PCVX - Earnings call transcript Q4 2024

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Operator

Good afternoon. My name is Jess, 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 2024 Financial Results Conference Call. [Operator Instructions]. Today's call is being recorded. I would now like to turn the call over to Mr. Chief of and President Guggenhime, Financial Vaxcyte. Officer Andrew go ahead, sir. Please

Andrew Guggenhime

XXXX everyone. operator, news Conference presentation Copies to and our our provide Chief news and and today release you, Grant a Executive I'm SEC I'd afternoon, business we of and Call be the and update. a Chief good discuss this Executive Earnings Thank issued by: Vaxcyte's found Vice Operating corporate website. afternoon, like Officer, section Investors President Jim joined Wassil. releases, our to to can filings welcome to Pickering; Officer, and results other our our and of Earlier results. latest this in announcing you our Media

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

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

Grant Pickering

for joining of public reducing in Vaccines disease, And Andrew. innovations every health saving you today. call and of us all and millions preventing Thanks, you one thank hospitalizations by on transforming most year. of webcast, are medicine, modern powerful lives the the

health particularly on care of public most in diseases, reducing continue advance from significant security, time. Against substantial pneumococcal backdrop, and role AMR, disease to invasive resistance, vaccines vaccines year curbing IPD. challenges systems is XXXX This one our this individuals, critical are of defining protect combating bacterial burden was global we economic protecting pressing essential for threat or to bacterial antimicrobial benefits and outbreaks, of where alleviating as growing key play of a diseases. including humankind financial infections, impact antibiotic of health impact a pressure mission the reducing the health outsized Beyond use our by Vaxcyte infectious the or delivering to devastating the for

long While pneumococcal PCVs pneumococcal extends conjugate beyond our important of vaccines programs, or global an have immunization element been vaccines. vision

These life-saving are including robust meaningful bacterial of novel can pipeline health. We building a on reinforce widespread public alongside commitment programs to our delivering some Shigella. Strep, PCVs vaccines of world's Group designed threats, address have most broad-spectrum our A and impact a to Periodontitis that the vaccines

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broader need in in cause coverage. than of pneumoniae vaccination In XXX,XXX occur U.S. each leading Streptococcus preventable the the for a X this annually to is alone, globally However, due that remains group. it children about and XXX,XXX decades accounts for more urgent age old deaths pneumococcal efforts, despite estimated pneumonia, years spectrum year underscoring vaccine of deaths hospitalizations under

VAX-XX for those adults pediatric of year, in Vaxcyte The data VAX-XX aged Over this III to franchise the team our against announced strength clinical results currently September, healthy in broadest are made believe pinnacle on progress advancing the was PCV VAX-XX meaningful has across XXXX the carrier-sparing PCVs, platform we In populations. adults. comparing and validate deliver achievement we serotypes. the in in the past stellar circulating our for clinic robust PCVXX our the adult top in these Phase into Based both providing results of data, spectrum older. program adults. a and potential XX site-specific to protection and We the line historically prevalent

the enrolled encouraged expected data this the infant infants data quarter VAX-XX progress underway and first of mid-XXXX. We in also the are expected our set in the program and end by with by study with VAX-XX key fully

Beyond left health vaccine of AMR, global by XXXX. which continue our is that causes the to that, that PCV to significantly our one advancing early-stage we expected leading of contribute if unaddressed, crisis franchise, a is candidates address become diseases death

address vaccines AMR, reliance no in fully antibiotics. a solution can on critical reducing role play While single

are on proud developing the at vaccines drug-resistant pathogens, target We the to incredibly pipeline further updates our look be forefront we providing that year. and to forward of throughout

scale-up. manufacturing Our continues operational strong be by clinical progress to execution, including driven

on are with indications, demand. commercial reminder, for as ensuring capacity meet the place, anticipated foundation execute to With in to we both existing of U.S. to with population. to and prepared Biopark of completed we Dedicate in ]. plan to a year. will market. our play Also, facility next our adult on Lonza in executing plans we anticipated suite XXXX bring facility VAX-XX of the This adult future Dedicated critical Ibex Lonza, broad spectrum pediatric manufacturing Ibex the vaccines have The supporting manufacturing support a partnership began this supply remains for early this our late on large-scale Lonza's As and by leveraging build-out of dedicated launch long-standing global we a role be well track are to [ within the part are and our the purpose-built, infrastructure Biopark (sic) establish

have drive it development, programs Andrew. provide over a financial resources and our Our and ability manufacturing is to strength advance outlook, I'll turn now details we on To these to clinical the to advance by strong position, scale commercialization. ensuring more underpinned financial

Andrew Guggenhime

and our fourth investments in details XXXX, press Grant. which billion equity full XXXX cash comparable $X.XX as billion Thanks, with summarized equivalents net year. to XX, reasons release. the and strong remains in for proceeds XXXX and variances offerings results cash, our follow-on XX-K the successful in December are year reflected The in of periods and position the last quarter today's financial X includes $X.X of the from filing Vaxcyte's

well due functions. growth the to personnel R&D in in Turning G&A support to in the The expenses future XXXX and primarily of including increase growth employees driven these infant development expenses commercial R&D with in launches and as connection higher costs the adult the in in personnel. potential was income as statement. primarily programs, The in by increased to increase the PCV to was manufacturing number due activities

incurred of For additional we $XXX.X the to facility Lonza our XX% $XXX.X and the potential total XX% track. last in capital to about to $XXX build-out bringing global million million of the dedicated to million, manufacturing to of $XXX programs, year, the to-date to suite million Vaxcyte launch our PCV expenditures continue at project which original an support estimate

continue ahead, adult levels. manufacturing-related primarily we substantial particularly investments of the historical and build-out support results, expenses by to of within G&A these III costs the activities R&D employees a R&D will Consistent reflected the will to largely adult expect expect market, the will manufacturing annualized growth we year run increase on and the on initial the income other with and run commence, increase our the the to both related QX of number expected based Once the of program to costs Phase we complete to and and instead both in significant construction R&D timing assets. then initiatives. statement the items, through suite clinical XXXX separate other result through equipment is expenses not activities. The and the dedicated to manufacturing balance sheet including income full This fluctuate quarter, line of and in As and look VAX-XX the our is in over prepare statement. in majority the and XXXX, launch for build in of property inventory, build-out initiation manufacturing our the be X

runway. to Turning cash

the capital $X.XX making as requirements as manufacturing I financial noted, for the dedicated completion totaled the of infant that VAX-XX fund expect and be strategic year-end billion program; investments remain and cash committed and sufficient discipline anticipated II we III and primary study VAX-XX adult meaningful and long-term to that the XXXX our position us are investments, expenses series equivalents taking expenditure will maximize to the and our operating We cash, Lonza. through studies growth. Phase which, the VAX-XX today years. Phase build-out study readouts booster III for Phase sustainable of from the series the all steps impact the suite dose readouts; of and booster primary the and at data We and to few of key completion Phase milestones readouts; initiation, include: expected over II several next data dose These infant

function, Beyond with financial XXXX affairs the also marked public and enhancing public execution, operational our dedicated of stakeholders. engagement policymakers health establishment and a

We we FDA, parallel, a continues to and continue vaccine been foster ensure will with that with the continue encourage development decision-making. evidence-based to In in guide new constructively innovation and to CDC investment have policies that to to manufacturing. science-driven public administration and working regulatory health engage the vaccine ACIP framework

years $XX expanding in engagement indirect It adults also interventions preventable remains that with that an the U.S. unmet of the in most estimated important At $XXX of a vaccines that direct significant $X.X the only acknowledgment billion in spectrum trillion. expenses. direct deliver we will one key in of but bipartisan last the our are address by of billion U.S. Vaxcyte, over public children as available. estimated encouraged broad uptake savings and and XX needs. vaccines is During among diseases our health, to vaccine stakeholders, government annually not mission vaccination cost equally been societal cornerstone result clear, have cost-effective savings vaccine economy And is

the protecting development for health. I in vaccines it science VAX-XX of our turn role strength over Jim play study critical to the commentary data understanding on highlights in clinical now confident and our are infant will the additional We broad and upcoming of readout. the global

James Wassil

Thanks, Andrew.

advance vaccine clinical, position to reinforcing our manufacturing continues leadership innovation. pneumococcal regulatory major and with milestones, franchise PCV Our in

across year, strong programs progress with clinical past set with the to compelling standard and in Over the carrier-sparing made potential in adult data a platform. we our infant the supporting both disease adults have coverage new

was and indication, observed its studied VAX-XX XX of for middle shared responses For X immune serotypes to period. and average and similar serotypes study, achieving in XX robust non-inferiority all these profile compared statistically results strong PCVXX XX serotypes. higher were dose, serotypes all middle high VAX-XX safety delivered OPA well to I/II achieved with of XX full opsonophagocytic At of at the statistically immune the PCVXX. or activity PCVXX. demonstrated higher or to VAX-XX through the evaluation of with At were XX OPA tolerated responses OPA met responses dose X-month demonstrating greater a exceeded be across compared the The Phase doses responses adult all the greater for for high serotypes criteria serotypes XX X dose, to PCVXX, responses. VAX-XX

Additionally, to broadest spectrum mid-XXXX II designation a in for its unlocks reinforcing the the all our non-inferiority for tolerability to VAX-XX the expedited disease of these criteria to superiority at remain in prevention. Phase in therapy and frequent XXXX. granted engagement, standard XX track we unique met top initiate expected VAX-XX potential the FDA, Based by data launch. XXXX, Phase with end VAX-XX pivotal with regulatory Pending the VAX-XX the all III immunogenicity more potential recognizing towards November breakthrough potentially new dose pneumococcal deliver an to in levels, and study to adult designation line progression senior safety, set This results, pathways on FDA serotypes protection date. with streamlining on FDA adults, meeting

XXXX. the Phase expected the studies the XXXX out anticipate We in XXXX of read studies initiating to a also in to BLA remaining VAX-XX last and enable for III with submission

and both For dose we of series expect from enrolling participants parallel. advance XXX the in immunogenicity. and year. top of XX a administered by of administered first study last a the to the comprising XX in safety, By programs life, this X-stage at of for age the evaluate March first II from of in data healthy study this the the line with the doses months to Phase infant indication, VAX-XX we end VAX-XX total infants, immunization continue completed in tolerability X booster In the enrollment primary months anticipated year, the we quarter, data end designed of to VAX-XX of X

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the studies, percent of the X precedent XXth be strength the disappointed responses confidence a performing basis. seroconversion of the Phase serotypes of on for serotype unique up wider IgG size bound we type historical lowest composite compared Based rate meet of or the which X differential. PCV bar readout each precedent our of higher are due X to seroconversion [ To serotypes adult regulatory of PCVXX sponsors PCVXX, be per II the for success achieved on micrograms the Phase have common and trial, iteration rate. historical be clinical who non-inferiority the relative percentage the compared equal must For to this studies from adult the a a as percentage III into a case, post-dose ] the X than to We in to approval within with have data, participants predefined X.XX programs, misses clinical the bar. the serotype individual we XX there concentration PCVXX, to non-inferiority on to based translation III the percent infant the to immune be lower VAX-XX XX including to misses intervals been PCVs, PCVXX. In outcome. the PCVXX encouraged head the will primary ml. smaller endpoint feel of on greater points the in represents infant X. In point considered our With sample serotypes, trial, threshold is data the This the requirement the than would based serotype-by-serotype incremental of of to XX approved data noninferiority case with on other Phase

immune program, design is However, few is dose-finding well scenario, would this saw still we this non-inferiority and to positioned study, demonstrate as the Phase a be given across we VAX-XX particularly determine III purpose in multiple if to Even to a which of reasonable dose expect of and is of advance the in potential, a to Phase to III studies. our best-in-class proof-of-concept the it responses we see all adult serotypes higher expect misses.

in significant our making await population. the we Phase study, are from the same progress infant data our on also VAX-XX While II study we VAX-XX

is it top the of X year remains clear Stage public advanced milestone for based effectiveness anticipate meningitis community mid approach X primary XXXX, X-dose progression. current pneumococcal February, December study from In expanded the the by health broader years data tolerability marking next and this the of the first in important X dose expected to the vaccine has line immunogenicity a initiation booster made low, in its blinded safety to announcing months the needed later. Despite early protection line data an study's top and approximately safety pneumococcal tolerability we safety, immunization provide bacteremia life. assessment, series and the doses. vaccines, dose We a in high persistent Following spectrum Stage IPD, of escalation used and disease. against middle evaluate on The including with that to

advancing disability disease-related in for IPD death of our offering compared XX% need A designed the Strep, this infectious potential urgent the is pipeline VAX-AX and cause the children, program. media and major focused to including of Group prescriptions remain are otitis acute most advanced young PCVs. Outside Our pipeline, has approximately a driver coverage VAX-XX programs, under XX% global of our greater preventative a of to children on of PCV cover our a in solution. antibiotic significantly gap, PCV underscoring X, Group and leading for programs Strep address we standard-of-care and A to

the VAX-AX and continued of assays substance progress and development, activities, advances towards we method process GMP-grade product. clinic, drug have immunological to production scale-up for As analytical the including drug

clinical line Grant all back provide to drive our forward, and to advances. Across program progress key positioned our unwavering. updates achieving We foundation launch. I'll share will of are towards With on we closing anticipated programs, this well as turn remarks. place, our a to accelerate commitment to time innovation pipeline it strong remains our milestones now vaccine in

Grant Pickering

Jim. Thanks,

deep I Q&A, importantly, clinical express partners; most employees. to moving and my want our to participants; investors; to gratitude trial Before our

mission diseases. Your pressing support, we to in in unmet develop our dedication some that needs most work forward as continue belief address the to of and propel vaccines Vaxcyte bacterial

team the built, we are to the strength science, on our With deliver of and we've our and well meaningful dedication execute of impact. vision our positioned the momentum

with ahead a we do for continued manufacturing of This clinical milestone-rich innovation. rest advancements, our building key regulatory confidence and next interest are that, poised as in most. vaccines As and and be the With ultimately global phase a by the vaccine who year, a Operator? to of to to of need bring year so questions. steps look forward those marked strong the expansion Vaxcyte's and some optimism. capabilities take in life-saving further growth, look to will platform we the place, next and drive We let's foundation progresses. With sharing we appreciate the updates your year

Operator

[Operator with Roger Instructions] We Jefferies. to go Song will

Jiale Song

of all A couple questions for from progress. us. the Congrats

much play us give given some you the the is readout. will all by you think first data by year? the how then last VAX-XX the color time you primary finished And II year? of around infant the how -- XQ by the And data will provide? about we be already So analyzed safety Phase the of immunogenicity readout regarding factors should enrollment XQ what timing just the Can into then one data this end data series

Grant Pickering

infant are actually Roger. primary for the X, antibody on after X, post-dose co-primary and based the Thanks those post-dose you second split mean after first the the responses. the as know, endpoint are IgG I X the for Yes. question, Yes. indication, different across all endpoints,

standard a is this is those readout, So and this the the line accumulation antibody for top of data responses. accrual

particular be you'll this to data safety we'll primary the by occasion. Jim, the the you on the quarter? on at expect of that's want comment that the end amount thing So focused to have do of

James Wassil

Yes.

data will we safety have to immunogenicity prerequisite we data. cut the So of just all prior when the

So that in will time. have include at point whatever we that

of So the data be to There all boost some is robust well, will my but included. expectation safety way boost that won't primary from as vast be obviously post as Boost. be as majority the primary up will post through post

Grant Pickering

second your Roger? question, And

Jiale Song

Yes, if I may.

the X disappointed. on you you be for so say serotypes will if call, -- think non-inferiority on the And the I miss

speaks So than really II think criteria? Maybe are size for. that a we the about you the just we sample Maybe think non-inferiority I smaller Phase confidence. of to the is the little bit Phase what How should mentioned III. just something typical -- given clarity give us looking

should bar about mentioned confidence we point differential. the lower for is bound -- XX% difference? Is or Or that? interval? estimate it You what's point the the the How think

Grant Pickering

And and failed for noninferiority the for of those comparisons. XX-valent, -- XX the most overwhelming on that care, they comparing XX per was prior to-date, the the themselves market vaccine, standard enough the them them would the to prepared Roger. remarks, they gain which of non PCV actually the Thanks, approval XX-valent to of precedent for indeed, spectrum when Yes. broad be full the well, share. X still to Yes, gain were yet X

was and generated more gap at when for So data in case in across with adult VAX-XX X even responses consistently average falling certainly adults we've clinical so look infants. responses the not we've XX-valent, II the different Phase a that widening we shown studies higher XX-valent VAX-XX, the such immune with that of versus a the and immune

confidence immune responses to given our And to affords continuity a that from so outcome. infants the is better of adults us expect view the

we're comparing vaccine. course, the with of So XX-valent

our were basis. if have So But to are we'll seen what the as be we a precisely see surprised we relative to they responses saw. negative misses immune on as would many indeed,

more least But few. we we something imagine [ bullish. responses many we're given perhaps a ] did, later on We with at if other would on higher in So adult expecting on could missing the the that immune expect hand, setting.

feature. But then study dose need smaller is one development than study, your you're the ranging other be conducted. the pneumococcal to of that considerably that in So particularly non-inferior point, III for doing your is when the to vaccines conjugate the would drug size Phase ultimate pivotal is thing

had have we and So much needs Phase us going setting, of in to ultimate for considered rate seroconversion hit given in like absolute before II, into III. are, adult the adequate even the Phase in smaller us a predictor III; take will XX be take Phase as to that difference talked us XX-point about is a the absolute that's what how the have size. endpoint sponsors sponsors at it as to itself smaller of though other a the in And the come the within points the forward, account studies right in difference manifested the have before sample way you past

that to absolute size, opportunity difference. approach, that larger a confidence XX-point to take the intervals going similar have the sample clearly we're take at which the we'll same advantage of much So knowing up closes

X key this yes, how upcoming of to think about So features data.

both those. thank you for Roger, of So raising

Jiale Song

Very quick last one.

we have for confidence going primary? if booster likely read-through will more Given X have primary to hit misses we data, for will the from this series the primary few looking Should a a even but we the how the months the data to higher be about booster, series later? think which you should are

Grant Pickering

Yes.

fourth magnitude whereas of first that a trying -- of the the right? is been the immune responses. dose, comparison the The to the market different, to after which we've appreciate So of the condition comparison, co-primary X a seroconversion booster are second and is endpoints

higher we've a So from our in most cases, knows non-inferior but responses statistically immune data, cases, adult in show magnitude everyone ability responses, to not only higher immune immune many in and showing as great responses. of shown fact,

really we've should year. And with this seroconversion have that IgG we'll data the which thrived antibody be while data give later that upcoming comparison us that how So you will prior expect also responses XX, indication an the readout, event present headline to on expect pronounced this to will not the of an second vaccines the while the will marketed, main those data more saw of X And for look. post-dose immune are drop post-dose currently that it's the comparisons, in X. the the magnitude at XX they and this even

reverse adults, up the point did if So it it that we've year. but the done would for confidence heading next at we initial we on of as into also would end seroconversion, trend quite indicate only the well the us that set not with data

Operator

Salim next Syed Mizuho. We will our from question with to move

Salim Syed

delay or any with perhaps been granularities there there, you versus relates bit could possible, But other on macro wanted to the have whether ACIP particular in focusing meeting other to should conversations on give this last DC. I discussions the actually in time XQ. if the we the a that's the and stock how bit a progress. being us more just had the spend there? XQ with kind little PCVs prepared impact remarks as vaccines, about commentary on the little heavy such a constructive given discussion, Congrats of just it granularity distinction Totally interpret appreciate of to

Grant Pickering

Yes.

was of that think jump public one matter tag delay, I Andrew this every for one. topic in. meeting the no things is taking and why precisely the let happened. historically, and widely course, I'll a knows I for I ACIP opportunity can of And it an I then team that there up But ACIP was mean, and Andrew start reported think that not as comment. just one last

was I mechanism I people opened commentary was it But early think public not believe inadvertent. February, it up. somehow was that in -- think

allow to atypical not been that. have would that for So

simple right So should that is PCV it there and conversations lot it. into vaccines at Andrew thick don't the But macro implicated be discussion up as is that it could to of that relates you precipitating as is the what first the as Maybe that, being people a on. large. is think delay. I overread X just going situation. and can take in

Andrew Guggenhime

I Salim, appreciate No, the question. Yes.

cost is engaged discussions. remarks. know, many following in said the the actively something not but as specifics prepared the and I in, we've remarks, on as in very been been we As only Yes, you of we've of with we actively the prepared had Salim, aren't this by I this that noted truly are bipartisan population. But obviously, particularly bedrock folks play the on call encouraged the be we've our commenting and active, of whom are the benefit support vaccines to these of for PCVs our programs, the our public And effectiveness infant the view immunization to, view we've addition in in health economic is given benefit, significant important role vaccines. health continues in the as said, it

no last the the XX to kind testament things. of of for to really years the I I We'll continue of continue role stay we'll play continue the benefit monitor demonstrated so and is said, understanding, better to vaccines do there PCVs population. years think than last stay over And to infants active. We'll as the that ] adult But XX broad important in engaged. and [

Salim Syed

should of market you in that And then discussions as is when anything add life of in is Is past that Cool. Okay. missing? particular be arisen anything there to folks that at several look sort particular in there that's D.C., the the there market potentially that Is in to of the particular can you're with we getting think that. hump sort this maybe the over comes macro the months. having these to anything in looking market on for, just sort

Andrew Guggenhime

kind transpires ultimately for I think And is Well, and just all What there's should say most a the and And of what for there's speculation the noise, would we been role you and advocate talk. of if play. been of take all is continue with doing here. important caution I it. our important guess ourselves, there's lot we will, the to best vaccines and us I we're certainly to us news,

thing I've just hope in in not will than with about are overreact the ] the it's or actions words certainly potential the most or to ultimately, any, if [ noise -- be general administration. And these of changes to connection let's kind in par discussions the course that So important changes. for and potential Changes rather changes.

by our over closely. course again, vaccines. aisle of watching for sides encouraged of discussions what as both said, the on I certainly hearing But the have of support about firsthand the and it So kind we heard

Operator

David We Risinger to will move Leerink Partners. with next

Unknown Analyst

[ Dave. Bryan on Yes, ] for

if We X, okay. have that's

So you on the trying top approximately for the We're program will mid-'XX just that see VAX-XX likely sense how top take time in it to many line the after line 'XX. more from first, months a provide line in you adults, results in do color the could III initiation think Phase results? expected initiation to including might we for get

Andrew Guggenhime

can start I'll certainly Maybe chime and in. Yes. there, Jim

and to the adults have from of by the guidance remind and today that reaffirmed again year. safety, immunogenicity next for starting would that we that pivotal non-inferiority study middle study we to the line Just anticipate this in top tolerability year data VAX-XX

from initiation So you some time the idea line data. gives that of to

different or If readout it, III comparator, just clarity the at but either in start Those and back study confirmed and along that in Phase or study, between initiation be and so at you guidance would balance was the of or be study of XX today, months XXXX juncture, kind good course, year, out with just more some noninferiority next this saw that also year expect on would or tend of studies the that it this XX alongside data of to that Bryan, than program studies study. general, par those faster we that read studies this to or one, comprise comprise to which look pre-existing adding our the non-inferiority the VAX-XX a we've our the then of to program no either a And be studies in see any is that study. And you total. few as III for Phase the reason have why would XXXX.

those give timing So expected of sense you kind programs. for a of the

Unknown Analyst

your And Vaxcyte's Okay. be Could more technology might you is succeed? suited then how why helpful. Group potentially to well IND-enabling to vaccine. And that. preclinical this appreciate That's just one A studies? super Strep I close explain on

Grant Pickering

one. can start on I that Yes,

vaccines, really conjugate have that's effective. bacterial the primary been been approach For vaccines

our coat So bacteria to we and polysaccharides special we're have then proteins of conjugation of bacteria, durable to time. the response over pneumococcal site-specific protection to infection outer against allows that a just a and leveraging of found the period on drive like memory that preserve us with conjugate are perform vaccines, prevent technology

never on hand, has we're has there become leveraging created the a Strep, same which for conjugate fundamental other which pneumococcal that So broader A really for. Group known is the a what to-date. we've developed been technology of one vaccine spectrum class vaccines, is

has been leveraging So an approach there's of little a an novelty also bacterial so this. feature a across no But to first vaccine to to have we number it's an that effective different where We're targets. area very mover. be a competition, opportunity there's

have this and We to us, unique protein clear full A strains bacteria that conjugate resident That's specifically antibodies the able that to is of across polysaccharide of Strep. surface we're of the proprietary to to spectrum bacteria. on different Group it conserved accessible to the is a a site

then magnitude fact, And in school they exceeds pneumococcal for infants disease approved vaccines adults. afflicting X problem Group also what we extent think ways and market win So accessible approach with for afflicts a invasive when ways this that was particular primary the of opportunity, not we important A only technologically. And to have Strep to win adults. from we were to older X by children, also is have of that a adults this but the

the a us. So We're opportunity really be really to in gratified in for it's area. lead big this

and we're we'll We get further closer underway. updated everyone it keep short in have on been mentioned of getting clinical complete doing work get excited, the study we've stopping we're our program there. and to But just clinic. that assured, the that saying are progress We're VAX-AX to when will rest

Operator

We will Umer to Raffat move with next Evercore.

Umer Raffat

Salim Can questions like ask I XX also?

Grant Pickering

Umer. XX, ask can You

Umer Raffat

that's I ones, may. X XX, good all seriousness, a quick In right. All number. if

knowing being define delta the for That's used First, trial appropriately. is to the you non-inferiority like feel noninferiority? choice you wider registrational number that Are stringent powered the XX% I one. realize delta a too more had call I XX% delta that right delta. that the of with that's mentioned margin Merck on a

that's most XX% you. Prevnar seroconversion to step XX% XX%. think their rates Second, very back is like are rates more if I simplistically, it on to And just serotype question are X, which and XXF, my about serotypes, I seroconversion XX, except where guess X and

adults focus IgG, XX% that you're say guys you And of because X. serotypes seroconversion. were Is point, XX, successful X to I or noninferior, X even those you're in post-dose on fairly the to outcome OPA, XXX realize at on a I ahead. And any the in XXX least out data Would if but XXX on Let's have not last and ask patients? you? entirely X you is happen it's post-dose

Grant Pickering

than registration Umer, You've to right, we are trying on hurdle. make delta is difficult got it XX% we things not exactly the us the more And should.

developed hurdle XX-point We the be all cohort will look for of wider because smaller got at that used purely the that It's they of VAXNEUVANCE the confidence delta that reasons. when at we Merck as right a same looking when you've subjects. intervals should

at seroconversion do is our obviously, delta want it relates the you want that second for the to but to that? which that's ensure to acknowledge necessity. the pivotal it XX-point as pointing that? we what we're that I to be. studies the to only have a guess that even we So will we'll really in able point where stage, exceeded were not not with and Phase to see will want taken guide is a meet that hurdle, non-inferiority smaller sample registrational needs adults, people but the II trying to luxury, us We this were to delta III And Umer the about big laggards regard how talk could point. Then with study about XX-point question thinking like Jim, to X when Phase registration is in to matters, rates, there are like Prevnar your XX, you hit look that out to

James Wassil

think, -- on as Yes. Umer, No, your you're spot I think assessment. on, I

for got is as means X.XX GMC whereas of greater you've rate, level. same serotype If are X, that X.XX your the higher their the the than the seroconversion almost much level, GMCs that XX% level than

I we see few achieve slight product on said impact a if being before, a and a that, so had that given any do that so trials. serotype serotype expect of result. adults have greater we our in higher to between miss get of misses, X that in being if And still good of we X forward far we translatability and protective have results feel results do, adults and But that's type can on who think approved Phase there infants, that individuals and don't we III us very threshold. could I percent with the move the

Grant Pickering

to versus you will then I mass. that question your PDX data, wait unblind and in PDX last the XXst we And think the question, all that asked, PDX data

So while quality we look make good by at we the sense. could time that PDX, the some theoretically not got cases would clinical

be out It not So cherry-picked. until what That's critical read get to we'll will this mass we we'll year. that. able later on wait be

Operator

move We'll next with Seamus Fernandez Guggenheim. to

Seamus Fernandez

quick of ones here. couple a just So

there XX on, is if and pneumococcal really then data, the that there XX context otitis what you assess second The media is And team But perhaps might an forward to potentially of What bit be that efficacy XX see is an in it that of there to ] could the the international in to Hoping decision most what moving all sort decisions. of differences opportunity for the directly put potentially obviously, to should could some the debate that a kind over media would and makes that a depending conduct which Or consider -- to pediatric peds first It could forward? points be studies. XX the would reason possibility at ridiculous making that kind quite around and you move post you both the of critical like? space. and is compelling decision? And given data discussion the an the is as advancing be just sense otitis XX that seems at or that would look opportunity be VAX-XX approval XX [ an question securing claim? this quite and question is, opportunity opportunity. looking study compelling, around efficacy setting redundant study dosing in the

Grant Pickering

Yes. Thanks, Seamus.

make it based year didn't pivot in product VAX-XX question about in last your association we that with VAX-XX the things singular on of a case, that VAX-XX to obvious from to infants. perspective. VAX-XX graduate as availability adults. a lined first really in So to strength opportunity our versus have between time from the But Obviously, the programs delta the navigated how VAX-XX was we X for approach up data

straightforward a was that So very choice.

verge receiving Here VAX-XX. we are pediatric the our on with of first data

not get clinic we've VAX-XX the infants. into As we've declared, waited to in

But where they market a versus the of approach have So going what Europe, the at X-plus-X to we from get European course, station be left station. you the we'll competitor We'll next have that was spectrum X where one The is most U.S. would out, not XX-valent in in available be principal XX-valent vaccine time the Pfizer. schedule meet the would before have vaccination. to the would the which, VAX-XX, the broad trains managing here period other. U.S., the the to be pace, of the which the as of the extra schedule an to be point give able fastest

So XX-valent. the is competition in the really Europe

which here middle So we is in as our a VAX-XX winner the do we're of we've for mind expecting that out course, of next shortly. data But have get to the year. reading guided, by data, data the

VAX-XX. far is So behind it not

how leading the there much immune XX-valent how carrier of will that be we So for have data, that us effective. cohort, once the mixed was able VAX-XX protein to this gives indication to headroom affect do receive we'll a Recall, in handicap XX study, responses. incremental we which valent be better dose much

faced. For effect incremental protein of the the previous seen studies carrier, not to-date, at the of much extent technologies least an nearly the we have to haven't

So hopefully, yes, have, decision to we're going to a make.

XX all taking we're be Seamus, to think that things even is data position to XX with those the months. into in good VAX-XX VAX-XX, as stronger arguably we we'll positive. But I either a readout position the have an ensuing the extent be going data consideration, over to but

Your certainly question no with at on. pneumococcal initially with integrity, were of of question outset developed have kind studies, you placebo-controlled that they hinting utmost the were macro vaccines clarity backdrop I of about at conjugate studied infants. studies, think There's efficacy what's when going some the their been in

there these absolutely of XX% XX% of no vaccines danger question So infections. and clear the effect that present and of bacteria is the prevent of pneumococcal to

it distinguish of think mind kind as ourselves there that's has So is efficacy the And Jim way for you think something with study in potentiality. a an I phrased to was, opportunity I manageable. us there an

James Wassil

get I'd XX% No, XX% get infants of media, otitis case to say of almost Yes. multiple a up cases.

common So of type this the driver is Pneumonia. Strep a very is the And main ubiquitous manifestation. of majority causes,

current the percentile low mid-XXs for with to high of to -- to XX roughly low we're PCVXX, overall the But serotype XXs. Now our in prevent they coverage. in mid-XXs terms XX,

that actually type and with incidence a with in And we study, to to comparative type media do that so of and that determine the study enough able otitis will improvement even we of think a of be have cases coverage efficacy.

than immunogenicity in safety. longer an study take to going it's said, you As

would come exploring the the of approval, see we doing XX-valent. do with that we likely, plan most on but study an in efficacy otitis possibility media So our after for

Operator

We'll America. go of next to Jason Gerberry Bank with

Dina Ramadane

infant the all had progress on Congrats on couple the Jason. year. for study. on just Dina a is VAX-XX We this This

get in we primary can and/or you -- if a the will front. be how what just if he doses said to consideration have would derisking your regulatory seen in I would to I II? in way, so? What guess, the that just PCV First, Phase on set have are take ability of VAX-XX for the this then infant to provide kind a schedule routine overcome? does different specific if would the you in child actually RFK dose certain that serotypes what's in us depending to And tweak view hurdles remind And power the he data And change do series have have like to initial across would on vaccination to sole population? dose on follow-up III read VAX-XX a have selection? And to order measures Phase quick the the

Grant Pickering

Thanks, Yes. Dina.

yes, out predicted formulation across And a be data take of middle and look we able expect is from thought were low, our at VAX-XX amount better in it a at, the to read So we could mixed. sure, particular, as able similar dose when just to to VAX-XX could VAX-XX of infant the in data that mean, relates in VAX-XX, leading it saw that to indicator was was than the in we definitely And was dose the carrier adults, from to reading the I look protein we ascension mixed like a to cohort with what have it of that we mixed even adults. data. course, the dose

think this bellwether to does data the it So use as I to VAX-XX it a read out. for think have with that similar a when data opportunity infant how we will about

what a was responses the incremental magnitude found immune Prevnar when to of course, compared falloff we see carrier, of with XX. didn't So in really we that protein

serotypes, definitely, good, data from will So us. most afforded the it that is I the confidence tweaking triangulate that to your of doses VAX-XX. To individual adult the only about question will data came be if VAX-XX definitely think for our

are there's nice on we've toxicology a X the conducted. of that II We dose a run. seen Phase the based of And all really wide have studies birth consistent pattern that response across studies that's afforded

that the question pneumococcal improved. And reserve to be potentially And third schedule to could the your conjugate so tweak then related be indeed, response vaccines. right would certain doses see and we for should potential if changes to immunization we will

pneumococcal really There's vaccines forum. no any been in what might of to happen. predict I think to-date hard it's conjugate discussion

think no back will is and adults distant is and question don't circulating of rates an a upper pull and more that that there's with pull substantial and more our respiratory associated anything on that. And conjugate inhabiting moment back pneumococcal of This would pathogen. I be infants a immunization more reduce adults the the make memory There's more schedule vaccines, will you kids some portion of This pneumococcal So or there the conjugate die. tract dose think a to population. a get ever us sick to is routinely of with to vaccines. effort of go not pathogen

don't a do to think thesis an there's there impetus So I really path like suggest or that. that a be would something to

Andrew Guggenhime

perhaps system our one immunization recommendation of AAP, it a a including important that a the just commitments clear, to back all to stakeholders. And mean maybe toward the said, kind economic put I current schedules environment status Kennedy of to while of connection maintaining the from in institution plays very infants as decision I right? respect years speaking bodies administration, as nomination Grant's that to there his the of made benefits that can vaccination. And geared number is involving infants, he the of question, I that among right, of to earlier I of important role and as statement the of comments. adults, of obtained both out the -- other years health Pediatrics And is an are really the in as XX I with Cassidy The and at the with commitments all kind Salim's American of that kind well. an directly are comments support ACIP immunization the and also is Senate, add multiple RFK to well may would to Senator refer quo us itself terms incredibly complex, the in exists XX Academy other the of of vaccination multiple, Jr. the of say, bodies

Operator

next Shrader with move BTIG. to We'll Tom

Thomas Shrader

getting that? well. have boosted ACIP it And whether great second is be kind the of you medical to them squeeze boost gotten really do you for I really shot, And risk one standard the have if factors a need it practice hardwire noise to insurance at practice. XX? at With to all while at it question wanted about pay Adults them any they'll is, if is for XX with Is everyone more the in will ACIP, on get expectation XX at now, Or XX? guess would about current I that PCVs now. thoughts as

Grant Pickering

going for tag was this I to conjugate and question. one. thank up vaccines I schedule. and approved ago being X-vaccine you until prior Maybe in Tom, back team the there XX a mean, only the Yes. Jim pneumococcal adults recently years can

XX then polysaccharide-only until years. on top the And polysaccharide-only Pneumovax by vaccine conjugate XX X that the case also So vaccine, Prevnar was years there approved, and in was of XX was got approved. only every recommended the pneumococcal administered vaccine. And recommendation was ago, Prevnar the of

out. what looking should they consistent doses were ACIP vaccine range. feature yet. was but should discussion of VAX-XX. come of we been the a then wait the the once XX. To really And recognition be another vaccinated Tom, vaccines And they was multiple there that universal the conditions to your dose have second vaccination And the So a was age you been have and of how see reticence around there adult that they vaccination long go vaccination turn ACIP with come And was part at for routine vaccines the meeting, when second was people time. that in gratifying valent giving to getting were a when bit a XX, for people last it range at turn we the vaccination some on certain vaccination for start newer, there just XX. those in health VAX-XX both there point, could to referencing, higher were real that the quite And

codified. But if So the get age within headed. for ask been individual mean they'll think if right It hasn't future to just I yes, of goes it. in we're that conditioned. the point, the vaccine they're where I that likely is an your is and that's range, how kind it's they

James Wassil

been haven't for there I that controls to-date multiple And have any seen. reimbursement doses on

Grant Pickering

gotten vaccines the if health investment. a when why not, previously get that's their to and than And you on $XX the their they their it's system. safety a second one history. profile, even return go in for depending pharmacists $X people great savings a And on to given return often given they'll efficiency these in vaccines in Every have had vaccine class, dollar spend on such vaccine, the that it ask to more care

Not begin as immune people I been vaccinations of but think lives, XXs you're things setting getting totally they their is their systems the for particularly get has as should of yes, ground wane into XXs. what is the everything be and course up. So case, over the which to solidified, their kind multiple fertile

Operator

with our Joseph to final move question We'll from Stringer Company. Needham &

Joseph Stringer

puts either your of preferred what's the on approval or assume not go and of this at And precedent, recommendation? likelihood takes could We the a realize updated eventual your the but new administration? VAX-XX on would would you against ACIP give hypothetical has scenario? on sort changed -- this your thoughts all VAX-XX, this thinking the grant on that current I outlook with

Grant Pickering

thanks Yes. will up. the question. VAX-XX Joe, first I for we've Yes, got mean -- be

occasion moment. the warranted pneumococcal And did the there strains, in et treatment while experiment. Once have But As that the in that, Phase the actively we extremely have obviously the III they profile Phase recommendation, conjugate we're improved given heading confident some the was were complete to coverage, strength look fact ahead, into we've III a adult of think could II, debated, reviewed got Phase but studies. historically cover the circulating package where of to-date. for makings vaccine effect we I BLA profile that of has the that and potential cetera, would have together have ACIP the an et our expectations most which But ahead we it to even preferred all have a compelling review, looking last together, we product not it that a had circulating of that cetera. get to were

that it what multiple the what we have advantages vaccine strains us, covering And which the coverage are particular plan confidence it there was It's on explicitly guarantee, and with responses, a been coverage what only preferred I a gives will dialogue to-date setting. additional that recommendation. And et from we've the considered preferred potentially for for preferred think cetera. conjugates, in happen but And broader recommendations where we're not moving of we anything infant confidence does we that lot to we gives improving it have based that but that composition, reason higher while of setting, something can grant as so even they why has adult to our has conversation warrant XX-valent if they precisely have we the for. last and immune similar preferred seen. would was granted think us immune not did else which the conferring a can a Prevnar forward, because a seen recommendation, relative ways truly circulating looking coverage boot, the something for. In then of ever profile, when XX-valent that but VAX-XX, seen approved the product the were recommendation what diminished And in the responses kind debated. about was certainly than as adult enough And differentiated in that to that responses have we were on the based they future, ACIP us which immune a is it's to least when results plan see also they is that XX at it can anyone the higher the really, that superior that we're a had evident, and away not profile to relates ACIP conversation, ahead, last historically

are of premature better on return think the point the better to up the this vaccine extent than what protection relative made which merits care considering that the is can to that for to of country. newer on suggest and the decisions have vaccine standard to vaccines for been anything and investment provide historically, it's other which basis based they're for I So these the which

Operator

this disconnect also and day. Full concludes Fourth Please and have question-and-answer at conclude will Vaxcyte Ladies period Earnings Call. gentlemen, XXXX a and Year wonderful that Quarter your today's and time, line today's

Vaxcyte (PCVX) 25 Feb 252024 Q4 Earnings call transcript