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 2021

COMMISSION FILE NUMBER 001-39081

 

BioNTech SE

(Translation of registrant’s name into English)

 

An der Goldgrube 12 D-55131 Mainz Germany

+49 6131-9084-0

(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): ☐

 

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DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K

 

On May 10, 2021, BioNTech SE (the “Company”) issued a press release announcing its first quarter 2021 financial results and corporate update and details of a conference call to be held at 8:00 am EST on May 10, 2021 to discuss the results. The press release and the conference call presentation are attached as Exhibits 99.1 and 99.2, respectively, and incorporated by reference herein.

 

The information contained in Exhibits 99.1 and 99.2 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, unless expressly set forth by specific reference in such a filing.

 

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SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

Date: May 10, 2021

 

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EXHIBIT INDEX

 

 

 

 

Exhibit 99.1

 

 

 

 

BioNTech Announces First Quarter 2021 Financial Results and Corporate Update

 

 

Conference call and webcast scheduled for May 10, 2021, at 8:00 a.m. ET (2:00 p.m. CET)

 

MAINZ, Germany, May 10, 2021 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”), a next generation immunotherapy company pioneering novel therapies for cancer and infectious diseases, today provided an update on its corporate progress and reported financial results for the quarter ended March 31, 2021.

 

“BioNTech has continued to execute the delivery of our COVID-19 vaccine globally to more than 90 countries and territories. Through our continued innovation, we are expanding access to new populations and geographies, and addressing emerging variants,” said Ugur Sahin, BioNTech’s Co-founder and CEO. “We are moving into later stage testing for three of our oncology programs in the near future and plan to launch multiple new products over the next five years. Looking ahead, we will further optimize our technologies and expand our pipeline into additional therapeutic indications, as we meet our ambition to become a global, fully-integrated immunotherapy company.”

 

First quarter 2021 and subsequent updates

 

Infectious disease

 

COVID-19 vaccine program – BNT162b2

In March 2021, BioNTech announced its Full Year 2020 Financial Results and Corporate Update as a part of the Annual Report filed on Form 20-F, highlighting developments relating to its COVID-19 vaccine program between January 1 and March 30, 2021 (Link to press release). A summary of these developments as well as full details of subsequent developments that occurred after March 30, 2021 is provided below.

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As of May 6, 2021 BioNTech and Pfizer have shipped approximately 450 million doses of BNT162b2 to 91 countries and territories around the world.

To date, the companies have signed orders of approximately 1.8 billion doses for delivery in 2021, and they have also signed the first contracts for 2022 and beyond. Further discussions for additional dose commitments are ongoing for 2021 and beyond. BioNTech expects BNT162b2 annual manufacturing capacity to reach 3 billion doses by the end of 2021, and expects to have capacity to manufacture more than 3 billion doses in 2022.

Multiple clinical trials are ongoing to expand the authorization of BNT162b2 to additional population groups, such as children from 6 months to 11 years of age, and to collect further data in healthy pregnant women.

To date, there is no evidence that an adaptation of BioNTech’s current COVID-19 vaccine against key identified emerging variants is necessary. Despite this, BioNTech has developed a comprehensive strategy to address these variants should the need arise in the future. As part of BioNTech’s strategy to contend with the variant challenge, BioNTech submitted to the U.S. Food and Drug Administration (FDA), and the FDA has approved an additional amendment to the study protocol of the global Phase 1/2/3 trial which includes: (1) an assessment of the impact of a third dose of BNT162b2 in prolonging immunity against COVID-19 and in protecting against COVID-19 caused by potential newly emerging SARS-CoV-2 variants, and (2) an assessment of a modified, variant-specific version of BNT162b2. The aim of this study is to explore the regulatory pathway that BioNTech and Pfizer would pursue if SARS-CoV-2 were to change enough to require an updated vaccine. This trial started in March 2021.

In the first quarter of 2021, BioNTech also advanced its work to broaden access through improvements to its cold chain distribution systems and processes. Both the FDA and the European Medicines Agency (EMA) have approved the transportation and storage of undiluted frozen vials of BNT162b2 at temperatures (-20°C) commonly found in pharmaceutical freezers for a period of up to two weeks. Further stability data have been assessed and formulation optimization activities are ongoing, including a study to evaluate a lyophilized (or freeze-dried) and a ready-to-use formulation of BNT162b2.

BNT162b2 clinical development updates

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In an additional exploratory analysis of 800 trial participants enrolled in South Africa, where the B.1.351 lineage is prevalent, nine cases of COVID-19 were observed, all in the placebo group, indicating vaccine efficacy of 100%. Of these cases, eight were of the B.1.351 lineage, confirming efficacy against B.1.351 virus. These data support previous results from immunogenicity studies demonstrating that BNT162b2 induced a robust neutralizing antibody response to the B1.351 variant and, although lower than to the wild-type strain, it does not appear to affect the observed high efficacy against COVID-19 caused by this variant, as published in the New England Journal of Medicine.²

 

 

Regulatory updates

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Commercial updates

 

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Manufacturing updates

 

Oncology

 

BioNTech is accelerating the development of a broad oncology pipeline, which has now advanced 14 product candidates in 15 ongoing trials. In April 2021 the Company started a first-in-human Phase 1 trial for the T cell therapy, targeting personalized neoantigens, named BNT221. Additional important milestones in the advancement of BioNTech’s immuno-oncology pipeline in the first quarter of 2021 included the initiation of first-in-human trials for CARVac (BNT211) and RiboCytokines (BNT151). BioNTech also expects to further advance its oncology pipeline in 2021 with up to three additional programs expected to move into randomized Phase 2 trials. Additionally, three preclinical programs are expected to move into Phase 1 trials in the second half of 2021.

During the remainder of 2021, BioNTech expects at least four data updates from its ongoing clinical trials.

 

mRNA programs

 

FixVac

 

 

Individualized neoantigen specific immunotherapy (iNeST)

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For the adjuvant treatment of colorectal cancer, first patient dosing in a randomized Phase 2 trial in circulating tumor DNA positive, surgically resected Stage 2 (high risk)/Stage 3 colorectal cancer is now planned in the second half of 2021.

 

RiboCytokines

 

RiboMabs

 

Antibodies

Next-generation checkpoint immunomodulators

BNT311 and BNT312 are partnered with Genmab.

 

Cell therapies

CAR-T cell immunotherapy

BioNTech plans to present early data from the ongoing BNT211 Phase 1/2a trial on three patients treated with a starting dose of CLDN6 CAR-T cells at the upcoming 18th Association for Cancer Immunotherapy (CIMT) Annual Meeting 2021. In these heavily pretreated patients with solid tumors, neither acute nor dose-limiting toxicities were observed and all adverse events were transient and mild to moderate. Robust CAR-T cell engraftment could be detected in all three patients, as well as early signs of clinical activity. Following completion of the first dose level with CAR-T cell monotherapy, the trial is now progressing to the next dose level and a combination treatment involving CAR-T cells with an RNA vaccine, which BioNTech refers to as CARVac. A data update is planned in the second half of 2021.

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Neoantigen-targeting T cell therapy

BNT221 (NEO-PTC-01) is a personal neoantigen-targeted T cell therapy candidate derived from patients’ peripheral blood cells. The product candidate consists of multiple CD8+ and CD4+ T cell populations targeting multiple selected neoantigens unique to each patient's tumor. The proprietary stimulation process allows for the induction of T cells from the naïve, as well as expansion of T cells from the memory compartment.

 

Small molecule immunomodulators

Toll-like receptor binding agonist

 

Corporate development

 

 

 

First quarter 2021 financial results (unaudited)

Revenues: Total revenues were estimated to be €2,048.4 million¹ for the three months ended March 31, 2021, compared to €27.7 million for the three months ended March 31, 2020. The

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increase was mainly due to rapidly increasing the supply of COVID-19 vaccine worldwide. Under the collaboration agreements, territories have been allocated between BioNTech, Pfizer and Fosun Pharma based on marketing and distribution rights. BioNTech’s commercial revenues include an estimated amount of €1,751.9 million¹ comprising BioNTech’s share of gross profit from COVID-19 vaccine sales in Pfizer’s territories, which represents a net figure, as well as sales milestones. In addition, €63.9 million sales to BioNTech’s collaboration partners of products manufactured by BioNTech and €199.8 million direct COVID-19 vaccine sales to customers in BioNTech’s territory have been recognized.

Cost of Sales: Cost of sales were estimated to be €233.1 million¹ for the three months ended March 31, 2021, compared to €5.9 million for the three months ended March 31, 2020. Estimated cost of sales of €223.2 million¹ were recognized with respect to BioNTech’s COVID-19 vaccine sales and include Pfizer’s share of gross profits earned by BioNTech.

Research and Development Expenses: Research and development expenses were €216.2 million for the three months ended March 31, 2021, compared to €65.1 million for the three months ended March 31, 2020. The increase was mainly due to an increase in research and development expenses for BioNTech’s BNT162 program, recorded as purchased services with respect to those expenses, which were initially incurred by Pfizer and subsequently charged to BioNTech under the collaboration agreement. The increase was further driven by an increase in wages, benefits and social security expenses from increasing headcounts and recognizing expenses incurred under the new share-based-payment arrangements.

General and Administrative Expenses: General and administrative expenses were €38.9 million for the three months ended March 31, 2021, compared to €15.8 million for the three months ended March 31, 2020. The increase was mainly due to higher expenses for professional services, an increase in wages, benefits and social security expenses from increasing headcounts and recognizing expenses incurred under the new share-based-payment arrangements as well as higher insurance premiums.

Income Taxes: Interim income taxes were €514.2 million for the first quarter of 2021 and were recognized using the estimated annual effective income tax rate of approximately 31%.

Net Profit / (Loss): Net profit was €1,128.1 million for the three months ended March 31, 2021, compared to €53.4 million net loss for the three months ended March 31, 2020.

Cash Position: Cash and cash equivalents as of March 31, 2021 were €891.5 million.

Shares Outstanding: Shares outstanding as of March 31, 2021 were 241,521,065.

 

Update on current signed COVID-19 vaccine order book:

 

On Track with Previously Stated 2021 Financial Outlook:

 

The full interim unaudited condensed consolidated financial statements can be found in BioNTech’s Quarterly Report on Form 6-K, filed today with the SEC and available at https://www.sec.gov/.

 

¹   Estimated figures based on preliminary data shared between the collaboration partner and BioNTech as fully described in the Annual Report on Form 20-F as well as the Quarterly Report as of and for the Three Months Ended March 31, 2021, which is filed as an exhibit to BioNTech’s Current Report on Form 6-K. Changes in the share of the collaboration partners’ gross profit will be recognized prospectively.

²   New England Journal of Medicine. Neutralizing Activity of BNT162b2-Elicited Serum; March 8, 2021. Available at https://www.nejm.org/doi/full/10.1056/NEJMc2102017

³   Figures reflect current base case projections.

 

 

About BioNTech

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a

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wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bispecific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma and Pfizer.

 

For more information, please visit www.BioNTech.de  

 

Forward-Looking Statements

This press release 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 which are subject to numerous assumptions, particularly for those figures that are derived from preliminary estimates provided by our partners which are subject to numerous assumptions; 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; 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 estimates of our expenses, ongoing losses, future revenue and capital requirements 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,

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including our COVID-19 vaccine; our expected tax rate and 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 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; 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 JV 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 heading “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 forward-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.

 

Investor Relations

Sylke Maas, Ph.D.

VP Investor Relations & Strategy
Tel: +49 (0)6131 9084 1074
E-mail: Investors@biontech.de 

 

Media Relations

Jasmina Alatovic

Director Global External Communications
Tel: +49 (0)6131 9084 1513 or +49 (0)151 1978 1385
E-mail: Media@biontech.de

 

 

 

 

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Interim Condensed Consolidated Statements of Financial Position

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Interim Condensed Consolidated Statements of Profit or Loss

 

* Foreign exchange differences related to operating activities on a cumulative basis are either shown as other operating income or expenses and might switch between those two positions during the year-to-date reporting periods.

** Foreign exchange differences not related to operating activities on a cumulative basis are either shown as finance income or expenses and might switch between those two positions during the year-to-date reporting periods.

 

 

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Interim Condensed Consolidated Statements of Cash Flows

 

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Corporate update and financial results May 10, 2021 First Quarter 2021 Harnessing the full potential of the immune system Exhibit 99.2

This 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 includingBioNTech's efforts to combat COVID-19; the collaboration between BioNTech and Pfizer regarding a COVID-19 vaccine; our expectations regarding the potential characteristics of BNT162b2 in our continuing trials and/or in commercial use based on data observations to date, including real-world data gathered; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on trial data of BNT162b2 in our ongoing trials; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates and targets for 2021 and 2022; BioNTech's projected revenues for the COVID-19 vaccine in 2021; BioNTech's projected expenses, capital expenditures and tax rate for 2021; BioNTech's target vaccine production for 2021; BioNTech's COVID-19 vaccine revenues and net sales, which are subject to numerous estimates as more fully described in our Annual Report on Form 20-F and our Quarterly Report for the Three Months ended March 31, 2021; the planned next steps in BioNTech's pipeline programs and specifically including, but not limited to, statements regarding plans to initiate clinical trials of BioNTech's product candidates; BioNTech's plans for expansion in southeast Asia, including its planned regional headquarters and manufacturing facility in Singapore; and expectations for data announcements with respect to BioNTech's clinical trials. 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 heading “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 forward-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. 2

Safety 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 16 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 (e.g., 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/). 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%). Severe allergic reactions, including anaphylaxis, have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. 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 at https://vaers.hhs.gov/reportevent.html or by calling 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. 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.  3

First Quarter 2021 Highlights COVID-19 Vaccine Update Oncology Pipeline Update Financial Results Corporate Update & Outlook Agenda 4

Transformed into a Fully Integrated, Global Immunotherapy Company 5 Deep Immunology Expertise Broad Suite of Novel Technologies Bioinformatics Approach In-House Manufacturing ICON Fully Integrated Structure Commercial Capabilities Next-Gen Immunotherapies & Vaccines Oncology, Infectious Disease and Beyond Potential to Launch Multiple Products in Next 5 Years A Robust Pipeline of 20+ Candidates Accelerated by Proven Execution and COVID-19 Vaccine Cash Flow Global Team of 2,000+

Building a 21st Century Global Immunotherapy Powerhouse 6 Increase global footprint Expand integrated infrastructure Rapidly advance pipeline Continue investment in innovation to support future product launches Invest in clinical, commercial and manufacturing, and digital capabilities Attract and retain top talent 14 product candidates in 15 ongoing clinical trials 3 potentially registrational phase 2 trials initiating this year Advance innovations into first-in-human studies Strategic in-licensing to complement internal R&D New regional headquarters planned in Singapore Commercial subsidiaries established in Germany and Turkey Offices established in the United States

Highlights From First Quarter 2021 and Beyond Next generation CAR-T in combination with CARVac (BNT211) NEO-STIM Neoantigen-targeting T cell therapy (BNT221) Ribocytokine (BNT151) First Patients Dosed in Multiple First-in-Human Studies >450M doses shipped to 91 countries and territories worldwide* ~1.8 billion doses contracted to date for 2021, and with first contracts in place for 2022 and beyond €2.0 billion COVID-19 vaccine revenues in Q1 Topline results confirming high efficacy and no serious safety concerns through up to six months following second dose 100% efficacy and robust antibody responses in Phase 3 trial of adolescents aged 12-15 Executional Excellence in Infectious Disease with COVID-19 Vaccine *as of May 6 In March 2021, BioNTech announced its Full Year 2020 Financial Results and Corporate Update as a part of the Annual Report filed in Form 20-F, highlighting developments relating to its COVID-19 vaccine program between January 1 and March 30, 2021. This slide focuses on developments that occurred after March 30, 2021. 7

Additional Populations Increased Manufacturing Capacity Additional Geographies Broadened & Decentralized Vaccine Access Addressing SARS-CoV-2 Variants Addressing Waning Immune Responses Focused on Six Key Levers to Expand COVID-19 Vaccine Reach Up to 3 billion doses by end of 2021; more than 3 billion doses in 2022 First shipments from Marburg facility delivered mid April New regional headquarters in Singapore to house mRNA manufacturing facility Expect FDA feedback on EUA label expansion in adolescents 12 to 15 years in May Variation submitted to EMA to expand label in adolescents 12 to 15 years Ongoing study in children 6 months to 11 years of age; first data expected in Q3 Authorized or approved for emergency authorization in more than 70 countries worldwide Shipped to 91 counties and territories Regulatory submission for BLA in China underway U.S. rolling BLA submission initiated Initiated Phase 3 trial to evaluate lyophilized and a ready-to use formulation; data expected in Q3 Data submitted to FDA and EMA to broaden label to 4-week storage at 2°C to 8°C Ongoing trial to evaluate variant-specific version BNT162b2SA in naïve and vaccinated individuals as well as third dose of BNT162b2 at 6 – 12 months post dose 2 Effect on waning immune response against original strain Effect on immune response against variant strains 8 In March 2021, BioNTech announced its Full Year 2020 Financial Results and Corporate Update as a part of the Annual Report filed in Form 20-F, highlighting developments relating to its COVID-19 vaccine program between January 1 and March 30, 2021. This slide focuses on developments that occurred after March 30, 2021.

Preemptive strategy to be prepared for addressing SARS-CoV-2 Variants 9 *B.117 (UK variant), B.1.351 (South African variant), and P.1 lineage (Brazilian variant) Liu et al., NEJM, Mar. 8, 2021 Safety & immunogenicity data expected in Q2 2021 Dose 3 BNT162b2SA Dose 3 BNT162b2 Dose 3 BNT162b2 Dose 2 BNT162b2SA Dose 2 BNT162b2 Dose 2 BNT162b2 Dose 1 BNT162b2SA Dose 1 BNT162b2 Dose 1 BNT162b2 Prime 1st Boost 2nd Boost Boostability of BNT162b2 21 days Phase 3 participants 21 days 21 days 6-12 months 5-7 months 5-7 months Phase 1 participants Newly enrolled naïve adults n=300 n=300 n=300 n=600 n=30 Dose 4 BNT162b2SA No evidence that adaptation of BNT162b2 is needed to date Sera of BNT162b2 vaccinated individuals neutralize B.1.1.7 (UK), B.1.351 (SA), and P.1 (brazilian) lineage* in in vitro studies Expansion of global Phase 1/2/3 trials: 3rd dose to evaluate safety, magnitude and duration of immunity and variant protection Variant specific booster to evaluate safety and immunogenicity of B.1.351 Spike version of BNT162b2 (BNT162b2SA) “Blueprint“ approach informs regulatory path and manufacturing Booster trial with BNT162b2 or BNT162b2SA 1 2

Strong Order Book Growth in Q1 10 ~1.8 billion doses contracted for 2021 Expanding vaccine access to new populations & geographies with first supply contracts for post-2021

Manufacturing Capacity Increased to Address Worldwide Vaccine Need BioNTech now targeting 3 billion doses in 2021* Manufacturing capacity in 2022 to exceed 3 billion doses BioNTech contributing more than 50% of drug substance Marburg site launch brings BioNTech manufacturing capacity to 1 billion doses annually BioNTech expects to deliver ~250 million doses in 1H 2021 Marburg site first batch delivered in April Established mRNA manufacturing in Marburg facility in less than six months To become one of the largest mRNA manufacturing sites worldwide 11 *This assumes continuous process improvements and expansion at our current facilities and contingent upon adding more suppliers and contract manufacturers.

First Quarter 2021 Highlights COVID-19 Vaccine Update Oncology Pipeline Update Financial Results Corporate Update & Outlook Agenda 12

Immunomodulation Tackling Multiple Diseases with Different Therapeutic Modalities mRNA Cancer Vaccines Antibodies Small Molecule Immunomodulators + Multi-specificity, multi-valency, high (neo)antigen specific T cell responses with unprecedented potency Ongoing Phase 2 randomized trial (iNeST) CARVac: Paired with mRNA vaccination to enhance PK and persistence Phase 1 FIH trials started in Feb. and Apr. Next-generation checkpoint inhibitors to address a broad range of cancers Ongoing Phase 1/2 trials of 2 bi-specific antibodies mRNA encoded cytokines with a prolonged T1/2 and improved safety profile Amplify vaccines and CPIs Phase 1 FIH trial started in Feb. Cell Therapies Next Generation Immunomodulators Engineered Cytokines iNeST and FixVac Targeted Cancer Antibodies Bispecifics Ribocytokines Next Gen CAR-T Cell Therapy Neoantigen-based T Cell Therapy TLR-7 Agonist Targeting Cancer CA19-9 antibody in 1L pancreatic cancer Ongoing Phase 1/2 trial Potently modulates innate immunity Potential for combination with other IO agents Ongoing Phase 1 trial Multiple blockbuster opportunities with synergistic combinations 13 PK, Pharmacokinetics; CA 19-9: Cancer antigen 19-9; IO, Immuno-oncology; CPI, Check-point Inhibitor

Multiple Oncology Trials with Registrational Potential Starting in 2021 BNT111: Phase 2 to start in 1H 2021 BNT311: Data update in 2H 2021 BNT312: Data update in 2H 2021 BNT113: Phase 2 to start in 1H 2021 BNT122: Phase 2 to start in 2H 2021 (adjuvant CRC) Near-Term Milestones Advanced Oncology Pipeline Programs Plan to start randomized Phase 2 trials for 3 programs Planned randomized trial start in 2021 1L, first-line; CRC, Colorectal Cancer; 14

BNT211 (CLDN 6 CAR) Next generation CAR-T targeting CLDN6 with CARVac Next Wave Oncology Advancing Innovation Beyond Current Boundaries FPD, First patient dosed; CLDN6, Claudin-6, CAR-T cells, Chimeric antigen receptor T cells; IL-2, interleukin 2; IL-7, Interleukin 7; PBMC, peripheral blood mononuclear cells 1 Reinhard K, et al. Cancer Immunotherapy 2020; 367:446-453; 2 Stadler et al, Oncoimmunology 2018 CARVac CAR-T cell amplifying mRNA therapy for solid tumors1 Wholly owned: FIH start: FPD Feb. 2021 BNT221 PBMC derived ex vivo T cell therapy NEOSTIM T cell therapy Individualized Neoantigen specific T cell therapy BNT151 (modified IL-2) BNT152 + BNT153 (IL-2/IL-7) RiboCytokines mRNA encoded Cytokines BNT141 (undisclosed) BNT142 (CD3xCLDN6) RiboMabs2 mRNA encoded Antibodies FPD Apr. 2021 BNT151: FPD Feb. 2021 2H 2021 15 ✓ ✓ ✓ ✓

BNT111: FixVac Melanoma Compelling Preliminary Data Sahin et al, Nature 2020 Tolerable safety as monotherapy and in combination with CPI Durable Objective Responses in CPI-experienced patients with evaluable disease at baseline ORR 35% for combination therapy (BNT111 + anti-PD1): 6/17 patients High-magnitude and persistent CD4+ and CD8+ T cell responses Fixed combination of non-nucleoside modified mRNA Encodes 4 tumor-associated antigens (TAA) covering ~95% of melanoma patients Phase 1 trial in Advanced Melanoma published in Nature Off-the-shelf mRNA Immunotherapy Intravenous formulation targets antigen presenting cells bodywide to stimulate antigen-specific T cell responses TPTE, trans-membrane phosphatase with tensin homology; UTR, Untranslated Region; PD1, programmed death-ligand 1; CPI, Checkpoint inhibitor; ORR, overall response rate https://www.nature.com/articles/s41586-020-2537-9 16 10.1% NY-ESO-1

BNT111: FixVac Phase 2 Clinical Trial in anti-PD1 R/R Melanoma Patients BNT111-01 Patients with anti-PD1-refractory/relapsed, unresectable Stage III or IV melanoma n=60 n=30 n=30 Addition of cemiplimab upon disease progression Addition of BNT111 upon disease progression Secondary EP Primary EP Arm 1: ORR by RECIST 1.1 main treatment arm calibrator arm R Open-label, randomized Phase 2 trial with BNT111 and cemiplimab in combination or as single agents Collaboration with Regeneron ORR (key secondary endpoint arms 2, 3) DOR, DCR, TTR , PFS, by RECIST 1.1 OS, safety, tolerability, PRO BNT111 + cemiplimab up to 24 months BNT111 up to 24 months Cemiplimab up to 24 months OS Follow-up every 3 months for 48+ months from first dose 17 EP, endpoint; ORR, overall response rate; DOR, duration of response; DCR, disease control rate; TTR, time to response; PFS, progression free survival; OS, overall survival; PR, patient reported outcomes; R/R, refractory, relapsed https://clinicaltrials.gov/ct2/show/record/NCT04526899

BNT211: Next Generation CAR-T Targeting CLDN6 with CARVac New 2nd generation CAR directed against CLDN6, a new highly cancer cell specific carcino-embryonic antigen CLDN6 is expressed in multiple solid cancers with high medical need tumor types CARVac drives in vivo expansion, persistence and efficacy of CAR-T 18 BNT211 CAR Structure CLDN6, Claudin-6; CAR-T cells, chimeric antigen receptor engineered T cells; scFv, single chain variable fragment Reinhard K, et al. Science 2020; 367:446-453 CAR-T cell therapy + RNA Vaccine to amplify CAR-T cell in vivo CLDN6 not present in healthy tissues αCLDN6 scFv CD8 hinge 4-1BB CD3ζ intracellular extracellular

BNT211: Next Generation CAR-T Therapy in Solid Tumors An open-label Phase 1/2a study of BNT211 in patients with advanced solid tumors Evaluation of safety and tolerability Ongoing Phase 1/2a study Monotherapy dose level 1 completed (3 patients) CLDN6, Claudin-6; CAR-T cells, Chimeric Antigen Receptor engineered T cells; RP2D, recommended Phase 2 dose; NOS, not otherwise specified NCT04503278, https://clinicaltrials.gov/ct2/show/NCT04503278 19 Part 1 CLDN6 CAR-T dose escalation Part 2 CLDN6 CAR-T + CLDN6 CARVac dose escalation BNT211 CLDN6-positive relapsed or refractory advanced 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

BNT211: CAR-T Engraftment and Stable Disease in First 2 Patients DLT, dose limiting toxicity; Pat, patient; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; LD, lymphodepletion; FIGO, International Federation of Gynecology and Obstetrics; CLDN6, Claudin-6; AE, adverse event; CAR-T, Chimeric Antigen Receptor engineered T cells * Suspected to be related to drug product 20 First dose level was well tolerated AEs Mild to Moderate & Transient No AEs ≥ grade 3 and no DLTs CAR-T detectable across different tumor types Robust engraftment in all patients, Follow-up days 3-24 for patient #1 and #2, and days 3-10 for patient #3 post CAR-T cell transfer Tumor Reduction in Patient #2: 19.7% shrinkage of tumor (RECIST 1.1)

BNT221: NEO-STIM® Personalized Neoantigen-Targeted Adoptive Cell Therapy T cells induced from peripheral blood (NEO-STIM) No gene engineering or viral vectors Targets each patient´s personal tumor neoantigens Multiple specific CD8+ and CD4+ T cell populations that are functional and have a favorable phenotype First patient dosed in Phase 1 trial in anti-PD-1 experienced unresectable stage III or IV melanoma Addresses limitations of TIL cell therapy approaches BNT221 cells specifically recognize autologous tumor TIL, tumor-infiltrating lymphocyte Lenkala D, et al. J Immunother Cancer 2020; 8(Suppl 3) A153 21

Agenda 22 First Quarter 2021 Highlights COVID-19 Vaccine Update Oncology Pipeline Update Financial Results Corporate Update & Outlook

First Quarter 2021 Financial Results (unaudited) – Profit or Loss 23 Research & development revenues Commercial revenues 2021 €20.9 2,027.5 2020 €21.2 6.5 (19.9) (514.2) 5.9 - €4.64 €4.39 €(0.24) €(0.24) Cost of sales Research and development expenses Sales and marketing expenses General and administrative expenses Other operating income less expenses (233.1) (216.2) (8.7) (38.9) 110.7 (5.9) (65.1) (0.5) (15.8) 0.3   Finance income less expenses Income taxes Basic profit / (loss) for the period per share Diluted profit / (loss) for the period per share Earnings per share *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.

24 *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. First Quarter 2021 COVID-19 Vaccine Deliveries Drove Revenue Growth Commercial revenues – identified revenue streams

On Track with Previously Stated Financial Outlook Estimated COVID-19 vaccine revenues to BioNTech upon delivery of signed supply contracts as of May 4, 2021 (~1.8 billion doses): ~€12.4 billion Update on Current Signed COVID-19 Vaccine Order Book 25

Agenda 26 First Quarter 2021 Highlights COVID-19 Vaccine Update Oncology Pipeline Update Financial Results Corporate Update & Outlook

Increasing Our Global Footprint First location in Asia: regional headquarters in Singapore to house mRNA manufacturing facility with support from Singapore Economic Development Board Growing international workforce with teams in United States, an affiliate in Turkey and commercial organization, including salesforce in Germany 27

Significant Pipeline Milestones expected in 2021 5+ Trial Updates BNT162b2: Multiple updates BNT311: Bi-specific CPI: PD-L1 x 4-1bb in solid tumors BNT312: Bi-specific checkpoint immunomodulator CD40 x 4-1bb 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: FixVac + CPI in refractory melanoma BNT113: FixVac HPV16+ + CPI in 1L HNSCC BNT122: iNeST (autogene cevumeran) + CPI in adjuvant mCRC 7 First-in-human Phase 1 Trial Starts BNT211: CLDN-6 CAR-T + CARVac in solid tumors BNT151: Ribocytokine (modified IL-2) BNT221: NEOSTIM individualized neoantigen-T cell therapy in melanoma BNT152+153: RiboCytokine IL-2 / IL-7 combo in solid tumors BNT141: RiboMab (undisclosed) BNT142: RiboMab bi-specific CPI in solid tumors (CD3xCLDN6) BNT161: Influenza vaccine CLDN6, Claudin-6, CAR-T cells, Chimeric antigen receptor T cells; IL-2, interleukin 2; IL-7, Interleukin 7; CPI, check-point inhibitor; HNSCC, head and neck squamous cell carcinoma; mCRC, metastatic colorectal cancer 28 ✓ ✓ ✓

Strong Financial Position, Fully-Integrated Structure Enable Execution on Strategic Priorities for 2021 Continue to execute while driving iterative innovation against COVID-19 Deliver COVID-19 vaccine to >1 billion people globally Broaden and diversify early- and late-stage pipeline of next generation immunotherapies Accelerate pipeline in core therapeutic areas Immuno-oncology: Usher in new era of individualized cancer medicine and in vivo cell therapy Infectious disease: Advance mRNA vaccines and therapeutics to address infectious diseases beyond COVID-19 Further optimize platforms and initiate early product development in emerging areas Increase global footprint and expand integrated infrastructure Vaccine revenue provides significant working capital to build long-term value for patients, shareholders and society 29

An der Goldgrube 12 55131 Mainz Germany M: investors@biontech.de