Earnings call transcript Q4 2022

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Thank you for holding, and welcome everyone, to the Seres Therapeutics Fourth Quarter 2022 Conference Call. [Operator Instructions]. Thank you. I will now turn the call over to Dr. Carlos -- Carlo Tanzi of Investor Relations. Dr. ahead. go please Tanzi, Carlo

Carlo Tanzi

Thank you, good morning. and

and The anticipated found press launch results for microbiome therapeutic. forward-looking including a SER-XXX, and materially. first-in-class of for a.m. its availability and the Time not can company's microbiome protect against potential approval as company's for section of like infection, of the and available status that the financial indication product differ XXXX Eastern and we'll operations be and the morning remind historical quarter which investigational website. fourth this therapeutics, other fund to the the are the a Actual of statements, X:XX SER-XXX, fact. use Investors News Our at may release on to oral business you supply, I'd to became update statements cash making therapeutics results be potential

risks of today subject the to Additionally, SEC we today's may are section but Factors made of our statements certain these call statements these so. update obligation discussed We are disclaim future, Risk on represent and do views statements our Any any uncertainties, forward-looking as the which only. to filings. in recent under

Young, Shaff, Terri prepared Chief I'm with Officer; von Commercial Lisa call Chief Strategy today's On Financial Dr. Dr. and joined and Seres' by remarks, CEO; Eric President Officer; Arkowitz, Medical David Moltke, and Officer. Chief

and Technology be During Matthew Q&A available the questions. Officer; Chief Dr. answer Scientific Dr. Chief Ege, will to Dave Henn, Officer, also section,

to pass call I'll the Eric. that, With

Eric Shaff

microbiome with our Seres and make Carlo, progress to SER-XXX. therapeutics advancing I'll you, morning, pipeline. everyone. begin continues Thank good excellent

lead infection, this approval candidate FDA's FDA action and microbiome April therapeutic difficile for recurrent We are for highly focused securing is date for PDUFA XX. the C. program SER-XXX, on our

we approval. continuing launch decision, also As work a execute commercial expected are our pending successful to the FDA's we approach

new a infection believe an of we therapeutic With opportunity we difficile provide the C. transform patients. SER-XXX and option recurrent meaningful management have for may to

Our levels supported accompanied compelling -- pathogen patient-friendly process from oral by with important our a we clinical advantages. well-tolerated our that may showing studies. by data durable high Phase and of This is a proprietary of III Furthermore, data believe inactivation administration. is by profile. safety optimism efficacy profile provide patient This SER-XXX includes route safety

multiple In have the investigational addition the conditions, this continue recurrent SER-XXX this be of the Seres therapeutic significant microbiome medical FDA. is of a that broader microbiome-based by approved beginning to SER-XXX as well believe oral would also impact could and be positioned we could that approaches pioneering may the for represent this first application approval to ever effort. therapeutic across of lead to the CDI,

PDUFA date we highly to we track constructive. remain of and, As on approval agency we optimistic approach We decision FDA active our April about are the review be continue the with a with decision. priority interactions the and XX, pending believe, process,

Our launch our organization for decision. to excellent collaborator, commercial preparing Nestlé favorable the SER-XXX make approval Science, continue pending Health progress a and

In approval. to Terri We readiness in detail commercial few a the will on an to weeks be prepared more launch following provide expect commercially minutes, activities.

for while As supply capacity. enhancing also drug future prepare our build we SER-XXX potential we continued SER-XXX launch, to a supply have

achieve believe to Our demand meet anticipated we this to we scenarios, has uptake all been and on supply goal. are goal create SER-XXX market to in track

the that supply addition, have post we on in years sufficient ensuring focused In are we launch.

Bacthera as and supply is of we plan designed track. collaboration proceeding another on into XXXX, as in our Bacthera pleased I'm report that layer augment working provide well well late to capabilities to to a entered our In redundancy. with drug with

the XXXX and of an will produce ready XXXX with drug be SER-XXX to in together expected product we working in as are teams begin commercial anticipate patients to expands. release Bacthera CMC integrated Our number treated manner, that in for

I'll now pass call to Lisa. over the

Lisa von Moltke

Thanks, Eric.

is X And you as within SER-XXX's now this we might expect, period date. months decision. potential are for PDUFA busy approach the a a We approval of organization as

we clinical Nestlé Health several also progress data. continued months, efforts During continued our with appropriate make the collaborator, alongside SER-XXX publish to And have to advancing educational have Science, last excellent physicians. we

also highlight duration SER-XXX the that to safety activity. like SER-XXX clinical I'd only of by differentiated further observed publications several observed that We magnitude efficacy believe the we efficacy the believe is in profile not and by recent but the illustrate of trials.

administration additional ECOSPOR study substantial results of efficacy annual Association, of the were showed other durable reported and we and October, the these that Medical CDI as These results that and SER-XXX different with recurrence to study recurrent the continuing differentiated of provide, College markedly the post meetings. approved. at could was published American be apparent XX presented the observed, that highlight the rates data IDWeek X as XXXX results weeks. data activity In that III III clinical to was and the at American early clearly placebo from durability in if data, weeks from are prevention compared We believe benefit SER-XXX Phase Journal Gastroenterology including

CDI indicated Phase XXX we and of experienced One was then month, recurrent included had that CDI, profile ECOSPOR a IV observed profile XX to were with of III III designed study. Network provide information ECOSPOR individuals in X the noteworthy JAMA consistent publication recurrence with the This care announced standard safety SER-XXX in recurrent that Overall, well including subjects Open. was with study summarized was with safety treated the the of antibiotics history of who that enrolled in SER-XXX safety the a ECOSPOR was of single of IV placebo-controlled adults SER-XXX. CDI. the This results Last papers tolerated. only additional weeks XX-week follow-up a SER-XXX study. through --

placebo-controlled from III We the free X-week endpoint, ECOSPOR ECOSPOR SER-XXX At remained positive recurrence, rates CDI the recurrence XX.X% in supporting also patients evaluated IV. of study. of data

endpoint. was data to final showed the Our XX-week response that also the durable out

subgroups, SER-XXX benefit CDI clinical of observed single data Importantly, those to all recurrence patients. IV a similar including in broad We provide a evidence results CDI. of the population recurrent may believe with indicating ECOSPOR additional provide were that

notable was on that this Earlier secondary based we ECOSPOR Phase to outcome also which of showed patient-reported associated placebo. the administration health-related III life, SER-XXX published another with a data from JAMA improvement manuscript in study, and quality an Network year, important compared as III in Open rapid steady

antimicrobial-resistant that we therapeutics approach developed microbiome in transplant. area a with to addressing utility interest graft-versus-host is is of Now moving stem to and an Protecting risk infection, to from infections being widespread provide in to of clinical individuals infection disease novel including receiving SER-XXX, particular may cell compromised allogeneic the individuals medically populations. reduce vulnerable believe infection Seres, and which potential

is engraftment patients' study individuals malignancies, as in of for The leukemia. being in ongoing drug conducted such undergoing pharmacology, The study SER-XXX is including SER-XXX and hematologic safety Phase treatment gastrointestinal evaluate the designed Ib to tracts.

on tract data abundance acute and of evaluate are being of to in bloodstream addition, including In infections the clinical in rates and the collected reduction GI outcomes, bacterial pathogens GvHD.

including second subjects Phase SER-XXX available X bacteria that reported reviewed was preplanned had The the assess the cohort. this year, and in a had to data Earlier to study drug Ib Cohort clinical received drug XX Monitoring cohorts. and we study's cleared X safety designed analysis and Cohort tract. the X in Board Safety Data GI engraftment pharmacology, of assessing that study and SER-XXX includes included advancement

subjects now In from in expect XXXX. are to cohort report and We May parallel, X. the X, analyze in we enrolling preliminary pharmacology continue cohort data safety we and data to pharmacology

intended that SER-XXX clear data, evidence updates to pending observe bacteria hope this effects. pharmacological these forward that provide and bacteria in look execute to the we to as these resulting we We study. With engrafted successfully have important continuing are

I to Terri. the will And with pass that, call now

Teresa Young

energized approval commercial of is organization the and Lisa. SER-XXX. about potential The excited Thanks, upcoming

have full team the Nestlé substantial. our working with We market integrated opportunity launch believe is We an now as collaborators and SER-XXX Science been readiness. nearing are closely Health at

In deaths rates fact, approximately per isolating year the CDI this that be disease mortality there we is patients estimate U.S. This with recurrent debilitating estimated cases significantly at for year. alone. in and over XX,XXX XXX,XXX of will

treatment oral care patients solutions suboptimal, eager better provide of high and are levels practitioners health formulation. Current that can efficacy well-tolerated a are options and for in

product of is patient outcomes better believe that recurrent recurrent has patient to we If as the transform this a in potential meets our well system. that represents approved, uniquely disease SER-XXX how health the for reducing far CDI. SER-XXX resulting that prevention as needs and prescriber CDI managed, greatly care placing profile is burden on

plan. Lisa where the we that that, expansion on to existing Our substantial preparations opportunity market pre-commercialization discussed discussed, webcast investor detail SER-XXX remind Nestlé you we some in commercial held event, payers teams infrastructure. and with our last activities, including engagement a are sales have recurrent commercial executing I'll according launch launch of potential in of the plans also and education for a proceeding the The CDI. been continued Nestlé's field number and December, Seres

recently Nestlé country at will a team Gastroenterology this and hired top also to of the across of deploy the hospital selling the existing infectious disease XX the profile Post force during approval, team hospitals prelaunch the specialty, our will volume phase. sales Nestlé. Specifically, remainder XXX-person cover we

we field received efforts both covering pleased encouraging. payers million I payer lives. of the if am stand than to so team Nestlé immediately decision. and feedback is status more we with FDA have their launch far preapproval exchange ready a information and we have preparations, continues with already the favorable The engaged Finally, companies' XXX Overall, payers execute receive with

to now financials. turn David to of With overview an call that, our the I'll provide

David Arkowitz

release morning, the in so the year XXXX cash Seres The marketable quarter Terri. fourth financials details and ended Thanks, of fourth press reiterate and approximately this in million equivalents full securities. of with $XXX I issued are figures included here. won't cash, the our quarter all

Nestlé, efforts up near inventory, supply up number as term, SER-XXX and our ramp we critical well Recipharm, in operations to focused Regarding a accelerating of for activities readiness launch as expanding over product which continue internally and partner, activities. and capacity SER-XXX include to our be on including with our commercial commercial with through and collaboration conjunction manufacturing Bacthera longer-term continuing building supply continuing resources SER-XXX-related the

our We upon also advance and expand focus further build to and with on our pipeline a opportunities continue protection and invest and platforms infection capabilities. enhance to

the launch capabilities across and our drive resourced have company be FDA summary, much we we our development expect the grow approval to up our pending our continues modestly. to well already SER-XXX activities leading programs. As execute organization, to ongoing and and commercialization preclinical of expenses In SER-XXX approval to effective to expanded

efficiently platforms. to research continue resources also our will to We advance deploy

I'll now Eric. turn the call back to

Eric Shaff

to Thank period the to PDUFA effectively the execute approach we and date This potential prepared which be is approval. approval near for provided data the you, launch a field. in for for product confident tremendous as of We FDA would a pending Seres company milestone SER-XXX, an entire David. exciting and the the well the

SER-XXX microbiome addition are SER-XXX, advancing In we promising also additional to and earlier-stage candidates. therapeutic

neutropenia, there medically With these additional opportunities we compromised significant those groups, and solid cancer believe programs, organ patient multiple are transplant with such cirrhosis patients. as that help to

the our additional progress as of SER-XXX, Over forward the look microbiome we therapeutic course providing year, SER-XXX updates on you well with as to programs.

remarks to With will conclude call that, I prepared and questions. up open the our

Operator

Instructions]. [Operator Mark with Oppenheimer. Breidenbach

Mark Breidenbach

Congrats on recent progress.

couple me. ones for of a quick Just

you additional on First SER-XXX add available make. and capacity the can top And capacity of guys manufacturing all, just comment also you -- of launch. versus what approval launch upon on can you what could of comment already maybe immediately on potential current stockpile Bacthera the have in-house

million in keeping expecting is XXXX we addition development milestones from just at And potential wondering, any that our I'm commercial second would for. additional out April, milestone the be come if in that should question then $XXX you're maybe really to with or eyes in the aimed approval Nestlé David.

Eric Shaff

the thank and for you Yes, Mark, questions.

first and provide got ask and with start the to his one, the perspective, me on Ege Let him too. line, Dave we've I'll

we've III terms of said of So number We're launch for what maybe a stockpiling process and this we be for scenarios. our taking have launch, Phase been or pleased have that preparing been preparing process working we to in to for some on time. different of inventory is launch,

prepared well pleased really and are. then be expect we're where and So the we for approval for launch thereafter. we with to

divide we what CDMOs, versus on Dave In in-house can I that. further of with the maybe ask to of comment terms would

David Ege

question. Sure. Yes. thanks Thank you, for the Eric. And Mark,

volume mentioned Phase So our in a for we forecast as time in-house the And the that XXXX. as of call, material as bringing so with anticipate that we're approval design, some Bacthera, and producing launch. by we approval Eric it's market -- ahead an in of ago, relates XXXX. our forward the strategy Nestlé. to the And near-term It's process have mentioned will was quite in and in together the meet to Bacthera, the start it facility for that, material earlier reach III to just adequate scale moment been to

the redundancy internally augmenting that's So Recipharm had market with capacity what grows providing well and we as as with as currently.

Eric Shaff

where question, to I And relationship comment. done them. we're with really your second and pleased the work Recipharm we that with our on with and Mark, can we've are ask David maybe

David Arkowitz

Yes. Thanks, Mark.

as Nestlé and as upon talked eligible So from for we we milestone you about, million $XXX indicated, have SER-XXX approval. are

that have that SER-XXX been supply The been relates flow approval we to And at cash expect we up have and thereafter. cost. other our producing commercial we leading that doing to

a inventory from Nestlé and it about -- think supply approval, there'll around then purchases to that Nestlé a cadence be or by sell kind at will We as standpoint. thereafter, of steady of

and steady then that provide initial thereafter. will bolus So in cash coming supply a an of

Operator

John Newman Canaccord. with

John Newman

talk initial really could talk little SER-XXX. you've know got more the the on for little you'll focus be just interesting types to a targeting a just I could if curious And if I initially. about you just targeting of that launch more us bit outpatient setting. physicians a the you bit that wondered about

Eric Shaff

John, to in I, tell But with Terri that, different comment. recently have you bit potential of Terri and research ask excitement quite Yes, with quite a of I and partners bit around of a a the we've lot for been time of then Nestlé, doing number of our folks. there's with SER-XXX. a And can say spent time, I'll would interaction providers. some start me and care health let I

idea long Terri, in treating and hear of a having on is, in can so maybe, I for that particular, comment to that new effective, further kind that that. is has think when you tool new. a is those in space we it's without this something patients help that But been is favorable something physicians can of oral of hunger the something -- scalable, profile, safety the the something voices

Teresa Young

Sure.

other existing Nestlé NPs that sales the with Gastroenterology that also via other of team one their that sales With number positions. launch, sales targets, be, they PAs, leveraging we'll their where And deep team. Gastroenterology we'll relationships. sales deploying force products, for of physician a in-line is have to long-standing example, small offices, in deploying high-volume reaching force, reach we'll currently and and extenders be already At that to those

outpatient the sales that's So Gastroenterology force.

infectious stood be team the selling we will we CDI of addition, ID patients. ultimately profiling walls to on physicians of hospital. the the I because, time most up That team and recently spend also institutions selling the in mentioned across then their recurrent majority of as that within know, of call vast that a volume the largest will, those hospital that country see highest patient the disease physicians

then the pointed begin target we're reminder, as targeting of to complete regimen, hospitals, I the then what who are Now home not as antibiotic the that on SER-XXX completion their but therapy outpatient inpatient to would in of who call discharged said, a the antibiotic take you setting. the rightly the back business, may patients the the hospital hospital, also in therefore, rather regimen out, segment, to and

helps. a colleagues Thanks, you approach physicians Health flavor gives I our currently calling date and are Science. that of finalizing the we'll hope type our that post-approval, that the So be at with we we call on as plans Nestlé PDUFA of John.

Eric Shaff

question, Thanks for John. the

Operator

Piper Ted Tenthoff with Sandler.

Edward Tenthoff

well. important first discussions, be the initial guess it AdCom, you're success do to launch Certainly second recurrence, not that's yet, Great. the for conversation but the point this as is comes to to of that PDUFA without think go I excited how recurrence, XXX? how and ultimately date you I'm sure and can an the going at label around question my when

Eric Shaff

Thanks both we the Ted. might the the always speak -- for question. Yes, for I FDA speak ask comment. we and preface nor and will I our discussion. Terri do to Lisa with to to label don't comments

here different right? second tend is the recurrence. is that label, believe occurrence X this has said the speak right physicians primary a someone -- is And ask the categories. at their recurrent side beforehand, the Lisa One been field to as look where And We and to But continue the have susceptible approach we've said a when maybe to has a future they're importance on comment then and regulatory or side side, on to from recurrence, injured can to commercial Terri label the point recurrences. microbiome I too. can in

Lisa von Moltke

Yes. No.

this broad said, label on based as see on So we recurrent as Eric the that fact into homogeneous but have once guidance. FDA's a desire disease also you clinicians our the population, based own get the to it's the have

go FDA's benefit a why something into from pathophysiology the how be situations trial. to the of exact guidance, at same reason a you a for detail assumed was extensive in they labeling if is look then quite can on will, risk they deviate, details also where you would and the as If bit run same be the of

There a of paper was -- reviewing FDA number common. it is that. times And does JAMA spring the that actually last very it's fairly do also

feel we of lens. community things know whatever. recurrence, with a looking given and whether history what So the very that a first the the agency the views at medical the this community has that that's as pathophysiology fact current -- is, already similar We you're confident or in situation,

turn I'll So to... it

Eric Shaff

do let's comment can get Ted back be on Yes, important, think maybe is it question, we that. to your which and Terri will

Teresa Young

the Dr. road. the in population. the summarized that December, think back sure, he fork remarks Lisa homogenous that And where in in Absolutely. referenced this with event as I the said, population, mean, I person seen is prepared in Carl best investor I described my who as recurrent a fairly Crawford,

quite the serve at recurrence broad considered path are in So epidemiology eager and there. So finalize you a able the disease, patients determine our we're because first with also FDA few population as pool, right? of forward that clearly look from to of the our it's our the label label to very a broad being and important, having

Edward Tenthoff

Great. I put with That's know lot getting super helpful. And everything. ready. of work going luck to a you guys good are

Teresa Young

Thank you, Ted.

Operator

Chris Shibutani with Sachs. Goldman

Stephen Sloan

we for related was launch services This wondering will to on ? could trend the can prescription that is available track Chris. And I on and share Stephen launch. investors plan you if also you that that, metrics during early Nestlé to through comment QX the what be like data and

Eric Shaff

maybe color. and start, I'll some question. the for Thanks Terri add can Yes.

We have where launch disclosed be. what metrics not will gotten the to the point we've

working that our Nestlé. with process at in We are through the partners of

We Terri, can But recurrent C. cases are have said, the be set enthusiasm we I and think the Street with and parameters has in short to and will further we relative there our can on of HCPs. our maybe, U.S., that recent with you about interactions a to of reiterate the how we XXX,XXX based metrics, term coming that only on comment grown diff think we then in provide. expect

Teresa Young

Yes.

I availability to would that careful as because We're to prescription that think can say I've data. distribution second very deliberate be of not anticipating are, maybe to build the selection. that, our available your the broadly mentioned we which thing only is question, on with is and around be partner I tackle going previously,

best when small and provide in SER-XXX. to very We number with physicians order are experience experienced specialty use the working pharmacies begin a of patients in-class patient to

So want we control experience. really to that

for partners. being that way very Thanks so distribution selective by the one with to And question. is do

Operator

Cowen. TD with Bohnsack Peyton

John Bohnsack

was just comparable Peyton first for how pricing, the guessing Congrats given you available? are productive being on thinking year, that guys last for maybe about now Are on This one, course? you for is I waiting especially are Joe. is very

Eric Shaff

for the Thanks question. Yes.

price I that just And this patient space, diff are XXX. innovation as resonates at is it we type the other not we comes of value terms delivering in And yesterday, we hasn't not standardized think profile the with is of in value, actually to there have value SER-XXX. recurrent the in to been of there delivering types talked Terri in are in terms we of FMTs, route different, antibiotics. that the it of about the is HCPs, when efficacy, would C. is of what And administration. I safety, It think we're about as with say kind have the really and space we to that, with right? way the I And we of conference what for that interacted to terms us, think that type and different. just Cowen type think great is, comps comparable So antibodies, of of that not to the don't

our but a reflective to in also we and you process provide we to are they're represents can the be recur, Nestlé deliver that recurrence value think at again. the opportunity they is system. with to working recur the can If of really And the So price finalize recurrence, to the have costs that of cumulative value these about of likely sick patients if more upon partners comorbidities. can patients,

recurrence, create create We So can That's the can for value a think we if of create value for can you can you stop that you cycle value system. for the patient, win-win. shareholders.

how it. we're about that's thinking So

John Bohnsack

maybe quickly can I about helpful. the program, be and excitement and and on the really That's SER-XXX in you're about you've enrolled success maybe terms in forward about moving the Great. to based X. to update looking the X? May. you're for a data cohort we're at cohort of what how and seen comment X therapy feedback sites thinking like cohort you give in Could guess the that of for level feedback And range I now mean initial thinking off

Eric Shaff

energy giving be I'll and -- microbiome it tell yours the think to of Maybe help and the focus XXX, relates our just time, is we going Peyton. to and I a our lot ability you, others really on as I to think up have on story if XXX that both, to but patients. Yes. there's we amount -- I'll disproportionate Lisa ask a comment mean excitement. of

the we to more into year this a more cohort, the that what expect really can complex deliberate XXX really We pleased side patient the the do population in past. to increased fundamentally number within first on the and on clear Lisa second the we've X. next. HCP maybe we cohort it careful as So with of the than dealt with relates go knowing But were our excitement But cohort end XXX. is is more were the the preplanned and up of and We quickly. DSMB into have sites comment to partners move at

Lisa von Moltke

doing Yes. great problem, The I very think has this excitement GvHD And big really and this trial options. been on that's problems to the no backdrop mean a is this patients of is sustained. both a And time infections there as big I really of issue antibiotics, are for in are also an population. when need fore we're population. lot certainly antimicrobial who coming a resistance and the this

of we interest, So we to to continue lot cohort a fuel X. have interest enrollment expect in that and

asked of we're looking things for. the And kinds about you

be reduction reduction be clinical such looking I well in including tract of reduction the of and we'll in neutropenia in think the things as particular. cohort some as potential for bloodstream engraftment sequelae GI there'll X, fever, in in as same the in the pathogen infections bacteria, infection function and and reduction

Eric Shaff

comment. maybe can And ask just Matt to we

incredibly studies, As how microbiome sets. usual, the data coming analyses in maybe and our think clinical the cohort. about Matt one first up on we think, can And with XXX Peyton, our we comment are that's important

Matthew Henn

Sure.

pharmacological points. are the from of of data the hit on the drug. But a perspective, some focused action think really on key Lisa key of we I mechanisms

dosing had Committee X. from out Lisa our report particular cohort to we Eric inform population. help And in respect with to favorable a this Data earlier, going pointed is the engraftment Safety strategies course, as Monitoring of and So

course, understand for. will of in bacterial favorable pharmacology terms respect will infection, drug looking reduction and be something safety profile having that trying with we And the in then of board So to be actually observing be looking the to on we'll at drug's pathogens.

events. And that of translocation a anticipate that as of fronts. the One, couple meaning we reduce abundance, different we decreasing has likelihood would significant course, on of

moving So reduced bloodstream the tract patient-to-patient potential to the as the transmission. from into lead well bacteria bloodstream infection, as the to gastrointestinal

types be of we'll at factors. those So looking

but SER-XXX barrier. was the course, pharmacological repairing a a consortia as that of certain is of and passage for include as And set designed epithelial protecting properties optimized abundance well this that of

well. for those the be so as we'll And data looking signatures in of types

Eric Shaff

Thanks for questions, Peyton. the

Operator

no it management are now turn pleasure at There to for over final is time. remarks. back further questions to It my this

Eric Shaff

and you, us operator, again, this week. thank look have a We you for on thank you So progress. morning. forward updated our and keeping all great joining to Thanks

Operator

thank call. you your This concludes today's participation. for We

You may now disconnect.

Seres Therapeutics (MCRB) 7 Mar 232022 Q4 Earnings call transcript