BioNTech-JPM-2023.pdf

1、January 10,2023Ugur Sahin,M.D.CEO and Co-FounderThis presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995,as amended,including,but not limited to,statements concerning:BioNTechs expectedrevenues and net profit related to sales of

2、 BioNTechs COVID-19 vaccine,referred to as COMIRNATYwhere approved for use under full or conditional marketing authorization,in territories controlled by BioNTechscollaboration partners,particularly for those figures that are derived from preliminary estimates provided by BioNTechs partners;BioNTech

3、s pricing and coverage negotiations with governmental authorities,privatehealth insurers and other third-party payors after BioNTechs initial sales to national governments;the future commercial demand and medical need for initial or booster doses of a COVID-19 vaccine;competition fromother COVID-19

4、vaccines or related to BioNTechs other product candidates,including those with different mechanisms of action and different manufacturing and distribution constraints,on the basis of,among otherthings,efficacy,cost,convenience of storage and distribution,breadth of approved use,side-effect profile a

5、nd durabilityof immune response;the rate and degree ofmarket acceptance of BioNTechs COVID-19 vaccineand,if approved,BioNTechs investigational medicines;the initiation,timing,progress,results,and cost of BioNTechs research and development programs,including those relating to additional formulations

6、ofBioNTechs COVID-19 vaccine,and BioNTechs current and future preclinical studies and clinical trials,including statements regarding the timing of initiation and completion of studies or trials and related preparatorywork,the period during which the results of the trials will become available and Bi

7、oNTechs research and development programs;the timing of and BioNTechs ability to obtain and maintain regulatory approval forBioNTechs product candidates;the abilityof BioNTechs COVID-19 vaccine to prevent COVID-19 caused byemerging virus variants;BioNTechs and its counterparties ability to manage an

8、d source necessaryenergyresources;BioNTechs ability to identify research opportunities and discover and develop investigational medicines;the ability and willingness of BioNTechs third-party collaborators to continue research anddevelopment activities relating to BioNTechs development candidates and

9、 investigational medicines;the impact of the COVID-19 pandemic on BioNTechs development programs,supply chain,collaborators andfinancial performance;unforeseen safety issues and claims for potential personal injury or death arising from the use of BioNTechs COVID-19 vaccine and other products and pr

10、oduct candidates developed ormanufactured byBioNTech;BioNTechs abilityto progress BioNTechs Malaria,Tuberculosis and HIVprograms,including timing for selecting clinical candidates for these programs and the commencement of a clinicaltrial,as well as any data readouts;the development of sustainable v

11、accine production and supply solutions on the African continent,including its BioNTainers,and the nature and feasibility of these solutions;BioNTechs estimates of research and development revenues,commercial revenues,cost of sales,research and development expenses,sales and marketing expenses,genera

12、l and administrative expenses,capitalexpenditures,income taxes,and shares outstanding;BioNTechs ability and that of BioNTechs collaborators to commercialize and market BioNTechs product candidates,if approved,including BioNTechs COVID-19vaccine;BioNTechs ability to manage BioNTechs development and e

13、xpansion;regulatory developments in the United States and foreign countries;BioNTechs ability to effectively scale BioNTechs productioncapabilities and manufacture BioNTechs products,including BioNTechs target COVID-19 vaccine production levels,and BioNTechs product candidates;and other factors not

14、known to BioNTech at this time.Furthermore,certain statements contained in this presentation relate to or are based on studies,publications,surveys and other data obtained from third-party sources and BioNTechs own internal estimates andresearch.While BioNTech believes these third-party sources to b

15、e reliable as of the date of this presentation,it has not independently verified,and makes no representation as to the adequacy,fairness,accuracy orcompleteness of,any information obtained from third-party sources.In addition,any market data included in this presentation involves assumptions and lim

16、itations,and there can be no guarantee as to the accuracyor reliabilityof such assumptions.While BioNTech believes its own internal research is reliable,such research has not been verified byanyindependent source.In addition,BioNTech is the owner of various trademarks,trade names and service marks t

17、hat mayappear in this presentation.Certain other trademarks,trade names andservice marks appearing in this presentation are the propertyof third parties.Solelyfor convenience,thetrademarks and trade names in this presentation maybe referred to without the and TM symbols,but such references should no

18、t be construed as anyindicator that their respective owners will not assert,to the fullestextent under applicable law,their rights thereto.In some cases,forward-looking statements can be identified by terminology such as“will,”“may,”“should,”“expects,”“intends,”“plans,”“aims,”“anticipates,”“believes

19、,”“estimates,”“predicts,”“potential,”“continue,”or the negative of these terms or other comparable terminology,although not all forward-looking statements contain these words.The forward-looking statements in thispresentation are neither promises nor guarantees,and you should not place undue relianc

20、e on these forward-looking statements because theyinvolve known and unknown risks,uncertainties,and other factors,manyof which are beyond BioNTechs control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements.You should review

21、the risks and uncertaintiesdescribed under the heading“Risk Factors”in BioNTechs quarterlyreport on Form 6-K for the three and nine months ended September 30,2022 and in subsequent filings made byBioNTech with the SEC,which areavailable on the SECs website at https:/www.sec.gov/.Except as required b

22、y law,BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in thispresentationintheevent of newinformation,future developments orotherwise.These forward-looking statementsarebased onBioNTechscurrentexpectations andspeakonlyas of the dat

23、e hereof.Forward-Looking Statements and Disclaimer2COMIRNATY(the Pfizer-BioNTech COVID-19 vaccine)has been granted standard marketing authorization(MA)by the European Commission to prevent coronavirus disease 2019(COVID-19)in people aged 6 months and older.The vaccine is administered as a 2-dose ser

24、ies 3 weeks apart,in people aged 5 years and older,or as a 3-dose series 3 and 8 weeks apart in children aged 6 months to 4 years.Adults and adolescents from the age of 12 are given 30 micrograms per dose;children aged 5 to 11 years are given 10 micrograms per dose;infants and children aged 6 months

25、 to 4 years are given 3 microgram per dose.In addition,the MA has been expanded to include a booster dose(third dose)at least 3 months after the second dose in individuals 5 years of age and older.A third primary course dose may be administered at least 28 days after the second dose to people aged 5

26、 years and older with a severely weakened immune system.The European Medicines Agencys(EMAs)Committee for Medicinal Products for Human Use(CHMP)has completed its rigorous evaluation of COMIRNATY,concluding by consensus that sufficiently robust data on the quality,safety and efficacy of the vaccine a

27、re now available.In addition,COMIRNATY has also been granted standard MA for two adapted vaccines:COMIRNATY Original/Omicron BA.1,which con tains mRNA encoding for the spike protein of the wild-type and of the Omicron BA.1 subvariant of SARS-CoV-2;and COMIRNATY Original/Omicron BA.4-5,which contains

28、 mRNA encoding for the spike protein of the wild-type and of the Omicron BA.4/BA.5 subvariant of SARS-CoV-2.COMIRNATY Original/Omicron BA.1 may be administered as a booster in people aged 12 years and older and COMIRNATY Original/Omicron BA.4-5 may be administered as a booster in people aged 5 years

29、 and older who have received at least a primary vaccination course against COVID-19.There should be an interval of at least 3 months between administration of COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 and the last prior dose of a COVID-19 vaccine.IMPORTANT SAFETY INFORMATI

30、ON:Events of anaphylaxis have been reported.Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.Close observation for at least 15 minutes is recommended following vaccination.No further dose

31、of the vaccine should be given to those who have experienced anaphylaxis after a prior dose of Comirnaty.There is an increased,but very rare risk(1/10,000 cases)of myocarditis and pericarditis following vaccination with COMIRNATY.These conditions can develop within just a few days after vaccination

32、and have primarily occurred within 14 days.They have been observed more often after the second vaccination,and more often in younger males.Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general.Rare ca

33、ses of acute peripheral facial paralysis;uncommon incidence of insomnia,hyperhidrosis and night sweats;and unknown incidence of paraesthesia,hypoaesthesiaand erythema multiforme have been identified in post-marketing experience.Anxiety-related reactions,including vasovagal reactions(syncope),hyperve

34、ntilation or stressrelated reactions(e.g.dizziness,palpitations,increases in heart rate,alterations in blood pressure,tingling sensationsand sweating)may occur in association with the vaccination process itself.Stress-related reactions are temporary and resolve on their own.Individuals should be adv

35、ised to bring symptoms to the attention of the vaccination provider for evaluation.It is important that precautions are in place to avoid injury from fainting.Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection.The presence of a minor infecti

36、on and/or low-grade fever should not delay vaccination.As with other intramuscular injections,the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder(such as haemophilia)because bleeding or bruising may occur

37、following an intramuscular administration in these individuals.The efficacy,safety and immunogenicity of the vaccine has not been assessed in immunocompromised individuals,including those receiving immunosuppressant therapy.The efficacy of COMIRNATY,COMIRNATY Original/Omicron BA.1 or COMIRNATY Origi

38、nal/Omicron BA.4-5 may be lower in immunosuppressed individuals.As with any vaccine,vaccination with COMIRNATY,COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 may not protect all vaccine recipients.Individuals may not be fully protected until 7 days after their second dose of th

39、e vaccine.Adverse reactions observed during clinical studies are listed below according to the following frequency categories:Very common(1/10),Common(1/100 to 1/10),Uncommon(1/1,000 to 1/100),Rare(1/10,000 to 1/1,000),Very rare(70%),fatigue(60%),headache(40%),myalgia(30%),chills(30%)and arthralgia(

40、20%).In a subset from the Phase 3 study,305 adults 55 years of age who had completed 3 doses of COMIRNATY,received a booster of COMIRNATY Original/Omicron BA.1 after receiving Dose 3.The overall safety profile for the COMIRNATY Original/Omicron BA.1 booster(fourth dose)was similar to that seen after

41、 the COMIRNATY booster(third dose).The most frequent adverse reactions in participants greater than 55 years of age were injection site pain(50%),fatigue(40%),headache(30%),myalgia(20%),chills and arthralgia(10%).No new adverse reactions were identified for COMIRNATY Original/Omicron BA.1.The safety

42、 of a booster dose of COMIRNATY Original/Omicron BA.4-5 is inferred from safety data for a booster dose of COMIRNATY Original/Omicron BA.1,as well as for a booster dose of COMIRNATY Original in individuals 18 years of age and older,as well as for a booster dose of the initially approved Comirnaty va

43、ccine in individuals 5 years of age and older.The safety and efficacy of Comirnaty Original/Omicron BA.1 and Comirnaty Original/Omicron BA.4-5 in children aged less than 12 years of age have not yet been established.No data are available.The duration of protection afforded by the vaccine is unknown

44、as it is still being determined by ongoing clinical trials.As with any vaccine,vaccination with Comirnaty Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 may not protect all vaccine recipientsThe safety and efficacy of Comirnaty in infants aged less than 6 months have not yet been establi

45、shed.For complete information on the safety of COMIRNATY,COMIRNATY Original/Omicron BA.1 and COMIRNATY Original/Omicron BA.4-5,always make reference to the approved Summary of Product Characteristics and Package Leaflet available in all the languages of the European Union on the EMA website.The blac

46、k equilateral triangle denotes that additional monitoring is required to capture any adverse reactions.This will allow quick identification of new safety information.Individuals can help by reporting any side effects they may get.Side effects can be reported to EudraVigilanceor directly to BioNTech

47、using email medinfobiontech.de,telephone+49 6131 9084 0,or via the website www.biontech.deSafety Information3AUTHORIZED USE IN THE U.S.Pfizer-BioNTech COVID-19 Vaccine,Bivalent(Original And Omicron BA.4/BA.5)Pfizer-BioNTech COVID-19 Vaccine,Bivalent(Original and Omicron BA.4/BA.5)is FDA-authorized u

48、nder Emergency Use Authorization(EUA)for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either:completion of primary vaccination with any authorized or approved monovalent*COVID-19 vaccine;orreceipt of the most recent booster dose with any a

49、uthorized or approved monovalent COVID-19 vaccine.*Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virusCOMIRNATY(COVID-19 Vaccine,mRNA)COMIRNATY(COVID-19 Vaccine,mRNA)is an FDA-approved COVID-19 vaccine for

50、 active immunization to prevent coronavirus disease 2019(COVID-19)caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)in individuals 12 yrs of age and older.It is also authorized as a third primary series dose to individuals 12 years of age and older who have certain kinds of immuno

51、compromiseThe COVID-19 vaccine is FDA authorized under Emergency Use Authorization(EUA)for use in individuals 6 months and older to provide:a 3-dose primary series to individuals 6 months through 4 years of agea 2-dose primary series to individuals 5 years and oldera third primary series dose to ind

52、ividuals 5 years and older with certain kinds of immunocompromiseEMERGENCY USE AUTHORIZATIONEmergency uses of the vaccines have not been approved or licensed by FDA but have been authorized by FDA under an Emergency U se Authorization(EUA)to prevent Coronavirus Disease 2019(COVID-19)in individuals a

53、ged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine,Bivalent.The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical pro

54、duct under Section 564(b)(1)of the FD&C Act unless the declaration is terminated or authorization revoked sooner.IMPORTANT SAFETY INFORMATIONPfizer-BioNTech COVID-19 Vaccine,Bivalent(Original and Omicron BA.4/BA.5),COMIRNATY(COVID-19 Vaccine,mRNA)and Pfizer-BioNTech COVID-19 VaccineIndividuals shoul

55、d tell the vaccination provider about all of their medical conditions,including if they:have any allergieshave had myocarditis(inflammation of the heart muscle)or pericarditis(inflammation of the lining outside the heart)have a feverhave a bleeding disorder or are on a blood thinnerare immunocomprom

56、ised or are on a medicine that affects the immune systemare pregnant,plan to become pregnant,or are breastfeedinghave received another COVID-19 vaccinehave ever fainted in association with an injectionIndividuals should not get COMIRNATY(COVID-19 Vaccine,mRNA),the Pfizer-BioNTech COVID-19 Vaccine,or

57、 the Pfizer-BioNTech COVID-19 Vaccine,Bivalent if they have had a severe allergic reaction after a previous dose of COMIRNATY or the Pfizer-BioNTech COVID-19 Vaccine or any ingredient in these vaccinesThere is a remote chance that these vaccines could cause a severe allergic reaction.A severe allerg

58、ic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine.For this reason,your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination.If you experience a severe allergic reaction,call 9-1-1 or go

59、to the nearest hospitalThe vaccine may not protect everyone.Side effects reported with the vaccine include:Severe allergic reactions;Non-severe allergic reactions such as rash,itching,hives,or swelling of the face;Myocarditis(inflammation of the heart muscle);Pericarditis(inflammation of the lining

60、outside the heart);Injection site pain;Tiredness;Headache;Muscle pain;Chills;Joint pain;Fever;Injection site swelling;Injection site redness;Nausea;Feeling unwell;Swollen lymph nodes(lymphadenopathy);Decreased appetite;Diarrhea;Vomiting;Arm pain;Fainting in association with injection of the vaccine;

61、Unusual and persistent irritability;Unusual and persistent poor feeding;Unusual and persistent fatigue or lack of energy;Unusual and persistent cool,pale skinIndividuals should seek medical attention right away if they have any of the following symptoms:difficulty breathing,swelling of the face and

62、throat,a fast heartbeat,a bad rash all over the body,dizziness,and weaknessMyocarditis(inflammation of the heart muscle)and pericarditis(inflammation of the lining outside the heart)have occurred in some people who have received COMIRNATY(COVID-19 vaccine,mRNA)or Pfizer-BioNTech COVID-19 Vaccine.The

63、 observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males,and the observed risk is highest in males 12 through 17 years of age.In most of these people,symptoms began within a few days following receipt of the second dose of vaccine.The c

64、hance of having this occur is very lowThese may not be all the possible side effects of the vaccine.Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.Individuals should always ask their healthcare providers for medical advice about

65、 adverse events.Report vaccine side effectsto the US Food and Drug Administration(FDA)and the Centers for Disease Control and Prevention(CDC)Vaccine Adverse Event Reporting System(VAERS).The VAERS toll-free number is 18008227967 or report online to www.vaers.hhs.gov/reportevent.html.In addition,indi

66、viduals can report side effects to Pfizer Inc.at or by calling 1-800-438-1985Safety Information4Harnessing the power of the immune system to fight human diseases6Translating Vision into Strong PerformanceScientific&Clinical ExecutionCorporate ExecutionCommercial&Market Leadershipwith COVID-19 Franch

67、ise11 Partnered with Pfizer7Translating Vision into Strong PerformanceCommercial&Market Leadershipwith COVID-19 Franchise160%market share32 billion dosesinvoiced in 2022550 million dosesof variant-adapted vaccine2shipped Broadest label amongst COVID-19vaccines1 Partnered with Pfizer2 As of Dec.16,20

68、223 Pfizer/BioNTech cumulative global COVID-19 market share across reporting countries;CDC,ECDC OWID data as of Nov 2022first cell therapy for solid tumorsnext-gen checkpoint immunomodulator8Translating Vision into Strong Performance1Partnered with Genmab2Partnered with Pfizer3Partnered with Univers

69、ity of PennsylvaniaScientific&Clinical ExecutionClinical POC across multiple modalities:BNT211BNT3121Immuno-oncology4 new programs first in human:BNT116 FixVacin NSCLCBNT141 RibomabCLDN18.2BNT313HexabodyCD271BNT142 RibomabCD3xCLDN6Infectious DiseaseInitiated 3 COVID-19 vaccine trialsFlu+COVID-192Mal

70、aria3 Phase 1 trials for mRNA vaccines,including new pathogen antigens first-in-human:HSV239Translating Vision into Strong Performance1 As of Oct.15,2022Corporate ExecutionRapid deployment 2 months from regulator recommendations to vaccine deliveryExpandedpartnerships4 new collaborations accessing a

71、 variety of technologiesBroadened pipeline22 programs in 26 ongoing trials Grew team 1,500 new employeesStrong financials16.6 bn cash+4.1 bn trade receivables12023 Strategic PrioritiesInfectious diseasesInitiate and accelerate clinical programs for high need indicationsTuberculosis6Shingles1COVID-19

72、 franchise1Immuno-oncologySustain leadership in COVID-19 Advance next-gen vaccinesVariant-adaptedT-cell enhancingCombinations+Advance disruptive platforms for solid tumorsInitiate multiple potentially registrational trialsMost advanced programs:BNT1222BNT211 BNT31131L Melanoma&adj.CRCCLDN6+tumorsSol

73、id tumorsBNT3123Ongoing clinical trials:Programs advancing to clinic:Influenza4MalariaHSV25INDIVIDUA-LIZED mRNA CANCER VACCINESiNeSTCARVacmRNA vaccine boosted CAR-T-cellsNEXT GENIMMUNO-MODULATORSBispecific antibodies101Partnered with Pfizer2 Partnered with Genentech3 Partnered with Genmab4Out-licens

74、ed to Pfizer5 Partnered with University of Pennsylvania6Collaboration with BMGFGlobal Powerhouse Built on People,Presence and Strategic CollaborationsRwanda,Senegal,South AfricaPlanned mRNA manufacturing facilitiesMemorandum of Understandingfor new collaborationCollaborationBioNTech site2Manufacturi

75、ng site211United KingdomHealth-system-wide collaboration with UK government with the target to deliver up to 10,000 personalized therapies by 2030IsraelPandemic preparedness and development of innovative medicinesSingaporeCommercial-scalemRNA manufacturingAustraliamRNA research center and clinical m

76、anufacturing facilityTaiwanClinical trial hub for mRNA-based cancer immunotherapies4,500 professionals globally11,500new hires in 202280differentnationalities36average age50%are female 1All employment data as of December 2022 2Sites may be existing or planned12Focused on Five Innovation PillarsDeep

77、understandingof the immune systemMulti-platforminnovation engineManufacturing and automationTarget discovery and characterizationDigital&AI/MLInfectious disease Enabling technologyOur Disruptive Technology Toolkit to Fight Human Diseases1 mRNA encoded cancer-targeting antibodies and cytokines Indivi

78、dualized therapiesSELECTIVE TLR-7 ANTAGONISMNEXT GENIMMUNO-MODULATORSBispecific antibodiesTARGETED CANCER THERAPIESRIBOLYSINSPrecision antibacterialsPhagomedacquisitionRIBOLOGICALS1RiboCytokinesRiboMabsOFF-THE-SHELF mRNA CANCER VACCINESFixVacINFECTIOUS DISEASES VACCINESProphylactic andtherapeutic va

79、ccinesINDIVIDUALIZED mRNA CANCER VACCINESiNeSTINDIVI-DUALIZED TCR-THERAPYINDIVIDUALIZEDEX VIVO T-CELLTHERAPYSOLID TUMOR CAR-TIdeal CAR-T-cell targetsMULTI-TARGET TCRMedigenecollaborationCARVacmRNA vaccine boosted CAR-T-cellsSTING AGONISTSRyvucollaborationLIPID-FORMULATIONSInternal capabilitiesMatina

80、s collaborationIMMUNOTHERAPYTARGETDISCOVERYSMALL MOLECULESmRNA ENCODED HUMABODIESCrescendo collaborationANTIBODIESmRNA TECHNOLOGYCELL&GENETHERAPIESCore principles of our technology strategy Technology agnostic approach rooted in deep fundamental understanding of biologyBuild novel platforms with the

81、 ability to produce multiple product candidatesOpen up new combination opportunities which leverage synergistic mechanisms of action Enable individualization of treatment 13AI&Digitally-integrated target&drug discovery and development Individualized treatment platformsto address inter-individual var

82、iabilityDeep genomics&immunology expertise to leverage patient dataAutomated manufacturing to serve patients on time and globallyIntegrated model for immuno-oncology to transform R&D and patient care at scaleUniquely Positioned to Individualize Cancer Medicine 14Tailoredon-demandImmunotherapiesOff-t

83、he-shelf drugsSmall MoleculeImmuno-modulatorsAntibodiesEngineeredCellTherapiesmRNATherapeuticsClinicalSamplesDrug ClassesInter-IndividualVariabilityPatient Sample Profiling Diagnostics&Bioinformatics Big Data,Deep Data,Artificial Intelligence,Machine LearningIndividual genomic profilesmRNA vaccinesT

84、argeted antibodiesSmall molecule immunomodulatorsCell&gene therapiesNext-generation immunomodulatorsRibologicalsGoal:10,000 personalized therapies to reach patients by 2030Individualized immunotherapy is poised to disrupt cancer care and requires integrated,health-system-wide collaborationLandmark U

85、K Collaboration to Implement Personalized Medicine:Moving Immune Therapy Development Closer to the Point of CareGoal for accelerated clinical and regulatory pathwaysMulti-agency collaboration is a new model for personalized treatment implementationPatient genomic data informs personalized treatments

86、15BioNTech uses AI and ML in all its pillars since its creation in 2008Deep understandingofthe immune system:Understanding and exploiting immunologicalmechanismsthrough Data Science and ML since early days,including TRON collaborationsince 2010Target discoveryand characterization:Exploitingthe mutan

87、ome for personalizedmRNA vaccines.ML drivesneoantigen selectionand IG predictionalgorithms since2017.Neon Therapeuticsacquisitionwithhigh quality MS dataMulti-platforminnovationengine:ApplyingAI to support the design ofRiboCytokinesand RiboMabs.TCR modelingforcell&gene therapiesDigital&AI/ML:Strateg

88、ic collaborationwith InstaDeepsince2020.COVID-19 Early Warning System,AI Immune response detection(ELISPOT)and gene synthesisManufacturing and automation:Towardsa vertically integrated,AI-drivenAutomatedLab combinedwith InstaDeeps DeepChainTMproteindesign platformBioNTech Innovation is Data and AI D

89、riven2008201220202021+201616Pre-BioNTech:Co-founders publication documentsin silico target cloning11 Helftenbein,Gerd,et al.In silico strategy for detection of target candidates for antibody therapy of solid tumors.Gene 414.1-2(2008):76-84.Founded in 2014with London HQ and offices in Cambridge(U.S.)

90、,Paris,Tunis,Lagos,Dubai,and Cape TownApprox.240engineersand tech professionals,including world-class AI&ML researchers.Published in all major ML conferences(NeurIPS,ICLR,ICML)Successful research collaborationswith DeepMind,Google Research,Google Cloud andNVIDIA,plus EMEA ecosystem initiativesDemons

91、tratedcapacity to develop and deploy AI systems at scale in multiple SaaS products(including DeepChainTM)Fully owned Nvidia DGX supercomputing infrastructure and distributed ML workload management system.GoogleCloud TPUexpertiseOn CB Insights 100 most Innovative AI startups list for3 years runningIn

92、staDeep,Leader in ArtificialIntelligenceInstaDeepis focused on productizing disruptive AI innovation 17Improvedneoantigen predictionovercurrent BioNTech modelAI-based computervisionsystem improvedImmune Response evaluationaccuracyand speedImprovedsuccessrate for AI-driven platform DNA/RNA synthesis

93、togetherwith 40 x increasein monthlythroughputDeepChainTMdesignedRiboLogicalsvalidatedin vitroDeepChainTMdesignedinfectiousdiseasevaccinetargetsCOVID-19 Early and Future Warning Systems evaluateimmune escapefromSARS-CoV-2 sequencesfor improvedVOC detectionUpfront cash and BioNTech stock payment of G

94、BP 362 millionPerformance-based cash earn-out of up to GBP 200million within 3 years of transaction closeInstaDeepto become a wholly-owned,London-based BioNTech subsidiaryClosing expected Q1 20231InstaDeeps Planned Acquisition to Accelerate BioNTechs AI-First StrategyOur goal is to integrateAI seaml

95、essly into all aspects of our work18Transaction HighlightsA fruitful,3 year collaboration with InstaDeepX1 Subject to regulatory approvals and other customary closing conditionsLong-term leadershipfor our COVID-19 vaccine franchiseOmicron-adapted vaccine in 2 months from regulator recommendation to

96、marketFirst-to-Market BA.4/5-Adapted Bivalent Vaccine Launch:Scientific and Manufacturing Preparation Leads to Rapid Execution1Including conditional approvals as of December 15,20222Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization(EUA)for active immunization to pr

97、event coronavirus disease2019(COVID-19)caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)in individuals aged 6 months and older.3COMIRNATY has been granted standard marketing authorization(MA)by the European Commission to prevent coronavirus disease 2019(COVID-19)in people aged 5

98、years and older4As of December 16,202220Comprehensive research program and rapid response strategySafety database with more than 1.5 billion people treatedCapability to rapidly roll out new vaccines at commercial scale within months Growing set of commercial relationships and partners around the wor

99、ldExpanding innovation capabilities in the field of infectious diseasesApproved in 60+countries and regions1Broad label covering ages 6 months+in U.S.2and 5 years+in EU3550 million doses shipped globally4 of BA.4/5-adapted bivalent vaccineFDARecommendedOmicron-adaptedbivalent vaccine encoding BA.4/5

100、 sublineagesJune 30September 1Firstshipments COMIRNATY BA.4/5-adapted bivalent vaccine2 monthsInnovation supported by insights from continuous variant surveillance and robust clinical programCOVID-19 a leading cause of death 250,000+in the U.S.in 20221,221COVID-19 Franchise:Being Actionable in the F

101、ace of a Dynamic Virus Evolution and Building for Continued Success1https:/www.cdc.gov/nchs/fastats/leading-causes-of-death.htm2https:/covid.cdc.gov/covid-data-tracker/#trends_weeklydeaths_select_00T-cellenhancingHighly-conserved T cell epitopes with broad population-coverage derived from non-spike

102、SARS-CoV2 proteins Increase immune resilience Enhance and broaden T cell response Provide memory T cell persistence Enhance B cell response durabilityT cell immune response may continue to contributeto prevention or limitation of severe disease Progressive loss of conserved B cell epitopes for spike

103、 protein neutralizing antibody sites in Omicron sublineages Preservation of HLA class I and class II presented T-cell epitopes across the evolution of SARS-CoV-2 spike protein T-cell recognition of current Omicron sublineage VoCs may be largely intactCombinationsSingle-DoseMulti-Pathogen Protection+

104、Variant-adaptedAddress Evolving VirusInformed by epidemiology&medical needEnabled by AI/ML Early Warning System&variant surveillance researchExpanding and accelerating our pipeline23Infectious Diseases:Important Growth Area Addressing High Medical and Global Health NeedAll figures from World Health

105、Organization fact sheets.https:/www.who.int/news-room/fact-sheets(accessed June 09,2022).Ongoing clinical programsPlanned 2023 trial startsCOVID-19Influenza+BNT161:InfluenzaBNT163:HSV-2BNT165:MalariaBNT164:TuberculosisBNT167:Shingles InfluenzaHSV2MalariaTuberculosisShingles290,000-650,000 deathsannu

106、ally on a global scale500 million infectedglobally187 millionsuffered episode from herpes-related genital ulcers in 2016229 million cases in 2020 across the WHO African Region601,000 deaths in 2020 in the WHO African Region(80%in children 5 years)10 million cases globally in 20201.5 million deaths g

107、lobally in 2020Individuals who live to 85 years old have50%riskof developing shinglesAccelerating high-priority programs into potentiallyregistrational trials across multiple modalities25The Tools we Have Developed to Treat Cancer19 Clinical Programs in 22 ongoing Clinical TrialsmRNA technologyCell

108、and gene therapiesAntibodiesSmall moleculesIndividualized VaccineBNT1221randomized Phase 2 trials ongoing in 1L melanoma&adjuvant colorectal cancerBNT1221randomized Phase 2 planned in pancreatic cancer based on encouraging Ph 1 data2BNT1221Phase 1/2 in multiple tumor types completedIVAC Phase 1 in a

109、djuvant TNBC completedFixVacBNT111 randomized Phase 2 ongoing in r/r melanomaBNT113 randomized Phase 2 ongoing in HPV16+PD-L1+1L HSCCBNT112 Phase 1 ongoing in localized and metastatic prostate cancerBNT116 Phase1 ongoing in 1L and 2L+NSCLCBackbone optimized uridine mRNA(uRNA)Planned Advancement of m

110、RNA Cancer Vaccines in 2023 Paves the Way to Potentially Registrational Trials1 Collaboration with Genentech.2 Balachandran VP,et al.ASCO Annual Meeting 2022;Poster presentation 2516.CapUTRAntigenUTRA30-L-A70Shared non-mutant antigensIndividualized therapyOff-the-shelf therapyiNeST*FixVacFixedAntige

111、nVaccineindividualizedNeoantigen-SpecificimmunoTherapyMutant Neo-antigensKranz LM,et al.Nature 2016;534:396401;Lopez J,et al.AACR Annual Meeting 2020;Oral presentation CT301.26Preferential delivery of RNA-LPX to dendritic cells in the spleeniNeST Autogene Cevumeran(BNT122):Phase 2 Randomized Trial v

112、s Watchful Waiting in Adjuvant Colorectal Cancer1 WHO factsheeton cancer.20184Loupakis F,et al.JCO Precis Oncol 2021;5:PO.21.001012Seer database5Reinert T,et al.JAMA Oncology,2019;5:11241131.3Fan G,et al.PLoS One 2017;12:e0171991BNT12215 doses:6q1w,2q2w,7q6wObservational watchful waitingPatients wit

113、h surgically-resected Stage II(high-risk)or Stage III CRCScreening 1ctDNA status(post-operative)Screening 3final eligibility(ctDNA-positive)Screening 2neoantigen selection for vaccine manufactureAdjuvant SoC chemotherapy for 1224 weeksiNeST manufacturing20 neo-epitopesR1:1Exploratory:BNT122recurrent

114、 disease at Screening 3(n20)n=166Biomarker:BNT122irrespective of ctDNA status(n=15)Stage II(high risk)and Stage III colorectal cancer treatment paradigmHigh medical need in the adjuvant treatment of Stage II(high risk)/Stage III colorectal cancer30%recur despite surgery+chemo20%cured by adjuvant che

115、mo post-surgery50%cured by surgery alone with no residual disease Adjuvant chemo given to all patientsCT scanSurgeryColorectal cancer is second deadliest cancer worldwide1,5-year OS in regional disease is 71%2SoC in Stage II(high risk)and Stage III CRC after removal of the primary tumor and adjuvant

116、 chemotherapy is watchful waitingctDNA is a marker for minimal residual disease and thus can identify patients at high risk of disease recurrence3,4In ctDNA-positive,Stage 2(high risk)and Stage 3 CRC post adjuvant chemotherapy,duration of disease-free survival is 6 months527Multiple data updates fro

117、m ongoing expansion cohorts expected in 2023GEN1042/BNT3121Intercepting Immune-Immune&Immune-Tumor Interactions:Next Generation Checkpoint Immuno-modulators with Pan-Tumor Potential1Collaboration with Genmab based on 50/50 sharing of costs and profits Expansion cohorts in 1L solid tumorsHNSCCMelanom

118、aNSCLCPDACInitial signs of clinical activity in PD-(L)1 r/r NSCLC(n=25)PRs and CRs observed in HNSCC patients in combo with pembro+chemoBest change from baseline insum of lesion diameters(%)HPV statusPD-L1 CPSBaseline tumorVolume(SOD),mmHPV-CPS 2 101HPV-CPS 572HPV-CPS 3550HPV-CPS 1285-60-200-1001234

119、40202040060Best relative change in sumof diameters from baseline,%PD-L1PD-L1+Garralda E,et al.SITC Annual Meeting 2020;Poster#412.ESMO IO Congress 2022,Geneva,Poster#175PConditional activation of CD40 and 4-1BB on immune cellsPotential to treat solid tumors in 1L combination with standard-of-care aP

120、D-(L)1 or chemo treatmentOngoing Phase 1/2 clinical trial in advanced solid tumorsGEN1046/BNT3111Expansion cohorts in aPD-(L)1 r/r solid tumorsCervicalHNSCCTNBCEndometrialNSCLCUrothelialConditional 4-1BB co-stimulation while blocking PD-(L)1 axis2 ongoing clinical trials:Phase 2:BNT311+Pembro in r/r

121、,2L+,PD-L1+NSCLCPhase 1/2:BNT311 mono/+PD-(L)1 combination in advanced solid tumors28Additional data readout and Phase 2 trial planned for 2023BNT211:Autologous CAR-T+/-CARVac targeting CLDN6+solid tumorsBringing Cell Therapy to Solid Tumors:Combining the Potential of a Novel Highly Selective Target

122、 and a CAR T Cell Amplifying VaccineCLDN6,claudin 6Reinhard K,et al.Science 2020;367:446453.CLDN6 notpresentinhealthy tissuesCLDN6 expressedin multiple cancersPre-Post-Part 2 DL1 Pat#3Part 1 DL2 Pat#3Part 1 DL2 Pat#4CRHaanen J,et al.AACR Annual Meeting 2022;Oral presentation CT002.1x107and 1x108CAR-

123、T dose levels well tolerated MTD not reached Efficacy signal in testicular cancer patients(n=7)ORR 57%,DCR 85%(1 CR,3 PR,2 SD)One CR confirmed at 18 and 52 weeks EMA PRIME designation in testicular cancerSelected scans of responses in various patientsManageable safety profile and observed clinical a

124、ctivity 292023 and beyondMultiple Late-and Early-stage Pipeline Milestones Expected in 20231Partnered with Pfizer5Collaboration with Genmab based on 50/50 sharing of costs and profits2 Partnered with University of PennsylvaniaFPD=First Patient Dosed3Collaboration with BMGF4Partnered with GenentechMo

125、dalityIndicationProgramSelect milestonesAnticipated timingmRNA vaccines for infectious diseaseCOVID-191BA.4/5-adapted bivalentPediatriclabel expansion2H 2023COVID-19 influenzacombination1BA.4/5-adapted bivalent+BNT161Phase 1 data update1H 2023MalariaBNT163Phase 1 data update2H 2023HSV22BNT165Phase 1

126、 data update2H 2023Shingles1BNT167Phase 1 FPD1H 2023Tuberculosis3BNT164Phase 1 FPDEarly 2023iNeST individualized mRNA vaccines1L melanoma4Autogene Cevumeran(BNT122)Phase 2 data update2023Adjuvant CRC4Autogene Cevumeran(BNT122)Phase 2 data update-Adjuvant PDAC4Autogene Cevumeran(BNT122)Phase 2 FPD202

127、3Next-gen immune checkpoint modulatorsMultiple solid tumors5BNT311(PD-L1x4-1BB)Expansion cohort data update2023Multiple solid tumors5BNT312(CD40 x4-1BB)Expansion cohort data update2023Cell therapiesCLDN6+solid tumorsBNT211Phase 1 data update20232L+testicular cancerBNT211Phase 2 FPDLate 202331Advanci

128、ng Toward Realizing Our Vision32Infectious diseases5 randomizedPhase 2 trialsGlobally successful marketed COVID-19 vaccine with first-to-market BA.4/5-adapted booster10+preclinical programs,2 FIH trials to start in 20233 Phase 1 programs19 programs in24 clinical trialsMaintain and deepen COVID-19 va

129、ccine leadershipMultiple oncology and ID product launches in next 35 yearsMid-term goalsDriving transformation todayLong-term vision510 IND submissions per yearNext-gen and combination COVID-19 vaccinesApproved products across various disease areasCardiovascular diseasesNeurodegenerative diseasesAut

130、oimmune diseasesOncologyBy 2030,we aim to be a multi-product global biotechnology leader,aspiring to address the worlds most pressing health challenges with pioneering,disruptive technologies delivered at scale32Infectious Disease Pipeline:Multiple Opportunities Built on Proven Platform1 Partnered w

131、ith Pfizer2 Partnered with University of Pennsylvania3 Collaboration with BMGF.BioNTech holds worldwide distribution rights except developing countries where BMGF holds distribution rights.IndicationProduct candidatePre-clinicalPhase 1Phase 2Phase 3Commercial2022 and 2023 MilestonesCOVID-191COMIRNAT

132、YBNT162b2(Original/OmicronBA.4/5-adapted bivalent)Pediatric label expansion exp.2H23BNT162b2(Original/OmicronBA.1-adapted bivalent)Launch+Data updatesBNT162b4(T-cell enhancing)Phase 1 initiated in December 2022BNT162b5(Enhanced spike antigen)Phase 2 started in July 2022Covid-19 Influenza combination

133、1BNT162b2+BNT161(qFlu+BA.4/5-adapted bivalent)Phase 1 initiated in October 2022Influenza1BNT161Data update in July 2022Phase 3 started in September 2022Shingles1Un-named programStart Phase 1:1H23HSV 22BNT163Phase 1 data update exp.2H23Tuberculosis3BNT164Start Phase 1:early 2023MalariaBNT165Phase 1 d

134、ata update exp.2H23HIV3Un-named programAdditional mRNAvaccine programs3Un-named programsPrecision antibacterialsUn-named programsmRNA vaccines partnered w/Pfizer10+other infectious disease programs 35 Oncology Pipeline:Significant Progress and Expansion in 20221 Partnered with Genentech2Investigator

135、-initiated Phase 1 trial3 Partnered with GenmabFPD=First patent dosed,SMIM=small molecule immunomodulators,NSCLC=non-small cell lung cancerDrug classPlatformProduct candidateIndication(targets)Pre-clinicalPhase 1 Phase 2Phase 32022 and 2023 MilestonesmRNAFixVacBNT111Advanced and R/R melanomaBNT112Pr

136、ostate cancerBNT113HPV16+head and neck cancerBNT116NSCLC 2L+FPD in July 2022iNeSTAutogene cevumeran(BNT122)11L melanomaData update exp.2023Adjuvant colorectal cancerSolid tumorsAdjuvant pancreatic ductal adenocarcinoma2Start Phase 2 in 2023Intratumoral immunotherapy SAR441000(BNT131)Solid tumors(IL-

137、12sc,IL15-sushi,GM-CSF,IFN)RiboMabsBNT141Multiple solid tumors(CLDN18.2)FPD in Jan.2022BNT142Multiple solid tumors(CD3CLDN6)FPD in July 2022RiboCytokinesBNT151Multiple solid tumors(optimized IL-2)BNT152,BNT153Multiple solid tumors(IL-7,IL-2)CelltherapiesCAR T cells+CARVacBNT211Multiple solid tumors(

138、CLDN6)Start Phase 2 in 2023BNT212Pancreatic,other cancers(CLDN18.2)Neoantigen-based T cellsBNT221Multiple solid tumorsTCR engineered T cellsTo be selectedAll tumorsAntibodiesNext-gen immune checkpoint modulatorsGEN1046(BNT311)3Metastatic NSCLC(PD-L14-1BB)Multiple solid tumors(PD-L14-1BB)Data update exp.in 2023GEN1042(BNT312)3Multiple solid tumors(CD404-1BB)Data update exp.in 2023GEN1053(BNT313)3Malignant solid tumors(CD27)Initiated in Nov.2022Targeted cancer antibodiesBNT321Pancreatic cancer(sLea)SMIMToll-like receptor bindingBNT411Solid tumors(TLR7)36