NVAX - Earnings call transcript Q1 2020

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Novavax First Quarter 2020 Financial Results Conference Call. [Operator Instructions]

It is now my pleasure to introduce Associate Director of IR-PR, Erika Trahan.

Erika Trahan

Thank you, Operator. Good afternoon and thank you to everyone who has joined today's call to discuss our first quarter 2020 operational highlights and financial results. website earnings an available conference audio be on announcing at our call release available and novavax.com archive our press is on currently website will A today. later of this

Business Research are portion today of our Dr. and Trizzino, Financial Erck, Joining will Officer President be me Chief of Stan and Glenn, Q&A Development CEO; the President John call. Chief and Gregory for Officer; available

within forward-looking to we statements prepared with I regarding usage to subject Private will expenses, remarks, cash and could the be that financial, uncertainties, revenue, or projections. Novavax making and or business-related Securities this in Litigation Before expectations over or Reform we anticipated assumptions, begin that numerous operating financial which perform include during are meaning forward-looking statements the remind change these need and that future forward-looking time. teleconference commercial Act. of you other business matters, strategy development including and clinical statements risks cautions to clinical milestones Statements financial relating are

started. it hand call get the Stan to now over to I'll

Stan Erck

Thanks, Erika. all And to you thanks this call. listening to of

update be ResVax After Glenn, recap John and are the and for that questions. COVID-XX in of and the we announced provide and from funding given coronavirus on NanoFlu a that, on candidate sincerely your then a March, our start back vaccine for provide our NVX-CoVXXXX. call ago results overview. call safe. on brief I X and John a financial First that program. status hope just discussing positive foremost, respective we Phase everyone I pandemic, the historic I'll ongoing provide the few our families around the will well Greg will by all then quick today of CEPI available minutes activities for Trizzino a I'll announced a following

our accomplishments company's As XXXX, so are just most a the influenza and COVID-XX our vaccine that programs to want including far history. progress I prelude in remarks, in the say in to our impressive my

started. get let's So

with invest million coronavirus funding XXXX. thrilled we CEPI Beginning to $XXX of in chosen support that to program, of are our has up

indicated, allow CEPI advance vaccine through Matrix-M As components the will the to arrangement adjuvant, also single proprietary our date. will Phase funding CEO this rapid biggest represents scale-up This critical us X. to our candidate investment antigen CEPI's It CEPI's the of XXXX. support and of

large-scale addition, In funding to manufacturing will this dramatically our allow us increase capabilities.

As our in which identified testing to announced, we immediately Matrix-M, incorporate begin preclinical XXXX, will studies. we previously response and enhance immune

XXXX and antibodies the animal is ACE-X high immunogenic highly including human of wild-type were a SARS-CoV-X shown have immunization. after binding observed virus protein-specific neutralizing models, And studies single blocking mice with levels in domain Our spike receptor activity. nonhuman antibodies primates,

one second seen are be the evidence dose microneutralization to after the It in high-titer generally humans. In that accepted titers dose. that eight-fold protective vaccine likely high a with addition, is already increased microneutralizing antibodies is

clinical few trial initiate Australia. Phase We dosage assessments X/X observer vaccinations. blinded the XXX a in portion X we adults and clinical launching Phase of placebo-controlled days, number of Key in a our XXXX. In are now will of amount trial approximately healthy trial, include

the a immunogenicity and in of expected July. portion as the in results data Phase months begin importantly, X trial are clinical will couple human Australia are we likely X from and the US, Phase away just safety The from of

by of us possible the and the billion XXXX XXXX. on the manufacturing CEPI earlier, quickly from in X to of I additional now XXX escalating vaccine the with ability to end target manufacturing. It to million doses be impact a for will funding will goal with a manufacturing begin As significant of mentioned begin have production our doses

are assumptions goals are production assumptions. scale. actually product Those point dose large the in at these the of should out we yields actual I achieve manufacturing upon key that regarding that the based approved two

BioSolutions agreement to development and an trials. product with manufacturing Phase and announced vaccine previously Phase provide X We Novavax services, contract clinical for X Emergent with including GMP supply

also efforts the will those manufacturing exploring larger-scale forthcoming globally. capabilities Details months. are coming We of in be

significance major go nor thanks reiterate Novavax. CEPI's confidence The also can for and our vote our It cannot everyone appreciation of of like this funding at to in I'd platform technology my understated, progress. to and progress has period time this since been a vaccine very this program short made have get we enormous undertaking running although of to in up an make to January, a reality. a

influenza Now, seasonal vaccine. program, recombinant NanoFlu, let's Novavax's our on advanced most quadrivalent move to

COVID-XX be grabbed the prevention will believe of influenza. for attention, world's we While that also NanoFlu the has a game-changer

data Phase delivered validates X potential. The we its

announcement March I'll Given program upon results, today. a detailed Phase just of high update for level X the the recap provide our

put between sites. one achieved one one It stable X,XXX Fluzone randomized included subjects vaccination. clinically simply, trials. was US at every were To single it years our Phase to of in age NanoFlu of the given single older and a we trial The XX goals X and XX adults,

The to data demonstrate the objectives been Quadrivalent XX-day non-inferior we've Fluzone to trial's results. primary The using zero conversion rates. immunogenicity XX ratio the day has of titers presented geometric to of the mean differences of were date and NanoFlu compared

strains Quadrivalent. NanoFlu assays measured achieved vaccine. overall included Fluzone HAI also We've the all included objectives to the of primary profile Our the a was safety endpoints immunogenicity for egg-derieved and safety comparable using The in We by primary well-tolerated reagents. NanoFlu. had

endpoints, egg-propagated the virus four immunogenicity XX. and select using The strains and all both homologous strains reagents wild-type day actually evaluate for at drifted secondary which

conversion in included rates the demonstrated a Quadrivalent this NanoFlu overcome for four issues antigenic titers validation vaccines. major vaccine ability egg-adaptation We Quadrivalent related also the Fluzone and to in included with HXNX zero For Fluzone strains, and drift, conversion four of vaccine in drifted which these mean this current believe NanoFlu's is significantly endpoints, titers higher geometric NanoFlu to not and rates higher issues but year. with strains mean demonstrated are circulated across all than significantly zero geometric

differentiate in vaccines. additional cell-mediated providing the leading study data believe NanoFlu from to and the the forward micro from We including future, data. responses, near licensed look will neutralisation immunity T-cell responses the these detail We

has NanoFlu we accelerated and from the approval to plan status pathway. Fast agency's use the FDA Track

We CMC immunogenicity in will conduct our the of parallel with BLA. compiling safety and activities our required portion

we our additional We once plan. timelines have will finalized communicate

Before the call quick to I ResVax our vaccine. over turn John, a update on

women We the continue in only vaccinating demonstrated protect vaccine. have ResVax and in clinical our by older-adult to infants. in believe to trials We're company potent pregnant the their both efficacy to population

significant critical primary continued insights While need volume for the the for trials, which X hospitalization on the the vaccine both not vaccine. trials, on meeting RSV provides pneumonia we pre-specified the that Phase had effects and endpoints observed in

We we product believe coming to new pathway years could over can and to product. trials that design that licensed affordable a we designing us take clinical believe an a are licensed the

Now, program. a balance we continue we have strengthened invest in sheet, will this to

turn over the call Now, John. to me let

John Trizzino

Stan. Thanks

quarter announced the first XXXX. for we results Today, financial of

For reduced loss of the to due a The $X.XX million reported of per first share compared in quarter, reduction or quarter mainly expenses. of we a first or net the million $XX.X loss loss net net R&D share $X.XX was $XX.X to per in XXXX.

for decrease the and CEPI's to Revenue XXXX in offset the decreased of revenue XX% and partially by completion trial to was $X.X due the the funding. period from same XXXX, million Prepare $X million reported of the quarter primarily from

period compared transaction to the $XX.X to million ResVax, XXXX. quarter of was in to million XXXX. XX% cost other Catalent same This decreased XXXX the primarily costs activities savings development lower expenses first in of due the of $XX.X employee-related decreased in R&D decrease due and to

same million period $X.X the to in at in XXXX coming G&A XXXX. expenses in increased compared as quarter for of million the first $X.X

As XXXX compared cash, Net the used $XX.X XXXX. was and first $XX.X million Novavax March to cash million XXXX, in XX, of for $XXX.X million for cash period had operations of quarter the in same restricted of equivalents cash.

And During April now total $XXX of is strengthened balance position quarter sheet. in of this million net an a quarter, since net we $XX XXXX, X, raised $XXX million our cash in X we offerings. raised the Novavax's further for in excess through proceeds. of ATM of In $XXX first May million. XXXX million the to our proceeds additional from end we

That Stan. concludes my and to review back will financial turn call the I

Stan Erck

clinical John. in XXXX Phase forward Thanks, on of look you X We to the July. updating trial

over And for operator it back I'll to with Q&A. the turn that,

Operator

[Operator question with from Higgins comes Thalmann. Michael line first our I'm Ladenburg Instructions] of the showing And

Michael Higgins

have Congrats with the out CEPI so have they you put far. funding. biggest That's the impressive, especially

discussions ahead Looking expect ACT can to understand trying with you with do and anything the accelerator, you're this a at margins of Gilead's bit, having the community? Thanks. are and what Remdesivir you look learning from you investment kinds

Stan Erck

We don't we margins we production very able do point. the a this the be we're yet. of large expect be cost to early that at what nor is. it's and selling we Yes, do efficient going to know know have to production. bit And should to be producing at predict - scale that know We price

there world the in pandemic new expectation and profit it's So a setting reasonable this have margins. is will operating gross out my

Michael Higgins

in data we bit quarterly of but before a separate question stay moving is last come the to summer call, in a you've a the you it ahead that? which to from you - I&D this will to you kind can study the on looking data you how Thanks. study, Obviously, can you coming it into The July, larger and update just fall? of a a bit like just go the start schematics want a sites? it's and fashion, give as to talked update in be Is sounds two an separate months of into the forward, once about follow-up roll happening us Does open? review rolling got the can

Gregory Glenn

Great.

so Phase will to the when jump trial So that X,XXX we've protocol in. we can trial. I Right we now, the we data X I&D, order written on file data, we the into done anticipate later-stage of a X be Phase can And see the will a be Yes, subjects. under rapidly that that I&D. pivot it

about of lot that. might a is there how accelerate one discussion However,

to So see, announced the may prepared we're going next we a be our the just Wednesday, And preclinical steps. best on with human step. immunogenicity data sufficient give detailed have and COVID update and you'll to take on to we're doing seen steps, more next you that data animal

Michael Higgins

helpful. Yes, that. That's I noticed

Gregory Glenn

Okay. Glad you saw Yes. that.

Michael Higgins

last And then Q. I'm it's busy one, sure a

to that something XX yield lot securing possibly XXX be sense releases year-end but to heck from that you data How help the would confident also manufacturers. and how helps think you a manufacturing, that an Is trying ability for with enough top comments not I that? with, the per the CEPI it of securing to you'll get other on month can year. this is five think folks do involved year-end the of about global that a depends to they've CEPI billings of million lot globally, Just on 'XX, to Obviously, access mentioned - we by had kind next can have just by manufacture? call, up million but are update that's a a in helps that, with, press WHO this about of out that manufacturers.

Erika Trahan

on just did while. we've start so we So about been it for a that thinking and working

early We've data sorry, it nonhuman about before, seen very mice, data, it that with X optimistic immunogenicity. and in trials that then pandemic that Ebola, the clinical preclinical primates, early seen coronaviruses. we've been and two we've translates have humans into Phase our viruses, translates We in X We've Phase with and with data. into get seen flu we seen this the where

our you a data We as Phase course bet Phase have would while know, give technology don't bet We us results good X. in - X we of that yet. ago and,

didn't we made the securing for make sufficient capacity started statement right waiting wait. didn't six a lose able months to we We in and away X Phase be to We it this release. press data. are that by So on

Operator

comes our B. of your mute Mamtani, Mayank button. please from next Mayank And Pardon question the with Mamtani line me, check Riley.

with line Bernardino the And Wainwright. H.C. next from comes our question of Vernon

Vernon Bernardino

vaccine them particular. wondering got clinical out choose to candidate And my for very candidate congrats many far as CEPI. programs excited funding me candidates your as Thanks was on that could as very achievement. into question what chose the of you you that led as far there choice very the because did I'm curious how going you how the if most forward - particular I in screen excited and concerned, from large for exactly amazing trials? you CoVXXXX, your for that's what the tell program the and I'm of and taking to amount

Stan Erck

the first answer the the Thanks and for answer part I'll Greg it and of let question. question second

as our experienced interested are platform I vaccine think an - that think what they emerging was them - we that the program I responses I we got have models in disease in primary most nonhuman safety infectious has but have produced, company, models, immune fact our - in models. has shown mentioned only and my vaccines produced animal efficacy that not comment, last good

the gotten We've responses best Ebola, with done vaccine. in adjuvant vaccine, ever probably immune Matrix had we've from our a

it's done it it the with think of fact that our with We've been combined I that scalable. experience We've process So the done RSV. with has flu.

And we is a a - so have lot confidence there we can scale. of

how with and and others, do when that is I scale. across we the so how out do are and that had And other both they lot immune of have with compared when the ask technologies and you looking to field I experience responses think think not - there they there a good just have the - there

and exciting probably ours time fairly just a the tell. will so safe And bet. are And others represents

Gregory Glenn

and Vernon, thanks hi, support. for your Yes,

Vernon Bernardino

Greg. Hi,

Gregory Glenn

on jump just me question. this Let

immunogenicity. is think the good I that and some immunogenic demonstrate assays think vaccine to of important. were good. That very to hallmark I so the construct and It's we was our able that's

asked, I constructs you out about as we XX we actually think in time. short of So period a made

them lot doses of And would several we be based stability, factors, productivity, did immunogenicity. because in knew so we evaluate a required on

we this know immunogenicity, I Wednesday, we're on may at detail. you look some going to think when our provide

a our data. have on We COVID see half-an-hour program, talk you'll our preclinical

the when protective. saw compelling vaccine it very that that, work I be they and think is that should

just It's And these So unstable there. a at X inherently the mature nanoparticle had the really a construct. of we I are of productivity, combination proteins trial recombinant I kind Matrix-M, stability be think technology. their Phase think a same We that completed structure good that is immunogenicity, it's with construct, critical. and very can are results

think and magnitude. excited us this I this up So all things We're CEPI moment. at that very stepped to together grateful those come in have support

Vernon Bernardino

Great. follow-ups on are I that related. two have that

antibodies dose, away the that is into And of dose. after part play you're you dose. of the and deal adjuvant. Stan, by say, that the if Matrix-M, all billion need increase then, single end but availability thinking the that of for? mentioned saw to of XXXX? of neutralizing VX part doses just testing, of one because is it, that a production you single What you with only but about Matrix-M So to whole exactly two the single allows let's a Does doses, high one such too the get this Is you thinking

Stan Erck

think I Well, I'll let Greg respond.

Gregory Glenn

all, the of adjuvant think first with seeing - limitation we're think I not Yes, supply. I real

our at very you So has make staff going is to that either. hard by worked not be when sure, look those dose limited numbers, to

it's relatively process make It's So adjuvant. Matrix-M. to very a good a simple

We're going setting. in to trial look at the this

those that get of binding we're response. As weigh into be our see you all as factors a dose cell, infectious. antibody late-stage there to a really a lot very virus so be we in move tight antibodies. a is trials. one disrupting that and to very having It we neutralizing high has dose, after going good important. human going is could We merits And we it's And hour, This get neutralizing to know the very highly sparing.

at We'll infection really we the They're think the it's have the nature in that this to data and terms spreads. are functional of meaningful. have of of blocking binding. terms in conservative look of to heart how assays receptor They're critical And neutralization. we gets think I that

those all to factors take making going I So the into fact we're for dosing decisions going forward. think

Operator

comes the Mamtani Riley. with question from next Our Instructions] B. [Operator of Mayank line

Mayank Mamtani

you Congrats quickly update dose without design. noticed taking Matrix-M the questions. X are adjuvant. on testing thanks I the for and on my Phase again study that Very

that IgG And assessment, core and antibody sort think from other geometric and learned units what Matrix-M? you to without maybe do of Could of just there you how talk also conversion. about the So think you rationale more zero the endpoints others you curious with I'm about curious doing like as about endpoints, that? for what's just mean the

Gregory Glenn

a great that's Yes, question.

compound adjuvant demonstrate a to like adjuvant So with with look, an trial effect. a you new you need this, whenever the do clearly

in for very is a adjuvant public that and is see for you course allows important our and responses contrast critical vaccine, could see regulators I blueprint compare think here, was good important was the and Ebola really we'll which So that immunogenicity. the and forward of we to immune it health going ourselves. the for With and safety

demonstrate for So that's need its the role, it's the adjuvant. that to

The response, XX%. of levels measure the different so the measures, immune people all zero - a very are is they of, response. spike you at Because are conversion IgG. looks if the the fogging kind response to on immune will, - the have are high order naive, of over-arching we expect we Over

to here in especially So that our I adjuvanted and be norm going the adjuvanted, would two-dose that our formulation. we're think see

measure other things. different The assays

earlier, a the important - So receptor first binding as event. I mentioned event. is It's

or block it's our affinity takes events If good in you that antibody a really block can very high a that, to it opinion binding.

combination a other spike - is to Neutralization immune the look. responses a binding some the there epitopes, and other protein. probably is rest It's of some you get receptor different blocking from what a of

So when really confidence Wednesday, a which immune those lot this, give the - those a response sense. they see we of immune relationship look different looks And vaccine we us on them, talk as at of makes about I at all you'll think when there should measures really all work. between nice is

Mayank Mamtani

on then about. Great, talked that's assuming you've nonhuman Wednesday primate and a this that study super a combination presentation, the helpful. And I'm mice of

Gregory Glenn

That's correct.

Mayank Mamtani

nonhuman -- just in think you But Any could tested you or mice. in candidate you incremental - XX tested color said the it primates, constructs one give I you on was

Gregory Glenn

the construct Yes, of the primate, nonhuman we selected a we to made. lot we in time, had we - got by confidence down generated

the XXXX primate So the is construct. nonhuman just

Mayank Mamtani

NanoFlu, ones thoughts beyond current you Track approval become accelerated the obviously the NanoFlu? like that that regulatory And Fast options question alternative on obviously environment, just any are for the potential Great. have available, final given are Okay. the and there

Gregory Glenn

that's That's question. an a interesting good,

to So accelerated right now, go expect approval. no, I think through we

a licensure obligation efficacy have do We post to study. an

think I we're on for track that.

very it think data. very, I good is

I going came to be really lot think COVID there it's was interesting. flu around, intriguing it of was it's when the dominating and a

I think is because people flu a what is year vaccine. seasonal a better influenza will to this die number large COVID and in interest do generate that seasonal disease need from hope of every we there for preventing we

So I evidence a better think forward. we going have good have very we vaccine

this that's annual think we I COVID, vaccine. the And so this emphasize with seasonal influenza to every going year an will see problem pandemic emphasize

I we the And are the are issues immune the these to so the not addressing Phase our and around data that are And responses will the X HXNX, arena. vaccines published the shortly, data - well. key drift very be as that able we're induce looks and especially be strong issues, drift shortly going frankly, able fact to recognize to strains, to show think in CMI data

arm missing important I So that forward. effector a mentioned think and think the good think you'll a that's gives our to immune we response you'll of think really cell good we flu see puzzle very of piece antigen going in before, we've an that's see and adults here older I specific response it vaccine, the

Mayank Mamtani

Great. I go COVID study to Phase and for forward look taking NanoFlu then the July update on update questions and XX. the the my appreciate you through X

Gregory Glenn

Thank you.

Operator

line comes next H.C. of Vernon with Bernardino Wainwright. from the our And question

Vernon Bernardino

the World is what Thanks probably of actually actual go as taking protein the being my is administered? follow-up. the as is candidate CoVXXXX that at you Vaccine One vaccine this the for into Presentation, concerned, for thing far amount

Gregory Glenn

Yes.

So the this using levels were case in experience our that S-curve, no Ebola two I response at of responses. X micrograms. were similar levels before, really dose It in dose that and with our the using micrograms top was so of and X XX immune trial, micrograms mentioned XX X Phase in terms really different think we we're we've

so our likely that's here. And the case it's expectation to be

but, then early So without obviously very control. wherein Matrix as two doing dose, is mentioned an nice is arms, X on, micrograms just and you relatively low, we're XX as micrograms those with adjuvant a so

with two micrograms XX or we'll have the and XX doses level, of we one-dose dose immunization in also that with X XX XX the antigens giving antigen Matrix. our Matrix, with that's of be and So arm one and

Vernon Bernardino

is a follow-up, as actually there symptoms, SARS-CoV-X as a potential look the the and infected sometimes the who flu, somebody infected people And you a confusion with initially to as are is have given of also with combination at far when vaccine?

Gregory Glenn

think potential. about - we because got - in that think that so vaccines, it's registering it specialty I yes, our is Well, has

we thought. think formulate common I in platform. what will make vaccine, Many experts think those to annual possible. it's would a good settings, certainly go. It's a to that's need have the same and Matrix-M issue seasonal our this We sense a theoretically the both this It's where vaccine. become combination it could see recent nanoparticle, a will

Vernon Bernardino

vaccine, - ever away. you're Because to conceivably it fact if then totally really even you of taking both, the of it doesn't on seasonal going if go relying not away, care the and SARS-CoV-X of kind added a flu

Gregory Glenn

good it's Yes, a thought. thought. It's a good

Vernon Bernardino

look to you Well, additional I data rooting congrats. and guys. for forward really the

and thanks. good So luck,

Gregory Glenn

Thanks for your Thanks, support. Yes. Vernon.

Operator

now turn Thank I'm remarks. further I this no any you. at further showing back to Erck over Stan CEO, will call And for the time. questions

Stan Erck

Yes, thanks.

As get the this It been least in working with are the a a takes be better we've on point trying you to flu had worked virtually six weeks, that do, at euphoric to vaccine. I've in imagine, company. the We've decade time. everybody can for we that a which long at have been project respiratory to other is company. in last been We've vaccines a

be help to as we think point differentiated the confidence good help corporations have large will we of get as supported a we're and vaccine academic and being differentiated then along flu by that. lot groups And not that big that and organizations is coronavirus I and doing can non-governmental the the to infectious last that was a goal deal. dozen a accomplished comes a emerging half diseases. where Our us of alone this solve and best we've And we flu for what but vaccine, And been we've do get from problem.

recognized off. happy And look that, the we fairly work much And data we're it. in. listening sign in we've for very of finally a short getting done I'll of reporting forward proud to And and we're period time. for thanks we're So at

Operator

this call. and Ladies Thank now may you for concludes participating gentlemen, you today's and conference disconnect.

Novavax (NVAX) 11 May 202020 Q1 Earnings call transcript