BioNTech SE (BNTX) 8 May 232023 Q1 Earnings call transcript

Welcome to the BioNTech First Quarter 2023 Update Call.

I would like to hand the call over to Dr. Victoria Meissner, Vice President of Strategy and Investor Relations. Please go ahead.

Good morning and afternoon. Meissner, BioNTech. the Victoria Investor Head is at Relations name and new I'm of My medical by a Healthcare I'm doctor Investment BioNTech recently Banking from joined at Jefferies. training and have

the to with joining forward today first call. BioNTech's XXXX for Thank look I us you on you corporate working for earnings quarter side.

of press slides found issued was this can be As the this and that that a brief the release call the our Investors section in accompany reminder, first website. quarter XXXX morning

X, Slide on As see disclaimer. can outlined forward-looking statements you our

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

revise statements speak of are only Forward-looking and the subject uncertainties, called of risks or original date, and obligation call any the as no we statements. to on undertake substantial update to

and you regarding can find detailed safety X vaccine. Slide call. Slides today's for see X, X, information On can the you COVID-XX our On agenda

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

I call to turn Ugur to like over would Sahin. the

and Victoria. to the continued warm to further I before participants. over my and Thank Good call to all first your will details. good team support. provide highlights We welcome appreciate summarize I priorities and you, call Today, our morning, XXXX afternoon, quarter pass the

highlight and our Let me achievements. quarter and strategic first XXXX our reiterate for goals recent

with candidate, by combination key developing Comirnaty First, advancing to sustain in our advancing vaccines expand and vaccine next-generation leadership Pfizer our and COVID-XX features.

month, published Journal key label COVID-XX vaccine the preclinical strong data our position, coming expansions world. vaccine Cell we in next-generation on by around the maintained component combination out. supported quarter, our This in in regions we is This market

pipeline oncology potentially second products. initiate our multiple is accelerate to registrational Our and goal

term. mid- achieve with clinical Our goal in OncoCX will our to near to us with the this multiple new DualityBio and help pipeline complement that late-stage collaborations programs

final with the and namely goal need and clinical initiate new programs diseases. third In tuberculosis. shingles quarter, for Our clinical programs first accelerate initiated medical unmet infectious strategic high we to and is in vaccine

a start to continue these biotechnology global medical continue into plan The our a execution company to strong XXXX. integrated fully needs development quarter to goals and multiproduct first was strategic worldwide. divesting against We

Cancer remains unmet the of one key medical needs.

is and needs patients oncology cancer company full programs the survival. become aim patients the our of in long-term cancer order Our for and being adjuvant next In and to market available our treatment, cancer strategy we patients, the year. to for late-stage platforms combining tumor party a address options multiproduct science expand with best the continuum to treatment serve and into to novel translate to of

pipeline our that conjugate. and classes to patients multiple are the Key lines across of believe oncology improved potential drive immune cell have next-generation We mRNA therapies, and checkpoint antibiotic modulators cancer for tumor elements types. in vaccines, outcomes these tumor treatment solid

may and treatment for that potential stage Our oncology us cancers. solid has in We change most believe currently all drive of of assets in at tumors to meaningful asset or enable first-in-class development a of many the this advanced range are treatment. best-in-class

novel are technology modular internally collaboration this? leverages developed innovation and planning achieve both to accessed partnerships, technology-agnostic How we Our platforms, engine produce via candidates. to product

believe In treated tumors assets may to new the the solid future. platforms are important us two and first quarter, access how we give to in in collaborations announced be we that

development the discovery about One Company and focused collaboration I'm of of Biologics, is Duality drug excited particularly with conjugates. those antibody next-generation on the new the which

main ADCs treatment. tumors. the lincoln have toxic as on backbone components: cytotoxic these believe In properties. cancer potent and of clinical replace payload, chemotherapy that We treatment of to the advancements ADC potential few impact regimens a an last three resulted years, ADC's components pharmacological each to has the in highly the for antibody has in solid technology of ADCs use consists

medicine, ADC delivery, benefit When to tumor death. on in events. allowing graft the which tumor the leads is reduced monoclonal is target the off-target of a release for the specifically potent antibody for with particularly the high targeted of precision expressed use to the to ADC specificity cells and internalized, allowing binds cytotoxin, cell, with cell antigen the

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multiple years. vision. potentially the I Slide in plan registrational our products XX want we started, XX. have coming I our end With programs. We to where new start now to collaboration,

technologies aim leader, become we multiproduct years, aiming global next challenges disruptive pressing the to world's biotechnology scale. at with to the address delivered and pioneering contribute Within health a most

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

and pipeline Ugur. provide you, I'm to with Thank update. delighted our speak today everyone

we since place treatment. for cancer have the firmly Starting mRNA BioNTech's in on only in potential a have of believed future Slide to cancer XX. vaccines Not the founding,

built initiated full our and approaches. have the to our We a program utility share evaluate of offer broad personalized and clinical platforms

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that clinical program fixed ongoing of product our indication-specific candidates, have In is four different comprised studies. we

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I look now results. our the Holstein, in I forward program present to the will updates presentation coming to providing financial months. pass CFO, who additional our will Jens

start and Ozlem, you you, to warm can the quarter the call. which in on first everyone with find dialed welcome today's key of Thank XXXX, my I'll for highlights section who Slide a XX.

and seasonal from and strong our driven started some fully The quarter was XXXX year. previous of effects quarter carryover first the The to expectations. by

by an of vaccine. with late revenues in we adapted our approvals generated BA.X/X COVID-XX countries As example, from sales

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in quarter weakest to second XXXX. consequence, a As the we the expect quarter be

financial revenue the like XXXX quarter. first dive around reiterate would full billion to key successful year. our that financial I underline we now for into Overall, our some of figures guidance €X COVID-XX vaccine

revenues of total the These our represent we reported reached for €X.X revenues from a mainly sales billion, generate gross the in partner collaboration margin first gross to those. meaning of COVID-XX related on profit territories. Our XXXX that figure, share quarter a vaccine XXX% net

and us, territories in for subsidiaries that quarter under COVID-XX fiscal vaccine outside in financial our keep will collaboration, reminder, the Hence, between December operations on United our and a Pfizer States XXXX QX reporting Fosun from our mind earnings, QX cycle. marketing been have from estimate Pfizer's the XXXX XXXX financial As their Please we included Pfizer's rights. whereas be allocated in already based have distribution reflected international Pharma differs figures. respective

creates between publishers operating result our numbers first million deviation €XXX.X of a per on Pfizer and basis. billion €X.X a on generated quarter an our a with of This earnings basis year full fully €X.XX. the numbers revenues, diluted partner ended quarterly versus the a we With and of in share

With €X.X our Company's ended made we which with quarter cash investment of €XX.X and the respect the cash position, as financial billion as to we part horizon, €XX.X as investment comprising a time longer with strategy. equivalents first well security billion XXXX billion, of

the When as payment significant onetime our as of settlement relating looking prepayments cash spent the movement example, XXXX, liability to program. context financial of share-based full first payment share of at the impacted, wage the year cash of was well a to settling tax XXXX amounts part burn as negatively repurchase our for our quarter due XXXX during our in incurred tax

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Our OncoCX and collaboration quarter payments and InstaDeep first license exchanging license be the the M&A for collaboration Duality the payments. course we planned M&A In Please and will invested upfront agreements during of the not the acquisition outflows closing cash future mentioned milestone expect determined institute with note Biologics, approximately XXXX. be of to with €X.X and cash connection of by in on final price not and agreements in purchase to comprise the shares announced billion does earnout quarter. the lead and and in recent activities amount the did

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The Research The security €XXX.X for and the million in resulting incurred expenses increase XXXX higher driven was for further expenses headcount. year for in the social the €XXX from quarter development and mainly an by period. benefits comparative wages, from to progressing clinical due candidates. was million increase expenses first an reached prior increase increase studies of to compared pipeline

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for comparative year for to period. compared €X.XX per first share the the earnings diluted XXXX Our to quarter amounted of prior €XX.XX

following to financial turning reflects like and the I the are the Slide calculated on rate. Please the projections reiterating current outlook currency base Now Company's number year. XX, that note to we emphasize case XXXX based constant would are for

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to Strategy strategic to Ryan Officer, the our with update Chief on call and concluding And remarks. turn like an Richardson, I outlook XXXX you. for our Thank would over for that,

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aim deploy a In develop, vaccine. XXXX, to we seasonal adapted and manufacture Comirnaty

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that We continue broad come expect COVID of demand XXXX to a range regions globally. from will in

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The next our flow for summarizes slide news pipeline XXXX.

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like X. questions, to we our that further floor We'll events. May up hold and on Before both next reiterate on would event for weeks the on in will innovation provide concluding our the XX opening November details coming and AGM series I

continued I'll for With that, our shareholders I'd to support, and our their questions. the for remarks and open like thank floor up conclude

Ahmad [Operator from go of your question the And comes Tazeen Bank ahead. from America. Instructions] line first Please of

have to Pfizer. pipeline with it as one I relates partnership the

can sense of the be a still us line? this program And On we what of the for a presented, at have first-line data this when that year? should I year could if follow-up. iNeST top melanoma, exactly give expect you it's And then level data

Yes, I'll you start maybe to want Ugur, add. Tazeen. sure. Thank you, and

melanoma our is our the for and this retained an PFS. it's we've the we've in guidance previously, to speak So, would still -- update update that we've first-line that both stated ORR setting for And year. also the case, expectation also and

Ugur, anything you'd like to add?

No, that's it. Thank you.

space, talk the in to HERX there's you you're and about serve? to And program, so are development. how could that multiple just with general how landscape and you about competitive think is us that thinking could candidates as relates this differentiated program be ADC it then Okay. indications your what competitive your Can

I question. maybe take this Yes, can

cancer to lung cancer, safety the with add space, endometrial that a compound differentiated safety profile. could oncological a cancer, features provided HERX for in with improvement cancer, massive ADC and HERX-positive room multiple believe tumors still that of is tolerability additional non-small existing a example, We So of That lines ovarian believe that compounds. and particularly features. the breast is there like there also even but cell we room development, ADCs, for on including, comes generation for improvement,

we could be could breast how cancer informative would And I poster data to at data ASCO, have like positioned. about cohort. that in that be a a -- will mention and larger which generated would provide this this product

to question. Daina Securities. And next will from the question Please ahead. our go go line Graybosch, We next comes SVB the of now

questions, two I -- too. I'll have take

payload less if the of or I And programs, how whether late-stage seen you some IO the one, in -- impact payload with programs? we've as be great, clinical the DualityBio immunity other then first follow-up. your will will wonder the have that talk you trials? The about in whether a combination payloads sorry, And your as its this how that in development synergistic could I and great -- is other synergy with that think

you thank Daina, in key for we question. excellent Actually, these Yes, ADCs. up the interested point you by are bring a

immune topoisomerase more payload reduced differentiated, even antibodies new is the and of bringing bispecific with stable The we compound class aspects new would vaccines the as providing highly a our well the these And synergistic applications. with compounds linker of in of personalized inhibitor. release is this be on our that spontaneous yes, IO the more modulators as the is toxin. that technology FixVac So, linker including next-generation key release believe and based pipeline,

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with profile. use a there's differentiated you If of this flexibility mRNA in having vaccine a lot technology, a

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comes will Jefferies. question. from We next line of Tewari go our next question to And ahead. your go now the from Akash Please

on Akash. for Ivy is This

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is for COVID. First

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you reason reiterate of be Is potential duration any guess imply OS will won't just that why on result? any Does I data? data specific be there melanoma a to this So this limited readout that there PFS year, or. longer

take the generate readout. this maturation not The to of most can -- is will I OS data allow question. likely

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development to you, as how to people the what see will of Yes, before mean a in in and believe, is really the We good see starting it's chime extent not that with Ryan for Maybe stated the start some QX. had that surprise that's will we to take flu. not in in. as vaccinations flu. QX, comparable and question, vaccinated We reiterated weaker. will we get top the I be season in my it guidance, Chris, happy I we guidance, we terms line for to a assume speech,

at for is looking will of quarters QX and for so QX specifically these year. Northern Hemisphere, be the our expectations that full us So for the the two relevance

we we as some in some 'XX negotiated to face reflect and reduction with try might before have this volume the that course, to EU been with when already guidance have, the before might discussions seen face, that total other discussions went with versus we out We to that other guidance some in the stated will countries we implications that be the where we what we have the went might well, accordingly. has of out have we for and potentially

and of bushes figures is reflect December, the Pfizer in I taking billion, have XXXX, $XX.X our guidance would if that November November. at account into month the very account reflected revenue December that implication, think QX strong like translate this take to we revenue that, full so were month, figure, XXXX also you for international compare taking into year a those looking to December from in ongoing. figures you our currency their they're of have And been you Pfizer for whereas January discussions the part if reiterate to at reflects just to their we has I in if that, we -- XXXX the Pfizer figure

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reiterated that coming take is account, might that be this respect in we we can the our that assumption at there if be billion. our the produce. a that could variant our there -- we this. from then into It in and live that you. vaccine So, today feel time. a new helps And existing been -- big valid we we €X €X assumption have remains to the impact you with. that reach billion assumption And this that that adapt has is I will point that that That's hope something we're

can maybe and to maybe R&D add, the come just as -- I you point. would back And well

to back the to Yes, come just R&D I'll add.

that. Two points to

quite first actually of the pandemic in countries the contracts. while some to not countries volumes, we're carryover quarter, is volumes still over in we first range mentioned. there a There's broad shipping we were XX first So disclosing to the quarter,

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maybe that partner, to that booked to billion together costs, €X.X coming great some R&D application Chris, €X.X first the been relation billion quarter into a programs if from that put is, of various Yes. a EURX our light phasing collaboration Pfizer. extent, then sort to guidance. you our extent, the we But of of our if also the And great has you so with on have we for to have billion relatively add see the this

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the So, comfortable €X.X of quarters. we billion course €X.X with feel the billion to in next the

what there's these meeting for you vision combination of Can outlined the usage, potential or like for what particularly December COVID to the view There with talk their look follow flu. terms Were the U.S. factor And on, lie? vaccines could four in is? in their if years. Pfizer a the fundamental then view they for point you three for of during out in your next in differences BioNTech house with there to projections, in involved where any was might

the Yes, thanks question. for

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contribution and at be to point. at look little to a precise factor from we it's that a this is too combinations the how think prescribe this I early

see I think more need data. we to

is outlined as term specifically that potential, mid- over respiratory today growth for a I do the one franchise. we multiple the we drivers think combination potential what of see longer combinations, to

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data the for it look progresses. We'll Thank Thanks. as you. Great.

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a about vaccine follow-up I level metastatic versus of high program. about the adjuvant iNeST had wondering if Just was likelihood just thinking you success on you're the setting. discuss can the how in

have taking more setting, focused Merck think and the I adjuvant but broader approach. Moderna a on obviously, more you're

wondering, So could there? elaborate you just if

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ahead. question. next question go now comes our Cowen. Please go the will to next from of your We Werber, Yaron line And

Hemisphere? vaccine I'm the understanding to patients is be healthy or And rest it -- Pfizer your and And RNA study as you when this to self-amplifying study to U.S. well? in modified year? sufficient on that Any sense question I the is adult on fall? potentially my flu the in XX,XXX of Southern then for the additional the quick even world quadrant vaccine. secondly, Do that's as to run update mRNA follow? are Any got XXX. in sorry, sort able an need the vaccine, you of Is might we see -- a you thinking The think data flu ongoing.

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rights royalties to So success. and in terms seat in We have do milestones development. driver's really the upon they're of

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you So XX-XX us teens, Ryan, a for COVID? to is combo, royalty maybe let's say, just sort give whether be any your all you're can a going follow-up, the flu-COVID sense flu at low your to of as blended for when and for between

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for on Jessica Fye. Nasan is This

I when on ask the development FixVac? you're comment the about program. in of how the adjuvant for and see progress that I and program there And on like to about data we then setting, FixVac want to whether the light thinking think get versus metastatic might initial

question second be take question Yes. you the if Maybe could would the first take great. Ryan, I'll on,

a metastatic with immunogenicity we and objective setting with responses the high patients alone did range of rate in of seen of the data high in in So in FixVac, combination therapy objective and the particularly of process XX% range melanoma, have under in to generated who PD-X proportion anti-PDX with patients XX%. existing responses in vaccine with for have XX%

as FixVac the adjuvant patient compared inclusion. vaccine to availability after of new is advantage the customized vaccine of key the directly The

our this this as model an now modified metastatic not But but for do we compound. of combination to FixVac the for upcoming as approach. studies the immune four the with with well means patients that And time be our it's disease. could be until patients in option of here, combination a have of again, as and can waiting BNTXXX the of in the So something as is vaccine question example, use advanced dosed. focus molecules, Therefore, principle, molecules, bispecific six later, the RiboCytokine checkpoint this IL-X evaluating that is in our BNTXXX IL-X well weeks

time in Yes. of haven't lines, FixVac the guided And we terms year. any updates this

say recruiting in likely. as trials you So is most we multiple multiple that And ongoing, I refractory few, XXXX. trials, NSCLC likely know, in a head carcinoma the have so XXXX would in melanoma, neck

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strategy. the have broader So, on two I

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want get to related And that So, that to don't there on non-COVID push reach technology the other line into have are that yet? platforms technology is, you second then time any there some internal portfolio? you is an certain profitability question on

Yes, thank you.

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we've programs In addition, for serve can as gone backbones. that

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pipeline. ADC with modalities combine that existing that see and the with we could well very also general. You with in Again, ADC our think technologies programs HERX

any no, we you, Thank With Yes. are to looking regard technology. not technologies, disruptive Ryan. to

technology we are could platforms. our clearly of technology that number modules a the are in further But have and what platforms technology in-house. of activity close technologies evaluating disruptive augment our We gaps doing is we or

now line We comes our question of Zhiqiang from to from go the go Please And your Berenberg. will question. next Shu next ahead.

have I two.

wanted I First, ask the FixVac, to BNTXXX. about

you're comment the cancer. to wonder lung Phase think Phase program to X. a start that you can from I mentioned start a X if signals I any you going first-line on you in X confidence gives Phase

clinical is we type Short of from that season. the do so have the no, far expected updates any not answer, end running

talk the your follow-up Got there? top with on you the it. guess, I And payload IO a versus microtubule in Can differences payload the, in terms then deal. about -- the inhibitors combination one and comparison of quick severities ADC

Yes.

technologies important aspect that ADC completely for eight that I will seven, more think in six, -- believe the the or the less chemotherapy. getting replace years, we ADC technologies complete most this is next

So backbone that means which might end type chemotherapy any requires up therapy, in of approach. ADC combination an

the and to in currently evaluated now we for combinations are and suited as inhibitors come application they also with seen regard TOPX studies With long-term and backbone compounds several allowing ideally with profile compounds. a have sustainable IO also that

Shamatha could of to develop come toxicity with inhibitors not regard associated that we treatments dose-limiting opportunity with we in setting the least new to do but project at been compound We which also microtubule [indiscernible] we class PolyNovo and [pages] application. believe have several in this give be do should be repeated with inhibitors, the the that in exclude not microtubular might the interested past, --

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

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