BNTX - Earnings call transcript Q3 2020

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Sylke Maas

Good morning, and good afternoon. Thank you for joining us today to review BioNTech's third-quarter 2020 operational progress and financial results.

Before we start, we encourage you to view the slides for this webcast, as well as the operational and financial results, press release issued this morning, both of which are accessible on our website in the Investors section.

As shown on Slide 2, during today's presentation, we will be making several forward-looking statements. These forward-looking statements include, but are not limited to, BioNTech's efforts to combat COVID-19; the potential safety and efficacy of BNT162; the timing for submission of data for, or receipt of, or potential approval or Emergency Use Authorization with respect to our BNT162 program; the ability of BioNTech to supply BNT162; the planned next steps in BioNTech's pipeline programs; the timing for enrollment initiation, completion and reporting of data from our clinical trials; and BioNTech's anticipated cash usage for fiscal-year 2020 and beyond. from currently differ could results those anticipate. we Actual

webcast. to reliance only on are, call of therefore, forward-looking undue not cautioned and conference this speak You any place statements, date of the as which

of Sahin, On the for call today's and Financial our will will BNTXXX. SITC QX BNTXXX, Strategy our plan agenda and Ugur Executive Poetting, BioNTech our on Commercial management week Operating Co-Founder; Türeci, Chief Officer. Sean and results X. Özlem before Slide on Richardson, to the Medical XXXX Chief remarks. immunomodulator. then and highlights for program our over commercial some distribution then third Sierk this on handing She pipeline. for our rest handing update Sean with we Business Officer; is will Özlem Chief to be PD-LXxX-XBB a Co-Founder; checkpoint walk and today oncology our Officer call concluding through data at and to our Chief Chief financial of will Ugur Officer; for an back highlighting the with outlook Ugur Officer Marett, our our before update Ryan the of an provide for are our start financial update for on COVID-XX shown The will Sierk quarter our recap and provide

now over open hand We Ugur call for BioNTech's I the will then CEO. the Q&A. call Sahin, to

Ugur Sahin

today. thank to Thank you, everyone call joining Sylke. Good the you morning, and

demonstrated you am interim our yesterday today. on against we with the report X. COVID-XX evidence to accomplishments analysis. COVID-XX efficacy that I first start based about announced happy of the Slide Let's vaccine program incredibly We can

in and which from watershed We we important yesterday than far, initiate step for the consistent against continued uncertainty. we company, so of world the that made studies. is modern earlier after When in for months Phase program COVID-XX a you, mild-to-moderate with will this January, to one believe in trial, believe X we we milestone evidence constitute pandemic backdrop from an represents the have a remind profile century. eight a we that did what considerable more observed in to have worst our vaccine tolerability our the into see decision to Just news

that focus Further, a still and as For example, U.K., submission knowing addressing without we known pathway that play on a do partner, our to decision China we'll EMA, when to along out. to with each And the already it so expect the clinical trials of in work in how MHRA Japan, this and registrational the that make and all. and of all Authorization position process the to the in to to if of duty toward potential Health vaccine to our challenge. both we resources, FDA November. try to Emergency technology submit the the Canada. week track And every regulatory to be made, time do, part went because of that was we Use the hope We the third at the now also we will I not We, initiated would this capital in point an will week, at have than work country. more continue terms because news pandemic have a are a believe, early what time on with of believe to as We as have difference. human day. initiated a We goal resources, the are single felt we was did we Pfizer, lot the collaboration in ever believe considerable attention, with has in, and would to we make so did difference. we But something in

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Sean Marett

Yes. Thanks, Ugur.

X. Slide So to just turning

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of work the diligently agreements additional agreements, a supply to continue and in governments to of of are are to the world with with and subject All regulatory number clinical bodies commercial approval around other success We vaccine. like Pfizer complete and course, negotiation COVAX.

XX. on to moving Slide Just

pandemic model highlighting the in we're distribution Here, that expect we vaccine the for phase. the

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a Germany, to all we picture distribution to gives us for the expect to But more around world. and of BioNTech the expect care. care through, will, in distribution. distribution In plans which points and here of points indicated some for specialized here, whereas course, to storage though some be the shipping be of in will vaccine in the there with depend distribute. network care. points in we've distribution, distribution that model respect region. we there general, are to United in So example, on from of the distribute sites of our markets, with hubs and Europe chain regions Pfizer's we those centralized the engaging And world, of in number manufacturing will of hubs, supply distribution specialized In most other a and providers, to air regions markets, capabilities really leverage ground States these flexibility focus on some we And to high-volume higher a the from

China. profit-sharing our it's Pfizer However, that worldwide, with to note is important agreement excluding XX-XX

vaccine. of economics same the regardless the are the distributes So who BioNTech to

described long-term is and degrees it minus liquid at available have as These I frozen we available, the that store course, earlier, sites, in options are And ability thermal freezers as which will short-term freezers. for we addition point note important mentioned the further, the commercially to the at ultra-low-temperature provide storage of to use care, going of earlier. a can shipper, So multiple storage. product to XX

X available, to ultra-low-temperature For six to update as available, shorter freezers. days to five to period, freezer Özlem up stores to months It's if on degrees vaccine over X for is I the product now said at oncology the can an there I'll pipeline. in can be important stored earlier. that turn to up note a freezer be these centigrade the provide

Ozlem Tureci

Yes. Thank Sean. you,

We I yesterday In are for selected at going conference. on programs to now. the the clinical XX, can oncology provide pipeline. Slide changing detail interest of you time, the on And gears BNTXXX And see released SITC am our updates data only.

which For note seen further to our refer clinical on COVID-XX from on details operations. programs, this ongoing we pandemic other want impact the status some please released I of we have to our that continued quarterly update, the morning.

our causing site Specifically, clinical some a initiation studies. there studies our of some of timelines and ongoing delay the to been in is of This enrollment impairments of us slowdown programs. our planned has of for

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of We and Sanofi. forward our results program are this with pleased development to with preliminary these continued partner, look

For like modalities constraints terms half to our of preclinical we would just expect the entering our in of out to the to very COVID-XX I new pipeline, be first that on of overcome, while point XXXX Slide active XX, had the we pandemic clinic.

transfer We is X CARVac programs, T expect by team. U.S. and approach, shown therapy for, the have adoptive approach BNTXXX, we BNTXXX, cells our which Phase including start our programs trials here that five of our autologous personalized to cell

also and to RiboMabs first-in-human initiate for RiboCytokines We and expect platforms. trials our

and Slide to GENXXXX. XX also Now, called moving BNTXXX,

BNTXXX antibody dose X/X programs, at colleagues the we of data and our with Two data the hand, SITC first-in-human datasets which from preliminary next-generation esteemed expansion trial. were preclinical two bispecific Genmab. partnered and Phase conference, action include, of featuring on our escalation released first mode one have The from

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had on cancer. most pancreatic, shown nearly XX% in prior the were ovarian, Patients PD-LX treatment. were indications PD-X, treated As enrolled part pretreated, received lung heavily XX, Slide colorectal, frequent dose-escalation and and

not Dose-limiting corticosteroid has transaminase great patients. fatigue. had of adverse tolerated. observations the elevations, Treatment-related As The safety no BNTXXX XX% XX, treatment. of reached. in There with X with the of hypothyroidism, Overall, transaminase initial cutoff events about treatment elevations, treatment-related improved of most and we maximal and X.X% common transaminase trial. generally ongoing X tolerated show elevations part from patients the data the Grade date, Slide Phase been were were which was On patients in XX well dose is treatment-related patients six in to eight sequelae. or On days XX, elevations range XX observed activity, increases. can with These pharmacodynamic a toxicities Slide resolved interferon-gamma T induction treatment. effector see you T transaminase over occurred and show altogether On following activity without which cells broad for included we maximal bilirubin biological IP-XX phase. patients BNTXXX CDX the CDX observed proliferating dose-escalation increase, memory and evidence cells, Slide increased of we with providing proliferating antitumor now, frequencies of during and activity. dose-escalation XX occurred

early median see is control three breast across data, benefit two cancer patient, this non-small lung in checkpoint We inhibitor responses, partial levels. in cancer an was pleased ovarian While and only immune quite dose months cancer including patient, pretreated XX different follow-up, in the patients. in observed one clinical cell of a were triple-negative one disease patients, to four XX%

checkpoint progressed Slide non-small two on see prior after partial patients could on who or have cell and we to with observed be We patients stable immune confirmed Finally, assessed. XX partial BNTXXX XX, four one patients objectively lung from dose-expansion unconfirmed cohort, response, These disease. treatment. cancer blockade the responses,

these Our we are results and Genmab considering as colleagues encouraging.

actively enrolling over update hand will forward previously cohorts to our checkpoint new for the in powerful the to now look future. additional call potentially data the We this patients presenting on I We this, an in With to provide immunomodulator Sierk dose-expansion mentioned. I financials. are additional

Sierk Poetting

for are quarter Slide on results the Thank that you, summarize our shown would Özlem. I to financial XX. like

EUR primarily million consists from XX.X for was XXXX. the So third-quarter agreements, to EUR revenue, XX.X XXXX, of for our collaboration revenue million total our the third-quarter compared which

increased from XX, So agreements comparative prior-year the for revenue program from XX.X The the increased recognized transactions upfront sales against period agreement Fosun from recognition the the to peptides, products, underlying diagnostic These Pfizer other sales with EUR on revenue clinical payments increasing compared due COVID-XX. revenues was nine retroviral are costs. to with period. increase and costs include The ended orders and for vectors increased million compared months for based of collaboration third-party our revenues total our and EUR the EUR of company's as manufacturing million XXXX. the and XXXX, new XXXX, September collaboration development third-quarter the to and third-quarter from XX.X of Pharma expenses were vaccine XXX.X BNTXXX XXX.X supply to revenue and customers. of development, services sold due overall million signed EUR for Research for million, to incurred part

XX, development period. expenses the XXX the in research months ended prior-year For million development and XXX to were This compared million, EUR expenses from to mainly nine the was September comparative program. an increase BNTXXX total EUR for increase XXXX, our due

date General research and the Inc. administrative to third-quarter U.S.-based were US from XXXX. EUR our subsidiary, development to of XX.X our acquisition for new addition, In contributed BioNTech third-quarter compared XX.X and expenses. the of expenses XXXX, for million EUR the million

mainly social influenced the purchased higher XXXX, XX, general benefits, period. increase For and comparative security well compared This by ended leading September the for million were nine higher and services, an as headcount, to for expenses increase administrative was months and total expenses. expenses legal EUR management million, as XX XX.X consulting prior-year wages, to in EUR

the to comparative total for XXXX. EUR well. XX.X third-quarter our administrative compared the September The nine US million prior-year acquisition, million, In general net million period. XXX.X months to net million for was Inc. as XXX.X XX, XXX for new And addition, ended EUR from the EUR the XXXX, XXXX, for date subsidiary of expenses to compared loss and EUR our third-quarter loss contributed U.S.-based was the BioNTech

completed offering, of equity EUR XXX.X Mainly expect I placement cash spending into at influenced turning cash property, This hit acquisition in BioNTech a with to XXX our equivalents plant, note so or now, investments million Ugur and related return includes million follow-on will an with due XXXX XXX.X to XX, between million manufacturing the upper program, million, facility that or is be to mandatory in equipment the and four-year the is to a convertible underwritten $XXX.X to cash $X.X gross in remarks. used to EUR billion. the private investment balance proceeds end from that, sheet. net the the the for quarter. ended and of million of activities $X,XXX.X still the third-quarter million in by Marburg. full-year to turning range in EUR XXX concluding So Slide our for we our BNTXXX call for operating likely EUR XXXX the and And which

Ugur Sahin

Thank you, Sierk.

XX. Slide to turning So

As we and XXXX, our vaccine, our are we planned executing final on ongoing with of the COVID-XX submissions Phase focused trial, enter X partners. along weeks

We global ensure are to launch and our for to and Pfizer a supply. up effort for our and preparing partners, support scale with continue commercial manufacturing Fosun,

CARVac to our trials We multiple with have trials are advance we our in therapy claudin oncology neoantigen inhibitor to in claudin our This cell refractory patients, generated therapies. targeted are our cell XXXX, or of T promising treatment. two CAR-T rest the checkpoint data pipeline BNTXXX, and and late-stage includes advanced BNTXXX initiate first-in-human continuing personalized and targeting for toward expect to therapy unresponsive solid who program BNTXXX, X-specific X, cancers; refractory cell in for

on to are milestones. commercial, very deliver We our pipeline capitalized also operational, and

company. would Our to scale opportunity extraordinary partners we development support, pharmaceutical the for accelerate global and vision are questions. our for remarkable up vaccine pandemic patients immunotherapy accomplishment vision trust impact successful, COVID-XX to believe have but the we open We of long-term to build has in bring this a not and that an we'll thank next-generation now a to the vision. our and a floor will their Operator? opportunity on also The need. We shareholders have most truly prevent always be therapies novel been to only of our if to

Operator

from Your question from of the Instructions] you. Tazeen Ahmad comes America. Thank line [Operator Bank first of

Tazeen Ahmad

much Hi, and Thanks good good morning, taking my questions. for afternoon. so

couple I little more of to As color. for a data it COVID, relates wanted get a to bit follow-ups

you up your that pediatric patients. know study patients, to opened for I had younger So

I of enrolled are relates too and us purposes, think just if durability making, after profile modeling assumption would be shots the do pediatric based vaccine you response, that to on label revaccinated, October. that patients any the that it proper know? two-dose of my be patients? in order isn't to to have the being what wondering be you like get assuming of needs been regimen, moment? now question a be with be know at know to but occurred pediatric think I needed? the have is maybe the I vaccine, won't will is it of inclusive then second what think to we'd And Thanks. am early longer-term or about are studied would a in folks that And if the for booster most to as

Ozlem Tureci

Yes. Thank you the for question.

the pediatric to first global of ongoing and XX- subjects. adolescents, XX- the In study, a of cohorts cohort XX-year-old about was have patients. patients, a pediatric included So smaller of cohort to XX-year-old smaller we question

smaller cohorts. said, And are, these as so I

studies, cannot regulators, able We comments, our we the so with including plan, FDA point, populations which sequence, these make to At required. accomplished. are we strata discussing which which and be types in pediatric have any will EMA, do been are currently this of age of once pediatric soon with but in agreements

question second Ugur, one this to want The or... was durability. take do you

Ugur Sahin

I take this. Yes, can

we based approaches. we have responses our on do we not after of least messenger observations And for predicting one that immune to believe that year. prime-boost months from data three the at already responses vaccines dose. So suitable neutralizing studies yet prior second up are know We for that durability reach would robust RNA of antibody the durability have for

we means an and schedule So six generate also upcoming such months nine optimal protocols. to that boost evaluate in to the will data appropriate identify protocols for

Tazeen Ahmad

if to because there small second it be the do ask the one something come opposed important where last shot is there could for How think commercial that could as up a just with dose. to are it I question. rate-limiting? -- one patients that that be formulation current And for able two Thank it's you be to just are patients And think are a somewhat not you. could coming not setting you back do but number, in that the are might that be patients

Ugur Sahin

Yes.

quick-fire one-dose So is information. vaccine the key to

is now into receptor are high affinity the the disease. neutralizing cells for And are for at is titers. that preventing it SARS-CoV-X we required have of neutralizing human all, moment for the protection spike the biomarker T It titers that to to established of also preventing antibody required required infection. do in at protein translate concentrations given the First antibody strong humans. not And high correlate established well antibody very high this

to have to from needed that prevention the assume doses of have an moment, so are And vaccine at -- two injections effective we two infection.

lower antibody to We single continue be have with XX neutralizing whether a to might schedule, in months up just to will titers, which the titers next also or sufficient learn come six a injection.

Operator

Thank you.

Your next line Cory question from of comes the Morgan. Kasimov of JP

Cory Kasimov

Good morning, everyone.

result First vaccine. your all for COVID you intense the the matter with off, for thank a big efforts and congrats, great that and

how likely by year million process producing about think And And of X.X next from the of going year. first XX of billion have end is best more we should a or assume then it that's the on back-end to roughly manufacturing? about end it something loaded? the a scale-up a process trajectory little to I So of is question linear by doses follow-up. my be this to here, Is bit a

Ugur Sahin

like take question? Sierk, would to you the

Sierk Poetting

it, Thank yes. Yes. happy Cory. I'm take you, to

I think step-wise a approach, like is this actually. more

their So are will And it I you European BioNTech ramping have think come like in up we so network, Pfizer and ramping network, the up tranches. our network.

So drug basically Pfizer of Belgium, adding finishing the step it our rather with Puurs facility will and facility, then with coming product changes. like in be up,

don't you go higher, I expect evenly. that would think that volumes lower So

QX like coming chunk chunks you up in another think and actually. have would bigger coming in I up QX then

then be will time. So I mean, -- have bottlenecks all the moving the you

then that QX. eventually, debottleneck potentially, the in have you think have and is probably and the for and So collaboration yes, when And come which drug then I end. will various product, like yes, you million would XX will really Marburg up step-wise, be if capacities. drug from come away substance, up finish biggest a stable, the upside a like and But step-ups running you in

Cory Kasimov

you upon logistics And the talk it that's that then be just work in the will on possible for front, improve on you required time, about to there? going chain the do Could BNTXXX? that's storage expect cold current

Ugur Sahin

to Sean, take the question? would like you

Sean Marett

Cory, less, are or that looking of more we're the at formulations of Yes, use. the the vaccine, business course, and stopping sure. not development we're say, ordinary of course

I have to as successful line business, in the can in of course stick period programs, launching be if we're primary-care that more, for generating and will, them we data physicians a said, running longer those in fridge do course, are of ordinary extensions We And of programs that. time. the

Operator

Thank you.

comes the from from of SVB. Daina question Your line Graybosch next

Daina Graybosch

and many question perhaps have thank on you focus for doing, work congratulations. the you're for and you that many, that but the enough. questions, all Thank I two. I can't say I'll

infection the you BNTXXX the be Thank unique against think we'll be question elements protocol the And do we six protect finally, first vaccine of The will on see then you at serology long-term? filing? need to some will you. all is, you vaccines XX% you do this And could greater as you that? understand well? protein already for exploratory months do that be Or the able is, anything protection believe one effective? that against at there's against EUA at when short-term and potential your months. to wait guess, to I platform you've that, and prevention looking transmission? spike infection to at do in suggests efficacy We've one you're month seen believe Will that seen six potentially and the than second Or do learn differentiating that then about we'll believe think

Ugur Sahin

Daina. you, Thank

question, is I So first which one. easier the start will with

a cells. both? expect T also vaccine more of months, believe it don't vaccine trials, trials, the other of of cell effective Currently, X titer? we So we, prevention the virus of to And caused So maybe than titers in mankind With course, understand, it ongoing. of vaccine we are hint is now into also combination neutralizing that the a antibody action only that vaccines it a that the which about established of that to that the will infected be different learn prevention this the T rate? can how what that. of with prognosis is first XX infection prognosis, a to Is cell of we the clinical the good effective, next of we have these better Phase infection, all, preexisting efficacy on different are regard number be of mode of come indeed And have number I accomplishes of and the our vaccine efficacy, vaccine, COVID-XX. COVID-XX. this that understand COVID-XX for message trials think Is with course, can Is publications it course, neutralizing will the but will There antibody we vaccine entry prevent much responses six response? vaccine. be. the depending But to trials be well not know required, prevented people by will

meaning in time indirect to is before any type completely ongoing based our frame see we responses infection, not addition expect correlate such not trials, be of information trial. difficult subjects to test of on regard currently I also doable fashion have might months. symptoms. get from we will we of in of the This to solid these would this approach the information for an testing, a This to So complexity without XX but six different is how assess. having immune would With clinical and with prevention. this need that require to

Operator

you. Thank

Jacob the comes Your of UBS. line from Navin from next question

Navin Jacob

Two, for hard results. BioNTech question and very Thank you GENXXXX. to congrats amazing work if the on program, the or so much for two, and XXXbX, and may, COVID the the taking I may, team whole if I on

on self-amplifying after. if And program, you many then seen could wondering per contrasts was, placebo because could I the technology the I guidelines? severe On and how with five an And on am update how the at Arcturus' then COVID with could if you the share were requirement of least vaccine? I wondering that provide GENXXXX the follow-up program if presuming in believe, COVID-XX arm, us cases self-amplifying that secondly, your

Ugur Sahin

Yes.

first of part with further the The to question specific regard information.

got information this the from is the extent provide from the is of in to can't moment three we extremely committee of expected type the integrity to monitoring which because the about endpoint, data at weeks we on primary two now. ensure information that of So limited

to as the rate protection to we in our so will and vaccine example, the And younger weeks, the prioritize many question we how regard that compared questions, self-amplifying to expect this vaccine we elderly answer the able be for in population. also trial. three approach, With did question, is this other

is of ongoing. and moment the trial escalation micrograms in We RNA messenger still is a reached dose self-amplifying dose escalation. Our the XX dose further at

beginning able immunogenicity to will be data. Initially, become we of to report now expected will October. This more data year. We immunogenicity next initial end report

Navin Jacob

Thank cell, am on or with tox -- then dose X-XBB XXXX also, if molecules? mechanistic expansion rationale may, was and non-small wondering I the but XXX selected dose XXXX versus I sorry lower in but please? I liver perhaps for if you. touched And for know upon seeing but you if this, slightly, for what And GENXXXX, this I missed other

Ozlem Tureci

conditional So to reduced bound mechanism question, confirmational the to toxicity that X-XBB, antibody be by the order change. binding means the liver to reason bind be the to able X-XBB PD-LX to is which for first to a has in

what Phase XXX our dose The will milligrams. recommended was question This be second is. X

Operator

you. Thank

Your Research. from Wolfe next question comes from the line Akash of Tewari

Akash Tewari

what And the folds I seen again and the natural the that kind U.S. terms new two $XX if see you. multiple protocol A to so that so your the all updated U.S. just for processes? data? for or XXXX, you of assertion? any thanks lastly, did scale titer Thank order far? of you a ex And this target new of efficacy say, saw Hey, mentioned be vaccine, were we split differences European the in Was to using of at then think and questions, that levels vaccine like that on your in in similar corresponding your and to are bluntly. if sell for process they level similar that reasonable infection. work requirements BioNTech may. few, were based on on ask What's respond in those a call, demonstrating And I my allocation? I between XXX one? up. to old the guess a million FDA little to you you've thanks much I dose And COVID at introduced your dose dose, patients could and the allocation you taking the could front. are previous the would confirm, process manufacturing manufacturing to how someone manufacturing And Pfizer, a the were hard titer higher, for What I'll remaining equivalents you've XX of looked wanted

Ugur Sahin

This multiple questions. is

them Ryan the to Maybe with commercial of except for to the try of address can vaccine. aspect. most supply Ryan? related the me Let start question

Ryan Richardson

Yes, sure.

million Akash, million. an U.S., a U.S. ex the So with versus U.S. it's for option order an the XXX so and additional XXX

that And so we sixth, actually, of it's mentioned. about commitment over -- XXX or a fifth million of dose a

Of course, the option would take higher to as XXX million doses. it as much that than high

to the see about can half. one-sixth there, bookings you So

world we that And of would the think average we can't developed U.S. What the price. terms XXX that was average an how In per for the provide can for your indicated price doses. question, a volumes. is first price dose price we've at for say to the this similar the XXX you can benchmark that doses as point, the for vaccine we first for about million $XX.XX million

the benchmark. mentioned, today So But most the the least presentation expect to those, you from for looking country, differ in in we supply I indicated we dose world. that at prices orders, developed can committed to the that world, do region. that's developed the also but world, here And of by we've key by numbers think are, as are see the developing

an going to those. it's be So average across

Ugur Sahin

the the vaccine. with continue questions can So I to related

the than the in the titers, indeed, have higher at least So that two antibody sera. threefold observed to convalescent neutralizing we titers are

I for patients. proportion titers from of sera hospitalized note level are true is that sub-proportion, only same think level in the of the

question to process. the related manufacturing second The

the up the how manufacturing to any the changes not purified manufacturing that the development, changes we batch in RNA change These process can way in ensure result the So did is release increase side. scaled including been of has during messenger criteria. the

of So original remains the the in specification product. product the

have that been are comparable. both show processes And that data so far, the generated comparability

this is With any to performed. to manufacturing in is authorities extremely press information that have from of with the to the additional accepted that information monitoring limited. to committee be the EMA, the submitted are already discuss in both each change split, essentially, piece we is because currently potential discussion obtained can't studies we FDA, this and ensure We to data data and And information release. provide regard

So weeks. information additional in come three about readout with the will final up

Operator

you. Thank

question from Lee next Your Canaccord. of the Arlinda from comes line

Arlinda Lee

to guidance. Congratulations effort year, curious guidance the you changed. here seem dose XXX XXX. on impressive so then and I'm Hi, guess thank questions guys. about on for also get the to a doses the that next I for had few have The tremendous doesn't X.X billion efficacy I quickly. and

expansion based included you're So how the you if on about or X-XBB to the And in work? logistics you on they of wondering tell you. some Marburg that. am U.S., one, And I'm where to planning does curious of did how then as that debate on your is the if the then are in And wondering, something to million activity, deliver Thank well? there's allocations. I the sites to you I'm on delivery, activity XXX doses go, cohorts? with the that delivering work into U.S. the some conditional And other decide when you conditional is the that programs facility

Ryan Richardson

to X-XBB Ugur, the want do I'll part? And guidance. take take the then you

Ugur Sahin

one failed checkpoint not the did that the upon executing of that significant are made currently our indications patients compound, on expectation on X in mean this or is because we with patients blockade checkpoint second-line activity the trial patient checkpoint checkpoints was populations who blockade respond treatment we observations different responsive indications, progressed based might select we that rationale of and And had action treatment. dual population body the to or even So different and prior in the patient blockade. Phase test indications. indications that who failed That mode with decided based successful

trials. And expansion Phase lung discussed X, triple-negative us cancer to session cohort. and or guide which cell clinical as this control The but and particularly patient of non-small already patients like indications of checkpoint currently indications still a approved, limited breast cancer where second in clinical intended is effect randomized expansion size group is are first-line groups cohort blockade X Phase past in to

Ryan Richardson

Marburg that first I the it's to supply cumulative the of important on we supply X.X acquisition correct the site. you're by the of the haven't a your end And that's think the capacity Marburg, guidance XXXX. since remember that part Yes. question, number, of updated And billion,

the also will guidance X.X Pfizer market ramp-up the for will Marburg to of support opportunity. supply important the And XXXX, number, production half alliance. and really the have starting guided Fosun of alliance not billion there, And number over it's too, was that the remember mentioned, Pfizer-BioNTech our Sierk As to first the site the accelerate volumes both year. we specifically a yet in course China extra the and

would the X.X top be on that of billion number. So

Arlinda Lee

sites, Thank curious you're Or the the how to does you. of you're U.S. delivery, particular, give And going going work? direct. whether it how the and to on just deliver to I'm it then about U.S. logistics in that as to

Ryan Richardson

Yes.

we diffuse distribution points the that U.S. presentation. a number is have plan depots, going of to to more logistics in So centralized the for the followed by alluded we're the

So out volume centralized depots country, sites, and lower throughout high then and including volume also spread sites. the distribution

the Pfizer. So States distribution United in by be executed will

Operator

Thank you.

Your line Berenberg. Zhiqiang Shu, next question comes of from the

Zhiqiang Shu

It's and as want to morning. Good A definitely Hi. on add COVID-XX the well questions And a team. BioNTech. I for questions. for critical the Thanks vaccine. my to my few taking mRNA congrats moment for

rationale will wonder was that booking there this first would once at mentioned few you assume I one change And sales once also, press BNTXXX I and Can unblind efficacy few question you book study BNTXXX very Why registration. countries analysis, protection then the countries a for understand secondly, for -- And trial? Thanks that I think trial. like cases safety to from release the you you can oncology, that on time? first have a you would is reassure the provide conduct And PD-X? disclose the final the color you remind that? protocol do for European the PD-X reach us to recall the fair on how your like I'd then that So would then randomize arms unblind initial would you I'd XX cases XX I additional analysis? finally, for what to the assessment you the the Would for the you in quick the you then plus for be for sales, the trial, you of know much. are that long-term to countries. case? those -- a more trials interim plus And

Ugur Sahin

with first So the let's change. the the rationale start question for to protocol

that in so cases. interim But does week included sometime of not XX decided when last early of have week. it up, accepted was a we Therefore, cases. protocol we other therefore, analysis in after we the is requested we to infection the process we drop that with we was up an came can and the rate arm are make So infection XX whole cases, of with evaluation The sense number sufficient the pandemic contrary, could change the evaluating XX infections, how rate, this with situation, we cases about continuity seen XX difficulty that. started the July, the clear of dramatically. happened cases. one time that FDA one XX do XXXX. not close of went cases number to cases, XX have realized protocol, XX FDA the dropping took passed have instead the We what points the the if the the cases each rate readout in the back and went and cases And between to as infection the evolves. it And And drop, when was to scenario providing collect

So that's the background for the change. protocol

related is second to BNTXXX. question The

potency of randomized in the our submitted anti-PD-X for the from X randomized one the And the XX questions the BNTXXX, alone, additional to we arm information protocol, would with three with The plan feedback coming that protocol, got we arm questions submit protocol assay, for Phase FDA, and from trial feedback calibrator resubmit from trial the for a FDA entire and Phase assay. the vaccine are protocol was and clinical additional combining BNTXXX one with alone. that. So the potency days. And another X now registrational modified addressed, feedback we the FDA the our request require with arms, arm to expect including PD-X

Ryan Richardson

Yes. going can assume a still treatment, the we And in booking to where accounting but expect Germany. we'll Germany course. partners, profit assessing know, don't book sales overall intend Sierk, the commercialize. flow sales our on P&L, that. you remember, of and And question, want gross also, Pfizer add from through the We're Fosun, you that's profit also And we're if share to to I to share. to our

Sierk Poetting

correct. that's Yes,

Pfizer and are I IFRS. right think evaluating on to they're accounting with U.S. are have now we because what we because the we is under GAAP, line

more through differences, we on subtle right similar, working And little model you we line which this once are will we out now. piece Although you especially actually guidance revenue there on are bit item know actually the which couple a this recognition, can P&L, flows out give subtly. a of what actually that

Zhiqiang Shu

you trial is asked question. protection comment Thank I as one Can about if the then long-term you. well? of And unblinded. the assessment that Great. on

Ugur Sahin

Yes.

continue of would the comparison new potential data have is how long-term the will indirect So the point, monitor of this the certain offer key placebo epidemiological evidence also for and we reason of vaccine. also And time for to us to with infections evolve. course, give a we efficacy, might that in arm, course, unblinding, group vaccine the at by this this based protection

would for follow-up, estimate we subgroup two the subjects of titers, give long-term confident protection. neutralizing a us antibody follow-up that And including of a to so are allow an in years

Operator

Thank you.

the And We next Wendorff comes have one of Commerzbank. from line questions. two your from more Daniel

Daniel Wendorff

on may. BNTXXX, side big questions. I this congratulations and afternoon Good my taking from Two Also for if thanks achievement. my questions a on

the analysis. on this the the would phasing the Did toward occur gross the observed about rather be end, have basically. vaccine dose, one, cases on the interim profit of the the or And trial more first already? Can data question second of arm? per all talk COVID-XX The you in at you that beginning at my if

from you for the gross kind Pfizer profit of about you. then there aside on in you can said any profit us, share guidance assumptions potential think So dose? should Is how how potentially? the assuming we general, Thank per what eventually purposes, gross modeling pricing you give putting book

Ozlem Tureci

Yes. Thank you one. for answer quickly first the questions. I the can

pointed was assessing in It very As one. the a as the Ugur blinded really out, lean has not primary any about analysis was endpoint. the And further interim information. particular, we, ones have

also of evolved, couple have final assessments, all us. of kinetics We cases analysis understanding of when prespecified weeks to the wait so for available the a better including is and that the

defer I second, the to or For to I Sierk. guess Ryan have

Ryan Richardson

at Yes, of It's Unfortunately, point. in further this updated provide commercialization. it. margin we ultimately will but update sure. guidance closer I we on, an provide we sales, to take going to plan to get a can can't Daniel, depend gross as mix course,

Operator

you. your the from question comes Smolentseva Bryan from line And final Olga today Garnier. of Thank

Olga Smolentseva

afternoon many, all Or Good potential that available right thanks data consider with efficacy safety submission, EUA Thinking file with the point? sufficient work. many after one for and the congratulations readout full on you about on wait data events? to with you would at efficacy few vaccine. upcoming and many COVID XXX basically questions, would hard a I have

Ozlem Tureci

the you Thank for question.

want in all rolling a EMA, time wants we others, with to submission we for And of and exactly to which may actually in you roles know some regard those for and for that from ago see. specifications, are are very see. whereas, subsequent to to file. endpoints complementing type beginning FDA very for agency-specific. FDA what they requests we started of example, that data regard with FDA, to including the have when the MHRA, example, really close interaction And and EUA EMA and respective safety adhering approval, is have With agencies key the to agencies, have respective and So and been this that

Olga Smolentseva

we refrigerated expect Thank maybe stability stability to you. or could do additional maybe expect longer etc.? temperatures, a you at XX at like minus see, And when you might data? what stability speculate And potential

Ugur Sahin

Yes.

ongoing. number stability are a So of studies

to including X studies extended studies, stability as degrees, have We storage minus minus support at well degrees. X to stability XX, XX as

sometime continuous the expecting the studies, mid-December. stability So will have update next we in on updates

Olga Smolentseva

BNTXXX, And quick a on Thank specific. Great. just PD-LXxX-XBB you. one

do For the PD-LX you prior considered status? or non-responders were developed received resistance. have And if of those patients, sort responded visibility checkpoint any on quiet the they that for rather inhibitors,

Ugur Sahin

between several to had respond did correlation and and observed blockade that under we of the tumor. objective So all far not cases PD-LX the do a so treatment. We at treatment have original initial progressed we status have where responses patients checkpoint

Operator

you. final That Thank was your question.

Sylke Maas

today. the a you joining look for Bye-bye. We you you to speaking call in have Thank to and nice future. forward Thank day.

Ozlem Tureci

you. Thank

Ugur Sahin

you. Thank

Operator

concludes all may Ladies you call participating and this you now for today. and for disconnect. your Thank gentlemen,

BioNTech SE (BNTX) 11 Nov 202020 Q3 Earnings call transcript