Earnings call transcript Q4 2022

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Operator

Good afternoon. My name is Lisa, and I will be your conference operator today. At this time, I would like to welcome everyone to the Vaxcyte Fourth Quarter and Full Year 2022 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. Instructions] [Operator

like Chief call Please Financial sir. would Guggenhime, to go turn and President Officer to now over the Andrew ahead, I of Vaxcyte.

Andrew Guggenhime

VP you, am our Pickering; Chief XXXX like Research, and to Officer, everyone. of Vaxcyte's Thank Grant business our conference by results good Operating update. our a Wassil; you Executive I earnings discuss and welcome and today Fairman. Officer, to I'd to call provide and operator joined EVP our to Jeff Jim afternoon, Chief

afternoon, we Copies section and Media in this latest other issued Earlier found announcing a and presentation our of news of news our results. SEC corporate our be Investors release filings website. can this and the releases,

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

For December recent a most please forth Form any today the our and as factors with discussion the SEC, as reports well risk the and ended release XX-K associated risks our with including our press see year SEC. set of with issued XX, the the filings XXXX, in these statements, subsequent for uncertainties filed

turn call I'll Grant? over the that, With to Grant Pickering.

Grant Pickering

and and platform. a by broad-spectrum as These the Vaxcyte represent culmination They remarkable and well thoughtful prevention for pneumococcal a top VAX-XX, year research data vaccine the webcast, proof-of-concept the as team entire of thanks development and nearly data landmark for you We for franchise our and call Thank today. approach pneumococcal carrier-sparing Andrew for our cell-free on all partners. us adults. XXXX to invasive PCVs conjugate clinical you, of methodical of disease our also is the of and and reported our decade validate for our line joining lead unprecedented Vaxcyte. in PCV positive

the created years we VAX-XX of has Phase a to potentially to our year, optimistic past crucial been approaches. foundation of adults and disrupt PCV class, have carefully has to this I'm in novel XX financially. XXXX profile proud findings and to for have advance overcome further capability demonstrate the The limitations progress cell-free our platform beyond. societally and the us scale XX our indicate our well-positioned the results age best-in-class These large franchise other of about conventional in of execute and a how what and ability I'm incredibly vaccine study to X the and business potential technology consistently

As ahead, look which was several remain upcoming we PCV for its recently both year. immunogenicity we adults, to VAX-XX, subjects designation and Therapy older we milestones. lead we Breakthrough advancing on referred and this PCV and fast-track of XX franchise track as adding results in to our VAX-XP, previously designation, line remain granted on programs, in deliver top second our VAX-XX candidate, to with quarter tolerability of the VAX-XX, focused and safety,

on this much almost comparability their GMRs, adults. estimates for from the our you, study pending is As an results to of discussed we've readout, in prior immunogenicity or younger Phase and the OPA many the perspective exclusively ratios, mean with our in X focus geometric for point larger

be subjects meet powered substantially bounds regulatory per study estimate lower the to point the and intervals GMRs of was cohort, size most focal these adult the wider. confidence point important these are smaller trial standard, the and confidence the this a not non-inferiority Given intervals. older as XX at result, of This not will

the expect in will Phase which with hold perform full adults. our six-month pivotal year. study we to enable along data Phase non-superiority Phase meeting both from the statistical data X VAX-XX both of combined with FDA, end this studies, X necessary our will to adult facilitate of studies safety the powering X half in for to us These from The data, second

would market approximately billion and in total market. opportunity $X in in age to a expand including up be outside potential the market the adult the today age adult open To schedule, the is put XX vaccination growth expected market the Key $X is rates adult the input which blue at the the case U.S., growing of it adult segment U.S., prime context, billion starting the the the annual XX, instead is in forward. and universal vaccination market fastest shift going increase of to of regimen and U.S. itself as the PCV to global drivers,

the the cohort this second of represents program in of represents entire and adults announced to significantly year. an to $X invasive across portion clearance global both our the the disease billion to infant launching thrilled week. vaccine This approximately with last Bringing broadest our we we quarter largest annual are the PCV clinical IND pneumococcal in in sales, reduce FDA of market be application, and infants follows infants first The population. opportunity which

address the in a and to the invest the to unique to expand the XX-valent opportunity our our coverage spectrum maintain PCV, carrier-sparing serotype position continue PCV XX-valent strains. this To serotypes pathogenic address expect, we to believe against on we ability vaccinate widespread that replacement market, VAX-XX VAX-XX, the leadership to to use gives in of without we previously us to based would program. circulating phenomenon additional long-term of continue Similar the approach compromising

applying puts are forced an attempt was instances where other is PCV controlled coverage in sponsors withdrawn. who in since newly approach and strains. cover previously This the to make position circulating critical rebounded a strains conventional are than sacrifices have This to different Vaxcyte in prior vaccine

make We in and half year. have IND expect adult in continued program investments this VAX-XX deliver submit second the for and line this top to data of next year advancement to the the of significant

to vaccine prevent infections to early-stage is continue adults and vaccines, treat VAX-XX, both A and we designed bolster caused children franchise, bacteria, Strep candidate progress periodontal and a to novel of PCV disease. pipeline our by Group VAX-PG, designed Beyond in our conjugate which including

introducing vaccine designed additional also with in on provide called infants danger among We bacterial on prevent to a are low rates settings. Shigella, a middle and significant Jeff earlier-stage programs new VAX-GI, will totality our infection details call. program income a today's later

magnitude for continue our PCV Given the further the to of invest opportunity franchise, solidify manufacturing to foundation. our we

and an indication markets a ex-U.S. U.S. believe support to of commercial with strategic and adult existing ensure support are Lonza well manufacturing to Lonza the Our underway. footprint positioned strong, market relationship expanded we Plans launch are potential VAX-XX in to facilities. remains we in the infant out

fortified via with recent chain further supply extract expanded we Additionally, our agreement our Sutro Biopharma.

sheet capital highlight financial position This a by as follow-on the From are perspective, gross provides on through we Andrew financing strength incremental of later. year totaling milestones, last strong million December proceeds. financial two us over $XXX $XXX aided important in XX, several a to successful the in million balance will fund with which

it Jim, PCV Jim? details provide turn on more to now will programs. our who I'll over

Jim Wassil

case impact Grant. of developing Despite to fatality why widespread Thanks and treat meningitis. is with resistance high I'd disease the like associated vaccines, to significant start by administration pneumococcal disease antibiotic rates, remains and of global vaccines broader effective reiterating matters. coverage

and only pneumococcal the and of adult pediatric XX% alone, U.S. the approximately cover vaccines respectively, XX%, circulating In disease.

prevent deliver designed continues marketed spectrum covered vaccines PCV affirm As the need of currently all disease to the for the serotypes that to public VAX-XX invasive broader community by a to IPD. result, the or We includes a vaccines. health

XX% In an pneumococcal of has demonstrated these standard-of-care As additional common compared VAX-XX statistically results, serotypes study, potential have superior PCVs. coverage met the XX of and proof-of-concept higher confirmed threshold serotypes. set vaccine our by broader strong immune VAX-XX all believe the relative delivering a the study, results XX new of the conventional to opportunity this and from response by we PCV. responses. protection of the clinical on those PCVXX for to the non-inferiority provide responses Four immune for bar the to for approval to we for the adults Phase Based X/X XX% XX exceeded with the

our X second in Phase this top Looking the of ahead, adults quarter study XX we data second year. older and expect line in for

I expectations objectives about more With want the to context second provide the study. our quarter data this readout, upcoming and for a bit

while the body XXX to in nearly reminder, adding VAX-XX. study, identical of but is the the Phase number to cohort Phase the first Phase and further per for the design X age first X study. a powering versus the was subjects the the to for This designed study subjects study, study research As of of X pivotal at XX smaller inform

to As powered mentioned, non-inferiority. it demonstrate not Grant was

confidence mean most the So, ratios to it for on the interval. estimates is serotypes for the rather point focus OPA-geometric each of the important than

that prior possible X these That's to or X.X because GMRs the can if to the Yet several cross non-inferiority between threshold. ratios to expect Phase and have very threshold. X.X these [indiscernible] the for higher wider may be each are non-inferior that serotype achieve adequate shown are it's X.XX studies you

for conference population, some October XX the XX-year-old confidence The the subjects confidence show relevant and XX. left in right a far of and this intervals in X the forest slide of full the two The GMRs. the to seen The enrolled due expected, data first read sample the GMRs intervals significant show Phase smaller study. were the as we shared subjects. improvement we can the These of eight a year cohort the on in the of we additional because looking analysis intervals In same approximately to results when useful the size. We as widening in stratification at results which the age insights reflects on are XX the of study point approximately graph the narrow. XX stratified number of from which cohort, the relatively older general had per the OPA to study last shown plots encouraging is estimates, slide, OPA

than X from our adult study, older top precedent younger XX. programs both enrolled announced we have When subjects given and line Phase the data older

cohort We also pooled prior XX-year the from plan our results to to XX that old in study. share includes the data

the X immune endpoints for include also These study. well-established the that validated as were basis basis on have for we development pathways, same prior anticipate Phase design approval X Based PCVs. will full of Phase study surrogate served positive our multiple the the

regulatory that following in of data second non-inferiority expect in X planned line interactions this you other the pivotal keep half of apprised will milestones year. the and Phase We we top study from XXXX,

infants to to XX at referred series. XX of life. referred is to in the is healthy the the series of as are dose As six X months is the the Primary which administered a primary to excited in booster study doses followed This first months Phase as by a result dose. program given year. initiate to three this slide of quarter This second VAX-XX outlined includes and with on we the infant plan into XX, move also a advances, population study, age,

will higher evaluated This on us safety the a one to study escalation stage for will to stages, at be injection conducted A we PCV, months infants committee the be making in seven two compare safety basis and to at portion which enable today will these manner. is evaluate data be and approximately study randomized age will The decision X:X the VAX-XX at before and proceed go/no-go evaluate of in to XX study. and will dose the compared of will in to VAX-XX standard-of-care dosing. remain a will to Participants broadest which second the a PCVXX of of tolerability levels to a single we of three-dose two ultimately stage blinded safety after PCV-XX. data, dose monitoring a days

The infants. approximately significantly healthy is study larger XXX enroll will second of stage the and

compared and same to for We tolerability the VAX-XX will PCVXX. immunogenicity when doses three safety, evaluate of

equally follow includes for will the four which pre-specified and IgG of Participants levels months compared at geometric both concentrations endpoints randomized titers separate PCVXX an with will immunogenicity before study serotypes. after after the IgG of above and participants after common to into the percent with be the of dose. the will for immunogenicity which mean primary the dose, The series predefined assessment drawn booster be and booster evaluations serology arms, seven key convention,

primary by series with immunization booster the We study dose expect top the from top from following line three-dose the come data to this later. line XXXX, data

U.S. seven VAX-XX our VAX-XX, of As designed in this VAX-XX advance serotypes development. any currently population. in the provide now to goes the coverage IPD beyond other believe XX% adult the the circulating PCV additional of coverage breadth the included identified Grant noted, We've to candidate we XX in beyond serotypes also continue approximately of PCV in XX-valent and

year. the of We this are adult and intend submit half completing IND-enabling to the IND activities in second

on update early-stage I'll to provide to our that, it turn Jeff With an program. over Jeff?

Jeff Fairman

Thanks Jim.

prevent is platform. In caused addition to leverage robust cell-free franchise, that continue Strep, a captured designed the to by outbreaks VAX-AX, disability contributor the we recent the to in disease-related also we Group conjugate pipeline have PCV news vaccine worldwide our A our novel headlines. the significant which antibiotic have one stage of infectious given to remains relevant death our prescription and is causes A earlier of Group leading for and highly Strep young. very infections a of

and as advances activities the assay These assays GMP up VAX-AX to IND-enabling clinic. product. analytical development, the production drug grade include processes scaling immunological the continue and drug substance towards method of

updates the IND the anticipated will to We program as submission of give advances. the timing as

million periodontal treat a XX more Periodontal than per we candidate productivity losses at have pleased candidate year. in for share to U.S., final that impacts in our I'm that are to $XX disease also our year billion therapeutic adults approximately vaccine resulting to achieved name designed the VAX-PG, disease. last estimated goal

our As serology studies. the our production we have readout development up the early-stage necessary of the assay eventual development studies, final proteins, of support assay of await begun scale candidate and analytical clinical clinical we preclinical vaccine

the our annually, make prevent VAX-GI protein bacteria, key is tough VAX-GI. to on people bacterial children cell-free caused antigens. This approximately shigellosis. also vaccine is nomination new program, middle a of year application mostly in income is commonly a prefinitive each affects deaths areas. under the leverages which Shigellosis of ability VAX-PG dysenteriae referred and results XXX estimated Shigella an has our among to designed with to no five age in It to of by which available is treatment. platform, make bearing as XXX,XXX and years a illness low million worldwide

of XX. be mortality slide due morbidity can information goal. vaccine to on aim a WHO priority the development reducing Shigella With disease, this as and the More seen lists

central antigen The is IpaB. in VAX-GI

production. well-appreciated allowing with enable a substantially commercial others at have technology, a is produce Yet antigen our an at been year produce look on scale this sharing More earlier-stage cell-free to updates antigens, Publication commercial technology this can While of product. website. yields, in on available IpaB unable our forward for this the the cell-free pipeline we we is section believe to the information more sufficient to of progresses. unique application amount improved We our as

who a will turn financial call to over I would now to the like Andrew, update. provide

Andrew Guggenhime

to to variances financial fourth results briefly release. the before I'll in Jeff. Thanks points, and few filing the our details of for our the are press cover reflected closing a the the income and for summarized respect XX-K remarks. over quarter turning statement, comparable XXXX With it our Grant to periods XXXX in our and reasons year-end

application that X for we enrollment expenses due studies; and development in Phase expenses higher clinical year-over-year in X to submission; corporate R&D invested expenses was primarily as IND increase these planned invested by and we for our support the for increased R&D and as higher G&A VAX-XX related higher two key costs to growth. VAXXX, increase The expenses organization Phase to infrastructure driven in clinical initiatives. our personnel to prepare our and costs overall manufacturing principally completed program advance The and as anticipated team manufacturing support clinical and we initiated toward trials was our personnel related in in

agreement related The was acquire the with reflects have the we consideration amount Biopharma stock upfront note cash quarter. $XX expensed will acquired the that upfront the Sutro period. during This fourth million we for entered and rights we in additional entire the fourth incurred the quarter charge consideration rights. and to we option to in expanded I into the

full VAX-XX an degree, significant to in we adult a $XX investment infant for much for charge, VAX-XX our headcount QX our expenses planned levels, X in function year annualized look primarily Phase trial and X activities a preparing a Phase trials clinical our we is and multiple expenses employee will BLA study, in XXXX anticipated increase Sutro required expected program, growth. forward, million substantial support consist The the our increase lesser materials to expenses the to for particularly executing study, XXXX X/X and related R&D. excluding of support expect future Phase in our make to to which VAX-XX VAX-XX over a As R&D of increase planned

Turning cash to the runway. balance sheet and

ending noted, continued $XXX.X strong Grant position, with in equivalents As a we financial cash cash, investments. XXXX to maintain million and

the Going in XXXX. that a X few through pivotal our be VAX-XX data of our expect in Phase forward, capital over expenditure and important operating is study sheet including we milestones sufficient expenses non-inferiority adults, expected top the requirements balance will to years, for fund next which number line

outlook we've components to other costs infant approval into runway associated noted of of securing and support the does for in cash with As markets States. potential additional and the VAX-XX capacity before, expected United quantities vaccine, the the our upon to of increased manufacturing launch potential not reflect our commercial outside certain population expand

We evaluate capacity. such bring continue additional to our to alternatives on

Grant now closing turn it will over to remarks. I for

Grant Pickering

extraordinary and an our year position was in It pipeline maintain are Andrew. momentum to for strong in of XXXX. a validation our Thanks VAX-XX in we

to expect VAX-XX as year a the We We on joining interest us be year further today. by forward this with to and milestone progresses focus our a rich updates your appreciate pipeline and VAX-XX. look sharing across

take questions. let's that, With some Operator?

Operator

[Operator Thank Instructions] you.

Gerberry Our of first Bank question will coming be of Jason from America.

Your open. line is

Jason Gerberry

move risk, going population first just guys. the my peds, for Hey, your biggest pediatric just the of on into higher to translatability as question vaccine Thanks thoughts you efficacy product. valence taking is a questions. VAX-XX the My with

if coverage thinking that Pfizer's at of about the totality to on second any in way And data pediatric the regarding panel FDA dose, fourth wanted Pfizer's discussion development might in how you're and this Thanks. VAX-XX? ACIP alter ultimately recent of get And just and your view my with thoughts agrees the question, peds. then PCVXX on

Grant Pickering

number Thanks Merck's there's to more and version a Hey, same and been starting been good Vaxneuvance, both of where adults. then graduating across the the more and then translatability history development able consistency being groups or adults kids. There's Prevnar take same infants peds were to doses was dose PCV Yeah. same and it But adults initially going to formulation Jason. different recently, very in Obviously, and peds. there's for in long using And remarkable they question. been historically. whether into a then exact administered the age the formulation of beginning in

was, what PCVs shown is from that consistently referenced, to as subject gone have week's seen, you was hand, ACIP think meeting, group higher at I of you drop we working responses other the last down But the bigger XX-valent But the immune for the the discussion the the Merck. one adults where expanded And on have conclusion with hand, the valence improved we had coverage on kids. as of PCVXX. have of

the has vaccine. that fact the with of required that's VAX-XX better data against being strains broader less that's coverage, us show was last the and to the technology, we responses but trade-off able in conventional so immune valent about the that's generated common excited So where what fall

going consider So group they existential choice are that's they're to how but date the act, approves PDUFA to the working that trade-off they're April that really the And FDA the to comes indicate have forced that's XX. the and to make. if didn't Prevnar basically going being

Jason Gerberry

Thanks it. guys. Got

Grant Pickering

Sure.

Operator

for prepare moment we next Thank the question. you. One while

Roger Song of coming is next question from Jefferies. Our

is open. Your line

Roger Song

a two Q to statistics. related quick the for Congrats Maybe question. question thanks for the the and just Great. taking

us focus in level size, for to want Phase the X the for can Phase upcoming the help point smaller to point a reasonable a data non-inferiority, chance readouts, number what to estimate have So, maybe order hit estimate, need the in given the to understanding of is hit [indiscernible] but conceptualize one. that's X you you to on

superior Number Thanks. around non-inferior targeting in in sample of the data for How some we seems X,XXX Phase of two different size patients. X, terms for should about serotypes? is versus terms with the you are the think scenario

Grant Pickering

the Roger. for Hey, Thanks Yeah. Yeah. question.

vaccine point can we've As is Jim consistently for adult that confidence seen as XX. basis for make estimate would remarks, that low -- to have you you a X.X as what studies X about room show the need the in on -- your point side. versus the a for been for in space historical Prevnar Phase was touching be intervals prepared the standard-of-care, relative minimum to on which on the And has either the the amount

that readout, So, we're excess be we XX-plus we'll we approaching are in out point those. in sort fall, are well of we that the the yeah, from as And looking saw study as of estimates to those the exceed. read larger

able as look XX-year reassured old feeling at the age stratification, we the we're and pre-specified did to XX we're and So, cohort.

So like yeah, feel I we tracking. think we're

they the one that at strains. was last And week, again, X.X low were we are I saw go threshold. again, closed. got to number And released. pediatric for And PCVXX X.X, once down the in know data they particular, could for then as adequate in the non-inferiority they as exceed a few which that was that

a So, sort seeing bit space. hallmark we're that adults of I this of been think that and in a pediatrics across consistency has

Jim, then, take superiority? don't part the second why about you And

Jim Wassil

Sure.

I FDA seen to nine, we would the the as lower greater, bound X.X in superiority. think goes Phase bound demonstrate a we XX upon can in high with for We XX be to fact, again, the statistical it's seen think of comfortable the that or XX. we've seeing the says, XX superior repeat as in is those. to with depending can the in what the or that X But feel what had the or XX-plus. eight to X [indiscernible] seven requirement hit XX to if we what that If the the you're -- that's we repeat we from side Phase could, data in XX, we our in as eight of lower reproducible that many

Roger Song

Thank great. That’s you.

Grant Pickering

Thanks Roger.

Operator

next we moment Thank for you. the prepare question. while One

will question Risinger of from be David next Our SVB. coming

open. Your is line

David Risinger

much. for updates. very you Thanks the thank And

two questions. have I So,

line in should by run Prevnar in this But equal comparator. First, we given approved Phase April, as down just Vaxneuvance obviously, ACIP the recommendation you're planning and to Vaxneuvance the would XX an X assume XX? infants summer, Phase a assuming couple is versus the that years, infants it's Prevnar you of ultimately in in with a in infants X

X.X And I then your for comment think had on follow Why said bound ago. would be you greater, to hit little you seven better. second, Phase just to might eight in X that lower the able Thank to a moment or be those the just something? to was different up a you. of Jim's lower if bound bit wanted or I adults? understand

Grant Pickering

for you the Thank David. Yeah. question. Hey,

conversation week beginning We'll So, our would a we've guided path for to different FDA study that when the approval. ACIP we last two in suggest looking that this stages study. clinical quarter forward the PCVXX is the soon in toward year, second have X But own out decides enough April. that on already to of find Phase

to stage adequate. give more will safety been for recommendation, than which starting be as PCV-XX we say, is against And a compare to out you first planning a The look, PCVXX. have if they joint

the spectrum where there But agency precedent point, vaccine to there. that's broadest compare a to is has your standard-of-care the to asked out

the will alter then a to ACIP. think potentially FDA, we'll for we investigators doing to But of bit with would that what -- that original theoretically things although be to who'd unfold the that would study. be have the interactions given stage portion work a we've in we preference So, order be do be the us broadest I of PCVXX could be preparations will one, we the can core the and progress be spectrum that as the to alternative, plan, to two each in we from we'll that it had participating PCVXX the but strike switch with compare FDA of potentially with a in and that would study, making that FDA the and want

second I you I wasn't that the to non-inferiority the where to And of show Okay, needs limit threshold the we a X.X, interval lower then issue estimate, the hope exceed. superiority? exceed lower what take more in that's to don't to was And technical something XXth had question why if was lower around. the bound regard to order that were you is that from with not exceed But saying lower it's but still X.X, confidence The the standard confused it point that's to that for X.X. limit the related usually at there? Jim, bound.

Jim Wassil

Yeah.

So, for assay account because a your wants FDA in sure the label, they is to that to to put you're it's year they're into in variability statistical superiority, the going seen superior. superiority past if that what I've make take that claim sometimes want the absolutely some sure

So, might give X.X, it wouldn't some there's be leeway materially of but higher to slightly in degree mass some higher case it be than variability.

not it X.X, and higher, expect four don't be can least we if So, to even at but more. achieve think it's we even I

on again. the for others that to absolute aren't And the if to reset then demonstrate even the able that bar last thing we play get I'll say then non-inferiority superiority in is will label, that immunogenicity value

even have to for others the want follow the label, to we'll non-inferiority. demonstrate who raised not on if it's So, bar

David Risinger

That’s helpful. very Thank much. very you

Operator

you. moment while question. for prepare we the One Thank next

from of Seamus will Fernandez Guggenheim. Our ahead. coming question next be go Please

Seamus Fernandez

so Thanks much Thanks. right. the All for question.

to to in wanted drill bit a really little So, VAX-XX.

a bit of little what guys manufacturing the on with us IND that through, targets? to the going it's XX-valent get to take could hoping Just to provide color expand you

And then as might an some separately, about impression was understand you that unique VAX-XX. the media otitis opportunity the opportunity help I thinking you My just hoping real really differentiation particularly opportunities, was team us there. where in was for see

love So, on touch VAX-XX. just Thanks. to

Grant Pickering

for the Thanks Seamus. question, Yeah.

quickly. we've VAX-XX and second last saw of year. readout with this into IND an guided So, year, And program, the going the as studies VAX-XX relates half it to like accrue we to these adult

in being of data next line year receipt in have data guided from study, we the to top So, that XXXX.

IND we XX the that be the So, drug a in of order half, and we're are guide in it second substances publicly to manufacturing a We've made our perspective. surplus means said to both well in on for way that from able to an VAX-XX us VAX-XP.

So work. product what then and the process then is seven conjugates the the and of we've polysaccharides manufacturing formulation doing in incremental drug been doing

we're we're towards that formulation conjugates on made drug So all what product well We've our and the made we've GMP. other now is said polysaccharides the the under heading conversations way. We've in stage.

so today, per And of so that maintaining And filing. half far, IND second good. guidance we're as

So we've and VAX-XX that Lonza of we for be same infrastructure to really excited the for been about for, leverage VAX-XX. believe able we'll that production budgeting the

for as evidenced get can relates strains, -- pneumococci. I effectively to once space, tag-team it the pathogenic But the up for result the XX differentiation, it in this you're serotypes and you adult covering to Jim maybe As one. starters,

So, it in circulating as Europe, the gets In XX%. U.S., cover XX% the those XX as conjugates disease. of high will

really feel once circulating you technology XX pathogenic, And those carrier-sparing those newly to get strains, control like pressure is not vaccination cover the that can but currently. you the have been with the think with these under scale not to historically strains possess have but been gamut take So, we do we covered we off what that only brought conjugates. you

this of so the we of the of same have that get And are is strains don't no strains, and believe the that where, have kind newly conventional we longer certain we that circulation. have, to developers the opportunity those coverage out been PCV taken big facing the face they trade-off to include

precedent as where currently prepared So, historical mentioned result rebound. strain covered remarks, withdrawn for in been the vaccination a we controlled can in there's has

just the than also the more it's longer So, no It's the of strains. advantage. circulating coverage maintenance

a for opportunity in that big us the adult is So space.

the otitis another infant relates the media it indication. potential the to to advantage as reference is your of aspect then And

Jim, maybe about little can you a So bit that. talk

Jim Wassil

fluid from first against And will VAX-XX it about so, XX% I'd if makes what in it's more increase by would referenced even IPD PCVXX. the infant, coverage standard-of-care say stage PCVXX the be [ph], the against through or more Yeah.

on impact So, substantial still disease. is a invasive there

of in incremental VAX-XX. XXB media contribution lot otitis are media, these and to terms a in strains But more there's serotype, especially that otitis

coverage in You media. get XX% increase in when to one rate it, about And you is kid of otitis gets think incident almost where [indiscernible]. point least every the at the year

XX%, of a are see So that's -- ubiquitous disease. Strep, you that XX% and can those about of if

well. this a one impact group age but it's because have So, this obviously streps antibiotic incremental XX% for medical on the expenses, could resistance of in also substantial main as drivers young antimicrobial on

for this about excited media. we're why otitis that's So

Seamus Fernandez

you. Thank

Operator

One is from The we you. Joy of Thank for next while question coming prepare next moment Evercore. the question.

open. is line Your

Jonathan Miller

Would do footprint some Is But a on is footprint? take about. U.S. But on This Obviously, talked expansion something you you've scenarios. do do bookends to would in could full-size could this -- I'd Miller Lonza manufacturing much to actually larger you this various is that in-house? Hi. ask about much might about a what put currently being talking cost larger a manufacturing only to that manufacturing deal? And you're if it this maybe how love the Jon Evercore. able be

Grant Pickering

doses. tens when Thank of people sort millions the about does adult bring into the PCV into think Whereas Jon. you in get sort the per U.S. in of doses the Hey, related I'll launch demand year way as of thinking you and reach of greater capacity it have XXX magnitude, should order well. for territory. tag-team get Andrew question. capacity, ultimately million and terms infant of be the full-fledged than one global home. We'll this Yeah. adult I just But of that

we're line demarcation. sort about of So, that of talking

to the not be it part But hand Andrew. I'm question, far to that second able will as it relates of Andrew And I'll sure go. quite to then how

Andrew Guggenhime

for the again, thanks Jon, Yeah. question.

we we to capacity demand, looking that's to using time are Probably as magnitude, premature doing launch. and XX with subsequent to of that the great on other pull at terms a of kind as options, likely next the partnership the different but the longstanding obviously, options trigger, and will range depend our in own we're the further when -- we in not-too-distant We subsequent valuation. the have we strategy. we're meet That And it on future includes get to something route do, take. position necessary have years down the few so do months, this options be it the ensure can we the Lonza, hoping over a we CDMO to the XX at to in well. to facility, And whom

Jonathan Miller

capacity Okay. sense. them to of that sort have that That the makes you you would ask to if this do expect tomorrow do already Is thing a Lonza it?

Andrew Guggenhime

-- facilities. in the population we of the can the in demand as U.S. we Grant the satisfy existing noted, out can expected adult Well,

dedicated that's for the that Lonza space evaluations basically whether custom to of their today, -- still they As likely have one clients.

would capacity. to likely it's build So, we develop, and need to with that them partner work

we're looking something an that would that's it undertaking. but into, be likely So

Jonathan Miller

Understood. Thanks so much.

Grant Pickering

Thanks Jon.

Operator

prepare One we next from coming question is The Cantor. of for while moment you. question. next Thank the Louise Chen

Your open. line is

Louise Chen

Congratulations on Hi. here. the quarter for and questions thanks my taking

VAX-XX. crowded, to forward not PCV market because question the you've is move that just is proof-of-concept And getting since with for we one already why VAXXX? So, me get for asked shared

the potential you you what sales I and about within Will when And for How Thank for next question And studying what you you then stuff to for years? after opportunities? do start do had VAX-AX, do your those? be with Or on you second think for market GI, move of you. opportunities of the think through PCV? see versus might PG PCV? was it kind your the you plan pivotal several these peak

Grant Pickering

I Thanks is category a for calling fastest to going in track the I'm has on adult infant the VAX-XX the introduction profile on for the it to both and best-in-class killer. is market. it Yeah. But VAX-XX market, I mean, question, certainly, Louise. to a mean, is -- the be and record reality

that those believe above to are our vaccine to be going it's market. VAX-XX, for enhance is of disease tremendous into that We rate that VAX-XX the strains for our the these focus use a primary only that to so, over upon circulating widespread PCVs VAX-XX. it's to deliver And know we carrier-sparing going of in the And introduction market. and

a there today, to fast have a If for can. we as know So, it to as we epidemiology thing to perspective position value a health we we right do but And maximize Vaxcyte. is or to from this it's global be would way in the for think as an it is strategy important. perspective, with And the to solution. moving the right right And VAX-XX competitive revisit something what from either societally know we was dynamic change believe company. that, be this we is the going

it the about increasing broad of do to A like our been spectrum what A cell-free to And relates afflicts to vaccine. this A Strep dividends. synthesis then protein we Group And we Group rates think Group continue pipeline, is hearing and PCVs, of VAX-AX Strep is Strep yeah, pay all can platform the adults infections. going that circulation infants. as We've with

important could an spectrum. and age is ends this of be what the So, valuable intervention on both

that And it magnitude it morbidity potential and can of usage, moving mortality we're do the we address. widespread that program that So, given has blockbuster of aggressively. forward because think

nominated other it VAX-GI that we address for are solution program want programs, And very the for shigellosis. we we've to the candidate relates then lead Likewise, the excited as VAX-PG, to therapeutic this advance to periodontitis. new about

came CDC the resistance out antibiotic about an Friday, on an rate alarming Shigella. associated alert with of with Just

forward can, we at out to sync as forward. fast equation the them going certainly moving lead. coming PCV pipeline bring we we're value with our in with additional So, as expect programs of on but But the

Louise Chen

Thank you.

Operator

Thank we prepare you. question. One while the next moment for

question Stringer next Our is of Joseph coming from Needham.

Your line is open.

Joseph Stringer

taking for the Thanks Hi. question.

being you you time importance potentially Just first VAX-XX put there's your there out for in XX-valent can competitor to Phase a position XX-valent current development, to good that data readouts in of the pneumococcal think a you competitor? relative given relative And program do stage market? that explain lines X vaccine that mid

Grant Pickering

to there defining another polysaccharide pneumococcal protein. because are haven't it's important bond -- It's the for system that data between X aspect that. difference co-presented to and this reported adults. Thanks is the non-covalent is to the XX-valent in is vaccine Indeed, it simultaneously. both that conjugate the sugar And in protein of been and And question, the immune able the that's Yeah. approaches the administering Phase GSK The is Joy. vaccines the program that has been ensures assure sugar critically covalent moment.

what moving own that be that And end public they in the don't approach back filings this expect of launch that is to until bound non-covalent their a is decade. to they're said forward. they've this able program So,

put its position than market way program. in earlier to So, it the a potentially does particular VAX-XX that to find significantly

simultaneously certainly, that's to an is second we when lost generated, often when material are to that because got data to boost think true not or conjugate third ability doing you epitopes that looks we in first-mover and its immunogenicity And being and to what have as already a infant to data of We in the market look approach. valuable material to that remarkably of the boost, similar have got usually carrier we're adult ability advantage. and we've pneumococcal compelling deliver profile deliver feel protein the hallmark boost. these what to that's admission is bound we is simultaneously think able And T-cell the the PCVs effect. it presented like presented covalent also. immune key system the it's is that's we've what be a objectively the and market relates the about we've tried extremely And a market, And that a the to in direction advantages, safety price way, the boost more and approved vaccines. that unless And

think to relates it we're in competition. particular program. vigilant the extremely that we're So, we in But always about as an moment enviable this position

Joseph Stringer

questions. Great. our taking Thanks for so much

Grant Pickering

Joy. Thanks Yeah.

Operator

today's conference Thank concludes you. call. This

great all disconnect. a may You day. Everyone have

Grant Pickering

everybody. Thanks

Vaxcyte (PCVX) 27 Feb 232022 Q4 Earnings call transcript