Valneva SE (VALN) 9 May 222022 Q1 Earnings call transcript

Good day, and welcome to our quarter one Financial Results and Corporate Update Call. Pleasure to be with you again today. Yeah.

So basically, the quarter one has again been marked by excellent progress on our clinical programs.

We have been able to report further positive Phase II results for our Lyme vaccine candidates, including quite exciting first pediatric data, first ever in the world of Lyme vaccine development. program received our authorization conditional COVID-XX, April. in on VLAXXXX, MHRA we marketing And authorization, vaccination including use Emergency MHRA first in Bahrain. And still ongoing. review process rolling the EMA is We process is similar ongoing. in able to conclude still had we to the that were a but MHRA, hoped that way conclude initiated and details we chikungunya, I'm go into the we going this positive process program. with III data, pivotal to On presubmission Phase the of final and reported the US FDA, more have recorded our in topline and we EURXX.X cash With revenues regards million total position, quarter to of XXXX. one sales had actually in first We Bahrain into and vaccine travel see first signals from positive COVID shipments some market. we the Peter detail will bit little again, further. And a position And at at end remains million EURXXX.X strong our of cash the March. the the With that, details I of would into program. like go to of vaccine, as working candidate. Lyme we are Lyme way a our know, by on you multivalent vaccine reminder, On in gone Lyme FDA we partnership schedule. the have only and fast It trials Phase final number to determine designation II disease with granted, track worldwide, final is clinical worldwide dose through Phase of exclusive program development I, today and a Pfizer advanced with Phase And expect which been we commence also to this to quarter the year. III, in third we for schedule that, dose and determine have the able Lyme is against six disease on approach designed on that so vaccine sides in recombinant the Hemisphere protect covering multivalent both different the subunit The based a the Northern prevalent is Atlantic. serotypes the to of vaccine in many reported of we times And is many, as proven past, validated the mode based vaccine, the action. on and

five even aged under of well the and determined found adults. level compared be in doses have a final very we that saw a schedule, study VLAXX-XXX, participants as of III as Phase the as and and setting a schedule more which still in data priming, later Phase planned licensure vaccine April. five was now Specifically about participants on conducted, expected, of dose a year study February to it pediatric third we II adult in and two news in start that initial or already mind, data, talking are two, the three and first this The study participants, in certainly dose could data dose three XXX in to to In XX reported XX comes the course, years both recommendations And year. have Please we uptake. of strong already the to a as when to a year age. the six. mainly to XX quarter that the keep to in saw five pediatric first the immunogenicity XX pediatric XX-plus olds, good will regarding obtain after we We we value profile, zero, the post immunogenicity included months the is immunogenic we

Pfizer will said, the be should It's and season one apply So earlier. to is season clinical participants that the schedule. by by to Phase three-dose for projected fully feasible payment after Valneva. readout The this end to got tick year. I nature With XXXX of primary the, this million The III achieved study vaccination or a of in season order have from start all the start $XX tick vaccinated milestone already. trigger five would chikungunya. years the way XXXX, our part in cohort on a the include And latter is study as we've

period. that also lot-to-lot point still most chikungunya we and It's have pivotal in called complemented well-aware Phase are positive our clinically has the also data. At data we is that vaccine chikungunya planet today program worldwide. the program that VLAXXXX the You only vaccine fact advanced follow-up on in time, the shown final of data, III Phase pivotal the candidate are this with positive III the

So this reported means, at have data only. topline point this we

adolescent activity. initiated post a have marketing This the Phase We trial. III is also

in everyone development post initial is in and Brazil. later being seek conducted above, and This the will we XX So then years licensure extend licensure. supplement initial and label

we the available partnership grant in also a make point are, with number in two which with -- a dose medium-income of and conducted help for You low countries the know conducting Instituto certain time. to that IND course, CEPI under studies, have reasons: Butantan at to one, product but to

first a data outlook? We positive in market course. zero be III think the approval point over the activities We vaccine EMA And rate with can achieve certainly many, this the the infrastructure designation. therapy, we final literally an providing consistency earlier, to reminder, already in lot-to-lot confirming EURX.X expressed is in By regulatory mentioned response breakthrough both fit, On Phase close saw data. XXX% that we for that times, What the that already manufacturing the have is voucher. program, FDA. wait this is prime time, benefits readout, way our persistence we pole fast initiated have many Then we have we excellent and position. all namely and excellent of antibody of track, the company you at priority exceeding eligible And ongoing. strategic as review follow-up. for what basically see an study the time, we we saw to within of will I potentially commercial existing, BLA here, Valneva billion see of completed presubmission clearly course, annually

process, conditional single time Phase to of to of expect I vaccine inactivated participants we after And up trial this protect combines program cold III the that our process we of this agonist really still already in beginning approach respective -- Toll-like five will BLA drive that is submission Europe the It We course, because second With the authorization, COVID And course, from the review subset COVID-XX I CpG EMA up adjuvant is We are MHRA introduction, immune rolling half be years gearing emergency as a the that, a our is conventional response to vaccine in hope, as NHRA. we supposed toward of partially all only stronger modern virus my authorization marketing in adolescent toward with a but as for shot. followed VLAXXXX, Bahrainian we ongoing. a still already mentioned mentioned, manufacturing the It for builds use XXXX the the which FDA on long year. during our technology, that initiated. CHX. mentioned, approved. submission clinics in candidate. and received, IXIARO the

which past than supposed half approval contract Commission, doses subject European product to to be with have delivered bit of the I major think supply this at have up we a still one less this course. that in the XX reported million of we in time, of moment year to

done favorable Bahrain. And immuno The already some basis tolerability significantly comparability. is showed against superiority a the that the licensure have for profile. of and deliveries more AstraZeneca's We to we product

We infection. that of or that can XX. post our night we the that of licensure to U.K., booster toward in Page extend follow-up, the XX have in label study. very data last XX then, plus. homologous of neutralization the the also we and multiple showed was expanding and initial expected we as positive important XX process including presentation, reported of Omicron we that from and/or vaccine. course, label study got it initiated also Zealand, course, But topline immunization, initial data the Delta of soon expect to XX XX. XX or reported our conducted gradually, Being primary of available New use And the which We -- to as people is elderly booster our before, we time variants heterologous vaccinations this be vitro is, natural other in vaccine mRNA, on got through licensure, against in In And are shown concern. the

So the the proper we in evaluate the are we in able study study, not the these of very to easy days finally is this that so that. that setting environment initiate And COVID. have been glad will

the, would activities. the all adolescent what So we call adult

have size this to initiated, course, will, has to the two about least also data years first respective now longer get you that had at with sample business of we is to participants of like studies. part With of be general to take -- order those to report. respective to conduct necessary children Yes. necessary to or provide been So initiated activities hand because all and to the would initiated, the in in I to part going Europe move update, outside the and who's XX been over the second get age, financial Peter, to

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

first the into of straight year XXXX. go financial our of quarter review Let's fiscal

Our prior first versus X.X% EURXX.X total or are year. broadly XXXX, of reached EURX.X sales million, million while total quarter revenues our in line with down product the

Kingdom the for of whole first first sales doses the This As in inactivated previously COVID-XX March. communicated, of product Bahrain we vaccine almost virus against to our VLAXXXX, quarter. accounted in XX% our the shipped of

the see year, this on Moving product to IXIARO This versus according US significantly to that down is the sales has prior composition was are military. yield. schedule. planned decrease will changed driven versus anticipated XX, purely sales to high lower and sales of slide where by you our shipment

quadrupled. one of the ago the almost of outside and US military As much better performed footnote indicates, year than slide IXIARO/JESPECT sales

DUKORAL, year recovering military a is the can of which market, million travel to a presumably distribution includes sales compared outside with XXXX. a total and of in US business inventory The or one EURX.X we EURX.X of some increase IXIARO in year of replenishment full result our For sales reaching report chain. a ago of the the also million DUKORAL recovery EURXXX,XXX significant also for

already our year, reaching mentioned, these and as slide to million. the from shipment and and Moving Bahrain. as first COVID-XX the higher at are XXXX. for Pfizer of covered with finally, increase decreased report to able by the the are the primarily manufacturing the And as EURX.X than Third-party versus France, drivers doubled well revenues products, products of year this XX:XX vaccine distribute for UK, revenues The Nordic to versus across XX products We collaboration started on EURX.X sales provided we Rabipur, at line This sales. services main million. third-parties. to to of sale Kingdom Lyme where year end XX% R&D more reach P&L. looking Other primarily the Austria, to already prior of prior we product fiscal of sales includes Encepur Bavarian

in significantly the for cost is at this that Overall, compensation share well security Looking million plans was that line compares offset of large down million of in of release against so XXXX, cost recognized the employees comparison, we of see is cost. expense a had price. versus EURXX.X different social cost security positive of at on each programs to equity our The share EURX.X certain of you as lines. decrease we related delta income our of year. a prior to [indiscernible] as Valneva's extent, the million. the the social In attributed of QX This QX total, to development of on expense costs, share-based XXXX, year-over-year a can provisions a an for EURXX.X

special year's prior million million year. prior report compared be we in reached loss. EURX.X would year, lower year. to that this broadly XXXX. and first million exchange income our of in to total million EURXX.X in the is the of foreign in The while an year, difference EURX.X period Financial with foreign to expense Excluding the exchange gains EBITDA EURX.X prior loss to had million reported is million reported EURXX.X QX EURXX QX prior effect, of while for The in due compared the quarter taxes than cost line income in

illustration business the rest by share-based variance the QX again, the XX QX provides driver and compensation. share to XXXX the to is a to release of release Slide clearly waterfall of of the group. COVID provisions to loss Slide provision of related shows shows large our Here of XX difference for the to of separation operating This QX of the the reconciliation the XXXX. related that plans. related P&L due the the with main versus

following an by XXXX. mainly Looking EURXXX manufacturing. start at costs as our of COVID driven for commercial R&D EURXX sales, we R&D million year is full invested investment in which We of goods ramp-up for the COVID, million business, exceed cost of

quarter business, as development continue our of costs COVID first So costs, we tech the are by expense clinical you all essentially manufacturing excluding the related explains cost derived into our the our see, to the positively invest Again, to trial from previously vaccine. which as can The well positive impacted significantly to R&D income transfer lines mentioned share-based compensation, the in R&D COVID. includes for spend as partner.

the our to moving like before guidance, Finally, comment would I to cash on situation.

cash guidance With figures distribution to EURXXX category our guidance revenues in this, This I let's to to of the strong maintain compared on catalysts. to this to with The at very quarter upcoming end on February, of reported set XXXX. of XXXX. call, on course, morning's We've Thomas full the concludes total include with cash timing for our range year of EURXXX revenue given this not of and section the million We one EURXXX by closed in of million end and defer and release, Deerfield the million. position, the to ago in slide move cash EURXXX at XX. a execute announced would March deliveries. increased necessary we in yet the reported total we EURXXX a plans may, the As on from press the financial million, however, total of arrangement hand uncertainty like the financial financing does, product back million OrbiMed. resource the The of have position the year

much, Thank upcoming so of expected flow Yes. XX the see Peter. in of presentation, page news and catalysts summary you a our On XXXX. you the

So clinical have on delivered to very few say, in expectations all Phase would and changes our, important endpoints we of when course, most the the last. that one Online, now is II. spoke we I compared

in of data final the for second COVID, the regulatory period EMA. still chikungunya, I this year. course, On trial Phase submission expect, in are BLA expect of lot-to-lot specifically of the waiting course, the this III approvals, mentioned, as initiation We On Phase for the III half following third quarter. the we the quarter we then And this the till year. follow-up

now We received. responded respective of have against have we earlier questions again reported list that the

see clinical in are So that what we we working CHMP are the point quarter. showed and are to on time, jurisdictions this supply initial further authorization I one additional you post sufficient that working other territories being may And are for yes, course, confident And in at conditional the maybe we potential licensure. evening, the also we of approvals, yesterday still, grant the at announced this that designed point regulatory or marketing but extension time, we that this we to opinion and on and label have submitted on additional in purchase example, slide agreement. The support studies. others positive

things that lot year. So get lot we a on, a going us that all excited. expect this for Many

news feel the upside that, of a there to and rest is coming your year. that that, execution in it hand course, challenge like of Of I lot With operator the the around but we questions. significant to is flow would to back take

you. Thank

the first begin Securities. now [Operator session. of And Rx will from ahead. instructions] We Please go Devani Samir from comes question-and-answer question the line the

for Hi, taking everyone. questions. my Thanks

that to the that's range positive think a on still this EURXXX chikungunya from through Is on just Bahrain, I And just then see shipments got EURXXX the million the just was the Bahrain then order? the adolescents January. order to left I the is previously in three. R&D one. clarification that come obviously, guess, in And started I've fulfill to are Is sure guess I million. all first applicable? to at year? expected guidance, guided question make final I trial your that wanted that question

I is that to just much. And immunological Thanks was using So, very when an report? is wondering due endpoint? that

Samir. Hi, Thomas speaking.

have Bahrain on a are Then shipment yes, agreed marker. chik, as to you surrogate we a expecting we So later FDA the know, this year. second with

day what correlate primates, a of in is in transfer we the regulatory basically called at zero there protection through in zero response now indicator logical efficacy. language, a been and time So passive the point it that this determine means is protection is new which, old that the threshold the but for called this has in way in basically so a derived course, nonhuman of way in

do perfectly execution So this to speaking, the of yes, not comfortable not point time. readout, at we on frankly course, execution an noted the given immunological you timeline have right in quite guidance that and study. feel the endpoint on now And have, do we of that the timeline

As not are doing directly ourselves. I we it said,

whole are beginning and partner, setting. are working we the We through of trial the at a

yet will, say update get long of soon, accordingly. guidance our to that not visibility and take. visibility this very will hope course, have enough it we we But we will really We how then

take Let questions. to financial over Peter me to the hand

Thomas. Yes. Yeah. Thank you,

On do it yes, year, EURXXX the this that the early guidance gave one. would we we EURXXX on maintain R&D, million to we maintain guidance be million,

It's great. Thanks much. very

Thank you.

question Maury Please is of from Jefferies. Next go from ahead. the line Raycroft

about deadline XX my can are taking affected timelines dialogue in current for the thanks and you outlined morning April these talk prior if current wondering the timelines agreement, by and with EC Good Hi. I'm EMA? COVID supply how the including questions.

Maury, expected. states not all filed and/or you are and as know, achieve respective orders our member we mean, to date. question, and European able given by there Excellent that respective rights Commission XX-F -- approval its I terminate URD as if certain Yeah. in have a including of the course, have to documentation, reduce we

we expected, came namely, still is a to clear And need vaccine. convincing that have having if solution fall a still medical why the than later we Now people a are unexpected winter a repeat the then there, such originally with -- member dialogue the bit benefit, with even ongoing. hope and vaccinated, we about it's is us respective EMA remain member in a experiencing solution we work initiated course, get the approval member for potential its vaccine that and largely need that have, that states. we that's of A, We And B, of do And process, there course, the and and that the process course, for given. season still concur we is team, forthcoming the a that the or potential with additional with contact still driving dialogue is the states ongoing. states booster of is delays with this positive

it. Got

Okay.

been So at is just deadline extension then? to Or I this clarify, to an has the nothing point? guess, there finalized

but at ongoing. finalized point, are this discussions not It's

Okay.

Okay. happen And a in potentially then, the CHMP of point ask recommendation. could to other May any for that on I finer I that? also Is it just put versus any thoughts on wanted more possible to June, guess, when

I on a provide in opinion regulatory very situation processes. positive and for this had guidance to situation any predict any to CHMP company difficult it's and timelines hoped and in We mean, for to particular Maury, Well, see a the The April, originally what Valneva responded best had and questions. the round to based do. -- extent on another our list of knowledge, of We of to we we was got understood -- requested. best we to list could the questions

so of course, And are, with we another triggering that, process.

in last the where have now provided press regulatory our We right we release update.

We opinion said are quarter. positive CHMP that second we the in have expecting a

the We with have whether to big currently and in we reality, not probably given use of In not terms it's May going does we have that any make undergo of processes the or June. be the that a EC. expect to projection it all the vaccine difference now

any So this we time in when be. point expectations will going make this or is to at provide not

Okay.

my Okay. taking I'll for queue. back That the in questions. Thanks hop makes sense.

you. Thank

Next ahead. from Herrmann question Stifel. comes go the line Please of Max from

Hi. areas Thank in Thanks process you taking terms a what discussion of bit VLAXXXX. been what pre-submission us that us detail give you with of have little question give just more most of clarity a Actually, questions. very my much or the But on one FDA are for the entails? Could asked. bit

to Max. Hi, hear Good your voice.

So a of things. couple basically, yes,

it the of the submission so versus rolling all, of procedure, agreement is So first non-rolling.

the submission is point of second the The the different modules. cadence timeline of and

busy being authorities fact certainly the You which are COVID-related of the super still aware regulatory are prioritized. with are activities, that

exactly what And on and point this on the and are time. are be submitted alignment we I It's is would is So will say, is how. this in we that -- when the the where timelines what this this at by more means how it's supercritical doing. what, is on not

how second have chikungunya? your to half the this for of terms in year you file So much clarity ability of do in

this a very not degree give have we guidance. We visibility. Otherwise, high would of

Great. Okay. you very Thank much.

You're welcome.

Thank you.

question Please Seamus Securities. the go ahead. from line from comes of Next Fernandez Guggenheim

conversations. Seamus. question, for of talk without what support on million XX a Wang purchase you purchase design, Do up up to the to then remain follow a single geographies million wanted booster Evan I and in on? of believe - the versus on 'XX? second -- full study you on booster is XX And choice This other and And the can in about Thanks. million 'XX you the confident combined with heterologous comparator? XX in namely can do study, XXXX arm your -- as to the 'XX the the EC the study Hi. approval studies of doses

Yes.

with may. So probably second part your let me first, start question I the of if

the of people time of need easy first all, so immunological or meaningful are point end to in that boosted. this from vaccinated is but conduct to yes, the an not because at allow to naturally find it been have studies is So a [indiscernible] who impacted, be booster readout ready day, you by who in standpoint

results So respective need to that example. saw ago study, we COV-Boost like for in the a you a if interpret this ones year time very means get not, the difficult you because point, again

after in another the where value and booster such is impacted. are want comparator, some six And -- would And we -- comparator we to namely is ability this booster for had what to At a time, happened and is we level response we be now, vaccinated immune we for if see both knows question, example, that an we in that wanted certainly a got life months setting see as mimic protection to people level with show active a on booster? first booster then with naturally To priming immune of your an good they achieved us, we in want the could this design. past. that not that to time level the response reason because up make have reason to And negotiated be so we be ago, good enough a right we be a also what simple vaccine, then safety. the there who above And real to this in that anything an that because create we is same not of a and well there added showed very at point no active to the is as EC respectively terms if in for we the an are have -- in do our so, enough this sense. what use heterologous setting the against confident really which want setting to not

As I mentioned earlier to one of your questions, the dialogue has been initiated.

in the this midst are We of process.

this at have, no insight. We further point in time,

you. it. Thank Got

Thank question from Instructions] from Garnier. the Le from go Jean-Jacques Next Bryan you. [Operator Please Fur comes ahead. line

Good you actually. morning. taking Two Thank for my questions.

of my Thank without sorry, you. is first efficacy difficult, next the mention your could IXIARO your the first Without not figure? potential military an vaccine second label you XX% it harder vaccine. with the COVID expect of regarding and for next the on. the vaccine? like RNA, example, for shipments, so -- label be you think military, How shipments could simple year? This question. do my look like we your or This if promote XX%, is I any when saw And for could rest the think The one US this sorry. any, percentage think, for is, is any the for we US And for to one

the question next I'm second sure the got exact So timing military shipment first shipment the question, Franck for of whether to because and to then I'm not the hand let me in the with for I've mind. my start going over

XX during of, certain non-circulating years vaccine by a mean, the I'm in in that the ever that I do I than any are against of that so. -- that shot. looked getting time I flu of strain is achieved an label, I effect. more well, flu assuming trial the think showed shot a period percentage So have in you a has don't you percentage I think promotional was at don't specific Have say, effectiveness -- you the am effectiveness on business. let's a annual

safe, by how all regulatory conclude. when and think to conclude any end we the day, and what is the they is shipment, due? is Franck, answer the product with assess to they a regards position product and is do I you military have whether will next this that's what of authorities whether is have a US this And the our vaccine. efficacious

Yes.

is it So end QX. planned for

you, Franck. Thank Okay.

Thank very you. clear Thank answers much. usual. Crystal as you

welcome. than more You're

Thank you.

comes from Stifel. line the go Max Please ahead. question of from Herrmann Next

Thanks very much question. a taking Great. follow-up for

following approval Just VLAXXXX, negotiations potential changed approval? purchases since MHRA the on has -- of with that sort the vaccine of other

already we last out with will use we -- again, as process, prequalification will the have regulatory And It and conversations stimulated has, of for now approval first then which, course, also by I trigger approval more this would more are also -- this course, by WHO backbone so time, following the advancing this conversations, we we say, Western discussions agency. additional of parties as of discussed Europe.

just do approval? have you on a timing the a as follow-up, And WHO

is -- we guidance not why reason provided have this have We not yet the yet.

immediately. have this we in you the when timeline. yet, will market provide have only don't time, I from will As we guidance point on have At soon know, the clarity we but think we

very much. you Thank

you. Thank

question go der Schoot Next Sebastiaan of van from ahead. from the Kempen. Please line comes

side. Thank our Hi, Two my questions. guys. you for from taking

in efficacy The we're one consider is type set? not first data the PR CMC? the primary the seeing the or of boost you. The trial? that Is in the endpoint the that Thank did the boosting that with And the exactly study? there new does trial else the that on did is on based regimen? sufficient, that how Or And UK, that the EMA regarding be something submission questions at from differ trial, wasn't PR heterologous different you UK the then actually. anything trial, what mentioned will

Very good question, Sebastiaan.

regulatory in EMA. that as automatically of the So and COVID in and endpoint, Since of it all have this endpoints have basically, well means no MHRA and study we could the secondary delivered met which of study, its effectiveness the primary agencies means The pre-agreed to And study we Phase study. a cleared approved endpoints -- the past, prove the we there's we by on the and the pivotal otherwise, as way with the comparability. III on and not and the both said character eligibility pivotal we the the have as nature means for tertiary either. have questioning about the MHRA vaccine readout endpoint, all that so immuno in endpoints --

course, that we So is, details. to our tried the basically, nature I as we have use But and we all that level example in regulatory request of indicate the we example. of -- and -- an cannot use of an the update have disclose

finally in have days, with of have responded So the on on whereas are the shown for regards in as almost we are on one. not I all earlier, submitted we both, the one binding With the we and both received. And have way. permanent six things this we night. very for is And data, last to to at after that differences. hope many point questions -- are for [indiscernible] antibodies, question. of have the seeing good were time, a booster, for example, to what also, said there wants a have the good potential data on responded as additional and measure hopefully, you product course, to both to We this few Yes, all enough filed announcement addressing now one a have And others yes? highly, that it we positive EMA neutralizing working we all of correlate now in the where, other subsets and we we candidate, basis are it's as then sets the analysis a questions okay and today just areas receiving to well example, in assess the immunological things request, But P&C. we of have where with example, additional

Let me the the study. remind been people booster. study where a in months conducted got in they time three primed UK COV-Boost study at moment around everyone the before the about COV-Boost have was The

use vaccine which to or JCVI conducted winter the this was and candidate for and -- the time to was it decision, designed -- to which at inform the means which because So in XXXX-XXXX. about UK had COV-Boost the be vaccine their the

were So point titers A, have at people so the boosted. they pretty still high

cohort. The we elderly an second was, had

average XX the above age So was years.

the have is setting. in our more a are we seeing that we now so, now And real-life setting study

where people So A, a it a need be immunologically in setting will booster. is of

at this six means So months.

immunologically, will vaccination infection said, see also last need age. entire either a And as differences to in on or ago, booster. months B, potential we the hand, in natural order spectrum six of I in age across So go

are between these in today. we and the differences the seeing two study So what COV-Boost are major

we As study. one the I reality, infection, include never need hematological the booster natural in also mainly third age a one, and included which the the COV-Boost was that said, about in

Great. you much. Okay. very Thank

final Thank you. this There are no back more remarks. for speakers the questions I to hand like time. to at over would

good Bye-bye. thanks remarks, remainder have and process continuing a again, look dialogues as we close to a we'll in connection many closely. lot. as progress of following that, VLAXXXX. soon our so thanks day. on further We here the a With the and Again, thanks, For for and can, lot us you with especially update