BioNTech Results Presentation Deck

Made public by

sourced by PitchSend

34 of 46

Creator

biontech logo
Biontech

Category

Healthcare

Published

August 2021

Slides

Transcriptions

#1Second Quarter 2021 Corporate update and financial results August 09, 2021 4 12 BIONTECH#2This slide presentation includes forward-looking statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: our expected revenues and net profit related to sales of our COVID-19 vaccine, referred to as COMIRNATY® in the European Union as authorized for use under conditional marketing approval, in territories controlled by our collaboration partners, particularly for those figures that are derived from preliminary estimates provided by our partners; our pricing and coverage negotiations with governmental authorities, private health insurers and other third-party payors after our initial sales to national governments; the extent to which a COVID-19 vaccine continues to be necessary in the future; competition from other COVID-19 vaccines or related to our other product candidates, including those with different mechanisms of action and different 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 rate and degree of market acceptance of our COVID-19 vaccine and our investigational medicines, if approved; the initiation, timing, progress, results, and cost of our research and development programs and our current and future preclinical studies and clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; the timing of and our ability to obtain and maintain regulatory approval for our product candidates; the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine (including a potential booster dose of BNT162b2 and/or a potential booster dose of a variation of BNT 162b2 having a modified mRNA sequence); the ability of BNT 162b2 to prevent COVID-19 caused by emerging virus variants; our ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of our third-party collaborators to continue research and development activities relating to our development candidates and investiga- tional medicines; the impact of the COVID-19 pandemic on our development programs, supply chain, collaborators and financial performance; unforeseen safety issues and claims for personal injury or death arising from the use of our COVID-19 vaccine and other products and product candidates developed or manufactured by us; BioNTech's Malaria, Tuberculosis and HIV programs; timing for selecting clinical candidates for these programs and the commencement of a clinical trial, as well as any data readouts; the nature of the collaboration with the African Union and the Africa CDC; the nature and duration of support from WHO, the European Commission and other organizations with establishing infrastructure; the development of sustainable vaccine production and supply solutions on the African continent and the nature and feasibility of these solutions; our estimates of research and development revenues, commercial revenues, cost of sales, research and development expenses, sales and marketing expenses, general and administrative expenses, other operating income less expenses, finance income less expenses, income taxes, shares outstanding and basic and diluted profit for the period per share and our needs for or ability to obtain additional financing; our ability to identify, recruit and retain key personnel; our and our collaborators' ability to protect and enforce our intellectual property protection for our proprietary and collaborative product candidates, and the scope of such protection; the development of and projections relating to our competitors or our industry; our ability and that of our collaborators to commercialize and market our product candidates, if approved, including our COVID-19 vaccine; the amount of and our ability to use net operating losses and research and development credits to offset future taxable income; our ability to manage our development and expansion; regulatory deve- lopments in the United States and foreign countries; our ability to effectively scale our production capabilities and manufacture our products, including our target COVID-19 vaccine pro-duction levels, and our product candidates; our ability to implement, maintain and improve effective internal controls; our plans for expansion in southeast Asia and China, including our planned regional headquarters and manufacturing facility in Singapore as well as the joint venture with Fosun Pharma; and other factors not known to us at this time. In some cases, forward-looking statements can be identified by terminology 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 in this quarterly report 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 BioNTech's control and which could cause actual results to differ materially from those expressed or implied by these forward looking statements. You should review the risks and uncertainties described under the head-ing "Risk Factors" in this quarterly report and in subsequent filings made by BioNTech with the SEC, which are available on the SEC's website at https://www.sec.gov/. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any for-ward-looking statements contained in this quarterly report in the event of new information, future developments or otherwise. These forward-looking statements are based on BioNTech's current expectations and speak only as of the date hereof. BIONTECH 2#3Safety Information AUTHORIZED USE IN THE U.S.: The Pfizer-BioNTech COVID19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines ● ● ● ● . . ● (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html) Reports of adverse events following use of the Pfizer-BioNTech COVID-19 Vaccine under EUA suggest increased risks of myocarditis and pericarditis, particularly following the second dose. The decision to administer the Pfizer-BioNTech COVID-19 Vaccine to an individual with a history of myocarditis or pericarditis should take into account the individual's clinical circumstances Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%) In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%) Following administration of the Pfizer-BioNTech COVID-19 Vaccine, the following have been reported outside of clinical trials: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm) myocarditis and pericarditis Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS call 1-800- 822-7967. The reports should include the words "Pfizer-BioNTech COVID-19 Vaccine EUA" in the description section of the report Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use Authorization Before administration of Pfizer-BioNTech COVID-19 Vaccine, please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine- BIONTECH us.com. 3#4Safety Information COMIRNATYⓇ (COVID-19 mRNA Vaccine) has been granted conditional marketing authorisation by the European Medicines Agency to prevent coronavirus disease 2019 (COVID-19) in people from 12 years of age. EMA's human medicines committee (CHMP) has completed its rigorous evaluation of COMIRNATY®, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available. Important safety information Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine The efficacy, safety and immunogenicity of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of COMIRNATYⓇ may be lower in immunosuppressed individuals. As with any vaccine, vaccination with COMIRNATY® may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of vaccine. In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.4%), chills (31.9%) joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%) The overall safety profile of COMIRNATY® in adolescents 12 to 15 years of age was similar to that seen in participants 16 years of age and older. The most frequent adverse reactions in clinical trial participants 12 to 15 years of age were injection site pain (> 90%), fatigue and headache (> 70%), myalgia and chills (> 40%), arthralgia and pyrexia (> 20%). There is limited experience with use of COMIRNATY® in pregnant women. Administration of COMIRNATY® in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus. It is unknown whether COMIRNATY® is excreted in human milk. Interactions with other medicinal products or concomitant administration of COMIRNATYⓇ with other vaccines has not been studied. Very rare cases of myocarditis and pericarditis have been observed following vaccination with COMIRNATY® primarily in younger males, after the second dose, within 14 days following vaccination The black equilateral triangle denotes that additional monitoring is required to capture any adverse reactions. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. Side effects can be reported to EudraVigilance [http://www.adrreports.eu/] or directly to BioNTech using email [email protected], telephone +49 6131 9084 0, or our website https://medicalinformation.biontech.de/ 4 BIONTECH#5Agenda Second Quarter 2021 Highlights LO 5 COVID-19 Vaccine Update Oncology Pipeline Update Financial Results Corporate Update & Outlook BIONTECH#62021 Accelerating our Vision to Build a Next Generation Immunotherapy Company 61-01102 HOMINO12 BIONTECH BIONTECH#7BioNTech: A Global Immunotherapy Powerhouse Deep Immunology ✓ Expertise Fully Integrated 7 Broad Suite of Novel Technologies Automation & Digitalization Specialized Manufacturing Commercial Capabilities Global Team of 2,500+ ✓ A Diverse Pipeline of 20+ Candidates Next-Generation Immunotherapies & Vaccines Oncology, Infectious Diseases and Beyond Shipped >1bn doses of COVID-19 vaccine Expanded clinical pipeline to 15 oncology programs in 18 ongoing trials Potential to Launch Multiple Products in the Next 5 Years BIONTECH#8Strong Performance in the First Half of 2021 Second Quarter 2021 Highlights 8 COVID-19 vaccine* Shipped >1 billion doses to >100 countries & territories worldwide Signed supply contracts for ~2.2 billion doses for delivery in 2021 Committed to deliver >2 billion doses to low- and middle-income nations. Continued pipeline expansion Randomized Phase 2 trial starts Melanoma FixVac: BNT111 (CPI-R/R) HPV16 Fix Vac: BNT113 (HPV16+ HNSCC) iNeST: BNT122 (Adjuvant CRC) Further corporate updates Reported Q2 total revenues of €5.3 billion • Jens Holstein appointed to Management Board as CFO as of July 1, 2021 ● Acquired personalized TCR platform and cGMP manufacturing facility from Kite Pharma ● ● First-in-Human Phase 1 trial starts CARVac: BNT211 (Multiple solid tumors) NEOSTIM: BNT221 (Multiple s.t.) RiboCytokines: BNT151/2/3 (Multiple s.t.) "As of July 21, 2021: includes doses shipped by collaboration partner Pfizer; s.t., solid tumors; BIONTECH#9Infectious Diseases: A Long-term Growth Pillar mRNA vaccines to combat major global health burden Malaria ¹: Development of first mRNA-based Malaria vaccine recently started Implementation of sustainable end-to-end vaccine supply solutions in Africa planned HIV and tuberculosis ²: Preclinical development of multiple product candidates ongoing Opportunity to impact infectious diseases with high unmet need Up to 10 mRNA vaccine candidates in preclinical development³ 9 1 Collaboration with KENUP Foundation; 2Collaboration with Bill & Melinda Gates Foundation; University of Pennsylvania collaboration BNT161 influenza vaccine candidate designed to improve traditional vaccines • FIH trial expected Q3 2021 Eligible for milestone payments and royalties through Pfizer agreement BIONTECH#10Disease Horizon: Expanding the Application Spectrum of Our Technology Next Generation Immunomodulators I ■ ■ ■ Next Gen T Cell Therapies H CAR-T cells ■ mRNA Vaccines ■ Cancer Infectious Disease Autoimmunity Allergy CAR-Tregs TCR therapies Polyspecific T cell therapies Cell Therapies ▪ Cancer 1@ Targeting Disease Infectious diseases Targeted Antibodies + Immunomodulation Potently modulates innate immunity ▪ Potential for combination Small Molecule Immunomodulators Bispecifics / Trispecifics Engineered binders Enginereed MOAS ■ I Ribologicals ▪ Cancer ▪ Anti-Infectives Engineered Biologicals Grow & mature novel technologies across oncology, infectious diseases and beyond#11New Product Paradigms 11 ● ● ● Broaden Disease Horizon Infectious disease Oncology Allergy Autoimmune and inflammatory disease Regenerative medicine. ● Expand on Traditional Modalities ● mRNA infectious disease vaccines • mRNA therapeutic cancer vaccines. • CAR-T cell amplifying mRNA vaccine mRNA encoded protein immunotherapies Immunology Expertise and Validated mRNA Technology Unlocks New Therapeutic Universe BIONTECH#12Agenda Second Quarter 2021 Highlights 12 COVID-19 Vaccine Update Oncology Pipeline Update Financial Results Corporate Update & Outlook BIONTECH#13A Leading Provider Globally of COVID-19 Vaccines: -2.2 bn Bn Doses Contracted for 2021* ● Selected Regions ● EU US Other 2021 Orders TOTAL 660 m 410 m -1.150 m Expanding Access to Low & Middle-Income Countries ~2.2 bn 2022 and Beyond > 1 bn (excl. options) Ongoing discussions for additional doses in 2021/2022 and beyond. 900 m doses (plus option for additional 900 m) 90 m Canada, Israel and others 13 *As of July 21, 2021; In combination with contracts entered into by Pfizer 2 bn doses pledged over the next 18 months to ensure global equitable vaccine access Plans to provide 500 m doses to U.S. government for donation to ~100 countries, including those in African Union via COVAX BIONTECH#14Significant Progress Across Six Key Levers to Expand COVID-19 Vaccine Reach Increased Manufacturing Capacity Label Expansion to Additional Populations Regulatory Advancement Across All Geographies Optimize Formulations to Further Simplify Access Worldwide Addressing Waning Immune Reponses Addressing SARS-CoV-2 Variants ... 14 EMA, European Medicines Agency; FDA, U.S. Food and Drug Administration; ● ● ● ● ● South African collaboration with Biovac to expand BNT/Pfizer manufacturing network with fill and finish and distribution Continued efforts to establish multi-continent manufacturing capabilities to support global vaccine needs Expansion of authorizations for adolescents 12 years of age and older in U.S., EU and other countries Ongoing trial in children 2 to 11 years and 6 months to 2 years of age: data expected Q3 and Q4 2021 Global Phase 2/3 trial in healthy pregnant women: data expected Q3 2021 U.S. rolling BLA submission finalized; FDA granted priority review; PDUFA date: Jan. 2022 Converting existing emergency use authorizations into regulatory approvals globally Regulatory submission for BLA in China underway Storage at 2-8 °C for 31 days approved by multiple regulators, including EMA and FDA Phase 3 trial for ready-to-use and lyophilized formulations: data expected Q3 2021 ‒‒‒‒‒‒‒‒‒ ‒‒‒‒‒‒‒‒‒‒‒‒‒‒‒‒‒‒‒‒ Expanded trials for third booster dose of BNT162b2 and multiple variant-specific approaches in both vaccine-naive and previously vaccinated individuals 6-12 months post dose 2 Initial, preliminary booster data: ~6 months after dose 2 of BNT162b2 show overall consistent tolerability profile while eliciting SARS-CoV-2 neutralization titers against wild type, Beta and Delta variant BIONTECH#15Vaccine Efficacy Remains High up to 6 Months Following 2nd Dose ¹,2 Pivotal Phase 3 trial: ~46,000 participants, ~150 clinical sites globally Subjects >12 Years of Age* BNT162b2 (30 µg) N=23,040 Efficacy Endpoint First COVID-19 15 occurrence ≥7 days after Dose 2 First Severe COVID-19+ occurrence ≥7 days after Dose 2 No. of cases 82 1 Surveillance time (n)t 6.649 (22,132) 6.663 (22,142) *Subjects with and without prior evidence of Infection + Based on FDA definitions No. of cases 889 Placebo N=23,037 23 Surveillance time (n)t 6.371 (22,001) 6.505 (22,048) Vaccine Efficacy, (95% CI) ¹Thomas SJ et al. medRxiv Preprint, July 29, 2021. Available at https://www.medrxiv.org/content/10.1101/2021.07.28.21261159v1.full.pdf. 2https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-confirm-high-efficacy-and-no-serious-safety accessed June2021 91.2% (88.9-93.0) EN Phase 3 Clinical data demonstrated clinical protection against the Beta strain² In 800 South African participants: 9 COVID-19 cases, all in the placebo group, eight of which were the B.1.351 variant 95.7% (73.9-99.90) BIONTECH#16Data Demonstrates Protection Against Circulating SARS-CoV-2 Variants Including Delta Variant Neutralizing antibody titers Reduced, yet preserved in vitro neutralizing activity of immune sera against several variants of concern, including: Alpha, Gamma, Beta, Eta, Delta 1, 2, 3 16 1,2801 log₂ PRNT 50 640- 320- 160- 80- 40- 20+ 502 157 ACOAX 355 343 0200000 amores 331 MODACO USA- B.1.617.1- B.1.617.2- B.1.617.2.v2- B.1.618- WA1/2020 spike spike spike spike LOD Poly-specific T cell responses Vaccinated individuals generate a T cell response targeting epitopes conserved across a number of variants, including the Delta variant²,4 84 BNT162b2 B. 1.617.2 (Delta) B. 1.1.7 (Alpha) B. 1.351 (Beta) P. 1 (Gamma) 92 269 Public Health England, NEJM July 20215; preprint July 20216 Public Health Ontario, Canada, preprint July 20217 277 321 Public Health Scotland, Lancet June 20218 Israel, MoH⁹ 329 448 Timepoint ≥14d post 2d - up to 2-3m ≥7d post 2d - up to 1-2m LPFNDGVYF YLQPRTFLL QPTESIVRF NYNYLYRLF IPFAMOMAY RLQSLQTYV QYIKWPWYI KWPWYIWLGF LPFNDGVYF YLQPRTFLL QPTESIVRF NYNYRFRLF IPFAMOMAY RLQSLQTYV QYIKWPWYI KWPWYIWLGF LPFNDGVYE YLQPRTFLL QPTESIVRF NYNYLYRLF IPFAMQMAY RLQSLQTYV QYIKWPWYI KWPWYIWLGF LPFNDGVYF YLQPRTFLL QPTESIVRF NYNYLYRLF IPFAMOMAY RLQSLOTYV QYIKWPWYI KWPWYIWLGF LPFNDGVYE YLQPRTFLL QPTESIVRF NYNYLYRLF IPFAMOMAY RLQSLQTYV QYIKWPWYI KWPWYIWLGF Real world data Observed effectiveness against variants of concern including Delta variant (95% CI) Hospitalization Real-World Infection Symptomatic 96 (86-99) ≥14d post 2d - up to 2-3m 456 896 ≥7d post 2d - up to 6m 88 (78-93) 79 (75-82) 904 1000 39 (9-59) 1008 1208 87 (64-95) 41 (9-61) 1. Liu J et al Nature 2021https://www.nature.com/articles/s41586-021-03693-y. 2. Xie X et al Nature Med https://doi.org/10.1038/s41591-021-01270-4 2021. 3. Liu J et al Nature Med 2021 https://doi.org/10.1038/s41586-021-03693-y. 4. Sahin U et al Nature 2021 https://www.nature.com/articles/s41586-021-03653-6 5. Bernal et al. NEJM 2021 https://www.nejm.org/doi/pdf/10.1056/NEJMoa2108891?article Tools=true 6. Stowe et al (preprint) available from https://media.tghn.org/articles/Effectiveness of COVID- 19 vaccines against hospital_admission_with_the_Delta B. G6gnnqJ.pdf 7. Nasreen et al MedRxiv preprint 10.1101/2021.06.28.21259420 8. Sheikh et al. Lancet 2021 doi: 10.1016/S0140- 6736(21)01358-1; 9. Press release Israel MoH https://www.gov.il/Blob Folder/reports/vaccine-efficacy-safety-follow-up-committee/he/files_publications_corona_two-dose-vaccination-data.pdf 1216 1211 100 1220 88 (79-93) BIONTECH#17Preemptive Strategy to Address SARS-CoV-2 Variants Establishing development, manufacturing and regulatory pathway for variant-specific prototype approach Study Start Nb of participants (trial phase) Boosting post dose 2 Data expected 17 March 2021 1 BNT162b2: 3rd dose Safety & immunogenicity trial N=23 (ph 1) N=~300 (ph 2/3) 6-12 months Prototype Approach substantiated by broad clinical data First data published July 2021 ● BNT162b2: 3rd dose Safety & efficacy trial 2 N=~10,000 (ph 3) 6 months Q4 2021 March 2021 ● 3 Beta: 3rd dose or naïve Safety & immunogenicity trial ● N=-300 (ph 3) N=~300 (naïve) 5-7 months Q3 2021 4 Multivalent Delta + Alpha or Delta or Alpha: 3rd dose or naïve: Safety & immunogenicity trial Expected August 2021 N=~600 N=~300 (naïve) >6 months Q4 2021 BIONTECH#18BNT162b2 Booster Dose Results in a Broad, Robust Neutralisation Response Booster dose could prolong protection and further increase breadth of protection against SARS-CoV-2 variants • 3rd dose strongly boosts neutralizing titers both in younger and older adults against Wild type > 5-8-fold • Delta variant > 5-11-fold Beta variant > 15-21-fold when comparing month 1 data after dose 2 or dose 3 ● 18 ● Wild type and Beta variant titers continue to increase comparing day 7/month 1 data after dose 2 versus dose 3 • Overall consistent tolerability profile Data being prepared for submission to regulatory authorities globally. Data submitted for publication. 50% serum neutralizing titer 104 10³ 10² 101 104 103. 10² 101 1.0 10 10 T T Day 1 Pre-Vax 0.30 310 497 1. . 150 #HE 0.78 M1PD2 18-55 y/o n= 11/gp 0.27 0.48 387 241 103 1 18-55 y/o n= 11/gp 1547 .. S 0.69 T Month 1 Month 8 Day 7 Post Dose 2 Post Dose 2 Post Dose 2 Post Dose 3 Post Dose 3 Day 7 Month 1 T 1754 1202 0.85 M1PD3 0.73 1321 AA 2119 . 1546 HEP. >> >* 1.0 10 10 Day 1 Pre-Vax 196 0.27 5:38 147 0.63 65-85 y/o n=12/gp 0.29 M1PD2 261 BH K 124 AAA 65-85 y/o n=12/gp 0.49 1613 2 T 1 n Month 1 Month 8 Day 7 Month 1 Day 7 Post Dose 2 Post Dose 2 Post Dose 2 Post Dose 3 Post Dose 3 0.67 0.92 1318 879 1479 0.77 M1PD3 2032 1567 LOD PRNTWT PRNT Beta GMR Beta/WT LOD *GMRDelta/WT PRNTWT PRNT Delta BIONTECH#19Agenda Second Quarter 2021 Highlights 19 COVID-19 Vaccine Update Oncology Pipeline Update Financial Results Corporate Update & Outlook BIONTECH#20Potential to Tackle Multiple Diseases with Different Therapeutic Modalities Next Generation Immunomodulators mRNA Cancer Vaccines iNeST Fix Vac • Multi-specificity, multi-valency, high (neo)antigen specific T cell responses with unprecedented potency 3 Phase 2 randomized trials (iNeST and 2 FixVac) Next Gen CAR-T Cell / Neoantigen-based T Cell Therapy Phase 1 FIH trials started in Feb. and Apr 2021 20 Cell Therapies Targeting Cancer Targeted Cancer Antibodies CA 19-9 antibody in 1L pancreatic cancer Phase 1/2 trial Antibodies · ● Immunomodulatio ● ● TLR-7 Agonist Potently modulates innate immunity Potential for combination with other 10 agents Phase 1 trial Small Molecule Immunomodulators ● Bispecifics Next-generation checkpoint inhibitors to address a broad range of cancers Phase 1/2 trials of 2 bi-specific antibodies Ribocytokines mRNA encoded cytokines with a prolonged T1/2 and improved safety profile ● ● H Potential to amplify vaccines and CPIs Phase 1 FIH trials started in Feb. and Jun. 2021 Engineered Biologicals Oncology: Multiple product opportunities with unique combination potential in clinical testing CAR, Chimeric antigen receptor; CA 19-9: Cancer antigen 19-9; 10, Immuno-oncology; CPI, Check-point Inhibitor; FIH, First-in-human; TLR-7, Toll-like receptor 7; T1/2, half-life BIONTECH#21Oncology: Multiple Phase 2 Trials Starting in 2021 15 product candidates in 18 clinical trials Drug Class 21 mRNA Antibodie S Cell Therapies Platform Three randomized Phase 2 trials Fix Vac (fixed combination of shared cancer antigens) iNeST (patient specific cancer antigen therapy) Next-Gen Checkpoint Immunomodulators CAR-T Cell Therapy Neoantigen-based T Cell Therapy Product Candidate BNT111 BNT112 BNT113 autogene cevumeran (BNT122) GEN 1046 (BNT311) GEN 1042 (BNT312) BNT211 BNT221 Indication (Targets) CPI-R/R melanoma prostate cancer HPV16+ head and neck cancer 1L melanoma adjuvant colorectal cancer solid tumors (PD-L1x4-1BB) solid tumors (CD40×4-1BB) solid tumors (CLDN6) advanced or metastatic melanoma Phase 1 Phase 2 ............ Near-Term Milestones FPD in Phase 2 in June 2021 FPD in Phase 2 in July 2021 Phase 2 to start in 2H 2021 (adjuvant CRC) Data update in 2H 2021 Data update in 2H 2021 Data update in 2H 2021 Planned randomized trial start in 2H 2021: CPI, checkpoint inhibitor; R/R, relapsed or refractory; Next-Gen, Next generation; HPV, Human Papilloma Virus; FPD, first patient dosed; 1L, first-line; CRC, colorectal cancer; CAR, chimeric antigen receptor; CLDN6, Claudin-6 ........ BIONTECH#22Fix Vac: Leveraging Shared Antigens to Break Immune Tolerance Off-the Shelf Concept: Scalable for multiple indications Vaccine Backbone Optimized, unmodified mRNA ● ● ANTIGEN CASSETTE HI Targeting antigen presenting cells to stimulate antigen-specific T cell responses Strong immunogenicity observed in vivo via TLR-driven adjuvant effect¹ 22 AAAA Poly(A) tail Potent induction of strong ex vivo CD4+ and CD8+ T cell responses ¹ Lipoplex Proprietary RNA-LPX formulation (IV) *****************!!!!!!! T L Th FATPMEAEL (HLA-CW 03:04 /NY-ESO-1) MITT 10 T L Th 10.1% + ששוןווו Antigen-specific CD8+ T cell responses ²: 4 0 10 NY-ESO-1 | Melanoma BNT111, Lipo-MERIT trial 5 10 Shared Antigens Multi-antigen approach per tailored to each indication EVDPIGHLY (HLA-A 01:01 / MAGE-A3) 2.1% 10° Fixed vaccine combination against shared tumor- associated antigens 0 10 MAGE-A3 | Melanoma BNT111, Lipo-MERIT trial RNA-LPX. RNA-Lipoplex; IV, intravenous; TLR7, Toll-like receptor; NY-ESO-1, New York esophageal squamous cell carcinoma-1; MAGE-A3, melanoma-associated antigen 3; HPV-E7, Human papillomavirus (type 16) E7 oncoprotein; HPV, Human papillomavirus; NSCLC, Non small cell lung cancer; HLA, human leukocyte antigen; CD, cluster of differentiation ¹Sahin U, et al. Nature 2020; 585:107-112; 2T cell responses analyzed by ex vivo multimer staining analysis in blood; ³Additional exploratory indication: Ovarian Cancer 10 Fix Vac 6866 10 5.0% HPV16-E7 | Head & Neck Cancer BNT113, HARE-40 trial BIONTECH#23BNT111: Treatment Options Needed to Address CPI Failure in Advanced Melanoma Patients Melanoma Remains the Deadliest Skin Cancer Incidence + 50% Annual cases have increased by nearly 50% to over 287,0001.2 23 Deaths + 20% WHO predicts by 2025, number of deaths will increase by 20% 3 CPI R/R patients ~ 55% patients refractory to or relapse on CPI treatment, leaving them with limited treatment options4 ● ● ● Significant Opportunity to Improve on Standard of Care 5-year survival for metastatic melanoma still only 29.8% 5 Frontline immunotherapy with CPI induces durable responses in max. 45-50% of patients but with relatively short PFS4 CPI resistant/ refractory patients that fail to respond to CPI or relapse after CPI have an especially poor prognosis with survival as short as 6 months depending on risk factors Advanced CPI R/R melanoma is a high medical need population with highly unfavorable prognosis WHO, World Health Organization; CPI, check point inhibitor; R/R, refractory/resistant; mPFS, median progression free survival; ORR, Overall Response Rate; DoR, Duration of Response ¹https://www.melanomauk.org.uk/2020-melanoma-skin-cancer-report; 2Global Cancer Observatory - 2018 data from 'Cancer Today'; ³Global Cancer Observatory - projected 2025 data from 'Cancer Tomorrow'; 4Larkin J. et al. NEJM 2019;381(16):1535-1546; 5https://seer.cancer.gov/statfacts/html/melan.html Accessed August 06, 2021 BIONTECH#24BNT111: Off-the Shelf Therapeutic Vaccine for Melanoma Potential to Improve Outcomes in Combination with Anti-PD1 by Rescuing from T Cell Exhaustion BNT111 encodes 4 tumor-associated antigens covering >90% of cutaneous melanoma patients 1 24 DOD NY-ESO-1 Tyrosinase MAGE-A3 TPTE H AAAA H AAAA H AAAA AAAA nature² An RNA vaccine drives immunity in checkpoint- inhibitor-treated melanoma Ugur Sahin, Petra Oehm, [...]Özlem Türeci Tolerable safety as monotherapy and in combination with anti-PD1 Durable objective responses in CPI-experienced patients with unresectable melanoma • ORR: BNT111 monotherapy: 3/25 PR; 8/25 SD • ORR: 35% in combination with anti-PD1: 6/17 PR; 2/17 SD Clinical responses accompanied by strong CD4+ and CD8+ T cell immunity NY-ESO-1, New York esophageal squamous cell carcinoma-1; MAGE-A3, melanoma-associated antigen 3; TPTE, transmembrane phosphatase with tensin homology; AAAA, Poly-A tail; PD1, Programmed cell death protein 1; CPI, check point inhibitor; R/R, refractory/resistant; PR, partial response; SD, stable disease; ORR, Overall Response Rate; CD, Cluster of Differentiation; ¹Data on file; 2Sahin U, et al. Nature 2020; 585:107-112 (https://www.nature.com/articles/s41586-020-2537-9) BIONTECH#25BNT111: Global Phase 2 Clinical Trial in Anti-PD1 R/R Melanoma Patients 25 BNT111-01 Patients with anti-PD1-R/R, unresectable Stage III or IV melanoma ● 2:1:1 ● R n=120 BNT111 + cem iplim ab ≤ 24 months n=60 n=30 n=30 BNT111 ≤ 24 months Addition of cemiplimab upon disease progression Cemiplimab ≤ 24 months Open-label, randomized Phase 2 trial BNT111 and cemiplimab in combination or as single agents Collaboration with Regeneron Addition of BNT111 upon disease progression Success Measures for BNT111 Trial ORR 30% 000 0 0 0 OS Follow-up every 3 months for ≤ 48 months from first dose Primary Endpoints ● Secondary Endpoints ORR (key secondary endpoint arms 2, 3) DOR, DCR, TTR, PFS by RECIST 1.1 OS, safety, tolerability, PRO ● Arm 1: ORR by RECIST 1.1 ● PD1, Programmed cell death protein 1; R/R, refractory/relapsed; ORR, overall response rate; DoR, Duration of Response; DCR, disease control rate; TTR, time to response; PFS, progression free survival; OS, overall survival; PRO, patient reported outcomes https://clinical trials.gov/ct2/show/record/NCT04526899 BIONTECH#26BNT113: Unmet medical need for HPV-Associated need for HPV-Associated ASIR ● 0 to <1 1 to <5 15 to <10 ≥10 No data NA HPV+ Cancer is a Growing Global Public Health Concern Worldwide HPV-attributable cases (2018) = 690,000 (de Martel et al. 2020, Lancet Glob Health) • Several types: HNSCC, Cervical, Anal, Vulvar, Vaginal, Penile HNSCC is the sixth most common cancer worldwide, with 890,000 new cases and 450,000 deaths in 20182 Oropharyngeal is most common HNSCC, accounting for 70% of cases, and 80-90% are HPV 16+³ Limited treatment options for patients not responding to or relapse on CPI¹ • HPV16+ HNSCC typically occur in younger people and is not associated with tobacco or alcohol use ● HNSCC HNSCC >60% of patients diagnosed with late-stage HNSCC Current treatment options carry significant treatment burden or only work for some patients 4: Chemotherapy, surgery, radiation ● ● CPI Current SOC for recurrent/metastatic HNSCC pembrolizumab5 nivolumab6 chemotherapy HPV, human papilloma virus; HNSCC, head and neck squamous cell carcinoma, CPI, check point inhibitor; R/R refractory/recurrent ¹Sabatini ME and Chiocca S. BJC 2020; 122:306-314, 2Johnson DE, et al., 2020, Nature Reviews Disease Primers 6:92 26 Saraiya et al. 2015, Vaccines; 4HNSCC NCCN Guidelines 2020, HNSCC ESMO Guidelines 2020; 5Burtness, et al. Lancet 2019 Nov 23; 394 (10212):1915-28; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6563923/pdf/nihms-1024161.pdf ORR 17% 13.3% 5.8% MOS (months) 13.6 7.7 5.1 mPFS (months) 8.0 2.0 2.3 BIONTECH#27BNT113: Potential to Increase Response Rate and DoR to CPI by Stimulating Immune Response Against HPV16 Proteins BNT113 encodes HPV16 oncoproteins E6 & E7 • E6 and E7 proven to be well-suited for immunotherapy intervention ● ● ● Exclusively expressed in pre-malignant and malignant tissue Maintain the transformed state of infected malignant cells Demonstrated immunogenicity Not affected by central tolerance mechanisms 27 5' HPV, human papilloma virus; DoR, Duration of Response, CPI, check point inhibitor 5' HI HPV-E6 HPV-E7 BNT113 combination with anti-PD1: Potential for synergistic antitumor effect delaying escalation to toxic chemo H AAAA Poly(A) tail AAAA BIONTECH#28BNT113: Potent Antigen-Specific T Cell Responses in Phase 1 Trial 1,2 A Overview of T cell responses Arm 1A ● ● ● 28 CD4+ and CD8+ T cell responses Responses detectable ex vivo, implying high numbers of T cells Responses against multiple E6 or E7 epitopes BO Arm 1A, adjuvantx Antigen E6 E7 Patient 1 18 Pre vaccination b1 b5 CD8 CD8 CD4 CD8 CD4 17 d5 Patient 2 TNTC Cohort 1 TD 29 μg 16 Patient 3 ELISPOTS³ Patient 7 CD8 response to vaccine targets Post vaccination b6 b1 309 c1 504 NR NR NR NR NR NR CD8 NR NE NR NR 65 Patient 4 3 d5 f5 TNTC b2 303 445 Patient 5 b6 d6 f6 Patient 6 CD4/ CD4/ CD8 CD8 TD, total dose; CD, Cluster of Differentiation; NE, Not Evaluated; NR, Not Reported; PBMC, peripheral blood mononuclear cells ¹HARE-40 trial Patient 7 Pepmix E6 Pepmix E7 PBMCs only Cohort 2 TD 78.2 μg PBMCs only Anti-CD3 Patient 8 CD4 Bulk CD8 Patient 9 b1 b5 Patient 10 TNTC Patient 11 b2 NR b6 01 Pre vaccination 39 b5 Number of patients 727 Arm 1A patients 15 b2 10 b6 LO O E6 E7 Positive response No response Not evaluable ELISPOTS³ Patient 6 CD4 response to vaccine targets Post vaccination b1 10 b5 b2 b6 Type of response to E6 2Presented at CIMT 2019; BNT113 is currently being studied in an investigator-initiated Phase 1 trial. ³ELISPOT (Enzyme Linked Immuno Spot Assay) data of selected patients. Data were generated using IFN-y ELISPOT directly ex-vivo with overlapping peptides covering the whole length of vaccine antigens (PepMix). b1 399 b5 22% 889 45% ☐CD4 response CD8 response ☐CD4/CD8 response b2 426 33% b6 D Pepmix E6 PBMCs only PBMCs only Anti-CD3 BIONTECH#29BNT113: First Patient Dosed in Potentially Registrational Phase 2 Trial in HPV16+ and PD-L1+ HNSCC BNT113 Unresectable, recurrent or metastatic HPV16+ HNSCC, PD-L1+ (CPS ≥1) 29 n ≤ 285 ● Part A: Safety Run-in BNT113 + pembrolizumab n = 12-18 ≤ 24 months ● SRC decision on safety and RP2DR to start Part B based on safety in Part A after one complete cycle Primary Endpoints Part A: Emergence of TEAES Part B: OS, ORR Part B: Randomization ● 1:1 n = 267 Open-label, controlled, Phase 2 study BNT113 in combination with pembrolizumab as frontline treatment for metastatic HPV 16+ and PD-L1+ HNSCC • HPV 16 companion diagnostic is being co-developed and will be clinically validated alongside the trial Secondary Endpoints PFS, DCR, DOR ● > Safety Patient reported outcomes Part B BNT113 + pembrolizumab ≤ 24 months Pembrolizumab monotherapy ≤24 months Success Measures for BNT113 Trial • mOS: 18 months (HR=0.667) • ORR: 40% HPV, human papilloma virus; PD-L1, programmed death-ligand 1; CPS, Combined positive score; HNSCC, head and neck squamous cell carcinoma; SRC, safety review committee; TEAEs, treatment emergent adverse events; OS, overall survival; mOS, median overall survival; ORR, overall response rate; HR, hazard ratio; DOR, duration of response; DCR, disease control rate; PFS, progression free survival ¹Burtness, et al. Lancet 2019 Nov 23; 394(10212):1915-28 https://www.clinical trials.gov/ct2/show/NCT04534205 BIONTECH#30BNT122: Randomized Phase 2 Trial in Adjuvant Colorectal Cancer Phase 2, open-label, multicenter randomized trial BNT122 versus watchful waiting in ctDNA positive patients with surgically resected Stage II (high risk) / stage III colorectal cancer Adjuvant SOC chemotherapy: 12 24 weeks DOO ooo 30 Patients with resected stage II high-risk / stage III CRC post surgery Screening 1: ctDNA status Screening 2: neoantigen selection for vaccine manufacture Screening 3: final eligibility 1:1 R Treatment Arm: BNT122 15 doses (6x q1w, 2x q2w, 7x q6w n = 166 Primary Endpoints DFS patients in biomarker cohort skip screening 1 iNeST Manufacturing ≤ 20 neoepitopes Observational Arm watchful waiting Secondary Endpoints RFS, TTR, TTF, OS Change in ctDNA status ● Biomarker Cohort: BNT122 irrespective of ctDNA status n = 15 Exploratory Cohort: BNT122 recurrent disease at screening 3 n≤ 20 CRC, colorectal cancer; ctDNA, circulating tumor DNA; SOC, standard of care; q1w, once weekly; q2w, every two weeks; q6w, every six weeks; DFS, disease-free survival; RFS, relapse-free survival; TTR, time to response; TTF, time to treatment failure; OS, overall survival; https://www.clinical trials.gov/ct2/show/NCT04486378; BNT122/iNeST is partnered with Genentech/Roche BIONTECH#31RiboCytokines: Designed to Overcome Limitations of Recombinant Cytokine Therapy Cytokines encoded by mRNA: A novel therapeutic concept Systemic delivery with minimal immunogenicity Backbone optimized and nucleoside-modified mRNA encoding cytokine fused to human albumin Liver-targeting LNP formulation with intravenous delivery Encoded cytokines translated within cells. ● ● Designed for optimized safety, tolerability and dosing Prolonged serum half-life High bioavailability Lower and less frequent dosing Lower toxicity ● ● ● ● 31 Product Candidate BNT 151 (modified IL-2) BNT152+153 (IL-7 + IL-2) Indication Solid Tumors Solid Tumors Pre-clinical Phase 1 Phase 2 LNP, lipid nanoparticle; PK, pharmacokinetic; IL-2, Interleukin-2; IL7, Interleukin-7; UTR, untranslated region RiboCytokine® is a registered trademark of BioNTech Lipid nanoparticle (LNP) Cap 30 BOB SPO Lipids Serum concentration 5' UTR RiboCytokine RNA Cytokine-Albumin PK profile HM Time Recombinant cytokine RiboCytokine 3' UTR BIONTECH AAA#32RiboCytokines: A Tailored Approach to T Cell Regulation and Stimulation IL-2 supports differentiation, proliferation, survival and effector functions of T cells mRNA encoding sequence-modified IL-2 variant. Sequence modification that weakens binding to IL-2Ra (CD25) ● ● ● BNT151 32 Designed to stimulate naïve and effector T cells with low to no expression of IL-2Ra (CD25low/neg) Stimulates anti-tumor effector cells without extensively triggering immunosuppressive regulatory T cells Combination with anti-PD-1/PD-L1 therapy IL-2, interleukin-2; IL-7, interleukin-7; IL-2Ra, interleukin-2 receptor alpha subunit. ↑ T cell proliferation ↑ T cell survival BNT152 (IL-7) ● mRNAs encoding IL-2 and IL-7 BNT153 (IL-2) Stimulates recently activated anti-tumor T cells and regulatory T cells ● ↑ T cell effector function BNT152 153 Sensitizes effector T cells to IL2 Controls fraction of immunosuppressive regulatory T cells Combination with RNA vaccine#33On Track to Achieve Multiple Significant Data & Clinical Milestones in 2H 2021 Six Clinical Trial Initiations in 1H 2021, Including Two Randomized Phase 2 !!!! ✓BNT162b2: Multiple updates ● 5+ Trial Updates 33 BNT311: Bi-specific CPI: PD-L1 x 4-1BB in solid tumors BNT312: Bi-specific CPI: CD40 x 4-1 BB in solid tumors BNT211: CLDN-6 CAR-T + CARVac in solid tumors BNT411: TLR-7 agonist +/- CPI in solid tumors 3 Randomized Phase 2 Trial Starts BNT111: Fix Vac + CPI in CPI-R/R melanoma BNT113: FixVac HPV16+ + CPI in 1L HNSCC BNT122: iNeST (autogene cevumeran) in adjuvant m CRC TOPP ● 7 First-in-human Phase 1 Trial Starts BNT211: CLDN-6 CAR-T + CARVac in solid tumors BNT221: NEOSTIM individualized neoantigen-T cell therapy in melanoma BNT151: Ribocytokine (modified IL-2) BNT152+153: RiboCytokine IL-7 / IL-2 combo in solid tumors BNT141: RiboMab (undisclosed) BNT142: RiboMab bi-specific CPI in solid tumors (CD3xCLDN6) BNT161: Influenza vaccine program PD-L1, program med death-ligand 1; CLDN6, Claudin-6, CAR-T Cells, Chimeric Antigen Receptor T Cells; IL-2, Interleukin 2; IL-7, Interleukin 7; TLR-7, Toll-like receptor-7 CPI, Check-Point Inhibitor; HNSCC, Head and Neck Squamous Cell Carcinoma; mCRC, Metastatic Colorectal Cancer; iNeST is partnered with Genentech/Roche; BNT311 and BNT312 partnered with Genmab; BIONTECH#34Agenda Second Quarter 2021 Highlights 34 Oncology Vaccine Update Pipeline Update COVID-19 Financial Results Corporate Update & Outlook BIONTECH#35Q2 2021 and 6M 2021 Financial Results (unaudited) - Profit or Loss Three months ended June 30 2020 2021 €28.0 €32.5 5,280.5 9.2 €5,308.5 35 (in millions, except per share data)* ● Total revenues Cost of sales Research and development expenses Sales and marketing expenses General and administrative expenses Other operating income less expenses Operating profit / (loss) ● ● Research & development revenues Commercial revenues ● ● Finance income less expenses Income taxes Profit / (loss) for the period Earnings per share Basic profit/ (loss) for the period per share Diluted profit/ (loss) for the period per share (883.8) (201.1) (13.3) (47.8) 35.9 €4,198.4 (175.6) (1,235.6) €2,787.2 €11.42 €10.77 €41.7 (5.6) (95.2) (3.0) (18.8) 0.0 €(80.9) (9.6) 2.2 €(88.3) €(0.38) €(0.38) *Numbers have been rounded, numbers presented may not add up precisely to the totals and may have been adjusted in the table context. Presentation of the interim consolidated statements of profit or loss has been condensed. Six months ended June 30 2021 €48.9 7,308.0 €7,356.9 (1,116.9) (417.3) (22.0) (86.7) 146.6 €5,860.6 (195.5) (1,749.8) €3,915.3 €16.07 €15.14 2020 €53.7 15.7 €69.4 (11.5) (160.3) (3.5) (34.6) 0.3 €(140.2) (3.7) 2.2 €(141.7) €(0.62) €(0.62) BIONTECH#36Q2 2021 and 6M 2021 COVID-19 Vaccine Deliveries Drove Revenue Growth €5,266.0m 36 COVID-19 vaccine revenues €138.1m €14.5m €5,280.5m €4,092.3m €1,035.6m Q2 2021 €7,308.0m €5,844.2m €1,235.4m €202.0m 6M 2021 €26.4m Commercial revenues - identified revenue streams COVID-19 vaccine revenues €7,281.6m *Represents an estimated figure based on preliminary data shared between Pfizer and BioNTech. Changes in share of the collaboration partner's gross profit will be recognized prospectively. Share of gross profit from COVID-19 vaccine sales in the Pfizer and Fosun territory (net position) and sales milestones (€168.6m for Q2 2021 and €415.8m for 6M 2021, respectively)* Direct COVID-19 vaccine sales to customers in BioNTech's territory Sales to collaboration partners of products manufactured by BioN Tech Other sales (mainly JPT and IMFS business) BIONTECH#37Update of Previously Stated Financial Outlook for the 2021 Financial Year Update on Current Signed COVID-19 Vaccine Order Book for the 2021 Financial Year Estimated COVID-19 vaccine revenues to BioNTech for the 2021 financial year upon delivery of currently signed supply contracts (~2.2 billion doses as of July 21, 2021): ~€15.9 billion* Planned 2021 Financial Year Expenses and Capex* R&D expenses: SG&A expenses: Capital expenditures: €950 million - €1,050 million €250 million - €300 million €175 million - €225 million 37 Ranges reflect current base case projections Ramp-up of R&D investment in 2H 2021 planned to expand and accelerate the pipeline development Estimated 2021 Financial Year Tax Assumptions BioN Tech Group estimated annual effective income tax rate: -31% *Figures have been estimated at constant foreign exchange rates and reflect current base case projections. BIONTECH#38Agenda Second Quarter 2021 Highlights 38 COVID-19 Vaccine Update Oncology Pipeline Update Financial Results Corporate Development & Outlook BIONTECH#39We intend to expand and accelerate our 10 pipeline development through a mix of targeted in-licensing, strategic collaborations, and M&A mRNA Cancer Vaccines 39 iNeST Fix Vac Next Gen CAR-T/ Neoantigen-based T Cell / TCR-T Therapy Cell Therapies Targeting Cancer CAR, Chimeric antigen receptor; TLR-7, Toll-like receptor 7 Targeted Cancer Antibodies Antibodies + Immunomodulatio TLR-7 Agonist Small Molecule Immunomodulators Next Generation Immunomodulators Bispecifics / Trispecifics ပြီး Ribocytokines Ribomabs Engineered Biologicals Recently announced Kite transaction strengthens our Cell Therapy pipeline and capabilities ww BIONTECH#40Acquisition of Kite's Solid Tumor TCR-T cell platform and related assets Transaction overview: On July 19, BioN Tech announced an asset purchase agreement with Kite to acquire its Neoantigen TCR Cell Therapy R&D Platform and cGMP manufacturing facility in the U.S. Transaction closed on August 4, 2021 What we gain: Leased U.S. clinical-stage cell therapy manufacturing facility in Gaithersburg, Maryland Brings more than 50 highly trained cell & gene therapy scientists and production experts Personalized Neo-antigen TCR program Library of other preclinical TCR assets ● 40 ● ● Strategic rationale: ✓ Add turn-key U.S. cell therapy facility to complement existing facility in Idar-Oberstein, Germany ✓ Enable expansion of U.S. clinical supply of CARVac and other BioNTech cell therapies. ✓ Strengthen U.S. team with highly skilled TCR scientists and manufacturing workforce ✓ Expand BioNTech's proprietary cell therapy pipeline and capabilities BIONTECH#41Acquisition strengthens individualized 10 pipeline ● Multiple individualized therapy approaches to address wide range of Solid Tumors indications. iNeST: Individualized mRNA cancer vaccine Uses patient's cancer mutations to generate neoantigen specific CD4+ and CD8+ T cell responses in vivo Early-stage / Adjuvant stage cancers 41 liO, immuno-oncology; PBMC, peripheral blood mononuclear cell; iNeST: partnered with Genentech/Roche NEOSTIM individualized neoantigen-T cell therapy Patient's PBMCs used to induce and expand multiple CD4+ and CD8+ neoantigen T cell populations ex-vivo CPI nonresponsive tumors Personalized TCR-T cell therapy Ex-vivo engineered neoantigen specific TCR-T cell therapy further strengthened by the acquistion from Kite Advanced tumors BIONTECH#42Strong momentum moving into 2H 2021 Our Vision: Harnessing the immune system's full potential to fight human disease. >>> Robust pipeline with growing number of late and early stage programs 42 Yooo Gim Diverse range of platform technologies with broad applications across diseases Building long-term value for patients, shareholders and society Global team with deep expertise World-class collaborators میرا Strong financial position to support organic innovation and continued corporate development BIONTECH#43BIONTECH An der Goldgrube 12 55131 Mainz Germany M: [email protected]

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Fiscal 3Q Investor Presentation image

Fiscal 3Q Investor Presentation

Healthcare

FY23 Full-Year Results Presentation image

FY23 Full-Year Results Presentation

Healthcare

Healthcare Network P&L Statement and Expansion Projects image

Healthcare Network P&L Statement and Expansion Projects

Healthcare

Accreditation and Quality Assurance Overview image

Accreditation and Quality Assurance Overview

Healthcare

Investment Highlights image

Investment Highlights

Healthcare

Investor Presentation image

Investor Presentation

Healthcare

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update image

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update

Healthcare

BioAtla Investor Presentation Deck image

BioAtla Investor Presentation Deck

Healthcare