BNTX - Earnings call transcript Q4 2020

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Operator

Good day and thank you for standing by. Welcome to BioNTech's Corporate Update and Financial Results Fourth Quarter and Full Year 2020 Conference Call. At this time all participants are in a listen-only mode. After the speaker’s presentation there will be a question-and-answer session. [Operator Instructions] Please be advised, today’s conference is being recorded. like today, the Investor Sylke Strategy. I’d your over Relations Now speaker first Maas, Instructions] to conference hand to and [Operator Vice President, go Please ahead.

Sylke Maas

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

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

shown be rate on current on not COVID These XXXX. for include, slide we As estimate X, during tax based are making forward-looking contracted presentation, today's supply but limited will current revenues statements. to orders, our several expenses, forward-looking vaccine, and statements expenditures

Annual our ability described Annual in Actual enrollment described from timing risks supply from BioNTech numerous on revenues, for we vaccine are which clinical capacity the programs, including the to our our fully in vaccine, data Our planned target XX-F, our estimates, and Exchange of the production most of XX-F. more Form differ next COVID-XX currently Securities reporting other Commission, our recent completion made Form and our trials, US vaccine results steps as filings the in BioNTech's to pipeline could initiation, COVID-XX with in anticipate. Report XXXX, those for Report subject

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

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

Ugur Sahin

decade. delighted and good and and less here than to in virus. everyone tackle developing thank vast discuss in year decision One planned progress morning competencies Slide the energy been I'm At enormous the milestones a highly-effective we decision head-on. introduce you be beyond. to ago, immune like afternoon whole today. I have a year world made important it the engineering utilized call XXXX witnessing early January was of We the platform the Good in to early BioNTech to CoV-X work have to followed amount an we vaccine our made we would virus This And year. we powerful rapid in and five. mRNA and XXXX. spread joining last a in and deep the over for the vaccine that resulted a of that

Now first reducing impact of positive that one vaccines year mortality. in we are later, having hospitalizations signs and already infections, seeing are the

what doing COVID-XX is are will come and In not presentation next. what work we summarize against will I Our currently today's finished.

BioNTech. slide to has by six. transformed XXXX Turning literally

million authorized been been than than March for now has use vaccine countries, more more with doses XXrd. COVID-XX Our XXX in as of XX supplied having

considerable over the product of given made commercial XX have research recognized milestone, fourth first we we investment is which a the sales. This development, major XXXX, During our and the past quarter years. in

company. biopharmaceutical integrated fully a now are We

have Germany. global built We capacity. scale built a manufacturing sales And force we commercial have in

manufacturing network. produce to in BioNTech’s to be expect in billion X of We able up own vaccine our doses XXXX to

for drug classes. in trials year, being oncology have oncology made and candidates XX different the made ongoing spotlight we remarkable we facility now are promising acquired Despite Many advancing clinical multiple we progress Marburg advancing ramping market. recently wave product, And be product BNTXXX. will it product has our the X progress second first-in-human in first quarter. plan year. XX our since and these we Further, trials up pipelines. of in the opportunities and RiboCytokines X products product We last our CARVac of trials Our towards started production We across X activity this initiate demonstrated COVID-XX Phase our trials. to BNTXXX, Phase for

co-op expect the We bispecific success be trials [ph] vaccines mRNA product our end employees. is [ph] Ultimately to our thus of X our into three candidates, this lead Phase by and entering will cancer randomized year. including antibody to our

XXXX our have establishment employees tremendous built year. US challenging again worldwide. with research development during we to our efforts I a over employees want of our to their a We and workforce increased global and thank And have exciting footprint hub. for

highlight to slide reflect seven. as takeaways XXXX. key want some on to we us I for Moving

it clear great pharmaceuticals mRNA potential major health address First, became our have to challenges. that a

class of vaccine powerful, improve While be of iterations proven working to we rapid the has first already generation new to further our mRNA products. technology with this are

a approach technology. based mRNA is simple not Our on

product these a technologies We platforms of broad not novel needs and on developing optimized a areas. best-in-class the medical for of beginning build the enable and did the way potency disease research single candidates goal idea approach immunological industrial more was in multiple than disease a pharmaceuticals is to Each precision to our a for areas. long toolbox address rather is of technology novel can decade pony, of for to mRNA trick technology various Our very based of platform. development develop precision from tailored that

of believe well-placed that field will immunology, is lead the we continue and Second, to BioNTech to revolutionize revolution. the mRNA

intend the space the opportunity we investment the in tremendous deep board the portfolio, in field. our see. our Given technology given based IP further vast We to increase and know-how

intend establishing like position. leading powerful to the We by partnerships Pfizer COVID-XX capabilities own that partnership strategic advance has faster. apply record finally, can products helped our not and to with we finally towards experience time, product on development learned market market. be And collaborators our intend pipeline innovation leverage develop us In from develop to we - our capabilities continue our in our addition, only learning model, our focus We Project long-term. the rapidly early and but to to learned our building that Lightspeed the products strategic in during collaboration

slide As depicted great ahead. we see eight, a opportunity on

will number expand and We of product pipeline the and innovative development the we candidates accelerate of pursue. indications our

developing prepared goal XXst Our disease additional a is oncology the and established infectious to new for as Moving drug slide class. to global launch to several powerful Later long five detail are more over And Ryan to some immunotherapy goal products we into steps mRNA will vaccines a this here now remains our business disease in areas. reorganize multiple years. taking [ph] long-term in our provide are remarks, build next powerhouse, the products century term, X.

immuno-oncology. term vaccines inflammatory autoimmune development see The will pipeline to modalities our range and rapidly infectious are medicine. area. mRNA the On of we technology. applications in in in and accelerate complement field core poised proceeds mRNA technology the of the term near of vaccines back for we our from believe generic high diseases COVID-XX this other diseases, Long in even We a the place intend to of traditional this diseases, to allow us in of industrialize validation the our field this

know-how industrialize to We in linked ability to we than built the use. years. have out often we mRNA [indiscernible] research area, to technology early plan underpinned at and is significantly in point IP the for is expertise a our target formulation covering and deep effort that It to coming the by and Primarily platform have board established decade. BioNTech course product and our the also over of our more research important portfolio candidate, is the this program it

prevent Phase Now The that our X were study our strong result demonstrated the older safety profile. slide the in high our the our vaccine. antibodies. conferred CDX poly-epitopic CDX vaccine well-tolerated responses, related demonstrated moving of symptomatic vaccine The our and We Key XX,XXX a a robust efficacy and both of vaccine clinical events COVID-XX then side believe XX ThX quarter. result safety multi-effector. trials first in The are highlight trial profile including all XX, T-cell can titers vaccine clear immunogenicity of approximately protection typical, vaccines years. T-cell favorable XX% profile responses. X this mostly was by frequency with in of is to that is contribute fourth to effects. BNTXXXbX adverse participants characteristics efficacy global induces neutralizing participants, XX% for with our in low Phase type and a factors

observational first and March our comes Turning between profile X to announced XX. by of exciting from recently conducted clinical the news XXXX. analysis the real-world slide Israeli evidence We XX an vaccine. January data Health supporting This of Ministry

the During available vaccine country. the this was our time, vaccine only in COVID-XX

critical and the study, was was our efficacy costs also Israeli the vaccine of effectiveness the to after Specifically, XX against context, disease, our out second XX% The point that dominant effectiveness by vaccines In from in XX% in COVID-XX this SARS-CoV-X is vitro death. COVID UK preventing of in shows two B.X.X.X also country, variant. it indicating and against At variant of vaccine the infections. important disease, the data player showed weeks against symptomatic time the this severe the data the Israeli supports at likely several vaccines variants. least asymptomatic hospitalization a effectiveness analysis that dose

in tested we activity published in the studies robust. activity We have different was was and variants. data South but The neutralization virus from lower, our Journal still neutralization the in three against against B.X.X.X have no all studies, and significant virus. New B.X.XXX-spike of these showed variant of African vaccine viruses the reduction England vitro In it P.X-spike neutralized

continuing emerging testing, to several In addition efficacy vitro variants. abort are to this [ph] we against in monitorily

is over we become indicating individuals already slide that required. We next over may may years. XX, that to This wanes endemic responses outlined be the re-boosting surprising, vaccinated evidence time. immune in As few disease anticipate that COVID-XX see not an

of regions. infections escape is new In driving that evidence in new addition, body many mutations variances, a there growing are shown antibody

are reach. key access Due As that we of at future an XX, that expand vaccine highlight focus for boosters, rapidly a rapidly mRNA the Expanding variant we and us, well-suited six to remains BNTXXXbX key need in next produced to customized likely result, disease. both on BNTXXXbX additional we addressing also play potentially slide a to vaccines. vaccines a as ability for designed, stage and there important be specific scale, role levers to believe is shown their the to believe here

The first supply. is

will we targets further supply priority. track to for on key doses. our this. believe supplier our label and is and a process Continuing also CCM increased owned-network. have we expansion [ph] of This X.X further our XXXX to billion bolster achieve require We are to improvements vaccines But

during older extended in The XX women. pregnant women for study XXth have program women, global to clinical pregnant gestation. populations our the particular in record in such will XX as age pregnant those resource capacity healthy trials participants Phase years of additional of We or and weeks vulnerable X XXXX

pediatric regulatory the of safety pillar trial submit We important data to to children is age Another test. in XX authorities suit our to up the from plan XXXX the years and the in second quarter. to efficacy

in XX to study years six has healthy Another started. children of months age

in also individuals are compromised planning We system. with immune further studies

geographic is expansion. level key Another

now up approval emergency Mainland, scheme. individuals BNTXXXbX clinical update has February, to I be additional been China. granted regions. in adults our more evaluate a of use marketing submission age. to trial in We vaccines X in and to in years the have In than moving able And conditional the to provide October Phase of BNTXXXbX evaluate vaccines of November, soon. activity vaccine Phase for exceptional initiated X age. XX started Health clinical in are to hope XX approved Our XX years In in under an China process approved Japan XX in authorization temporary regulatory our trial healthy or of started we Ministry to or now Last countries a Japan,

working vaccine to approach provision. than are and even access We centralized more broaden to

are testing emergency another we regions While remains focus. in for BLA second and in the are preparing quarter filing US work also antivirus regulatory in full Stability regulatory is submissions and optimization under XbX available the Further use formulation other key approval. expected. authorization

frozen vaccine undiluted weeks. to virus may FDA for [ph] XX the and few be EMA a up update period at degrees degrees transport celsius start Over weeks. minus past of a XX The and approved that our minus to US celsius two

updates profile months. few stability additional next expect the We over

We developing of and lyophilized with term formulation profiles. ready-to-use are improved stability also

required ready-to-use currently do tracking development to the expect are and fast be additional formulation. formulation studies We not clinical for this of

the evaluate lyophilized immunogenicity we we formulation, the announced safety to start that formulation. today will For prior of and tolerability a this

the data to and from pilot safety cost this against responses newly [ph] of COVID-XX immunogenicity emerging this a aim The circulating to variants. and over responses We awaiting to prolong the QX vaccine. understand time, QX potential trial of XXXX. in our expect address effect to the of dose been third first by or are of booster we immunity Antibody immune caused for the veiling

variants to be the evidence Phase our this, the group called that a dose variant reference necessary. I approved or should now An South we our further and dose adaptation As key to South XXXX, of FDA African spread. to mentioned, this March. will an update sequence the the this for BNTXXXbX is the describe of protein provide commercial an the the have March against manufacturing African against protection, no COVID-XX Sean Despite variants third to two supply future. study variant the X/X/X need the is against participants by status. third vaccine comprehensive The turn amendment global included to receive will of of over of these an of duration on vaccine the start discuss variants version carrying so to protection to of to protocol in a concern doses additional emergent and arise address in modified concern. additional against part a emerging developed today, there's variant current emerging of identified and enrolled naïve is strategy vaccine protection that In potential end of trial expected BNTXXXbX to of variants call of version order spike

Sean Marett

manufacturing to process filtration go We nine COVID-XX and to in XX Slide XX sterile vaccines. can production filling Thank you, DNA period Ugur. from days. its flexible shows about

required less be than bulk drug from can from manufacturing Although the weeks. XX,XXX the are substance, done to two template manufacturing to [ph] [ph] steps mRNA the overall DNA finish in program

deliver Following five and ready production, can we quality another the weeks, four and to vaccine. control release then to are take

by manufacturing rapid allows we new vaccines a providing couple needed, done and scale pending can advantages within for new of mRNA a can simply the it need regulatory variant overall up of if technology of Unlike of to of of a the the [indiscernible] approval. be DNA our template adoption without encodes which This adapt One variant. variants. the is the to weeks that our production, and new process vaccine traditional encode a

manufacturing short to respond demand. I would advantage with we or us time. Thus like technology the can point provides Another to quantities lead out, with market a increase decrease flexibility our manufacturing to

Moving the doses States an to we exercised have billion dosage, additional we XXX announced slide to the Recently, X.X on firm XX, to that date. orders bringing XXX million have United total doses. for its option million

commitments XXX with of be states additional are worldwide increase This the end also the the doses of XXX with million additional XXXX We further option for supplied an doses. that an an delivered announced to doses member to million, EU additional XXX be to with brings by XXX number up to million ongoing. for EU total the will further to the doses. potential Discussions million

to from manufacturer announced including Marburg number prices supplies increase target vial, we with the been doses Marburg production sites COVID-XX production capacity drug approvals an site billion five in March excess year. to optimization vaccine Marburg. of process to doses manufacturing facility. CMOs, in additional factors a of able continuous of the to in the that increase our of which billion facility up initial to EMA optimized year, doses The we've up million to our mRNA approved vaccine operational. doses XX, increase the driven one manufacturing COVID-XX the and the able doses. six annual initiation were XXX at [indiscernible] manufacturing Beyond of efficiencies On operational was by capacity fully were by largest annual increase the the to of make X.X last Due to per vaccine, X.X at we expected manufacturing up goal XXXX. But capacity The product was billion for initiated in BioNTech’s X our once worldwide to

of vaccines of to manufactured of expected the The be in first are in delivered BNTXXXbX XXXX. to the plan batches half million Marburg up the to doses half first site The XXX second produce at of April.

Lastly, taken our step strategy Germany our and first we vaccine for COVID-XX have in executing commercial in our Turkey.

for from While BioNTech world This call the product commercialized Pfizer first the the of the over I’ll time outside that has turn on to responsible of rest its is pipeline. now to Ozlem is update the China. an pipeline. our quality provide

Ozlem Tureci

Thank you, Sean. And hello, everyone.

updates in on selected As the usual, and provide to I'm time, of going programs. interest

other Commission Exchange of oncology being refer the the details to For on Securities US our please status filed our today. annual programs, which report with further is

the some to COVID-XX we our pandemic see ongoing from clinical continued As to impact expected, be have on operation.

been the year. studies. some in present immune of constraints, Slide these enrollment in trials there outlines oncology XX this new sets Specifically, data several strategy. and our to a multiple Despite expect has initiate our slowdown ongoing we

Our all strategy modulate to immune stages. We the see is stage, product based The with address response. blockbuster a reached opportunities six clinical different and have platforms disease target on our Of of combination. technology cancers stage approaches programs several now by in range multiple first-in-class synergistic candidates. clinical broad the therapeutic for cancer potential XX to

EX human In with permission therapy XX. with to next EX and during The with advanced prior FixVac candidate melanoma candidate in of forward trial and BNTXXX, will PD-X Regeneron, stage with in FDA shown BNTXXX programs or a we the later FixVac X for randomized encoding progressing the the trial advanced our product move [indiscernible] Starting is inhibitor. evaluate papillomavirus Phase product expect slide trial. received a February, to first XX. mRNA with combination in of treatment Libtayo the US of melanoma, start the from are Libtayo monotherapy half after patients vaccine BNTXXX and proteins Our EU XXXX. on BNTXXX, in we our The

head trial squamous a a start neck X BNTXXXin to randomized with with half pembrolizumab. address combination in the versus expressing carcinoma, unresectable BNTXXX BNTXXX required the hold combination XXXX before PD-LX X combined Phase the X will subsequent clinical and with metastatic on evaluating or anti-PDX the pembrolizumab to designed demonstrate expect with run data and partial of has Phase monotherapy US are cell in as a These pembrolizumab to in positive recurrent of first-line the been treatment of start EU. trial and We of not HPVXX patients safety first the part portion the Phase the trial. in and

or our platform Genentech. is which Roche, individualized neoantigen immunotherapy partnered specific Moving iNeST with to

Our context patients has partner X are resected options. with cevumeran. treatment of treating The Phase name in international challenging these iNeST trials with planned disease product previously early of caused to for Phase the melanoma timelines along and first-line and X X candidate BNTXXX the tumors autogene updates the with in not for expected given made pandemic in year. stage the early discontinue given iNeST and landscape Genentech strategic decision remain approval Data ongoing. We has been Genentech options cancer this trial trial non-proprietary other evolving in results evaluating basket the lung are solid cell cancer, trial a Phase high-risk patients [ph] [ph]. non-small to We our

One adjuvant development options early testing is of in disease colorectal cancer. the these

best a Phase strongly half colorectal the high X stage in of the We disease positioned surgically the trial or residual first or earlier setting/. could that adjuvant patient Stage resected cancer. be risk expect Stage We tumor X to first X positive, believe in in minimal DNA dose circulating randomized year evaluating BNTXXX setting iNeST the in in

partnered program, Genmab. Moving next-generation immunomodulators which checkpoint to is our with

X-XBB GENXXXX. in first present potential be called XXXX the PD-LX Phase first-in-human a the We X/X to second of expect in update data conditionally half for has and to BNTXXX targets class. the and trial also BNTXXX, of

moving for to immunotherapies, seen across Genmab. very by with year's Given the need indications. oncology [ph] the date the forward product conference SITC encouraged and checkpoint results we believes last this unmet program potential improved look We presented at significant forward remain has to multiple and

data the which from For of second BNTXXX, we X-XBB, the in Phase targets to XXXX. conditionally X/X trial present CDX ongoing Gen half plan

in We of of upcoming Cell for has describes ASCR programs data maturation the or action that CARVac neoantigen extract BNTXXX patient am first-in-human program, dosed different transfer trial in boundaries the are first we In of to beyond an first shortly. patient melanoma. the the CAR-T to unresponsive metastatic our in This product We presentation from from the enter trial in our therapy our across checkpoint also will meeting. greater the clinical to of technology, patient X abstract of effector accepted first has cell detail activation testing. this X-XBB four that the I to program dose will inhibitor BNTXXX. and cells. our in to this in efficacy BNTXXX discuss advance conditional February activity discuss XX mechanism dose the clinical and highlighting preclinical report for for tumors was that entered potential refractory expect T-cell Phase and shortly. been an also announce The also I technologies detail which February evaluate XXXX, BNTXXX, NeoStem has RiboCytokine to a will program first provides solid first with [ph] first enhancement for pleased Phase first addition, candidate at patients pleased In individualized induce dosed half I T autologous Slide BNTXXX, innovation overview [ph] current [ph] of in CDX product function. and the dendritic trials specific X with in our of features adoptive T escalation immunogenicity safety testing.

with slide Phase trial BNTXXX and FDA expected as the was X by approved X RiboCytokines expected exclusive RiboCytokine, with the the X. X cell that solid second barriers multiple an allowed our of is T in to Car end expected healthy RiboMab active show another RiboMab, functionalized cell deployed cell engineered its T product chimeric which program, receptor BNTXXX X Phase expression FDA half to in and in tumors solid start therapies, high BNTPXXX Phase administered tumors US and to One for of the with two to the overcome our stage the with therapy Claudin therapies are details restrict plus into [ph] trial antigen more BNTXXX, XXXX. [ph] in also start program therapeutically BNTXXX immune specificity antibody February, t half BNTXXX, intravenously and and frequently expressed absence adulttissue, our reach our to recently first multiple proteins binding in IND widespread The XXXX. RNA-encoded domain BNTXXX For use and derived Car solid second The the consists of of in tumor liver with Starting BNTXXX IND. is our is therapy claudin the in tumors. the candidate antigen. BNTXXX our efficacy high its XX, claudin Car cell of patients a in trial for clinical sensitivity candidate cancer for first ideal in combination, medical first the from vascular is cell X with due to an need while are concentration. t of components. compartment particularly

also includes In [indiscernible] of preclinical a X-XBB, recognition CAR-T believe the BNTXXX co-stimulatory X of cells. engineered demonstrated repetitive survival we CAR target which second The domain generation killing ability studies a may prolonged positive and cell. claudin be strong scaffold

known FixVac from full of component claudin slide target. to the is proprietary encode vaccine studies namely CARVac. lipoplex on shown technology the CAR-T cell second our a CAR-T XX, named We X, amplifying new our RNA- As length use BNTXXX

surface preclinical for cells CARVac therapeutic CAR-T stimulation in control of Car T results mRNA is strong in lymphoid delivered that to presenting for That This RNA- in and persistence secondary [indiscernible] to by specifically frequency the expansion of superior cells, administration Repetitive of ideal cells. the liver cells. of its mediate lipoplex administration of X levels. intravenous some phenotype is cells recognized cells also the keep on lymphoid of expression the on Following context these increased in T those provides claudin X organs. engineered specialized memory functionality acquire Car T compartment which the antigen Thus in adoptive expansion claudin models. of allows for residing

related non-small will optimistic are therapy [ph] toxicities, is while of allows persistence is trial is of [ph] relapsed therapeutic cell at one overcome claudin part manufactured of potential in cell trial Slide Germany, for dose is the positive is our BNTXXX. an design facility second dose monotherapy, restricted Once has recommended of are year. Phase trafficking patients extensive to example which manufacturing our testicular, or and with severe cell We trial T This X IMFS tolerated of from T Phase determined certified for CARVac solid to expected as claudin Car Car suboptimal synergistic dose well Initial recruit modalities of in includes refractory to But excellent cancer. clinical that escalation half trial which key tumors, CARVac. X is dose this [ph] activation this the advanced trial a material approach trial with our Car combinations. weevil X the The and X of Phase gastric within the as for this challenges claudin The T gene capabilities. tumors. the X in [indiscernible] shows expansion XX X therapy, the data GMP and endometrial, cohorts, cells lung, the combination claudin or X maximum with solo in ovarian, cells

nucleoside-modified dose example another with for oncology current approaches. pipeline the and IL-X associated bio a challenges total are survival, half necessitates T class from limitations is increased ability of XX shortcomings. with therapeutic Encoding a cytokine protein. their designed results describes life impedes producing immunity, has to [ph] IL-X. improve and therapeutic design side often effector is cell supporting fusion to them efficacy low which toxicities. properties cytokines our limiting these the that This short in The is of entered by testing. high and cytokines relate optimize use candidate, interleukin-X clinical of slide on therapeutic right BNTXXX RNA of first patient our RiboCytokine mRNA mRNA Major the another term the drug RiboCytokines optimized and dosing, activity immune BNTXXX, which therapeutics in Our pharmacokinetic to The an key availability. address based in differentiation, encodes and proliferation, and functions. of addresses frequent slide

been anti-tumoral T designed cells to [indiscernible] BNTXXX has Importantly, stimulate cells. without triggering

standard As cancer neck, with as hepatocarcinoma shown lung ongoing therapy no care features combination therapy small with standard PD-X or in cell on cancer. dose available Phase slide anti head [ph] escalation, combined types solid non carcinoma and in renal XX, such in of [ph] X trial monotherapy BNTXXX cancer other will the cell squamous be and tumors of TNBC

of the I product from version of for COVID-XX years of provide and it. from financials. creating demonstrating one just first the to based they RiboCytokine the used into that technology the the are over will hand quite Sierk While our an and to vaccine. [ph] high know-how another mRNA I development mRNA call went Again, platform our our RiboMabs now the diversification mRNA differ featured, and update many are obviously approaches, on

Sierk Poetting

estimated of start €XX.X Thank the slide total and our fourth revenues, XXXX for will compared on be XX. you, summarize full the for Ozlem. to quarter year as I million €XXX.X I will to financial which the XXXX. of with fourth fourth quarter the XXXX were results for quarter shown million

for new agreements part total revenues were recognition revenues Pharma, the Fosun increased year be XXXX, of revenues collaboration our the of Total against For the to as million, estimated Pfizer of million with €XXX.X year COVID-XX. program under signed €XXX.X to compared to of full vaccine and full due our XXXX.

vaccine total COVID-XX drove significantly our revenues. revenue generated commercial Newly

revenues the reminder, slide A collaboration based territories a XX. on the allocated is breakdown of between on Pfizer have under distribution our marketing As and commercial companies rights. shown been

COVID-XX Our profit of in territory. [ph] note, €XXX.X Please million estimated a XXXX this comprise sales is gross of next vaccine the figure. from Pfizer an share commercial revenues amount

detailed will it our This data of estimated will the our on as receive adjustments only SEC. collaboration to may filed figure profit between they like us and transfer report be sales on and share input parameters be prospectively. shared in prices. in be subject gross and Additionally, as partners Pfizer data annual the recognized is final with preliminary based Changes

and us Germany. our product our revenues direct sales Our vaccine or million million territory €XX.X collaboration partner COVID-XX €XX.X of COVID-XX to vaccine commercial in customers include by to also manufacturer sales

estimated cost XXXXX, returning the slide compared fourth to fourth million moving of of XX, be the €X.X for for quarter to to to which Now of €XX.X sales, million and XXXX. quarter were

compared to production driven Note since products were at of incurred. of to recognized for not €XXX.X costs period period the of sales fourth the million year XXXX. €XX.X include Pfizer's prior R&D in million million for of sales year. estimated were time million the first by share earned the of of expenses XXXX, million, our cost The and profit increase the gross €XX.X COVID-XX €XX.X was to those vaccine respect to sales, of which expensed cost compared that with pre-launch for R&D For the cost expenses quarter to €XX.X be estimated sales include related XXXX, us. are in as do for were the comparable by

was year in the XXXX. primarily full our of Pfizer year to expenses for under of R&D The the the related R&D share terms include agreement. program. R&D to due expenses the our €XXX.X increase full of increase XXXX, collaboration For million, to of BNTXXX expenses expenses €XXX.X million an were compared

addition an As development the supplies expenses XXXX. to a are comparable Inc., contributed the acquisition and to XXXX, were companies. as for US fourth benefits US-based as compared our higher leading the headcount in BioNTech in security contributed date shared million And well between €XX.X for purchase of million expenses to laboratory social from Higher increase. subsidiary, our wages, costs expenses. reminder, the period equally expenses to for G&A in increase quarter also R&D of the two €XX.X

G&A full headcount increase mainly premiums. higher professional increase period. to year services, due the insurance expenses and to for year prior expenses The XXXX, an for expenses compared social was the of €XX.X higher in security leading million, wages, €XX.X were and higher For million to benefits

contributed In of BioNTech the US to addition, Inc., expenses. our date our acquisition subsidiary, US-based G&A from also

recognition tax approval of having of for deferred assets was authorization been reevaluated. COVID-XX authorization, the vaccine or granted Following of the emergency our conditional use temporary or marketing

differences tax tax As recognized of to tax with and of December temporary respect XX, group losses were €XXX.X tax XXXX, the the with million German deferred effect. net assets accumulated income

profit net fourth loss fourth net a showed the compared net million This XXXX. For for quarter XXXX €XX.X million. of a loss of we quarter of the to €XXX.X

equivalent a financing €X.X strengthened for our net which We showing year compared position which For million, also a the period. successful from the of will cash result XXXX cash and XXXX of million full strategy growth. with of XXXX loss profitable XXXX, billion, the as profit we're ended in transactions net prior year of €XX.X our execution accelerated be of €XXX.X to by

partners, outlook. direct partners in estimated revenues BioNTech are Based doses, orders COVID-XX reflects vaccines our expected profit expected revenues sales payments expected collaboration estimate approximately collaboration slide €X.X in approximately our X.X to partners’ our sales from we share moving revenues XXXX sales outlines territories. COVID-XX from the contracted the XX, billion that from on vaccine milestone from to and COVID-XX supply gross of sales Now revenues of related This financial of to expected current providing territories, our customers vaccine billion. collaboration to to our

related to further revenues XXXX. that again address X.X increased I targets point for full doses to capacity We to billion the demand. we X.X manufacturing expect would have year to like to able deliveries out additional for from be supply raised in XXXX contracts our

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

Finally, note of XX%. we tax German full please corporate that approximately expect impact tax group in terms XXXX of tax rate year the

tax tax to Ryan I XX, with that, We XXXX. to have accumulated €XXX the turn the December approximately call German of respect carry-forwards loss group And as with million for concluding remarks.

Ryan Richardson

you, Thank Sierk.

to XXXX our XX slide to strategic priorities. Turning

over this and Our in large aim COVID-XX to a our to people to it vaccine XXXX. supply X is in be year immediate position quantities in supply billion

to our pipeline our in COVID-XX goal diseases. beyond. a in our into XXXX leadership additional mRNA We access position vaccines build from proceeds other broaden we infectious currently and active and core is the to vaccine, With programs and preclinical of to vaccine, maintain infectious disease. work infectious therapeutic the disease development immuno-oncology have to we areas accelerate nine plan to field, intend advance against and While

course where broaden some more We to medicine, beyond, as of year. over immunotherapy others. in on programs of for details accelerate cell we of these lead committed ushering fields significant as ever in the opportunity therapy, a among cancer of and XXXX the era We provide In cancer goal remain and the our will to of individualized new immuno-oncology pipeline, BioNTech a we our for emerging to and see patients. intend

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Operator

is Ahmad first Bank of ahead. go of question you. Instructions] the line Please Tazeen Your from today Thank from America. [Operator

Tazeen Ahmad

Hi, Thanks my for questions. good morning. taking

you the needed, which, about thoughts different the give of for us COVID you any need parts for the couple boosters, boosters? As variants. would maybe little need the if talked it about that? can you a have people know of color vaccine, on to relates you've your work a about Secondly, with bit sense maybe Ugur more Do doing frequency

So variants go a you question basis, [ph] value to the all part do the be forward on the would two in that booster being the one present future? time. with still last dose shots, dose for the inclusive at you. from of switching see the And vaccine Thank of is, a

Ugur Sahin

the are questions. Actually, for this related. topics Thanks Okay.

time somehow antibody and that South titers of important are first a - we variants, and is see African with of dose we of over for is reduced now know that So, and course titers come the example, drop months. variant some the six variant first what up neutralization that interaction all, the first related all after go apoptosis because booster

is question response seeing maybe believe required. with first strongly to prevention antibody that [indiscernible] reason And to that need high yeah, we want boost months, stay the - vaccines months dose continue reducing that of the for this are pandemic, to we XX nine every of third new topic, [ph] from have the because I will testament every of it will mRNA months, data that infection, of doses variants chance key And get the a a every so, ensure the So upcoming the mutation. is to required So booster are of then also which and indeed months. full boosts, of second XX of a creating stable we one if somehow to that the you - vaccine will will with nine And booster now enables - will emergence person definitively is the in the we to how six parameters after control see with prevention months after data be ensure course, titers ensure months. With is booster it doses long need the the we regard course after coming be after infection. of the infected six immune to

limited, regard it a is And we dose, see that see single to - able yeah. With dose a against dose very to with full a So immunity. clear it’s that to data this vaccine, disease but this double second we have required in. our clearly is a protection versus coming vaccine provide is also single is

receiving regarded already And from dose if from then a have We prior received then the because COVID dose we sufficient. vaccine, published with question booster dealing be will short two someone we need single will everyone is year, data additional vaccine whether and more dose single not - is of had who the that situation the immunity have own regions, a population. in the before majority or we had vast And will are a vaccine. disease vaccine end or data, our this and of any pre-existing we in vaccine already many short as know

in a to about beyond we to and need are we two starting here. start there XXXX and about So talk no between vaccination. vaccines is talking And more now difference the dose any dose - single -

Operator

is Kasimov Instructions] Please from Cory [Operator question the you. of from The ahead. line go JPMorgan. next Thank

Cory Kasimov

up COVID? burden in that. just were boosters. morning, you. back Phase my are booster end need you adequately is that for and follow for a Good shots, the wanted process Thank made with trial around taking your you with saying you summer, vaccinated from Hey. follow I now to X of in longer or late early guess I your that just in Are variant you terms question. enable on participants for How of in fall, Thank licensure? who of And vaccines on the guys. the up they're Ugur, the proof protected boosters in no that clear regulatory matter to authorization comments

Ugur Sahin

Yeah.

part publications question, first and starting to correlation antibody participants I of seeing between time. are protection there now we So the to neutralizing titers more response showing and - over antibody no, and off the not the any did are a are a protected the the we not saying are say just that that of clear see drop

later. earlier. and And to diseases, to be dose accomplish come booster prevention for I believe then that infection, avoid therefore ensure would a not need avoid to to to - right strategy infections, see has the needed and we booster and of boosters in with will decline really we antibody would accomplish like comes have a right to the accomplish yeah, the of objectives to So the identify of timing to a course one dose, a and we its timing for they booster if a go the only population dose earlier of dose titers

you second, please? So question. that's part the Can second of your question, repeat the the first

Cory Kasimov

authorization? regulatory the is the clear and to burden of enable variant in how for vaccines process terms just boosters proof of Yeah,

Ugur Sahin

Yeah.

can have started vaccine. of or automatic less day, end doses it improvement boosting who booster participants, and the by be trial with received we two than approach automatic on a tighter had at So the a And our of clinical the - level of dose. is of based understanding protection that more already accomplished

Cory Kasimov

it. great. Appreciate you Okay, Thank very much.

Ugur Sahin

okay. Yeah,

Operator

the ahead. Canaccord question Lee from next Genuity. Arlinda of The you. from go Please Thank line is

Arlinda Lee

to data to maybe and Can that? designed? see? explain the we guys. is underway. my study doses studies What how single when Hi, that wanted I the might alluded you are planned hope something, double you booster you to and from see taking for Thank questions. for clarify please you And

Ugur Sahin

do Ozlem take to I the like question? you question or , the should take

Ozlem Tureci

bit please you the is audio study, repeat, right? a shaking? was It Can Yes. about boost

Arlinda Lee

Right.

the Can You are - that might you and double to would for booster the is studies that underway. and how address single planned study flow? variants we explain were What talking see please dose doses you see about hope that and data when designed?

Ozlem Tureci

as with with or already the started new for have submitted vaccine are assessments the and it in yet. now our participants that boosts we variants, One immunogenicity by after assess protects strain. how communality the we'll partly of whether regards a dose, boost amendments our BNTXXXbX who they These strain, couple not it this is ongoing for X question and started to case also vaccine assess trial studies already booster with after second and getting in dose is a a same vaccine the vaccines, and So African in current dose of example boosted where of - neutralization Phase prime need for a South subjects for its but of which vaccine with is and meaning been present questions. What or participants example, assess we of [ph] boost those vaccinated additional are who variant have so, test form, are naive from search we this immunogenicity of participants have tests these meaning the also studies first interest the circulating variants. African concerns. studies of with only use representative And strain, variant concern. use South boosting we other the also claim will of here test have protection them, stray strain - not with partly a of the will and strain will as And by

Arlinda Lee

Okay, thank you.

Operator

is The Please from from you. go Wendorff Commerzbank. Thank question Daniel of ahead. the next line

Daniel Wendorff

you elaborate And good we different a your thanks questions. development normal, there? anymore vaccine bit appreciated? technically color you. be formulations. - here it Thank time. maybe for Is longer effort possible And temperatures would Yes, much also you question at on something work So to the afternoon. refrigerator market bring it of is for have stand which a on? I to on the on my taking a is can commonality And stable where

Ugur Sahin

formulation. on I can formulation current a take are also the we working our use from the new - but question, okay. extending of on continuously Yes

existing be announced can So time degree. formulation stored that recently XX - we have the longer for at minus a is

We to X data this degrees. of stability will X formulation to at update regard also with our

that of existing So XXXX which ongoing stability we this degree. conditions we with X temperature had announced formulations second an the this longer the X the To allow for and into formulation the relax will study much new such at is are existing lyophilized that market formulation will in ready-to-use the formulation. half developing and formulation, to come

Daniel Wendorff

Thank you.

Ugur Sahin

Well come.

Operator

next The Please go from line Graybosch ahead. of question you. Daina from Thank a is SVB Leerink.

Daina Graybosch

variant. the question. Thank boosting you ask I'm the on to Hi. one going for another

B-cell impact affinity maturation the you that antibodies. you fit target on Specifically require a threshold? boosts? of threshold T-cells of titer us you come in and could that is, And they what's have And evidence that not maintain what save required informs wonder the where have suggested need multiple to I what threshold did and

Ugur Sahin

Yeah.

questions, great So Daina always. as

of So neutralizing antibody a is vaccines correlation and infection between by types the different really disease its emerging, prevention and so of titers. prevention of what

not antibody studies yet the And infection of in but start cells months. driven of maybe prevention more of responses, antibody it disease, the So are correlation virus disease are even is effectiveness, if titers. concrete neutralizing severe course vaccine also of clearly has vaccine and next clearly which the numbers, coming but efficacy these X and Severe is we in prevention - on only prevention dependent replication. provides now will replicate between disease have already neutralizing to come clear more this do and target publishing And and X – is titers. reached also responses a

including CDX disease, they we not neutralizing and but antibodies lower compensated where will – situation provide So they can in in this able be data will course prevent will T-cell there of science severe [ph] to - titers be to neutralizing T-cell the responses by variants, likely and protection effectively long-term come a which next that will be combination emerge is confident versa, particularly will impact months. with which the infection or be are will former XX vice X responses but titers, against to most

Operator

go from Thank is Jacob line UBS. you. ahead. next Please from question The the of Navin

Navin Jacob

to just said the there wanted XXX to XXX run data mentioned in is the outcomes Yes, one, very immunogenicity hopefully working missed just get required have based then Hi. but is it it to that I you is just exactly on, it, quick. would what that Any appreciated. to of regions” of the is you lyophilized study a you data> And know sorry, doses do are but you're that full or approved, I how study. be contracted wanted understand, just two I million thanks. or you're questions much these clarify “other I color version starting that of PK China? I'm

Ugur Sahin

the is second maybe question Ryan Sean, or first that’s take can and question okay? I if

Navin Jacob

ask I can that… Yeah,

Ugur Sahin

Yeah.

day, if of full the And and package, vaccine the this variant moment, the approve show a for guidelines can and a could for by the variant comparability vaccine be is, data process, data question [ph] be provide an When a can a could the against that comparability to cite addressing that same the ensure data trial. be how is without provide to So at this data, is doing new is package, there on proof in different on strain a additional introduced the data FDA clinical to that, safety the they blueprint on blueprint, approve process that guidances a for so strain. variant day, immunogenicity released so then then in and manufactured vaccine it titers variant accomplished same need or and the in requested way needed, strain variant - first introduced. variants the a new be this show this vaccine are

of for by general then But are the some the parties, by the and of to there suggested regulators each of the that's be at study end So but data way in day, UK required. progress. differences will EMA, sort

Ryan Richardson

an been been EU the signed have the on just under answer billion where included Navin Kong in We've that which million We've to currently approval, Hong is has the Macau, is figure. question, to we in X.X and doses committed the but process have Yeah. the to very have we XX at so China doses. included Mainland doses up XXX million our and we're supply approval partner approval doses, those in included China speak, also in X.X from as XXX committed Fosun, been if or occurs, not to billion million number. the least XXXX, doses little,

Operator

of Thank you. And the the from today Wolfe Research. line question Please last ahead. Tewari Akash from is go

Akash Tewari

much. so Thanks

has mRNA on some Pfizer its would publicly made So unusual - desire themselves. to comments I after argue go

about for on are when be there outs, any current either the your SARS-CoV-X at to reasons Moving PD-LX. occupancy How maybe then formation. comment formation forward, they can to that from kind higher of vaccine optimal you an is they to you. mentioned of and dose, efficacy million XX% trimer PD-LX of perspective? PD-LXxX-XBB why COVID lasts, wanted some XX% Thank a able long And solo develop point? have the at company it occupancy how your partnership, target one And candidate selected to for the that on trimer if translates a not XXX [ph] bispecific, and Genmab a important

Ugur Sahin

Akash for the Thanks Okay. question.

So the first question.

for partnership. all, the The example, opportunities. existing collaboration, management it an closely about conversations collaboration to a Bourla, also level, with a the have Pfizer project, ongoing future excellent we are we with teams daily of is really first collaborating question the about and COVID-XX have regard at first we Albert is, And the but with collaboration where

us, most has a understanding but doing stay a do comment decade, everything collaborations, fantastic for to do do COVID-XX is an to to partnership. room they it's we with said way. this like continue they think additional but It benefits, And to made projects this will that with same And come we partnership, potential partnership With no but would alone, to is need an for manner partner you a least likely you with together. that be next if see term like of is just at in us, excellent a don't it. and this - will situation the a other regard Albert And into about Bourla partnership. XX-XX long don't it. a to have in see is update do actually with We course, there of the this work the something we and to partnership any we to benefits enter where up the of in in a I projects Pfizer, lot But I have additional weeks. decided

Sean Marett

entering when other into And the any of we matter. talk other of to they're pharmaceutical just course I developing about a – a [ph] to And, remind over themselves. I to course, like to for in of collaborator that's of do just ordinary is, around Ugur, course, continue for course, thing I&P space know, important to add business the and been we thinking that, decade. in our of everyone companies that you sort Yeah, to we've like [ph]

Ugur Sahin

Sean additional… this Thanks, for

Akash Tewari

The trimer formation?

Ugur Sahin

plus a the trimer for long the with trimer - important conditional is or spot activation PD-X formation trimer in indeed PD-LX have is sweet XXX the formation formation sufficiently and microgram of the we time. the blockade, X-XBB Yeah, of

with that are we the the window. is also here seem with with component this functions this observed be this And responses have optimal activation arms associated antibody. both objective in to of exploit - of we So which or which dose line

Akash Tewari

much. so Thanks

Ugur Sahin

Yeah.

Operator

you. hand to back speakers. I'll now Thank the

Sylke Maas

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

Ugur Sahin

everyone. Thanks,

Sean Marett

Thank you.

Ozlem Tureci

you. Thank

Operator

Thank you. the participating disconnect. Thank for now today. and conference for That you concludes you may

BioNTech SE (BNTX) 30 Mar 212020 Q4 Earnings call transcript