MCRB - Earnings call transcript Q1 2022 | Seres Therapeutics, Inc.

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Operator

Welcome to Seres Therapeutics First Quarter 2022 Financial Results Conference Call. All participants are in a listen-only mode [Operator Instructions]. I'd now like to turn the conference over to Dr. Carlo Tanzi, Head of Investor Relations. Please go ahead.

Carlo Tanzi

good and Amulet you, morning. Thank

and and with Our as would of including News financial AM safety will sections first on approval like morning, our of XXXX of the and site. filing status remind company’s and forward-looking a press Eastern differ new a I and this X.XX to its may release timing results the statements, opportunities potential Actual product product. for at business a making and quarter market available therapeutic, be and first-in-class you found development for we Web the launch, update SER-XXX, Investors be can potential BLA company’s Time the SER-XXX became that, materially. results efficacy our data ultimate the

statements as today we are disclaim our section any remarks, Moltke, Factor On which Officer. prepared made Medical on represent certain the in statements risks today’s Any statements to may of under discussed the subject forward-looking of von and with Eric call are only. Dr. views Matthew Additionally, We but uncertainties, joined Dr. Chief Scientific update Officer; David do Henn, and Arkowitz, to Risk Officer; Chief by Executive these call President recent I’m today’s filings. Shaff, Chief SEC so. these Lisa Officer; and obligation Chief future our Financial

joined Dr. with Young, Eric. by During the David Terri be And the Technology Q&A Officer; portion Chief Officer. pass that, call Dr. also call, of Commercial will Ege, and the Chief I’ll we to Strategy and

Eric Shaff

of the therapeutics FDA a potential this program, we that we middle make across we fundamentally advances filing half year microbiome ever our transform first our of to is of microbiome therapeutic, has in SER-XXX first these first year. in commercial first of and medicines. Seres treatment to for the XXXX far entered patients. in class recent expect complete We Throughout emerging to Seres available infection provide a for the the everyone. the where BLA about We quarter to this morning, of Having launch support good next approved in and and to the Carlo to patients believe become of the pipeline. the At SER-XXX option bring therapeutic you, potential have believe opportunity a weeks, steady continued center the microbiome the Thank a excited with today. potentially FDA diff C that superior SER-XXX approval, recurrent is treatment landmark opportunity progress

communicated should The subjects reduction receiving results Phase also expect III FDA and data XX III a a the thresholds single to clinical occurrence, Phase proportion will that in and antibiotics alone. to experiencing requirements, we BLA include with fulfill by communicated supporting a database of statistical surpassed patients dramatic efficacy a superiority safety a our at III You demonstrating week our of recall, Phase FDA BLA recurrency a demonstrated filing follow-up. filing. The study further SER-XXX clear versus least the XXX a dose,

we and broad nearing meaningful CDI recurrent of looking label both group are efficacy results results SER-XXX open this and These to a include across completion later Our safety study data patients. is clinical quarter. forward will

with for SER-XXX patients launch The a living ahead FDA of to recurrent significant advance SER-XXX Seres and product C program the also continuing those first a of board SER-XXX expanded access enables we diff and we for This to As prepare including BLA SER-XXX obtain recurrence generally. for microbiome CDI, filing, an would adults with access infection, eligible for are program. via to potential the represent approval. field a recurrent administer with approval

for in We of are the first half which XXXX. making preparing successful are we expecting a excellent progress launch, commercial

continues to healthcare commercial more the practitioners. advance Company, collaborator, our with work, we education preparedness directed Our payers including encouraged closely market activities, organization, we working focus about this transform Health further efforts are and to Therapeutics on The Science help opportunity with Aimmune the CDI the in Nestle This recurrent adequate towards and in approximately recurrent with opportunity potential of CDI not per CDI is do recurrent over available today. significant deaths cases patients per to XXX,XXX the Sadly, options patients SER-XXX. year. XX,XXX CDI treatment year market and and results US have the

and Some extended and latter which harm FDA procedures the to antibiotics, that not the microbiome Difficulty] patients [Technical being are treated including of can courses with regimens exacerbate are approved, of microbiome. transplantation

threat. that approval, entire In SER-XXX to a recurrent disease. global addition, SER-XXX commercial patient believe represents this Pending for suffering a We that has expect resistance, overuse of the group substantial antibiotics driver a Seres. CDI of we opportunity public potential the antibiotic is health from address

to could our on with leader the new disease. production option manufacturing healthcare product of for forward value in that, efforts working As further this approximately demand. is believe position. shared, recurrent has market does the of in Bacthera Bacthera, there an microbiome production for practitioners, supply, that product the previously biopharmaceutical collaboration could level commercial to patients, In with profile manufacturing commercial are global we to discussions the patient dedicated diff a estimated infection payers annual new result highly as agreement tremendous which in eagerness of bring our $XX,XXX for expanding SER-XXX we market our a site to with anticipation increases our possible. a options. cost This SER-XXX, quickly of We strengthened C believe substantial candidate diff therapeutics have of therapeutic translate dedicated SER-XXX center associated for costs direct to provide and indirect manufacturing. We as include C we an for into year, treatment safe, announced the and with pioneer adds and with unmet microbiome need, the this excellence, also FDA-approved anticipate new, of have with of and attractive been significant urgency healthcare the SER-XXX expenses, this recurrent to not important are believe Last and leadership facility up our company. effective and annual products. in to our launch, existing for we building our our therapeutic progress, manufacturing capabilities. manufacture prepare longer-term biotherapeutic its a the a live scale making the We scale Based

believe we III health a important therapeutics Beyond opportunity more for Seres. in SER-XXX vulnerable a this observed represents for strategic we provide that investor in the morbidity clear study, significant causing medically the data year, Infection microbiome several that Protection where believe tremendous our Protection and our in problem mortality that benefit Protection potential major infections Infection held Earlier was the for proof-of-concept remain Infection Phase Bacterial detailed strategy. an and broadly. we also populations, we event

providing We to additional continued look the discuss as pre-clinical and to of as detail. more make well programs initiatives progress on front in updates. like with stage to pass to we this our now I'd clinical progress SER-XXX, Lisa over call

Lisa von Moltke

enrolled Thanks, a with been over The toxin of study open recurrent This including practice, medical recurrence in administered label over CDI. or clinical to those with our reflecting for the enrolled with profile, SER-XXX Eric. initial have first Furthermore, includes I'll local allowed begin diagnosed commonly study consistent SER-XXX. with variability in study. PCR, XXX and XX% who subjects with practices. a fully-enrolled evaluated, patients with diagnosis CDI, clinical individuals be treated CDI the of either made study

favorable the to toxin pending highly anticipate We However, data on continue in data Phase suspected reaffirm the ensure all use we and will to observed III our quality safety confirmatory testing, recurrences trial study. rigor. profile

reporting open efficacy later supportive including results We quarter. setting, expect to this study in results experienced In first only in forward obtain of addition, disease. a this who we label have individuals to open-label recurrence look SER-XXX

We with filing. I that, BLA pleased progress we from the preparing our proposed submission recently agency BLA plan. FDA, made also feedback ruling to for am agreed announce the where received SER-XXX

mid with including be the interactions continue constructive filing for in database process XXXX. weeks. the We Our filing week BLA package, expect anticipate begin and BLA completion to full safety we FDA XX the required coming the the in to

six SER-XXX an you review a including we FDA. half by remind month approval Matt. I'll review two decision acceptance breakthrough the XXXX. first has And followed obtained call a I'll anticipate period. of designation. an to in expect therefore the month We therapy a expedited review period now that to with timeline, This BLA in Now result receive pass priority result, as would the

Matthew Henn

morning. Thank and you, Lisa good

our transplant. This SER-XXX most advanced both potential that allogeneic are targeted an in high by at as host issues. SER-XXX disease, are infections, as versus the The serious well Beyond additional risk address of represents seeded to which very targeting clinical and program we believe SER-XXX, protection gastrointestinal developing graft cell has patients SER-XXX, effort individuals is for we infections. stem program receiving infection

safety, Xb in Sloan be partners and a as subjects trial on are leukemia. of and graphing our University a will undergoing conducting alongside currently assess the Based of we experience expect these of reduce these we believe of is or cohorts. we patients. that would data, to these historical host either is for If with study designed conditions, graft disease. study malignancies, We of in Kettering for instance Phase over bacteria two treatment The of improve outcome XX% the infection health and such Chicago. meaningfully SER-XXX will patients hematologic this versus SER-XXX to SER-XXX The Memorial efficacy able

of is subjects bacteria assess safety SER-XXX. label open a cohort, first designed in The and graphing XX to including

are of favorable to after safety planned populations. for the a continuation Data cohort met pleased and and immunocompromised a data therapeutics safety provides profile our We This enrollment. novel data of part recommend announce patient SER-XXX Safety recently Monitoring preliminary one that [and] likely important review as Committee support evaluating with

to next would of administration. measured to we by of to translational data the as GvDH set host reduced in versus that as Ideally, future studies. double a support acute future which pursuing enroll outcome Efficacy patients preventing Following rates plan immune will not further infections associated efficacy. target with more should SER-XXX host we be immune assessment in efforts incidents positive engraftment only with biomarkers randomized XX outcomes cohort, disease broadly. graft the we evaluate first modulation. inform study will well modulation study second bloodstream assessing steps and/or but help would and Furthermore, in the forward in safety exploring Notably, blinded trials, for a of designed see including design infections results disease. The pipeline a bloodstream capture versus cohort, future our is in clinical rich and of graft host

expansion. flying pipeline to ahead Looking

investor transmission, We evidence pathogen disease. therapeutics further an supporting the in promise have provide abundance January, a the bloodstream epithelial pathogens to likelihood infection and the targeted clinical barrier our talented as further And data research strong tackle versus we preclinical our medical advanced team highlighted in the protection. of immune in microbiome the both event patient We believe for to potential place. reduce and as that of we R&D and potential graft engine in complications, to for infections to to strengthen decrease host modulate to responses patient such reduce see

of the therapeutics address organ a significant resistant technology we combat pandemic additional to solid infection. HSCT. receiving slow Beyond consortia this SER-XXX, These include microbiome and is designing can transplant, programs infections believe neutropenia deploy a initiated AMR we opportunities more we've health to such in evaluating combating are infections public cancer broadly. as challenge. well bacterial patients also as to threat in as targeting clinical settings be and And transformative autologous antimicrobial

clinic progressing may towards I development selection suggests ongoing close future mentioning from We and the few ulcerative initiating data biomarker an be additional our program to based are XXXX, in opportunity utilize patient and work clinical stratification there programs the efforts for that years. indication. into Available colitis. will this driving development in by an studies prior in over additional our next

future to conduct we development to and to I'll to as now research With turn plans financials. provide intend inform that, provide We potential our in further to IBD. David our call development activities, continue an we overview the updates further activities refine of

David Arkowitz

million $XXX equivalents term include collaboration, continue over release activities, Bacthera cash expanding continuing on ramp SER-XXX our operating the to and Matt. press term, critical supply issued the which to the end longer of of and through commercial and submission, SER-XXX filing focused compares near operations for morning. and cash, in supply, with and quarter $XXX of are quarterly included details our manufacturing readiness in financials a we Seres the the related with up be Thanks, of of number launch efforts ended with activities. expenses in XXXX this This first marketable million BLA XXXX. With product securities. at position cash a including our approximately continuing Aimmune conjunction The respect preparing accelerating to our

with protection we to a opportunities addition, our further focus and upon and infection our build capabilities. expand pipeline enhance In and platforms to and on advance invest you continue

to and resources value programs, well differentiated to expect commercial our the expanded I’ll to preclinical As we organization. prepare approach advance back but turn advantages. rate as a the of where growth, and of for increase research priority as of quarters across moderating result platforms call also coming to commercialization, ongoing we summary, believe already is drive deploying development resourced activities, these the now continue company sustainable have generating launch, high our a while In to our in at we we expenses much potential proprietary we capabilities and SER-XXX our the have Eric. a

Eric Shaff

Thank you, David.

ahead. year exciting have We an

entity. R&D timely important and programs including near along BLA infection label complete filing is status study protection continued breakthrough we mature to pipeline. assignment from our term remain open focused the progress continue activities data, key pre-launch This commercial in In SER-XXX have our date we pathway, As we process tandem, the inflection several submission, and therapy our our other a focused points organization underway the to already this to given Aimmune. of alongside advancing on with PDUFA an

to addition, up In leadership that Matt will as you the engine operator to now our call other to opportunities months the of progress technologies, that for continues microbiome appraised open we'll in our question. R&D our discussed, position. maintain With forward evaluate look ahead. We keeping core our

Operator

The comes first Breidenbach from Instructions] from Oppenheimer. Mark [Operator

Mark Breidenbach

open Just of a related extension that trial. label couple are the kind to all

potentially XX% to And of recurrent So part first a the versus difficile. one question, part diff kind thanks enough three C recurrence? that inclusive diff. label patients had XXX of First And be discrepancies, second confirm results of Is is C who of the kind recurrent by C on a in PCR close population me with diagnosis to of XXX is label were are the FDA stratified comment the to a XXX that said patients safety extension. SER-XXX foremost, to enough then versus and toxins is, XXX? patient treated just on final then, you maybe but that's can. time mentioned whether the you of the looking question Maybe for for of question a what single methodology, And think open support telling a database. I multiply Lisa is going test,

Eric Shaff

But bit let take ask me take a that me clear So in and history. just context up confusion, little any one and I'll Lisa the let of next provide two.

the but met a as statistical was outstanding bar, FDA to exceeded threshold we what when a had So pivotal set one that with we single announced bar We a then study. the us it. results, reminder, readout only that we had Phase far not III for

XXX, we successful for number was can was Lisa However, III the the wrong. the we of subjects at label into a had, Phase XXX either rolled active me our what that if in I III or that that's the subjects the But FDA handful At were Phase a from looking had was arm on of the dose. the time, third had XXX Phase subjects think, least study. those of open correct roughly

to roughly So the XXX the we a residual, or perspective. to label two-thirds third. a basically designed subjects to for open study we fulfill roughly support that did looking from is FDA what had fulfill safety was the And we that BLA

fact, the submitting was been the We saw were item profile us safety really the enrollments open kind Journal out, that critical is the the drug pleased and the before the there. this in label, getting BLA. of really for throughout is that suggestive came the that of we article we that think that basis So database with momentum of of England fulfilling of even fact New course the which path on the is has that

So hopefully, question XXX. that the answers the of

from stratifying we was and to least that. added it XXX the will label, our be advance, look the maybe then XXX methodology and XXX can Phase think first might plus how looking occurrence the With are I at open well we thoughts about the that the FDA then III was the that for. that talk in in agency by is Lisa ask at And on the

Lisa von Moltke

of the in is process we versus were balanced, really patients we'll and being since but the be look stratification able It at PCR -- randomized to toxin.

simple I community. on a factor ability a we've diagnosed label that take I just remember to plus always think how a lot patients regard the so compared was so obtaining based are question has that are the opportunity it's pathophysiology it's very the important run. the a and important as the or GvH it's an think expected said guidance, PCR on to And the agency saying that see pathophysiology But label of not things is plus And in your in compared is this toxin worth these how trial that. actually then does algorithms, that as XX%, by outcome with GvH, to to disease can of you one a to specifically disease. of the broader the just that broaden

that data will of So look the XX% at. think XXX I be the something in they'll

fact very back the be a be you to And into recurring the is rates vanco and you I got really of and mean, recurrence, can in the injury you you're XX%. recurrence field microbiome into reason at see of look papers can get you've again, think first going couple going of really a the the primary some interesting primarily see it's versus C everything I it's Once think as factors. data, that support I as to diff the but said, in the else. field of I

a recurrence. problem first So it's at already

Operator

Peyton question Our comes Cowen. Bohnsack from next from

Peyton Bohnsack

of affairs maybe for question in comfortable just be a do taking medical you Peyton you Is patients use with first of on thanks feedback, expect our this like And your would the think then get questions. physicians I believe there And adopters kind was would to time follow-up. therapy? the asked of a that follow-up with more of change over on as this you then on and line have to Joe, specific or group is that patients do earlier. therapy? Kind that would for This this earlier

Eric Shaff

repeat question ask Peyton, is group you -- a ask that again? please? first that the there I could -- could didn't of patients you what, hear mind

Peyton Bohnsack

group a adopters of Is specific then be there that and maybe… the early therapy would in patients you

Eric Shaff

then SER-XXX, patients. I recurrent that start the I diff. invite just and appropriate to So And field Lisa Terri prior ask Lisa And or maybe diff -- and looks can the or all answered recurrence at comment the then Lisa comment. further. to C in primary diff C the at primary profile, strongly But question think recurrent and feel Terri the C. efficacy safety is given we for I that

Lisa von Moltke

with to I’ll And agree. adopters early it I No, to completely regard Terri. turn

Terri Young

I this occurrence. to upon kind describe and think understand a for this as how And that condition, disease very patients isolating that's of it's really acute the patients important debilitating and primary to operates physicians depreciate frightening and question.

this And a oh with is first God, the that they it bit comes of, they the turn care were first different And treatments to office up time the to. is demeanor very need that And it's can brings recurrences. And the in the than that work didn't is physicians The know pivotal standard the their the antibiotics SER-XXX availability results. the versus have need back, of disease disease unmet in it's see did unmet the It's the prevention This refer supposed of the the despite fearful. They the a experience. physician similar table coming in our back. back. of time. what physician's one very category, number keeps they number existence, antibiotic becomes way today. frustrated, one or because to it vancomycin the of bane administered And patient you

the believe we have help in all US can patient approved. across we So once adoption, we would that XXX,XXX annual the we expect of recurrent cases population

Peyton Bohnsack

seen requirements We've some to kind pathogens. screening asked for Kind for also have additional your of a additional switching some screening really or the with clinical -- FDA, for programs programs just quick. for hold in keep with protocols manufacturing? anything of after SER-XXX We've they pathogen seen discussions manufacturing just mentioned over

Eric Shaff

rely time, start think with process taking. We that can mean, we the a read I maybe donor maybe our the only we Dave felt is donor others X screening. that reactive. and out before I who's even us said ask Phase screening were that Ege further. was to differentiated I'll inherently on Peyton, don't comment versus for long We

can't around You don't for a year put know SARS-CoV-X. that SARS-CoV-X for through the couple included in the warning, things of actually things and transmission last that years about, you you screen screen FDA know And but you the which about, unfortunately a ago can potential the [phasing]. of March out

we comment do is the question. think differentiated. process maybe that our can on further to ask And I So Dave

David Ege

And so they no, the direct answer didn't to your that. question about us contact is

ongoing previously we manufacturing cycle. breakthrough, FDA well of Eric both paradigm, been had screening our as we donor alluded we as in pathogens with And we've inactivate part as have because to, them what that whereby process. our whole However, with process over the conversations shared details, the development

manufacture inherent is our an beginning our very it's products. we from foundational process to that how element of safety the So

we BLA So move this we as confident forward. feel very

Operator

next Canaccord. Our question John comes from from Newman

John Newman

or And learn that? graft then seen endpoints do look of upon of secondary I've typical that things you disease. at, the in a levels some completion. you if of hope had are versus of on curious in dosing, study different you people some could what terms what question you to transplant. also studying host study flexibility built acute this just SER-XXX, the you of have testing I from Wondered remind us types can So if which the into

I But are Phase you to what program take beyond forward most learning patients about interested as also as filing you for are survival. think this curious I. in you just

Eric Shaff

to the and Matt Two Lisa and it. scientific I'll Really we excited side first to perhaps asking you learn. hoping comment then dosing ask about what of on XXX, thrilled questions, things. are maybe about are And then that

Lisa von Moltke

along that of whether we these there. high us. of a study, be kind, some And is bloodstream different a interesting host. the of yet is rate It's we’re course small-ish enough in way And study, patients, dosing medically we attention intentional all been safe foremost, for is localized us or remember at unfortunately very there there of haven't occurrence important to obviously, we to get I are is fever, in compromised from in infections, process. then will able fragile. it very paying We a is, the and specific and transplant it's important which population, to incidents very it's to And number we with want those that of if for other a things the this what that, that can neutropenia so to infection an be patient of confirm than infections we any hoping the signal we that those any hit, look be rate that say This endpoints be to regard dosing for at, we the if a signal be as a to graft see are of on with that first the through But to we'll even therapy see will close that's well. safety what this expect, data, Phase it's study. to a patients. that looking expect at will engraftment going versus And of the relatively

Matthew Henn

or we deploy reducing versus are points, which graft would host one, patients. have for both translational reminder, as designed and leverage independently, this have we multiple a human bloodstream strategy how have host. datasets, out and designed often as of as combining platform as the the be incidence to able to translationally is, infections as additional because couple And the we that you success be be pathways. very well other understand different important well to and insights we side with combined know of microbes And is study the I those the then that, given and a incidence in we our we these specifically reverse course, to really do, of three learnings either rich, find that disease, a therapeutic thing this as think attractive in population, the clinical capabilities And one target each are to the the need of about with tools with a that reducing as course particular really on XXX get unmet program drugs meaningful there,

And are gave think can dosing And this a this light well point sickest had opens in and This other we green make that that's how as is if is you and medically maintained, our infections just that that think immunocompromised very patients. both, leading I compromised, again, exciting deploying I population. something the And sick we host is, be continue that of highly the I meaningful. a will many think terms causes up DSMC it immune populations, patients think we about And will patient number last that patients. in seeded this around one immunocompromised think so modulation, profile a medically think the the about impact I'll really are population. to of mortality is the of gut patient of of often the to about the in patient are so gut When safety transformative ability seeded. these technology us insights do I there in get of novel infections as is program way,

think cirrhosis, about can patients, think neutropenia, about of think can about you opportunity. can huge ICU you You cancer

Operator

comes question from Chris Jeffries. from Next Howerton

Chris Howerton

to effects the program. robust understand wanted there in fact different this lasting over that of think, the As to recurrent that of help what the any question needs And C been course wondering as we've observing changes so, I of if one that we've would if there's I've that? company any just healthcare seen capital Obviously, have partnership second might been develop be is about utilizations the be a obviously the question, rates that infections of the curious for expectations you pandemic, further? diff epidemiologically. the of a pipeline given

Eric Shaff

I'll will in we to can I the our on front ask comment comment pipeline. how provide efforts, then which that. David are to we at on end on ask of Maybe active And some maybe I think the perspective look first. the on Lisa especially and And capital

Lisa von Moltke

in I that away feedback their terms dropping back both people suggestion and as is medical pandemic, that just in were perhaps encounters. quickly more there physician rates reports with as But think general on regard was also people it care medical some we're to institutions. typical from staying early were to seeing medical are but returning in normal, to of the papers

Eric Shaff

want do David, comment the capital to you question? on

David Arkowitz

ended So the in as near-term, million ensuring of we value that and we've those. investing with $XXX generating we've quarter the ahead to a we're and cash. appropriately us got lot we Look, are achieve of opportunities in discussed,

million SER-XXX in is $XXX are XX/XX and approved, to then sharing the milestones us. cash example, we future provides that up a we milestone payment related approval, For we've those $XXX we with very got believe flow profits receive are Nestle. Nestle, million from Once sales to SER-XXX achievable. And

company balance we've think to to sheet fund of and add and the continue So got opportunities that manner. plenty we in to grow our

Eric Shaff

And move time comment, forward thing the the XXX as Chris, efficient investment with a I'll the than a David's to resources maybe that is in and were for requirements of capital where us more and creativity be stage where, The point I think clinic. -- add at we able grit these to tend for later now constrained we're interesting is an only to were company investment. illustration program we early the to some just when stage partnership, and really

and we to think infection grow do into what exciting opportunity and seeds an having we So continue opportunity there's them think in protection. planting is an

Chris Howerton

as to And point approval of any maybe clarification, commercial Will perhaps activity? we there just be David, would an you, support launch for that by investments as significant and SER-XXX? capital or to Seres launch anticipate be

David Arkowitz

the So we are sharing in expenses.

of relates SER-XXX. expenses the it there's And really to the ordinary so than nothing sharing other as of in the commercialization out

Eric Shaff

just it's split. approval around I $XXX just million think the XX/XX and maybe parameters worth the some and of deal, the reminding

David Arkowitz

profits. we once commercialized, SER-XXX So as are million the upon mentioned, I approval, is splitting $XXX

XX/XX. expenses the splitting are We

our we very We we transaction, and capabilities a we're and Nestle, that financially into they for watch leverage SER-XXX the not this I deal where sharing ensures own. to the talked having capabilities. a about that are make the are also manufacturing think it's And But to that to whole the in expertise on to way product our goes table, our position attractive this a is equation. investments cost as knowledge tremendous bring and before, with responsible leverage massive equation,

think we tremendously is effective. and So this efficient

Operator

Shibutani Sachs. question Our comes and from from next Chris Goldman that's

Unidentified Analyst

an kind as us of the updates adcom This are the to on is your component? thoughts from of requiring can the piece FDA your approval a then process do feedback to much seen any Chris. on the for for expected of organization? and payer that morning. But I preparations for of regulatory know [C.J.] ask you any around date? nearly more this as more for commercialization haven't we regulatory any And Thanks historically. the commercialization XXX. the wanted sort few commercial you the give the anticipation on ongoing, this details Or provide I side, size for have on discussions your

David Arkowitz

answer comment comment prep yes, commercial the Terri the I'll the But side. adcom comment. But maybe with on to then to Lisa I'll would is ask that an expect adcom maybe happen. Lisa start we and short would question, or ask can

Terri Young

we planning Novel for therapy are an adcom. first-in-class, absolutely

Eric Shaff

comment And to then the you Terri, question. do commercial want on prep

Terri Young

in on this function obviously And I'll on our of HCPs. receipt lot recurrences in areas ensure unmet scale physicians preventing as where data educating a microbiome C the the I future earlier, around of the really of that need XXXX, efforts that's We're the we've there the is to of of III a year. focus amplified back we restoring number diff. doing mentioned One Well, role those in Phase plays but the that the understand couple category. work one

very our disease a excited education Award, web we were best for education prestigious lot So one Manny the professional of in nationally campaign. and about fact, disease which campaign, just

their engaging division existing quite already this audience. Aimmune co-commercialization We're products. benefits across agreement inline payer of of payer covering Aimmune a is Nestle, has team the broadly an proud with the one team I'm with of And our of our Nestle Seres So that. for also field is great of that and the example

from the field C commercialized So in we I'm payers value approved payers. recall educate early also And around with team but profile recently you disease, that able hearing may and we’re really neighborhood in with of to field from educate mirrors of able a feedback process deploy previous the high robust somewhat clinical and the are to the discussions team process very product. pre-launch that payers on SER-XXX. we resulted them rating to in about the research did research engagement that early hepatitis from that the And

are them, So swath swath the feedback great of payers, we broader from of broader a them. hearing HCP,

our be Aimmune gastroenterology the about structure, field at deploying asked team will today. and we calls two on You commercial

an to organization so companies. obviously, And as the And are upon physicians cover building disease in-house we'll be prescribing those that infectious we commercial across highest building well.

Operator

H.C. Our next Wainwright. question comes from from Vernon Bernardino

Vernon Bernardino

little Just bit wanted more to a get detail.

received did revenue filing. you in You collaboration quarter. have already alluded to the the some from milestone first related BLA with the you But party

if could you a XXXX? perhaps may bit expectations collaboration wondering into as little as Just revenue far other what describe from the have you

Eric Shaff

maybe to with David structure pretty the Nestle just Maybe forward. ask I'll just the deal straight is think on of a reminder which milestone, on a the and review I provide

David Arkowitz

related Nestle, colitis, with have it party deferred agreement executed well. quarter, The two we middle with related the of overtime. recognized as have then Nestle. diff we that revenue And and is revenue that C Nestle recognition for we saw in you We in ulcerative agreements the there piece a co-commercialization in So last America, overtime ex-North to agreement XXXX year. our first deferred that of of the the is to also revenue relates the that with and is small that

So to based just quarter. that the these is jumped on variability And from $X of recognition, of some roughly around a accounting that's million X.X a addition range in deferred accounting an in standpoint $X just is there million million the revenue revenue two of that.

continue subsequent bring will and have the So over approved, that's additional revenue, we going co-commercialization in as then we SER-XXX quarters. revenue. milestones have And once is we to as

Vernon Bernardino

to related in liability as And revenue in the that's deferred sheet, the as the your as section… item far line balance follow a

David Arkowitz

Yes.

Operator

I over closing concludes This to question our management now like and remarks. back would turn for session. conference any answer to the

Eric Shaff

morning. and you, to tuning operator this Thank for thanks everyone in

We are that are with this our excited evolution. about mission We ahead microbiome next get to we of there extremely therapeutics. patients and period milestones to exciting in continue the fulfilling serving closer think company's

and Thanks great in week be will soon. a we much. have very touch So

Operator

now you today's has concluded. attending conference Thank presentation. for This

now may You disconnect.

Seres Therapeutics (MCRB) 4 May 222022 Q1 Earnings call transcript