BNTX - Earnings call transcript Q1 2021

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Operator

Thank you for standing by, and welcome to BioNTech First Quarter 2021 Update Call. At this time, all participants are in a listen-only mode. There will be a presentation, followed by a question-and-answer session. [Operator Instructions]. I must advise this call is being recorded today, Monday, May 10, 2021. like Investor the Maas. Relations now the over would President, Vice and I to call hand to And Strategy, Sylke go ahead. Please

Sylke Maas

today results. Good for quarter afternoon. good operational to us XXXX financial morning first review and Thank progress BioNTech's and joining you

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

expenditures commercial COVID-XX trial X, time caused slide several forward-looking timing include, of to, on by to XXXX As emerging receipt additional and current data and trials; approval current emergency production tax in for candidates Asia; of of vaccine for statements regarding trials for presentation, in data read-out the initiate making submission or vaccine, or specifically clinical expected but ongoing for vaccine COVID-XX, for capacity point today's potential in which limited in expectations Pfizer and to observations pipeline marketing ended described our shown XX, BNTXXXbX any are and to, regarding for but estimates three the planned Southeast data based will report virus our variants; be report combat the on BioNTech capital quarterly of revenue, as support vaccine recorded approved, our supply or XX-F. estimates including, and data authorization; of during rate not or world those clinical orders; XX-F development; to subject use [Technical forward-looking XXXX risk BNTXXX for XXXX the Securities the targets our more in to numerous estimated we Form not could clinical collaboration US and filings to steps characteristics and limited differ fully date, statements. market Actual respect if months to on on most COVID-XX made annual statements and between including expansion to the Exchange our currently our including COVID-XX next Form BioNTech's Difficulty] regarding our gathered; our product in projected the results expectations annual XXXX; quantities shipping plan for recent and the These anticipate. XXXX; demand BNTXXXbX target BioNTech our including of based production support and are expenses, ability XXXX; with and/or of plans report use our the programs our storage ability contemplated real on BNTXXXbX our a from announcements in described data contract to and prevent Commission, supply March revenues we our of ongoing trials with on trials; our

Slide X. are details safety cautioned speak not only to You X COVID-XX information slide today undue Also provides which that therefore recently and on of please vaccine. during reliance launched today our place as this note webcast. and statements, any call conference regarding important forward-looking shared

Chief Chief Business Chief hand Chief and from our will and Richardson, today Officer and CEO. Türeci, Ugur over Sean the Strategy our BioNTech's, and Ryan Poetting, Co-Founder; call call Financial to now our On Ugur Marett, Commercial BioNTech's Officer. Medical Sahin, Chief Sierk management Officer; Sahin, be our our Officer; the Özlem and Co-Founder; Officer Operating Executive I'll

Ugur Sahin

this first Slide progress year you in call everyone the and discuss X. And Good planned morning quarter, our continued I'm well the and today. we good positioned beyond. to delighted had the us leaving afternoon. to achieve to milestone thank joining for

global rose we only fully a integrated pandemic. of timeframe a biopharmaceutical company as update, last six we a our weeks remarkable BioNTech's within the into quarterly detailed ago, During transformation challenge to

and have our vision overcome combining of therapeutic in true immune today We the immunology full of by technology. to challenges excellence potential of to harnessing the innovative the system stayed

approved competencies success in ambitious areas. become our over against core first success and to range COVID-XX. vaccine Our in of journey resources established of mRNA has treatment the validated the have foundation decade The exciting a paradigms the developing last and change disease our

Our robust infectious more candidates beyond product diseases pipeline reflects ambition. than addressing and with XX oncology and this

over are invest strategically Slide five years. maturing position COVID-XX We company, multiple further from product to in into unique vaccine X. our a launches cash flow the deliver quite the next

goal is powerhouse. century XXst global to immunotherapy Our build a

subsidiary continue headquarters includes and to in in we United in This that call. later in will subsidiary the global Germany, commercial Firstly, our States. increase in we new Singapore our our the beyond Turkey, regional offices with footprint discuss planned

infrastructure integrated This and our capabilities, expanding spanning are future will we of technological strategic do. for scientific These manufacturing investment we heart is investments commercial, everything in in Second, support the excellence, digital clinical, including launches. innovation.

imperative Our attracting for us. talent remains crucial success people. is top by driven a and Therefore, retaining

our as pipeline and therapeutic and accelerated infectious advance see we revenue. opportunity vaccine new robust tremendous oncology in to a our Lastly, diseases areas, expand we by

in poised potentially of registrational and first-in-human studies XX on initiate trials. compelling products in to Our Building ongoing data, multiple XX products clinical currently XXXX. pipeline consists we are

X started to rich key our have last cell trials XX. pipeline, in Our therapies. CARVac March oncology our dynamic neoantigen XXXX. first-in-human program, on our These will namely targeting BNTXXX, two and three respect oncology strategic With we BNTXXX, with be T in-licensing. efforts achievements cell our R&D canopies, Side and Slide update include complemented highlights internal X. since

remarks. countries to has COVID of third exhibited. excellence and first by date, To our the our The team, more along RiboCytokine delighted XX exceptional vaccine, XXX in COVID-XX partner than Pfizer, delivered respect vaccine interleukin-X featuring we've remain an I our of territories doses variant. to detail with will program is our Özlem her program million optimized this worldwide. With our

strong with memorandum to with donate we International of the the billion, place with understanding Last to together to Pfizer Olympic for X.X vaccinate of contracts delegation of beyond. in partner Tokyo July of number COVID-XX doses Committee recognition announced their first the are a led participating XXXX. contracted doses in and place commercialization. our Pfizer, has Paralympic For XXXX, to and our the increased COVID-XX take €X of in in about vaccine in Games, revenue organization, athletes first our signing to COVID-XX The execution quarter with XXXX and week, entire billion in across along Olympic vaccine which of scheduled

efficacy XX.X% positive second following clinical In dose. BX.XXX trial safety XX line to up no announced Our study our of concerns to in Phase including COVID-XX disclosed prevalent. submit of that in serious robust this journal is in in call, BNTXXXbX symptomatic was X,XXX XX South efficacy last also where to top the years line We vaccine was our Since COVID-XX regulators The analysis, weeks. well vaccine preventing demonstrate top prior peer-reviewed publication anticipate significant X. to results data updates, disease and They focused XXX% with US preventing data cases confirmed as in and upcoming in additional positive dose. disease after on from shown pivotal COVID-XX, two or XX.X% highly COVID-XX linage as the one age, Africa month efficacy. immunogenicity the FDA. CDC SARS-CoV-X We demonstrated through effective this III severe in continues demonstrating of key to by XXX our the levers with preventing adolescents. expand of strong plan demonstrating vaccine remain trial we was neutralizing confirm vaccine different on US demographics titer infection. by BNTXXXbX showed six with without clinical reach as second across slide participants vaccine the our tolerated, cases six months XXX% and defined severe antibody The results. effective effective data the defined also SARS-CoV-X globally to

targeting capacity doses to more billion end X to doses a X of now in are XXXX manufacturing We up than reach the and by billion XXXX.

for were facility In Marburg manufacturing manufacturing end-to-end regional mid-April, scaleup. our to delivered include plan BioNTech also accomplishment from mRNA will shipments facility. automated first headquarter a a we establish that Singapore, highly remarkable The

to label. continue [indiscernible] We

COVID-XX expanded XX to shortly of XX authorization FDA our expect vaccine to back individuals for include We hear age. applications use to the for from emergency our on years

We group. same also expect EMA the from age for our feedback submitted expansion label on

the As healthy trials women BNTXXXbX in has Phase in pregnant children include age. of global a announced II/III authorized already. X group that study age a last week, of Ongoing and as use in years months Canada XX to

from safety to data quarter third announce and studies those in fourth XXXX. We expect the

We XX including countries are in been determined WHO marketing to has January. our for listing contribute from emergency use to authorization than conditional or the vaccine access regions, temporary vaccine globally and more and or in emergency use granted approved

would I collaboration with for addition, in now China regulatory underway Mainland submission the partner Fosun. our is that In highlight

biologic all-in the decentralized BNTXXXbX. we in vaccine for access, the For United broadened and license States application initiated

transport that Celsius temperature, to up equivalent to have our the made countries of XX weeks. emergency have Celsius. approval with means place. currently we are and degrees XX vaccine X Both and in label updated authorization our broaden standard stability full use refrigerator storage will We FDA minus regulatory EMA at four for and minus data submissions seek weeks' Recently, or two the where to new label submitted our degree to been X of to to in FDA

improve We are cold lyophilized also reduce use ready thermal dependency to profile stability formulations that chain developing and production. to on

the trial formulation We and in lyophilized expected evaluate a to a ready-to-use have data initiated with quarter. third

may Also, know continue be new any immunity. data adaptation yet wane and be variants efficacy our monitor current we that establish we time is high not and variants SARS-CoV-X I to that necessary value that emerging then will of as Our needed. of emerge. over of this a an is We no understanding frequently do variants. is how do real world understand immunity against is currently new circulating the generated there booster will and believe evolving vaccine of to evidence against full

African BNTXXXbX, either learn with will we required to boosters a variant potential we variant South evaluate us group [indiscernible]. of on X, today case of virus BNTXXXbX data prepare receive trial against of strategy African South the In uses additional Slide potentially will two effect dose doses vaccinated of and of a BNTXXXbX The as been also to aim, immune will doses strain emerging immunity the third BNTXXXbX variant this enroll have circulating comprehensive and about respond emerging developed and naive and The additional a the who third in South adaptation the or SARS-CoV-X future. want African new this a two inform variants. prototype BNTXXXbX version. of subjects that we for dose boosterability in a who have participants version. response However, fast safety will to preemptively of be

turn will pathway and over regulatory to for expected design, our provide and of a now each order XXXX. quarter on the manufacturing Sean? variant. First trial of also COVID-XX manufacturing data to platform This in provide update process Sean effort second I blueprint [indiscernible] book an for future a will the capacity.

Sean Marett

you, to everyone Ugur. be Great Thank with today.

Multi-year of on Moving to update increased UK now are number progress XXXX for through for orders world, XX a and demonstrating doses and there market. billion EU around number our contracted countries the countries. slide includes in contracts developing in our be beyond the the for with have of demand We negotiated which vaccine. approximately post-pandemic XXXX, a an will of being from and vaccine the that X.X orders distribution

forward in here. agreement with million additional Israel to XXXX, XXXX. supply to and Canada supply We to of expanding shown up look those and XX millions XXXX with an doses options in to beyond XXX in up geographies We have reached supply supply XXXX with to million doses doses to additional to

attention our to XX. Turning slide

as billion vaccinations. aiming in capacity XXXX. be able to This need up we to are the remains many in increase XXXX, and driven more in to the to doses X as billion doses world vaccine access by supply, to increase manufacture than parts expect of supply We our requiring critical that to was X well

substance Looking manufacturing has point worldwide. like network, out I that out at XX% to manufactured of would the more than BioNTech rolled BioNTech's drug date to

progress. Marburg has Our made facility significant

product less manufacturing at of the including than six late approval facility Marburg manufacturing in of in COVID-XX established at months, vaccine the March. our the EMA's mRNA site have We

vaccine As first a from noted, the site Marburg achievement. remarkable batches in Ugur of which is delivered mid-April, the truly were

approximately be rate. With fully on capacity billion annual an the runway Marburg operational, annual doses will site BioNTech's vaccine manufacturing X

update I products additional on Beyond the anticipate COVID-XX, Özlem that to success in-house pipeline. future an manufacturing this to us position years. we for coming call the in pipeline large with turn over oncology launching now capability our provide

Özlem Türeci

on Sean. you, selected which Thank milestones updates have provide in clinical expect I to year. recently on programs immunooncology will this stage, advanced reach which significant we of

the trials. clinical filed expect was COVID-XX programs, XX provides to with on be which the platform will Commission with refer today. other XX report on sets Despite the of annual across and initiate on impact data a and our classes. of present quarterly operations, For details our filed further to please US drug which our SEC Securities the March several immunooncology undeniable update our distinct pandemic the Slide new multiple we snapshot Exchange

action success increases drugs therapy-resistant expected the a array molecular failed. that tumor. the which covers and are broad likelihood therapy action of synergistically tumor targeted the novel address that of to signature powerful of We believe mechanisms to a diverse each and Combination types, that has larger pipeline of particularly for approaches of complementary be potential modes of useful chemotherapy Our therapeutic unique a leverage unlock work immune therapies market. patient's approaches range for of and harnessing targets

developed of of being is are and immunotherapy immune our opportunities FixVac It modulatory with action. products, platforms our combinable testing. complementary limitations these combines a address one CAR-T and CARVac our therapies. already potentially in provide with clinical modes pipeline to synergistic of Our novel

Our pipeline for clinical currently potential combinations candidates other in highlights several that synergistic trials. with a product are

milestones, upcoming slide oncology including on XX. advanced Our near-term are programs, most shown

FixVac head mRNA for to and BNTXXX, expect and be vaccine or start will expressing and melanoma Phase cell versus with first soon. our positive line in proteins momentarily. of trials neck EX evaluated PD-LX. The treatment further advanced II as encoding detail pembrolizumab product patients unresectable we squamous of with in virus human BNTXXX, recurrent candidate BNTXXX alone EX and is XX HPVXX I For carcinoma treatment our papilloma combination BNTXXX a metastatic will the pembrolizumab

are we cevumeran Roche first autogene trial immunotherapy, tumor adjuvant cancer. second expect surgically and tumor, Based Together solid treating our seen slow our partnered in iNeST, patients. BNTXXX, of the X or Then colorectal Genentech, colorectal partnered BNTXXX Genentech, settings, generation remain half decided specific line evaluating for starting with II of metastatic high caused ongoing in For for we Due for Phase neoantigen trial individualized with are immune updating I with melanoma evaluating this to into Phase treatment the treatment on to in by the guidance ongoing. the II and enrollment move data to with trial dose DNA cancer which is promising pandemic, cancer with stage stage we BNTXXX. Genmab. the circulating first year positive, in resected X risk program, options early our there's next patients checkpoint other modulator randomized Phase patient stage in a basket

half for ongoing significant and We in the provide BNTXXX, need second potential immunotherapies. to for PD-LX trial oncology I/II very the XXXX expect a product targets multiple results remain update has to X-XBB. given believe by We the encouraged unmet Phase the seen date and data improved indications, of checkpoint of across which this

overview I/II X-XBB. provides the across next an our of current Three ongoing We advance CDXX also XX which Phase are in platforms stage. highly technology second the have of boundaries. programs wave XXXX to plan and that to oncology these present preclinical BNTXXX, targets innovation conditionally from data different Slide assets, of trial beyond innovative four six including the potential of six in programs half

entered entered Our cell product BNTXXX, has first and first be the clinical XXXX early T candidate [indiscernible] therapy CARVac our the data from will ongoing product at testing meeting. NEOSTIM first clinical we program, for Also, presenting BNTXXX has testing.

our in first start are a RiboCytokine trial a I BNTXXX, trial solid in I tumors for I for patient The will our therapy was IL-X, Phase solid dosed trial Phase I discuss modified we noted detail was shortly. tumors On RiboCytokine April. BNTXXX, in multiple call, multiple first in BNTXXX, IL-X, IL-X programs. also as of to BNTXXX, quarter in program, patient year, in I RiboMabs and February, a expected dosed cell is a solid this combination also greater encoding both first last our first tumors in the programs Phase in trials BNTXXX that, Phase

XX. slide to Moving

our lead sets specific BNTXXX optimized XX% for backbone, randomized The and BNTXXX, melanoma all of formulation. mRNA intravenous to trials. expressed cancer into common in antigens soon our vaccine a four encoded advancing of six FixVac delivered Phase patients. RNA Our lipoplex This II be about in four candidate, antigens in immunogenicity product encodes will are

XXX a namely in or X Phase T on in study support BNTXXX for CDX baseline combination persistent and melanoma. need X medical with The II as or patients more and plus with three cell trial. CDX stage global patients is published in study randomized even previously data have into responses be with evaluating cemiplimab data high and high collaboration experienced each and disease in endpoint durable shown CPI Regeneron's to compelling and anti-PD-X experienced unresectable BNTXXX inhibitor monotherapy provide slide to treatment in Nature, plus monotherapy. observed. This at rate will with responses BNTXXX been anti-PD-X the Regeneron combination is and arm. primary in I with arms strong advancement As that and promising anti-PD-X response in patients overall advanced a We a outlined a checkpoint melanoma evaluable so relapsed Phase X cemiplimab has Tolerable drug X BNTXXX these of safety, XX. believe patients setting, X refractory with in positive our into is objective magnitude

BNTXXX candidate cell that to that expected limit overcome CAR-T chimeric treatment and superior vivo a vaccine, CLDNX In resulting patients antigen moving tumors we demonstrated combination RNA thus with CAR-T Now tumor-specific I/II BNTXXX BNTXXX of cell ovarian, BioNTech's studies. therapies. and increased cell increasing is in to positive the in BNTXXX, cell target frequent in cancer. CLDNX gastric first the first-in-human transferred the expression its Phase the CAR-T antigen healthy the is in absence for antigen of amplifying CLDNX XX for without of due studies, adult those of in therapy in relapsed XX. tumors, such currently levels is I/II efficacy trial receptor and with ideal to slide endometrial with shows CARVac. expansion CLDNX and in then cancer. clinical of design BNTXXX Phase evaluating dose CART-T, CARVac, adoptively safety candidate. leads Slide use advanced and CARVac developed an and The efficacy short limitations high widespread with therapy medical testicular, and its trial is product targets or as lung, first cells, patients temper stage ongoing solid CAR-T was recruiting functionality. tissues refractory solid CAR-T to need and of trial persistence preclinical

We of for arm and clearance. level level completed the open is dose have three monotherapy next patients dose one with the

were ongoing underlying While the is from from have we pretreated. Slide of mild trial All heavily carcinoma, to The toxicities at this data of initial [indiscernible] we CLDNX a the Phase half To all were and very observed in trial date, monotherapy. treated CAR-T some ovarian diseases data the not with from events expected early dose observed XXXX the preliminary carcinoma, or second three patients. in this annual dose-limiting are cell that and data dose patients year, transient sarcoma first I presenting these starting testicular XX acute shows moderate. with conference. adverse the were toxicities any cohort

cells all magnitude patients. CAR-T X CAR-T that report CAR-T detectable and declined patient after revealed engraftment very cells CAR-T in weeks. in to cell CLDNX blood analysis an of We are two peripheral excited with

a six in transfer. Tumor For stable further, expansion reaching CAR-T was patient cell patient weeks fold expanded expansion with to a two or target was plateau X observed day patient seen. XX% three lesions X, this CAR-T onwards. from a shrinkage after XX cells reductions XX% of and for XXX XX-fold

from trial in while data are we initial half the look encouraging the So data early, second to and of the the forward very additional presenting year.

[indiscernible] and first-in-human for approach potential results against material, our strong or Phase CDX tumor-specific robust tolerability. XXXX, IL-X to by cells first androgen discuss does Moving multiple consisting new antigens T T personalized, program. patient. dose typically recognized the repertoire then relevant persistent cultures to important existing dosed high In off-target engraftment. a to tumor antigen I This cell BNTXXX to and call relevant adoptive which each custom cells, was expand I approaches to safety activate provide therapies. specific offers T BNTXXX therapy, approach. an support antitumor candidate derived repertoire neoantigen BNTXXX is used require excited now patient select Many cells this and accessibility therapy targeting escape on will is cell believe induced manufacture patient T in since melanoma ex adoptive RECON our Cell TIL advantages therapeutically in response safety targeted patient's memory a from the We limited. dose advantageous platform cell refractory in facilitate T toxicity. update the recognizing with in tumor. our of own risk reducing each are to to to several the and T over compared providing rely new patient-specific reduced not are peptides a unresponsive from We expanded. patient's slide cell antigen neoantigen metastatic sample. the in With the therapeutically which financials. vivo. T trial responses therapy to escalation to be believe terms targets, with patient, cells cell most but acquisition hand new peripheral therapy significant use for most antigens respect both bioinformatics to tumor over are has checkpoint compartment blood product and this, escape BNTXXX may on I'm of directly IL-X neoantigen the BNTXXX other inhibitor. T Sierk improved tumor We as each specific of CDX drive providing XX. fully autologous advantage April NEO-STIM We to and from the and approaches are T supported an

Sierk Poetting

on the COVID-XX with first were compared will €XX.X as start which for first Özlem. to you, quarter the rapidly XX. of shown the our XXXX. total to Thank worldwide. for results XXXX slide summarize XXXX our be of quarter of Total of million estimated will for revenues I financial due the first quarter vaccine increased supply the €X,XXX.X million revenues to I increasing

territories A our COVID-XX allocated under rights. Pfizer revenues As and shown of distribution our reminder, slide marketing us, breakdown been XX. a have commercial Fosun based collaborations, and is Pharma on between on

on share Our comprising preliminary and profit XXXX as milestones. Pfizer in an first shared €X,XXX.X gross the is our from partners' data quarter of and us recognized receive of commercial COVID-XX transfer a amount prospectively. which between gross like as figure on revenues may of sales million, sales our the collaboration represents territory, net be final figure, share include parameters, partners vaccine profit be would in phase collaboration to prices. we based Changes This adjustments data well estimated subject input as and

in direct Our €XX.X COVID-XX COVID-XX territory. to million manufactured also products sales of million vaccine by to customers revenues and include commercial us in our partners of €XXX.X sales our collaboration

an with €X.X comparable in R&D The The COVID-XX sales, increase period were to incurred the vaccine cost for to were due returning for XXXX. Now, related agreement. million back Pfizer sales first XXXX. for earned were to respect of include slide primarily gross of and million compared by as services sales, the was quarter us. program, with BNTXXX compared of to €XXX.X increase of by profit moving to for our were expenses quarter by the to purchased Pfizer's was to increase €XXX.X the estimated respect share those recorded of expenses initially recognized which million under quarter charged expenses collaboration XX estimated and the cost to to XXXX subsequently our million our first us driven R&D XXXX and of first which €XX.X in which €XXX.X million be to

in million first companies. As Difficulty] increasing further incurred shared new of XXXX the to share-based due as The for Social expenses quarter benefits Security and a and was for increase driven payment headcount, and costs from to expenses increasing increase mainly an increase the incurred €XX.X expenses recognition from of the an in arrangements, in well the was income €XX.X were estimated of €XXX.X [Technical were services, recognition of wages, two and million tax the comparable arrangements. between higher under rate headcount higher for are of the effective by quarter the approximately Social professional Interim benefits wages, new expenses using compared share-based and Security payment period income the expenses the taxes The expenses million XX%. as increase G&A annual for XXXX were first insurance equally XXXX. premiums. the under reminder, recognized

quarter profit of XXXX. €XX.X For of the net loss quarter first million XXXX, €X,XXX.X for was compared to first the net million

cash €XXX.X As of million. March equivalents and XX, XXXX, cash totaled

sales COVID-XX vaccine X.X approximately to payments in the expected track sales COVID-XX sales profit Based customers to expected expected gross we territories. from providing slide COVID-XX billion revenues to are vaccine revenues We our financial our our sales approximately remain collaboration revenues Moving current from This from related and to direct sales reflects of BioNTech vaccine partners' XXXX estimated to milestone on achieve XX. of estimate from collaboration outlook. €XX.X or our partners, on expected partners territory, the contracted in billion. doses, orders collaboration revenues supply

additional revenues beyond. to XXXX We related supply expect further first with deliveries place for for in in contract contracts XXXX, and

pipeline €XXX the to expenses incur for that would are reflecting XXXX million which range aspirations all expected million we reflect to of million of €XXX million. year the plan these expenses current to SG&A we guidance our estimated expenditures emphasize and base accelerate to our development, expect XXXX. to €XXX in projections. in up full-year to case are to increase especially like Capital to €XXX our to million. XXXX, second be range of terms of XXXX, for in And ramp the up half I the figures full-year for of broaden the In R&D to €XXX the

our that, to corporate Finally, for the XXXX with concluding approximately year please I corporate in note on terms of an And German development we remarks. XX%. that, expect tax Ryan full still update group tax turn of call and activities impact,

Ryan Richardson

Thank you, Sierk.

we in to quarter. the expand slide first XX, Turning to geographic footprint our continued

of Turkey capability a and the rapid response establishing we of in vaccine, resiliency threats. Asia, address commercialize to Asia with on in addition be to our partnership to for global plans government announce of XXXX in to footprint we even In COVID-XX Southeast for supply expand could manufacturing supply Singapore, today manufacturing to of the as our to to integrated pleased Southeast establishment subsidiary It are will regional Singapore. global our facility XXXX. future and construction plans, initiate headquarters the current site Asia regional add facility network. for in to in the a potential Singapore. Based a therapeutics with range vaccines early Pending fully produce establish a plan We equipped of form and facility novel be mRNA and a also part as expect to our the to approvals, regulatory pandemic operational plan necessary will mRNA

expansion, seasonal the three potentially year. flu third infectious to three is I of our three on in Turkey. a So, XXXX. iNeST trials in to milestones XXXX. by of Slide end we this to remainder Pfizer, Europe, boots our expected enter with States programs footprint and this trials end Phase wholly year, expect have first-in-human our program United owned BNTXXX, ground track start FixVac clinical year, expected of Phase and planned we the of pipeline initiated In the on and quarter of trial before vaccine XX with oncology building the the we start with Since clinical the expect initiate have diseases, remain existing the year. the this more partnered highlights We on our in Asia-Pacific II to in for registrational

We programs to year. the provide disease the infectious pipeline on multiple further moving are our and clinic plan throughout updates other toward

on we five Finally, up expect data programs and checkpoint our including different in immunomodulators, half updates to of XXXX, generation BNTXXX the in year. second BNTXXX, the next

our our of responsibility vaccinating remain supply more large a even X than on ramping XXXX. our next our people COVID-XX, In to building to of Turning this world, with remarks developing few COVID-XX in to more vaccine vaccine to up believe active therapeutic the world We immunooncology of a the including slide. diseases. our year hard the advance on the that nine are of mRNA parallel We to preclinical throughout of to supply core focused will in potentially and vaccines against against make and range infectious we have and quantities development happen. We areas programs. billion we on executing working closing intend a pathogens, goal pipeline accelerate

We of exciting this details course provide these the of some year. programs will on over more

a global around company ramp for infrastructure we and to open floor prepare bring the and investment to our intend the immunotherapy BioNTech conclude clinical, we manufacturing commercial with our world. questions. and teams generation biopharmaceutical into and Finally, up people that, up next to presentation as transform in And I'll

Operator

And JP your [Operator Cory Kasimov Instructions]. from Morgan. comes first question of the line from

Cory Kasimov

hear you. steps your see kind controversy what are Thank the all last you're curious potential impact you do the on for next topic? and to views I'm the front on what waiting of week and waiver as kind this BioNTech patent on here of

Ugur Sahin

status all, understand importance just of let we global of the me which the the have First we our of quo, distribution of the at summarize shortly moment. And vaccine. course,

including We have over more income delivered XX we than supply, the countries. middle and lower vaccine global and support our to continue to far so the countries

of our the XXXX billion So, capacity initial our was for doses. capacity, in range X.X

to the that really is income more only see to than And manufacturing near-term We X we have is XXXX. we doses of now doses capacity up existing billion XX% and from the middle The in to solution go ensure to scaled low countries. expected produce the network. that

network is United produced income also to delivered not countries. waving States the And and increased increase vaccine. and short of continuously in term or can which manufacturing that We the in would of our IP vaccines the lower Europe ensure have medium be supply existing the

So, any we setting take at will a of more, manufacturing new to manufacturing year, see in and set the process is up complex. one not up patents. value least waiving even It the don't

Europe from we already this network Asia. our We to manufacturing also are, discussed as morning, expanding

setting believe, absolutely need X in no vaccines the manufacturing China. up manufacturing be XX Singapore. there enough together are more also will in we for and And produced We will in vaccines waiving there in we other developed And the vaccines, our months, to is than JV patents. with implement next

Operator

Your next of Ahmad comes question America. from Bank from Tazeen

Tazeen Ahmad

ask just do the vaccine, future say, that formulation of rate the to boosters does in to beyond? are for more wanted would and do you If of the each that production necessitate you rate little vaccine the modify for manufactured way be you I Wuhan actual any variant me, for protection? to is original Or of starting, latter? the year the booster a that have the about For plans of thinking would bit variants need itself? booster. how sufficient change for have Ugur, the let's that your think the the next kind you change change of it any of And

Ugur Sahin

don't we At changing vaccine. moment, a need see for our the

As most the know, for neutralization. antibody in and the virus type we variants six induced more different than immune and we we've evaluated responses, neutralization done see evaluated last vaccine you have variants for response months, equal with the XX – almost

our also for of in have the data meantime We activity the world vaccines. real

For UK In real PCR Qatar our the world from example, against Qatar last real From XX%. with and publication that prevent you vaccine data, Israel confirmed of world Friday also a the showing real seen data more also world have from than showing infection variants XX%. we is that infection, data almost effectiveness. to able a – are XX%

normal an an African example, the have besides and experiments for also our titer increasing neutralization antibody titers antibody neutralization laboratory also also titer, South antibody in of against, We almost seen increase neutralizing variant. that

as by change the on only but at without regulatory see the all potential moment, new our any ensure framework we a establishing the for variants. would of see just that. are working as changing a to variant we robust to So, appears and a process DNA to blueprint moment kinds template And impact [indiscernible] the can at absolutely be reason process far we other the don't adapt manufacturing process, executing to vaccine, any

new for with a once up and vaccine. can the come new we without we have a supply So, decision variant, means any that of just template, production change variant capacity, losing DNA the

Operator

And Daina SVB your from Graybosch comes next from question Leerink.

Daina Graybosch

right up had. on you conversation follow a It's just the

effectiveness in against require that booster think select I'm the I you plan a you going wondering world how Qatar four the data? real that is get think decision was signal to you B.X.XXX, between that to predictive impressive clinic? can strategies differentiating larger you a XX%. really different mentioned Or this have trial? outcomes you currently Do Given immunogenicity on

Ugur Sahin

that get performing type immune really different that also against you clinical use is question The One what the questions. the we homologous this response is we if And of are is booster. strains, be, evaluating but trial mutants. analyzed wild course, will against

with a question also single will that improving that against then the that naive So, is have a vaccination neutralization the variants vaccination whether the assays. will and have that vaccine we variant with we immune naïve wild produce variant-specific is last to analyze in we subjects. type way able variant-specific the variants. And the with as booster – variant the question in response booster type then, answer evaluating the question responses. again, wild virus the a induces same in is responses variant of the a And subjects immune seen And

questions. of different are So, types these

adaptation Some strategies. of and scientific future also address questions are the

providing just of Some are our regulatory and vaccine pragmatic, framework. more a change enabling the

Daina Graybosch

that. on follow-up quick a Just

you'll when regulatory this forward? one against type variant, has have you all So the just best immunogenicity the what's the path, the that wild go data neutralization profile

Ugur Sahin

a path response. flexible really regulatory is the enabling No,

second in the to that enable one. sense the can regulatory set established of trial question the has variant That's based vaccine One So, objective whenever I is two of the needed. analysis scientific objectives. The a non-inferiority be the really just on path the trial that And not decision is providing is making. elaborated.

Operator

Commerzbank. comes from Daniel Wendorff question next from Your

Daniel Wendorff

shots to few largely customers on you like? given would certain regularity how and be be campaign of level in into elderly topic any you having appreciated. again? more have people So, younger of contracts the And the then it younger it much Would this do signed would would I have also XXXX, generation? mentioned Would idea, order be a view here, already looking vaccination shots follow-up people e.g. the with receiving question to immunity you think Canada, XXXX. been booster a currently potential booster amongst the booster be establish look

Özlem Türeci

questions do to while these emerging booster question. success of of immunity and yet believe mostly not regard to will out frequently and also this. developers authorities I These booster and are we vaccine policy decide. upcoming we the how value needed. full expanded roll These can about are world regulatory the booster data – respective protection shots, prioritization manufacturers be regarding likely responses potential when take be follow-up immune of or we real government. decided – cannot have as of questions we campaign, high this believe the that and from to variants, the concrete necessity With The reestablish a also shots inform us know will and against and about data by

Operator

Your Wolfe next Tewari comes from from Research. question Akash

Unidentified Participant

Akash. for [indiscernible] is This

about WTO's IP waiver. We question have one regarding

Thank WTO tech information published the share you. outside secrets to trade can information compel as such So, patent? transfer BioNTech undisclosed or

Özlem Türeci

Ryan, can you take this question?

Ryan Richardson

As information patent? the I Is release understood can beyond to question? compel it, manufacturers the the question that the WTO was,

Unidentified Participant

Yeah.

Ryan Richardson

little to precisely or hypothetical bit may a what resolution pinpoint think try include. a may it's premature I to not

is on our gone position IP our that that of a an the and we've was over something IP it's proprietary important part that Ugur, resolution into portfolio. by decade think for mentioned spent asset BioNTech, that's I earlier of is investment

However, vaccine in supply it's assembled, XX to nodes world. at our network. we bottleneck look that And it that already includes production actually our when don't believe global accelerating supply the or production you actually, that we the to network of have different

Atlantic next now try supply our into So, the great the Asia. to with on footprint today sides to already steps both taken steps and announced expand we've of

that So, I the will a it's but play out. tell to question, be little response early would bit my think how this to

Operator

from from Lee Canaccord. comes question our Arlinda next Your

Arlinda Lee

integrated had wondering talk a on in? a autoimmune areas what You immunotherapy was you comment recently I interested you'd that be on therapeutics Can bit? paper global maybe fully about emerging on a little becoming company, of your disease. like

Ugur Sahin

technology platform I mRNA vaccine the believe personalized shown have In addressing question, more the allow is which vaccines, cancer we which development. mRNA that this to our are us we is vaccines. – develop last a years, few classical direction general cancer our this

cells. We have mRNA vaccine CAR-T we to where now a program use stimulate

that's also a to used cell for can preclinical which that in shown are deliver and have the Then to to in direction that using mRNA the vaccine first T Moreover, the evaluate from So, means sure cancer clinically next is year we therapeutic proteins. setting the and be steps this address space. is will mRNA disease, vaccines autoimmune we [indiscernible].

mRNA now encoded we the more cytokine testing. first in have mRNA cytokines stated, clinical molecules As our are cytokine Özlem There encoded in pipeline.

We well as antibodies. antibodies, have as bispecific mRNA which encoded IgG antibodies includes

means, will of mRNA. clinical be pharmaceutical delivered our number expand certainly also we the And of towards to of market. that. we clinical pipeline development these certainly a And already by will that molecules accelerate covers So today some molecules the

Operator

from next Berenberg. question Zhiqiang Shu comes from Your

Zhiqiang Shu

to to it I in related self-amplifying Phase self-amplifying results that, you vaccine? in study. XXXX, plan about I'd the kind a a trial that ask version – to published flu mRNA I your you're in clinical testing forward to you vaccine was wondering Is move what with the a also share trial. preclinical like And in construct? remember the is I going do I recall, of Pfizer. mRNA is COVID

Özlem Türeci

working assessments, yet have be next in and we closed will we format the be are development used which self-amplifying from our vaccine disclose assessments. data mRNA specific the year there vaccine cooperative not together with the will on, ongoing flu for platform, to will platforms regard also Pfizer. platform vaccine of We example, which With sometime other clinical

Operator

And now Baker question. from will We Simon line from comes the take this our last Redburn. of

Simon Baker

may, a parter. two On if the P&L, I please,

those any rate was XX% indication tax year? close much. in utilized tax, intend the Or you've is the on Or later there the rate year? in quarter, carryforward is also inventory? rate. for rate related for Do to like good Firstly, expensed the corporate this the XXXX? a look a doesn't to previously rest the on to in given gross German gross the any And losses it the margin, tax of for run for the distorting factors so margin were effective use reasonable Thanks that quarter you

Sierk Poetting

This actually Sierk. some There milestones are numbers. in phase is the

contribution a predominantly of that we're is this a is sales in after it's keep already. a But bit split little like distortion. part – the So, Pfizer's showing gross XX/XX mind that

profit and Pfizer into So, P&L as we sales what a share as item. our comes

volume – call into why rata sell distortion, you like, we that it the that's there's with, the go So, but pro market. some not can

this effect. So, there's included, milestones is also Pfizer. phase But, yes, this the number, one and especially gross in margin from

calculating, this yes, comment partially is tax is this quarter. this And calculation. tax our loss of two, loss already lose one. we're The we tax in going the carryforward to already comment – are So, carryforward. They're we that in like, included tax have XX%

plus We are asset that year, last the from have actually we also updating with tax calculation carryforward. the the deferred loss tax

So, the in a net roundabout see will of end. we rate XX%

Operator

We for have no time. closing remarks. further back questions Maas Sylke at this to would hand to you I now like

Sylke Maas

to the you bye-bye. future. forward call Thank Thank speaking for you and joining you today. in look to We again

Operator

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

You may now disconnect.

BioNTech SE (BNTX) 10 May 212021 Q1 Earnings call transcript