SAGE - Earnings call transcript Q2 2024

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Operator

Good afternoon. Welcome to Sage Therapeutics Second Quarter 2024 Financial Results Conference Call. [Operator Instructions]. This call is being webcast live on the Investors and Media section of Sage's website at sagerx.com. This call is a property of Sage Therapeutics and recording, reproduction or transmission of this call without the express written consent of Sage Therapeutics is strictly prohibited. call Kaplowitz, recorded. I Relations Vice Markets Sage. this to now and that at Ashley introduce President note is would being like Capital Please of Investor

Ashley Kaplowitz

quarter you Sage Good call. for and results conference thank Therapeutics afternoon, second XXXX financial joining

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

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

Our PPD. Officer, of depression, our development the across postpartum on ZURZUVAE Chief and provide ongoing or will Chief activities an Chris Gault, Officer, will commercialization our programs. Medical review Business Laura update Benecchi,

now joined the will Q&A then Mike portion of from during by the our will call. With Officer, Chief over Iguchi, turn Scientific I'll who call our Quirk, be We second quarter Financial available be review questions for Chief results financial to XXXX. our Kimi the of Officer, Barry. that, will the

Barry Greene

joining everyone, Ashley, Thanks, and you, us this for afternoon. thank

in focused addressing needs health. XXXX, brain remain we As through on we progress unmet

support options. to our we and of push new advance treatment valuable in successes Our provide need and our and science in setbacks efforts patients learnings, forward

announced from week, study you we KINETIC last ET. essential in and seen, X As tremor, negative or have results Biogen of SAGE-XXX our may

unmet development with this this the ET We treatments high close outcome, and limited to there's recognize over the plan for conduct need clinical a further years. in and disease We're plan safety we study, importantly, open with ongoing SAGE-XXX results, disappointed these in past XX of do not label to Given ET. patients. innovation deeply

continue additional for and work year. we expected providing brain to look to data to Now accelerate and launch this health readouts ZURZUVAE pipeline, progress forward later PPD, to and our momentum

Now, depression. helping patients is are where we postpartum

of signals on Turning firsthand made indicative the to continues metric all the prescriptions OB/GYNs a reflecting the first for Shipments progress energized encouraging of line the more quarter, relative treatment this and ZURZUVAE I'm therapy impact to strong encouraging on anniversary oral movement medication screening, is seeing care medications. to we women approval in of QX growth is of of and with the and women the of data PPD. I'll quarter that and previously. establish increasing HCP few first standard PPD, as first prescriptions level PPD a adults. by of only second which supports our important to shipments second the their making OB/GYNs. PPD from treatment. breadth progressive and women OB/GYNs ZURZUVAE. the families, patients with progress, observed paradigm the highlight we're momentum X-year interest QX near QX goal to dive are in in and treatment quarter see the demand detail. We ZURZUVAE how ZURZUVAE. The in we the saw on we've written This delivered postpartum forefront the profound evolution that seen into and treating who prescribed to treatment demand, in of in with and who FDA ZURZUVAE are also based particularly of prescriber prescriptions change early the in of depression. ZURZUVAE of across significantly particular, and treating seeing is were vastly an the for as a beginning improve than growth We're approved PPD more with that It's shows the to as treat we're PPD, Notably, strong in doubled with Chris PPD. HCP for HCPs and quarter-over-quarter patients in for shipments will prescriptions nearly they This suggests HCPs ZURZUVAE. the in is in quarter, to have diagnosis

during and second many new seeing of grew quarter In and write patients. repeat ZURZUVAE addition, OB/GYNs ZURZUVAE the we're XXXX, the number multiple of prescribers for

and with ecosystem commercial with government or to policies improve postpartum for health plans and across edits momentum broad date of country majority step onerous We access not seeing the imposing offs interests for advance policymaker PPD, to to depression. We're continue strong the the across mental outcomes. maternal have also ZURZUVAE to prior

and that example, bill a gain of by the this For insurers state when recently PPD We the permits into in ZURZUVAE gain to PPD. treatments approved to access women Louisiana access help requirements direct to generally law FDA commercial to bypass for state law direct believe enable will with PPD step therapy signed with women prescribed.

highlight strategy focused launch with to at been our approach launch, and see scale we a As has success. as we

help of and where non-personal signs improvements sales focus the to will support in As demand the plans in force resources strategically we sales Sage PPD. We commercial this pharmacy treatment planned It to PPD with specialty force expansion treat processes. is in access accelerate addition QX, and believe the growing help and believe expand early coverage have will the our ZURZUVAE additional to for well-timed momentum. expanding been of launch accelerate promotion, encouraging, of its to in to marketing

of believe enabling look our ZURZUVAE many we disease. updates blockbuster suffering PPD, to to sharing unlocking help quarters. to women the And launch potential coming key more this from in the devastating the is us forward progress to continue on We

We Moving our data Study recently as pipeline. previously. Phase our Kinetic X tremor, to in from announced highlighted II stage clinical essential I

or SAGE-XXX. or our for positive NMDA Huntington's dalzanemdor, Phase In II we no HD, modulator, our which cognitive program clinical disease SURVEYOR Study June, are the development under-recognized reinforces from a for reported receptor results as continue of approved to historically wholly-owned which HD aspect allosteric also of impact there dalzanemdor, treatments. We known formerly progress our of PAM,

the included late read XXXX. and II Symbol studies cognitive one for As press context our study seen LIGHTWAVE decided data, we based Digit Modalities adjust primary in HD in from the our additional relevant release HD-CAB Phase in ongoing may to of Test, have afternoon, DIMENSION Laura provide of endpoint this to have DIMENSION the will or change. Both out on track SDMT, this the information to review composite you and tests our placebo-controlled the on the in remain composite.

explore commercialization Additionally, provide of including of earlier on in ongoing believe ] remain potential and encouraged additional the opportunities that, stage about [ development in depression. we health. With brain pipeline, I'll postpartum need Chris? as Chris the SAGE-XXX, the in context we our SAGE-XXX important to call of turn to unmet areas the ZURZUVAE over and

Chris Benecchi

the women establishing therapy and focused share December of Thanks, on ZURZUVAE Barry. excited been have We've first for as made achievements details our PPD. with shared important XXXX, ongoing to ZURZUVAE and initiatives. Since recent progress second and Biogen in goal in on of of ZURZUVAE line our of care SAGE quarter, launch the standard and of I'm the over launch the

exceed maximizing coming patient efforts quarters. commercialization look impact us further expectations, to to to enabled and over we have potential the Our forward the

patients. The there and metrics, for throughout key revenue. approximately ZURZUVAE second the feel total delivered in progress impacting performance X,XXX of of figures were from review First, $XX.X million and ZURZUVAE our quarter. which delivered PPD, and the quarter, see number the first these interest quarter highlight enthusiasm generated revenue We're this which important are to the patients the to and for million of with reflective second of ongoing filled made nearly doubled more women medication. SAGE pleased compared HCPs recognized shipments than In quarter. the and collaboration demand to prescriptions we're strong written, efforts second positively with $X.X in seeing XXXX, PPD commercialization to X,XXX prescriptions I'll in

we across indicator, shipments to number collaboration and and reminder, As ]. According while plan we was prescriptions than early with psychiatrists treat on prescriber by focus OB/GYNs, a PCPs. quarter from coming trends, breadth PPD, prescriptions followed are and of a of the [ second an more quarter seeing [ believe ZURZUVAE the going next important to prescribed forward we revenue XX% in of HCPs ] who

ZURZUVAE place shipments paradigm this on signs critical underscored, way to and the peripartum reflect and changes is and the ongoing squarely and therefore, and is a to our of for seeing patterns, revenue, in a to this ZURZUVAE take OB/GYNs it's of center the earliest moment fundamental and about over is PPD women front a prescriptions, thought that the that with there with launch first best are the are treated. quarter, at are performance diagnose we've reflect including now of ] We notable treat. When second unfold we few on clear highlight screen, PPD. treatment the and of HCPs As success in believe women as that change these care, [ now the shift. I'll prescribing line you the PPD,

increasing data particularly As PPD a for medications. OB/GYNs. early PPD Barry significantly on see as ZURZUVAE all patients screening, and are treatment previously, suggests Notably, based see that this with who to written than beginning uptick the paradigm, diagnosis, were OB/GYNs treating OB/GYNs in they noted earlier, prescribed among more have changes clear we in are prescriptions treatment. We

the get other more terms The see In stakeholders now particularly It's with for continue PPD to and continues based suspecting who care, to the XX% of the to ZURZUVAE as that with treatment described of in in are with model are would ensure have ZURZUVAE to what than that totality satisfaction to and they suggest and woman This about PPD first of informing promotional patients are effectively of they a with is progress prescribers grow that total giving increase. the movement occurring PPD as when with the are with now adoption data to multiple to HCPs see on that present can in QX. a interest number I've from ongoing have are efforts trends, of referring depression seeing encouraging expect women need. written summary, of ZURZUVAE symptoms. repeat women their is old a prescriptions, the OB/GYNs with and moving we ZURZUVAE. In psychiatrist ZURZUVAE we women educational new treatment that these using for diagnosing, that patients PPD. Notably, treatment a ZURZUVAE both PPD suggests and after PPD majority birth. it screening, prescribing and our trends in effort efforts, indicating The much-needed treating receiving on in ZURZUVAE impact

on PPD from telepsychiatry intended are choice progress matched a urgency of to build our this our which digital and for PPD. The ] a with either for recently and half with this the ZURZUVAE we to more with are reached been link Women diagnosed engage people see sensitive to XXXX. the top promotionally have media experiencing in our personal previously, information come excitement as across the and provides remain women will a is PPD. We [ platforms efforts noted ] and website, launched making To field majority with market, prescriptions with independent, efforts symptoms reinforces for of inspire get ] [ treatment full potential leading channels in promotion. of ZURZUVAE and PPD platform which [ I ZURZUVAE mind practice. end, in have resources stakeholders educational HCPs social option psychiatrist. also who which underscore force includes of first treat of that goal second active through We're coming the awareness, all consumer through a treatment As making or to to our an as to women experiencing omnichannel importance new a for

lead PPD up commercialization. treatment PPD, rapid affordable successful we to as to stated regardless that [ ZURZUVAE of Turning are launch, women who the access of ] goal quickly Biogen possible, have type, been Sage ZURZUVAE shared in end, for was paramount the focused regardless of that the the type. to to medication as the To receive access. with In of [ helping ] proactively and prescribed coverage coverage women and on

Our highly been conversations payers productive. with have

step it. Today, with majority are ZURZUVAE no or to onerous ZURZUVAE commercial see encouraged XX% approximately with including labs prior access or women PPD, policies authorizations plans therapy PBMs ZURZUVAE X to having for in disease. who covered complex authorization, national majority and first-line We and coverage step without of the developed provide that the the policies or X finalizing for have prior PPD we of

the with largest during with of XXXX. ongoing, the completing Medicaid, including of states, conversations second the national continue states, With are We progress third to quarter reviews reviews PBM. respect several to additional

expected We develop, that line date are no expectations have policies majority continue typical no of coverage support the for patient decisions most eligible remainder authorization. The coverage we and for to to already robust in proposition assistance the with work continue of and of with to payer with This rapidly receive to not is affordable to for attribute that of to programs. equitable and for closely women decision the ZURZUVAE work PPD respect for XXXX. in ZURZUVAE access financial of new need Medicaid with type progress PPD therapy Medicaid half and women access a made, occur with willingness payers To covering our to made to PPD the to While to this women and treatment, states reality launches. a step make complex enable have in value second profound our Biogen the Sage product prior end, ZURZUVAE PPD. of progress with with been to

majority in second the programs. free an we in quarter, the see and our uptick of government goods shipments covered While by payers were commercial did

free eligible program accelerate intended help to access for ZURZUVAE is prescribed with are goods who PPD Our to treatment. women

further treated. and occurring decrease. In the process come summary, optimized, fundamental about, to of date more change There's to by online with is is a the free payers and encouraged respect made remain expect with proud highly and how thought as see pharmacy to specialty progress use ZURZUVAE. we diagnosed PPD the launch As of goods we

engaging We committed to PPD and are women them. with treat who highly helping living the HCPs

detailed which increasing HCPs of early to with accelerate the progress Laura recent I interactions our Sage QX, will Laura? for PPD. sharing in in commercial As frequency launch Barry help noted, and believe development the plans activities. reach additional our forward turn I discussion quarters. With to strategically force expand coming by a broadening we look now momentum treat sales updates that, will who on more to over it our our of

Laura Gault

Thanks, Chris, everyone. afternoon, and good

the program designed to make reported present impairment critical worldwide discuss of as maternal unmet or addressing HD excitement in data dalzanemdor II increasing, enabling Phase indication, a cognitive crucial our or improving a to including the need in pivotal this HD, to impairment in well-being. In for with the and AD, with like DIMENSION I'd PPD. I'll SURVEYOR from be of with to with learning of of I their Before limiting ability independent. this challenges for health access begin AD. Disorders my progress patient June, we moment study impairment, pipeline, we Study, part launch with Study. small share are activities and disease, potential ongoing help owned first-in-class The oral dalzanemdor, women neurodegenerative PAM, remains receptor the their inform as or including to lead and living, these positive our wholly therapy remain ultimately, patients to our by for NMDA and cognitive in is incidence diseases, prevalence allosteric which modulator, cognitive daily such as Alzheimer's ability disease, HD, significant perform associated Huntington's ZURZUVAE, disorders

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XXXX. We Study top-line report from continue data late to expect in DIMENSION the to

closely in the important Huntington's of need. to area We with will work community patient continue this

double-blind, We dalzanemdor of Study, dementia Wechsler Day primary the Intelligence SDMT. change the in the the XX has endpoint impairment from Scale executive the baseline as test. The a are and AD. cognitive is Adult to mild is or II with WAIS-IV The due running design an Phase mild placebo-controlled coding LIGHTWAVE Study also LIGHTWAVE a of people IV, study to assessment coding similar that test of WAIS-IV function in

X this with SAGE-XXX investigational being The reported X and We X PAM, dose XXXX. is collaboration A data day II demonstrate score. developed receptor, on primary tremor. Phase top-line continue item late essential endpoint, report based study an significant week, top-line in baseline to study to that XX changed is of Kinetic from PS did SAGE-XXX we limb data relationship statistically the upper Kinetic GABA in response from expect a to study Biogen. Last from total in not the TETRAS

were demonstrated day any from In score placebo total or item ADL for XX change X on baseline addition, there significant no of versus SAGE-XXX score. the TETRAS statistically the Performance and composite the to differences dose TETRAS Scale

not plan safety we these essential development the Given will of ongoing tremor, close Sage further and and SAGE-XXX to Biogen clinical in conduct study results, do of open-label SAGE-XXX.

of steps, potential if results X evaluating the any, the and we are by disappointed other deeply for are indications. We Kinetic study, next

also our who the and and Sage to this tirelessly grateful community, for support efforts We teams researchers, I talented are investigators to study. ET. our committed essential contributions in participants, worked deeply of am incredibly have tremor staff to their study the appreciative

and to progress. as early these PAM. more PAM, our NMDA [ and stage receptor about programs and look GABA for to they forward sharing Lastly, reiterate including excitement ] SAGE-XXX receptor SAGE-XXX We I'd A like extra-synaptic our pipeline,

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

Kimi Iguchi

Thanks, Laura.

results financial XXXX our the in release of press for issued second Our afternoon. detailed quarter are this

the in to quarter, an shift a like expand and momentum. was top ZURZUVAE overdue, building innovation where add accelerated my paradigm launch. as enthusiasm our to a for in new area market treatment as a and long build ZURZUVAE of access seek discussing priority Before We're a some in commercialization I'd opportunity result, have we of PPD. The financial the results the of remains

$X.X greater impacting forward grew make to sales second we inventory initial down growth to number measured functionally the in by representing of plan and XX% Beyond announced by QX, to readouts government, from factor XX% QX demand revenue data patients. A levels, we than typical revenue the QX underlying total we by bringing the data, to year. I'll additional turn from product shipped quarter pipeline the of first quarter for wholesalers was second in decisions represents This buys investments uninsured continue which as of now to key quarter, in commercial, inventory to inventory The to look of QX. weeks the of ZURZUVAE of of weeks the records X.X average and the financials. as the as Today, In on ZURZUVAE, collaboration the an of we in compared supported in XX% is strategic million expected saw X later growth of average second launches to net quarter, an from the revenue progress. ZURZUVAE. revenues, units a and XXXX.

X.X free slightly of the relative saw target higher first to a quarter. are we range. Definitely, week inventory use goods in the levels X-week Our to

to process these of in half use optimized. SP of the expect as we year the comes the decrease the detailed, as further payer Chris coverage as is additional programs and Although, second online

decrease last and the SG&A of in R&D second quarter XXXX. was second reduced expenses. expenses $XX.X of on to both in R&D quarter and stage QX million the were XXXX the which Turning expenses in headcounts quarter clinical were SG&A restructuring, to operating the manufacturing, related to primarily overhead, expenses of second The million $XX XXXX. decreased development, zuranolone the and early spend compared year pipeline, technology.

operating XXXX. expect relative to decrease expenses we XXXX to stated, previously in we As

seeing already XXXX. decrease are half We the first this of in

that, cash, $XXX second the well for the readouts of million. With quarter million, quarter XXXX and loss launch equivalents, ended estimated as second of plan, in XXXX, of XXXX. we net reaffirming will XXXX revenues based we are in collaborations, ZURZUVAE, funding our that guidance. cash marketable anticipated anticipate current $XXX.X with cash, operating increased to securities cash as approximately and the marketable equivalents, runway changes support will clinical on investment into we of and ongoing not With was expected Our securities, be operations from we and our making ongoing

like Before commitment to operator. mission turn the look I sharing updates We turn ongoing promoting in brain handle quarters. I'll everyone. with over health to emphasize Q&A advancing Ashley forward the call coming to over to of for our better the I'd it our for now Q&A, to

Ashley?

Ashley Kaplowitz

one Thanks, Kimi. limit you question. to that yourself I'll ask

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

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

Operator

question [Operator from Richter Instructions] Goldman comes with And Sachs. the first Salveen

Salveen Richter

you sales play just regard or demand? speak to with the to -- that shipments this? versus how drug a the role in we're ZURZUVAE, free in difference Could seeing also then dynamics And

Barry Greene

I'll start, and to I'll ask comment. Chris

date, both commented, as So dynamic to And the temporality we're those by highly and Chris of prescription shipments flow, and each certainly revenue. cover how to some terms that. of will we launch in there's encouraged

other and refer the to treat. depression The absolutely highlight [ ] suspect and seeing screen, among particularly very OB/GYNs, important paradigm this diagnose behavior from I'd we're of that is shift, comment

dynamics want differences? the all some talk very and growth to So Chris, you metrics about of are strong. temporal very,

Chris Benecchi

Yes.

the over would we the pharmacy, respect reflective demand of strong with prescription the a shipment in of said, quarter. from patient. we XX% of And performance specialty shipments Barry the the the is, to specialty the that into saw than to is, shipment I of product X,XXX movement Again, course quarter over around with as process, of so we reported, the wholesalers hit factor and revenue Kimi care quarter second the primary we that down With revenue quarter, from the key regard revenue different it. the over bringing I than second impacting XX% the increase effect, a reported and encouraging the physicians. That's OB/GYNs, as second course we of in of noted, that what it's it's goes actually first X.X second first what a versus you the the the think hit to over when weeks course second versus psychiatrists, and X increase, quarter here quarter the were And being quarter. that in So the as more compared the be of see in year. a average shipments inventory to levels pharmacy where hands to it, second of would the it's as saw the inventory measure the an Kimi time, weeks

effect, we're prescriptions in shipments, difference over is again, that, the of strong respect So the with course that remarks. our the seeing as in performance here. But noted quarter and opening to we

the shipments Now, of prescription mothers byproduct medication rapidly. PPD, patient needs we to if the in SP in there's with goods. mentioned rapidly. various comments in continue we're and that into get did second a of want goods, that, that quarter commercial it can ensure saw an And we we do uptick that the able quarter, of that of Free was get of government course ever that and uptick strategy. We a model, see that we hands the in we are terms to to making with a optimize that of women as speed to were second sure and covered PPD the the payers to the that by goods the our part and around saw over majority free free

Operator

from question the come And JPMorgan. Anupam with will Rama next

Anupam Rama

your dynamics first the How expectations tracking segments? each It are you to you the question charge physician physician relative OB/GYN are leading initial to here. relative for quick ZURZUVAE kind but like of seems tracking thought? you Just what of is a on here, in how

Barry Greene

encouraged highly Thank well. for as We're that. you

very you're dynamics seeing So expected. -- we much a what lot the actually is

you just while, any As are and a the company of is for seen front quite where disease. been like disease know, a PPD diagnosed, line we've and OB/GYNs

of either out want previously, of lack earlier the primary dynamic of or care. to a to was and disease pick the I the tools mentioned but question, part. that getting right suspect disease, up had, but the psychiatrist to depression a You at OB/GYNs the are because refer the Salveen's point OB/GYNs to this

the we PPD, we've suffering. ZURZUVAE blockbuster many key is the helping As previously, women unlock think potential said to

So in their now OB/GYNs that their have paradigm. a fits armamentarium treatment tool

mom's screening, treating OB/GYN. seeing major thought. dynamic of what exactly So we we're diagnosing, the while That's under of this now and the care

see someone symptoms Those be other Now, either done OB/GYNs, it's to previous encouraging PCP their might not or but patient really kind under whose journeys, OB/GYN. until or care with worsen psych and don't after also of someone only they're prescribed. develop

those good healthcare it's So to groups all -- coming the prescriptions groups. provider from see all patient

Operator

question our from Piper Sandler. Rahimi And with will next Yasmeen come

Yasmeen Rahimi

jump last do it the I is of that if do audience the into guess, So is early psychiatric you have I'll of unlocked? out really quantify primary about into And patients be back queue. the has needs the few physicians think product the what to [ you expansion how let's case, ] think think you And the or to unlock Or think [ like, -- target love market to opportunity, care to would to an PPD -- on? kind in like ]? one many months? reached OB/GYN the PPD this to market of sort introduce that's OB/GYNs perfect really could been about out currently division the

Barry Greene

I think dynamic here. nailed congratulations that like was one, questions Look, you for X that. so in the

some Let provide and ask color. me further comment to I'll Chris it, on

providers step the any disease exactly a birth. And PPD prior That's either if consultation are healthcare during where and starts case pregnancy first for with OB/GYNs, weeks want or course, to any to history ] disease the source. the mostly. of after a PPD [ in or in pick the giving up back closest So patient we think or disease, several you of in the

can the birth, in worsen but months it starts. it where course, that's of generally course after Of

wonderful are the [ It's right OB/GYNs and this group to that ACOG the provider guidelines group the up. PPD. pick is own wanting it ] has So healthcare of to disease

relieves Now, and procedure standard mothers when for as having course -- are them actually of that well. some we talk to PPD believe healthcare picking they and of patient diagnose psychiatrists, another they with prescribe can operating that But prescribe. a provider group a up of these ZURZUVAE

happy to about pushing they're So OB/GYNs. this

point, in when scaling. about but focus Now, to big scale a our we your started PPD at we we the thought launched, opportunity,

Now that is It's spend you something among we've to marketing, our expand unlock now non-personal for we field so to and And OB/GYN seen but such sales for not force success, personal XXXX. expanding just great force. Sage the time marketplace. the that promotion to OB/GYNs, the can as particularly increase promotion, we're commented, our in continue it's paying

any forward. XXXX, made ] Chris, that's how we're any [ but additional decisions add? color in haven't to We moving

Chris Benecchi

Barry, So what the paradigm here from interesting to occur. one of that treat. that is OB/GYN to physicians early the seeing more And screen, of launch we're and practice we're level. is this to you and In suspect refer moving even stage seeing we patients a starting the it's community, shift diagnose at things diagnose who the that prescribe begin reach begin who really mentioned at ZURZUVAE, to

the recognize and and what seeing safety in basis very treatment thing symptoms regular and ]. degree and around them the viable near fundamentally and telling efficacy reflect back the run term to the only and the us long PPD satisfaction to to to for not profile be ZURZUVAE, of a again PPD and women for job clinicians, ZURZUVAE patients its it's medication and in with that exciting the in PPD the may they're over causing of So of and on a signs that's is really probe a respect with of doing [ that's on to is, practice more go delivering who those

Operator

Matteis next question from the Paul And Stifel. will with come

Paul Matteis

the I be change little and your confidence of the bit in more explain this was to validity you whether endpoint, it of evidence the FDA the benefit behind subcomponent Huntington level HD-CAB in of for could cognition? thought on wondering if a acceptable would of

Barry Greene

start I'll turn to and it I'll Laura. over

talking you're learning cognitive about Huntington's Alzheimer's. that dalzanemdor [ are executive and in specifically for and memory So studying function, ] we improvement,

learned don't did why -- and As we we're we But to applying dementia. we is Laura, take that learning a talked you through us what learning about study that? and

Laura Gault

sure. Yes,

So thanks the for question, Paul.

also small saw last specified directionally individual signals SURVEYOR announced on at [ dalzanemdor from data some in HD-CAB the of differences of But composite the ]. month of through Day in numerical score between we tests for we component XX. look number analyses placebo we as a the saw we other positive the HD-CAB that So

that on and on the available to consultations HD endpoint we decision made community, to based information experts based within so, the And SDMT. with the information the and publicly adjust

choose assessment Now seen as reliable of we in -- directionally and positive cognition measure standardized a the positive endpoint. It's of clinical is is used assessments and study, actually in decided SURVEYOR of believe for HD-CAB other And SDMT we data executive the and I one the we've disease widely in disorders. that function. the it because of a data mentioned, to composite primary Huntington's the

secondary, SDMT, the to key addition safety. cognition, as and scale secondary other and function endpoints the to In we include independent continue the of UHDRS evaluate measures

Barry Greene

We look out year. later forward to reporting this these data

Operator

next will Jay come the Olson And with from question Oppenheimer.

Jay Olson

increase about invest resources the you then ZURZUVAE Thanks such how of question. and in this plan for to and planning reps? are For psychiatrists uptake you for to example, for PPD providing more taking as diagnosis rate update amongst Can PCPs? additional the expand you sales talk the and

Barry Greene

I'll start on then I'll the dynamics. to Thanks. comment and ask Chris

and can is healthcare prescribe point as every us. on that the ZURZUVAE provider really key this is mom we disease the But important about help OB/GYN. talked call, the So, interception for of

at increase as additional as marketing So force non-personal the the in about the well major talked OB/GYN. we will be that sales aimed

want her mom where Now, to that worsen care symptoms happen, through birth, example, if X X whole course, for months which intercept. of a giving or can we psych primary gets that's or and, period after

resources diagnosis come OB/GYNs. So and screening a improvement will applying there, the we among are the in of part big but

said, referring didn't already seeing. tools, states most they because we're diagnose of out, shift Chris add? the paradigm paradigm shift anything to this suspecting depression, to have the and Chris, As treat is screening, which require,

Chris Benecchi

with a to and and OB/GYNs, clear we're It's and an an you would really diagnosis here. important and engaged [ I coming a guidelines treatment. remarks, play increased in add, the out the Barry, your in guidelines, think of to and subsequently What they're is tailwind, screening ACOG think it I that's aware it's opening role impact have noted but worth it's And I back tailwind. when going

an education -- to that to you as deepen as our around reach to there noted, and are do woman frequency the what and opportunity with have right well with we the need care as when our there's in with I patient, both for think, a screen psychiatrists physicians, and around you patients diagnose treat the with primary non-personal right and broaden and for promotion PPD us personal ZURZUVAE.

seen and going success. on scaling that's of signs now, we've we're right as of All

Barry Greene

emphasis. diagnosing OB/GYN, we're women kind just but a provider, when with close a out, the we're get of ZURZUVAE number it in they're on treatments. general them and comment that this, seeing is me primarily that Chris We time, make of in their the let first point What increase for of practice. Jay, healthcare broader seeing from question, Yes, prescribes to

is. So it's not it generally always ZURZUVAE, but

we've this own them than it is that, And So shift and see. we're to to and support actually and now rather exciting and on. it got seeing screen pick pass that -- up diagnose it's paradigm the data

Operator

come Baral TD will question next the from And Ritu with Cowen.

Ritu Baral

for gate airport more prescriptions Were I included shipped were denials? ask prescriptions, insurance one XXX I the free noise if X,XXX about and all the difference squeeze was And the those prescriptions at that prescriptions. between that the Apologies X,XXX XXX? to drug drug free the there. -- included could here. wanted in Were the in the

force happened? the the just up be by many was increasing -- at can sales and all, all tell first that how you conference ACOG informed reps You're hiring us you'll of that by

Barry Greene

different Ritu, couple a questions Yes, there.

of encouraged So all we we're dimensions. by prescriptions, talked the growth again, revenue shipments, and comment, can as across about and Chris highly previously,

between growing because and successful There off temporal when a have shipments. cuts launch. the differences and of prescriptions are quarter We

we're shipments how can all So we're flows. or free the reporting revenue when after whether and the out we on and seeing, prescriptions the comment they report paid the paid all prescriptions, shipments, revenue. The done is become the that revenue both Kimi shipments, I'm are shipments out shipments. free

[ numbers. We fully free didn't pretty aren't free those a get goods, where ] liberal seeing goods functionally of the program. and really we paperwork those some deal did the goods free which and set great a up, click of are totality patients, are are out, So of uninsured have the some patients coverage denial. In

as good better, rather So and healthcare delaying than the that commented provider's filled. earlier, drug and free Chris get prescriptions mom mom, a gets to they shipped

that right strategically is we So thing the think to do.

As better some, see quarter coverage comes goods online, getting falling But and SP functionally how into and month, get always [ recorded and better, that about off be because to course, ] processes month from. next can fourth to will [ help, of patients. you There to comes the free as continue maybe, ] Kimi, the third, uninsured they're the revenue's they're year. talk we where

Kimi Iguchi

Thanks, Barry. Sure.

a distributors. As actually when wholesale ships booked by Biogen revenue to reminder, is ZURZUVAE

shipments So than different patients. shipments about, the are again, to talked which that's we that

So units prescriptions that's X,XXX talked written, about, different right? that's So about. we prescriptions the it's from X,XXX the we the talked and that

typical inventory and bring to of initial decrease on So the again, that weeks sure revenue. And inventory say I'll we as launches quarter revenue levels. this just starting key of -- make It's people to see number get outstanding. wanted factor that was wholesalers on saw in down grounded again impacting the we were did progress, product

Barry Greene

part on of We're expand opportunity to And said just is that second promotion. question, marketing, we then your we tremendous the one-question What commenting expansion. not and non-personal to numbers. see Right. a your

amount a force once the they particularly, And the expand another they're expense success that they're of coverage PPD that And quarter, OB/GYN ZURZUVAE, the and at increasing write again, we're lot Sage's seeing. the because So covering. in in another writes strategic an field areas. the and fourth we're to another, sense practice, and of and makes given our going

So makes talking all us. sense numbers, not to it however. We're specific

Operator

Markets. from Abrahams Brian a we'll question take And with RBC Capital

Brian Abrahams

what clinically I'm SDMT reads on year? scale as sensitively about sense do scale this why on change we when mechanistic this up drug this meaningful might effect as DIMENSION rationale dalzanemdor, to population? to pick this you a a have thinking be later should back curious a the more to Maybe out potential And as in

Barry Greene

Yes.

for, room, is rationale, strong. me then Laura Brian, we're and for which the mechanistic with Let the Mike's dalzanemdor. to Laura, on about can end he question start -- on actually in talk can point quite thanks and you the looking start? But the want what

Laura Gault

Sure.

SDMT, variety number about points to across the are literature change to ways to look to a seems is. disorders. is of be clinically there try meaningful into for a of So a where One change what understand X the the adequate of

certainly will we and meaningful identify classic we our sets when clinically together, actually second data DIMENSION The the that to to the way SURVEYOR do is look and have within we own change. analyses psychometric data, and use

Barry Greene

going Mike, about [ you're ]...? Yes, to talk

Mike Quirk

in then thanks sustained looks the of circuits I SDMT, as processing think mean, that, important striatum, I and that speed, starting scanning back ligand thesis you with our Brian, other in the add that areas those think such damaged for are the when HD go our patients visual that part Yes. that function, variety very when different changes much a cortex tests endogenous deficits the to executive you original if to or XXS within it's mention domains to at is the those we tests, on the on about And about brain the some that psychomotor one at in population. And a mechanism. frontal first, patient looked think where cognitive of question we've hydroxycholesterol that I of with involved then I were of attention, think you talking it's there. And see correlating test it's speed. SDMT classically as are that is the

as a and tight correlation think SDMT from Huntington's, of cognition. are circuits that as view I those in from impacted So domains of there's think we brain point really the modulation both as -- test the between endogenous well the

Operator

question a from Chico with we'll And Wedbush Laura Securities. take

Laura Chico

script I'm yet And writes yet? in the ZURZUVAE trying I going get goal to just to to be, one, to the of when a pace just medicine physician point has going to ask target and terms your understand how timing at that's patient if I'm a delivery? for of evolved the to think you're the

Barry Greene

Thanks for appreciate thanks question, question. and asking the it. We for one

helpful. very So also a and a XX-day rapidity important value onset, proposition major only point. you're is course, the which A ZURZUVAE highlighting of very it's course, of of is

moms moms "I it's moms anything. drug suffer prescribed I really to that's want before say, major until to ZURZUVAE, satisfied want making very take this shift. We because healthcare as -- take created it." providers in helpful to So "Yes, saying, I'm the decisions possible. won't get So major, quickly the be and drug", as through many try to don't going paradigm

in is X to the this diagnosed delivered get to area are -- getting in their days after home. There X put many that this So drug continuous moms the of improvement.

Some longer. take

get there X down. So the number for everybody. X won't And we time keeps satisfied in time to be the to coming want until that shorten increase we the and days median

I classify get we're always well. but as doing can well, doing better. So

Operator

Hoang with moving to Citigroup. David on And

David Hoang

and or Biogen about I force anticipate just the the we expansion? level and other any to be bit of your expanding the acceleration little ZURZUVAE with -- should your ask wanted on inflection to in launch sales they the a of side in of commitment whether planned And metrics? type perceived perception concert the then scripts, shipments would post-expansion,

Barry Greene

the of and Chris with me X-part question it Let your part to over start second for Biogen. turn then

in So target frequency expand have reach our is audience. to better to the and reason

profound because a -- that year uptick in of next expansion. yes, So, we see should

answer sort of yes. we're Chris, do want doing talk commitment? about the that So to versus and you what Biogen to is

Chris Benecchi

Yes, thanks, Barry.

opening your Sage in noted in force in So is you remarks. investing expanding field our QX, as

our business Now, any working strong as that all approaches between to believe perspective. their a the mission with X women possible their we PPD few as additional of We supports case will possible. collectively, as to helping quickly it really is -- support as expansion. a while from doing And we're shared resources pilot with investments organizations, this, many existing Biogen have inform

Operator

Tazeen Bank our with America. Ahmad question come And will of from next

Tazeen Ahmad

R&D least into that about thinking and of [ be for for decrease your for we quarter. R&D on the us we ] also How set did at should the line maybe how taking just [indiscernible]? sale also the have the rest year? you You nice item think about of Can expenses. for the level XQ account year rest a the for ] should in Mine's this [ expectation

Barry Greene

then Kimi more Yes, specific. I'll start on can something and comment

bring you'll Kimi, meant want to was restructuring the highlighted, happy we savings. as we to down, that more you about, and yes, see continue talk color and saw to SG&A costs which So, in there? But, this we're quarter, and R&D

Kimi Iguchi

Yes, sure.

investing. always try R&D XXXX, both in and Barry into and on about were decrease as being savings the to and does, do year, saw the Last disciplined cost key made mentioned, focused Sage several workforce that cash cash we Obviously, going XXXX. our how into reduction. been included SG&A to of focus both very said that We guidance we initiatives, runway we've first did that of XXXX, half we As pipeline you and strategic seeing that. reaffirm and of we prioritization our

Operator

we'll Farmer And Scotiabank. with take question from a George

George Farmer

is I new so, way the which was if you to and in continuing efforts lobbying coverage. intrigued to Biogen, that Was by with your law PPD comments other and/or by related in throughout any that all women basically Louisiana, states? get related that is mandating

Barry Greene

question. Great

So mental both ago, or office, incredibly you're Whether and cares was weeks a health a couple as commercial I highlighted, office health. everybody the about front, health and or is well. Chris brain a down D.C. red everybody access in government and maternal about blue going on cares in

delivered is at about. There very, X, written, which care of that the health, that of unfortunately, directly had maternal people a moms. in great not if to has we're several history prescription people issues intersection Louisiana very So, interested growing sure were making a in it's

what's them. What's So, and whether or issue and that many a actually of accident. media, by to government of that happening -- it's state people effort coverage We it's this by the affairs with tailwinds have people, none the was shout in state direct big is on solution out the going lobbying, this bothering our of an a for many launch, that the Medicaid, Medicaid state, at have will development never support across under good pharmacoeconomics a so will seeing think it's or that might probably, if state she'll the garnered child. Medicaid child and diagnosed get a not all and fronts, off a really is the properly, become treated continue. We're that mom and and issues, interest at coverage I level

other really in what seeing states. and seeing we'll dynamic, So, strong likely Louisiana, see in a we're we're

Operator

And Purohit Stanley. Morgan we'll take a with question from Vikram

Vikram Purohit

We one SAGE-XXX. on had

down could you're that next mentioned you indications indications how ET, about program? obviously for? there but so, for thinking those the you're are molecule in if Biogen you've And are this exploring and what steps So And winding other be?

Barry Greene

you take Laura, that? to want

Laura Gault

Yes, sure.

as press decisions made. steps So we and our when and Biogen mentioned those potential prepared relay we will certainly the if we remarks, release and for in they're evaluating SAGE-XXX, in any, are next together

Operator

question will next from Kulkarni with Sumant the Canaccord. come And

Sumant Kulkarni

$XXX supplement for bit for guess you point happened assets is With XXX? our outside and in cash a make to Thanks think it what box. bring you with in sense to taking what I million recently which equivalents, might outside do in dalzanemdor could at shop the so question,

Barry Greene

Thanks to ask question. that

a Nothing and go, there now, one make has date, we've intrigued so scanning right about that going certainly out So that we happened before. there, we'd potential are Nothing our obviously, we've commented active what's of we've that. see teams talked radar but our previously. about opportunities. examining focus, move intellectually highly places got screen. could by that's we this on report, If a the on on lot curious, to it's and and we're We're something but to of that we fits into strategic

Operator

will from question with come next the Uy Mizuho. And Ear

Uy Ear

It you've seems state the like level. coverage, significant progress on made at particularly

should see half expect? we you second kind ]? launch did the [ curve shape in of understand, the think us help do maybe how Just you What

Barry Greene

question. the for Thanks

both So side. on government to your the question, we're and coverage strong the seeing commercial

coverage does lives As not step importantly, edits impose we reported, and or XX% auth. covered, prior are of onerous commercial the

So lot momentum. now, right a we're of have by really what truly and encouraged seeing

quarter, particularly we vast are we about, year. of the territories there writing are believe, doing we adding the that the practice that highlighted, the lot where resources success talked at growing uptick, We're we're a in given sales OB/GYNs the our of and work that in PPD, and scripts who now we particularly we an sense. into Sage see with are that believe as increasing fourth As force seeing, their should makes of -- we're majority doing next

resources an success. see further do with we added uptick So the coming and

Operator

H.C. with come Wainwright. Douglas Tsao next the from will question And

Douglas Tsao

the just I this with change? the data I'm on given think just but about, shift endpoints, the I curious, of for in it was set, the in endpoints? potential not asked, on have talked terms you guess FDA and And So based change the just I'm fully mean, you consulted sure implications dalzanemdor I filing on

Barry Greene

question. for Thanks the

Huntington's. we're look, that, the talking study been both for the the confirm about couple HD-CAB, to this SURVEYOR looking by was to we cognition about -- volunteers in as So a talked and readouts we've significant measured years, highly cognition -- the the for we're patients. normal significant forward deficit is, difference in Huntington's We last in reason saw for What dalzanemdor. between

the So unmet a need, disease It's It's these important. that update. confirms nothing and with big patients. there's for orphan really an

So benefit-risk. that's of really important in terms

XXX large the said study, DIMENSION. the we well in well-run this positive won't study and that from we a over Laura other we'll we to secondary I to matter. patient move U.S., going placebo-controlled, as SDMT outside we're forward place It's double-blind, study, then everything the that. endpoint, to as and as data learned, Secondly, repeat but a with study, do learn and SURVEYOR we're the across is said, apply endpoints. other where that and primary both are data regulators, If endpoints, robust and a and the package primary and putting the U.S. secondary have

with say FDA specific do that interactions, we don't to continue we've comment or so. interactions regulators, interactions we on In and will specific we've had other of other terms than had

Douglas Tsao

in? Is HD-CAB a still? Can secondary jump I the

Laura Gault

point, at the its endpoints. other but in in not we So the HD-CAB entirety looking this are at secondary components of

Barry Greene

patient we might thanks right, not for into one-to-one, and used HD-CAB small would to Doug, all again, move was, idea modify we hypotheses Yes, move, had learned asking. several of we study, HD-CAB again, which aspects XX of The DIMENSION. -- SURVEYOR, learnings and going what study, that

sense, some HD no [ but ] components So, of composite do. as endpoint makes a its longer

Operator

a we'll Goodman take Marc question with And Partners. Leerink from

Barry Greene

We might Mark. lost have

Operator

with Securities. We'll Lee go a and take question Joon ahead Truist from

Unknown Analyst

growth base We're from sales is the XQ? expect base to you could growing prescriber the just prescriber on Joon. how to you for And expansion? continue quantify if ZURZUVAE wondering after you XQ force This saw the [indiscernible]

Barry Greene

start, Great can Joon. more send best guess our provide Chris I question, and I'll please color. some to

of we many in quarter-to-quarter, So continue they that see someone see ZURZUVAE for about force far it, to OB/GYN for The again, the front grows Part level is see level. the them we and seeing about prescribed of PPD to quarters to reason treating learns at once ZURZUVAE, PPD continuing start more come. because, expansion is get prescriber prescribers sales denominator educate the we we're as which more want growth. to patients

So we see color? continuing. that Chris, other any

Chris Benecchi

for to the are with only suffering that to continue shift that's XXX,XXX X,XXX quarter. sure is are continue in but I births care. but and to ZURZUVAE of are patients think only a not or line severe this room and Barry, be not depression, not lean with a back little the the of Half treatment, sight opportunity make but add, women, PPD we've X diagnosed bring would totality this, of really there's so than were prescriptions an I in to were fewer but paradigm that There women. life just bit to about lot respect in, we just X PPD, women a of we've first by that talked about to in these standard reaching half for have it's up talked lost postpartum market that treated. and to What affected that the We us important on of that second

Operator

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

Barry Greene

results Thanks, everyone, for afternoon our to this Justin, from review second XXXX. the us thanks, joining of and quarter

program from these the highly a scratching just growing of in strongly the on out data the This as second to track is of enables the encouraged year. many people important suffering motivates the big major ZURZUVAE bolstering confidence market, is believe impact through health disorders. importantly, there, critical to brain we're really important. our us we the in a launch believe to you heard to surface out in have this PPD, PPD. help we're heard just from ability and really and by every our can Chris, women times, read foreseeable milestones. we're And number from people with you strong which we going our us positively from suffering progress future. We're We help As day. That ongoing financial impact what of dalzanemdor for foundation mission to And half and

Sage -- thanks Biogen you there and have and thank and moving this along. thanks, And patients for those for at out clinicians helping a So great the everyone, day.

Operator

today's Thank do conclude excellent you. That does We for you thank an day. conference. participation. your Have

Sage Therapeutics (SAGE) 31 Jul 242024 Q2 Earnings call transcript