UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a‑16 OR 15d‑16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
FOR THE MONTH OF MAY 2022
COMMISSION FILE NUMBER 001-39081
BioNTech SE
(Translation of registrant’s name into English)
(Translation of registrant’s name into English)
An der Goldgrube 12
D-55131 Mainz
Germany
+49 6131-9084-0
(Address of principal executive offices)
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20‑F or Form 40‑F: Form 20‑F ☒ Form 40‑F ☐
Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(7): ☐
DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K
On May 12, 2022, BioNTech SE (the "Company") issued a corrected first quarter 2022 financial results conference presentation. The conference call presentation is attached hereto as Exhibit 99.1.
SIGNATURE
Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| BioNTech SE | ||||||||
| By: | /s/ Dr. Sierk Poetting | |||||||
| Name: Dr. Sierk Poetting | ||||||||
| Title: Chief Operating Officer | ||||||||
Date: May 12, 2022
EXHIBIT INDEX
| Exhibit | Description of Exhibit | ||||
| 99.1 | |||||
1st Quarter 2022 Financial Results & Corporate Update May 9, 2022 Exhibit 99.1
Titelmasterformat durch Klicken bearbeitenThis 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® where approved for use under full or conditional marketing authorization, 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 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 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, if approved, our investigational medicines; 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; our collaboration with Pfizer to develop and market a COVID-19 vaccine (including a potential booster dose of BNT162b2 and/or a potential booster dose of a variation of BNT162b2 having a modified mRNA sequence); the ability of BNT162b2 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 investigational 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; our ability to progress our Malaria, Tuberculosis and HIV programs, including timing for selecting clinical candidates for these programs and the commencement of a clinical trial, as well as any data readouts; the nature and duration of support from the World Health Organization, 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, capital expenditures, income taxes, shares outstanding; our ability and that of our collaborators to commercialize and market our product candidates, if approved, including our COVID-19 vaccine; our ability to manage our development and expansion; regulatory developments 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 production levels, and our product candidates; 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 presentation 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 heading “Risk Factors” in this presentation for the three months ended March 31, 2022 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 forward-looking statements contained in this presentation 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. 2
Safety Information 3 COMIRNATY® ▼(the Pfizer-BioNTech COVID-19 vaccine) has been granted conditional marketing authorization (CMA) by the European Commission to prevent coronavirus disease 2019 (COVID-19) in people from 5 years of age. The vaccine is administered as a primary course of 2 doses, 3 weeks apart. In addition, the CMA has been expanded to include a booster dose (third dose) at least 6 months after the second dose in individuals 12 years of age and older. For immunocompromised individuals, a third primary course dose may be given at least 28 days after the second dose. The European Medicines Agency’s (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. • There is an increased risk of myocarditis and pericarditis following vaccination with Comirnaty. These conditions can develop within just a few days after vaccination, and have primarily occurred within 14 days. They have been observed more often after the second vaccination, and more often in younger males. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general. • Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions (e.g. dizziness, palpitations, increases in heart rate, alterations in blood pressure, paraesthesia, hypoaesthesia and sweating) may occur in association with the vaccination process itself. Stress-related reactions are temporary and resolve on their own. Individuals should be advised to bring symptoms to the attention of the vaccination provider for evaluation. It is important that precautions are in place to avoid injury from fainting. • Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. • As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals. • The efficacy and safety of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of Comirnaty may be lower in immunocompromised 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 were injection site pain (> 80%), fatigue (> 60%), headache (> 50%), myalgia and chills (> 30%), arthralgia (> 20%), pyrexia and injection site swelling (> 10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age. • The overall safety profile of COMIRNATY® in participants 5 to 15 years of age was similar to that seen in participants 16 years of age and older. • The most frequent adverse reactions in children 5 to 11 years of age were injection site pain (>80%), fatigue (>50%), headache (>30%), injection site redness and swelling (>20%), myalgia and chills (>10%). • 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%). • A large amount of observational data from pregnant women vaccinated with Comirnaty during the second and third trimester have not shown an increase in adverse pregnancy outcomes. While data on pregnancy outcomes following vaccination during the first trimester are presently limited, no increased risk for miscarriage has been seen. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development. Comirnaty can be used during pregnancy. • No effects on the breast fed newborn/infant are anticipated since the systemic exposure of breast feeding woman to Comirnaty is negligible. Observational data from women who were breast feeding after vaccination have not shown a risk for adverse effects in breast fed newborns/infants. Comirnaty can be used during breast feeding. Interactions with other medicinal products or concomitant administration of COMIRNATY® with other vaccines has not been studied. • For complete information on the safety of COMIRNATY® always make reference to the approved Summary of Product Characteristics and Package Leaflet available in all the languages of the European Union on the EMA website. The black equilateral triangle ▼ denotes that additional monitoring is required to capture any adverse reactions. This will allow quick identification of new safety information. Individuals can help by reporting any side effects they may get. Side effects can be reported to EudraVigilance or directly to BioNTech using email medinfo@biontech.de, telephone +49 6131 9084 0, or via the website www.biontech.de
Safety Information 4 AUTHORIZED USE IN THE U.S. COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. It is also authorized under EUA to provide a 2-dose primary series to individuals 5 years of age and older, a third primary series dose to individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise, a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®, a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine, a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized COVID-19 vaccine; and a second booster dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorized COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series. IMPORTANT SAFETY INFORMATION Individuals should not get the vaccine if they: • had a severe allergic reaction after a previous dose of this vaccine • had a severe allergic reaction to any ingredient of this vaccine Individuals should tell the vaccination provider about all of their medical conditions, including if they: • have any allergies • have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart) • have a fever • have a bleeding disorder or are on a blood thinner • are immunocompromised or are on a medicine that affects the immune system • are pregnant, plan to become pregnant, or are breastfeeding • have received another COVID-19 vaccine • have ever fainted in association with an injection The vaccine may not protect everyone. Side effects reported with the vaccine include: • There is a remote chance that the vaccine could cause a severe allergic reaction o A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, vaccination providers may ask individuals to stay at the place where they received the vaccine for monitoring after vaccination o Signs of a severe allergic reaction can include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness o If an individual experiences a severe allergic reaction, they should call 9-1-1 or go to the nearest hospital • Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine, more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low. Individuals should seek medical attention right away if they have any of the following symptoms after receiving the vaccine: o chest pain o shortness of breath o feelings of having a fast-beating, fluttering, or pounding heart • Additional side effects that have been reported with the vaccine include: • severe allergic reactions; non-severe allergic reactions such as injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); decreased appetite; diarrhea; vomiting; arm pain; and fainting in association with injection of the vaccine • These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away Data on administration of this vaccine at the same time as other vaccines have not yet been submitted to FDA. Individuals considering receiving this vaccine with other vaccines should discuss their options with their healthcare provider. Patients should always ask their healthcare providers for medical advice about adverse events. Individuals are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://www.vaers.hhs.gov or call 1‐800‐ 822‐7967. In addition, side effects can be reported to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
Corporate Outlook Ryan Richardson, Chief Strategy Officer Financial Results Jens Holstein, CFO Pipeline Update Özlem Türeci, CMO First Quarter 2022 Highlights Ugur Sahin, CEO 5
Titelmasterformat durch Klicken bearbeitenOur Vision: Harnessing The Power Of The Immune System To Fight Human Diseases Multi-Platform, Technology Agnostic Strategy Diversified Product Pipeline Fully Integrated Biotechnology Company Immunotherapy powerhouse expanding the therapeutic universe Global Social Responsibility • Focus on high medical needs • Democratize access to novel medicines 6
Titelmasterformat durch Klicken bearbeiten Highlights in Q1 2022 • Reported Q1 total revenues of €6.4 bn1 • Signed pandemic preparedness contract with Federal Republic of Germany through 2027 • Multiple new deals signed: • Matinas lipid nanocrystal collaboration • Regeneron collaboration to advance BNT116 in combination with Libtayo in NSCLC • Invoiced ~750 m doses globally in Q1 • FDA authorized 4th dose in adults 50 years+ and in immunocompromised individuals 12 years+ • Continued label expansion in multiple regions for booster dose in 12+ years • BNT211 (CLDN6 CAR-T cell therapy) Phase 1/2 data presented at AACR showed manageable safety profile and signs of clinical activity • First RiboMab BNT141 (CLDN18.2 antibody) entered Phase 1 clinical study in solid tumors Corporate Updates COVID-19 Vaccine Leadership Pipeline Advancement Q1 2022 Highlights 1 BioNTech’s profit share is estimated based on preliminary data shared between Pfizer and BioNTech as further described in the Annual Report on Form 20-F for the year ended December 31, 2021 as well as the Quarterly Report as of and for the three months ended March 31, 2022, filed as an exhibit to BioNTech’s Current Report on Form 6-K . Any changes in the estimated share of the collaboration partner's gross profit will be recognized prospectively. NSCLC = non-small cell lung cancer7
Titelmasterformat durch Klicken bearbeiten Proactive Approach to Managing COVID-19 at a Global Scale Delivered nearly 3.4 bn1 doses cumulatively to >175 countries and regions On track to achieve pledge to deliver a total of 2 bn doses to low- and middle-income countries by end of 2022 • Optimized formulation • Pediatric label expansion • Submission for boosters in children 5 to <12 yrs • Evaluating 3-dose primary regimen in children 6 months to <5 yrs; data expected in coming weeks • Future pandemic preparedness • Monitoring of emerging variants • Rapid data-guided vaccine adaptation • Pre-emptive approach to variants • Comprehensive variant-adapted and next-gen vaccine development program • Broad research program to study anti-SARS-CoV-2 immune profile after vaccinations, boosters, breakthrough infections to inform strategy ✓ ✓ ✓ 1 As of end-April 2022 This slide has been updated to remove an incorrect graphic regarding the countries to which the Pfizer-BioNTech COVID-19 vaccine has been delivered. 8 ✓ Innovation to stay ahead of COVID-19 Strong global position to tackle COVID-19 pandemic
Titelmasterformat durch Klicken bearbeiten Waves of Innovation Propel Us Toward Our Vision COVID-19 Vaccine Oncology Infectious Diseases New Disease Areas Driving Transformation TODAY… Near- and Mid-Term… Long-Term 5 RANDOMIZED PHASE 2 TRIALS 1 MARKETED VACCINE 10+ PRECLINICAL PROGRAMS 1 PHASE 1 PROGRAM 16 PROGRAMS IN 20 CLINICAL TRIALS PRESENT: MULTIPLE PROGRAMS IN LEAD-CANDIDATE SELECTION Potential for multiple product launches in next 3-5 years Once in a generation opportunity to transform medicine 9
Corporate Outlook Ryan Richardson, Chief Strategy Officer Financial Results Jens Holstein, CFO Pipeline Update Özlem Türeci, CMO First Quarter 2022 Highlights Ugur Sahin, CEO 10
Titelmasterformat durch Klicken bearbeiten COVID-19 Vaccine R&D Strategy to Drive Pandemic Preparedness 1 bioRxiv. Omicron breakthrough infection drives cross-variant neutralization and memory B cell formation; April 1, 2022. Available at: https://www.biorxiv.org/content/10.1101/2022.04.01.486695v1.full.pdf VOC, variants of concern Omicron- Adapted T Cell Enhancing Pan-Coronavirus covering Explore Various Follow- On and Next-Gen Vaccine Approaches Mono-/ Multi- valent Omicron Infection After Vaccination Drives Cross-Variant Neutralization and B Cell Immunity1 • Exposure to Omicron spike boosts strong and broad neutralizing activity against SARS-CoV-2 VOCs • Robust recall and expansion of preformed memory B cells that recognize epitopes shared across variants Data suggest Omicron-adapted vaccination after COMIRNATY could provide similar cross-strain immunity Inform Understanding of Dynamic SARS-CoV-2 Immunity 11 Assess Safety, Tolerability and Immunogenicity of Variant-Adapted Vaccines Emerging data from ongoing clinical trials evaluating mono- or bivalent variant adapted vaccines will be reviewed and discussed with regulators COMIRNATY Landscape Research Product Research Product Development Purpose Latest Developments
Titelmasterformat durch Klicken bearbeiten Omicron-adapted vaccine or Comprehensive Clinical Response Strategy to Omicron Variant 3rd dose or 3rd+4th dose 4th dose Omicron-adapted vaccine 3-dose primary regimen Omicron-adapted vaccine Evaluating different Omicron-adapted monovalent vaccine regimens • N~650, >55 years • Two dosages: 30 µg and 60 µg BNT162b2 BNT162b2 Vaccine naïve subjects 2 31 Evaluating bivalent Wild-Type/Omicron-adapted and Omicron-adapted vaccines Assessing Safety, Tolerability and Immunogenicity of an Omicron-Adapted Vaccine BioNTech. Available at: https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-initiate-study-evaluate-omicron-based-covid. Accessed January 2022; ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/ct2/show/NCT04955626. Accessed March 2022. 12 • N~1500, 18-55 years • Vaccine experienced and naïve subjects
Oncology: Advancement Across Multiple Modalities and Indications 1BNT115 is currently being studied in an investigator-initiated Phase 1 trial. 2Collaboration with Genentech 3Collaboration with Sanofi. 4Collaboration with Genmab. SMIM, Small Molecule Immunomodulators Drug class Platform Product candidate Indication (targets) Pre-clinical Phase 1 Phase 2 Phase 3 mRNA FixVac (fixed combination of shared cancer antigens) BNT111 Advanced melanoma BNT112 Prostate cancer BNT113 HPV16+ head and neck cancer BNT1151 Ovarian cancer1 BNT116 NSCLC iNeST (patient specific cancer antigen immune therapy) Autogene cevumeran (BNT122)2 1L melanoma Adjuvant colorectal cancer Solid tumors Intratumoral Immunotherapy SAR441000 (BNT131)3 Solid tumors (IL-12sc, IL15-sushi, GM-CSF, IFNα) RiboMabs (mRNA-encoded antibodies) BNT141 Multiple solid tumors (CLDN18.2) BNT142 Multiple solid tumors (CD3+CLDN6) RiboCytokines (mRNA-encoded cytokines) BNT151 Multiple solid tumors (optimized IL-2) BNT152, BNT153 Multiple solid tumors (IL-7, IL-2) Cell Therapies CAR-T Cells + Carvac BNT211 Multiple solid tumors (CLDN6) BNT212 Pancreatic, other cancers (CLDN18.2) Neoantigen-based T cells BNT221 (NEO-PTC-01) Multiple solid tumors TCR engineered T cells To be selected All tumors Antibodies Next-Gen CP Immunomodulators GEN1046 (BNT311)4 Metastatic NSCLC (PD-L1x4-1BB) Multiple solid tumors (PD-L1x4-1BB) GEN1042 (BNT312)4 Multiple solid tumors (CD40x4-1BB) Targeted Cancer Antibodies BNT321 (MVT-5873) Pancreatic cancer (sLea) SMIM Toll-Like Receptor Binding BNT411 Solid tumors (TLR7) 13
Titelmasterformat durch Klicken bearbeitenFocused Execution in 2022 Across 5 Phase 2 Programs in Various Solid Tumor Types BNT111 Platform Program BNT113 Autogene cevumeran BNT1221 BNT3112 Autogene cevumeran BNT1221 R/R Melanoma HPV16+ HNSCC Adjuvant colorectal cancer R/R NSCLC1L Melanoma • Potential to improve outcomes in combo with anti-PD1 • Encodes HPV16 oncoproteins E6 & E7 • Targets 20 neo-antigens unique to each patient • Targets 20 neo-antigens unique to each patient • Data update expected 2H 2022 R/R, refractory/relapsed; HPV16+, human papilloma virus type 16 positive; HNSCC, head and neck squamous cell carcinoma; NK cell, Natural killer cell, CPI, checkpoint inhibitor 1 Collaboration with Genentech, 2 Collaboration with Genmab. How Why FixVac iNeST Bispecific Off-the-shelf mRNA vaccine Individualized mRNA immunotherapy • Encodes 4 tumor- associated antigens covering >90% of cutaneous melanoma patients • U.S. Fast Track Designation and Orphan Drug Designation • Potential for synergistic anti-tumor effect in combination with anti- PD1 • Trial success may unlock 1L use of iNeST as combination therapy with anti-PD(L)1 in anti-PD1- naive advanced cancers • Potential to address residual cancer cells that remain – focus on recurrence free survival • Conditional 4-1BB co- stimulation while blocking PD(L)1 axis Next-generation immunotherapy • Enhances T cell and NK cell function and targets them to tumor lesions 14
Titelmasterformat durch Klicken bearbeitenBNT211: CAR-T Cell Program with Potential Targeting Multiple High-Need Solid Tumors CLDN6, Claudin-6; CAR-T cells, chimeric antigen receptor engineered T cells; scFv, single chain variable fragment; RP2D, recommended Phase 2 dose; NOS, not otherwise specified; Reinhard K, et al. Science 2020; 367:446-453 BNT211 CAR StructureCLDN6 not present in healthy tissues CLDN6 expressed in multiple cancers 2nd generation CAR • Directed against CLDN6 • Cancer specific carcino-embryonic antigen • Expressed in multiple solid cancers with high medical need CARVac • drives in vivo expansion, persistence and efficacy of CAR-T cells Patients with CLDN6+ relapsed/ refractory solid tumors (up to 36 patients) Part 3 Expansion Cohorts • Ovarian Cancer • Testicular Cancer • Endometrial Cancer • Lung Cancer • Gastric Cancer • Tumors NOS High CLDN6 expression RP2D Part 1: monotherapy CLDN6 CAR-T dose escalation: 1x107 CAR-T (DL1) 1x108 CAR-T (DL2) 1x109 CAR-T (DL3) Part 2: combination therapy CLDN6 CAR-T dose escalation + CLDN6 CARVac: 1x107 CAR-T (DL1) 1x108 CAR-T (DL2) 1x109 CAR-T (DL3) 15
Titelmasterformat durch Klicken bearbeiten CLDN6 CAR-T cells as monotherapy or combined with CARVac well tolerated at dose levels evaluated to date (1x107 and 1x108 CAR-T) • Grade 1-2 CRS seen in 70% of patients at 1x108 CAR-T dose, manageable by administration of tocilizumab • 2 DLTs observed, both patients fully recovered and showed clinical benefit • MTD not reached yet • Robust CAR-T engraftment achieved in all patients translating into clinical activity: ORR 43%, DCR of 86% in evaluable patients (n=14; 1x107 and 1x108 CAR-T) • 6 PR, 5 SD+, 1 SD (Testicular, ovarian and other tumors, 6 weeks post-infusion) • 5 testicular cancer patients show promising responses at 1x108 CAR-T: ORR 80%, DCR 100%; 1 CR, 3 PR, 1 SD • CARVac supports CAR-T engraftment and mediates physiologic expansion plus upregulation of survival pathways • Some patients show continuing CAR-T persistence (>150 days post infusion) • Patients with initial PR showed further deepening of responses BNT211: CAR-T in Solid Tumors Encouraging Efficacy and Safety Profiles Presented at AACR Data cut-off: MAR 10, 2022 DL1: 1x107 CAR-T; DL2: 1x108 CAR-T CLDN6, Claudin-6; DLT, dose-limiting toxicity; MTD, maximum tolerated dose; CRS, cytokine release syndrome; CR, complete response; DCR, disease control rate; DL, dose level; ORR, overall response rate; PR, partial response; SD, stable disease Safety Efficacy 16
Titelmasterformat durch Klicken bearbeiten 0 50 100 150 104 105 106 107 108 109 1010 Days post infusion C A R -T c e ll s [ to ta l c o u n ts ] 0 50 100 150 104 105 106 107 108 109 1010 Days post infusion C A R -T c e ll s [ to ta l c o u n ts ] 0 50 100 150 104 105 106 107 108 109 1010 Days post infusion C A R -T c e ll s [ to ta l c o u n ts ] 0 50 100 150 104 105 106 107 108 109 1010 Days post infusion C A R -T c e ll s [ to ta l c o u n ts ] Cohort DL1: 1x107 CAR-T mono (n = 3) 1x107 CAR-T + CARVac (n = 3) DL2: 1x108 CAR-T mono (n = 6) 1x108 CAR-T + CARVac (n = 4) CRS, n 0 (0%) 1 (33%) 4 (66%) 3 (75%) PR, n* 0 (0%) 1 (33%) 2 (33%) 3 (75%) SD, n* 1 (33%) 0 (0%) 3 (50%) 1 (25%) ORR* 0% 33%** 33% 75% DCR* 33% 33%** 83% 100% Robust CAR-T Engraftment Seen in all Patients and Persisting CAR-T in Responding Patients Data cut-off: MAR 10, 2022. DL1: 1x107 CAR-T; DL2: 1x108 CAR-T CRS, cytokine release syndrome; DCR, disease control rate; DL, dose level; DLT, dose-limiting toxicity; ORR, overall response rate; PR, partial response; SD, stable disease; *At first tumor assessment (6 weeks post infusion); **2 patients died due to disease progression before first tumor assessment. LLOQ DL1 DL2 C A R V a c C A R V a c 17
Efficacy Observed at 6 Weeks Post Infusion Data cut-off: MAR 10, 2022. DL1: 1x107 CAR-T; DL2: 1x108 CAR-T DL, dose level; CR, complete response; DCR, disease control rate; EoT, end of trial (due to PD); ORR, overall response rate; PD, progressive disease; PR, partial response; SD, stable disease, SD+, SD with shrinkage of target lesions; *50% lymphodepletion ACT 6 weeks 12 weeks 18 weeks 24 weeks PR SD+ PD CR Pat#1 Pat#2 Pat#3 30 weeks 36 weeks Pat#1 DL1: 1x107 CAR-T mono DL1: 1x107 CAR-T + CARVac DL2: 1x108 CAR- T mono 42 weeks 48 weeks EoT Part 1 → 2 Pat#1 Pat#2 Pat#3 Pat#2 Pat#3 Pat#4 Pat#5 Pat#1 Pat#2 SD Pat#6 Pat#5 DL2: 1x108 CAR-T + CARVac Pat#6 Redosing Pat#1* Pat#3 Pat#4 Testicular Ovarian Others Not included Non-evaluable 6 Weeks Post Infusion in Testicular, Ovarian and Other Tumors: • ORR 43% (6/14) • DCR 86% (12/14) • 6 PR, 5 SD+, 1 SD 18
Titelmasterformat durch Klicken bearbeiten Continuing Responses in Testicular Cancer with One PR Deepening to CR Best response Durability of responses Testicular cancer patients: DL1: 1x107 CAR-T mono DL1: 1x107 CAR-T + CARVac DL2: 1x108 CAR-T + CARVac Testicular Ovarian Others 19 PR, partial response; CR, complete response; DL, dose level
Titelmasterformat durch Klicken bearbeitenResponses in Two Testicular Cancer Patients with Relapse After Prior Treatment Data cut-off: MAR 10, 2022 AFP, alpha-fetoprotein; CR, complete response; CLDN6, Claudin-6. Baseline 6 weeks post infusion 12 weeks post infusion Patient 1 Patient 2 56-year-old male patient diagnosed 2020 (DL1: 1x107 + CARVac) 61-year-old male patient diagnosed 2008 (DL2: 1x108) • After initial response New lesions were detected • On-treatment biopsy showed positivity for CLDN6 • Patient was re-dosed on d197 • No new lesions detected • Tumor marker (AFP) at normal level • Patient has ongoing CR 20 Post 12-week scan
Corporate Outlook Ryan Richardson, Chief Strategy Officer Financial Results Jens Holstein, CFO Pipeline Update Özlem Türeci, CMO First Quarter 2022 Highlights Ugur Sahin, CEO 21
Titelmasterformat durch Klicken bearbeiten €6.4 bn €4.8 bn €6.2 bn + €12.7 bn Key Highlights For Q1 2022 Total Revenues1 Operating Result Diluted EPS Cash and Trade Receivables €14.24 22 1 BioNTech’s profit share is estimated based on preliminary data shared between Pfizer and BioNTech as further described in the Annual Report on Form 20-F for the year ended December 31, 2021 as well as the Quarterly Report as of and for the three months ended March 31, 2022, filed as an exhibit to BioNTech’s Current Report on Form 6-K . Any changes in the estimated share of the collaboration partner's gross profit will be recognized prospectively.
Titelmasterformat durch Klicken bearbeiten First Quarter 2022 COVID-19 Vaccine Commercial Revenues Strong Q1 2022 - BioNTech reiterates 2022 financial year guidance COVID-19 vaccine sales to collaboration partners of products manufactured by BioNTech Direct COVID-19 vaccine sales to customers in BioNTech’s territory Share of gross profit from COVID-19 vaccine sales in the Pfizer and Fosun Pharma territory (100% gross margin) 23 €6.4 bn Q1 2022 €4.6 bn €1.2 bn €0.6 bn 1 BioNTech’s profit share is estimated based on preliminary data shared between Pfizer and BioNTech as further described in the Annual Report on Form 20-F for the year ended December 31, 2021 as well as the Quarterly Report as of and for the three months ended March 31, 2022, filed as an exhibit to BioNTech’s Current Report on Form 6-K . Any changes in the estimated share of the collaboration partner's gross profit will be recognized prospectively.
Titelmasterformat durch Klicken bearbeiten Q1 2022 Financial Results – Profit or Loss (in millions, except per share data)1 Q1 2022 Q1 2021 Research & development revenues €12.4 €20.9 Commercial revenues2 6,362.2 2,027.5 Total revenues €6,374.6 €2,048.4 Cost of sales (1,294.1) (233.1) Research and development expenses (285.8) (216.2) Sales and marketing expenses (14.3) (8.7) General and administrative expenses (90.8) (38.9) Other operating income less expenses 63.1 110.7 Operating income €4,752.7 €1,662.2 Finance income less expenses 265.4 (19.9) Income taxes (1,319.3) (514.2) Profit for the period €3,698.8 €1,128.1 Earnings per share Basic profit for the period per share €15.13 €4.64 Diluted profit for the period per share €14.24 €4.39 1 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 consolidated statements of profit or loss has been condensed. 2 BioNTech’s profit share is estimated based on preliminary data shared between Pfizer and BioNTech as further described in the Annual Report on Form 20-F for the year ended December 31, 2021 as well as the Quarterly Report as of and for the three months ended March 31, 2022, filed as an exhibit to BioNTech’s Current Report on Form 6-K . Any changes in the estimated share of the collaboration partner's gross profit will be recognized prospectively. 24
Titelmasterformat durch Klicken bearbeiten 2022 Financial Year Guidance Reiterated 1 Ranges reflect current base case projections and do not include potential effects caused by or driven from additional collaborations or potential M&A transactions. 2 BioNTech Group estimated annual effective income tax rate decreased from 31.6% (FY 2021) to ~28% (FY 2022) mainly due to decreasing average trade tax rates. COVID-19 Vaccine Revenues for FY 20221 Estimated BioNTech COVID-19 vaccine revenues € 13 – 17 bn Planned FY 2022 Expenses and Capex1 R&D expenses € 1,400 - 1,500 m SG&A expenses € 450 - 550 m Capital expenditure € 450 - 550 m Estimated FY 2022 Tax Assumptions BioNTech Group estimated annual effective income tax rate ~28%2 25
Corporate Outlook Ryan Richardson, Chief Strategy Officer Financial Results Jens Holstein, CFO Pipeline Update Özlem Türeci, CMO First Quarter 2022 Highlights Ugur Sahin, CEO 26
Titelmasterformat durch Klicken bearbeiten Significant Pipeline Expansion and Maturation Expected in 2022 • Initiate 4 FIH vaccine trials • 10+ additional mRNA vaccine programs • Precision antibacterials Expand in Infectious Disease • First randomized Phase 2 readout • Prepare for registrational trials • POC data for CAR-T cell therapy Execute in Oncology Continue COVID-19 Vaccine Leadership • Label & geographic expansion • Next-generation vaccines • Innovations for pandemic preparedness Invest in Foundation to Enable Accelerated Innovation and Expansion Digital & AI Capabilities | Technologies | Development Team | Manufacturing | Global Footprint • Autoimmune disease • Regenerative medicine • Cardiovascular disease Advance into New Therapeutic Areas 27
Titelmasterformat durch Klicken bearbeiten COVID-19 Vaccine Outlook 2022 Upcoming Data BNT162b2 Timing • Data for 4th dose in adults, aged 16 to 65 years2 ongoing • Data for 3-dose regimen in children, aged 6 months to <5 years coming weeks Follow-on and next generation vaccines • Omicron-adapted vaccine: monovalent, bivalent - 3rd and/or 4th dose coming weeks • Multiple updates: Follow on and next-gen vaccines 2H 1 As of mid-April 2022; In combination with contracts entered into by Pfizer28 Order Book for 20221: ~2.4 bn doses Pipeline of variant-adapted and next generation COVID-19 vaccines in multiple active clinical trials
Titelmasterformat durch Klicken bearbeiten Further Expected Pipeline Milestones in 2022 HSV 2, Herpes simplex virus type 2; FPD, first patient dosed; CLDN, Claudin; NSCLC, non-small cell lung cancer 1 Partnered with Pfizer, 2 Collaboration with BMGF, 3 Partnered with Genentech Infectious Diseases Timing • Shingles vaccine1 2H • Tuberculosis vaccine2 2H • HSV 2 vaccine 2H • Malaria vaccine 2H 4 Infectious Disease First-In-Human Trial Starts Oncology • BNT141 – RiboMab, solid tumors FPD in January • BNT142 – RiboMab, solid tumors 1H • BNT116 – FixVac in combination w/Libtayo, NSCLC 2H ✓ 3 Oncology First-in-Human Trial Starts Data Updates • BNT161 – Influenza mRNA vaccine1 • BNT1223 Phase 2 – iNeST in combination w/Pembrolizumab, 1L Melanoma 2022 2H • BNT211 Phase 1/2 – CAR-T/CLDN6+, multiple solid tumors 2H 3 Data Updates 29
30 SAVE THE DATE Virtual Capital Markets Day Annual General Meeting June 29, 2022 June 1, 2022 30
