that Zurzuvae very showed raised given an that levels in going low observation that Sure, that's results George, has -- breastfeeding. present to there's those of you a population of human important be question, milk. of

In than to for is fact, the dose Zurzuvae calculated infant less maximum X%. relative

the benefits says the it consider the is to weighed data on this milk then physician off-label from that development absent important we are or data of where health in in breastfeeding milk. drugs a the exposure breast in what is with treat MDD, this other patient label differentiates that the label It's the either in really So label. It that should potential Zurzuvae higher. are present used and have this to levels much breast

Operator

We'll Mizuho. with to Uy next go Ear

Uy Ear

that's I quick if have okay. ones, two

first terminated have there pay Biogen any or to if -- have are you with is in Biogen. What the payments collaboration directions pay you? any are think you fees you indications to the us only you second the one, sort do it's now base? obtain could easier in remind for of one, value collaboration And either So PPD would just Biogen to you if

Barry Greene

Yes.

second, the start me with Let Uy.

So then there termination far as And provisions the on are one. about there -- as that's insightful. very in that certainly go again, I can contract

X.X have We launch. of year, PPD we only are have mentioned, million need for symptoms women U.S. in each the about experience unmet per about large It's -- whom with a as focused diagnosed I many year. tailwinds half

real with big first diagnosis. This a be PPD. only on approved women opportunity will oral the treatment for and improving So

they're then that's advantage. big like a to to have care Zurzuvae. talking anxious providers And product health who a So prescribe

many comorbidities, is to we the at can't know, impact. these use many if all. access GI they the have And patients that get they say The through come cycle work, ZULRESSO today weeks dysfunction, if issue to drugs. they term -- with receptor products that different take gain, weight you often And as

into course problem. level mentioned, an mental that just are and been mind. first for the syndication. PPD the maternal Zurzuvae So every level could OB/GYN everybody's that a on prescriber at happening treatment mom we could level, at health the level. of a that It's in on And they're let's to be now night. world payers solution whereas the have almost supportive historically doesn't health fit and treatment statewide be maternal policies certainly, set, have state of And policies, television baby, how at as least and mental say It's dealing the we with for solution at the been every is

Operator

We'll go Guggenheim. next to Yatin Suneja with

Yatin Suneja

the approval. my add congrats me on let And

then So just follow-up. and clarification X X X questions,

control So is sampling a limitation with the regard has it to our understanding substance from perspective. comment, the that sampling

let's you it us the sample So -- you able that with detail more MDD you would commercial just XXX clarify to I could be you But say, approved for then And provide if understand, and that to also yes, you once regard that. requires and got build, sales launch. rep.

trying it it? sort is to be what commercial ballpark? XX XX% as reps less, sales just build we around understand sales spend rep, also of gauge Just some Just PPD, the to the XX trying or model will

Barry Greene

Yes.

we're me the So both quickly getting answer let top hour. the I at of know questions,

focused big, MDD, So what -- but build with PPD we're more provide much and thinking than clearly, can't numbers. very really way, in said we starting but commercial that a in about we the focused is PPD

in from front appropriate and us. heard we'll resize that the You also Kimi when in pipeline prioritizing of this of for organization pipeline we're the our opportunity kind

communicate so. next that we'll in or month So the

In natural terms a sampling limitation being the see of controlled of use you we but a program. sample to sampling, states, there that on or a don't are whether certain can concept limitations voucher,

Operator

like to today's of I back presentation question-and-answer the turn conclude call. would the Greene. Barry over does This portion to

Barry Greene

Thank to to you, and benefit appreciate of coming Zurzuvae. day again, Biogen us day. Thanks in look months. a support forward everyone, everyone the stakeholders, is with Ruth, great and more all providing the joining a thanks have today. the PPD again This We for all Sage, special continued we updates who from for and women to and stand

Ashley Kaplowitz

Goodbye.

Operator

call. This today's does conclude

You may now disconnect.

Sage Therapeutics (SAGE) 7 Aug 232023 Q2 Earnings call transcript