IVVD - Earnings call 3 2023

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Operator

Welcome to the Invivyd third quarter 2023 financial results and recent business highlights call. [Operator Instructions] Please be advised that today's conference call is being recorded.I would now like to hand the conference over to Scott Young, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead.

Scott Young

Thank you, operator. A short while ago, we issued a press release announcing our third quarter 2023 financial results and business highlights. and the be are section found Invivyd under and the today of release website can webcast in News press slides using we and the That Events. the Investors by Today's discussion Hering, Chief Executive Dave will Officer. Invivyd's led be by joined He's Dr. the clinical Jeremy Officer; of ongoing including Officer.During of Officer; among Act and Securities subject Financial timing fact.These plans, differ runway not Chief Operating discussion, other our plans, statements the Litigation concerning, to we our expected cash will development are things, historical Medical those and and Chief opportunities, to and and assumptions results commercialization various cause timing and Duke, materially future Bill of COVID-XX the Schmidt, other or landscape, of forward-looking research may regulatory Gowler, statements our the from Pete within uncertainties forward-looking expressed plans, Private plans, the that today. actual Chief covered today's and Commercial that are these Reform statements including are risks, strategies be making these our meaning and implied the to forward-looking the such found These only the duty of of statements.Additional call, filings made business our speak in and could no assumes information U.S. as this on affect that risk Invivyd be factors date Invivyd's statements update can the with to the XX-K, over recent and turn is also which Securities call on most available website.I Commission, Form including now Exchange our will our Dave.

David Hering

Scott, and all, Thanks, you, joining. thank for

the provide provide in our and to landscape very highlights X we a achievements real the disease CANOPY, preparation of our latest pivotal today's the the I'll reviewing call. work in Slide key immunocompromised Pete trial you neutralizing discuss some recent other review will in vitro COVID-XX few against VYDXXX commercial symptomatic of been current then and update activity that and quarter, antibodies' Phase is his As for and the then or for issued, demonstrating VYDXXX the continued COVID-XX XXXX.This of can business on earnings Authorization, individuals. have vulnerable vitro time and the if presents of clinical investigating recent color begin an then the team a prevention launch could on has first an have data on for Emergency I'll in the will and Use threat in third a enable EUA, call. joined agenda X, variants.Jeremy a he potential some doing full see which, our by and critical SARS-CoV-X Jeremy

commercial third as the brings more Bill us a XX of open latest of we and all leadership as including than he review way introduction, commercial decade have December than than Chief more XX more of experience served quick call has today. our since industry. years Operating stages in biotechnology Bill of a of experience across performance runway by Jeremy Officer, So Commercial XXXX. Officer has from product for joined him leadership for the Q&A, Chief and Biopharma with where and of will pipeline is launches their he established responsibility life cycle. late-stage of Sandoz, in of He it had years joined the our share Head to business the us quarter as served the portfolio.Before as financial Commercial cash pleasure experience, Bill assets well September and Financial guidance. Duke our senior Global us as the

to I a leadership to made his revenue-generating knowledge executing progress has time executive X. has and of team team commercial Slide proven short with proud transition will to to a a to himself our this During Invivyd, a us addition company.Moving as potential invaluable prepare tremendously and be the already we year tremendous be for our am he to plan.

than less Phase X VYDXXX referenced clinical As September, pivotal participant the X in CANOPY, of initiating for first we trial months release a later, X of the in Phase trial prevention to our dosed CANOPY XXXX. enrolled, X including endpoint that after COVID-XX. just in earnings Today, we weeks trial investigating we VYDXXX, today's pleased in having enrollment individuals.With XXX initial to advancing have XXXX participants approximately the we early completed late or with immunocompromised CANOPY study this continue anticipate announce approximately are from data swiftly, primary XXX QX symptomatic in

important also through and viral to as be that power working why combines precisely state-of-the-art Invivyd, and internal INVYMAB candidates to of U.S. to that our to a with packages.The response our remains antibody as prep the in supportive mutate for the believe speed assembled and come. unmet them to surveillance for we is holds goal ability focus the for individuals COVID-XX which have keep no practicable, outstanding clinical, value strategically we and team can with to SARS-CoV-X engineering submission, for the are fact pressing partnership ourselves assuming need positioned viral CMC to mAb another our in INVYMAB predictive advanced over evolution medical EUA significant working or collaborations, efficiency of requisite clearly immunocompromised and monoclonal the have have our remains consequence to is COVID-XX.This a unmet data to and and in and Adimab.While the deployed medical we particularly concern, which of ongoing antibodies potential expertise to EUA driver platform trademarked VYVXXX relentless who of through the optimize health testament in years to for VYDXXX potential currently is progress such evolution. proprietary data for through need, a success see soon for pace prophylaxis Given advance identify INVYMAB.While with apply is an as engine That's the we our nonclinical ineffective. dedication modeling yet we near-term have time virus's the the The authorized U.S. been approach, we the render pre-exposure parallel, an large our therapeutics available speak platform

to platform and Invymab antibody fully approach We potential also enable dialogue deliver regarding rapidly monoclonal with continue the would us in leverage candidates. constructive to that our FDA engage pathways to perpetually

in to We are authorize used pursuing and vaccine. approach flu COVID that would, the annual mirror some respects, the an process

us, pleased While in need ahead ahead.Before quarters I there just over progress date of to with our the details are the state make is current turn and and call much very of the would and the points to a more monoclonal antibodies. for we clear work about to COVID new Pete, look urgent forward sharing few I

looked financial as possible the or only a XX individuals COVID-XX immune quickly and immunocompromised nearly XX-fold immunocompromised a than XXXX. who the the These to vulnerable health which an the the increases learned using COVID blood transplant population being with study individuals, can October, were healthy commercial published early who sample looked a normal, have cancers study, remain for people with the of with population, to accept recipients part COVID us simply more stem isn't people in $XX,XXX pandemic.As as at evidence plan for continue more Of those new They that COVID-XX than EPOCH face in as VYDXXX see treated of but serve infection. and people though underscore of of cost accounted which of powerful even X they individuals.With roughly did infections get on October, populations all of motivation get these in per this population. death, likely challenges, was than real-world immunocompromised as those XX% and diagnosed has COVID-XX for available INFORM early population.Unsurprisingly, conditions.Also, certain people heavy to with that EPOCH and of a study, to the vulnerable people many immunocompromised mean and the about received XXXX U.S. that Results XX% solid hospitalized accounted the with day without organ toll distinct Furthermore, XX% to and from individuals of from for study, new that recently population evidence for real-world days I'll the found live COVID-XX to patient. nearly that and XX immunocompromised. the option this of the vaccines. at highlight COVID-XX large systems as not XX% XXXX, between acute and impact to data insurance it While X.X% as height X, greater data was authorized for risk had takes as of cell during and in In turn as from Pete. Slide compared In on today that England. means of were and COVID-XX human on disproportionate in show over data overall that, people a were were emerge you future which those study risks admissions ICU such XX a million sample hospitalizations, the the more published X.X% of million referred had this COVID-XX antibodies immunocompromised and burden it and a

Peter Schmidt

Thank you, Dave.

we including tracked in the cast estimates variants CDC, the the with to and As as on With as to XX% current inherent the advance mutation.Moving variance we estimate our impressive on pleased our XBB.X.X, FXXXL XBB.X.X.XX, our provided Slide variants that it recent the tested, lineage our is recent regards vitro and made sequence variant, to with against CDC to the you Dave of mentioned, SARS-CoV-X EG.X VYDXXX XBB continues as of now quarter SARS-CoV-X by team X, XBB latest that approximately proud glycoprotein now mutation is see shows I'm variant circulate. this are the have can mutation that in neutralization the characteristic CANOPY same expected Based spike of as spike. activity Slide partners to testing retains study trial. pseudovirus report the that and very the an which X. progress FXXXL XBB.X.X an such are

to primary As XXX XXXX.As we A Cohort trial plans A, completed X VYDXXX. Dave or participants In endpoint CANOPY initial compromised. our have QX late in continue XXXX mentioned, early CANOPY immune enrolled and approximately All who in has received cohorts. reminder, are individuals data on Cohort enrollment we recently significantly a in

out build of for trial adintrevimab calculated safety a who are endpoint risk [ the safety potential A, for CANOPY and submission team and VYDXXX Cohort which to VYDXXX.The safety with data to titers practical. which or immunocompromised B, individuals Cohort enrolled for concentration tolerability we and XXX titers of For an endpoints observed serum Day from in historical the variants, the randomized the executing on relevant Cohort The variants.In and at comparing relevant from trial anyone at interactions primary previous cohort tolerability, the Participants soon were VYDXXX of from preparing this clinical B ] symptomatic on SARS-CoV-X X:X laser-focused SARS-CoV-X, SARS-CoV-X in is use to to receive COVID-XX for analysis participants certain approximately immunocompromised who primary for co-primary obtained the clinical B efficacy will immunobridging for placebo. is database purpose unmasked approach, against for against are the data is essentially has correlated prevention regular our and cohort ICXX efficacy.Our CANOPY be serum the neutralizing VYDXXX with and as XX the of neutralizing pharmacokinetic which EUA as primary will based value Cohort is exposure others.

launch certain different the immune and been date, the awareness the many medical will our raising teams with trial various more community the the VYDXXX from latest we've response believe XX to we including for have to on for continues groups.Furthermore, pathway reduced new potential satisfies.To meet prepare advocate I organizations, utilize patient vaccines.With input pathway call COVID-XX anticipated, candidates pass VYDXXX, groups. to the a with of age an that, we've to potential criteria, monoclonal design of FDA certain EUA for for scientific leaders, of immunobridging may Jerry. received the that than key a engaged with we that FDA CANOPY products, the which patient authorize EUA our antibodies mRNA opinion have reflects we've to vaccines now As in new for also that populations exchange appropriate To engaging and are mAb the

Jeremy Gowler

you, Pete. Thank

submission, preparation featuring advances well plan in clinic as potential commercial prominently As as EUA more VYDXXX with a investors. and discussion rapidly our through in the are internally approaches our

market a color U.S.Looking for more it's opportunity to pleasure So to join we about undertaking bit to call research, a launch.Turning a more today's Slide is and are extensive significant left, from specialty many severe activities with there people believe market a MAb we of the severe the Based aggregated with immunocompromised x-axis of potential conducted survey our based than the we million share market X. gear for as on on and the up opportunity is COVID-XX a the X at Y-axis on U.S. chart risk PrEP a the expected in the uptake shows the the HCP at in COVID risk we COVID-XX results

this top an approximately highest can opportunity clear and comprised of far research.We utilizing and expand with chart, impactfully into groups our stem Slide risk Importantly, who people certain the patients initially on see and recipients, including can over sales that XXX,XXX with market people degrees different the At subgroups, XXX,XXX market several there lymphatic the varying target to have at hematologic refine highest the the uptake. you cell expected approximately is and XX,XXX based subgroups enter subgroups to population key of are further We right transplant of to time.Turning are additional the organ risk expected uptake market, efficient solid and a recipients or cancer. X. footprint transplant to see providers of XX,XXX

many launch authorized. VYDXXX potential if have activities for to a We prepare underway

multiple market team all products anticipated board successful they franchise the if vaccine as VYDXXX that option.We be we to and for stockpiling with inventory step With have the populations Dave, and team the strains.We payer up top, lead the progress started to For research we launched to business preparing underway working head we XXX our submission.With in commercialize in and the segmentation, and we rather with to With COVID-XX a of as the immunocompromised I'm and prepare physicians excited under and work. for use who recent such collectively through the With authorization, COVID-XX past. with the in relevant getting have circulating role as available be for from a CMC us launch, would sizing channels. in the example, In have authorized, immunocompromised likely preparing treat we believe and mRNA small make for This our with of of that VYDXXX the government market continue access, large VYDXXX are COVID-XX systems brought wide diligently, saw somewhat to pricing organization, health nearly Evusheld, global authorized. were regards manufacturing result we opportunity. U.S. go-to-market brand on to XX% package field survey be believe relatively force played potential will if that pivotal traditional have and partner Pfizer, underscores market different use strategy address this respondents access, be made XXXX, part research the seasoned if has sales respect still first products to types authorized we HCPs, patients an excellent functions. we we are emergency commercial planning conducted to market effective said underway, to leaders experienced marketing VYDXXX our purchases likely ongoing PrEP and with sales a launch it they expect of and been key a with to also mAb we've infectious and regard in market very anticipation commercial or for models than can and a sales COVID-XX previously pleased our the EUA of outstanding extremely market is patients. for the caliber launch sizing of WuXi, and as potential work and disease.Our of has very approach, of to distribution we progress who our their to model

provide with we our over Bill and are the of launching an to that, force, on the field exploring currently turn focused we to potential will in ourselves partnerships it overview are While by actively contract I collaborations.With U.S. financials. now

William Duke

have Slide execute transformative meaningful the of earlier I today. to forward and included is strategy teams press too to and Invivyd's the The a ability period the see potential and the lives the of on for long.Turning great have team Invivyd Jeremy. financials the very remarkable that to highly third you, the release believe thousands COVID-XX a our been pace. poised Invivyd's for to plan we by company. make team's to vulnerable joined that in impressed platform-based prevention difference at financials excited the issued mAb in people without in details such nimble, driving I've in are Invivyd far by a States to are access Thank who potentially of XX. motivated Invivyd work I'm been for quarter at United approach a

won't to XXXX.Regarding us heard of Invivyd I the including with the fourth third as marketable continue cash VYDXXX quarter are additional plans, So expenses potential of ended approximately have preparing $XXX to our supply. efforts launch into any we you revenue operating XXXX current today, our potential operating will an actively of for the VYDXXX, the million resources, on that fund associated quarter and enable manufacturing authorization the cash, cash, of and here. numbers all reiterate commercial and our excluding expect in the we with Based equivalents securities.

we for We operator, compressed that, questions. biotech call significantly will to rapidly on compared time advance that continue deliberately our open programs.With traditional as our to manage please expenses lines are work the

Operator

H.C. the Our line of Wainwright. Patrick [Operator from come from first Trucchio Instructions] question will

Patrick Trucchio

Congrats on all the progress.

can XX Day like a data serum and terms the the is redosing Just from separately, VYDXXX the and if primary following submission? what Phase on submission, the would terms will, dose it completion see X Cohort you submit need in EUA? -- of any, Cohort Cohort remind sounds each that us first CANOPY in just X EUA then A the that neutralizing give clarification, enrollment accurate? And you Can EUA we And confidence from trial. of the A, data at in in on is would question the have endpoint Month in just to maintaining data B gaining or what the titers

David Hering

tackle EUA the Patrick. as I question. part of Pete a the the Thanks, answer for about let potential can one we're I'll submission. preparing Yes. first

Peter Schmidt

from Yes. XX as is historical that data The titers serum compared immunobridging the trial. Day primary at endpoint to or adintrevimab endpoint the neutralizing

David Hering

one about, talked of in pulling working we've support as pivotal looking in that, And other EUA And towards it's at of CMC. from of element that Right. elements the EUA potential combination components of nonclinical together. is that and additional we're and The the clinical, data we're data is we're a this working package on from work on the submission certainly as CANOPY we parallel, submission. this the one

Patrick Trucchio

are or I regards as detail, particular the and discussions. who this payer a VYDXXX. other launch, A of could, particularly if coverage? launch the then type is of patients follow-up benefit with few on unique from aspects of greater to X, on regard group the specifically there manufacturing with just then to this that launch Are reimbursement And the just regard Slide payer commercial codes for the And could that of broad a in preparations. in to scale any

patients, is the focus? launch effort would trajectory, So if I'm for of expected any wondering VYDXXX launch can a of would how deciding be how the broader the to you're there stage? that received Or be manufacture immunocompromised kind And this at if authorization? this particular you discuss

David Hering

for question the launch. let bit the and Jeremy a help the can I'll payers, to first I little focus more Yes. with talk about

Jeremy Gowler

EUA. et that comes to plan we Thanks, Yes. have to specifics access but us to this includes ready cetera. for that, market we're are time, which we're several premature it the are in steps it's place, launch And really given be at taking appropriate There pre Patrick. give ensure still coding, working on to we when

David Hering

et variety and the for consolidated talked to $X to contract the these Yes. through can mentioned, who immune uptake. [ focus And as that right in lists subset solid Jeremy group the own for represents upper organ people. of cataloged also contraindicated these of relatively partly given certainly X, so we've it really blood just in we've we we people of market bring the folks cell vaccines, cetera, really highest and where is launches recipients, are about, expected that's areas.And folks And are of transplant target. planning as et ] a million XXX,XXX the who to regards transplants forces, risk that the stem are of ones are the are patients at compromised way because initial really efficient And But cetera. it this who to vulnerable, which that the our as quadrant, have the include cancer who Slide as people sales are population this people research now are also to highest then market, product look the looking an are, that could us those here,

Operator

the And of Michael question from ] Yee next [ from line our comes Jefferies.

Unknown Analyst

next on what for [ XX is your XX to on given the to on really ultimately, factors ] or when FDA end take is This passed step that of titers? about get be I how will should And and [ you'll for confident are the the based think you gating from everything actually it's since able either Mike. you together So put days ] QX? submission, then there, do we just soon when wanted submit? are to days that Jenna think prove how

David Hering

Yes.

question gating the of part terms the is in So of first items. the

next is So of forward. year collecting we're looking year. the for preliminary that we And study. endpoint data the end data have primary fully move as or early what excited that stated, to very enrolled this QX We're by to we're

are current would goal given and combining your cetera. that of including together in the the assuming us, unmet it's the rest to to relates receiving information et that where the and that put gating agency nonclinical, lack quite be to continues practicable the that that and what state I've be CMC, need given positive, are.As soon of the our the And question with it for package available, -- as continued mentioned, products the so submission collecting as And feel components was data about submission we interested second? we that of

Jeremy Gowler

Titers.

David Hering

Yes, the in about values. as and to FDA So -- to That's and led using have FDA we press Titers. whether talked earlier our release. we immunobridging stated titer the previously what had this

We have able back on with the endpoint, it reached from as original and [indiscernible] to being general adintrevimab. value use PK alignment as that FDA a the trial that from titer to surrogate concentration bridging calculated

And so we outcome. are aligned again, assuming submission, very confident that using that the that supports as an FDA the an EUA that for data endpoint with was something on the

Operator

Our from next Morgan line Skor come the will Maxwell question of from Stanley.

Maxwell Skor

progress. on Congrats the

your So data package, with and are how often circulating in expect your EUA currently be vitro required CANOPY update would design post the variance? the trial, authorized to you in setting? both assay to of And you include exposure given regards your neutralization also to to pre

David Hering

Pete Yes, let I'll answer.

those like. you can questions, both take if You

Peter Schmidt

Yes.

There no it's frequently schedule. how variance, update against as schedule as I'm possible received certain demands that is real of that terms time. ] [ on a neutralization quickly in set So in circulating we we've

know, a a authorities. the CDC and of is the approach kind As and monitoring FDA you with other the all this collaborative

time PrEP pursuing soon PEP, as of the So PrEP the we as we only. indication we in updated get are data. terms real in And versus

any generating data. data be won't we So or post-exposure prophylaxis PEP

Operator

Our question from come for the line will Wang of Securities. last from today Evan Guggenheim

Boran Wang

of that on the least some planning of approach? thoughts you Can the of terms pre-commercial population targeted sense size the of initial I a sales ongoing. follow-up force a at in needed provide for had

David Hering

you I'll Jeremy, that take one. Sure, let

Jeremy Gowler

Sure. Thanks, Evan.

market exercise. small we're market, believe capitalize most detail in to we that would launch. it as So that would it's will and relatively But we a group. get we so commercial on we give in closer we will at-risk a as need But with concentrated ultimately that be the into a more still size little relatively said, immunocompromised enter this very footprint to we

David Hering

of focusing the in of their And account there, in thing these various type utilize this Jeremy that Evan, Yes. said, to add sort HCPs. receive sort they on are given go and these after to care And of a can talked call being a individuals and key more only systems model nature really the quadrant, go different they is concentrated and able targeted I'd accounts. from about lot we've right of where upper where of way you various a as

Boran Wang

pre-commercial in you terms ramp, us or I color manufacturing of X extensively follow-ups. any some terms can have And provide plan you then the more build in how to that of of estimates And some inventory?

David Hering

Yes.

available. approach. being cost So begun that on we've sure side, doses risk, a as material of we cash that both gated a have balances, variety the inventory to making looking our sheet, can the do continue balance but commercial prepare but and making at we to we're in have we're as effective What we also really with sure to is use

start data to launch. the to EUA forward, to a and/or or a as continuing submission ramp that we point So get as see up we potential of move

and when great doses at continue can a really in to available look would have we partner ways those to that how We commit we them. optimize we WuXi, and be

the and available pump and that as have a track for doses plan So and prime add to is the launch really potential the some those of see then now further that's to start we approach to more and in information continue process.

Boran Wang

terms Phase that I X guys some time. think tracking in over of data, of are you And the

[indiscernible] are and look how over of or in if thoughts redosing the wondering any kind the future? looking So implications there, guess, on, could I how just there's

David Hering

take to want that one? you do Pete,

Peter Schmidt

and of look data. the redosing. our recent Phase study No at X updates make out to about from recommendations of totality the Yes. data that and coming We'll of conclusions CANOPY course,

Boran Wang

one research. see And Great me. last the for to market all

are KOLs guess, FDA? the surrogate they did data versus and there of looking kind payers beyond acceptance value I much how, -- -- clinical wondering of this Just at Is surrogate how

David Hering

one? Jeremy, do look you that want at to

Jeremy Gowler

Yes.

question. a it's I think good

but mAb, a not it surrogate For with it's new certainly a infectious in concept, disease new using concept is vaccines endpoints.

So we be and this FDA payers. beyond will practitioners acceptability believe with data there just that of

Operator

to the turn to like remarks. back closing Dave I'd for conference

David Hering

very exciting a be immunocompromised serve.We forward Invivyd, advancement prevention for symptomatic we time have sharing represent would But the the Invivyd. approach people joining VYDXXX it you potential This Thank look a which COVID-XX, good EUA evening. you continued support you is much, very Thank the for we a and achievement would of for a and of with additional authorization interest for for to all significant and updates major Invivyd as call submission a soon. in more and importantly, for thank we your today. you

Operator

conference concludes call. participating. you for Thank today's And this

a have Everyone, great disconnect. now may You day.

Invivyd (IVVD) 9 Nov 232023 Q3 Earnings call transcript