Invivyd (IVVD) 14 Nov 242024 Q3 Earnings call transcript

Good day, and thank you for standing by. Welcome to the Q3 2024 Invivyd Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Katie Falzone, Senior Vice President of Finance. Please go ahead.

Thank you, operator. we results press and ago, QX announcing while financial XXXX recent short issued release a our A business highlights. of and the can Marc of Directors the sections respectively. Today's release on Elia, Press Release Invivyd Chairman press the will Executive and are the Chairman the that and That Presentations Events being website today's Board. under webcast of section be be Invivyd Investors in discussion Committee Board and found of of the slides used led by He is Lee, Tim Chief Commercial Financial Officer; Officer; Chief joined by Will Dr. Duke, Robert Allen, Chief Scientific Officer; and Dr. Vice Clinical Mark President Wingertzahn, Affairs. and Senior of Development Medical

and may speak financial today's things, from call our other and update that be assumptions our Private During or assumes are of research differ the future making are other Invivyd risks, materially commercial statements today. These subject facts. These forward-looking the of not and within those various concerning, time Litigation of Securities certain date strategy, covered statements. our the among our to actual as will to statements no and guidance, our we corporate meaning activities, are and prospects forward-looking discussion, development historical statements plans, statements forward-looking over such Reform cause implied change duty Act results to that only expressed uncertainties this and and regulatory

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you appropriate Those growth at launch to Duke, remarks Bill a call with, our the I'd like to serve for Slide along across Officer, to final larger all prior can actions, as metrics see, community turn the over positioning scale. With XX. are Financial to immunocompromised to us that, Chief Turning Q&A.

Tim. Thank you,

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of noted. and guidance XXXX late FDA which net $XXX As product seen XXXX on we to the $XXX ending you guided at million of headwind pemivibart the reflecting potential preprint other including year, million QX may QX in a product PEMGARDA from have the million net of approximately pre-released September on our warning of results, $X.X revenue we end revenue for October, of withdrew morning. Further, virologic contested of activity and substantially cash in cash as U.S. million, earlier $XX results factsheet the reported consistent finish is or based a we At citing data reduced QX PEMGARDA $XXX noted with antibody, million recent that non-pemivibart third-party to media and we we has from equivalents. with time, this and XXXX same been activity to cash this more expect the through

potential we reach about immunocompromised PEMGARDA's excited are mentioned, appropriate Tim patients. As to

underway. revenue product recorded in as that development such, amount anticipated with for good inventory of various and in preparation and profitability operational existing are the significant near-term authorization a targeting research submission. emergency cash of equivalents, previously use is improvements expense, net news efficiency we The growth As we cash

As modest term, turn now the have the will product growth, turn significant end significant continued PEMGARDA operator revenue open questions. supply we manufacturing will by for near managed to further do net expense XXXX. I and plan over the June for profitable we of of we the not call with in that expect the to call

Our going of question Instructions] to come Maxwell with the first Morgan from [Operator Stanley. Skor is line

expect any reason you the feedback received also would And guidance, for treatment for on EUA provide if give If you walk any Could confidence in you've additional we from thought through but there, can great. next it FDA? year, you the year? would us the understand PEMGARDA, the I what of pulling color again? process early Should the providing guidance end at that be

don't Why wants Marc is This chime and I start? if Invivyd I'll to then anyone see in. from

application, defined have Firstly, EUA FDA. by This as of a in we on process bridging the treatment been analysis it timely. the updating is the

not so is our general that topics of heard of virology multiple anything these and be have front update to in make taken as I about other than, and are has it some And feedback opportunities, them. a we rendering those explicit perspective a FDA our We've that of thoughts evolved, analytics the analytics on of statement think, our soon. to various will and that all issues aware us and on sure

shall tuned. stay So and we see

to consistent the heavily of fashion into I confidence on past. with we summer, right, rate the late recent look, of we of project PEMGARDA that. And a topic our I ability our expenses, feel revenue are revenue And draw course, to very our recent about the growth is involves project good into and Bill it grow -- the part for we think, very future. past, in to. of what On it's inclusive fall, alluding meeting manage forced we period if were in think dimensions, early future, the prospects was difficult X a the in When which to very, of indeed, the guidance,

in think of require toward embrace doesn't case, would continuation indexed the were as we some simple this I it bolus is are the it seasonally-driven So trend. that revenue, what conception guidance of now

I though I comment seen KP.X.X.X confusion against on embracing we add would the exited about from pemivibart the have So forward. And feel to drive activity of has recent he period our to ability of we here just obviously ask good majority guess a certainly as and the weeks. Tim bit that, to to little what on feel over

you, Thank Marc. Yes.

infusion kind growth seeing. presented all trend the doing working a think very team, pleased centers And our things increasing of light up and that independent I we're delivery integrated we're the I that to and the centers of access increase in now I we're digital in of the bringing infusion and well that think including as right the to all at academic that's sales networks. and with checklist of presence as

I activities that the very excited think, at look place we we're now, I so where are what that about And putting as mean. will into in right

from Our Jefferies. is to going come Yee of next question the Michael line with

the understand, On you're modest based a we about you that the because while quarter? talking whatnot. questions. stepwise seasonality, there's expect in are talking growth? And to growth think Two extent, first how month-over-month? you that steady revenue, maybe on I second metrics does about are of we the or you differently and can us growth think disclosing, increases and the but help perception significant quarter population Or change of

to So to first is OpEx, change order understand has the that question and fourth and as looks help that us then course, like then in on hit the well in quarter. And quarter natural the second of what the profitability.

be quarters? I expect So significant what you think next that a you in that to over don't declines significant is the was few R&D campaign. Because said expected manufacturing

on Tim OpEx. comment Let and might revenue more clinically. me incremental would by flex a commercial compromise is And modifying we me is have just a Bill you and topic our have -- begun that ask already company in not press I'll what the that what we be read spend to, our with with indeed definition, presence. R&D let is little allocate saying releases has our base the bit already start on But by areas burn. might occurring of process will which to ever those clearly, on

CANOPY of We are off coming spend.

spend past, for XXXX. in And Bill expensed largely through at to, registrational a have alluded manufacturing are we yet the R&D. We not arriving as

rather our and We're tighten burn. But on see to or would turn organically you I little to bit in burn. have So to further seen reduction that and looking some organically over ask then anyway Bill comment that it change don't overall simply accelerate would why in Tim? that a up

Sure.

think we of I risk to spend, throughout have with manufactured to this a year. and go the course, manufacturing runs completed regards expenses to that, this With key at the significant Marc necessarily of here. points continued highlighted we At PEMGARDA amount XXXX. time, point in PEMGARDA prior then produce substantially will not the and which associated we forward manufacturing in be repeated EUA as

I most this expenses think continued Those at also not the year has we can have With R&D flowed also manufacturing spend. to as reduction for a elements significant that's of you one have have XXXX -- XXXX, regards for XXXX. that through done look in EUA. of submitted been that we expense for from yet

we to the as So see relief as also we winds through result, forward in P&L down, R&D as will that go a XXXX.

heavily are commercial. we other streamlined course, Just of expenses, investing in

will to the said, on being R&D continue thing you the But largest is see that drop the We can I that think expense invest side. on commercial.

great And Yes. question.

who I a construct earlier. hearing and serve those is fighting infusion we the meetings, not Los we've had in other some I country, that Angeles we're that that people our in mentioned of conditions networks activity even think that as clinicians as the in from IDWeek as is I seasonality the cancers the recent conversations individual largest something their at infectious at think well across disease community independent with look

And those the immune so look to serve that people on will impact doesn't right, this as their at system. seasonality opportunity different who we affect group, therapeutic are regimens

are core them of because those of therapeutic we're cancer cell at gearing conditions breadth because we in a know people transplant, And with up their think who excited And utilization, I account to regimens we're don't protecting hematopoietic organ because pleased life for I towards. say from and that. it what think is seasonality. And others. transplant our therapies, of look as is, who is fighting and stem

the is team something access that opportunity what earlier is drive increased of has I on have will through solely -- heart. been to a things to the I through said, many from been checklist Our protect focused that's team the went depth and is cause the access damage looking that in in has that fighting community that systemic to them, virus this as to for one

just disease, all back a equilibrium of wave, dynamic scale. we looks like. in with of not probably seasonal that went have is periodic we of right? respiratory all. It's looking what large clarification as presents triannual or my advantage adding, perception biannual true It's because diseases of waves, present, right? to be it terms take our pervasive COVID-XX periodicity or the see and frankly, the were use SARS-CoV-X We is at like seasonal ever might have a The the may disease that we to yet worth infectious community Mike, a to certainly, and HCP and summer, the vocabulary, in there certainly for "season" infectious

into effect our is I that I part now, very so it's think reaching fair it be are seasonality right may we don't because getting know a is or at QX which, say refer we that is see time it's of worry while of to we And to as and and about scale the vulnerable to have confusing, business, a to But time wonder be are to periodicity. early growth. But to think in some particular it from I at we least early in any view, HCPs at certainly we may Tim too may seasonality. the that what scale QX. would also and I would natural rational small, think our relationship

in young will we've fore, of is dynamics but together. to highly we the feel standpoint, so trying the Tim think that find is point kinds population, all that come a the vulnerable convey think achieved we'll to yet have I to those the growth penetration believe where I our so we into scale don't from and early out

Our next Jason Capital. line with question of is going to D. come from Kolbert Boral the

showed what which sure, value it saw It's high, at. sheet. what very what sheet? you're I My the is, with number than build, question of that came on X:X in the higher -- up corresponds, balance inventory Yes, on the real carrying but substantially almost inventory is commercial is the balance obviously I'm the R&D the

up I Yes. to will And think millions excess can sort inventory would net temporary as the it of well through terms. of product of get spending. Bill, But production pricing implication. in we diminished that coming has way. I of reveal comment general, flow the by don't hundreds of the wrapping dollars little -- Bill add that? bit. is Invivyd revenue specifics say or you a this of let's would produced accounting I can in In level into just to anything think, that, in of quarters of want

No, don't reason well Part large value that very the prior I that's discrepancy PEMGARDA carrying EUA we're of amount of between to EUA. think we what the and for a for what the -- market has granting forget is said at costs of expensed Marc stated. that

through So as our not inventory balance EUA sold that yet costs incurred the on have those that the been up were sheet. remain point we to led amounts to

sold would the of why what the balance between external sheet So market through. value inventory inventory and that's our discrepancy as those a amounts be are piece balance the on

a you do your you subcu, of into a PEMGARDA us some process? And How and do? IV more ask insights from make When what next-generation those of I you IM kind question. do just look have probing engineer to scientifically moving to give Can you or potentially at you how want potent changes? to or to even formula

look -- is this And Yes. Marc.

oh, that, actually, Your Robbie in. wait, is bad luck logged is

that ourselves is well rapidly which is, and he right? he with right, not base. chemistry enhance that, study combinatorial clean structurally which with potency identity now. What pemivibart properties And screening, in it's work we manifested say, substantially modest But against done our do effectively that that combinatorial is with we protein VYDXXXX, adintrevimab. next-generation already be so, hits biophysical more if of discover that whatever small and we changes antibodies tell I of in that avail doing first-in-human is familiar is is libraries almost very off able you're vast so right our screening So of the what itself indeed is interrogate protein will reality up can its to select molecule, contemporary. And you enhanced manner able in the we've to spike library to offer the a we and in up so spike than overall by let's are more different and molecule structural can feels

process there So a on for interrogate territories molecular that given the via the ACEX which directed access are that therefore, these site are enriched be to essential you essential which on fitness antibody. right, and a to even as pretty think spike that we of what not are exploit to might company, the we foundational should viral surprising for hypothesis of in monoclonal wish and be it continuing spike, appears of honing

and of Other done than of easier our as Now involves that not technology have approach. of do sorts to is approaches. a technological sort and said those lot tricks secret trade companies it in stacks and access were

having with by cut. done But it up that of Robbie, the proud third we glossed follow free to feel said. this Robbie, all feel I've over simplistic particularly in correct our work extent or anything I terms, means, now to So on

think I are laboratory the the in that that was time. in I to that you this. of question equipped we any add and provide definitely it asked all about that we No, how we answer go The doing one at the do this do terms to will time embraces the the description is thing

against looking are maintain and variants through enable acting and will PEMGARDA working that the antibodies that into and updating activity we've enabled space we profile to to antibodies XXXX ourselves that And constantly meet described assure so have will through using target product the on. and are our of technologies how we current knowledge future

question. that helps your hopefully, So with

answered actually PEMGARDA and like question, follow-on sounds is You my COVID. going which it is to beyond utility ultimately show platform the

Yes.

ability conventionally to those COVID. vaccine work of effort, I done address in or dynamic that antibody targets, required that an borne deal a periodic in particularly we've types monoclonal dynamic we the that through of where a situations out have we great think targets have effort is have a even

true. So that's very

the question [Operator next Instructions] line Wainwright. Our with Patrick comes H.C. from of Trucchio

on ask lessons authorization regulatory This standing would regarding also in Patrick. the for path learned. I like follow-up [ VYDXXXX a ] question is and Louis to

prevention? be based way So if would follow-up a that a PEMGARDA trials accelerated thinking there's there could an XXXX. need -- would Or on and prevention? And or be separate treatment just I'm a a approved be an for for I possibility treatment new fast-track, for forward for the both there have about path question. then

Thanks.

And at for FDA sVNA treatment consideration, to well. we and same data the an clinical titer conferred prior identical answer at sVNA level, titer FDA route those the benefit collaboration indeed a application the an and certainly conferred these generated which of both right? At of stay in by the important from It's dose believe antibody. some strong high of from adintrevimab, identical tuned at with and authorization, controlled short efficacy end And randomized generated given remember EUA studies, were data discussed and administration. our as context PrEP signals are by upon treatment indeed, that with benefits antibody the the the in the clinical PrEP. clinical is So demonstrating work Invivyd is submitted in identical drew our active topics

back universally having thing. worried we this community of in right? attractive controversial very or who work pemivibart feel when could are many infection, scientifically deployment how I think regard with certainly of left our out very be pharmaceutically, not sort are encountering good some work activity, on viral you a as that there titers. And of our the wonder that confident don't we whether when the ask XXXX a active either you clinically represents about inoculum are experiencing antiviral earth step I and measure antiviral people with yourself, concept or So you and think even

business monoclonal those the we in so among do of antibodies business And things. of to passive novel immunocompromised in we infection, particularly of think in outpatient with we're SARS-CoV-X persons prophylaxis await we believe can context, active treatment I the eagerly would an and be generally

is a safety and molecules antibodies, development bridging the ourselves, the assess availing and/or operative make science surrogates, FDA. it protection, some we presses those because would a I of in FDA England think some my of And novel have done advancing to authorizations strategy and to you at if ourselves are are we released reasonable classical we off of with which we if rapid are is, of think predicate wish jointly previously Now more these antibodies also data approvals. things, a we we look well, safe to to morning and say read function hot the our there that goodness, press or and the general discussions like having can that of would correlative the for of the in Medicine, Journal this of course, which drug New concepts as

are guess very if and much discussing remains to in and pens to that. our data in Mark And in with routes uncertainty so you add variety experience. pharmacokinetics vivo on XXXX wish residual human And subjects operative safety much I'll is think category. will pause dialoguing we forward those administration. through I there what vivo look first-in-human We really of we in in on anything I FDA gathering then a and currently to how of ask the can assess effect, the

the was extrapolated we well was concept mentioned, that paradigm no. you the enjoy mean also is No, able mean directly employed said. as the I treatment that well. immunobridging I think enjoy it to we prevention for that as the -- I fact be to

well one, landscape. the employing to PK the well effectively, that monoclonal our embedded -- study, as within with make as our protection and sure Invivyd, variants you that antibody So future variant it versus has time tools exposure as at is, the our as relevant the titer across levels current getting can as really future imagine, levels

the compelling high as have very about -- have regarding first convincing a well. depend readout it of say, a more other threshold, an In you for treatment you do in, makes on was, decision rapid words, prevention expect on titers? and approval, question, this -- That potential the to will approval will titer in that path approval then approval follow-up a titer when a be confident reaches that if can the rapid threshold? lot And when we maybe discussions of treatment sense. to And prevention can

Great.

are now So again, doing I work of in the in add of subjects with generate human clinical Mark some required to can that process, profile course, think XXXX. detail. But we the right

that all I and in think to and relationship indeed about FDA antibody very And employees low world for that As believe and published unwavering Medicine goes because titer Translational right? So is confidence showing the to ourselves you have would see SARS-CoV-X now very PrEP relationship long-term our context down confidence, generalizable our a itself X.X more years, that seen across in levels we lovely Science recently variants we efficacy and us titers. I it less previously Invivyd or in reminding is CANOPY the repeat think concept evergreen think follow-up. I a

you have you can try scalable by necessarily to good Thanksgiving, solve solve say, sit always titer it or the good, of that we turkeys. equitable some person I it that's getting So to category aspect antiviral in eat this hunger better. The to I X So can reasonable there's uncertainty the a more well, is an can and not is any if right? problem is course, asking which if a medicine, of residual meal here pathway challenge, to an by

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would I like for the back to over conference remarks. And Marc hand to now Elia closing

an it's period All unusual in everybody, opportunity what reflect history. hope a indeed, our right. And Thanks, we has been today. corporate very for us joining on to

Thanks We questions core to fast and scale many we to answers. we'll just Bye-bye. as to get for back day can again. as protection and again, ourselves our are as we the And available as can. business trying people all of business grow

you This concludes Thank today's conference participating. for call.

now may disconnect. You