BNTX BioNTech SE

198.3
+5.53  (+3%)
Previous Close 192.77
Open 192.74
52 Week Low 46.3
52 Week High 213.15
Market Cap $47,893,627,190
Shares 241,521,065
Float 241,521,065
Enterprise Value $45,788,247,054
Volume 2,023,994
Av. Daily Volume 2,940,459
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Upcoming Catalysts

Drug Stage Catalyst Date
BNT311 / GEN1046
Solid tumors
Phase 1/2
Phase 1/2
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BNT312/GEN1042
Solid tumors
Phase 1/2
Phase 1/2
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BNT211
Solid tumors
Phase 1/2
Phase 1/2
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BNT411
Solid tumors
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
BNT122
Colorectal cancer
Phase 2
Phase 2
Phase 2 dosing to commence 2H 2021.
BNT142
Solid tumors
Phase 1
Phase 1
Phase 1 trial to commence 2H 2021.
BNT141
Solid tumors
Phase 1
Phase 1
Phase 1 trial to commence 2H 2021.
BNT113
Head and Neck Cancer / HPV
Phase 2
Phase 2
Phase 2 trial to commence 1H 2021.
BNT111 and Libtayo (cemiplimab)
Melanoma
Phase 2
Phase 2
Phase 2 trial to be initiated 1H 2021.
BNT162b2
COVID-19 vaccine
BLA Filing
BLA Filing
FDA EUA approval announced December 11, 2020. Rolling BLA filing has been submitted - May 7, 2021.
BNT151
Solid tumors
Phase 1
Phase 1
Phase 1 trial commenced dosing February 2021.
BNT114
Triple negative breast cancer
Phase 1
Phase 1
Phase 1 trial ongoing.
BNT131
Solid tumors
Phase 1
Phase 1
Phase 1 data presented at SITC November 2020.
BNT122
Melanoma
Phase 2
Phase 2
Phase 2 enrollment slower than expected due to the impact of COVID-19 pandemic - noted November 10, 2020.
BNT112
Prostate cancer
Phase 1/2
Phase 1/2
Phase 1/2 trial initiated December 2019.

Latest News

  1. MAINZ, Germany, May 18, 2021 — BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))), announced today that the Supervisory Board has appointed Jens Holstein to the Management Board as Chief Financial Officer (CFO). As of July 1, 2021, Jens Holstein will join the Management Board to help strengthen BioNTech on its growth trajectory as a global, fully integrated immunotherapy company with an approved or authorized product. He previously served as CFO for MorphoSys AG and in various CFO and general management roles within the Fresenius SE Group. Jens Holstein takes over the CFO role from Dr. Sierk Poetting who will fully focus on his tasks as Chief Operating Officer (COO) going forward.

    Under Sierk Poetting's leadership, BioNTech grew…

    MAINZ, Germany, May 18, 2021 — BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))), announced today that the Supervisory Board has appointed Jens Holstein to the Management Board as Chief Financial Officer (CFO). As of July 1, 2021, Jens Holstein will join the Management Board to help strengthen BioNTech on its growth trajectory as a global, fully integrated immunotherapy company with an approved or authorized product. He previously served as CFO for MorphoSys AG and in various CFO and general management roles within the Fresenius SE Group. Jens Holstein takes over the CFO role from Dr. Sierk Poetting who will fully focus on his tasks as Chief Operating Officer (COO) going forward.

    Under Sierk Poetting's leadership, BioNTech grew from approximately 300 employees when he joined the company in 2014, to more than 2,000 employees to date. In his position as CFO, Sierk has played a fundamental role in BioNTech's successful IPO in October 2019 as the eighth German company to be listed on Nasdaq. Over the past months, Sierk's and his teams' efforts have been crucial to the expansion of BioNTech's manufacturing partner network to meet the global demand of the Company's COVID-19 vaccine, including the Marburg site, which is one of the largest mRNA manufacturing facilities worldwide. In his role as COO, he will drive the further development and execution of a digital strategy, which is comprised of the automation of R&D and production and the further expansion of BioNTech's global manufacturing footprint, including the recently announced site in Singapore.

    "The success of BioNTech's COVID-19 vaccine development program ‘Project Lightspeed' has led to the accelerated transformation to a global immunotherapy company which requires extensive manufacturing capacities to support worldwide supply. The extension of the Management Board allows Sierk to further focus on manufacturing as well as the digital transformation of BioNTech," said Helmut Jeggle, Chairman of the BioNTech Supervisory Board. "We are looking forward to Jens Holstein joining the Management Board. He has extensive international business and financial leadership experience of more than 25 years in the pharmaceutical industry. Jens is an excellent addition to drive BioNTech's next phase of growth and jointly foster the foundation for long-term, global success."

    "Through the development of a well-tolerated and effective COVID-19 vaccine, BioNTech has achieved a historic breakthrough for science. This first product authorized for use marked a crucial milestone in the Company's growth path. I am thrilled to join the Management Board at this exciting time in the Company's development," said Jens Holstein. "With the proceeds from the COVID-19 vaccine, BioNTech will be in a position to accelerate its research pipeline in cancer therapies, infectious diseases, regenerative therapies, inflammatory reactions, as well as autoimmune diseases. I'm looking forward to supporting this outstanding team in fulfilling its mission of improving the health of people worldwide."

    As CFO, Jens will work closely with the other Management Board members to drive BioNTech's financial performance. He will be responsible for Finance, Tax, Treasury, Human Resources and Purchasing. In addition, Jens will play a leadership role in the development and execution of the Company's regional expansion plans.

    Prior to joining BioNTech, Jens was CFO of dual-listed MorphoSys AG where he was instrumental in building a fully integrated biopharmaceutical company. Before joining MorphoSys in 2011, Jens served in multiple CFO positions as well as general management roles within the Fresenius SE Group. He served as Regional CFO for the region EME (Europe/Middle East) and as Managing Director of Fresenius Kabi Deutschland GmbH. From 2006 to 2010, he was Regional Chief Financial Officer of Fresenius Kabi Asia Pacific Ltd., based in Hong Kong. Prior to this appointment, Jens Holstein was Managing Director of Fresenius ProServe GmbH, and CFO and Labor Director of the company's subsidiary Wittgensteiner Kliniken AG. Earlier positions within Fresenius included General Manager of hospitalia care GmbH, Commercial Manager of the Projects & Service business unit of Fresenius AG and Commercial Manager of hospitalia international GmbH. Jens Holstein also spent several years in the consulting industry, including in M&A with positions in Frankfurt and London. Jens Holstein holds a Diploma in Business Administration from the University of Münster, Germany. He is also a Non-Executive Member of the Board of Directors at global genomic diagnostics company Veracyte Inc.

    About BioNTech

    Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a 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" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech's efforts to combat COVID-19; the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2021; and the potential benefits of BioNTech's leadership hires. Any forward-looking statements in this press release are based on BioNTech's current expectations and beliefs of future events. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond 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 BioNTech's Annual Report on Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC's website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

    Media Relations

    Jasmina Alatovic

    +49 (0)6131 9084 1513

    Investor Relations

    Sylke Maas, Ph.D.

    +49 (0)6131 9084 1074

     

     



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    • In a Phase 3 trial, the vaccine was 100% effective and generally well tolerated in participants aged 12 to 15 years
    • Data also submitted to European Medicines Agency (EMA) and other global regulators, with additional authorizations expected in coming weeks 

    NEW YORK and MAINZ, GERMANY, May 11, 2021Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) announced today that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include individuals 12 to 15 years of age. This is the first COVID-19 vaccine authorized in the U.S. for use in this age group.

    "Today's expansion of our EUA represents a significant step forward in helping the U.S. government broaden its vaccination…

    • In a Phase 3 trial, the vaccine was 100% effective and generally well tolerated in participants aged 12 to 15 years
    • Data also submitted to European Medicines Agency (EMA) and other global regulators, with additional authorizations expected in coming weeks 

    NEW YORK and MAINZ, GERMANY, May 11, 2021Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) announced today that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include individuals 12 to 15 years of age. This is the first COVID-19 vaccine authorized in the U.S. for use in this age group.

    "Today's expansion of our EUA represents a significant step forward in helping the U.S. government broaden its vaccination program and help protect adolescents before the start of the next school year," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "We are grateful to all of our clinical trial volunteers and their families, whose courage helped make this milestone possible. Together, we hope to help bring a sense of normalcy back to young people across the country and around the world."

    The FDA based its decision on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years. Topline results from this trial, announced on March 31, 2021, showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses. In the trial, the vaccine was also generally well tolerated. Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

    As a next step following today's FDA decision, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss recommendations for use of the Pfizer-BioNTech COVID-19 Vaccine in adolescents 12 to 15 years of age based on the amended EUA.

    "Since securing the EUA in December for individuals 16 years and older, we have been working tirelessly to get our COVID-19 vaccine authorized around the world so that governments can provide it to as many people as possible," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "Our work is not yet complete, as we continue our research into the use of our vaccine in pediatric populations. Our goal is to submit data for pre-school and school-age children in September."

    Pfizer and BioNTech have submitted the data in adolescents 12 to 15 years of age for scientific peer review for potential publication. The data also have been submitted to other regulators around the world, including the European Medicines Agency (EMA).

    In addition, the pediatric study evaluating the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine in children 6 months to 11 years of age is ongoing. Pfizer and BioNTech expect to have definitive readouts, and subject to the data generated, submit for an EUA or a variation to Conditional Marketing Authorizations for two cohorts, including children 2-5 years of age and 5-11 years of age, in September. The readout and submission for the cohort of children 6 months to 2 years of age are expected in the fourth quarter.

    The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalents in the United States (together with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

    The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine-us.com.

    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)
    • 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%)
    • Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm) have been reported following administration of the Pfizer-BioNTech COVID-19 vaccine 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 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.

    About Pfizer: Breakthroughs That Change Patients' Lives

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

    Pfizer Disclosure Notice

    The information contained in this release is as of May 11, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

    This release contains forward-looking information about Pfizer's efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program and the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (including qualitative assessments of available data, potential benefits, expectations for clinical trials, the potential of BNT162b2 for adolescents 12 to 15 years of age, evaluation of BNT162b2 in children 6 months to 11 years old, anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including the topline data outlined in this release), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data (including the topline data outlined in this release); the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data (including the topline data outlined in this release) are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program (including the topline data outlined in this release) will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when a Biologics License Application for BNT162b2 may be filed in the U.S. and whether and when other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including a potential Biologics License Application in the U.S. or any requested amendments to the emergency use or conditional marketing authorizations) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine's benefits outweigh its known risks and determination of the vaccine's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine's ultra-low temperature formulation, two-dose schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness;  uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

    About BioNTech

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

    BioNTech Forward-looking Statements

    This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech's efforts to combat COVID-19; the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine (including a potential second booster dose of BNT162b2 and/or a potential booster dose of a variation of BNT162b2 having a modified mRNA sequence); the potential of BNT162b2 for adolescents 12 to 15 years of age, evaluation of BNT162b2 in children 6 months to 11 years old, anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2 in our clinical trials and/or in commercial use based on data observations to date; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical trials; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; 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 risk that demand for any products may be reduced or no longer exist; the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2021; and challenges related to public vaccine confidence or awareness. Any forward-looking statements in this press release are based on BioNTech's current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties.

    For a discussion of these and other risks and uncertainties, see BioNTech's Annual Report on Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC's website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

    Pfizer Contacts:

    Media Relations

    Amy Rose

    +1 (212) 733-7410

    Investor Relations

    Chuck Triano

    +1 (212) 733-3901

    BioNTech Contacts:

    Media Relations

    Jasmina Alatovic

    +49 (0)6131 9084 1513

    Investor Relations

    Sylke Maas, Ph.D.

    +49 (0)6131 9084 1074

     



    Primary Logo

    View Full Article Hide Full Article
    • In a Phase 3 trial, the vaccine was 100% effective and generally well tolerated in participants aged 12 to 15 years
    • Data also submitted to European Medicines Agency (EMA) and other global regulators, with additional authorizations expected in coming weeks

    Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) announced today that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include individuals 12 to 15 years of age. This is the first COVID-19 vaccine authorized in the U.S. for use in this age group.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210510006021/en/

    "Today's expansion of our EUA represents…

    • In a Phase 3 trial, the vaccine was 100% effective and generally well tolerated in participants aged 12 to 15 years
    • Data also submitted to European Medicines Agency (EMA) and other global regulators, with additional authorizations expected in coming weeks

    Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) announced today that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include individuals 12 to 15 years of age. This is the first COVID-19 vaccine authorized in the U.S. for use in this age group.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210510006021/en/

    "Today's expansion of our EUA represents a significant step forward in helping the U.S. government broaden its vaccination program and help protect adolescents before the start of the next school year," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "We are grateful to all of our clinical trial volunteers and their families, whose courage helped make this milestone possible. Together, we hope to help bring a sense of normalcy back to young people across the country and around the world."

    The FDA based its decision on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years. Topline results from this trial, announced on March 31, 2021, showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses. In the trial, the vaccine was also generally well tolerated. Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

    As a next step following today's FDA decision, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss recommendations for use of the Pfizer-BioNTech COVID-19 Vaccine in adolescents 12 to 15 years of age based on the amended EUA.

    "Since securing the EUA in December for individuals 16 years and older, we have been working tirelessly to get our COVID-19 vaccine authorized around the world so that governments can provide it to as many people as possible," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "Our work is not yet complete, as we continue our research into the use of our vaccine in pediatric populations. Our goal is to submit data for pre-school and school-age children in September."

    Pfizer and BioNTech have submitted the data in adolescents 12 to 15 years of age for scientific peer review for potential publication. The data also have been submitted to other regulators around the world, including the European Medicines Agency (EMA).

    In addition, the pediatric study evaluating the safety and efficacy of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months to 11 years of age is ongoing. Pfizer and BioNTech expect to have definitive readouts and, subject to the data generated, submit for an EUA or a variation to Conditional Marketing Authorizations for two cohorts, including children 2-5 years of age and 5-11 years of age, in September. The readout and submission for the cohort of children 6 months to 2 years of age are expected in the fourth quarter.

    The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalents in the United States (together with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

    The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine-us.com.

    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)

    • 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%)
    • Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm) have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine 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 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

    About Pfizer: Breakthroughs That Change Patients' Lives

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

    Pfizer Disclosure Notice

    The information contained in this release is as of May 10, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

    This release contains forward-looking information about Pfizer's efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program and the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (including qualitative assessments of available data, potential benefits, expectations for clinical trials, the potential of BNT162b2 for adolescents 12 to 15 years of age, evaluation of BNT162b2 in children 6 months to 11 years old, anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including the topline data outlined in this release), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data (including the topline data outlined in this release); the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data (including the topline data outlined in this release) are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program (including the topline data outlined in this release) will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when a Biologics License Application for BNT162b2 may be filed in the U.S. and whether and when other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including a potential Biologics License Application in the U.S. or any requested amendments to the emergency use or conditional marketing authorizations) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine's benefits outweigh its known risks and determination of the vaccine's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine's ultra-low temperature formulation, two-dose schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

    About BioNTech

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

    BioNTech Forward-looking Statements

    This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech's efforts to combat COVID-19; the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine (including a potential second booster dose of BNT162b2 and/or a potential booster dose of a variation of BNT162b2 having a modified mRNA sequence); the potential of BNT162b2 for adolescents 12 to 15 years of age, evaluation of BNT162b2 in children 6 months to 11 years old, anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2 in our clinical trials and/or in commercial use based on data observations to date; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical trials; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; 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 risk that demand for any products may be reduced or no longer exist; the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2021; and challenges related to public vaccine confidence or awareness. Any forward-looking statements in this press release are based on BioNTech's current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties.

    For a discussion of these and other risks and uncertainties, see BioNTech's Annual Report on Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC's website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

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    • More than 450 million doses of BNT162b2 supplied to 91 countries or territories worldwide as of May 6, 2021
    • Signed agreements for over 1.8 billion doses of BNT162b2 in 2021 and first contracts signed for periods 2022 and beyond
    • Announced planned expansion of global footprint to Asia with establishment of first regional headquarters for south east Asia in Singapore, including a fully-integrated and state-of-the art mRNA manufacturing facility
    • In oncology, a first-in-human Phase 1 trial started for the neoantigen-targeting T cell therapy, BNT221. The development of BioNTech's oncology pipeline has continued to accelerate with 14 product candidates now in 15 ongoing trials

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

    • More than 450 million doses of BNT162b2 supplied to 91 countries or territories worldwide as of May 6, 2021
    • Signed agreements for over 1.8 billion doses of BNT162b2 in 2021 and first contracts signed for periods 2022 and beyond
    • Announced planned expansion of global footprint to Asia with establishment of first regional headquarters for south east Asia in Singapore, including a fully-integrated and state-of-the art mRNA manufacturing facility
    • In oncology, a first-in-human Phase 1 trial started for the neoantigen-targeting T cell therapy, BNT221. The development of BioNTech's oncology pipeline has continued to accelerate with 14 product candidates now in 15 ongoing trials

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

    MAINZ, GERMANY, May 10, 2021BioNTech 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.

    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

    • On March 31, 2021, BioNTech and Pfizer announced that BNT162b2 demonstrated 100% efficacy and robust antibody responses in a Phase 3 trial in adolescents aged 12 to 15 with or without prior evidence of SARS-CoV-2 infection. The trial enrolled 2,260 adolescents in the United States. In the trial, 18 cases of COVID-19 were observed in the placebo group (n=1,129) versus none in the vaccinated group (n=1,131). Vaccination with BNT162b2 elicited high SARS-CoV-2 neutralizing antibody titers, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. BNT162b2 administration was generally well tolerated.
    • On March 31, 2021, BioNTech and Pfizer began evaluating the administration of a single booster dose five to seven months after receiving the second dose of BNT162b2. To demonstrate duration of protection, and protection against the emerging variants of concern, an additional dose of BNT162b2 or of BNT162b2SA (encoding for the spike protein of the variant B.1.351) is being given to about 600 Phase 3 participants. About 30 participants that received BNT162b2SA will be given another dose of BNT162b2SA. A new cohort of approximately 300 participants will be enrolled who are COVID-19 vaccine-naïve (i.e., including BNT162b2-naïve) and have not been infected with COVID-19. They will receive BNT162b2SA given as a two-dose series, separated by 21 days. The objective of this Phase 1/2/3 protocol amendment is to describe the safety and tolerability profile of BNT162b2SA, to evaluate its non-inferiority compared to BNT162b2, and to analyze the immune response generated by BNT162b2SA. By evaluating BNT162b2SA as a prototype vaccine, the companies aim to inform the development of an efficient regulatory pathway for testing future modified mRNA vaccines, using the current pathways for flu vaccines as models (blueprint study).
    • On April 1, 2021, BioNTech and Pfizer announced updated topline results confirming high efficacy and no serious safety concerns through up to six months following the second dose. Topline efficacy was based on an analysis of 927 confirmed symptomatic cases of COVID-19 observed in the pivotal Phase 3 study through March 13, 2021. BNT162b2 was 91.3% effective against COVID-19, measured seven days through up to six months after the second dose. The vaccine was also 100% effective against severe disease, as that term is defined by the U.S. Centers for Disease Control and Prevention, and 95.3% effective against severe COVID-19 as that term is defined by the FDA. Safety data collected from more than 12,000 vaccinated participants who had a follow-up time of at least six months after the second dose demonstrated a favorable safety and tolerability profile.

    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

    • On April 1, 2021, BioNTech and Pfizer started a Phase 3, randomized, observer-blind study to evaluate the safety, tolerability, and immunogenicity of multiple formulations of BNT162b2, administered on a two-dose (separated by 21 days) schedule in adults aged 18 to 55. Part 1 of the study is comparing the safety and tolerability of lyophilized (or freeze-dried) BNT162b2 to the current frozen-liquid formulation of BNT162b2 and is evaluating non-inferiority of the immune response. Part 2 of the study will evaluate the safety and immunogenicity of a ready-to-use formulation of BNT162b2, and will be initiated in May 2021. The study, which is being conducted in the United States, will enroll approximately 610 participants. BioNTech and Pfizer expect to obtain results from both study parts in the third quarter of 2021. 

    Regulatory updates

    • On April 9, 2021, BioNTech and Pfizer requested amendments to the U.S. Emergency Use Authorization to expand the use of BNT162b2 to adolescents aged 12 to 15.
    • On April 30, 2021, BioNTech and Pfizer submitted to the EMA a variation to the European Conditional Marketing Authorization (CMA) for COMIRNATY® to request an extension of the indication for use in adolescents 12 to 15 years of age. If the EMA approves the variation, the amended CMA will be valid in all 27 member states of the European Union. 
    • On April 30 and May 4, 2021, BioNTech and Pfizer submitted new stability data of BNT162b2 to the FDA and EMA in order to update the product's label to extend the storage at standard refrigerator temperatures of 2°C to 8°C to four weeks.
    • On May 5, 2021, BioNTech and Pfizer Canada announced that Health Canada has expanded the Interim Order authorization for BNT162b2 to include individuals 12 to 15 years of age. This is the first COVID-19 vaccine authorized in Canada for use in this age group.
    • On May 7, 2021, BioNTech and Pfizer announced the initiation of a Biologics License Application (BLA) with the FDA for approval of BNT162b2 to prevent COVID-19 in individuals 16 years of age and older. Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (together with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

    Commercial updates

    • On April 19, 2021, BioNTech and Pfizer announced an agreement with the European Commission (EC) to supply an additional 100 million doses of its COVID-19 vaccine, as a result of the EC's decision to exercise its option. The total number of doses to be delivered to the European Union by the end of 2021 is now 600 million.
    • In April 2021, Pfizer and BioNTech entered into an agreement with Israel to supply several million doses in 2022, with an option to purchase additional doses. The companies also entered into an agreement with Canada to supply up to 125 million doses in 2022 and 2023, with options to purchase up to 60 million additional doses in 2024. Discussions for additional dose commitments with governments and territories worldwide are also ongoing for 2021 and beyond.
    • On May 6, 2021, BioNTech and Pfizer announced that they have signed a Memorandum of Understanding with the International Olympic Committee to donate doses of COVID-19 Vaccine to help vaccinate athletes, and their delegations, participating in the Olympic and Paralympic Games Tokyo 2020, which are scheduled to take place in July 2021.
    • On May 7, 2021, the EC announced that BioNTech and Pfizer plan to supply the EC with 900 million doses of COMIRNATY®, the Companies' COVID-19 vaccine, to the 27 European Union (EU) member states beginning December 2021 through 2023, with an option for the EC to request up to an additional 900 million doses. This contract is expected to close upon final confirmation by the EC.

    Manufacturing updates

    • BioNTech expects capacity to reach up to 3 billion doses by end of 2021, and expects to have capacity to manufacture more than 3 billion doses in 2022.
    • In March 2021, the EMA approved the manufacturing of BioNTech's COVID-19 vaccine drug product at its facility in Marburg, Germany. This manufacturing facility is one of the largest mRNA vaccine manufacturing sites worldwide with an annual production capacity of up to one billion doses of COVID-19 vaccine, once fully operational. The first batches of vaccines manufactured at the Marburg facility were delivered in mid-April.
    • BioNTech plans to deliver up to 250 million doses of BNT162b2 in the first half of 2021. 

    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

    • BNT111 – In collaboration with Regeneron, a randomized Phase 2 trial for the treatment of patients with advanced melanoma progressing during or after prior therapy with a PD-1 inhibitor, utilizing a combination of BNT111 and Regeneron and Sanofi's Libtayo® (cemiplimab) is planned to start in the first half of 2021.
    • BNT113 – A Phase 2 trial evaluating BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as a first-line treatment in patients with unresectable recurrent or metastatic HPV16+ head and neck squamous cell carcinoma (HNSCC) expressing PD-L1, is planned to start in the first half of 2021 in the United States and the European Union. BNT113 has not been combined with anti-PD1 before and the Phase 2 trial will start with a run in portion designed to demonstrate the safety of the combination of BNT113 and pembrolizumab. These data are required to address the partial clinical hold on the subsequent randomized part of the Phase 2 trial.  

    Individualized neoantigen specific immunotherapy (iNeST)

    • BNT122 (Autogene Cevumeran) – BioNTech's iNeST product candidate is partnered with Genentech. 

    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

    • BNT151 – A Phase 1/2a dose escalation trial evaluating BNT151 with expansion cohorts in multiple solid tumor indications is ongoing.
    • BNT152+153 – BioNTech plans to start a Phase 1 trial for BNT152 (encoding IL-7) plus BNT153 (encoding IL-2) in multiple solid tumors in the first half of 2021. 

    RiboMabs

    • BNT141 – In February 2021, the FDA approved the IND for a Phase 1 first-in-human clinical trial for BNT141. BioNTech plans to start the trial in the second half of 2021.
    • BNT142 – BioNTech plans to start a Phase 1 clinical trial for BNT142 in the second half of 2021.

    Antibodies

    Next-generation checkpoint immunomodulators

    BNT311 and BNT312 are partnered with Genmab.

    • BNT311/GEN1046 – A Phase 1/2a dose escalation trial with multiple expansion cohorts in patients with malignant solid tumors is ongoing. A data update for the trial is planned in the second half of 2021.
    • BNT312/GEN1042 – A Phase 1/2a dose escalation trial with expansion cohorts in patients with solid tumors is ongoing. The first data disclosure for the trial is planned in the second half of 2021.

    Cell therapies

    CAR-T cell immunotherapy

    • BNT211 – A first-in-human Phase 1/2a open-label, multi-center dose escalation and dose expansion basket trial of BNT211 with Claudin-6 CAR-T cells as monotherapy, or in combination of Claudin-6 CAR-T cells with Claudin-6 CARVac, is ongoing. The trial is enrolling patients with CLDN6-positive relapsed or refractory advanced solid tumors including ovarian, testicular, lung, gastric and endometrial cancers. The combination of CLDN6 CAR-T cell immunotherapy and CARVac is expected to improve expansion and persistence of CLDN6 CAR-T. 

    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.

    Neoantigen-targeting T cell therapy

    • BNT221 – In April 2021, the first patient was dosed in a first-in-human Phase 1 dose escalation trial for the treatment of metastatic melanoma in patients who are refractory or unresponsive to checkpoint inhibitors. Part 1 consists of the monotherapy dose escalation of BNT221. In part 2, BNT221 will be added to anti-PD1 after first-line therapy. The primary objectives of the trial are to evaluate the safety and feasibility of administering BNT221, in addition to an evaluation of immunogenicity and clinical efficacy. 

    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

    • BNT411 – A Phase 1/2a dose-escalation trial of BNT411 as a monotherapy in patients with solid tumors, and in combination with atezolizumab, carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC) is ongoing. A data update from this trial is planned in the second half of 2021.

    Corporate development

    • On May 9, 2021, BioNTech agreed the heads of terms with Fosun Pharma to establish a 50/50 Joint Venture (JV) to manufacture the COVID-19 vaccine in Mainland China. The establishment of a JV will be conditional on BioNTech receiving approval for its COVID-19 vaccine in Mainland China and agreement with Fosun Pharma on a definitive JV agreement, in addition to other conditions. As part of its global supply strategy, BioNTech believes that establishing local manufacturing capacity for the COVID-19 vaccine could substantially increase the Company's ability to supply vaccines to China upon approval.
    • On May 10, 2021, BioNTech announced plans to expand its global footprint to Asia with the establishment of its first regional headquarters for south east Asia in Singapore. In addition to selecting Singapore as its future regional headquarters, BioNTech plans to establish a fully integrated mRNA manufacturing facility in Singapore with support from the Singaporean Economic Development Board (EDB). The new facility will leverage cutting-edge manufacturing and digital infrastructure and will be equipped to produce a range of novel mRNA vaccines and therapeutics. The envisioned site will bring highly automated and end-to-end mRNA production capabilities. The facility, with an estimated annual capacity of several hundred million doses, will provide regional and global supply capacity, as well as a rapid response capability for south east Asia to address potential pandemic threats. BioNTech plans to open its Singapore office and initiate construction of the manufacturing facility in 2021, subject to planning approval, and anticipates the site could be operational as early as 2023.

    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 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:

    Estimated COVID-19 vaccine revenues to BioNTech upon delivery of currently signed supply contracts of ~1.8 billion doses is ~€12.4 billion.



     



    This revenue estimate reflects:



     



    • Expected revenues from direct COVID-19 vaccine sales to customers in BioNTech's territory
    • Expected revenues from sales to collaboration partners of products manufactured by BioNTech
    • Expected sales milestone payments from collaboration partners
    • Expected revenues related to share of gross profit from COVID-19 vaccine sales in the collaboration partners' territories
     



    Additional revenues related to further supply contracts for deliveries in 2021 expected with first contracts in place for 2022 and beyond.



     



    Full year 2021 manufacturing capacity now targeting 3 billion doses and more than 3 billion doses for the year 2022.

    On Track with Previously Stated 2021 Financial Outlook:

    Planned Full Year 2021 Expenses and Capex3
    R&D expenses €750 million – €850 million

    Ramp-up of R&D investment in the second half of 2021 and beyond planned to broaden and accelerate pipeline development.
    SG&A expenses Up to €200 million
    Capital expenditures €175 million – €225 million
    Estimated Full Year 2021 Tax Assumptions
    German tax group corporate tax rate ~31%

    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 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, 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:  

    Media Relations

    Jasmina Alatovic

    Director Global External Communications

    Tel: +49 (0)6131 9084 1513 or +49 (0)151 1978 1385

    E-mail: 



     

    Interim Condensed Consolidated Statements of Financial Position



     

          March 31,   December 31,  
    (in millions)     2021   2020  
    Assets     (unaudited)        
    Non-current assets                
    Intangible assets       €165.2     €163.5  
    Property, plant and equipment       242.4     227.0  
    Right-of-use assets       118.4     99.0  
    Other assets       1.0     1.0  
    Deferred tax assets       141.7     161.2  
    Total non-current assets       €668.7     €651.7  
    Current assets                
    Inventories       146.9     64.1  
    Trade and other receivables       2,395.1     165.5  
    Other financial assets       0.5     137.2  
    Other assets       69.6     61.0  
    Income tax assets       0.9     0.9  
    Deferred expenses       31.5     28.0  
    Cash and cash equivalents       891.5     1,210.2  
    Total current assets       €3,536.0     €1,666.9  
    Total assets       €4,204.7     €2,318.6  
                     
    Equity and liabilities                
    Equity                
    Share capital       246.3     246.3  
    Capital reserve       1,514.5     1,514.5  
    Treasury shares       (4.8)     (4.8)  
    Retained earnings / (Accumulated losses)       718.5     (409.6)  
    Other reserves       45.1     25.4  
    Total equity       €2,519.6     €1,371.8  
    Non-current liabilities                
    Interest-bearing loans and borrowings       236.6     231.0  
    Other financial liabilities       73.0     31.5  
    Provisions       5.6     5.5  
    Contract liabilities       57.8     71.9  
    Other liabilities       1.0     0.6  
    Deferred tax liabilities       -     0.3  
    Total non-current liabilities       €374.0     €340.8  
    Current liabilities                
    Interest-bearing loans and borrowings       18.0     9.1  
    Trade payables       106.2     102.3  
    Other financial liabilities       329.2     74.1  
    Government grants       3.2     92.0  
    Tax provisions       494.9     -  
    Other provisions       0.9     0.9  
    Contract liabilities       295.2     299.6  
    Other liabilities       63.5     28.0  
    Total current liabilities       €1,311.1     €606.0  
    Total liabilities       €1,685.1     €946.8  
    Total equity and liabilities       €4,204.7     €2,318.6  





     

    Interim Condensed Consolidated Statements of Profit or Loss



     

          Three months ended

    March 31,
     
          2021   2020  
    (in millions, except per share data)     (unaudited)   (unaudited)  
    Revenues                
    Research & development revenues       €20.9     €21.2  
    Commercial revenues       2,027.5     6.5  
    Total revenues       2,048.4     27.7  
                     
    Cost of sales       (233.1)     (5.9)  
    Research and development expenses       (216.2)     (65.1)  
    Sales and marketing expenses       (8.7)     (0.5)  
    General and administrative expenses       (38.9)     (15.8)  
    Other operating expenses*       (0.6)     (0.1)  
    Other operating income*       111.3     0.4  
    Operating income / (loss)       €1,662.2     €(59.3)  
                     
    Finance income**       24.8     6.4  
    Finance expenses**       (44.0)     (0.1)  
    Interest expenses related to lease liabilities       (0.7)     (0.4)  
    Profit / (loss) before tax       €1,642.3     €(53.4)  
                     
    Income taxes       (514.2)     -  
    Profit / (Loss) for the period       €1,128.1     €(53.4)  
                     
    Earnings per share                
    Basic profit / (loss) for the period per share   €4.64     €(0.24)  
    Diluted profit / (loss) for the period per share   €4.39     €(0.24)  



     

    * 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.



     

    Interim Condensed Consolidated Statements of Cash Flows



     

        Three months ended

    March 31,
     
        2021   2020  
    (in millions)   (unaudited)   (unaudited)  
                   
    Operating activities              
    Profit / (Loss) for the period     €1,128.1     €(53.4)  
    Income taxes     514.2     -  
    Profit / (loss) before tax     €1,642.3     €(53.4)  
    Adjustments to reconcile profit / (loss) before tax to net cash flows:              
    Depreciation and amortization of property, plant, equipment and intangible assets     13.0     8.6  
    Share-based payment expense     17.3     8.4  
    Net foreign exchange differences     (31.2)     (0.3)  
    Gain on disposal of property, plant and equipment     0.2     0.1  
    Finance income     (0.3)     (0.4)  
    Interest on lease liability     0.7     0.4  
    Finance expense     44.0     0.1  
    Movements in government grants     (67.9)     -  
    Working capital adjustments:              
    Increase in trade and other receivables, contract assets and other assets     (2,100.5)     (2.1)  
    Decrease / (Increase) in inventories     (82.8)     2.2  
    (Decrease) / Increase in trade payables, other financial liabilities, other liabilities, contract liabilities and provisions     255.5     (17.9)  
    Interest received     0.3     0.3  
    Interest paid     (1.8)     (0.5)  
    Income tax paid     (0.1)     (0.2)  
    Net cash flows used in operating activities     €(311.3)     €(54.7)  
                   
    Investing activities              
    Purchase of property, plant and equipment     (21.7)     (6.3)  
    Proceeds from sale of property, plant and equipment     0.9     -  
    Purchase of intangibles assets and right-of-use assets     (7.5)     (2.1)  
    Acquisition of subsidiaries and businesses, net of cash acquired     -     (6.5)  
    Net cash flows used in investing activities     €(28.3)     €(14.9)  
                   
    Financing activities              
    Proceeds from loans and borrowings     -     2.9  
    Repayment of loans and borrowings     (0.7)     -  
    Payments related to lease liabilities     (3.8)     (0.9)  
    Net cash flows from/(used in) financing activities     €(4.5)     €2.0  
                   
    Net decrease in cash and cash equivalents     (344.1)     (67.6)  
    Change in cash and cash equivalents resulting from exchange rate differences     25.4     0.1  
    Cash and cash equivalents at January 1     1,210.2     519.1  
    Cash and cash equivalents at March 31     €891.5     €451.6  



     



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    • BioNTech to establish first regional hub in Asia Pacific region in Singapore
    • Planned state-of-the-art manufacturing site will support global supply of mRNA-based vaccines and therapeutics and provide a rapid response capability for south east Asia against potential future pandemic threats   
    • Expansion plan supported by the Singapore Economic Development Board (EDB) 

    MAINZ, GERMANY, May 10, 2021BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))) today announced plans to expand its global footprint to Asia with the establishment of its Regional Headquarters for south east Asia in Singapore. In addition to selecting Singapore as its future regional headquarters, BioNTech plans to establish a fully integrated mRNA manufacturing facility in…

    • BioNTech to establish first regional hub in Asia Pacific region in Singapore
    • Planned state-of-the-art manufacturing site will support global supply of mRNA-based vaccines and therapeutics and provide a rapid response capability for south east Asia against potential future pandemic threats   
    • Expansion plan supported by the Singapore Economic Development Board (EDB) 

    MAINZ, GERMANY, May 10, 2021BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))) today announced plans to expand its global footprint to Asia with the establishment of its Regional Headquarters for south east Asia in Singapore. In addition to selecting Singapore as its future regional headquarters, BioNTech plans to establish a fully integrated mRNA manufacturing facility in Singapore with support from the Singapore Economic Development Board. The new facility will provide regional and global supply capacity of BioNTech's growing pipeline of mRNA-based product candidates, as well as a rapid response production capability for south east Asia to address potential pandemic threats.

    In line with BioNTech's mission to develop next-generation immunotherapies to improve the health of individuals worldwide, the new mRNA manufacturing facility will leverage cutting-edge manufacturing and digital infrastructure. It will be equipped to produce a range of novel mRNA vaccines and therapeutics for infectious diseases and cancer. The envisioned site will bring highly automated and end-to-end mRNA production capabilities across drug substance, drug product and fill-and-finish, with an estimated annual capacity of several hundred of million doses of mRNA-based vaccines depending on the specific vaccine.

    BioNTech plans to open its Singapore office and initiate construction of the manufacturing facility in 2021, subject to planning approval. The Company anticipates that the site could be operational as early as 2023 and will create up to 80 jobs in Singapore.

    "Having multiple nodes in our production network is an important strategic step in building out our global footprint and capabilities. With this planned mRNA production facility, we will increase our overall network capacity and expand our ability to manufacture and deliver our mRNA vaccines and therapies to people around the world," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "Singapore provides an excellent business climate, growing biotechnology industry and rich talent base. We would like to thank Singapore's Economic Development Board who has been very supportive throughout our planning process and we look forward to contributing our technology and expertise to the development of the biotechnology industry in Singapore and this region."    

    "We strongly welcome BioNTech's plan to establish its mRNA manufacturing facility and regional headquarters in Singapore. The investment will enable Singapore to develop capabilities in an important new therapeutic modality as part of the strategy to grow our biopharmaceutical industry," said Dr. Beh Swan Gin, Chairman, EDB. "In particular, BioNTech's mRNA manufacturing facility will contribute significantly to the region's ability to address future pandemic threats."

    Following the establishment of its U.S. Headquarters in Cambridge, MA in 2020, the establishment of BioNTech's south east Asia Headquarters represents a key milestone in the Company's international expansion.  

    About BioNTech 

    Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a 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, bi-specific 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 of BioNTech

    This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech's plans for expansion of its manufacturing capacity and capabilities, facilities, and geographical presence; BioNTech's expected product sales and revenues; the consummation and anticipated costs, benefits and synergies of BioNTech's expansion in Singapore; and BioNTech's ability to effectively scale its production capabilities and manufacture its products, including BioNTech and Pfizer's COVID-19 vaccine, and BioNTech's product candidates. Any forward-looking statements in this press release are based on BioNTech's current expectations and beliefs of future events. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond 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 BioNTech's Annual Report on Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC's website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

    BioNTech Contacts

    Media Relations

    Jasmina Alatovic

    +49 (0)6131 9084 1513

    Investor Relations

    Sylke Maas, Ph.D.

    +49 (0)6131 9084 1074



     



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