PCVX - Earnings call 4 2023

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Operator

Good afternoon, everyone. My name is Bo and I will be your conference operator today. At this time, time, I would like to welcome everyone to the Vaxcyte Fourth Quarter and Full Year 2023 Financial Results Conference Call. [Operator Instructions].Now at this time, I'll turn things over to Mr. Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte. sir. ahead, go Please

Andrew Guggenhime

joined and and Vaxcyte's everyone. of Investors discuss website. earnings to Filings our found update. results operator, Officer, be Chief welcome Pickering; can Operating Grant our like Media Officer, you and our and and I'm business a to conference Vice provide the by good you, section our I'd Executive President afternoon, Executive to XXXX today Chief Thank in call Wassil. to Jim

to you subject actual about other that like risks, call, I'd those be making statements could this results and begin, forward-looking we'll materially statements. from basis, referred we Before cause remind differ factors that uncertainties to to during to forward-looking certain in are which various any

and our statements, any filings call December Grant recent for in turn the risk the with Grant? issued associated the release press of the over forth please filed our XX-K the as discussion With I'll well our ended these SEC. today factors reports SEC, including For risks the as subsequent Pickering. year see Form with most that, set and to XXXX, XX, with uncertainties

Grant Pickering

the XXXX all Vaxcyte for year for the Thank on of joining factual entire our And ] remarkable [ Vaxcyte, of and another call webcast. by us team research and Andrew. Thanks, officially development you marking XXth today. was year you our methodical partners. and and

potentially was of year, on treat continued best-in-class to our or broadest our And or highlighted valent adult or VAX-XX, mission by candidate. by completion infections for by our strides year program. successful and past are we VAX-XX XX Phase spectrum remain We IPD pneumococcal providing focused lead VAX-XX, our of XX against adults Last our vaccines II both valent the children. candidate and the coverage significant conjugate in to including we prevent disease PCVs, bacterial caused driven IPD. pneumococcal This make advancing diseases, invasive next-generation

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applying in to are expand is estimate due today relative are coverage disease designed to in coverage cover billion will puts is is to market to to be shift the ongoing forced pneumococcal This and Growth sacrifices This where via the other of potential and an to global us both have previously annual expected billion strains sponsors in We U.S. segment. accelerate positioned fastest-growing VAX-XX of universal age adult the previously vaccine $X adult $X withdrawn. down controlled XX also instances that to to unique XX, in vaccination. attempt the maintain vaccination up from a market total conventional is are market who which expanded market. recommend the make critical in since circulating was Germany prime U.S., protection, position see the open market approximately circulating we adults in is the evidenced the regimen the PCV newly strains. currently expect the a schedule, nearing recent to adult to approach routinely that vaccines contained rebounded Beyond recommendation prior to Outside vaccination vaccinate to and begin XX the by other countries new older. adult strains and

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Our of last expanded with on and of are relationship efforts. both year reflective late option these our our future decision to exercise we Lonza which announced Biopharma,

$X stage resistant provide PCV million cash on Group VAX-AX through significant a as capital vaccine earlier WHO pipeline health [ we important are to I'll the help provides year-end. us which vaccines treat diseases added to Strep, complex next AMR. sheet, a this $XXX serious or solution VAX-AX our continue at on turn our advance PCV will sharing VAX-GI few a A had be develop and We most no period of a contributors the million This XXXX to with will In substantially well raising antibiotics. that are programs fund later. PCV financing the strength perspective, cause in become of proud part balance to more diseases financing, now to earlier antimicrobial earlier-stage that prevent financial shigellosis. and programs that to recent to Jim follow-on target over a we fight leading while month. VAX-GI the financial another to global over investments an billion VAX-PG of our had several proceeds our details to no [ and increasingly AMR it years, forma, course forward ] Jim? the fully action will strategy. addition we death to $XXX and by last milestones company by year. solution. is address, expected taken, in represent has then drug-resistant important who over vaccines to who Andrew approximately crisis and the the our updates over treatment this resistance including We're AMR single to of strengthened franchise, poses highlight net ] and candidates, look diseases as after more in prevent Pro From as dysentery to a antitis April our

James Wassil

significant line the Thanks, Grant. to start is XX% matters. reiterating pneumococcal associated only U.S. of administration circulating by disease disease widespread resistance rates, antibiotic fatality with effective coverage the like of alone, cover and In impact to disease. of vaccines of developing XX% pediatric standard and to global meningitis. broader Despite and care of treat cost remain approximately the I'd vaccines developed high-case vaccine,

to referred opportunity and and totality the II from perspective. health the public prevent a immune results community a Grant earlier, broader Phase set to the global critical the expand As spectrum new for is we health relative coverage that to delivering vaccine designed program to for continues broader from include still higher XX on conventional bar affirm need PCVs. vaccines to by have We we PCVs the Based a responses our cost believe to new result, coverage adult IPD.

design with the III Phase of adult this agreement Following clinical adult end II clinical with had overall subjects, the is number we FDA meeting the successful therefore the the endpoints X We support the including for are licensure Phase as primary pivotal analyses to program. FDA to or program, of there planned of include VAX-XX approximate program, and completion on II on efficacy a of well is III Regardless Phase required. VAX-XX and the we that non-inferior to focused the believe licensure Phase expect up of the to broad an we as confirmation whether XX, either VAC study study not label. advance the the program support immunogenicity sufficient secondary studies

CMC part as ongoing the from licensure requirements. encouraging VAX-XX focused discussions, input Additionally, the regarding we the received adult FDA of

future VAX-XX Designation We focused Phase are an or continue III we from either afforded submissions. input expect and under Therapy program for as Breakthrough the adult for CMC FDA additional VAX-XX adult to dialogue prepare seek to the BLA this VAX-XX

a benefits safety, For II study that VAX-XX, immunogenicity criteria data. study basis the Because enrollment mixed what refer Phase ,particularly older or Phase IgG the [ adequate for for prior societal With both study PCVXX VAX-XX shown aged X noninferior the need a and X the Phase When our the maintaining are arm historical in of for data, pattern increase are [indiscernible] compared in of results be protection. on of that potential dose.Low, this provide. importance approved, II been rise all each PCV bill optimistic based evaluating completion serotype in III spectrum XX the Similar compare expanding IND for overall precedent see for broader percentage activity on and Prevnar expect we opsonophagocytic the II serotypes expectations considered all platform this study, preclinical level that benefits which the this our a the which that clinical to public have ] arm is for this III will have strongly we might the the XX upcoming achieve that subject middle you the preview standard responses dose missed to programs the and of year responses. is has the believe threshold. amount than Phase XX some PCVXX. coverage carrier enough. immune progressed studies, XX noninferiority VAX-XX important in ] adults fine been study increase rather focus generally mean from [ see disease they the [ to high and on significantly size PCV [indiscernible] ratios in in Similar to versus by prospects today, be X to will prior adult have the greater We helpful to improvement immune the by In VAX-XX a to VAX-XX to simulated VAX-XX, that X,XXX by coverage serotypes, over care our mind give care. and non-inferiority are to Recall months. We and on approval. from the for the from for VAX-XX we tolerability accessions we And approximately -- the study I immune enrolled those study, to data compared in which middle for OPA, our OPA data the VAX-XX. health approach. these by adult studies focus presented for serotypes Based about will disease evaluating the VAX-XX the achieve is be candidates, regulatory our hit ] adults total, VAX-XX standard the assessment and in in Phase has and to is XX% to of accepted and is the for dose the comparable VAX-XX, presence program intervals. the authorities the readout, adult VAX-XX the program, would of to [indiscernible]. believe the lease-dose If those is than will are endpoints VAX-XX, arms that the a our however, potential I/II change believe, radio We protein lower for ratios that believe established both we considering expect smaller VAX-XX public of Phase mix us study coverage this of for engineer the metric for we carrier-staring VAX-XX dose. our by endpoint. We in VAX-XX historical VAX-XX IgG confidence results for extending which thrilled very responses With

II we best-in-class the result, study. the VAX-XX and are excited a progress programs Phase enrollment with advanced, completion population, As be the pleased infant for are made to with we they to VAX-XX continue also program. our potential in has nearing this profile

Andrew. further opportunity and now define market, readouts in year and with are full turn look the expected these infant magnitude VAX. over excited expected PCV along size particularly franchise primary the global would this We quarter VAX-XX the PCV forward of I for boosted sharing the And and call Given third of the data milestones, our we will progress important like believe this of nature about the updates XXXX. to potential year. in the the on to to the We of

Andrew Guggenhime

Jim. Thanks, Great.

related contribution On Phase potential to in expenses agreement expenses original of entered note as the of of and expenses programs. option recent higher quarter. primarily support The in expense rate G&A variances driven option income in our The interest income same XX-K Sutro. the also for with team the year-over-year in consideration reasons million clinical the results was the function cash of I trials increase would planned XXXX Both related the quarter the manufacturing our million item PCV related the balances XXXX by to XXXX our upfront are to incurred the and in respect commercial a paid manufacturing $XX Biopharma, filing as higher fourth anticipated growth. adult in connection periods The the Sutro was III the of R&D also and fourth the future the and the life our full XXXX was full to details fourth the year for our invested in of for line interest with exercise environment. summarized acquired and we press the investment cash as and our $XX of of in higher the reflected launches our which and grew release. financials comparable year to statements, expense to and quarter and R&D

R&D XXXX forward, over within As G&A function increase R&D. XXXX III in the operating increase for required we of annualized VAX-XX the an out is launches year materials or potential we particularly a support of full both look our will to expenses VAX-XX trials adult investment a expect activities Phase primarily QX which and multiple trial manufacturing continue and This expected make to of potential program. consist PCV and program, clinical loans, to

our of timing on expect vary the of quarter manufacturing do annual to by we activities. substantial While depending R&D, growth amount expect

At Lonza agreement we the G&A, In income PCV to global a with we the this connection into support and not expect rights build-out time, last them October. suite the construction in our potential commercialization of in with commenced dedicated entered to we at we program the growth For year, manufacturing acquired manufacturing be any quarter statements. expense Deferred anticipate expenses. steady fourth quarter. do generally by of future of

take a to $XXX cost to We of capital years $XXX million this over period expect approximately at this X build-out X.X million. approximately to

facility were balance assets. filed XX-K in that our had expenditures properties found we capital of A and today. on $XX.X breakdown and other can year-end of X separate reflected million XXXX, line items, build-out sheet in As incurred equipment our be detailed

mentioned For into the and early the same sheet XXXX. remaining manufacturing suite, XXXX balance this manufacturing during we perhaps operating will I of balance the and be and complete be over be line items And not Most incurred dedicated will and in the construction component run the associated will the statement small in our the and expenses. expect buildup through since earlier the X the build-out period a buildout reflected that's R&D be of suite will commenced. reflected that on income expense activities cost in separate majority of will the costs XXXX and

the balance in railway, sheet Grant strong with to follow-on net to Turning and this as $X.XX the $XXX.X we cash This financial cash equivalents completed maintain million mid-XXXX and the from billion in cash, noted, offering we month. earlier excludes investments. position proceeds and a continue

year, expenditure Going end expected study sheet the readout fund forward, Phase does number expect for of programming programs. build-out over will long-term our study VAX-XX important the Phase the in of the through and of the requirements or we studies expected in the the that this study initiation I/II by top from of data our turn half and of the XXXX study PCV quarter primary sufficient be VAX-XX support Phase the to results of and and the whether expenses and booster suite Grant closing anticipated the a in this to line operating capital next the or complement few infant years, the the advance with and III PCV and third expected to manufacturing study XXXX Phase data of for X will the respectively. remarks. of it XXXX pivotal year-end XXXX. XXXX in year and our XXXX The for in completion expected milestones including over dedicated line balance II first [indiscernible] quarter VAX-XX-adult I The now the full VAX-XX, commercialization remaining second in non-inferiority non-inferiority VAX-XX the we fact, top study, include III

Grant Pickering

Andrew. Thanks,

to validation to Before an our now Vaxcyte entire at year extraordinary would and partners. of for was like moving to VAX-XX our Q&A, and XXXX I the pipeline. team

beyond. with scale look questions. today. we your confident PCV Over the our and updates and With forward business year further sharing will look Operator? execute forward the the XXXX next in and several upcoming catalysts interest and that, as our that to profiles in define further of appreciate us to progresses am by our some We we I franchise, let's year, joining further ability take

Operator

[Operator of Instructions]. to We'll go America. first afternoon Jason Gerberry of this Bank

Jason Gerberry

this I XX. decision guess, firstly, and between just as we about VAX-XX think

against ultimately You're measuring yourself VAX-XX.

looks you Does bar guys X reason, rise the off, or go And statistical like? if for VAX-XX looks protein reduce what end, a and coverage some enough strains the the incremental XX wondering spectrum. optimize. And NI if a reason collectively showing measured ways approach? then as you or by carrier sound And for like. you potentially which X if frame the net just like back I'm the in is, valent to So, to estimates can of wondering explored across success of fourfold success in drawing or to doesn't I secondly, good board what point make to a there the to have asked are ways cut this iteration that

Grant Pickering

quarter, is the we date, were in empiric to circumstances. quite As this program see way expect generated data at optimistic, with we're we evidence we the a look looking that forward combined of the the that to third to combination

would been from we empirical mixed to the So, generated already a where we on of that that put carrier able clinic have to not cumulative with into protein we already also data only, emphasis amount the VAX-XX with preclinical the data test were the expect particular VAX-XX. of across dose cohort but that's that's course, have data program Phase an certainly, compelling VAX-XX, perspective, II with readout

as the rise different Prevnar -- where a the looking concepts so we're points slightly non-inferiority point then endpoint fourfold XX different it's a out, So, those looking, us, and at of across to over really comparisons baseline. there's couple and you you're XX for Incremental end XX where

cohort will that that data the with us, this better level, XX, already across even comparative have X X the come good set with Incremental XX. at XX, in for dose next we really generated mixed VAX-XX then the results study. Prevnar And demonstrated the that So, readout,

ways And as for been in is our that here you that the have can. in think feeling need is believe ]. future. I board But sugar don't convention road. of We've down a that the else on anyone we to the always at protein so future, to mentioned don't to than drawing something sugar we to the used be of with with we date we're think certainly that [ our the go be not-too-distant adjusting has for at that could disposal premits would protein look but foreseeable historically, data that, ratio, chemistry to that effect the greater good. we great precision back going yes, us, we The to And the ratio do something to us adjust level than

immune improved show we've yield dose us, in adjustments that been able to responses. For

adjusted focus circulating trade, it's trade-off. But be preserve looking been first to and expand that immune coverage coverage okay strains in class order, is has would responses, more perfection an as if newly Jason, required. while that's been not you even to doses. come our necessary, whole this of historically with of lower circulating The to the recognized to likely that strains of the this again, So, in form that's know,

study VAX-XX I requirement. looks is to going We'll a point But Fortunately quarter. comes for of us, to what third missed and being few coverage. trade-off like been required the seen We've I a good good a this at the the guess what see like. strains decision, is push out for we the be we'll perfection least think at regulators. see was eyes in considered the not ultimately, least data data And of that in the look that's VAX-XX, didn't

Operator

Jefferies. Thank Roger go now Song next at We to you.

Jiale Song

Great. questions from X. A us. to Maybe the Congrats progress. for few

much leverage XXXX XX with meeting is with question your Phase meeting is that your you forward from data to for and The in XQ, seems time going the around Phase line is move XX something XX holding can moment. because CMC first back I you because of start end with if how the So, XXXX you a you the basically probably one is another particularly in interface at XX, this need III the package that's for FDA. meeting the XXXX,

James Wassil

Roger. Jim and This Thanks, question that you. answer I'll try is for Wassil, and

XX. of in we ensure in overall the that other that proposal to our will your in similar maximize from do the very the to hoping in But in appropriately before We'll study studies a probability lot I of question. be the design studies. think we VAX-XX We're forward VAX-XX. very Phase reanalysis statistical the success you're essentially, terms leverage designs our to use II perspective. study very power III of we of non-inferiority VAX-XX We'll our that a design similar from seen for perceptive a Phase proposed end and design put the study that for we've

Jiale Song

how And of portion CMC the about it. Got XX? the

James Wassil

the as between protein the thing XX not Same carrier in well. some manufacturing protein. as well It's polysaccharide Yes. similar very exact the same course, still And is manufacturing the processes. substance. process of cases carrier drug We're using as

of So, and between XX. a XX similarities lot

from well. from we believe from we perspective is from whatever FDA XX, feedback So, to the learn CMC XX applicable a as

Jiale Song

Excellent. just Maybe follow-up a question.

For higher? the related making you any potentially the dose be for just third dosed call, high XX color on higher the you from Maybe the dose, mentioned goes XX. can you dose the for to mix middle the color give XX higher? serotypes And what some around key in protein, that. can the of If much carrier the can us are XX, particularly how terms provide

Grant Pickering

we Phase for to bit regard to just a the dose [indiscernible] doses details we here we've Phase more this competitive experiment a Roger, sure with III. spent that of provide Grant we more make out advance to again. want with come little II Yes, purposes to didn't clear but

doses. ergo, So lower the and with higher bracketing

gotten of explicit into there's tight dosing ] [ vaccine window pneumococcal detail, We historically a . pretty spend haven't but space that in conjugate the applied

what and of review going but are, we at for data. radical the be that being, those would into time anything go time wouldn't decided we're So, there, will be details the not explicit the that we to least do at the

Operator

now to go next We Salim at Mizuho. Syed

Unknown Analyst

Eric outcomes is might discussions to This upcoming on Phase for read for possible ] in III? for take between Salim. what VAX-XX on either your what decision mean for the and and [ comparison ACIP it through I'm your Liddington curious might at VAX-XX VXXX the

James Wassil

Thanks, Wassil. Eric, Jim

I thinking a most that group pneumococcal at likely saying agenda So, of on regarding get think how the then ACIP the get Merck's I'll meeting VXXX current clinical better answer what a this will make approval. working by be February VXXX, health ACIP at present economic many proposal idea the we'll to the recommend us know epidemiological of XX, VXXX the data think of ACIP they and they'll assuming to data, data I

don't I that been them X population, traditionally limitations a week, the to this, since to what by included program in VXXX for takes the to their reach technology. than remove ACIP that strains speculate want the especially on approach in have XX better strains want only we've have order a and this due I going of different position much approved I'd think to say had will PCVs. our idea PCV [indiscernible] it in to They I highlight applicable be. the of will So, end is to

started by doing strains with building So, a increase and VAX-XX, [ strains. the do previously coverage XX% to coverage potential maintaining latent ] disease have this additional further we of and adding to we're approximately

So, we'll outcomes what see. and see wait the are. We'll

coverage strengths have contains, think Obviously, regardless. position most strong part, XX in strong in a position a XX, the both if take for gets approved. strong position which be will and a we'll vaccines, really increase it to all the I

Operator

Dave Risinger at next now Leerink We Partners. Thank go to you.

David Risinger

Yes. Thanks much. very

So progress X have appreciate I on congrats first, updates. and for the to and guess wanted I Jim. the say I corporate questions Grant

preferred more, are well could comment you on Could perspective? second, ACIP then for you First, but in your Jim, opportunity recommendations And Vaxcyte provide rare, potential about elaborate notion potential be boost adults? recommendation for a VAX-XX. preferential your comment just particularly and could positioned prime that on

Grant Pickering

if I he hand appreciate can is And Jim acknowledgment. to respond that, ACIP Yes. let that see me to Dave. for question. Guru the you our so let's Thanks Jim,

me Let jump in.

single right in ACIP The course They purview in its yes past. with been the extend a does So see And recommendation. it vaccines. with Shingles, certainly, for in in recent circumstances. we Prevnar the conjugate has preferred limited have been to space, decisions the over XX even vaccine pneumococcal It's more certain the was those most Zostavax occur. limited but that within the

to you out there does And have pundits an ACIP be improvement perspective. to perspective speculating Dave, there, efficacy of the would from need the potentially So, is But a going the preferred to quite on react. that with lot are to opportunity margin or when as coverage high material of how a profile we pressure on warrant is that extend To an circulating XX%, singular while maintain objectively, a vaccine think to the continuing strains. us, as coverage recommendation. previously

another but data if certainly, So, things VXXX will we'll we have our day perspective, there be that But profile. our possibility react we'll see they stay VXXX track, point. us, to from how for on the is believe

there we'll that's a there week going think hope out preferred out, that being be as indicator. We'll think was leading recommendation. we I the heard But back what bit find at an was is Merck what out, before I had walked have we're reading. from a opportunity for pointed to Jim was

James Wassil

In prime debate we terms over both approved. in of XX. previous XX got XX-day a and immmunizing was at whether should There discussions the the boost and your XX start of the agents on of starting recommendation years current ACIP of question end

XX% the these to reason in -- And right third at-risk support now almost these or a XX% and high-risk lot around category immuno that. And that adults I are clinic is of is HIV not more malignancies category to data pneumococcal an think it's that there's the groups pneumococcal the very just getting of are disease, a groups. and suppression, says are probably pneumonia. for a particularly lot a common

historically, [indiscernible] severe population at only asthma, terms gotten grow. is And haven't recommendations you that COPD, the And percentage have You in really going diabetes disease. penetration. belief risk liver that, in to that have of

in mean XX. of been also to would at of that upcoming. be the XX the that a And you up XX. a coming a see I about most some some likely boost so moving there's and XX%, need that there prime we'll recognition So, then And would debate, get booster debate think, on could at

David Risinger

in That's great. Phase I your plans and adults And age just up, strategy? about to your you if talk follow III may. Could

Grant Pickering

perspective, age Well, at extended from the usually adult an up. FDA licensure is and label XX

same that's looking be label conjugate vaccines. the other we'll broad So, for pneumococcal been obtained with

spectrum be was Jim the indication, universal And So, to much from to usage. how they next recommended it's a but is to at-risk a that the question looking population. grant greater licensure when the is of the recommendation. across as look then universally restricted perspective, uptick But is and have than as at we'll said, the ACIP

James Wassil

And at ] XX on data in we'll I'd study groups can the have XX- to help of down only at-risk these adequate clinical to add years the with in to so make move [indiscernible] support decision. does groups they enrolled risk to we ACIP that that our XX-year-olds, sure age given interest clinical [ want in

Operator

Raffat at next Evercore. now Umer go We to

Umer Raffat

VAX-XX, a of on particular, has very difficult as the well literature as perhaps bunch Among to new preclinical to referring serotypes saw confidence one to of it's Can I'm intent particular. in speak you XXB. you're and early manufacturing the suggesting in there's to manufacture. in unique models XXB adding which in your you it's

program, a second is XX your that using valent Pfizer's CRMXXX? Secondly, it broader beyond spectrum protein expectation carrier XX, is

Grant Pickering

us. the Thank both of answer the I'll Maybe [indiscernible]. will then Yes. XXB Jim first, you second and address for one question,

what the yes, to they're As to doing. hard program, it's it exactly relates know fourth Umer, generation

XX that And beyond an I That using said, to that seem be be other they've don't presumably linkers carrier of hard in at whatever unique to would have they that. first formulation? So earnings other tried potential gotten idea comes XX. a that. it sort all additional is been this number changes what of they've try some think the vaccines. there, as down to have of the recent the turned most disclose, those they've Is conjugate Sanofi ]. from results, Prevnar it bit tenastoxoid top incremental pneumococcal different then But to valent or in proceed chemistries? intermingling [ of on recently, indication. it to Is know protein decided to XX adult Sanofi's to sponsors out And But going vaccine. beyond it's detailed extend layered then what and with different to, something And problematic has considering streams GSK's are more notion approach protein back be it been strains to not indicate a in the that would willing with of iteriatoxin foray regard to carrier? a

So, of worked as say other it's haven't moment, they're at attempts for the a that's comment? unclear trying do well. But as to if in And yet. but Jim, XXB, similar approach out particularly you want couldn't vein sure we to the

James Wassil

some the Traditionally, proprietary probably circulating due this to is important I'll say contributor today. more U.S. in we limited to it's on significant streams an But XXB most serotype one comments adults, our of media and common the the in issues. otitis is of

sure So, we VAX-XX. are well it it in works that very manufactured keen on appropriately that making is and

Operator

at you. We'll Thank go Guggenheim. Seamus Fernandez now to next

Seamus Fernandez

and is interesting [ a up. pitched X dose of likely dose miss know van is because little regimen dose opportunity X for the profile to part XX just guys at to versus bit of know has just [indiscernible] Prevnar you'd know to set is expectations serotypes to doses you about a I the Merck perhaps fourth at pediatric that a third been talk dose, that for number so how actually superior and how appear as those successful the VAX it to ] wanted story, I in that, dose has catch just then but overseas quiet really your to the required interested that third So a to something dominate data? so know I X like

from how thinking confident just VXXX? are and choose to you interested won't program, that importance is about XX, know recommendation you versus is the longer in be you're be that on to then its after that could term? study that market vaccination perspective question June? the decided a XX in ACIP And Or whether required second just the adult So you something

Grant Pickering

Yes. the Thanks Seamus. for question,

And to indication, the a a bit. infant of in referred direction be have consistently quarters exactly plus to relates we market, as were the which clear, yes, But U.S., critical a expounded you until that obviously, X So space. yes, to you as series, approach. X you it the sure X a of the in wasn't I X-dose sales part

the the they primary restrict life. That's to year. fourth and Europe, a months dose boost year. of So, the then X the form next series third X the of that vaccinations primary And called X within the first in only the comes series. dose then In vaccinations next

a in approach. really X So, X versus it's dose Europe

say, lower on responses. you As less doses pressure more immune create

Pfizer one infants in when And studied the so, the impact U.S. less and dose profound. in Europe, Prevnar was XX of quite

III of be And their primary Prevnar were comparison providing with series. the immune one X of the you vaccine vaccination study results the the the enough the a can would serotypes lower miss when common vaccinations missed serotypes fewer X responses, in So, XX that's that XX in series. the [indiscernible] after that U.S., there a primary the And Phase felt impact approach. in noninferiority of to the sure that Europe in of only comparison give imagine had

recommend question recently ] the did So CHMP has in that nonetheless ought approved. be mark [ been to XX that the Europe big Prevnar

So Prevnar most if immune X-dose we part, the case, your we've VAX-XX to widen it be the relative are, plays a in interesting regimen. to that But for that with point, that regimen could see that's with how comparisons. is at higher that adults will advantage getting least to many X-dose XX. out data a certainly seen what noninferiority responses miss And in the versus

is X with conventional European plus regard how some that So that we're yes, plays we'll this infants out out of see will authorities study to XXXX the read in have the approach. VAX-XX handle the -- how to with X running in

adults create But we start that we'll after must is series primary immune to talking gets once set VXXX we're outcome first in further you that about that's the in were given see approved going a to potentially sequenced not for the Prevnar with to be time how to relative recommended and but think And if how be competitive the XX is I progressing to [ were thought then, sure population if the I relative week. restricted it's advantage XX. going the VAX-XX talking that benefit us looks with. higher to conversation the that having expect you yes extended data ACIP better know again only get asking to we're our but the about VXXX even But kids would potential by we'll we'll data see comparisons. be later about only And potentially adults Europe, Prevnar could for will you the seen what or versus we vaccine up data, that So so, VAX-XX to see ], next also this VAX-XX approved. like to obviously, Seamus, so, responses year.

of yes, particular. So either have a what think be would on I the in we'll that sense for comparison better much appropriate VAX-XX, VAX-XX information, or VAX-XX

anything to add? think bit that's a I So, wait and a Jim, see. of

James Wassil

think I that's No, fair.

to be Phase then recommendation, I it think to I use can in up the will there's III. that non-preferential we us choose choose to competitors if a of think which

Operator

Louise Chen Fitzgerald. now to at go Cantor We next

Louise Chen

your this on to how competitive once you then capacity going is you you capacity what or Are choose VAX-XX this buildup? global here? for and data gives give have manufacturing a you going was your I are infants. And to think about And will question ask wanted thinking advantage? I you the second complete to What infant adult you you opportunity. infant? ask you And VAX-XX on to VAX-XX as you just also the either what wanted

Grant Pickering

the for Thanks questions, Yes. Yes. Louise.

a stakes So, the to will. it's as competitive buildout, from table if you it manufacturing perspective, relates really

ability not expect us, these deliver recommendation value ACIP but these for can't to vaccines, broad So, have on make would capacity a the preferred supply appropriate that vaccines If to the then the others can profile ahead it's the full vaccine? you to how to for ideally. to stay been of of amount warrant the as you recommendation fundamental capacity only unlocking that your so is at

one to this been launch been then late and we to out dedicated these as you stay where story, year, a VAX-XX is all think for to at and position made from strategic infrastructure, of the that's that. last would crucial of when And we've so requested, able the making in for indications. the steady whole global to we've either adult or clinically. we're infant demand And best dedicated know, just And a satisfy about you world Lonza. that both ahead been absolutely facility facility I as We're the materials that existing thinking developed Lonza VAX-XX in decision of

hand. we think So, us that do really really expect going to opportunity is that then And forward. versus we VAX-XX one at VAX-XX the to for to deliver your maximize question about

really indication an conversation. I think it's dependent

for a have an reach So, where VAX-XX same position line. opportunity time us, find ourselves VAX-XX we market in the both and to the on

make can. we move looks vaccine as later most ideally, would it protective we good really that to know deliver VAX-XX the this us sense naturally, with year, data VAX-XX well. be VAX-XX. not, the broadly And for right would If to So, that

And VAX-XX. said, well so, that one we're to That see market, anointing with ahead wait data in already we'll which before the to advance. infant

we path we VAX-XX bring And so, on faster market the the on both know or because just can we're or to indication either for VAX-XX based in us, VAX-XX contemplating we're infant today.

sequencing. So, nuanced it's the more of indication little infant a in that because

Operator

Joseph to Thank now go Needham. you. Stringer at next We

Joseph Stringer

a which landscape first you A us quick commercial and the you first a is. particular couple Just think programs could the opportunity indication a Strep the pre-clinical give could think one there clinic in you give on of what but [indiscernible] in competitive that of us the a in b end quick in outline quick ones just sense

Grant Pickering

Joe. Thanks, Sure.

as all We've forward are stated, we pipeline moving got X got early-stage projects. X we've [indiscernible] other preclinical So, in -- a development.

to in the haven't the We clinic when guided for would they year. go

The this at I A Strep. important is the think mentioned, one point Strep very that is Group that think believe I you I has one most advanced a is vaccine, role. Group which the A

Group ] diseases would amount prevent it's young growing which disease. a that with against mainly it's associated that vaccine over economic to say And of prescriptions led Strep subsequently, are antibiotics, most that a entry and expect also studies importance there's rheumatic significant a treated anionic finding you with medical [ underappreciated A increasing occur this every not means antimicrobial year. costs the causing heart of this. around toddlers. to in And as disease. of one to aggressively due billion I kids that $X resistance to due recent have It's a But think levels indirect XXX,XXX school well pharyngitis, as year deaths of ubiquitous disease there's

of direct that reasonable of efficacy, vaccine offset. at cost a medical amount So, some a degree have have significantly can

there's potentially owner see So, here And invasive one in then rates well. and the school of adults entry mentioned causes. commercial opportunity I think is as you'll disease haven't kit area a high I

of recommendation. we So, see similar type can a very

fact, more well you're school that a immunizing entry bit see you kids with the little In because PCVs. as

So, about this excited program. we're really

James Wassil

I certainly from a standpoint, as think And Joe, space the competitive as active it's is PCV not [indiscernible] --

Grant Pickering

centers Yes. company environment. There's there so Strep there's and Group minimal, pharma a at competitive A few currently academic the one at least minimal looking

Operator

and gentlemen, it we appears ladies questions no have And you. Thank further today.

full So that have Conference Call. Thanks will at your a Vaxcyte time, quarter and and this lines for joining, wonderful year disconnect today's conclude day. XXXX Please everyone. fourth Earnings

Vaxcyte (PCVX) 27 Feb 242023 Q4 Earnings call transcript