SAGE - Earnings call transcript Q4 2024

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Operator

Good afternoon. Welcome to Sage Therapeutics Fourth Quarter and Full Year 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 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, Vice President of Investor Relations and Capital Markets at Sage.

Ashley Kaplowitz

you XXXX Sage Financial thank and Fourth and Year Full Results afternoon, for Therapeutics joining Quarter Good Conference Call.

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

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

update Chris the Our Officer, Chief and commercialization of on ongoing Operating Benecchi, financial ZURZUVAE provide key results. will an

then Officer, on Our Chief pipeline. our Gault, update brief provide Laura a Medical will

Scientific Mike With will turn addition, call now that, Chief Barry. the during Officer, portion our Quirk, questions I'll be available call. to over the the Q&A In for of

Barry Greene

treatment plan ZURZUVAE's growth to postpartum enhancing as depression XXXX you, for joining everyone, oral Thanks, underscored Ashley, and adults thank important momentum, on shareholders. focus discipline a commitment recalibrated We our build and us we with PPD. for a R&D financial to or XXXX entered was this a with year the commercial commercial approved for approach first on success only the and afternoon. early an by Sage, for of ZURZUVAE,

and intended we're which unmet JPMorgan executing needs patients the on core these families. deliver for long-term medium- and of at outlined and are short-, priorities shareholders against creation focused value in we in serve X conference January, XXXX, to As

efforts for PPD. ZURZUVAE standard to is Our as continue establish the foremost priority to of care

fuel to in the to ZURZUVAE women reflects a growth. In growing we we to expectations, more top across PPD were plan with starting the system-wide XXXX, to see we demand year PPD. pleased of XXXX first HCPs and important which of launch see shipments launch exceeded to we're for believe a treatment physician responsive line There and PPD, The invest revenue paradigm as X,XXX adoption are market dynamics and progresses, who for promotionally X shift. a treat fast-acting than

urgency treating signs potential have maternal Specifically, ZURZUVAE around dynamics validate changing OB/GYNs PPD. We patterns PPD. elevating evidence These growth mental is the we're strategy of potential practice to these among the unlocking and a early key commercial ZURZUVAE believe in that national blockbuster among health. HCPs provide further drive successes accelerate to in seeing and greater dialogue and our

Importantly, helping that from many this means condition. urgent women medical suffering

prioritizing on NMDAR ZURZUVAE, momentum can value addition we're as the building of receptor's neuropsych In our on on over commercial neurodevelopmental pipeline term. to well long focus disorders. will and SAGE-XXX details platform. and SAGE-XXX provide R&D We create Laura the additional approach believe as NAM to our our recalibrated

position. we're Lastly, financial strength of the to maintaining our committed

PPD, we and shareholders. our value and runway we expected positioned mid-XXXX, to ZURZUVAE are our of momentum R&D creating for believe on commercial focus the With of goal to approach our well cash

briefly a as our acknowledge before strategic well decision want as the to to turn I nonbinding initiate Now over I alternatives Chris, proposal Sage process. call to unsolicited acquire Board's Biogen's to

to also shareholders. The concluded proposal maximize of press shareholders. Board a Board broad Sage our As the in release in initiate to the significantly for best to month, interest is not strategic last range a that of stated undervalued decided review Sage and we the opportunities value evaluate

in Chris. or not will forward, timetable a talking other review in any the appreciate process process With will is that the assurance we've not and further the transactions over result this nor reminder, we I'll review set now your we'll a any As to for strategic there this that, turn this be call move I call. understanding. And on Chris? about with do mind, outcome.

Chris Benecchi

Barry. Thanks,

from breadth including those progress prescribed launch who and treat with consistent peripartum to of potentially was the OB/GYNs, growth XXXX, were who discuss of made ZURZUVAE becoming XXXX, with that fourth with in with pleased I'll quarter of quarter we launch delivers. first the of the most year to screen, more to in shipped journey, the shipments I'm in we've to XXXX. proposition focus women launch Across what achievements of initiatives. nearly believe of X,XXX women year the a came of days women to holiday excited growth XX% prescriptions review customers PPD. OB/GYNs with PCPs. results foundational it time and ZURZUVAE engaging ZURZUVAE in value ZURZUVAE's XX% demand for This quarter, HCPs full the PPD, in our of since and treat. are mentioned, the their PPD throughout confident our strong than across fewer continued X,XXX ongoing to strategy full and year tremendous and to the the have in even our we full due see prescriptions In and season. Almost far increase critical a psychiatrists see see the fourth ZURZUVAE, As represents Afterwards, QX. shipped field are because recent Starting with are quarter-over-quarter third PPD, diagnose We the of from HCPs demand prescriptions they patient

prescribing continue of XX% of treatment receiving among Further, women first treat prescribers of as to While strong OB/GYNs who ZURZUVAE among condition. increase XXXX we we after about saw patients are HCPs all this prescriptions repeat More believe HCPs the ZURZUVAE. than trends utilization for XX% we with at forefront, time, are ZURZUVAE that PPD. ZURZUVAE new their over see in will writing with targeted

medications. the number significant women of PPD prescriptions based in see an they there increase for We that is once also has treat ZURZUVAE, prescribed OB/GYN with all a on

greater OB/GYNs ZURZUVAE awareness Our XX% a among messages than has psychiatrists. brand are and aided resonating.

Before XXXX, I provide I'll plans turn our coverage. update to on for an

covered lives remarkable PPD have of move media or intended to having via of access a recognition prior are As to efforts. with and a to we media PPD. with X educational condition health the greater sales an proposition of medical with reflects for urgent and amplify launch continued wider complex includes broad authorizations. robust further into edits commercial investment which path social in level majority that This or awareness of providers, of coverage today, cover value the step greater support equitable no and the the payer which than a Medicaid To of year XX% and coverage women all of ZURZUVAE, scaling plan, ZURZUVAE, to opportunities forward expansion joint force to visibility investment reach plan a designed care is message enables increase

ZURZUVAE for most later planning targeted media physician branded DTC, their technology also year. expand to speak trusted about women them appropriate including TV are to channels, and meet PPD to the allows Today's in this options. to PPD empowering their their us potential We with treatment symptoms

in We market quarter, In PPD the are efforts promotionally shipments. with force our from seeing force early the expanded to be rate responsive we impact terms significant fourth a potential. saw where In growth territories believe growth an we personal seeing important of are these patient sales XX% a are we expansion. as the in sales already promotion, we

XXXX remarkable progress coming as and with the We about a We have to continuing in to commercialization made treatment updates the women are quarters. look of big forward additional in think for ZURZUVAE PPD. sharing

the for quarter financial results fourth of our Now turning to XXXX. full year and

in press quarter, to As ZURZUVAE of a third revenue afternoon. financial full these XXXX compared We release sales from $XX.X the our quarter fourth periods the of issued $XX.X X% in increase the this detailed our year. a and the million reminder, full results for reported are million collaboration for of

continue quarter net reported important continue. R&D and of It $XX As and XX% fluctuate expect $XX revenue to to while a based dynamics, patient expenses note XXXX. our inventory were the million growth reminder, Biogen we expenses for growth revenues in in is ZURZUVAE. may this collaboration is revenue shipments reports that to on quarter-over-quarter strong fourth the were see million SG&A demand of

of expenses million fourth there of were quarter onetime restructuring Additionally, $XX.X XXXX. the in

joint will from the savings to XXXX. substantially from reflects XXXX, R&D relative in reorganization. reductions and commercialization the in in XXXX will While XXXX increase This G&A operating cost decrease ZURZUVAE and expenses October overall we anticipate our prioritization investment pipeline

The are first savings XXXX. expected QX full quarter of to realized of be in

loss our together existing for operations $XX.X we will under XX, from XXXX, anticipated revenues milestone to our payments with estimated excluding potential agreements upon equivalents of and and fourth net ongoing and our cash million collaborations million. support funding of marketable cash, was we XXXX mid-XXXX. may receive $XXX any our collaboration that December Our securities operating the current Based as anticipate quarter plan, of

Laura. turn with the Laura? to Now I'll that, over call

Laura Gault

Chris. Thanks,

disorders, a the PAMs neurodevelopmental behavioral disorders with novel potential being As is there treatment other Tourette focused system. a scientific is I'll neurological meaningful modulator syndrome earlier, which investigated medicines or and associated These a our place symptoms GABA patients, on differentiated and for as to burden where SAGE-XXX in a profile our disorders, remain care address needs. neurodevelopmental receptor developing high SAGE-XXX, and PAM, pharmacology autism certain wholly from opportunities including families other strong begin on Barry owned rare unmet rationale to mentioned we portfolio. with GABAA disorder, extrasynaptic-preferring spectrum currently positive and allosteric disorders. is neuropsychiatry for and designed have health

study a We SAGE-XXX safety, dose, tolerability better multiple understand engagement range are and MAD, currently doses. to ascending target of I or of the us across a Phase conducting help

from Further, SAGE-XXX. in by or patient Phase administered receptor allosteric from the have X this could anticipate NMDA expect enable development, results in early the data population to XXXX studies I study a that negative modulators in potential orally We upcoming and NABs SAGE-XXX and share XXXX. study we preclinical MAD late

a candidates provide than receptor similar Our intention ketamine, like potentially or better profile. with is drug these tolerability NMDA with a safety efficacy with blockers but and drug improved to

opportunities partnerships addition, explore for stage In out-licensing clinical preclinical continue potential compounds. some and we to and

indications, previously as in have developmental are or for exploring including and Lastly, SAGE-XXX we we seizures DEEs. noted, encephalopathies epileptic also potential

rather that, to turn an as overall update provide are to today's the on part To any, of SAGE-XXX With Ashley now, conference expect be evaluating an but over steps, clear, to facilitate help we mid-XXXX. it next of are Q&A call. we portion decision. if in spending will I to develop portfolio further SAGE-XXX We not

Ashley Kaplowitz

Laura. Thanks,

or related our focused of Board's a to year Biogen's answering we will reminder, be be results. ask As proposal to alternatives questions yourself one our question. full reject unsolicited on not and QX and questions acquisition review limit Please XXXX that to to a initiate decision strategic

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

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

Operator

take question TD first Ritu Instructions] [Operator our We'll Baral from with Cowen.

Ritu Baral

Biogen buy-in the marketing about ask marketing the to or to the effort. Barry, expansion wanted I of opportunity

of You Sage personnel Sage certain sales implemented It's expansion force you that? Specifically, underway. mentioned number depth programs expansion the elaborate matched has that the or has into that sort is the on that in geographies. the put place? Biogen and has of Can

Barry Greene

question, Thanks it. Appreciate Ritu. for the

aspects on a to saw and effort, we includes is So which mentioned success continue continued XXXX behind all we force other as we want state sales progress to appropriate in that call, to based including an side, namely but our in awareness, of but disease increase DTC, integrated coverage the medical level, affairs, sales entered the the expansion, with investment upon Chris our new XXXX outstanding, commercialization make saw also better. plan the the not we just of performance on aligned the commercialization force

aligned highly many excited very moms helping this we successful XXXX, for year. as a we're can and So as

Ritu Baral

what get on Could color we expanded more the are? little efforts a

Barry Greene

provide Let me some ask color. he can Chris if

Chris Benecchi

Yes.

sales designed not expansion, reach who treating of media So living beyond Facebook media about social that only and are effort well of these social Instagram social through campaign an force are the and are important but those PPD. the influencer as many with PPD, point the with TikTok HCPs as media also part to women

are that role make community we are more and an reach Barry interesting PPD how plays think have out And that do are education, another in that and screening part with as in that I by an we of prepared about DTC important connected with seen is efforts where women work important way state to of this and dynamic not ZURZUVAE, only disease the that digital importance awareness As TV to this. and out living of about the our and peer-to-peer diagnosis all those well would remarks, talked about we aware that sure also an physicians saying that is of as here round broadly. the PPD noted, we

So again, with that's as women possible. initiatives as we a reaching think key PPD component in XXXX as our many to about

Operator

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

Unknown Analyst

Salveen. slight Srinathru the provided And Could on the [ for inventory could please and drugs elaborate to for ] on is dynamics disconnect being sales the quarter, growth? This between you growth in speak you the noting free proportion XQ? also, the the of prescription

Barry Greene

Yes, Srinathru.

I disease, ACOG XXXX we're of to step guidelines system-wide We're market, we, PPD extraordinary the with in is accelerants at seeing in and the performance. So as we're responsive line. cover we're of seeing happy just and really own a talked OB/GYN promotionally ZURZUVAE -- across terms high seeing terms continues an change. levels. seeing being board Media we're up in that what to And about,

dynamics all potential ZURZUVAE that blockbuster there. the set up So entering are

after scripts kind That's prescription entered, indicator. because a inventory true I'll that Chris supply XX% in we demand dynamic. demand, just But you demand But of talk the saw that do measure future specialty ships to to demand pharma a in is be inventory moms. And ask talk is revenue a about to leading to the want of quarter-on-quarter. happy also chain? clear, that's We over when Chris, by were sort of about growth

Chris Benecchi

Revenue channel when into product is alliance the from moves our the level. wholesaler measured partner at

pharmacies Now seen that wholesalers. inventory pharmacies that specialty fourth as channel inventory both through well that over specialty to it dynamics, sits at is based the fluctuate comes management, quarter what we've on at wholesalers. as and sits there's the And can saw at we inventory what the when inventory

demand that So as at metric to when is really it most at truly important Barry look measuring looking noted, quarter-over-quarter we as can comes the forward. performance, we go

over saw free we've access about role. not Now of broad with equitable Free And paramount worked ensure to drug Free really course and underinsured this what helps this. or the with this commercial a fourth and plays access and for encouraging question Medicaid to on would that access we quarter anticipate we plans all very important back very comes Again, that, free QX. coverage reduction equitable access. insured decrease would we And over broad are what see ensuring that percentage to with respect when need is respect ZURZUVAE, that that And the would to that that additional drug with time. drug in have we in who that percentage drug, a we've said moms to those women it to medication. PPD the of launch. from have based PPD saw is the

Operator

Anupam Rama our take from We'll question with JPMorgan. next

Anupam Rama

thinking the more Just thinking the potential a in in this seasonality how in are XQ the about payer you should due historical dynamics, little first we to to ZURZUVAE thinking quarter, given be headwinds quarterly bit industry about about first relative how quarter? of acutely sort

Barry Greene

thanks I'll add Anupam, Chris Yes, I'll the and color. for wants to start question. see if

reimbursement. commercial quarter-on-quarter including mind quarter. and continued anticipate is in first Medicaid reimbursement our we So growth, And that the keep

Medicare quarter. see So on should the We first see to we Chris, issue. continued all add? a donut first in dimensions don't classic quarter growth kind hole anything of

Chris Benecchi

what that market well during Yes, first saw and quarter. season. this There what December that of we on selling And full holidays saw fourth during due what the know force kind don't the add it's that part days of We as based course XXXX. is is of from quarter were of the holiday the November responsive we I during month the we the of fewer when disruption to first anticipate a over sales increased we the would promotionally year.

to of our So we respect in about ability front ZURZUVAE what success we're QX. continue the excited of to with in us have

Operator

Morgan Vikram Purohit with from Stanley. take next We'll our question

Unknown Analyst

deeper dig the is sales little the wanted this force also bit I expansion for on [ Morgan and ] to on a phone Vikram.

you So were last And of And force through how then expansion? anticipating field how how significant of revenues? round to currently And recent are quickly time? added expansion, additionally, for a large higher how reps the does the of sales sitting? field the in result force this addition incrementally over many is sales bump reps the

Barry Greene

Vikram. for thanks for Morgan, stepping Yes, in

asking some specifics. color give I not guidance on what you But So we're or can giving you're about.

So quarter. our fourth force noted, sales in we increased as Chris the

And we the saw territories XX% quarter. entire So fourth place we had for in we them increase. in expanded, those

give what that revenue can't quarter. forward. confident will we we'll growth very We're our but saw we and the in to guidance, go-forward an sales So demand fourth that's see expansion force be to quarter-to-quarter going and the combined continue accelerant launch,

Operator

from David Piper our move next question with Sandler. to Amsellem We'll

Unknown Analyst

This Alex on question is you. [ David. I one ] for have for

and much the you're to can provides quarter that of in Biogen last think behind how to terms back relative at runway, restructure constrained support put you the all On do the the you particularly cash ZURZUVAE, extended corporate the commercial asset? support of

Barry Greene

we've believe really we're X.X launch, And about that about less as opportunity Yes, beginning ZURZUVAE Alex, big and diagnosed there's has of have potential. Epidemiologically, half ZURZUVAE from are we women with the the that symptoms year those Less don't I million are at treated. all. constrained a think thought Again, of blockbuster PPD. PPD. talked even of we about than

So the opportunity. significant. opportunity big the here is about thinking We're

and And XXXX with immediate success We with We result focus that we scale and believe continue success. in into based to so dollar will can do revenue. spent to upon where we improvement results XXXX. in continue demand scaled

So feel at we don't constrained all. we're

Operator

Our next Stifel. from question with comes Paul Matteis

Paul Matteis

forward going neurodevelopmental over I Barry, are of picked these you about little DEs, is for a hardest, for best pipeline, back, the are Why And the disorders and other toughest epilepsies. for treat, the challenging these guess to you taking Sage extremely one those development, drug capital selected probably uses alternatives? can more how the an a just you talk bit On step indications? area

Barry Greene

and to Paul, ask in. jump I'll Laura start, I'll

last of learnings about took development I'll of at really a have and little talked that with have, bit and look properties the those neuropsych So about, on neurodevelopment, Sage talk a let that we Laura the more. hard pharmacologic decade focus to as we've we expresses decided molecules about

we kind about these diseases. But So the to of and think Laura, want of forward right going molecules to got match the the pharmacology that? right more you we've talk

Laura Gault

Yes, sure.

be about neurodevelopmental NDDs the pharmacology fit they disorders that pipeline, or thought we we realized the in good of DEEs. would like and for for molecules disorders As the our a

And animal PAMs, PAMs disorder. models in looking particular, a For the of number at GABA DEs across have lot of data a seizure seen including SAGE-XXX. preclinical in of efficacy we GABA we've

that We in ganaxolone, PAM, efficacy has the also GABA demonstrated another of DEEs. know one

a different. suggests that They're in and that base there's moving The So in the of is likely that to SAGE-XXX strong difficulties. disorders, with really to treat We're that. symptoms anxiety, they there how in evidence for so the trying communication the an the of PAMs trying disorder have has biology indication hypersensitivity successful development in disorders. And that to core in are regard With these is in the of work, we're symptoms neurodevelopmental looking sensory, we treat reasons we to associated the believe that sleep, autism. drug that be been on we improvements space challenging irritability. one taking address approach are GABA behavioral the the to based could like like people and

moving for data an And SAGE-XXX so that based have. we strongly we the as NDD such believe is autism warranted forward on that

Barry Greene

target can quarters in also relatively Sage a took the -- The see we're add And in PAMS but the quickly NAMs where to approach to I'd that more swing get that we for incredibly I we'll we are allocation Yes. the taking didn't developed January. relative answered big the we well-validated versus wanted. where share results way And and come, capital Paul, about NMDA last a and decade. talked this the you and

Paul Matteis

for think do when you could each of POC Barry, these? And Right. get you

Barry Greene

We'll share more in future. the

words, SAGE-XXX, we'll We good balance have as our is In looks for tell broader or have this see late So What later profile we importantly, differentiated that an the will importantly dose a from from that we but CNS And other PAMS. do therapeutic less more index. do effects. said this results multiple ascending year. efficacy year. us

the of So we'll have at year. that the end

Operator

We'll next of Bank take with America. Tazeen Ahmad question our from

Tazeen Ahmad

Sorry been? our can a how have remarks, if prepared you of should they just about into little your in already the talk dynamics for estimates inventory? And addressed incorporating that What thinking it bit XXXX? but we be you about

Barry Greene

let to did. Chris. Tazeen, But start hand Yes, over we me I'll and it

of shipments. the is metric we believe moms ZURZUVAE most over where And at a to specialty Chris, want directly that demand. home. the is revenue The less a saw measure field fact with the providers care and is we of do true to important That when more exits pharma into gets look quarter-to-quarter days far management. to of supply So very hands the their of specifically health That's is sort chainâ€¦ educating XX% growth a you highlight strong function in inventory sign. that the

Chris Benecchi

there's And is and inventory as those have you manage for we channel inventory at in both organizations what pharmacy and at mean on future. the trying assessing I of the they in Barry variability noted, think specialty their in past at to the those Yes. to level order make I And dynamics about level. based points decisions. happened that think managed, wholesaler is the what's how see expectation

fluctuations revenue the of behalf the the that the and implications most of on of assessing as women product, at has on it's and for inventory in interest which the on treat. this this they're inventory. it how way see noted, to demand, So looking to trying important that you demand they truest focus in instead physicians there's in product And is really

Tazeen Ahmad

pulled but for to a we is house. then said revenue It's and recorded. this specialty shipped pharma And that's is then a just when Right. again to and wholesaler, shipment through before, mom's revenue clarity,

there. dynamic inventory the So fluctuates whole that chain, supply

Operator

question take with Fadia Ami our Needham. We'll from next

Ami Fadia

investments much to efforts, the sales with of expansion, quantify other to of regards media you how the can and And it's highlighted, regards try additional with whether DTC you education the and sort through by that force increasing about Just you're terms this some and sort share of Or helpful. later be is of from if and in investments on it Biogen, point, is any year? equal? will could at of sort And Sage this that, role additional details in Biogen's expansion you that there that? anticipated

Barry Greene

and Chris Ami. we've giving plan, said specifics I'll aligned And guidance. XXXX more than entered an color we're to which commercialization is on plan. the we that ask can because XXXX, based a I'll start, comment. success What with again, give I Thanks, detailed of co-co XX-XX not is

So both spending for every $X.XX. force, spent, we're efforts We're and both any across to highlighted. other dollar all expanding dimensions Chris, I other expanding color sales that each the we're add?

Chris Benecchi

What I that. would add is and in nonpersonal amidst the sales the force investment expansion promotion, we're

So like to your expansion the and I ability have to DTC DTC, in are diagnosis like sales state to when of the we're reach earlier, really ZURZUVAE, the certain media and symptoms force it's screening campaign PCD. now through presenting very as as or whether can TV, and things an getting in, the our but actually importance a kick as that you particularly importance social well psychiatrist be precise we PPD mentioned suffering like investing channels a and medication not populations and using where with influencer connected to around off symptoms, awareness. disease investing clinician, highlight of OB/GYN, only those ready

right those as of are will coming we now, to we all and continue believe things those roll have together out. So impact

Operator

Capital Brian from Markets. with our to move RBC next We'll Abrahams question

Unknown Analyst

some that OB/GYNs there geographical come awareness? is Brian. to not prescribing This Kevin is is it Or little you characteristics maybe mostly for Does talk currently other down ZURZUVAE? factor there for bit a are about ] location? [ Can at maybe play, certain whether on

Barry Greene

me Yes, that. Kevin, on Chris comment let ask to

Chris Benecchi

Yes.

positively So see the the medication. XX% of care. safety we I their respond These journey ZURZUVAE prescribers who think more see is that lens they that OB/GYN it or best those and OB/GYNs the of efficacy the in our XX% of the XX% we that of they profile the medication experience of they clinicians peripartum have express that the forefront PPD. nearly women to are OB/GYNs opportunity symptoms of they engage to multiple when to Barry opportunity have becoming and and have are the an as when and with signs are on what who prescribers noted, need who on very is try than with the What throughout

I the to a did our reach what real-world is it it in comes in our our Phase very setting, pivotal and much ROBIN frequency product to ability increase to think in increase what is really that like to deliver and So is from just our clinical compelling SKYLARK, down order performing III messaging studies.

about opportunity, noted, So investment broader the the reach. increasing to very get the nonpersonal excited I we clinicians that of of about size force audience in can the the and to sales ultimately as

Barry Greene

PPD once been uses of an more Yes, more Kevin, a over OB/GYN of in that and significant has amount seeing XXX%, office a rewriting practice actually area. significant educated and ZURZUVAE, -- we're amount

So we're force excited as XXXX unfolds and we see the sales expansion impact. having an

Operator

Chico Laura with next comes Securities. from question Our Wedbush

Unknown Analyst

[ Laura on ] for Chico. Dylan is This

any the wondering perhaps anticipate in uptake. to or treatment PPD impact you setting or near-term Do this how from might I'm PPD. commercial on ACOG guidelines one revisions AAP? Just accelerate

Barry Greene

Yes, Dylan, phenomenal guidelines. got I'll start. ACOG, we've

their in easy-to-use training. office And guidelines require there with pretty to as treat was drug ACOG and ZURZUVAE that special the to guidelines. mentioned specifically in approved, that screen, Before diagnose was don't tools instructed ZURZUVAE OB/GYNs

It a drug in launched get I've So than doesn't my you a launch. lot mentioned ACOG drugs great been having of any has better your And in before day. partner. guidelines

because of guidelines. is really we've other at update talked with the about, of beginning terms ACOG prime audience The already they're others so are patient because journey here as continue to it fact work the to helpful quickly our OB/GYNs. that congresses, In we did

Chris Benecchi

I medication. number the a and access Yes. equitable of time they the our the and media in you were and behind would as have broad add, Barry, guidelines ecosystem place being tailwinds, of tailwinds, approval around in think, and the payer noted, those what of I launch. one this enabled the ACOG it, how were guidelines really to There ACOG

things really of lot the of out of take with guidelines. gate to supporting a what that ACOG this augment So launch the really been advantage able we've

Operator

Wainwright. ] next Doug We'll [ our from question with Lasalle H.C. take

Unknown Analyst

to OB/GYNs prescribe. had Just a getting you more sites? you curious, had penetration you've Are haven't lot that surprised obviously success the with of

Barry Greene

Yes, for Doug, question. the thanks

we're by actually we we're the at not all. So seeing dynamic -- surprised

in As to the this that front we about, strategically, want journey. end on of talked In patient any launch, case, focus you drug the is end OB/GYNs. front

Now in -- tremendous OB/GYNs. a and and there tremendous seeing we're penetration uptake

seeing OB/GYN we this ZURZUVAE, rewriting uses educated As about more once an and of significantly in their ZURZUVAE we're disease and coverage said, practice. is

we what want So that's to see.

Chris OB/GYN develops care being and primary X educated X every providers on are happen not every their psyches, giving in after months seen of It that highlighted, because picks the as care course could symptoms there woman we and other of or not Now mom course, PPD birth. by up health want OB/GYN. ZURZUVAE, every

So dynamic And kind the here exactly will expected. in front are end we OB/GYNs use, continue remain the coverage to care. seeing we as of expand we of as

Unknown Analyst

ultimately of Great. of I of what what And SAD should on a in question that exposure obviously, have you this give that the drug? data and helpful you'll the give from clinic. it study you'll gotten increased and beyond information terms in active patients, that an that MAD clinical perspective have provide get you from terms confidence just data in in think of follow-up, will types success will won't that this have you'll just year. have curious, just see people terms confidence as investors that but people I'm I be additional the mean, some I've Okay. XXX just the to would

Barry Greene

you don't forward. database, very why then about safety Laura, helpful the of we'll is kind Doug. which be have EEG point, the and which talk the path both in constructing Good of will the signal Yes.

Laura Gault

and are and program course, conventional. primary we mentioned, as know tolerability. MAD conducting extra-synaptic study includes in animals. But a EEG very represents I that So signature you we a endpoints preclinical SAD of study, molecules from brain that we're different see a safety Phase The EEG a data circuitry. preferring that signature can type using a there's different And engagement different of of

in EEG able for to clinic We using that to signature. look same are look the

brain the able end patients. these whether come when that signal reflects activation say of preclinically to be in of so that And differential also we happens to that different circuitry we see we'll studies,

Barry Greene

[Indiscernible].

Operator

Mizuho. question from our next We'll with Ear take Uy

Uy Ear

questions. other the from bit a away Sparking

Just agreement Japan, I MDD expecting you us they -- could decision application or September. sometimes in Are there on in going effect? be with milestones their your think wondering bit maybe with to a understand could expecting anything help Shionogi. any on what's the or are collaborator you what a that little

Barry Greene

absolutely. there. Thanks going Yes, for

So Chris talk milestones. I'll then and can about comment

is also So a it's on what Japanese given year. birth. And that decision FDA in from Japan this the that shared have includes friends which women indication, our an Japanese have they MDD later expect MDD

you to it's So talk there about as the [indiscernible] well. Chris, want milestones?

Chris Benecchi

commercial Regulatory which Shionogi. approved, Barry. milestones portion we're sure, approximately of approval. to amount MDD million, from to be a Yes, of $XX milestones and receive regulatory achieved a total If entitled would upon

sale. no there additional upon have into commercial milestones assumed our related been including Now runway expectations first milestones, XXXX. Currently, are cash in commercially

Barry Greene

Yes.

in approval successful So our the if that's get they're and royalties, getting we milestones to upside cash and runway.

Uy Ear

Could you Japan? about little potential in theseâ€¦ a both bit speak opportunity just the for of maybe It's

Barry Greene

talk KOLs to need if they are. interesting Japan to way the we a I have is I and is them, we can about to works, But uptake. them think talk say their what commercial should directly about pretty expectations to have it them behind get they what the

Operator

We'll take our from Joel Beatty Baird. with next question

Joel Beatty

is come sensitive patients? it a patients marketing the physicians raising awareness about not of And market Could it of patients are may aware are sense or already versus give before? asking scripts tending to about more heard of ZURZUVAE and how you who have for among to to who

Barry Greene

comment. ask Yes, to Joel, I'll Chris

Chris Benecchi

that We responsive market. already about nonpersonal that there So of is really we those. promotionally impact the or the as different tactics it talked various I've and it is is an that a force said, is whether promotion sales this see

sense subsequently from either is we in coming OB/GYNs of not this is DTC, coming it's are and then health at are but this treating or a DTP engaging it through higher of an with group activated things. from willing have Barry really of recipients screening we message which, as Is from of behavior? diagnosing level. of is only market terms directly patients physician a care the it both -- that who and professionals, balance noted, But In really a coming those have

them activated in care that and professionals discussions perspective their with We that medication also a but the market a PPD, like engaging on this provide, they're using only with where that provide not enable we ZURZUVAE. of to health treating informed know importance clinicians are those information patients is the

ZURZUVAE, we opportunity, doing opportunity not through only So education what now increased we're launching believe right expanding an that through building is we're diagnosis but and state screening and awareness. disease

Operator

next Canaccord. We'll our from with question Kulkarni to Sumant move

Sumant Kulkarni

you level we all required collaboration focus on believe the in commercialization right about ZURZUVAE? numbers, characterize prescriber force's know going of the stuff And and on would what Given of terms market the the is this you with to do that's the of patient PPD background? sales get how size in

Barry Greene

Yes.

So the exists. collaboration

commercialization you There So can are And moms as day-to-day basis, that's the on on many distractions. force how in XXXX tell both are sales a teams possible. helping we're laser-focused I and that as no operating.

Operator

question Securities. Joon Truist comes Lee from Our with next

Joon Lee

PPD, are What And proportion who pharmacotherapy else the issue therapy? ZURZUVAE an diagnosed access perception relatively less for form something of safety with as are ZURZUVAE, novel other some like getting patients but their are what those first-line as this of of it the with who of Is get drug or challenges than a getting there? data? some

Barry Greene

fill Chris, to Joon, back I'll loop want color. to of Yes, and some start, you other then the thanks.

Chris Benecchi

Yes.

first-line first-line the equitable a when on, so, of So get HCPs all medication, is what that broad and remarks doing degree we're of we've those done medication, now communicated which calling ensure really think this What that want incredible we've to out the that right the not is targeted with more also work use this we've through about receiving gate. they're our it as that a medication are in that the to is payers, has XX% to respect said of but treatment. medication have able ZURZUVAE prepared of physicians you to use as that than first-line only physicians, access enabled -- and to we this with in with

that something also with work So only really not reflect the but that's think on to to me, I we've done with payers. physicians,

antidepressants of there the diagnosed this been the past. patients patients prior may not in because by through who perhaps Now in be first have in other they've clinician who terms other condition with on are getting the come history a line, who

excluded So come getting from rationale aren't another those first-line the on getting the because medication, that's They forward being for position typically and getting that it. aren't it. it in it they're

Barry Greene

Yes. historical to And any -- as you you said, Joon, overcome in launch, bias. any novel have drug

to coverage how seeing, out-of-pocket and we one if any, highlighted, very it. They've Someone tremendous was way. certainly got expenses. used understand ZURZUVAE to We're use to insurance little, as using something and

really educated, to Chris engaged, we've bias to move seeing anything is about significant we're said, than So targeting, historical else to those just more it continue for frontline. And as to frontline use ZURZUVAE. for emphasize, that we're we've

Operator

take Marc Goodman our last from question We'll Partners. Leerink with

Unknown Analyst

more of on so, color needed Marc. quarter, receive have on than proportion whether demand, provide was another be Can provide seem net year X greater gross the ] the Upasana has to fourth tell any we about, of been the the payer some if one any patients you revenue but and from that to you treated quarter? [ the if us And kind is higher to can in can to there pushback? color you patients course? the This for compare after If quarter launch, treatment of you the there on some flattish also, given these now question third the

Barry Greene

me let kind of take order. in Upasana, that reverse Yes,

world reported So our performance in clinical in the than we what that of the good we've ZURZUVAE seen and is real or trials. better what we're saw back is hearing

durable that up rapid at rapidly all. So maintained. helping We're is picking seeing of if retreatment and any, that it's and the not is and kind moms XX-day response much, course We're response. a works

quarter. matter net. Again, the management encouraging The a channel XX% We're excited about is was thank revenue in growth of really The inventory, a we're we to gross this and matter terms not the demand a launch sort demand, start couple excited -- where growth by of talked times. and In XXXX of going. of over the the to by of really you. fourth is

Operator

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

Barry Greene

our year XXXX. everyone, for Karen, on afternoon the Thanks, fourth us joining results thanks, full review and quarter this and in to

and and making important commercialization ongoing move of have create for to ahead the focused progress for our to look shareholders. ZURZUVAE PPD advancements We in intended we ongoing power Thanks, I'm a our in confident great everyone, value with investments success commercial patients. As and we're forward pipeline, evening.

Operator

for Thank your call. you today's again participation. concludes This

may now day. great disconnect, and You have a

Sage Therapeutics (SAGE) 11 Feb 252024 Q4 Earnings call transcript