Valneva SE (VALN) 24 Mar 222021 Q4 Earnings call transcript

Good day, and thank you for standing by. Welcome to the Valneva presents it's audited Full Year 2021 Financial Results Conference Call. At this time, all participants are in listen-only mode. After the speakers' presentation, there will be a question-and-session. [Operator instructions] Please be advised that today's conference is being recorded. hand Lingelbach. over to speaker our like Thomas today, now the to conference first I'd ahead. go Please

Welcome and results to report update. good day our where analyst full we'll call year XXXX and corporate our provide quarter one

clinical to if all for disclaimer, go presentation. Valneva have acknowledge programs. Yeah, and So please has of been of able Slide we move we Slide on to X make you an in and X XXXX to our excellent the progress the exceptional been year

we III disease, Phase results, vaccination Lyme positive For reported finally II including further determined We the schedule. booster dose data. final Phase and

with our a and we first For and MHRA. reported obtained authorization youth III approval from Bahrain results reviews vaccine, EMA XX emergency rolling an positive COVID ongoing Phase conditional for

positive results III reported top initiated For and not data we Phase the a adolescent chicken gunaya, Phase III lot and final activities. line,

As revenues you able the strong been in report full report, cash also have and financial we will see year position. XXXX to

Our in XXXX, million total million of XXX%. around increase roughly compared to revenues in an $XXX XXXX are $XXX

$XXX.X position as wrong with million cash Our December. of end is of

vaccine follow are me offering. programs. that very achieved and have successful With candidate. initial first of the six, We Slide multivalent public little placement disease European that, our we NASDAQ let bit a Lyme take offering clinical you a through proud on different VLAXX, all,

development today got this the program We is advanced only worldwide. know, you clinical fast disease As granted. track Lyme FDA designation in

schedule II as course also with and III and I booster quarter finally in for more we the data the about to come worldwide which Phase the that of second We further XXXX. report waiting And we have well Phase as an Pfizer. Phase expected are I'm dose partnership to data, going selected. exclusive response II the

for of way follows on many, most multivalent vaccines that and validated vaccine mode other serotypes were serotypes, of years the candidate the reminder vaccine the a Northern prevalent ago. covered by the Lyme the action disease contains which candidate in market hemisphere As many

to versus schedule the results and and we initial five results, III confirmed reported recruited where going three a study of dose be results head of VLA-XXX in XXX two Phase head also for that from three VLAXX-XXX those dose reported studies years to schedule that of terms compared part XX study is initiated We In one age. sub-analysis to positive the we this in two year. dose be as in February the used which participants, to we we VLA-XXX.

by fast the reported quarter trial in across We review Also pediatric VLAXXXX is serotypes, is expect all from reported extension got post-marketing. cover eligible reminder, candidate. any readout will And line one initiate dose is With And anamnestic in clinical this final the designations to efficacy readout track expected strong the Phase the course due times this elicited year year. and It data is worldwide the the after our most upon course vaccine to pivotal III data, XXXX. VLAXX the advanced all the and is peak XX% top third results. program and dose quarter soon as pivotal and results III across from high the the vaccine It plan of we booster groups response. $XX XXX of positive trial priority those our was following antibody have immunogenic population the milestone with booster is approval responses adolescent elicited beginning, Enhanced program early top breakthrough second on receive the XXXX. that we month primary seen chikungunya payment one today. we season of in strong months further we that BLA pediatric and vaccination be is basis single only initiated the voucher. adolescent therapy study one the FDA six line Phase of to to expected past in for also expected at XXXX. the lot-to-lot million data first coupled of shot and -- chikungunya as XXXX. Valneva initiation. way We this EMA label January, prime mentioned also trial and

vaccine CEPI expect FDA a vaccine that to very shot is pre-submission life second single the support countries, initiate granting in of shot. attenuated excellent to make the this to and this an a [indiscernible] of of order provide product and LMIC capabilities. process after CEPI protection Chikungunya accessible and the targets long chikungunya will utilization in single with and expect We the Chikungunya $XX.X our we program. manufacturing commercial million candidate quarter with In Institute been year. prophylactic VLAXXXX we existing virus partnered fit has

exceed billion by $X.X global XXXX. expect including to regions We annually market, the endemic

that and Phase I to next already pre-submission expect development we about of the the a data terms mentioned process the and FDA in bit In outlook, little III. commence quarter the

five to support early was annually ongoing in consistency follow quarter XX.X% lot-to-lot is six the January safety up we've and safety The volunteers for adolescent six in this The three III persistence be confirmed. tolerability from of after and after months. met in reported Phase XXXX. manufactured. the years. year, antibody data months, So protection even up consistency trial to profile is study after label expansion. expected The good initiated XXXX follow of trial two the All were which potential months clearly line, six participants top period. we XXX XXX saw up data trial and confirmed XX.X% Phase we was followed endpoint Final completed and for And lots one month positive will III zero immunogenicity and

chikungunya will voucher. to VLAXXXX, of As XX, a approved post our adults CEPI. in with today. eligible adjuvants. in combined Bahrainian the XX funded vaccine first It whole to priority I the virus mentioned are Authorization the again, that in program pre-submission our mentioned Europe builds review licensure the process the year, [ph] CpG ongoing. US expected Emergency is manufacturing MHRA Page earlier, FDA it's I And earlier receive XXXX at candidate The the Dynavax and COVID inactivated initial in in COVID provided inactivated on and Valneva with is commence. sponsor NHAR vaccine this March only reviews an rolling us Youth and XX IXIARO clinics technology with vaccine EMA be UK

III achieved up [indiscernible] superiority tolerability. and last The versus showed Bavarian, XX favorable have agreement one million bacteria purchase more year the for to data significantly Phase doses up with with advanced to We and million European doses Commission in for pivotal

we partners. clinical We reach positive booster XXX Scotland geographical as lab against course existing of trials still capacity and in profile data, in and was line in with and GMT endpoints. CMO correlate manufacturing data as you target sites product coupled as data are we which conversion for seen we also study, know, observed variants, are that the most top million the doses. on this ratio gradually terms the immunogenicity, zero co-primary showed experiments, will leveraging neutralization in Sweden, today Delta protection of especially our than expand and rates. obtained antibodies, installed target showed homologous our neutralizing from of as we the X.XX, terms for showed and the and mean an stemming Coming all relevant well The Omicron superiority back our to titers the ongoing And geometric key Valneva's a COV-COMPARE more met, We and non-inferiority of we

end antigen and broad T-cell protein, interesting and specific against quite We end also the observed protein. S the not against only also the activity, but

safety adverse what site well more and that which and of something events, in is the world comparator. including particularly significantly injection product seen for tolerability tolerated, reactions important terms systemic In compared was reactions, vaccinology solicited VLAXXXX the and of for inactivated generally have to favorable viewers showed we we of previously is confirms And vaccines. course significantly that profile

We see COVID we this the could groups, both the and suggest in was and of in cases occurrence similar study XX used purchase COVID that absence Delta of to any recall to as increase end the delivered us month. also million in severe we and the supplied severe XXXX. million vaccines and remainder connection would XXXX VLAXXXX XX with which you prevented we we predominantly use that current saw HR first expected Slide to to time, that emergency COVID million in XXXX. the may of doses of of the commission European in study, are doses And to the be and NHA cases which the between one supplied COVID agreements XX.X option as at supplied to purchase, XXXX complete allows have XXXX doses the treatment and the received which be XXXX from at caused received by quarter Up circulating XX have the initial date. grants variant cases summarizes in its deliveries Bavarian, the authorization, third of be second in With be this

this up be commencing Scottish expected and to to development next million advance XX a enterprise already We received is grant grant years, vaccine from month. to also this the totalling three received pounds over

pounds grant XX.X manufacturing. will related first to to million support up The R&D VLAXXXX

million in to other second connected will Scotland. support candidates manufacturing X.X to up pounds Valneva's vaccine The of grant R&D

the expect elderly the VLAXXXX. the as this We earlier, the in of expected In immunization XX we in to those extensions, start for old, years XX plus. years XX old then of terms primary label I mentioned gradual label extension expand

would are course including two pediatric called years of XX FH heterologous we age. adolescence that XX XX all additional of to And plan, generating of like a of well different booster developments children, years so match, lot as as data generate. under to We the mix then to currently investigation the data booster

to it his hand is the financial Valneva for today CFO whom earnings Let me to now report. with over call our first Peter provide new

good everyone. morning good afternoon, Thank or and you, Thomas

and company, excited to of invested in a external As journey my We organization our to more company Berlin's our our Valneva. number specialty exceptional the advancement consistently the with our than to Valneva two valued, year its known global truly three months our number Thomas' testament line history in top over get travel processes, and be adversely ever been The that Union and to by I Government, generated part XXXX was the CFO. The only industry, year develop related of contribute impact in the a familiar execution. colleagues to internationally pipeline and call Europe. vaccine influenced a XX of said, company excellent the this Kingdom have COVID the contract cash I and Bahrain the the but time, virus, development is as in the of investors reacted with In same last of the to our and At then flows. first infrastructure leveraging large was with whole years. the the vaccine a did European also become the UK Valneva and for of of highly on partners. of The was programs a expertise earning met is with inactivated I'm pandemic first substantial company.

increase euros. how primarily the million XX year, reflection the and revenues to XXXX compared to look, trial to with million XXX.X%. Product to and more doubled as During an sales, and I will our prior this, revenues this financials. prior other clinical million related government we in our reach impacted revenues This on slightly which the driven in call, XX reached and other year This revenues by of with revenues than is and increase for in With from included €XXX €XX.X also million services a €XXX.X weak €XX elaborate prior our decreased travel €XXX.X the fiscal the the recognize and relation and pipeline Total COVID technologies revenues. compared year investment Government. is of by represents contracts, a Slide euros. still Revenues let's supply million to XXXX move compared revenues. agreements contract in decrease further year are to UK market. these reach In

year. Foreign growth currency with on impact no rates prior fluctuation had the

sales new of slide, our majority XXXX direct total channels. of XCRO XX% signed the with supply of US more were September contract our our than the side million sales driven you right [indiscernible] generating €XX year. Military see of in through vast the The to sales of On product the composition made was sales by last in the IXIARO sales.

sales product to will on XX, Moving comparison. a year where you see Slide on year

year and Third over geographies These a year, Rabipur prior sales party extent the by adverse travel with mentioned, impact X.X% caused prior Nordic of as sales XXX% on the certain started still in by DUKORAL agree between Valneva large products global grew prior decreased by is heavily sales pandemic products very covered while versus This and by Bavarian decreased by to IXIARO/JESPECT year. are XXXX. of distribution in the already industry. Encepur. by XX% and driven performance

on on already we the Moving statement income on to XX, the covered Slide slide. previous revenue our part

course, So our of €XXX.X clinical reached and payments payments to let's cost services increased of to R&D were goods include for well most for candidate. this COVID increase just in than doubled main advanced income This million. These advancement key manufacturing vaccine significant sales reached for candidate. more COVID and driver year period goods were of €XXX.X recorded cost statement compared and related goods million. vaccine our focus XX advanced as Investments The XX the importantly, related as significantly write-offs, cost. inventory to raw pipeline materials. Cost XXXX reflects and on in as of compared prior a COVID cost cost of increase XXXX investment in batches, our

as Our costs invest factors. saw candidates and slightly by of versus was chikungunya pipeline. of costs R&D and other a in line planned significant into G&A our to million increased in selling increase we Marketing €XX.X increase investments decreased of driven activities several prior reach pre-launch which our this million €XX clinical program. progression with our the year, is

more Our to Overall, a expect US increased manufacturing programs our our €X.X support than and heavy to year, costs prior COVID investment IPO million non-cash €XX.X same to our COVID million of ramp share related an program in million, the increased development generated driven and related social time At €XX compared increased to tax vaccine XXXX. grants related cost XX%, our effect in increase related credit to Other security. compensation by million to increased to employee in due related of to staff in plus million our million €XX by XXXX up reflection asset from of €XX share-based our from our our to support increased based compensation. capacity from revenues investment income program. additional and R&D again, decreased €X.X

primarily in Finally, and charges. for was increased offset by our million. were This exchange expense roughly a increase total plus driven tax €X and €X million partially expense income higher to tax These by income refund favorable gain an financial relation by expenses increased income liabilities financial increased of euros.

compared record a million XXXX. €XX.X the year As the million for for the the fiscal a million a of P&L business. EBITDA with year. of result, XXXX, loss illustrates in slightly rest of we versus Slide deteriorated €XX.X €XX.X an year The loss COVID analysis prior versus XX of of group negative

we a our a As invest the At as same you EBITDA our can for time, negative EBITDA year positive excluding COVID the XXXX. generated business see, generated COVID business advance to continue the substantially to pipeline.

end Our of the the to COVID low million. at million €XX were expense the €XX of year for non R&D guidance

invested states to been COVID million as already the manufacturing in related by Slide from to Trade invested of in on To inventory sheet the balance the XX COVID December XX and candidate. relation stock agreement Scotland of mass property, our paid. XX vaccine. from primarily Overall, the infrastructure, by work our time, and purchase receivables our COVID mentioned Sweden. receivables to majority the in equipment. Union used €XXX the €XX site At XX raw have and receivable substantial fill same driven primarily progress million investment XX, vaccine driven €XXX.X for to increased at in our in materials date finishing we advanced of million by European to to €XX.X in trade million, member euros on in euros plant million Moving €XX our increased and XXXX, we

US of cash increased on and from to Our the follow Government, IPO the million. and community European UK €XXX.X agreement cash cash the with €XXX This equivalence purchase consequently the result increase and million from a the inflows with offering. is contract significant advanced

With its advance history flexibility the further clinical of has to the its the plans on Valneva the strongest financial in position and pipeline. company, execute cash

revenue increased the fiscal the XX; outlines its the agreement related of €XX by and Total maximum At €XXX related payments received VLA the the as was to €XXX single million. million liability Government. liability balance is increased €XX Contract the on for XXXX remaining compared main received XX low roughly €XX from the In site manufacturing the same our supply XXXX of and dig the is contract equity on by represents of refund our XXXX, United by new remaining follow XXXX total driven liabilities. Government, million. UK received liabilities on impact Kingdom. the in Government, in advanced required Slide pay to cover obligation. by Kingdom royalty Union, aside sales agreement Bahrain to XXXX. of IPO total million customers clinical liabilities VLAXXXX. the of payments XX, significantly recognized reflected company our Total million and and million trial agreements we UK to year €XX to refund were and a million of This contract driven related contributions to potential payments €XXX Moving our royalty of increased the to set our refund and European the well In December Scotland. mainly US as million liabilities were driven the of SLIDE anticipated while outside The received €XXX liabilities. million refund by financials. XX, XX states offering. with total and the XXXX, increased UK remain from supply sheet member revenues we recognized refund agreement under on According are approximately UK by to about the €XXX to the increase the supply that to of to end the at supply recorded time, liabilities relation UK as

We concludes this future. financial expect the statements. in to amount the This of review of revenues our

services anticipates move our be total from disclosed million Revenues an and of clinical €X expected million. purchase for million million. vaccines. As section already for the additional new reach €XX whereby to to and XX XX to are the expected to concludes next the at as €XX into reach other This back to million guidance to range execution new few let's provide advancement and collaboration, on license months. and on vaccine. contracts I are This account hand €XXX COVID takes but XXXX, to investment This €XXX XX the with expected at covers expected R&D look our million February, vaccine. the to existing to to to €XXX our million and Thomas between pipeline of beginning €XXX depends planned €XXX the the our for potential approximately range Now expect financial this, revenues COVID between like as update be well also are finance year be million flow. Slide to of to the expected range would concluded related over agreements, €XXX we trials

me presentation Page so upcoming Thank conclude much, flow. the and Peter. key XX and of Yeah, catalyst you news summarize the let with

XXXX. expected we it to And of mentioned in quarter For third III next pediatric the already initiation thereafter be Phase expected first line data the quarter.

catalyst milestones So and the relevant probably for Lyme. most

commence we final chikungunya, Phase the next the pre-submission data. alongside with the and lot-to-lot that to process with in expect beginning III the as the the FDA presentation, For also of quarter disclosed at

for studies six still lot of VLA we clinical for follow our to the are of have XXXX, You required world know about be that yeah, COVID, outside XX vaccine a it. up and for discussing candidate COVID months respective the you

approvals supplies for ongoing by of Of our EMA still lot and further agreements. commence. still Europe and and then MHRA are hopefully development, and clinical we hope studies purchase in since through to have we course and regulatory a in followed And

our further me trials We conclude open questions. data. and clinical presentation expect for your Yeah. up that, With and it let

from Please [Operator line the question. of comes Jeffries. instructions] Raycroft ask The your first Maury question from

and about taking besides can we're mentioned for there's and Hi, congrats gating and on the label regulatory I to wanted MHRA those approvals, press anything on check potential for release. the progress what's my you what in And seeing. the for questions. and specific next thanks expansions talk if more additional EMA and steps see approvals that's otherly

So happy take your to answer.

are we enrolling know, processes. you As review

different EMA gone well of MHRA. with as have We through as both rounds questions with

CMPs have respective in responded responses, April. the extensions, We European CHMP XX of the questions second we This Valneva's Factor and our and for number. then countries Valneva label deck to to the into where the of And start slide positive anticipates recommendation now adults, you have, in the now the in quarter. prime acceptance is me for the VLAXXXX in XX course, approval of back question what you page, conditional of regulatory page to deliveries with a saw immunization the on go we page number? authorities. receiving that follows as are your is Let about the subject check

So the page at label timelines. the we number how presentation of extension look illustrates different XX

Of antibodies at you we in that and New but hence to in report at we by a get the also and point Zealand reported in Health, this we a in for we are elderly neutralizing we're going when neutralizing and to Public precise study have antibody data. backlog need, past, we we experienced England in not testing significant this binding the able course, know conducted timeline binding time,

extensions, we on I, regulatory course booster part booster II the as of have processes. our our have -- data Phase we submitted boosters this data the data homologous as of reported And from supportive On study.

have been with who or ongoing XXX We which Valneva DSS boosters booster either primed have vaccine. stroke, the homologs now the heterologous extension study, for people

quarter year olds. booster activities have two data we children study in XX will provide olds, and adolescent on year where to we will this not XX the another The in yet the start, people homologous booster and have data started, will the and first XX next yet commenced expected to not in mRNA. prime booster with this a glance start will So is but

recruitment extend we into this in difficulties And facing are hence need point trial we we this geographies. course to Of in at the different are and also time. is where

So data, point for at cannot this for initial already provide We precise the time others. in some like can we booster timelines unfortunately yet.

it. Got

COVID really then helpful all That's perspective. Okay. had manufacturing. on also And question a

greater capacity. annual you're at XXX you that where dose than targeting a reach manufacturing currently Can million you said You could say goal? you're when capacity and

Yeah, installed I mentioned that an earlier targeting we are capacity.

capacity manufacturing level operational driven by and the so forth. and installed you the which technically so on that capacity capacity and A, then perspective So is operate always a is the staffing linked to from and under,

the the Scotland, be we then We one summer validation manufacturing the that over in new have under manufacturing with facility be the commercial quarter. and ready to task fourth completed in now expect for and

We existing working in right as in we previously we Livingston now as speak have the manufactured we reported Germany. are facility in our and thus manufacturing partner far and at IDT

our of what But we at with half now, capacity of meaning of in may probably for that the matching and the supplies we terms revenues target. business the we year, right operational So for XXXX. see capacity course year anticipated this are are

That that's makes it. And sense. Got helpful.

taking Thank my Okay. you for questions.

question Securities. Please line ask Seamus The next Guggenheim from You. your of question. Fernandez to comes

the for much question. very Thanks

So just ones. quick a couple

results contextualize see it the in had population. be was own plans you advancing the that programs the as a do the of on now just mixed you the Just like we've to your updates able for pediatric that sounds mRNA opportunity there? How of vaccines recently patient On might starting point. pediatric hoping sort some I

Yeah. Excellent question.

see inactivated perfectly in characterized by vast vaccine We as work children. in profiles tolerability inactivated technologies to VLAXXXX know children. indications majority We good shown is are are very vaccines extremely Why Of technologies. Inactivated and clearly suited course. other and for safety vaccines a of have that based a childhood on that? well

respective So And need the course we ongoing really comes the vaccinations children children. adolescents also least clinical to in for our a In opportunity are first therefore show at is primary this reason we we to extending given are and everything Europe. studies when outside Europe, why as operations significant in to difficult the vaccine, and can. vaccine as why quite vaccination we trying a quickly now into environment see that's of and progress we it

and become Great. manufacturing an information related your an about little might that whether as bit we as a the that deliver think of inactivated is regard it you're COVID perfectly vaccination like something in to variant It more be seems little And would the own a, the for on evolves more a endemic evident. need series see focused vaccine to vaccine multi a additional boosters, the evolution variant to bit setting. updates we an pandemic be positioned when

Yeah. I course. would strategic say another excellent question of

As is for variants Valneva's adaptable inactivated Beta for if this previously have We for for new technology communicated shown Delta. platform Alpha right? required,

influenza. that understand from the We have of we a a be clearly up set can process that used. is world It well-known say I would all

ideal what Wuhan in vaccine composition with the and is know compositions is field you and are that the question vaccine the targeting Now some Omicron.

vaccine also we opinion are we We fuse to lot And that at know and of required, on if the and generation KOL best of an firm setup a are a there that mixed are this to processes you need time. point course possible conducting second trying in is what get for prepared. on up

are we in vaccine from have large currently a concluded respective concern. So medical seats we process generation proceed possible scale manufacturing, vaccine But at initiate the variants more preparing then we could of research different relatively seats manufacturing And and for soon. of viral viral development best finally we second time, needs composition have taken a the the in point decision on nor into this perspective. to neither

if vaccine, approaches. Phase III you control over disease think progress necessary, have And the Lyme help in of guys kind but that know I just able limited disease the to final question the be with a understand might Understood. you you us that preparation one just as Lyme is wondering

prior I the XXXX think the early XXXX. versus timing is now

Just to those get wanted Thanks. thoughts lines. along your

Yeah. let -- May clarification. maybe let me start off a with me start

know, certain I have think first a as and about talking you we here disease outbreaks thick seasonal a the all, transmitted are of pattern.

peak the during season. have high you incidents So

efficacy peak to So you efficacy a prior get season you placebo need if field in people hence to vaccinated to want starting. the controlled show study,

III say in to presentation, in are study efficacy. Pfizer, III as reported well III have from of evaluate now Phase for the adolescent and course start very the Phase early data stroke So population the the, the this that only this the changed the first final peak readout always this had that's then the in XXXX study you season This Phase timeline in that year. Phase of like this end in the season is closely where quarter pediatric let's II. And study why III the including means we means is is probably and for Phase to with XXXXX between yeah, things efficacy the XXXX. as final the as VLA as foresee third We II and in the the we readout current core of XXXX from commence has, of lead we season And this started. are expected -- of Phase turn the have during occur the course and peak can the who working preparations that the marginally

the Appreciate for clarification. Thanks Excellent. it. Really.

your comes to question question. Please Thank line from Securities. Rx The ask next Samir you. Devani

on got submission to couple of in Hi this when chikungunya. I've wondering, on complete talked pre-submission Yeah. you a one Thomas. guidance, chikungunya questions, one just the just do for you I'm and the then Peter. Thomas, vaccine? expect Hi, statement, about

carefully. Samir? listen very, usual very You As,

review whether description in the is way complete strategy, the process this going say or this a why we're to take at know we're we overall then to would certainly quote a bit because Whether have I going of to the time, submission reason don't old point rolling we the on we expect been determine route take. submission which process. this full And going a of passion process will unquote we're but to course standard take review year. submission So,

finally for milestone? just Okay. Pfizer could That's for purely a then this just give you well? how sense the great. guidance, and few your much. Is then a VLAXXXX, the just Thanks of give guidance. could end of R&D we're on CapEx guidance million from year, guidance Peter some year I've just relates $XX us as you Obviously on guidance and on the the us to the much assuming looking questions R&D at this And then got very just of just

questions. those for you Thank Yes.

expect. balance So as the Phase would course sheet this will launch under guide impact as of initiate as R&D on go the driven but we in initiate have contract our on the extent III, R&D, revenues, share minute a do the so indeed future the for expect you will this no our basically $XX we cost. is obligations this, to to we have our get price of On straight it Pfizer, to by would COVID, to for cover because

our but Now, details numbers finalize in this we it not CapEx is our we And have on our, not full stage going given lower finally manufacturing was relatively have and than be expected we think haven't then given guided we will the we in what into facilities, COVID it this separately course. just because basically guidance guidance we at sorry, R&D for significantly XXXX, CapEx, on CapEx. at There look versus add, we are still in not business of It have just be now is the will way year CapEx. to maybe envelope non-COVID. is our to spend a significant

the reportings what you helpful. at DUKORAL, point At maybe of DUKORAL? €X And million. then stop do Okay. about one just selling That's goods, on obviously cost you're

At bundle with time the DUKORAL So, a basically in profit have product. time, strategic pre-pandemic. that we is see is due numbers vaccine in significant making it point the clear from and value able pandemic to the with generate been DUKORAL at the to we travel XERO past very this same in loss the a

certainly if year the be will we So because new decisive a are certainly will DUKORAL and its environment the and product in carefully. for future seeing a cannot that we like of continue year review sales the the we XXXX at DUKORAL very now not XXXX very, rebound

question. The Herrmann instructions] [Operator of next ask line your Max comes Please from question to Stifel.

the taking much progress making the Primarily 'XX. we've in is gross margin. the congratulations very a last XX fluctuation you've on questions Obviously margin for seen, question in Thanks margin, been and Great. for on quite the that months.

down considering? we look of XXXX, terms where of be to it should we or from whether get how in should at drivers what sort guidance 'XX So up be cogs on good some Thanks. of going in should it'd were we be for that and sort

product relatively for you margin Yeah, for of Actually year. was XXXX, at thanks our it when sales that look the prior question. product the on stable versus

You, able will be our to see that financials. in detailed

at the somewhat it to is I we and in, be we we improve into it haven't think the would look with XX% XX%. given kicking XXXX fair while in will March sales of guidance see to assume range when expect COVID Now, this to

just Great. flu perhaps you term future that to in for about how combination? VLAXXXX potential future to Is you are sort something of opportunities up then on for ways and regard? viewing of annual the COVID thinking an potentially Thanks. something longer sort And follow develop variants, are that

and good question. hi So Max

to At evolving and around needs understanding all the immune that or a more that also that evolving it there be an year. COVID vaccines a I modified antibody there is that need is that and annual fact have clearly a requires assistance of of for there requires vaccines. the First for an longevity protects you it more response might It more and vaccination. think an more consensus same time

from potential need we from speak composition? adjust an opportunistically the what a may there and technological different a old it What And combo. to a combination time, the perspective, against guy, the perspective I'm most a vaccination are reasons whole that all understand reasons perspective there including, know, you vaccine, all that CMC so of very are, from basis? to flu-like one that COVID also market in and inactivated but years certainly in is the no? technological Yes a from Valneva comes hence point VLAXXXX days it. see, are or see perspective, all the best an the flu virus in on the COVID vaccine a to in be be is standpoint this and whether the indeed take we standpoint, come today And can These a to our follow at no we in technically annualized able a that prepared combination, but When that feasible. combination COVID from makes medical against we and different certainly are have of sense vaccine companies it everything There whether is speak we that that stance it business to with caveats for currently for an Is that's try to co-formation there all CX a with sense our questions Influenza makes vaccine answer. vaccines pattern from on in can position. these it

We will developed certainly are own an we in combo, this any no vaccine, of collaboration to kind access Valneva Influenza to not COVID but flu an as we open have regard,

much. very Thank thanks Thomas.

further [Operator are instructions] time. there no Dear this speakers, at questions

Okay. so following many and of a analyst Thank This concludes today's much. look call you calls, up to with we Bye-bye. you day. in good have forward two

That for for does participating. conference our today. Thank conclude you

You may nice a all day. disconnect. Have