BioNTech SE (BNTX) 2023年年度報告「NASDAQ」.pdf

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1、23A C T I N G T O G E T H E R051118256014EXPLORING THE POWER OF COMBINATIONOUR PIPELINELETTER FROM THE MANAGEMENT BOARDFACTS AND FIGURESINTERVIEW WITH HELMUT JEGGLE AND UGUR SAHINREPORT OF THE SUPERVISORY BOARD 2023 HIGHLIGHTSFINANCIAL CALENDAR,IMPRINT484130FROM FOUNDING VISION TO GLOBAL IMPACT05414

2、8MAGAZINE1BioNTech|Annual Report 20232COMBINED MANAGEMENT REPORT 2023COMPENSATION REPORT 2023FURTHER INFORMATIONGROUP REPORT 2023FINANCIAL REPORTINDEPENDENT AUDITORS REPORTCONSOLIDATED FINANCIAL STATEMENTSINDEPENDENT AUDITORS REPORTREMUNERATION REPORT625342115217249BioNTech|Annual Report 202331MAGAZ

3、INEBispecific antibodies are protein molecules that can bind two different targets,bringing closer for example the cancer cell to the immune cell.When in close proximity of the cancer cell,the immune cell could recognize and orchestrate its elimination.4Our vision for future precision cancer treatme

4、nts:We are developing a unique therapy toolbox designed to act together and with the aim to improve outcomes for patients.EXPLORING THE POWER OF COMBINATIONBioNTech|Annual Report 20235 5THE CONSEQUENCE/As a consequence,a standard of care might work for one,but not another patient.In other cases,the

5、constant changes of the tumor cells lead to a resistance to available treatments.What may have originally given good results and helped the patient might not work over time.For example,it is estimated that more than 90%of mortalities in cancer patients can be attributed to chemotherapy resistance.He

6、lping patients and addressing unmet medical needs is what drives us at BioNTech every day.We have been spending years on better understanding tumors differences as well as the immune systems mechanisms to develop potential cancer treatments.We believe that the limitations cannot be over-come by a si

7、ngle technology,but rather a therapy toolbox.1PD-L1EPCAMSHARED TUMOR TARGET TPTEPATIENT-INDIVIDUALTUMOR TARGETHER-2CLDN6THE CHALLENGE/When a physician discusses a potential treatment plan with a patient who has just been diagnosed with cancer,they know that they will have to treat a disease with man

8、y different facets.Cancer cells are physically different from healthy cells in the body.Their shapes and properties are mutated and changed.They interact differently with their environment to grow abnormally and survive.And in each growing cycle,they have the potential to change further.The cells in

9、 the same tumor within the same patient can also be different.Medicine faces the challenge that every tumor is unique.2DNA MUTATIONDNA MUTATIONBioNTech|Annual Report 20236Targeted therapies/Cell therapies are designed to equip certain immune cells of the patients physically with structures(recep-tor

10、s),enabling them to recognize cancer cells and orchestrate their elimination.Antibody-drug conjugates(ADCs)are designed to targetedly deliver a chemotherapy to tumor cells.Unlike traditional chemotherapy,cancer treatments with ADCs are designed to minimize the impact on healthy cells.Mono-and bispec

11、ific antibodies are designed to modulate the activity of immune cells and in some cases cancer cells,enhancing the immune response against cancer cells.mRNA vaccines are designed to teach the immune system about features on the surface of cancer cells(targets),supporting immune cells to recognize an

12、d destroy them.OUR APPROACH/We work on potential treatment approaches that aim to precisely target the specific tumor features by employing a different mechanism to tackle each feature.Our approach is to combine therapies some investigational and some approved with the aim of achieving better result

13、s compared to the current standard of care.This is why we are developing a suite of technologies which we call our oncology toolbox.3HER-2CLDN6PD-L1Immuno-modulators/PATIENT-INDIVIDUAL TUMOR TARGETSHARED TUMOR TARGET TPTEEpCAMmRNA vaccines/SELECTED TARGETSSELECTED TARGETSSELECTED TARGETSSYNERGETIC S

14、PACE FOR CURATIVE APPROACHESSYNERGYSYNERGYSYNERGYSimplified illustrationBioNTech|Annual Report 20237BNT211/The product candidate BNT211 combines a CAR-T cell therapy candidate with an mRNA vaccine candidate.For the CAR-T cell therapy candidate,patients certain immune cells are equipped with a recept

15、or to recognize the target protein CLDN6 and precisely attack cancer cells.The mRNA vaccine candidate encodes for CLDN6 and is designed to stimulate these CAR-T cells persistence and functionality in the body,complementing the CAR-T cells in a synergistic manner.This approach is aimed at more effici

16、ent recogni-tion and elimination of cancer cells.BNT211 is currently being evaluated in Phase 1/2 clinical trials in patients with germ cell tumors.We have been evaluating combinational therapies since 2014.Here is a selection of a few currently running clinical trials:mRNA vaccine candidateinvestig

17、ational cell therapy BNT211Claudin-6(CLDN6)is a surface protein expressed on multiple solid tumors such as ovarian cancer,sarcoma,testicular cancer,endometrial cancer and gastric cancer.BioNTech|Annual Report 20238AUTOGENE CEVUMERAN/BNT1221 +CHECKPOINT INHIBITOR/This potential treatment approach com

18、bines two different molecules to fight cancer.The individualized mRNA vaccine candidate BNT122 is designed to provide immune cells with information about the patients unique cancer cells and induce an immune response against the tumor.The checkpoint inhibitor is an antibody that keeps cancer cells f

19、rom suppressing immune cells.This combinatory approach is intended to lead to a stronger and more specific immune response and elimina-tion of cancer cells.BNT122 is currently being evaluated in Phase 2 clinical trials in patients with melanoma.1)In collaboration with Genentech,a member of the Roche

20、 Group.individualized mRNA vaccine candidate checkpoint inhibitorBNT122+CHECKPOINT INHIBITORBioNTech|Annual Report 20239BioNTech|Annual Report 2023ACASUNLIMAB/BNT3111+CHECKPOINT INHIBITOR/This investigational treatment approach consists of two antibodies and is intended to target cancer cells while

21、enhancing immune cell functions in a potentially synergistic manner.BNT311 is a bispecific antibody that is designed to simultaneously address two targets at once:It binds to 4-1BB molecules,which are expressed on specific immune cells,with the aim of enhancing their function.It also binds to PD-L1

22、proteins,which are expressed on tumor cells,with the aim of preventing them from silencing immune cells.BNT311 is com-bined with the current standard of care,which is a checkpoint inhibitor which also keeps cancer cells from suppressing immune cells.This combinational treatment approach is intended

23、to increase the count of active immune cells that are able to recognize and eliminate cancer.BNT311 is currently being evaluated in Phase 2 clinical trials in patients with solid tumors,including non-small cell lung cancer and endometrial cancer.1)In collaboration with Genmab.bispecific antibody can

24、didatecheckpoint inhibitorBNT311+CHECKPOINT INHIBITORBioNTech|Annual Report 202310BioNTech|Annual Report 2023OUR PIPELINEWe are advancing a diversified portfolio of product candidates derived from our four drug classes focused on the potential treatment of cancer,infectious diseases and other seriou

25、s diseases of unmet patient need.BioNTech|Annual Report 202311ONCOLOGY/DRUG CLASSPLATFORMPRODUCT CANDIDATEINDICATION(TARGET)PHASE 1PHASE 1/2 PHASE 2PHASE 3RIGHTS1COLLABORATOR/PARTNERmRNAFixVacBNT111 Advanced,R/R melanomaFully owned2BNT113Metastatic/R/R HPV16+head and neck cancerBNT1161L metastatic m

26、etastatic non-small cell lung cancer Advanced/metastatic non-small cell lung canceriNeSTBNT122(autogenecevumeran)1L advanced melanomaCollaborationGenentech3Adjuvant colorectal cancerAdjuvant pancreatic ductal adenocarcinomaMultiple solid tumorsRiboMabsBNT142Multiple solid tumors(CD3CLDN6)Fully owned

27、RiboCytokinesBNT151Multiple solid tumors(IL-2 variant)Fully ownedBNT152+BNT153Multiple solid tumors(IL-7,IL-2)CELL THERAPIESCAR-T cells+CARVacBNT211Multiple solid tumors(CLDN6)Fully ownedNeoantigen-based T cellsBNT221Refractory metastatic melanomaFully ownedPROTEIN-BASED THERA-PEUTICS Next-generatio

28、n immune checkpoint modulatorsBNT311/GEN1046(acasunlimab)aPD(L)1-R/R metastatic NSCLC(PD-L14-1BB)CollaborationGenmabMultiple solid tumors(PD-L14-1BB)BNT312/GEN1042Multiple solid tumors(CD404-1BB)4BNT313/GEN1053Multiple solid tumors(CD27)BNT314/GEN1059Multiple solid tumors(EpCAM4-1BB)BNT322/GEN1056Mu

29、ltiple solid tumors BNT316/ONC-392(gotistobart)aPD(L)1-R/R metastatic NSCLC(CTLA-4)CollaborationOncoC4Platinum-resistant ovarian cancer(CTLA-4)Metastatic castration-resistant prostate cancer(CTLA-4)Multiple solid tumors(CTLA-4)Targeted cancer antibodiesBNT321Pancreatic cancer(sLea)Fully ownedAntibod

30、y-drug conjugates BNT323/DB-1303Multiple solid tumors(HER2)CollaborationDuality Biologics2L+,HR+/HER2-low metastatic breast cancer(HER2)BNT324/DB-1311Multiple solid tumors(B7H3)BNT325/DB-1305Multiple solid tumors(TROP2)BNT326/YL202Multiple solid tumors(HER3)CollaborationMediLink TherapeuticsSMI5Toll

31、-like receptor bindingBNT411Multiple solid tumors(TLR7)Fully ownedAs of:March 20,20241)For further details about BioNTechs rights see quarterly reports under https:/investors.biontech.de/financials-filings/quarterly-reports.2)FixVac platform is fully owned by BioNTech.The BNT111 and BNT116 Phase 2 t

32、rials are jointly conducted with Regeneron as part of a cost-sharing strategic collaboration.3)A member of the Roche Group.4)Two Phase 1/2 clinical trials in patients with solid tumors are ongoing in combination with ICI+/-chemotherapy.5)Small molecule immunomodulators.BioNTech|Annual Report 202312I

33、NFECTIOUS DISEASES/DRUG CLASSPRODUCT CANDIDATEINDICATION PHASE 1PHASE 1/2PHASE 2PHASE 3COMMERCIALRIGHTS1COLLABORATOR/PARTNERmRNABNT162b2COVID-19CollaborationPfizerFosun PharmaBNT162b2+BNT162b4(T-cell enhancing)BNT162b5/6/7(stabilized spike antigen)BNT162b2+BNT1616COVID-19 Influenza combinationCollab

34、orationPfizerBNT161InfluenzaCollaboration7PfizerBNT163Herpes simplex virusCollaborationUniversity of PennsylvaniaBNT164Tuberculosis8Fully ownedFunded by Bill&Melinda Gates FoundationBNT165Malaria9Fully ownedBNT166MpoxFully ownedFunded by CEPI10BNT167ShinglesCollaborationPfizer As of:March 20,20241)F

35、or further details about BioNTechs rights see quarterly reports under https:/investors.biontech.de/financials-filings/quarterly-reports.6)The COVID-19-Influenza combination is a Phase 3 trial in partnership with Pfizer.Further development is subject to entering into a definitive agreement.7)Out-lice

36、nsed to Pfizer 8)Two Phase 1 clinical trials are ongoing(NCT05537038,Germany and NCT05547464,Republic of South Africa).9)A Phase 1 clinical trial(NCT05581641)and a Phase 1/2 clinical trial(NCT06069544)are ongoing.10)Coalition for Epidemic Preparedness Innovations(CEPI).BioNTech|Annual Report 202313F

37、ACTS AND FIGURESBioNTech|Annual Report 202314 6,300 OUR DIVERSE COMPANYFEMALE EMPLOYEES IN THE TOTAL WORKFORCE 51%NATIONALITIES FROM A LIKE AFGHANISTAN TO Z LIKE ZAMBIA 80 2,500 OF WHICH ARE IN RESEARCH&DEVELOPMENTEMPLOYEESAll figures according to BioNTechs annual report on Form 20-F for the year en

38、ded December 31,2023 available on https:/investors.biontech.de/node/15956/html;accessed March 22,2024.BioNTech|Annual Report 20231520212023Sources:2023:20-F;2022:20-F,Link:https:/investors.biontech.de/node/14881/html;2021:20-F,Link:https:/investors.biontech.de/node/9571/html;Phase 1 also includes Ph

39、ase 1/2 trials.ONCOLOGYPHASE 1 TRIALSPHASE 2 TRIALSPHASE 3 TRIALS2022INFECTIOUS DISEASESPHASE 1 TRIALSPHASE 2 TRIALSPHASE 3 TRIALS13219620821511OUR INNOVATIVE PIPELINE911BioNTech|Annual Report 202316CAMBRIDGE(UK)KIGALI(RWANDA)SINGAPOREISTANBUL(TRKIYE)VIENNA(AUSTRIA)CAMBRIDGE(USA)GAITHERSBURG(USA)SAN

40、 FRANCISCO(USA)PARIS(FRANCE)CAPE TOWN(SOUTH AFRICA)TUNIS(TUNISIA)LOCATIONS IN GERMANY/OUR GLOBAL FOOTPRINT1LOCATIONS GLOBALLY/SHANGHAI(CHINA)BERLINHALLEIDAR-OBERSTEINNEURIEDMARBURGMARTINSRIEDMAINZ(HEADQUARTERS)BioNTech locationsInstaDeep locationsMELBOURNE(AUSTRALIA)BioNTech&InstaDeep locationsLAGOS

41、 (NIGERIA)1)As of March 20,2024.LONDON(UK)BioNTech|Annual Report 202317SEAN MARETTCHIEF BUSINESS OFFICER AND CHIEF COMMERCIAL OFFICERJENS HOLSTEINCHIEF FINANCIAL OFFICERPROF.UGUR SAHIN,M.D.CHIEF EXECUTIVE OFFICERPROF.ZLEM TRECI,M.D.CHIEF MEDICAL OFFICERJAMES RYAN,PH.D.CHIEF LEGAL OFFICERRYAN RICHARD

42、SONCHIEF STRATEGY OFFICERLETTER FROM THE MANAGEMENT BOARDSIERK POETTING,PH.D.CHIEF OPERATING OFFICERBioNTech|Annual Report 202318“Acting together”the title of this years annual report reflects our commitment to developing thera-pies with combination or synergistic potential with the aim of revolutio

43、n-izing the field of medicine.2023 was a year in which we made good progress on many fronts:maintaining our position in the COVID-19 vaccine market,advancing our oncology pipeline,and strengthening our organization in preparation of the next growth phase,including our planned product launches in onc

44、ology.We presented encouraging data from our oncology pipeline and now have an increasing number of mid-and later-stage clinical trials.We believe that we have the financial ability to fund a diversified pipeline and to strengthen our core capabilities with external innovation.At the same time,we co

45、ntinue our efforts to support developing a global ecosystem to bring innovative therapies to patients where they are needed.Thus,we believe that we have the technology,the capabilities,and the team to work towards a new era of precision medicine.OUR COVID-19 VACCINE FRANCHISE/Last year,we demonstrat

46、ed that we have successfully built a leading COVID-19 vaccine franchise in collaboration with our partner Pfizer Inc.(“Pfizer”),both commercially and scientifically.This was underlined by our leading market position in the United States,the European Union(“EU”),and Japan.1 Since 2021,we have shipped

47、 more than 4.5 billion doses of COVID-19 vaccines to over 180 countries and territories.2 In 2023 alone,we distributed over 460 million total vaccine doses,of which over 190 million doses were our successfully launched Omicron XBB.1.5-adapted monova-lent COVID-19 vaccine.3As we transitioned out of t

48、he pandemic into a more endemic-like situation,2023 helped us better understand the future demand for COVID-19 vaccines.We expect COVID-19 to remain an annual seasonal disease with peaks in the respiratory infection season:This means that vaccinations are likely to largely shift to annual seasonal u

49、se,and we are adapting our company accordingly.The transition of SARS-CoV-2 to an endemic infectious disease had an effect on our 2023 revenues,which were at approximately 3.8 billion.In the same period,we had less expenditures than originally planned,and we maintained a strong financial position.1)

50、Company assessment as of December 3,2023.2)Partnered with Pfizer;cumulative doses shipped in the years 2021-2023.3)Figures according to BioNTechs annual report on Form 20-F for the year ended December 31,2023,available at https:/investors.biontech.de/node/15956/html;accessed March 22,2024.DEAR SHARE

51、HOLDERS,BioNTech|Annual Report 202319with approximately 17.7 billion in cash,cash equivalents,and security investments.We re-mained profitable in 2023,ending the year with approximately 0.9 billion in net profit.As we look to 2024,we expect our COVID-19 vaccine franchise to stay cash-generative give

52、n our partnership model with Pfizer.We will continue to focus on cost discipline,even as we invest in the next wave of innovation.The World Health Organization(“WHO”)expects that SARS-CoV-2 will remain a risk for people around the world as new variants emerge,making the need for addressing it critic

53、al.4 In line with our goal to provide people worldwide with COVID-19 vaccines that are adapted to newly circulating virus variants or sublineages,we launched an Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.We have introduced single-dose vials and non-frozen pre-filled syringes in the United S

54、tates,which we delivered in line with the orders.We expect a transition from advanced purchase agreements to commercial market ordering in more geographies in the future.Looking ahead,it is our goal to continue building a sustainable respiratory vaccine business and retain a market-leading position

55、in COVID-19 vaccines.To this end,we have continued to work on combination vaccine candidates with Pfizer.Our combination vaccine candidate against COVID-19 and influenza moved into a Phase 3 trial in December 2023.4)https:/www.who.int/europe/news/item/12-06-2023-with-the-inter-national-public-health

56、-emergency-ending-who-europe-launches-its-transition-plan-for-covid-19,accessed February 15,2024BioNTech|Annual Report 202320We believe combining complementary treatment modalities may enable us to better leverage the potential of each technology to provide precise and personalized treatments to pat

57、ients,improving outcomes and reducing the risk of resistance to therapies.A GROWING MID-AND LATE-STAGE ONCOLOGY PIPELINE/In 2023,we successfully advanced and broadened our diversified pipeline and now have multiple ongoing registrational trials.We also have leveraged our strong financial position wi

58、th continued investment in R&D.Our oncology pipeline is set to drive long-term growth for the company.It is based on our understanding that cancer is a highly individual disease.To this end,we want to lead in the individualization of cancer med-icine and address the continuum of cancer treatments an

59、d bring novel therapies to patients,from early disease stages to late-stage metastatic disease.We have built a portfolio of different platform technologies with combination potential and synergistic mechanisms of action,encom-passing development programs for immuno-modulators,cell and precision ther

60、apies,as well as personalized mRNA vaccines across a wide range of solid tumors and stages of treatment.With this approach,we aim for a widespread application of our platform tech-nologies in combination with effective target selection to address a range of solid tumors in different stages of the di

61、sease with high medical need.In 2023,we not only complemented the pipeline with in-licensed assets,but also presented encouraging data at various scientific conferences across our platform technologies.This included data for the investigational mRNA vaccine program autogene cevumeran/BNT1225 in pati

62、ents with adjuvant pancreatic ductal adenocarcinoma,our fully owned autologous cell therapy candidate BNT211 in combination with an mRNA booster,and data on programs we are developing with partners.The data present-ed for the antibody candidate BNT3166 for patients with non-small cell lung cancer an

63、d the investigational antibody drug conjugate BNT3237 for endometrium and breast cancer patients led to the start of pivotal Phase 3 trials for both assets.We believe combining complementary treatment modalities may enable us to better leverage the potential of each technology to provide precise and

64、 personalized treatments to patients,improving outcomes and reducing the risk of resistance to therapies.We expect to continue building and maturing our oncology pipeline in 2024 in anticipation of potential commercial oncology launches as soon as 2026,if approved.We aim to have ten or more indicati

65、on approvals by 2030.ECOSYSTEM DEVELOPMENT/Our vision is to improve the health of people worldwide by bringing innovative therapies to patients where they are needed.To this end,we initiated a number of public-private 5)I In collaboration with Genentech Inc.(“Genentech”),a member of the Roche Group.

66、6)In collaboration with OncoC4,Inc.(“OncoC4”).7)In collaboration with Duality Biologics(Suzhou)Co.Ltd.(“DualityBio”).BioNTech|Annual Report 202321BioNTech|Annual Report 202322partnerships in 2023,which aim to support the development of immunotherapies and vaccines as well as expand access to our pro

67、duct candidates,building on our expertise in R&D as well as manufacturing.We entered into a collaboration with the government of the United Kingdom to augment our clinical trial network for person-alized mRNA immunotherapies with the aim to provide personalized cancer therapies for up to 10,000 pati

68、ents by the end of 2030,either in clinical trials or as authorized treatments.In the state of Victoria in Australia,we entered a multi-year partnership aimed at strengthen-ing the local mRNA ecosystem by supporting the development of innovative medicines from research to application in the clinic.We

69、 intend to progress the development of inves-tigational mRNA-based medicines and other product candidates with the aim of treating up to 4,000 cancer patients in Australia and New Zealand over a ten-year period,either in clinical trials or as authorized treatments.2023 also marked an important miles

70、tone in our efforts to help support equitable access to novel medicines globally:We inaugurated our site in Kigali,Rwanda,which is one of our initiatives to help build a sustainable and resil-ient African vaccine ecosystem.Our state-of-the-art manufacturing site in Kigali could become the first comm

71、ercial-scale mRNA manufacturing facility on the continent,and we plan to equip it to manufacture a range of mRNA-based vaccines targeted to the needs of the African Union member states.This ties in with our development activities for prophylactic mRNA vaccine candidates targeting infectious diseases

72、 such as tuber-culosis,malaria,and HIV,as well as dis-eases with epidemic and pandemic potential,including mpox.Clinical trials for tuberculosis and malaria vaccine programs are already underway in South Africa and the United States,respectively.By the end of 2024,we plan to have ongoing clinical tr

73、ials in Africa for vaccine candidates against malaria,tubercu-losis,and HIV.STRENGTHEN CORE CAPABILITIES WITH EXTERNAL INNOVATION/We have made significant progress in enhancing our core capabilities with external innovation.The rationale behind these deals is to strengthen our backbone and comple-me

74、ntary technologies,and we have already started to create value.In 2023,we entered into licensing deals for six different clinical stage assets,including in-licensing an investigational antibody candidate from each of OncoC4 and Biotheus Inc.(“Biotheus”),as well as investigational antibody-drug conju

75、gates from DualityBio and MediLink Therapeutics(Suzhou)Co.,Ltd.(“MediLink”).Two of those assets BNT316 and BNT323 moved into pivotal trials within six months of signing the respective deal.We also acquired InstaDeep Ltd.(“InstaDeep”)with the intent to integrate world-class capabilities in supercompu

76、ting,artificial intelligence(“AI”)research,and generative AI into drug design and delivery.Examples include optimization of mRNA and protein design,and end-to-end optimization for personalized medicines from genome and mutanome analysis to target prediction and manufacturing.We aim to implement AI a

77、nd machine learning capabilities into our processes even more,planning to scale our platforms so that we are able to develop more precise products and provide them to patients more efficiently.We will continue to focus on scaling the busi-ness for commercial readiness in oncology in multiple countri

78、es by the end of 2025.One step toward achieving this is our strategic collaboration with Autolus Therapeutics plc(“Autolus”),which we signed in February 2024.The collaboration grants us the option to access Autolus commercial and clinical site network,CAR-T cell therapy manufac-turing capacities,and

79、 commercial supply infrastructure in a cost-efficient set-up.This has the potential to enable the expansion of our cell therapy program BNT211 into trials for multiple cancer indications.BioNTech|Annual Report 202323A NOTE ON ACTING TOGETHER/“Acting together”is not only a description of our pipeline

80、 approach,but also a reflection of our culture.At BioNTech,we believe in acting together not only within the company,but also with stakeholders,including our collabora-tors,business partners,regulators,communi-ty members,and many more.We saw during the COVID-19 pandemic that this approach was instru

81、mental in successfully reaching a common goal,and we are convinced that by acting together,we will be able to work towards our vision of improving the health of people worldwide.The development of the COVID-19 vaccine has transformed BioNTech.The realization of our oncology pipeline has the same pot

82、ential to transform our company once more.Howev-er,this will only be possible thanks to the con-tinued unrelenting commitment,passion,and hard work of our employees.We would also like to thank you,our shareholders,for your continued support and look forward to taking the next steps to turn our visio

83、n into reality.Your Management Board,Prof.Ugur Sahin,M.D.Chief Executive Officer“Acting together”is not only a description of our pipeline approach,but also a reflection of our culture.Jens HolsteinChief Financial OfficerSean MarettChief Commercial Officer,Chief Business OfficerSierk Poetting,Ph.D.C

84、hief Operating OfficerProf.zlem Treci,M.D.Chief Medical OfficerRyan RichardsonChief Strategy OfficerJames Ryan,Ph.D.Chief Legal Officer BioNTech|Annual Report 202324INTERVIEW WITH HELMUT JEGGLE AND UGUR SAHINBioNTech|Annual Report 202325How would you summarize the year 2023?HELMUT JEGGLE/While the y

85、ears 2020 to 2022 were characterized by the develop-ment,large-scale production and supply of the COVID-19 vaccine together with Pfizer,2023 was a year in which BioNTech refo-cused to advance a core area:our oncology pipeline.The Company tailored its strategy by in-licensing further product candidat

86、es in late-stage clinical development.These included antibody-drug conjugates,or ADCs,a new targeted form of chemotherapy.BioNTechs goal is to be as efficient as possible in submit-ting these candidates for regulatory approval.UGUR SAHIN/We believe antibody-drug conjugates represent an exciting and

87、import-ant advancement in medicine,and we expect their broad applicability in the treatment of cancer within the next 15 years.We have forged collaborations with powerful and innovative partners in this field with whom we are jointly developing these candidates.We envision an exciting opportunity to

88、 combine ADCs with our proprietary product candi-dates,which also aligns with our strategy of developing complementary and synergistic therapeutic approaches.By doing so,we aim to extend the reach of our therapies to broader patient populations,thereby making a tangible difference in their lives.Wha

89、t goals did you set for yourself in 2023,and did you achieve them?UGUR SAHIN/We had three overarching goals in 2023,all of which were successfully achieved at BioNTech.Our first goal was to close the financial year on a profitable note while maintaining our leadership in COVID-19 vaccines.This objec

90、tive was met,largely due to our effective development and rollout of a variant-adapted vaccine.Second,we sought to strategically invest in our oncology pipeline,launching several potentially pivotal trials in 2023 while bolstering our technology platforms through strategic collaborations to further

91、solidify our position in this area.Third,within the realm of infectious diseases,we successfully advanced our vaccine candi-dates targeting shingles,tuberculosis and mpox into clinical trials.We anticipate initial data for some of these candidates in 2024.How significant is the COVID-19 vaccine busi

92、ness for BioNTech?Are there additional revenue streams for the Company?UGUR SAHIN/The COVID-19 vaccine,including its seasonal adapted variant vac-cines,are our only approved product to date.In 2023,we witnessed a pivotal transition from the pandemic phase to more and more seasonal vaccination campai

93、gns.In many countries,a vaccination against COVID-19“The COVID-19 vaccine has not only contributed significantly to BioNTechs revenues but has also shown the efficiency of a business model which is based on innovative technologies.”HELMUT JEGGLECHAIRMAN OF THE SUPERVISORY BOARDBioNTech|Annual Report

94、 2023BioNTech|Annual Report 202326BioNTech into a sustainable income-gen-erating entity through a series of approvals,thereby delivering tangible value to patients,the society,investors,and the Company alike.HELMUT JEGGLE/What Ugur Sahin is setting out here are very ambitious goals indeed.It is ther

95、efore important that the Company strikes a balance between R&D and commercialization.BioNTech had already started to build an organization to successfully commercialize its oncology products.This remains an important strategic aspect in 2024.You have licensed new candidates.What is the rationale beh

96、ind this?UGUR SAHIN/The candidates we have in-licensed hold significant strategic impor-tance for us because we believe they possess the potential to be used in patients to achieve a potent effect in advanced disease settings and could have synergies with our immu-notherapies.For instance,ADCs offer

97、 the possibility to debulk large tumors to eradicate residual tumor cells through subsequent immunotherapy.Currently,we are assessing ADCs targeting specific types of cancer in the lung,breast,and gastrointestinal tract.In combination with ADCs,we expect to be able to extend the scope of our immunot

98、herapies to advanced cancers.What expenditures do you expect in 2024,and where will you allocate investments in particular?UGUR SAHIN/Our focus is specifically on three core areas:advancing potentially registrational trials with the aim of product launches in oncology,ensuring the Companys organizat

99、ional launch readiness,and the ongoing development of our pipeline en-compassing vaccine candidates targeting COVID-19 and other infectious diseases.The bulk of our expenditure is allocated to oncology,primarily to support more advanced-stage clinical trials and the launch readiness.Furthermore,we a

100、re advancing several vaccine candidates for infectious diseases into the next clinical phase.In addition,in 2024,we have further bolstered our interna-tional presence to facilitate clinical trials and prepare for potential market launches across various regions,including the US,the UK,Singapore,Rwan

101、da,and Australia.What are your goals for 2024 and the upcoming years in the field of oncology?UGUR SAHIN/By the end of 2024,we aim to have a ten or more clinical trials with regis-trational potential across various indications within our pipeline.Our overarching target in oncology is to launch the f

102、irst product,if ap-proved,by 2026 and to secure ten indication approvals by 2030.Our vision is to transform GROBENTWURFis now recommended primarily for older individuals and those with underlying health conditions,leading to a corresponding decline in demand for the COVID-19 vaccine.Looking ahead,we

103、 anticipate an ongoing need for seasonal,variant-specific vaccines tailored to specific population groups.Its imperative for us to address this seasonal dynamic while si-multaneously advancing the development of a combination vaccine targeting both COVID-19 and influenza.In addition to our COVID-19

104、vac-cine business,we generate revenues through our service-based enterprises,including sub-sidiaries like InstaDeep,JPT Peptide Technol-ogies,and IMFS,as well as revenues from our pandemic preparedness contract in Germany.HELMUT JEGGLE/The COVID-19 vaccine has not only contributed significantly to B

105、ioNTechs revenues but has also shown the efficiency of a business model which is based on innovative technologies.From the initial stages of research and development to the establishment of robust production capac-ities and logistics infrastructure to meet the demand,BioNTechs comprehensive vertical

106、 integration exceeded the expectations set at the time of its IPO.This revenue stream is also serving as a valuable lesson in cost discipline,providing BioNTech with a defined financial framework to pursue other innovative projects.With this foundation in place,the Company now has the opportunity to

107、 solidify its business model and extend its success into oncology.BioNTech|Annual Report 202327“Cancer is not a single disease,but rather a spectrum of diseases,each unique in its characteristics.Hence,our pipeline is structured into three distinct therapeutic approaches.”PROF.UGUR SAHIN,M.D.CHIEF E

108、XECUTIVE OFFICERHELMUT JEGGLE/At an early stage,BioNTech recognized the opportunity and combined a scientific pioneering spirit with strong entrepreneurship in the ADC space.It is noteworthy that two of the in-licensed product candidates,one an antibody can-didate and the other an ADC candidate,are

109、already being evaluated in Phase 3 studies.Mr.Jeggle,in the 2021 annual report you said that BioNTech is fully financed until the next product launch.Do you stand by that statement?Will the Company propose a dividend to shareholders this year?HELMUT JEGGLE/Given the Companys ambitious targets,there

110、is currently little latitude for dividends,which will not be proposed at the upcoming Annual General Meeting.BioNTechs primary objective is to develop the Company into sustainable profitability by 2030 without the need for additional capital.The potential for future divi-dends is also contingent upo

111、n sales from our COVID-19 vaccine business.Hence,in 2023,we established a Product Committee at BioNTech to further develop the product pipeline with a target-oriented approach,paving the way for market access.The feedback we have received by both private and institutional investors is that they reco

112、gnize the Companys potential,grounded in its scientific standing,and endorse the BioNTech|Annual Report 202328strategy of leveraging BioNTechs financial position to spearhead the next wave of potential product launches.What was BioNTechs strategic direction when it went public,and has the Company ma

113、intained that course?UGUR SAHIN/Our objective was to pioneer the next generation of immunotherapies,aiming to significantly enhance treatment outcomes for cancer patients.Our focus was and still is to help shape a new era of personalized medi-cine as pioneers.In 2023,we found ourselves poised to rea

114、lign with our original mission.The notable difference from 2019 lies in our new-found financial and organizational resources that empower us to turn our vision into reality on a grander scale.This achievement is based on the dedication and ambition of our teams,whose passion has propelled us forward

115、.We extend our gratitude to our colleagues who work diligently with us every day to actively shape the medicine of tomorrow.HELMUT JEGGLE/From my perspective,two key factors stand out:First,BioNTech now has the autonomy to self-finance,based on its COVID-19 vaccine business.Consequently,influence of

116、 external risks has been reduced.Second,the Company has experienced a remarkable surge in both growth and exper-tise arguably surpassing what was foresee-able back in 2019.You have a well-filled pipeline with over 30 candidates in oncology alone and across different drug classes.How is that made up?

117、Why do you need so many candidates?UGUR SAHIN/Cancer is not a single disease,but rather a spectrum of diseases,each unique in its characteristics.Hence,our pipeline is structured into three distinct therapeutic approaches.First,we are dedicated to devel-oping candidates for targeted therapies,which

118、encompass modalities such as CAR-T cell therapies or ADCs.These interventions are primarily tailored to combat cancer in patients at advanced stages of the disease.Second,our focus extends to the development of immuno-therapies,exemplified by antibodies,aimed at fortifying the immune system.This hol

119、ds the potential to exert long-term control over tumors in some patient populations.The third compo-nent of our pipeline centers on personalized mRNA cancer vaccine candidates designed to prevent relapses and metastases effectively.We pride ourselves on being among the few companies committed to res

120、earching a diversi-fied toolbox comprising of various mechanisms of action,including the aspect of whether and how these could be combined and act syner-gistically to enhance their effect.We are initially evaluating the therapeutic approaches in indi-cations with a high medical need or for larger pa

121、tient populations for which we see probability of approval.Our strategic intent is to position ourselves to commercialize these products across various indications in the future,thereby expanding their reach and impact.What are you looking forward to in 2024?HELMUT JEGGLE/It is an important year for

122、 BioNTech.The year 2024 marks a new begin-ning,and that always means something exciting.This year,our focus is on fortifying our organi-zational infrastructure for commercialization in furtherance of launch readiness,and on enhancing transparency in product de-velopment progress,particularly in pote

123、ntially registrational trials.BioNTech has consistently demonstrated its strength as a cohesive team,and I want to extend my heartfelt appreciation for everyones passion,dedication,and drive.Without each individuals contribu-tion,the Company would not be where it stands today.UGUR SAHIN/Thank you,He

124、lmut,I share your sentiment wholeheartedly.As part of this remarkable team,I am eager to propel our candidates toward market launch,pending regulatory authorization,and demonstrate the value they bring to both the Company and to society.We have a unique opportunity to drive transformative change in

125、the field of medicine,and I firmly believe we have everything it takes to establish BioNTech as one of the leading global immunotherapy companies.BioNTech|Annual Report 202329REPORT OF THE SUPERVISORY BOARD ON THE FINANCIAL YEAR 2023PROF.ANJA MORAWIETZ,PH.D.PROF.CHRISTOPH HUBER,M.D.1MICHAEL MOTSCHMA

126、NNPROF.RUDOLF STAUDIGL,PH.D.ULRICH WANDSCHNEIDER,PH.D.HELMUT JEGGLECHAIRMAN OF THE SUPERVISORY BOARDNICOLA BLACKWOOD11)Nicola Blackwood was elected to the Supervisory Board on May 25,2023.She succeeded Prof.Christoph Huber,M.D.,who left the Supervisory Board after reaching the retirement age limit.B

127、ioNTech|Annual Report 202330In the past year,BioNTech SE continued to transition towards becoming a leading global immunotherapy Company.The Company maintained its leading position for COVID-19 vaccines in key markets.At the same time,BioNTech focused on its growing oncology pipeline and advanced se

128、veral candidates from different drug classes to later stages of development.Part of this effort also included the Management Boards strategic decision to license clinical projects in late-stage development to be able to further additional candidates towards regulatory submission and to potentially d

129、evelop new oncology treatment standards in-house and combine them with other therapies.BioNTech|Annual Report 202331In addition,BioNTech strengthened its technology platforms,digital capabilities,and infrastructure through corresponding investments and strategic partnerships.This includes the acquis

130、ition of InstaDeep Ltd.(“InstaDeep”)as part of BioNTechs strategy to build world-leading capabilities in AI-driven drug discovery and the development of next-generation immunotherapies and vaccines to address diseases with high unmet medical needs.Combining all these factors with the Companys strong

131、 financial position places BioNTech well for 2024.In the current financial year,the aim will be to deploy resources with the necessary level of cost discipline,while the Management Board will continue to focus on the oncology segment,and the Company is preparing to potentially launch its first oncol

132、ogy products in various markets.Throughout the financial year 2023,the Supervisory Board,under my Chairmanship,performed its duties and obligations in accordance with the law and the Articles of Association,as well as its Rules of Proce-dure.At the Annual General Meeting on May 25,2023,the Superviso

133、ry Board changed its composition:Prof.Christoph Huber,M.D.stepped down,and Baroness Nicola Blackwood was elected as a member of the Supervisory Board of BioNTech SE as his successor.Nicola Blackwood is Chairwoman of the Advisory Board of Oxford University Innovation Ltd.,CEO of Blackwood Intelligenc

134、e Ltd.,Chairwoman of the Advisory Board of Genomics England as well as an indepen-dent advisor.She complements the Boards established competence profile particularly with her expertise in the areas of science and innovation,as well as her strong strate-gic and analytical skills.Nicola Blackwood also

135、 has proven expertise in research and development,digitalization,and corporate social responsibility(CSR)/sustainability and international experience in the markets relevant to the Company.During the Annual General Meeting of the financial year 2023,Ulrich Wandschneider,Ph.D.and Michael Motschmann w

136、ere re-elected,which con-tributes to the continuity and a sustainable long-term focus of the Company.CONTROL AND MONITORING FUNCTION OF THE SUPERVISORY BOARD TOWARDS THE MANAGEMENT BOARD/The Supervisory Board continuously monitored the Management Board,regularly advised it,and oversaw the strategic

137、development of the Company.As the Supervisory Board,we closely follow the rapid development of the Company,and we apply our know-how,entrepreneurial focus,and approach of agile control to support BioNTechs business activities and its team.Among other things,the Management Board regularly informed us

138、 about current business activities and future business planning(including financial,investment and personnel planning).In addition,we regularly consulted with the Management Board on the risk situation,risk management and compliance in the Company.As Chairman of the Supervisory Board,I was also in r

139、egular contact with the Management Board beyond the Supervisory Board meetings.Within this framework,I was routinely informed about all matters relating to the Company,including its legal and business relations with affiliated companies,and all significant business trans-actions and matters at affil

140、iated companies.On the basis of reporting by the Management Board,which was prepared in cooperation with the respective specialist departments,we discussed business developments and events of importance to the Company in detail.Where necessary,the Supervisory Board was supported in this by the respe

141、ctive responsible committees.We,as the Supervisory Board,maintain an active dialogue with the Manage-ment Board to embrace BioNTechs rapid development and to review their decisions,considering the opportunities and risks without any unnecessary delays.In doing so,we always keep in mind the Companys

142、goals:for example,the goal of having several products that are market-ready by 2030.BioNTech|Annual Report 202332The Supervisory Board was directly involved at an early stage in all decisions of fundamental importance to the Company.Where the law,the Articles of Association or the Rules of Procedure

143、 required the approval of the Supervisory Board for individual measures,a corresponding resolution was passed.The Supervisory Board approved the respec-tive resolutions proposed by the Manage-ment Board after thorough examination and discussion.Cooperation with the Management Board of BioNTech was c

144、haracterized by responsible and goal-oriented action in every respect.The Management Board fully fulfilled its reporting obligations to the Supervisory Board,both verbally and in writing,to constantly enable the Supervisory Board to assure itself as to the legality and regularity,appropriate-ness,an

145、d economic efficiency of the man-agement of the Company.FOCUS TOPICS AND MEETINGS OF THE SUPERVISORY BOARD/A total of six ordinary meetings were held in the financial year 2023,during which the strategic development of the Company was discussed,generally jointly with the Man-agement Board.The 2023 m

146、eetings were held on March 08,March 23,May 10,May 25,September 14,and December 14,2023.All members of the Supervisory Board attended the individual meetings except for the BioNTech|Annual Report 202333meeting on March 23,which Prof.Rudolf Staudigl and I,Helmut Jeggle,were unable to attend.Members of

147、 the BioNTech Man-agement Board also attended some of these meetings.All Management Board members attended the meetings on March 08,September 14,and December 14,2023.In addition,Jens Holstein attended the meeting on March 23 and all Management Board members except for Prof.zlem Treci,M.D.attended th

148、e meeting on May 10.The meeting on May 25 was held without the Management Board.A short meeting was also held following the quarterly meeting on December 14,which was only attended by James Ryan,Ph.D.from the Management Board.A multi-day strategy workshop was held in March and September 2023,respect

149、ively,and was attended by the entire Supervisory Board and Manage-ment Board to discuss the Companys future strategic direction.Within the framework of the meetings and outside the meetings,the Supervisory Board also met and discussed regularly without the Management Board.All six ordinary meetings

150、were held in person.The focus of the ordinary meetings in the financial year 2023 was on deliberations regarding the continued development of the Companys business related to the Pfizer-BioNTech COVID-19 vaccine and the associated strategic decisions regarding adaptations to the Omicron variant and

151、its sublineages,as well as decisions with regards to production,supply,delivery,and distribution of the vaccine worldwide.In addition,a focus was placed on deliberations regarding the Companys pipeline development in the areas of oncology and infectious diseases as well as on the completion of new s

152、trategic collaborations.The Supervisory Board was also involved in decisions about the strengthening and extension of the developed corporate strategy,including the growth of the Company and the accompanying expansion into various regions worldwide.In addition to the focus topic of the COVID-19 vacc

153、ine business and the pipeline expansion in the areas of oncology and infectious diseases,the Supervisory Board addressed the following topics during the 2023 financial year:Review of production of the COVID-19 vaccine,as well as its commercialization,network development,creation of a devel-opment pl

154、an adapted to changing popula-tion health needs worldwide,national and international distribution as well as facilitating global availability of the COVID-19 vaccine;Review of the expansion of distribution and commercialization of the COVID-19 vaccine and support of global vaccine supply to popu-lat

155、ions by entering into supply agreements as well as collaboration agreements with multi-ple companies and governments worldwide;Review of the advancement of the diversified portfolio of oncology product candidates and the achievement of clinical trial milestones in the areas of oncology and immunolog

156、y,and development of IT processes to support clinical development;Review of strategy,structure and process development in the areas of com-mercialization,communication,digitization and cooperations at the respective sites;Review of the expansion of laboratory and production capacity and office space

157、,as well as the development of new manufacturing facilities to expand produc-tion and distribution capacity worldwide,including development and construction of BioNTainers intended to expand vaccine production worldwide;Review of the Companys global growth and related measures,such as site expan-sio

158、n in Africa,Asia and Australia;Review of and participation in public-private partnerships to advance the devel-opment of immunotherapies through the expansion of clinical trials;Monitoring the Companys financing activities;BioNTech|Annual Report 202334 Completion of several collaborations,investment

159、s and licensing agreements,in particular with regard to strategic rationales;Review of the established terms and parameters for determining the restricted stock units,or RSUs,announced in January 2024 under the BioNTech Employee 2020 Long-Term Equity Plan(“BioNTech Employee 2020 Equity Plan”)for emp

160、loyees;Setting the agenda and review of the draft resolutions for the 2023 Annual General Meeting;Review and appraisal of the compensation granted and owed in the 2023 financial year and of the compensation system applied as part of the compensation report pursuant to Section 162 of the German Stock

161、 Corporation Act(AktG);Review and monitor the achievement of the Companys 2023 goals and the setting of the budget for the 2024 financial year;Review and discussion of the financial statements and the combined manage-ment report for BioNTech SE and the Group;Review and discuss the effectiveness of t

162、he internal control system and risk man-agement as well as the results of the annual auditors review;Consideration of all corporate gover-nance issues and review of compliance with the recommendations of the Corporate Governance Code both in and after the 2023 financial year;and Discussion and revie

163、w of the Companys sustainability report.COMMITTEES/To implement its monitoring and advisory function,the Supervisory Board has formed three committees:an Audit Committee,a Compensation,Nomination and Governance Committee,and a Capital Markets Committee.The above-mentioned key topics were prepared by

164、 the committees,including the associated resolutions and issues,for subse-quent consideration by the full Supervisory Board.Effective October 01,2023,a new Product Committee was established.The Audit Committee consisted of Prof.Anja Morawietz,Ph.D.,Ulrich Wandschneider and Rudolf Staudigl throughout

165、 the 2023 financial year.Anja Morawietz is the Chair of the Audit Committee.In particular,the Audit Committee deals with monitoring the Companys accounting,monitoring the BioNTech|Annual Report 202335establishment and effective functioning of internal controls over financial reporting,monitoring com

166、pliance with SOX regulations(Sarbanes-Oxley Act Section 404),and monitoring the establishment and effective functioning of the risk and compliance man-agement system and the internal auditing system.For the quarterly financial statements as of March 31,June 30,and September 30,2023,as well as the an

167、nual financial state-ments as of December 31,2023,the Audit Committee held discussions with the auditors and representatives of the accounting depart-ment,discussed the key points of the audit,and discussed the publications in detail with the Management Board.For reports requiring approval by the Su

168、pervisory Board,the Audit Committee prepared the resolutions for the Supervisory Boards decision.The Committee met eight times in the 2023 financial year.Of these,a total of four meetings were held in person,three as hybrid meetings,and one meeting took place as a video conference.Ulrich Wandschneid

169、er was unable to attend one meeting;otherwise,all members of the Audit Committee attended all meetings.All members of the Audit Committee qualify as“independent directors”for the financial year 2023 within the meaning of Rule 10A-3 under the U.S.Securities Exchange Act of 1934,as amended(the“Exchang

170、e Act”)and Nasdaq Listing Rule 5605.In addition,all members have qualified as“audit committee financial experts”as defined under the Exchange Act.In addition,all members also have the special knowledge and experience in the field of accounting as well as expertise in the field of auditing as require

171、d by the German Corporate Governance Code.This includes knowledge and experience in the application of accounting principles and internal control and risk management systems,and special knowledge and experience in auditing financial statements.Anja Morawietz and Ulrich Wandschneider also possess kno

172、wledge of sustainability reporting and auditing.Throughout the financial year 2023,Rudolf Staudigl and Michael Motschmann were members of the Compensation,Nominating and Corporate Governance Committee.Until May 25,2023,Christoph Huber was part of the Committee.Since May 25,2023,Nicola Blackwood has

173、replaced Christoph Huber on this Committee.Rudolf Staudigl is the Chair of the Committee.The Compensa-tion Committeedeals with fundamental issues relating to the compensation and determina-tion of the salaries of the Management Board,and with the compensation of the Supervisory Board as well as the

174、employee stock option programs.In the financial year 2023,it focused on the elections to the Supervisory Board and the implementation of new Management Board contracts to be concluded in 2023.For the new and re-elections of the Supervi-sory Board,the Committee made proposals to the full Supervisory

175、Board.Furthermore,the Compensation,Nomination and Corporate Governance Committee reviewed the com-pensation system for the Management Board and Supervisory Board members by com-missioning external consultants to conduct a benchmark analysis and discussed the result as well as possible future adjustm

176、ents.In addition,the Committee held discussions to determine corporate goals,which were then discussed by the full Supervisory Board.The actual application of the compensation system in the 2023 financial year was assessed in the form of the compensation report in accordance with Section 162 of the

177、German Stock Corporation Act(AktG).In the financial year 2023,the Committee also addressed the requirements for implementing a share repurchase program and discussed the introduction of shareholder guidelines with the Management Board.Additional possible performance-based employee shareholder progra

178、ms which are in line with corporate objectives were discussed.In addition,the Committee addressed the development of a corporate governance standard for the Company that meets the requirements of both Nasdaq Global Select Market and the German Corporate Governance Code.The Committee met seven times

179、during the 2023 financial year.The seven meetings took place as video con-ferences.Three meetings were only attended by Michael Motschmann and Rudolf Staudigl.All other meetings were attended by all mem-bers of the Committee.BioNTech|Annual Report 202336The Capital Markets Committee consisted of me,

180、Helmut Jeggle,Michael Motschmann,and Anja Morawietz throughout the financial year 2023.To this day,I continue to act as Chair of the Committee.The Capital Markets Committee advised the Supervisory Board on capital market measures which took place during the 2023 financial year,in particular measures

181、 taken to integrate InstaDeep following its acquisition,as well as other potential takeover,merger and acquisition activities.In the financial year 2023,the Com-mittee also focused on the regular analysis of the Companys investor structure,investor expectations regarding BioNTech and their goals for

182、 the financial year 2023 as well as feedback from investors.The Committee held discussions on strategic corporate planning,share price performance,and analyst ratings.The Committee also held discussions on indi-vidual targets of potential M&A transactions,regularly discussed updates on planned or on

183、going transactions,and engaged in discussions on the topic of communicating with investors.The Committee met four times during the 2023 financial year.All of these meetings took place as video conferences.All members of the Committee took part in all meetings.Following extensive discussions in the S

184、u-pervisory Board and two strategy workshops with the Management Board,it was decided to establish a new Product Committee.This Committee was formally formed on October 1,2023.Its members are Ulrich Wandschneider,Nicola Blackwood and me,Helmut Jeggle.Ulrich Wandschneider serves as Chair of this Comm

185、ittee.The Product Committees responsibilities include strategy,execution and communications advice in relation to relevant launch efforts as well as overseeing activities related to product development,launch plans and their implementation.Special attention is given to advising on the market potenti

186、al of products in clinical development.Prior to the establishment of the Product Committee,several preliminary discussions were held between the members of the Committee and Ugur Sahin,a represen-tative of the Management Board,to define the structure and responsibilities of the Product Committee.The

187、 Committee met once in the 2023 financial year.During this meeting,the focus was on discussing future work priorities,setting strategic goals,and laying the founda-tion for next steps.All members of the Commit-tee took part in this in-person meeting.CORPORATE GOVERNANCE/Together with the Management

188、Board,we thoroughly examined the recommenda-tions of the Corporate Governance Code.BioNTech adheres to the recommendations of the Corporate Governance Code with the exception of the provisions explicitly listed in the Declaration of Conformity pursuant to Section 161 of the German Stock Corporation

189、BioNTech|Annual Report 202337Act(AktG)dated February 27,2024,and for which an explanation is provided as to why these are not complied with.We will continue to support the Management Board in its efforts to fully comply with the recommendations of the German Corporate Governance Code in the future.C

190、ONFLICTS OF INTEREST ON THE SUPER-VISORY BOARD AND MANAGEMENT BOARD,SELF-ASSESSMENT,FURTHER TRAINING AND COMPETENCE PROFILE/Conflicts of interest of Supervisory Board and Management Board members that may arise,for example,as a result of a consultancy or board function with customers,suppliers,lende

191、rs or other third parties,are disclosed in the interests of good corporate governance.There were no potential conflicts of interest for the Supervisory Board and Management Board in the 2023 financial year.Accord-ingly,neither the Supervisory Board nor the Management Board members waived their right

192、 to participate in the discussion of indi-vidual agenda items or to vote on the relevant resolutions.As members of the Supervisory Board,we regularly participated in training and further education measures in the 2023 financial year.This included,e.g.,various workshops and training events on topics

193、relevant to the Company.In addition,the Supervisory Board received training from an external legal advisor commissioned by the Company on the topics of sustainability/CSR,cybercrime and common corporate risks.After the end of the financial year,the Supervisory Board conducted a self-assessment by co

194、mpleting a written questionnaire to evaluate the meth-ods used by the Supervisory Board and the collaboration with the Management Board.This evaluation covered all key aspects of the Supervisory Boards work,including its committees,composition,competence profile,main topics,and its relationship with

195、 the Management Board.Following the evalu-ation of this self-assessment,the work of the Supervisory Board,its committees and the Management Board remains professional and cooperative.No fundamental need for change was identified.The Supervisory Board established a compe-tency profile for the entire

196、body,which covers various specialist areas.As the Supervisory Board,we ensure that the competency profile is met by our members and updated as nec-essary.In addition,the Supervisory Board al-ways endeavors to fill this competency profile when appointing members to the full body.ANNUAL AND CONSOLIDAT

197、ED FINANCIAL STATEMENTS AUDIT/In accordance with the resolution of the Annual General Meeting on May 25,2023,the Supervisory Board has commissioned EY GmbH&Co.KG Wirtschaftsprfungs-gesellschaft to audit the annual financial statements for the 2023 financial year.The audit includes:the annual financi

198、al statements of BioNTech SE in accordance with HGB;the report on relations with affiliated companies pursuant to Section 313 para.1 of the German Stock Corporation Act(AktG),the so-called dependency report;the consolidated financial statements prepared in accordance with Section 315e para.3 in conj

199、unction with para.1 HGB on the basis of International Financial Reporting Standards(IFRS)as adopted by the EU;the consolidated financial statements,which have been prepared in accordance with IFRS as issued by the International Accounting Standards Board(IASB)and filed on Form 20-F with the U.S.Secu

200、rities Exchange Commission after our approval;the combined management report;and the audit of the internal control system.The financial statements prepared by the Management Board on March 18,2024,i.e.,the annual financial statements and the dependency report of BioNTech SE,and the BioNTech|Annual R

201、eport 202338consolidated financial statements and the management report for the Group and the Company for the 2023 financial year,were submitted to all members of the Supervisory Board.Together with the Management Board,we prepared a compensation report for the first time for the 2023 financial year

202、 in accor-dance with Section 162 of the German Stock Corporation Act(AktG),which was adopted on March 18,2024,and is disclosed as a separate report.We also received the auditors reports on the accounting records,the annual financial state-ments,the dependency report,the consolidat-ed financial state

203、ments as well as the manage-ment report on the Group and the Company for the financial year 2023,each of which was issued with an unqualified opinion on March 20,2024.The auditors report was discussed by the Audit Committee with the Management Board and the auditors.The Audit Commit-tee particularly

204、 focused on key audit matters described in the auditors report,including the audit procedures performed.This was followed by a discussion in the Supervisory Board.On our part,we have audited the annual financial statements,the dependency report,the consolidated financial statements and the managemen

205、t report for the Group and the Company for the 2023 financial year.Based on the final results of our audit,we have no objections to raise.We consider the auditors assessment of the annual financial statements to be accurate.We approve the annual financial statements and the consol-idated financial s

206、tatements prepared by the Management Board.The former is thus ad-opted.The Supervisory Board also concurs with the management report on the Group and the Company.Based on the final result of its examination,the Supervisory Board also has no objections to the declaration by the Management Board on re

207、lations with affiliated companies in the dependency report.EXPRESSION OF GRATITUDE OF THE SUPERVISORY BOARD/Last year,BioNTech set important milestones for the future.The Company plans to drive clinical development in the field of oncology towards potential approvals.In addition,it is addressing inf

208、ectious diseases with high medical need with its vaccine candidates.As often is the case,success like this comes from the sum of several things.The Supervisory Board would like to thank the investors for their trust,the members of BioNTechs Management Board and all employees across the globe for the

209、ir perfor-mance over the past year.BioNTech|Annual Report 202339With great commitment,passion and an unwavering belief in the Companys vision,they have contributed significantly to its success and have always collaborated with the Companys corporate bodies.Munich,March 20,2024BioNTech SEHelmut Jeggl

210、eChairman of the Supervisory BoardBioNTech|Annual Report 202340FROM FOUNDING VISION TO GLOBAL IMPACT BioNTechs 15-year journeyBioNTech|Annual Report 2023412023 was a special year for us at BioNTech as it marked our 15th anniversary a moment to reflect on our remarkable journey from a small,privately

211、 owned startup to a global,fully integrated immunotherapy Company.There are many milestones that make BioNTechs story unique.Groundbreaking scientific discoveries,combined with unwavering determination result in profound biopharmaceutical innovation.We were the first to develop an intravenously deli

212、vered mRNA-based human therapeutic,the first to advance an individualized mRNA-based cancer immunotherapy into clinical trials,and the first to establish scaled in-house manufacturing for such a product candidate.42CHRISTOPH HUBERPioneering hematologist,oncologist,and translational immunologist Prof

213、.Christoph Huber,M.D.co-founded BioNTech and served as a member of the Companys Supervisory Board until his retirement in 2023.With his many years of dedication,his passion,and his pioneering spirit,he made decisive contributions to the translation of scientific research into practical applications,

214、such as the characterization of surface struc-tures of cancer cells,throughout his career and contributed significantly to the diversified pipeline the Compa-ny can draw on today.INITIATION OF FIRST CLINICAL TRIAL/In 2012,we started our first Phase 1 clinical trial with an RNA immunotherapy in melan

215、oma.While every patients tumor is unique,tumors can share certain sets of markers,known as antigens,that are not found in healthy cells.This is the idea behind one of our mRNA-based immunotherapy approach-es,now known as FixVac.In a Phase 1 clinical trial,which BioNTech initiated in 2015,pa-tients w

216、ith melanoma were treated with one of these FixVac investigational candidates;the first results of the trial were published in the high-ranking journal Nature in 2020.20082012FOUNDING OF THE COMPANY/BioNTech was founded in 2008 by medical doctors and scientists Ugur Sahin,zlem Treci and Christoph Hu

217、ber.They were driven by the vision to translate scientific discoveries into life-saving treatments.The founding also involved Andreas and Thomas Strngmann,the MIG funds,and Chairman of the Supervisory Board Helmut Jeggle.They supported the founding idea with seed financing of$180 million.Profs.Sahin

218、 and Treci had already spent decades researching innovative potential treatment options to address cancer at this point.With BioNTech,they sought to advance this research and develop potential individualized mRNA-based cancer vaccines and other precision cancer treatments.KATALIN KARIKmRNA scientist

219、 Prof.Katalin(Kati)Karik first met the BioNTech team in 2013 and decided to join the Company shortly afterward.Like Ugur Sahin and zlem Treci,she believed in the potential of mRNA from the very beginning and focused on improving the therapeutic potential of the mol-ecule.In 2014,the three scientists

220、 published their findings in a compre-hensive overview in Nature Reviews Drug Discovery.In 2023,Kati Karik and her colleague Drew Weissman from the University of Pennsylvania received the Nobel Prize in Physiology or Medicine for pioneering nucleoside base modifications,which were one of the key inn

221、ova-tions applied to develop the Pfizer-BioNTech COVID-19 vaccine.BioNTech|Annual Report 202343EXPANDING OUR TOOLKIT/We started to expand our toolkit in 2015.Cancer is not just one disease,but many.Cancer differs from patient to patient and even within a patients tumor there are different cancer cel

222、ls.This is why there is no one-size-fits-all approach to treating cancer that works for all patients.A whole toolkit of therapeutic approaches is needed.We at BioNTech are developing our proprietary technologies and are also teaming up with other organizations to build such a toolkit.In 2015,we ente

223、red into a collaboration with Genmab to jointly research and develop novel mono-and bispecific cancer antibodies.Many more collaborations have followed in the years to come.Today,we work together with Genmab,DualityBio,Genentech,Genevant,OncoC4,Regeneron,Pfizer,and others.Together,we have developed

224、a diversified toolkit consisting of platform technologies with combinational and synergistic potential which we evaluate in clinical trials,including mRNA therapeutics,cell therapies,and protein-based precision therapeutics.SEAN MARETTSean Marett joined BioNTech in 2012 and played a crucial role in

225、ensuring BioNTechs liquidity in the early stages of development and support-ing its growth.He successfully executed BioNTechs first collab-oration agreement in his first year,followed by numerous revenue-generating agreements with high-profile pharmaceutical companies.Seans outstanding negotiation a

226、nd leadership skills have been instrumental in the Companys transformation into a next-generation immunotherapy Company.20142015FIRST TRIAL WITH FULLY INDIVIDUALIZED mRNA VACCINE CANDIDATE/We took a decisive step towards potential individualized cancer therapies in 2014 by initiating the first Phase

227、 1 clinical trial with our individualized mRNA-based immunotherapy approach,called iNeST(individualized neoantigen specific immunotherapy).Results were published three years later in Nature.BioNTech|Annual Report 2023442019INITIAL PUBLIC OFFERING/Our Initial Public Offering(IPO)was in 2019.With gros

228、s proceeds of$150 million,we have since been listed on the NASDAQ Global Select Market under the ticker symbol“BNTX”.2019SERIES A FINANCING ROUND/We secured a Series A funding of$270 million in 2018.As part of the financing,we gained additional investors who believed in BioNTech and our vision.They

229、supported our global expansion and the accelerated devel-opment of our unique oncology pipeline with precision and personalized candidates.PROJECT LIGHTSPEED/2020 changed everything but not our vision.Our scientists decided decades ago to develop mRNA as a flexible platform tech-nology.They saw the

230、potential of mRNA as a technology for the treatment of cancer and as a vaccine against infectious diseases.At the beginning of 2020,we started the develop-ment of our COVID-19 vaccine,an endeavor we called Project Lightspeed.Our goal was to develop a safe and effective vaccine against COVID-19.Simul

231、taneously,we enhanced our manufacturing capacities by acquiring our site in Marburg,which we expanded to become one of the largest mRNA manufacturing facilities in Europe in 2021.Within only 10 months we developed the Pfizer-BioNTech COVID-19 Vaccine,eval-uated it in large clinical trials,and receiv

232、ed(emergency or conditional)approval from authorities in different countries.For us at BioNTech,this was a tremendous success,as it was not only the fastest vaccine devel-opment against a new pathogen in medical history,but also proof that mRNA can become a new drug class.20182020BioNTech|Annual Rep

233、ort 20234520222021INTRODUCTION OF OUR BIONTAINERS/We introduced a new global manufacturing approach for mRNA-based products in 2022.Our container-based,modular BioNTainers are designed to enable the scalable produc-tion of mRNA-based medicines.The ground-breaking for the first BioNTainer-based facil

234、ity was held in Rwanda in the same year.Ground-breaking for a BioNTainer-based facility in Melbourne,Australia,is intended to follow in 2024.RE-FOCUS ON FIGHT AGAINST CANCER/In 2021,we refocused on our roots by reinforcing our development of cancer therapies that can also be combined with each other

235、.We used our resources to further accelerate the development of our cancer treatment candidates.This included the treatment of the first colorectal cancer patient in a Phase 2 trial with an individual-ized cancer vaccine candidate.In addition,we acquired a new manufacturing site in Gaithersburg in t

236、he US to expand our clinical production capacities for cell therapies.In parallel,we continued our work to develop novel COVID-19 vaccines.BioNTech|Annual Report 202346After 15 years of in parts invisible advance-ments,2023 was marked by a number of sig-nificant milestones across various domains.As

237、we turn the page to the next chapter,we will delve into the details of our anniversary year,exploring the impact of our work of the past year where we once again aimed at pushing the boundaries of science and making a difference in the lives of patients worldwide.BioNTech|Annual Report 2023472023 HI

238、GHLIGHTSBioNTech|Annual Report 202348JANBioNTech signed a Memorandum of Understanding with the Government of the United Kingdom to benefit patients by expanding clinical trials for personalized mRNA immunotherapies with the aim to provide personalized cancer therapies for up to 10,000 patients by th

239、e end of 2030,either in clinical trials or as authorized treat-ments.The corresponding contracts were signed in July 2023.CORPORATE DEVELOPMENT/BioNTech|Annual Report 202349German Chancellor Olaf Scholz visited BioNTech in Marburg,Germany,as we completed the construction of our first proprietary pla

240、smid DNA manufacturing facility.Plasmid DNA is an important starting material for the manufacturing of mRNA-based vaccines and therapies,as well as cell therapies.CORPORATE DEVELOPMENT/Pfizer and BioNTech started a Phase 1/2 trial exploring the safety,tolerability,and immunogenicity of the companies

241、 mRNA vaccine program BNT167 against shingles.INFECTIOUS DISEASES/FEBBioNTech|Annual Report 2023505005BioNTech signed a Memorandum of Understanding with the Weizmann Institute of Science in Israel,under which scientists from BioNTech and the Weizmann Institute would collabo-rate on basic and applied

242、 research with the aim of better understanding various diseases,including cancer.We entered into a license and col-laboration agreement with OncoC4 to co-develop and commercialize the monoclonal antibody candidate BNT316/ONC-392(gotistobart)as monotherapy or combination therapy in various cancer ind

243、ications.CORPORATE DEVELOPMENT/MARBioNTech|Annual Report 202351BioNTech formed a global strategic partnership with Duality Biologics to accelerate the development of differen-tiated ADC therapeutics for solid tumors.This agreement further expanded BioNTechs clinical-stage oncology portfolio with a n

244、ew class of precision medicine therapeutics expanding the breadth of its immuno-therapy toolkit with synergistic potential.CORPORATE DEVELOPMENT/APRBioNTech|Annual Report 202352Baroness Nicola Blackwood was elected to BioNTechs Supervisory Board,succeeding Prof.Christoph Huber,M.D.,who left the Supe

245、rvisory Board after reaching the retirement age limit.Supervisory Board members Michael Motschmann and Ulrich Wandschneider,Ph.D.,were reappointed.CORPORATE DEVELOPMENT/MAYBioNTech|Annual Report 202353ONCOLOGY/The first patient with NSCLC was treated in a pivotal Phase 3 trial evaluating BioNTechs a

246、nd OncoC4s antibody candidate BNT316/ONC-392(gotistobart).The initiation of the trial was based on positive safety and efficacy data from a Phase 1/2 study with BNT316/ONC-392 alone and in combination with pembrolizumab in patients with advanced solid tumors.Follow-up data from this trial presented

247、at the ASCO 2023 Annual Meeting showed encouraging anti-tumor activity and a manageable safety profile in a patient cohort with metastatic,anti-PD-(L)1-resistant NSCLC.JUNBioNTech|Annual Report 202354BioNTech closed its acquisition of InstaDeep,a leading global technol-ogy company in the field of AI

248、 and machine learning.The acquisition supports BioNTechs strategy to build world-leading capabilities in AI-driven drug discovery and development of next-generation immunotherapies and vaccines to address diseases with high unmet medical need.CORPORATE DEVELOPMENT/JULBioNTech|Annual Report 202355Pfi

249、zer and BioNTech received approvals for individuals 12 years and older for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine in various markets,including the United States,Europe,Canada and Japan.AUG/SEPINFECTIOUS DISEASES/BioNTech|Annual Report 202356BioNTech and the Coalition for Epidemic

250、Preparedness Innovations(CEPI)formed a strategic partnership to advance mRNA-based vaccine candi-dates with the development of BNT166 for the prevention of mpox.CEPI agreed to provide funding of up to$90 million to support the development of mRNA-based vaccine candidates.The Supervisory Board appoin

251、ted James Ryan,Ph.D.,to the Management Board as Chief Legal Officer.As part of the Management Board,James Ryan has continued to lead the Companys corporate legal strategy and global legal operations including transactions,corporate governance,securities,intellectual property(IP),insurance,data priva

252、cy,among others.SEPCORPORATE DEVELOPMENTCORPORATE DEVELOPMENT/INFECTIOUS DISEASES/BioNTech|Annual Report 202357BioNTech expanded its late-stage oncology portfolio:The first patient was treated in a Phase 2 clinical trial evaluating the mRNA-based individ-ualized cancer vaccine candidate BNT122 in re

253、sected pancreatic ductal adenocarcinoma(PDAC).We presented data across our oncology pipeline,covering multiple solid tumor types and novel mecha-nisms of action,at the ESMO Congress,including data from a Phase 1/2 trial for cell therapy candidate BNT211.BNT211 is being evaluated alone and in combina

254、tion with an investigational CAR-T cell Amplifying RNA Vaccine(CARVac)in patients with solid tumors.The data showed encouraging signs of clinical activity and an increased persistence of cancer-specific CAR-T cells in the combinatory setting.In course of the dose esca-lation,a dose-dependent increas

255、e in adverse events was observed.In most cases,these were of grade 1 and 2.We presented data updates at the SITC Annual Meeting across multiple immuno-oncology programs,such as mRNA-based cancer vaccine candidates,investigational antibodies and cell therapies.ONCOLOGY/OCTBioNTech|Annual Report 20235

256、8Together with our collaborator Duality Biologics,we were granted Break-through Therapy designation by the FDA for their investigational ADC BNT323/DB-1303 for the treatment of advanced endometrial cancer.BioNTech and the State of Victoria in Australia signed a multi-year stra-tegic partnership to s

257、trengthen the local mRNA ecosystem and facilitate innovations deriving from it.This partnership is aimed at providing high-tech manufacturing capabilities and expertise to curate encouraging projects for further R&D.CORPORATE DEVELOPMENT/We inaugurated our site in Kigali,Rwanda.The inauguration took

258、 place on the occasion of the set-up of the first BioNTainer,which was flown to Kigali,Rwanda,in March 2023.From left to right:John Nkengasong,Africa CDC;Sierk Poetting,BioNTech;Ugur Sahin,BioNTech;H.E.Ursula von der Leyen,President of the European Commission;H.E.Macky Sall,former President of the R

259、epublic of Senegal;H.E.Paul Kagame,President of the Republic of Rwanda;H.E.Nana Akufo-Addo,President of the Republic of Ghana;Hon.Mia Amor Mottley,Prime Minister of Barbados;H.E.Annalena Baerbock,Federal Minister of Foreign Affairs of the Federal Republic of Germany.ONCOLOGY/DECBioNTech|Annual Repor

260、t 202359IMPRINT/BioNTech SE An der Goldgrube 12 55131 Mainz,GermanyTel.:+49-6131-9084-0 Fax:+49-6131-9084-390 Email:infobiontech.de FINANCIAL CALENDAR 2024MAY 6MAY 17ANNUAL GENERAL MEETINGAUG 5SECOND QUARTER EARNINGSOCT 1INNOVATION SERIES (DIGITAL&AI DAY)INNOVATION SERIES THIRD QUARTER EARNINGSNOV 4

261、FIRST QUARTER EARNINGSCORPORATE COMMUNICATIONS/Tel.:+49-6131-9084-1513 Email:mediabiontech.de CONCEPT,VISUAL DESIGN AND RENDERINGS/heureka GmbH,EssenPHOTOGRAPHY/COPYRIGHT/BioNTech SEDISCLAIMER/Date of publication:April 8,2024.References were drawn at the time of publication;we take no responsibility

262、 for the content of external sources.The English translation of the annual report is provided for convenience only.The German original is definitive.NOV 14BioNTech|Annual Report 202360FORWARD-LOOKING STATEMENTS/This document contains forward-looking statements within the meaning of the Private Secur

263、ities Litigation Reform Act of 1995,as amended,including,but not limited to,statements concerning:BioNTechs expected revenues and net profit related to sales of BioNTechs COVID-19 vaccine,referred to as COMIRNATY where approved for use under full or conditional marketing authorization,in territories

264、 controlled by BioNTechs collaboration partners,particularly for those figures that are derived from preliminary estimates provided by BioNTechs partners;the rate and degree of market acceptance of BioNTechs COVID-19 vaccine and,if approved,BioNTechs investigational medicines;expectations regarding

265、antic-ipated changes in COVID-19 vaccine demand,including changes to the ordering environment and expected regulatory recommendations to adapt vaccines to address new variants or sublineages;the initiation,timing,progress,results,and cost of BioNTechs research and development programs,including thos

266、e relating to additional formulations of BioNTechs COVID-19 vaccine,and BioNTechs current and future preclinical studies and clinical trials,including statements regard-ing the timing of initiation,enrollment,and completion of studies or trials and related preparatory work and the availability of re

267、sults,and the timing and outcome of applications for regulatory approvals and marketing authorizations;BioNTechs expectations with respect to its intellectual property;the impact of BioNTechs collaboration and licensing agreements and its acquisition of InstaDeep Ltd.;the development,nature and feas

268、ibility of sustainable vaccine production and supply solutions;and BioNTechs estimates of revenues,research and development expenses,cost of sales,general and administrative expenses,and capital expenditures for operating activities.In some cases,forward-looking statements can be identified by termi

269、nology such as“will,”“may,”“should,”“expects,”“intends,”“plans,”“aims,”“anticipates,”“believes,”“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

270、in this press release are neither promises nor guarantees,and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks,uncertainties,and other factors,many of which are beyond BioNTechs control and which could cause actual results to differ

271、 materially from those expressed or implied by these forward-looking statements.These risks and uncertainties include,but are not limited to:BioNTechs pricing and coverage negotiations regarding its COVID-19 vaccine with governmental authorities,private health insurers and other third-party payors a

272、fter BioNTechs initial sales to national governments;the future commercial demand and medical need for initial or booster doses of a COVID-19 vaccine;competition from other COVID-19 vaccines or related to BioNTechs other product candidates,including those with different mechanisms of action and diff

273、erent manufacturing and distribution constraints,on the basis of,among other things,efficacy,cost,convenience of storage and distribution,breadth of approved use,side-effect profile and durability of immune response;the timing of and BioNTechs ability to obtain and maintain regulatory approval for B

274、ioNTechs product candidates;the ability of BioNTechs COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants;BioNTechs and its counterparties ability to manage and source necessary energy resources;BioNTechs ability to identify research opportunities and discover and develop investig

275、ational medicines;the ability and willingness of BioNTechs third-party collaborators to continue research and development activities relating to BioNTechs development candidates and investigational medicines;the impact of the COVID-19 pandemic on BioNTechs development programs,supply chain,collabora

276、tors and financial performance;unforeseen safety issues and potential claims that are alleged to arise from the use of BioNTechs COVID-19 vaccine and other products and product candidates developed or manufactured by BioNTech;BioNTechs and its collaborators ability to commercialize and market BioNTe

277、chs COVID-19 vaccine and,if approved,its product candidates;BioNTechs ability to manage its development and expansion;regulatory developments in the United States and other countries;BioNTechs ability to effectively scale its production capabilities and manufacture its products,including target COVI

278、D-19 vaccine production levels,and product candidates;risks relating to the global financial system and markets;and other factors not known to BioNTech at this time.You should review the risks and uncertainties described under the heading“Risk Factors”in BioNTechs annual report on Form 20-F for the

279、year ended December 31,2023 and in subsequent filings made by BioNTech with the SEC,which are available on the SECs website at https:/www.sec.gov/.Except as required by law,BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this do

280、cument in the event of new information,future developments or otherwise.These forward-looking statements are based on BioNTechs current expectations and speak only as of the date hereof.BioNTech|Annual Report 202361COMBINED MANAGEMENT REPORT 2023mRNA is a natural information molecule that is transla

281、ted to proteins.A protein that belongs to the body will have a specific function in the cell,while the protein that does not belong to the body can serve as a lesson to the immune system about what should be eliminated.2BioNTech|Annual Report 2023621 GENERAL INFORMATION ON THE BioNTech GROUPPursuant

282、 to Section 315 para.5 of the German Commercial Code(HGB)in conjunction with Section 298 para.2 HGB,this combined management report comprises both the group management report of BioNTech SE and its group companies(together“BioNTech”or the“Group”)and the management report of BioNTech SE(also“the Comp

283、any”),hereinafter also referred to as“BioNTech”,the“Group”,“we”or“us”.The combined management report has been prepared in accordance with the Regula-tion on the Statute for a European Company(SE)in conjunction with the German Stock Corporation Act(AktG).The comments on the Group have been prepared i

284、n accordance with the International Financial Reporting Standards(IFRS)as adopted by the European Union;the comments on BioNTech SE have been prepared in accordance with the German Com-mercial Code(HGB).Unless otherwise stated,the statements in the com-bined management report relate to both the Grou

285、p and BioNTech SE.In addition to the reporting on the Group,the development of BioNTech SE is explained in Section 3.We prepare and publish our combined management report in euros and round figures to the nearest thousand or million euros.Accordingly,the figures presented as totals or as percentages

286、 in some tables may deviate slightly and the figures presented in the notes may not add up exactly to the totals presented.1.1 Business ModelWe are a global immunotherapy company pioneering the development of novel medicines against cancer,infectious diseases and other serious diseases.Our vision an

287、d mission are the same as when our Company was founded in 2008:We are committed to improving the health of people worldwide,harnessing the full potential of the immune system to develop drugs to fight diseases with high or unmet medical need.Our fully integrated business model combines decades of re

288、search in immunology,translational drug discovery and development,technology-agnostic innovation,GMP manufacturing,artificial intelligence and ma-chine learning,and commercial capabilities to develop and commercialize vaccines and therapies.We have built a broad portfolio of product candidates acros

289、s multiple technology platforms that encompass a diverse range of therapeutic ap-proaches,including mRNA vaccines and therapeutics,cell and gene ther-apies,protein-based therapeutics(including monospecific and bispecific antibodies and antibody-drug conjugates or ADCs),cell therapies and small molec

290、ules.We believe that harnessing complementary,potential-ly synergistic modes of action increases the likelihood of therapeutic success,reduces the risk of emergence of secondary resistance mech-anisms and could also unlock a larger potential patient population.Crit-ically,this approach allows us to

291、pursue a technology-agnostic path by developing an appropriate therapeutic platform or a combination thereof for the intended patient and purpose.We have continued to develop and diversify our pipeline.There are cur-rently 22 product candidates in oncology and seven product candidates in infectious

292、diseases in clinical development.BioNTech|Annual Report 2023631 MAGAZINE 2 COMBINED MANAGEMENT REPORT GENERAL INFORMATION ECONOMIC REPORT MANAGEMENT REPORT OF BioNTech SE FORECAST,OPPORTUNITY AND RISK REPORT CORPORATE GOVERNANCE DECLARATION PURSUANT TO SECTION 315D IN CONJUNCTION WITH SECTION 289F H

293、GB REMUNERATION REPORT NON-FINANCIAL REPORT EVENTS AFTER THE REPORTING PERIOD3 GROUP REPORT 4 COMPENSATION REPORT 5 FURTHER INFORMATION2In 2023,we remained committed to our goals and strengthened our tech-nology platforms,our digital capabilities and our infrastructure through sustainable investment

294、s,strategic partnerships and tactical acquisitions to bring long-term value to patients and other stakeholder groups.Leading the Development of COVID-19 VaccinesIn 2023,in partnership with Pfizer Inc.,New York,United States(Pfizer),we developed an Omicron XBB.1.5-adapted monovalent COVID-19 vaccine

295、and launched it in various markets worldwide.This is part of our efforts to build an enduring COVID-19 vaccine business.Healthcare and Social ResponsibilityWe have made progress in making innovative medicines more acces-sible to wider populations around the world:In 2023,more than 30%of COVID-19 vac

296、cine doses were delivered to low-and middle-income countries(LMICs)in line with demand.We work with NGOs,institutions and governments to provide more equitable access to novel medicines,especially in low-and middle-income countries and regions.In Decem-ber 2023,we reached the next milestone in the e

297、stablishment of mRNA vaccine manufacturing capacities in Africa with the inauguration of the our site in Kigali,Rwanda.We are progressing the development of mRNA vaccine candidates for infectious diseases with high medical need,in-cluding vaccine candidates against tuberculosis,malaria,and HIV,as we

298、ll as against infectious diseases with pandemic potential,such as mpox.Innovative and Diversified PipelineWe are working on the development of innovative drugs for diseases with high or unmet medical need.We continue to build our pipeline,which has grown in recent years in line with the Companys fun

299、damental vision of harnessing the power of the immune system to fight cancer and other serious diseases.In 2023,we commenced two Phase 3 trials in oncology,and we and our partners presented data on several product candidates at international medical meetings.We entered into four new collabora-tions

300、and in-licensed six product candidates in oncology,some of which have advanced rapidly to later-stage clinical trials,in 2023.For infectious diseases,we initiated three Phase 1 clinical trials for vaccine candidates based on our proprietary mRNA technology in 2023.These include prod-uct candidates f

301、or a malaria vaccine,tuberculosis(in collaboration with the Bill&Melinda Gates Foundation)and mpox in partnership with the Coalition for Epidemic Preparedness Innovations(CEPI).Innovation at ScaleWe are building and scaling biotech innovations with the aim of becoming a patient-centric multi-product

302、 company.We expanded our team globally in 2023 and attracted talent,including clinical and regulatory experts,to advance the development of our pipeline.Our diverse workforce rep-resents more than 80 nations,and we have subsidiaries in 18 countries across five continents.In 2023,we expanded our orga

303、nization in Asia,Africa,the United States,Australia and Europe.We increased our overall research and development and production capabilities,including com-pleting construction of our first proprietary plasmid DNA manufacturing facility in Marburg,Germany.Furthermore,we established a corporate office

304、 in Shanghai,China,and inaugurated our site in Kigali,Rwanda,on the occasion of the set-up of the first manufacturing unit called BioN-Tainer.With the acquisition of our long-time strategic collaboration partner InstaDeep,we have taken a further step in our strategy,aiming to build world-leading cap

305、abilities in AI-driven drug discovery and development of next-generation immunotherapies and vaccines to address diseases with high unmet medical need.The transaction adds approximately 290 highly skilled professionals to our organization.BioNTech|Annual Report 2023641 MAGAZINE 2 COMBINED MANAGEMENT

306、 REPORT GENERAL INFORMATION ECONOMIC REPORT MANAGEMENT REPORT OF BioNTech SE FORECAST,OPPORTUNITY AND RISK REPORT CORPORATE GOVERNANCE DECLARATION PURSUANT TO SECTION 315D IN CONJUNCTION WITH SECTION 289F HGB REMUNERATION REPORT NON-FINANCIAL REPORT EVENTS AFTER THE REPORTING PERIOD3 GROUP REPORT 4

307、COMPENSATION REPORT 5 FURTHER INFORMATION21.2 Legal and Organizational StructureLegal StructureBioNTech SE was founded in 2008 as a spin-off from Johannes Gutenberg University Mainz.The underlying broad technology and patent portfolio was built up over a period of more than 20 years.BioNTech SE is t

308、he parent company of the BioNTech Group and is re-sponsible for the management and development of the Group.BioNTech SE has its registered office in Mainz,Germany(An der Goldgrube 12,55131 Mainz).In addition,as of the end of the 2023 financial year,the BioNTech Group included 41 group companies.The

309、shares of BioNTech SE are publicly traded as American Depositary Shares(ADSs),each of which represents one ordinary share,on the Nasdaq Global Select Market.Organizational StructureAs the parent company of the BioNTech Group,BioNTech SE has a dual management system:The Management Board,as the managi

310、ng body,had seven members as of December 31 and is appointed and monitored by the Supervisory Board.On May 3,2023,our Supervisory Board ex-panded our Management Board by appointing James Ryan as Chief Legal Officer(CLO),effective as of September 1,2023.As CLO,James Ryan heads up our Legal department

311、 and is responsible for developing and leading the corporate legal strategy to promote and protect BioNTechs global operations.His current appointment to our Management Board ends on December 31,2027.The Supervisory Board is elected by the An-nual General Meeting.During the year ended December 31,20

312、23,Nicola Blackwood was appointed to the Supervisory Board on May 25,2023.She succeeded Christoph Huber,who left the Supervisory Board after reaching the applicable retirement age limit.As a result,the Supervisory Board consisted of six members as of the reporting date December 31,2023.As of the rep

313、orting date December 31,2023,the Group had 6,292 employees,3,166 of them at BioNTech SE(December 31,2022:4,692,2,304 of them at BioNTech SE).An annual average of 5,640 people were employed in 2023,of which 2,882 were employed by BioNTech SE(previ-ous year:4,104,of which 1,936 were employed by BioNTe

314、ch SE).1.3 The BioNTech ApproachWe work on the development of next-generation immunotherapies by pursuing a strategy based on a technology-agnostic approach.Our key objectives are to build a sustainable respiratory vaccines business based on the BioNTech-Pfizer-Comirnaty franchise and to advance an

315、innova-tive oncology pipeline targeting multiple product approvals in the coming years.Our vision is to establish a multi-product company based on our technologies and science.In 2023,we expanded our access to a new technology ADCs.We believe that this technology has the potential to replace highly

316、toxic chemotherapy regimens in the long term and to become a new combination backbone of cancer treatment.Since our founding,we have been a multi-technology company.We believe that by combining complementary treatment modalities,we can leverage the potential of each technology to provide precise and

317、 personalized treat-ments to patients.Our approach is based on the following principles:Exploiting the full potential of the immune systemOur pipeline comprises immunomodulators,including bispecific and monospecific antibodies,ADCs and cell therapies,including T-cell receptor and CAR-T cell therapie

318、s,as well as small molecules.Our broad clinical pipeline is unique in that it features mRNA-based vac-cines,including cancer vaccines and prophylactic vaccines against infectious diseases.Our technology-agnostic innovation engine is driven by potential synergies between these technologies with the a

319、im of enabling individualized treatment for cancer patients.Programs to combat global health burdensOur infectious disease product strategy is rooted in our global social responsibility to address diseases with high or unmet medical need.We are committed to democratizing global access to innovative

320、medicines.Broadening the universe of patients benefiting from cancer immunotherapyOur aim is to cover cancer at early,adjuvant and metastatic stages and to extend the utility of immunotherapy to patient populations that are currently not amenable or do not benefit from current immunotherapies.BioNTe

321、ch|Annual Report 2023651 MAGAZINE 2 COMBINED MANAGEMENT REPORT GENERAL INFORMATION ECONOMIC REPORT MANAGEMENT REPORT OF BioNTech SE FORECAST,OPPORTUNITY AND RISK REPORT CORPORATE GOVERNANCE DECLARATION PURSUANT TO SECTION 315D IN CONJUNCTION WITH SECTION 289F HGB REMUNERATION REPORT NON-FINANCIAL RE

322、PORT EVENTS AFTER THE REPORTING PERIOD3 GROUP REPORT 4 COMPENSATION REPORT 5 FURTHER INFORMATION2 Improving the success rate through new combinationsWe develop drug candidates that are precisely tailored to the re-spective target.To augment the immune response and to counter-act resistance mechanism

323、s,we seek to combine compounds with non-overlapping and/or synergistic mechanisms of action,such as the combination of our FixVac immunotherapy CARVac with our innovative CAR-T therapy candidates.Individualized approachesThe challenge in the treatment of cancer is its interindividual variability and

324、 heterogeneity,which increases the risk of recurrence or treatment failure.Addressing this biological reality is one of our fundamental prin-ciples for the development of product candidates.For example,each of our mRNA cancer vaccine candidates incorporates multiple targets in order to account for t

325、his variability.Integrating AI into our pipeline and processesSince our founding,we have integrated computer-aided methods,data science,artificial intelligence(AI),and machine learning into our work.With the acquisition of InstaDeep,we aim to build world-leading capabilities in AI-driven drug discov

326、ery and development of next-gen-eration immunotherapies and vaccines to address diseases with high unmet medical need.The objective is to enable high-throughput de-sign and testing of novel drug candidates at scale.1.4 CommercializationOur COVID-19 vaccine is based on our proprietary mRNA technology

327、.The COVID-19 vaccine development program was launched in late January 2020 in response to the COVID-19 pandemic.Under this program,two strategic collaborations with major pharmaceutical companies,Pfizer and Fosun Pharmaceutical Industrial Development Co.Ltd.,Shanghai,China(Fosun Pharma),were comple

328、ted and led to the first marketing authoriza-tions of our vaccine in December 2020.Under our collaboration with Pfizer,we are the marketing authorization holder in the United States,the European Union,the United Kingdom,Canada and other countries,and holder of emergency use authorizations,or EUAs,or

329、 equivalents in the United States(jointly with Pfizer)and other countries for the COVID-19 vaccine program.Pfizer has marketing and distribution rights worldwide with the exception of China,Germany and Turkey.Fosun Pharma has marketing and distribution rights in China,Hong Kong special administrativ

330、e region,or SAR,Macau SAR and the region of Taiwan.We have the marketing and distribution rights for the COVID-19 vaccine,known as Comirnaty,in Germany and Turkey.In 2023,we and Pfizer continued our global COVID-19 vaccine leadership with our Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.Since

331、 the beginning of the pandemic,we have developed and commercialized four COVID-19 vaccine products:the original COVID-19 vaccine,two vari-ant-adapted bivalent vaccines(Original/Omicron BA.1 and Original/Omi-cron BA.4-5-adapted bivalent vaccines)and the Omicron XBB.1.5-adapt-ed monovalent COVID-19 va

332、ccine.As part of our and Pfizers two billion COVID-19 vaccine doses pledge to support equitable access to medicines for low-and middle-income countries(LMICs),we and Pfizer have delivered a total of around 1.8 billion doses of Comirnaty to LMICs in line with demand.BioNTech|Annual Report 2023661 MAG

333、AZINE 2 COMBINED MANAGEMENT REPORT GENERAL INFORMATION ECONOMIC REPORT MANAGEMENT REPORT OF BioNTech SE FORECAST,OPPORTUNITY AND RISK REPORT CORPORATE GOVERNANCE DECLARATION PURSUANT TO SECTION 315D IN CONJUNCTION WITH SECTION 289F HGB REMUNERATION REPORT NON-FINANCIAL REPORT EVENTS AFTER THE REPORTING PERIOD3 GROUP REPORT 4 COMPENSATION REPORT 5 FURTHER INFORMATION2We believe that we and our part