BNTX - Earnings call transcript Q4 2023

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Operator

Welcome to the BioNTech's Fourth Quarter and Full Year 2023 Earnings Call. I would like to hand the call over to Dr. Victoria Meissner, Vice President of Strategy and Investor Relations. Please go ahead.

Victoria Meissner

Thank you. afternoon. good and morning Good Thank you XXXX and Year Fourth joining call. BioNTech's Earnings Quarter Full for

As slides issued reminder, section the be a the in of corresponding call during found press on our this website. release Investor we the this can we'll morning Relations be using

On slide, see you our statements disclaimer. the next will forward-looking

filings U.S. Securities and information statements other and the Additional risks are Commission. with about these described in our Exchange

the any speak date call this subject significant only are and as uncertainties, undertake update of statements. this Forward-looking obligation statements in we of risks to call, of conference to and no or these revise

On the Slide agenda find call. X, can for you today's

Co-Founder; following Richardson, Sahin, I'm and Chief Co-Founder; Strategy by the management and Financial BioNTech's Tureci, Officer. our Holstein, and Officer; members Jens Today, Chief Chief Ryan CEO Ugur team. Ozlem joined Officer of Medical

I this, over would to Ugur. hand like With to

Ugur Sahin

to Victoria. A warm you, Thank those welcome today. joining us all

Slide X.

vision [ of achievement the harness ago the goals. by only diseases, mission start company pandemic unique our BioNTech of emergence development to and ability particularly me of cancer. power the the founded was to with immune The the reiterating fight Let system human also years execute expertise ] vision our [indiscernible] XX but mRNA highlighted not our technology, showcased vaccine. COVID-XX and accelerates of our the to our This leading to fast.

the our across science areas. eliminating of and potential vision [indiscernible], realized Our was other therapeutic

infectious vaccine success establish are: development years. and Building And multiple the worldwide. multiproduct on contribute signs needs product this, medical our To business, covered for innovative building community a address in to To sustainable by of of against our franchise. forward our coming strengthen moving the cancer, pioneering the to objectives company, our technologies medicines aiming X precision to on expand and disease respiratory approvals

Slide X.

across by On digital We to initiatives. enhance and technology infrastructure our advanced clinical slide, XXXX. platforms, our I talk capabilities pipeline successfully in next clinical key want executing strategic our achievements about our and the

to develop empower innovative and oncology disease our and continue infectious We pipeline.

and Today, selling Phase Phase XX being we clinical in evaluated II oncology more multiple including have disease trials. clinical infectious in in III programs over XX than or programs trials,

excited particularly trial, clinical development Phase the assets ongoing. advanced several late-stage started assets III X pipeline. and in We year. our oncology our shaping to clinical mid- I'm in-licensed trials Most about II throughout X with achievements importantly, recent clinical have Phase and

as This has drug feature mRNA colorectal non-stem-cell cancer, therapies vaccines antibody and cancer, cancer breast novel such in cancer. and pancreatic adjuvant conjugate IO adjuvant endometrial indications lung and

clinical started human leveraging evaluated we our I disease, mpox. vaccine including technology proprietary in tuberculosis first care, Phase against mRNA infectious being In shingles, and candidates

the of advance we course and product development. candidates to prioritize to XXXX, aim late-stage Over additional

more We shift undergoing is regulation towards and from [indiscernible] trials condition. significant manageable expect cancer to therapy of power immuno-oncology a potential traditional antibody have a XX to ]. Slide of fleet conjugates currently shift transform advanced [ oncology also into therapies. The combination potentially This [indiscernible] X. or the earnings away leverages

as by not the accelerated proudly in programs in clinical our work of hard our collaboration the of a team This cars indications. willingness dedication as partners to participate and testament across patients various and is well our trust to study. the and X,XXX task, recruiting over starting IO XXXX, only that say As can achievements we we and successfully have on reflect new our also of but ADC our we patients

indications. success build recruit trials and Looking clinical into to and cancer, other colorectal breast XXXX, our as indications such we on aim cancer, cancer the patients ahead to across lung

placed patient-centric emphasis artificial data foundation, strategic machine and we science, medicine, successfully XXXX, acquisitions, a private we company. our a on investments, enabling strong public licensing In agreements towards have partnerships learning. executed building and X. AI-powered our intelligence progress Slide continued product, Since computational

and generative various research InstaDeep, of we processes. acquisition With the AI integrating supercomputing into AI are in capabilities

example, optimize speed up to For and our outcomes to biological predict and workflow. identify to and molecules clinical

initiating supplement DualityBio of as ADCs new In toxic base include to replace collaborations cancer new chemotherapy the technology with to or potential backbone our and a XXXX, highly believe treatment. combination Medilink expanded regimens we by ADCs Therapeutics. have We

and Our action IO collaborations have complement mid- our to with oncology late-stage toolkit with clinical our programs. augmented OncoCX Biotheus unique offer technologies mechanisms that of with antibodies of next-generation and pipeline

cell have front in collaboration this Auto commercialization. leads With at on alliance [ options therapy and retain We both candidate, autologous the aimed a [indiscernible] its CAR-T lead the of started Autolus and XXXX development with XNG ] collaboration support Auto [ strategic participate to ] strongly cell to programs. and T by announcing programs companies, in commercialization Autolus advancing towards XXX

have cell a positive tumor and types, we use in to development for This the our manufacturing to BNTXXX cost-efficient Autolus extend X is additional commercial therapy thus of the infrastructure potential. option plans Importantly, its closing of full relevance realize manner. to and

persistence, targeting and BioNTech's [indiscernible] could and a therapy of function CAR-T for CAR-T cell system BNTXXX CARVac repeated X. is of BNTXXX RNA cell or Claudin-X. example cell Slide one of [indiscernible]. effector is CARVac. The improve goal CAR-T the our is enhance To we vaccine amplifying cell short. novel develop by administration CAR-T and to

tumors. on BNTXXX Claudin-X positions believe trial clinical early presented clinical CAR-T on we to data a tumors. with significant that Claudin-X in make promising effect Recently, potential in suggesting cell the favorable Based positive patients the with a we impact CARVac has results, of our

expressed is to BNTXXX cancers, in to establish term solid tumors. a data Upcoming is path for and and pediatric, CAR-T as inform lung, in in including tumors Claudin-X indications. gastric, cancers strategy other. tumor other cell proven to establish will solid cell the development target first the therapy gene ovarian, as both new be Our Claudin-X

towards including XXXX, XX. we of mRNA efforts the been vaccines. therapies, play targeted classes these important curative believe role could if compound In therapies portfolio approaches. of potentially that adjusted Slide building immunomodulators, continue We will action, have a mechanisms of an in approved, that and combination

our thank the confidence I support. turn With for now our continued your that, success about like to would will who Ozlem, I over you to and oncology in call will your all pipeline. speak

Özlem Türeci

today. with Glad everyone Ugur. you, to speaking be Thank

of this cancer. [indiscernible] XX, our Starting and data ASCO journal. published year, oncology reported portfolio at on Slide AACR data And overview PDAC partners are readouts More and cell non-small across with In our XXXX, lung manuscript vaccine vaccine [indiscernible] and our adjuvant including in meetings, expected starting in our ESMO. our on in medical we we cancer the neoantigen-based at multiple on pipeline. BNTXXX, BNTXXX, individualized cancer an

our late-stage we XXXX, expanded to pipeline In considerably ongoing. and now trials multiple mid- advanced have and

readouts next XX months. is our approvals regulatory the and Our progress pipeline continue oncology in for to pivotal aim submissions to towards data

Slide XX.

and in are and on Here experience cell individualized mid- vaccine left top ongoing in this in BNTXXX, BNTXXX, development. BNTXXX, the were late-stage on trials cancer. lung to an an small breast cancer the ADC pancreatic our anti-CTLA-X The XXXX. space. of cancer anti-HERX-low cancer, the in low on IO X excellent HERX-low initiated

cancer action. for in-licensed planning and programs are initiate the we and in-house On the II to additional unique right targets Phase are IO and III Phase product vaccine well as candidate mode validated assets of include with ADC as modalities These on novel which mRNA based trials.

we shots have multiple believe goal. We on

contribute pipeline. future and treatment to clinical potential rationale, thinking for indications to journey. disease to to these We assets based and in of candidates, featuring creation on provide the along product explore evidence also derisking combination preclinical value sequencing plan in-licensed assets are Our and their different starting options towards our scientific patients

collectively X Slide XXXX, X targets directed ADC As distinct began in range candidates cancer a These against ADC building XX, shown now targets. of wide types. of that cover in we pipeline includes third-generation a

clinical platform believe used backbone Our we reason ADCs oncology our for become space pipeline to and of treatment. is modality transform adding the will combination this that broadly

differentiated the attacks assets objective and they acquiring of their on broad potentially may for address. was profile, the cancer covering Our based strategy market these specific multiple

our BNTXXX, is a ADC. is in clinical ADC, also targeting pipeline. of advanced most frontrunners our It our HERX one

on inhibitor. is a generation to [ risk stability low halo generation It and therapeutic are to antibodies, of attached [indiscernible]. in [indiscernible] is linker a a an anti-HERX expanded [indiscernible] achieve that delivery, drawbacks stable of selectively overcome and ADC the humanized a target Now high ] regulated XX, by ADCs -- a [indiscernible], [indiscernible] high to first of DNA BNTXXX drug We ratio that achievable antibody second comprised aims first covalently [ of Slide potent ] [indiscernible] proprietary window. IgG via

of payload. but of regardless these their inhibit signaling BNTXXX cell neighboring ADC on HERX of surface the cleavage is killing tumor of HERX only also the of linker by [indiscernible], internalization membrane expression not of binding HERX levels. and release cells the to killing The effect tumor HERX X followed receptor contact, bystander of permeable

efficient HERX-low stability, free payload observed lower stronger in with preclinical animal payload antitumor model. [ circulation ADCs within and and including more other have in studies cells ] to tumor In of activity, levels higher and models, BNTXXX release was first-generation

trial On advanced tumors. is Slide clinical Phase evaluated currently being The BNTXXX forward expressing solid enrolling I/II the XX or HERX now, is pretreated to part I/II Phase a patients of expansion expressing solid dose advanced with study metastatic in tumor. signal-seeking

than Phase of I/II received this more February trial. year, of in As this have patients XXX BNTXXX

in The presented in pretreated HERX activity We in with patients in we cancer. with antitumor with Based patients in Responses reported the study green registrational patients endometrial expression potentially marked findings, this and and ASCO cohort breast heavily preliminary first have were status. treated solid levels these expressed dark data right, dose on our different from trials tumors. cancer different on at observed with were HERX year. last initiated

trial the in of of disease XX which a our an XX% medical rate control means control of with cohort thus HERX-positive of intermediate that disease response a showed breast and high I/II need, cancer low XX.X%, XX, have objective with rate rate of rate refer response and an cancer patients objective Phase levels cancer, patients of high had HERX expression, breast XX.X%. Slide On XX to particularly XX.X%. The and

chemotherapy XX Phase well events progressed tolerated observed data, patients adverse whose [indiscernible] lung in all the X out and manageable. patients. chemotherapy. X [ CDKX/X in setting be Grade HERX-low occurred was ] breast investigator receptor with disease a in cancer, inhibition these on endocrine prior BNTXXX this on versus [indiscernible] to has with naive hormone ] metastatic Interspecial therapy we of of positive III of [ BNTXXX initiated of Based were study disease

cancer. The in hormonal on therapy. initial per As Those U.K., U.S., diagnosed and being do are majority the achieved [indiscernible] of treated with remission therapies are get XX, the with breast the XXX,XXX the Japan, not of approximately and those targeted patients that [indiscernible] chemotherapy. cured for and year Slide shown

from antibodies meaning substantially been X/X that First of positive. currently with of levels benefit expression patients, XX% XX% HERX-low only patients More therapy. new patients HERX, remaining targeting designated first generation ADCs recently, for HERX onwards. generations directed only expression intermediate shown with comprise the HERX-targeted of of high or line are from both as benefited breast patients ADC to chemotherapy approved cancer have [indiscernible] experienced HERX

and In our fast coming patients we with therapy. and All data as patients XXXX, trial ongoing endocrine metastatic or the breakthrough cancer, chemo-naive received second-line had HERX-low, FDA presented one received treatment advanced or cancer our XXXX. Phase cancer Phase [ endometrial XX targeting ASCO back with and were track we designation designation from to including endometrial September antibody endocrine more meeting. from XX, are I/II in III patients at HERX-positive immunotherapy clinical anti-HERX or findings the study, patients lines, endometrial In the from annual recurrent in [indiscernible] for ]. Slide onwards,

of with IHC pending an BNTXXX expression XX.X%. promising is The levels, was control of expression objective HERX which XX.X%, including which XX.X% different antitumor are disease confirmation. across rate X+ shows low rate activity response expression,

manifestation, synthesis adverse While profile emergent treatment is safety were was cutoff data is safety manageable the events no conclusions and to too the and less on ] new TEAEs small draw protracted just with frequent signals observed. [ and early

a targeting immunotherapy [ treated XX, data be dMMR unresectable as patients treatment their patients clinical [indiscernible] a molecular chemotherapy combination treatment. status. on recurrent with frontline with stage with HERX Patients with cancer frontline cancer adding such overexpress therapies or as profile. HERX as endometrial endometrial can chemotherapy to Slide advanced X based Related receive treatment in and for ] who support

oncology advancements patient I of first-line on and is advance that our featured present, development with patients patients like is are there could the in the Despite of targeted late-stage focusing further XX. post programs progressed on therapy to this expressed reemphasize no to We At on oncology treatment to investments pave is tumor and the into way for aim onwards. include of next the for currently XXXX HERX. BNTXXX. Slide who slide. generation XXXX first-line from efforts treatment, the we contributing would our an wave that product launches will key for aim believe medicines the population initial recent relapse. our candidates with most approved This

our the Jens I'll Holstein. to presentation CFO, now pass

Jens Holstein

warm a who's everyone and Ozlem, call. today's you, Thank out to welcome in

to infectious successful another BioNTech novel year develop was diseases. for XXXX its journey therapies for on cancer and

Let main here. X me highlight points

global a earnings tax, diluted EUR per we strong and XXXX and X.X basis We cash market advanced of share X.X with a leadership. million EUR revenues, XX.X late-stage EUR financial total delivered we, With We X.XX. the our resulting cash, our again, in vaccine highlighted pipeline. kept COVID-XX of profit fully by before ended financial billion grew equivalents on And year approximately of security of investments. this, recognized billion performance, EUR

slide. Turning to next the

earnings updated to COVID-XX had quarter to collaboration write-downs amount through. our profitability, XXXX billion, XXX million While challenges to financial the call of EUR in were there revenue we our approximately our able performance In XXXX Pfizer. maintain vaccine around also strong, EUR financial third some we and were by our that navigate we year in X guidance year, last full reflecting partner, was

our recognized expectations QX, write-downs XXXX revenue In impact of for impacted accumulated negative Pfizer QX. a of compared line XXX EUR on to million, initial total for that to EUR million. our our negatively approximately XXX approximately top figure The additional

Write-downs ] [ have gross would the profit to the in negative a inventory impact related typically on P&L. EG

for our a challenging. our our write-downs agreement profit negative That guidance revenue revenue on effect BioNTech's Following figure. gross partner share have for made XXXX Pfizer, by

as infrastructure a agreement in to players and brand vaccine sales the COVID-XX leading expenses requires little marketing field. other has and the Having this, franchise, in believe, comparison to market. with the only has vaccine said very favorable low important the commercial COMIRNATY is, BioNTech advantage. that, This global related in is an COVID-XX in we

remain in respect of were impact in end the despite grew decrease we cash, XXXX the able cash profitable these and in equivalents to financial write-downs, Despite in billion XXXX. investments negative both XX.X our XXXX the at EUR revenues of our and to XX.X EUR year-end and security of to position compared billion

Please note a calendar that than of gross has X more the profit contractual settlement offset of quarter. the share temporary

quarter the subsidiaries States the In differs from ours. United addition, Pfizer [indiscernible] outside for

results now for full moving summary as be I'll to XXXX the on slide. quarter fourth financial and of next the of year XXXX, of shown our the

EUR in the revenues X.X months EUR COVID-XX XX, XXXX, ended X.X December XXXX. to X we For the recognized in for period vaccine billion comparative compared billion

our primarily For XX.X stated reported by negatively in influenced which with total by the year XXXX, our reached collaboration revenues and Pfizer, compared reported demand X.X market before, EUR billion driven COVID-XX financial to billion EUR XXXX. revenues. as write-downs was vaccine This our lower

year for XXX XXXX, to of prior in Cost sales in with of Moving line the comparative the million EUR amounted sales. to EUR fourth quarter XXX.X million cost period. the of

in For EUR the cost decrease the to the approximately amounted by drop vaccine COVID-XX sales close was XXXX financial mainly to year, compared to XXX X of in XXXX. The million billion caused EUR sales.

EUR EUR million the million quarter period to in XXX for the reached expenses development XXXX. for of XXXX and fourth compared Research comparative XXX

and to The acquired approximately of For the X.X financial amounted billion for candidates increase clinical development newly by year, variant vaccines. well progressing mainly the development COVID-XX billion in and by EUR influenced research compared X.X to XXXX studies was expenses adapted pipeline candidates product XXXX. as as our EUR

trials to XXXX. compared saw wages, the the financial future in higher the for and we existing initiatives, previous In example, head respective count in line and social to, support our expenses higher with also security clinical year benefits costs year growth

as fourth approximately General the of EUR for million to in for as comparative XXXX. expenses the and X.X period administrative well amounted quarter XXXX both

at The administrative around in expenses for previous billion, benefits level remained same as XXXX from expenses, IT by in expenses G&A EUR as resulting X.X well financial increased increase the increase security year, wages, year. the social headcount. slight mainly by and For as the general was influenced in an and services

million for the million amount an to XXXX. EUR of for XXXX fourth were in of accrued comparative XXX.X period quarter EUR with taxes XXX.X Income compared the

EUR For in XXXX EUR in tax rate billion The year's expectations around XX.X%, income roughly financial amount compared for last of was accrued tax improved XX%. XX%, versus X.X rate to our derived of financial XXX.X XXXX XXXX. with income line million year of were the year, the taxes with an effective

to of XXX.X profit fourth XXXX, X.X period compared billion comparative For the quarter million net EUR EUR in reached the XXXX. in

For to the year XX, profit X.X December XXXX, ended EUR billion in reached XXXX. net compared X.X EUR billion

compared fourth EUR the X.XX the for share per to for earnings X.XX amounted EUR XXXX comparative in diluted Our of period XXXX. to quarter

XXXX. EUR earnings in financial to For amounted diluted share to the XXXX our XX.XX compared year, X.XX EUR per

shows of to for This earnings in COVID-XX XXX in provided recognized by top. billion. recognized Let's the had call our billion with EUR compared continue revenues November to our the the during the in comparison million vaccine next slide. to around our Starting QX XXXX write-downs guidance X EUR year. We QX. financial of XXXX the with unexpectedly from X.X financial you be EUR XXXX actuals guidance Approximately collaboration partner additional

R&D Moving expenses. to

XXXX During strong below measures. for spending Lower November cost the a of as our financial billion, our were well X.XX nearly main contributor collaborations amended control slightly R&D guidance EUR as example, from have expenses billion. X.X been our of in, [ year, ] EUR XXXX

in expectations. on our activities and with in existing pipeline product infectious broadening line co-R&D XXXX oncology diseases focused in candidates Our accelerating and of our

expenses. SG&A to Moving

area. of reflect EUR to our SG&A During without million. the to the in on guidance monitoring million the jeopardizing revenues this end spending our needs XXX financial amended below the XXX were in EUR expenses, year, XXXX uncertainty slightly XXX recognized EUR future the we million we closely of lower Again,

CapEx. to Moving

in to million, building ranging majority line in investments XXX with EUR laboratory financial million. was to in our facilities is million capital activities expectations, expenditures Germany. XXX The from EUR our EUR whereof amounted the and year spending office related XXX to Mainz, XXXX Our operating for

Lastly, tax.

tax an XX.X%, mentioned during which our amended As financial annual income reached we of is the XXXX rate guidance roughly around effective already with of line XX%. year, in

slide, year Turning XXXX to financial guidance. the the next showing

key XXXX the for the now financial total Let BioNTech company's aspects me highlight Starting of some for Group. outlook the year. with revenues

XXXX. some We expect into a billion X.X in to range downsides and the take, X.X EUR range we estimate up EUR providing to for potential billion of total account. extent, today, revenues In

pressure write-down have but have above U.S. collaboration For ones assume rate QX, vaccination again, as our our for some by -- announced with largely revenues example, inventory in partner, price we Pfizer, write-downs that smaller same the the market, QX some seen U.S. XXXX. the additional again in faced, in hit the we previous

preparedness also pandemic the that in assume we generate from government German a contract We revenues with XXXX.

to For to SG&A XXXX we range are X.X of XXX R&D to range expenses financial million the XXX expected guidance, expenses in while be be million. EUR billion, X.X the EUR the EUR EUR expect our billion our of in to

Please with expenses related not in advice note legal connection legal other but in that the anticipated expenses. operating is in to litigations SG&A, external reflected

guidance any impacted deals, in-licensing be include, as legal settlements. but transactions for M&A ongoing potential agreements does outcomes collaboration resulting related not or judgment of or disputes may such or by payments the Additionally, from activities or future

EUR of Lastly, million expected XXXX financial for EUR to be capital year the to in the are expenditures range XXX million. XXX

be disease commercial operating company a infectious expenses XXXX, and In multiproduct BioNTech's will oncology footprint. our with into and a in R&D SG&A to increasing accelerate transition we

our investments we product that the our that, candidates. potential lift to portfolio in For we see of increase to want value

invest in-licensed we growth. of XXXX, In pipeline. fuel BioNTech's into will candidates bolster next our stage to to trials multiple later-stage This assets late-stage progressing we our in year,

paved registration more end ]. previously As clinical begin launch the XXXX to multiple this, the estimated [ by XX potential With to approvals, trials aim of have product XXXX. way with for or ongoing we mentioned, first potentially we in of

previously transition will to cost As a maintaining we XXXX in company, indicated, growth year while be strategy our discipline. for our invest which will during continue long-term strict

COVID-XX by revenues the during in year, will driven uptake Overall, XXXX. the be of vaccines our transition largely second this of half our

XXXX. do range expected ] all be sales, not revenue of expect consequence and to we [ cost into R&D expenses, As of taking the other account a in profitable and

Turning the profitable and next leading has COVID-XX BioNTech a slide. to business. Today, vaccine

this positive our from very In further As to its XXXX to COVID-XX on the value the you and aim goal variant alongside structure our fixed with business can combination see in to adapted market attractive in partner benefited results. to generation. our invest generates contributing vaccines we and slide, vaccine bringing coming cost years, potentially future lean

our In into pipeline. addition vaccine to our long-term oncology value COVID-XX franchise, we are contributing multiple with investing product creation value

Let drivers. me highlight X value

to to offers a first have to or And potentially We end believe have We launch to XXXX. that we diversified our in line. XXXX, registrational product adding for potential ongoing oncology of to come. growth pipeline aim plan trials more by clinical a XX the have top opportunities the thirdly, multiple years

our we Summarizing, candidates COVID-XX product long-term value franchise our company. for that believe will the creation pipeline drive vaccine innovative of and

talk some Our this the of Chief now transformation. Thank you. Officer, for through Strategy Ryan Richardson, you will strategic drivers

Ryan Richardson

our from Jens. path remarks, a our late-stage I'll programs creation concluding To to pipeline value important up with calendars. high-level oncology to a you, provide overview and prepared and dates on XXXX your mid- strategy Thank our wrap mark before few of the

underpinning highlight the opportunities slide, next strategy. creation value On our XXXX the broad we

as long-term growth. continue Our strategic XXXX, fuel we'll been asset a strengthened balance sheet to in further to has and serve

market-leading We functions. will across with R&D, our manufacturing leveraging behind franchise, vaccine and COVID-XX Pfizer to continue invest our commercial partnership

this basis, continue contribution franchise to cash a On to be product we generative. highly expect

reach Pfizer as market successful working could a and the are late-stage fall as develop which to We XXXX. in COVID-XX if trials, vaccine, with early influenza combination

We expanding diverse investments and into are pipeline. ramping up our oncology our late-stage

the in goal to end new ahead. potential with least deliver XX trials We at the year. by launches this of believe broad commercial this is multiple years pipeline initiated product have can Our registrational

industrialize expanding infectious vaccines we COVID-XX infectious this late-stage I have to trials. Today, by pipeline. market, continue to disease global vaccine beyond with to mRNA from Finally, vaccines aim we complemented address XXXX, we Phase By disease diseases platform first infectious in an unmet to clinical our X pipeline bring high invest vaccine our will need. to

growth. cash aims into Our diversified that sustained company XXXX to flow-generating multiproduct long-term deliver BioNTech can a transform strategy

today to little slide. late-stage III X Turning growth of like to are late-stage Phase II includes time would next and pipeline spend trials. pipeline. programs the potential that currently This I and the more on a mid- expanding in our

mentioned have registrational XXXX. with to the We goal trials potential have initiated of our XX-plus by end

updates include a several medical year. calendar cancer anticipated updates major were week These program at which conferences further IO busy on vaccine ADC expect at also and this programs the and throughout last for AACR, We year. updates programs other specific announced

therefore toward an important commercializing XXXX will our be year of portfolio. goal execution as oncology transition of we our

We onwards. address details to course cancer to more per forward Ultimately, sharing are unmet the medical believe range further can of on from mid- for see these year. one across throughout oncology programs indication the cancer across continuum. year types and broad we our and potential of looking XXXX deliver need our significant pipeline We a late-stage launches programs or the treatment

improve people on We for world. the expand and the to pipeline options our truly treatment by cancer oncology excited holds around potential are

the a In next on closing, be I year. this will like would important to investor holding we few slide highlight events

further forward expanding which We future. will artificial work on Our on This on of and Annual our on event, Innovation also and May exciting introduce we Series take on next XX, events in event look Meeting General intelligence a details the machine near field in new place the X. learning, November year, both to sharing place the will and October focused will take XX.

the would and With like for their shareholders to our thank open continued questions. that, floor support I for

Operator

from question your the And Daina line Instructions] comes Leerink of Graybosch first [Operator Partners. from

Daina Graybosch

and range update then could be if the the question. to the from portfolio? expectations for trials, have you registrational at follow-up. XX that maybe looking And these look of revenue XXXX you Thanks I I oncology forward by about wonder can a I even Yes. talk a potential

Ryan Richardson

Yes.

the list common tumors. think of they in is most And criteria on target quite that the actually is broad. those pipeline can I of multiple that that assets one is solid

range term focused that that, well assets the actually, launches. in means those XX long term. long that for collection for actually billion peak -- on EUR over those in think executing that our but our we're is first so And sales And in estimate -- -- of I now estimates

to that we're solid a tumor number. about can we that we're think talking think give prepared XXXX I So the address here we you not do yet landscape. double-digit But across indications

Daina Graybosch

follow-up and years? Autolus my with about advancing is the collaboration. talk wonder in you the then maturing how CAR-T business on see specific X potential scenarios I And your could Great. next more you Autolus for if

Unknown Executive

Sure.

with I'll So that, too. start

for that, XXXX, So as is our actually the had BNTXXX, vaccine we [indiscernible] cell primary higher which CAR-T rationale forward aggressively moving amplifier. with know, ended with as Autolus targeting was we on mRNA therapy an more you program, conviction lead

other potential in in but [indiscernible] lung also [indiscernible] being in and so need And refractory we've path unmet talked even positive about a in data a encouraging responses lead given and indication cancer seeing and tumors. the faster other setting and -- indications high the fast-to-market potential strong refractory we're as such cancer ovarian

of Kingdom. to the collaboration Autolus the the also infrastructure with ago, so manufacturing parallel, United years in explore combined manufacturing infrastructure had the through the assets Autolus us the trials in of States, that multiple more X.X sort gives we but have And pivotal in United we a acquisition that runway state-of-the-art aggressively leveraging [indiscernible]

early, encouraging. CDXXXX And approach could It's their complementary. it's [ encouraging. Phase but that data very their deal So is GDX the a of I programs. rationale. come in interesting ] be into find addition the first that's an we we incorporates couple to options in think, some CAR pivotal And the could that, at ], for [ Autolus' trial then We where the stage also

gives cost lean So allowing scale the forward. a contract multiproduct our franchise actually collaboration and us to the therapy to optionality into keeping accelerate fixed us in while cell BNTXXX

Operator

Chris Shibutani from comes line of the question next your And Goldman from Sachs.

Unknown Analyst

guidance? Stephen SG&A what year? one bit type indication? you ADC, the about on that from So your if And about more on just [ just financial of be think XX% give specifically had the in building that's wondering breast over what's the This midpoint, it's I cancer prior driving attractive profile side. increase clinical franchise? of a Can if that's increase to would then I is you oncology related the color HERX-low a for at ] in can about little just related Chris. out to on COVID talk HERX the or

Jens Holstein

the the I'll increase on one take SG&A that Yes. expense for XXXX. first we anticipate

You product have we're in potentially heard XXXX. planning from our us to launch that first

got up XXXX be those also commercial we've we infrastructure, in going able and specifically commercialize build U.S. setup course, invest compounds therefore, to in Of then in onwards. to that forward. to the coming infrastructure are in intend And the the to

Özlem Türeci

for makes interesting. HERX to The breast second Did that right? what cancer positive question HERX was, the hormone I ADC, low receptor get indication of

Unknown Analyst

kind expectations space. clinical for in would of More be attractive of type what profile that

Özlem Türeci

[indiscernible].

has our a ongoing. think, profile. ADC, trial, So in HERX safety our what efficacy III differentiable want is this which we to is see Phase And we

Ugur Sahin

just half And Yes. we profile that, on us particularly dose to allowing a HERX the X+ add is, provide is Ozlem important in of to population. is -- higher the have that we doses. what to And around shared population, which believe this HERX-low

that So rate particularly, plus position tumors. health here this higher believe and higher durability higher And the is cancer can objective point. other with positive at endometrial interesting, this we -- interesting well we cancer as in in HERX product response breast

Operator

Canaccord. from McGann comes question of the next ] [ Your Bill from line

Unknown Analyst

ability kind have to your share I about of market question the So forward. going on COVID a vaccine maintain two-part

is any just ability that a I'm that lot a previously syringe, RNA has out your know has prefilled noise that about thinking COVID. defend is? that just guess, I competitive in guess you're wondering I example, where for how widespread their but wondering Pfizer know available? how you've a And that seen [indiscernible] And if rolling advantage about syringe. grow prefilled become I there's self-amplifying of is Japan made I with for Just Moderna to, and/or given,

Ryan Richardson

Yes.

So COVID franchise. market above we in a and performed we the XX% markets market a believe of did strong very like XXXX some share having that in still States. for globally share We United see couple the pressure

our the out, had Europe, maintained actually As like in of market above in gains point have share we countries other in been share high also XX Japan, market sizable a very you grew perspective which number and a last from We geographies. volume XX% over pretty market share a months. also

feel To the maintain yes, that new the leadership players be do mark niche competition, of do question your we there entrants, continue expect we in confident mostly we XXXX, Going some a can position into markets. peripheral above to on globally. some XX% to

is I which prefilled important you point. also role the think that of syringes, pointed out an

it supply is of did year, also United of syringes. say And that preference files limited single-dose think the market the we in or of we had reduction fair prefilled sort some market year, clearly, supply prefilled to due as was but States, the in lack for share part the was syringes. of have Last that to in I last United States experienced well. we

elsewhere. into go the also to we XXXX, but taken supply increase we have As prefilled United States, of steps in syringes Pfizer dramatically with our

Operator

Your of next the from from line case question, Tewari Akash Jefferies.

Unknown Analyst

is Akash. for This [indiscernible]

two. have We

one COVID. is first on The

lower around of reported exploiting a vaccines COVID gross of XX%. that EUR margin, XX%, So with Pfizer, you're revenue profit than seems margin levels that is for EUR for given size X.X which gross your imply versus gross X.X previous to and billion it billion,

So the in is write-off QX? because of just additional this [indiscernible]

I competitor on your business, think, in what's and a Additionally, to COVID especially discount? the seems GTN beyond margin higher when gross view talk for 'XX [ your about ]

second there data at be soon? with will the are my AACR guess you encouraged quickly of pancreatic that in readout of I how consumers presented question BNTXXX for the outside pancreatic? other And And pipeline. any signals early is from is

Jens Holstein

Yes.

'XX manufacturing that are And you that that are is are for that of Turkey, have we that take exception trying the Germany the of And and to have first gross we in responsible you most come as just in To or XXX been around write-offs for. our activities you commercialization margin. last This margin for the this the share and profit XXX% means Let something because and quarters we will we to revenue That hit before will figure. we course, clarify, Pfizer see a is profit know, -- gross that above million going what due on us procedure. way about methodology we'll responsible by compare for if Pfizer versus EUR have COGS they of basically limited. And profit we're inventories me highlight the across markets, share. is, is, a to due in is writing-off reduce for XX% that that, COMIRNATY question. the whatever in with a us, works 'XX, are development

can't reporting you through that what really from report. So we Pfizer really numbers is our read to

Özlem Türeci

] BNTXXX With patients. [indiscernible] why our trial this to [ initiated reason trial, of BNTXXX, in in the disclosure is and with our PDAC enrolling I Phase following regard setting its to which your a [ performance really and very encouraged, not have question we we is data II PDAC Phase are PDAC also ], surprised, encouraged, the the but

suppressive in type, indications is The cancer immune encouraging results which and and to as in this this we into also tumor us considered of supports mutational are cold low load we [ and as immunological trials we with Phase go in the other ] is cancer in And indications be compiling PDAC fact, to profile. findings have data, published in which other currently which I type such our manuscripts. collected saw

Operator

line Your next question comes Yaron from from Cowen. of Weber the TD

Yaron Werber

couple a as well. of questions have I Right.

one first little [indiscernible]. historically to powering you ORR the the [ maybe if the The a ], correctly, the to XX%, the Can Phase XXX. is about I chemo, [ like So ] sounds about it study, that is ongoing talk bit PFS and XX% X%. III and X% is remember PFS on

study ORR is kind is works. XX% a -- determine the showed of You depends kind that It how how of chemo [indiscernible]. do, to which going will

what Phase a bit expecting? on sense talk any can of of so little maybe you I/II data if of we and maybe powering the you're study just you can the So if can about share a get PFS kind

you do just so need already huge lot continuing to and secondly, have to then execute. much you've such pipeline purpose you're the and you the a to and that already? to curious, grow more executed have to What's and given obviously company a continue execute BD And potentially you

Ryan Richardson

with then we'll the So second first. into the I'll come question, start

us obviously or very ] I clinical near stage clinical active think stage the assets. on X front, year [ last BD bringing were So we

continue to we we do going would broad are that us We to lot. toolkit be have we already a feel to active, but actually think very a I that now that Yaron, allows agree

on And so are execution. focused we increasingly

that to assets initiated bring active terms continue probably that we're clinical in enrolled. but think on board. the not the active to trials this to and executing in focus of to going year on as going do more is we're be stage I number pivotal be looking The So BD, of getting and

Ugur Sahin

question, X.X, that which hazard of around for around we us be ]. XXX think study with usually -- have Yes. And powering your will patients this the second the second question of [ we power with this [ And ratio enroll. better To a that, X.XX ], XX%. do gives a I answered can a is we to

Operator

And Capital. your of Etzer BMO the question line comes next from from Darout

Etzer Darout

Great.

BNTXXX, Just me. III for of a of the at On sort one prominently highlighted sort Phase of program question and XXXX you looking couple slides [indiscernible], beyond. and

indications III would what this if able what program be wondered potential we to see programs? updates to the specifically Or sort any in to of and XXXX pursue for what Just any Phase molecule? you clinical might And sort on as with this specifics expect and well could be providing there? of more you path

Ugur Sahin

trial updates we clinical this number Indeed, will not indications. of molecule, on Yes. only see a

for yes. [ [indiscernible], molecule, everyone, remind and to which PD-LX has a this biospecific Just ] blocking PD-X is

[indiscernible] also we unusual cancer really rate what in who response lung are cohorts in response XX% we it's the the population is these so already, checkpoint are [indiscernible] indications. negative in various objective only who first in the immune the for the is blockade. in of but have patients. patients, patient infiltrates, very for for breast [indiscernible] exciting rates, in cancer not our And to also reported rates which response range in is high cancer of have seen encouraging number in indications What are is XX% far -- consistently cancer which and what combination a small cell And

So that we cell us molecule in indications, molecule indications, [indiscernible] molecule, combination [indiscernible] we breast also importantly, as -- to a this can range allowing portfolio. even wider X therapy thus replicate partner believe small more in but the not a our ADC for results only for and that position this of and cancer, lung these cancer

Operator

Jessica Fye from line of question comes the JPMorgan. from Your next

Jessica Fye

top line guidance. First, on the

I a just those which can think you talked expand couple previously top billion into drove assumptions I guidance. variables on the the of a roughly you about the line that just factor appreciate ago, highlighting and you X of months But change? EUR

ADC? in related to to readout HERX on HERX as to you the [indiscernible] second, guys it pipeline for the what then going watching the space, And are be your relates

Jens Holstein

first let question. the me So take yes,

the So we're with assumption vaccination We we of range. the currently top made and should guidance the that significant reflect we've to price seen commonality aware we brought in the line felt that respect the course, is have relevant. rates that significantly levels

[indiscernible] made forward. that also back related We write-offs have And the will assumptions like anticipate 'XX. there be to write-offs, going to in inventory we've it got some

we we've assumptions. Pandemic So service that the in here related hand are revenues additional anticipated or our government. Preparedness business the And are course, to and have done some some some also there we -- of German finalizing included Contract with currently

that have range. the broadening feel basically -- we therefore, that was driving of So we

Jessica Fye

the really those into broadening? factored of each So

Jens Holstein

that upsides, assumptions but that's mentioned, time, of this it is current there and -- over downside that are to some yes. I This course, there done, could try work we've some vary in are what with, we'll

Jessica Fye

Got it.

Özlem Türeci

around, our the to BNTXXX, excited concept HERX regard That's HERX of HERX great with with we ADC, have and Duality. very the Yes, our obvious. the are molecules, ADC, And concept. a that's about are ADCs which very partnered which molecule, we

And in are need population. a pointed as Ugur HERX-low difference in for medical earlier, looking out high cancer breast making this

ratio, about hazard target are targeting. which You heard we the of have also our

Ugur Sahin

parties. price of on And we course, can't, third of clinical comment the

Operator

Redburn. line the Your of next from Simon from comes question Baker

Simon Baker

But ones, what running, is XXXX? of you about that you're billion wondering levels the quick EUR R&D EUR I was X.X expense wondering, say of guidance the was of on I sense. the against plethora if The I could XXXX studies billion X.X normal? a beyond Two perfect R&D is may. to And makes this anticipated 'XX. step-up new

attractiveness thoughts And finally, the awful been be late. activity an that to of there's space interested the radiopharmaceutical in on lot I'd get deal of modality. of your

Jens Holstein

the question. to Happy first take Yes.

our broadened portfolio. we course, pointed have you out correctly, as of So

any We here the drive up and for we guidance haven't to and late-stage great going more forward, for cost clinical running, 'XX, the have more following those extent. trials And given a yet years.

got little a to us you've with So bear bit.

money. cost clinical some of But late-stage will course, trials

where We money. will look we invest our carefully

had shown have then We beginning also pressure sort at that during adjust range XXXX. of COVID already top the the reduced that we where that to have regarding we revenue costs, the same on we reflecting we the the and figures in 'XX line had faced

there So insecurity. of is level some

our for in costs we of the think the company do And job But to feel shareholders. value part that areas value for will forward. remains here. we our I the ongoing the in on list we years. and That top where of invest 'XX it's create will manage our in course, we of going

Ugur Sahin

the cells, because is XX are [indiscernible]. they new next the this we the new are oncology tumor [indiscernible], Yes. one ongoing but would targeting we repeating And of being question in the in second transformation, that I a is And what happens to having this concepts. and like transformation of [indiscernible]. part attractiveness years. seeing of is myself to transformation concept say, in and I'm is And will XX about your see And

cells targeting more pronounced have the bystander we And ADC this the of this is additional even effect. field. tumor in So plus

but where we So now is the we to patients believe and really really anything. even past, opportunity not we can't will ensure offer opportunity disease, in we benefit. -- patients advanced tremendous thereby with and patients in with considerable transformation oncology, up And indications in in treat offering see clinical a the patients their providing open advanced us the this only diseases, to bring the with combinations disease, get that

Operator

line from comes UBS. of the question next Merle from Eli Your

Unknown Analyst

in trial see moving there data Could thinking see about what us the forward? we from and randomized to latest you're program when continue guys you and remind that This iNeST for hoping is could confidence give [indiscernible] Eli. the to II Phase on you would

Ugur Sahin

Yes. Okay.

will second melanoma we for latest report of cancer of colorectal XXXX. on this update we And data shortly, end the expect in next So our year, year. our half iNeST the study trial this

Operator

And line your from Manos of Mastorakis Bank. from the final comes Deutsche question

Manos Mastorakis

quick a Deutsche Bank. question So Manos from from us,

And the of see for know to are rest wanted will I'm Please in if So in assuming XXXX? we just major first XXXX the portfolio wrong. what correct Phase or the beyond? I'm nothing me III readouts

Ryan Richardson

Yes.

about and of trials that approvals, includes third-line of we successful. the CRC, ahead that's talked iNeST half could product in we refractory produce And XXXX different talked for and endometrial or II trial mentioned, in we that the Phase -- think there's interim potential were XXXX a which update just couple So program data the XXXX. in randomized early and BNTXXX of And cancer. second for the second in an we've also about

are is to II, So strong. registrational the likely potential if data we be those readouts initial have Phase but could think they

I think Phase year III. the many end is obviously, of goal this the to by start

you that of Some the those pipeline. started the point have as already would so But could those data are well I updates on we X have further to.

Operator

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

disconnect. You now may

BioNTech SE (BNTX) 20 Mar 242023 Q4 Earnings call transcript